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Incretin-Based Diabetes Drug Lawsuits Allege Increased Risk of Pancreatic Cancer

In August 2013, the United States Judicial Panel on Multidistrict Litigation (JPML) decided to consolidate all incretin-based diabetes drug lawsuits filed in federal court – including Januvia®, Janumet®, Victoza®, and Byetta® – into a centralized Multidistrict Litigation (MDL 2452). All federally filed incretin-based diabetes drug cases have been consolidated in the United States District Court for the Southern District of California before The Honorable Judge Anthony J. Battaglia. The first status conference in the MDL took place on October 17th in order to discuss the appointment of lead and liaison counsel for plaintiffs and defendants in order to aid the court in effectively managing and facilitating the litigation. Judge Battaglia has not yet issued a case management order (CMO) regarding the organization and structure of the MDL.

MDL 2452 involves four incretin-based diabetes drugs:

  1. Januvia®, manufactured by Merck Sharpe & Dohme, and introduced onto the United States market in 2006 as an oral medication;
  2. Janumet®, manufactured by Merck Sharpe & Dohme, and introduced onto the United States market in 2007 as a combination pill containing Januvia® and Metformin®;
  3. Victoza®, manufactured by Novo Nordisk Inc., and introduced onto the United States market in 2010 as a daily injection; and
  4. Byetta®, manufactured by Amylin Pharmaceuticals, and introduced onto the United States market in 2005 as a twice daily injection.

These lawsuits have been filed on behalf of injured persons who allegedly claim that these incretin-based drugs – used to treat type-2 diabetes – have led them to develop pancreatitis and pancreatic cancer. According to the most recent report issued by the JPML, there are currently 150 incretin-based diabetes drug lawsuits pending in MDL 2452.

Since the first incretin-based drug became available in 2005, concerns have mounted regarding potential side effects. In 2007, the FDA received 30 reports of acute pancreatitis in patients taking Byetta®, prompting its manufacturer to amend the drug’s warning label. By 2009, the FDA had mandated similar changes to prescribing information for Januvia®. In March 2013, a study published in JAMA Internal Medicine found that users of Januvia® and Byetta® are twice as likely to develop acute pancreatitis. Soon thereafter, the FDA issued a Drug Safety Communication and launched an investigation into whether there is an increased risk of pancreatitis and precancerous changes to the pancreas in patients taking incretin-based drugs.

 

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