RECOMMENDED FOR FULL-TEXT PUBLICATION
Pursuant to Sixth Circuit Rule 206
File Name: 10a0250p.06
UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
_________________
X
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OLIVER WIMBUSH, Individually and as
Plaintiff-Appellant, --
Executor of the Estate of Mary Buchanan,
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No. 09-3380
,
>
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v.
WYETH; WYETH-AYERST LABS. CO.; WYETH -
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PHARM., INC.; WYETH PHARM.,
Defendants-Appellees. N
Appeal from the United States District Court
for the Northern District of Ohio at Cleveland.
No. 03-02042—Solomon Oliver, Jr., Chief District Judge.
Argued: January 13, 2010
Decided and Filed: August 18, 2010
Before: MARTIN, BOGGS, and WHITE, Circuit Judges.
_________________
COUNSEL
ARGUED: Paul W. Flowers, PAUL W. FLOWERS CO., L.P.A., for Appellant.
George E. McDavid, REED SMITH LLP, Princeton, New Jersey, for Appellees.
ON BRIEF: Paul W. Flowers, PAUL W. FLOWERS CO., L.P.A., Benjamin H.
Anderson, ANDERSON LAW OFFICE, L.L.C., Cleveland, Ohio, for Appellant. George
E. McDavid, Eric L. Alexander, REED SMITH LLP, Princeton, New Jersey, David R.
Cooper, COOPER & WALINSKI, Toledo, Ohio, M. Sean Laane, ARNOLD & PORTER
LLP, Washington, D.C., for Appellees.
MARTIN, J., delivered the opinion of the court, in which BOGGS, J., joined.
WHITE, J. (pp. 20-22), delivered a separate opinion concurring in part and dissenting
in part.
1
No. 09-3380 Wimbush v. Wyeth, et al. Page 2
_________________
OPINION
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BOYCE F. MARTIN, JR., Circuit Judge. Mary Buchanan sued Wyeth, a
publicly-held corporation, Wyeth Pharmaceuticals, an unincorporated division of Wyeth,
and Wyeth-Ayerst Laboratories Company and Wyeth Pharmaceuticals, Inc., wholly-
owned subsidiaries of Wyeth, regarding a diet pill, Redux, that the companies
manufactured and sold. Buchanan’s claims sound primarily in strict liability and
common law negligence. Buchanan appeals the district court’s entry of summary
judgment for Wyeth on all of her claims. Relatedly, Buchanan requests a finding that
the district court abused its discretion in denying her Motion to Alter and Amend
Judgment and that the final judgment be reversed.
For the reasons set forth below, we REVERSE the judgment of the district court
finding that approval of Redux by the Food and Drug Administration (FDA) preempted
Buchanan’s negligence claims taking issue with Wyeth’s actions before FDA approval,
as well as the district court’s related dismissal of Buchanan’s request for punitive
damages, and REMAND those issues back to the district court. We AFFIRM the
judgment of the district court on all other claims.
I.
Buchanan alleged that she was prescribed and that she ingested Redux for several
months during 1996 and 1997 in order to control her weight. After her November 2001
diagnosis with primary pulmonary hypertension,1 she filed a complaint against Wyeth
in the United States District Court for the Northern District of Ohio on October 2, 2003.
She died December 18, 2003, allegedly as a result of having taken Redux.
1
Pulmonary hypertension is characterized by an abnormally high blood pressure in the arteries
of the lungs, which forces the right side of the heart to work harder than normal. There is no
known cure. See Pulmonary Hypertension, Medline Plus Medical Encyclopedia, a service of the
U.S. National Library of Medicine and the National Institutes of Health,
http://www.nlm.nih.gov/medlineplus/ency/article/000112.htm.
No. 09-3380 Wimbush v. Wyeth, et al. Page 3
Wyeth marketed and sold Redux after its approval by the FDA in April 1996.
Redux became available in June 1996 and was taken off the market on September 15,
1997. While Wyeth sold Redux to the public, it provided several warnings regarding the
health risks associated with ingesting Redux. In April 1996, Wyeth sent health
professionals a letter stating that “a small risk of a serious, potentially life-threatening
cardiovascular condition, primary pulmonary hypertension (PPH)” was “associated with
the use of all types of prescription weight loss drugs. This risk is . . . about 18 cases per
1,000,000 users per year.” On the first Redux label, the warning about PPH was written
in all bold typeface and contained the information above.
Wyeth provided a second warning letter to physicians in August 1996, which
explained that a final report of clinical studies indicated that the risk of PPH was greater
than previously stated and that “the risk of PPH [is] calculated to be about 23 times
higher for patients using anorexigens for three or more months compared to non-users.”
It further warned that “PPH is a serious disorder with an estimated 4-year mortality rate
of 45%” and warned doctors that patients experiencing symptoms should immediately
discontinue their use of Redux.
New labels were sent to health-care professionals in December 1996 along with
a third letter reporting changes made to the label. The letter stated that “Redux . . .
increase[s] the risk of developing primary pulminory hypertension, an often fatal
disorder.” The new labels provided updated information regarding the increased risk
of PPH reflected by new studies in boldface capitalized letters.
Buchanan’s2 amended complaint, filed on January 22, 2007, stated claims for:
(1) strict product liability encompassing both design defect pursuant to O.R.C. § 2307.75
and failure to warn pursuant to O.R.C. § 2307.76; (2) common-law negligence; and
(3) wrongful death pursuant to O.R.C. § 2125.01, et. seq. Buchanan also sought
economic, non-economic, and punitive damages pursuant to O.R.C. § 2307.80(C). She
2
This case was originally filed by Mary Buchanan, whose estate, upon her death, was represented
first by Romona Longs and then Oliver Wimbush. For consistency purposes, we refer to plaintiff as
“Buchanan.”
