Blocking Medical Product Suits (editorial)
It is disheartening that the Bush administration has been intervening in court to block lawsuits filed by people seeking compensation from manufacturers for harm allegedly caused by drugs or medical devices. As described by Robert Pear in last Sunday's Times, the administration has argued in several cases that individual consumers have no right to sue for such injuries if the products have been approved by the Food and Drug Administration. If the Bush administration's campaign proves broadly successful, people injured by drugs or medical devices may be left without legal recourse, no matter how just their complaints....
The administration argues that allowing consumers to sue the manufacturers would undermine federal regulation of drugs and devices by encouraging lay judges and juries to second-guess the experts at the F.D.A. The result could be a hodgepodge of conflicting judgments around the country as to the safety of a product and the need to change warning labels. Skittish manufacturers might then remove good products from the market or issue scary warnings that would discourage their use.
These concerns seem overblown and are offset by other considerations. The F.D.A. is not infallible. It seems poor policy to assume that once the agency has judged a product safe enough to use, the manufacturer should be insulated forever from lawsuits that could force improvements. Simple justice suggests that victims harmed by a product should be able to seek compensation. If a manufacturer has acted in good faith and received the agency's approval, the likelihood of huge punitive damages — the real bêtes noires of the tort reformers — seems slight.
Angered by the F.D.A.'s intervention on the side of manufacturers against consumers in several cases, Representative Maurice Hinchey, Democrat of New York, persuaded the House to amend an appropriations bill to strip $500,000 from the agency's legal budget as a penalty and use it instead to police the accuracy of drug advertising. If the Senate finds that approach too punitive, it might forgo the financial penalty and simply direct the agency not to intervene in product liability cases unless it is asked to do so by the courts. Or perhaps Congress should devise a new compensation fund so that victims who are blocked from suing can nevertheless be compensated for any damage they have suffered. Meanwhile, if the administration wants to "reform" the tort system it should tackle the problem broadly, not piecemeal through individual suits.
