Januvia & Byetta Lawsuits May be Consolidated
This month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) will determine whether more than fifty product liability lawsuits alleging Byetta and Januvia caused pancreatic cancer should be consolidated into multidistrict litigation (MDL) proceedings. The JPML will hear oral arguments for and against consolidating Byetta, Janumet, Victoza and Januvia lawsuits. The meeting is scheduled to take place on July 25.
The motion to centralize litigation was filed in April by a group of plaintiffs who developed pancreatic cancer after taking the incretin mimetic drugs. Research has shown incretin mimetics can increase the risk of pancreatitis and pre-cancerous cellular changes.
A scheduling order issued by the court states there are currently 53 product liability lawsuits pending in seven U.S. District courts. If it takes place, the MDL is likely to grow considerably, as more cases are filed.
The oral arguments for consolidation will be heard at the Edward T. Gignoux Federal Courthouse in Portland, Maine. Once a decision has been reached, the JPML will ascertain the most appropriate venue for the proceedings.
Cancer sufferers seek damages in Januvia lawsuit
The products at the center of the allegations work by mimicking the body’s natural production of incretin hormones that release insulin after eating. Known as incretin mimetics, Byetta, Januvia, Janumet and Victoza are used widely in the treatment of type 2 diabetes, and generate billions of dollars in annual sales.
Incretin mimetics have been available since 2005, when Amylin Pharmaceutical’s Byetta was first approved by the FDA. Requiring a twice daily injection, Byetta was followed a year later by Merck’s more convenient oral treatment Januvia. Janumet was released by Merck in 2007, and Victoza – an injectable produced by Novo Nordisk – in 2010.
Januvia and Janumet are two of Merck’s best-selling medications, pulling in combined sales of $4 billion in 2012. The same year, Victoza racked up sales worth $1.8 billion, and Byetta reportedly earned $149 million.
But there have been increasing incidents of pancreatic cancer among individuals who take the medications, prompting scores of patients to take legal action by filing a Januvia lawsuit in an attempt to recover damages.
Manufacturers consent to Januvia MDL
All manufacturers of the incretin mimetics have consented to centralizing lawsuits into MDL, as many of the plaintiffs involved have used more than one company’s product. In Ohio, a woman filed a Januvia and Byetta lawsuit alleging that both drugs contributed to her father’s death.
Each of the 53 cases make similar allegations: the drug makers knew or should have known about the increased risk of pancreatic cancer and failed to adequately warn the public or the medical community.
Some litigation proceedings have already been streamlined. In Southern California, the U.S. District Court has centralized over a dozen Byetta and Januvia lawsuits for discovery.
Consolidating the lawsuits is designed to reduce duplicative discovery across a large number of cases and to be more convenient for the witnesses, plaintiffs, defendants and the courts.
Speculation regarding the potential venue for the MDL ranges from California, where a number of Januvia side effects cases have been filed, and New Jersey, where defendants Merck have their headquarters.
Resources
- U.S. JPML, Scheduling Order Notice of Hearing Session http://www.jpml.uscourts.gov/sites/jpml/files/Hearing_Order-7-25-13.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