Eleanor Fulgenzi v. PLIVA, Inc. , 711 F.3d 578 ( 2013 )

RECOMMENDED FOR FULL-TEXT PUBLICATION
Pursuant to Sixth Circuit I.O.P. 32.1(b)
File Name: 13a0065p.06
UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
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X
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ELEANOR FULGENZI,
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Plaintiff-Appellant,
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No. 12-3504
v.
,
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Defendant-Appellee. -
PLIVA, INC.,
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Appeal from the United States District Court
for the Northern District of Ohio at Akron.
No. 5:09-cv-01767—Sara E. Lioi, District Judge.
Argued: January 16, 2013
Decided and Filed: March 13, 2013
Before: BOGGS and WHITE, Circuit Judges; and McCALLA, District Judge.*
_________________
COUNSEL
ARGUED: Louis M. Bograd, CENTER FOR CONSTITUTIONAL LITIGATION, P.C.,
Washington, D.C., for Appellant. Jeffrey F. Peck, ULMER BERNE LLP, Cincinnati,
Ohio, for Appellee. ON BRIEF: Louis M. Bograd, CENTER FOR
CONSTITUTIONAL LITIGATION, P.C., Washington, D.C., Richard W. Schulte,
BEHNKE, MARTIN & SCHULTE, LLC, Vandalia, Ohio, for Appellant. Jeffrey F.
Peck, Linda E. Maichl, Joseph P. Thomas, ULMER BERNE LLP, Cincinnati, Ohio, for
Appellee.
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OPINION
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BOGGS, Circuit Judge. This case involves a state tort suit brought by Eleanor
Fulgenzi against the generic-drug manufacturer PLIVA, Inc., for failure to adequately
*
The Honorable Jon Phipps McCalla, Chief United States District Judge for the Western District
of Tennessee, sitting by designation.
1
No. 12-3504 Fulgenzi v. PLIVA, Inc. Page 2
warn of the risks of developing tardive dyskinesia from extended treatment with
metoclopramide. The question is whether the Food, Drug, and Cosmetic Act preempts
such suits. In 2009, the Supreme Court held that with respect to branded drug
manufacturers, state failure-to-warn suits were not preempted by federal law. Wyeth v.
Levine, 555 U.S. 555 (2009). In 2011, however, the Court held that such suits could not
go forward against generic drug manufacturers, as it is impossible for them to comply
simultaneously with their state duty to adequately warn and their federal duty of
sameness (federal law requires generic drug labels to be the same as their branded
counterpart). PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011). Fulgenzi argues that her
case is different: after the branded-drug manufacturer of metoclopramide strengthened
the warnings on its label, PLIVA failed to update its label as required by federal
law—rendering compliance with both federal and state duties no longer impossible.
PLIVA argues that Mensing admits of no such exception, and alternatively that Fulgenzi
is improperly trying to bring a state tort suit premised on violation of federal law.
Fulgenzi has the stronger argument, and we reverse the decision of the district court.
I
A
For three months starting in September 2004 and for over a year from 2006 to
2007, Eleanor Fulgenzi was prescribed the generic drug metoclopramide, sold originally
under the brand name Reglan, a drug approved for short-term treatment of patients
suffering from gastroesophageal reflux disease. She now alleges that taking the drug
caused her to develop tardive dyskinesia, an often irreversible neurological disorder that
causes involuntary movements, especially of the lower face.
Metoclopramide was first approved by the Food and Drug Administration (FDA)
in 1980; five years later generic manufacturers also began to produce the drug. Over
time, evidence has mounted that long-term use of metoclopramide poses a substantial
risk of causing tardive dyskinesia, among other serious side effects. Initially, the only
disclaimer on the labeling of Reglan was: “Therapy longer than 12 weeks has not been
No. 12-3504 Fulgenzi v. PLIVA, Inc. Page 3
evaluated and cannot be recommended.” In July 2004, however, the FDA approved a
labeling change proposed by Schwarz Pharma, the manufacturer of Reglan, which stated
in bold-face type: “Therapy should not exceed 12 weeks in duration.” The new
warning appeared twice, as the first line in both the “Indications and Usage” and
“Dosage and Administration” sections of the label. The earlier disclaimer, however, was
not replaced, and remained in the dosage section for gastroesophageal reflux disease.
