Schrock v. Wyeth Inc. ( 2013 )

FILED
United States Court of Appeals
Tenth Circuit
PUBLISH
August 28, 2013
UNITED STATES COURT OF APPEALS
Elisabeth A. Shumaker
Clerk of Court
TENTH CIRCUIT
SUSAN SCHROCK; STEVE
SCHROCK,
Plaintiffs–Appellants,
v.
No. 12-6078
WYETH, INC.; SCHWARZ PHARMA,
INC.; PLIVA USA, INC.; QUALITEST
PHARMACEUTICALS, INC.,
Defendants–Appellees.
APPEAL FROM THE UNITED STATES DISTRICT COURT FOR
THE WESTERN DISTRICT OF OKLAHOMA
(D.C. No. 5:08-CV-00453-M)
Terrence J. Donahue, McGlynn Glisson & Mouton, Baton Rouge, Louisiana, for the
Plaintiffs-Appellants.
Jeffrey Francis Peck, Ulmer & Berne LLP, Cincinnati, Ohio (Linda E. Maichl and Joseph
P. Thomas with him on the brief) for Defendant-Appellee Pliva, Inc..
Kannon K. Schanmugam, Williams & Connolly LLP, Washington, D.C. (James M.
McDonald, Williams & Connolly LLP, Washington, D.C.; Henninger S. Bullock and
Andrew J. Calica, Mayer Brown, LLP, New York, New York, with him on the brief) for
Defendant-Appellee Wyeth, Inc. and Schwarz Pharma, Inc..
Richard H. Nakamura Jr., Morris Polich & Purdy, LLP, Los Angeles, California
(Tammara Tukloff, Morris Polich & Purdy LLP, San Diego, California; J.R. Baker and
Kim A. Tran, Hiltgen & Brewer, P.C., Oklahoma City, Oklahoma, with him on the brief)
for Defendant-Appellee Qualitest Pharmaceuticals, Inc..
Before LUCERO, HARTZ, and HOLMES, Circuit Judges.
LUCERO, Circuit Judge.
Susan and Steven Schrock filed suit against brand-name and generic
manufacturers of the drug metoclopramide, alleging that Susan Schrock’s use of generic
metoclopramide caused her to develop tardive dyskinesia, a neurological disorder
characterized by involuntary body movements. The district court dismissed all claims in
favor of the manufacturers in a series of orders. On appeal, the Schrocks challenge the
dismissal of their claims against PLIVA USA, Inc. (“PLIVA”), Qualitest
Pharmaceuticals, Inc. (“Qualitest”), Schwarz Pharma, Inc. (“Schwarz”), and Wyeth, Inc.
(“Wyeth”).
Following oral argument, we abated this appeal pending the Supreme Court’s
decision in Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013). In light
of the Court’s opinion in Bartlett, we are compelled to conclude that the Schrocks’
breach-of-warranty claims against PLIVA and Qualitest, the generic drug manufacturers,
are preempted by federal law. We also agree with the district court that the Schrocks’
non-warranty claims against the generic manufacturers are barred by Oklahoma’s two-
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year statute of limitations. Okla. Stat. tit. 12 § 95.
With respect to the Schrocks’ claims against Schwarz and Wyeth, name-brand
manufacturers of metoclopramide, we are in accord with the district court’s determination
that Oklahoma tort law would not provide a remedy. Given prior Oklahoma precedent
and the clear consensus of courts in other jurisdictions, we predict that Oklahoma would
not impose a duty on brand-name drug manufacturers to consumers of a generic
manufacturer’s products.
Finally, we reject the argument that the Schrocks’ notice of appeal was untimely
as to certain orders they seek to appeal. Exercising jurisdiction under 28 U.S.C. § 1291,
we affirm.
I
A
Under the 1962 amendments to the Federal Food, Drug, and Cosmetic Act
(“FDCA”), Pub. L. 87-781, 76 Stat. 780 (1962) (codified at 21 U.S.C. §§ 301 et seq.), a
manufacturer seeking federal approval to market a new drug “must prove that it is safe
and effective and that the proposed label is accurate and adequate.” PLIVA, Inc. v.
Mensing, 131 S. Ct. 2567, 2574 (2011) (citing 21 U.S.C. § 355(b)(1), (d)). Initially, the
same rules applied to all drug manufacturers. See Mensing, 131 S. Ct. at 2574.
However, Congress later passed the Drug Price Competition and Patent Term Restoration
Act of 1984, Pub. L. 98-417, 98 Stat. 1585 (codified as amended in scattered sections of
21 and 35 U.S.C.), known as the Hatch-Waxman Amendments, that created special rules
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for generic drug manufacturers. See Mensing, 131 S. Ct. at 2574.
These Amendments were intended “to provide a swifter route for approval of
generic drugs.” Bartlett, 133 S. Ct. at 2471. “Under Hatch-Waxman, a generic drug may
be approved without the same level of clinical testing required for approval for a new
brand-name drug, provided that the generic drug is identical to the already-approved
brand-name drug in several key respects.” Id. To be approved for sale, a generic drug
must be “identical [to its branded equivalent] in active ingredients, safety, and efficacy,”
as well as in “the safety and efficacy labeling.” Mensing, 131 S. Ct. at 2574 & n.2
(quotation and alteration omitted).
After a generic or brand-name drug is approved, “the manufacturer is prohibited
from making any major changes to the ‘qualitative or quantitative formulation of the drug
product, including active ingredients, or in the specifications provided in the approved
application.’” Bartlett, 133 S. Ct. at 2471 (quoting 21 C.F.R. § 314.70(b)(2)(i)). Generic
manufacturers “are also prohibited from making any unilateral changes to a drug’s label,”
thus “approval for a generic drug may be withdrawn if the generic drug’s label is no
longer consistent with that for the brand name drug.” Id. (quotation and alteration
omitted) (citing 21 C.F.R. §§ 314.94(a)(8)(iii), 314.150(b)(10)).
B
Metoclopramide was first approved by the Food and Drug Administration
(“FDA”) under the brand name Reglan. Generic manufacturers began production of
metoclopramide in 1985, the same year the FDA-mandated label for all versions of
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metoclopramide was modified to warn that “tardive dyskinesia . . . may develop in
patients treated with metoclopramide.” Mensing, 131 S. Ct. at 2572. The labeling also
added that “therapy longer than 12 weeks has not been evaluated and cannot be
recommended.” Id. (alteration omitted).
