Lead Opinion
MARTIN, J., delivered the opinion of the court, in which BOGGS, J., joined. WHITE, J. (pp. 646-48), delivered a separate opinion concurring in part and dissenting in part.
OPINION
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. Re-latedly, 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) preemptеd 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
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 Aрril 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 anorexi-gens 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 ... increased] 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’s
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),
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.-,
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.,
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 ah, Baldwin’s Ohio Practice, Ohio Tort Law, § 6.1
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 fаilure-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 plaintiffs use of the drug and the plaintiffs injury or whether the product was unavoidably dangerous. Frey v. Novartis Pharm. Corp.,
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.,
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 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,
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 about Redux, that Defendants should have taken Redux off the market sooner, or that Defendants’ alleged failure to take Redux off the market sooner proximаtely 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.,
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.,
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.,
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.
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 Re-dux 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 information obtained, and concealing and misrepresenting the results of studies to physicians and to the public.
Longs I,
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
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 makе 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 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 cаusation 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.
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, Plaintiffs strict liability 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 alleg*642 es 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 Re-dux should never have been placed on the market interferes with the FDA’s objectives. Consequently, all claims relating to pre-FDA approval are prеempted by the FDA.
Longs I,
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.,
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,
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.,
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.,
Conflict preemption rеfers 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,
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, prоtect the public health by ensuring that—
(B) human ... drugs are safe and effective;....
Longs I,
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,
In Geier v. American Honda Motor Co., Inc.,
Wyeth also cites Riegel v. Medtronic, Inc.,
Nоthing 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,
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] bеtween them.”
Levine,
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,
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,
CONCURRING IN PART AND DISSENTING IN PART
Notes
. 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.
. 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.”
. 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 /,
. 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,
. 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
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,
. 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.
. Both the district court, Longs II,
. 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.
Concurrence Opinion
concurring in part and dissenting in part.
I join the majority opinion except Part 11(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 mаjority 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 Buchаnan’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
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 negligenсe 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,
“Notice and oppоrtunity 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,
Further, the dismissal of the post-FDA approval negligence claims prejudiced Buchanan because it foreclosed a potential avenue of relief. See Yashon v. Gregory,
. As the district court noted, much confusion could have been avoided if Buchanan had been clearer in identifying and distinguishing her claims.
. 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.