Theresa Huck v. Wyeth, Inc. D/B/A Wyeth Schwarz Pharma, Inc. and Pliva, Inc. , 850 N.W.2d 353 ( 2014 )

IN THE SUPREME COURT OF IOWA
No. 12–0596
Filed July 11, 2014
THERESA HUCK,
Appellant,
vs.
WYETH, INC. d/b/a WYETH; SCHWARZ PHARMA, INC.;
and PLIVA, INC.,
Appellees.
On review from the Iowa Court of Appeals.
Appeal from the Iowa District Court for Sac County, Gary L.
McMinimee, Judge.
Plaintiff seeks further review of court of appeals decision affirming
summary judgments dismissing her personal injury claims against
pharmaceutical companies. DECISION OF COURT OF APPEALS
VACATED; DISTRICT COURT JUDGMENTS AFFIRMED IN PART,
REVERSED IN PART, AND REMANDED WITH INSTRUCTIONS.
Terrence J. Donahue Jr. of McGlynn Glisson & Mouton,
Baton Rouge, Louisiana, and James R. Van Dyke of Eich, Van Dyke,
Werden & Steger PC, Carroll, for appellant.
2
Henninger S. Bullock and Andrew J. Calica of Mayer Brown LLP,
New York, New York, and Carl J. Summers of Mayer Brown LLP,
Washington, DC, for appellee Schwarz Pharma, Inc.
Jeffrey F. Peck, Linda E. Maichl, Joseph P. Thomas of Ulmer &
Berne LLP, Cincinnati, Ohio, and Gregory M. Lederer of Lederer Weston
Craig PLC, Cedar Rapids, for appellee PLIVA, Inc.
Kevin C. Newsom and Lindsey C. Boney IV of Bradley Arant Boult
Cummings LLP, Birmingham, Alabama, for appellee Wyeth, Inc.
Richard J. Sapp and Ryan G. Koopmans of Nyemaster, Goode,
West, Hansell & O’Brien, P.C., Des Moines, for appellees Wyeth, Inc. and
Schwarz Pharma, Inc.
3
WATERMAN, Justice.
This products liability action against pharmaceutical companies
presents several issues involving the interplay between state tort law and
federal prescription drug regulation. This case is one of many litigated in
state and federal courts nationwide alleging severe side effects from
prolonged use of metoclopramide, sold under the brand name Reglan
and as a competing generic formulation. The plaintiff in this case used
only the generic product. After developing a neurological disorder, she
sued the manufacturer of the generic drug as well as the manufacturers
of the branded formulation.
The district court dismissed all of plaintiff’s claims in several
summary judgment rulings. The district court, relying on PLIVA, Inc. v.
Mensing, 564 U.S. ___, ___, 131 S. Ct. 2567, 2580–81, 180 L. Ed. 2d 580,
595 (2011), ruled plaintiff’s claims against the generic manufacturer were
preempted by federal law that requires conformity with the brand
manufacturers’ warning labels approved by the Food and Drug
Administration (FDA). The district court granted summary judgment for
the brand manufacturers based on Mulcahy v. Eli Lilly & Co., which
requires proof the defendant manufactured or supplied the product that
caused plaintiff’s injury. 386 N.W.2d 67, 76 (Iowa 1986). The court of
appeals affirmed. We granted plaintiff’s application for further review.
For the reasons explained below, we hold plaintiff’s state common
law tort claims against the generic manufacturer based on inadequate
warnings are not preempted to the extent that the generic manufacturer
failed to implement a stronger warning approved by the FDA in 2004.
We decline, however, to alter long-standing Iowa products liability law to
allow recovery against a manufacturer for injuries caused by use of its
competitor’s product. We thereby join the overwhelming majority of
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courts, including every federal circuit court of appeals, in holding Reglan
brand manufacturers are not liable to plaintiffs who consumed only the
competing generic formulation. Accordingly, we vacate the decision of
the court of appeals, affirm the district court’s summary judgment for the
brand manufacturers, reverse in part the summary judgment for the
generic manufacturer, and remand for further proceedings against that
defendant alone.
I. Background Facts and Proceedings.
We begin with a discussion of federal drug labeling regulation to
provide the necessary context for the fighting issues. In 1984, Congress
passed the Hatch-Waxman Amendments to the Food, Drug, and
Cosmetics Act (FDCA) in order to expand access to affordable generic
drugs by reducing barriers to generic market entry. Drug Price
Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-
417, 98 Stat. 1585 (codified in relevant part at 21 U.S.C. § 355 (1988));
see also Mensing, 564 U.S. at ___, 131 S. Ct. at 2574, 180 L. Ed. 2d at
588. Prior federal law compelled virtually all companies to file a new
drug application—requiring costly clinical trials—to receive FDA approval
to market a drug. Mensing, 564 U.S. at ___, 131 S. Ct. at 2574, 180
L. Ed. 2d at 588. Hatch-Waxman eliminated this requirement for a
generic drug applicant, instead requiring the applicant to demonstrate its
product’s chemical and biological equivalence to a previously approved
drug—i.e., a brand manufacturer’s drug. See id. at ___, 131 S. Ct. at
2574, 180 L. Ed. 2d at 588; see also 21 U.S.C. § 355(j)(2)(A) (2006).
When a brand manufacturer first files a new drug application, the
FDA must approve the accuracy and adequacy of a drug’s label. See 21
U.S.C. § 355(a), (b)(1), (d); Wyeth v. Levine, 555 U.S. 555, 566–67, 129
S. Ct. 1187, 1195, 173 L. Ed. 2d 51, 61 (2009). After the initial approval
5
of the new drug application, a brand manufacturer may update its label
by filing an application with the FDA to “add or strengthen a
contraindication, warning, precaution, or adverse reaction” or to “add or
strengthen an instruction about dosage and administration that is
intended to increase the safe use of the drug product,” but it need not
wait for FDA approval. 21 C.F.R. § 314.70(c)(6)(iii)(A), (C) (2006); see also
Levine, 555 U.S. at 567–68, 129 S. Ct. at 1196, 173 L. Ed. 2d at 62. The
equivalence of brand-name and generic drugs is the foundation of the
generic drug approval process, and accordingly, federal regulations
“require that the warning labels of a brand-name drug and its generic
copy must always be the same—thus, generic drug manufacturers have
an ongoing federal duty of ‘sameness.’ ” Mensing, 564 U.S. at ___, 131
S. Ct. at 2574–75, 180 L. Ed. 2d at 589; see also, e.g., 21 U.S.C.
§ 355(j)(2)(A)(v), (4)(G); 21 C.F.R. §§ 314.94(a)(8), .127(a)(7); Abbreviated
New Drug Application Regulations, 57 Fed. Reg. 17950–01, 17961 (Apr.
28, 1992) (“[T]he [generic drug’s] labeling must be the same as the listed
drug product’s labeling because the listed drug product is the basis for
[generic drug] approval.”). The requirement that generic labeling mirrors
that of the brand drug ensures generic manufacturers do not mislead
consumers by “inaccurately imply[ing] a therapeutic difference between
the brand and generic drugs.” Mensing, 564 U.S. at ___, 131 S. Ct. at
2576, 180 L. Ed. 2d at 590. Manufacturers—both brand and generic—
are required to propose stronger warning labels to the FDA if they believe
such warnings are needed. Id. at ___, 131 S. Ct. at 2576, 180 L. Ed. 2d
at 591.
The United States Supreme Court decisions of Levine and Mensing
set parameters for when state-law failure-to-warn claims are preempted
by federal prescription drug labeling regulations. First, Levine held that
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federal drug regulations do not preempt state-law failure-to-warn claims
against brand manufacturers because federal law allows brand
manufacturers to unilaterally strengthen their warnings. 555 U.S. at
573, 129 S. Ct. at 1199, 173 L. Ed. 2d at 65 (concluding requiring brand
drug manufacturers to comply with a state-law duty to warn would not
obstruct the purposes and objectives of federal drug labeling regulation).
“The Court did not find it significant that the FDA has authority to reject
unilateral labeling changes . . . finding it ‘difficult to accept’ that the FDA
would not have permitted a change to a stronger warning.” Fulgenzi v.
PLIVA, Inc., 711 F.3d 578, 582 (6th Cir. 2013) (quoting Levine, 555 U.S.
at 570, 129 S. Ct. at 1197, 173 L. Ed. 2d at 63). After Levine, some
courts reasoned that generic drug manufacturers would then also be
subject to state-law failure-to-warn claims. See, e.g., Demahy v. Actavis,
Inc., 593 F.3d 428, 430 (5th Cir. 2010) (“[Levine] shadows our conclusion
that the federal regulatory regime governing generics is also without
preemptive effect.”), rev’d sub nom. Mensing, 564 U.S. at ___, 131 S. Ct.
at 2573, 180 L. Ed. 2d at 587); Mensing v. Wyeth, Inc., 588 F.3d 603, 607
(8th Cir. 2009) (“After [Levine], we must view with a questioning mind the
generic defendants’ argument that Congress silently intended to grant
the manufacturers of most prescription drugs blanket immunity from
state tort liability when they market inadequately labeled products.”),
rev’d sub nom. Mensing, 564 U.S. at ___, 131 S. Ct. at 2573, 180
L. Ed. 2d at 587.
But, the Supreme Court held otherwise in Mensing, a case
involving generic manufacturers of metoclopramide. 564 U.S. at ___, 131
S. Ct. at 2572, 180 L. Ed. 2d at 586. The five-justice majority noted the
FDA interprets its regulations “to allow changes to generic drug labels
only when a generic drug manufacturer changes its label to match an
7
updated brand-name label or to follow the FDA’s instructions.” Id. at
___, 131 S. Ct. at 2575, 180 L. Ed. 2d at 590 (emphasis added).
Otherwise, a generic manufacturer is obligated to copy the brand
manufacturer’s approved label. See id. at ___, 131 S. Ct. at 2575, 180
L. Ed. 2d at 590. Accordingly, the Court agreed with the FDA’s
interpretation of its regulations that “changes unilaterally made to
strengthen a generic drug’s warning label would violate the statutes and
regulations requiring a generic drug’s label to match its brand-name
counterpart’s.” Id. at ___, ___, 131 S. Ct. at 2575, 2580, 180 L. Ed. 2d at
590, 595 (emphasis added) (highlighting that “[b]efore the Manufacturers
could satisfy state law, the FDA—a federal agency—had to undertake
special effort permitting them to do so”). Due to this conflict, the Court
held federal law categorically preempts state-law failure-to-warn claims
against generic manufacturers. Id. at ___, 131 S. Ct. at 2580–81, 180
L. Ed. 2d at 595. “The Court distinguished the situation in [Levine],
which it characterized as holding that ‘the possibility of impossibility’
(i.e., possible FDA subsequent denial) was not enough for impossibility
preemption from the case at hand, which concerned ‘the possibility of
possibility’ (i.e., possible FDA prior approval).” Fulgenzi, 711 F.3d at 583
(quoting Mensing, 564 U.S. at ___ n.8, 131 S. Ct. at 2581 n.8, 180
L. Ed. 2d at 596 n.8). The Mensing Court acknowledged “the unfortunate
hand that federal drug regulation has dealt” those whose pharmacies
filled their prescriptions with generic metoclopramide instead of Reglan.
Mensing, 564 U.S. at ___, 131 S. Ct. at 2581, 180 L. Ed. 2d at 596.
In response to Mensing, the FDA proposed a rule to amend generic
labeling regulations. Supplemental Applications Proposing Labeling
Changes for Approved Drugs and Biological Products, 78 Fed. Reg.
67985–02 (proposed Nov. 13, 2013) [hereinafter Proposed Rule] (setting
8
deadline of January 13, 2014, for comments). The proposed rule “would
create parity” between brand and generic manufacturers, granting both
the ability to unilaterally improve labeling and then seek approval from
the FDA. Id. at 67986.
Against this backdrop, we now turn to the facts of this case. In
1980, the FDA approved the new drug application for metoclopramide
tablets, which are designed to treat digestive tract problems, including
gastroesophageal reflux disease (acid reflux). This FDA approval allowed
for the manufacture and distribution of a patented formulation of the
drug, which was branded Reglan. Wyeth, Inc. came to own the Reglan
brand in approximately 1989 1 and later sold the rights and liabilities
associated with Reglan to Schwarz Pharma, Inc. in December 2001. 2 In
addition to the Reglan tablets marketed by Wyeth and Schwarz
[hereinafter referred to collectively as the brand defendants], a generic
formulation of the drug was manufactured and distributed by PLIVA, Inc.
In February 2004, Theresa Huck’s physician prescribed Reglan to
treat her reflux. Her physician relied upon information published by the
brand defendants in the Physician’s Desk Reference, which contained the
FDA-approved labeling for the drug. Huck’s pharmacy filled this
prescription with the PLIVA generic.
The FDA-approved labeling at the time Huck began taking
metoclopramide stated “Therapy longer than 12 weeks has not been
evaluated and cannot be recommended.” The label also contained a
warning about possible side effects, including tardive dyskinesia.
1A.H. Robinson Company, Inc. obtained the original FDA approval for Reglan.
Wyeth is the successor in interest to A.H. Robinson.
2Schwarz then manufactured and distributed Reglan until February 2008, when
the brand was again sold.
9
Tardive dyskinesia is a severe, often irreversible neurological disorder
resulting in involuntary and uncontrollable repetitive body movements of
slow or belated onset. Symptoms include “grotesque facial grimacing
and open-mouthed, uncontrollable tongue movements, tongue thrusting,
[and] tongue chewing.” Fisher v. Pelstring, 817 F. Supp. 2d 791, 802
(D.S.C. 2011). There is no known treatment or cure for tardive
dyskinesia. The FDA-approved warning stated that tardive dyskinesia
was expected to occur in one in every five hundred patients.
In July 2004, approximately five months after Huck began taking
metoclopramide, the FDA approved additional label warning language
requested by Schwarz. Printed in bold on the first line of both the
“Indications and Usage” and “Dosage and Administration” sections of the
label, the new language indicated, “Therapy should not exceed 12
weeks in duration.” While this language appeared on the label for
Reglan, it was not published in the Physicians’ Desk Reference.
Although required by federal regulations to mirror the brand defendant’s
label, PLIVA did not update its metoclopramide packaging to include the
new warning approved in 2004. The record is silent as to why PLIVA
failed to add that warning. Neither the brand defendants nor PLIVA
communicated the new label information to Huck or her physician.
Huck testified she never would have taken metoclopramide had she been
warned its possible side effects included a neurological disorder.
Taking an average of 2.7 pills per day, Huck continued to refill her
PLIVA generic prescription until March 2006. Though Huck had been
experiencing symptoms of tardive dyskinesia for some time, she was not
diagnosed with the disease until June 6, 2006.
Based on growing evidence that prolonged use of metoclopramide
causes tardive dyskinesia, on February 26, 2009, the FDA imposed
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heightened warnings for the drug’s packaging. The FDA required the
following black-box warning—its strongest—for metoclopramide:
Chronic treatment with metoclopramide can cause
tardive dyskinesia, a serious movement disorder that is often
irreversible. The risk of developing tardive dyskinesia
increases with the duration of treatment and the total
cumulative dose. * * *
There is no known treatment for tardive dyskinesia;
however, in some patients symptoms may lessen or resolve
after metoclopramide treatment is stopped. * * *
Prolonged treatment (greater than 12 weeks) with
metoclopramide should be avoided in all but rare cases
where therapeutic benefit is thought to outweigh the risks to
the patient of developing tardive dyskinesia.
On May 27, 2008, Huck filed suit against the brand defendants,
PLIVA, and several other defendants no longer involved in the case. 3 Her
petition did not distinguish between the brand defendants and PLIVA,
instead referring to them collectively as “manufacturing defendants.” In
total, Huck pled thirteen claims against these manufacturing defendants:
(1) strict products liability, (2) strict liability for a manufacturing defect,
(3) strict liability for a design defect, (4) breach of express warranty, (5)
breach of implied warranties (based on inadequate warnings), (6)
negligence (based on inadequate warnings), (7) negligent
misrepresentation, (8) breach of undertaking a special duty, (9) fraud
and misrepresentation, (10) constructive fraud, (11) fraud by
concealment, (12) violation of the Iowa Unfair Trade Practices Act, and
(13) intentional infliction of emotional distress.
3Huck’s petition also named as defendants two of her physicians, Trimark
Physicians Group, and Barr Laboratories (PLIVA’s parent company). The district court
granted summary judgment in favor of Barr Laboratories after Huck failed to serve the
company with original notice. Huck’s physicians and Trimark Physicians Group were
later granted summary judgment based on Huck’s failure to timely file expert
designations. Huck did not appeal the summary judgments for those parties.
11
Huck filed a “Notice of Product Identification” on October 6
admitting she ingested only generic metoclopramide manufactured by
PLIVA. In response, the brand defendants moved for summary
judgment. Huck filed no resistance. On March 2, 2009, the district
court granted the brand defendants’ unresisted motion for summary
judgment on all claims. The district court noted it was undisputed that
the brand defendants “did not manufacture or sell the generic
metoclopramide ingested by [Huck]” and, citing Mulcahy, concluded
Huck’s claims against the brand defendants therefore failed as a matter
of law. Huck did not file a motion for reconsideration or immediately
appeal the ruling.
For the next two and one-half years, Huck pursued her claims
against PLIVA, the only remaining defendant. On February 26, 2010,
PLIVA filed two motions for summary judgment, one arguing no genuine
issues of material fact existed and the other arguing Huck’s claims were
preempted by federal law. On April 12, the district court ruled on
PLIVA’s motions. First, the district court rejected PLIVA’s preemption
argument. The district court also ruled that a factual dispute existed
relating to whether Huck would not have ingested metoclopramide had
she received (or, if the learned intermediary doctrine is applied, her
physician received 4) an adequate warning. The district court then
dismissed several of Huck’s claims, 5 but her common law claims for
4The learned intermediary doctrine is not at issue in this appeal.
5The district court dismissed the following claims: strict liability for failure to
warn, strict liability for design defect, design defect, strict liability for manufacturing
defect, breach of express warranty, breach of implied warranty (excluding breach of
implied warranty of merchantability), fraud (to the extent they are not based on
nondisclosure), breach of undertaking a special duty, the Unfair Trade Practice Act,
intentional infliction of emotional distress. Huck does not appeal the dismissal of those
claims.
12
breach of the implied warranty of merchantability, negligence (based on
failure to warn), negligent misrepresentation, fraud and
misrepresentation, constructive fraud, and fraud by concealment were
allowed to proceed. Trial was set for February 7, 2011.
On December 14, 2010, PLIVA moved to stay all deadlines and
continue the trial based on the United States Supreme Court’s grant of
certiorari in Mensing, which consolidated two lawsuits involving state
tort-law claims against generic metoclopramide manufacturers. 564 U.S.
___, 131 S. Ct. 2572–73, 180 L. Ed. 2d 586–87. The district court
granted the stay, acknowledging that two of the cases it had relied on in
its denial of PLIVA’s preemption motion were at issue in the Mensing
appeal. See id. at ___, 131 S. Ct. at 2573, 180 L. Ed. 2d at 587.
After Mensing held federal preemption precluded plaintiffs’ failure-
to-warn claims, see id. at ___, 131 S. Ct. at 2580–81, 180 L. Ed. 2d at
595, PLIVA again moved to dismiss Huck’s claims based on federal
preemption. Additionally, on September 26, 2011, Huck filed a “Motion
for Relief” from the 2009 summary judgment dismissing the brand
defendants. Huck invoked the district court’s “inherent power to correct
interlocutory errors” and argued Mensing’s holding that generic
manufacturers do not have the ability to unilaterally strengthen drug
labels necessarily shifted responsibility for generic manufacturers’
insufficient labeling to brand manufacturers, who are able to unilaterally
strengthen labels. Asserting the Mensing decision overturned prior
precedent, Huck asked the court to reinstate her claims against the
brand defendants.
On January 9, 2012, the district court ruled on the pending
motions. Regarding Huck’s motion for relief, the district court
highlighted that it granted the brand defendants’ summary judgment
13
“based upon the rule in Iowa ‘that a Plaintiff in a products liability action
bears the burden of proving the Defendant manufactured or supplied the
product that caused the injury.’ Mulcahy v. Eli Lilly & Co., 386 N.W.2d
67, 69 (Iowa 1986).” The court further concluded Huck’s argument
based on Mensing was meritless and denied the motion for relief as to the
brand defendants. The district court granted PLIVA summary judgment
on grounds of federal conflict preemption.