Over time, evidence began to suggest that long-term use of metoclopramide can
cause tardive dyskinesia. Id. In 2004, brand-name manufacturers of the drug requested a
label change, which the FDA approved, to add that “therapy should not exceed 12 weeks
in duration.” Id. (alteration omitted). In 2009, the FDA ordered a “black box
warning”—the strongest warning issued by the agency—to be placed on the label of
metoclopramide stating, “[t]reatment with metoclopramide can cause tardive dyskinesia,
a serious movement disorder that is often irreversible . . . . Treatment with
metoclopramide for longer than 12 weeks should be avoided in all but rare cases.” Id.
Susan Schrock was prescribed brand-name metoclopramide (Reglan) on three
occasions between March 2000 and March 2005. Each time, however, she purchased
generic metoclopramide instead. On either May 2 or 3, 2005, Susan Schrock visited Dr.
Michael Tribbey, a neurologist, complaining of “neck drawing and arm weakness” that
began six to eight weeks prior. Dr. Tribbey diagnosed her with “a form of dystonia,” a
neurological movement disorder, that was “quite possib[ly] related to metoclopramide,”
and recommended that she stop taking it. Susan Schrock discontinued the drug, and
researched side effects of metoclopramide online. Following a hiatus during which her
symptoms abated, she reported a worsening of her uncontrollable neck twisting in
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October 2006. In July of 2007, she was formally diagnosed with tardive dyskinesia.
C
On April 30, 2008, the Schrocks sued Schwarz and Wyeth, former manufacturers
of Reglan, and PLIVA, a manufacturer of generic metoclopramide, along with others not
at issue in this appeal. Claims of negligence, strict products liability, breach of
warranties, misrepresentation, and fraud were advanced in the federal court proceedings.
After the district court concluded that Schwarz and Wyeth did not owe a duty to the
Schrocks because Susan Schrock used only generic versions of metoclopramide, it
granted summary judgment in favor of those companies on March 11, 2007. Schwarz
and Wyeth sought certification of the district court’s order under Fed. R. Civ. P. 54(b).
The district court entered a judgment in their favor on April 20, 2009, but did not
explicitly certify the order as final under Rule 54(b).
On April 14, 2010, the district court granted the Schrocks’ motion for leave to file
an amended complaint adding claims against Qualitest, which pharmacy records showed
had manufactured some of the generic metoclopramide that Susan Schrock used.
Qualitest promptly moved to dismiss, arguing the suit was barred by the statute of
limitations. PLIVA filed a motion for summary judgment on the same basis. On July 20,
2010, the district court granted summary judgment in favor of PLIVA, and dismissed all
but the breach-of-warranty claims against Qualitest. On December 8, 2011, the district
court dismissed the breach-of-warranty claims pursuant to a Rule 12(b)(6) motion by
Qualitest, concluding the claims were preempted. On the same date, the court entered
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final judgments in favor of PLIVA and Qualitest.
On January 5, 2012, the Schrocks filed a motion to alter or amend the December 8,
2011 judgment in favor of Qualitest. The district court denied the motion on February
24, 2012. On March 23, 2012, the Schrocks filed a notice of appeal designating the
grants of summary judgment in favor of Wyeth, Schwarz, and PLIVA, and the grants of
Qualitest’s motions to dismiss as the orders being appealed.
II
We first determine whether the Schrocks’ notice of appeal was timely. Schwarz
and Wyeth argue that the district court’s April 20, 2009 judgment in their favor was a
final judgment, thus the Schrocks’ March 23, 2012 notice of appeal is untimely under
Fed. R. App. P. 4(a)(1)(A). After the district court granted Schwarz and Wyeth’s motion
for summary judgment, those companies filed a motion under Fed. R. Civ. P. 54(b). In
granting this motion, the district court entered a judgment stating: “[i]n light of the
Court’s Order granting said defendants summary judgment and having reviewed the
parties’ submissions, the Court hereby enters judgment in favor of defendants WYETH,
INC. and SCHWARZ PHARMA, INC. . . . .”
Under Rule 54(b), a “court may direct entry of a final judgment as to one or more,
but fewer than all, claims or parties only if the court expressly determines that there is no
just reason for delay.” Fed. R. Civ. P. 54(b). Because “Rule 54(b) entries are not to be
made routinely,” we have held that:
[C]ertification under Rule 54(b) is only appropriate when a district court
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adheres strictly to the rule’s requirement that a court make two express
determinations. First, the district court must determine that the order it is
certifying is a final order. Second, the district court must determine that
there is no just reason to delay review of the final order until it has
conclusively ruled on all claims presented by the parties to the case.
Oklahoma Tpk. Auth. v. Bruner, 259 F.3d 1236, 1242 (10th Cir. 2001).
Schwarz and Wyeth concede that the district court did not make the express
determinations required by our decision in Oklahoma Turnpike; however, they urge us to
follow an approach taken by other circuits and look beyond the text of the district court’s
order to determine whether it can be said to have made the requisite determinations. See,
e.g., Denson v. United States, 574 F.3d 1318, 1335 n.52 (11th Cir. 2009); Askanase v.
LivingWell, Inc., 981 F.2d 807, 810 (5th Cir. 1993). Under this approach, they argue that
their motion seeking Rule 54(b) certification, considered along with the judgment,
reflects the district court’s intent to allow an immediate appeal.
Regardless of the desirability of this alternative rule, “one panel cannot overrule
the judgment of another panel of this court . . . absent en banc reconsideration or a
superseding contrary decision by the Supreme Court.” Barber v. T.D. Williamson, Inc.,
254 F.3d 1223, 1229 (10th Cir. 2001) (quotation omitted). In Oklahoma Turnpike, we
noted that although Rule 54(b)’s “requirement that these determinations be stated
explicitly in the district court’s certification order is to some extent a formality, the
requirement does provide district courts with one last opportunity to discover errors in
their decision to certify an order for appeal.” 259 F.3d at 1244. We have adhered to this
formal requirement. See Stockman’s Water Co., LLC v. Vaca Partners, L.P., 425 F.3d
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1263, 1264-65 (10th Cir. 2005) (dismissing appeal for lack of jurisdiction without
considering the merits of a Rule 54(b) certification or the motion seeking certification
because district court did not make the necessary findings). Because the district court did
not make the requisite determinations under Oklahoma Turnpike, we reject the argument
that the district court’s April 10, 2009 judgment was final for purposes of appeal.
