An Onglyza lawsuit from a Kentucky couple claims the diabetes drug caused a heart condition severe enough to require surgical intervention.

Plaintiffs Linda and Robert E. say that Linda took Onglyza, also referenced in the couple’s lawsuit by its generic name saxagliptin, from around February 2009 to June 2015. She later developed a heart condition that required placement of coronary stents in March 2014 and again in April 2015, they allege.

The couple now believes Linda’s heart condition was caused by Onglyza. Her alleged Onglyza side effects caused Linda to suffer significant pain, physical and mental injuries, and loss of earnings and earning capacity, they say, in addition to generating both past and future medical expenses.

The couple is now bringing an Onglyza lawsuit against Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals LP, McKesson Corp., and IPR Pharmaceuticals Inc. of Puerto Rico, all of whom the plaintiffs allege are involved in “designing, manufacturing, marketing, selling and distributing” Onglyza.

Onglyza Lawsuit Claims Inadequate Studies

The couple says that during the development of Onglyza, the defendants never performed adequate studies to evaluate the risks of cardiovascular adverse events associated with the drug.

Even after the release of an FDA memorandum in 2008 requiring pharmaceutical companies to ensure that their type-2 diabetes drugs do not present an unacceptable increase in cardiovascular risk, the companies still did not undertake any cardiovascular studies of Onglyza, the plaintiffs say.

Linda and Robert say the defendants marketed and sold Onglyza for five years before finally completing an adequate study of the risk of related heart failure. This study, known as the SAVOR study, found that users of Onglyza and other saxagliptin-based drugs bear a significantly increased risk of being hospitalized for heart failure.

An FDA advisory committee responded to the SAVOR study by recommending the addition of a warning about heart failure to the labeling for Onglyza. One committee member would have preferred to take the drug off the market entirely.

But despite the defendants’ knowledge of the risks of Onglyza side effects, the plaintiffs claim, they continued to promote the drug as being safe and effective for treatment of type-2 diabetes. Plaintiffs say that since the publication of the SAVOR study, the defendants have not made an effort to strengthen the warning label for Onglyza.

Linda and Robert say their own physicians were unaware of the risk of heart failure associated with Onglyza. Had their physicians been better informed, the couple says, they would have adjusted the way they counseled the plaintiffs about Onglyza side effects, or would have declined to prescribe Onglyza at all.

The couple’s Onglyza lawsuit raises claims for strict products liability, negligence, failure to warn, breach of warranty, and violations of the Kentucky Consumer Protection Act. Robert is including his own claim for loss of consortium, based on the effect his wife’s alleged injuries have had on their marital relationship.

They seek an award of both compensatory and punitive damages, plus attorneys’ fees and costs of the litigation.

This Onglyza Lawsuit is pending under Case No. 3:16-cv-296 in the U.S. District Court for the Western District of Kentucky.