Sarah Speed v. Wyeth Pharmaceuticals, Inc. ( 2013 )

RECOMMENDED FOR FULL-TEXT PUBLICATION
Pursuant to Sixth Circuit I.O.P. 32.1(b)
File Name: 13a0335p.06
UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
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Plaintiffs-Appellants, -
GLORIA STRAYHORN, et al.,
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Nos. 12-6195/ 6198/ 6200/
v.
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6203/ 6208/ 6209/ 6210
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Defendants-Appellees. -
WYETH PHARMACEUTICALS, INC., et al.,
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Appeal from the United States District Court
for the Western District of Tennessee at Memphis.
Nos. 2:11-cv-02058; 2:11-cv-02059; 2:11-cv-02060; 2:11-cv-02083; 2:11-cv-02095;
2:11-cv-02134; 2:11-cv-02145—S. Thomas Anderson, District Judge.
Argued: July 31, 2013
Decided and Filed: December 2, 2013
Before: GILMAN, GRIFFIN, and STRANCH, Circuit Judges.
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COUNSEL
ARGUED: Collyn A. Peddie, LAW OFFICES OF COLLYN PEDDIE, Houston, Texas,
for Appellants. Henninger S. Bullock, MAYER BROWN LLP, New York, New York,
for Appellees Schwarz and Alaven. Jeffrey F. Peck, ULMER & BERNE LLP,
Cincinnati, Ohio, for Appellees Watson, Duramed, PLIVA, and Barr. Richard A.
Oetheimer, GOODWIN PROCTER LLP, Boston, Massachusetts, for Appellee TEVA.
ON BRIEF: Julie L. Rhoades, MATTHEWS & ASSOCIATES, Houston, Texas, for
Appellants. Henninger S. Bullock, Andrew J. Calica, MAYER BROWN LLP, New
York, New York, for Appellees Schwarz and Alaven. Kannon K. Shanmugam,
WILLIAMS & CONNOLLY LLP, Washington, D.C., for Wyeth Appellees. Jeffrey F.
Peck, Linda E. Maichl, Joseph P. Thomas, ULMER & BERNE LLP, Cincinnati, Ohio,
Richard A. Oetheimer, GOODWIN PROCTER LLP, Boston, Massachusetts, Irene C.
Keyse-Walker, Julie A. Callsen, Michael J. Ruttinger, TUCKER ELLIS LLP, Cleveland,
Ohio, Kathleen Kelly, HINSHAW & CULBERTSON LLP, Boston, Massachusetts,
Katherine Frazier, BAKER & WHITT, PLLC, Memphis, Tennessee, Daniel J. Herling,
KELLER AND HECKMAN LLP, San Francisco, California, Shea Sisk Wellford,
MARTIN TATE MORROW & MARTSON, Memphis, Tennessee, Mark S. Cheffo,
Rachel B. Passaretti-Wu, SKADDEN, ARPS, SLATE, MEAGHER & FLOM LLP, New
York, New York, Albert C. Harvey, THOMASON, HENDRIX, HARVEY, JOHNSON
1
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& MITCHELL, Memphis, Tennessee, Jonathan I. Price, GOODWIN PROCTER LLP,
New York, New York, William F. Sheehan, GOODWIN PROCTER LLP, Washington,
D.C., Habib Nasrullah, Kelly A. Laudenslager, WHEELER TRIGG O’DONNELL LLP,
Denver, Colorado, for Appellees.
GILMAN, J., delivered the opinion of the court, in which GRIFFIN, J., joined
and STRANCH, J., joined in part. STRANCH, J. (pp. 40–55), delivered a separate
opinion concurring in part and dissenting in part.
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OPINION
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RONALD LEE GILMAN, Circuit Judge. These seven consolidated cases are
among the many that have been filed nationwide against the manufacturers of both the
prescription drug Reglan and its generic equivalent, metoclopramide. The plaintiffs
allege that they ingested generic metoclopramide and, as a result, developed a serious
neurological disorder known as tardive dyskinesia. They filed suit against both the
generic and brand-name manufacturers, alleging a wide variety of product-liability
claims.
The makers of the generic metoclopramide moved to dismiss the claims against
them, arguing that all of the plaintiffs’ claims are preempted by the Federal Food, Drug,
and Cosmetic Act (FDCA), 21 U.S.C. §§ 301-399f, under the Supreme Court decision
in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). And the brand-name manufacturers
moved for summary judgment, contending that they are not liable to the plaintiffs
because none of the plaintiffs ingested Reglan.
The district court granted both motions. For the reasons set forth below, we
AFFIRM the judgment of the district court and DENY the plaintiffs’ pending motion
to certify a proposed question to the Tennessee Supreme Court.
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I. BACKGROUND
A. Factual background
The basic facts are undisputed, and the lawsuits filed in the district court for each
of the consolidated cases are identical to one another. We will therefore refer to the
seven consolidated cases as “the present case.”
The manufacturers of Reglan are Alaven Pharmaceuticals LLC; Pfizer, Inc.;
Schwarz Pharma, Inc.; Wyeth Pharmaceuticals, Inc.; Wyeth LLC; and Wyeth, Inc. We
will refer to these defendants collectively as the Brand-Name Manufacturers. The
makers of generic metoclopramide are Actavis Elizabeth LLC; Barr Pharmaceuticals,
Inc.; Duramed Pharmaceuticals, Inc.; Generics Bidco I LLC; McKesson Corporation;
Mutual Pharmaceutical Co.; Northstar RX, LLC; PLIVA, Inc.; Ranbaxy
Pharmaceuticals, Inc.; TEVA Pharmaceuticals USA, Inc.; The Harvard Drug Group;
United Research Laboratories, Inc.; and Watson Laboratories, Inc. We will refer to these
defendants collectively as the Generic Manufacturers.
The district court took the following facts from the plaintiffs’ amended complaint
as true for the purpose of ruling on the Generic Manufacturers’ Motion to Dismiss:
Reglan is a prescription drug, and metoclopramide is its generic
bioequivalent. (Am. Compl. ¶ 6.) Reglan and metoclopramide’s product
labeling recommends them for use as short-term therapies for
symptomatic gastroesophageal reflux—heartburn—and acute and
recurrent diabetic gastric stasis—bloating. (Id. ¶ 13.) The labels
recommend therapy for up to twelve weeks in adults for heartburn, but
they did not contain a durational limit for bloating. (Id. ¶ 14.) At no
time have Reglan or metoclopramide been shown to be either efficacious
or safe when used for long-term treatment. (Id. ¶ 15.)
Reglan and metoclopramide affect the brain’s movement center, typically
causing involuntary, repetitive movements. (Id. ¶ 7.) Overuse of Reglan
and metoclopramide can result in extra-pyramidal symptoms including,
but not limited to, tardive dyskinesia, dystonia, and akathisia,
Parkinsonism, and Reglan-induced tremors. (Id. ¶ 8.) Reglan and
metoclopramide have also been associated with central nervous system
disorders, depression with suicidal ideation, visual disturbances, and
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memory loss. (Id.) Tardive dyskinesia, dystonia, and akathisia are
serious neurological movement disorders resulting in involuntary and
uncontrollable movements of the head, neck, face, arms, or truck [sic],
as well as involuntary facial grimacing and tongue movements, including
tongue thrusting, tongue chewing, extreme anxiety, and restlessness or
other involuntary movements. (Id. ¶ 9.) These disorders have no known
cure. (Id. ¶ 10.)
Patients using Reglan or metoclopramide for longer periods of time are
at an “unreasonably dangerous increased risk of developing one or more
severe and permanent neurological movement disorders, significantly
and substantially greater than disclosed or suggested in the product
labeling for the drug or in any other materials disseminated by the
defendants to either the medical community or the public.” (Id. ¶ 16.)
Ordinary consumers would not appreciate the risk of developing one or
more incurable severe neurological movement disorders when taking
Reglan or metoclopramide as discussed above. (Id. ¶ 17.) Similarly, a
prudent manufacturer would not market Reglan or metoclopramide due
to the risk of severe and permanent neurological movement disorders and
the availability of less dangerous alternative treatments. (Id. ¶ 18.)
Reglan is the reference listed drug (“RLD”) in abbreviated new drug
applications (“ANDAs”) for generic versions of metoclopramide. (Id. ¶
25.) ANDAs for new drugs must disclose to the Food and Drug
Administration (“FDA”) the drug’s chemistry, pharmacology, and other
matters, including its proposed labeling. (Id. ¶ 26.) For the FDA to
approve a drug’s ANDA, its ANDA must include proposed labeling
which discusses data and information about the risks and side effects of
the drug, the drug’s test results, results of animal studies, results of
clinical studies, and the drug’s bioavailability, all of which enable
physicians or other foreseeable prescribers to use the drug safely. (Id.)
Federal law requires the owner of an FDA-approved ANDA to ensure
that the drug’s labeling remains accurate and adequate, to conduct safety
surveillance for adverse drug effects, and to periodically report to the
FDA data related to the safety of the drug or the accuracy of its label.
(Id. ¶ 27.) The FDA has not approved Reglan and metoclopramide for
long-term or pediatric use. (Id. ¶ 28.)
The Amended Complaint contains three categories of claims: those
against the Brand Name Defendants, the Generic Defendants, and all
Defendants. . . . Plaintiffs allege that all Defendants knew or should have
known that most physicians did not know or fully appreciate the
seriousness of the risks associated with Reglan or metoclopramide. (Id.
¶ 31.) Moreover, all Defendants knew that physicians commonly
prescribed the drug for inappropriate long term and pediatric use, as well
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as short term use for certain adults. (Id.) Thus, all Defendants “should
have known that the Physician’s Desk reference monograph for Reglan
and the package inserts for Reglan and metoclopramide were deficient,
inaccurate, [or] false and misleading in communicating [information] to
the medical community in general, to physicians, or to the public.” (Id.)
Plaintiffs allege that all Defendants “failed to adequately inform
physicians and misled [them] about the risks associated with their
metoclopramide drug products.” (Id. ¶ 33.)
Plaintiffs aver that all Defendants “knew or . . . should have known that
the labeling for Reglan and generic metoclopramide substantially
understated the frequency of acute and long term side effects of the
drug.” (Id. ¶ 35.) Thus, all Defendants “failed to use reasonable care to
ascertain or communicate to physicians or to the public information that
would constitute adequate and effective warnings.” (Id.) Additionally, all
Defendants knew through their own studies or “publicly available
published literature” that doctors commonly prescribed metoclopramide
for longer than twelve weeks, for pediatric use, or in other unsafe
situations. (Id. ¶ 37.) All Defendants also knew that their “individual and
collective failure to communicate [information] to the medical
community . . . about the risks of long term and other metoclopramide
therapy would . . . likely . . . result in serious injury.” (Id. ¶ 38.)
Defendants failed to adequately communicate this information and failed
to exercise due care to ensure that their warnings were effectively
communicated; Defendants also had a duty to adequately communicate
these warnings. (Id. ¶ 38–39.) All Defendants breached this duty in a
number of ways. (Id. ¶ 40a–40g.) Moreover, all Defendants “failed to
make reasonable efforts to ensure that accurate and adequate information
regarding metoclopramide was provided to the medical community” and
consumers or “to inform the FDA of the need for changes to its label.”
(Id. ¶ 48.)
The Amended Complaint also contains facts related directly to the
Generic Defendants’ “failure to communicate adequate warnings.” (Id.
at 22.) The Food, Drug, and Cosmetic Act (“FDCA”) requires a generic
drug’s ANDA to include proposed labeling identical to the brand-name
RLD in all material respects. (Id. ¶ 43.) Accordingly, the Generic
Defendants submitted ANDAs for metoclopramide containing labels
identical to the FDA-approved label for Reglan. (Id. ¶ 44.) The Generic
Defendants had several duties, including the duty to ensure that their
metoclopramide labels contained accurate information regarding the
drug’s intended uses and other common uses, to conduct post-market
safety surveillance, to review adverse drug event information, to make
timely revisions to the labels after revisions were made to the RLD label,
and to ensure that information regarding the drug’s safety was
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communicated to the medical community and consumers. (Id. ¶ 46.)
The Generic Defendants were also required to effectively communicate
the labels and their warnings to physicians and patients. (Id.) Plaintiffs
allege that the Generic Defendants violated these duties in a number of
ways, including by failing to “actually and effectively communicate” the
labels and their warnings, to properly evaluate and understand how
physicians and patients were using metoclopramide, to properly research,
test, and market metoclopramide, to periodically review all medical
literature, to independently monitor metoclopramide sales to alert them
that it was widely overprescribed due to inadequate warnings, and to
engage in marketing practices designed to minimize the risks associated
with metoclopramide. (Id. ¶ 47a–47f.)
On February 26, 2009, the FDA exercised its new agency powers and
ordered all Defendants to add a black box warning to Reglan’s label. (Id.
