Several drug makers won an unexpected victory this week when a federal judge ruled that they were not required to update product labels to warn of cancer risks. pancreas with their diabetes medications.
In a 35-page judgment Justice Anthony Battaglia of the United States District Court explained that labeling changes were not necessary because the Food and Drug Administration Drug Administration would not have approved these changes. As a result, about 750 cases are launched.
At issue is a legal concept known as preemption, which refers to the federal law that prevails over state law. The companies argued that the lawsuits were dismissed as the FDA would not have asked them to update the labels to reflect the risks of pancreatic cancer.
In their view, the FDA's requirements take precedence over the right of individuals to rely on state laws that allow them to complain about alleged injuries. And the judge agreed, writing that "clear evidence exists that the FDA would have rejected a reference to pancreatic cancer in the labeling of products."
"The record establishes that the FDA has specifically examined the risk of pancreatic cancer, publicly commented on the adequacy of drug labeling and maintained its position that scientific evidence of an association causal relationship between pancreatic cancer and indeterminate are indeterminate, "writes Battaglia.
Controversy erupted several years ago over concerns that some type 2 diabetes can cause pancreatic cancer, but the FDA and the European Medicines Agency have not found conclusive evidence. The most popular 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 that a Vermont woman had been allowed to sue because a drug manufacturer had not sufficiently enacted guard against serious risks. In this case, known as Wyeth c. Levine, the court ruled that the approval of a drug by the FDA does not protect drug manufacturers from legal action, unless there is clear evidence.
A plaintiffs' attorney, Hunter Shkolnik, wrote us that an appeal was planned. "I do not expect it to continue, but it is very disturbing and now gives the builder a security rating," he wrote. The attorney of another plaintiff, Louis Bograd, told us that the judge "incorrectly reasoned that the FDA would not have approved a warning proposed by the manufacturers."
Since the Levine case, decisions in favor of drug makers have been made, but are unusual, according to Carl Tobias, a professor at the University of Richmond Law School who follows the litigation of the pharmaceutical industry. But he cautioned that the facts in each lawsuit may vary, so it may be difficult to draw radical conclusions from a single judgment.
"Right now, it's a decision of a district judge in California, so at this point, it does not have huge implications." But there is , potentially, a lot at stake here for plaintiffs and similar cases, "he tells us. "If companies were to prevail, this could become an important precedent for companies in similar cases, as this could clarify what a manufacturer must show to avoid any liability."