Murphy v. Playtex Family Products Corp. , 69 F. App'x 140 ( 2003 )

UNPUBLISHED
UNITED STATES COURT OF APPEALS
FOR THE FOURTH CIRCUIT
ALLISON A. MURPHY, a minor, by 
Rita and John Murphy, as Parents
and Next Friends,
Plaintiff-Appellant,
and
RITA MURPHY, individually; JOHN
MURPHY, individually,  No. 02-1110
Plaintiffs,
v.
PLAYTEX FAMILY PRODUCTS
CORPORATION,
Defendant-Appellee.

Appeal from the United States District Court
for the District of Maryland, at Greenbelt.
Andre M. Davis, District Judge.
(CA-00-3664-AMD)
Argued: May 7, 2003
Decided: June 26, 2003
Before WILKINS, Chief Judge, and WILKINSON and
MOTZ, Circuit Judges.
Affirmed by unpublished per curiam opinion.
COUNSEL
ARGUED: Lloyd David Inglehart, Columbia, Maryland, for Appel-
lant. William H. Robinson, Jr., WRIGHT, ROBINSON, OSTHIMER
2 MURPHY v. PLAYTEX FAMILY PRODUCTS CORP.
& TATUM, Washington, D.C., for Appellee. ON BRIEF: Terrence
M.R. Zic, WRIGHT, ROBINSON, OSTHIMER & TATUM, Wash-
ington, D.C.; C. Ervin Reid, WRIGHT, ROBINSON, OSTHIMER &
TATUM, Richmond, Virginia, for Appellee.
Unpublished opinions are not binding precedent in this circuit. See
Local Rule 36(c).
OPINION
PER CURIAM:
Plaintiff Allison Murphy sued Playtex Products, Inc., after con-
tracting toxic shock syndrome while using Playtex brand tampons.
The district court found that Murphy’s state law claims relating to the
failure of Playtex to adequately warn her of the dangers of using tam-
pons were preempted by federal regulation in the field. Additionally,
the district court found that her design defect claims failed as a matter
of law. We agree with the district court and dismiss all counts.
I.
Plaintiff Allison Murphy suffered from toxic shock syndrome
("TSS") in January 1998 while using Playtex tampons. After her bout
with TSS, Murphy, along with her parents as next friends, filed this
action against Playtex alleging negligence, strict liability, breach of
express warranty, and breach of implied warranty under Maryland
law, as well as violation of the Maryland Consumer Protection Act.
Murphy sought restitution and punitive damages based on Playtex’s
failure to adequately warn her of the risk of TSS associated with tam-
pon use and Playtex’s alleged negligent use of rayon fiber instead of
cotton fiber in the manufacture of its tampons.
TSS is a rare but potentially life-threatening illness caused by the
bacterium staphylococcus aureus. The disease is most commonly
linked to the use of high absorbency tampons in young women.
MURPHY v. PLAYTEX FAMILY PRODUCTS CORP. 3
The risk of contracting TSS from tampons has been recognized by
the United States Food and Drug Administration ("FDA") for over
twenty years. In light of this risk, the FDA has promulgated regula-
tions for the manufacture and distribution of tampons. Playtex prints
the mandated federal warning about TSS in three spots on its packag-
ing. Because higher absorbency tampons are more likely to cause
TSS, Playtex also prints the range of absorbency of its tampons in
five spots on the tampon packaging. Each box of Playtex tampons
also contains an insert with a warning about TSS and detailed infor-
mation about the symptoms of TSS and ways to decrease the risk of
getting TSS.
When the FDA first promulgated these regulations in 1982, FDA
researchers reviewed extensive amounts of material on the relation of
TSS to tampon use. The researchers concluded that although tampon
use was associated with TSS, tampons were not in themselves danger-
ous. Moreover, these researchers found that no particular tampon
fiber or ingredient increased the risk of TSS. During its review of
tampon regulations in 1988 and 1989, the FDA again found that
"none of the comments favoring ingredient labeling cited, discussed,
or submitted any data showing an association between any particular
ingredient and any risk to health." In 1989, the Center for Disease
Control ("CDC") concurred that no particular composition of tampons
affected the risk of contracting TSS.
Based on this information, Playtex moved for summary judgment
on all claims. Specifically, Playtex contended that Murphy’s failure
to warn claims were preempted by § 360k(a) of the Federal Devices
Act, which requires the labeling of tampon packages, and that her
other claims were insufficient under Maryland law. On December 19,
2001, the district court granted Playtex’s motion for summary judg-
ment. Murphy v. Playtex Family Prod., 176 F. Supp. 2d 473 (D. Md.
2001). Murphy now appeals.
II.
