Onglyza Lawsuit News: Bernstein Liebhard LLP Partner, Daniel C. Burke, Appointed to Plaintiffs’ Executive Committee in Federal Heart Failure Litigation

Published on September 14, 2018 by Sandy Liebhard

Daniel C. Burke, a partner at the nationwide law firm of Bernstein Liebhard LLP, has been appointed to the Plaintiffs’ Executive Committee in the multidistrict litigation established for all federally-filed Onglyza heart failure lawsuits.

Mr. Burke’s appointment was announced in an Order issued by the U.S. District Court, Eastern District of Kentucky, on September 4^th.

Role of the Plaintiffs’ Executive Committee

The Order also appointed attorneys to serve as Plaintiffs’ Co-Lead Counsel, Plaintiffs’ Liaison Counsel, and Plaintiffs’ Federal-State Court Liaison Counsel.

The Plaintiffs’ Executive Committee includes 3 attorneys.  Mr. Burke and his fellow committee members will work closely with Plaintiffs’ Co-Lead Counsel and Liaison Counsel to coordinate case management of the litigation, including assisting in the organization of subcommittees and the delegation of tasks to those subcommittees.

The Plaintiffs’ Executive Committee will also assist in scheduling meetings for Plaintiffs’ Counsel, keep minutes and records of all such meetings, and perform other administrative functions as needed.

FDA Onglyza Heart Failure Warnings

Onglyza (saxagliptin) was approved by the U.S. Food & Drug Administration (FDA) in 2009. The drug is indicated to control blood sugar in patients with Type 2 diabetes in conjunction with diet and exercise.

Kombiglyze XR (saxagliptin and metformin) was approved the following year.

Lawsuits involving the two diabetes drugs began to mount in 2014, after the FDA announced it was reviewing a possible link between saxagliptin and heart failure. The agency launched its review after early results from the SAVOR-TMI study suggested that patients exposed to saxagliptin were 27% more likely to be hospitalized with heart failure. Saxagliptin also appeared to be associated with a higher risk of all-cause mortality.

In April 2015, an FDA advisory committee voted overwhelmingly to recommend that new heart failure warnings be added to the labels of all saxagliptin-containing medications. The labels for Onglyza and Kombiglyze XR were modified in April 2016 in accordance with those recommendations.

Onglyza Heart Failure Litigation

More than 200 Onglyza and Kombiglyze XR lawsuits are currently pending in the Eastern District of Kentucky, all of which were filed on behalf of patients who allegedly experienced heart failure or other cardiovascular complications due to treatment with saxagliptin.

The complaints allege that AstraZeneca and other defendants were aware that exposure to saxagliptin would increase a patient’s risk for heart failure and other serious injuries, as this was evident in the defendants’ own studies. However, rather than provide doctors and patients with appropriate warnings, the drug makers prevented those findings from being released to the public.

The federal multidistrict litigation was established by the U.S. Judicial Panel on Multidistrict Litigation in February, when 41 Onglyza and Kombiglyze XR lawsuits were transferred to the Eastern District of Kentucky.

Plaintiffs who petitioned for centralization predicted that the litigation could eventually grow to include hundreds of similar claims. Centralization before a single judge was intended to eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the courts.