SCOTUS signals support for FDA pre-emption

The Supreme Court of the United States (SCOTUS) has issued a strong indication that it is prepared to accept the legal argument that Food and Drug Administration regulations pre-empt state law in pharmaceutical injury cases. 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.

US drug major Wyeth expects to hear by before the end of June, whether its appeal against a lower court award of $6.8 million in damages to a patient in Vermont, who sustained a gangrene infection from a Phenergan (promethazine for injection) injection for nausea. The more conservative-oriented Supreme Court, to which President George W Bush has made two appointments since 2001, including the Chief Justice, John Roberts, both of whom have shifted the Court's political center towards the right. Another case, concerning global behemoth Pfizer's Warner-Lambert unit (Marketletter October 8, 2007) is also awaiting a decision. The oldest Supreme Court Justice currently in office is the 87-year-old John Paul Stevens, appointed in 1975, who is considered a liberal member of the Court.