Law suits stall awaiting FDA pre-emption verdict

A series of law suits against drugmakers in US courts have been postponed until the Supreme Court of the United States (SCOTUS) has had a chance to rule whether the Food and Drug Administration's regulation of prescription drugs pre-empts state tort laws (Marketletters passim). However, one case involving US biotechnology firm Biogen Idec and Ireland-based Elan's multiple sclerosis drug Tysabri (natalizumab) will not be referred to a federal court in Iowa on the grounds that, for the time being, Massachusetts product liability legislation has not been overturned.

The case illustrates some of the reasons why pharmaceutical firms are pressing for the FDA's rules to take precedence. Lawyers acting for a deceased patient who had been prescribed Tysabri and died three months after taking a single dose of the drug successfully argued that the case should be heard in Massachusetts, where Biogen has its corporate headquarters and where product liability laws are stricter than average for the USA. The firm, however, wanted the case heard in a federal court in Iowa, where the alleged victim, who developed herpes encephalitis, a rare brain disease, resided. So far, the dispute over jurisdiction has taken 14 months to resolve, the lawyer acting for the plaintiff said. According to a report on the Wall Street Journal's Health Blog, the decision to keep the case at a state court level "is a blow, though perhaps only a fleeting one, for the supporters of pre-emption..."

Supreme Court to rule in November