PRE-EMPTION REDUX Godosky & Gentile Attorneys New York New York

PRE-EMPTION REDUX

Posted by: William Gentile
November 11, 2008
Topic: Products Liability

The New York Times has a cautionary editorial (hat-tip TortDeform) on the Wyeth pre-emption case we addressed last week. As we discussed, a Supreme Court decision applying the doctrine of pre-emption to FDA-approved drugs would bar injured plaintiffs from sucessfully suing the producer of an FDA-approved drug for any harm caused by that drug. In the editorial, the Times warns that the effects of this application would be far-reaching:

For the court to broadly endorse the concept of "implied pre-emption" in this case would show disrespect for the considered decisions of Congress and could foreclose injury suits involving not only drugs, but also motor vehicles, household products and other things. The ultimate effect would be to undermine consumer safety.

Far from usurping the F.D.A.'s power, litigation aimed at holding drug companies liable for problems like those in this case complement the agency's efforts to protect the public. For many years the F.D.A. welcomed state failure-to-warn suits as reinforcing those efforts; two former commissioners, David Kessler and Donald Kennedy, made that point in a brief in the case.

It is only during the Bush administration that the FDA leadership has viewed litigation as a hindrance to its consumer protection efforts. In fact, the Wall Street Journal reported recently:

Bush administration officials, in their last weeks in office, are pushing to rewrite a wide array of federal rules with changes or additions that could block product-safety lawsuits by consumers and states.

The administration has written language aimed at pre-empting product-liability litigation into 50 rules governing everything from motorcycle brakes to pain medicine. The latest changes cap a multiyear effort that could be one of the administration's lasting legacies, depending in part on how the underlying principle of pre-emption fares in a case the Supreme Court will hear next month.

The good news is that the Bush administration's eight-year attack on the civil justice system is almost over. If he chooses, Barack Obama can undo in short order much of the damage Bush has wrought. The problem, however, is that the Wyeth case is in the hands of the Roberts Court, which has already decided in favor of pre-emption in a recent case.