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It began with a bang and ended with a whimper. At the height of the litigation over the Norplant contraceptive device, 50,000 women had claims seeking potentially millions in damages. Then, the case essentially was dormant for almost three years while most plaintiffs settled out of court for a payment of $1,500 each. Now, a ruling handed down on Aug. 14 by a federal judge in Texas granted partial summary judgment to the makers of Norplant and dismissed the claims of most of the remaining 3,000 women, leaving only 10 plaintiffs to pursue their cases. The ruling by U.S. District Judge Richard Schell of the Eastern District of Texas in Beaumont is a victory for pharmaceutical company Wyeth, formerly known as American Home Products, which for eight years fought allegations that it failed adequately to warn women and their prescribing physicians of dangerous side effects of Norplant, a long-term birth control device consisting of six plastic capsules implanted under the skin. The plaintiffs in the suits collectively claimed that they suffered from almost 1,000 different side effects since the device went on the market in 1991. Wyeth defense attorney F. Lane Heard III, a partner in Williams & Connolly in Washington, D.C., refers questions to a company spokesman at Wyeth headquarters in Madison, N.J. “We’re pleased with the ruling,” says spokesman Doug Petkus. “It’s a positive step toward final resolution of this matter.” He declines further comment. Schell’s ruling affects plaintiffs represented by the firms of Provost * Umphrey of Port Arthur, Texas; Parker & Parks, also of Port Arthur; Ness, Motley of Mount Pleasant, S.C.; and Sybil Shainwald of New York City. Christopher Parks of Parker & Parks, listed in courts records as an attorney for the plaintiffs, and representatives of Ness Motley did not return several calls seeking comment by press time. D’Juana Bellue Parks, the lawyer Provost * Umphrey says handled the Norplant case, and Shainwald were out of their offices last week and could not be reached for comment. ‘EXOTIC CONDITIONS’ Beginning in 1994, thousands of women sued Wyeth and distributors of Norplant in state and federal courts, alleging they suffered from one or more of 26 side effects — including headaches, nausea and irregular menstrual bleeding — listed as possible adverse reactions in the device’s labeling or from at least one of 950 other side effects, described in Schell’s ruling as “exotic conditions,” that weren’t listed. Exotic conditions included polyarthralgia, fibromyalgia and rheumatoid arthritis. According to Schell’s ruling, the company responded that the learned intermediary doctrine required it to warn only prescribing physicians about the dangerous propensities of Norplant, not each individual patient, and that there was no evidence that Wyeth had failed to do that. In addition, the company claimed, there was no link between its product and the so-called exotic conditions. All the actions filed in federal courts were transferred in 1994 to Schell’s court for consolidated pretrial handling as a multidistrict litigation case called In Re: Norplant Contraceptive Products Liability Litigation, or MDL No. 1038. The judge denied a motion to certify the matter as a class action, saying that he first would hold several small trials, called bellwether trials. A small number of plaintiffs were selected for three trials, and discovery was conducted in the first one. Wyeth then moved for summary judgment, contending that even if its labeling was inadequate — and Wyeth said it wasn’t — the plaintiffs had failed to show that the supposed inadequate warnings about the 26 adverse effects had led to their alleged injuries. Schell granted the motion in the spring of 1997, finding that the learned intermediary doctrine applied to the claims and that the plaintiffs failed to prove that their physicians would not have prescribed Norplant if the warning labels had been different. The 5th U.S. Circuit Court of Appeals upheld Schell’s decision in 1999. After that ruling, Wyeth filed motions with Schell for partial summary judgment asking for dismissal of claims by all plaintiffs who allegedly suffered any of the 26 adverse side effects or the exotic conditions. Schell put a decision on hold after the two sides said they were holding settlement talks. In August 1999, Wyeth-Ayerst Laboratories, a subsidiary of American Home Products, agreed to pay $1,500 to any American woman who filed suit before March 1 of that year. Over the next three years, about 32,000 plaintiffs accepted the offer, and about 2,960 either rejected it or failed to respond, according to Schell’s ruling. In his Aug. 15 ruling, Schell applied the learned intermediary doctrine to cases involving the 26 side effects listed on warning labels. He also dismissed the other cases, writing, “Notably, in the three years since Defendants filed this motion for partial summary judgment, Plaintiffs have not produced a shred of evidence or expert testimony that supports an association between Norplant and any of the exotic conditions.” The decision essentially ends the litigation except for 10 cases in which Schell ruled that New Jersey law governs. He suggested that those cases be transferred to the jurisdictions in New York and Illinois where they were filed originally. The ruling follows a decision by Wyeth in late July to discontinue marketing Norplant in the United States. Petkus says the decision was primarily due to the short supply of certain components of the product and not to the litigation. Says Petkus, “Wyeth will continue to research and develop other contraceptive methods in the future.”

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