First Avandia Trial to Be Split Into Compensatory and Punitive Phases

A federal judge has decided to split the first Avandia trial into two phases, requiring jurors to determine liability and compensatory damages before deciding whether punitive damages should be awarded against GlaxoSmithKline PLC for their conduct in failing to warn about the side effects of Avandia.

The first Avandia lawsuit is scheduled for trial to begin January 24th in the U.S. District Court for the Eastern District of Pennsylvania, involving a claim filed by the family of James Burford.

This trial and a second case scheduled to begin March 28, were selected as bellwether trials to help the parties gauge how juries are likely to respond to testimony and evidence that will likely be similar to what is presented in other cases, and may help facilitate an Avandia settlement agreement in other pending cases.

Burford died in November 2006 from a myocardial infarction at the age of 49. According to the lawsuit brought by his wife, Deborah and their two minor children, he began using Avandia in December 2005 to control his diabetes, and the family alleges that his death may have been prevented if GlaxoSmithKline had adequately researched their medication and warned about the increased risk of heart problems from Avandia.

Avandia (rosiglitazone) was first approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales plummeted following concerns about potential Avandia heart risks. Some experts estimate that Avandia has caused between 60,000 and 200,000 heart attacks and deaths due to cardiovascular problems in the U.S. from 1999 to 2006, and it has been alleged that GlaxoSmithKline actively attempted to minimize the risks associated with Avandia and intimidate experts who spoke out about the dangers associated with the diabetes drug.

A black box warning was added to the medication in 2007 due to the increased risk of heart problems from Avandia. However, earlier this year, the FDA determined that the warning was not enough and has severely restricted use of the medication instead of issuing an Avandia recall.

In an order issued January 6, U.S. District Judge Cynthia M. Rufe, who is presiding over the consolidated federal Avandia litigation, granted GlaxoSmithKline’s motion to seperate, or bifurcate, the trial of punitive liability and damages in the Burford Avandia trial.

The first phase of the Avandia trial will involve a determination of whether the company is liable for the death of James Burford as a result of a failure to provide adequate warnings, and what amount of damages should be awarded to compensate the plaintiff, known as compensatory damages.

If the plaintiff wins the first phase of the trial, the jury will then consider evidence about whether additional punitive damages should be awarded. Such damages are designed to punish particularly egregious behavior, and the plaintiffs must establish by clear and convincing evidence that GlaxoSmithKline acted with conscious and intentional disregard and indifference for the safety of others.

GlaxoSmithKline called for the trial to be bifurcated to avoid prejudicing the jury. The drug maker argued that there was a chance evidence used to show whether GlaxoSmithKline was liable for Burford’s death would be confused by the jury and applied to determining whether the company should be ordered to pay punitive damages. Instead, the company argued, the same jurors should be presented punitive damages evidence and arguments in a separate stage of the case.

The plaintiffs had opposed bifurcation, saying that Glaxo has not met the burden of proof showing that it would increase convenience, avoid prejudice or expedite the judicial process. In a motion filed in late December, the plaintiff’s Avandia lawyers argued that bifurcating the trial would have the opposite effect.

Judge Rufe sided with GlaxoSmithKline, determining that bifurcation would enhance juror comprehension and avoid prejudice to the drug maker.

Certain evidence that may not be admissible for purposes of determining compensatory damages may be admissible for punitive damages in the Avandia lawsuit, such as Glaxo’s wealth and ability to pay a punitive damages award. Other factors considered during the punitive damages phase could also include the motives of the drug maker in failing to warn about the heart risks with Avandia, the reprehensibility of the drug maker’s actions, similar past conduct and whether the company profited from their actions.