Drug makers beat diabetes lawsuits with an unusual ruling

Several drug makers were handed an unexpected victory this week when a federal judge ruled they weren’t required to update product labels to warn about risks of pancreatic cancer with their diabetes medicines.

In a 35-page ruling, US District Court Judge Anthony Battaglia explained the labeling changes were not required because the Food and Drug Administration would not have approved those changes. As a result, approximately 750 cases are being tossed.

At issue is a legal concept known as preemption, which refers to federal law trumping state law. The companies argued to have the lawsuits dismissed, since the FDA would not have required them to update labels to reflect risks about pancreatic cancer.

In their view, FDA requirements took precedent over the right of individuals to rely on state laws that allow them to file lawsuits over alleged injuries. And the judge agreed, writing that “clear evidence exists that the FDA would have rejected a reference to pancreatic cancer in product labeling.”

“The record establishes the FDA has specifically considered pancreatic cancer risk, commented publicly on the adequacy of drug labeling, and maintained its position that scientific evidence of a causal association between [the drugs] and pancreatic cancer is indeterminate,” Battaglia wrote.

Controversy erupted several years ago over concerns that some type 2 diabetes may cause pancreatic cancer, but the FDA and the European Medicines Agency, did not find conclusive evidence. The most popular such drug is Januvia, which is sold by Merck. Others are sold by Novo Nordisk and Eli Lilly.