Hundreds of heart failure lawsuits involving the Type 2 diabetes drugs Onglyza and Kombiglyze XR continue to move forward in the federal multidistrict litigation currently underway in the U.S. District Court, Eastern District of Kentucky.
According to a Case Management Order dated July 30th, the Court has established a new schedule for causation discovery:
Onglyza (saxagliptin) received U.S. Food & Drug Administration (FDA) in 2009. The cleared Kombiglyze XR, a combination drug that contains saxagliptin and metformin, the following year.
Five years after launching Onglyza, AstraZeneca completed a post-market study called SAVOR TIMI 53 to assess saxagliptin’s relationship to heart failure, congestive heart failure, cardiac failure, and death related to those events. That trial results suggested that patients taking the medication had a statistically significant increased risk of being hospitalized for heart failure.
Those findings prompted the FDA to begin a saxagliptin safety review. In April 2015, an agency advisory panel voted 14 to 1 to recommend new heart failure warnings for saxagliptin-containing medications, with the dissenting panel member arguing that Onglyza and Kombliglyze XR should be withdrawn from the market.
A year later, the FDA confirmed that saxagliptin might increase the risk of heart failure, especially in patients with pre-existing heart or kidney disease. AstraZeneca was ordered to add new heart failure warnings to the Onglyza and Kombiglyze labels.
More than 272 lawsuits that blame Onglyza and Kombiglyze XR for causing heart failure are now pending in the Eastern District of Kentucky.
Plaintiffs claim that AstraZeneca and other defendants continued to promote saxagliptin as a safe treatment for Type 2 diabetes, even though they had long been aware of its potential to harm the heart. The further allege that the Onglyza and Kombiglyze XR labels do not adequately address the potential risk for heart failure, congestive heart failure, cardiac failure, and death, despite the findings from the SAVOR TMI 53 study.
Daniel C. Burke, a Bernstein Liebhard LLP partner, is serving on the Plaintiffs’ Executive Committee for the Onglyza and Kombliglyze litigation.