No. 09-3380 Wimbush v. Wyeth, et al. Page 4
later withdrew her claims for failure to warn, pursuing only a strict product liability
design defect claim, negligence claims, and punitive damages.
Wyeth filed three separate motions for partial summary judgment on
September 21, 2007: one based on federal preemption; one arguing lack of evidence of
proximate causation; and one related to punitive damages. Oral arguments were held on
January 17, 2008.
On February 28, 2008, the district court granted summary judgment in favor of
Wyeth on all claims. Longs v. Wyeth (Longs I), 536 F. Supp. 2d 843 (N.D. Ohio 2008).
The court found that Buchanan’s strict liability and negligence claims relating to
Wyeth’s conduct prior to the FDA’s approval of Redux for placement on the market
were preempted by the FDA’s subsequent approval of the drug and that any post-FDA-
approval claims, which were not preempted, failed on their merits. As relevant to this
appeal, the court further held that: (1) Buchanan’s strict liability design defect claim
failed because Buchanan failed to provide evidence refuting Wyeth’s showing that the
Redux warnings were adequate as a matter of law; (2) Buchanan’s negligence claims
failed because Buchanan did not provide evidence of proximate causation; and (3) the
request for punitive damages was moot because, as a result of the dismissal of all of the
substantive claims, Buchanan could not establish liability under any theory for which she
could be entitled to any damages, much less punitive damages. As a result of these
holdings, the district court dismissed the case.
On March 10, 2008, Buchanan moved to vacate the order and judgment and to
alter the judgment. Buchanan argued that: (1) her pre-FDA-approval claims were not
preempted in light of the Supreme Court’s intervening decision in Wyeth v. Levine, __
U.S.__, 129 S. Ct. 1187 (2009); (2) Wyeth bore the burden of proving that its warnings
were adequate rather than Buchanan bearing the burden of proving the warnings
inadequate; (3) Wyeth did not properly raise the argument that Buchanan lacked
evidence showing the inadequacy of Wyeth’s warnings with regard to Buchanan’s
design defect claim; and (4) Wyeth did not properly raise the issue that Buchanan lacked
evidence of proximate causation in regard to her negligence claim. The court denied
No. 09-3380 Wimbush v. Wyeth, et al. Page 5
Buchanan’s motion on March 20, 2009. Longs v. Wyeth (Longs II), 621 F. Supp. 2d 504
(N.D. Ohio 2009). Buchanan timely appealed.
II.
Buchanan appeals the district court’s summary judgment order as well as the
order denying her motion to vacate and alter judgment.
A. Standard of Review
“The Sixth Circuit reviews de novo a district court’s grant of summary
judgment.” Hamilton v. Starcom Mediavest Group, Inc., 522 F.3d 623, 627 (6th Cir.
2008) (citing Hardesty v. Hamburg Twp., 461 F.3d 646, 650 (6th Cir. 2006)).
“Summary judgment is proper where no genuine issue of material fact exists and the
moving party is entitled to judgment as a matter of law.” Id. (citing Fed. R. Civ. P.
56(c)). “The moving party has the initial burden of proving that no genuine issue of
material fact exists,” Vaughn v. Lawrenceburg Power Sys., 269 F.3d 703, 710 (6th Cir.
2001) (citing Street v. J.C. Bradford & Co., 886 F.2d 1472, 1477 (6th Cir. 1989)), and
the court must draw all reasonable inferences in the light most favorable to the
nonmoving party. Id. (citing City Mgmt. Corp. v. U.S. Chemical Co., 43 F.3d 244, 250
(6th Cir. 1994)). When a motion for summary judgment is properly made and supported
and the nonmoving party fails to respond with a showing sufficient to establish an
essential element of its case, summary judgment is appropriate. See Celotex Corp. v.
Catrett, 477 U.S. 317, 322-23 (1986); see also Street, 886 F.2d at 1479-80.
In Ohio, three basic theories of liability exist “under which a claimant may assert
a product liability action: (1) under the Ohio Product Liability Act; (2) negligence; and
(3) breach of warranty.” Christopher M. Ernst, et al., Baldwin’s Ohio Practice, Ohio
Tort Law, § 6.1 (2009). We will address Buchanan’s design defect claim under the Ohio
Product Liability Act and her common law theories of negligence first, and then address
the district court’s preemption ruling.
No. 09-3380 Wimbush v. Wyeth, et al. Page 6
B. Strict Liability Claims
Strict liability for manufacturers and suppliers is codified by the Ohio Products
Liability Act, O.R.C. §§ 2307.71-2307.80, effective January 5, 1988. Recent
amendments to the Act provide that the legislature intended the Act to abrogate all
common law product liability causes of action. See O.R.C. § 2307.71(B), effective April
7, 2005. Buchanan initially brought strict liability claims for design defect and failure
to warn, though she subsequently dropped the failure-to-warn claim. But, dropping the
failure-to-warn claim did not render the warnings irrelevant.
According to Ohio law, so long as adequate warning has been provided for a
pharmaceutical product, then the manufacturer cannot be strictly liable for design defect
under Ohio law, regardless of whether there is a causal connection between the
plaintiff’s use of the drug and the plaintiff’s injury or whether the product was
unavoidably dangerous. Frey v. Novartis Pharm. Corp., 642 F. Supp. 2d 787, 794 (S.D.
Ohio 2009) (citing Seley v. G.D. Searle & Co., 432 N.E.2d 831 (1981)). This is because
the common law “learned intermediary doctrine” is codified in the Act:
An ethical drug is not defective due to inadequate warning or instruction
if its manufacturer provides otherwise adequate warning and instruction
to the physician or other legally authorized person who prescribes or
dispenses that ethical drug for a claimant in question and if the federal
food and drug administration has not provided that warning or instruction
relative to that ethical drug is to be given directly to the ultimate user of
it.
