Onglyza Lawsuit Plaintiffs Petition JPML for Centralization of Federal Heart Failure Claims

Published on October 27, 2017 by Sandy Liebhard

A plaintiff who allegedly developed heart failure due to Onglyza has filed a petition with the U.S. Judicial Panel on Multidistrict Litigation requesting that all such federal claims be transferred to  the U.S. District Court, Northern District of California for coordinated pretrial proceedings.

The October 11th petition notes that 40 lawsuits involving Onglyza and a related drug called Kombiglyze XR have been filed in various federal courts around the country. The plaintiff further asserts that hundreds of similar actions could be filed in the near future.

“Though filed in different jurisdictions within the federal court system, these cases are closely related: they share the same Defendants, the same basic theory of liability, and the same basic factual allegations,” the petition states. “All the cases will involve the same core discovery, fact witnesses, and experts. Moreover, none of these cases have made any substantial progress toward trial, making this the ideal time to order transfer.”

In proposing the Northern District of California as an appropriate venue for the consolidated litigation, the petition notes that two Onglyza lawsuits are already pending in the jurisdiction. One of the defendants is also based in San Francisco.

The plaintiff further points out that the judge overseeing a state-level Onglyza litigation in San Francisco Superior Court has also expressed a willingness to coordinate with any federal proceeding.

“The ability of the parties to conduct joint status conferences, a joint science day, and coordinate discovery between these two venues would be extremely beneficial for the parties, judges, and counsel,” the petition asserts.

Onglyza Heart Failure Allegations

The U.S. Food & Drug Administration (FDA) approved Onglyza (saxagliptin) in 2009. Kombiglyze XR (saxagliptin and metformin) was approved the following year.

The FDA launched a review of all saxagliptin-containing drugs in February 2014, after interim data from a large clinical trial called SAVOR-TMI indicated that patients treated with the medication were 27% more likely to be hospitalized for heart failure compared to those who were not. Saxagliptin also appeared to be associated with a higher risk of all-cause mortality.

A year later, the agency’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) overwhelmingly voted to recommend that the prescribing information for all saxagliptin-containing medications be modified to warn of a potential heart failure risk. The FDA ordered label modifications for Onglyza and Kombiglyze XR in April 2016.

Plaintiffs pursuing Onglyza and Kombiglyze XR lawsuits claim that the drugs’ manufacturers failed to warn doctors and patients about their potential side effects, including the increased risk of causing heart failure, congestive heart failure, cardiac failure, and death from heart failure. They further assert that the defendants ignored patient safety and sold saxagliptin products for nearly five years before completing an adequately powered and designed study of the medication’s cardiovascular risks.