PLIVA, Schwarz, and Wyeth also claim that the March 23, 2012 appeal is
untimely on the theory that the Schrocks’ Rule 59(e) motion—which challenged only the
judgment in favor of Qualitest—did not toll the time to appeal with respect to the other
defendants. We reject this argument. Federal Rule of Appellate Procedure 4(a)(4)(A)
states: “[i]f a party timely files in the district court any of the following motions,”
including a motion to “alter or amend judgment under Rule 59,” then “the time to file an
appeal runs for all parties from the entry of the order disposing of the last such remaining
motion.” Fed. R. App. P. 4(a)(4)(A) (emphasis added).
Our opinion in TBG, Inc. v. Bendis, 36 F.3d 916 (10th Cir. 1994), is not to the
contrary. TBG holds that “a motion to reconsider one final judgment does not extend the
time to appeal another final judgment just because they are part of the same litigation.”
Id. at 921. Unlike the case at bar, however, in TBG the district court had “certified as
final and appealable under Rule 54(b)” both of the separate judgments at issue,
effectively severing the two judgments for appellate purposes. Id. We specifically
recognized that the result would have been different, if, as in the case at bar, the
judgments had not been properly certified as final and appealable. See id. (under Rule
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4(a)(4), “a motion for a new trial by one [party] also extends the time to appeal a verdict
in favor of a second [party], unless the district court certifies the judgments as separate
and final under Rule 54(b)”). Because the district court did not properly certify the
judgments at issue under Rule 54(b), we conclude that the Schrocks’ Rule 59 motion
tolled the time to appeal as to each of the orders. The notice of appeal is therefore timely
as to each order appealed.
III
“We review a grant of summary judgment de novo, applying the same standard as
the district court.” Jaramillo v. Adams Cnty. Sch. Dist. 14, 680 F.3d 1267, 1268 (10th
Cir. 2012). Summary judgment is appropriate only if “there is no genuine dispute as to
any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ.
P. 56(a). We view all facts and evidence in the light most favorable to the party opposing
summary judgment. Morris v. City of Colo. Springs, 666 F.3d 654, 660 (10th Cir. 2012).
We also review de novo a district court’s grant of a motion to dismiss under Fed.
R. Civ. P. 12(b)(6). Khalik v. United Air Lines, 671 F.3d 1188, 1190 (10th Cir. 2012).
We accept as true “all well-pleaded factual allegations in a complaint and view these
allegations in the light most favorable to the plaintiff.” Kerber v. Qwest Group Life Ins.
Plan, 647 F.3d 950, 959 (10th Cir. 2011). To survive a motion to dismiss under Rule
12(b)(6), a complaint must contain “enough facts to state a claim to relief that is plausible
on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007).
All the parties agree that Oklahoma law controls our analysis. Accordingly, “our
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task here is to interpret and apply the law of [Oklahoma] as we believe the [Oklahoma]
Supreme Court would.” High Plains Natural Gas Co. v. Warren Petroleum Co., 875 F.2d
284, 288 (10th Cir. 1989); see also United States v. DeGasso, 369 F.3d 1139, 1145 (10th
Cir. 2004) (“It is axiomatic that state courts are the final arbiters of state law.”). If a state
supreme court has not resolved a legal issue, we “may seek guidance from decisions
rendered by lower courts in the relevant state, appellate decisions in other states with
similar legal principles, district court decisions interpreting the law of the state in
question, and the general weight and trend of authority in the relevant area of law.”
Wade v. Emcasco Ins. Co., 483 F.3d 657, 666 (10th Cir. 2007) (citations and quotation
omitted).
A
The district court concluded that the Schrocks’ claims against PLIVA and
Qualitest, other than their warranty claims, were barred by Oklahoma’s two-year
limitations period. See Okla. Stat. tit. 12, § 95; Kirkland v. Gen. Motors Corp., 521 P.2d
1353, 1361 (Okla. 1974). Oklahoma follows the “discovery rule,” under which “the
statute [of limitations in product liability cases] does not begin to run until the plaintiff
knows, or as a reasonably prudent person should know, that he has the condition for
which his action is brought and that the defendant caused it.” Daugherty v. Farmers
Coop. Ass’n, 689 P.2d 947, 950 (Okla. 1984) (quotation omitted). However, a plaintiff
need not know the “extent of injury” or know that it is “permanent” for the limitations
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period to commence. Kang v. Kang, 11 P.3d 218, 219 (Okla. Civ. App. 2000);1 see also
Daugherty, 689 P.2d at 950-51 (under the discovery rule, “acquisition of sufficient
information which, if pursued, would lead to the true condition of things will be held as
sufficient knowledge to start the running of the statute of limitations”).
We agree with the district court that the Schrocks’ non-warranty claims against
PLIVA are untimely. It is undisputed that in May of 2005 Susan Schrock’s doctor
informed her that metoclopramide was “quite possib[ly]” responsible for her symptoms,
including her uncontrollable neck movement. Yet the Schrocks did not file suit until
April 30, 2008, nearly three years later.
We reject the Schrocks’ assertion that the limitations period began to run only
when Susan Schrock’s symptoms returned, sometime in mid- to late-2006, because it was
then that she developed tardive dyskinesia, rather than the previously diagnosed acute
dystonia.2 Susan Schrock admits that in May 2005 she understood that metoclopramide
was causing her symptoms, recorded by her physician as including uncontrollable neck
movements. At that time, the label for metoclopramide warned that involuntary
1
“Although we are not required to follow the dictates of an intermediate state
appellate court, we may view such a decision as persuasive as to how the state supreme
court might rule.” Sellers v. Allstate Ins. Co., 82 F.3d 350, 352 (10th Cir. 1996).
2
Both dystonia and dyskinesia refer to involuntary movement disorders. The
record indicates that acute dystonia refers to the abrupt onset of muscle spasms and often
involves involuntary twisting and abnormal postures. Dyskinesia refers to any abnormal,
involuntary movement resulting from certain drugs. “Tardive” means “tending to or
characterized by lateness esp. in development or maturity.” Webster’s Third New Int’l
Dictionary 2340 (1993). Thus, tardive dyskinesia features involuntary muscle
movements that develop or persist after a drug is discontinued.