O.R.C. § 2307.76(C); see also Meridia Prods. Liab. Litig. v. Abbott Labs., 447 F.3d 861,
867 (6th Cir. 2006) (explaining that, in a case involving a drug prescribed by a
physician, the learned intermediary doctrine provides that the adequacy of a product’s
warning is based on “whether the doctor, rather than the patient, would reasonably
understand the risks”).
The parties disagree as to which party carries the burden of proof regarding the
adequacy of warnings in a design defect claim under O.R.C. § 2307.75(D). Buchanan
contends that, as is the case under the common law, adequacy of warning is an
No. 09-3380 Wimbush v. Wyeth, et al. Page 7
affirmative defense on which the defendant carries the initial burden of proof and the
plaintiff carries only a burden to produce rebutting evidence. Wyeth, on the other hand,
claims that the text of section 2307.75(D) makes the inadequacy of warnings an element
of the prima facie claim for design defect, so the plaintiff carries the initial burden of
proof and the defendant carries only a burden to produce rebutting evidence. After
considering the authorities, the district court found that the plaintiff bears the burden of
proving inadequate warnings in a design defect claim under the Ohio Products Liability
Act. Longs I, 536 F. Supp. 2d at 851. We need not pass upon3 this question as,
regardless of whether Buchanan or Wyeth carries an affirmative burden of proof or
merely a burden of producing rebutting evidence on the question of warning adequacy,
Wyeth has met its burden and Buchanan has not.
Wyeth contended at summary judgment that Buchanan’s strict liability design
defect claim failed because Wyeth had provided adequate warnings to Buchanan’s
physician about the risks of Redux as information became available, thus qualifying for
protection under O.R.C. § 2307.75(D)’s codification of the learned intermediary
doctrine. Wyeth submitted voluminous evidence in support of this argument with its
motion for summary judgment. Wyeth presented substantial evidence that it had
distributed information regarding risks to doctors, including Buchanan’s physician, and
that those warnings were adequate to inform a physician of the known risks associated
with Redux.
In response, Buchanan did not specifically point to any evidence in the record
that would contradict Wyeth’s evidence, such as expert reports opining that the warnings
were inadequate to inform a physician of the true risks of the drug. As the district court
summarized, and as is supported by the record, Buchanan did “not put forward any
evidence that Defendants did not take appropriate steps in providing adequate warnings
3
Because it is neither necessary for us to decide who has the burden regarding adequacy of
warnings under O.R.C. § 2307.75(D), nor was it ultimately necessary for the district court to decide, and
because the question presents an important issue of the interpretation of the Ohio code, we believe it to be
a question best answered by the Ohio state courts without the weight of a federal decision unnecessarily
tilting the scales one way or the other. Accordingly, the portion of Longs I, 536 F. Supp. 2d at 851, that
holds that the plaintiff bears the burden of proving the inadequacy of a warning under section 2307.759(D)
is vacated as moot.
No. 09-3380 Wimbush v. Wyeth, et al. Page 8
about Redux, that Defendants should have taken Redux off the market sooner, or that
Defendants’ alleged failure to take Redux off the market sooner proximately caused
Buchanan’s injury and/or death.” Id. at 856. Instead, Buchanan argued the law,
insisting that adequacy of warning was a jury question because Wyeth bore the burden
of proof on the issue.
But this argument misses the point as, even if Buchanan is correct and adequacy
of warnings is an affirmative defense for which Wyeth bears the initial and ultimate
burden, summary judgment is available on affirmative defenses. E.g., Thornton v. Fed.
Express Corp., 530 F.3d 451, 457-58 (6th Cir. 2008). Thus, even under Buchanan’s
interpretation of section 2307.75(D), Wyeth met its burden at summary judgment of
providing evidence that its warnings were adequate, at which point it became
Buchanan’s burden to point to evidence creating a genuine issue of fact as to the
adequacy of the warnings. For whatever reason, Buchanan did not point to any such
evidence.4 When responding to a summary judgment motion with legal argument
instead of factual rebuttal, a litigant takes the ever-present risk that she is wrong on the
law, leaving her with no factual safety net. Because she failed to point to any evidence
creating a factual dispute as to the adequacy of warning, the strict liability design defect
claim under the Ohio Products Liability Act fails as a matter of law. Thus, it was proper
to grant Wyeth’s motion for summary judgment on this claim.
4
The most that Buchanan may point to as far as rebutting evidence is a large packet of evidence
attached to her response to Wyeth’s partial summary judgment motion regarding punitive damages. This
evidence was not attached to her brief responding to Wyeth’s merits argument, nor was it cross-referenced
in that brief. Instead, Buchanan suggests that the fact that the evidence was in the record somewhere is
sufficient to create a question of fact and survive summary judgment. This is simply incorrect. Even if
the evidence to which Buchanan now refers was sufficient to rebut Wyeth’s evidence of adequate warning,
it was Buchanan’s job to point to the evidence with specificity and particularity in the relevant brief rather
than just dropping a pile of paper on the district judge’s desk and expecting him to sort it out. As we have
previously noted, it is not the district court’s duty “to search the entire record to establish that it is bereft
of a genuine issue of material fact.” Street, 886 F.2d at 1480-81. The non-moving party must present
affirmative evidence on critical issues sufficient to allow a jury to return a verdict in its favor. Id. at 1476-
77. Here, as Buchanan did not adequately present evidence demonstrating a genuine issue of material fact
as to the issue of adequacy of warning, the district court did not err in granting Wyeth’s motion for
summary judgment on this issue.
No. 09-3380 Wimbush v. Wyeth, et al. Page 9
C. Negligence Claims
Because Buchanan dismissed her failure-to-warn claims and cannot show that
Wyeth is strictly liable for defective design under the Act, her only remaining claims are
for negligence and for punitive damages.
