Gladys Mensing v. Wyeth, Inc. ( 2009 )

United States Court of Appeals
FOR THE EIGHTH CIRCUIT
___________
No. 08-3850
___________
Gladys Mensing, *
*
Plaintiff - Appellant, *
*
v. *
*
Wyeth, Inc., doing business as Wyeth; *
Pliva, Inc.; Teva Pharmaceuticals, *
USA, Inc.; Alpharma, Inc., doing *
business as Alpharma Pharmaceuticals; *
UDL Laboratories, Inc.; Actavis *
Elizabeth, LLC; Schwarz Pharma, Inc.; *
Purepac Pharmaceutical Company, and *
the following fictitious party defendants *
(whether singular or plural, individual * Appeal from the United States
or corporate): No. 1, that entity which * District Court for the
originally obtained permission from the * District of Minnesota.
U.S. Food and Drug Administration to *
market the drug branded Reglan No. 2, *
that entity which obtained permission *
from the FDA to market the Reglan, *
metoclopramide and/or metoclopramide *
HCI ingested by Gladys Mensing No. 3, *
that entity which originally *
manufactured and sold any Reglan *
which was ultimately ingested by *
Gladys Mensing No. 4, that entity *
which originally manufactured and sold *
any Reglan, metoclopramide and/or *
metoclopramide HCI which was *
ultimately ingested by Gladys Mensing *
No. 5, that entity which marketed *
Reglan or generic metoclopramide *
and/or metoclopramide HCI, jointly *
and individually, *
*
Defendants - Appellees. *
___________
Submitted: October 20, 2009
Filed: November 27, 2009 (Amended per Court
___________ Order of 09/29/11)
Before WOLLMAN, MURPHY, and BYE, Circuit Judges.
___________
MURPHY, Circuit Judge.
Gladys Mensing brought this failure to warn and misrepresentation case against
a number of manufacturers of Reglan and its generic form, alleging that the
medication she had taken caused her to develop tardive dyskinesia, a severe
neurological movement disorder. The manufacturers moved for summary judgment
and dismissal. The district court dismissed her claims against the generic defendants
on the basis of federal preemption and against the name brand manufacturers on the
basis that she had not taken their products. Mensing appeals, and we affirm the
judgment in favor of the name brand manufacturers but reverse as to the generic
manufacturers.
I.
In March 2001 Gladys Mensing's doctor prescribed Reglan to treat her diabetic
gastroparesis, and her pharmacist filled her prescription with its generic bioequivalent,
metoclopramide. Minn. Stat. § 151.21. After four years of ingesting metoclopramide,
Mensing developed tardive dyskinesia. Mensing sued the manufacturers and/or
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distributors of generic metoclopramide (generic defendants). Mensing's complaint
includes a variety of claims, but she has not challenged the district court's
characterization that "at the core" they all assert failure to warn. Mensing v. Wyeth,
Inc., 562 F. Supp. 2d 1056, 1058 (D.Minn. 2008). Mensing argues that despite
mounting evidence that long term metoclopramide use carries a risk of tardive
dyskinesia far greater than indicated on the label, no metoclopramide manufacturer
took steps to change the label warnings. According to her allegations,
metoclopramide manufacturers in fact promoted the drug for long term use. Although
she never ingested the name brand drug, Mensing also sued the manufacturers of
Reglan (name brand defendants) for fraud and negligent misrepresentation on the
theory that her doctor relied on Reglan's label when assessing the risks and proper use
of metoclopramide.
All defendants filed motions to dismiss or for summary judgment. The district
court granted the motions to dismiss by generic defendants Actavis Elizabeth and
Pliva and motions for summary judgment by generic defendants Teva, Wyeth, and
UDL Laboratories on the ground of federal preemption. The court concluded that
Mensing's failure to warn claims created an impermissible conflict with federal law
because they would require generic manufacturers to deviate from the name brand
drug label; they were therefore preempted. The court also granted summary judgment
to name brand defendants Schwarz and Wyeth,1 holding that they owed Mensing no
duty of care under Minnesota law because she never ingested their product.
