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A Virginia man has filed a personal injury lawsuit in San Diego Superior Court against Amylin Pharmaceuticals, the manufacturer, and Eli Lilly and Company, the co-marketer, of the injectable diabetes drug Byetta(R). This personal injury lawsuit may be the first of its kind against the manufacturer of a pharmaceutical company.

In 2007 Amylin negotiated with the FDA to inform patients of the risk of acute pancreatitis by adding it to the “precautions” on the ByrettaR warning label provided to physicians and patients . This addition to the warning label was a direct result of 30 cases of acute pancreatitus from using the drug.

The personal injury lawsuit alleges the manufacturer “failed to adequately warn prescribing physicians of the risk of pancreatitis, of measures needed to properly assess the appropriateness of prescribing the drug to certain categories of patients, and of measures doctors and patients could and should take to minimize the risk.”

The plaintiff, who was prescribed ByettaR for his diabetes, was hospitalized in December, 2007 for pancreatitis, or inflammation of the pancreas. Pancreatitis can cause bleeding and even death. The plaintiff’s attorney, Thomas M. Moore of Moore Labriola LLP, states “it is pretty obvious that the label change in 2007 was not adequate.”

Coincidently, two days after the lawsuit was filed, the FDA reported that six cases of hermorrhagic or necrotizing pancreatitis in patients who were prescribed ByettaR and two of those six victims died. And just yesterday Amylin and Lilly reported that four more people have died from taking ByettaR.

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