A plaintiff has come forward and alleged saxagliptin heart failure associated with the use of Onglyza—a medication used to treat type-2 diabetes.

Plaintiff Ruben B. filed a lawsuit in U.S. District Court, Southern District of New York seeking damages from the Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals LP, and the McKesson corporation for their roles in manufacturing, marketing, and distributing Onglyza and Kombiglyze XR—brand name drugs containing saxagliptin.

Ruben, a citizen and resident of the state of Texas, says he was prescribed and took the diabetes medication for a two and a half year period from May 2014 to February 2017. He says his physician made the treatment choice in consultation with Ruben based upon assurances of safety on the part of the defendants. The complainant, according to the lawsuit narrative, later suffered saxagliptin heart failure and cardiovascular injuries as a direct consequence of this drug regimen.

In addition to the saxagliptin heart failure, the plaintiff claims that he endured pain and suffering, mental anguish, loss of earnings and earning capacity, and is saddled with high medical bills from past treatment. Some of this treatment will likely continue into the future and generate further costs for him and his family, he alleges.

Ruben is accusing the defendants of knowing of the potential for Onglyza to bring on cardiovascular events such as saxagliptin heart failure, but still proceeding to market the medication without warning for the purposes of profit. He is bringing the following counts against them:

Count 1: Design Defect

Count 2: Negligence

Count 3: Failure to Warn

Count 4: Breach of Warranty of Merchantability

Count 5: Breach of Express Warranty

Count 6: Breach of Implied Warranty

Ruben is asking for a compensatory award for all losses associated with each lawsuit count. He requests consideration for all attorney fees, costs of litigation, economic damages for past and future medical care, and lost wages. He also requests that punitive damages be assessed against the named companies.

Saxagliptin Heart Failure and the SAVOR Study

According to the factual section of the lawsuit in question, the defendants pursued and gained approval for Onglyza and Kombiglyze XR between July 2009 and November 2010. Despite the fact that type-2 Diabetics have a higher risk of developing serious cardiovascular issues, no heart-centered clinical studies were undertaken with the medications until they had been widely commercially circulated for five years.

When such a clinical trial was undertaken—the SAVOR trial—the resulting data had strong indications for saxagliptin heart failure. The U.S. Food and Drug Administration’s advisory committee voted to have the defendants put a cardiovascular warning on the label, but they have not followed through.

To date, the warning has not been put on the medications. Meanwhile, saxagliptin products continue to be promoted as online and in print materials as completely safe.

The Saxagliptin Heart Failure Lawsuit is Case No. 1:18-cv-07054-AT in U.S. District Court Southern District of New York.