Grants of motions to dismiss and for summary judgment are subject to de novo
review. We affirm a dismissal if, taking all the plaintiff's allegations as true, they
"state a claim to relief that is plausible on its face." Bell Atlantic Corp. v. Twombly,
550 U.S. 544, 570 (2007). On review of summary judgment, we "view the evidence
1
Wyeth manufactured both Reglan and generic metoclopramide. It joined in the
summary judgment motions of both the generic and name brand defendants.
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in the light most favorable to the nonmoving party" and affirm only when "there are
no genuine issues of material fact[.]" Takele v. Mayo Clinic, 576 F.3d 834, 838 (8th
Cir. 2009) (quotations omitted).
II.
We first address the generic defendants' argument that federal law preempts
state failure to warn claims against them. Since a purely legal issue of statutory
interpretation is raised, the generic defendants' motions for summary judgment and
dismissal will be considered together.
A.
All prescription drugs require approval by the Food and Drug Administration
(FDA) before they may be marketed. Manufacturers of new drugs submit a new drug
application (NDA) to the FDA. 21 U.S.C. § 355(a)-(b). An NDA must include
information about the drug's safety and efficiency gleaned from clinical trials. Id. at
§§ 355(b), (d). It must also propose a label reflecting appropriate use, warnings,
precautions, and adverse reactions. 21 C.F.R. § 201.56.
Recognizing a need to bring more affordable generic drugs to market as quickly
as possible after the patents of name brand drugs expire, Congress passed the Drug
Price Competition and Patent Term Restoration Act in 1984. This statute amended
the Food, Drug, and Cosmetic Act (FDCA) and is therefore referred to as the
Hatch-Waxman Amendments to the FDCA. The Hatch-Waxman Amendments
provided an abbreviated new drug application (ANDA) procedure for generic
manufacturers. 21 U.S.C. § 355(j). Generic manufacturers do not need to repeat the
clinical trials conducted by name brand manufacturers. ANDA's are approved based
on the initial safety profile of the name brand drug, as well as any postmarketing
surveillance. See Bartlett v. Mutual Pharmaceutical Co., Inc., --- F.Supp.2d ---, No.
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08-cv-358-JL, 2009 WL 3126305, at *2-*6 (D.N.H. Sept. 30, 2009) (detailing
requirements and history of ANDA procedure). As a result, ANDA applicants must
show the FDA that their drug is essentially the same as the name brand drug and that
their proposed label is in relevant part identical to the name brand drug label. 21
C.F.R. § 314.94(a)(8).
Drug labels are subject to change. New risks may become apparent only after
the drug has been used more widely and for longer periods. When a manufacturer has
"reasonable evidence of an association of a serious hazard with a drug[,]" the drug's
label must be revised; "a causal relationship need not have been proved." 21 C.F.R.
§ 201.57(e) (redesignated as 21 C.F.R. § 201.80(e) in 2006, after the conduct at issue
here). Manufacturers cannot distribute a "misbranded" drug, 21 U.S.C. §§ 331(a)-(b),
including a drug whose "labeling is false or misleading in any particular." Id. at §
352(a). The FDA has several enforcement mechanisms to ensure that drugs with
misleading labels are taken off the market. See, e.g., id. at § 333, 355(e).
There are several procedures in 21 C.F.R. § 314.70 by which a manufacturer
may supplement its application and propose changes to the drug or its label. "Major
changes" require the FDA's prior approval through a prior approval supplement. 21
C.F.R. § 314.70(b). Manufacturers may implement "moderate changes," including
changing a label to strengthen a warning based on newly acquired information,
through a Changes Being Effected (CBE) supplement. 21 C.F.R. §
314.70(c)(6)(iii)(A)-(D). Manufacturers may implement CBE changes before the
FDA formally approves them.
