A man has sued the makers of Januvia and Byetta in California court accusing them of concealing the risk of pancreatic cancer posed by their type 2 diabetes drugs.
The complaint, pending in U.S. District Court for the Southern District of California, says Merck & Co. Inc. (NYSE: MRK), Amylin Pharmaceuticals Inc. and Eli Lilly & Co (NYSE:LLY) willfully and negligently failed to warn doctors, as well as the public, that their drugs were not safe for their intended use.
The original complaint was filed September 28, 2012 by Moses Scott in San Diego County Supreme Court and alleges that Regina Kelly’s ingestion of the diabetes drugs caused her to develop fatal pancreatic cancer. Ms. Kelly was prescribed the drugs in December 2007 and was diagnosed with cancer in October 2010.
The lawsuit was transferred to federal court on October 19th.
The U.S. Food and Drug Administration (FDA) approved Januvia made by Merck in 2006 “as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.”
Byetta, manufactured by Amylin Pharmaceuticals and Lilly, was approved by the FDA in 2005 and is a member of a new class of drugs known as glucagon-like-peptide-1 receptor analogs. These drugs act by enhancing the activity of a hormone in the gastrointestinal tract, which results in lower sugar levels.
Byetta and Januvia have been linked to life-threatening pancreatic problems, including hemorrhagic pancreatitis. In 2008, the FDA said it had received more than 30 reports of acute pancreatitis in Byetta users, as well as two deaths and four hospitalizations for pancreatic problems. In 2009, the FDA instructed the manufacturer of Byetta to conduct six post-marketing studies to help further define and confirm the mechanism, incidence and risk factors for the development of acute pancreatitis, including hemorrhagic pancreatitis, associated with use of Byetta, as well as explore a potential signal of a serious risk of thyroid cancer and pancreatic cancer.
Chronic pancreatitis is often a precursor to pancreatic cancer, which is one of the deadliest types of cancer. For that reason, Byetta patients need to be aware of the warning signs and symptoms of pancreatitis. It is imperative that they seek medical attention immediately, should they experience any symptoms. Possible symptoms of Byetta pancreatitis include:
– Abdominal pain
– Rapid heartbeat
– Swollen and tender abdomen
– Any change in bowel habits
It is alleged that the manufacturers of these drugs concealed risks linked to pancreatic cancer by misrepresenting and failing to list any risks on their labels or reporting the potential risks to doctors.
The complaint lists California state law claims of strict liability (failure to warn), negligence, breach of implied and express warranties, deceit by concealment, negligent misrepresentation, fraud by concealment, violation of Business and Professions Code sections 17200 & 17500, violation of Civil Code section 1750 and wrongful death.
If the drug makers had knowledge that their drugs could increase the risk of cancer, it is their responsibility to make it known to the doctors who prescribe it and to patients before they ingest it. If they conceal this knowledge, they should be held negligent for the lives they ruined. Once again, the pharmaceutical companies put their profits before the safety of consumers.
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