Wimbush v. Wyeth

Wimbush v. Wyeth

Opinion

 [*634]  [***2]   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  [**2] 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.

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  [*635]  November 2001 diagnosis with primary pulmonary hypertension, ¹ she  [**3] 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.

 [***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  [**4] 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.

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