Onglyza Lawsuit Alleges “Concerted Effort” to Conceal Heart Failure Risk

Published on November 20, 2018 by Sandy Liebhard

Onglyza lawsuits continue to mount in the multidistrict litigation now underway in the U.S. District Court, Eastern District of Kentucky, where a recent filing claims AstraZeneca and other Defendants engaged in a concerted effort to conceal the relationship between saxagliptin and heart failure.

According to a complaint filed in the U.S. District Court, Eastern District of Kentucky, on November 5^th, Bobbie Jean Singletary was prescribed Onglyza to treat Type 2 diabetes on May 10, 2013.

The North Carolina resident continued to take the medication as directed until May 7, 2016.

Singletary was diagnosed with heart failure on February 25, 2014, while she was still using Onglyza. The complaint asserts that her exposure to saxagliptin – the drug’s active ingredient — caused her heart failure.

Timeline: Saxagliptin Heart Failure Warning

The U.S. Food & Drug Administration (FDA) approved Onglyza in 2009 to treat Type II diabetes. The Defendant’s obtained FDA approval for Kombiglyze XR, a combination drug that contains saxagliptin and metformin, the following year.

Among other things, Singletary’s Onglyza lawsuit claims AstraZeneca marketed and sold saxagliptin for nearly 5 years before completing a study to assess its relationship to heart failure, congestive heart failure, cardiac failure, and death related to those events.

That trial – SAVOR TIMI 53 – found that patients using saxagliptin had a statistically significant increased risk of being hospitalized for heart failure.

The FDA launched a safety review of saxagliptin in February 2014, in light of the disturbing findings from SAVOR study.

In April 2015, an FDA advisory panel voted 14 to 1 to recommend  new heart failure warnings for saxagliptin-containing medications.  What’s more, the single panel member voting “no” stated that a warning was insufficient and actually called for the drugs to be withdrawn from the market.

In April 2016, the FDA announced that its review had found saxagliptin might increase the risk of heart failure, especially in patients with pre-existing heart or kidney disease. As such, the agency ordered the Defendants to add new heart failure warnings to the Onglyza and Kombiglyze labels.

Onglyza Lawsuit Claims Heart Failure Warnings Remain Inadequate

Singletary claims that AstraZeneca and other Defendants continued to promote saxagliptin as a safe treatment for Type 2 diabetes, even though they had long known of its true relationship with heart failure and other cardiovascular injuries. She further alleges that they the labels for Onglyza and Kombiglyze XR do not adequately address the potential risk heart failure, congestive heart failure, cardiac failure, and death, despite the findings from SAVOR TMI 53.

Finally, Singletary asserts that her doctor would not have prescribee Onglyza had suffcient heart failure warnings been made available.

“At all relevant times, Defendants acted in concert with one another to fraudulently convey false and misleading information concerning the safety and efficacy of Saxagliptin and to conceal the risks of serious adverse events, including heart failure, congestive heart failure, cardiac failure, death from heart failure, and other adverse effects associated with Saxagliptin from the public, Plaintiff, physicians, and other healthcare providers,” the lawsuit states.

“These concerted efforts resulted in significant harm to those treated with Saxagliptin, including Plaintiff. But for the actions of Defendants, individually, jointly, and in concert with one another, Plaintiff would not have ingested Saxagliptin.

Onglzya and Kombiglyze XR Heart Failure Litigation

Singletary’s complaint is one of more than 220 Onglyza and Kombiglyze lawsuits undergoing coordinated discovery and other pretrial proceedings in the Eastern District of Kentucky. All of the pending claims were filed on behalf of individuals who allegedly developed heart failure due to their use of saxagliptin-containing medications.

The multidistrict litigation was created in February to promote judicial efficiency and preserve the resources of the court, parties, and witnesses involved in these lawsuits.  At the time, just 41 Onglyza and Kombiglyze XR lawsuits were pending in federal courts nationwide. However, plaintiffs who sought centralization had predicted that the litigation would eventually grow to include hundreds of similar Onglyza and Kombiglyze XR lawsuit.

Daniel C. Burke, a Bernstein Liebhard LLP partner, is serving on the multidistrict litigation’s Plaintiffs’ Executive Committee.