1. State Law Abrogation
We first address whether Buchanan may bring her claims under common law
negligence theories at all or whether Ohio has abrogated by statute all common law
products liability claims. The Ohio Products Liability Act defines a statutory product
liability claim. O.R.C. § 2307.71(M). In addressing whether passage of the Act
abrogated common law negligence claims, the Ohio Supreme Court in Carrel v. Allied
Prod. Corp., 677 N.E.2d 795 (Ohio 1997), held that “in the absence of language clearly
showing the intention to supersede the common law, the existing common law is not
affected by the statute . . .” and that, therefore, the statute did not abolish “common-law
actions sounding in negligence.” Id. at 798-99. In an amendment to the Act effective
April 7, 2005, however, the Ohio General Assembly explicitly eliminated “all common
law product liability claims or causes of action.” O.R.C. § 2307.71(B). Buchanan’s
claims were brought prior to the passage of this amendment, so her common law
negligence claims would be abrogated only if the amendment applied retroactively. See
Miles v. Raymond Corp., 612 F. Supp. 2d 913, 920 (N.D. Ohio 2009).
Since the amendment came into effect, at least three decisions of the Ohio Court
of Appeals have held that the amendment is not retroactive, meaning that Buchanan’s
claims would not be abrogated. See Doty v. Fellhauer Elec., Inc., 888 N.E.2d 1138,
1142 (Ohio Ct. App. 2008); Luthman v. Minster Supply Co., No. 2-06-43, 2008 WL
169999, at *3 (Ohio Ct. App. Jan. 22, 2008) (unpublished); Hertzfeld v. Hayward Pool
Prods., Inc., No. L-07-1168, 2007 WL 4563446, at *9 (Ohio. Ct. App. Dec. 31, 2007)
(unpublished) (all holding that the amendments applied only prospectively and did not
apply retroactively). The Doty court also noted that “statutory-construction rules dictate
that a statute is presumed to be prospective” and that, although the amendment “clearly
No. 09-3380 Wimbush v. Wyeth, et al. Page 10
states the intent to abrogate all common-law product-liability claims, it does not provide
that causes of action accruing prior to the effective date would be subject to the
amendment.” Doty, 888 N.E.2d at 1142. The court therefore held that the amendment
did not apply retroactively. Id.
Buchanan filed her original complaint in 2003, well after the Act was enacted but
before the 2005 amendment expressly abrogated all common law product liability
claims. Thus, her negligence claims survive the enactment of the Ohio Products
Liability Act and the 2005 amendment and are not abrogated.5
2. Merits of the Negligence Claim
The nature of Buchanan’s negligence claim is unclear. Her Amended Complaint
states that Wyeth had a duty
to manufacture, promote, and sell only safe drugs, and the duty to
investigate and disclose material facts about risks associated with their
drugs. Defendants breached their duty by . . . putting Redux on the
market in 1996, when Defendants knew the active ingredient in th[is]
drug[], namely, dexfenfluramine, was unreasonably dangerous.
Defendants further breached their duty by . . . failing to update the
drug[’s] labels, failing to adequately monitor the effects of the drug[],
failing to make timely . . . warning to the medical profession, failing to
timely and accurately report to the FDA all adverse drug experience
5
This finding conflicts with a previous Sixth Circuit ruling on this issue. We previously “applied
OPLA to product liability negligence claims [arising before the 2005 amendment of OPLA] and [have]
therefore implicitly concluded that common law negligence claims have been preempted by OPLA.”
Tompkin v. Am. Brands, 219 F.3d 566, 575 (2000) (citing Amendola v. R.J. Reynolds Tobacco Co., No.
98-4506, 1999 WL 1111515 , at *2 (6th Cir. Nov. 24, 1999)) (holding that a plaintiff’s negligent
misrepresentation and negligent infliction of emotional distress claims are governed by the Ohio Products
Liability Act).
Typically, “[w]ithout taking a case en banc, a panel cannot reconsider a prior published case that
interpreted state law, absent an indication by the state courts that they would have decided the prior case
differently.” Rutherford v. Columbia Gas, 575 F.3d 616, 619 (6th Cir. 2009) (internal citations, quotations,
brackets omitted). Plainly stated, we are “bound by a prior published case that interpreted Ohio law unless
Ohio law has measurably changed in the meantime.” Id. (brakets omitted). Although the district court’s
order in this case was issued prior to the Ohio Court of Apeals’s decision in Doty, and thus the court did
not have the benefit of the only published state appellate court case, we “must give an intervening state
decision its full force and effect, despite the fact that the decision was unavailable to the district court at
the time it rendered its decision.” Chandler v. Specialty Tires of Am. (Tenn.) Inc., 283 F.3d 818, 823 (6th
Cir. 2002) (quoting Siegler v. IBM H08 Mktg., Inc., 249 F.3d 509, 518 (6th Cir. 2001)). We therefore find
that, although the Ohio Supreme Court has not yet spoken on the issue, the Ohio appellate courts’ decisions
provide the best indication of how the Ohio Supreme Court would rule on this issue and thus present such
a measurable change in state law that reconsideration of our precedents is justified. Thus, Tompkin and
Amendola are overruled to the extent that they provide that Ohio common law negligence claims arising
prior to the 2005 amendment of the Ohio Products Liability Act are abrogated by the Act.
No. 09-3380 Wimbush v. Wyeth, et al. Page 11
information obtained, and concealing and misrepresenting the results of
studies to physicians and to the public.
Longs I, 536 F. Supp. at 854 (reproducing Buchanan’s Amended Complaint verbatim).
The district court noted that at oral argument Buchanan characterized her negligence
claim as attacking (1) Wyeth’s alleged failure to investigate, prior to FDA approval, the
early warning signs that led to the drug being taken off the market and (2) Wyeth’s
failure to take the drug off the market sooner. Id. at 855. We take this to mean that
Buchanan’s negligence claims may be divided into two general categories: (1) claims
regarding Wyeth’s acts and omissions, prior to the FDA’s approval, in bringing the drug
to market and (2) claims regarding Wyeth’s acts and omissions subsequent to the FDA’s
approval of Redux.