Huck appealed both the district court’s grant of summary
judgment in favor of PLIVA and its denial of her motion for relief against
the brand defendants. We transferred the case to the court of appeals,
which affirmed the district court’s rulings. The court of appeals held
Huck’s claims against PLIVA “attack the adequacy of the labeling” and
therefore are preempted because they “fall[] within Mensing’s sphere.”
The court of appeals specifically rejected Huck’s argument that PLIVA
can be held liable for failing to update its label to provide the additional
bolded warning approved in 2004, reasoning federal law prohibits private
attempts to enforce a generic manufacturer’s obligation to match the
brand manufacturer’s label. As to the brand defendants, the court of
appeals noted Huck failed to resist their motion for summary judgment,
file a postjudgment motion, or immediately appeal the summary
judgment. Consequently, the court of appeals concluded the only
preserved issue relating to that summary judgment ruling is the issue
explicitly decided by the district court: whether the brand defendants
owed Huck a duty under Iowa law when she did not ingest a product
manufactured or sold by them. The court of appeals held Mensing did
not alter state-law principles requiring the dismissal of a claim brought
against a defendant whose product plaintiff never used.
We granted Huck’s application for further review.
14
II. Standard of Review.
We review rulings that grant summary judgment for correction of
errors at law. Parish v. Jumpking, Inc., 719 N.W.2d 540, 542 (Iowa
2006). Summary judgment is appropriate when there is no genuine
issue of material fact and the moving party is entitled to judgment as a
matter of law. Iowa R. Civ. P. 1.981(3). “A fact is material if it will affect
the outcome of the suit, given the applicable law.” Parish, 719 N.W.2d at
543. “An issue of fact is ‘genuine’ if the evidence is such that a
reasonable finder of fact could return a verdict or decision for the
nonmoving party.” Id. We view the evidence in the light most favorable
to the nonmoving party. Id. Summary judgment is properly granted
when the moving party shows “the nonmoving party has no evidence to
support a determinative element of that party’s claim.” Id.We may review the issues actually decided in a ruling granting an
unresisted motion for summary judgment when the nonmoving party
filed a postjudgment motion that gave the district court the opportunity
to correct the alleged error. See Cooksey v. Cargill Meat Solutions Corp.,
831 N.W.2d 94, 98–99 (Iowa 2013); id. at 107 (Mansfield, J. dissenting);
Otterberg v. Farm Bureau Mut. Ins. Co., 696 N.W.2d 24, 28 (Iowa 2005)
(noting the party moving for summary judgment has the burden “to show
the district court that there was no genuine issue of material fact and
that it was entitled to a judgment as a matter of law”); Bill Grunder’s
Sons Constr., Inc. v. Ganzer, 686 N.W.2d 193, 197–98 (Iowa 2004) (“[T]he
nonmovant must at least preserve error by filing a motion following entry
of [the unresisted summary] judgment, allowing the district court to
consider the claim of deficiency.”).
15
III. Analysis.
A. Whether Any of Huck’s Claims Against PLIVA Survive
Mensing. We must decide whether the district court correctly ruled that
all of Huck’s claims against PLIVA are preempted by Mensing. Applying
Mensing, the district court ruled Huck’s claims against PLIVA are
preempted because it was impossible for PLIVA to alter its label. The
court of appeals agreed. Huck argues Mensing preempts only claims that
require the generic manufacturer to vary its labeling from that of the
branded drug. She points out that PLIVA failed to update its label in
2004 to include the FDA-approved warning stating, “Therapy should
not exceed 12 weeks in duration.” Mensing did not decide whether
that claim is preempted. The Court of Appeals for the Sixth Circuit in
Fulgenzi, however, recently adjudicated this very issue and squarely held
Mensing does not preempt claims based on the generic manufacturer’s
failure to update its label warning with the language the FDA approved in
2004. Fulgenzi, 711 F.3d at 584. As the Sixth Circuit observed, “not
only could PLIVA have independently updated its labeling to match [the
warning added in 2004], it had a federal duty to do so.” Id. (citation
omitted). We find Fulgenzi persuasive and hold Huck’s claims survive
preemption to the extent they are based on PLIVA’s failure to adopt the
additional warning language approved by the FDA in 2004.
The federal preemption doctrine derives from the Supremacy
Clause of the Federal Constitution. See Ackerman v. Am. Cyanamid Co.,
586 N.W.2d 208, 211 (Iowa 1998). Under the doctrine of conflict
preemption, “[when] state and federal law directly conflict, state law must
give way.” Mensing, 564 U.S. at ___, 131 S. Ct. at 2577, 180 L. Ed. 2d at
592 (internal quotation marks omitted). But, “[t]here is a presumption
against preemption which counsels a narrow construction of preemption
16
provisions.” Ackerman, 586 N.W.2d at 213. We must evaluate each of
Huck’s surviving claims 6—breach of the implied warranty of
merchantability, negligence (based on failure to warn), negligent
misrepresentation, fraud and misrepresentation, constructive fraud, and
fraud by concealment—“to determine if it is impossible for PLIVA to
comply with both the state-law duties underlying those claims and its
federal labeling duties” or if state law “would obstruct the purposes and
objectives of federal drug labeling regulation.” See Levine, 555 U.S. at
568, 573, 129 S. Ct. at 1196, 1199, 173 L. Ed. 2d at 62, 65.
We will first evaluate her claims to determine if they make it
impossible for PLIVA to comply with both state and federal law. Next, we
will decide if her claims pose an obstacle to the purposes and objectives
of Congress. Finally, we will consider PLIVA’s argument that Huck’s
claims violate a federal law prohibiting private enforcement of the FDCA. 7
6PLIVA argues Huck preserved error only as to her failure-to-warn and breach-
of-implied-warranty claims. When PLIVA moved for summary judgment in the wake of
Mensing, Huck resisted this motion and argued her claims were still viable. On
January 5, 2012, the district court dismissed all of Huck’s remaining claims as
preempted by Mensing. In her motion for reconsideration, Huck mentioned only her
failure-to-warn claims and breach-of-implied-warranty claims. Nevertheless, we
consider error preserved as to the additional claims because Huck resisted summary
judgment and argues those claims on appeal.
7PLIVA argues that Huck cannot base her failure-to-warn claim on the 2004
label update because she has asserted the label was inadequate even with the
additional language. The court of appeals agreed, concluding, “Iowa law does not
provide a cause of action for failing to disseminate allegedly inadequate warnings.” This
mischaracterizes the issue. This argument—that “there is no such thing as a ‘failure to
inadequately warn’ ”—was rejected by the Sixth Circuit. Fulgenzi, 711 F.3d at 587–88.
As that court observed:
It may well be more difficult to prove proximate causation in a case
where the warning that the defendant failed to provide was also legally
inadequate. But there is no reason to believe that a severely inadequate
warning would never cause an injury that a moderately inadequate
warning would have prevented. A plaintiff need not prove that the
alternative warning would have been objectively reasonable, only that it
would most likely have prevented the injury in this case.
17
1. Impossibility preemption. We first consider Huck’s negligence
claim based on PLIVA’s failure to warn. Huck concedes her failure-to-
warn claim is preempted to the extent it required PLIVA to adopt a label
different than that of the approved brand label, but argues she can base
her common law negligence claim on PLIVA’s failure to adopt the
language approved in the 2004 warning against use of metoclopramide
for longer than twelve weeks. We agree.
The facts of this case present a narrow path around Mensing
preemption. Once the additional warning language was approved by the
FDA in July 2004, PLIVA needed only to go through the “changes being
effected” process to revise its label to match the updated brand-name
___________________________
. . . [I]t is sufficiently plausible that the use of a neutral warning
disavowing approval instead of a bold-faced warning affirmatively
discouraging long-term use proximately caused [plaintiff’s] injury.
Whether in fact these allegations are true is a matter for further
proceedings.
Id. We agree with the Fulgenzi court’s reasoning.
The court of appeals also stated, “Huck has not argued these [2004 updated]
warnings—providing what she argued is faulty information—would have prevented the
harm she suffered.” We do not find Huck has conceded that issue. To the contrary,
Huck successfully resisted PLIVA’s motion for summary judgment, in which PLIVA
argued Huck was unable to prove that if she or her physician “had received an adequate
warning, she would not have ingested the drug.” The district court denied PLIVA’s
motion, finding that based on the record provided fact issues precluded summary
judgment. Cf. Clinkscales v. Nelson Sec., Inc., 697 N.W.2d 836, 841 (Iowa 2005) (“[W]e
reiterate the well-settled maxim that questions of negligence or proximate cause are
ordinarily for the jury—only in exceptional cases should they be decided as a matter of
law.”); Lovick v. Wil-Rich, 588 N.W.2d 688, 700 (Iowa 1999) (affirming denial of directed
verdict on failure-to-warn claim; noting “proximate cause can be established by showing
a warning would have altered the plaintiff’s conduct so as to avoid injury”); see also
Restatement (Third) of Torts: Prods. Liab. § 2 cmt. i, illus. 11, at 31 (1998) (“Whether
the warning actually given was reasonable in the circumstances is to be decided by the
trier of fact.”); cf. In re Prempro Prods. Liab. Litig., 586 F.3d 547, 569 (8th Cir. 2009)
(“ ‘[[T]]he vast majority of jurisdictions hold that where a warning is inadequate, the
plaintiff is entitled to a rebuttable presumption that an adequate warning would have
been heeded if one had been given.’ ” (quoting Thom v. Bristol–Myers Squibb Co., 353
F.3d 848, 855 (10th Cir. 2003)). We decide today only the preemption issue as to
Huck’s claims against PLIVA and leave for further proceedings issues concerning the
adequacy of PLIVA’s warnings and whether an updated warning in 2004 would have
reached Huck or her physicians and altered her behavior.
18
label. See Mensing, 564 U.S. at ___, 131 S. Ct. at 2575, 180 L. Ed. 2d at589–90 (citing the FDA’s interpretation of 21 C.F.R. § 314.94(a)(8)(iv) )).
This process allows manufacturers to update their label without waiting
for FDA approval. Id. at ___, 131 S. Ct. at 2575, 180 L. Ed. 2d at 589.
Though the FDA could have rejected PLIVA’s request after the fact, such
a rejection would have been unlikely. Cf. Levine, 555 U.S. at 571, 129
S. Ct. at 1198, 173 L. Ed. 2d at 64 (“[A]bsent clear evidence that the FDA
would not have approved a change to [defendant’s] label, we will not
conclude that it was impossible for [defendant] to comply with both
federal and state requirements.”). Accordingly, it was not impossible for
PLIVA to update its label and send informational letters consistent with
the updated language, warning health care professionals and consumers
that metoclopramide therapy should not exceed twelve weeks. To the
contrary, PLIVA had a federal duty to match its label to Wyeth’s. See 21
U.S.C. § 331(a) (prohibiting the introduction into interstate commerce
any drug that is misbranded); 21 C.F.R. §§ 314.94(a)(8)(iii) (requiring
generic applicant to match label of brand drug); 21 C.F.R.
§ 314.150(b)(10) (providing FDA may withdraw drug approval if the
generic’s label “is no longer consistent with that for [the brand-name]”);
see also Fulgenzi, 711 F.3d at 584 (“[C]ompliance with federal and state
duties was not just possible; it was required.”). We therefore conclude
Huck’s state-law negligent failure-to-warn claim is not preempted by
federal labeling regulations to the extent it is based on PLIVA’s failure to
adopt the additional warning language approved in 2004. A growing
number of courts have reached the same conclusion. 8
8These courts include: Neeley v. Wolters Kluwer Health, Inc., No. 4:11-CV-325
JAR, 2013 WL 3929059, at *9 (E.D. Mo. July 29, 2013); Phelps v. Wyeth, Inc., 938
F. Supp. 2d 1055, 1061 (D. Or. 2013); Johnson v. Teva Pharm. USA, Inc., No. 2: 10 CV
404, 2012 WL 1866839, at *3 (W.D. La. May 21, 2012); Cooper v. Wyeth, Inc., No. 09–
19
Moving to Huck’s remaining claims, we note at the outset that
“there is no general, inherent conflict between federal pre-emption [sic] of
state warning requirements and the continued vitality of state common-
law damages actions.” Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 518,
112 S. Ct. 2608, 2618, 120 L. Ed. 2d 407, 424 (1992). “Of course any
direct challenge to the adequacy of a label or warning is preempted.”
Ackerman, 586 N.W.2d at 213. But, “[w]e also examine whether a claim
is merely another way of alleging the label or warning was inadequate.
Such an indirect challenge is also preempted.” Id. If Huck’s claims
against PLIVA do not require the company to change its labeling to differ
from that of the approved label, they are not preempted. See id. (“[O]ur
task remains to identify whether [plaintiff’s] claims are predicated upon
labeling and packaging requirements in addition to and different from
those required by [federal law].”).
Huck argues her claims for negligent testing and postmarket
surveillance thus are not preempted. But, “merely to call something a
design or testing claim does not automatically avoid [the] preemption
clause.” Id. at 214. The line between a claim for mislabeling and a claim
for negligent testing is “razor thin.” See id.___________________________
929–JJB, 2012 WL 733846, at *4 (M.D. La. Mar. 6, 2012); Lyman v. Pfizer, Inc.,
No. 2:09-cv-262, 2012 WL 368675, at *5–6 (D. Vt. Feb. 3, 2012); Couick v. Wyeth, Inc.,
No. 3:09–cv–210–RJC–DSC, 2012 WL 79670, at *5 (W.D.N.C. Jan. 11, 2012); Del Valle
v. PLIVA, Inc., No. B:11–113, 2011 WL 7168620, at *5 (S.D. Tex. Dec. 21, 2011); Fisher,
817 F. Supp. 2d at 805; In re Reglan Litig., No. 289, 2012 WL 1613329 (N.J. Super. Ct.
Law Div. May 4, 2012); Hassett v. Dafoe, 74 A.3d 202, 216 (Pa. Super. Ct. 2013); see
also Teva Pharm. USA, Inc. v. Super. Ct., 158 Cal. Rptr. 3d 150, 158 (Ct. App. 2013)
(relying on Fulgenzi to hold failure-to-warn claim not preempted when generic
manufacturers of alendronate sodium did not mirror the branded Fosamax label). In
contrast, the Court of Appeals for the Fourth Circuit recently affirmed a summary
judgment dismissing all claims against PLIVA based on Mensing’s impossibility or
conflict preemption, while expressly noting the 2004 update theory was not timely made
in that case. Drager v. PLIVA USA, Inc., 741 F.3d 470, 474–76 (4th Cir. 2014).
20
[T]he rule is that a claim based on negligent or inadequate
testing will not be considered a disguised label-based
challenge if adequate testing would have caused the
manufacturer to alter the product itself. Conversely, the rule
is that if defendant could remedy any problems with its
product, that it learned about through adequate testing, by
altering the product’s label rather than by changing the
product, then any challenge concerning negligent testing is
preempted.
Wright v. Am. Cyanamid Co., 599 N.W.2d 668, 673 (Iowa 1999).
Federal drug regulation adds a wrinkle to the application of this
rule: generic manufacturers are prohibited from altering the composition
of a drug because they must mirror the formulation of the brand-
manufacturer drug. See, e.g., 21 U.S.C. § 355(j)(2)(A) (requiring
bioequivalence); id. § 355(j)(2)(A)(ii), (iii) (requiring generic drug to have
the same “active ingredients,” “route of administration,” “dosage form,”
and “strength” as its brand-name counterpart); id. § 355(j)(8)(B)
(requiring the same “rate and extent of absorption”). Moreover, both
generic and brand manufacturers are prohibited from making major
changes to the “qualitative or quantitative formulation of the drug
product, including active ingredients, or in the specifications provided in
the approved application” after their drug is approved. 21 C.F.R.
§ 314.70(b)(2)(i).
In light of these regulations, the only way for PLIVA to avoid
liability for negligent testing would be to withdraw from the market. This
issue is addressed by Mutual Pharmacy Co. v. Bartlett, 570 U.S. ___, ___
133 S. Ct. 2466, 2477, 186 L. Ed. 2d 607, 622–23 (2013). In Bartlett, the
Supreme Court rejected the “stop selling” argument because “if the
option of ceasing to act defeated a claim of impossibility, impossibility
pre-emption [sic] would be ‘all but meaningless.’ ” Id. at ___, 133 S. Ct.
at 2477–78, 186 L. Ed. 2d at 622 (quoting Mensing, 564 U.S. at ___, 131
S. Ct., at 2579, 180 L. Ed. 2d at 594) (noting “[j]ust as the prospect that
21
a regulated actor could avoid liability under both state and federal law by
simply leaving the market did not undermine the impossibility analysis
in [Mensing], so it is irrelevant to our analysis here”). But, as with her
failure-to-warn claim, we conclude Huck’s negligent-testing and
postmarket-surveillance claims avoid preemption to the extent the claims
are based on PLIVA’s failure to adopt the 2004 label change. Cf. Wright,
599 N.W.2d at 675 (concluding negligent testing claim was “a disguised
label-based claim” preempted by federal law).
Huck next argues her claim of breach of the implied warranty of
merchantability based on warning defects escapes Mensing preemption
because (1) metoclopramide was unfit “for the ordinary purposes for
which such goods are used”—namely, for prolonged therapy; (2) PLIVA
did not include the revised 2004 label limiting the duration of use to
twelve weeks; and (3) metoclopramide did not conform to the statements
of fact that appear on its label. See Iowa Code § 554.2314(c), (e), (f)
(2005). Once more, we agree this claim may proceed if she is able to
ground it on PLIVA’s failure to adopt the 2004 additional approved
warning. See Fisher, 817 F. Supp. 2d at 821 (denying PLIVA’s motion for
summary judgment on implied warranty of merchantability because “the
Court does not find as a matter of law that long-term use was not an
ordinary purpose for which metoclopramide was used”); see also Wright
v. Brooke Grp. Ltd., 652 N.W.2d 159, 182 (Iowa 2002) (citing the
Restatement (Third) of Torts: Prods. Liab. § 2(b)–(c), at 14 (1998) as
authority to allow breach of the implied warranty of merchantability
claim based on inadequate warnings); cf. Ackerman, 586 N.W.2d at 213–
14 (dismissing claim of breach of implied warranty of merchantability
based on federal preemption).
22
Finally, Huck appeals the dismissal of her claims alleging fraud,
misrepresentation, constructive fraud, and fraud by concealment. Our
common law recognizes fraud claims by a consumer against a product
manufacturer who “made misleading statements of fact intended to
influence consumers” or “made true statements of fact designed to
influence consumers and subsequently acquire[d] information rendering
the prior statements untrue or misleading.” Brooke Grp. Ltd., 652
N.W.2d at 177 & n.4 (declining to decide whether such claims were
preempted). We conclude her fraud and misrepresentation claims escape
preemption to the extent they are based on the additional 2004 warning
language PLIVA failed to adopt.
2. Purposes and objectives analysis. Next, we must consider
whether state tort suits against generic manufacturers would frustrate
the purposes and objectives of Congress, thus warranting preemption.9
In Levine, the Court held suits against Reglan manufacturers would not
obstruct the purposes and objectives of federal drug labeling regulation.
Levine, 555 U.S. at 573, 129 S. Ct. at 1199, 173 L. Ed. 2d at 65. We
reach the same conclusion with respect to Huck’s claims against PLIVA.
Levine recognized that Congress has not provided a federal remedy
for consumers harmed by prescription drugs and, as such, “state law
offers an additional, and important, layer of consumer protection that
complements FDA regulation.” Id. at 574, 579, 129 S. Ct. at 1200, 1202,
173 L. Ed. 2d at 66, 69 (noting additionally that, “[i]f Congress thought
state-law suits posed an obstacle to its objectives, it surely would have
9Because defendants in Mensing argued only that it was impossible for a generic
manufacturer to unilaterally strengthen its label without running afoul of federal law,
the Mensing opinion did not consider the purposes and objectives prong of the conflict
preemption analysis. 564 U.S. at ___, 131 S. Ct. at 2587, 180 L. Ed. 2d at 602–03
(Sotomayor, J., dissenting).
