Pharmaceutical giants- AstraZeneca and Bristol Myers- are facing hundreds of lawsuits that their antidiabetic drugs Onglyza (Saxagliptin) and Kombiglyze XR (Saxagliptin plus metformin HCL extended-release) cause cardiac injuries. All the heart failure cases have been consolidated in a Multidistrict Litigation under the jurisdiction of the federal court in Kentucky. The lawsuits allege that the companies failed to properly warn patients of the risks associated with the drugs and that has led to personal injury or death of the plaintiffs.
The consolidated cases involve people who suffered congestive heart failure, heart failure or myocardial infarction between July 2009 and April 2016. The plaintiffs have been using the drug before an FDA panel ordered AstraZeneca to update the warning on the Onglyza’s label. The update is to inform medical practitioners that the drug is associated with an increased risk of heart failure.
The panelists’ votes were informed by data from post-marketing surveillance involving 16,000 patients on Onglyza- the SAVOR study. The study showed that about 27% of the patients developed symptoms that are consistent with heart failure. Although the figure is below FDA’s 30% threshold for cardiovascular episodes, the death rate of users reportedly made panelists vote in support of updating the warning on the label. The flurry of litigations the company has had to face is a predictable outcome of such an update.
Litigations emphasize lack of adequate studies and warnings
In most of the litigations, the plaintiffs allege that the manufacturing companies failed to warn physicians and patients about the increased risk of heart failure and other cardiovascular events associated with taking the drug. The lawsuits also allege that the companies are privy to clinical findings suggesting that the drug may increase the risk of heart failure and an FDA advisory committee recommended a warning.
Furthermore, the lawsuits claim that the manufacturers failed to perform adequate studies on the drug before seeking FDA approval. Already, people suffering from Type 2 diabetes are at greater risk for heart problems. Thus the 2008 FDA guidance stipulates that manufacturers of drugs used for managing the condition need to demonstrate that their drug does not put the patient at greater risk. However, AstraZeneca and Bristol-Meyers failed to properly assess the risk, according to the lawsuits.
The multidistrict litigation was first created in February 2018 and it involved only 84 cases. In a June 2018 report released by the Judicial Panel on Multidistrict Litigation, more than 200 lawsuits have been included in the MDL. Currently, there are no reports indicating that AstraZeneca and Bristol-Meyers may be willing to settle the litigations out of court. However, the narrative may change after the first bellwether trial which is expected to take place sometimes next year.
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.