A Louisiana woman has filed a lawsuit against Amylin Pharmaceuticals and Eli Lilly and Co., alleging that she developed pancreatic cancer from the diabetes Byetta pen.
The complaint (PDF) was filed by Electia Johnson in the U.S. District Court for the Sourthern District of California on June 10, alleging that the makers of the popular diabetes injection failed to adequately warn about the pancreatic cancer risks.
Johnson indicates that she began receiving the Byetta pen injections in December 2006 for treatment of her type 2 diabetes. The complaint states that she continued to use the medication until May 2010, and that the long-term use resulted in her developing pancreatic cancer that was diagnosed last July.
The complaint joins a growing number Byetta Pen lawsuits filed in courts throughout the United States, which allege that Amylin and Eli Lilly knew or should have known about the effect the Byetta pen may have on the pancreas, including an increased risk of chronic pancreatitis that may ultimately lead to pancreatic cancer.
“Due to the flawed formulation of Byetta, it increases the risk of pancreatic cancer in those diabetic patients to whom it is prescribed,” the lawsuit filed by Johnson states. “Defendants concealed their knowledge that Byetta can cause life threatening pancreatic cancer from Plaintiff, other consumers, the general public, and the medical community. Indeed, the manufacturers of Byetta do not even mention ‘pancreatic cancer’ in the Drug’s product insert.”
The complaint charges the makers of the Byetta pen with failure to warn, designing a defective product, negligence, breach of warranty, and fraudulent concealment. The claim seeks compensatory and punitive damages.
Entire Class of Diabetes Drugs Linked to Pancreatic Cancer
Byetta (exenatide) is a subcutaneous injection that is administered twice a day through a self-contained device commonly referred to as a “Pen”.
The medication is part of a class of medications known as incretin mimetics, which work by mimicking the incretin hormones that are normally stimulated to release insulin following a meal to help reduce blood sugar levels in type 2 diabetics.
Originally introduced in 2005, the twice-daily Byetta Pen injection was the first member of this class of medications to be approved in the United States. The following year, Merck introduced Januvia (sitagliptin), which is a pill, and Janumet, which combines Januvia and metformin. Victoza (liraglutide) was introduced by Novo Nordisk in 2010 as a daily injection.
Earlier this year, the FDA launched an investigation into the potential risk of pancreatic cancer with all incretin mimetic diabetes drugs. The safety review was initiated after results of a recent 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.
More than 50 lawsuits over Januvia, Byetta and Victoza have been filed in U.S. District Courts throughout the country, all involving similar allegations that the drug makers failed to adequately warn about the risk of pancreatic cancer and the importance of monitoring for changes to the pancreas during treatment.
In April, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking to consolidate all pancreatic cancer lawsuits filed by former users of Byetta, Victoza, Januvia and Janumet, asking that the cases be centralized before one judge in the federal court system for coordinated pretrial proceedings.
The U.S. JPML is scheduled to hear oral arguments on the motion at an upcoming session scheduled for July 25 in Portland, Maine. If an MDL is established for all Byetta lawsuits, Victoza lawsuits, Januvia lawsuits and Janumet lawsuits filed throughout the federal court system would be centralized.