Bad news for those plaintiffs who developed incurable pancreatic cancer from using incretin mimetic Byetta, Januvia, Janumet and Victoza diabetic medications.
U.S. District Judge Anthony Battaglia has ruled that Byetta, Januvia, Janumet and Victoza diabetic medication manufacturers should be shielded from liability for failure to warn based on federal pre-emption. Judge Battaglia, has granted the defense’s motion for summary judgment.
The ruling will lead to the dismissal of 750 pancreatic cancer lawsuits filed by users of Byetta, Januvia, Janumet and Victoza, which are centralized and consolidated in Southern District of California in San Diego, as part of a federal multidistrict litigation (MDL).
The state-court failure to warn pancreatic cancer claims are also pre-empted by federal law, since federal law trumps state laws.
Byetta, Januvia and Victoza Diabetes Drug Litigation
Since August 2013, all federal pancreatic cancer personal injury and product liability lawsuits involving diabetic patients diagnosed with pancreatic cancer after the use of these diabetes drugs have been consolidated before Judge Battaglia for pretrial discovery.
The plaintiffs claimed that the pharmaceutical manufacturers of Byetta, Januvia, Janumet and Victoza, failed to research the catastrophic side effects of their drugs or warn patients or their doctors that they are exposed to an increased risk of pancreatic cancer.
Federal Incretin Mimetic Litigation Torpedoed
Byetta, Januvia and Victoza are a new class of diabetic medications, known as Incretin Mimetics. Incretin mimetics are an extremely popular class of diabetes drugs, which work by copying the action of incretin hormones that the body produces to stimulate the release of insulin following food. Diabetic patients have a problem in that either they don’t produce enough insulin or that they have insulin resistance.
Judge Battaglia found that the failure to warn claims are pre-empted, and that the FDA would not have allowed the drug makers to make the warning label changes notifying the public about pancreatic cancer risks. In essence, the litigation has been stopped cold and unless successfully appealed, these devastating pancreatic cancer cases will be dismissed.
FDA Powerless to Act
Judge Battaglia’s ruling is in accordance with Wyeth v. Levine, a 2009 U.S. Supreme Court ruling. Wyeth v. Levine provides any drug manufacturer with a “get out of jail free card,” essentially full immunity for selling dangerous and defective drugs if they can show that the FDA approved the medication or would have rejected a warning update, even if the pharmaceutical companies know the warnings are deficient.
According to the ruling, “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 incretin mimetics and pancreatic cancer is indeterminate. Because an indeterminate causal association falls below the federal regulatory standards required for labeling changes, clear evidence exists that the FDA would have rejected a reference to pancreatic cancer in product labeling.”
The plaintiffs in the pancreatic cancer litigation have indicated they will appeal the ruling to the U.S. Court of Appeals for the Ninth Circuit.
2014 New England Journal Medicine Report
According to a report in the New England Journal of Medicine on February 27, 2014, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regulators assessed the risk of pancreatitis and pancreatic cancer associated with incretin mimetics.
The report found that there is no evidence establishing a causal link to pancreatic cancer with Byetta, Januvia or other incretin mimetics. Several recent studies have found an increased risk of acute pancreatitis, pancreatic cancer and thyroid cancer among users of these drugs. But the governmental agencies state that they looked at the same data, but were unable to reach the same conclusions.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.