A lawsuit over injuries allegedly caused by the multiple sclerosis drug, Tysabri, is staying in Massachusetts state court. The decision in the Tysabri case is a win for the opponents of federal preemption theory, which holds that Food & Drug Administration (FDA) approval of a drug disallows the filing of product liability suits against its maker in state courts.
Lawyers for Biogen Idec and Elan, the makers of Tysabri, had used the preemption argument to try to convince Judge Douglas Woodlock to move the lawsuit involving the late Joseph Tofanelli to federal court because, they argued, it ultimately hinges on the FDA’s role as regulator of prescription drugs. But the judge refused, mainly because the Supreme Court is set to hear a case involving the preemption issue this fall. “The Defendants are essentially proposing that I exercise federal jurisdiction given the unsettled nature of the law in this area. I decline their offer,” Judge Woodlock wrote in his opinion.
While the decision is a victory for the foes of pre-emption, it could be a brief one. This fall, the Supreme Court is scheduled to hear Wyeth vs. Levin, a case in which drug maker Wyeth is claiming that FDA approval bars state product liability lawsuits. The High Court has already ruled that such preemption exists in regards to medical devices, and it is widely expected to side with drug makers in the Wyeth case.
About 31,800 people take Tysabri, which is also used to treat Crohn’s disease, a digestive condition. The Tofanelli case involved a brain infection called herpes encephalitis that the victim’s family claims was caused by Tysabri. The drug has been linked to another fatal brain infection, known as progressive multifocal leukoencephalopathy, or PML. Tysabri was actually removed from the market in 2006 after patients in a clinical trial died from PML. But it was returned to the market just a year later.
Last week, Elan and Biogen Idec confirmed that two more patients in Europe have developed PML. At this time, one is ambulatory and the other is hospitalized. One patient had been taking Tysabri for 14 months and the other for 17. The most disturbing aspect of these latest PML cases was that both patients had been taking Tysabri as monotherapy – with no other drugs. It had been theorized that patients contracting PML had done so because of exposure to multiple medications and that monotherapy with Tysabri was less risky.
In 2005, the law firm Parker Waichman Alonso LLP was retained by the estate of Anita Smith, a patient who died from a confirmed case of PML while taking Tysabri. In its 2005 Annual Report, Elan Inc. informed shareholders that it had entered into settlement talks with the lawyers representing Anita Smith’s estate. When contacted, Jerry Parker, the managing partner of Parker Waichman Alonso LLP said the Anita Smith Tysabri case had been resolved, but that the case was confidential.
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