Januvia & Byetta Lawsuit
Januvia and Byetta are medications widely used in the United States to treat Type 2 diabetes. Although the two have been approved for use only since 2005 (Byetta) and 2006 (Januvia), many lawsuits have been filed charging that the drugs led to serious, sometimes life-threatening complications.
Attorneys at The Sanders Firm have over four decades of experience representing victims in personal injury cases, including lawsuits for those injured by dangerous drugs. Our lawyers have a history of success against Merck for its manufacture and marketing of Vioxx, since taken off the market.
Merck currently manufactures Januvia – indeed, sales of that drug grew faster than any other Merck product until mid-2013, reaping the company billions of dollars every year. Byetta is made by Amylin, Eli Lilly and Bristol-Myers Squibb, which have earned millions in sales of the drug over the years. Our skilled personal injury attorneys help those who’ve been harmed by Januvia and Byetta recover compensation for their losses.
Januvia and Byetta – how do they work?
People with Type 2 diabetes cannot produce enough insulin, which is necessary to move sugar from the blood into cells. Cells require sugar for survival and proper growth; when high levels of sugar remain in the blood, on the other hand, patients risk heart disease, blindness, liver and kidney damage and other serious conditions.
Both Januvia and Byetta help manage the effects of an enzyme (called DPP-IV) that interferes with the body’s release of insulin. They are in class of drugs known as incretin mimetics. Januvia prevents the enzyme from working; Byetta evades DPP-IV by supplying insulin-stimulating proteins that are immune to the enzyme’s effects. The FDA approved Byetta in 2005 for patients whose blood sugar could not be properly regulated using existing drugs. In 2006, the FDA approved Januvia as the first so-called DPP-IV inhibitor, a new type of diabetes drug that, in conjunction with diet and exercise, could help patients with Type 2 diabetes control their blood sugar levels.
Januvia and Byetta complications
Both Januvia and Byetta have numerous side effects, some of which are fairly minor. But both drugs have been linked to pancreatic cancer, which typically forms the basis of Januvia and Byetta lawsuits.
Januvia’s serious side effects include:
- Pancreatitis (inflammation of the pancreas) that can be life-threatening
- Pancreatic cancer
- Thyroid cancer
- Kidney failure
Byetta is associated with complications such as:
- Kidney damage or failure
- Thyroid cancer
- Pancreatic cancer
- Severe allergic reactions
- Acute pancreatitis
Studies document pancreatitis and pancreatic cancer
In 2011, physicians reviewed reports made to the FDA concerning harmful side effects caused by Januvia and Byetta use. The doctors published their findings in a peer-reviewed journal, noting that both pancreatitis and pancreatic cancer had been reported as complications.
Two years later, the Journal of the American Medical Association — Internal Medicine published a study based on data from a very large health insurance plan. The article reported that Type 2 diabetes patients using Januvia or Byetta were more than twice as likely to be hospitalized for acute pancreatitis as were control group patients who did not use either of the drugs. Pancreatitis, in turn, is a risk factor for pancreatic cancer.
In April 2013, the non-profit Institute for Safe Medicine Practices reviewed FDA data concerning complications from use of Januvia and Byetta compared to side effects from other diabetes drugs. The study found that the odds of pancreatitis among Januvia users were more than 20 times higher than among the control group; among Byetta users the pancreatitis odds were over 28 times higher.
For pancreatic cancer, the odds for Januvia users were more than 13 times higher than among the control group. Byetta users were over 30 times more likely to report pancreatic cancer. The odds of thyroid cancer were 15 times higher among Byetta users.
Litigation mounts alleging pancreatic cancer
Patients who have been seriously injured after taking the incretin mimetics have filed Byetta and Januvia lawsuits around the country. In most cases, those injured seek compensation for their pain and suffering, ongoing treatment for their serious conditions, and any wages they may have lost as a result of their injuries.
Because the cases involve similar facts, and the drug manufacturers are charged with similar acts and omissions (negligence, failure to warn, misrepresentation, fraud, selling a defective product, etc.), in August 2013, fifty-three cases were transferred to federal court in San Diego as part of multidistrict litigation. All of these lawsuits involved claims that Januvia, Byetta and other incretin mimetic drugs caused pancreatic cancer. The court noted another 44 lawsuits that potentially could be added for centralized handling.
The multidistrict litigation (MDL) permits one judge to manage pretrial proceedings that are common to all the lawsuits, including the defendants’ production of documents and witnesses. The court will then schedule a trial on a representative case against each of the pharmaceutical companies. These ‘bellwether’ cases can facilitate future settlements, as the companies recognize the risks they face by going to trial. If a bellwether case is tried, the verdict can enhance the settlement of other cases involving similar facts and the same defendant. Though MDL centralizes claims for pretrial proceedings, each plaintiff is guaranteed his or her day in court.
Speak to a reputable personal injury attorney
Helping injured people get their day in court — that’s exactly what we aim for at The Sanders Firm. Over 20 million Americans have Type 2 diabetes and must rely on daily medication to maintain their lives and health. We believe that no one should have to risk life-threatening complications such as pancreatitis, pancreatic cancer or thyroid cancer, simply because he or she uses a particular diabetes drug.
But if a person with diabetes does suffer those side effects, he or she deserves full compensation. We stand ready to assist those who’ve suffered harm from dangerous drugs.
Find out if you have grounds for seeking damages in a Januvia or Byetta lawsuit. Call us at 1-800-FAIR-PLAY to schedule a free case review.
- Institute for Safe Medication Practices, QuarterWatch (April 2013 Issue) Perspective On GLP-1 Agents For Diabetes http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=46
- FDA, FDA Approves New Treatment for Diabetes, First in a New Class of Diabetes Drugs http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108770.htm
- JAMA Internal Medicine, Glucagonlike Peptide 1–Based Therapies and Risk of Hospitalization for Acute Pancreatitis in Type 2 Diabetes MellitusA Population-Based Matched Case-Control Study http://archinte.jamanetwork.com/article.aspx?articleid=1656537#RESULTS
- U.S. Judicial Panel on Multidistrct Litigation, Transfer Order http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2452-Initial_Transfer-07-13.pdf
- FDA, Notice of Violation Letter Re: NDA No. 21-995 JANUVIA™ (sitagliptin) Tablets, et al. March 26, 2009, http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/f