Murphy first argues that the district court erred in finding her state
law failure to warn claims preempted by § 360k(a) of the Federal
Devices Act. Preemption is appropriate, however, where a plaintiff
seeks to impose labeling requirements which are "different from, or
4 MURPHY v. PLAYTEX FAMILY PRODUCTS CORP.
in addition to," specific regulations promulgated by the FDA. Duvall
v. Bristol-Myers-Squibb Co., 103 F.3d 324, 328 (4th Cir. 1996).
Therefore, the district court was correct to find that Murphy’s state
law failure to warn claims, no matter how they were framed, were
preempted by the extensive federal regulation in the field.
The FDA has promulgated specific regulations mandating the sub-
stantive content of TSS warnings on tampon boxes. See 21 C.F.R.
§ 801.430. While not every federal regulation will preempt state law
claims, preemption will be found when it is clear that "the Federal
Government has weighed the competing interests relevant to the par-
ticular requirement in question, reached an unambiguous conclusion
about how those competing considerations should be resolved in a
particular case or set of cases, and implemented that conclusion via
a specific mandate on manufacturers or producers." Medtronic, Inc.
v. Lohr, 518 U.S. 470, 501 (1996). In this case, the regulations at
issue are "not only device-specific (tampons), but also disease-
specific (TSS)." Papike v. Tambrands, Inc., 107 F.3d 737, 740 (9th
Cir. 1997). Thus, it is clear that the federal regulators considered
exactly the risk that Murphy was exposed to and determined how best
to warn consumers of this risk through product labeling.
Moreover, other courts faced with similar cases have specifically
held that federal labeling requirements for tampons preempt state law
warning claims. See Papike, 107 F.3d at 740; Nat’l Bank of Com-
merce v. Kimberly-Clark Corp., 38 F.3d 988 (8th Cir. 1994); Moore
v. Kimberly-Clarke Corp., 867 F.2d 243 (5th Cir. 1989). We agree
with these courts and thus find that the district court correctly deter-
mined that "plaintiffs’ failure to warn claims, including plaintiffs’
Consumer Protection Act claim, are expressly preempted by the
requirements of 21 C.F.R. § 801.430."* Murphy, 176 F. Supp. 2d at
483.
*Murphy also argues that summary judgment was inappropriate
because her negligent manufacture claims "were not preempted by
360k(a) to the extent that such claims rested on allegations that the man-
ufacturer negligently failed to comply with the duties equal to, or sub-
stantially identical to, requirements imposed under Federal law by the
FDCA." Murphy does not actually allege, however, that Playtex does not
comply with the labeling regulations. Indeed, Murphy explicitly con-
ceded that the tampon box contained several warnings as required by the
FDA. This claim is therefore without merit.
MURPHY v. PLAYTEX FAMILY PRODUCTS CORP. 5
III.
Murphy next argues that the district court erred in dismissing her
design defect claims. The district court found that these claims were
insufficient as a matter of law. Murphy, 176 F. Supp. 2d at 487.
Because Murphy’s evidence fails to raise an issue of triable fact under
either test utilized by the Maryland courts, we affirm the district
court’s grant of summary judgment.
The elements of proof for a design defect claim under Maryland
law are the same whether the claim is for strict liability, negligence,
or breach of warranty, all of which Murphy alleges. Watson v. Sun-
beam Corp., 816 F. Supp. 384, 387 n.3 (D. Md. 1993). In order to
recover on a product defect claim, a plaintiff must prove that a defect
which renders the product unreasonably dangerous might arise from
the design of the product, a deficiency in its manufacture, or from the
absence or inadequacy of any instructions or warnings as to its safe
and appropriate use. Simpson v. Standard Container Co., 527 A.2d
1337, 1339-40 (Md. Ct. Spec. App. 1987). In other words, Murphy
must show that Playtex acted unreasonably when, knowing the risk
inherent in its product, it nonetheless put the product on the market.
Ziegler v. Kawasaki Heavy Indus., Ltd., 539 A.2d 701, 705 (Md. Ct.
Spec. App. 1988).
Maryland courts have applied both a risk/utility test and a con-
sumer expectation test for determining whether a product is unreason-
ably dangerous due to a design defect. Murphy argues that Playtex’s
choice of rayon fiber instead of cotton fiber for its tampons is unrea-
sonable under either test. We address each theory in turn.
A.
Maryland courts applying a risk/utility test focus on "whether the
benefits of a product outweigh the dangers of its design." Tannen-
baum v. Yale Materials Handling Corp, 38 F. Supp. 2d 425, 430 (D.
Md. 1999). Murphy contends that she has proffered sufficient evi-
dence to establish a prima facie case under the risk/utility test.
