Byetta and Januvia Lawsuits Coordinated in California District Court
The controversial diabetes drugs marketed as Januvia, Janumet, Byetta and Victoza all belong to the same class of medications known as incretin mimetics. Patients have reported life-threatening side effects from each, including chronic and acute pancreatitis – a serious condition that is often a precursor to pancreatic cancer. Over the past year, a growing number of product liability complaints have been brought by former users of Byetta and Januvia, in which plaintiffs claim they developed pancreatic cancer – one of the most deadly types of cancers, with just a five-year survival rate.
To more efficiently manage pretrial proceedings for all Byetta and Januvia lawsuits filed in the federal court system, cases have been consolidated before one judge to help expedite the discovery process and reduce burdens on the judicial system. According to a transfer order released on August 26, qualifying Victoza, Janumet, Januvia and Byetta lawsuits will be centralized as the Incretin Mimetics Product Liability Litigation. The site of the Januvia multidistrict litigation will be the Southern District of California before Judge Anthony J. Battaglia.
Byetta, Januvia lawsuits alleging cancer centralized as MDL
Court dockets show there are at least 53 pancreatic cancer lawsuits alleging incretin mimetics caused the disease pending in seven districts, though the bulk of the claims were brought in the U.S. District Court for the Southern District of California. Legal analysts familiar with dangerous Januvia and Byetta side effects alleged in the ongoing litigation anticipate that the incretin mimetics MDL will eventually amass hundreds if not thousands of additional lawsuits.
Even though the lawsuits bring claims against several manufacturers, the Judicial Panel on Multidistrict Litigation (JPML) decided in favor of coordinating incretin mimetic complaints as one MDL because most patients took a combination of the diabetes drugs before discovering their side effects and complications.
The judicial panel stated, “Plaintiffs in the cases now before us, however, make highly similar allegations about each of the four drugs that manage blood insulin levels and the propensity of those drugs to cause pancreatic cancer…Several plaintiffs took more than one of the drugs at issue, which suggests that discovery specific to the plaintiffs in those cases will involve many of the same or substantially similar documents and witnesses.”
FDA investigates Byetta/Januvia and pancreatic cancer risks
Merck has enjoyed robust sales from its Janumet and Januvia, earning more than $4 billion in sales last year. Launched by Novo Nordisk in 2010, Victoza is an injectible similar to Amylin Pharmaceuticals’ Byetta. While the FDA has not reached definitive conclusions regarding pancreatic cancer risks, the agency released a communication in March 2013 stating it was investigating research about pancreatic toxicity associated with incretin mimetics.
The study that prompted the FDA evaluation was published in JAMA Internal Medicine. Results of the research conducted by Johns Hopkins Hospital showed that Januvia and Byetta exposure could double a patient’s risk of developing pancreatitis – a finding that concerned many in the medical community, since pancreatitis may develop into cancer of the pancreas.
Those who have filed a Januvia or Byetta lawsuit argue that the manufacturers failed to warn about possible side effects, and should be held liable for their injuries.
- U.S. Judicial Panel on Multidistrict Litigation, IN RE: INCRETIN MIMETICS PRODUCTS LIABILITY LITIGATION Transfer Order, http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2452-Initial_Transfer-07-13.pdf
- FDA, Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication - Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas, http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm343805.htm