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Fred Baron and Compassionate Use

By James M. Beck and Mark Herrmann

We were saddened to read that prominent trial lawyer Fred Baron is dying of multiple myeloma.

In a funny (peculiar, not funny "ha, ha" -- there's nothing "ha, ha" about this) way, it's fitting that a legal twist would arise in the last days of his life.

We've posted before (here, here, and here) about Gunvalson v. PTC, the case in which a federal trial court ordered a drug company to provide an experimental drug (outside of the context of a clinical trial) to a boy suffering from muscular dystrophy.

Baron's in a similar situation. According to today's report in Pharmalot, "despite a furious publicity campaign," Biogen refuses to make Tysabri, which is in Phase I clinical trials for use to treat multiple myeloma, available to Baron. Pharmalot reports:

"A Biogen spokeswoman tells us the drugmaker has a policy of not making Tysabri, which is approved only for treating multiple sclerosis and Crohn?s disease, available for any other treatment, even for compassionate use. . . . The Biogen spokeswoman tells us that, given the drug?s complicated history, any inadvertent reactions Baron may experience could, theoretically, jeopardize its use for multiple sclerosis and Crohn?s patients if it would somehow cause labeling to change or spark another regulatory review."

There's nothing easy about legal situations such as these.

Full post as published by Drug and Device Law on October 16, 2008 (boomark / email).