Apparently, PLIVA never updated its metoclopramide labeling to include the new
warning, nor communicated the change to any physicians. In February 2009, the FDA
went further and ordered a “black-box warning”—the strongest form of warning the
FDA requires—indicating the serious risk of developing tardive dyskinesia. The
warning urged avoiding treatment longer than 12 weeks “in all but rare cases where
therapeutic benefit is thought to outweigh the risk of tardive dyskinesia.”
B
Under federal law, all prescription drugs require approval of the FDA before they
can be marketed. The Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301, as
amended by the Drug Price Competition and Patent Term Restoration Act of 1984
[Hatch-Waxman Act], Pub. L. No. 98-417, 98 Stat. 1585 (1984), establishes different
approval processes for branded- and generic-drug manufacturers. Branded-drug
manufacturers must submit a New Drug Application (NDA) that demonstrates safety and
effectiveness through clinical trials, 21 U.S.C. § 355(b), (d), and provides a label to
explain the proper use and possible risks of the drug, 21 U.S.C. § 352(f)(2). Generic-
drug manufacturers, in contrast, need only submit an abbreviated NDA (ANDA) to
obtain approval. 21 U.S.C. § 355(j)(2)(A). An ANDA need only show that the generic
drug is chemically and practically the same as its branded equivalent. In addition, the
labeling must be the same as that approved for the branded drug. 21 U.S.C.
§ 355(j)(4)(G).
No. 12-3504 Fulgenzi v. PLIVA, Inc. Page 4
After initial approval of a drug, branded-drug companies may seek modification
of their labeling1 in two ways: first, through a “Prior Approval Supplement,” which
requires submission to and approval by the FDA prior to distribution of the product, and
applies to most labeling and other changes with “potential to have an adverse effect on
the identity, strength, quality, purity, or potency of the drug product,” 21 C.F.R.
§ 314.70(b), and second, through a “Changes Being Effected” (CBE) supplement, which
must be submitted 30 days before distribution, but does not require prior FDA approval.
21 C.F.R. § 314.70(c). Label changes “[t]o add or strengthen a contraindication,
warning, precaution, or adverse reaction” may be made through the CBE process.
21 C.F.R. § 314.70(c)(6)(iii)(A). Branded-drug companies, therefore, are free to update
their labeling, subject only to subsequent FDA disapproval. Wyeth, 555 U.S. at 569.
The rules apply differently to generic-drug manufacturers. Generic-drug
manufacturers must maintain labeling consistent with their branded counterpart, or else
the FDA may withdraw approval. 21 C.F.R. § 314.150(b)(10). As a result, “CBE
changes unilaterally made to strengthen a generic drug’s warning label would violate the
statutes and regulations requiring a generic drug’s label to match its brand-name
counterpart’s.” Mensing, 131 S. Ct. at 2575. A generic-drug manufacturer may only use
the CBE process to “change[] its label to match an updated brand-name label or to
follow the FDA’s instructions.” Ibid. This is the exception under which Fulgenzi argues
that her claim is not preempted. Although generic-drug manufacturers cannot strengthen
labels unilaterally, the FDA requires that they follow changes and strengthenings made
by branded-drug manufacturers.
C
On July 30, 2009, Eleanor Fulgenzi filed suit against PLIVA, Inc., and several
other pharmaceutical manufacturers, for failure to warn of the risk of developing tardive
dyskinesia, among other related claims. Since all of Fulgenzi’s prescriptions were filled
1
The FDA construes “labeling” broadly, to include not just the written label associated with the
drug, but communications with physicians and other healthcare professionals containing additional
warnings (“Dear Doctor” letters) and information published in the Physician’s Desk Reference. Mensing,