Murphy’s sole evidence is contained in the affidavits of designated
experts Philip M. Tierno, Ph.D. and Bruce A. Hanna, Ph.D. Both are
6 MURPHY v. PLAYTEX FAMILY PRODUCTS CORP.
microbiologists who have collaborated in conducting unblinded test
tube experiments allegedly proving that tampons made with cotton
fiber present less risk of TSS than tampons with rayon fiber. Both sci-
entists have conceded in deposition testimony, however, that tampon-
associated TSS will occur regardless of what fiber is used. They have
also conceded that no other scientists have corroborated their views
and that their work has not been verified by epidemiological studies
of any sort. Murphy, 176 F. Supp. 2d at 477.
In fact, significant research done in published, peer-reviewed scien-
tific studies has refuted their conclusions. Every other study done in
the field has indicated that no greater quantity of TSST-1, the toxin
that causes TSS, is produced in the presence of rayon fibers than in
the presence of cotton fibers. These studies have been replicated both
in the laboratory and in animal testing and are also consistent with the
conclusions reached by the FDA and CDC. Murphy, 176 F. Supp. 2d
at 477-78.
Faced with this overwhelming scientific evidence, at least two
other circuits have already found that the unproven opinions of Tierno
and Hannah were insufficient to create a genuine issue of material
fact as to the risks associated with rayon tampons. See Haddix v.
Playtex Family Prods. Corp., 138 F.3d 681, 685-86 (7th Cir. 1998);
Papike, 107 F.3d at 743. The district court, citing to these opinions,
found that Murphy could not "establish by a preponderance of the evi-
dence to a reasonable jury a necessary element of [her] case — that
Playtex acted unreasonably in designing or manufacturing tampons
with rayon fiber." Murphy, 176 F. Supp. 2d at 493. We agree that
Murphy failed to show that the risks inherent in marketing rayon tam-
pons outweighed the benefit to consumers. Therefore her case cannot
survive summary judgment on a risk/utility analysis.
B.
The consumer expectations test "focuses on what a buyer/user of
a product would properly expect that the product would be suited
for." Tannenbaum, 38 F. Supp. 2d at 430. Using this test, Maryland
courts have found that a product is unreasonably dangerous if it is
"dangerous to an extent beyond that which would be contemplated by
the ordinary consumer who purchases it, with the ordinary knowledge
MURPHY v. PLAYTEX FAMILY PRODUCTS CORP. 7
common to the community as to its characteristics." Phipps v. Gen-
eral Motors Corp., 363 A.2d 955, 959 (Md. 1976). Murphy argues
that Playtex tampons were dangerous beyond the expectations of the
average consumer because the warnings on the package did not suffi-
ciently convey the dangers of using high absorbency tampons.
Since January 1987, Playtex has printed a TSS warning statement
in three separate locations on the outside of each box of Playtex tam-
pons. The alert reads as follows:
ATTENTION: Tampons are associated with Toxic Shock
Syndrome (TSS). TSS is a rare but serious disease that may
cause death. Read and save the enclosed information.
Playtex also includes on the outside of each box the range of absor-
bency available in different tampons. Printed next to this absorbency
range is a statement that consumers should "[s]elect the minimum
absorbency needed to control your menstrual flow in order to reduce
the risk of getting TSS." All Playtex tampon packages also include a
package insert concerning TSS which is printed in bold face block
and bridged across the top of the tampons. The FDA has never found
that this packaging does not comply with the mandatory federal TSS
warning requirements.
The mandated warnings on each box of Playtex tampons clearly set
forth the risk of acquiring TSS through the use of tampons. Murphy
testified that she had read the TSS alert statement on the outside of
the tampon package prior to her illness and that she was aware of the
risk of TSS from tampon use. Murphy was further aware that Playtex
tampons come in different absorbencies and that she should use the
minimum absorbency that she needed. Murphy, 176 F. Supp. 2d at
482.
The district court found that "[u]nder such circumstances, an ordi-
nary consumer would expect to be exposed to the risk of TSS associ-
ated with Tampon use" and that allowing Murphy’s claim to go
forward on a consumer expectation theory would allow "the anoma-
lous circumstance that a consumer is entitled to expect a product to
perform more safely than its government mandated warnings indi-
cate." Murphy, 176 F. Supp. 2d at 488 (internal citations omitted).
8 MURPHY v. PLAYTEX FAMILY PRODUCTS CORP.
The district court concluded that as a matter of law the tampons man-
ufactured by Playtex were not dangerous to an extent beyond that
which would be contemplated by the ordinary consumer because
Playtex fully complied with federal labeling requirements. Id. We
agree and therefore find that Murphy cannot prevail on a consumer
expectation theory.
IV.
For the foregoing reasons, the judgment of the district court is
AFFIRMED.