Rivera v. Wyeth-Ayerst Labs.
United States Court of Appeals for the Fifth Circuit
February 15, 2002, Decided
[*316] JERRY E. SMITH, Circuit Judge:
Pursuant to FED. R. CIV. P. 23(f), defendants Wyeth-Ayerst Laboratories ("Wyeth") and American Home Products Corporation appeal the certification of a nationwide class of drug purchasers and their insurance companies. Because we conclude that this suit does not present a justiciable case or controversy under Article III of the Constitution, we reverse and render a judgment of dismissal.
In July 1997, Wyeth began distributing Duract, a non-steroidal anti-inflammatory drug ("NSAID") prescribed for short-term management of acute pain. Although all NSAID's carry certain risks of liver and gastrointestinal damage, clinical trials revealed that Duract had additional negative effects. Wyeth included a package insert in each box of Duract detailing these dangers, reporting the results of the clinical trials, recommending Duract be used for only short periods ("generally [**2] less than ten days"), and warning that Duract may not be appropriate for those with preexisting [*317] liver conditions. The Food and Drug Administration ("FDA") approved Duract, its labeling, and its package insert.
In December 1997, Wyeth received three reports of liver failure by patients who had taken Duract for long-term relief without undergoing liver testing. In February 1998, after receiving FDA approval, Wyeth issued a new, revised package insert reporting these cases of liver failure and reemphasizing that Duract was intended "only for the short term (10 days or less)." After receiving new reports of liver failure among long term users, Wyeth voluntarily withdrew Duract from the market in June 1998.
Wyeth explained that of the twelve patients injured by Duract, eleven had taken the drug for over ten days, and one had preexisting liver disease. Wyeth stated that because no change in Duract's package insert could guarantee physicians would stop prescribing the drug for long-term use, it was withdrawing Duract from the market. Wyeth established a program to refund Duract users for any unused portion of their prescription.Read The Full CaseNot a Lexis Advance subscriber? Try it out for free.
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283 F.3d 315 *; 2002 U.S. App. LEXIS 2411 **; CCH Prod. Liab. Rep. P16,271
ELIZABETH RIVERA; ARKANSAS CARPENTERS HEALTH AND WELFARE FUND, ON BEHALF OF THEMSELVES AND OTHERS SIMILARLY SITUATED, Plaintiffs-Appellees, VERSUS WYETH-AYERST LABORATORIES, A DIVISION OF AMERICAN HOME PRODUCTS CORPORATION; AMERICAN HOME PRODUCTS CORPORATION, Defendants-Appellants.
Subsequent History: [**1] As Revised February 22, 2002.
Prior History: Appeal from the United States District Court for the Southern District of Texas. G-00-CV-345 and G-00-CV-498. Samuel B Kent, US District Judge.
Rivera v. Wyeth-Ayerst Lab., 197 F.R.D. 584, 2000 U.S. Dist. LEXIS 17630 (S.D. Tex. 2000)
Disposition: Reversed and dismissed.
district court, warnings, patients, discovery, class certification, injury in fact, liver, contract law, prescribed, causation, damages, courts, users
Civil Procedure, Justiciability, Standing, General Overview, Constitutional Law, Case or Controversy, Elements, Preliminary Considerations, The Judiciary, Separation of Powers, Injury in Fact, Special Proceedings, Class Actions, Appellate Review, Prerequisites for Class Action, Appeals, Standards of Review, De Novo Review, Clearly Erroneous Review, Contracts Law, Measurement of Damages, Foreseeable Damages, Benefit of the Bargain, Remedies, Restitution, Advisory Opinions