March 1, 2000-Lawsuit claims drug companies downplayed painkiller's dangers

In a complaint that sounds remarkably similar to those filed in thousands of diet drug cases, 16 plaintiffs are alleging that American Home Products Corp. (AHP) and its pharmaceutical subdivision, Wyeth-Ayerst Laboratories, negligently and fraudulently understated the dangers of Duract while aggressively marketing it as a safe and highly effective new painkiller.

The plaintiffs' attorney, stated that Duract has caused severe liver complications, including liver transplants and deaths. The defendants failed to provide adequate warnings, misled the U.S. Food and Drug Administration (FDA), and downplayed the dangers of the drug, the plaintiffs' attorney said. Like the diet drugs fenfluramine and dexfenfluramine, which were manufactured or distributed by Wyeth-Ayerst, Duract was recalled from the market soon after the adverse affects were reported to the FDA.

In the complaint, the plaintiffs claim that AHP and Wyeth Ayerst knew of the Duract's dangers at the outset of their marketing activities but failed to provide complete and accurate warnings. The defendants "falsely and fraudulently" kept relevant information from potential users, the plaintiffs allege. Instead, the defendants' strategy has been "to aggressively market and sell Duract by misleading consumers, pharmacists, and physicians about Duract and/or to purposefully downplay and understate the dangers," plaintiffs continue.

The plaintiffs assert that studies conducted by AHP and Wyeth Ayerst clearly showed that Duract was toxic to the liver and could cause elevated liver enzymes and stomach injury. Based on these studies, the FDA refused to approve Duract for anything other than short-term pain management, generally less than 10 days, the plaintiffs say.

Moreover, the plaintiffs contend that the defendants "actively resisted" an FDA request to include a black box warning on the package insert. Consequently, the suit alleges, Duract went on the market in July 1997 with no clear warning to prescribing physicians of the potential for serious and severe liver damage, particularly for patients who take the drug for more than 10 days.

The lawsuit contends, the defendants conceded that their original warnings were inadequate when they changed Duract's product label in February 1998 to include information regarding its toxic effects. The drug was eventually pulled from the market in June 1998. The plaintiffs are individuals and families of individuals who took Duract to ease pain ranging from backaches to rheumatoid arthritis. They contend that they developed severe stomach and liver complications from use of the product.

The lawsuit also asserts causes of action for negligence, strict product liability, breach of express and implied warranties, and fraud. The plaintiffs contend that the defendants knew or should have known of the foreseeable risks that Duract presented and that they failed to use due care in the design, manufacture, and testing of the drug. They further allege that the defendants failed to accurately, adequately, or timely inform medical providers and patients of the dangers. The plaintiffs also allege that the defendants both intentionally and negligently misrepresented the risks and benefits of the drug.

The plaintiffs seek actual and punitive damages. The families of individuals who suffered alleged Duract-related deaths also seek damages pursuant to wrongful death and survival acts and loss of consortium.

If you or a loved one has suffered an injury as a result of taking any drug or supplement, call Law Offices of Robert Dourian now at 800-790-8856 or CLICK HERE TO SUBMIT A SIMPLE CASE FORM. The initial consultation is free of charge, and if we agree to review your case, we will work on a contingent fee basis, which means we get paid for our services only if there is a monetary award or recovery of funds. Don't delay! You may have a valid claim and be entitled to compensation for your injuries, but a lawsuit must be filed before the statute of limitations expires.

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