Ohio Plaintiff Blames Byetta for Husband’s Fatal Pancreatic Cancer

On June 28, 2013 a Byetta lawsuit was filed in U.S. District Court for the Southern District of California (San Diego). Brought by Rebecca Richard individually and on behalf of the estate of her deceased husband, the complaint alleges that David Richard developed deadly pancreatic cancer as a direct and proximate result of his use of the diabetes medication, Byetta. Drug manufacturers Amylin Pharmaceuticals and Eli Lilly are named as defendants on the complaint.

As detailed in court documents, the decedent was prescribed Byetta on July 27, 2005 and continued taking the medication through May 2010. After experiencing extreme pain in his abdomen, David Richard sought urgent medical attention in April 2011. By May he was diagnosed with advanced pancreatic cancer, which caused his premature death on July 27, 2011.

Plaintiff Rebecca Richards contends that the defendants failed to adequately inform consumers and health care providers about the risks of pancreatic cancer associated with Byetta, and also failed to caution physicians to introduce monitoring procedures looking for the first signs of changes within the pancreas. Once pancreatic cancer spreads, a patient stands just a 1.8% chance of surviving longer than five years.

Byetta side effects investigated by FDA

The FDA approved Byetta – a member of a new class of drugs called incretin mimetics (GPL-1) – in 2005 to help stabilize blood glucose levels and prevent complications in patients with Type 2 diabetes. However, by 2010 concerns were published regarding the GLP-1 drug  Byetta and DDP-4 inhibitors, including Januvia, and their potential link with pancreatic cancer.

Researchers wrote in the medical journal Diabetes Care, “However, in the context of a new class of medical therapy, the proverb ‘What you do not know cannot hurt you’ clearly does not apply. We feel that enough preliminary evidence has accumulated to suggest that there is a plausible risk that long-term recipients of GLP-1–based therapy may develop asymptomatic chronic pancreatitis (Fig. 1), and worse, subsequently a minority of individuals treated by this class of drug may develop pancreatic cancer.”

In 2011, additional research on Byetta side effects was published in the online journal Gastroenterology. The study showed that rates of pancreatic cancer was 2.9-fold greater in patients treated with Byetta versus other therapies.

On March 14 of this year, the FDA announced that it discovered evidence of pre-cancerous cell changes in pancreatic tissue samples of patients who took incretin mimetics like Byetta and Januvia. The drug safety communication stated, “The FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics.”

Prior clinical studies have already demonstrated that GLP-1 based therapies like Byetta substantially increase the risk of pancreatitis, a condition associated with higher instances of pancreatic cancer.

Plaintiff holds Byetta manufacturers liable for husband’s death

According to the Byetta lawsuit, Rebecca Richards says the defendants never sought to revise their product labeling to include warnings about pancreatic cancer risks associated with Byetta.  She further alleges that as a result of their acts and omissions, her husband suffered “severe personal injuries, which were permanent and lasting in nature, including death, physical pain, and mental anguish, including diminished enjoyment of life, as well as the need for medical treatment, monitoring and/or medications.”

The following causes of action are leveled in the complaint:

• Strict Liability – Failure to Warn
• Strict Products Liability – Design Defect
• Negligence
• Breach of Implied Warranty
• Breach of Express Warranty
• Negligent Misrepresentation
• Fraudulent Concealment
• Loss of Consortium

The widowed Byetta lawsuit plaintiff also requests punitive damages to punish the defendants for their alleged willful and wanton disregard for public safety.