The FDA approved Reglan in 1980. Manufacturers began seeking approval for
generic versions of metoclopramide five years later. The generic metoclopramide
labels have always been in relevant part the same as the Reglan label. The label
warnings about tardive dyskinesia, and other similar but less severe extrapyramidal
symptoms, did not change from 1985 through the time Mensing stopped ingesting the
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drug in 2005. Mensing alleges that despite mounting evidence that long term
metoclopramide users were at a much greater risk of movement disorders than
indicated by the drug's label, no manufacturer took any step to enhance the warnings.2
Moreover, Mensing asserts that defendants promoted metoclopramide for long term
use even though the FDA had approved the drug only for use up to 12 weeks.
Acting on its own initiative pursuant to the Food and Drug Administration
Amendments Act of 2007, Pub. L. No. 110-85, 121 Stat. 823 (FDAAA), the FDA
ordered manufacturers of Reglan and generic metoclopramide on February 26, 2009
to add a boxed warning to their labels about the increased risks of tardive dyskinesia
from long term metoclopramide usage.
B.
In considering a preemption defense we must be attuned to Congressional intent
and the presumption against preemption. Wyeth v. Levine, 129 S. Ct. 1187, 1194-95
(2009) (quotation omitted) (courts must assume "that the historic police powers of the
States were not to be superseded by the Federal Act unless that was the clear and
manifest purpose of Congress."). In Wyeth, the Supreme Court ruled that failure to
warn claims against name brand manufacturers are not preempted by the FDCA. The
Court noted the historic coexistence of state tort remedies and federal regulation of
prescription drugs:
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. But despite its 1976 enactment
of an express pre-emption provision for medical devices, . . . Congress
has not enacted such a provision for prescription drugs. . . . Its silence on
2
Mensing notes that in July 2004 the FDA approved Schwarz's request to add
a sentence to the Reglan label: “Therapy should not exceed 12 weeks in duration.”
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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.
The Hatch-Waxman Amendments are part of this 70 year history and they do
not explicitly preempt suits against generic manufacturers. Congress could have
crafted a preemption provision for generic drugs in its 1984 amendments, having done
so for medical devices less than 10 years earlier. It chose not to do that. Seven in ten
prescriptions filled in this country are now for generic drugs. Susan Okie,
Multinational Medicines–Ensuring Drug Quality in an Era of Global Manufacturing,
361 New Eng. J. Med. 737, 738 (2009). After Wyeth, we must view with a
questioning mind the generic defendants' argument that Congress silently intended to
grant the manufacturers of most prescription drugs blanket immunity from state tort
liability when they market inadequately labeled products.
The generic defendants distinguish Wyeth on the ground that it concerned
claims against brand name manufacturers, but the decision carries important
implications for their situation as well. See, e.g., Wyeth, 129 S. Ct. at 1197-98 ("[I]t
has remained a central premise of federal drug regulation that the manufacturer bears
responsibility for the content of its label at all times. It is charged both with crafting
an adequate label and with ensuring that its warnings remain adequate[.]"). The
district court did not have the teachings of Wyeth available when it rendered its
decision, but courts which have subsequently considered this issue have almost
uniformly ruled that tort claims against generic manufacturers are not preempted. See,
e.g., Stacel v. Teva Pharmaceuticals, USA, 620 F. Supp. 2d 899, 906-907 (N.D. Ill.
2009); Schrock v. Wyeth, 601 F. Supp. 2d 1262, 1265-66 (W.D.Okla.2009). The
Fourth Circuit reached the same conclusion much earlier in considering whether a
plaintiff injured by a generic drug can hold a name brand manufacturer liable. Foster
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v. American Home Products Corp., 29 F.3d 165, 170 (4th Cir. 1994) ("The statutory
scheme governing premarketing approval for drugs simply does not evidence
Congressional intent to insulate generic drug manufacturers from liability for
misrepresentations made regarding their products, or to otherwise alter state products
liability law.").
Even when a federal law does not expressly preempt state law claims, a court
may find that Congress impliedly preempted such claims by "conflict" if 1)
compliance with both federal and state law is impossible, or 2) the claims would
"stand[] as an obstacle to the accomplishment and execution of the full purposes and
objectives of Congress." Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372-73
(2000) (quotation omitted). The district court concluded that each basis for conflict
preemption was present. We disagree.