131 S. Ct. at 2576.
No. 12-3504 Fulgenzi v. PLIVA, Inc. Page 5
with generic metoclopramide, and since PLIVA was the largest generic manufacturer of
metoclopramide, the district court dismissed the other manufacturers, leaving PLIVA as
the sole defendant. After the Supreme Court’s decision in Mensing narrowed the scope
for state failure-to-warn claims against generic drug manufacturers, Fulgenzi was given
leave to amend her complaint. In her Second Amended Complaint, Fulgenzi alleged that
PLIVA’s failure to include the updated 2004 warning in its labeling was in violation of
its federal duty of sameness, and that failure to update “rendered its warnings inadequate
under Ohio law.” As Fulgenzi did not begin taking metoclopramide until September
2004, PLIVA’s label was not updated the entire time Fulgenzi was prescribed the drug.
PLIVA filed a motion to dismiss, which the district court granted in March 2012.
The district court reasoned that “regardless of how Plaintiff attempts to cast these claims,
they are at the core, failure-to-warn claims that are clearly preempted by Mensing.” In
addition, the court found that Fulgenzi’s allegations failed to state a claim under Ohio
law, since there is no private cause of action for violations of FDA regulations. The
district court also relied on the implicit holding of Smith v. Wyeth, 657 F.3d 420 (6th Cir.
2011), finding no exception to preemption for a state-law warning claim based on failure
to comply with FDA regulations. Fulgenzi now appeals her product-liability claims,
contesting the district court’s dismissal of her allegations based on the 2004 failure to
update.
II
In determining the viability of state tort claims against drug manufacturers, we
are guided by two recent decisions of the Supreme Court. In a 2009 opinion authored
by Justice Stevens, the Supreme Court held that failure-to-warn claims against branded-
drug manufacturers were not preempted by federal law, because 1) “it is not impossible
for [a branded-drug manufacturer] to comply with its state and federal law obligations”
and 2) state “common-law claims do not stand as an obstacle to the accomplishment of
Congress’ purposes in the FDCA.” Wyeth, 555 U.S. at 581. In finding no impossibility
preemption, the Court found that because the “changes being effected” (CBE) process
allowed branded-drug manufacturers to strengthen warnings without prior approval of
No. 12-3504 Fulgenzi v. PLIVA, Inc. Page 6
the FDA, compliance with both federal and state duties was not impossible. Id. at 568.
The Court did not find it significant that the FDA has authority to reject unilateral
labeling changes made pursuant to the CBE process, finding it “difficult to accept” that
the FDA would not have permitted a change to a stronger warning. Id. at 570. Without
“clear evidence that the FDA would not have approved a change,” the Court was
unwilling to find impossibility. Id. at 571. The Court also denied “purposes and
objectives” preemption, finding that the absence of an express preemption provision
“coupled with [Congress’] 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 575. The Court noted that while
Congress did include an express preemption provision for medical devices, 21 U.S.C.
§ 360k(a), no such limitation was enacted for prescription drugs. Id. at 574. Convinced
that state-law remedies furthered Congressional consumer-protection policies, the Court
rejected the argument that the FDA should be “presumed to have performed a precise
balancing of risks and benefits . . . that leaves no room for different state-law
judgments.” Id. at 575.
In 2011, the Court issued another preemption decision, with Justice
Thomas—who had concurred in Wyeth—writing the majority opinion that held failure-
to-warn suits preempted against generic drug manufacturers. Mensing, 131 S. Ct. 2567.
The Court reviewed the regulations relevant to generic drug manufacturers, finding that
because generic manufacturers have a duty of sameness, they cannot use the CBE
process to strengthen their labels unilaterally. Id. at 2575. As a result, generic
manufacturers cannot independently change their drugs’ safety labels. Ibid. In
conducting its preemption analysis, the Court explained that the “question for
‘impossibility’ [preemption] is whether the private party could independently do under
federal law what state law requires of it.” Id. at 2579. The Court distinguished the
situation in Wyeth, which it characterized as holding that “the possibility of
impossibility” (i.e., possible FDA subsequent denial) was not enough for impossibility
preemption, from the case at hand, which concerned “the possibility of possibility” (i.e.,
possible FDA prior approval). Id. at 2581 n.8. The Court did not find such conjecture
No. 12-3504 Fulgenzi v. PLIVA, Inc. Page 7
sufficient to negate impossibility. Id. at 2579. Summing up its analysis, the Court held
that “[t]o decide these cases, it is enough to hold that when a party cannot satisfy its state
duties without the Federal Government’s special permission and assistance, which is
dependent on the exercise of judgment by a federal agency, that party cannot
independently satisfy those state duties for pre-emption purposes.” Id. at 2580–81.
