Onglyza Lawsuit Defendants Push Back on Bid to Centralize Federal Heart Failure Claims

Published on November 8, 2017 by Sandy Liebhard

Plaintiffs seeking to centralize federal heart failure lawsuits involving Onglyza and Kombiglyze XR are facing opposition from AstraZeneca PLC, which asserts that there are too few cases pending to justify the creation of a new multidistrict litigation.

Onglyza and Heart Failure

Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin) are indicated to treat adults suffering from Type 2 diabetes. Onglyza was approved by the U.S. Food & Drug Administration in 2009, while Kombiglyze XR was cleared the following year.

The labels for both drugs were modified in April 2016 to include information about a possible risk of heart failure, after interim data from a 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.

Onglyza Lawsuit Plaintiffs Predict Hundreds of Filings

Last month a group of Onglyza plaintiffs filed a petition with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking the centralization of all federally-filed heart failure claims in the U.S. District Court, Northern District of California. The petition noted that 40 Onglyza and Kombiglyze XR lawsuits are currently pending in the federal courts throughout the country and argued that the cases would benefit from coordinated discovery and other pretrial proceedings.

The petition also predicted that the heart failure litigation involving Onglyza and Kombiglyze XR could soon grow to include hundreds of cases.

AstraZeneca’s Arguments

In a response filed with the JPML on November 2^nd, AstraZeneca disputed that assertion. The company further argued that the currently pending Onglyza and Kombiglyze lawsuits can be readily coordinated across the litigation without creating a multidistrict litigation.

“At the same time, an MDL could frustrate resolution of these cases. Determinative merits issues will overwhelmingly focus on varying plaintiff-specific facts,” the response states. “For example, unlike other MDLs that focus exclusively on a narrowly-defined injury type, these cases involve a range of claimed injuries not well suited for consolidation, including heart failure, unrelated forms of cardiovascular injury, and a form of lung injury.”

AstraZeneca also asserted that the Southern District of California would be the most appropriate jurisdiction for any multidistrict litigation involving Onglyza and Kombiglyze XR.

“Should the Panel conclude that centralization is warranted, any proceeding should be centralized in the Southern District of California, where Judge Battaglia has ably managed the diabetes medicine litigation, In re Incretin-Based Therapies Products Liability Litigation, and its companion Onglyza-related cases,” the company stated.  “Judge Battaglia in particular has developed substantial experience with both the basic scientific aspects of these types of diabetes medicines generally and with the discovery record to date relating to both Onglyza and Kombiglyze XR.”

The JPML will likely hear oral arguments on this matter at its January 2018 Hearing Session.