Tradjenta is a popular type 2 diabetes medication used to regulate high blood sugar levels. A brand name version of the generic drug linagliptin, Tradjenta is the product of an ongoing collaboration between Boehringer Ingelheim (BI) and Eli Lilly (EL), two of the largest pharmaceutical companies in the world. Tradjenta received approval from the U.S. Food and Drug Administration (FDA) in 2011.
Health care professionals often prescribe Tradjenta in conjunction with other diabetes medications. As a result, BI and EL manufactured a new drug called Jentadueto that combines Tradjenta (linagliptin) and metformin (a common type 2 diabetes medication). The FDA approved Jentadueto in 2012.
Unfortunately, concerns have been raised in the last few years regarding the suspected side effects of Tradjenta and Jentadueto. With possible links to serious complications, these drugs could subject its manufacturers to government fines and class action lawsuits.
Regulating Blood Sugar Levels
Diabetics have difficulty producing insulin, a hormone that prevents sugar from building up in the bloodstream. Insulin is produced by the pancreas until the enzyme dipeptidyl peptidase-4 (DPP-4) causes the pancreas to stop production. Tradjenta and Jentadueto are part of a class of drugs known as "incretin mimetics" that mimic incretin, a hormone with the key function of blocking the DPP-4 enzyme. By raising incretin levels, Tradjenta and Jentadueto decrease the presence of DPP-4, thus allowing the pancreas to continue producing insulin. Ultimately, this results in lower blood sugar levels.
Packages of Jentadueto carry a black box warning, the FDA's strongest type of warning. A black box warning indicates a potentially serious health risk or life threatening complication. The black box warning for Jentadueto alerts consumers to the risk of lactic acidosis, which is attributed to the metformin used in Jentadueto. Lactic acidosis is the build up of lactic acid in the bloodstream. It requires immediate medical attention and can sometimes be fatal.
Pancreatitis & Pancreatic Cancer
In 2013, the FDA announced that it would evaluate a research study suggesting that incretin mimetics pose a serious risk of pancreatitis (inflammation of the pancreas) and possibly even pancreatic cancer. The study found evidence of pancreatitis and pre-cancerous cells in tissue samples taken from deceased patients that had used incretin mimetics.
This study comports with the results of previous clinical trials that had linked incretin mimetics to pancreatitis. Even before the results of this study were disclosed, there were already warning labels on Tradjenta and Jentadueto informing consumers of reports of acute pancreatitis (short duration of inflammation).
On the other hand, the research study's conclusion that incretin mimetics may lead to pancreatic cancer are relatively novel. The FDA has asked the academics behind the study to provide their data and methodology for verification. As of May 2014, the FDA has not reached any conclusions as to whether incretin mimetics cause or contribute to the development of pancreatic cancer. The FDA will continue to evaluate all relevant material connected to this issue.
Boehringer Ingelheim & Eli Lilly Legal Liability
If the FDA corroborates the study's assertion that incretin mimetics lead to pancreatic cancer, or if new evidence emerges that links the two together, numerous Tradjenta and Jentadueto lawsuits will likely be filed against Boehringer Ingelheim and Eli Lilly.
If this occurs, the lawsuits will probably be based on product liability law. Under product liability, manufacturers and sellers have a duty to ensure that their products are free from any unexpected dangers or defects. A successful product liability lawsuit will prove two important elements: first, the product was defective, and second, this defect caused plaintiff's injuries.
A likely claim in a potential Tradjenta lawsuit or Jentadueto lawsuit is defect in warnings. Manufacturers have a duty to provide proper instructions and warnings about any dangers associated with their products. If manufacturers fail to fulfill this obligation, then their products have a warning defect. For example, in a Tradjenta lawsuit, a plaintiff may allege that BI and EL were aware that Tradjenta could cause pancreatic cancer but failed to warn consumers. The plaintiff may further argue that if he or she had known of the risk of pancreatic cancer, the plaintiff wouldn't have used the drug in the first place.
As Tradjenta and Jentadueto are relatively new to the market, there has been very little litigation focused on them. However, as mentioned above, if more reports of links to pancreatitis or pancreatic cancer emerge, more lawsuits against BI and EL are likely to follow.
If you're considering filing a Tradjenta lawsuit, you should consult with a product liability attorney to discuss your options. It would be in your best interest to have a consultation as soon possible because most states have statutes of limitations (time limits) on filing a product liability claim.
Contact a qualified product liability attorney to make sure your rights are protected.