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movement symptoms may “remit, partially or completely, within several weeks-to-
months after metoclopramide is withdrawn” but that tardive dyskinesia is nevertheless
“potentially irreversible.” This was informed by the Schrocks’ contemporaneous online
research on the side effects of metoclopramide shortly after speaking with Dr. Tribbey.
Based on these facts, we agree with the district court that the Schrocks acquired
“sufficient information which, if pursued, would lead to . . . sufficient knowledge to start
the running of the statute of limitations.” Daugherty, 689 P.2d at 951.
Although Oklahoma law might recognize that some symptoms are “too isolated or
inconsequential to trigger the running of the [s]tatute of [l]imitations,” Wetherill v. Eli
Lilly & Co. (In re N.Y. Cnty. DES Litig.), 678 N.E.2d 474, 478 n.4 (N.Y. 1997), this is
not such a case. Susan Schrock is suing based on involuntary muscle movements caused
by metoclopramide: she was aware of both symptom and cause in May 2005. Oklahoma
courts have squarely rejected an acute versus permanent distinction. See Kang, 11 P.3d
at 219 (holding that the statute of limitations is not tolled until the discovery of
permanent, as opposed to temporary, injuries). We therefore affirm the district court’s
dismissal of the Schrocks’ non-warranty claims against PLIVA.
We reach the same conclusion as to the Schrocks’ non-warranty claims against
Qualitest.3 The Schrocks did not amend their complaint to add these claims until April
3
Qualitest argues that the Schrocks do not challenge the district court’s dismissal
of the non-warranty claims against them on appeal. In their opening brief, the Schrocks
assert only a general statute of limitations argument without stating whether they are
Continued . . .
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14, 2010, after pharmacy records indicated that Qualitest manufactured some of the
generic metoclopramide taken by Susan Schrock. Under Oklahoma law, the Schrocks are
charged with knowledge of facts they would have learned through “reasonable diligence”
in acquiring evidence that would implicate a defendant. See Daugherty, 689 P.2d at 951.
The Schrocks do not attempt to explain the reason they did not obtain Susan Schrock’s
own pharmacy records until two years after filing their complaint and approximately five
years after first learning that metoclopramide was causing her symptoms. The district
court correctly dismissed the Schrocks’ non-warranty claims against Qualitest.
B
Summary judgment in favor of Wyeth and Schwarz was granted on the ground
that the brand-name manufacturers do not owe a duty to the Schrocks because Susan
Schrock did not take brand-name metoclopramide. Although the Oklahoma Supreme
Court has not had an opportunity to speak on this issue, we predict—consistent with the
trend among courts nationally and Oklahoma tort law in general—that it would not
recognize a duty flowing from brand-name drug manufacturers to consumers of generic
drugs.
Oklahoma courts usually require that a defendant have some relationship with the
product alleged to have caused a plaintiff’s injuries, either through manufacturing,
selling, or distributing the product. This is clearly the case in strict products liability
challenging the district court’s orders in favor of Qualitest, PLIVA, or both. Due to this
ambiguity, we decline to treat the issue as waived.
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actions. See Kirkland, 521 P.2d at 1363 (to prevail on strict liability claim for a defective
product, plaintiff must show the product was defective when it left the defendant’s
“possession and control”); see also Dutsch v. Sea Ray Boats, Inc., 845 P.2d 187, 190
(Okla. 1992) (plaintiff asserting manufacturer’s product liability must establish that “the
product was defective when it left the hands of the manufacturer”). Because Wyeth and
Schwarz were never in control or possession of the metoclopramide Susan Schrock took,
the Schrocks cannot establish this element of their strict liability claim.
Several federal district court cases that have applied Oklahoma law have rejected
products liability claims on this basis. See Muniz v. Masco Corp., 744 F. Supp. 266, 267
(W.D. Okla. 1990) (“In Oklahoma, a product liability cause of action lies only against a
manufacturer, seller, or supplier of a defective product.”); Mayberry v. Akron Rubber
Mach. Corp., 483 F. Supp. 407, 412 (N.D. Okla. 1979) (rejecting a products-liability
claim based on the “critical” fact that the products at issue “were not manufactured by
[defendant]”). And we have recently emphasized in an unpublished order and judgment
that under Oklahoma tort law, “responsibility for the defect must still be traced to the
proper Defendant.” Edwards v. PepsiCo, Inc., 268 F. App’x 756, 762 (10th Cir. 2008)
(unpublished).
In addition, the Schrocks contend that Oklahoma law permits claims against an
entity that negligently designs, but does not manufacture, a product that causes harm if
the plaintiff’s resulting injury is foreseeable. They rely primarily on Keel v. Titan
Construction Corp., 639 P.2d 1228 (Okla. 1981), in which the Oklahoma Supreme Court
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held that plaintiffs could bring suit for negligent breach of contract against an architect
who designed their home, absent privity between the plaintiffs and the architect. Id. at
1232. In Keel, however, the architects designed the particular structure that resulted in
plaintiffs’ injury. See id. at 1230. Keel is simply not analogous to the present case, in
which a competitor of the brand-name manufacturers utilized a design originally
conceived by them, and the competitors’ product harmed the plaintiffs.
Oklahoma courts have also required a relationship between the defendant
company and the product at issue for other theories of liability, including negligence. In
Spence v. Brown-Minneapolis Tank, Co., 198 P.3d 395 (Okla. Civ. App. 2008), the court
rejected a negligence claim premised on the same facts as a strict liability claim because
the defendant “had nothing to do with the manufacture” of the product at issue and did
not “occupy a relationship which gives rise to a legal obligation . . . for the benefit of the”
plaintiff. Id. at 401. Similarly, in Copeland v. Admiral Pest Control, 933 P.2d 937 (Okla.
Civ. App. 1996), the court noted that for a claim in negligence, “[w]hether or not a duty
exists depends on the relationship between the parties.” Id. at 939. The brand-name
manufacturers do not have any relationship with the Schrocks.
We are directed to Independent-Eastern Torpedo Co. v. Price, 258 P.2d 189 (Okla.
1953), as supporting the Schrocks’ negligence claim. In Price, the Oklahoma Supreme
Court held that a company had a duty to warn an individual injured by a company
employee. Id. at 201. The duty, however, was based on the employer-employee
relationship between the defendant and the person who injured the plaintiff. Id. (citing
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Southland Cotton Oil Co. v. Renshaw, 299 P. 425 (Okla. 1931)). Such a relationship is
not present between the generic and brand-name manufacturers.
