Health Plans Fight to Revive Avandia Suit at 3rd Circuit

PHILADELPHIA (CN) – Fighting to revive a class action, a lawyer for health plans told the Third Circuit on Wednesday that GlaxoSmithKline fumbled its responsibility to warn about the diabetes drug Avandia’s link to cardiovascular problems.

“GSK executed one of the largest healthcare frauds in history,” Hagens Berman attorney Hannah Brennan said this morning at oral arguments in Philadelphia.

Brennan’s clients, led by UFCW Local 1776, brought the appeal here after U.S. District Judge Cynthia Rufe threw out their case at summary judgment.

Though Rufe relied on the Food and Drug Administration’s regulation of Avandia to toss the suit on pre-emption grounds, Hagens Berman says this judgment failed to address its claims that GSK intentionally concealed the truth about Avandia’s health risks in its marketing.

Hagens Berman attorney Thomas Sobel told the Third Circuit today that GSK was dishonest, falsely representing to people with diabetes that Avandia could reduce heart problems. 

“Glaxo misrepresented cardiovascular characteristics in every imaginable way,” Sobel said, noting that the drugmaker had multiple studies showing the effects before it first launched the drug in 1999.

Chief U.S. Circuit Judge D. Brooks Smith, one of three on the Third Circuit panel, pressed Sobel on this point.

“You wanted GSK to have the warning that is there now, but at an earlier point in time,” he said.

Jay Lefkowitz, an attorney for GSK at the firm Kirkland Ellis, told the judges meanwhile that the buck stopped at the FDA.

“We asked for the very label that they asked for,” Lefkowitz said, gesturing to the opposing counsel.

Despite pressure by GSK to strengthen the Avandia label, Lefkowitz says the FDA would not do so without more studies. The lawyer also noted that GSK suffered as well because of Avandia’s heart-related side effects.

“As soon as the risks were disclosed,” said Lefkowitz, “the bottom fell out of this market.”

GSK holds the title for the largest health care fraud settlement in U.S history with a $3 billion settlement for criminal and civil liabilities related to three of its’ drugs, including Avandia. Avandia makes up $242 million of the settlement.

GSK was also represented by Sean Fahey of Pepper Hamilton law firm.

The panel was round out by U.S. Circuit Judges Thomas Ambro and U.S. Circuit Judge L. Felipe Restrepo.

Wednesday’s hearing comes nearly four years after the Third Circuit upheld a decision by Judge Rufe that advanced the UFCW’s case.

%d bloggers like this: