A Virginia man has filed a personal injury suit in San Diego, California Superior Court against Amylin Pharmaceuticals and co-marketer Eli Lilly & Company for Byetta, an injectable drug used for the treatment of the disabling condition of diabetes. The suit is believed to be the first of its kind against the manufacturer of a pharmaceutical product.
In 2007, Amylin negotiated with the U.S. Food and Drug Administration in order to make patients aware of the risk of acute pancreatitis by adding it to the “precautions” on the warning label for Byetta.
The suit alleges that the manufacture was negligent for its failure to adequately warn prescribing physicians of the risks of pancreatitis, the proper measures to asses the appropriateness of prescribing the drug to certain kinds of patients, and measures doctors and patients should take in order for the risk to be minimized.
In December of 2007, the plaintiff was sent to the hospital for pancreatitis, which is inflammation of the pancreas, after he was prescribed Byetta to treat his diabetes. Pancreatitis can cause bleeding and potentially death.
Incidentally, mere days after the suit was filed, six cases of hemorrhagic or necrotizing pancreatitis in patients who were prescribed Byetta with two of the six dying.