¶ 49.) This new warning—the strongest available under FDA
regulations—highlighted the “high risk of tardive dyskinesia with long
term, high dose, or pediatric use of metoclopramide, even after the drugs
are no longer taken.” (Id.) The FDA also required all Defendants to
create a Risk Evaluation and Mitigation Strategy to ensure that they
communicated information regarding the risks associated with
metoclopramide directly to the consumers of the drug. (Id. ¶ 50.)
Plaintiffs allege that prior to 2007, when the FDA did not have the
authority to demand such action from drug companies, all Defendants
knew that the metoclopramide and Reglan warnings were insufficient,
but they “did nothing to communicate accurate information to individuals
prescribing and consuming metoclopramide.” (Id. ¶ 51.) Plaintiffs aver
that they were injured due to overexposure to Reglan or metoclopramide
caused by all Defendants’ failure “to monitor the safety of their drug
products, to provide accurate and complete information to the FDA, to
use reasonable means to correct inaccuracies appearing in their labels, to
communicate to the medical community, physicians, Plaintiffs’
physicians, Plaintiffs[,] and other foreseeable users of the drug adequate
warnings about risks associated with common and foreseeable uses of
their metoclopramide products.” (Id. ¶ 54.) “Concurrently, Plaintiffs’
injuries came about as a foreseeable and proximate result of [all
D]efendants’ inaccurate, misleading, materially incomplete, and
otherwise false information concerning the potential effects of exposure
to the drug substance metoclopramide and the ingestion of
metoclopramide products manufactured and sold by [all] Defendants.”
(Id.)
Strayhorn v. Wyeth Pharm., Inc., 887 F. Supp. 2d 799, 804-806 (W.D. Tenn. 2012)
(alterations other than [sic] in original).
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In a separate order granting summary judgment to the Brand-Name
Manufacturers, the district court noted an additional material fact not in dispute by the
parties: “Plaintiffs in this case never took Reglan; rather, they ingested only generic
metoclopramide manufactured by companies other than [the] Brand Name Defendants.”
Strayhorn v. Wyeth Pharm., Inc., 882 F. Supp. 2d 1020, 1025 (W.D. Tenn. 2012).
B. Procedural background
In November 2011, after the Supreme Court’s decision in PLIVA, Inc. v.
Mensing, 131 S. Ct. 2567 (2011), the plaintiffs filed amended complaints, all of which
are identical. The Generic Manufacturers moved to dismiss the amended complaints,
arguing that the plaintiffs’ various claims boiled down to the single claim that the
Generic Manufacturers had failed to provide adequate warnings to medical professionals
about the dangers of long-term use of metoclopramide. These defendants argued that,
under Mensing, state-law failure-to-warn claims against generic drug manufacturers are
preempted because federal law prohibits generic manufacturers from unilaterally altering
their warning labels; therefore, generic manufacturers cannot simultaneously comply
with both federal and state law.
The district court agreed that Mensing controlled. It concluded that the plaintiffs
had abandoned their claims for unfair and deceptive trade practices/conspiracy and for
unjust enrichment, and further determined that all of the plaintiffs’ other claims against
the Generic Manufacturers were essentially failure-to-warn claims preempted under
Mensing. The plaintiffs do not challenge the court’s determination regarding those
claims deemed abandoned, but they do challenge the dismissal of all of their other
claims.
The Brand-Name Manufacturers separately moved for summary judgment on the
ground that the Tennessee Products Liability Act, Tenn. Code Ann. §§ 29-28-101 et seq.
(TPLA), allows for recovery solely against the manufacturer or the seller of the product
actually causing the harm. Because the plaintiffs did not ingest Reglan, but only generic
metoclopramide, the Brand-Name Manufacturers argued that they could not be held
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liable. Agreeing with the Brand-Name Manufacturers, the district court granted
summary judgment in their favor.
II. ANALYSIS
A. Standard of review
1. Motion to dismiss
To survive a motion to dismiss for failure to state a claim, a complaint must
allege sufficient facts that, accepted as true, “state a claim to relief that is plausible on
its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). “A claim has facial
plausibility when the plaintiff pleads factual content that allows the court to draw the
reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft
v. Iqbal, 556 U.S. 662, 678 (2009). When determining facial plausibility, the court must
construe the complaint in the light most favorable to the plaintiff. Lambert v. Hartman,
517 F.3d 433, 439 (6th Cir. 2008). The district court’s grant of a motion to dismiss is
reviewed de novo. Paige v. Coyner, 614 F.3d 273, 277 (6th Cir. 2010).
2. Motion for summary judgment
Summary judgment is proper when “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). In considering a motion for summary judgment, the district court must construe
the evidence and draw all reasonable inferences in favor of the nonmoving party.
Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). The
central issue is “whether the evidence presents a sufficient disagreement to require
submission to a jury or whether it is so one-sided that one party must prevail as a matter
of law.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 251–52 (1986). We review de
novo a district court’s grant of summary judgment. Huckaby v. Priest, 636 F.3d 211,
216 (6th Cir. 2011).
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B. Claims against the Generic Manufacturers
Our analysis of the claims against the Generic Manufacturers is guided by two
recent decisions of the United States Supreme Court: PLIVA, Inc. v. Mensing, 131 S. Ct.
2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013). We
will therefore begin with a detailed discussion of these two decisions.
1. PLIVA, Inc. v. Mensing
In Mensing, which involved consolidated appeals from decisions by the Fifth and
Eighth Circuits, the Supreme Court held that state-law failure-to-warn claims against
generic manufacturers of metoclopramide are preempted by federal law. The Court first
noted that the Louisiana and Minnesota tort laws at issue “require a drug manufacturer
that is or should be aware of its product’s danger to label that product in a way that
renders it reasonably safe.” Mensing, 131 S. Ct. at 2573. Federal law, on the other hand,
imposes different requirements. A brand-name manufacturer must prove that its
proposed drug is “safe and effective and that the proposed label is accurate and
adequate,” which occurs by way of clinical testing. Id. at 2574. But under the 1984
Drug Price Competition and Patent Term Restoration Act, 98 Stat. 1585 (popularly
known as the Hatch-Waxman Amendments to the FDCA), generic drugs may be
approved if their active ingredients are equivalent to a reference listed drug
(RLD)—generally a brand-name drug—that has already been approved by the FDA.
Generic drugs’ proposed labels must be “the same as the labeling approved for the
brand-name drug” in order to gain approval by the FDA. Id. (brackets and internal
quotation marks omitted). The issue was therefore whether “it was impossible” for
generic drug manufacturers to simultaneously comply with both state and federal
labeling laws. Id. at 2578.
Although the plaintiffs in Mensing argued that generic manufacturers could
unilaterally change their labels under the FDA’s “changes-being-effected” (CBE)
process, which permits certain preapproval labeling changes that add or strengthen a
warning to improve drug safety, the FDA contended that the CBE process could not be
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used by generic manufacturers in this manner. This is because the FDA “interprets the
CBE regulation to allow changes to generic drug labels only when a generic drug
manufacturer changes its label to match an updated brand-name label or to follow the
FDA’s instructions.” Id. at 2575. Nor could the generic manufacturers have used “Dear
Doctor” letters to send warnings to healthcare professionals because, according to the
FDA, such letters are considered “labeling” and must match the prescription drug’s
approved labeling. Id. at 2576.
The Supreme Court acknowledged that “[h]ad Mensing and Demahy taken
Reglan, . . . Wyeth [v. Levine, 555 U.S. 555 (2009),] would control and their lawsuits
would not be pre-empted.” Id. at 2581. In Levine, the Supreme Court held that state-law
failure-to-warn claims against a brand-name manufacturer are not preempted by federal
law because such manufacturers have the capability of complying with both state and
federal law. 555 U.S. at 571. The Mensing Court noted that, from the plaintiffs’
perspective, “finding pre-emption [in Mensing] but not in Wyeth makes little sense.”
Mensing, 131 S. Ct. at 2581. Despite the apparent unfairness of the result, the Court
rested its decision on the fact that “the federal statutes and regulations that apply to
brand-name drug manufacturers are meaningfully different than those that apply to
generic drug manufacturers.” Id. at 2582. It further commented that the unique
regulation of generic drugs has allowed the generic-drug industry to flourish and has
brought cheaper drugs to the market. Id. The Court declined to “decide whether the
statutory scheme established by Congress is unusual or even bizarre,” noting that
“Congress and the FDA retain the authority to change the law and regulations if they so
desire.” Id. (internal quotation marks omitted).
2. Mutual Pharmaceutical Co. v. Bartlett
The Supreme Court recently reaffirmed Mensing in Mutual Pharmaceutical Co.
v. Bartlett, 133 S. Ct. 2466 (2013). Bartlett took sulindac, a generic nonsteroidal anti-
inflammatory drug. She developed toxic epidermal necrolysis, a condition in which the
skin deteriorates or turns into an open wound. Bartlett sued the manufacturer of generic
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sulindac in New Hampshire, asserting failure-to-warn and design-defect claims. New
Hampshire’s strict-liability regime imposes a duty on manufacturers “to ensure that the
drugs they market are not unreasonably unsafe.” Bartlett, 133 S. Ct. at 2470. On appeal,
the First Circuit affirmed the jury’s finding of liability and its award of $21 million in
damages to Bartlett. In concluding that Bartlett’s design-defect claim was not preempted
under Mensing, the First Circuit reasoned that the generic manufacturer “could simply
choose not to make the drug at all and thus comply with both federal and state law.” Id.
at 2472 (internal quotation marks omitted).
The Supreme Court reversed. It first noted that “New Hampshire’s design-defect
cause of action imposes affirmative duties on manufacturers,” including the “duty to
design [a] product reasonably safely for the uses which [the manufacturer] can foresee.”
Id. at 2473 (internal quotation marks omitted). Specifically, design-defect liability is
imposed in New Hampshire when “the design of the product create[s] a defective
condition unreasonably dangerous to the user.” Id. at 2474 (internal quotation marks
omitted). A product is unreasonably dangerous under the New Hampshire Supreme
Court’s “risk-utility approach” “if the magnitude of the danger outweighs the utility of
the product.” Id. This inquiry balances
the usefulness and desirability of the product to the public as a whole,
whether the risk of danger could have been reduced without significantly
affecting either the product’s effectiveness or manufacturing cost, and the
presence and efficacy of a warning to avoid an unreasonable risk of harm
from hidden dangers or from foreseeable uses.
Id. at 2475 (internal quotation marks omitted).
The Supreme Court reasoned that the first two factors (increasing the usefulness
and desirability of the product and reducing the risk of harm) would require redesign of
the product, which is not possible under FDA regulations that require generic drugs to
have the same active ingredients as brand-name drugs. Redesign of the product was also
not possible because sulindac is a one-molecule drug. Therefore, “the only way for [the
generic manufacturer] to ameliorate the drug’s ‘risk-utility’ profile—and thus to escape
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liability [under New Hampshire law]—was to strengthen ‘the presence and efficacy’”
of the drug’s warning. Id. But the warnings provided for a generic drug must be the
same as the warnings found in the labeling approved for the brand-name drug in order
to gain approval by the FDA. Mensing, 131 S. Ct. at 2574. As a result, the generic
manufacturer could not possibly comply with both state and federal laws. Bartlett,
133 S. Ct. at 2477.
In reaching this conclusion, the Supreme Court rejected the First Circuit’s “stop-
selling” rationale as a basis for finding that the generic manufacturer could comply with
both state and federal laws, stating that the Court’s “pre-emption cases presume that an
actor seeking to satisfy both his federal- and state-law obligations is not required to cease
acting altogether to avoid liability.” Id. at 2477. Such a narrow reading would render
the impossible-to-comply preemption doctrine “all but meaningless.” Id. (internal
quotation marks omitted). “Adopting the First Circuit’s stop-selling rationale would
mean that . . . the vast majority—if not all—of the cases in which the Court has found
impossibility pre-emption[] were wrongly decided.” Id. at 2478. The Court therefore
held that “state-law design-defect claims that turn on the adequacy of a drug’s warnings
are pre-empted by federal law under [Mensing].” Id. at 2470.
Perhaps acknowledging that its preemption jurisprudence might be viewed as
unjust because it bars plaintiffs from recourse against generic manufacturers, the Court
stated:
Suffice to say, the Court would welcome Congress’ “explicit” resolution
of the difficult pre-emption questions that arise in the prescription drug
context. That issue has repeatedly vexed the Court—and produced
widely divergent views—in recent years. . . . [T]he FDCA’s treatment of
prescription drugs includes neither an express pre-emption clause (as in
the vaccine context, 42 U.S.C. § 300aa–22(b)(1)), nor an express
non-pre-emption clause (as in the over-the-counter drug context,
21 U.S.C. §§ 379r(e), 379s(d)). In the absence of that sort of “explicit”
expression of congressional intent, we are left to divine Congress’ will
from the duties the statute imposes.
