As Executor Of The Estate Of Mary Buchanan v. Wyeth

• Decision Date: 18 August 2010
• Docket Number: No. 09-3380.,09-3380.
• Citation: 619 F.3d 632
• Parties: Oliver WIMBUSH, Individually and as Executor of the Estate of Mary Buchanan, Plaintiff-Appellant, v. WYETH; Wyeth-Ayerst Labs. Co.; Wyeth Pharm., Inc.; Wyeth Pharm., Defendants-Appellees.
• Court: U.S. Court of Appeals — Sixth Circuit

619 F.3d 632

Oliver WIMBUSH, Individually and as Executor of the Estate of Mary Buchanan, Plaintiff-Appellant,

v.WYETH; Wyeth-Ayerst Labs. Co.; Wyeth Pharm., Inc.; Wyeth Pharm., Defendants-Appellees.

No. 09-3380.

United States Court of Appeals,Sixth Circuit.

Argued Jan. 13, 2010.

Decided and Filed Aug. 18, 2010.

Rehearing and Rehearing En Banc Denied Oct. 14, 2010.

COPYRIGHT MATERIAL OMITTED.

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.

Before MARTIN, BOGGS, and WHITE, Circuit Judges.

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

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.

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's ² 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 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, 173 L.Ed.2d 51 (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 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, 106 S.Ct. 2548, 91 L.Ed.2d 265 (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.

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...