Federal Judicial Panel Centralizes Onglyza Heart Failure Lawsuits in Eastern District of Kentucky

Published on February 5, 2018 by Sandy Liebhard

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has granted a plaintiffs’ motion seeking centralization of all federally-filed Onglyza lawsuits in a single jurisdiction.

In an Order dated February 2^nd, the Panel transferred all such federal claims to the U.S. District Court, Eastern District of Kentucky, where they will undergo coordinated pretrial proceedings before the Honorable Karen K. Caldwell.

The litigation will also include federal product liability claims involving a related medication, Kombiglyze XR.

Onglyza Heart Failure Litigation

Onglyza (saxagliptin) was approved by the U.S. Food & Drug Administration (FDA) in 2009 to treat adults with Type 2 diabetes.  Kombiglyze XR (saxagliptin and metformin) was cleared the following year.

The litigation involving the two medications began to gain momentum shortly after the  FDA mandated new heart failure warnings for saxagliptin-containing drugs in April 2016. The agency acted in response to clinical trial data linking saxagliptin to a 27% increased risk of heart failure. The drug also appeared to be associated with a higher risk of all-cause mortality.

Plaintiffs involved in this litigation claim they were never warned that exposure to Onglyza and Kombiglyze XR could increase their risk of heart failure and other cardiac injuries.

A group of Onglyza lawsuit plaintiffs motioned the JPML for centralization in October, asserting that consolidation of the 41 pending cases – which they predicted would ultimately number in the hundreds – would improve judicial efficiency and preserve the resources of the courts, parties and witnesses involved in the litigation.

AstraZeneca and other defendants opposed centralization, countering that “informal coordination” would be a feasible alternative to the creation of a multidistrict litigation.

According to the JPML’s Order, the litigation has now grown to include 84 Onglyza and Kombiglyze XR lawsuits pending in 30 U.S. District Courts. In agreeing to centralize the docket, the Panel voiced doubt that informal coordination among so many cases scattered throughout the country would even be possible.

“Given that the drugs at issue here were marketed nationwide, and no action or group of actions is significantly advanced, any number of potential transferee districts would be appropriate. We select the Eastern District of Kentucky, a relatively accessible district that is supported by defendants and certain plaintiffs, as transferee district for this litigation,” the Order states. “The longest-pending action (Taylor) is proceeding apace in this district. We are confident that Chief Judge Karen K. Caldwell will steer this litigation on a prudent course.”

What Happens Now?

All pending Onglyza and Kombiglyze XR lawsuits – as well as any filed in federal courts in the future – will now undergo coordinated discovery and other pretrial proceedings in the Eastern District of Kentucky. At some point, the Court will select several representative cases for  a series of test, or bellwether, trials. Verdicts in bellwether trials are intended to provide insight into how other juries might decide similar lawsuits and could, potentially, provide a pathway to settlements.

All Onglyza and Kombiglyze XR lawsuits transferred to Kentucky will maintain their own individual identity. Any not resolved in the course of the multidistrict process will be returned to their court of original filing for trial.