Alleging his clients were injured or died after taking the diabetes drug Avandia, Provost Umprhey attorney Chris Kirchmer has filed 16 new lawsuits against drug maker GlaxoSmithKline.
Fifteen of the suits were filed in the Beaumont Division of the Eastern District of Texas, while one was filed in the Lufkin Division. All the 16-page suits were filed on Aug. 18 and Aug. 19.
The plaintiffs seek damages for personal injuries they claim were caused by "a defective and dangerous pharmaceutical product, Avandia, which was manufactured, marketed, distributed and/or sold by GlaxoSmithKline to the general public."
Two lawsuits were filed by family members of deceased plaintiffs whose deaths were allegedly caused by taking Avandia.
Each suit seeks damages in excess of $75,000.
According to the original complaints, GSK has engaged in "repeated and persistent fraud by misrepresenting, concealing and otherwise failing to disclose to physicians and patients information in its control concerning the safety and effectiveness of Avandia."
Avandia, also known as Rosiglitazone, was initially approved by the U.S. Food and Drug Administration as safe and effective for treating diabetes mellitus type 2. Type 2 diabetes occurs when the body fails to properly use insulin, which is made in the pancreas to help cells use sugar from the bloodstream.
Kirchmer writes that most people with diabetes have other health problems, such as high blood pressure and cholesterol that increase the risk for heart disease and stroke.
"Cardiovascular disease is the main cause of death in diabetes patients," the complaints state. "Thus, it is important that an anti-diabetic agent reduce, or at least not exacerbate the risk of cardiovascular injury."
The suits claim that GSK widely advertised and marketed Avandia as "a safe and effective anti-diabetic agent that promised fewer side effects than other similar treatments."
GSK was aware of numerous reports of congestive attacks, strokes and other serious cardiovascular injuries and death associated with Avandia, the suits allege.
"The product warnings for Avandia … were vague, incomplete or otherwise inadequate to alert prescribing physicians as well as consumer patients of the actual risks associated with Avandia," Kirchmer writes.
The attorney goes on to allege that three separate studies have shown that Avandia increases the risk of cardiovascular injury.
One study by the FDA resulted in a recommendation that the Avandia label include a boxed warning about possible increased risks.
Kirchmer claims that even before the approval of Avandia by the FDA that GSK should have known of the "significantly increase risk of heart attacks, cardiovascular-related deaths, strokes or other serious and life-threatening conditions, which it has concealed from the medical community and patients."
"In fact, as early as 1999, Dr. John B. Buse (current president-elect of the American Diabetes Association), a diabetes expert and head of endocrinology at the University of North Carolina-Chapel Hill, raised concerns about Avandia and heart problems," the suits state.
The suits claim that 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."
Kirchmer alleges that after the FDA required GSK to change its label in February 2001 to reflect the increased risks, "GSK defied FDA recommendations by engaging in false and misleading promotional activities."
Causes of action in the suits include strict products liability-failure to warn, negligent design and negligent failure to warn.
Damages sought include mental anguish, pain and suffering, disfigurement, physical impairment, medical expenses, lost income, court costs, interest and other just and proper relief.
Kirchmer filed his first Avandia lawsuit in Texarkana federal court in March.
The first Avandia lawsuit in the country was also filed in the Eastern District of Texas on June 19, 2007, by attorney Stephen Drimion in the Marshall Division, on behalf of the family of a Dallas man that allegedly died from taking the drug.
Both cases have been transferred to U.S. District Judge Cynthia Rufe in the Eastern District of Pennsylvania, who is handling multidistrict cases for Avandia Marketing, Sales Practices and Product Liability Litigation (MDL 1871).
GlaxoSmithKline is headquartered in Philadelphia.
Case No. 1:08-cv-489 Joy Courtier, estate of Donna Anderson, deceased vs. GlaxoSmithKline
Case No. 1:08-cv-497 Jimmie Broussard vs. GlaxoSmithKline
Case No. 1:08-cv-500 Elivis Jacks vs. GlaxoSmithKline
Case No. 1:08-cv-501 Linda Kuritz vs. GlaxoSmithKline
Case No. 1:08-cv-502 Robert Martin vs. GlaxoSmithKline
Case No. 1:08-cv-503 Gary Stelly vs. GlaxoSmithKline
Case No. 1:08-cv-504 Nathan Whitmire vs. GlaxoSmithKline
Case No. 1:08-cv-505 Davide Baker vs. GlaxoSmithKline
Case No. 1:08-cv-506 Shirley English vs. GlaxoSmithKline
Case No. 1:08-cv-507 Jeanette Hendrix vs. GlaxoSmithKline
Case No. 1:08-cv-509 Bruce Jacks vs. GlaxoSmithKline
Case No. 1:08-cv-510 Harry Krolcyzk, estate of Carolyn Krolcyzk, deceased vs. GlaxoSmithKline
Case No. 1:08-cv-511 Paul Sanchez vs. GlaxoSmithKline
Case No. 1:08-cv-512 Barbara Ward vs. GlaxoSmithKline
Case No. 1:08-cv-513 James Young vs. GlaxoSmithKline
(Lufkin Division) 9:08-cv-155 Jonathan Humble vs. GlaxoSmithKline