We will address the post-FDA-approval negligence claims first. As characterized
by Buchanan and the district court, the post-approval negligence claims are either a
general negligence claim or a design defect claim. Whatever the label, the claim focuses
on Wyeth’s actions after the drug went to market, primarily Wyeth’s failure to take the
drug off of the market sooner. Wyeth moved for summary judgment on the basis that
Buchanan could not show that Wyeth’s actions or omissions after FDA approval caused
any of her injuries. Specifically, Wyeth contended that it had updated its warnings about
the risks of Redux as information became available and that it removed Redux from the
market as soon as it became aware of the extent of the risk, and it submitted a substantial
amount of evidence in support of this position.
But, just as she did with regard to Wyeth’s request for summary judgment on the
strict liability design defect claim, Buchanan did not highlight any evidence in the record
that would contradict the evidence submitted by Wyeth. Instead, Buchanan again argued
the law, insisting that the warnings were irrelevant because Wyeth should have known
that the drug was so dangerous that no warning could make the drug acceptable.
Critically, Buchanan did not point to any facts or evidence in the record that would
reveal why Wyeth should have known any of this. The district court found that
Buchanan failed to present evidence demonstrating proximate cause between Wyeth’s
No. 09-3380 Wimbush v. Wyeth, et al. Page 12
alleged negligence after the FDA approved Redux and Buchanan’s injury or death
sufficient to survive a motion for summary judgment. We agree, for principally the same
reasons as we agreed that summary judgment was proper on the strict liability design
defect claim. When Buchanan failed to point to any actual evidence in a particularized
manner, she failed to meet her burden under Rule 56. Accordingly, we affirm the entry
of summary judgment for Wyeth on the post-FDA-approval negligence claims.
3. Federal Preemption
However, Buchanan’s failure to provide evidence of proximate causation for
negligence occurring after the distribution of Redux does not dispose of her claims that
Wyeth was negligent for bringing Redux to market at all. Doctor notification of
potential harms necessarily does not factor into a claim of negligence for bringing a drug
to market in the first place.6 Buchanan argues:
the theory of causation supporting the remaining negligent introduction
and failure to withdraw theories set forth in Count II was completely
different. Had Defendants heeded the persistent and near unanimous
consensus of authority and either refrained from seeking approval of the
diet medication or at least terminating production by the Fall of 1996, the
Decedent never would have been exposed to Redux at all.
(Appellant Br. at 59.) Thus, we must address the district court’s finding that the FDA’s
approval of Redux preempted all state law claims based on Wyeth’s actions before that
approval.
The district court found that Buchanan’s pre-approval negligence claims were
preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 391 et
seq., which is enforced by the FDA, 21 U.S.C. § 393(b). The district court concluded
that:
the FDA is responsible for regulating which drugs are on the market and
the warnings such drugs must provide. As such, Plaintiff’s strict liability
6
This discussion assumes the viability of such a claim under the Ohio common law. We do not
address whether such a claim actually exists; instead, we address only whether FDA approval would
preempt such a claim if it does exist.
No. 09-3380 Wimbush v. Wyeth, et al. Page 13
and negligence claims that Redux was an “unreasonably dangerous” drug
for which no warning would have been adequate directly conflicts with
the FDA’s authority to determine which drugs are sufficiently safe and
effective to be marketed. Although Plaintiff asserts that she alleges only
that Defendants should not have marketed Redux, and that she does not
argue that the FDA did anything wrong, the court finds that her claim that
Redux should never have been placed on the market interferes with the
FDA’s objectives. Consequently, all claims relating to pre-FDA
approval are preempted by the FDA.
Longs I, 536 F. Supp. 2d at 847 (emphasis in original).
As the district court framed it, the issue is whether a state-court finding that a
manufacturer was negligent in bringing the drug to market conflicts or is inconsistent
with the FDA’s subsequent approval of that drug for the market. Determining whether
this is so requires some degree of understanding of the FDA approval process. A recent
Fifth Circuit case summarized the FDA’s role in approving new drugs:
All prescription drugs marketed in this country must first receive FDA
approval. Manufacturers of new drugs must submit a new drug
application (NDA) to the FDA that demonstrates the drug’s effectiveness
and safety for its intended use. The 1962 Food, Drug and Cosmetics Act
(FDCA) established this avenue for pioneer drugs, with the core
objective of ensuring that drugs are both safe and effective; the FDA has
codified the NDA regulations at 21 C.F.R. Part 314. New drug approval
requires, among other deliverables, the results of successful clinical trials
and labeling that accurately portrays the benefits and risks of the drug,
as indicated by those trials and other data.
Demahy v. Actavis, Inc., No. 08-31204, 2010 WL 46513, at *2 (5th Cir. Jan. 8, 2010)
(internal footnotes omitted). With this basic understanding of FDA drug approval in
mind, we turn to federal preemption.
Federal preemption draws its force from the Supremacy Clause of the United
States Constitution. U.S. Const. art. 6, cl. 2. “Here, as in every preemption case, ‘[t]he
purpose of Congress is the ultimate touchstone.” Demahy, 2010 WL 46513, at *3
(quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996) (plurality)). “[I]n all
preemption cases, and particularly in those in which Congress has legislated in a field
which the States have traditionally occupied, we start with the assumption that the
No. 09-3380 Wimbush v. Wyeth, et al. Page 14
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.” Levine, 129 S. Ct. at 1194-95
(internal quotation marks and ellipses omitted). “Although there is a presumption under
the Supremacy Clause that Congress did not intend to preempt state law, ‘an assumption
of non-preemption is not triggered when the State regulates in an area where there has
been a history of significant federal presence.’” R.R. Ventures, Inc. v. Surface Transp.