C.
The Supreme Court characterized "[i]mpossibility pre-emption [as] a
demanding defense." Wyeth, 129 S. Ct. at 1199. To prevail on that defense, the
generic defendants must show that compliance with both federal law and the state
laws Mensing seeks to enforce is not merely difficult, but "a physical impossibility."
Fid. Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153 (1982) (quotation
omitted). The parties agree that generic labels must be substantively identical to the
name brand label even after they enter the market. See, e.g., 21 C.F.R. §
314.150(b)(10) (FDA may withdraw approval of a generic drug if its label is "no
longer consistent" with the name brand label); 57 Fed. Reg. at 17961, cmt. 39 (1992).
Because of this requirement, the generic manufacturers argue they are prohibited from
implementing a unilateral label change without prior FDA approval through the CBE
process. Yet, 21 C.F.R. § 314.97compels generic manufacturers to "comply with the
requirements of §[] 314.70[.]" Section 314.70 includes the CBE process and the prior
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approval supplement process.3 In this case we need not decide whether generic
manufacturers may unilaterally enhance a label warning through the CBE procedure4
because the generic defendants could have at least proposed a label change that the
FDA could receive and impose uniformly on all metoclopramide manufacturers if
approved.
The regulatory framework makes clear that a generic manufacturer must take
steps to warn its customers when it learns it may be marketing an unsafe drug.
Generic manufacturers are subject to the requirement that their labeling "shall be
revised as soon as there is reasonable evidence of an association of a serious hazard
with a drug[.]" 21 C.F.R. § 201.57(e). The generic defendants argue that they
comply with this statute by simply ensuring that their labels match the name brand
label. Mensing alleges that the Reglan manufacturers did nothing to strengthen the
label despite reasonable evidence of the drug's association with a serious hazard. In
these circumstances,§ 201.57(e) does not permit generic manufacturers passively to
accept the inadequacy of their drug's label as they market and profit from it. See
3
See supra sec. II-A for a discussion of these regulatory processes. If the
defendants were correct that generic manufacturers can use the CBE process only to
copy label changes initiated by the name brand manufacturer, it is curious that §
314.70(c) was never revised to distinguish between name brand and generic
manufacturers.
4
The district court relied heavily on two FDA statements that no longer carry
the same weight after Wyeth. In light of Wyeth, the FDA formally withdrew its
amicus briefs in Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D.Pa. 2006); aff'd
in part and rev'd in part, 521 F.3d 253 (3d Cir. 2008); vacated, 129 S. Ct. 1578 (2009).
The other FDA statement appears in a footnote in the "Supplementary Information"
section of a notice of proposed rule making for a regulation not pertaining to generic
drugs. 73 Fed. Reg. 2848, 2849 n.1 (Jan. 16, 2008) ("CBE changes are not available
for generic drugs."). Even the defendants admit that generic manufacturers can use
the CBE process, § 314.97, to copy an updated name brand label. See also Demahy
v. Wyeth, Inc., 586 F. Supp. 2d 642, 655 (E.D.La. 2008), appeal docketed, No. 08-
31204 (5th Cir. Dec. 16, 2008); Wyeth, 129 S. Ct. at 1201.
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Wyeth, 129 S. Ct. at 1202 ("The FDA has limited resources to monitor the 11,000
drugs on the market[.] . . . [M]anufacturers, not the FDA, bear primary responsibility
for their drug labeling[.]"). The statute itself empowers the FDA to withdraw approval
for a drug that is "misbranded" due to an insufficient label. 21 U.S.C. §§ 331(a)-(b),
352(a).
Interpretive commentary outside the regulations supports the requirement that
at a minimum a generic manufacturer should alert the agency to any new safety hazard
associated with its product. In commentary published contemporaneously to the
adoption of the Hatch-Waxman Amendments, the FDA stated: "After approval of an
ANDA, if an ANDA holder [a generic manufacturer] believes that new safety
information should be added, it should provide adequate supporting information to
FDA, and FDA will determine whether the labeling for the generic and listed drugs
should be revised." 57 Fed. Reg. 17950, 17961 cmt. 40 (Apr. 28, 1992) (emphasis
supplied).
