In re Diet Drugs, MDL DOCKET NO. 1203 (E.D. Pa. 8/28/2000)

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IN RE: DIET DRUGS (PHENTERMINE, FENFLURAMINE, DEXFENFLURAMINE) PRODUCTS LIABILITY LITIGATION THIS DOCUMENT RELATES TO: SHEILA BROWN, et al., v. AMERICAN HOME PRODUCTS CORPORATION.

MDL DOCKET NO. 1203.

CIVIL ACTION NO. 99-20593.

United States District Court, E.D. Pennsylvania.

August 28, 2000.

MEMORANDUM AND PRETRIAL ORDER NO. 1415

BECHTLE, Judge.

Presently before the court is the Joint Motion of the Class Representatives and American Home Products Corporation ("AHP") for an order certifying and approving the nationwide settlement class embodied in the Settlement Agreement entered into between the parties on November 19, 1999. For the reasons set forth below, the court will grant the motion and will certify the class and approve the settlement pursuant to Federal Rule of Civil Procedure 23. The court's findings of fact and conclusions of law are as follows.

I. BACKGROUND

A. The Diet Drug Litigation

This litigation involves claims regarding the health effects of two related prescription drugs — fenfluramine and dexfenfluramine. Fenfluramine is an appetite suppressant that affects blood levels of the neurotransmitter, serotonin. Dexfenfluramine, the "d-isomer" of fenfluramine, is chemically related to fenfluramine and acts as an appetite suppressant by stimulating the release of serotonin from nerve cells in the brain and by reducing the reuptake of the released serotonin. In 1973, The United States Food and Drug Administration ("FDA") approved A.H. Robins, Inc.'s new drug application to market fenfluramine in the United States. (Ex. P-180.)

Before 1989, A.H. Robins, Inc. was responsible for the marketing, sale and labeling of fenfluramine in the United States. In 1989, AHP acquired A.H. Robins. Following the acquisition, fenfluramine was marketed by AHP under the trade name "Pondimin." Between December 1989 and September 15, 1997, AHP was the only company to market fenfluramine in the United States and had the exclusive responsibility for its regulatory compliance, adverse event reporting, safety surveillance and labeling.

Sales of Pondimin were relatively flat until 1992. In 1992, a series of articles by Michael Weintraub, M.D., were published in the Journal of Clinical Pharmacology and Therapy, in which Dr. Weintraub advocated the use of fenfluramine together with the drug phentermine for weight loss management without the adverse side effects associated with the use of fenfluramine alone. This regimen popularly became known as "Fen-Phen." With the introduction of "Fen-Phen" therapy to the market place, sales of Pondimin skyrocketed. From January 1995 to mid-September 1997, approximately 4,000,000 persons in the United States took the drug Pondimin. (Tr. 5/2/00 at 26-27; Ex. P-183 at 29 of 33; Ex. P-182 at 5 of 13.)

Dexfenfluramine, the chemical cousin of Pondimin, was developed by Les Laboratories Servier S.A. ("LLS") in France. The drug afforded the same anorexic effects as Pondimin without the need to add phentermine to ameliorate adverse side effects. Before 1994, the Lederle Division of American Cyanamid Company had the right, together with Interneuron Pharmaceuticals, Inc., to develop and promote dexfenfluramine in the United States under the trade name "Redux." In 1994, AHP acquired American Cyanamid. Following that acquisition, responsibility for the development and promotion of Redux in the United States in conjunction with Interneuron was assumed by AHP. Interneuron received approval to market Redux in the United States in mid-1996. As with Pondimin, sales of Redux were brisk. From June 1996 through September 15, 1997, two million people in this country took Redux. (Tr. 5/2/00 at 28; Ex. P-183 at 29 of 33; Ex. P-182 at 5 of 13.)

The distribution of Redux users by age and sex was virtually the same as that for Pondimin. (Ex. P-94 at 3 of 41; Ex. P-53 at 9 of 54.) Most of the individuals who took the diet drugs Pondimin and Redux were middle aged women. (Ex. P-94 at 3 of 41; Ex. P-53 at 9 of 44.)

From the viewpoint of plaintiffs' counsel, the evidence reveals that before Pondimin and Redux were withdrawn from the market in 1997, which is discussed infra, AHP received considerable information from a number of sources that both drugs could cause damage to the valves in the heart leading to valvular regurgitation. This information consisted of reports in the medical literature, reports from animal studies, reports concerning heart valve damage in patients taking drugs with similar effects on serotonin metabolism, adverse event reports and reports from a doctor commissioned to analyze certain facts for Interneuron. According to plaintiffs, notwithstanding this information, during the period of time AHP marketed dexfenfluramine and fenfluramine, it failed to investigate these reports, to look at whether or not the drugs were cardiotoxic or to label the drugs as being potentially harmful to the heart valves.