In support of their misrepresentation, fraud, and failure-to-warn claims, the
Schrocks advance two arguments. First, they argue that the brand-name manufacturers
concealed a latent defect in their product. However, in the Oklahoma cases they cite as
permitting such claims, the plaintiff and defendant were engaged in a buyer-seller or
other contractual relationship. See Rogers v. Meiser, 68 P.3d 967, 976 (Okla. 2003)
(“[A] vendor is guilty of fraudulent concealment of a latent defect affecting the value of
property for the purpose for which it was bought.”); Dawson v. Tindell, 733 P.2d 407,
408-09 (Okla. 1987) (suit by home buyers against realtor); O’Quinn v. Nothaff, 205 P.
498, 500 (Okla. 1922) (“[T]he defendants induced the plaintiff to enter into the contract
for the exchange of the cars by committing a fraud.”); Von Brauchitsch v. Cravens, 604
P.2d 379, 380 (Okla. Civ. App. 1978) (“A latent soil defect, known to the seller of a
house built on such soil, creates a duty of disclosure in the seller.”). See also Okland Oil
Co. v. Conoco Inc., 144 F.3d 1308, 1312 (10th Cir. 1998); Uptegraft v. Dome Petroleum
Corp., 764 P.2d 1350, 1351-52 (Okla. 1988). No authority is cited to suggest that a
manufacturer may be held liable under Oklahoma law for concealing a defect in a product
that is never purchased or used by the plaintiff.
Second, the Schrocks argue that Oklahoma law imposes a duty upon brand-name
manufacturers to speak rather than to remain silent in certain circumstances. The
Schrocks recognize, however, “[i]n determining whether there is a duty to speak,
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consideration must be given to the situation of the parties and the matters with which they
are dealing.” Silk v. Phillips Petroleum Co., 760 P.2d 174, 179 (Okla. 1988). Even
accepting the Schrocks’ assertion that the brand-name manufacturers conveyed “a false
impression by the disclosure of some facts and the concealment of others,” Deardorf v.
Rosenbusch, 206 P.2d 996, 998 (Okla. 1949), it nonetheless remains true that the brand-
name manufacturers had no relationship with the Schrocks; there were no “matters with
which they [we]re dealing,” Silk, 760 P.2d at 179.
To the same effect, the Schrocks argue that under Oklahoma law, liability may be
imposed if a defendant has knowledge of a dangerous situation yet fails to warn of that
danger. They cite two cases for this contention: one involves a relationship that clearly
requires a duty, and in the other the court held that there was no duty. Wells v. Boston
Ave. Realty, 125 F.3d 1335, 1339 (10th Cir. 1997) (holding that a “business owner is not
liable for third person assaults”); Rogers v. Hennessee, 602 P.2d 1033, 1034 (Okla. 1979)
(noting that the “parties stand in an undisputed invitor-invitee relationship”). These cases
do not persuade us that Oklahoma courts would impose a duty on drug manufacturers to
warn of dangers in their competitors’ products.
The Schrocks do not develop any specific argument regarding their breach of
warranty claims. Nonetheless, the Oklahoma Uniform Commercial Code contemplates
such claims only as against the seller of the product at issue. See Okla. Stat. tit. 12A,
§ 2-313 (express warranties are “created” by the seller with representations that become
“part of the basis of the bargain”); § 2-314 (“[A] warranty that the goods shall be
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merchantable is implied in a contract for their sale if the seller is a merchant with respect
to goods of that kind.”); § 2-315 (“Where the seller at the time of contracting has reason
to know any particular purpose for which the goods are required and that the buyer is
relying on the seller’s skill or judgment to select or furnish suitable goods, there is unless
excluded or modified under the next section an implied warranty that the goods shall be
fit for such purpose.”). This cause of action does not apply.
We are told that the brand defendants may be held liable under “traditional
theories of tort law.” Several provisions of the Restatement (Second) of Torts, which
recite general tort principles of duty and foreseeability, are relied on by the Schrocks.
See, e.g., Restatement (Second) of Torts §§ 302A; 310; 315; 324A. Although several
other provisions of the Restatement are cited by the Schrocks in response to Wyeth and
Schwarz’s motion for summary judgment, they did not bring these specific Restatement-
based theories to the attention of the district court. Arguments that were not raised below
are “waived for purposes of appeal.” Quigley v. Rosenthal, 327 F.3d 1044, 1069 (10th
Cir. 2003). This rule applies when a “litigant changes to a new theory on appeal that falls
under the same general category as an argument presented at trial or presents a theory
that was discussed in a vague and ambiguous way.” Bancamerica Comm. Corp. v.
Mosher Steel of Kan., Inc., 100 F.3d 792, 798-99 (10th Cir. 1996) (quotations omitted).
Moreover, as the foregoing discussion demonstrates, the Schrocks fail to cite
Oklahoma case law suggesting that these general tort principles impose liability with
respect to a defendant that did not sell, distribute, manufacture, or otherwise have contact
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with the allegedly harmful product. Instead, they ask this court to expand the scope of
tort liability under Oklahoma law by imposing a duty under entirely unprecedented
circumstances. “As a federal court, we are generally reticent to expand state law without
clear guidance from its highest court.” Taylor v. Phelan, 9 F.3d 882, 887 (10th Cir.
1993). And the Schrocks’ novel claims are not supported by “decisions rendered by
lower courts in the relevant state” or “district court decisions interpreting the law of the
state in question.” Wade, 483 F.3d at 666 (citations and quotation omitted).
We may also look to “appellate decisions in other states with similar legal
principles . . . and the general weight and trend of authority in the relevant area of law” in
predicting whether the Oklahoma Supreme Court would recognize a cause of action
against a brand-name drug manufacturer under the present circumstances. But the courts
of other states have overwhelmingly rejected the very theory advanced by the Schrocks.
See Mensing v. Wyeth, Inc., 588 F.3d 603, 613 (8th Cir. 2009) (the “overwhelming
majority of courts” have declined to impose liability against brand-name manufactures on
claims by consumers of a generic equivalent drug), rev’d in part on other grounds sub
nom. PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011).
In Foster v. American Home Products, 29 F.3d 165 (4th Cir. 1994), the Fourth
Circuit rejected “the contention that a name brand manufacturer’s statements regarding
its drug can serve as the basis for liability for injuries caused by another manufacturer’s
drug.” Id. at 170. The court explained:
Name brand advertising benefits generic competitors because generics are
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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. 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. This would be especially
unfair 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. Since Foster was decided, every federal circuit court to address this issue—applying
the law of numerous states—has consistently followed. See Guarino v. Wyeth, LLC, No.
