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According to allegations raised in a product liability lawsuit filed against Bristol-Myers Squibb and AstraZeneca, a Kentucky man was left with heart damage from Onglyza and Kombiglyze XR, indicating that the diabetes drugs caused him to suffer heart failure and other injuries.
The complaint (PDF) was filed by Wilma Sexton in the U.S. District Court for the Eastern District of Kentucky on August 22, indicating that the drug makers failed to adequately warn about the heart risks associated with saxagliptin contained in both medications.
AstraZeneca and Bristol Myers Squibb jointly developed Onglyza, introducing the type 2 diabetes treatment in 2009. Kombilgyze XR is a combination treatment that contains saxagliptin from Onglyza together with the older diabetes drug metformin.
Although it has been marketed as safe and effective, concerns have emerged in recent years about potential risk of heart damage, resulting in a number of similar Onglyza lawsuits being filed by former users in courts nationwide.
The litigation emerged after the FDA launched an investigation into the heart risks with Onglyza in 2014, following the publication of a study, known as “SAVOR”, in the New England Journal of Medicine. However, the lawsuit filed by Barrientes claims that clinical trials showed that users had a significantly increased risk of being hospitalized for heart failure as far back as 2008, a year before Onglyza was introduced.
In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend stronger warnings about the potential Onglyza heart side effects, after a review of data from clinical trials suggested that users may face a higher than expected risk of hospitalization for heart failure and all-cause mortality.
The review looked at two large clinical trials involving patients with heart disease. In both trials, patients given drugs containing saxagliptin or alogliptin were at a higher risk of being hospitalized for heart failure than those given a placebo.
According to allegations raised in the lawsuit filed by Sexton, the drugmakers should be responsible for both compensatory as result of the Onglyza heart damage, as well as punitive damages designed to punish for failing to warn about the potential risks.
“Defendants’ conduct was committed with knowing, reckless, conscious, wanton, willful, and deliberate disregard for the value of human life and the rights and safety of consumers, including Plaintiff, thereby entitling Plaintiff to punitive and exemplary damages so as to punish and deter similar conduct in the future,” the lawsuit states.
Sexton’s case will be consolidated with other Onglyza cases pending in the federal court system, which were combined as part of a federal MDL, or multidistrict litigation, earlier this year for coordinated discovery and pretrial proceedings. The litigation is centralized before U.S. District Judge Karen K. Caldwell in the U.S. District Court for the Eastern District of Kentucky.