Contrary to PLIVA’s contention, the Court’s decision rested squarely on this
impossibility-preemption analysis and did not suggest that all suits against generic-drug
manufacturers would be preempted, especially when different regulations and duties
applied.
After Mensing, some suits against generic-drug manufacturers were summarily
dismissed, while other courts permitted certain claims to go forward. Compare Demahy
v. Schwarz Pharma., Inc., 702 F.3d 177, 186–187 (5th Cir. 2012) (design-defect claims
preempted) and In re Darvocet, Darvon and Propoxyphene Prods. Liab. Litig., 2012 WL
718618, at *4 n.8 (E.D. Ky., Mar. 5, 2012) (failure-to-update claims preempted), with
Bartlett v. Mutual Pharma. Co., 678 F.3d 30, 37–38 (1st Cir.), cert. granted, 133 S. Ct.
694 (2012) (design-defect claims not preempted) and Fisher v. Pelstring, 817 F. Supp.
2d 791, 805 (D. S.C. 2011) (failure-to-update claims not preempted). The Sixth Circuit
has dismissed one such case, explaining that “[t]he Supreme Court held unequivocally,
however, that federal law preempts state laws that impose on generic-drug manufacturers
the duty to change a drug’s label, thus barring the plaintiffs’ state-law tort claims.”
Smith v. Wyeth, Inc., 657 F.3d 420, 423 (6th Cir. 2011). Although the Smith plaintiffs
did raise the same arguments that Fulgenzi does here, they were raised only on
supplemental briefing and, from the court’s opinion, it does not appear that they were
considered. As a result, we are not controlled by Smith and are faced with a question of
first impression. Since none of the foregoing authorities are dispositive, we proceed to
conduct a preemption analysis in accord with the principles of Wyeth and Mensing.
No. 12-3504 Fulgenzi v. PLIVA, Inc. Page 8
III
A
We review the question of whether a federal statute preempts state law de novo.
State Farm Bank v. Reardon, 539 F.3d 336, 340 (6th Cir. 2008). The Supremacy Clause
provides that federal law is “the supreme Law of Land . . . any Thing in the Constitution
or Laws of any State to the Contrary notwithstanding.” U.S. Const., Art. VI, cl. 2. State
laws, therefore, may be overridden by conflicting federal laws, both expressly and
impliedly. Fidelity Fed. Sav. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 152–53
(1982). Implied preemption has been divided into “field” preemption, where
“pervasive” federal regulation “preclude[s] enforcement of state laws on the same
subject,” Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947), and “conflict”
preemption, which nullifies state law “to the extent that it actually conflicts with federal
law,” Fidelity Fed. Sav. & Loan Ass’n, 458 U.S. at 153. A state law actually conflicts
with federal law if either 1) compliance with both is impossible, Florida Lime &
Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142–43 (1963), or 2) the state requirement
is an obstacle to “the full purposes and objectives of Congress,” Hines v. Davidowitz,
312 U.S. 52, 67 (1941). In any preemption analysis, the “purpose of Congress is the
ultimate touchstone,” as discerned from the statutory language and structure of the
statute as a whole. Medtronic, Inc. v. Lohr, 518 U.S. 470, 485–86 (1996). Recognizing
federalism concerns, courts have typically applied a presumption against preemption,
especially in fields that the states have “traditionally occupied,” like health and safety.2
Id. at 485.
