An Illinois man recently filed a heart failure lawsuit accusing AstraZeneca and other drug makers of concealing the risks associated with Onglyza and Kombiglyze XR.
According to a complaint filed in the U.S. District Court, Central District of Illinois, Jerald Adams took Onglyza and Kombiglyze XR, both of which contain the active ingredient saxagliptin, to control Type 2 diabetes between April 2015 through December 2015.
He was later diagnosed with heart failure and cardiovascular injury, which Adams claims was a direct and proximate result of his saxagliptin exposure. (Case No. 1:18-cv-01015-JES-JEH)
“At all relevant times, Defendants had knowledge that there was a significant increased risk of adverse events associated with Saxagliptin including heart failure, congestive heart failure, cardiac failure, and death related to those events, and despite this knowledge Defendants continued to manufacture, market, distribute, sell, and profit from sales of Saxagliptin,” the complaint states.
“Despite such knowledge, Defendants knowingly, purposely, and deliberately failed to adequately warn Plaintiff, patients, consumers, medical providers, and the public of the increased risk of serious injury associated with using Saxagliptin, including, but not limited to, heart failure, congestive heart failure, cardiac failure, and death related to those events,” the lawsuit continues.
Onglyza (saxagliptin) was approved by the U.S. Food & Drug Administration in 2009, while Kombiglyze XR (saxagliptin and metformin) was cleared the following year.
The labels for all saxagliptin-containing medications were modified in April 2016 to warn of the potential for heart failure, after interim data from a clinical trial called SAVOR-TMI indicated that patients treated with the medication were 27% more likely to be hospitalized for heart failure compared to those who were not. Saxagliptin also appeared to be associated with a higher risk of all-cause mortality.
Next Thursday, the U.S. Judicial Panel on Multidistrict Litigation will hear Oral Arguments on a petition to centralize all federally-filed Onglyza and Kombiglyze XR lawsuits in a single U.S. District Court for the purpose of coordinated pretrial proceedings
A group of plaintiffs filed the petition in October, asserting that the federal docket would benefit from coordinated proceedings. Among other things, they pointed out that all pending cases share the same basic theory of liability and factual allegations. They further assert that the lawsuits will involve the same core discovery, fact witnesses, and experts.
At the time, 40 lawsuits involving Onglyza and Kombiglyze XR had been filed in federal courts around the nation. However, plaintiffs contend that the saxagliptin litigation will eventually grow to include hundreds of similar cases.