12-13263, 2013 WL 3185084, at *6, __ F.3d __ (11th Cir. June 25, 2013) (“[T]he
overwhelming national consensus—including the decisions of every court of appeal and
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., No. 12-1674, 2013 WL 2661189, at *3
716 F.3d 1087 (8th Cir. June 14, 2013) (“Because Bell never used Reglan the brand
defendants manufactured, Bell cannot hold them liable under Arkansas law.”); Demahy
v. Schwarz Pharma, Inc., 702 F.3d 177, 183 (5th Cir. 2012) (per curiam) (under
Louisiana law, plaintiff’s “claims against Wyeth and Schwarz fail because they did not
manufacture the medication she actually consumed”), rev’d in part on other grounds sub
nom. Mensing, 131 S. Ct. 2567; Smith v. Wyeth, Inc., 657 F.3d 420, 423-24 (6th Cir.
2011) (argument “that the name-brand defendants’ liability stems from the fact that the
regulatory structure governing name-brand and generic drugs makes it foreseeable that
patients and their physicians will rely on the name-brand labels to use and prescribe
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generic drugs” was “rejected by all but one of the courts that have considered it”), cert.
denied, 132 S. Ct. 2103 (2012); Mensing, 588 F.3d at 614 (concluding that “under
Minnesota law Mensing has not shown that the name brand manufacturers owed her a
duty of care necessary to trigger liability”), rev’d in part on other grounds sub nom.
Mensing, 131 S. Ct. 2567.
Courts that have concluded brand-name manufacturers are not liable to consumers
of generic drugs relied on three principal rationales. 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 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).
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In contrast to the dozens of cases holding to the contrary, only a handful of
courts—and no federal courts of appeals—have held that brand-name manufacturers can
be held liable for injuries caused by their generic counterparts. See Kellogg v. Wyeth,
762 F. Supp. 2d 694 (D. Vt. 2010); Easter v. Aventis Pasteur, Inc., No. 5:03-CV-141,
2004 WL 3104610 (E.D. Tex. Feb. 11, 2004) (unpublished); Wyeth, Inc. v. Weeks, No.
1101397, 2013 WL 135753, __ So. 2d __ (Ala. Jan. 11, 2013); Conte v. Wyeth, Inc., 85
Cal. Rptr. 3d 299 (Cal. Ct. App. 2008).
We predict that the Oklahoma Supreme Court would not recognize this novel
theory of liability.4 Accordingly, we affirm the district court’s grant of summary
judgment in favor of Wyeth and Schwarz.
C
Finally, the Schrocks argue that the district court erred in concluding that their
breach of express and implied warranty claims against Qualitest were preempted by
federal law under the doctrine of impossibility preemption.5 The Supremacy Clause
provides that the Constitution, laws, and treaties of the United States “shall be the
supreme Law of the Land . . . any Thing in the Constitution or Laws of any State to the
Contrary notwithstanding.” U.S. Const., art. VI, cl. 2. State law is preempted if it is
4
Notably, the Schrocks did not request certification of this issue to the Oklahoma
Supreme Court.
5
The Schrocks do not appeal the district court’s dismissal of their breach of
warranty claims against PLIVA.
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“impossible for a private party to comply with both state and federal requirements.”
English v. Gen. Elec. Co., 496 U.S. 72, 79 (1990). As the Supreme Court explained in
its recent FDCA preemption case, state tort law is preempted if it imposes a duty upon
manufacturers to take some action that is prohibited under federal law, because such a
regime “actually conflicts with federal law by making it impossible for a private party to
comply with both state and federal requirements.” Mut. Pharm. Co., Inc. v. Bartlett, 133
S. Ct. 2466, 2479 (2013) (quotation and alterations omitted).
Our analysis of whether the Schrocks’ state law warranty claims are preempted
thus “begin[s] by identifying [Qualitest’s] duties under state law.” Id. at 1473. Under
Oklahoma law, an express warranty is defined as “[a]ny affirmation of fact or promise
made by the seller to the buyer which relates to the goods and becomes part of the basis
of the bargain,” “[a]ny description of the goods which is made part of the basis of the
bargain,” or “[a]ny sample or model which is made part of the basis of the bargain.”
Okla. Stat. tit. 12A, § 2-313(1)(a)-(c). Unless excluded or modified, a warranty that
goods are “merchantable is implied in a contract for their sale if the seller is a merchant
with respect to goods of that kind.” Okla. Stat. tit. 12A, § 2-314(1). To comply with this
warranty, goods must:
(a) pass without objection in the trade under the contract description; and
(b) in the case of fungible goods, [be] of fair average quality within the
description; and
(c) [be] fit for the ordinary purposes for which such goods are used; and
(d) run, within the variations permitted by the agreement, of even kind,
quality and quantity within each unit and among all units involved; and
(e) [be] adequately contained, packaged, and labeled as the agreement may
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require; and
(f) conform to the promises or affirmations of fact made on the container or
label if any.
§ 2-314(2) (a)-(f).
Consistent with these statutory provisions, the Schrocks alleged under the “Breach
of Warranties” heading in their amended complaint that: (1) Qualitest “expressly and
impliedly warranted that . . . metoclopramide [was] not unreasonably dangerous and
instead [was] merchantable and fit for its intended use”; (2) Qualitest’s metoclopramide
“contained descriptions of the safety profile of the medication to which it did not
conform”; (3) Qualitest’s metoclopramide was “not adequately contained, packaged, and
labeled, and did not conform to the promises [and] affirmations of fact made in the label
which accompanied the drug”; and (4) Qualitest’s “metoclopramide did not conform to
express warranties present on its labeling, was not merchantable, was unfit for its
intended use, and was unreasonably dangerous.”
Both the complaint and the Oklahoma statute refer to the manner in which a
product is labeled, packaged, and otherwise described to the consumer. See Okla. Stat.
tit. 12A, § 2-313(1)(a)-(b) (“promise[s]” and “description[s]” of the goods); § 2-314(2)
(a) (“pass without objection in the trade under the contract description”); § 2-314(2)(b)
(“are of fair average quality within the description”); § 2-314(2)(e) (“are adequately
contained, packaged, and labeled as the agreement may require”); § 2-314(2)(f)
(“conform to the promises or affirmations of fact made on the container or label”).