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Id. at 2480. This invitation for congressional action echoes the one in Mensing. See
131 S. Ct. at 2582.
3. Failure-to-warn claims
The relevant preemption question after Mensing is whether a generic
manufacturer can simultaneously comply with both its state and federal duties. See id.
at 2577. Mensing considered Louisiana and Minnesota laws that “require a drug
manufacturer that is or should be aware of its product’s danger to label that product in
a way that renders it reasonably safe.” Id. at 2573. Louisiana law states that “a
manufacturer’s duty to warn includes a duty to provide adequate instructions for safe use
of a product.” Id. (internal quotation marks omitted). Minnesota law similarly states
that “where the manufacturer . . . of a product has actual or constructive knowledge of
danger to users, the . . . manufacturer has a duty to give warning of such dangers.” Id.
(internal quotation marks omitted) (alterations in original). That is, “[i]n both States, a
duty to warn falls specifically on the manufacturer.” Id. In the two consolidated cases
before the Supreme Court, the parties admitted that if the generic manufacturers knew
of a danger associated with their product that their labels did not adequately warn of,
then they were obligated under state law to “use [] different, safer label[s].” Id. at 2574.
The plaintiffs in the present case read Mensing narrowly and argue that the
Supreme Court’s decision was based on the fact that Louisiana and Minnesota laws
“would require a manufacturer to actually change the content of its label”—that is,
“provide different, additional warnings.” They further contend that, under Mensing,
only claims “based on the adequacy of the information contained in the drug’s label” are
preempted, not claims based on “a manufacturer’s duty to provide a warning” beyond
the label. The Generic Manufacturers, they argue, “could have sought FDA approval for
a labeling change, or they could have notified health care professionals by other means,
or could have ceased selling their products but chose not to do so.” In particular, they
argue that the Generic Manufacturers, on their own initiative, could have distributed
“Dear Health Care Professional” or “Dear Doctor” letters to medical professionals to
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warn them of the dangers of metoclopramide that were not adequately communicated on
the drug’s label. Finally, they argue that generic manufacturer PLIVA failed to update
its labels to include information found on the labels of Reglan as of 2004.
The plaintiffs’ narrow reading of Mensing has been soundly rejected by all
circuits to consider the argument. These circuits have interpreted Mensing to broadly
preempt claims that are, at their core, claims that the generic manufacturer failed to
provide additional warnings beyond that which was required by federal law of the brand-
name manufacturers. See Schrock v. Wyeth, LLC, 727 F.3d 1273, 1287-90 (10th Cir.
2013) (holding that federal law preempts breach-of-warranty claims premised on a
theory that generic manufacturers provided improper descriptions or warnings); Guarino
v. Wyeth, LLC, 719 F.3d 1245, 1247-49 (11th Cir. 2013) (holding that the plaintiff’s
state-law claims against the generic manufacturer for not “adequately warn[ing] medical
providers of the risks associated with long-term use of metoclopramide” were all claims
“premised upon an allegedly inadequate warning” and therefore preempted under
Mensing); Bell v. Pfizer, Inc., 716 F.3d 1087, 1095-96 (8th Cir. 2013) (rejecting the
plaintiff’s argument that Mensing’s preemption analysis “applies only to allegations that
a generic manufacturer should have unilaterally changed the content of its
metoclopramide label,” finding this to be an “unduly narrow view of Mensing” and
holding that the plaintiff’s claims for negligence and misrepresentation under the
Arkansas Product Liability Act were “preempted failure to warn claims” (emphasis
omitted)); Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013) (per curiam)
(holding that “Mensing forecloses such [failure-to-communicate] claims because failure
to ‘communicate’ extends beyond just a label change” and includes “affirmative steps
to alert consumers, doctors, or pharmacists of changes in the drug label,” actions that the
generic manufacturer is prohibited from taking unilaterally under federal law); see also
Gaeta v. Perrigo Pharm. Co., 469 F. App’x 556 (9th Cir. 2012), aff’g 562 F. Supp. 2d
1091 (N.D. Cal. 2008) (granting summary judgment in favor of the generic manufacturer
of over-the-counter ibuprofen because the plaintiff’s state-law claims for negligence,
breach of express warranty, and breach of implied warranty based on an inadequate
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warning were preempted). Furthermore, the plaintiffs conceded at oral argument that
the majority of their claims do not survive after Bartlett.
We may not, of course, rest our holding on such broad language from other
circuits, but must evaluate the plaintiffs’ claims in light of Tennessee law. As the district
court correctly noted,
[t]he TPLA governs products liability actions in Tennessee and defines
“product liability action[s]” as “all actions brought for or on account of
personal injury, death or property damage caused by or resulting from the
manufacture, construction, design, formula, preparation, assembly,
testing, service, warning, instruction, marketing, packing, or labeling of
any product.” The TPLA also encompasses several different theories of
products liability: “strict liability in tort; negligence; breach of warranty,
express or implied; breach of or failure to discharge a duty to warn or
instruct, whether negligent or innocent; misrepresentation, concealment,
or nondisclosure, whether negligent or innocent; or under any other
substantive legal theory in tort or contract whatsoever.”
Strayhorn v. Wyeth Pharm., Inc., 887 F. Supp. 2d 799, 813 (W.D. Tenn. 2012) (internal
footnotes omitted). The TPLA governs all of the plaintiffs’ claims because the claims
were brought for or on account of personal injury resulting from the design, warning,
instruction, marketing, packaging, and labeling of metoclopramide. See, e.g.,
Richardson v. GlaxoSmithKline, 412 F. Supp. 2d 863, 868 (W.D. Tenn. 2006) (stating
that although the plaintiff’s complaint for personal injuries against a drug manufacturer
under the theories of negligence, strict liability, and breach of warranty “does not cite
the specific basis for his allegations, product liability suits in Tennessee are governed
by the Tennessee Products Liability Act”). A manufacturer or seller of a product in
Tennessee “shall not be liable for any injury to a person or property caused by the
product unless the product is determined to be in a defective condition or unreasonably
dangerous at the time it left the control of the manufacturer or seller.” Tenn. Code Ann.
§ 29-28-105(a).
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Under the TPLA, a product is deemed defective when it is in a condition “that
renders it unsafe for normal or anticipatable handling and consumption.” Id. § 29-28-
102(2). In contrast, a product is considered 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
common to the community as to its characteristics, or [if] the product
because of its dangerous condition would not be put on the market by a
reasonably prudent manufacturer or seller, assuming that the
manufacturer or seller knew of its dangerous condition.
Id. § 29-28-102(8). The TPLA provides two tests to determine whether a product is
unreasonably dangerous: the consumer-expectation test and the prudent-manufacturer
test. Under the consumer-expectation test, a product is deemed unreasonably dangerous
if it would be “dangerous to an extent beyond that which would be contemplated by the
ordinary consumer who purchases it, with the ordinary knowledge common to the
community as to its characteristics.” Ray by Holman v. Bic Corp., 925 S.W.2d 527, 530
(Tenn. 1996) (internal quotation marks omitted).
“[T]he prudent manufacturer test,” on the other hand, “requires proof about the
reasonableness of the manufacturer or seller’s decision to market a product assuming
knowledge of its dangerous condition.” Id. at 531. The two tests are not mutually
exclusive; either or both might be applicable to cases where the product is alleged to be
unreasonably dangerous, but “the prudent manufacturer test will often be the only
appropriate means for establishing the unreasonable dangerousness of a complex product
about which an ordinary consumer has no reasonable expectation.” Id.
With respect to the duty to warn, the Tennessee Supreme Court has stated that
[m]anufacturers of prescription drugs, like the manufacturers of any other
unavoidably dangerous product, have a duty to market and distribute
their products in a way that minimizes the risk or danger. They may
discharge their duty by distributing the drugs with proper directions and
adequate warnings to those who foreseeably could be injured by the use
of their products. . . . Warnings concerning prescription drugs generally
are adequate when they contain a full and complete disclosure of the
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potential adverse reactions to the drug. A reasonable warning not only
conveys a fair indication of the dangers involved, but also warns with the
degree of intensity required by the nature of the risk.
Pittman v. Upjohn Co., 890 S.W.2d 425, 428, 429 (Tenn. 1994). Tennessee law thus
appears to track the laws of Louisiana and Minnesota discussed in Mensing, which
impose a similar duty on the manufacturer to warn of known dangers associated with its
product. See PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2573-74 (2011).
In the present case, the plaintiffs essentially argue that the Generic Manufacturers
have a duty to warn under state law, ignoring the limitations imposed on that duty by the
federal labeling requirements. See Am. Compl. Count I - Strict Liability, ¶ 57 (“Each
of the . . . defendants is liable under the common law and/or Product Liability Act for
. . . failure to give adequate warnings and/or to effectively communicate adequate
warnings . . . bearing on the . . . foreseeable uses of the specific metoclopramide product
. . . .); Count III - Negligence, ¶ 87b (“[Defendants] failed to use ordinary care in
marketing, labeling, and communicating adequate warnings about their respective
products . . . .); Count V - Fraud, Misrepresentation, and Suppression, ¶ 99 (“Defendants
are liable [for] willful and fraudulent misrepresentations to physicians[] regarding the
safety, efficacy, and risk/benefit ratio” of the drugs); Count VII - Breach of Express and
Implied Warranties, ¶ 123 (“[Defendants] fail[ed] to deliver products that were safe for
their intended uses . . . in light of the substantially greater risk of dangerous side effects
associated with its ordinary and expected uses . . . than disclosed and warranted in the
product label and/or other advertising and promotional representations.”); Count XI -
Civil Conspiracy, ¶ 153 (“Defendants acted with a common purpose to intentionally
and/or fraudulently withhold information from the medical community and physicians
regarding the safety of” the drugs).
A few recent decisions have permitted claims similar to these to go forward.
Two such decisions were issued on the same day by the Pennsylvania Superior Court in
Hassett v. Dafoe, 74 A.3d 202 (Penn. Super. Ct. 2013), and in In re
Reglan/Metoclopramide Litig., — A.3d —, 2013 WL 3874905 (Penn. Super. Ct. July 29,
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2013). The majority opinion in both cases discounted “the tsunami of [federal] cases
applying Mensing to pre-empt virtually all state tort claims against generic
manufacturers,” criticizing those decisions for their general failure to explicitly identify
“state law duties associated with various causes of action” and explain “how they
conflict with federal law.” Hassett, 74 A.3d at 211-12 (internal quotation marks
omitted).
In particular, the Pennsylvania court majority discussed claims for breach of
express and implied warranties and for fraud and misrepresentation. It stated that the
claims for breach of express and implied warranties sought to impose liability “for
failing to deliver products that conformed to the properties described in the label and
promotional materials,” and that such claims were “not premised on the inadequacy of
the label but rather on the product’s failure to live up to or conform to its label and
advertising.” Id. at 215. Advertising and promotional materials did not fall into the
FDCA’s definition of “labeling,” the majority further reasoned. Id. The claims were
therefore not deemed preempted. With respect to the fraud and misrepresentation
claims, the majority found that these claims were also not preempted because the
plaintiff pled that the generic manufacturers fraudulently misrepresented the safety of
the drugs “in their advertising and promotional materials, not just [on] their labels.” Id.
Although the Pennsylvania court majority criticized the federal courts for not
engaging in a nuanced comparison of federal and state duties, the dissent pointed out that
the majority “offer[ed] virtually no state statutory or caselaw . . . in support of its
conclusion that Appellees have presented allegations of state law tort claims which
survive preemption.” Id. at 220 (Platt, J., concurring in part and dissenting in part). We
are obviously not bound by the majority opinion of the Pennsylvania Superior Court, and
the omission pointed out by the dissent undermines the persuasive force of these outlier
cases.
Moreover, we reject as unpersuasive the Pennsylvania Superior Court’s
reasoning that breach-of-warranty claims avoid federal preemption to the extent that they
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are “not premised on the inadequacy of the label but rather on the product’s failure to
live up to or conform to its label and advertising.” Hassett, 74 A.3d at 215. Under the
FDCA, “labeling” embraces “all labels and other written, printed, or graphic matter
(1) upon any article or any of its containers or wrappers, or (2) accompanying such
article.” 21 U.S.C. § 321(m). The Supreme Court has held that the first clause “clearly
embraces advertising or descriptive matter that goes with the package in which the
articles are transported.” Kordel v. United States, 335 U.S. 345, 349-50 (1948). With
respect to the second clause, “[o]ne article or thing is accompanied by another when it
supplements or explains it. . . . No physical attachment one to the other is necessary.”
Id. Furthermore, the Code of Federal Regulations includes brochures, booklets,
mailings, catalogues, films, sound recordings, and literature, among other things, in the
definition of “labeling.” 21 C.F.R. § 202.1(l)(2). Such labeling must be consistent with
the drug’s approved labeling. 21 C.F.R. § 201.100(d)(1); see also 21 C.F.R.
