Provost Umphrey attorney Christopher Kirchmer was busy in 2008 filing dozens of suits against GlaxoSmithKline and is starting the new year with more suits against the pharmaceutical company.
In January, Kirchmer filed four more suits on behalf of clients who allege GSK's diabetes drug Avandia is dangerous and defective and has caused cardiac complications.
The suits were filed Jan. 27 in the Beaumont Division of the Eastern District of Texas by plaintiffs Maria Hernandez, James Lollar, James Merrill and Bluet Doyle Jr. against SmithKline Beecham Corp., doing business as GlaxoSmithKline.
Hernandez is a Jefferson County resident, Lollar resides in Jasper County and Merrill and Doyle are residents of Hardin County.
"GSK has engaged in repeated and persistent fraud by misrepresenting, concealing and other failing to disclose to physicians and patents, information in its control concerning the safety and effectiveness of Avandia," Kirchmer writes.
According to the complaints, Avandia was initially approved by the U.S. Food and Drug Administration as safe and effective for treating diabetes mellitus type 2. Since most people with diabetes have other health problems including heart disease, "it is the important that an anti-diabetic agent reduce, or at least not exacerbate, the risk of cardiovascular injury," the suits state.
The plaintiffs' claims involve the drug Rosiglitazone manufactured and distributed by GSK under the trade names Avandia Tablets, Avandamet Tablets and Avandaryl Tablets, referred to collectively in the suits as Avandia.
Kirchmer writes that GSK's marking efforts were designed to create the impression to physicians and diabetics that Avandia is safe and effective for patients and that "it carries less risk of side effects than other available treatments."
"GSK was aware of numerous reports of congestive attacks, strokes and other serious cardiovascular injuries and death associated with the use of Avandia that exceeded background rate, and was well beyond the risks associated with other anti-diabetic agents," the suits allege.
The plaintiffs also allege that product warnings for Avandia were vague, incomplete or inadequate to alert prescribing physicians as well as patients for the actual risks.
Kirchmer cites three scientific analyses of the use of Rosiglitazone-based drugs. The first, done by GSK in 2006, found an overall increase in the incidence of myocardial ischemia in subjects, which "equated to more than a 30 percent excess risk of myocardial ischemic events in Rosiglitazone-treated patients," the suits state.
A second study by Dr. Steven Nissen and statistician Kathy Wolski published in the New England Journal of Medicine on May 21, 2007, was based on data available through published literature, the FDA Web site and GSK's clinical-trials registry and showed an increased risk "estimated at this time to be on the order of 43 percent."
Finally, the suits refer to an FDA analysis presented in July 2007 which "similar to the GSK and the Nissen and Wolski findings" found "an increased risk of heart attack, cardiovascular death, stroke and other serious ischemic-related adverse events in diabetics who took Rosiglitazone."
After the analysis, the complaints state that the FDA recommended a black box warning be placed in the Avandia label warning of those risks.
Kirchmer also alleges GSK "attempted to silence" Dr. John B. Buse, a diabetes expert who raised concerns about Avandia and heart problems.
"Instead of warning the public about the risk, GSK attempted to silence Dr. Buse by threatening him with a $4 million lawsuit and by characterizing him as a liar according to his testimony before Congress," the suits state.
Causes of action in the lawsuits include strict products liability defective design, strict products liability/failure to warn, negligent design and negligent failure to warn.
Plaintiffs are seeking damages for personal injuries including mental anguish, pain and suffering, disfigurement, physical impairment, medical expenses and lost income.
None of the suits detail any specific adverse health events experienced by plaintiffs, except to say that plaintiffs have been "damaged."
The case has been assigned to U.S. District Judge Thad Heartfield.
Hernandez vs. SmithKline Beecham Corp., Case No. 1:09-cv-124-TH
Lollar vs. SmithKline Beecham Corp., Case No. 1:09-cv-125-TH
Merrill vs. SmithKline Beecham Corp., Case No. 1:09-cv-126-TH
Doyle vs. SmithKline Beecham Corp., Case No. 1:09-cv-130-TH