Bd., 299 F.3d 523, 562 (6th Cir. 2002) (quoting United States v. Locke, 529 U.S. 89, 108
(2000)). The analysis of whether the presumption of non-preemption applies “accounts
for the historic presence of state law but does not rely on the absence of federal
regulation.” Levine, 129 S. Ct. at 1195 n.3.
Here, Buchanan is entitled to the presumption that Congress did not intend to
preempt state law because hers are claims under “preexisting state products liability
law.” Desiano v. Warner-Lambert & Co., 467 F.3d 85, 94 (2d Cir. 2006) (stating that
“state-based tort liability falls squarely within [a state’s] prerogative to regulate matters
of health and safety, which is a sphere in which the presumption against preemption
applies, indeed, stands at its strongest.”) (internal quotation marks and brackets omitted)
(aff’d Warner-Lambert Co., LLC v. Kent, 522 U.S. 440 (2008) (per curiam) (4-4
decision)). Although “[i]t is not a valid argument against preemption to say that the state
seeks to impose greater obligations than Congress did,” Smith v. Provident Bank, 170
F.3d 609, 613 (6th Cir. 1999), “[w]here possible, a court should try to reconcile federal
law and state law.” Rollins v. Wilson County Gov’t, 154 F.3d 626, 629 (6th Cir. 1998).
Keeping in mind that we operate under a presumption against preemption in this
case, we turn to the substance of federal preemption. “In general, a federal law may
preempt a state law in any of the following three scenarios. First, a federal statute may
expressly preempt the state law. Second, a federal law may impliedly preempt a state
law. Third, preemption results from an actual conflict between a federal and a state
law.” Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 965 (6th Cir. 2004) (citations
omitted). Wyeth argues, and the district court based its holding on, the third type of
preemption, conflict preemption.
No. 09-3380 Wimbush v. Wyeth, et al. Page 15
Conflict preemption refers to circumstances “where compliance with both federal
and state regulations is a physical impossibility, or where state law stands as an obstacle
to the accomplishment and execution of the full purposes and objectives of Congress.”
State Farm Bank v. Reardon, 539 F.3d 336, 342 (6th Cir. 2008). Conflict preemption
analysis “should be narrow and precise, ‘to prevent the diminution of the role Congress
reserved to the States while at the same time preserving the federal role.’” Downhour
v. Somani, 85 F.3d 261, 266 (6th Cir. 1996) (quoting Nw. Cent. Pipeline Corp. v. State
Corp. Comm’n, 489 U.S. 493, 515 (1989)). The Supreme Court has described
impossibility preemption as a “demanding defense.” Levine, 129 S. Ct. at 1199.
In this case, as a general proposition, we can discern no physical impossibility
between complying with a state law duty to exercise reasonable care in the process
leading up to placing a drug on the market and complying with the federal government’s
process for approving drugs. This is not to say that such a physical impossibility could
never exist, for instance if a state duty required that the manufacturer do something that
the FDA forbade or vice versa. But such a situation would, we think, be the exception
to the rule. Thus, we are not persuaded that it is always impossible to comply with both
state law duties and FDA regulations in the process leading up to FDA approval.
The only remaining rationale to support conflict preemption, therefore, is that
allowing state tort lawsuits would stand as an obstacle to the accomplishment of the
statute. The district court quoted the FDCA to find that the purpose of the FDA is to:
(1) promote the public health by promptly and efficiently reviewing
clinical research and taking appropriate action on the marketing of
regulated products in a timely manner;
(2) with respect to such products, protect the public health by ensuring
that–
....
(B) human . . . drugs are safe and effective; . . . .
Longs I, 536 F. Supp. 2d at 847 (quoting 21 U.S.C. § 393(b)). The district court then
determined that permitting common-law negligence claims regarding a drug
manufacturer’s pre-approval conduct would conflict with this function of the FDA.
No. 09-3380 Wimbush v. Wyeth, et al. Page 16
However, we cannot agree with the district court’s conclusion as, not only is
there a presumption against preemption, but the case law supports the conclusion that
Congress did not intend to preempt state tort law claims when it passed the FDCA. Part
of the Desiano analysis is applicable here:
Significantly, all of the claims advanced by Appellants in this case are
premised on traditional duties between a product manufacturer and . . .
consumers. None of them derives from, or is based on, a newly-
concocted duty between a manufacturer and a federal agency. As a
result, were we to conclude that Appellants’ claims were preempted, we
would be holding that Congress, without any explicit expression of
intent, should nonetheless be taken to have modified (and, in effect,
gutted) traditional state law duties between pharmaceutical companies
and their consumers. We see no reason, nor can we identify any
precedent, to justify such a result.
Desiano, 467 F.3d at 94-95. Simply because tort liability “parallel[s] federal safety
requirements” does not mean that liability is preempted. Id. at 95. Allowing a state tort
claim under the instant circumstances would not “interfere[] with the methods by which
the federal statute was designed to reach its goal.” Verizon North, Inc. v. Strand, 309
F.3d 935, 940 (6th Cir. 2002) (internal brackets omitted) (quoting Gade v. Nat’l Solid
Wastes Mgmt. Ass’n, 505 U.S. 88, 103 (1992)). Wyeth defends the district court’s
preemption finding by citing two Supreme Court cases for the principle that “[s]tate tort
law disrupts the federal scheme . . .”, but these cases are distinguishable.
In Geier v. American Honda Motor Co., Inc., 529 U.S. 861 (2000), the Court
found that the plaintiffs’ tort suit that “would have required manufacturers of all similar
cars to install airbags rather than other passive restraint systems, such as automatic belts
or passive interiors” would have presented an obstacle “to the variety and mix of devices
that the federal regulation sought” and “to the gradual passive restraint phase-in that the
federal regulation deliberately imposed.” Id. at 881. Such conflicts do not exist here
because the state duty urged by Buchanan does not create an obstacle to following the
federal regulatory scheme.
