The Committee's report says GSK's behavior at the time that Dr Buse voiced his concerns and since the Committee first brought the allegations about Avandia to light was "less than stellar."
"Instead of acknowledging the misdeed to investors, apologizing to patients, and pledging to change corporate behavior, GSK launched a public relations campaign of denial," the report notes.
The Committee also points out that GSK's concerns over Dr Buse reemerged in 2002, as his professional stature grew and in September 2002, one GSK official described him as the "most powerful Endocrinologist in the Carolinas...." and said, "[H]e is gaining power nationally and internationally."
In the report, the Committee notes concerns not only about the culture of leadership at GSK, but also a "fear that the situation with Dr Buse is part of a more troubling pattern of behavior by pharmaceutical executives."
As an example, the report cites another case in which Stanford University researcher, Dr Gurkirpal Singh, testified at a November 18, 2004 hearing on Vioxx, and said a Merck executive intimidated him by calling his superiors and warning Dr Singh that Merck would make life very difficult for him if he persisted in his request for Vioxx data.
"Merck's intimidation of Dr. Singh as it sought to protect Vioxx bears striking similarities to apparent threats by GSK against Dr. Buse to protect Avandia," the report notes.
In a November 15, 2007 speech on the Senate floor, Senator Grassley said the Vioxx hearing "turned the spotlight on systematic problems" at the FDA and described in detail how Merck had used power, influence and access to discredit safety expert Dr David Graham and said that it was "troubling" three years later to learn of another case where a drug company used power, influence, and access to intimidate a researcher.
On December 18, 2007, the Los Angeles based Baum, Hedlund, Aristei & Goldman law firm announced the filing of an Avandia lawsuit against GSK on behalf of Rogelio Larosa and his adult son, Eric, in the US District Court, Southern District of California accusing GSK of causing the death of Milagros Larosa, their wife and mother, due to negligence, fraud, breach of warranty and a failure to warn about the risks of Avandia.
The lawsuit alleges that GSK over-promoted Avandia, carelessly promoted it as safe and effective and refused to adequately warn the medical community and consumers about the risks associated with the drug until the FDA finally took action.
According to the complaint, over the course of a year, Ms Larosa was hospitalized 3 times for heart problems, classified as myocardial ischemic events, before she had a fatal stroke.
She suffered the first heart blockage in December of 2004 and two more occurred in January 2005 and July 2005, with each requiring a heart bypass or "coronary revascularization" to restore oxygen and nutrients to her heart.
After the last blockage, Ms Larosa had to be placed in a nursing home where she received constant care for 6 months until a stroke killed her on December 20, 2005. She was prescribed Avandia to treat type 2 diabetes and she had no prior heart problems before taking the drug, according to the complaint.
Baum Hedlund attorney Roger Drake reports that there are currently about 50 state and federal lawsuits filed against GSK in the US.
The Larosa lawsuit will be consolidated with all the other federal Avandia lawsuits against GSK that were joined together in October 2007 by the Judicial Panel on Multidistrict Litigation, under the title, "In re Avandia Marketing, Sales Practices & Products Liability," with US District Judge Cynthia Rufe of the Eastern District of Pennsylvania overseeing the litigation.
According to Mr Drake, Baum Hedlund has obtained a number of Avandia-related documents during prior litigation against GSK. In addition to Avandia cases, the firm has 23 Paxil related suicide lawsuits pending against GSK with several scheduled for jury trials in 2008. The firm also handles Paxil-related birth defects cases.
Baum Hedlund has the longest track record of any law firm in representing plaintiffs against GSK. Over the past 18 years, the firm has handled thousand of cases and served as lead counsel for the Plaintiffs' Steering Committee in Paxil Products Liability Litigation.
