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 theEuropean 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.
In a famous case in 2009, the Supreme Court ruled a Vermont woman was allowed to proceed with a lawsuit because a drug maker failed to adequately warn about serious risks. In that case, known as Wyeth v. Levine, the court ruled FDA approval of a drug does not shield drug makers from a lawsuit, unless there is “clear evidence” the agency would not have approved labeling changes.
An attorney for the plaintiffs, Hunter Shkolnik, wrote us that an appeal is planned. “I don’t expect it to stand but this is a very disturbing and now give the manufacturer a pass on safety,” he wrote. Another plaintiffs’ attorney, Louis Bograd, told us the judge “incorrectly reasoned that the FDA would not have approved a warning proposed by the manufacturers.”
Since the Levine case, rulings in favor of drug makers have occurred, but are unusual, according to Carl Tobias, a professor at the University of Richmond law school, who tracks pharmaceutical industry litigation. But he cautioned that the facts in each lawsuit can vary, so it can be difficult to draw sweeping conclusions from any one ruling.
“Right now, it’s a ruling by one district judge in California. So at this point, it doesn’t have huge implications. But there is, potentially, a lot at stake here for the plaintiffs and similar cases,” he tells us. “If the companies were to prevail, it could become an important precedent for companies in similar cases, because it could clarify what a manufacturer has to show to avoid liability.”