23
enacted an express pre-emption [sic] provision at some point during the
FDCA’s 70–year history”); see also Bates v. Dow Agrosciences LLC, 544
U.S. 431, 451, 125 S. Ct. 1788, 1802, 161 L. Ed. 2d 687, 707 (2005)
(“Private remedies that enforce federal misbranding requirements would
seem to aid, rather than hinder, the functioning of [federal law].”). The
Levine Court’s reasoning on this issue applies to state tort claims against
both generic and brand manufacturers:
State tort suits uncover unknown drug hazards and provide
incentives for drug manufacturers to disclose safety risks
promptly. They also serve a distinct compensatory function
that may motivate injured persons to come forward with
information. Failure-to-warn actions, in particular, lend
force to the FDCA’s premise that manufacturers, not the
FDA, bear primary responsibility for their drug labeling at all
times.
555 U.S. at 579, 129 S. Ct. at 1202, 173 L. Ed. 2d at 68–69.
The Sixth Circuit’s decision in Fulgenzi reinforces our conclusion
that Huck’s claims against PLIVA do not frustrate congressional goals.
In Fulgenzi, the court considered the differences between brand and
generic manufacturers, singling out the “promotion of generic drugs, and
the attendant reduction in costs” as “[t]he most easily identifiable policy”
of the FDCA. 711 F.3d at 585. “Permitting state tort actions to go
forward against generic-drug manufacturers [as opposed to brand
manufacturers], the argument goes, would increase costs and reduce
usage.” Id. Yet, the Fulgenzi court held this hypothetical difference does
not justify preemption. Id. Citing the Mensing dissenters’ observation
that “the inability to sue for inadequate warnings may actually reduce
consumer demand,” Fulgenzi reasoned “[t]his is an empirical question,
and we should not affirmatively answer on the basis of mere speculation
about Congressional purposes.” 711 F.3d at 585. The court concluded:
24
It is hard to see how permitting state tort suits to go forward
against sameness-violating generic defendants frustrates
federal policies where permitting suits against FDA-compliant
branded defendants does not. A vague policy of encouraging
use of generic drugs, untethered from the structure of the
Act, is not enough to support purposes-and-objectives
preemption.
Id. at 586 (citation omitted). We agree with this analysis and hold Huck’s
claims survive impossibility preemption.
3. Private right of action. PLIVA argues Huck’s claims are merely
attempts to enforce the FDCA, which 21 U.S.C. § 337(a) disallows. The
court of appeals and district court agreed. That section states: “[A]ll
such proceedings for the enforcement, or to restrain violations, of this
chapter shall be by and in the name of the United States.” 21 U.S.C.
§ 337(a). This provision ensures private suits do not “deprive the [FDA]
of the ability to use its enforcement authority to achieve a delicate
balance of statutory objectives.” Fulgenzi, 711 F.3d at 586. PLIVA reads
§ 377(a) to mean “private litigants are barred from asserting claims
involving violations of the FDCA or FDA’s implementing regulations.” We
disagree and instead conclude Huck’s claims—as limited by our decision
today—are based on traditional state tort law principles that supplement
federal requirements.
This case presents us with a “situation[] implicating ‘federalism
concerns and the historic primacy of state regulation of matters of health
and safety,’ ” a situation governed by a presumption against preemption.
Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348, 121 S. Ct.
1012, 1017, 148 L. Ed. 2d 854, 861 (2001) (quoting Medtronic, Inc. v.
Lohr, 518 U.S. 470, 485, 116 S. Ct. 2240, 2250, 135 L. Ed. 2d 700, 715
(1996)). “Where [a] claim is based on traditional state-tort-law principles,
the lack of a private cause of action within a federal regulatory scheme
will not preempt the claim for damages (even if state regulations might be
25
preempted).” Fulgenzi., 711 F.3d at 586; accord Silkwood v. Kerr-McGee
Corp., 464 U.S. 238, 255, 104 S. Ct. 615, 625, 78 L. Ed. 2d 443, 457
(1984) (“[T]raditional principles of state tort law . . . apply with full force
unless they [are] expressly supplanted.”). Likewise, an independent state
law cause of action that parallels federal requirements is permissible.
See Riegel v. Medtronic, Inc., 552 U.S. 312, 330, 128 S. Ct. 999, 1011,
169 L. Ed. 2d 892, 906 (2008) (“[The express preemption provision in the
Medical Device Amendments to the FDCA] does not prevent a State from
providing a damages remedy for claims premised on a violation of FDA
regulations; the state duties in such a case ‘parallel,’ rather than add to,
federal requirements.”); Lohr, 518 U.S. at 495, 116 S. Ct. at 2255, 135
L. Ed. 2d at 721 (“Nothing in [the statute] denies Florida the right to
provide a traditional damages remedy for violations of common-law
duties when those duties parallel federal requirements.”). “But if the
claims ‘exist solely by virtue of’ the regulatory scheme, they are
preempted.” Fulgenzi, 711 F.3d at 586 (quoting Buckman, 531 U.S. at
353, 121 S. Ct. at 1020, 148 L. Ed. 2d at 864 (finding “fraud on the FDA”
claim preempted because “the existence of . . . federal enactments is a
critical element” of plaintiff’s case)).
Huck’s petition does not attempt to allege a prohibited private
federal cause of action under the FDCA. Rather, she alleges state
common law tort and warranty theories that exist regardless of whether
the FDCA required a duty of sameness. Indeed, Huck could try her
claims without reference to the FDCA. Cf. Fulgenzi, 711 F.3d at 588
(noting “the logic of Buckman would encourage exclusion of evidence of
federal-law violations where possible”). Fundamentally, with variations
on a theme, she asserts:
26
(1) PLIVA had a duty to warn her that she should not take
metoclopramide for longer than twelve weeks. 10
(2) PLIVA breached this duty.
(3) Huck took metoclopramide for longer than twelve weeks
because she was not instructed otherwise.
(4) Huck suffered damages as a result of ingesting
metoclopramide for more than twelve weeks.
Neither the federal duty of sameness nor the duty to report safety risks to
the FDA are “critical element[s]” of her state law claims. 11 See Buckman,
531 U.S. at 353, 121 S. Ct. at 1020, 148 L. Ed. 2d at 864. Federal law
has limited the way in which she can frame her claim: she cannot raise a
claim based on labeling that would require PLIVA to unilaterally
strengthen its label. She has managed to avoid that difficulty because
PLIVA did not include the additional 2004 approved language. In sum,
Huck’s claims fit into a “narrow gap”: she is suing for conduct that
violates the FDCA, but she is not suing because the conduct violates the
FDCA. See In re Medtronic, Inc., 623 F.3d 1200, 1204 (8th Cir. 2010)
(internal quotation marks omitted).
B. The Brand Defendants. We next address whether the district
court correctly entered summary judgment dismissing Huck’s claims
10This is distinct from the duty of label sameness imposed by federal law. If
Huck premised her claim upon the duty of sameness, it would be preempted as an
attempt to enforce federal law. See Fulgenzi, 711 F.3d at 588–89. Yet, we do not expect
Huck to try her case without reference to the fact that the FDA approved a warning
against prolonged use in 2004. We agree with the Fulgenzi court:
Although federal-law violations here are not as relevant as they would be
in a negligence per se case, references to federal law will inevitably arise.
To avoid Mensing preemption, [plaintiff] must use the language of the
2004 FDA-approved label in her proximate-cause argument, not (or not
merely) the fact of the failure to update. Federal standards are also likely
to arise in determining the adequacy of PLIVA’s warning, since FDA
approval and industry practices may be relevant to the state duty of care.
Id.
11In contrast, “[f]ailure to update from one adequate warning to another would
violate the FDCA, but not [state] law.” Fulgenzi, 711 F.3d at 586–87.
27
against the brand defendants based on the undisputed fact that Huck
consumed only the generic formulation sold by PLIVA—their
competitor—and never used Reglan. The district court granted the brand
defendants’ unresisted motion for summary judgment, applying our
decision in Mulcahy. The court of appeals affirmed, stating, “To the
minimal extent Huck argues Mulcahy is either distinguishable or not
applicable, we disagree and find the district court’s application of
Mulcahy is correct.”
Mulcahy applied a well-settled requirement of Iowa law—the
plaintiff must prove injury caused by a product sold or supplied by the
defendant. 386 N.W.2d at 76. This long-standing requirement bars
Huck’s recovery from the manufacturers of a brand she never used.12
Under Iowa law, manufacturers owe duties to those harmed by use of
their products. We decline to change Iowa law to impose a new duty on
manufacturers to those who never used their products and were instead
harmed by use of a competitor’s product. The FDA has responded to
Mensing through a proposed rule to allow generic manufacturers to
update their labeling on their own, regardless of the brand manufacturer
labeling. See Proposed Rule, 78 Fed. Reg. at 67985. The rule change
would vitiate the preemption defense of generic manufacturers. This is
the appropriate way to address the unfairness resulting from Mensing,
rather than turning Iowa tort law upside down.
12Our preservation-of-error rules permit us to review issues the district court
actually decided when granting an unresisted motion for summary judgment.
Otterberg, 696 N.W.2d at 27–28. The brand defendants agree error is preserved to
review whether the district court correctly entered summary judgment in their favor
based on Mulcahy. Huck gave the district court the opportunity to revisit the issue in
light of Mensing when she filed her motion for relief from judgment. See Ganzer, 686
N.W.2d at 197–98 (requiring postjudgment motion to preserve error for appellate review
of unresisted summary judgment). Accordingly, we conclude error is preserved.
28
Huck argues we should reinstate her claims against the brand
defendants because PLIVA was required to use the same warnings that
accompanied Reglan. An overwhelming majority of courts adjudicating
this issue have affirmed judgments or granted dispositive motions
dismissing claims against the brand defendants when the plaintiff used
only the generic formulation. See, e.g., In re Darvocet, Darvon and
Propoxyphene Prods. Liab. Litig., ___ F.3d ___, ___, 2014 WL 2959271,
*17–18 (6th Cir. June 27, 2014) (affirming dismissal of claims against
brand defendants when plaintiffs consumed only generic painkiller;
applying laws of twenty-two states in a multidistrict litigation action with
sixty-eight lawsuits); Moretti v. Wyeth, Inc., ___ Fed. Appx. ___, ___, 2014
WL 2726886, at *1 (9th Cir. June 17, 2014) (affirming summary
judgment for brand defendants based on Nevada law); Lashley v. Pfizer,
Inc., 750 F.3d 470, 476–78 (5th Cir. 2014) (affirming summary
judgments for brand defendants because plaintiffs ingested only generic
metoclopramide); Strayhorn v. Wyeth Pharm., Inc., 737 F.3d 378, 406
(6th Cir. 2013) (noting “every federal court of appeals to consider this
issue has held that brand-name manufacturers are not liable to plaintiffs
who are injured by a generic manufacturer’s drug”); Schrock v. Wyeth,
Inc., 727 F.3d 1273, 1284–86 (10th Cir. 2013) (stating “the courts of
other states have overwhelmingly rejected the very theory advanced by
the Schrocks”); Guarino v. Wyeth, LLC, 719 F.3d 1245, 1252 (11th Cir.
2013) (“[T]he overwhelming national consensus—including . . . the vast
majority of district courts around the country to consider the question—
is that a brand-name manufacturer cannot be liable for injuries caused
by the ingestion of the generic form of a product.”); Bell v. Pfizer, Inc., 716
F.3d 1087, 1092–94 (8th Cir. 2013) (affirming summary judgment for
brand defendants because Bell never used Reglan and noting “ ‘[a]n
29
overwhelming majority of courts considering this issue,’ including the
Eighth Circuit, have rejected Bell’s theory of liability” (quoting Mensing,
588 F.3d at 613)); Foster v. Am. Home Prods. Corp., 29 F.3d 165, 170 (4th
Cir. 1994) (“There is no legal precedent for using a name brand
manufacturer’s statements about its own product as a basis for liability
for injuries caused by other manufacturers’ products, over whose
production the name brand manufacturer had no control.”). As the Sixth
Circuit Court of Appeals summarized, “almost every court has
. . . reason[ed] that a brand manufacturer does not owe a duty to a
consumer unless the consumer actually used the brand manufacturer’s
product.” Darvocet ___ F.3d at ___, 2014 WL 2959271, at *4 (citing
Victor E. Schwartz, et. al., Warning: Shifting Liability to Manufacturers of
Brand–Name Medicines When the Harm Was Allegedly Caused by Generic
Drugs Has Severe Side Effects, 81 Fordham L. Rev. 1835, 1857–58 (2013)
[hereinafter Schwartz], which catalogs cases following the majority
trend).
The Court of Appeals for the Tenth Circuit recently discussed three
principal rationales used by courts, concluding “brand-name
manufacturers are not liable to consumers of generic drugs”:
First, they based their view on traditional common law tort
principles under which a manufacturer is liable for injuries
caused by its own product. See, e.g., Mensing, 588 F.3d at
604, 613 (holding name brand manufacturers liable for harm
caused by generic manufacturers “stretches the concept of
foreseeability too far” (quotation and alteration omitted)).
Second, they reason that brand-name manufacturers’
warnings and representations do not create a basis for
liability to consumers of competitors’ products because
brand-name manufacturers only “intend[] to communicate
with their customers, not the customers of their
competitors.” Id. at 613 n.9; see also Stanley v. Wyeth, Inc.,
991 So. 2d 31, 34 (La. Ct. App. 2008) (“A manufacturer
cannot reasonably expect that consumers will rely on the
information it provides when actually ingesting another
company’s drug.”). Finally, they conclude that public policy
30
considerations weigh against holding name-brand
competitors liable for injuries caused by their generic
competitor’s drug. See, e.g., Foster, 29 F.3d at 170 (citing
the expense in development, research, and promotion
undertaken by name-brand manufacturers not undertaken
by generic manufacturers).
Schrock, 727 F.3d at 1285. We agree with each rationale.
In Mulcahy, we squarely held that “under Iowa common law a
plaintiff in a products liability case must prove that the injury-causing
product was a product manufactured or supplied by the defendant.” 386
N.W.2d at 76. The brand defendants correctly argue this “product-
identification requirement is decisive here because it is undisputed
[Huck] did not use brand defendants’ product, but instead used a generic
equivalent product that was manufactured and sold by another
company”—PLIVA—their competitor. We see no indication Congress
intended to alter common law principles of causation to create liability
for injuries caused by use of a competitor’s product. See Norfolk Redev.
& Hous. Auth. v. Chesapeake & Potomac Tel. Co. of Va., 464 U.S. 30, 35,
104 S. Ct. 304, 307, 78 L. Ed. 2d 29, 34 (1983) (“It is a well-established
principle of statutory construction that ‘[t]he common law . . . ought not
to be deemed to be repealed, unless the language of a statute be clear
and explicit for this purpose.’ ” (quoting Fairfax’s Devisee v. Hunter’s
Lessee, 11 U.S. (7 Cranch) 603, 623, 3 L. Ed. 453, 459–60 (1812))).
“Absent clearer indications, we cannot impute to Congress an intent to
repeal, sub silentio, this deeply-rooted legal principle.” State Eng’r v.
S. Fork Band of Te-Moak Tribe of W. Shoshone Indians of Nev., 339 F.3d
804, 814 (9th Cir. 2003) (citing Norfolk, 464 U.S. at 35–36, 104 S. Ct. at
307, 78 L. Ed. 2d at 34, and discussing common law doctrine of prior
exclusive jurisdiction). We have never relaxed the product-identification
causation requirement to impose liability for injuries caused by the use
31
of a competitor’s product, and we decline to do so here. Cf. Mulcahy, 386
N.W.2d at 76 (“The imposition of liability upon a manufacturer for harm
that it may not have caused . . . is an act more closely identified as a
function assigned to the legislature under its power to enact laws.”).
Huck contends the product-identification causation requirement
does not apply to her negligent misrepresentation and fraud claims. We
disagree. The plaintiffs in Mulcahy sued pharmaceutical companies for
personal injuries resulting from the ingestion of DES, a synthetic
estrogen compound. Id. at 69. The plaintiffs “set forth theories of
recovery against the defendants based upon strict liability, negligence,
misrepresentation, breach of warranties, alternate liability, enterprise
liability, market share liability, and concert of action.” Id. (emphasis
added). We held the product-identification causation requirement
applied “ ‘[r]egardless of the theory which liability is predicated upon.’ ”
Id. at 72–73 (quoting Annotation, Products Liability: Necessity and
Sufficiency of Identification of Defendant Manufacturer or Seller of Product
Alleged to Have Caused Injury, 51 A.L.R.3d 1344 § 2[a], at 1349 (1973)).
Moreover, the tort of negligent misrepresentation does not apply to
sellers of products but rather is limited to those in the business or
profession of supplying information for the guidance of others. See Pitts
v. Farm Bureau Life Ins. Co., 818 N.W.2d 91, 111–12 (Iowa 2012). “We
have found accountants, appraisers, school guidance counselors and
investment brokers all fall within this class of potential defendants.” Id.
at 112 (collecting cases). “However, we have refused to allow a suit for
negligent misrepresentation where the defendant was a retailer in the
business of selling and servicing merchandise . . . .” Id. Federal courts
applying Iowa law likewise hold the tort of negligent misrepresentation
does not apply to sellers of products:
32
Even if Plaintiff’s negligence actions were not barred by
the contract’s limitation of remedies, Defendant would be
entitled to summary judgment on Plaintiffs’ negligent
misrepresentation claim. Plaintiffs concede that Meier v.
Alfa–Laval, Inc., 454 N.W.2d 576 (Iowa 1990) applies in this
case. The Meier court held that liability based on the tort of
negligent misrepresentation was limited to those persons in
the business of supplying information versus persons who
give information incidental to selling goods. Id. at 581.
Clearly Defendant’s business is more accurately described as
selling goods than it is supplying information. In addition,
even if Defendant were in the business of providing
information, Plaintiffs’ claim would fail in that Defendant did
not supply “false information for the guidance of others in
their business transactions.” Restatement (Second) of Torts
§ 552(1) [(1965)]. Thus, summary judgment is appropriate
as to Plaintiffs’ negligent misrepresentation claim.
Nelson v. DeKalb Swine Breeders, Inc., 952 F. Supp. 622, 628 (N.D. Iowa
1996), aff’d sub nom. Brunsman v. DeKalb Swine Breeders, Inc., 138 F.3d
358, 360 (8th Cir. 1998).
Courts in the Reglan litigation have applied the same limiting
principles to dismiss negligent misrepresentation claims against brand
name manufacturers when the plaintiff used only the generic product.
See, e.g., Baymiller v. Ranbaxy Pharm., Inc., 894 F. Supp. 2d 1302, 1309–
10 (D. Nev. 2012) (noting that Nevada law “limited the application” of
section 552 to business transactions and concluding that because
plaintiff did not purchase the brand-name product, there was no
business transaction and section 552 did not apply); Strayhorn v. Wyeth
Pharm., Inc., 882 F. Supp. 2d 1020, 1030 (W.D. Tenn. 2012) (rejecting
plaintiffs’ claims of negligent and fraudulent representation against
brand manufacturers when the Tennessee Supreme Court had declined
to apply section 552 to fraudulent misrepresentation or in products
liability actions previously), aff’d, 737 F.3d 378, 383 (6th Cir. 2013);
Mosley v. Wyeth, Inc., 719 F. Supp. 2d 1340, 1345–46 (S.D. Ala. 2010)
(finding that section 552 did not apply in a products liability action
33
against brand manufacturers and stating, “Under the restatement, drug
manufacturers cannot be classed, at least not in the same sense as
accountants and real estate appraisers, as ‘persons [who] make it a part
of their business . . . to supply information for the guidance of others in
their business transactions,’ ” and concluding, “under the facts of this
case Wyeth and Schwarz did not engage in any business transaction with
the Mosleys” (alternation in original) (citations omitted); see also
Darvocet, ___ F.3d at ___, 2014 WL 2959271, at *16–18 (“After
conducting a state-by-state Erie analysis, we conclude that the highest
courts in each of the 22 implicated states would not recognize Plaintiffs’
misrepresentation claims under their respective state laws.”). We too
decline to extend the tort of negligent misrepresentation to the brand
defendants when Huck used only the generic drug sold by their
competitor.
We did not retreat from the product-identification causation
requirement for fraud cases in Brooke Group Ltd., as Huck argues.
Rather, we noted the general rule that “a manufacturer’s failure to warn
or to disclose material information does not give rise to a fraud claim.”