Courts will find impossibility preemption where it is “impossible for a private
party to comply with both state and federal requirements.” Freightliner Corp. v. Myrick,
514 U.S. 280, 287 (1995). This analysis can become difficult when applied to the
regulatory context—overlapping federal duties, ex-post and ex-ante agency approval,
2
Four members of the Mensing majority (not joined by Justice Kennedy) cast some doubt on this
presumption, arguing that the “non obstante” provision in the Supremacy Clause indicates that courts
should not distort federal law to accommodate state law. 131 S. Ct. at 2579–80.
No. 12-3504 Fulgenzi v. PLIVA, Inc. Page 9
and ambiguous regulations make the question of whether a party is acting in accord with
federal policies uncertain. In the wake of Wyeth and Mensing, however, the application
of impossibility preemption principles has become clearer. Mensing explains that the
key question is “whether the private party could independently” comply with its state
duty—without relying on the prior exercise of federal-agency discretion. 131 S.Ct. at
2579, 2580–81. Wyeth, by contrast, holds that there is no impossibility as long as the
approval comes after the independent action of the private party (especially where denial
is speculative and unlikely). 555 U.S. at 573. In our case, not only could PLIVA have
independently updated its labeling to match that of the branded manufacturer through
the CBE process, see Mensing, 131 S. Ct. at 2575, but it had a federal duty to do so,
21 C.F.R. § 314.150(b)(10). As a result, compliance with federal and state duties was
not just possible; it was required. Impossibility preemption is inappropriate in such a
case. It is true that the FDA had the authority to reject PLIVA’s labeling change after
the fact. But this is precisely the “possibility of impossibility” that Wyeth found
insufficient to warrant preemption. Indeed, as PLIVA had a clear federal duty to update
its label, it is even less likely here that the FDA would have rejected the change. This
case, therefore, presents an even weaker case for impossibility preemption than Wyeth.
We note at this point that Fulgenzi’s claims survive only to the extent PLIVA’s
actions were permitted by federal law. She cannot claim that PLIVA should have
included an aggressive black-box warning; any such allegations are preempted under
Mensing. Instead, she is left to argue only that PLIVA’s warning was inadequate to the
extent that it did not include the language contained in the updated Reglan label from
2004. This leaves her with a weaker case than if she were suing a branded-drug
manufacturer, but that is the statutory scheme provided to us by Congress. See Mensing,
131 S. Ct. at 2582.
B
We turn next to whether state tort suits against generic-drug manufacturers would
frustrate the “purposes and objectives” of Congress, and thus warrant preemption.
Hines, 312 U.S. at 67. Arguments have been made that state tort suits against generic-
No. 12-3504 Fulgenzi v. PLIVA, Inc. Page 10
drug manufacturers should be preempted by the FDCA. See Wyeth, 555 U.S. at 609(Alito, J., dissenting) (“Where the FDA determines, in accordance with its statutory
mandate, that a drug is on balance ‘safe,’ our conflict pre-emption cases prohibit any
State from countermanding that determination.”). The FDA must strike a balance
between safety and ensuring access to life-saving drugs. Buckman Co. v. Plaintiffs’
Legal Comm., 531 U.S. 341, 348 (2001); cf. Geier v. Am. Honda Motor Co., Inc., 529
U.S. 861 (2000). The FDA is an expert body, and better placed to set drug policy than
state legislatures, much less state juries in after-the-fact verdicts. Riegel v. Medtronic,
Inc., 552 U.S. 312, 315 (2008); but see Silkwood v. Kerr-McGee Corp., 464 U.S. 238(1984). Nevertheless, the reasoning of the Wyeth majority all but closes off this line of
argument. Wyeth, 555 U.S. at 573–75, 581 (“In short, Wyeth has not persuaded us that
failure-to-warn claims like Levine’s obstruct the federal regulation of drug labeling.”).
The Court concluded that at the time of the FDCA’s passage, Congress had evidently
determined that “state rights of action provided appropriate relief for injured customers.”
Id. at 574. In addition, the Court found that 70 years of Congressional failure to enact
an express preemption provision for prescription drugs—despite the enactment of an
express provision for medical devices—to be “powerful evidence” that Congress did not
intend to preempt state remedies. Id. at 574–75.
