A Type 2 diabetic, Lany Stanford died of a heart attack on May 21, 2007, the very same day that an article published in the New England Journal of Medicine claimed his prescribed medication Avandia increased one's chances of a heart attack.
Stanford was taking the popular diabetes drug to help regulate his insulin. Type-2 diabetes increases a patient's risk for heart disease and other complications. However, Stanford's family doesn't believe it was a coincidence that he died the same day the study was published.
Peggie Stanford, a Dallas County resident, and her son Ryan filed their wrongful death suit against GlaxoSmithKline with the U.S. District Court for the Eastern District of Texas, Marshall Division, on June 19.
According to the GSK Web site, in 1999 Avandia (rosiglitazone maleate) was approved by the Food and Drug Administration. It is an oral anti-diabetic agent that acts primarily by increasing insulin sensitivity.
The Stanfords, along with their lawyer Stephen Drimion, allege the global pharmaceutical manufacture "unfairly" convinced the FDA to approve its drug, and then went on a "marketing assault" with a drug GSK officials knew was harmful.
"On May 21, 2007, Dr. Steven Nissen, a prominent cardiologist associated with the Cleveland Clinic, published a study in the New England Journal of Medicine with (evidence that Avandia could increase a patient's risk of a heart attack)," the suit said.
"GSK (was aware of Nissen's findings) since September of 2005."
The suit alleges GSK concealed the evidence because such findings would diminish sales. "Apparently, the phenomenal profits that GSK accumulated between May of 1999 through the summer of 2005 were not enough."
"By September of 2005, GSK was in possession of evidence that could reasonably be expected to diminish the sales of its second largest selling drug, rosiglitazone," the suit said. "The evidence in its possession at the time was an overview analysis of approximately 42 different studies of patients using its drug, rosiglitazone. However,
GSK provided only preliminary results of the analysis to the FDA in September 2005. The complete results of the study were not provided to the FDA for another year."
The suit goes on to say that during the following year of alleged concealment, GSK pressed its sales of Avandia to a distribution of approximately 13 million prescriptions in the U.S. "With a month's supply of rosiglitazone costing between $90 and $200, GSK was able to rack up sales of $2.2 billion in 2006 even though it was finally
compelled to disclose the complete study results to the FDA in August 2006."
"GSK continued onward and upward with its sale of rosiglitazone after August 2006," the suit said. "Knowing that its drug was unreasonably dangerous and that the diabetic patient population was uninformed of the dangers, (the company) continued to expand sales of rosiglitazone to existing and new patients."
The suit faults GSK with negligently and recklessly failing to warn the general public of the risks associated with taking Avandia, product liability, marketing a defective drug,failing to provide adequate warnings, fraud, negligence, misrepresentation, expressed
warranty for goods, warranty of merchant ability, warranty of fitness, unjust enrichment and wrongful death.
The plaintiffs are suing for damages to punish GSK for Stanford's death, funeral expenses, mental anguish, medical and counseling expenses, loss of companionship and suffering of plaintiffs' decedent.
Case No. 2:07-cv-00254-DF-CE