A founding partner at the firm, Eric has negotiated groundbreaking settlements that resulted in reforms to business practices, and have favorably shaped the laws impacting plaintiffs’ legal rights.
Gibbs Law Group represents third party payors, including unions and corporate health and welfare funds, in a class action lawsuit against Glaxo Smith Kline (GSK), seeking reimbursement of the prescription drug costs associated with Avandia. The lawsuit specifically alleges that Glaxo Smith Kline deliberately concealed the significant safety risks associated with the use of Avandia, and continued to promote it as a safe treatment for diabetes despite the known risks of heart attack and disease.
Eric Gibbs was appointed by a Pennsylvania federal court judge to serve on the Plaintiffs’ Executive Committee in consolidated class action litigation against the drug maker.
Third party payors (TPPs) typically provide medical coverage, including prescription drug coverage, for their members and members’ dependents. Coverage of a TPP member’s prescription, in whole or in part, is determined based on whether the drug is listed in the TPP’s “formulary,” or preferred drug list. Pharmacy Benefit Managers (PBMs) determine which drugs will be included a TPP formulary by analyzing research on a variety of factors including a drug’s cost, effectiveness, and safety.
Background: Avandia & Cardiac Risks
The FDA approved Avandia for sale in the US in 1999. Glaxo Smith Kline marketed Avandia a safer and more effective alternative to the cheaper, existing Type II diabetes medications. In turn, TPPs included Avandia in their formularies and covered Avandia prescriptions at a favorable rate for their members.
According the lawsuits, soon after the FDA approved the drug, concerns began to surface regarding possible heart-related side effects. In 2006, the FDA required Glaxo Smith Kline to update the drug’s warning label to include new data about the potential increased occurrence of heart attack and chest pain in some Avandia patients.
Clinical Trial Data
In May 2007, the “Nissen Study” was published in The New England Journal of Medicine, documenting the results of forty-two clinical trials of Avandia. The lawsuits allege that the study concluded that, compared to competing diabetes drugs, Avandia use was associated with a significant increase in the risk of heart attack.
Black Box Warning
On May 23, 2007, the FDA recommended that Glaxo Smith Kline add a “black box” warning to Avandia’s label to warn of the risk of congestive heart failure, which the company ultimately added to the drug in August 2007.
U.S. Senate Finance Committee Report
In February 2010, the U.S. Senate Finance Committee released a report on Avandia. According to the lawsuits, the Committee concluded:
According to the lawsuits, the Committee also concluded that Glaxo Smith Kline failed to notify the FDA and the public of these risks despite its duty to do so. Furthermore, the report noted that Glaxo Smith Kline attempted to minimize or misrepresent those risks in order to contradict the 2010 Nissen study and to intimidate independent physicians, the lawsuits say.
FDA Restricts Access
Ultimately, on September 23, 2010, the FDA restricted access to Avandia in response to increasing evidence of its cardiovascular risks.
Status of Avandia Lawsuits
Several third party payors filed class action lawsuits against Glaxo Smith Kline, alleging that the company deliberately concealed the significant safety risks associated with the use of Avandia and continued to promote the drug as a safer treatment for diabetes despite the known risks of heart attack and disease.
The lawsuits were ultimately consolidated on behalf of a group of union health and welfare funds who seek to represent a class of third-party payors for injuries suffered as a result of Glaxo Smith Kline’s fraudulent misrepresentation and concealment of serious safety risks. Specifically, the Plaintiffs assert that Glaxo Smith Kline’s failure to disclose the drugs’ significant heart-related risks violated the Racketeer Influenced and Corrupt Organizations (“RICO”) Act, and various state consumer protection laws.
The Avandia Marketing Sales Practices and Products Liability Litigation, MDL No. 1871, is pending in the Eastern District of Pennsylvania before the Honorable Judge Cynthia M. Rufe.
On February 1, 2016, Judge Rufe set forth a formalized structure of counsel for the Third Party Payors and designated Eric Gibbs of Gibbs Law Group to the Plaintiffs’ Executive Committee.
The case is currently proceeding in the discovery phase.
OUR TEAM & EXPERIENCE
Complex pharmaceutical fraud litigation has occupied a central role in our firm for more than ten years. We represent individuals who have been injured by defective drugs and devices, as well as health benefit funds that have paid higher prices than they should have due to illegal conduct by pharmaceutical manufacturers.
In addition to our litigation experience, our attorneys are leaders in legal organizations and associations focused on pharmaceutical fraud issues. This gives us direct exposure to the top practitioners in the country, knowledge of developments in the law, critical information about newly-filed cases, and cutting edge legal theories as they are being litigated. Our attorneys regularly organize and lead seminars and webinars on the subjects of pharmaceutical fraud litigation and class actions.