Wyeth also cites Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). That case
addressed the Medical Device Act, which expressly preempts state requirements
No. 09-3380 Wimbush v. Wyeth, et al. Page 17
“‘different from, or in addition to, any requirement applicable . . . to the device’ under
federal law.” Riegel, 552 U.S. at 321 (quoting 21 U.S.C. § 360k(a)(1)). There is no
similar express preemption provision for drugs under the FDCA. Indeed, in the 1962
amendments to the FDCA, Congress expressly limited the preemptive effect of the
statute by stating:
Nothing in the amendments made by this Act to the Federal Food, Drug
and Cosmetic Act shall be construed as invalidating any provision of
State law which would be valid in the absence of such amendments
unless there is a direct and positive conflict between such amendments
and such provisions of State law.
Drug Amendments of 1962 (Harris-Kefauver Act), Pub. L. No. 87781, ¶ 202, 76 Stat.
780, 793 (1962); see also Levine, 129 S. Ct. at 1195-96 (“As it enlarged the FDA’s
powers to ‘protect the public health’ and ‘assure the safety, effectiveness, and reliability
of drugs,’ Congress took care to preserve state law.”) (internal citations omitted).
The Supreme Court also observed that “[i]n keeping with Congress’ decision not
to pre-empt common-law tort suits, it appears that the FDA traditionally regarded state
law as a complementary form of drug regulation.” Levine, 129 S. Ct. at 1202. The Court
further stated:
If Congress thought state-law suits posed an obstacle to its objectives, it
surely would have enacted an express preemption 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, see § 521, 90
Stat. 574 (codified at 21 U.S.C. § 360k(a)), Congress has not enacted
such a provision for prescription drugs. Its 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. As Justice
O’Connor explained in her opinion for a unanimous Court: “The case for
federal preemption is particularly weak where Congress has indicated its
awareness of the operation of state law in a field of federal interest, and
has nonetheless decided to stand by both concepts and to tolerate
whatever tension there [is] between them.”
No. 09-3380 Wimbush v. Wyeth, et al. Page 18
Levine, 129 S. Ct. at 1200 (internal citation and footnote omitted).7 Moreover, even
before the Supreme Court’s clarification in Levine, we previously found that the FDCA
did not preempt pre-approval design defect claims. Tobin v. Astra Pharm. Prods., Inc.,
993 F.2d 528, 537-38 (6th Cir. 1993). Finally, we are aware of no federal appeals court
decision since Levine concluding that FDA regulation preempts any aspect of state tort
law, though we admit that, until today, there is also no post-Levine court of appeals
authority for the proposition that the Levine rationale extends beyond the realm of
failure-to-warn claims to apply to all pre-approval state law claims.
For these reasons, we hold that the district court erred in granting summary
judgment to Wyeth on preemption grounds on Buchanan’s pre-approval common law
negligence claims. In so holding, however, we do not pass upon whether there may be
alternative bases for adjudicating these claims short of trial. Neither the parties nor the
district court have asserted any such alternative, so the issue is not before us. We hold
merely that FDA approval does not automatically preempt state law tort claims for
negligence, and we remand for such further proceedings as may be appropriate under the
facts and circumstances. Moreover, because we remand for further proceedings on the
7
Both the district court, Longs II, 621 F. Supp. 2d at 508-09, and Wyeth seek to distinguish
Levine from the present case on the basis that Levine involved a state law inadequate warning claim
whereas the instant case involves a state law negligent-bringing-to-market claim. It is indeed true that the
question presented in Levine dealt solely with state tort inadequate warning claims versus FDA-approved
labels, Levine, 129 S. Ct. at 1193, whereas this case pits state tort negligent-bringing-to-market claims
against FDA approval to market. However, we find this to be a distinction without a difference, as the
rationale in Levine applies with equal force to this claim as it did to the inadequate warning claim. Just
as state tort law on adequacy of warnings can be seen as “complementary,” id. at 1201, to the FDA’s
labeling regulation, so too can state law duties regarding the decision to bring a product to market be seen
as complementary to the FDA’s function of approving a drug for market. This makes sense, as whether
the FDA approves a drug for market depends, in very large part, upon the results of the manufacturer’s
investigation and testing prior to seeking FDA approval. Demahy, 2010 WL 46513, at *2. If the
manufacturer is negligent in this investigation, then the entire FDA approval process is tainted from the
outset. And it is in this way that Buchanan’s pre-approval negligence theory varies from a fraud-on-the-
FDA claim. Finally, the overwhelming take-away from the Levine majority opinion is that state tort law
has historically played a substantial role in the regulation of drug manufacturers and that Congress has
never indicated an intent to change this role. Thus, while Levine did leave open the possibility that there
may be some state law claims that would conflict with the FDA’s regulatory authority and function, the
claim at issue in Levine was not one of them. We do not believe that Buchanan’s pre-approval negligence
claims are, either.
No. 09-3380 Wimbush v. Wyeth, et al. Page 19
common law pre-approval claims, the district court’s mootness ruling as to punitive
damages must also be reversed and remanded.8
III.
For the reasons set forth above, we REVERSE the judgment of the district court
as to the pre-FDA-approval negligence claims and punitive damages and REMAND
those issues to the district court for further proceedings; we AFFIRM the judgment of
the district court on all other claims. Moreover, we VACATE AS MOOT the portion
of Longs I, 536 F. Supp. 2d at 851, that holds that the plaintiff bears the burden of
proving the inadequacy of a warning under section 2307.759(D).
8
Because we conclude that the district court erred in granting summary judgment on the pre-FDA-
approval negligence claims but affirm summary judgment on all other claims, we do not address
Buchanan’s appeal of the court’s order denying the subsequent motion to vacate and amend judgment.