In response, AHP has vigorously contested the plaintiffs' interpretation of these events, noting that much of this information was submitted to the FDA for its own analysis; that none of the doctors or scientists who reported on Pondimin or Redux, either in the published literature or in the adverse event reports, concluded that either product caused any valvular disease; and that, given the substantial prevalence of such valvular disease in the general population, it was not possible to conclude, on the basis of these reports, that its products caused disease.

In March 1997, researchers at the Mayo Clinic in Rochester, Minnesota began observing an association between the use of fenfluramine and/or dexfenfluramine and a particular type of valvular heart disease. Eventually, the Mayo Clinic researchers observed this unusual form of valvular heart disease in 24 women who had used fenfluramine in combination with phentermine. (Ex. P-95 ¶ 39; Tr. 5/2/00 at 29; Ex. P-113; Ex. P-181; Ex. P-182.) The findings of the Mayo researchers were first brought to the attention of the public in a July 8, 1997 press release and were eventually published on August 28, 1997, in the New England Journal of Medicine. (Exs. P-181 & P-113.)

On July 8, 1997, the FDA issued a public health advisory, followed by letters to 700,000 physicians requesting information about similar patients. Based on information the FDA received in response, the FDA requested the withdrawal of fenfluramine and dexfenfluramine from the U.S. market. On September 15, 1997, AHP and the FDA announced that there would be no further sales of Pondimin and Redux in the United States. Subsequently, the causal relationship between valvular heart disease and the use of dexfenfluramine and fenfluramine was investigated and confirmed in three epidemiological studies published in the New England Journal of Medicine in September 1998. (Exs. P-127 (Jick), P-130 (Khan) & P-170 (Weissman).)

A wave of litigation followed. As of the time that class notice issued in this matter, approximately 18,000 individuals who used Pondimin or Redux filed lawsuits against AHP. (Tr. 5/2/00 at 196-97.) Many of these lawsuits involved actions in which individuals sought to recover for personal injuries, primarily valvular heart disease, that they sustained as a result of using Pondimin or Redux. In addition, over one hundred plaintiffs instituted class actions in which they sought either: (1) to create an equitable fund to provide medical screening services to patients who had used Pondimin and/or Redux for varying periods of time to determine if they had asymptomatic valvular heart disease; and/or (2) to recover the amounts expended by consumers to purchase Pondimin and/or Redux or to obtain echocardiograms as a consequence of exposure to these drugs; and/or (3) to recover personal injury damages on behalf of classes of persons who took Pondimin and/or Redux. (Tr. 5/2/00 at 20-21 & 36-39.)

To the extent that these actions were filed in the federal judicial system, the Judicial Panel for Multidistrict Litigation entered an order transferring all of the actions to the United States District Court for the Eastern District of Pennsylvania for coordinated and/or consolidated pretrial proceedings under MDL Docket No. 1203. As the transferee court, this court entered an order creating and appointing a Plaintiffs' Management Committee ("PMC") to oversee the conduct of the coordinated/consolidated pretrial proceedings on behalf of the plaintiffs. See Pretrial Order No. 6.¹

By the summer of 1999, a combination of state court and federal court decisions certified classes to pursue some form of relief on behalf of those persons who had used AHP's diet drugs. See Pretrial Order No. 865, Jeffers v. American Home Prods. Corp., C.A. No. 98-CV-20626 (certifying nationwide medical monitoring class in MDL court); Burch, et al. v. American Home Prods. Corp., C.A. No. 97-C-204(1-11) (certifying medical monitoring and personal injury class in West Virginia); Rhyne v. American Home Prods. Corp., 98 CH 409 (certifying medical monitoring class in Illinois); Vadino, et al. v. American Home Prods. Corp., Docket No. MID-L-425-98 (certifying class seeking medical monitoring and damages for unfair and deceptive trade practices in New Jersey); In re: New York Diet Drug Litig., Index No. 700000/98 (certifying medical monitoring class in New York); In re: Pennsylvania Diet Drug Litig., Master Docket No. 9709-3162 (CCP, Phila.) (certifying medical monitoring class in Pennsylvania); Earthman v. American Home Prods. Corp., No. 97-10-03970 CV, (certifying medical monitoring class in Texas); St. John v. American Home Prods. Corp., 97-2-06368-4 (certifying medical monitoring class in Washington).

By the summer of 1999, the parties in both the state litigation and the federal MDL litigation had virtually completed discovery with respect to AHP's conduct. (Tr. 5/2/00 at 21-23.) More than 6,000,000 documents were produced by AHP and carefully reviewed, analyzed and collated by the plaintiffs. Id....