A multidistrict litigation (MDL) is a group of lawsuits with similar complaints that, while still kept separate, are funneled into one district of the federal court system for streamlining of judicial processing. The Onglyza MDL is an example of this process.

Onglyza—known generically as saxagliptin—is a medication used to treat type-2 diabetes. It has allegedly been linked to serious cardiovascular side effects such as myocardial infarction and congestive heart failure.

In February 2018, 80 pending lawsuits claiming injuries and in some cases death from this type-2 diabetes drug were gathered and sent to the U.S. District Court for the Eastern District of Kentucky to be the first cases in the Onglyza MDL.

The Onglyza MDL is intended to prevent duplication of the necessary steps to prepare evidence and arguments for both sides of a judicial debate such as repeat discovery and pretrial hearings. Cases in the Onglyza MDL that go to a jury trial will be heard by one federal judge.

The Onglyza MDL Grows Exponentially

The U.S. Judicial Panel on Multidistrict Litigation (JPML) issued an update on June 15, 2018, indicating that legal complaints against Bristol Myers Squibb have more than doubled in the five months since the Onglyza MDL was created.

Plaintiffs are coming forward with allegations that the pharmaceutical giant knew or should have known of these dangerous side effects but failed to warn the public appropriately.

These complaints target both Onglyza and Kombiglyze XR—a combination of saxagliptin and metformin, which is a more traditional blood-sugar lowering drug. To date, there are 207 pending Onglyza MDL cases in Kentucky.

The History of Onglyza

The U.S. Food and Drug Administration (FDA) commercially approved Onglyza in 2009 for the treatment of type-2 diabetes. In November of the following year, Kombiglyze XR went through a similar process to enter the marketplace. Six years later, in April 2015, a special consulting panel recommended the FDA require Bristol Myers Squibb to change its Onglyza label.

It was at this time that initial data from a post-market clinical study known as SAVOR-TMI revealed a nearly 30 percent increase in hospitalizations related to heart failure or other cardiac events and an overall higher risk of death for participants taking the diabetic medication.

A year after the panel made its suggestion, the FDA followed the advice and demanded that Bristol Myers Squibb change the warning section of the label to indicate findings associated with the SAVOR study data.

At the time the initial SAVOR-TMI information came to light, product liability lawsuits for both saxagliptin-based medications started accumulating in federal courts. Now that the Onglyza MDL has been formed, this trend shows no sign of abating.

Onglyza MDL Bellwether Trials

All individual lawsuits that are streamlined into the Onglyza MDL retain their individual integrity and allegations. The first step in adjudication will be picking a few representative cases to go to trial that will test the plaintiff allegations and arguments against the pharmaceutical company.

These test cases are known as bellwether trials; they allow each side to predict how future cases may play out. Sometimes these test cases set the stage for settlement.  No bellwether cases have been scheduled as yet.