One might argue that while Wyeth’s purposes-and-objectives analysis may
control for branded drugs, the Hatch-Waxman Act sets forth different policies with
respect to generic drugs. The most easily identifiable policy is promotion of generic
drugs, and the attendant reduction in costs. See Congressional Budget Office, How
Increased Competition from Generic Drugs Has Affected Prices and Returns in the
Pharmaceutical Industry (July 1998) (identifying Hatch-Waxman Act as major factor in
dramatic rise in sales of generic drugs and the resulting savings). Permitting state tort
actions to go forward against generic-drug manufacturers, the argument goes, would
increase costs and reduce usage. However, the Mensing dissenters plausibly observed
that the inability to sue for inadequate warnings may actually reduce consumer demand.
Mensing, 131 S. Ct. at 2593. This is an empirical question, and we should not
affirmatively answer on the basis of mere speculation about Congressional purposes. Cf.
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Wyeth, 555 U.S. at 587–88 (Thomas, J., concurring) (criticizing the “freewheeling
judicial inquiry” of purposes-and-objectives preemption).
It is enough to resolve the question here that nothing in the text or structure of
the Hatch-Waxman Act evidences an intent to achieve such savings at the cost of safety,
effectiveness, or consumer protection. Instead, the abbreviated approval process created
by the Act is premised on the duty of sameness, which ensures that generic drugs are of
the same safety and effectiveness as their branded counterparts. Since 1962, the FDCA
has required that all new drugs—both generic and branded—be shown safe and effective
before being marketed. Kefauver-Harris Amendments, Pub. L. No. 87-781, 76 Stat. 780(1962). The Hatch-Waxman Act did not change this requirement; it simply recognized
that conducting new human clinical trials for generic drugs was “unnecessary and
wasteful” where demonstrating sameness was enough to show the drug to be “safe and
effective.” See H.R. Rep. 98-857, pt. 1, at 16 (1984), reprinted in 1984 U.S.C.C.A.N.
2647, 2649. The Hatch-Waxman Act’s cost savings, therefore, were accomplished
without comprising the FDCA’s core safety policies. Here, it is uncontested that
PLIVA’s failure to update was in violation of its federal duty of sameness, and thus
federal safety and effectiveness policies. Further, the duty of sameness does not involve
the delicate balancing that other regulatory decisions (e.g., whether a life-saving but
dangerous drug should be approved for marketing) require the FDA to make. It is hard
to see how permitting state tort suits to go forward against sameness-violating generic
defendants frustrates federal policies where permitting suits against FDA-compliant
branded defendants does not. Wyeth, 555 U.S. at 573–75. A vague policy of
encouraging use of generic drugs, untethered from the structure of the Act, is not enough
to support purposes-and-objectives preemption. We hold therefore that state laws that
provide damages for inadequate warnings in violation of the federal duty of sameness
do not conflict with federal drug policy, with respect to purposes-and-objectives
preemption.
No. 12-3504 Fulgenzi v. PLIVA, Inc. Page 12
IV
A
Although PLIVA’s violation of its federal duty of sameness defeats its
impossibility-preemption arguments, the result of this violation does raise concerns that
Fulgenzi is simply attempting to enforce a federal-law violation through state litigation.
Where, as here, the statute specifically excludes a private cause of action, 21 U.S.C.
