More than 1,000 lawsuits alleging pancreatic cancer side effects from Byetta, Victoza, Januvia, and other similar diabetes medications are being thrown out after a federal judge determined that the claims were preempted by federal law and lacked evidence of general causation. The judge’s ruling was a substantial victory for the drug manufacturers, who argued that they were not required to update their product labeling to include warnings about the risk of pancreatic cancer and that plaintiffs failed to establish a causal link between pancreatic cancer and their products. Sadly, the decision to dismiss the cases comes as a blow to type 2 diabetes patients who have been burdened by the physical, emotional, and financial strain of a pancreatic cancer diagnosis. If you or someone you know developed pancreatic cancer or pancreatitis after taking an incretin mimetic like Byetta, Januvia, or Victoza, we can help. Contact Consumer Safety Watch today to find out if you may be eligible to file a claim against the drug maker.
The incretin mimetic class of diabetes drugs includes Byetta (exenatide), Januvia/Janumet (sitagliptin), Victoza (liraglutide), and other similar medications prescribed to treat type 2 diabetes. After evidence emerged linking the popular drugs to pancreatitis and pancreatic cancer side effects in patients with type 2 diabetes nearly a decade ago, former users began suing the drug manufacturers for failure to warn. In 2013, all incretin mimetic lawsuits pending in the federal court system were centralized in the U.S. District Court for the Southern District of California for coordinated pretrial proceedings, as part of a multidistrict litigation (MDL). Two years later, the federal judge overseeing the incretin mimetic MDL, U.S. District Judge Anthony Battaglia, dismissed the claims, ruling that the lawsuits were preempted by federal law.
Preemption is a legal term having to do with the invalidation of a U.S. state law that conflicts with a federal law. When Judge Battaglia dismissed the incretin mimetic lawsuits in 2015, he did so on the assumption that the FDA would not have approved the addition of pancreatic cancer warnings to the product labeling, which allowed the drug makers to dodge failure to warn claims based on state law. However, in 2017, the U.S. Court of Appeals for the Ninth Circuit overturned Judge Battaglia’s ruling and reinstated the incretin mimetic lawsuits, only to have them dismissed once again last month. In an omnibus order issued by the court on March 9, 2021, Judge Battaglia once again indicated that the incretin mimetic cases should be dismissed, granting the defendants’ renewed joint motion for summary judgment based on preemption, which asserts that it is impossible for the drug makers to comply with both FDA regulations and state law failure-to-warn requirements.
“In discharging its regulatory duties, the FDA oversees the introduction of new drugs into the market, regulates the content of drug labeling, and ensures manufacturers comply with post-marketing requirements,” the order states. “Despite the FDA’s broad regulatory duties, a drug manufacturer remains primarily responsible for maintaining the adequacy of product labeling. State tort law is therefore generally viewed as a complimentary form of drug regulation, providing additional protections and recourse for injured consumers. Yet, when state tort law imposes a duty impossible to meet in light of FDA regulations, federal law will preempt state law.”
Judge Battaglia also granted the defendants’ motion for summary judgment based on a lack of general causation, which is a key component of product liability cases and requires expert evidence. The defendants argued in their motion that the plaintiffs failed to provide proof of a causal link between incretin mimetic medications and pancreatic cancer. “As previously analyzed, the opinions of Plaintiffs’ experts are unreliable and therefore do not constitute admissible evidence,” Judge Battaglia states in the omnibus order. “With no expert evidence to show a causal relationship between incretin-based therapies and pancreatic cancer, Plaintiffs cannot demonstrate a genuine dispute of material fact as to the element of general causation.”
There are currently more than 1,000 lawsuits pending in the federal Incretin-Based Therapies Products Liability Litigation, all of which involve similar allegations that the manufacturers of Byetta, Januvia, Victoza, Janumet, and other incretin mimetics failed to warn patients and healthcare providers about the potential for their drugs to cause pancreatic cancer in users. Sadly, these claims are now under threat due to Judge Battaglia’s ruling, which is yet another example of drug manufacturers escaping liability for the alleged harm caused by their dangerous drugs. If you took Byetta, Januvia, or another popular incretin mimetic drug for type 2 diabetes, and you were subsequently diagnosed with a major medical condition like pancreatic cancer or pancreatitis, do not hesitate to seek legal help from an experienced product liability attorney. With the help of a reputable lawyer, you may be able to pursue a legal claim against the drug manufacturer for compensation.