Id. at 177. We noted two exceptions: “where the manufacturer (1) has
made misleading statements of fact intended to influence consumers, or
(2) has made true statements of fact designed to influence consumers
and subsequently acquires information rendering the prior statements
untrue or misleading.” Id. (citing Restatement (Second) of Torts
§ 551(2)(b)–(c), at 119 (1977)). But, the exceptions were expressly based
on the existence of the relationship between the “customer/buyer and
manufacturer,” a relationship that created a duty. Id. We never held or
suggested a fraud claim could be brought by a plaintiff against a
manufacturer who owed the plaintiff no duty, as we conclude is the case
34
here. Our decision in Brooke Group Ltd. also forecloses another liability
theory urged by Huck on appeal: “Good Samaritan” liability for a
voluntary undertaking. See id. at 177–78 (holding marketing and
advertising on the health effects of smoking are not an “undertaking”
within the scope of Restatement (Second) of Torts section 323)).
Huck argues we should revisit Mulcahy in light of our adoption of
section 7 13 of the Restatement (Third) of Torts: Liability for Physical and
Emotional Harm, at 77 (2010) in Thompson v. Kaczinski, 774 N.W.2d
829, 835 (Iowa 2009). We disagree. Thompson was not a products
liability case, and we have not applied section 7 of the Restatement
(Third) of Torts in products liability actions. Rather, in products liability
actions, we turn to the Products Restatement. See Brooke Group Ltd.,
652 N.W.2d at 167. Huck cannot evade the proof requirements of Iowa
products liability law merely by labeling her claim as a common law
negligent failure-to-warn theory. Her claims arise from injuries from her
use of a product—PLIVA’s generic metoclopramide. Products liability law
broadly refers to the legal responsibility for injury resulting from the use
of a product. Bingham v. Marshall & Huschart Mach. Co., 485 N.W.2d 78,
79 (Iowa 1992). It encompasses the theories of negligence, strict liability
and breach of warranty. Id. Although each is a separate and distinct
theory of recovery, the same facts often give rise to all three claims. See
id. “The underlying theories ordinarily concern improper design,
inadequate warnings, or mistakes in manufacturing.” Smith v. Air Feeds,
13Section 7 provides:
(a) An actor ordinarily has a duty to exercise reasonable care
when the actor's conduct creates a risk of physical harm.
(b) In exceptional cases, when an articulated countervailing
principle or policy warrants denying or limiting liability in a particular
class of cases, a court may decide that the defendant has no duty or that
the ordinary duty of reasonable care requires modification.
35
Inc., 519 N.W.2d 827, 830 (Iowa Ct. App. 1994) (emphasis added). Thus,
the Products Restatement applies to this case and its specific provisions
control over general tort principles found in the Restatement (Third) of
Torts provisions adopted in Thompson.
Moreover, section 7 of the Restatement (Third) of Torts addresses
duty, not causation. See Restatement (Third) of Torts: Liab. for Physical
Harm § 7, at 77. We have never applied section 7 to eliminate the
requirement that the plaintiff prove her injuries were caused by a
product sold or supplied by the defendant or to impose liability for
injuries caused by a competitor’s product. Nor has any other appellate
court in the country. The product-identification requirement applied in
Mulcahy remains good law. The Sixth Circuit Court of Appeals, applying
Nebraska law, expressly rejected the argument that section 7 supported
imposing liability on brand defendants for injuries of consumers of the
generic competing product. Darvocet, ___ F.3d at ___, 2014 WL 2959271,
at *27–28.
Huck points to no provision of the Products Restatement that
would eliminate Mulcahy’s product-identification causation requirement
or that would impose liability on a defendant whose product the plaintiff
never used. We adopted sections 1 and 2 of the Products Restatement in
Brooke Group Ltd., 652 N.W.2d at 169. Those provisions require proof
the defendant’s product injured the plaintiff. Section 1 provides, “One
. . . who sells or distributes a defective product is subject to liability for
harm to persons or property caused by the defect.” Restatement (Third)
of Torts: Prods. Liab. § 1, at 5. Section 2 defines defect to include
36
inadequate warnings or instructions. 14 Id. § 2, at 14. Section 6
specifically addresses prescription drugs and imposes “liability for harm
to persons caused by the defect.” Id. § 6(a), at 144. Section 15 provides,
“Whether a product defect caused harm to persons or property is
determined by the prevailing rules and principles governing causation in
tort.” Id. § 15, at 231. The prevailing rule requires cause-in-fact
causation. See Restatement (Third) of Torts: Liab. for Physical Harm
§ 26, at 346 (“Conduct is a factual cause of harm when the harm would
not have occurred absent the conduct.”). Cause-in-fact is lacking when
the plaintiff used only a competitor’s product, not the defendant’s. See
Mulcahy, 386 N.W.2d at 76. As noted above, the overwhelming majority
of courts apply this product-identification causation requirement in
Reglan litigation to reject claims against brand defendants for injuries
caused by use of a competitor’s generic drug.
We are not persuaded by the two outlier appellate decisions cited
by Huck: Wyeth, Inc. v. Weeks, ___ So. 3d ___, ___, 2013 WL 135753, at
*19, reargument granted (June 13, 2013) (Ala. Jan. 11, 2013) (applying
Alabama law); Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299, 304–05 (Ct.
App. 2008) (applying California law). 15 Both concluded the product-
14Section 2(c) states:
[A product] is defective because of inadequate instructions or warnings
when the foreseeable risks of harm posed by the product could have been
reduced or avoided by the provision of reasonable instructions or
warnings by the seller or other distributor, or a predecessor in the
commercial chain of distribution, and the omission of the instructions or
warnings renders the product not reasonably safe.
Restatement (Third) of Torts: Prods. Liab. § 2(c), at 14.
15Huck cites several unpublished trial court decisions allowing claims to proceed
against brand defendants when plaintiffs used only the generic formulation, and one
published district court decision, Kellogg v. Wyeth, 762 F. Supp. 2d 694 (D. Vt. 2010).
Kellogg applied Vermont law that, unlike Iowa’s, permits recovery for harm inflicted by a
competitor’s product. See 762 F. Supp. 2d at 708–09. Kellogg is at odds with Mulcahy.
The unpublished decisions cited by Huck are similarly at odds with Mulcahy and lack
37
identification causation requirement for strict liability claims did not
apply to fraud and negligent misrepresentation theories under the
applicable state law. Weeks, ___ So. 3d at ___, 2013 WL 135753, at *19;
Conte, 85 Cal. Rptr. 3d at 317–18. Iowa law differs. As we held in
Mulcahy, a plaintiff seeking recovery for the side effects of a prescription
who sues a pharmaceutical company under any theory, including
misrepresentation, must prove she was injured by using the prescription
drug manufactured or supplied by that defendant. 386 N.W.2d at 69,
72–73, 76. Additionally, the Alabama Supreme Court subsequently
granted Wyeth’s application for rehearing and reset Weeks for a second
oral argument heard in September 2013. Lorelei Laird, Generic drugs
leave a bad taste for patients filing tort suits, ABA Journal (Feb. 1, 2014),
http://www.abajournal.com/magazine/article/generic_drugs_leave_a_
bad_taste_for_patients_filing_tort_suits/. Judge Murdock, in his well-
reasoned dissent from the initial decision, observed:
[A]lmost every one of the 47 reported cases decided before
the United States Supreme Court’s decision in [Mensing],
including cases decided by two United States Circuit Courts
of Appeals, hold that a manufacturer of a brand-name drug
has no duty to the consumer of a generic drug manufactured
and sold by another company. (Only three courts, including
the court certifying the question in this case, have held
otherwise.) Since the Supreme Court’s 2011 decision in
PLIVA, every one of the 11 cases that have addressed the
issue, including decisions by three United States Circuit
Courts of Appeals, has reached this same conclusion.
___________________________
precedential value. A more recent Court of Appeals for the Seventh Circuit case, In re
GlaxoSmithKline LLC, No. 14–2051, 2014 WL 2506461, at *1 (7th Cir. June 4, 2014),
provided by Huck subsequent to oral argument is also unpersuasive. Though the
plaintiff in that case ingested only a generic medication, the district court denied the
brand manufacturer’s motion for summary judgment. Id. The brand manufacturer
petitioned the Seventh Circuit for a writ of mandamus to correct that ruling. Id. The
Seventh Circuit acknowledged “that a majority of federal courts has ruled in favor of the
[brand] manufacturer,” but denied the brand manufacturer’s petition for a writ of
mandamus, reasoning that the legal issue could be resolved on appeal from a final
judgment. Id.38
As these numbers indicate, the Supreme Court’s
holding in [Mensing]—that state-law claims against generic-
drug manufacturers are preempted by the federal regulatory
scheme—did nothing to undermine the essential rationale in
the plethora of pre- and post-[Mensing] decisions holding
that brand-name manufacturers are not liable for injuries
caused by deficient labeling of generic drugs they neither
manufactured nor sold. In fact, as discussed below, the
opinion in [Mensing] expressly says as much, and opinions
in post-[Mensing] cases are even more explicit in saying so.
Weeks, ___ So. 3d at ___, 2013 WL 135753, at *21 (Murdock, J.
dissenting). It remains to be seen how the Alabama Supreme Court will
ultimately decide whether brand defendants may be held liable under
Alabama law to consumers who used only the generic formulation sold
by a competitor.
Not only is Huck unable to satisfy Mulcahy’s causation
requirement, she cannot establish that the brand defendants owed her a
duty. Cf. Hoyt v. Gutterz Bowl & Lounge L.L.C., 829 N.W.2d 772, 775
(Iowa 2013) (“[T]he determination of whether a duty is owed under
particular circumstances is a matter of law for the court’s
determination.”). We have made clear that our adoption of section 7 of
the Restatement (Third) of Torts in Thompson did not supersede our
precedent limiting liability based on the relationships between the
parties. McCormick v. Nikkel & Assocs., 819 N.W.2d 368, 374 (Iowa
2012) (noting general duty of care under section 7(a) is “subject to ‘an
articulated countervailing principle or policy’ ” in section 7(b), which
“ ‘may be reflected in longstanding [sic] precedent’ ” (quoting Restatement
(Third) of Torts: Liab. for Physical Harm § 7(b) & cmt. a, at 77–78)). In
McCormick, we discussed how the law of duty remains intact in
important ways after Thompson:
Historically, the duty determination focused on three
factors: the relationship between the parties, the
foreseeability of harm, and public policy. [Thompson, 774
39
N.W.2d] at 834. In Thompson, we said that foreseeability
should not enter into the duty calculus but should be
considered only in determining whether the defendant was
negligent. Id. at 835. But we did not erase the remaining
law of duty; rather, we reaffirmed it. Id. at 834–36. In short,
a lack of duty may be found if either the relationship
between the parties or public [policy] considerations
warrants such a conclusion.
McCormick, 819 N.W. 2d at 371. We reiterated “our previous law of duty
was otherwise still alive and well.” Id. We affirmed summary judgment
for the defendant electrical subcontractor under the control rule that
predated Thompson. McCormick, 819 N.W.2d at 375; see also Feld v.
Borkowski, 790 N.W.2d 72, 76–77 & n.1 (Iowa 2010) (applying contact-
sports rule that predated Thompson to tort claim arising from injury to
player during high school intramural softball game because the
Restatement (Third) of Torts “expresses the notion that a reasonable-care
duty applies in each case unless a special duty, like the contact-sports
exception, is specifically recognized” (citing Restatement (Third) of Torts:
Liab. for Physical Harm § 7 cmt. a, at 77)).
Due to the unique nature of the relationship between generic and
brand manufacturers, a “ ‘countervailing principle or policy warrants
denying liability in [this] particular class of cases.’ ” Thompson, 774
N.W.2d at 835 (quoting Restatement (Third) of Torts: Liab. for Physical
Harm § 7(b), at 90) (Proposed Final Draft No. 1, 2005); accord Kelly v.
Wyeth, No. Civ.A.MICV20003314B, 2005 WL 4056740, at *4 (Mass.
Super. May 6, 2005) (concluding “strong social policy reasons” weigh
against finding brand manufacturers owe a duty to generic consumers).
As we concluded in Mulcahy, to expand tort liability to those who did not
make or supply the injury-causing product used by the plaintiff involves
policy choices and “social engineering more appropriately within the
legislative domain.” 386 N.W.2d at 76. Congress has created a
40
symbiotic relationship between brand and generic drug manufacturers.
In this relationship,
[n]ame brand manufacturers undertake the expense of
developing pioneer drugs, performing the studies necessary
to obtain premarketing approval, and formulating labeling
information. Generic manufacturers avoid these expenses
by duplicating successful pioneer drugs and their labels.
Name brand advertising benefits generic competitors
because generics are generally sold as substitutes for name
brand drugs, so the more a name brand drug is prescribed,
the more potential sales exist for its generic equivalents.
Foster, 29 F.3d at 170. The Foster court recognized that, as between
these competing pharmaceutical companies, it would be “especially
unfair” to find brand manufacturers have a duty to those who take
generic drugs “when, as here, the generic manufacturer reaps the
benefits of the name brand manufacturer’s statements by copying its
labels and riding on the coattails of its advertising.” Id.; see also Kelly,
2005 WL 4056740, at *4 (highlighting that “[the drug] approval process
can be a very time consuming and costly endeavor [for brand
manufacturers], as the manufacturer bears the cost of research and
development, as well as performing clinical studies of the drug’s safety
and effectiveness” while “[t]he makers of generic drugs, by contrast, do
not have to expend the same amount of resources”).
Through carefully crafted legislation, Congress has made policy
choices that impact the economics of prescription drug sales to increase
access to medication. Huck cites nothing in the text of the Hatch-
Waxman Amendments or congressional record suggesting Congress
intended to render brand defendants liable to consumers of generic
products. To impose such liability would alter the relationship between
generic and brand manufacturers. Specifically, extending liability to
brand manufacturers for harm caused by generic competitors would
41
discourage investments necessary to develop new, beneficial drugs by
increasing the downside risks. See Schwartz, 81 Fordham L. Rev. at
1870–72 (elaborating reasons why “expanding liability for a competitor’s
product is not sound health policy”).
Economic and public policy analyses strongly disfavor imposing
tort liability on brand manufacturers for harm caused by generic
competitors. See generally Richard A. Epstein, What Tort Theory Tells Us
About Federal Preemption: The Tragic Saga of Wyeth v. Levine, 65 N.Y.U.
Ann. Surv. Am. L. 485 (2010) [hereinafter Epstein]. As Professor Epstein
observed:
The powerful influence of common law decisions creates
gratuitous expense and uncertainty that feed their way back
into the cycle of drug development, testing, and marketing.
Properly understood, the entire duty-to-warn apparatus has
become a tax on drugs, which, in some instances, may drive
both old and new products off the market and, in most
instances, will increase drug cost and reduce the levels of
beneficial patient use.
Id. at 514. Professor Epstein further noted:
The judicial failure to understand the historical arc of
the law of torts leads to a second set of unsound judgments
on matters of institutional competence . . . . There is
nothing that erratic and expensive juries can do to make
accurate scientific judgments that will allow people to plan
their conduct in advance. Stability of expectations is
indispensable in marketing dangerous compounds, and, for
all its manifest failings, the FDA is better at this task than
juries.
Id. at 522. As Professor Epstein elaborated:
The FDA, for all its flaws, does have one advantage over a
system of tort liability: It makes its judgments on the overall
effects of drug use, not on the particulars of individual cases
where the question of proper warning is compromised in a
number of ways.
42
Id. at 488 (footnote omitted). 16
Huck fails to articulate any persuasive case that public health and
safety would be advanced through imposing tort liability on brand
defendants for injuries caused by generic products sold by competitors.
We agree with Professor Epstein that courts are not institutionally
qualified to balance the complex, interrelated, and divergent policy
considerations in determining labeling and liability obligations of brand
and generic pharmaceuticals. Courts deal ad hoc with the record made
by private litigants. By contrast, the FDA, with its four billion dollar
budget, engages in public rulemaking allowing transparent input from all
interest groups, guided by its own staff of qualified scientists.
Fundamental tort principles of risk apportionment further support
a no-duty holding in this case. Liability generally follows control in our
tort law. Cf. McCormick, 819 N.W.2d at 374 (noting the party in control
“is best positioned to take precautions to identify risks and take
measures to improve safety”). But, the brand defendants “d[id] not place
[the generic product] in commerce, ha[d] no ability to control the quality
of the product or the conformance of the product with its design, and
d[id] not have the opportunity to treat the risk of producing the product
as a cost of production against which liability insurance can be
obtained.” See Am. L. Prod. Liab. 3d § 5:10 (noting that, under these
circumstances, “the defendant has not undertaken and assumed [a]
special responsibility toward the consuming public”). Accordingly, the
brand defendants cannot be classified as the sellers of the generic
16Epstein favors preemption of state law failure-to-warn claims against brand
defendants brought by consumers of Reglan, Epstein, 65 N.Y.U. Ann. Surv. Am. L. 485,
a view rejected in Levine. See Levine, 555 U.S. at 581, 129 S Ct. at 1204, 173 L. Ed. 2d
at 70. Yet his policy arguments apply with greater force to efforts to extend state tort
liability to brand defendants for injuries to consumers who used only the competing
generic drug.
43
metoclopramide Huck ingested. See Restatement (Third) of Torts: Prods.
Liab. § 1, at 5.
A brand manufacturer cannot ensure that a generic manufacturer
complies with federal law—the two are, after all, competitors. The brand
defendants had no control over whether PLIVA used their improved
warning language approved by the FDA in 2004. Indeed, in this case
PLIVA failed to update its label to conform to the improved warnings by
the brand defendants approved by the FDA in 2004. Huck will have her
day in court against PLIVA. We adopted products liability to place
responsibility for the harm caused by a product on the party who profits
from its manufacture and sale. See Brooke Grp. Ltd., 652 N.W.2d at 164(noting our purpose in adopting principles of products liability was to
ensure “ ‘that the costs of injuries resulting from defective products are
borne by the manufacturers that put such products on the market’ ”)
(quoting Hawkeye-Sec. Ins. Co. v. Ford Motor Co., 174 N.W.2d 672, 683
(Iowa 1970))). PLIVA, not the brand defendants, profited from its sale of
the generic formulation that harmed Huck.
We reject Huck’s argument based on Bredberg v. PepsiCo, Inc., 551
N.W.2d 321 (Iowa 1996). Huck relies on Bredberg to argue Iowa law
permits liability on a party who designs, but does not manufacture or
sell, the product that injured the plaintiff. In Bredberg, plaintiff was
injured by an exploding glass bottle of Diet Mountain Dew. Id. at 323.
He sued the retailer, PepsiCo, Inc. (which made and sold the Diet
Mountain Dew concentrate), as well as Pepsi Cola General Bottlers, Inc.
(which bottled and distributed the soft drink under a license agreement).
Id. at 323 & n.1. The bottler was “required to mix the concentrate
pursuant to a formula provided by PepsiCo.” Id. at 323 n.1. The
defendants moved for a directed verdict on grounds the evidence was
44
insufficient to prove the bottle was defective. Id. at 324. Importantly for
present purposes, PepsiCo did not move for a directed verdict on grounds
it did not manufacture or sell the bottle. The jury returned a verdict for
plaintiff and allocated fault fifty percent to plaintiff, five percent to the
retailer, twenty-five percent to the bottler, and twenty percent to PepsiCo.
Id. at 325. The district court entered judgment for half the damages, and
PepsiCo and the bottler appealed. Id. at 325. We transferred the case to
the court of appeals, which reversed. Id. We granted Bredberg’s
application for further review. Id. at 326. In a footnote, we stated
“PepsiCo contends that its licensing agreement with [the bottler] Pepsi
Cola is not sufficient to impute liability on it as a manufacturer.” Id. at
326 n.4. We declined to follow a case based on a Georgia statute
because it “says nothing about whether PepsiCo could be held liable as a
product ‘designer,’ as alleged by plaintiff against PepsiCo in the present
case.” Id. We went on to review the evidence and conclude it was
sufficient to support the verdict that the bottle was defective. Id. at 326–
29. We held the district court correctly denied defendants’ posttrial
motions and affirmed the judgment for plaintiff on that basis. Id. at 329.