§ 337(a), state tort suits premised on violations of federal law may be impliedly
preempted, since they deprive the agency of the ability to use its enforcement authority
to achieve a delicate balance of statutory objectives. Buckman, 531 U.S. at 348.3 Where
the claim is based on traditional state-tort-law principles, the lack of a private cause of
action within a federal regulatory scheme will not preempt the claim for damages (even
if state regulations might be preempted). Silkwood, 464 U.S. at 249. But if the claims
“exist solely by virtue of” the regulatory scheme, they are preempted. Buckman,
531 U.S. at 353 (finding “fraud-on-the-FDA” claim preempted). If nevertheless there
are independent, pre-existing state law causes of action that parallel federal safety
requirements, the suit is not preempted. Medtronic v. Lohr, 518 U.S. at 481; see also
Riegel, 552 U.S. at 330 (“[The express preemption provision in the Medical Device
Amendments to the FDCA] does not prevent a State from providing a damages remedy
for claims premised on a violation of FDA regulations; the state duties in such a case
‘parallel,’ rather than add to, federal requirements.”).4 Here, Fulgenzi’s suit is not even
premised on violation of federal law, but rather on an independent state duty. The
alleged breach arises from the same act, but the legal basis is different. This is simply
not grounds for preemption. The federal duty of sameness is not “a critical element” in
3
Buckman distinguished its “fraud-on-the-agency” claim from “situations implicating ‘federalism
concerns and the historic primacy of state regulation of matters of health and safety,’” which instead
warrant a presumption against preemption. Buckman, 531 U.S. at 348. We should be cautious, therefore,
in extending the reasoning of Buckman to claims to which the presumption applies, such as the traditional
state-tort-law claims at issue here. See Bausch v. Stryker Corp., 630 F.3d 546, 557 (7th Cir. 2010).
4
Lohr and Riegel are both express-preemption cases, dealing with the express preemption
provision of the Medical Device Amendments to the FDCA. 21 U.S.C. § 360k. Here, there is no express
preemption provision, so a more relaxed standard than set out in those cases is appropriate. It is
unnecessary for us to define the precise contours of this standard, since Fulgenzi’s claim comfortably
conforms with the “parallel”-claim principle identified in Lohr and Riegel.
No. 12-3504 Fulgenzi v. PLIVA, Inc. Page 13
Fulgenzi’s case. Buckman, 531 U.S. at 353. Failure to update from one adequate
warning to another would violate the FDCA, but not Ohio law. Her suit instead relies
upon the adequacy of the warnings and the causation of her injuries. The theory of her
case would work equally well against a branded-drug manufacturer, or a generic-drug
manufacturer whose branded counterpart had not updated its warning (of course, under
Mensing the second case would be preempted under an impossibility theory). Fulgenzi’s
claim, therefore, is not preempted under Buckman.
B
PLIVA makes a similar argument that Fulgenzi has failed to state a claim under
Ohio law, since “Ohio law does not require the manufacturer of a generic drug product
to update its labeling to match the branded equivalent.” Appellee Br. at 28. This
misstates Fulgenzi’s claim. PLIVA’s violation of the federal duty of sameness is
essential to her case—but only to avoid preemption under Mensing. On the merits,
whether PLIVA has violated its federal duties is irrelevant to the adequacy of its
warnings. A jury need not know about the duty of sameness at all to determine whether
the warning label used by PLIVA in 2004 and 2006 was inadequate, and whether the
failure to include the updated warning was a proximate cause of Fulgenzi’s injuries.5
PLIVA also tries to argue that there is no such thing as a “failure-to-
inadequately-warn” claim under Ohio law. Appellee Br. at 30. To start, Fulgenzi’s
complaint does not have to be read as asserting such a claim. While her allegation that
any warning short of the FDA’s 2009 “black-box” warning was unreasonable is
preempted, she is free to argue in the alternative that any label lacking Reglan’s 2004
updated warning was inadequate. Further, there is nothing in the Ohio product-liability
law inconsistent with a claim that a defendant failed to warn, even inadequately. In a
failure-to-warn case, the plaintiff must show that “[t]he manufacturer failed to provide
the warning or instruction that a manufacturer exercising reasonable care would have
provided.” Ohio Rev. Code § 2307.76. Since Fulgenzi alleges that the non-updated
5
As will be discussed in Part IV.C infra, evidence of such duty might be admissible, but is not
a necessary element of Fulgenzi’s claim.
No. 12-3504 Fulgenzi v. PLIVA, Inc. Page 14
warning used by PLIVA in 2004 does not meet the standard of reasonable care, this
element is satisfied. Fulgenzi must also demonstrate proximate causation, specifically,
“whether lack of adequate warnings contributed to the plaintiff’s [use of the product].”