§ 202.1(e)(4) (prohibiting advertisements that “recommend or suggest” any use that is
not in the labeling approved by the FDA).
Because such advertising and promotional materials are considered labeling, and
because labeling is limited by federal law to the information contained in the brand-name
drug’s labeling, all of the warranty claims against the Generic Manufacturers based on
these materials are preempted under Mensing. This follows from the fact that the
Generic Manufacturers cannot meet their alleged state-law duty to provide an adequate
warning without violating their federal duty of conformity to the Reglan label. See
PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2577-78 (2011).
Somewhat closer to home are two recent decisions by the Eighth Circuit Court
of Appeals, which remanded design-defect and breach-of-warranty claims for
reconsideration. One of these decisions is Bell v. Pfizer, 716 F.3d 1087 (8th Cir. 2013),
where the court determined that the “vast majority” of Bell’s allegations were essentially
“preempted failure to warn claims” based on inadequate warning or labeling, but it
remanded for reconsideration the design-defect and breach-of-implied-warranty claims
that appeared not to be based on the warnings. Id. at 1096. The district court had simply
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construed all the claims as failure-to-warn claims and had not analyzed whether the
plaintiffs “adequately state[d] viable claims under Arkansas law” or whether the claims
were barred by “impossibility preemption.” Id. And in Fullington v. Pfizer, 720 F.3d
739 (8th Cir. 2013), the Eighth Circuit remanded the plaintiff’s design-defect claim for
reconsideration in light of Bartlett because, under Arkansas’s consumer-expectation test,
“it [was] not immediately clear” whether generic drug manufacturers in that state could
“somehow alter an otherwise unreasonably dangerous drug” without running afoul of
federal law. Id. at 747.
In the present case, we find no similar inadequacy of analysis by the district
court. We also conclude, unlike the Eighth Circuit in Bell and Fullington, that the
plaintiffs’ implied-warranty claims boil down to the failure to give additional warnings.
The plaintiffs allege that the Generic Manufacturers “fail[ed] to deliver products that
were safe for their intended uses, including long term metoclopramide therapy, in light
of the substantially greater risk of dangerous side effects associated with its ordinary and
expected uses, including long term therapy, than disclosed and warranted in the product
label and/or other advertising and promotional materials.” Am. Compl. ¶ 123. These
claims are clearly based on the alleged inadequacy of the warnings given.
Before further analyzing the plaintiffs’ implied-warranty claims, we note that
their express-warranty claims are without merit because the labels never explicitly
warranted that metoclopramide was safe for long-term use. In fact, the plaintiffs do not
allege that the Generic Manufacturers ever made such an affirmative representation; they
instead allege that the labeling failed to strongly warn that the product was not
appropriate for such use. See Am. Compl. ¶¶ 13-15 (“The ‘indications’ (recommended
uses) listed in the product labeling for Reglan/metoclopramide include adult short-term
therapy . . . for up to twelve (12) weeks in adults, for gastroesophogeal reflux
(heartburn), and specified no durational limit in therapy for gastric stasis or gastroparesis
(bloating). . . . [But the drug has never] been shown to be either efficacious or safe when
used for long term treatment.”); ¶¶ 33-34 (“The defendants failed to adequately inform
physicians . . . about the risks associated with . . . metoclopramide . . . [and therefore]
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Plaintiffs’ physicians did not know or appreciate fully the risks of side affects associated
with the use, particularly with the long term use, of the drug.”)
In order to establish a prima facie claim for breach of express warranty in
Tennessee, a plaintiff must prove that: (1) the seller made an affirmation of fact
intending to induce the buyer to purchase the goods, (2) the buyer was in fact induced
by the seller’s acts, and (3) the affirmation of fact was false regardless of the seller’s
knowledge of the falsity or intention to create a warranty. Coffey v. Dowley Mfg., Inc.,
187 F. Supp. 2d 958, 969 (M.D. Tenn. 2002), aff’d, 89 F. App’x 927 (6th Cir. 2003).
The plaintiffs’ allegations in the present case do not identify any affirmation of fact
made on the product labeling that they allege to be false; rather, they allege that the
labeling was inadequate. We thus find no merit in their express-warranty claims.
The plaintiffs’ implied-warranty claims under Tenn. Code Ann. § 47-2-314 fare
no better because they are entirely premised on a failure-to-warn theory. In particular,
the plaintiffs do not allege that the generic metoclopramide they took was ineffective for
treating the gastrointestinal conditions for which it was prescribed; only that it was
unsafe when used long-term because of the drug’s dangerous side effects. See Am.
Compl. ¶ 15. Any long-term use, they further allege, was due to the Generic
Manuacturers’ failure to warn about the consequences of such use. Id. ¶ 31. Indeed, the
plaintiffs allege that the Generic Manufacturers delivered products that were “[un]safe
for their intended uses . . . in light of . . . the product label and/or other advertising or
promotional representations.” Id. ¶ 123 (emphasis added). In order to escape liability
for such an alleged defect, the Generic Manufacturers would have had to give a stronger
warning than they were permitted to give under federal law. But such implied-warranty
claims are preempted by both Mensing and Bartlett.
To the extent that the plaintiffs allege that the Generic Manufacturers should
have unilaterally changed the label to reflect any danger posed by long-term use of the
drug, this claim is clearly preempted. See PLIVA, Inc. v. Mensing, 131 S. Ct 2567, 2578
(2011). And to the extent that the plaintiffs allege that the drug itself should have been
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modified to conform to the properties described in the label, generic manufacturers are
prohibited by their federal duty of sameness from designing their drugs differently from
the RLD. See Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2475 (2013) (noting that
“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 based”). When a generic manufacturer cannot obey federal law without being held
liable under a state-law warranty action, the state action is preempted. See Mensing, 131
S. Ct. at 2577.
Our conclusion is consistent with this court’s previous decision in Smith v.
Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011), cert. denied, 132 S. Ct. 2103 (2012), which
affirmed the district court’s determination that the plaintiffs’ state-law claims—centering
on a failure to warn under Kentucky law that included claims for breach of implied
warranty—were preempted. We further note that Kentucky’s implied-warranty regime
is substantially the same as that of Tennessee. Compare Ky. Rev. Stat. § 355.2-314 with
Tenn. Code Ann. § 47-2-314. To not find preemption in the present case would require
us to disregard this court’s binding precedent.
Nor does the Pennsylvania Superior Court’s evaluation of the fraud and
misrepresentation claims in Hassett help the plaintiffs in the present case. As an initial
matter, the plaintiffs’ allegations with respect to these claims appear to relate only to the
Brand-Name Manufacturers. See Am. Compl. ¶ 100 (“Through its [sic] actions and
omissions in advertising and other activities to promote the use of Reglan, defendants
intentionally and fraudulently made misrepresentations of material facts . . . .”); ¶ 105
(“BRAND NAME DEFENDANTS made these material misrepresentations and
omissions to physicians knowing that they were not true, and knowing and intending that
physicians would consider the misinformation disseminated to be reliable . . . .”); ¶ 106
(“In the alternative, BRAND NAME DEFENDANTS made the false material
representations and omissions with reckless disregard of whether these representations
were true or not.”); ¶ 110 (“BRAND NAME DEFENDANTS overstated the benefits and
safety of Reglan and concomitantly downplayed the risks in its use . . . .”).
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But even if the complaint is read to assert these claims against the Generic
Manufacturers, the claims boil down to an alleged duty to provide additional information
about generic metoclopramide. See Am. Compl. ¶ 108 (“Each of the DRUG
COMPANY DEFENDANTS . . . is obligated to give physicians and their patients . . .
accurate and material scientific information and data regarding the association between
exposure to metoclopramide and the [risks of the drug].”); ¶ 111 (“The DRUG
COMPANY DEFENDANTS passively assented to and indirectly cooperated in the
misrepresentations, concealment, suppression and omissions made directly by the
BRAND NAME DEFENDANTS . . . .”). These claims are essentially failure-to-warn
claims that are preempted under Mensing.
The plaintiffs’ design-defect claims suffer a similar fate under Bartlett because
all of their claims rest on inadequate warnings. Although Tennessee caselaw has not yet
addressed whether the prudent-manufacturer test or the consumer-expectation test
applies to design-defect claims involving prescription drugs, the former test would
appear to be the appropriate choice in this case because the ordinary consumer would not
have the medical knowledge necessary to have a reasonable expectation about the safety
of metoclopramide. See Ray by Holman v. Bic Corp., 925 S.W.2d, 527, 531 (Tenn.
1996) (“By definition, [the consumer-expectation test] could be applied only to those
products in which everyday experience of the product’s users permits a conclusion. For
example, ordinary consumers would have a basis for expectations about the safety of a
can opener or coffee pot, but, perhaps, not about the safety of a fuel-injection engine or
an air bag.” (ellipsis, emphasis, internal citation, and internal quotation marks omitted)).
In analyzing whether a product is unreasonably dangerous under Tennessee’s
prudent-manufacturer test, the court engages in a risk-utility analysis similar to New
Hampshire’s by considering
(1) the product’s usefulness and desirability; (2) the product’s safety
aspects—the likelihood and probable seriousness of injury; (3) the
availability of a substitute product that would safely meet the same need;
(4) the manufacturer’s ability to eliminate the product’s unsafe character
without hindering its usefulness or causing the maintenance of its utility
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to be too expensive; (5) the ability of the operator or user to avoid danger
through the exercise of care in using the product; (6) the user’s
anticipated awareness of the product’s inherent dangers and their
avoidability; and (7) the feasibility of the manufacturer spreading the loss
by setting the price of the product or maintaining liability insurance.
Brown v. Crown Equip. Corp., 181 S.W.3d 268, 282-83 (Tenn. 2005). The Supreme
Court in Bartlett considered factors such as these to effectively require either a redesign
of the product or a stronger warning to avoid liability for a design defect, with neither
course of action being available to a generic manufacturer under federal law. See Mut.
Pharm. Co. v. Bartlett, 133 S. Ct. 2475-76 (2013). In any event, we need not decide
which test applies in the present case because the plaintiffs conceded at oral argument
that Bartlett forecloses their design-defect claims.
We next turn to the plaintiffs’ argument that the Generic Manufacturers should
have sent Dear Doctor letters to communicate additional warnings. Such letters,
however, would violate the duty of conformity, as explained in PLIVA, Inc. v. Mensing,
131 S. Ct. 2567, 2576 (2011):
A Dear Doctor letter that contained substantial new warning information
would not be consistent with the drug’s approved labeling. Moreover,
if generic drug manufacturers, but not the brand-name manufacturer, sent
such letters, that would inaccurately imply a therapeutic difference
between the brand and generic drugs and thus could be impermissibly
“misleading.” [] [S]ee 21 CFR § 314.150(b)(3) (FDA may withdraw
approval of a generic drug if “the labeling of the drug . . . is false or
misleading in any particular”). . . . Accordingly, we conclude that federal
law did not permit the Manufacturers to issue additional warnings
through Dear Doctor letters.
See also Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 581 n.1 (6th Cir. 2013) (noting that the
term “labeling” is broadly construed and includes Dear Doctor letters).
As the Fifth Circuit recently explained, “the inquiry is whether the brand-name
manufacturers sent out a warning, not whether the proposed warning to be disseminated
contains substantially similar information as the label. Because no brand-name
manufacturer sent a warning based on the 2004 label change, the generic manufacturers
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were not at liberty to do so.” Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013)
(per curiam). Nor can the plaintiffs proceed on a failure-to-withdraw or stop-selling
theory, a theory recently rejected by the Supreme Court in Bartlett.
Finally, the plaintiffs argue that Mensing does not control, and that their claims
instead survive preemption under Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992),
Bates v. Dow Agrosciences, LLC, 544 U.S. 431 (2005), and Altria Group, Inc., v. Good,
555 U.S. 70 (2008). These latter cases involved federal statutes that expressly preempt
certain state-law failure-to-warn claims, but leave available other state-law causes of
action such as express warranty, conspiracy, and design defect.
But express preemption is not at issue in the present case. The Supreme Court
clearly based its decision in Mensing on conflict or impossibility preemption, which
requires a comparison of the conflicts between state and federal duties to determine
“whether the private party could independently do under federal law what state law
requires of it.” Mensing, 131 S. Ct. at 2579. Simply because certain claims survived
express preemption in other cases does not mean that they will survive conflict
preemption in this case. See id. at 2577 n.5 (“[T]he absence of express pre-emption is
not a reason to find no conflict pre-emption.” (emphasis in original)). The plaintiffs’
attempt to avoid Mensing by analogizing their claims to the express-preemption cases
is therefore unavailing. We find no error in the district court’s dismissal of the plaintiffs’
claims that are, at their core, all failure-to-warn claims.
