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In April 2018, an Ohio widow filed a new Onglyza lawsuit in the U.S. District Court for the Southern District of Ohio on behalf of her deceased husband. The plaintiff blames Onglyza manufacturers Bristol-Myers Squibb and AstraZeneca Pharmaceuticals for injuries her husband suffered as a result of taking Onglyza and seeks both compensatory and punitive damages.

All federally-filed Onglyza lawsuits were recently consolidated into one court in the U.S. District Court for the Eastern District of Kentucky, so this new case may soon be transferred there.

Widow Blames Onglyza for Her Husband’s Heart Failure

According to her complaint, the plaintiff’s husband started taking Onglyza (saxagliptin) in July 2012 to help treat his diabetes and continued to take it for years. In October 2015, he then developed congestive heart failure. The plaintiff says as a result of this injury, her husband suffered significant bodily and mental injuries, pain and suffering, mental anguish, disfigurement, and loss of earnings and earning capacity.

Defendants knew about the risk of congestive heart failure, the plaintiff states, yet they continued to manufacturer, market, and sell the drug, while profiting from those sales. They also failed to warn both doctors and patients about the risks of injury. Had her husband’s doctors been properly warned about the risks associated with Onglyza, she states, they would not have prescribed the medication.

“A reasonable person who had actual knowledge of the increased risks associated with using the drugs would have concluded that Onglyza and Saxagliptin should not have been marketed to or used by Decedent and his physicians,” the complaint reads.

Manufacturers Slow to Test Onglyza for Cardiovascular Outcomes

The FDA issued a memo to companies developing anti-diabetic drugs, including Onglyza manufacturers, in December 2008, stating that companies applying for approval of new drugs for the treatment of type 2 diabetes should show that their products were not associated with an unacceptable increase in cardiovascular risk. Yet the defendants failed to perform adequate clinical trials to find out if Onglyza created such a risk.

Instead, they released the drug onto the market on July 31, 2009, where it was marketed to type 2 diabetes patients all over the country. At that time, they did not warn of an increased risk of heart failure. Once they had established the product in the market, they finally conducted the “SAVOR” study, a cardiovascular outcome trial, which found that patients using saxagliptin had a significantly increased risk of being hospitalized for heart failure.

After receiving the findings, the FDA requested the raw clinical data and performed its own analysis. It then convened an advisory committee, which voted 14 to 1 for the FDA to order a new heart failure warning be placed on the product. The single dissenting voter stated that instead of a warning, the product should be withdrawn from the market.

The plaintiff brings counts of strict products liability, negligence, and failure to warn.

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