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Januvia Cancer Lawsuit Filed by Tennessee Couple

A couple have filed a lawsuit against Merck & Co., manufacturers of type 2 diabetes drug Januvia, claiming the medication caused the husband’s pancreatic cancer. Filed on July 12, 2013 in the United States District Court for the Southern District of California, it is the latest Januvia cancer lawsuit to claim the drug maker failed to adequately warn the public of the potential health hazards caused by the medication. At least 53 lawsuits related to similar diabetes drugs were recently consolidated into a multidistrict litigation (MDL).

The couple hail from Ten Mile, Tennessee. Their doctor prescribed Januvia to the husband  in July 2011 as a long-term treatment for type 2 diabetes. He continued to take Januvia until around May 2012, and was diagnosed with pancreatic cancer early in 2013. According to court documents, the plaintiff would not have taken Januvia had he or his doctor been aware of the risk of pancreatic cancer. The couple’s Januvia cancer lawsuit states that the medicaion is “quite simply too dangerous and defective as formulated. The Defendants should withdraw Januvia from the market.”

With an estimated 350 million sufferers around the world, type 2 diabetes is one of the major health problems of the 21st century. Incretin mimetics – including Januvia – were developed to deal with the challenge. They work by mimicking the body’s natural production of incretin hormones, responsible for releasing insulin into the bloodstream after eating.

Incretin mimetics first reached the market in 2005. Januvia is an oral drug, marketed by Merck as more convenient than injectables. Since being approved by the FDA in 2006, it has gone on to be one of the top selling drugs in the United States, with sales of $919 million in the first quarter of 2012 alone.

Januvia cancer lawsuit cites German study

Since the availability of Januvia and other incretin mimetics, there has been growing concern surrounding the risk of pancreatic cancer associated with the drugs. In a report cited in the Januvia lawsuit filed in California, the incretin mimetic Byetta is alleged to have caused an “unusually high” number of cases of cancer and pre-cancerous cellular changes in the pancreas.

The report, published by the Drug Commission of the German Medical Association, notes 11 cases of pancreatic cancer in 4 years. It adds that the period between beginning treatment and being diagnosed was, on average, 12.2 months. Pancreatic cancer is not mentioned on the list of Byetta or Januvia side effects.

Diabetes journal advises caution for new drugs

In 2010, online diabetes journal Diabetes Care published an article, quoted at length in the Januvia cancer lawsuit filed in California. Titled GLP-1-Based Therapy for Diabetes: What You Do Not Know Can Hurt You, the article stated:

“History has taught us that enthusiasm for new classes of drug, heavily promoted by the pharmaceutical companies that market them, can obscure the caution that should be exercised when the long-term consequences are unknown… 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 [Januvia et al.] may develop pancreatic cancer.”

Manufacturers consent to MDL

Earlier this month, the drug makers responsible for Januvia, Byetta and other incretin mimetics agreed to the consolidation of more than fifty lawsuits. The unusual decision to look at products from several manufacturers in one MDL was due to the large number of plaintiffs who have taken more than one company’s medication.

The plaintiffs’ claims are similar to the allegations made in the Tennessee couple’s Januvia cancer lawsuit: that the companies responsible for making the drugs knew or should have known about the increased risk of pancreatic cancer, and that they failed to adequately warn physicians or patients.

Consolidating the litigation is intended to reduce duplicative discovery across a large number of cases and serve the convenience of the parties, witnesses and courts.