Further, 21 C.F.R. § 314.98 requires that generic manufacturers follow the same
record keeping and reporting of adverse drug experiences post marketing that name
brand manufacturers must undertake. In discussing this provision, the FDA noted that
"ANDA applicants [must] submit a periodic report of adverse drug experiences even
if the ANDA applicant has not received any adverse drug experience reports or
initiated any labeling changes." 57 Fed. Rep. 17950, 17965 cmt 53 (Apr. 28, 1992)
(emphasis supplied). See also CDER, Guidance for Industry, Major, Minor, and
Telephone Amendments to Abbreviated New Drug Applications 1-3 (Dec. 2001)
(describing ANDA amendments addressing "labeling deficiencies" as "minor
amendments" that the FDA will attempt to review within 60 days).
Implicit in these comments is the FDA's expectation that generic manufacturers
will initiate label changes other than those made to mirror changes to the name brand
label and that the agency will attempt to approve such proposals quickly. The
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availability of one particular procedure (the CBE process, on which the district court
expended the majority of its discussion) is immaterial to the preemption analysis in
light of this clear directive to generic manufacturers and the availability of the prior
approval process.
Because there is nothing in the FDCA or Hatch-Waxman Amendments that
explicitly forbids them from proposing a label change through the prior approval
process, the generic defendants cite regulatory language in § 314.70 to the effect that
the prior approval procedure is for "major changes" while changes to enhance
warnings are subject to the CBE procedure. Defendants' reading of § 314.70 is too
restrictive. The section they cite establishes various methods of proposing changes
to approved drugs. The more significant the change, the more notice the FDA needs
prior to its implementation. The section repeatedly uses the nonrestrictive phrase
"[t]hese changes include, but are not limited to" in order to describe the changes
manufacturers can propose through each kind of supplement. §§ 314.70(b)(2), (c)(2),
(d)(2). Section 314.70 does not evidence an FDA policy, let alone Congressional
intent, to prevent generic manufacturers from proposing changes to a label's warning
through the prior approval process. Indeed, manufacturers are required to use the
prior approval process for "labeling changes" (with a few exceptions including
permissive use of the CBE process for warning enhancements, § 314.70(b)(2)(v)(A)).
In addition to proposing a label change, the generic manufacturers could have
suggested that the FDA send out a warning letter to health care professionals. When
the FDA first adopted its labeling regulations, well before the Hatch-Waxman
Amendments, it stated that the requirements "do not prohibit a manufacturer . . . from
warning health care professionals whenever possibly harmful adverse effects
associated with the use of the drug are discovered." 44 Fed. Reg. 37434, 37447 (June
26, 1979); see also CDER, Manual of Policies and Procedures (MAPP) 6020.10,
NDAs: “Dear Health Care Professional” Letters (July 2, 2003) (guidance document
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to name brand manufacturers stating that the letters may be ordered by the FDA or
sent by manufacturers without FDA involvement).5
The generic defendants argue that they have no duty under the FDCA to
propose stronger warnings, but the issue here is whether they have such a duty under
state law. The question before this court is whether generic defendants can both fulfill
a state law duty to warn and comply with the FDCA. Does federal law forbid them
from taking steps to warn their customers? The district court concluded that generic
drug manufacturers "may seek to add safety information to a drug label" through the
prior approval process or by requesting that the FDA send "Dear Health Care
Professional" letters, but it remained uncertain what the FDA might have done had
they proposed a label change. It therefore hesitated to impose liability based on
speculation.
