GlaxoSmithKline has been slapped with a lawsuit after Utah Attorney General Mark Shurtleff alleged that the company illegally marketed rosiglitazone (Avandia) as a “wonder drug” to fight off type 2 diabetes, and misled consumers in the sales and promotion of the drug.
The complaint alleges that GSK defrauded the state of Utah out of $7.8 million, the amount the state Medicaid program spent on rosiglitazone between Jan. 1, 2001, and June 30, 2010.
In addition, the suit alleges that GSK “aggressively exploited” loopholes in the structure of the Medicaid program and “misrepresented” information to the public and the FDA stating that the drug reduced diabetic cardiovascular risks and lowered blood sugar better than other drugs on the market, such as metformin and sulfonylureas.
The suit alleges that GSK knew of adverse side effects of rosiglitazone—heart injury, fluid-overload disease, liver damage, liver failure, stroke, etc.—but failed to warn its consumers, perscribers, FDA or the state of Utah of the potential cardiovascular risk involved.
Recently, several studies and analysis have proven rosiglitazone may increase cardiovascular risk in some patients and the drug has been pulled from the European shelves and the FDA has restricted its use in the U.S.
“GSK did not just fail to disclose the potential cardiovascular risks Avandia posed, which include heart attacks and sudden cardiac death, it affirmatively represented that Avandia could reduce diabetics’ cardiovascular risks,” the suit states. “GSK has conducted this marketing effort knowing that prescriptions for Avandia are generally reimbursed by the Utah Medicaid Program.”
The complaint states that “GSK’s aggressive marketing campaign did not go unnoticed by the FDA,” and stated that the FDA cited GSK for “engaging in false and deceptive advertising for Avandia before the drug was even launched.”
In fact, in Oct. 20, 2000, the FDA found that GSK’s promotional materials for the drug were “false and misleading” and that they suggested the drug decreased glucose by higher rates than the data actually proved. In 2001, FDA issued a warning letter to GSK and said that promotional materials minimized the potential for serious risks.
“The State Medicaid Program paid significantly more for a drug that in fact was no more effective than traditional drugs that were less expensive,” says Assistant Attorney General Robert C. Morton, with the Utah Medicaid Fraud Control Unit. “Unlike the less expensive traditional drugs, Avandia exposed Utah Medicaid recipients to greater risks of heart attacks and other cardiac complications.”
The plaintiffs asked that the company pay for all damages sustained by the state of Utah including the cost of all Avandia prescriptions paid by the state, for Avandia-related damages of the past, present and future medical expenses for recipients of the Utah Medicaid program, and restitution for all damages sustained by the state, among others.