A California man filed a complaint in late September in the San Diego County Superior Court on behalf of his now deceased wife, suing the makers of Januvia and Byetta for allegedly concealing pancreatic cancer risks arising from use of the type-2 diabetes drug.
The case was transferred to federal court on October 19, and is currently pending in the U.S. District Court for the Southern District of California.
His complaint alleges that manufacturers Merck & Co. Inc., Amylin Pharmaceuticals Inc., and Eli Lilly & Co. willfully and negligently failed to warn doctors, as well as those prescribed the medications, that these drugs were not safe for their intended use.
His wife was originally prescribed the medication in December 2007 and was diagnosed with fatal pancreatic cancer in October 2010, which she blames solely on her ingestion of these drugs.
Merck’s Januvia, originally approved by the U.S. Food and Drug Administration (FDA) in 2006, was designed as a diet and exercise “substitute” by improving glycemic control for those suffering from type-2 diabetes mellitus. Januvia earned the title of being the first among a new drug class known as incretins, which basically block out certain enzymes so that those with type-2 diabetes can regulate glucose more efficiently.
Amylin and Lilly received FDA approval for Byetta in 2005, and belongs to a new class of drugs called Glucagons-Like Peptide-1 (GLP-1) receptor agonists.
In the complaint, the man’s attorney alleges that “due to the flawed formation of Byetta and Januvia, both drugs increase the risk of pancreatic cancer in those diabetic patients to whom they are prescribed. [The manufacturers] concealed their knowledge that both Byetta and Januvia can cause life-threatening, pancreatic cancer from” doctors, as well as those who rely on the medication for a more enjoyable lifestyle. His attorney adds that the mention of “pancreatic cancer” is nowhere to be found in the product inserts or the medication itself.
Concerns of pancreatic cancer resulting from these drugs first was raised in February 2010 in an article called “GLP-1 Based Therapy for Diabetes: What You Do Not Know Can Hurt You,” where the authors found that “preliminary evidence suggested the potential risks of asymptomatic chronic pancreatitis and, with time, pancreatic cancer.”
His attorney contends that the drugs’ warning labels are inadequate. “Even if the warnings were sufficient, Januvia and Byetta still lack any benefit sufficient to tolerate the extreme risk posed by ingestion of these drugs. Other drugs to treat diabetes are available. Januvia and Byetta are quite simply too dangerous and defective as formulated. [These manufacturers] should withdraw the drugs from the market.”
Gastroenterology published an article in February 2011 which also showed a significant increase in the risk of developing pancreatic cancer as a result of taking these drugs. The article, “Pancreatitis, Pancreatic and Thyroid Cancer with Glucagon-Like Peptide-1 Based Therapies,” states that pancreatitis (which is one of the early sings of pancreatic cancer) was reported over ten times more frequently reported as an adverse side effect in those prescribed Byetta, and over six times more frequently reported in those taking Januvia. Byetta yielded a 2.9x greater diagnosis of pancreatic cancer, and2.7x greater for Januvia, as compared to other diabetes treatments.
In his closing statements, the attorney states that these manufacturers “both over-promoted the drugs and under-warned about their risks. [My client’s deceased wife and her] prescribing health care providers were unaware of the true degree and incidence of pancreatic cancer associated with the use of the drugs and would have used and prescribed other methods for diabetes control if they had been so informed.” He believes these manufacturers actively concealed risks which they had knowledge to believe existed, by using affirmative misrepresentations and omissions, as well as following FDA standards for conducting post-approval marketing studies on the safety of these drugs.
The complaint consists of claims of strict liability (more specifically, failure to warn), negligence, breach of implied and express warranties, deceit by concealment, negligent misrepresentation, fraud by concealment, various violations of Business and Professional Codes and Civil Codes, as well as wrongful death.
Should the court find these manufacturers liable, they will be forced to be a hefty award to the man, but unfortunately, no amount of money will revive his wife. It is also unfortunate that whatever the amount awarded, it will, in all likelihood, be a miniscule proportion of these manufacturers’ profits. Is this justice?
For more information, contact a Gacovino Lake attorney at 1-800-246-HURT (4878).