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Januvia Lawsuit Filed After Decedent Dies From Pancreatic Cancer

Bridget Nickerson is suing Merck Sharp & Dohme Corporation for more than $75,000 following the untimely death of her mother, Mary Williamson. The Januvia lawsuit, filed in the Southern District of California, alleges that the drug is defective and caused the decedent to suffer from pancreatic cancer. Magistrate Judge Ruben B. Brooks will preside over the case.

Facts of the Januvia lawsuit

Mary Williamson’s doctor prescribed Januvia to help lower her blood sugar levels and control type 2 diabetes. She began using the drug in June of 2009 and continued using it through July 2011. On June 1, 2011, the decedent was diagnosed with pancreatic cancer. It wasn’t until two years later that the plaintiff and decedent became aware that the injuries may have been caused by Januvia.

Eight specific causes of action are listed in the Januvia lawsuit, including:

  • Strict liability – failure to warn
  • Strict liability – design defect
  • Negligence
  • Breach of implied warranty
  • Breach of express warranty
  • Negligent misrepresentation
  • Fraudulent concealment
  • Loss of consortium (for the Decedent’s spouse)

Plaintiff Bridget Nickerson is pursuing this lawsuit on behalf of the surviving spouse of Mary Williamson to cover the cost of pain and suffering, wrongful death, burial and funeral expenses, loss of companionship, attorney fees, interest, and any further relief the jury deems necessary.

Januvia pancreatic cancer risk

Januvia is a dipeptidyl peptidase-4 inhibitor, which represents one of the most recently approved classes of type 2 diabetes medications. Like the glucagon-like peptide-1 receptor agonist (such as Byetta), Januvia works by increasing insulin production in the pancreas and decreasing the sugar made in the liver. After obtaining approval from the FDA in October 2006, Januvia became one of the top-selling drugs in the country, with sales of $919 million in the first quarter of 2012 alone.

The first concerns about drugs like Januvia and Byetta surfaced in February 2010. An article in Diabetes Care stated that preliminary evidence suggests “the potential risks of asymptomatic chronic pancreatitis and, with time, pancreatic cancer.”

In February 2011, the journal Gastroenterology published a review of adverse reports filed with the FDA.  They found a 10-fold increase in the risk for pancreatitis among patients who took Byetta and a 6-fold increase in pancreas inflammation among patients taking Januvia. This type of chronic inflammation is a risk factor for pancreatic cancer, researchers noted. In the German adverse event database, there were 11 cases of pancreatic cancer among users of Byetta in four years, with most people developing the cancer within a year.

In April 2012, non-profit consumer advocacy group Public Citizen sent a petition to the FDA asking that another drug in the class (liraglutide) be withdrawn from the market. Dr. Sidney Wolfe said that his concern extended to diabetes drugs that alter the GLP-1 pathway, including Byetta and Januvia, and that there was clear evidence of a pancreatic cancer risk.

Once an individual receives a diagnosis for pancreatic cancer, the patient stands just a 1.8% chance of surviving more than five years, which makes these drugs particularly volatile, according to the Januvia lawsuit.

FDA stance on Januvia pancreatic cancer risk

In 2012, Bloomberg News reported that they planned to fine Merck & Co for $250,000 after they were almost a year late on a post-market study of its diabetes drugs to determine if the pills inflame the pancreas in rodents. However, they have said they will not update the warning label regarding Januvia side effects because there is no evidence to confirm a link between the product and pancreatic cancer. Despite their reticence to act, there are at least 100 similar lawsuits filed under MDL 2452.

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