TEXAS LAWYER
January 10, 2000
Houston Counsel Sue Painkiller Maker Over Alleged Side Effects
by SHANNON P. DUFFY
Claiming that the painkiller Duract caused the deaths of at least three people and left others with permanent liver damage, a team of lawyers from Texas and Pennsylvania have joined forces to file suit against New Jersey-based American Home Products and its subdivision Wyeth-Aherst Laboratories.
The suit, filed Dec. 30, alleges that AHP purposely hid the seriousness of possible side effects in an aggressive marketing campaign that misled doctors, pharmacists and consumers by "downplaying" the drug's dangers.
In clinical trials, Duract was found to be highly toxic to the liver, and the FDA refused to approve the drug for anything other than short-term pain management, generally less than 10 days, the suit claims. But when the FDA asked AHP to include a "black box" warning on its package inserts to put doctors on notice of the potential for serious liver damage, the suit alleges, the manufacturers "actively resisted," and the drug hit the market in July 1997 with no black-box warning.
Attorneys Zoe Littlepage, Chenta Koshy and Joshua Brockman, of Littlepage & Associates in Houston, and Richard A. Stanko, of Kassab Archbold & O'Brien in Media, Pa., contend that the original warnings were not strong enough.
Packaging materials, the suit alleges, "did not contain warnings or explanations sufficient to reflect the severity of the toxicity to the liver" and failed to stress the increased risk to those who used the drug longer than 10 days.
In February 1998, AHP changed the warnings to include additional information about liver toxicity. But the suit alleges that AHP knew of the toxic effects long before it beefed up its warnings. "By failing to include complete and accurate warnings at the outset of their marketing and selling activities, [AHP] falsely and fraudulently kept relevant information from potential Duract users, and minimized user and prescriber concern regarding the safety of the product," the suit alleges.
Duract quickly became a popular alternative to narcotic drugs for short-term relief of acute pain. In the eight months it was on the market, doctors wrote 2.5 million prescriptions.
"It's clear from Wyeth's own research and testing that this was a drug which showed its true colors even during development," plaintiffs' attorney Littlepage says. "Wyeth chose to downplay, and ignore, the writing on the wall and market the drug anyway."
AHP spokesmen Lowell Weiner in the company's Madison, N.J., headquarters declines comment, saying the company had yet to see the suit. A spokesperson at St. Davids, Pa.-based Wyeth Ayerst also declines comment.
Drug Recalled Duract was one of the most powerful of a class of drugs known as nonsteroidal anti-inflammatory drugs, or NSAIDs, that include aspirin and ibuprofen.
From its inception, it attracted controversy in the medical community. Consumer groups like Public Citizen warned that doctors could easily prescribe one of at least 18 similar treatments as an alternative. The drug's warning label was changed in February 1998, but at least four deaths had been reported by then.
Plaintiff Mary Elizabeth Emery, of Powell, Ohio, says she suffered permanent liver damage after being prescribed Duract and taking 14 pills in just under four days. She says she began feeling abnormally tired and listless soon after taking the drug, then found out three months later of her condition. Emery says she had never had any liver problems before taking Duract.
"It's kind of frustrating to think that you go in with hip pain and come out with a totally changed way of life," says Emery, 35. "I could never understand, besides pure profit, why they would put it out on the market."
After the drug was recalled, Wyeth-Ayerst sent letters to more than 600,000 doctors in the United States urging them to stop prescribing the drug immediately.
The case, Barber v. Wyeth Aherst Laboratories and American Home Products, has been assigned to Senior U.S. District Judge
Copyright 1999, Texas Lawyer. All rights reserved.