4. Failure-to-conform claims
In their complaint, the plaintiffs alleged that several of the Generic
Manufacturers “were negligent in failing to include information present in the label for
the RLD and in failing to implement changes to their own labels to ensure that the
information they provided was current and not outdated” and, in some cases, “waited
years to conform their labels to the RLD label.” Am. Compl. ¶ 87l. And in the
plaintiffs’ brief on appeal, they argue that “PLIVA failed to include instrumental
warnings in its label for metoclopramide that had been approved by the FDA and were
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in use by the name brand manufacturers in their FDA approved labeling.” The district
court characterized these allegations as “failure-to-conform claims.” Other courts refer
to claims of this nature as “failure-to-update claims.”
In Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013), this court held that the
plaintiff stated a claim by alleging that the generic manufacturer failed to update its label
in 2004 to match that of the prescription drug Reglan. The court held that the claim was
not barred by the impossibility-preemption doctrine because the generic manufacturer
could have complied with federal law by using the same label as the brand-name
manufacturer (and in fact was required to do so). Fulgenzi, 711 F.3d at 584. Because
the claim survived preemption, Fulgenzi was free to argue that the outdated warning was
inadequate. That decision, however, is based on facts clearly distinguishable from the
present case.
The plaintiff in Fulgenzi alleged that “in July of 2004, the FDA approved
Schwarz’s request to add a sentence to the Reglan label as follows: ‘Therapy should not
exceed 12 weeks in duration.’ Consequently, the name brand warning label for Reglan
contained the foregoing warning against treatment in excess of 12 weeks after this date.”
Fulgenzi v. PLIVA, Inc., No. 5:09-cv-1767, Second Am. Compl. (D.E. 60) ¶ 46.
Fulgenzi amended her complaint after Mensing to include a claim that PLIVA, the
generic manufacturer, “failed to update its . . . label(s) as to metoclopramide to include
the July, 2004 label change warning against any therapy in excess of 12 weeks.” Id. ¶ 60.
She also specifically alleged that she ingested PLIVA-manufactured metoclopramide
during the time when the generic’s label was not updated, i.e., “September, 2004;
September, 2006; December, 2006; March, 2007; June, 2007; and August, 2007,” id.
¶ 17, allowing this court to conclude that “PLIVA’s label was not updated the entire time
Fulgenzi was prescribed the drug,” Fulgenzi, 711 F.3d at 582.
In the present case, nothing in the complaint indicates when the plaintiffs
ingested generic metoclopramide. They simply allege that “several” of the Generic
Manufacturers “fail[ed] to include information present in the label for the RLD and
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fail[ed] to implement changes to their own labels,” and that some Generic Manufacturers
“waited years to conform their labels to the RLD label.” Am. Compl. ¶ 87l. The
plaintiffs attempt to enlarge their pleadings on appeal by arguing that “PLIVA failed to
include instrumental warnings in its label for metoclopramide that had been approved
by the FDA and were in use by the name brand manufacturers in their FDA approved
labeling.” But “[t]he appropriate method for adding new factual allegations to a
complaint is not via an appellate brief, but by filing an amended complaint.” Harvey v.
Great Seneca Fin. Corp., 453 F.3d 324, 328 (6th Cir. 2006). Moreover, these new
statements still fail to allege when the metoclopramide was ingested and by whom it was
used with regard to specific generic manufacturers, facts essential to show that a
particular generic manufacturer’s label was not updated during the time that a particular
plaintiff was using its product.
In evaluating whether a complaint states a claim for relief, we “should not
assume facts that were not pled.” Id. at 328. We will instead consider “only those facts
alleged in [the plaintiffs’] complaint and the reasonable inferences that can be drawn
from those facts.” Id. at 329. So even assuming that the failure-to-conform claims are
not preempted under Fulgenzi, the plaintiffs have nonetheless failed to “state a claim to
relief that is plausible on its face,” see Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570
(2007); see also Bowman v. Wyeth, LLC, No. 10-1946, 2012 WL 684116, at *7 (D.
Minn. Mar. 2, 2012) (declining to reach the question whether the failure-to-conform
claim was preempted because the plaintiff’s complaint did not allege that he ingested
metoclopramide after July 2004 or that he ingested metoclopramide for more than twelve
weeks, nor did it allege any specific facts relating to the 2004 labeling change).
The plaintiffs requested at oral argument an opportunity to amend their complaint
once more in light of Fulgenzi, but they have offered no argument as to why they were
unable to include the dates during which they took the drugs in their first amended
complaint. Contrary to the plaintiffs’ assertion at oral argument that such information
need not be in the complaint, such a factual averment is critical to the question of
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whether the plaintiffs’ alleged injuries are in any way connected to the alleged failure
to conform.
The plaintiffs are responsible for pleading their cause of action and are “not
entitled to an advisory opinion from the Court informing them of the deficiencies of the
complaint and then an opportunity to cure those deficiencies.” Winget v. JP Morgan
Chase Bank, N.A., 537 F.3d 565, 573 (6th Cir. 2008) (brackets and internal quotation
marks omitted). This is especially true here, where the plaintiffs were already given
leave to amend their complaint once and where the key facts that might make their
claims plausible are easily within their own knowledge. We therefore find no error in
the district court’s dismissal of the plaintiffs’ failure-to-conform claims.
5. Civil conspiracy
In their brief on appeal, the plaintiffs argue that they have adequately pled a
cause of action for civil conspiracy. The district court held that the plaintiffs had not
alleged any facts in support of their civil-conspiracy claim, and that such a claim was in
substance another failure-to-warn claim. We find no error in the district court’s analysis.
The plaintiffs’ complaint with regard to this claim does no more than recite the elements
of a cause of action for civil conspiracy; on appeal, they simply reiterate their pleadings.
Because “[t]hreadbare recitals of the elements of a cause of action, supported by mere
conclusory statements, do not suffice” to state a claim, Ashcroft v. Iqbal, 556 U.S. 662,
678 (2009), the complaint fails to state a claim for civil conspiracy. Moreover, even if
the civil-conspiracy claim was adequately supported by factual allegations, the essence
of such a claim is that there was a tacit agreement between the manufacturers not to
warn, or not to adequately warn, about the dangers of long-term metoclopramide use—a
failure-to-warn claim that, for the reasons already discussed, is preempted under
Mensing.
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6. Punitive damages
The plaintiffs further argue that “Mensing clearly does not mandate dismissal of
the punitive damages claim as to the Generic Defendants.” But their claims for punitive
damages are “derivative in nature.” See Graham v. Am. Cyanamid Co., 350 F.3d 496,
514-15 (6th Cir. 2003). “A derivative cause of action may not provide greater relief than
that available under the primary cause of action.” Id. at 515 (internal citation omitted).
Because the district court did not err in dismissing the plaintiffs’ substantive claims
against the Generic Manufacturers, it did not err in dismissing their punitive-damages
claims.
C. Claims against the Brand-Name Manufacturers
Turning now to the Brand-Name Manufacturers, the plaintiffs contend that the
information disseminated by them was “materially false, incomplete, and misleading”
and that this deficiency proximately caused the plaintiffs’ injuries. They assert that the
Brand-Name Manufacturers had an affirmative duty under the FDA regulations to
accurately label their products because a medical professional could foreseeably rely on
that information in prescribing metoclopramide, the generic equivalent of Reglan. The
Brand-Name Manufacturers respond that none of the plaintiffs took Reglan, only the
generic metoclopramide, so the plaintiffs’ claims against them are barred by the TPLA.
Agreeing with the Brand-Name Manufacturers, the district court held that the
plaintiffs, who conceded that they never took Reglan, could not meet the “threshold
requirement” of a Tennessee products-liability claim—i.e., “that the plaintiff assert that
the defendant’s product caused the plaintiff’s injury.” Strayhorn v. Wyeth Pharm., Inc.,
882 F. Supp. 2d 1020, 1029 (W.D. Tenn. 2012). The court found that Smith v. Wyeth,
Inc., 657 F.3d 420 (6th Cir. 2011), cert. denied 132 S. Ct. 2103 (2012), a decision
involving Kentucky law, controlled the present case.
The Smith plaintiffs sued Wyeth and Schwarz, both makers of Reglan, alleging
fraud and tortious misrepresentation. Examining the Kentucky Product Liability Act
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(KPLA), this court noted that the Act “defines a product liability action as any action
brought for or on account of personal injury, death or property damage caused by or
resulting from the manufacture, construction, design, formulation[,] . . . warning,
instructing, marketing, advertising, packaging or labeling of any product.” Id. at 423
(internal quotation marks omitted) (second alteration in original). This court further
noted that the Kentucky Supreme Court had held that the KPLA “applies to all damages
claims arising from the use of products, regardless of the legal theory advanced.” Id.
(internal quotation marks omitted). Kentucky law also requires that the plaintiffs assert,
as a threshold matter, “that the defendant’s product caused the plaintiff’s injury.” Id.
But the Smith plaintiffs, just as the plaintiffs in the present case, had ingested only
generic metoclopramide, not Reglan.
This court in Smith also rejected the plaintiffs’ 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 generic drugs.” Id. at 423-24. It noted
that the “leading case” on this issue, Foster v. American Home Products Corp., 29 F.3d
165 (4th Cir. 1994), held that “the manufacturer of a name-brand drug has no duty to
patients who ingested only a generic version of the drug manufactured by the name-
brand drug company’s competitors.” Smith, 657 F.3d at 424. This court therefore joined
“the majority of courts to address this question” and held that the plaintiffs could not
bring their state-law tort claims against the brand-name defendants. Id.
The plaintiffs’ arguments in the instant case track those of the Smith plaintiffs.
They contend that their suit is not governed by the TPLA and that they have stated viable
causes of action for negligent and fraudulent misrepresentation and for breach of express
and implied warranties under Wyeth v. Levine, 555 U.S. 555 (2009) (finding no
preemption against the brand-name manufacturer), and Conte v. Wyeth, Inc., 168 Cal.
App. 4th 89 (2008) (holding that an injured plaintiff may hold a brand-name
manufacturer liable for its alleged misrepresentations even though the actual injury was
caused by a generic manufacturer’s drug). That is, they focus their arguments on
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whether the TPLA even applies to them. The plaintiffs do not challenge the district
court’s dismissal of their remaining claims against the Brand-Name Manufacturers.
Unfortunately for the plaintiffs, the relevant language in the TPLA is essentially
the same as the language of the KPLA discussed in Smith. Both statutes define a
“product liability action” to include all harm caused by a product regardless of the legal
theory advanced. Compare Tenn. Code Ann. § 29-28-102(6) with Ky. Rev. Stat.
§ 411.300(1).
The TPLA’s definition of “product liability action” has been interpreted broadly.
See, e.g., Richardson v. GlaxoSmithKline, 412 F. Supp. 2d 863 (W.D. Tenn. 2006)
(concluding that although the plaintiff’s complaint for personal injuries against a drug
manufacturer under the theories of negligence, strict liability, and breach of warranty
“does not cite the specific basis for his allegations, product liability suits in Tennessee
are governed by the Tennessee Products Liability Act”); Spence v. Miles Labs., Inc., 810
F. Supp. 952, 959 (E.D. Tenn. 1992) (“Whether formulated as a ‘strict liability’ claim
for damages resulting from untested blood products . . . or as a negligence claim, the
plaintiff’s claims manifestly relate to a product [and] clearly fall within Tennessee’s
broad definition of products liability actions.”), aff’d, 37 F.3d 1185 (6th Cir. 1994);
Penley v. Honda Motor Co., 31 S.W.3d 181 (Tenn. 2000) (applying the TPLA to the
plaintiff’s express- and implied-warranty claims for injuries caused by an all-terrain
vehicle).
As relevant to the present case, the TPLA clearly applies to the plaintiffs’ claims
for breach of warranty against the Brand-Name Manufacturers. And although the
definition of a “product liability action” does not explicitly state whether fraudulent
misrepresentation claims are covered, see Tenn. Code Ann. § 29-28-102(6) (stating that
the TPLA covers claims for “misrepresentation, concealment, or nondisclosure, whether
negligent, or innocent”), we conclude that such a cause of action is fairly encompassed
in the catch-all provision of this section, see id. (stating that a “product liability action”
includes “any other substantive legal theory in tort or contract whatsoever”).
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The plaintiffs’ injuries allegedly caused by the Brand-Name Manufacturers’
purported fraudulent misrepresentations in the present case are the result of the Brand-
Name Manufacturers’ “advertising, promotions, in-office and group presentations[,] . . .
sponsored education and continuing education programs and seminar speakers, the
planning, sponsorship, ghost-writing, and arranged publication of non-scientific and
misleading medical research,” as well as their failure to warn the medical community
about the true risks of Reglan. See Am. Compl. ¶¶ 101-03. In other words, they are the
result of the “warning, instruction, marketing, packaging or labeling of” Reglan. See
Tenn. Code Ann. § 29-28-102(6).
