Our view on pharmaceutical safety: If a drug has FDA’s OK, should you be able to sue?
When the Food and Drug Administration approves a new drug as safe and effective, that isn’t always the end of the story
Sometimes, after the drug has been widely marketed, adverse effects start to appear. The most notorious recent example is Vioxx, the painkiller that went from new blockbuster medicine in 1999 to off the market in 2004, after studies showed a significantly higher risk of heart attack and stroke in certain patients.
(Photo - USA TODAY)
Such cases raise provocative questions: Should victims of drugs gone bad be able to sue and collect from the makers of the drug? Or should the FDA’s seal of approval shield the pharmaceutical companies from litigation?
If the drugs’ makers and the Bush administration get their way in a case pending at the U.S. Supreme Court, the FDA’s endorsement of a medicine or a warning label could be enough to bar lawsuits. And in a perfect world, that’s how it should be. The FDA would be able to police the pharmaceutical companies, detect fraud or deceit, and monitor drugs effectively after they’re released to the market.
In the real world, though, the underfunded, understaffed FDA can be overmatched by pharmaceutical companies that withhold or manipulate information when seeking FDA approval, or are slow to report adverse results once drugs are in widespread use. The problem is so severe that a bipartisan majority in Congress appears poised to increase the agency’s resources, but it will still be severely stretched given the new threat of tainted drug imports from abroad.
That’s where the legal system comes in. For all the excesses of trial lawyers, litigation or fear of litigation play important roles in backstopping the FDA and promoting pharmaceutical safety. Litigation can ferret out crucial information about drug company deception and risky drugs. Just last week, documents unearthed in lawsuits indicated that Merck, the maker of Vioxx, apparently downplayed evidence that the medicine tripled the death risk in Alzheimer’s-prone patients.
Striking the right balance, though, is tricky. Plaintiffs are right when they charge that companies are sometimes derelict or deceptive when they seek approval for drugs or warn about their hazards. But pharmaceutical companies are also right to complain that they’re often subject to enormously costly litigation that in some cases has more to do with plundering their deep pockets than redressing legitimate grievances. Such frivolous lawsuits drive up the costs of medicine for everyone and can have a chilling effect on research and development of the next wonder drugs.
How, then, to be fair to all?
Simply blocking lawsuits, by ruling that FDA approval pre-empts them, would be destructive. Short-circuiting the discovery process would let companies conceal damaging secrets and make it virtually impossible to hold them accountable or correct the lapses of the FDA.
So let the suits proceed — but place a high burden of proof on the plaintiffs. Unless they can demonstrate that a company deliberately deceived the FDA or knowingly failed to warn about the risks of its medicines, they shouldn’t be able to collect a dime.
That should both protect the drug companies and help keep them honest.