Tysabri Negligence Case Dismissed
A Utah federal court has granted summary judgment to Biogen Idec and Elan, dismissing a negligence case brought against them by a man whose wife died from progressive multifocal leukoencephalopathy (PML) after being prescribed Tysabri (natalizumab) for her multiple sclerosis. The suit claimed negligence, negligent failure to warn, and negligent misrepresentation on the part of the companies.
The suit claimed that the companies had a duty to ensure that their product was safe and had a duty to warn consumers of reasonably foreseeable dangers. It also said they acted negligently in not updating the Tysabri label with sufficient information. It argued that the label should have included warnings about increased risk of developing PML if a patient had previously tested positive for JC virus antibodies, had used immunosuppressant drugs in the past, or had taken Tysabri for an extended period. Each of those factors was on the label by the end of 2012, the court says, but were not listed at the time the woman took the drug and died in 2009.
The companies offered several reasons why they were entitled to summary judgment, including that the plaintiff offered no expert testimony about alleged inadequacies in the labeling, that the labeling was adequate as a matter of law, that the plaintiff could not establish proximate cause, that the company had no legal duty to develop and commercialize a JC virus antibody assay, and that the plaintiff’s claims were preempted by federal law.
The court noted that the learned intermediary doctrine applies in Utah and thus any warnings were directed to the patient’s doctor and not to the patient. The patient’s doctor testified that the label was sufficient to inform him of the drug’s risks and also testified that the patient and her husband had signed multiple consent forms acknowledging the risks as they were known at the time.
Summary judgment was granted on all of the companies’ arguments other than the question of whether they had a duty to develop and commercialize an antibody assay. In that instance, the judge said that the question was not whether the companies had a legal duty to develop an assay, but rather whether their conduct had been reasonable under the circumstances. He said that had the case gone to a jury, it could have determined the reasonableness of the companies’ actions. But the case did not go to a jury because summary judgment was granted on three grounds — federal preemption of the state law claims, the adequacy of the Tysabri labeling as a matter of law because FDA exercised significant control over the label contents and the label specifically warned about PML risk based on the extent of scientific knowledge at the time, and the plaintiff’s failure to provide expert testimony to support any argument about the inadequacy of the Tysabri label.