SCOTUS signals FDA pre-emption support

The Supreme Court of the United States (SCOTUS) has issued several strong indications that it is prepared to accept the legal argument that Food and Drug Administration regulations pre-empt state law in pharmaceutical injury cases. First, the Court emphatically approved, by an eight to one margin, the case of Riegel versus Medtronic (Marketletters passim) that an FDA-approved device cannot be the object of a state law suit. A precedent had been made in a similar case by the SCOTUS in 1996 which had produced an opposite verdict. However, supporters of tort law claims argue that there are important legislative differences between a case involving medical devices and one for a drug.

Days later, the Supreme Court examined one element of the Warner-Lambert vs Kent case, in which the Pfizer unit was accused of withholding evidence from the FDA that would have prevented marketing approval of a diabetes drug Rezulin (troglitazone; Marketletter October 8, 2007), which has subsequently been withdrawn. The Justices, by the tone and direction of their questions and comments, seemed to be considering the view that the federal agency, not a jury in a state court, was best equipped to resolve issues involving drug law suits.

Even liberal members, such as Stephen Breyer, Anthony Kennedy and Ruth Bader Ginsberg, challenged lawyers acting for the 27 Michigan plaintiffs in the Warner-Lambert case. Justice Breyer asked: "what happens if the jury is wrong?" Justice Kennedy asked if the plaintiffs were arguing that Rezulin "should not have been on the market," while Justice Ginsberg (who was the lone dissenter in the Medtronic case) asked if the case was not "the kind of thing that the FDA would want to police itself?"