Avandia Litigation Will Move Forward On Cases Not Settled: Judge

After helping facilitate the settlement of about 25,000 additional Avandia lawsuits, the federal judge presiding over the litigation has indicated that the Court will proceed forward with any remaining cases, although not all of the cases will make it to trial. 

A court-appointed mediator has successfully helped the parties negotiate Avandia settlement agreements in the bulk of lawsuits filed throughout the United States, in which plaintiffs allege that the GlaxoSmithKline diabetes drug caused them to suffere heart attacks and other health problems.

All federal cases involving side effects of Avandia have been centralized before U.S. District Judge Cynthia Rufe, in the U.S. District Court for the Eastern District of Pennsylvania, where the cases are currently consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation.

Last year, Judge Rufe pressed the parties to reach an agreement to settle at least 85% of the cases remaining in the Avandia litigation. During a hearing Tuesday, Judge Rufe suggested that mediating Avandia lawsuits will no longer be the Court’s focus, and the remaining cases will be resolved through litigation.

This likely means that individual Avandia trials will be scheduled in the MDL, or that Judge Rufe will begin remanding cases back to the federal district courts where they were originally filed for trials throughout the United States.

Although there are not a large number of Avandia suits remaining that have not been settled, Judge Rufe suggested that not all of the cases will be permitted to go before a jury, as some of the cases may be dismissed following additional pretrial motions practice if they do not have sufficient evidence to proceed to trial.

In addition to the most recent settlements, it was previously reported that Glaxo agreed to pay an estimated $700 million to resolve about 15,000 Avandia lawsuits filed in state and federal courts throughout the United States.  The amount of any additional Avandia payments that will resolve these most recent cases has not been disclosed.

Avandia (rosiglitazone) was a popular type 2 diabetes drug that was used by millions of people before it was linked to an increased risk of heart attacks and heart problems. Some estimates suggest that more than 100,000 heart attacks may have been caused by Avandia since it was introduced.

After concerns about the Avandia heart risks first surfaced in May 2007, the FDA required a “black box” warning, which is the strongest warning that can be placed on a medication label. However, many critics continued to argue that the warning was not strong enough and called for federal regulators to issue an Avandia recall because the risks greatly outweigh any benefit provided by the medication.

In July 2010, an FDA advisory panel was convened to review the risks associated with Avandia. Although the panel indicated that Avandia increases the risk of heart attacks when compared to older drugs, a majority of the committee voted to recommend that the FDA allow GlaxoSmithKline’s diabetes drug to remain on the market.