A panel of federal judges has sent around 85 lawsuits involving the type 2 diabetes drugs Onglyza and Kombiglyze XR to a Kentucky federal court, creating a new Multi-District Litigation to consolidate the claims. The lawsuits draw on the results of an FDA review, which linked Onglyza's active ingredient to an increased risk for heart failure. Learn more about the recent Onglyza tv commercial.
On February 2, 2018, the US Judicial Panel on Multi-District Litigation announced the creation of In Re: Onglyza (Saxagliptin) and Kombiglyze XR (Saxagliptin and Metformin) Products Liability Litigation, assigning the coordinated proceedings to Chief Judge Karen K. Caldwell of the US District Court for the Eastern District of Kentucky.
In Lexington, the newly-consolidated lawsuits will undergo pre-trial proceedings together, allowing plaintiffs' counsel to efficiently litigate their case against Astra Zeneca, Bristol-Myers Squibb and McKesson. As new plaintiffs step forward to file lawsuits of their own, it's likely that their claims will ultimately be transferred to Kentucky and included in the Onglyza MDL.
Onglyza is a type 2 diabetes medication that helps the body increase insulin production after eating to control blood sugar levels. It can be prescribed on its own or, alongside other drugs, as a combination therapy. The drug's active ingredient, a chemical known as saxagliptin, can also be found combined with metformin, the world's most popular type 2 diabetes drug, in Kombiglyze XR. Both medications were co-developed by AstraZeneca and Bristol-Myers Squibb. Another pharmaceutical company, McKesson Corporation, helps to distribute the drugs.
Today, all three companies find themselves named in nearly 90 product liability lawsuits, in which type 2 diabetes patients blame Onglyza and Kombiglyze XR for causing severe cardiovascular complications, including heart failure.
In 2016, the US Food & Drug Administration reviewed the safety of saxagliptin and found troubling results. Saxagliptin, the active ingredient in both Onglyza and Kombiglyze XR, appears to increase the risk of heart failure, federal officials say, "particularly in patients who already have heart or kidney disease."
To arrive at their conclusion, FDA reviewers analyzed the results of two large clinical trials in which saxagliptin's safety was evaluated in patients with pre-existing heart disease. Compared to people who received a placebo, patients taking Onglyza or Kombiglyze XR were more likely to be hospitalized for heart failure, the FDA says. The rate of hospitalization increased, reviewers found, from 2.8%, among placebo patients, to 3.5% in people taking drugs based on saxagliptin.
And, while new warnings were soon added to the drugs' warning labels, some patients believe that AstraZeneca and Bristol-Myers Squibb were well-aware of Onglyza's heart failure risk long before 2016.
In their lawsuits, around 85 plaintiffs accuse the companies of "acting in concert" to "fraudulently convey false and misleading information concerning the safety of Onglyza and to conceal the risks of serious adverse events, including heart failure [and] congestive heart failure."
Their argument relies equally on saxagliptin's mechanism of action and a 2008 FDA guidance, which instructed companies who develop anti-diabetic drugs to prove, prior to approval, that their products do not create an "unacceptable increase in cardiovascular risk."
In developing Onglyza and Kombiglyze XR, AstraZeneca and Bristol-Myers Squibb utterly failed to comply with these guidelines, plaintiffs claim. "Instead of adequately assessing the potential, and now established, significant risk of heart failure, congestive heart failure, cardiac failure, and death related to those events," the patients write, "Defendants ignored patient safety and sold Saxagliptin before studying the risks."
It's important to note, as the plaintiffs do, that the clinical trial on which the FDA's heart warnings are based was conducted by AstraZeneca and Bristol-Myers Squibb. The study, known for short as SAVOR, began in 2010, ultimately including almost 16,500 patients. The initial results were published in a 2013 article for the New England Journal of Medicine. That was more than four years after AstraZeneca and Bristol-Myers Squibb had begun marketing Onglyza to millions of type 2 diabetes patients.
Why did it take so long, plaintiffs ask, for the companies to complete "an adequately powered and designed study of the risks of heart failure"? The question becomes even more pointed in light of the FDA's guidance, issued in 2008, that instructed diabetes drug manufacturers to adequately test their products for cardiovascular risks.