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| Chaffin Luhana LLP

On July 13, 2016, a Kentucky family filed a new lawsuit against the manufacturers of Onglyza, a type 2 diabetes drug. They claim that after the husband took the drug, he suffered from serious injuries.

The filed the case in the Eastern District of Kentucky, and seek in excess of $75,000 in damages.

Plaintiff Takes Onglyza, Suffers from Heart Attack

According to the complaint, the plaintiff started taking Onglyza (saxagliptin) in April 2015 and continued until June 2015 as part of his type 2 diabetes treatment. In July 2015, he suffered a heart attack, which caused significant physical and mental injuries, pain and suffering, and loss of earnings and earning capacity. He asserts that will continue to need medical attention in the future.

The plaintiff states that his healthcare providers would not have prescribed the drug had they known of its potential side effects, including the risk of heart failure, congestive heart failure, cardiac failure, and death related to these events. He blames the manufacturers—Bristol-Myers Squibb Co. and Astrazeneca Pharmaceuticals—for failing to provide adequate warnings about these risks on the product label.

Had they been aware of those effects, the plaintiff alleged his healthcare providers would not have prescribed the medication. Instead, the manufacturers downplayed the potential risks, resulting in the patient unnecessarily suffering from a serious condition.

Late Trial Shows Onglyza Increases Risk of Heart Failure

Onglyza belongs to a class of drugs called “dipeptidyl peptidase-4 (DDP-4) inhibitors,” or “incretin mimetics,” that work by stimulating the production of insulin after a meal. This drug is intended to help type 2 diabetes patients lower their blood sugar levels.

Diabetics are already at an increased risk for cardiovascular problems. Because of this, the FDA warned pharmaceutical companies in 2008 that any manufacturer applying for approval of new anti-diabetic medications for the treatment of type 2 diabetes must demonstrate that the products were not associated with an unacceptable increase in cardiovascular problems.

The plaintiff in this case claims that Onglyza manufacturers ignored this requirement and sold their product before adequately studying the risks. They began marketing the drug in July 2009, and only after they had received substantial profits, did they begin the cardiovascular outcome trial (entitled “SAVOR”).

The SAVOR trial found that people taking saxagliptin had a statistically significant increased risk of being hospitalized due to heart failure. Considering these results, the FDA requested the raw clinical trial data, and performed its own analysis. It then convened a drug advisory panel of experts and scientist, which voted 14 to 1 for the manufacturers to add a heart failure warning to the drug label.

Plaintiff Seeks Punitive Damages

The plaintiff adds that in addition to failing to study the product for its cardiovascular risks, the defendants also over-promoted and under-warned about the product’s benefits and risks in their print marketing, advertising, and promotional materials.

He brings counts of strict products liability, negligence, failure to warn, and breach of warranties, and his wife claims loss of consortium. He also asserts that his injuries are the result of fraud, malice, and/or gross negligence on the part of the defendants, and seeks punitive damages.




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