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A Kentucky woman has filed a new Onglyza lawsuit in the U.S. District Court of the Eastern District of Kentucky. She names drug manufacturers Bristol-Myers Squibb Company and AstraZeneca Pharmaceuticals as defendants, and claims they should be held liable for the injuries she sustained after taking the type 2 diabetes drug. She seeks in excess of $75,000 in damages.

Plaintiff Claims Kombiglyze XR Led to Heart Failure

According to her complaint, the plaintiff took Kombiglyze XR (a combination of the saxagliptin in Onglyza and metformin HCL) between December 28, 2011 and July 2018. She says her doctor prescribed the drug for the treatment of her type 2 diabetes. While she was using it, she says she developed serious and/or permanent adverse effects, including heart failure and congestive heart failure.

As a result of these injuries, the plaintiff says she suffered significant bodily and mental injuries, pain and suffering, and loss of earnings and earning capacity. She also claims that she has incurred and will continue to incur medical expenses. She claims that the defendants were aware that their drug could increase a patient’s risk of heart failure, yet continued to sell the product anyway, to profit from those sales.

She adds that the defendants failed to provide adequate warnings about the risks and that if they had, her doctors wouldn’t have prescribed the drug to her.

Manufacturers Delay Cardiovascular Testing on Kombiglyze XR

Saxagliptin belongs to a class of medications called “dipeptidyl peptidase-4 (DDP-4) inhibitors,” or “incretin mimetics.” These drugs work by stimulating the pancreas to produce more insulin after a meal. The excess insulin helps process the glucose in the blood, keeping blood sugar levels stable.

When the FDA first approved saxagliptin (Onglyza) in 2009, they did it on the basis of eight clinical trials provided by the manufacturers. The plaintiff claims, however, that the defendants failed to follow the FDA’s suggestion—issued in 2008 to all type 2 diabetes drug manufacturers—to conduct clinical trials meant to determine whether the drug could increase risk of cardiovascular complications. Instead, the manufacturers simply released the product on the market and started profiting from it.

Then in 2010, the defendants started marketing Kombiglyze XR, too. It was only after both Onglyza and Kombiglyze XR were on the market that they followed the FDA’s instructions and conducted a cardiovascular trial called the “SAVOR” trial. Results showed that those patients taking saxagliptin had a statistically significant increased risk of being hospitalized for heart failure.

FDA Requires New Warnings on Saxagliptin Drugs

After receiving the results of the trial, the FDA requested the raw data and performed their own analysis. They then convened a drug Advisory Committee Meeting (“AdCom”) to go over the results. The AdCom committee voted in favor of the FDA ordering the defendants to add a heart failure warning to all saxagliptin drugs. (One member voted to have the drug withdrawn from the market, instead.)

The FDA did just that in April 2016. They also advised patients to report symptoms of heart failure to their doctors and recommended that health care professionals consider discontinuing the drug in patients who developed heart failure.

The plaintiff asserts that the drug makers over-promoted saxagliptin while downplaying the risks in their print marketing and promotional materials, as well as on their websites and blogs, and in their promotions to doctors and clinics. She brings counts of design defect, negligence, failure to warn, breach of warranties, and violation of the Kentucky Consumer Protection Act. She seeks compensatory and punitive damages.

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