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A lawsuit filed by a California woman who alleges that she developed pancreatic cancer from Byetta and Victoza side effects is being sent back to state court, after a federal judge determined that a local distributor will remain as a defendant in the case.
Dawn Smith originally filed her case in San Diego Superior Court, presenting claims against the makers of the diabetes drugs Byetta and Victoza, Amylin Pharmaceuticals, Eli Lilly and Novo Nordisk, Inc., as well as the distributor for the medications in California, McKesson Corporation.
The case was removed to the U.S. District Court for the Southern District of California earlier this year, after Amylin claimed that McKesson was improperly joined in the lawsuit, resulting in federal diversity jurisdiction. However, U.S. District Judge Anthony Battaglia ruled (PDF) last week that McKesson Corporation will remain as a defendant and remanded the case back to California state court.
According to allegations raised in Smith’s pancreatic cancer lawsuit over Byetta and Victoza, she indicates that all of the defendants were responsible for failing to adequately warn concerns about the potential side effects of the medications. Smith argued that McKesson is a proper defendant since the company helped “assist pharmacists, counsel patients, and market, promote, and distribute safety information regarding Byetta.”
Diabetes Drug Pancreatic Cancer Concerns
Byetta and Victoza are two popular diabetes drugs that are part of a class of medications, known as incretin mimetics, which have been linked to an increased risk of pancreatic cancer and acute pancreatitis. The medications, as well as other members of the same class, such as Januvia and Janumet, have been the subject of a number of similar lawsuits brought in recent months by patients who allege the drug makers ignored information about the risk of pancreatic cancer.
Byetta (exenatide) was the first member of this class approved by the FDA, introduced by Amylin Pharmaceuticals in 2005 as a twice daily injection. Januvia (sitagliptin) was introduced by Merck the following year as an oral medication, and a combination pill containing Januvia and the older diabetes medication metformin was introduced in 2007 under the brand name Janumet. Victoza (liraglutide) was introduced by Novo Nordisk in 2010 as a daily injection.
The medications are widely used among individuals with type 2 diabetes, generating billions in annual sales. Januvia and Janumet are among the best selling medications for the global pharmaceutical company Merck, generating about $4 billion in sales last year. Victoza sales were about $1.8 billion last year for Novo Nordisk and Byetta earned a reported $149 million for Amylin Pharmaceuticals.
Concerns about the risk of pancreatic cancer following Januvia, Janumet, Victoza or Byetta use have emerged over the past year, with a number of studies suggesting that asymptomatic pancreatitis caused by the medications may cause some users to subsequently develop cancer.
In March, the FDA launched an investigation into the potential pancreatic cancer risk associated with incretin mimetics after a study identified pre-cancerous cellular changes in pancreatic tissue taken from individuals treated with one of the drugs. European health officials have also launched a similar review.
Later this month, the U.S. Judicial Panel on Multidistrict Litigation is scheduled to hear oral arguments on a motion to consolidate and centralize all Byetta lawsuits, Victoza lawsuits, Januvia lawsuits and Janumet lawsuits brought throughout the federal court system by individuals diagnosed with pancreatic cancer.
If the MDL is established, all cases pending in U.S. District Courts throughout the country would be transferred to one judge for coordinated pretrial proceedings to reduce duplicative discovery, avoid conflicting rulings from different judges and to serve the convenience of the witnesses, parties and courts.