Subsequently, the Supreme Court made it clear in Wyeth that uncertainty about
the FDA's response to such measures makes federal preemption less likely. "[A]bsent
clear evidence that the FDA would not have approved a change to [the drug's] label,
we will not conclude that it was impossible for [the manufacturer] to comply with
both federal and state requirements." Wyeth, 129 S. Ct. at 1198; see also Grand River
Enterprises Six Nations, Ltd. v. Beebe, 574 F.3d 929, 936 (8th Cir. 2009) ("[A]
hypothetical or potential conflict is insufficient to warrant the pre-emption of the state
5
Mensing argues that the generic defendants themselves could have warned
their customers of the risk of tardive dyskinesia through such letters. The letters are
considered regulated labeling, 21 C.F.R. §§ 202.1(1)(1), (2), and under the FDAAA,
the FDA sends the letters out on behalf of ANDA holders if it determines that such a
letter is a necessary part of a risk evaluation and mitigation strategy. 21 U.S.C. § 355-
1(i)(2). Although the FDAAA was not in effect when Mensing took metoclopramide,
it provides support for the defendants' contention that Congress did not intend that
generic manufacturers send out "Dear Healthcare Provider" letters uncoordinated with
other manufacturers of the drug.
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statute."), citing Rice v. Norman Williams Co., 458 U.S. 654, 659 (1982).6 To support
preemption the generic defendants must show the likelihood of FDA inaction. The
record contains nothing, let alone "clear evidence," to suggest the FDA would have
rejected a labeling proposal from any of them. In fact, earlier this year the FDA
mandated that metoclopramide manufacturers enhance the label's warning of the risks
of tardive dyskinesia. See Letter from Joyce Korvick, CDER (Feb. 26, 2009),
available at http://www.fda.gov/downloads/Drugs/DrugSafety/.../UCM111376.pdf.
The generic defendants attempt to minimize the significance of Wyeth by
focusing on Justice Breyer's one paragraph concurring opinion, in which he
emphasized the majority's point that an agency could preempt state law through
"lawful specific regulations[.]" Wyeth, 129 S. Ct. at 1204 (Breyer, J. concurring). The
defendants cite no regulations specifically mandating preemption like those posed as
examples in Wyeth, however. Id. at 1201, n.9. On the face of the regulations in
effect, generic manufacturers must comply with the CBE procedure and maintain
adequate warnings. 21 C.F.R. §§ 314.97, 201.57(e). As Judge William K. Sessions
6
The generic defendants argue that they would risk rescindment of their ANDA
by implementing a unilateral label change through the CBE procedure without prior
FDA approval. 21 C.F.R. § 314.150(b)(10). FDA commentary to § 314.150 makes
clear that the section's purpose is to enforce the undisputed requirement that generic
manufacturers change their label to match a name brand change. 57 Fed. Reg. 17950,
17970 cmt. 78 (Apr. 28, 1992). The issue of preemption does not rest on the
availability of the CBE procedure, and hypothetical conflicts are not favored.
In Wyeth, the Supreme Court found it "difficult to accept" that "the FDA would
bring an enforcement action against a manufacturer for strengthening a warning
pursuant to the CBE regulation." Wyeth, 129 S. Ct. at 1197. The defendants have not
cited a single instance in which the FDA even threatened an enforcement action
against a generic manufacturer for unilaterally enhancing its label warnings.
Moreover, "[t]he FDCA does not provide that a drug is misbranded simply because
the manufacturer has altered an FDA-approved label;" the misbranding provisions
focus on the accuracy of the label's substance, including the adequacy of its warnings.
Id.; see also 21 U.S.C. §§ 355(e); id. at 352.
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III has observed, Justice Breyer's concurrence "does not come close to a hint that an
unofficial FDA interpretation at odds with the plain language of a regulation will have
preemptive effect." Kellogg v. Wyeth, 612 F. Supp. 2d 437, 442 (D.Vt. 2009)
(concluding that Wyeth undermines preemption claims of generic manufacturers).
The generic defendants were not compelled to market metoclopramide. If they
realized their label was insufficient but did not believe they could even propose a label
change, they could have simply stopped selling the product. Instead, they are alleged
to have placed a drug with inadequate labeling on the market and profited from its
sales. If Mensing's injuries resulted from their failure to take steps to warn their
customers sufficiently of the risks from taking their drugs, they may be held liable.