The fighting issue in Bredberg was whether there was substantial
evidence the bottle that exploded was defective. See id. at 327–28. That
was the basis of the rulings on the directed verdict motion and the
motion for JNOV, rulings our holding affirmed. Id. at 324–25. PepsiCo
supplied the concentrate and, therefore, was a component parts supplier
of the completed product—the full bottle of carbonated soft drink. See
id. at 323 n.1. PepsiCo essentially outsourced the manufacture of the
glass bottle and distribution of the finished product to its licensee, the
bottler. PepsiCo controlled part of the manufacturing (mixing) process
for the very product that injured plaintiff. See id. PepsiCo was thus in
45
the chain of distribution of the injury-causing product, with significant
control over the process for which it profited. PepsiCo was held liable for
injuries caused by the Pepsi™ product, consistent with Mulcahy—not for
injuries from an exploding Coca-Cola bottle sold by a competitor. 17
By contrast, the brand defendants control the brand label, but do
not otherwise control PLIVA. As we noted, PLIVA failed to adopt the new
warning language used by the brand defendants in 2004. And, the
brand defendants, who incurred the costs to develop Reglan, do not
profit from PLIVA’s sale of the competing generic formulation.
Judge Murdock observed that limiting liability to the defendant
that made the drug used by the plaintiff is consistent with “bedrock
principles of tort law and of economic realities underlying those
principles”:
From the beginning, what Alexander Hamilton referred
to as “[t]he spirit of enterprise, which characterizes the
commercial part of America,” has animated Americans to
work hard to produce innovative goods and services that
have benefited not only themselves, but also their children,
their communities, and America as a whole. An enterprising
spirit alone, however, is not enough. The law must protect
the fruits of enterprise and create a climate in which trade
and business innovation can flourish. Concomitantly, the
17Huck does not attempt to support her innovator liability theory against the
brand defendants by relying on our court’s professional malpractice decisions in which
defective plans or specifications caused harm. See, e.g., Schiltz v. Cullen-Schiltz &
Assocs., Inc., 228 N.W.2d 10, 12 (Iowa 1975). In Schiltz, a professional engineering firm
was paid to design plans for the construction of a sewage treatment plant. Id. at 12.
The general contractor built the facility in accordance with the engineer’s design, which
failed to provide for a dike for flood protection. Id. at 12–13. A nearby creek flooded
and damaged the facility. Id. at 13. The contractor sued the engineering firm for
negligently designing the facility without adequate flood protection, and the jury
ultimately found for the plaintiff-contractor. Id. at 12–13. We affirmed the submission
of the negligence theory. Id. at 18. Schiltz does not support imposing liability on brand
defendants. The defendant engineer was hired and paid to design the facility built by
the plaintiff. The engineer provided a service, not a product. Schiltz is not a case in
which a different engineer copied and sold the design made by defendant for another
project. There was no attempt in Schiltz to impose liability on a remote designer who
was not retained and paid for the construction project at issue.
46
law must justly allocate risks that are a function of that free
trade and innovation.
These dual needs have resulted in an economic and
legal system that always has coupled the rewards from the
sale of a good or service with the costs of tortious injury
resulting from the same. Indeed, this and the corollary
notion that parties are responsible for their own products,
not those of others, are so organic to western economic and
legal thought that they rarely find need of expression.
Weeks, ___ So. 3d at ___, 2013 WL 135753, at *20 (Murdock, J.
dissenting) (alteration in original) (footnote omitted).
We adhere to these bedrock principles today, and join the
multitude of courts that have concluded brand defendants owe no duty
to consumers of generic drugs. See, e.g., Darvocet ___ F.3d at ___, 2014
WL 2959271, at *17–18 (affirming dismissals of claims against brand
defendants on no-duty grounds); Lashley, 750 F.3d at 476 (“[B]ecause
Appellants did not ingest the brand manufacturers’ products, these
defendants have no common-law duty to them.”); Strayhorn, 737 F.3d at
405 (acknowledging that “ ‘[a]lthough a product manufacturer generally
has a duty to warn of the dangers of its own products, it does not have a
duty to warn of the dangers of another manufacturer’s products’ ”
(quoting Barnes v. Kerr Corp., 418 F.3d 583, 590 (6th Cir. 2005)));
Schrock, 727 F.3d at 1282 (recognizing “[w]hether or not a duty exists
depends on the relationship between the parties” and “brand-name
manufacturers do not have any relationship” with the plaintiff who
ingested a generic drug (alteration in original) (internal quotation marks
omitted)); Bell, 716 F.3d at 1093 (“[N]othing in Arkansas law . . .
supports extending such a duty of care to the customer of a competitor
using a competing product.”); Foster, 29 F.3d at 171 (concluding “Wyeth
has no duty to the users of other manufacturers’ products”).
47
We are unwilling to make brand manufacturers the de facto
insurers for competing generic manufacturers. Cf. Schwartz, 81 Fordham
L. Rev. at 1871 (“Deep-pocket jurisprudence is law without principle.”) It
may well be foreseeable that competitors will mimic a product design or
label. But, we decline Huck’s invitation to step onto the slippery slope of
imposing a form of innovator liability on manufacturers for harm caused
by a competitor’s product. Where would such liability stop? If a car seat
manufacturer recognized as the industry leader designed a popular car
seat, could it be sued for injuries sustained by a consumer using a
competitor’s seat that copied the design? Why not, under Huck’s theory,
if it is foreseeable others will copy the design?
In sum, we will not contort Iowa’s tort law in order to create
liability for brand manufacturers. The unfairness resulting from Mensing
is best addressed by Congress or the FDA. See Mensing, 564 U.S. at ___,
131 S. Ct. at 2582, 180 L. Ed. 2d at 597 (“As always, Congress and the
FDA retain the authority to change the law and regulations if they so
desire.”); Schwartz, 81 Fordham L. Rev. at 1875 (“Congress and the FDA
. . . are the appropriate arms of government for making [drug liability]
decisions in the context of fashioning the best health care policy for the
country.”); see generally Daniel Kazhdan, Wyeth and PLIVA: The Law of
Inadequate Drug Labeling, 27 Berkeley Tech. L.J. 893 (2012) (discussing
Levine and Mensing and “propos[ing] ways that drug companies, the
FDA, Congress, and the states could remedy the harmful effects of the
Court’s distinction between brand-name drugs and generic drugs”).
Indeed, the FDA’s proposed rule allows generic manufacturers to
unilaterally strengthen their labels. See generally Proposed Rule, 78 Fed.
Reg. 67985–02. This rule would abrogate the Mensing holding,
48
permitting consumers of generic drugs to bring a claim against generic
manufacturers consistent with the Levine analysis.
We will continue to apply the same long-standing causation rule
applied in Mulcahy, which required Huck to prove the defendant
manufactured or supplied the product that caused her injury, and we
decline to extend the duty of product manufacturers to those injured by
use of a competitor’s product. We will not impose liability on the brand
defendants for injuries to those using only the competing generic
formulation. The district court correctly concluded the brand defendants
were entitled to summary judgment in their favor.
IV. Disposition.
For the foregoing reasons, we vacate the decision of the court of
appeals, reverse in part the district court’s summary judgment for PLIVA
and remand for further proceedings on Huck’s claims against PLIVA
based on its failure to adopt the 2004 warning language approved by the
FDA for Reglan. We affirm the district court’s summary judgments
dismissing the other claims against PLIVA and dismissing Huck’s claims
against the brand defendants.
DECISION OF COURT OF APPEALS VACATED; DISTRICT
COURT JUDGMENTS AFFIRMED IN PART, REVERSED IN PART, AND
REMANDED WITH INSTRUCTIONS.
All justices concur except Cady, C.J., who concurs specially, and
Hecht, Wiggins, and Appel, JJ., who concur in part and dissent in part.
49
#12–0596, Huck v. Wyeth, Inc.
CADY, Chief Justice (concurring specially).
I concur in the opinion of the majority on the claims by Huck
against PLIVA, but otherwise concur in the result only. I agree with
much of the dissent on the claims against the brand defendant, but
decline at this time to conclude the public policy considerations that
ultimately drive the decision in this case, on balance, support the
imposition of a duty of care as suggested by Justice Hecht’s opinion.
After the United States Supreme Court held in PLIVA, Inc. v.
Mensing, 564 U.S. ___, ___, 131 S. Ct. 2567, 2580–81, 180 L. Ed. 2d 580,
595 (2011), that warning claims against a generic drug manufacturer
were preempted, consumers of generic drugs harmed by its label had
little avenue of relief except to turn to the brand drug manufacturer. A
credible legal theory of recovery against the brand drug manufacturer
has now been pieced together with the aid of our prior cases, but these
efforts do not confront the existing congressional preemption into the
broad area of brand and generic drugs. The law can stitch together legal
theories into legal claims of action, but the underlying public policy
ultimately drives the creation of a duty of care. Normally, courts are able
to discern the public policy and apply it to reach an outcome; but in this
case, the policies exist within an area fully occupied by Congress and
which is still developing. The public policy considerations normally at
play to impose a duty of care on manufacturers to protect product
consumers are simply too general and attenuated to support the
imposition of market-wide liability on the brand manufacturer, especially
at a time when its market share is steadily being consumed by the
generic drug manufacturer protected from liability.
50
Courts normally seek to find remedies for wrongs, but the
complexity and sheer size of the particular area of inquiry and the role
that has been assumed by Congress in regulating and navigating
through the area should make courts more than cautious to step in to
create legal liability for brand-name manufacturers. The policies at play
are currently being developed and shaped by Congress and include
policies that militate against court intervention at this time.
51
#12–0596, Huck v. Wyeth, Inc.
HECHT, Justice (concurring in part and dissenting in part).
I join the majority’s analysis with respect to Huck’s claims against
PLIVA. As I believe the majority’s 18 “product-identification causation
requirement,” however, has no application in a case where the product
and warning allegedly responsible for injury have been identified, and
because I believe our caselaw regarding duty and factual causation
support the possibility of the brand defendants’ liability here, I
respectfully dissent from the majority’s analysis and disposition of the
claims against the brand defendants.
I. Iowa Products Liability Law and Mulcahy.
We have previously explained the law of products liability in Iowa
“may involve causes of action stated in negligence, strict liability, or
breach of warranty,” among others. Bingham v. Marshall & Huschart
Mach. Co., 485 N.W.2d 78, 79 (Iowa 1992). We have noted these three
theories are separate and distinct theories of recovery, and a single set of
facts may give rise to any combination of the three. Lovick v. Wil-Rich,
588 N.W.2d 688, 698 (Iowa 1999). Typically, the underlying theories will
involve claims of improper design, inadequate warnings, or defects in
manufacturing. Id.The imposition of liability for manufacturing defects has a long
history in Iowa caselaw. See, e.g., Hawkeye-Sec. Ins. Co. v. Ford Motor
Co., 174 N.W.2d 672, 684 (Iowa 1970). In Hawkeye, we adopted the
special, narrow principle of strict liability found in section 402A of the
Restatement (Second) of Torts. Id. We explained that for various policy
18I will continue to refer to the analysis in Part III.B of the opinion by Justice
Waterman as the “majority” for ease of reference only. As Chief Justice Cady’s special
concurrence makes clear, the analysis in Part III.B of Justice Waterman’s opinion has
the support of three justices, while Chief Justice Cady has concurred in the result only.
52
reasons, a commercial seller of a defectively manufactured product may
be liable for harm caused by the defect regardless whether the plaintiff
might establish negligence or breach of warranty by the seller. Id.; see
also Restatement (Third) of Torts: Prods. Liab. § 1 cmt. a, at 7 (1998).
While the facts in Hawkeye gave rise only to a claim of manufacturing
defect, our explanation of strict liability principles suggested the strict
liability theory might be applicable in cases involving allegations of
design defect as well. Hawkeye, 174 N.W.2d at 684 (quoting authority
applying strict liability when “ ‘the defect arose out of the design or
manufacture’ ” of the product). We gave no indication whether the theory
might also apply in a case giving rise to a claim of failure to warn, and it
was not until many years later we concluded failure-to-warn claims
typically invoke a reasonableness standard incompatible with a strict
liability theory. See Olson v. Prosoco, Inc., 522 N.W.2d 284, 289–90 (Iowa
1994); see also Restatement (Third) of Torts: Prods. Liab. § 1 cmt. a, at
6–7.
After setting forth the justifications for our adoption of the strict
liability theory given the claim of manufacturing defect before us in
Hawkeye, we took care to note analysis of any claim of negligence was “a
different matter.” Hawkeye, 174 N.W.2d at 685. We had no occasion to
decide in Hawkeye how theories of negligence or strict liability might
apply in cases not involving a manufacturer, because the special strict
liability rule at issue there and elucidated in section 402A had no
application to a party not engaged in the activity of making or selling a
product as part of its business. See Restatement (Second) of Torts
§ 402A cmt. f, at 350–51 (1965). While it may often be deceptively simple
to regard an actor’s liability for injuries related to a product as “strict,”
we cautioned in Hawkeye, the Restatement (Second) did not preclude
53
liability based on the alternative ground of negligence when negligence
could be proved—the special rule of section 402A often simply had no
application to those claims. Hawkeye, 174 N.W.2d at 684–85; see also
Wright v. Brooke Grp. Ltd., 652 N.W.2d 159, 164 (Iowa 2002).
We more recently addressed the prospect of liability for injury
caused by a product in Wright, a case presenting a claim of design defect.
Wright, 652 N.W.2d at 169. We acknowledged our conclusion in Olson
that cases involving claims of failure to warn should be analyzed under
the rubric of negligence. Wright, 652 N.W.2d at 166. We noted the
Restatement (Third) of Torts: Products Liability had, in addressing claims
of design defect, abandoned the consumer-expectations test traditionally
employed in strict liability analyses in favor of a risk–utility test typically
found in negligence analyses. Id. at 169. We concluded we favored the
Restatement’s preference for avoiding doctrinal designation of design-
defect claims as claims involving negligence or strict liability. Id. Like
the drafters of the Restatement, we explained, we favored a functional
risk–utility analysis for these claims without application of a doctrinal
label. Id. We therefore adopted the framework for analyzing the liability
of sellers and distributors of products for manufacturing defects,
defective designs, and inadequate instructions and warnings found in
sections 1 and 2 of the Restatement (Third) of Torts: Products Liability.
Wright, 652 N.W.2d at 169; see also Restatement (Third) of Torts: Prods.
Liab. §§ 1–2 at 5, 14. In so doing, we reiterated the Restatement’s
recognition that a traditional conception of strict liability may well be
appropriate in manufacturing defect cases, but that negligence principles
will often be more suitable in cases involving other types of claims.
Wright, 652 N.W.2d at 168.
54
In the course of our analysis in Wright, we identified two principles
further illuminating our examination of the brands’ obligations here.
First, we suggested that in certain instances, manufacturers and other
parties may be liable in tort for damages suffered as a result of product
defect, regardless whether the parties actually produce the specific object
causing the damages. See Wright, 652 N.W.2d at 173 (examining civil
conspiracy scenario where “manufacturers agree to suppress information
about their product for the lawful purpose of facilitating the sale of their
product, and in effectuating this plan subject themselves to liability for
failure to warn of the risks of using their product”). Second, and more
importantly for purposes of our analysis here, in examining a claim for
failure to warn, we explained “what is really important is that the
statements were made for the purpose of influencing the action of
another,” and these claims need not “involve[] a business transaction
between the parties . . . .” Id. at 175–76. In Wright then, as in Hawkeye,
we took care to establish that specific theories of products liability,
whether strict liability or otherwise, did not displace other claims of
negligence, and that each theory of liability must be analyzed in terms of
the relevant facts and legal principles. Wright, 652 N.W.2d at 176;
Hawkeye, 174 N.W.2d at 685.
Long before we made these analytical refinements to our law of
products liability in Wright, we confronted certified questions from a
federal case involving parents who had suffered damages as a result of
the mother’s ingestion of DES during pregnancy. See Mulcahy v. Eli Lilly
& Co., 386 N.W.2d 67, 69 (Iowa 1986). Unable to identify the
manufacturer of the DES ingested by the mother, the parents brought
suit against twenty-five drug companies who had manufactured or
marketed DES during the period in which the mother had ingested it. Id.55
The parents brought claims of strict liability, negligence,
misrepresentation, and breach of warranty, among others. Id. We made
no reference to whether specific claims of manufacturing defect, design
defect, failure to warn, or any others had been advanced, but we gave no
indication we had any occasion to consider the DES manufacturers’
liability for claims of design defect or failure to warn. 19 See id. at 69–70.
Setting forth legal principles applicable for analyzing the parents’
tort claims, we noted a “plaintiff in a products liability action must
ordinarily prove that a manufacturer or supplier produced, provided or
was in some way responsible for the particular product that caused the
injury.” Id. at 70. As authority for that proposition, we cited the
Restatement (Second) of Torts section 402A—the strict liability provision
having no application to negligence claims—and our earlier case of
Osborn v. Massey-Ferguson, Inc., 290 N.W.2d 893, 901 (Iowa 1980).
Mulcahy, 386 N.W.2d at 70. In Osborn, we had similarly noted claims of
strict liability for manufacturing defects typically involve a requirement of
manufacture by the defendant, but we had distinguished the negligence
claims at issue and noted those claims were to be analyzed in accordance
with our standard negligence principles. See Osborn, 290 N.W.2d at 901;
see also Wright, 652 N.W.2d at 168 (explaining principles underlying
“strict liability [are] appropriate in manufacturing defect cases, but
negligence principles are more suitable for other defective product
cases”). We cited our earlier case of Schiltz v. Cullen-Schiltz & Associates,
Inc., 228 N.W.2d 10, 16–18 (Iowa 1975), as illustrative of the appropriate
negligence analysis. Osborn, 290 N.W.2d at 901.
19Our failure to address the theories of design defect and failure to warn might
be attributable to the fact the DES manufacturers were manufacturers, and to the fact
we had not often distinguished those claims from claims for manufacturing defect at
that point. See Mulcahy, 386 N.W.2d at 69–70.
56
In Schiltz, we had encountered a claim alleging defective design of
a sewage treatment facility. Schiltz, 228 N.W.2d at 17. We explained
that to prevail on a claim of negligent design by the engineers, the
claimant must prove the work fell short of the “degree of skill, care and
learning ordinarily possessed and exercised” in the engineering
profession and the substandard care resulted in the damage. Id.Notably, our negligence analysis in Schiltz imposed no requirement that
the engineers had built or manufactured the defective sewage treatment
facility. See id. Indeed, they had not, as they had merely provided plans
and specifications for the facility’s construction to an independent
contractor, who had independent obligations to inspect the site and
circumstances attending the project and to diligently pursue, supervise,
and complete the construction. Id. at 12–13. Instead, for purposes of
the negligence analysis, we made clear the important questions in Schiltz
were whether the engineers had negligently designed the facility and
whether that negligence had caused the damages suffered. Id. at 17; see
also McCarthy v. J.P. Cullen & Son Corp., 199 N.W.2d 362, 367–68 (Iowa
1972) (examining architects’ duties with respect to plans and
specifications and noting duty extended to protection of owners of
adjacent properties from harms “which reasonably could be expected to
flow from” the plans).
We acknowledged and employed the principles of these cases in
Mulcahy neither to elide theories of strict liability and negligence, nor to
suggest all products liability claims were to be treated as claims of
manufacturing defect, but to ensure a “causal connection between the
defendant’s product and plaintiff’s injury.” Mulcahy, 386 N.W.2d at 70.
Our general negligence principles, we noted, require a claimant to prove
“the defendant caused the complained of harm or injury.” Id. at 72. In a
57
case involving so many apparent manufacturers of DES, some of which
had not been named as defendants, we explained, the claimants could
not prove any of the named defendants “was in some way responsible
for,” or had actually “caused the injury to” the plaintiff. Id. at 70, 72. In
a case involving fewer manufacturers, we noted, the plaintiff might not
have run up against the same causation problem—if, for instance, the
“plaintiff established that only two manufacturers’ DES products were
sold at a certain pharmacy, and [she] bought her DES only at that
pharmacy but c[ould not] identify which brand she purchased.” Id. at
73. Other theories of liability, such as enterprise liability, might also
have “avoid[ed] the legal causation problem that arises from an inability
to identify the manufacturer of the specific injury-causing product” in
cases involving so many possible responsible parties, but we found those
theories inapplicable given the facts before us. Id. at 72. Instead, given
the sheer number of possibly responsible parties, we declined to adopt
the special liability theories advanced by the plaintiffs and concluded we
would not impose “liability upon a manufacturer for harm it may not
have caused.” Id. at 76.
