Should the FDA be the last word in drug safety? Apparently, the U.S. Supreme Court will answer that question soon. The court has decided to hear arguments in two drug liability cases: one over a Medtronic balloon catheter that burst during a procedure and another over Rezulin, a now-withdrawn diabetes drug. The manufacturers claim that FDA approval should act as a force field against state liability claims; as long as the agency says a drug or device is safe, then patients shouldn't be allowed to sue.
Consumer groups, of course, are up in arms over the prospect of block patients' access to redress in the courts. Sometimes, they say, the FDA approves products based on faulty or even falsified research--think Bayer's withholding of negative data on Trasylol (now withdrawn) or Merck's alleged burying of adverse info on Vioxx (also withdrawn). And the FDA hasn't exactly been dressed in laurels lately. The agency's own Science Board said Friday that it's so badly organized and underfunded that it can't guarantee drug safety.
Tort-reform advocates, however, say making companies vulnerable to state lawsuits muddies the legal waters for companies and confuses consumers. Companies say they can't give their all to R&D if they're distracted by product litigation. Soon, the Supremes will have their say; they'll hear arguments in one case today and in another in February.
- read the report from the Los Angeles Times
Merck settling Vioxx claims for $4.85B. Report
Bayer kept Trasylol safety study hidden from FDA. Report
Report: FDA underfunded, understaffed. Report
Judge whacks Vioxx class action suit. Report
Judge dismisses Louisiana's Rezulin suit. Report