D.
Even if compliance with state and federal law is not impossible, state claims
could still be preempted if they would obstruct the purposes and objectives of federal
law. The generic defendants argue that proposing a label change would necessitate
expensive clinical studies, thwarting the goal of the Hatch-Waxman Amendments to
bring low cost generic drugs to market quickly. Yet the FDA did not conduct its own
studies when it mandated an enhanced warning for metoclopramide. It simply
referenced studies published elsewhere. Requests for label changes must be supported
by scientific substantiation,7 but there is nothing to indicate that the information must
be acquired through a manufacturer's own clinical tests. As a matter of fact, the
Supreme Court concluded in Wyeth that multiple reports of an adverse experience
with a drug provided the scientific substantiation to justify a manufacturer's request
to change a label. Wyeth, 129 S. Ct. at 1197. Generic manufacturers are already
required to collect and report adverse drug experiences with their products. 21 C.F.R.
7
Section 314.70(c)(6)(iii)(A) addresses CBE labeling changes to strengthen
warnings; the applicable version during the period when Mensing took
metoclopramide did not specify an evidentiary standard.
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§ 314.98, referencing 21 C.F.R. § 314. 80. Mensing alleges that if the generic
manufacturers had merely taken note of the accumulation of adverse drug experiences
reports and the published medical studies about metoclopramide, they would have had
sufficient substantiation to warrant a label change.
The obligation Mensing seeks to impose upon generic manufacturers does not
obstruct the purposes and objectives of the Hatch-Waxman Amendments in any way.
On the contrary, "[f]ailure-to-warn actions," like Mensing's, "lend force to the FDCA's
premise that manufacturers, not the FDA, bear primary responsibility for their drug
labeling at all times." Wyeth, 129 S. Ct. at 1202. The generic defendants argue that
the Hatch-Waxman Amendments supply the relevant statutory framework, rather than
the whole FDCA. Yet additions to the statute like the Hatch-Waxman Amendments
must be considered part and parcel of the FDCA. These amendments provided for
cheaper, expedited approval of generic drugs, not relief from the fundamental
requirement of the FDCA that all marketed drugs remain safe. Congress and the FDA
have long viewed state tort law as complementing, not obstructing, the goals of the
FDCA. Wyeth, 129 S. Ct. at 1199-1200 (Congress "determined that widely available
state rights of action provided appropriate relief for injured [drug] consumers" and that
"state-law remedies further consumer protection by motivating manufacturers . . . to
give adequate warnings."); id. at 1197 ("[T]he statute contemplates that federal juries
will resolve most misbranding claims[.]").
"If Congress had intended to deprive injured parties of a long available form
of compensation, it surely would have expressed that intent more clearly." Bates v.
Dow Agrosciences LLC, 544 U.S. 431, 449 (2005). Like the Fourth Circuit in Foster,
29 F.3d at170, we decline to assume that Congress intended to shield from tort
liability the manufacturers of the majority of the prescription drugs consumed in this
country and leave injured parties like Mensing no legal remedy.
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III.
We turn next to Mensing's claims against the name brand manufacturers.
Traditional products liability requires a plaintiff to show that she actually consumed
the defendant's product. See, e.g., Bixler by Bixler v. Avondale Mills, 405 N.W.2d
428 (Minn. App. 1987). Although she never ingested name brand Reglan, Mensing
claims that the name brand manufacturers are liable for various common law torts
including negligent representation and fraud for misrepresenting the risks of tardive
dyskinesia associated with metoclopramide.
Mensing's theory was rejected in Foster. There, the plaintiffs argued that
"because generic drugs are required by federal law to be equivalent to their name
brand counterparts," the name brand defendant should be responsible for
representations or omissions on the generic manufacturer's label. Foster, 29 F.3d at
169. The Fourth Circuit's response was that the plaintiffs were reframing products
liability claims which they could not prove. Id. at 168. Presuming that generic
manufacturers were responsible for altering their own labels when postapproval safety
concerns arose, the court found no legal precedent to hold the name brand
manufacturers liable for injuries caused by their competitors. Id. at 170.
