We believe that Amylin possessed data prior to the 2007 label revision that justified a stronger and more prominent warning than the precaution language that Amylin ultimately negotiated with FDA
San Diego, CA (PRWEB) August 20, 2008
A Virginia man yesterday filed what is believed to be the first personal injury lawsuit stemming from injuries associated with the use of Byetta®, an injectable medication for diabetes. Victor Deleon alleges in a lawsuit filed in San Diego Superior Court (Case No. 37-2008-00090003-CU-PL-CTL) that the manufacturer of the drug, San Diego-based Amylin Pharmaceuticals, Inc., and the drug's co-marketer, Eli Lilly and Company, failed to adequately test and monitor the side effects of Byetta®, and didn't warn doctors or patients of the risk of developing pancreatitis. Deleon was hospitalized in December of 2007 after developing the condition, which causes inflammation of the pancreas and can lead to bleeding and death.
Deleon's lawsuit comes two days after the Food and Drug Administration (FDA) announced that it has received six reports of hemorrhagic or necrotizing pancreatitis in patients taking Byetta® since October of 2007. Two of the six patients died. In a press release, the FDA said it is "working with the maker of Byetta®" to add "stronger and more prominent warnings" to the product's label.
Deleon's lawsuit alleges that Amylin "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."
In the fall of 2007, Amylin agreed to add information about pancreatitis to the "precautions" section of the Byetta® label after the FDA reported 30 post-marketing reports of acute pancreatitis associated with the drug.
"It is pretty obvious that the label change in 2007 was not adequate," said Thomas M. Moore of Moore Labriola LLP in Newport Beach, who jointly represents Mr. Deleon with Michael Schmidt of The Schmidt Firm, LLP in Dallas, TX. "We believe that Amylin possessed data prior to the 2007 label revision that justified a stronger and more prominent warning than the precaution language that Amylin ultimately negotiated with FDA," Moore added.
The Schmidt Firm, LLP
Lthomas @ schmidtlaw.com