Based on our products liability principles, and based on the
specific problem at issue in Mulcahy, I believe our Mulcahy analysis
provides useful but limited guidance for our resolution of the case before
us. We are not faced here with a claim of strict liability for
manufacturing defect on behalf of the brands, and thus the strict liability
causation requirement that the manufacturer be responsible for the
manufacturing defect, set forth in cases like Hawkeye and Osborn and
imported in Mulcahy, is inapplicable here. See Mulcahy, 386 N.W.2d at
70; Osborn, 290 N.W.2d at 901; Hawkeye, 174 N.W.2d at 684; see also
Wright, 652 N.W.2d at 164. More importantly for purposes of our
58
analysis with respect to the claims of negligence here, we are not faced
with a case involving numerous possibly responsible defendants or
involving the possibility an unnamed party might actually be responsible
for the harm suffered in lieu of any named defendant. See Mulcahy, 386
N.W.2d at 71–72. Instead, by contrast, the parties here have stipulated
to the relevant facts: the brands designed and manufactured branded
Reglan; PLIVA manufactured the generic product actually ingested; and
federal laws and regulations establish various obligations for PLIVA and
the brand defendants. The causation problem we identified in Mulcahy
therefore does not present itself here, and although our exposition of
general negligence principles has application here, Mulcahy gives us no
specific guidance as to how to resolve the negligence claims in scenarios
like this one where all relevant actors have been identified. Instead, the
negligence principles we have set forth in numerous cases like Schiltz
must guide our resolution here, and those cases have never required an
actor who has breached an obligation of care be a manufacturer for
purposes of tort liability. See Schiltz, 228 N.W.2d at 17–18; see also
Bredberg v. PepsiCo, Inc., 551 N.W.2d 321, 327 (Iowa 1996) (noting
product designers are also subject to strict liability claims).
Moreover, the brands have not offered any explanation as to why
we must treat them as manufacturers for purposes of our negligence
analysis. In fact, all parties involved have stipulated the brands were not
manufacturers of generic metoclopramide at the time of Huck’s ingestion.
As noted, we have in numerous prior products liability cases held an
actor need not be a manufacturer for purposes of analyzing liability,
regardless whether the claim is one of negligence or strict liability. See
Weyerhaeuser v. Thermogas Co., 620 N.W.2d 819, 825 (Iowa 2000)
(noting several justifications for holding an assembler liable in both
59
negligence and strict liability for the failure of a component it did not
manufacture); Bredberg, 551 N.W.2d at 327; Schiltz, 228 N.W.2d at 18;
cf. Wright, 652 N.W.2d at 169 (adopting sections 1 and 2 of the
Restatement (Third) of Torts: Products Liability); Clark v. McDaniel, 546
N.W.2d 590, 592–94 (Iowa 1996) (holding used-car dealer liable for
misrepresentation of car quality). Our negligence cases have always
required a negligent act or omission on the part of an actor, causation,
and damages within the actor’s scope of liability. See, e.g., Thompson v.
Kaczinski, 774 N.W.2d 829, 834 (Iowa 2009); Stotts v. Eveleth, 688
N.W.2d 803, 807 (Iowa 2004); Van Essen v. McCormick Enters. Co., 599
N.W.2d 716, 718 (Iowa 1999). As we have taken great care to emphasize
in our products liability cases, no principle of products liability law
displaces that framework. See Wright, 652 N.W.2d at 164; Hawkeye,
174 N.W.2d at 685.
Courts from numerous jurisdictions have recognized these
principles and declined to dismiss claims against brand defendants given
similar factual circumstances. See, e.g., Dolin v. SmithKline Beecham
Corp., No. C6403, 2014 WL 804458, at *6 (N.D. Ill. Feb. 28, 2014)
(“[T]hese parties stood in a relationship to one another that, while clearly
not ‘direct,’ was sufficient for the law to impose a duty of reasonable
conduct upon GSK for the benefit of Plaintiff.”); Chatman v. Pfizer, Inc.,
960 F. Supp. 2d 641, 654 (S.D. Miss. 2013) (“Chatman may pursue her
common-law claims under ‘old’ state law theories of liability, even though
she may have been injured by a product manufactured by another.”);
Kellogg v. Wyeth, 762 F. Supp. 2d 694, 704 (D. Vt. 2010) (“To date,
however, Vermont has not eliminated common law actions for negligence
or fraud merely because they involve products.”); Easter v. Aventis
Pasteur, Inc., No. 5:03-CV-141 (TJW), 2004 WL 3104610, at *9 (E.D. Tex.
60
Feb. 11, 2004) (“Lilly, as a designer, has a duty to develop a safe design
for thimerosal. Also, Lilly’s design of and intimate knowledge about
thimerosal also gives rise to a duty to inform users of hazards associated
with the use of thimerosal. Therefore, the Court finds that the plaintiffs
have adequately stated a design defect claim against Lilly.”); Wyeth, Inc.
v. Weeks, ___ So.3d ___, ___, 2013 WL 135753, at 19 (Ala. Jan. 11, 2013),
reargument granted (June 13, 2013) (“Under Alabama law, a brand-name
drug company may be held liable for fraud or misrepresentation (by
misstatement or omission), based on statements it made in connection
with the manufacture of a brand-name prescription drug, by a plaintiff
claiming physical injury caused by a generic drug manufactured by a
different company.”); Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299, 320–21
(Ct. App. 2008) (“We hold that Wyeth’s common-law duty to use due care
in formulating its product warnings extends to patients whose doctors
foreseeably rely on its product information when prescribing
metoclopramide, whether the prescription is written for and/or filled with
Reglan or its generic equivalent.”); Lance v. Wyeth, 85 A.3d 434, 461 (Pa.
2014) (“There has been no supported presentation here which would
persuade us to immunize companies from the responsibility to respond
in damages for such a lack of due care resulting in personal injury or
death.”); Clark v. Pfizer, Inc., No. 1819, 2008 Phila. Ct. Com. Pl. LEXIS
74, *29 (Ct. Com. Pl. 2008) (“[T]he relationship between the purchasers of
generic Gabapentin and these defendant [brand] manufacturers herein is
that of purchaser of drugs which never would have been purchased but
for defendants’ [conduct].”). See generally Allen Rostron, Prescription for
Fairness: A New Approach to Tort Liability of Brand-Name and Generic
Drug Manufacturers, 60 Duke L.J. 1123, 1160 (2011) [hereinafter
Rostron] (noting courts have recognized “[n]egligence and strict products
61
liability are separate and distinct bases for liability” and “do not
automatically collapse into each other merely because there are some
situations in which a plaintiff might be able to assert both types of
claims” (internal quotation marks omitted)).
Several courts have recognized that given the obligations created
by the Hatch-Waxman Act, the causation problem we identified in
Mulcahy is inapplicable here, because “whether a consumer ingests the
name-brand or generic version of a given drug is immaterial as to the
likelihood that negligence in the design or warning label of that drug will
cause injury.” Dolin, 2014 WL 804458, at *5; see also, e.g., Schedin v.
Ortho-McNeil-Janssen Pharm., Inc., 808 F. Supp. 2d 1125, 1131 (D. Minn.
2011) (“[u]nder the pre-2007 statutory framework . . . a brand-name
manufacturer was the only entity in the trifecta of actors (the FDA, the
brand-name manufacturer, and the generic) that could strengthen an
inadequate label.”), aff’d in part, rev’d in part on other grounds, 700 F.3d
1161 (8th Cir. 2012); Kellogg, 762 F. Supp. 2d at 702 (“A reasonable jury
could conclude that inadequate, misleading and inaccurate information
provided by the [brand defendants] was a . . . cause of her injury.”);
Weeks, 2013 WL 135753, at *19 (“In short, the patient must show that,
but for the false representation made in the warning, the prescribing
physician would not have prescribed the medication to his patient.”);
Rostron, 60 Duke L.J. at 1164 (“Throughout the long line of precedent
that flowed out of Foster, courts have repeatedly made the same mistake,
dwelling on the irrelevant concept of liability being imposed on multiple
manufacturers because of uncertainty about who made a product and
conflating that concept with the separate and distinct issue of whether a
manufacturer can be liable for wrongdoing other than making and selling
the product the plaintiff received.”). Several courts have reasoned “case
62
law, commonsense and fairness dictates” the brands cannot both avoid
claims of strict products liability on the ground they were not
manufacturers of the generic version of the drug, and avoid claims of
negligence on the ground they were manufacturers of some other drug.
Chatman, 960 F.Supp.2d at 653 (“[T]hey cannot have it both ways.”); see
also Dolin, 2014 WL 804458, at *4 (“GSK has not shown why Plaintiff
should be precluded from claiming at common law that GSK,
independent of its capacity as a manufacturer . . . was negligent in
connection with its [other responsibilities] . . . .”).
Many courts have recognized proper resolution of negligence
claims turns not on a question of whether a product is somehow
involved, but on an analysis of traditional negligence principles. See,
e.g., Dolin, 2014 WL 804458, at *4–5 (rejecting defense of manufacturer
immunity and applying Illinois negligence law to claims against brand
defendants); Easter, 2004 WL 3104610, at *9 (rejecting defense of
manufacturer immunity and applying Texas negligence law to claims
against brand defendants); Lance, 85 A.3d at 458–60 (rejecting defense of
manufacturer immunity and applying Pennsylvania negligence law to
claims against brand defendants); see also Kolarik v. Corey Int’l Corp.,
721 N.W.2d 159, 162–63, 166 (Iowa 2006) (noting olives were “products”
for purposes of products liability and nevertheless allowing plaintiff to
proceed on general negligence claim for failure to warn).
Finally, several courts have persuasively argued a decision to
eviscerate an enormous segment of our negligence law and “immunize
companies from the responsibility to respond in damages for such a lack
of due care resulting in personal injury” is a “weighty and consequence-
laden policymaking” judgment best left to Congress and the state
legislatures—none of which have granted such immunity just yet. Lance,
63
85 A.3d at 461–62; see also Chatman, 960 F.Supp.2d at 654–55 (noting
“the Mississippi legislature has abolished the requirement of privity ‘in all
causes of action for personal injury . . . brought on account of
negligence’ ” (quoting Miss. Code Ann. § 11-7-20 (West, Westlaw through
2014 Regular (end) and First Extraordinary (end) Sess.)); Kellogg, 762
F.Supp.2d at 704 (“Neither the Vermont courts nor the Vermont
legislature have collapsed negligence actions into strict liability actions
where products are involved.”).
I believe each of these principles is applicable in the case before us,
and I believe both our law of products liability and our law of negligence
dictate the brand defendants may be subject to liability here. As
numerous authorities have noted, the causation problem the majority
has identified in Mulcahy is irrelevant given the facts and claims before
us. Instead, we must analyze the claims given our long-standing
principles of negligence—a task I turn to now.
II. Duty.
We have often noted that while summary adjudication is rarely
appropriate in negligence cases, the determination of whether a duty is
owed under particular circumstances is a matter of law for the court’s
determination. See, e.g., Hoyt v. Gutterz Bowl & Lounge L.L.C., 829
N.W.2d 772, 775 (Iowa 2013); Thompson, 774 N.W.2d at 834. In
Thompson, we adopted the duty analysis of section 7 of the Restatement
(Third) of Torts: Liability for Physical and Emotional Harm, and we
concluded an actor generally has a duty to exercise reasonable care
when the actor’s conduct creates a risk of physical harm. Thompson,
774 N.W.2d at 835; see also Feld v. Borkowski, 790 N.W.2d 72, 75 (Iowa
2010) (“As a general rule, our law recognizes that every person owes a
duty to exercise reasonable care to avoid causing injuries to others.”).
64
We explained that in most cases, a court need not concern itself
with the existence or content of the duty, and should instead proceed to
analysis of the remaining elements of negligence liability. Thompson, 774
N.W.2d at 835; see also Feld, 790 N.W.2d at 76. In exceptional cases, we
noted, an actor’s general duty to exercise reasonable care might be
displaced or modified based on countervailing policy considerations
justifying limited or no liability in certain classes of cases—but those
policy reasons were not to depend on the specific facts of any given case.
Thompson, 774 N.W.2d at 835. In detailing this analysis more recently,
we have noted we may look to the comments and principles of the
current Restatement, the comments and principles of prior
Restatements, and our prior caselaw in determining whether policy
considerations dictate departure from our general recognition of a duty to
exercise reasonable care in particular broadly drawn classes of cases.
See McCormick v. Nikkel & Assocs., Inc., 819 N.W.2d 368, 371–74 (Iowa
2012).
A. Applicable Duty Principles From Our Caselaw and the
Restatements of the Law. The drafters of the Restatement (Third) have
set forth several important duty principles to guide us in our analysis
here. The drafters explain an actor’s business operations may provide a
fertile source for natural risks or third-party misconduct that creates
risks that would not have occurred in the absence of the business.
Restatement (Third) of Torts: Liab. for Physical & Emotional Harm § 37
cmt. d, at 5 (2012). Section 19, they note, specifically sets forth the
standard of care for scenarios where an actor’s conduct increases the
risk of third-party conduct causing harm. Id. We adopted that
reasoning in Hoyt, where we concluded the duty of care applies to all
risks arising from a given course of conduct, even if also created in part
65
by a third party’s conduct, regardless “whether innocent, negligent, or
intentional.” Hoyt, 829 N.W.2d at 779. In cases where business
operations provide a source of risk, the drafters note, “the actor’s
conduct creates risks of its own and, therefore, is governed by the
ordinary duty of reasonable care in [section] 7.” Restatement (Third) of
Torts: Liab. for Physical & Emotional Harm § 37 cmt. d, at 5.
The drafters also note section 315 of the Restatement (Second) of
Torts has often led to pronouncements that “absent a special relationship
an actor owes no duty to control third parties.” Id. Section 315,
however, addressed only affirmative duties to control third parties—it
had nothing to say about “the ordinary duty of reasonable care with
regard to conduct that might provide an occasion for a third party to
cause harm.” Id. The Restatement (Second) actually addressed that
latter scenario in section 302B, the drafters explain, in providing for a
duty of care when an actor’s conduct “ ‘has created or exposed the other
to a recognizable high degree of risk of harm through such [third-party]
misconduct.’ ” Restatement (Third) of Torts: Liab. for Physical &
Emotional Harm § 37, cmt. d, at 5 (quoting Restatement (Second) of Torts
§ 302B cmt. e, at 90). Thus, the drafters note, both the Restatement
(Second) and the Restatement (Third) provide for liability when actors
engage in conduct that increases the magnitude of natural or third-party
risks. Id. § 37, cmt. d, at 4–5. Even when the actor and victim are
complete strangers and have no relationship, the drafters explain, the
basis for the ordinary duty of reasonable care under section 7 is conduct
creating risk to another. Id. § 37 cmt. b, at 3; see also West v. Broderick
& Bascom Rope Co., 197 N.W.2d 202, 209 (Iowa 1972) (noting Iowa
courts have “extricat[ed] themselves from the erroneous imposition of the
privity requirement”). A relationship, in other words, does not typically
66
define the line between duty and no duty—instead, the line is drawn by
conduct creating risk to another. Restatement (Third) of Torts: Liab. for
Physical & Emotional Harm § 37 cmt. b, at 3; see, e.g., Keller v. State,
475 N.W.2d 174, 179 (Iowa 1991) (“[L]inking the existence of legal duty to
a particular relationship between the parties is not an unwavering
requirement for all negligence torts.”); see also Chatman, 960 F. Supp. 2d
at 654 (“As a general rule, in the context of negligence claims a
relationship is not necessary for a duty to exist.”); Gipson v. Kasey, 150
P.3d 228, 232 (Ariz. 2007) (“A special or direct relationship, however, is
not essential in order for there to be a duty of care.”).
Further, the Restatement (Third) devotes an entire section to
conduct creating an ongoing risk of physical harm, in providing “[w]hen
an actor’s prior conduct, even though not tortious, creates a continuing
risk of physical harm of a type characteristic of the conduct, the actor
has a duty to exercise reasonable care to prevent or minimize the harm.”
Restatement (Third) of Torts: Liab. for Physical & Emotional Harm § 39,
at 31. As the drafters make clear, the initial conduct need not be
actionable or even tortious for a duty to arise under the section. Id. § 39
cmt. c, at 31. In addition, they explain that even in the rare case a court
declines to apply the general section 7 duty we have recognized in our
caselaw, an actor will nonetheless have an ongoing duty to use
reasonable care to warn or otherwise mitigate risk under section 39. Id.
§ 39 cmt. d at 33–34.. Even if the actor does not know his or her
conduct has created a risk of harm, the drafters point out, the duty
provided in section 39 exists. Id. § 39 cmt. d, at 34. In that case,
however, “[b]efore a breach of the duty occurs . . . an objectively
foreseeable risk of harm must exist,” and that question, the drafters
note, “is a question of fact for the jury.” Id. § 39 cmt. d, at 34–35. The
67
section 39 duty, the drafters explain, is justified both by an actor’s
creation of a risk, even if nontortiously, and by “the absence of the
pragmatic and autonomy explanations” for the no-duty rule set forth in
section 37. 20 Id. § 39 cmt. c, at 32. We have recognized the principles
expressed in section 39 for many years. See, e.g., Lovick 588 N.W.2d at
696 (“Our decision today confirms the existence of a post-sale duty for
manufacturers to warn . . . .”); see also Mercer v. Pittway Corp., 616
N.W.2d 602, 623–24 (Iowa 2000) (“[T]he inquiry is whether a reasonable
manufacturer knew or should have known of the danger, in light of the
generally recognized and prevailing best scientific knowledge, yet failed to
provide adequate warning to users or customers.”).
Section 552 of the Restatement (Second) of Torts provides
additional insight. This section, setting forth requirements for the tort of
negligent misrepresentation, provides that an actor supplying false
information for the guidance of others may be liable for losses caused by
justifiable reliance upon the information. See Restatement (Second) of
Torts § 552, at 126–27. We have a long history of applying the section
552 principles in Iowa, and we have noted our caselaw ensures those
liable are in a position to weigh potential uses of the information against
20Section 37 of the Restatement (Third) provides the standard autonomy-based
no-duty rule: “An actor whose conduct has not created a risk of physical or emotional
harm to another has no duty of care to the other unless a court determines that one of
the affirmative duties provided in §§ 38–44 is applicable.” Restatement (Third) of Torts:
Liab. for Physical & Emotional Harm § 37, at 2. The most common justification for this
rule, the drafters note, “relies on the liberal tradition of individual freedom and
autonomy” and places limits on “requiring affirmative conduct.” Id. § 37 cmt. e, at 5.
Tensions between the section 37 justification and our common “values about
humanitarian conduct” is reflected in the numerous exceptions to the rule elsewhere in
the Restatement. Id. § 37 cmt. e, at 6. The section 37 rule also has other less common
pragmatic justifications, the drafters explain, such as the concern that an affirmative
duty to aid others in peril might be confused with a general duty of self-sacrifice. Id.
§ 37 cmt. e, at 5–6. As the drafters note, the rule has no application in any case where
“the entirety of the actor’s conduct . . . [has] created a risk of harm.” Id. § 37 cmt. c, at
3.
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the potential magnitude and probability of loss if the information is
inadequate or incorrect. See Van Sickle Const. Co. v. Wachovia
Commercial Mortg., Inc., 783 N.W.2d 684, 691–92 (Iowa 2010).
As the drafters of the Restatement (Second) recognized long ago,
“[w]hen there is a public duty to supply the information in question . . .
the maker of the negligent misrepresentation becomes subject to liability
to any of the class of persons for whose benefit the duty is created.”
Restatement (Second) of Torts § 552 cmt. k, at 138. The rule, the
drafters explained, applies to both public officers and private individuals
or corporations required by law to file information for the benefit of the
public. Id. § 552 cmt. k, at 139. In cases where the group to be
protected by the filing requirement is a broad one, the drafters noted, a
corporation might be liable to “any one who may reasonably be expected
to rely on the information and suffer loss as a result.” Id. As an
illustration of the principle, the drafters offered the following example:
A, a United States government food inspector, in the
performance of his official duties, negligently stamps a
quantity of B’s beef as “Grade A.” In fact the beef is of
inferior quality. In reliance upon the stamps, C buys the
beef from D, and suffers pecuniary loss as a result. A is
subject to liability to C.