Seley v. G. D. Searle & Co., 423 N.E.2d 831 (Ohio 1981). It may well be more difficult
to prove proximate causation in a case where the warning that the defendant failed to
provide was also legally inadequate. But there is no reason to believe that a severely
inadequate warning would never cause an injury that a moderately inadequate warning
would have prevented. A plaintiff need not prove that the alternative warning would
have been objectively reasonable, only that it would most likely have prevented the
injury in this case.
Thus Fulgenzi does not fail to properly state a claim. Fulgenzi alleges that
PLIVA’s use of the old warning (“Therapy longer than 12 weeks has not been evaluated
and cannot be recommended.”) instead of adding the updated one (“Therapy should not
exceed 12 weeks in duration.”) was unreasonable, and the proximate cause of her
injuries. At the motion-to-dismiss stage, it is sufficiently plausible that the use of a
neutral warning disavowing approval instead of a bold-faced warning affirmatively
discouraging long-term use proximately caused Fulgenzi’s injury. Whether in fact these
allegations are true is a matter for further proceedings.
C
There is one final point to emphasize. Although Fulgenzi’s claims are not
preempted, they must pass through the “narrow gap” between Mensing and Buckman,
and will be constrained as a result. Cf. In re Medtronic, Inc., Sprint Fidelis Leads Prods.
Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010). The arguments she makes, the proofs
she offers, and the evidence she submits are all subject to limitation by preemption
principles. Under Mensing, Fulgenzi’s claims are viable only to the extent PLIVA’s
actions were permitted by federal law. Thus she must argue that PLIVA should have
included the language contained in the updated Reglan label by soon after July 2004, and
that the failure to include that language proximately caused her injuries.
No. 12-3504 Fulgenzi v. PLIVA, Inc. Page 15
On the facts of this case, Buckman does not necessitate similar narrowing of
Fulgenzi’s claims. Buckman only applies where a link in the causal chain or element of
the claim is premised on a federal-law violation and not in all circumstances. See Garcia
v. Wyeth-Ayerst Labs., 385 F.3d 961, 966 (6th Cir. 2004) (fraud exception to state-law
immunity for FDA-approved drugs not preempted, as long as the FDA itself determined
that fraud occurred); see also Stengel v. Medtronic Inc., 704 F.3d 1224, 1234 (9th Cir.
2013) (en banc) (claim premised on failure to warn the FDA not preempted). Here, as
discussed supra Part IV.A, the federal duty of sameness is not essential to Fulgenzi’s
claim. Thus there is no “partial” preemption, unlike in Mensing.
Nevertheless, the logic of Buckman would encourage exclusion of evidence of
federal-law violations where possible. See Bouchard v. Am. Home Prods. Corp., 213 F.
Supp. 2d 802, 811–12 (N.D. Ohio 2002) (excluding evidence of fraud on the FDA if
offered only to show FDA was misled, and also to prevent confusion of the jury as to the
nature of the claims). Unless federal law bears on the state duty of care, evidence of
such law is inadmissible. If such evidence is relevant, however, Buckman is no bar to
its admission. Thus courts have found that, as long as authorized by state law,
negligence per se suits premised on violation of federal law could go forward. See
Howard v. Sulzer Orthopedics, Inc., 382 F. App’x 436, 442 (6th Cir. 2010) (negligence
per se claim for failure to follow federal “Good Manufacturing Practices” not
preempted); see also Hughes v. Boston Scientific Corp., 631 F.3d 762, 771–72 (5th Cir.
2011) (negligence per se claim for failure to warn not preempted). Although federal-law
violations here are not as relevant as they would be in a negligence per se case,
references to federal law will inevitably arise. To avoid Mensing preemption, Fulgenzi
must use the language of the 2004 FDA-approved label in her proximate-cause
argument, not (or not merely) the fact of the failure to update. Federal standards are also
likely to arise in determining the adequacy of PLIVA’s warning, since FDA approval
and industry practices may be relevant to the state duty of care.
No. 12-3504 Fulgenzi v. PLIVA, Inc. Page 16
V
For the foregoing reasons, the decision of the district court with respect to
Fulgenzi’s failure-to-warn claim is REVERSED and REMANDED.