Judge strikes down Biogen preemption case

Biogen and Elan--along with proponents of preemption--were dealt a setback today as a federal judge declined to transfer a case from Massachusetts to a federal court in Iowa. The lawsuit stems from the death of a patient who contracted PML [1] after taking Tysabri; the drug was pulled from the market 11 days later. The patient's wife sued the drugmakers in Massachusetts, where Biogen is based. But drugmakers are waiting for the Supreme Court to rule on the issue of preemption, which asserts that the FDA's approval of a drug shields companies from lawsuits. They're expected to hear a precedent-setting case--Wyeth v. Levine [2]--this fall. Biogen and Elan argued that the Massachusetts case should be moved to federal court because the fundamental question is whether the FDA's word protects drugmakers.

However, Judge Douglas Woodcock ruled against the developers, saying that preemption is not part of the law at this time and as such, the suit should stay in state court where it was filed. "The Defendants are essentially proposing that I exercise federal jurisdiction given the unsettled nature of the law in this area. I decline their offer," he said in his opinion. "Present posture of case law does not justify removal from state court to this [federal] court.

- here's the Wall Street Journal article [3]
- check out the Pharmalot post [4] for more

Related Articles:
Reps introduce anti-preemption bill [5]
Dems plan anti-preemption bill for devices [6]
Quaid: Preemption unfair to patients [7]
Preemption debate heats up [8]
Bush: FDA's word shields against lawsuits [9]