Restatement (Second) of Torts § 552 illus. 18, at 139; see also id. § 552
cmt. i, at 136 (“When a misrepresentation creates a risk of physical harm
to the person, land or chattels of others, the liability of the maker
extends, under the rules stated in §§ 310 and 311, to any person to
whom he should expect physical harm to result through action taken in
reliance upon it.”).
We have applied reasoning presaging the drafters’ section 552
analysis for more than a century here in Iowa. See, e.g., Warfield v.
Clark, 118 Iowa 69, 72–73, 91 N.W. 833, 835 (1902) (“If the defendant in
69
fact falsely reported the financial condition of his company for the
purpose of deceiving the public in relation to its responsibility as an
insurer, it seems clear to us that we should not say as a matter of law
that he only intended to wrong that particular class, and that those
dealing in its stock were not his intended victims; for he knew that stock
in such companies was often bought and sold, and that reliance might be
placed upon his sworn statement by those dealing therein.”). As a
general proposition, we have long recognized and continue to recognize
an actor may be liable to third parties who reasonably rely upon
information prepared by the actor where the actor has reason to believe
the information will be relied upon by the third party. See, e.g.,
Van Sickle, 783 N.W.2d at 691; Ryan v. Kanne, 170 N.W.2d 395, 403
(Iowa 1969). The point of this discussion, of course, is not that a brand
defendant must owe a duty to a consumer under section 552; the point,
instead, is the tort of negligent misrepresentation is another illustration
of the principle that an actor may create a risk of harm and thus owe a
duty to another even in the absence of having sold or manufactured a
product. Accordingly, the majority misses the mark in concluding the
brand defendants owe no duty to Huck because they never sold her a
product.
Similarly, just as we have applied the duty principles of the
Restatement (Second) for many years, we have also applied the duty
principles of the Restatement (Third) both before and after our adoption
of the section 7 general duty in Thompson. See, e.g., Bohan v. Hogan,
567 N.W.2d 234, 237 (Iowa 1997) (“An act or omission may be negligent
if the actor realizes or should realize that it involves an unreasonable risk
of harm to another through the negligent or reckless conduct of the other
or a third person.” (quoting Restatement (Second) of Torts § 302A, at
70
86)); Fiala v. Rains, 519 N.W.2d 386, 389 (Iowa 1994) (same); see also
Mitchell v. Cedar Rapids Cmty. Sch. Dist., 832 N.W.2d 689, 702 (Iowa
2013) (“[W]e have adopted the duty principles of the Restatement (Third)
. . . .”); Hoyt, 829 N.W.2d at 775–76, 776 n.4 (examining duty principles
of Restatement (Third) sections 7, 19, 37, and 40).
Our analysis in Bohan is particularly illustrative of this point. See
Bohan, 567 N.W.2d at 235–37. In Bohan, a group of investors brought
negligence claims for losses suffered as a result of a deception by a
securities broker. Id. at 235. The broker had secured funds from the
investors by delivering them fictitious certificates of deposit purporting to
have been issued by a Chicago bank. Id. At issue in the case were not
the claims of the investors against the broker, but the investors’ claims
against a small Iowa printer who had printed the certificates, without
knowledge of the deception, at the broker’s request. Id. Despite the
printer’s lack of knowing involvement in the broker’s scheme, and despite
the lack of any special relationship between the printer and the
investors, we reasoned the investors had stated a claim of the printer’s
“own active negligence in furnishing an instrumentality that caused
harm to these claimants.” Id. at 236. With the aid of the principles set
forth in Restatement (Second) section 302B, and later in Restatement
(Third) sections 7, 19, and 37, we concluded a duty to exercise
reasonable care exists when an actor’s conduct creates a risk of harm,
even if the risk involves the negligent or reckless conduct of another. See
id. at 236–37. No special relationship, we explained, was required
between the parties to give rise to the duty. Id. at 237. We were thus
“unable to conclude that there could be no set of facts proved that would
support a claim of actionable negligence on the part of” the printer. Id.
at 236.
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Our cases following Thompson have applied the same principles.
In Feld, we explained all actors owe a duty to exercise reasonable care to
avoid causing injury to others, and the actor may be liable if the injury
caused by the actor’s conduct resulted from the risks rendering the
actor’s conduct negligent. Feld, 790 N.W.2d at 75–76; see also
Restatement (Second) of Torts § 284(a), at 19 (providing negligent
conduct includes acts “which the actor as a reasonable man should
recognize as involving an unreasonable risk of causing an invasion of an
interest of another”). We noted our long-standing contact-sports
exception to the general duty to exercise reasonable care, and noted
various policy reasons supported our modification of the general duty in
the realm of slow-pitch high school softball. Feld, 790 N.W.2d at 76–78.
We retained the general duty for that class of cases, but modified it such
that actors in slow-pitch softball games now have a duty to avoid
reckless disregard for the safety of others. Id. Similarly, in McCormick,
we noted we had affirmed our law recognizing the general duty in
Thompson and explained an actor generally has a duty to exercise
reasonable care when the actor’s conduct creates a risk of physical
harm. McCormick, 819 N.W.2d at 371, 374. Concluding the
subcontractor there owed no duty to a property owner’s employee who
had been electrocuted by a switchgear, we explained the subcontractor
had not “create[d] a ‘risk of physical harm,’ ” and thus our general
negligence principles and the principles of the Restatement (Third) would
not support liability. Id. at 374–75 (quoting Restatement (Third) of Torts:
Liab. for Physical & Emotion Harm § 7(a), at 77). Finally, in Hoyt, we
reiterated our long-standing rule that an actor has a duty to exercise
reasonable care when his or her conduct creates a risk of harm, while
explaining no-duty rulings should be limited to exceptional classes of
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cases invoking specifically articulated countervailing policy
considerations. Hoyt, 829 N.W.2d at 775.
Notably, we never invoked the duty question at all in Bredberg or
Mulcahy. See Bredberg, 551 N.W.2d at 323–29; Mulcahy, 386 N.W.2d at69–76. The majority appears to agree Mulcahy had nothing to say about
duty—the court there was concerned with the majority’s proposed
“product-identification causation requirement,” because the existence of
a duty was never in question. The duty principle most prominently
applicable in both Mulcahy and Bredberg was surely the long-standing
strict products liability principle that “the seller, by marketing his
product for use and consumption, has undertaken and assumed a
special responsibility toward any member of the consuming public who
may be injured by it.” Restatement (Second) of Torts § 402A cmt. c, at
349; see also Bredberg, 551 N.W.2d at 326–27 (citing section 402A);
Mulcahy, 386 N.W.2d at 70 (same); see also Moore v. Vanderloo, 386
N.W.2d 108, 117 (Iowa 1986) (“A drug manufacturer may be held liable
for a defective product in a strict liability action.”).
That strict liability principle, however, was not the only principle
resolving the duty question in those cases or any other products liability
cases, because as we have long noted, our long-standing general duty of
reasonable care is also applicable in these cases. See, e.g., Osborn, 290
N.W.2d at 901 (citing cases examining “defective design of a product or
project as negligence”); see also Lovick, 588 N.W.2d at 696 (confirming
duty to exercise reasonable care in post-sale warning); Cooley v. Quick
Supply Co., 221 N.W.2d 763, 771 (Iowa 1974) (explaining question of
whom should receive warning is “to be decided [by a jury] by standards
of reasonable care.”); Hawkeye, 174 N.W.2d at 685; Bengford v. Carlem
Corp., 156 N.W.2d 855, 864 (Iowa 1968) (“Applying these rules to the
73
evidence in this case it seems clear a jury could find defendant, Ford
Motor Company, failed to follow these recognized standards of care and
that as a proximate cause thereof plaintiff was injured.”); Wagner v.
Larson, 257 Iowa 1202, 1222, 136 N.W.2d 312, 324 (1965) (“If a
manufacturer does everything necessary to make the machine function
properly . . . then the manufacturer has satisfied the law’s demands.”
(quoting Campo v. Scofield, 95 N.E.2d 802, 804 (N.Y. 1950))). As we have
more recently explained, affirmative duties created as a result of a special
relationship or undertaking, like the strict liability duty, may often
overlap with the general duty, but the existence of an affirmative duty
does not displace the general duty. See, e.g., Hoyt, 829 N.W.2d at 775–
76; see also Hawkeye, 174 N.W.2d at 685; Restatement (Third) of Torts:
Liab. for Physical & Emotional Harm § 6 cmt. e, at 68–69 (explaining
special rules of law, “such as various rules of strict liability,” may impose
liability even in the absence of the general duty, and noting Restatement
(Third) of Torts: Products Liability details those strict liability rules); id.
§ 40 cmt. c, at 40 (explaining relationship between general and
affirmative duties); id. § 40 cmt. h, at 42–43 (same).
B. Application of Our Duty Principles. Applying our duty
principles as we always have, the existence of a duty should not be
controversial here. The brand defendants created risks in designing and
manufacturing Reglan®, and created risks in developing its warning,
which, by virtue of federal law, generics were required to mimic. Those
risks gave rise to duties. These are not novel propositions in our
caselaw. See, e.g., Cooley, 221 N.W.2d at 771 (requiring “reasonable
assurance that the information will reach those whose safety depends
upon their having it” (internal quotation marks omitted)); West, 197
N.W.2d at 209 (noting we recognize a duty of reasonable care “as to any
74
product which [an actor] can reasonably expect to be dangerous if he is
negligent in its manufacture or sale”); Tice v. Wilmington Chem. Corp.,
259 Iowa 27, 43, 141 N.W.2d 616, 626 (1966) (“When a manufacturer,
distributor, producer or retailer markets a product with representations
as to its condition there should most certainly be imposed a strict
accountability where the ultimate consumer relies upon those
representations and suffers injury. . . .”); see also PLIVA, Inc. v. Mensing,
564 U.S. ___, ___, 131 S. Ct. 2567, 2585–86, 180 L. Ed. 2d 580, 600–01
(2011) (Sotomayor, J., dissenting) (noting FDA requires drug companies “
‘to seek to revise their labeling and provide FDA with supporting
information about risks’ ” and explaining it is “undisputed” that drug
companies “have a duty under federal law to monitor the safety of their
products”); Restatement (Third) of Torts: Prods. Liab. § 6(c), at 145
(establishing duty of care to balance risks and benefits of prescription
drugs with respect to design); id. § 6(d), at 145 (establishing duty of care
to balance risks and benefits of prescription drugs with respect to
instruction and warning); cf. Lamb v. Manitowoc Co., 570 N.W.2d 65, 68
(Iowa 1997) (“A duty to warn exists when a party reasonably foresee[s] a
danger of injury or damage to one less knowledgeable unless an
adequate warning is given.” (Internal quotation marks omitted.)). Neither
the majority nor the parties have suggested we depart from our long-
standing recognition of both general and special duties when an actor’s
conduct creates a risk of physical harm, and I believe our recognition of
those duties settles the question here. See Restatement (Third) of Torts:
Liab. for Physical & Emotional Harm § 7, at 77; see also Hoyt, 829
N.W.2d at 776–77; Feld, 790 N.W.2d at 75–76; Thompson, 774 N.W.2d at
835; Restatement (Second) of Torts § 327, at 146 (“One who knows or
has reason to know that a third person . . . is ready to give to another aid
75
necessary to prevent physical harm to him, and negligently prevents or
disables the third person from giving such aid, is subject to liability for
physical harm caused to the other by the absence of the aid which he
has prevented the third person from giving.”). Whether countervailing
policy considerations may modify those duties is a separate question,
and a question the parties do not address directly, but I will analyze it in
turn.
Before tackling that question, however, I note even application of a
relation-based conception of duty would establish duties on behalf of the
brands, because federal law establishes the brands’ responsibility for
both the design of the drug and the warning in question here. See, e.g.,
Dolin, 2014 WL 804458, at *4 (explaining brand “was responsible for”
generic’s “design and warning label”); see also Mulcahy, 386 N.W.2d at
70 (explaining liability may attach when actor “was in some way
responsible for the particular product that caused the injury”); Lance, 85
A.3d at 453 n.24 (explaining “federal law also imposes post-marketing
duties on pharmaceutical companies, including the obligation to ‘ensur[e]
that [their] warnings remain adequate as long as the drug is on the
market’ ”). With respect to design, federal law requires the generic
version’s chemical equivalence to the approved brand-name drug: it must
have the same “active ingredient” or “active ingredients,” “route of
administration,” “dosage form,” and “strength” as its brand-name
counterpart. 21 U.S.C. § 355(j)(2)(A)(ii)–(iii) (2012). The generic must also
be “bioequivalent” and have the same “rate and extent of absorption” as
the branded drug. Id. § 355(j)(2)(A)(iv), (8)(B). With respect to the
warning, as the majority explains, the FDA must approve the accuracy
and adequacy of the brands’ labeling, and generic drug manufacturers
are required, by law, to show “the labeling proposed for the new drug is
76
the same as the labeling approved for the [approved brand-name] drug.”
Id. § 355(a), (b)(1), (d), (2)(A)(v). And, after initial approval of the new
drug application, a brand manufacturer may update its label to “add or
strengthen a contraindication, warning, precaution, or adverse reaction”
or to “add or strengthen an instruction about dosage and administration
that is intended to increase the safe use of the drug product” by filing an
application with the FDA, but it need not wait for FDA approval, and the
generic manufacturers are subject to an ongoing obligation of sameness.
21 C.F.R. § 314.70(c)(6)(iii)(A), (C) (2008); id. §§ 314.94(a)(8), .127(a)(7);
Abbreviated New Drug Application Regulations, 57 Fed. Reg. 17950–01,
17961 (Apr. 28, 1992) (“[T]he [generic drug’s] labeling must be the same
as the listed drug product’s labeling because the listed drug product is
the basis for [generic drug] approval.”). Moreover, every state now has a
drug substitution law, which requires pharmacists filling prescriptions
under most circumstances to substitute generic alternatives for branded
drugs when available. Dolin, 2014 WL 804458, at *5 n.5; see also, e.g.,
Iowa Code § 155A.32 (2013).
There can be no doubt, then, the brands understood other
manufacturers were producing generic versions of the drug, those
versions were required by law to use the brands’ design and warning
label, consumers were purchasing those versions, and the brands had
the ability both initially and upon later investigation to remedy any
defects in the drug’s design or warning. Dolin, 2014 WL 804458, at *5–6;
see also Henkel v. R & S Bottling Co., 323 N.W.2d 185, 192 (Iowa 1982)
(“A manufacturer must anticipate the nature of the environment in which
the product [will] be used and [design against] the foreseeable risk
attending the product’s use in that setting.”). A mountain of authority
from other jurisdictions supports recognition of a duty on the part of a
77
brand manufacturer given these considerations. See Dolin, 2014 WL
804458, at *6 (“[T]hese parties stood in a relationship to one another
that, while clearly not ‘direct,’ was sufficient for the law to impose a duty
of reasonable conduct upon GSK for the benefit of Plaintiff.”); Schedin,
808 F. Supp. 2d at 1136 (“[T]he jury had sufficient evidence from which
to conclude [the brand] breached its duty to warn and that this breach
caused [the generic consumer’s] injuries.”); see also Chatman, 960
F. Supp. 2d at 655 (“In an affirmative misrepresentation case, even
though a defendant does not have a relationship with the plaintiff, it is
still possible for the defendant to be liable for causing the plaintiff's
physical injury if the plaintiff reasonably relies on false information
provided by the defendant”); Kellogg, 762 F. Supp. 2d at 706 (“To
recognize that a brand name drug manufacturer owes a duty to use
reasonable care to avoid causing injury to consumers of the generic
bioequivalents of its drugs does not ‘recognize a new cause of action or
enlarge an existing one’ . . . .”); Easter, 2004 WL 3104610, at *9 (“Lilly’s
design of and intimate knowledge about thimerosal also gives rise to a
duty to inform users of hazards associated with the use of thimerosal.”);
Weeks, 2013 WL 135753, at *19 (“[I]t is not fundamentally unfair to hold
the brand-name manufacturer liable for warnings on a product it did not
produce because the manufacturing process is irrelevant to
misrepresentation theories based, not on manufacturing defects in the
product itself, but on information and warning deficiencies, when those
alleged misrepresentations were drafted by the brand-name
manufacturer and merely repeated by the generic manufacturer.”); Conte,
85 Cal. Rptr. 3d at 315 (“We hold that Wyeth’s duty of care in
disseminating product information extends to those patients who are
injured by generic metoclopramide as a result of prescriptions written in
78
reliance on Wyeth’s product information for Reglan.”); Lance, 85 A.3d at
457 (“Wyeth—as the proponent of a contraction of existing tort law—has
failed to persuade us that federal regulatory involvement warrants a
departure from Pennsylvania’s system of civil redress, where there is a
demonstrated lack of due care in the face of an existing duty.”); Clark,
2008 Phila. Ct. Com. Pl. LEXIS 74, at *28–32 (concluding brand
manufacturer owed duty to generic purchaser).
Accordingly, I believe both relation-based and risk-based
conceptions of duty compel our recognition of a duty here.
C. Countervailing Policy Considerations. As noted, we have
recognized categorical principles or policy considerations may sometimes
provide a basis for modifying or eliminating our long-standing general
duty of care for certain broadly drawn classes of actors. See, e.g., Feld,
790 N.W.2d at 76. In the context of prescription drugs, the drafters of
the Restatement (Third) have explained the general trend has not been to
disembowel the long-standing duty to warn—instead, courts have
typically recognized the duty, and modified it slightly such that the duty
is generally to warn and provide instructions to the prescribing
physician. See Restatement (Third) of Torts: Liab. for Physical &
Emotional Harm § 7 cmt. i, at 82. Of course, as the drafters recognize,
even that minor modification is subject to important exception, as courts
have generally recognized the duty to warn extends even to patients
when a drug company “knows or has reason to know that health-care
providers will not be in a position to reduce the risks of harm.” See
Restatement (Third) of Torts: Prods. Liab. § 6(d)(2), at 145. Neither the
parties nor the majority has advanced a suggestion we discard duties to
warn generally in the pharmaceutical industry, and I do not believe any
79
court from any jurisdiction or any policy principle would support that
approach.
I do not discount the impact of litigation on the pharmaceutical
industry. I would note, however, we have been presented with very little
information for purposes of undertaking any reasoned comparison of
that impact with the substantial social impact of filleting our long-
standing law of fault-based liability in Iowa. We do know the brands
have been granted significant advantages in exchange for the burdens of
responsibility they bear for drug design and labeling. They are entitled to
an initial period of government-protected monopoly privileges in the form
of patent protection. See 35 U.S.C. § 154. They are entitled to an
extension of those monopoly privileges when generic versions of their
drugs receive FDA approval. See id. § 156 (patent-term extension); Drug
Price Competition and Patent Term Restoration Act of 1984, Pub. L. No.
98-417, 98 Stat. 1585 (codified in relevant part at 21 U.S.C. § 355(1988)) (pairing generic approval with patent-term extension). We know
they enjoy “the fiscal rewards of name-brand recognition and the
commensurate ability to charge a higher price . . . , even after [their]
exclusive marketing period expires.” Conte, 85 Cal. Rptr. 3d at 317.
Moreover, we know our recognition of a duty does not subject the brands
to any new obligation here—as all parties involved concede, the brands
are already subject to these obligations with respect to the branded
versions, and the design and warning must remain the same for the
generic versions.
Perhaps most importantly, we know Congress weighed each of
these considerations in enacting the Hatch-Waxman amendments to the
FDCA, and notably, made no reference to elimination of the brands’
fault-based legal obligations. See Drug Price Competition and Patent
80
Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984).
Indeed, I believe both courts and legislatures have typically regarded the
tort system as providing powerful incentives to engage in responsible,
reasonable behavior to promote safety in numerous industries, including
the pharmaceutical industry. See generally Wyeth v. Levine, 555 U.S.
555, 578, 129 S. Ct. 1187, 1202, 173 L. Ed. 2d 51, 68–69. Our general
assembly codified that recognition shortly after the Hatch-Waxman
amendments, in noting our general tort duties are applicable even in
products liability actions, to actors well outside the direct stream of
product distribution in both negligence and strict liability. See, e.g., Iowa
Code § 668.12 (1987) (“Nothing [contained in subsection providing state-
of-the-art defense] shall diminish the duty of an assembler, designer,
supplier of specifications, distributor, manufacturer, or seller to warn
concerning subsequently acquired knowledge of a defect or dangerous
condition that would render the product unreasonably dangerous for its
foreseeable use or diminish the liability for failure to so warn.”); see also
Lovick, 588 N.W.2d at 693 (explaining “section 668.12 clearly established
our legislature’s understanding of the duty”).