These are essentially the same allegations made against the brand-name
manufacturers in Smith. See Smith v. Wyeth, Inc., No. 5:07-CV-18-R, 2008 WL
2677051, at *3 (W.D. Ky. June 30, 2008) (“Specifically, Plaintiff argues that Defendants
distributed false and misleading information concerning Reglan . . . . In effect, Plaintiff
is arguing that Defendants’ warning, labeling, and marketing concerning Reglan should
also be seen as the warning, labeling, and marketing of [competing generic
manufacturers].” (emphasis added)). We thus conclude that the TPLA applies to all of
the plaintiffs’ claims against the Brand-Name Manufacturers. This determination is
consistent with the determination in Smith that the KPLA covers product-liability actions
for fraud and misrepresentation despite the lack of any specific language to that effect
in the statute. See Smith v. Wyeth, Inc., 657 F.3d 420, 423 (6th Cir. 2011), cert. denied
132 S. Ct. 2103 (2012) (holding that the KPLA “applies to all damages claims arising
from the use of products, regardless of the legal theory advanced”) (internal quotation
marks omitted).
Similar to the KPLA, the TPLA contains multiple references to manufacturers
and sellers. See Tenn. Code Ann. § 29-28-102(4), (7) (defining the terms
“manufacturer” and “seller”); § 103(a) (setting forth the statute of limitations for “[a]ny
action against a manufacturer or seller of a product for injury to person”); § 104(a)
(discussing the rebuttable presumption that a product is not unreasonably dangerous if
the manufacturer or seller complied with federal and state regulations). These references
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fairly imply that a claim falling under the definition of a “product liability action” may
be asserted only against the manufacturer or the seller of the product that harmed the
plaintiff. See Maness v. Boston Sci., 751 F. Supp. 2d 962, 968 (E.D. Tenn 2010) (“Only
sellers and manufacturers may be held liable under the TPLA.”).
The plaintiffs’ citation to Gaines v. Excel Industries, Inc., 667 F. Supp. 569
(M.D. Tenn. 1987), does not persuade us otherwise. In that case, the plaintiffs were
injured by stamp presses in their employer’s plant. They sued the parent corporation of
their employer, alleging under a “Good Samaritan” theory that the parent corporation
assumed a duty of care to the plaintiffs by performing safety-inspection tours of the plant
and negligently failed to implement appropriate safety measures. In response, the
defendant argued that because the claim was one for injuries resulting from the
construction, assembly, testing, service, or instruction of a product (the stamp presses
and related safety devices) under a negligence theory, the TPLA’s statute of limitations
operated to bar the claim.
The district court in Gaines disagreed with the defendant because the Good
Samaritan claim was “not based on any actions defendant took in a role as
‘manufacturer’ or ‘seller,’” as those terms are defined in the TPLA. Id. at 574. Rather,
the claim against the parent corporation was due to its role as a safety inspector. The
court, however, was careful to note that any claims relating to the parent corporation’s
role in “designing, fabricating, or assembling the safety apparatus attached to the
presses” were in the nature of its role as a manufacturer or seller and, therefore, fell
under the TPLA. Id.
In contrast to the Good Samaritan theory in Gaines, all of the claims against the
Brand-Name Manufacturers in the present case are based on these defendants’ status as
the manufacturers of Reglan. As such, the Brand-Name Manufacturers were responsible
for proposing an accurate and adequate label to the FDA (as well as for updating that
label), which, in turn, controlled the label for the Generic Manufacturers through the
ANDA process. They were also responsible for distributing adequate warnings about
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the product. But they undertook no separate duties as did the parent corporation in
Gaines.
The TPLA therefore applies to all of the plaintiffs’ claims against the Brand-
Name Manufacturers. Unfortunately for the plaintiffs, however, these defendants were
not the manufacturers or sellers of the generic drugs that injured the plaintiffs. Yet “[i]n
order to recover [under the TPLA], a plaintiff must show that the product manufactured
and sold by the defendant . . . caused the injuries he alleges to have sustained.”
Richardson v. GlaxoSmithKline, 412 F. Supp. 2d 863, 868 (W.D. Tenn. 2006) (brackets
and internal quotation marks omitted); see also Tenn. Code Ann. § 29-28-105(a) (“A
manufacturer or seller of a product shall not be liable for any injury to a person or
property caused by the product unless the product is determined to be in a defective
condition or unreasonably dangerous at the time it left the control of the manufacturer
or seller.” (emphasis added)); Wyatt v. Winnebago Indus., Inc. 566 S.W.2d 276, 280
(Tenn. Ct. App. 1978) (stating that the “first requirement [of proximate cause] is that the
defendant’s act or, in this products liability case, the defect in the product, be a cause in
fact of the injury”).
The Supreme Court’s decision in Wyeth v. Levine, 555 U.S. 555 (2009), is not
to the contrary. In Levine, the Court held that state-law tort claims against brand-name
manufacturers are not preempted by federal law because “it is not impossible for
[a brand-name manufacturer] to comply with its state and federal obligations.” 555 U.S.
at 581. Specifically, the CBE process permits brand-name manufacturers to strengthen
their warnings without prior approval from the FDA, thus allowing brand-name
manufacturers to comply with both state and federal law. But unlike in the present case,
Levine was injured by the brand-name manufacturer’s own product.
The plaintiffs nonetheless argue that the Brand-Name Manufacturers are liable
because they could foresee that physicians would rely on the information provided by
the Brand-Name Manufacturers when prescribing metoclopramide. But simply because
a particular harm is foreseeable “is not dispositive in determining the existence of a legal
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duty.” Burroughs v. Magee, 118 S.W.3d 323, 333 (Tenn. 2003); accord Satterfield v.
Breeding Insulation Co., 266 S.W.3d 347, 366 (Tenn. 2008) (“[F]oreseeability alone is
insufficient to create a duty.”). Finding the existence of a duty requires a substantive
public-policy determination. See Bradshaw v. Daniel, 854 S.W.2d 865, 869-70 (Tenn.
1993) (stating that, to determine the existence of a duty, the court considers whether “a
relation exists between the parties that the community will impose a legal obligation
upon one for the benefit of the others—or, more simply, whether the interest of the
plaintiff which has suffered invasion was entitled to legal protection at the hands of the
defendant”).
Despite the above considerations, our dissenting colleague embraces the
plaintiffs’ theory of brand-name-manufacturer liability. She repeatedly quotes the
concurring opinion in Fullington v. Pfizer, Inc., 720 F.3d 739, 748 (8th Cir. 2013), to
support her argument that the basis for insulating brand-name manufacturers from suit
has been “severely eroded” since this court decided Smith v. Wyeth, Inc., 657 F.3d 420
(6th Cir. 2011). In our opinion, however, three factors militate against reaching such a
conclusion. First, the Eighth Circuit in Fullington in fact affirmed the district court’s
grant of summary judgment in favor of the brand-name manufacturers, relying on its
prior decision in Bell v. Pfizer, Inc., 716 F.3d 1087 (8th Cir. 2013). Judge Murphy’s
four-paragraph concurrence in Fullington indeed questions the soundness of Bell and
similar decisions, but is hardly enough for us to overrule our own circuit’s decision in
Smith.
Second, we are bound by Smith’s holding even if, as our dissenting colleague
contends, its analysis might be flawed. See United States v. Dunlap, 209 F.3d 472, 481
(6th Cir. 2000) (“[A] subsequent panel of this circuit court is powerless to revisit,
modify, amend, abrogate, supersede, set aside, vacate, avoid, nullify, rescind, overrule,
or reverse any prior Sixth Circuit panel’s published precedential ruling of law.”); see
also Salmi v. Sec’y of Health & Human Servs., 774 F.2d 685, 689 (6th Cir. 1985) (“The
prior decision remains controlling authority unless an inconsistent decision of the United
States Supreme Court requires modification of the decision or this Court sitting en banc
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overrules the prior decision.”). Because Smith ruled in favor of the brand-name
manufacturers in a case virtually identical to the one before us, the dissent’s reliance on
the concurring opinion in Fullington to reach a contrary result strikes us as misplaced.
Finally, and perhaps most importantly, we have no basis to conclude in this
diversity case that the Tennessee Supreme Court would overrule its prior decisions
holding that a manufacturer owes no duty of care to consumers of products made by
others. Tennessee law instead “requires manufacturers to warn of hidden and unknown
dangers in their product.” Pemberton v. Am. Distilled Spirits Co., 664 S.W.2d 690, 693
(Tenn. 1984) (emphasis added) (internal quotation marks omitted). Furthermore, “[d]rug
manufacturers have a duty to exercise ordinary and reasonable care not to expose the
public to an unreasonable risk of harm from the use of their products.” Pittman v.
Upjohn Co., 890 S.W.2d 425, 428 (Tenn. 1994) (emphasis added). In Tennessee, a
relationship exists between manufacturers and “those who foreseeably could be injured
by the use of their products,” not those persons injured by some other product. See id.
(emphasis added). This court has previously interpreted this principle to mean 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.” Barnes v. Kerr Corp., 418 F.3d 583, 590 (6th Cir. 2005) (holding that a
dental-amalgam manufacturer had satisfied its duty to warn about the dangers posed by
the mercury in its products even though it did not warn that those dangers remained
when combined with other manufacturers’ dental-amalgam ingredients).
The plaintiffs have presented no authority indicating that manufacturers of a
brand-name drug have a duty under Tennessee law to consumers of the brand-name
manufacturers’ competitors, and we are loath to expand Tennessee’s substantive law
without direction from the Tennessee Supreme Court. See Combs v. Int’l Ins. Co.,
354 F.3d 568, 577 (6th Cir. 2004) (“[W]hen given a choice between an interpretation of
[state] law which reasonably restricts liability, and one which greatly expands liability,
we should choose the narrower and more reasonable path.” (second alteration in
original) (internal quotation marks omitted)).
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Nor does Conte v. Wyeth, 168 Cal. App. 4th 89 (2008), save the plaintiffs’
claims. In Conte, the California Court of Appeal stated that it “ha[d] no difficulty
concluding that [the brand-name manufacturer] should reasonably perceive that there
could be injurious reliance on its product information by a patient taking generic
metoclopramide.” Id. at 104. But this court in Smith v. Wyeth, Inc., 657 F.3d 420 (6th
Cir. 2011), cert. denied, 132 S. Ct. 2103 (2012), considered Conte and characterized it
as an outlier, choosing instead to follow Foster v. American Home Products Corp.,
29 F.3d 165 (4th Cir. 1994), and the majority of other courts that have rejected such a
theory. See also Mensing v. Wyeth, Inc., 588 F.3d 603, 613-14 (8th Cir. 2009)
(“Whatever the merits of Conte under California law, . . . 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. PLIVA, Inc. v. Mensing,
131 S. Ct. 2567 (2011).
Although our decision is grounded in Tennessee law, we would note that 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, whether
under a state’s product-liability act or under general principles of duty. See, e.g.,
Schrock v. Wyeth, LLC, 727 F.3d 1273, 1284-86 (10th Cir. 2013) (noting that every
federal circuit court has rejected—and that the Oklahoma Supreme Court would not
recognize—brand-name liability under these circumstances); Guarino v. Wyeth, LLC,
719 F.3d 1245, 1251-53 (11th Cir. 2013) (noting the “overwhelming national consensus”
on the issue); Bell v. Pfizer, Inc., 716 F.3d 1087, 1092 (8th Cir. 2013) (same); Demahy
v. Schwarz Pharma, Inc., 702 F.3d 177, 182-83 (5th Cir. 2012) (per curiam), petition for
cert. filed, 81 U.S.L.W. 3519 (U.S. Mar. 7, 2013) (No. 12-1093) (same). And this court,
following the majority view in Foster, has previously come to the same conclusion in
Smith. See Smith, 657 F.3d at 424 (“As have the majority of courts to address this
question, we reject the argument that a name-brand drug manufacturer owes a duty of
care to individuals who have never taken the drug actually manufactured by that
company.”).
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Only three cases to our knowledge have decided the other way: Conte v. Wyeth,
168 Cal. App. 4th 89 (2008), Kellogg v. Wyeth, 762 F. Supp. 2d 694 (D. Vt. 2010), and
Wyeth v. Weeks, — So.3d —, 2013 WL 135753 (Ala. Jan. 11, 2013) (reargument granted
June 13, 2013). For differing reasons, we find each of these cases either unpersuasive
or distinguishable. As explained above, this court rejected Conte in Smith and we do so
again in the present case. The district court in Kellogg, on the other hand, recognized
that common-law actions for fraud and negligence with regard to product-liability claims
remain viable in Vermont, the state having no statute comparable to the TPLA. 762 F.
Supp. 2d at 704, 707. As such, the court concluded that determining whether the
plaintiff had ingested the defendant’s product was not essential to the claim. Id. at 709.
