A $23 MILLION verdict against a drug manufacturer in Texas last week could signal the start of the next big medical liability stampede. Those who watched with alarm as breast implant lawsuits careened out of control can expect some of the same from the 3,100 lawsuits now pending against the makers of the diet pill Pondimin, widely prescribed until 1997 with another diet drug in the treatment known as "fen-phen."
Like the implants lawsuits, the fen-phen suits suggest the shortcomings of the courts as a venue for medical regulation. The fen-phen diet drug combination was composed of two drugs independently approved as safe by the Food and Drug Administration: fenfluramine, made by American Home Products Corp. (AHP) and marketed as Pondimin, and phentermine. Some years after Pondimin came on the market, AHP began encouraging its use together with phentermine for long-lasting weight loss -- a so-called "off-label" use not studied by the FDA.
Off-label uses are legal -- any drug, once approved for one use, can be prescribed for any other use -- but the FDA has long barred drug manufacturers from actively promoting a drug for any use that hasn't been specifically studied and approved. Drug companies have fought these restrictions on off-label marketing; a federal judge recently overturned part of the ban.
When a Mayo Clinic study in 1997 showed the fen-phen combination led to serious heart valve damage in some patients and a rare lung condition in others, critics seized on the case to illustrate the dangers of off-label promotion and more generally of a weakened FDA (then fighting efforts at "reform" by Congress). At FDA request, the manufacturer pulled Pondimin from the market. Now the plaintiffs and their energetic lawyers (one of whom is leading 100 of the cases) accuse AHP of withholding indications of the drug's danger. The company denies any such knowledge. But the Texas jury cited recklessness and malice in awarding $23 million to a plaintiff -- 36-year-old Deborah Lovett -- who is not currently ill and, moreover, had heart valve damage before she took Pondimin.
It's a terrible signal, almost guaranteed to bring thousands more plaintiffs to court on flimsy evidence. Tighter curbs on off-label promotion might not block all harmful side effects -- they couldn't -- but at least when a danger does surface, there might not be so many pill-takers poised to sue.