Repeatedly, the Schrocks’ complaint refers to the “descriptions” and “labeling” of the
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metoclopramide. These warranty claims are thus based on the theory that Qualitest
provided improper descriptions or warnings in the labeling and packaging of
metoclopramide or that the content of the metoclopramide Qualitest sold rendered it
unreasonably dangerous or unmerchantable.
In Mensing, the Court recognized that federal law imposes “an ongoing federal
duty of ‘sameness’” that precludes generic drug manufacturers from altering their
products labels. 131 S. Ct. at 2575 (citing Abbreviated New Drug Application
Regulations, 57 Fed. Reg. 17,950, 17,961 (1992)). Further, generic manufacturers may
not use “‘Dear Doctor’ letters to send additional warnings to prescribing physicians and
other healthcare professionals.” Id. at 2576. Deferring to the FDA’s interpretation of its
regulations, the Mensing Court held that “Dear Doctor letters qualify as ‘labeling’” and
thus such a letter “that contained substantial new warning information would not be
consistent with the drug’s approved labeling.” Id. Based on these determinations, the
Court held that state law failure-to-warn claims against generic drug manufacturers are
preempted by federal regulations because it is impossible for a generic manufacturer of
metoclopramide to unilaterally alter its drug’s label to comply with state law without
violating FDA regulations. Id. at 2577-78.
Key to the Mensing decision was the Court’s deference to the FDA’s broad-
definition of “labeling.” Id. at 2576. Under FDA regulations, the term “labeling” in the
prescription drug context is expansive, including:
[b]rochures, booklets, mailing pieces, detailing pieces, file cards, bulletins,
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calendars, price lists, catalogs, house organs, letters, motion picture films,
film strips, lantern slides, sound recordings, exhibits, literature, and reprints
and similar pieces of printed, audio, or visual matter descriptive of a drug
and references published (for example, the “Physicians’ Desk Reference”)
for use by medical practitioners, pharmacists, or nurses, containing drug
information supplied by the manufacturer, packer, or distributor of the drug
and which are disseminated by or on behalf of its manufacturer, packer, or
distributor . . . .
21 C.F.R. § 202.1(l)(2); see also Del Valle v. PLIVA, Inc., No. B:11-113, 2011 WL
7168620, at *4 (S.D. Tex. Dec. 21, 2011) (unpublished) (“In essence, virtually all
communication with medical professionals concerning a drug constitutes labeling.”)
adopted sub nom. Del Valle v. Qualitest Pharm. Inc., 2012 WL 2899406 (S.D. Tex. June
22, 2012) (unpublished)).
Plaintiffs attempt to distinguish Mensing by asserting that it only addressed
failure-to-warn claims in the context of a drug’s label, which they appear to construe
narrowly. Yet the same federal regulatory scheme that prevented generic manufacturers
from unilaterally issuing label changes and “Dear Doctor letters” at issue in Mensing
applies to a broad array of communications. No effort is made to identify a mechanism
through which Qualitest could have modified or supplemented the warranties allegedly
breached without running afoul of the duty of sameness identified in Mensing.
Accordingly, the Schrocks’ claims are preempted to the extent they rest on inadequate
labeling as broadly defined by the FDA.
It is also alleged in the complaint that Qualitest’s product “was not
merchantable, was unfit for its intended use, and was unreasonably dangerous.” See
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Okla. Stat. tit. 12A, § 2-314(2)(c) (implied warranty that product is “fit for the ordinary
purposes for which such goods are used”). Under Oklahoma law, products are
“merchantable” or “fit” if they “operate for their ordinary purpose.” Perry v. Lawson
Ford Tractor Co., 613 P.2d 458, 463 (Okla. 1980). We conclude that these claims, based
on allegations of dangerousness or ineffectiveness, are also preempted because Qualitest
could not have altered the composition of the metoclopramide it manufactured without
violating federal law. In Bartlett the Supreme Court held that the reasoning of Mensing
extends to “warning-based design-defect cause[s] of action” asserted against generic
manufacturers. Bartlett, 133 S. Ct. at 2477. The Court noted that under the state law at
issue, a manufacturer has a duty to “ensure that the products they design, manufacture,
and sell are not unreasonably dangerous,” which can be “satisfied either by changing a
drug’s design or by changing its labeling.” Id. at 2474. As in Mensing, the Court
explained that labeling changes are preempted because generic manufacturers have a
“federal-law duty not to alter [a drug’s] label.” Bartlett, 133 S. Ct. at 2473.
Further, the Court extended its reasoning in Mensing to claims that a generic drug
is ineffective or unreasonably dangerous. “In the drug context, either increasing the
‘usefulness’ of a product or reducing its ‘risk of danger’ would require redesigning the
drug: A drug’s usefulness and its risk of danger are both direct results of its chemical
design and, most saliently, its active ingredients.” Bartlett, 133 S. Ct. at 2475. But “the
FDCA requires a generic drug to have the same active ingredients, route of
administration, dosage form, strength, and labeling as the brand-name drug on which it is
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based.” Id. (citing 21 U.S.C. §§ 355(j)(2)(A)(ii)-(v) and (8)(B); 21 C.F.R. § 320.1(c)).
Under Bartlett, a claim that a generic drug manufacturer’s product is unfit for its intended
use or unreasonably dangerous is one that would impose a duty to alter the composition
of that drug. See Bartlett, 133 S. Ct. at 2474-75; see also Bartoli v. APP Pharm., Inc., (In
re Pamidronate Prod. Liab. Litig.), 842 F. Supp. 2d 479, 485 (E.D.N.Y. 2012) (a “breach
of implied warranty claim necessarily alleges that defendants should have changed the
design of [a drug] to make it safe and fit for its intended uses” and is therefore preempted
(quotation omitted)); In re Fosamax Prods. Liab. Litig. (No. II), No. 08-008, 2011 WL
5903623, at *8 (D.N.J. Nov. 21, 2011) (unpublished) (“[B]reach of implied warranty
claim necessarily alleges that manufacturers should have changed [a drug’s] design. This
would be in violation of the federal duty of sameness, and therefore, this claim is
preempted.”).
