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Back in July 2009, the FDA approved the new drug Onglyza (saxagliptin) for the treatment of type 2 diabetes. In 2014, however, they issued a drug safety communication stating that they had requested additional clinical trial data from the manufacturers, “to investigate a possible association between use of the type 2 diabetes drug and heart failure.”

In 2015, an FDA advisory panel suggested that the FDA require updated warnings on the Onglyza product label to alert doctors and patients to the increased risk of heart failure. In July 2016, the FDA did just that, adding new warnings to Onglyza and other similar medications indicating that they could potentially increase the risk of heart failure.

Meanwhile, some patients who took the drug and then suffered from heart failure have filed Onglyza lawsuits against the manufacturers, Bristol-Myers Squibb and AstraZeneca. As more and more patients entered the court system, a group of plaintiffs filed a request with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all Onglyza lawsuits into the Northern District of California.

Studies Link Onglyza to Higher Risk for Heart Failure

OnglyzaOnglyza belongs to a class of drugs known as “dipeptidyl peptidase-4 (DDP-4) inhibitors,” also called “incretin mimetics.” These drugs stimulate the pancreas to make more insulin after a meal, to help process sugar and keep blood sugar levels steady in type 2 diabetes patients.

Studies have indicated that these drugs can create dangerous side effects, however. In 2013, researchers compared Onglyza with a placebo, and found that 27 percent more patients taking Onglyza were hospitalized for heart failure than those taking a placebo.

The FDA, when they heard the results of the study, conducted their own analysis of the results, and in 2014, requested additional studies from the manufacturers to investigate possible associations between taking Onglyza and suffering from heart failure.

The results of their analysis showed that the concerns about heart failure were valid, and also showed that people taking the drug could be at an increased risk of dying from all causes.

Plaintiffs Say Northern California is the Best Location for Centralization

Plaintiffs who have filed Onglyza lawsuits say that the company failed to provide adequate warnings about the risks for heart failure, and that they should have conducted more clinical trials to detect this risk before they released the product on the market.

Currently, there are at least 44 Onglyza lawsuits pending in 24 different courts around the nation, and more will likely be filed in the future. When requesting consolidation, the plaintiffs asked for the Northern District of California. There are already 12 cases centralized in a mass tort in San Francisco County, the only consolidation connected to Onglyza.

The plaintiffs also assert that all the Onglyza cases involve common questions of fact, including whether Onglyza was marketed with an adequate label, whether the manufacturers conducted adequate testing of the product, and whether they failed to warn about the product’s potential to increase risk of heart failure, congestive heart failure, cardiac failure, and death from heart failure.

They add that centralization would make pre-trial proceedings more efficient and convenient, while failing to consolidate would “almost certainly lead to inconsistent and conflicting rulings.”

The JPML is expected to consider arguments on the motion on November 30, 2017.

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