The court also concluded that, under Vermont law, there was a duty on the part of the
brand-name defendant to the generic’s consumer, id. at 708-09, a legal principle that is
contrary to Tennessee law. Finally, the Alabama Supreme Court has decided to rehear
Weeks, which makes its ultimate outcome far from certain. In sum, none of these cases
persuade us to alter our analysis as set forth above. We therefore find no error in the
district court’s grant of summary judgment in favor of the Brand-Name Defendants.
D. Motion to certify a question to the Tennessee Supreme Court
Finally, the plaintiffs have moved to certify the following question to the
Tennessee Supreme Court: “Is there a duty on the manufacturer of a pharmaceutical
drug to cease sales of a product, if that product is ‘unreasonably dangerous’ under [the]
Tennessee Products Liability Act?” The Supreme Court recently rejected this very stop-
selling rationale “as incompatible with [its] pre-emption jurisprudence,” Mut. Pharm.
Co. v. Bartlett, 133 S. Ct. 2466, 2477 (2013), and the plaintiffs conceded at oral
argument that Bartlett forecloses reliance on this theory. Accordingly, the plaintiffs’
motion has no merit.
E. “Catch 22” dilemma
Although we feel compelled to affirm the judgment below in light of the
controlling caselaw, we cannot help but note the basic unfairness of this result. The
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plaintiffs’ problem is that all of their claims fall within the purview of the TPLA as a
“product liability action.” See Tenn. Code Ann. § 29-28-102(6). This is true despite
their most artful efforts to dress up a relatively simple failure-to-warn claim in a great
variety of tort and contract causes of action. The plaintiffs are therefore caught in a
classic “Catch 22,” barred from all claims against the Generic Manufacturers whose
drugs they ingested (due to federal preemption) and from all claims against the Brand-
Name Manufacturers (due to the TPLA). See PLIVA, Inc. v. Mensing, 131 S. Ct. 2567,
2592 (2011) (Sotomayor, J., dissenting) (“If a consumer takes a brand-name drug, she
can sue the manufacturer for inadequate warnings . . . . If, however, she takes a generic
drug, as occurs 75 percent of the time, she now has no right to sue.”).
This unfairness has been acknowledged by the Supreme Court in both Mensing
(see supra p. 10) and Bartlett (see supra pp. 12-13), but the Court has suggested that any
resolution of this dilemma rests with Congress. Relief could also come from the
Tennessee General Assembly revising the TPLA to allow claims against brand-name
manufacturers whose labels control the warnings that the generic manufacturers are
compelled by federal law to duplicate. But unless or until such change comes, we find
no basis to afford the plaintiffs any relief.
III. CONCLUSION
For all of the reasons set forth above, and despite the “Catch-22” dilemma, we
AFFIRM the judgment of the district court and DENY the plaintiffs’ motion to certify
their proposed question to the Tennessee Supreme Court.
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___________________________________________________
CONCURRING IN PART AND DISSENTING IN PART
___________________________________________________
JANE B. STRANCH, Circuit Judge, concurring in part and dissenting in part.
Before this panel comes another of the developing line of pharmaceutical cases in which
a grievous harm is found to be without remedy for a large subset of the injured. The
universal explanation for finding such a remediless wrong is that existing law drives
these cases into the proverbial box canyon of precedent from which there is no hope of
escape. I do not agree that case precedent consigns this group of plaintiffs to such an
inequitable result. Accordingly, I respectfully concur in part and dissent in part from the
majority opinion.
In the cases before us, plaintiffs’ physicians prescribed generic metoclopramide
for stomach distress. After taking the drug for more than twelve weeks, the plaintiffs
developed an irreversible, incurable, life-altering neurological disorder called tardive
dyskinesia. This disorder causes involuntary and rhythmic muscle movements, such as
chewing, grimacing and frowning, eye blinking, lip puckering, and tongue rolling. See
United States v. Grigsby, 712 F.3d 964, 966 n.1 (6th Cir. 2013). Evidence indicates that
the manufacturers of generic metoclopramide and the brand-name drug Reglan knew that
tardive dyskinesia occurs with much greater frequency than they warned about on their
product labels. Now that the damage has been done, must the plaintiffs alone bear the
burden of the harm they have suffered? The majority opinion says they must bear this
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burden alone because the law does not permit plaintiffs to pursue any state-law tort
remedies against the generic or brand-name manufacturers.
I cannot agree that recent changes in the law leave plaintiffs such as those before
us with absolutely no remedy to redress their harm. While these plaintiffs may not be
able to press all of their causes of action against the generic manufacturers, they should
be permitted to pursue the failure-to-conform claim against them. As to the brand
manufacturers, moreover, there exists a potentially viable path to recovery.
A. Generic drug manufacturers
I address the generic drug manufacturers first because the law concerning them
is more settled, at least at the present time. Unfortunately I find myself compelled to
join that portion of the majority’s decision holding that plaintiffs cannot, under current
law, bring design-defect or failure-to-warn claims against generic drug manufacturers
because such claims are preempted by the Federal Food, Drug, and Cosmetic Act
(FDCA), 21 U.S.C. §§ 301–399f. See Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466
(2013); PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). In both Mensing and Bartlett
the Supreme Court adopted the position of the Food and Drug Administration (FDA) at
that time that a generic drug manufacturer may not use the federal “changes-being-
effected” (CBE) regulation to act independently of the brand-name manufacturer to
strengthen a warning label so that known risks are adequately disclosed to medical
providers and patients. See Bartlett, 133 S. Ct. at 2476; Mensing, 131 S. Ct. at 2575
(citing U.S. Brief at 15–16; 21 U.S.C. § 355(j)(4)(G); 21 C.F.R. §§ 314.94(a)(8)(iii),
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314.150(b)(10)). Although state tort laws place “a duty directly on all drug
manufacturers to adequately and safely label their products[,]” the CBE regulation as
interpreted by the FDA prevents generic manufacturers from complying with federal law
and state law relating to failure-to-warn and design-defect claims at the same time.
Mensing, 131 S. Ct. at 2577. As a result, state tort law is preempted by federal law,
leaving the plaintiffs without state-law tort remedies for these types of claims. Id.;
Bartlett, 133 S. Ct. at 2476–77.
This analysis “strips generic-drug consumers of compensation when they are
injured by inadequate warnings” even though “Congress would [not] have intended to
pre-empt state law in these cases.” Mensing, 131 S. Ct. at 2592 (Sotomayor, J.,
dissenting). Regrettably, Mensing and Bartlett prevent the plaintiffs from pursuing
their failure-to-warn and design-defect claims against the manufacturers of generic
metoclopramide, a medication that caused them permanent, debilitating harm. I follow
Mensing and Bartlett because I am bound to apply Supreme Court law. My views on
the liability of generic drug manufacturers on failure-to-warn and design-defect claims,
however, coincide with those of the well-reasoned dissents in Mensing, 131 S. Ct. at
2582–93, and Bartlett, 133 S. Ct. at 2480–96.
Mensing and Bartlett, moreover, do not seal the doorway to all claims. In
Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 584–85 (6th Cir. 2013), this court permitted a
failure-to-conform claim to proceed against a generic drug manufacturer of
metoclopramide where the plaintiff alleged that the generic manufacturer did not update
its label beginning in 2004 to match the label of the brand-name drug, Reglan, and the
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plaintiff specifically alleged the time periods during which she ingested the drug. The
majority invokes Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007), to reject the
failure-to-conform claim alleged against generic manufacturers in this case solely on the
basis that the plaintiffs failed to allege facts specifying when they ingested
metoclopramide. Because Fulgenzi issued in 2013 after the filing of the Amended
Complaint in this case in 2011, I would grant the plaintiffs one additional opportunity
to amend their complaint to specify more precisely the dates they ingested
metoclopramide, thereby drawing the link between their use of the drug during a time
period when the generic manufacturers failed to conform their labels to the label of the
brand-name drug, Reglan. Accordingly, I dissent from subsection II.B.4. of the majority
opinion, but otherwise I concur in sections II.A and II.B.
B. Brand-name drug manufacturers
Turning to the brand-name drug manufacturers, I further part ways with my
colleagues. Brand-name drug manufacturers stand in a far different posture than generic
drug manufacturers. Plaintiffs injured by brand-name prescription drugs retain state-law
tort remedies against the manufacturers of those drugs. See Wyeth v. Levine, 555 U.S.
555 (2009). Proper application of federal and Tennessee law does not absolve brand-
name drug manufacturers of all responsibility for the plaintiffs’ harm simply because the
plaintiffs ingested generic metoclopramide and not brand-name Reglan. The plaintiffs’
state-law causes of action against the brand-name drug manufacturers are based on the
lack of an adequate warning by the entity responsible for providing that warning. For
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the reasons explained below, I respectfully dissent from subsection II.C. of the majority
opinion.
In Wyeth, the plaintiff suffered an arm amputation following an injection of
Phenergan, a drug that was administered to curb her nausea from a migraine headache.
Id. at 558–59. She alleged that Phenergan’s warning label was defective because it did
not instruct medical clinicians to use the IV-drip method of intravenous administration
rather than the higher-risk IV-push method. Id. at 560. “More broadly, she alleged that
Phenergan is not reasonably safe for intravenous administration because the foreseeable
risks of gangrene and loss of limb are great in relation to the drug’s therapeutic benefits.”
Id.
Wyeth asserted that Levine’s claims were preempted because Wyeth could not
possibly comply simultaneously with the duties imposed upon it by state tort laws and
federal labeling laws. Id. at 568. This argument was comprised of several components.
First, Wyeth contended that the CBE regulation was not implicated in the case
because a 2008 amendment allowed a manufacturer to change its label only to reflect
newly acquired information. Id. Because Levine had not pointed to any new
information about the risks of the IV-push method of drug administration, Wyeth
asserted that it could not fulfill its state-law duty to provide a stronger warning about that
method of drug administration without violating federal law. Id. at 568–69. The
Supreme Court disagreed, pointing out that Wyeth could have revised the Phenergan
label even under the 2008 amendment because “newly acquired information” includes
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“new analyses of previously submitted data.” Id. at 569 (internal quotation marks
omitted). “Wyeth could have analyzed the accumulating data” on the frequency of
amputations and “added a stronger warning about IV-push administration of the drug.”
Id. at 569–70.
The same is true in this case. The brand manufacturers could have analyzed the
accumulating data on the frequency of tardive dyskinesia and added a stronger warning
on the Reglan label without waiting for the FDA to approve a supplemental application.
The brand manufacturer also argued in Wyeth that, if it had added a stronger
warning without first obtaining the FDA’s approval, it would have violated federal laws
on misbranding and unauthorized distribution of its drug. Id. at 570. These arguments
were not persuasive to the Court because strengthening the warning would not make
Phenergan a “new drug” distributed without FDA authorization nor would such a
warning misbrand the drug. Id. “[B]ecause the statute contemplates that federal juries
will resolve most misbranding claims,” the Court explained, “the FDA’s belief that a
drug is misbranded is not conclusive.” Id.
The same reasoning applies here. Strengthening the warning label would not
make Reglan a new drug distributed without FDA authorization, nor would it misbrand
the drug. And because “[f]ederal law does not dictate the text of each generic drug’s
label, but rather ties those labels to their brand-name counterparts,” Mensing, 131 S. Ct.
at 2578, generic manufacturers have a duty to replicate the strengthened brand-name
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label to intensify the warnings on their own labels for metoclopramide. See Fulgenzi,
711 F.3d at 584.
The brand-name manufacturer cannot shift the duty to warn to the FDA. The
Supreme Court made this clear in Wyeth when it stated that it is a “central premise of
federal drug regulation that the manufacturer bears responsibility for the content of its
label at all times.” Wyeth, 555 U.S. at 570–71. The manufacturer must produce an
adequate drug label initially and then ensure that the warnings on the label remain
adequate throughout the time the drug is marketed. Id. at 571. Prior to 2007, the FDA
did not have authority to order manufacturers to revise their labels, but “[w]hen
Congress granted the FDA this authority, it reaffirmed the manufacturer’s obligations
and referred specifically to the CBE regulation, which both reflects the manufacturer’s
ultimate responsibility for its label and provides a mechanism for adding safety
information to the label prior to FDA approval.” Id. at 571. The FDA can reject
labeling changes made under the CBE regulation, “[b]ut absent clear evidence that the
FDA would not have approved a change to Phenergan’s label,” the Supreme Court
declined to “conclude that it was impossible for Wyeth to comply with both federal and
state requirements.” Id.
The same principles apply here. The responsibility to draft a warning label that
is accurate at the time the product is issued and remains adequate during the entire time
the product is on the market lies solely with the brand-name manufacturer, not the FDA.