In advancing their warranty claims, the Schrocks allege that Qualitest had a duty
under state law to alter either the composition or the labeling, as broadly defined by the
FDA, of its generic metoclopramide. Because Qualitest could not have taken either
action under federal law, we conclude these claims are preempted. The Eleventh Circuit
has reached the same conclusion. See Guarino, 2013 WL 3185084, at *1-2 (holding
claims against generic manufacturer, including breach of warranty claim, preempted
because all claims were “premised upon an allegedly inadequate warning”). And the
Ninth Circuit summarily affirmed a district court decision concluding that similar
warranty claims were preempted on remand from the Supreme Court following Mensing.
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See Gaeta ex rel. A.G. v. Perrigo Pharms. Co., 469 F. App’x 556 (9th Cir. 2012)
(unpublished); see also Gaeta v. Perrigo Pharms. Co., 562 F. Supp. 2d 1091, 1097-98
(N.D. Cal. 2008) (express and implied warranty claims preempted because generic
manufacturer could not alter labeling and be consistent with federal law).6
In Metz v. Wyeth, LLC, 872 F. Supp. 2d 1335 (M.D. Fla. 2012), the Middle
6
In Bell v. Pfizer, Inc., 716 F.3d 1087 (8th Cir. 2013), the Eighth Circuit reversed
a grant of summary judgment based on preemption because it was unable to determine
whether plaintiff’s “breach of implied warranty claims, other than those based on an
inadequate warning or labeling, are in essence, failure-to-warn claims.” Id. at 1096. As
noted supra, however, the Supreme Court has since extended the holding of Mensing to
cover not just failure-to-warn claims, but also those claims that would require a redesign
of a generic drug. Bartlett, 133 S. Ct. at 2476-77.
We reject the Schrocks’ reliance on the Eighth Circuit’s decision in Fullington v.
Pfizer, Inc., No. 12-2945, 2013 WL 3491060, __ F.3d __ (8th Cir. July 15, 2013). In
Fullington, the court reversed the dismissal of warranty claims against generic
manufacturers of metoclopramide because it concluded that the district court improperly
“categorized [the claims] as failure-to-warn claims,” and thus concluded the claims were
preempted under Supreme Court precedent. Id. at *4. For the reasons stated supra, we
hold that the Schrocks’ warranty claims are properly characterized as failure-to-warn
claims or as design defect claims. And as the Eighth Circuit states, “Bartlett casts doubt
on the viability of [design defect claims].” Fullington, 2013 WL 3491060, at *5.
We are similarly not persuaded by the Schrocks’ reliance on pre-Bartlett case law.
For example, they cite Wyeth v. Levine, 555 U.S. 555, 574-75 (2009), for the proposition
that the FDCA does not preempt all state torts against drug manufacturers. We are not
inclined to make such a sweeping holding; we simply construe Bartlett as indicating the
Schrocks’ warranty claims are preempted. Bartlett stressed the Court had not “ignored
Congress’ explicit efforts to preserve state common-law liability,” citing Levine.
Bartlett, 133 S. Ct. at 2480. The Schrocks also point to Bates v. Dow Agrosciences,
LLC, 544 U.S. 431 (2005), as providing the rule of decision in this case. But the majority
in Bartlett explicitly rejected the argument that Bates was dispositive, explaining that in
Bates “the design-defect claim in question was not a requirement for labeling or
packaging” and also that Bates addressed a different statutory scheme than the FDCA,
which was the relevant statute both in Bartlett and the case at bar. Bartlett, 133 S. Ct. at
2479 (quotations and emphasis omitted).
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District of Florida held that metoclopramide-related warranty claims were preempted
because they stemmed from a failure to warn. Id. at 1341. We are pointed to the court’s
dicta stating that “an implied warranty claim may survive preemption” if it is based on a
claim that the generic manufacturer provided a warranty “contrary [to] the FDA approved
label.” Id. at 1342; see also Fisher v. Pelstring, 817 F. Supp. 2d 791, 820 (D.S.C. 2011)
(claim that generic manufacturer did not update label to match changes in brand-name
label not preempted); Couick v. Wyeth, Inc., No. 09-210, 2012 WL 79670, at *3-4 (W.D.
N.C. Jan. 11, 2012) (unpublished) (same). There is no allegation, however, that
Qualitest’s label deviated from the FDA-approved label.
We do not lend credence to the Schrocks’ argument that Qualitest could have
complied with its alleged duty under state tort law and with the federal requirements by
simply declining to manufacture metoclopramide. The Supreme Court squarely rejected
this contention in Bartlett, holding that the “‘stop-selling’ rationale [is] incompatible with
our pre-emption jurisprudence. Our pre-emption cases presume that an actor seeking to
satisfy both his federal- and state-law obligations is not required to cease acting
altogether in order to avoid liability.” 133 S. Ct. at 2477.
Finally, we reject the argument that the state law warranty claims are not
preempted because they simply parallel requirements imposed by federal law. See Riegel
v. Medtronic, Inc., 552 U.S. 312, 330 (2008) (federal law 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”). The
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Schrocks argue that the requirements of Oklahoma state law regarding warranties parallel
federal law because the metoclopramide was “misbranded” under 21 U.S. C. §352(j),
and are therefore not preempted. But the Bartlett court indicated in dicta that “a drug is
misbranded under federal law only when liability is based on new and scientifically
significant information that was not before the FDA” and that allegations of
dangerousness based on “the medical literature or published FDA analyses” would not
qualify. 133 S. Ct. at 2477 n.4. A misbranding claim along these lines has not been
advanced.
IV
We recognize the catch-22 situation in which existing jurisprudence places the
Schrocks and similarly situated consumers of generic drugs. They cannot obtain relief
from brand-name drug manufacturers because, as we predict, Oklahoma would not
impose a duty on the brand-name manufacturers that flows to consumers of generic
drugs. Yet the Schrocks’ claims against generic drug manufacturers are preempted under
Mensing and Bartlett. As a federal court, however, we have limited authority to correct
this potential injustice. It is for the state courts, rather than this panel, to engage in the
delicate policy considerations predicate to the expansion of the scope of state tort law.
See Taylor, 9 F.3d at 887. Moreover, as the Mensing court acknowledged, courts are not
asked “to decide whether the statutory scheme established by Congress is unusual or even
bizarre” despite the “the unfortunate hand that federal drug regulation has dealt”
consumers of generic drugs. 131 S. Ct. at 2581-82. If consumers of generic drugs are to
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obtain federal relief, it must come from Congress.
We AFFIRM. PLIVA’s motion to dismiss for lack of jurisdiction is DENIED.
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