District Judge Michael A. Telesca

 

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Plaintiff’s wrongful death action alleged his wife’s death was a direct result of taking the prescription drug Tysabri—developed, marketed, and sold by defendants—to treat her relapsing multiple sclerosis. Plaintiff claimed the drug caused his wife to develop progressive multifocal leukoencephalopathy (PML) an incurable, and ultimately fatal, brain infection, and that the warnings included with Tysabri inadequately warned of such risk. The court granted the defendant pharmaceuticals firms summary judgment, concluding that under the learned intermediary rule, Tsyabri’s “black box” warning label specifically warned treating physicians of an increased risk of PML. Moreover, the physician treating plaintiff’s wife deposition testimony that he was fully aware that PML was a risk of Tysabri use supported the conclusion that the warnings were adequate. The court agreed with the reasoning in Gentile v. Biogen Idec Inc. wherein the court ruled Tysabri’s warnings adequate as a matter of law under New York law because, when read as a whole, they unmistakably conveyed the seriousness of PML and its association with Tysabri treatment. The court further concluded that plaintiff’s claims were preempted by federal law.

District Judge Michael A. Telesca

 

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Plaintiff’s wrongful death action alleged his wife’s death was a direct result of taking the prescription drug Tysabri—developed, marketed, and sold by defendants—to treat her relapsing multiple sclerosis. Plaintiff claimed the drug caused his wife to develop progressive multifocal leukoencephalopathy (PML) an incurable, and ultimately fatal, brain infection, and that the warnings included with Tysabri inadequately warned of such risk. The court granted the defendant pharmaceuticals firms summary judgment, concluding that under the learned intermediary rule, Tsyabri’s “black box” warning label specifically warned treating physicians of an increased risk of PML. Moreover, the physician treating plaintiff’s wife deposition testimony that he was fully aware that PML was a risk of Tysabri use supported the conclusion that the warnings were adequate. The court agreed with the reasoning in Gentile v. Biogen Idec Inc. wherein the court ruled Tysabri’s warnings adequate as a matter of law under New York law because, when read as a whole, they unmistakably conveyed the seriousness of PML and its association with Tysabri treatment. The court further concluded that plaintiff’s claims were preempted by federal law.