Furthermore, as I have noted, the Supreme Court has rejected the
notion that negligence claims against brand defendants for failure to
warn based on state tort law are preempted by federal law. See Levine,
555 U.S. at 581, 129 S. Ct. at 1204, 173 L. Ed. 2d at 70. Yet, the
majority quotes at length from an article authored by Professor Epstein
asserting the Supreme Court got it wrong on preemption. Repurposing
Epstein’s rejected policy arguments favoring preemption, the majority
advances them in favor of a no-duty rule in this case. As they failed in
furtherance of preemption, they must come up short here as well.
81
Epstein would place great reliance on the expertise of the FDA in
assessing the risks posed by medications to consumers, allocating the
duty to warn, and regulating the content of warnings. But there is
another side of the story. As the Supreme Court noted in Levine, the
resources of the FDA are limited while the volume of regulated
medications is vast. Levine, 555 U.S. at 578–79, 129 S. Ct. at 1202, 173
L. Ed. 2d at 68 (noting the FDA has limited resources with which to
regulate 11,000 medications). This reality has prompted a former FDA
commissioner, along with a noted administrative law authority, to
express reservations about the agency’s ability to effectively monitor the
safety of the consuming public, and to affirm the ameliorative purposes
served by state tort law:
Our second concern is that the FDA’s pro-preemption
arguments are based on what we see as an unrealistic
assessment of the agency’s practical ability—once it has
approved the marketing of a drug—to detect unforeseen
adverse effects of the drug and to take prompt and effective
remedial action. After all, there are 11,000 FDA-regulated
drugs on the market (including both prescription and over-
the-counter drugs), with nearly one hundred more approved
each year. The reality is that the FDA does not have the
resources to perform the Herculean task of monitoring
comprehensively the performance of every drug on the
market. Recent regulatory failures, such as the agency’s
ineffectual response to Vioxx, have demonstrated the FDA’s
shortcomings in this regard. Given the FDA’s inability to
police drug safety effectively on its own, we question the
wisdom of the FDA’s efforts to restrict or eliminate the
complimentary discipline placed on the market by failure-to-
warn litigation.
....
The information-gathering tools lawyers have in
litigation are, by any measure, more extensive than the
FDA’s.
....
Statutory gaps in the FDA’s authority to gather information,
especially post-approval, hamstring its ability to ensure the
82
safety of drugs on the market. The FDA Amendments Act
may help close those gaps somewhat, but they remain
substantial. . . . . The benefits of this litigation should not
be discarded lightly, and, as we have said, we see no benefit
to the FDA or the public in finding failure-to-warn litigation
pre-empted.
David A. Kessler & David C. Vladeck, A Critical Examination of the FDA’s
Efforts to Preempt Failure-to-Warn Claims, 96 Geo. L. J. 461, 465, 492,
495 (2008). If the reasons advanced by Kessler and Vladeck—and by the
Supreme Court in Levine—for rejecting preemption of failure-to-warn
claims are to be given any practical recognition, they must apply with
equal, if not greater, force to the majority’s contention the courthouse
doors should be closed to consumers like Huck by a court-made no-duty
rule. See Levine, 555 U.S. at 592, 129 S. Ct. at 1210, 173 L. Ed. 2d at
77 (Thomas, J., concurring) (“Initial approval of a label amounts to a
finding by the FDA that the label is safe for purposes of gaining federal
approval to market the drug. It does not represent a finding that the
drug, as labeled, can never be deemed unsafe by later federal action, or
as in this case, the application of state law.”).
It is instructive, in my view, that Congress has not chosen to
preempt failure-to-warn cases brought against brands. The policy choice
against preemption maintained by Congress during the more than seven
decades of the FDA’s existence evidences that the legislative branch
values the salutary effects of tort law in this area. Congress clearly
knows how to prescribe preemption, as it did so in the medical device
field in 1976. See 21 U.S.C. § 360k(a) (2012); Levine, 555 U.S. at 574,
129 S. Ct. at 1200; 173 L. Ed. 2d at 66. The choice by Congress in
eschewing preemption for brand pharmaceuticals reveals faith in the
beneficial impact of the civil justice system in augmenting the protections
afforded by the FDA. See Levine, 555 U.S. at 574, 129 S. Ct. at 1200,
83
173 L. Ed. 2d at 66 (“If Congress thought state-law suits posed an
obstacle to its objectives, it surely would have enacted an express pre-
emption provision at some point during the FDCA’s 70-year history.”);
see also id. 555 U.S. at 574, 129 S. Ct. at 1199–1200, 173 L. Ed. 2d at65–66 (“Congress did not provide a federal remedy for consumers harmed
by unsafe or ineffective drugs in the 1938 statute or in any subsequent
amendment. Evidently, it determined that widely available state rights of
action provided appropriate relief for injured consumers. It may also
have recognized that state-law remedies further consumer protection by
motivating manufacturers to produce safe and effective drugs and to give
adequate warnings.” (Footnote omitted.)); Rostron, 60 Duke L.J. at 1191
(“The FDA’s regulatory oversight repeatedly has proven insufficient to
prevent unreasonably dangerous drugs from reaching consumers. Tort
law provides vital incentives for drug makers to act with appropriate
care. Courts should apply tort law in a manner that encourages drug
companies to continue producing innovative products but to act
reasonably to ensure that their products are safe and accompanied by
adequate warnings and accurate information. Striking the right balance
is a challenge, but it is one that courts must continue striving to meet.
These issues can quite literally be matters of life and death.” (Footnote
omitted.)); cf. Allison Stoddart, Missing after Mensing: A Remedy for
Generic Drug Consumers, 53 B.C. L. Rev. 1967, 1998 (2012) (“The tort
system incentivizes manufacturers to strengthen warnings by allowing
tort claims against manufacturers when the probability of harm from an
inadequate warning is greater than the burden of enhancing the
warning—that is, when the manufacturer is negligent.”).
The majority’s claim that the pharmaceutical industry will be
substantially harmed by a rule imposing a duty on the brands, who
84
controlled the content of the warning PLIVA was legally required to use,
is, in my view, speculative and overblown. See Steven Garber, Economic
Effects of Product Liability and Other Litigation Involving the Safety and
Effectiveness of Pharmaceuticals, Rand Institute for Civil Justice, at xv
(2013), available at www.rand.org/pubs/monographs/mg1259.html
(suggesting policymakers should be “wary of broad claims about
economic effects of pharmaceutical liability, including generalizations
based on anecdotes or examples”). 21 The safety-based regulations
promulgated by the FDA can comfortably coexist with the brands’ duty to
exercise reasonable care in warning consumers of grave health risks
attending the use of pharmaceuticals. 22 See, e.g., Levine, 555 U.S. at
21Although interests advocating restriction of tort liability contend certain
products have been either withdrawn or withheld from the market because of the costs
associated with the civil justice system, there is scarce direct empirical evidence
supporting these contentions. Even if we were to credit the contentions, however, our
analysis would require examination of additional crucial questions: Were the products
bad or dangerous? Was their withdrawal from the market in the public interest? See,
e.g., Gary T. Schwartz, Reality in the Economic Analysis of Tort Law: Does Tort Law
Really Deter?, 42 UCLA L. Rev. 377, 410–13 (1994) [hereinafter Schwartz].
22Principles of federalism and practicality bolster this understanding. Numerous
commentators and authorities have recognized states are independent sovereigns in the
federal system, and play a historic and important role in the local regulation of health
and safety. See, e.g., Ernest A. Young, Federal Preemption and State Autonomy, in
Federal Preemption: States’ Powers, National Interests 249, 251–52 (Richard A. Epstein
& Michael S. Greve eds., 2007) (noting preemption problematically limits regulatory
diversity by constraining state autonomy). Similarly, numerous commentators have
noted tort claims operate as an important check even in federally regulated fields. See,
e.g., Catherine M. Sharkey, Preemption by Preamble: Federal Agencies and the
Federalization of Tort Law, 56 DePaul L. Rev. 227, 230–33 (2007) (criticizing the
Consumer Product Safety Commission’s inclusion of an express preemption clause in
its mattress flammability standards as “[r]emoving a significant incentive for industries
to improve outside of meeting the federal standard” (internal quotation marks omitted));
see also Thomas O. McGarity, The Preemption War: When Federal Bureaucracies Trump
Local Juries 236–38 (2008) (explaining common law reinforces incentives for compliance
with federal regulations, fills gaps for unanticipated consequences of regulations, and
provides protection while agencies take time to formulate responses to problems);
Schwartz, 42 UCLA L. Rev. at 385 (“Likewise, tort suits can (first) uncover and (then)
dramatize information in a way that can set in motion a regulatory response.”). See
generally Thomas H. Sosnowski, Narrowing the Field: The Case Against Implied Field
Preemption of State Product Liability Law, 88 N.Y.U. L. Rev. 2286, 2293–94 (2013).
85
593, 129 S. Ct. at 1211, 173 L. Ed. 2d at 78 (Thomas, J., concurring)
(“The federal statute and regulations neither prohibited the stronger
warning label required by the state judgment, nor insulated Wyeth from
the risk of state-law liability.”). As Robert Rabin has explained,
Tort duties do not “require” anything other than the
payment of damages. If tort liability does lead a defendant to
a private assessment in favor of greater future precautionary
measures, then tort, of course, has had a regulatory effect.
But tort itself dictates no particular change in a losing
defendant’s conduct.
....
[T]here is no inexorable principle that productivity
gains from uniform national health and safety standards—a
frequently invoked rationale for preemption—should be
borne by injury victims in cases of residual harm. Moreover,
once again, it is critical to underscore the dynamics of tort.
Liability does not entail enforced departure from regulatory
standards; it only compels payment of damage awards.
....
If the tort claim rests on an assertion that substantial
post-approval new evidence of risk has come to light, and
has neither been incorporated into a revised warning, nor
rejected by the agency as insubstantial, the foundational
risk/benefit analysis on which agency certification was based
is inapposite. Hence, the tort claim is not an effort to revisit
and supersede the regulatory approval process.
....
In proposing a framework for addressing these
tensions, based on focused examination of whether the
agency directive is grounded in the same evidence-based
risk/benefit inquiry as the tort process would entail, I join
those commentators who seek to forge a path that recognizes
the distinct benefits that both regulation and tort have to
offer.
Robert L. Rabin, Territorial Claims in the Domain of Accidental Harm:
Conflicting Conceptions of Tort Preemption, 74 Brook. L. Rev. 987, 991,
993, 1002, 1009 (2009) (emphasis added).
86
Given these considerations, and taking account of the vast range of
information that must be weighed when balancing the interests of the
pharmaceutical industry and those of consumers, I do not believe we are
adequately equipped to craft a bright-line no-duty rule here. I would
leave that policymaking to our general assembly, which has continued to
recognize duties in this realm. I would therefore continue to hew to the
long-standing and widespread recognition of the brands’ general and
affirmative duties here.
III. Factual Causation.
In addition to establishing the existence of a duty or duties, we
have often explained in both products liability and traditional negligence
cases the plaintiff “must establish a causal relationship between the
alleged negligence and injury.” Lovick, 588 N.W.2d at 700 (products
liability); accord Thompson, 774 N.W.2d 836–39 (negligence). In the
context of failure to warn claims, we have noted factual causation is
established by demonstrating “a warning would have altered the
plaintiff’s conduct so as to avoid injury.” Lovick, 588 N.W.2d at 700.
More generally, as the drafters of the Restatement (Third) have provided,
“[c]onduct is a factual cause of harm when the harm would not have
occurred absent the conduct.” Restatement (Third) of Torts: Liab. for
Physical & Emotional Harm § 26, at 346; accord Thompson, 774 N.W.2d
at 837–39 (adopting Restatement (Third) factual causation and scope of
liability principles); see also Asher v. OB-Gyn Specialists, P.C., 846
N.W.2d 492, 500 (Iowa 2014). This is tort law’s familiar “but-for” test,
and both the First and Second Restatements of Torts endorsed this
standard in providing “the harm would not have occurred had the actor
not been negligent.” See, e.g., Restatement (Second) of Torts § 431 cmt.
87
a, at 429; see also Restatement (Third) of Torts: Liab. for Physical &
Emotional Harm § 26 cmt. b, at 347.
Here, as the majority explains, Dr. Gyano relies upon information
published by the brands—for purposes of covering both branded versions
of drugs and their generic counterparts—in the Physician’s Desk
Reference in making prescription decisions generally, and she relied on
this information in 2004 to prescribe branded Reglan for Huck.
Dr. Gyano has explained the risk–benefit analysis she uses in making
prescription decisions has changed as a result of her access to the
brands’ updated information and labeling. She now supplements the
conversation she typically has with patients with this risk–benefit
information before making prescription decisions. Further, she has
noted she would have modified her treatment conversations and
decisions in the same way had she received this information back in
2004, and the information would have had the same impact. Finally,
Dr. Gyano and Huck have explained had this information been available
sooner, and had they discussed the implications back then, Huck would
never have taken metoclopramide, and would never have developed
tardive dyskinesia. Applying our principles of factual causation in
straightforward fashion, we may safely conclude Huck has advanced
evidence sufficient to allow a jury to find her harm would not have
occurred had the brands not allegedly failed to satisfy their obligation of
reasonable care, and similarly, she has advanced evidence sufficient to
allow a jury to find a warning would have altered her conduct such that
she would have avoided injury. See Lovick, 588 N.W.2d at 700(“[C]aus[ation] can be established by showing a warning would have
altered the plaintiff’s conduct so as to avoid injury.”).
88
Although that analysis resolves the factual causation question
simply and completely, I think it prudent to point out several general
principles relevant to the factual causation analysis in both products
liability cases in general and in the case we actually confront here. Dolin,
2014 WL 804458, at *7 (noting courts have often “conflate[d] two facially
similar, but fundamentally distinct, tort liability problems”); Rostron, 60
Duke L.J. at 1164 (“[C]ourts have repeatedly made the same mistake,
dwelling on the irrelevant concept of liability being imposed on multiple
manufacturers because of uncertainty about who made a product and
conflating that concept with the separate and distinct issue of whether a
manufacturer can be liable for wrongdoing other than making and selling
the product the plaintiff received.”).
As I have already noted, the factual scenario we confront here is
not the one we examined in Mulcahy, where we could not identify the
actor allegedly responsible for harm. Instead, we face here a scenario
where an injury occurred in connection with a given product and the
plaintiff can demonstrate tortious conduct by someone other than the
product’s manufacturer had a causal role in producing the injury. This
latter scenario is not a novel one in the field of products liability law. See
generally Madden & Owen on Products Liability § 19:4, at 370–78 (3d ed.
2000) (collecting cases); Melissa Evans Bush, Products Liability and
Intellectual Property Licensors, 22 Wm. Mitchell L. Rev. 299, 311–14
(2000) (collecting cases).
The scenario arises in numerous ways, and in each, courts have
not hesitated in finding factual causation. Where an organization in the
business of testing products and affixing labels certifying the results of
its testing is negligent in its labeling, for example, courts have concluded
the tester’s negligence may be a factual cause of injuries when these
89
products fail to perform in accordance with the labeling. See, e.g.,
Hempstead v. Gen. Fire Extinguisher Corp., 269 F. Supp. 109, 118 (D.
Del. 1967) (“If plaintiff succeeds in proving his charge that Underwriters
was negligent in approving the design of a fire extinguisher which was
imminently dangerous, and that plaintiff’s injury was a result thereof,
Underwriters must respond in damages.”). When a publisher is in the
business of placing an endorsement or seal of approval on products, and
fails to exercise ordinary care in approving a particular product, courts
have concluded the publisher’s conduct may be a factual cause of
damages when the product fails to perform in accordance with the
publisher’s representation. See, e.g., Hanberry v. Hearst Corp., 81 Cal.
Rptr. 519, 522 (Ct. App. 1969) (“[I]ts seal and certification tend to induce
and encourage consumers to purchase products advertised in the
magazine and which bear that seal and certification.”). Likewise, courts
have concluded nonmanufacturing seed certifiers constitute a nontrivial
link “in the chain of distribution which [places] a [product] in the stream
of commerce,” and thus those certifiers may play a causal role in any
damage suffered by third parties relying on those certifications.
Rottinghaus v. Howell, 666 P.2d 899, 907 (Wash. Ct. App. 1983) (“MPIA’s
conduct in certifying the defective seed, issuing a blue tag stating such
and representing the quality of the seed in the 1977 directory created an
issue for the jury as to whether defendant was liable for negligence and
negligent misrepresentation.”). Similarly, a trade association or other
organization setting insufficient safety standards for a product may
factually cause harms flowing from the plaintiff’s use of the product. See
Meneely v. S.R. Smith, Inc., 5 P.3d 49, 57 (Wash. Ct. App. 2000) (“We hold
the evidence and the reasonable inferences therefrom support the jury’s
findings that NSPI negligently caused Mr. Meneely’s injuries. . . .”).
90
Perhaps more to the point, we recognized in both Schiltz and
McCarthy designers and suppliers of specifications may have a causal
role in damages resulting from the failure of structures built according to
those designs or specifications. See Schiltz, 228 N.W.2d at 17; McCarthy,
199 N.W.2d at 367–68. In Schiltz, we explained the plaintiff had
advanced substantial evidence an engineering firm had negligently
designed protective dikes for a sewage treatment facility and substantial
evidence the negligence was a factual and legal cause—using our old tort
terminology—of the plaintiff’s damage. Schiltz, 228 N.W.2d at 18.
Similarly, in McCarthy, we recognized an architect’s negligence in
supplying plans and specifications for the construction of a school might
constitute the factual cause of “improper collection and discharge of
surface waters upon” a plaintiff’s adjacent property. McCarthy, 199
N.W.2d at 367.
In addition to those propositions, I note products liability cases
have never displaced our age-old torts principle that “an intervening act
will not relieve a negligent defendant of liability if that act or force was a
normal consequence of the defendant’s conduct or was reasonably
foreseeable by that defendant.” Iowa Elec. Light & Power Co. v. Gen. Elec.
Co., 352 N.W.2d 231, 235 (Iowa 1984); see also, e.g., Rossell v.
Volkswagen of Am., 709 P.2d 517, 526 (Ariz. 1985) (explaining “an
intervening force becomes a superseding cause only when its operation
was both unforeseeable and when with the benefit of ‘hindsight’ it may
be described as abnormal or extraordinary” and applying rule in case of
negligent placement of car battery); Larson Mach., Inc. v. Wallace, 600
S.W.2d 1, 9 (Ark. 1980) (explaining “[t]he mere fact that other causes
intervene between the original act of negligence and the injury for which
recovery is sought is not sufficient to relieve the original actor of liability,
if the injury is the natural and probable consequence of the original
91
negligent act or omission and is such as might reasonably have been
foreseen” and applying rule in case of fertilizer spreader); Weyerhaeuser,
620 N.W.2d at 831 (“[T]he fire and resulting explosion were . . .
foreseeable intervening causes [of product’s defect] that did not
supersede [defendant]’s responsibility.”); Zacher v. Budd Co., 396 N.W.2d
122, 135 (S.D. 1986) (explaining “even if a plaintiff is assumed
contributorily negligent, whether that intervening force supersedes the
defendant’s negligence is for the jury to decide” and applying rule in case
of wheel explosion).
In short, the universe of imaginable scenarios in which an actor
who has not manufactured or sold a product may nevertheless both
cause and be liable for damages caused is enormous. The majority’s
proposed “product-identification causation requirement” does no work to
address the vast majority of these scenarios. See Dolin, 2014 WL
804458, at *8 (“Taken out of context, language in product identification
cases . . . may well appear to support GSK’s argument. In truth, the
principles for which that line of cases stands are inapposite here.”). The
majority’s invocation of the requirement here improvidently forsakes our
clear and easily applied principles of factual causation. I would instead
apply our traditional principles of factual causation in this case and
conclude Huck has advanced evidence sufficient to allow a jury to find
the brands’ alleged negligence was a but-for cause of the harm she has
suffered here. I would therefore reverse the district court’s entry of
summary judgment on Huck’s claims with respect to the brands and
remand for trial.
Wiggins and Appel, JJ., join this concurrence in part and dissent
in part.