No. 09-3380 Wimbush v. Wyeth, et al. Page 20
____________________________________________________
CONCURRING IN PART AND DISSENTING IN PART
____________________________________________________
HELENE N. WHITE, Circuit Judge, concurring in part and dissenting in part.
I join the majority opinion except Part II(C)(2) and the related portion of Part III, from
which I respectfully dissent. I would reverse the summary dismissal of claims based on
Wyeth’s alleged negligence in failing to adequately investigate adverse reports regarding
Redux after FDA approval, and in failing to timely remove Redux from the market, and
remand such claims to the district court for further proceedings. Although I agree with
the majority that Buchanan failed to present evidence in support of these claims, my
review of the record convinces me that this is because Wyeth’s motions for summary
judgment did not attack the factual support for these claims.
Buchanan’s Amended Complaint included claims that Wyeth was negligent in
“failing to adequately monitor the effects of the drug[] . . . failing to timely and
accurately report to the FDA all adverse drug experience information obtained, and
concealing and misrepresenting the results of studies to physicians and the public.”
Wyeth brought three motions for summary judgment. The only motion potentially
related to the post-FDA-approval negligence claims was Wyeth’s Motion for Summary
Judgment Based on Lack of Evidence of Proximate Causation. Wyeth included two
arguments in that motion. The majority of the brief was dedicated to Wyeth’s argument
that Buchanan’s “failure to warn” claim is barred by the “learned intermediary” doctrine.
Wyeth’s second argument was that Buchanan’s “design defect” claim under the OPLA
is barred because Wyeth had provided a statutorily sufficient “adequate warning” under
Ohio Rev. Code Ann. § 2307.75(D), and that even if the warnings were inadequate,
Buchanan had not “established that any such claimed inadequacy proximately caused
her physician to prescribe the drug to her.” These arguments were not addressed to
Buchanan’s allegations that Wyeth is responsible for “[n]egligence in failing to
investigate adverse reaction reports and in other conduct below the industry standard of
No. 09-3380 Wimbush v. Wyeth, et al. Page 21
care . . . leading to Wyeth’s failure to withdraw Redux from the market before December
1996.”1
In its order granting summary judgment, the district court identified two
negligence claims, general negligence and negligent design. In granting summary
judgment to Wyeth on all negligence claims, the district court cited Wyeth’s evidence
regarding the warnings it sent to physicians, and specifically to Dr. Erokwu, and faulted
Buchanan for not submitting evidence that Wyeth should have taken Redux off the
market sooner. Although that failure was justifiably regarded as fatal to the design-
defect claims based on inadequate warnings (which were directly addressed by Wyeth’s
summary judgment motion), it should not have been regarded as fatal to the general
negligence claims alleging failure to adequately investigate and/or to take Redux off the
market sooner.
In effect, the district court granted summary judgment on these claims sua
sponte. Although this is permitted, it is disfavored. Saxe v. Dlusky, 162 F. App’x 430,
432 (6th Cir. 2006) (“Sua sponte grants of summary judgment are disfavored.”) (citing
Employers Ins. of Wausau v. Petroleum Specialties, Inc., 69 F.3d 98, 105 (6th Cir.
1995)); Chance v. Mahoning County, 105 F. App’x 644, 649 (6th Cir. 2004) (noting that
grants of summary judgment sua sponte are discouraged in the Sixth Circuit). If a
district court is to do so, the losing party must be “on notice that she ha[s] to come
forward with all of her evidence.” Celotex Corp. v. Catrett, 477 U.S. 317, 326 (1986).
“Notice and opportunity are determined from the totality of the proceedings
below, including whether any party filed a motion for summary judgment on the claim
and whether the losing party addressed the claim in its arguments.” Aubin Indus., Inc.
v. Smith, 321 F. App’x 422, 423 (6th Cir. 2008). In this instance, Buchanan did not have
notice that she had to present her evidence as to the post-FDA approval failure to
investigate/failure to remove from the market negligence claims because Wyeth’s motion
did not address these claims. See Black Shield Police Ass’n v. City of Cleveland, 838
1
As the district court noted, much confusion could have been avoided if Buchanan had been
clearer in identifying and distinguishing her claims.
No. 09-3380 Wimbush v. Wyeth, et al. Page 22
F.2d 470, at *3 (6th Cir. 1988) (unpublished table decision); see also Shelby County
Health Care Corp. v. S. Council Indus. Workers Health & Welfare Trust Fund, 203 F.3d
926, 931 (6th Cir. 2000) (“[W]e have held that Fed. R. Civ. P. 56(c) mandates that the
losing party must ‘be afforded notice and reasonable opportunity to respond to all the
issues to be considered by the court.’”). As a result, Buchanan had “no reason to believe
that [her] cause of action was in danger of being dismissed.” Moisenko v.
Volkswagenwerk Aktiengesellschaft, 198 F.3d 246, at *5 (6th Cir. 1999) (unpublished
table decision).
Further, the dismissal of the post-FDA approval negligence claims prejudiced
Buchanan because it foreclosed a potential avenue of relief. See Yahon v. Gregory, 737
F.2d 547, 552 (6th Cir. 1984) (appellant of sua sponte entry of summary judgment must
show prejudice); see also Moisenko, 198 F.3d at *5 (“This Court has held that ‘not
having an opportunity to respond constitutes prejudice,’ as a plaintiff is entitled to be
informed of the deficiencies in his case ‘in order that he might respond to the district
court’s proposal to grant summary judgment with whatever arguments and evidence in
the record that he could muster.’” (quoting Yashon, 737 F.2d at 552)). Buchanan had
no notice that the district court was contemplating granting summary judgment on the
post-FDA-approval general negligence claims, and therefore should not be penalized for
failing to address that point.2
2
To be clear, I would not hold that summary judgment on this claim is inappropriate, only that
the issue should be squarely addressed by the parties before the district court rules on it.