Subsequently, the overwhelming majority of courts considering this issue has reached
the same conclusion.8
The Minnesota Court of Appeals is one of these courts. In Flynn v. American
Home Products Corp., 627 N.W.2d 342 (Minn. App. 2001), a plaintiff like Mensing
sought to hold name brand manufacturers liable for the harm caused by ingesting a
generic equivalent. The court declined to recognize the "fraud on the FDA" claim
essentially based on the name brand defendant's misrepresentations to the FDA about
8
Thirty two courts applying the laws of at least seventeen states, according to
the defendants.
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the drug's safety, and it also rejected an alternative argument based on Minnesota tort
law. Id. at 350-52. Mensing argues that, unlike the Flynn plaintiffs, she did allege
that the name brand defendants' representations "were relied upon by her physician
when issuing the prescription." Id. at 349-50. Mensing cites only one court since
Foster to have found such a factor determinative. Conte v. Wyeth, 85 Cal. Rptr. 3d
299 (Cal. Ct. App. 2008).
Whatever the merits of Conte under California law, the Flynn court concluded
that "central" to a fraudulent misrepresentation claim under Minnesota law is "a
suppression of facts which one party is under a legal or equitable obligation to
communicate to the other, and which the other party is entitled to have communicated
to him." Flynn, 627 N.W.2d at 350 (quotations omitted). In other words, regardless
of whether her doctor relied upon the Reglan label, Mensing must show that the name
brand manufacturers owed her a duty of care. Duty is a threshold requirement for all
of the tort claims Mensing asserts.9 See, e.g., Noble Systems Corp. v. Alorica Central,
LLC, 543 F.3d 978, 985 (8th Cir. 2008) (finding that under Minnesota law negligent
misrepresentation requires the plaintiff to "prove some relationship that is sufficient
to create a duty owed by the defendant to the plaintiff").
Such a duty of care does not extend to all potential Reglan consumers.
"Minnesota common law . . . requires a stronger relationship and a direct
communication." Flynn, 627 N.W.2d at 350. Since Mensing "did not purchase or use
[the name brand defendants'] product, . . . there was no direct relationship between
9
Mensing's attempt to characterize her fraud claim as a type requiring no proof
of a duty of care is unavailing. A plaintiff claiming fraud in Minnesota must show
that the defendant intended to induce another to act in reliance on its fraudulent
statement. Specialized Tours, Inc. v. Hagen, 392 N.W.2d 520, 532 (Minn. 1986).
Mensing's relationship with the Reglan manufacturers is too attenuated, and she has
cited no Minnesota case in which the court imposed liability for fraud on a defendant
who did not intend to communicate with the plaintiff. The Reglan manufacturers
intended to communicate with their customers, not the customers of their competitors.
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them, let alone a fiduciary relationship that gave rise to a duty." Id. at 350. Mensing
focuses on the foreseeability of harm from the defendants' action. Like the Fourth
Circuit, we conclude that holding name brand manufacturers liable for harm caused
by generic manufacturers "stretch[es] the concept of foreseeability too far." Foster,
29 F.3d at 171. As for Mensing's negligent misrepresentation claim, "the Minnesota
Supreme Court has recognized negligent misrepresentation involving damages only
for pecuniary loss[.]" Flynn, 627 N.W.2d at 350, citing Smith v. Brutger Cos., 569
N.W.2d 408, 414 (Minn. 1997). We find it unlikely the Minnesota Supreme Court
would extend the doctrine to misrepresentation involving the risk of physical harm in
these circumstances. We conclude that under Minnesota law Mensing has not shown
that the name brand manufacturers owed her a duty of care necessary to trigger
liability.
IV.
In sum, we conclude that Mensing has stated a viable claim against the generic
metoclopramide manufacturers. Far from prohibiting them from taking steps to warn
their customers of new safety hazards, federal law requires such action. For the
reasons stated we reverse the judgment in favor of the generic manufacturers but
affirm the judgment as to the name brand manufacturers.
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