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Finally, in Wyeth the brand-name manufacturer argued that the purposes and
objectives of federal drug labeling regulation would be obstructed if Wyeth had to
comply with a state-law duty to provide a stronger warning. Id. at 573. Once the FDA
approves a drug’s label, Wyeth posited, a state court jury “may not deem the label
inadequate, regardless of whether there is any evidence that the FDA has considered the
stronger warning at issue.” Id. at 573–74. The Supreme Court rejected this contention
because it relied on an “untenable interpretation of congressional intent and an overbroad
view of an agency’s power to pre-empt state law.” Id. at 573. The “most glaring
problem” with the argument, the Supreme Court said, was “that all evidence of
Congress’ purposes is to the contrary.” Id. at 574. “Congress did not provide a federal
remedy for consumers harmed by unsafe or ineffective drugs” because it evidently
“determined that widely available state rights of action provided appropriate relief for
injured consumers.” Id. State-law tort claims remain intact because 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.”
Id. Because Congress has not adopted an express preemption provision for prescription
drugs, “[i]ts silence on the issue, coupled with its certain awareness of the prevalence of
state tort litigation, is powerful evidence that Congress did not intend FDA oversight to
be the exclusive means of ensuring drug safety and effectiveness.” Id. at 574–75.
In declining to preempt state-law tort claims against brand-name drug
manufacturers, the Supreme Court refused to defer to the FDA’s “newfound opinion,”
first expressed in 2006, that state law frustrates the agency’s implementation of the
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FDCA. Id. at 580. The Court reasoned that a “complex and extensive” regulatory
history “undercut the FDA’s recent pronouncements of pre-emption, as they reveal the
longstanding coexistence of state and federal law and the FDA’s traditional recognition
of state-law remedies—a recognition in place each time the agency reviewed Wyeth’s
Phenergan label.” Id. at 580–81 (internal quotation marks omitted). Likewise, the Court
refused to give deference to the amicus brief of the United States because “the
Government’s explanation of federal drug regulation departs markedly from the FDA’s
understanding at all times relevant to this case.” Id. at 580 n.13. Unfortunately for the
plaintiffs, however, two years later the Supreme Court fully deferred to the FDA’s
“newfound opinion,” as again expressed in an amicus brief of the United States, and
found the claims against a generic manufacturer subject to federal preemption. Mensing,
131 S. Ct. at 2574–76.
The upshot is that Wyeth, Mensing, and Bartlett draw a sharp distinction between
brand-name and generic drug manufacturers. Injured plaintiffs can bring state-law tort
claims against brand-name manufacturers. Wyeth, 555 U.S. at 581. Injured plaintiffs
may not bring certain state-law tort claims against generic manufacturers. Bartlett, 133
S. Ct. at 2476; Mensing, 131 S. Ct. at 2577. “It is beyond dispute that the federal statutes
and regulations that apply to brand-name drug manufacturers are meaningfully different
than those that apply to generic drug manufacturers.” Mensing, 131 S. Ct. at 2582.
Mensing’s acceptance of the FDA’s “newfound opinion” created a different
landscape in pharmaceutical litigation. Brand-name drug manufacturers now stand in
direct relationship with consumers who ingest generic drugs because only the brand-
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name manufacturers can control and change labeling to strengthen warnings about drug
safety. Mensing and Bartlett “stripped any discretionary authority from the generic
manufacturers to ensure the safety of their products or the adequacy of their labels,
instead placing the burden entirely on the brand manufacturers.” Fullington v. Pfizer,
Inc., 720 F.3d 739, 748 (8th Cir. 2013) (Murphy, J., concurring). The “privileged
position accorded to the brand manufacturers may alter their state law relationship to the
generic drugs whose composition and labeling they control, since at this point such a
manufacturer is the party that actually controls the manufacturing and labeling of the
product in question.” Id. (internal quotation marks omitted).
Concomitantly, it is now reasonably foreseeable to brand-name drug
manufacturers that medical providers and consumers rely on brand-name labeling to
warn them about risks inherent in the use of brand-name and generic medications. See
Fulgenzi, 711 F.3d at 586–88 (permitting failure-to-conform claim to proceed where
plaintiff alleged that generic drug manufacturer failed to update its warning to match
brand-name manufacturer’s new warning). Any defect or omission in the labeling for
the brand-name drug will necessarily be repeated in the labeling for the generic drug, see
id. at 581–82, causing reasonably foreseeable harm to a patient who ingests only the
generic product. See Wyeth, Inc. v. Weeks, ___ So.3d ___, 2013 WL 135753, *15 (Ala.
Jan. 11, 2013), argument granted, (June 13, 2013). Further, because Tennessee and all
other states have laws requiring pharmacists to substitute less-expensive generic drugs
for higher-priced brand-name drugs to lower health care costs, see Tenn. Code Ann.
§ 53-10-204; Mensing, 131 S. Ct. at 2583 (Sotomayor, J., dissenting), it is reasonably
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foreseeable to brand-name manufacturers that most prescriptions will be filled with a
generic version of the drug prescribed, unless the physician insists that the patient
receive the brand-name drug only. See Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299, 315
(Cal. Ct. App. 2008).
In Tennessee, “[d]rug manufacturers have a duty to exercise ordinary and
reasonable care not to expose the public to an unreasonable risk of harm from the use of
their products.” Pittman v. Upjohn Co., 890 S.W.2d 425, 428 (Tenn. 1994). Drug
manufacturers, “like the manufacturers of any other unavoidably dangerous product,
have a duty to market and distribute their products in a way that minimizes the risk or
danger. They may discharge their duty by distributing the drugs with proper directions
and adequate warnings to those who foreseeably could be injured by the use of their
products.” Id. Drug manufacturers may reasonably rely on “learned intermediaries”
such as physicians “to transmit their warnings and instructions” to patients, thereby
potentially avoiding liability for failure to warn of known risks. But “physicians can be
learned intermediaries only when they have received adequate warnings” from the drug
companies. Id. at 429.
A reasonable warning “conveys a fair indication of the dangers involved, but also
warns with the degree of intensity required by the nature of the risk.” Id. Whether a
drug manufacturer’s warning is adequate is a question of fact based on several factors,
including whether the warning adequately indicates the scope of the danger and
reasonably communicates the extent or seriousness of the harm that could result from
misuse of the drug. Id. Other pertinent factors are whether the warning alerts a
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reasonably prudent person of the danger and the consequences that might result from
failure to follow the warning, and whether the means to convey the warning is adequate.
Id. The adequacy of a drug warning is a question of law only if the warning is accurate
and unambiguous. Id. at 429–30.
The record evidence suggests that the brand-name drug manufacturers knew that
the drug they created—metoclopramide by generic title and Reglan by brand-
name—caused tardive dyskinesia to occur far more frequently, especially with long-term
use of the drug, than was disclosed in the labeling. Yet they failed to warn physicians
or patients about this known incidence rate. Under the changed landscape created by
Mensing and Bartlett, the duty to warn of these dangers of Reglan and generic
metoclopramide rests with the brand manufacturers. Tennessee law defines the
parameters of that duty to warn. I cannot agree with my colleagues that the duty to warn
as assigned by these cases simply ceases to exist because the plaintiffs ingested generic
metoclopramide and not brand-name Reglan where the same warning—crafted by the
brand-name manufacturer—is required as to both. See Fulgenzi, 711 F.3d at 584
(finding no impossibility preemption because the generic manufacturer could—indeed
was required to—comply with its federal duty to update its labeling to match the brand-
name manufacturer’s labeling). The Tennessee Supreme Court has not yet had an
opportunity to discuss Wyeth and Mensing in the context of a state-law claim that a
brand-name drug manufacturer failed to warn consumers adequately about the dangers
of its drug, a warning that federal law requires the generic manufacturer to replicate. See
Fulgenzi, 711 F.3d at 584. Therefore, it is too early to speculate, as the majority does,
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about whether the Tennessee Supreme Court would limit the liability of brand-name
manufacturers to injuries caused by their “products,” and not their “warnings.”
The majority opinion reaches the conclusion that the brand-name manufacturers
can only be held liable if patients ingest brand-name Reglan by relying on our previous
opinion in Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011), decided under Kentucky
products liability law. Smith included claims against the manufacturers of Reglan and
the manufacturers of generic metoclopramide. The case was decided very shortly after
Mensing, which included only a claim against the generic drug manufacturer. Smith
followed Mensing to reject the claim against the maker of the generic drug on federal
preemption grounds. Id. at 423. Smith went further, however, and rejected the claim
against the brand-name manufacturer because adopting the plaintiffs’ “theory of liability
would require the court to attribute any deficiency in a name-brand manufacturer’s
labeling and marketing of its products to products manufactured by its generic
competitors.” Id. Smith further stated: “The plaintiffs’ 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 generic drugs—has been rejected by
all but one of the courts that have considered it.” Id. at 423–24. For this latter
proposition, Smith cited the “leading case” of Foster v. American Home Products Corp.,
29 F.3d 165 (4th Cir. 1994), “in which the court held that the manufacturer of a name-
brand drug has no duty to patients who ingested only a generic version of the drug
manufactured by the name-brand drug company’s competitors.” Id. at 424.
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This part of Foster rested on the Fourth Circuit’s understanding in 1994 that a
generic drug manufacturer could use the federal CBE regulation to strengthen its own
product labeling, independently of the brand-name manufacturer. Foster, 29 F.3d at
169–70. With generic manufacturers in control of warning labels for their own products,
courts understandably followed Foster to hold that brand-name drug manufacturers
could not be held liable for injuries caused by generic medications. Some courts in other
jurisdictions have continued to rely on Foster to hold that brand-name manufacturers of
Reglan cannot be held liable for injury caused by metoclopramide manufactured by their
generic competitors. See e.g., Schrock v. Wyeth, Inc., 727 F.3d 1273, 1284–85 (10th Cir.
2013) (and cases cited therein); Guarino v. Wyeth, 719 F.3d 1245, 1252–53 (11th Cir.
2013) (same).
These courts, like our own in Smith and the majority here, fail to recognize that
Foster’s foundation was “severely eroded” by the Supreme Court’s recent decisions in
Mensing and Bartlett.1 See Fullington, 720 F.3d at 748 (Murphy, J., concurring). Under
Mensing and Bartlett, a generic manufacturer no longer retains independent control to
strengthen its own label to disclose known risks of using the drug. The brand-name
manufacturers control the warning labels for their own and their generic competitors’
products. See Mensing, 131 S. Ct. at 2578. “With the brand manufacturers solely
responsible for the content and updating of a generic’s labels, it can no longer be
credibly argued that communications regarding the risks of their product are not also
1
The majority recasts my argument to be that “the basis for insulating brand-name manufacturers
from suit has been ‘severely eroded’ since this court decided Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir.
2011).” That is not correct. My point is that Foster was “severely eroded” by Mensing and Bartlett. See
Fullington, 720 F.3d at 748 (Murphy, J., concurring).
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directed at consumers of the generic bioequivalents.” Fullington, 720 F.3d at 748
(Murphy, J., concurring).
The majority criticizes my reliance on Judge Murphy’s concurrence in Fullington
because in that case the Eighth Circuit affirmed a summary judgment in favor of brand-
name manufacturers, relying on Bell v. Pfizer, Inc., 716 F.3d 1087 (8th Cir. 2013). But
Bell, too, rested on the disintegrating Foster analysis, see id. at 1092, and that is
precisely the point Judge Murphy made in her Fullington concurrence and that I make
here. The majority also adheres to Smith on the ground that one panel may not overrule
the decision of another panel. I have no disagreement with that general proposition. The
majority concedes, however, that an inconsistent Supreme Court opinion can require
modification of our decision. See Salmi v. Sec’y of Health & Human Servs., 774 F.2d
685, 689 (6th Cir. 1985). Thus so here—Mensing precluded the reliance we placed on
Foster in the Smith decision. We should not now repeat the same mistake in our analysis
of Tennessee law.
Consumers—who do not have the knowledge required to weigh the benefits of
a medication against its risks—rely on the superior expertise of the manufacturer
charged with the duty to provide label warnings. Those in need of medicine rightly
expect that the manufacturer will disclose a medication’s potential to cause them
physical harm. Thus, the plaintiffs’ state-law causes of action against the brand-name
drug manufacturers are predicated on the lack of an adequate warning from the entity
charged with providing that warning, not on whether the plaintiffs ingested Reglan or
a generic competitor’s product. Once this distinction is realized and the flaw in reliance
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on Foster recognized, section II.C. of the majority’s analysis lacks sufficient grounding
to deny the plaintiffs the right to proceed on their state-law claims.
For all of these reasons, I would hold that the plaintiffs may pursue their state-
law tort claims against the brand-name manufacturers and their Fulgenzi claim against
the generic manufacturers. Accordingly, I dissent from the majority’s conclusions
otherwise. I concur with the majority’s conclusion that plaintiffs cannot pursue other
state-law tort claims against generic drug manufacturers under the law as it presently
exists.