The widow of a Nevada man is pursuing a wrongful death lawsuit against the manufacturers of Onglyza and Kombiglyze XR, alleging saxagliptin caused his death from heart failure.
The complaint, which was filed on September 14th in the U.S. District Court, District of New Jersey, accuses AstraZeneca Pharmaceuticals and Bristol-Myers Squibb of concealing the cardiovascular side effects allegedly associated with the Type 2 diabetes medication. (Case No. 3:18-cv-13904)
According to the lawsuit, the Decedent was prescribed and ingested saxagliptin – the active ingredient in Onglyza and Kombiglyze – on various occasions between 2015-2017.
During that time, and as “direct and proximate result” of his sitagliptin use, the “Decedent developed serious and/or permanent adverse effects including, but not limited to, coronary artery disease, congestive heart failure and death.”
“Saxagliptin as manufactured and supplied by Defendants was defective due to inadequate warnings and instructions because, after Defendants knew or should have known of the risk of injuries from use, Defendants failed to provide adequate warnings to the medical community and the consumers to whom the drugs were directly marketed and advertised; and, further, Defendants continued to affirmatively promote Saxagliptin as safe and effective,” the complaint charges.
Onglyza (saxagliptin) was approved by the U.S. Food & Drug Administration (FDA) in 2009. The drug is indicated to control blood sugar in patients with Type 2 diabetes in conjunction with diet and exercise.
Kombiglyze XR (saxagliptin and metformin) was approved the following year.
In 2014, the U.S. Food & Drug Administration (FDA) announced it was reviewing a possible link between Onglyza and heart failure. The agency launched its review after early results from the SAVOR-TMI study suggested that patients exposed to saxagliptin were 27% more likely to be hospitalized with heart failure. Saxagliptin also appeared to be associated with a higher risk of all-cause mortality.
In April 2015, an FDA advisory committee voted overwhelmingly to recommend that new heart failure warnings be added to the labels of all saxagliptin-containing medications. The labels for Onglyza and Kombiglyze XR were modified in April 2016 in accordance with those recommendations.
Hundreds of Onglyza and Kombiglyze XR lawsuits have been filed in U.S. courts since the FDA announced it was investigating saxagliptin-containing drugs.
More than 200 of these claims are currently undergoing coordinated pretrial proceedings in the U.S. District Court, Eastern District of Kentucky, where all such federal lawsuits were consolidated in a multidistrict litigation earlier this year.
Daniel C. Burke, a partner at the nationwide law firm of Bernstein Liebhard LLP, was recently appointed to the federal litigation’s 3-member Plaintiffs’ Executive Committee.