Suit against GSK claims Avandia not worth the risks

Michelle Massey, East Texas Bureau May 13, 2009, 3:26pm

MARSHALL � After taking Avandia for five years, Frank Casteel underwent heart bypass surgery in 2007. Now Casteel is suing the drug's manufacturer alleging that the drug is not worth the risks.

Casteel filed a product liability lawsuit against Smithkline Beecham Corp., doing business as GlaxoSmithKline, on May 13 in the U.S. District Court of the Eastern District of Texas, Texarkana Division.

FDA approved in 1999, Avandia is in a class of drugs that are insulin-sensitive anti-diabetic agents used to treat type 2 diabetes. The drug is used in conjunction with diet and exercise to improve control of blood sugars.

Type 2 diabetes is the condition that occurs when the body does not properly use insulin or is insulin deficient. People with diabetes have risks of significant health problems including high blood pressure and cholesterol, blindness, kidney disease and nervous system diseases.

According to the court records, more than two-thirds of diabetic people die from heart disease or stroke.

The plaintiff alleges that GSK went on a "spectacular" marketing and distribution strategy despite knowing that "its drug was unreasonably dangerous and that the diabetic patient population was uniformed of the dangers."

In May 2007, a prominent cardiologist, Dr. Steven Nissen, published a study that revealed that patients taking the drug had an increased risk of heart attack.

The suit alleges GlaxoSmithKline "negligently, recklessly and wantonly" allowed the public disclosure of positive information, but withheld or concealed negative information about Avandia's safety and effectiveness.

"Defendant Glaxo did not provide sufficient warnings and instructions that would have put Plaintiff and the general public, on notice of the dangers and adverse effects caused by ingesting [Avandia], including without limitation to risk of heart attack," the lawsuit states.

The plaintiff argues that Avandia is defective in design and unreasonably dangerous and state that the risks of using Avandia far outweighed the benefits.

According to the complaint, the drug was defective due to inadequate warnings, instructions, and/or labeling and inadequate testing.

The complaint accuses the defendants of fraudulent behavior stating they "widely advertised and promoted Avandia as safe and effective medication"

Causes of action filed against the defendant include strict products liability, design and marketing defect, inadequate and improper warnings, fraud, negligence, negligent misrepresentations, breach of express and implied warranty, and unjust enrichment.

Seeking punitive damages, the plaintiff argues GlaxoSmithKline's conduct "exhibited such an entire want of care as to establish that its actions were a result of fraud, ill will, malice, recklessness, and/or willful and intentional disregard for the safety and rights of plaintiff, as well as the general public and/or consumers."

The plaintiff is seeking damages for physical pain and suffering, mental anguish, medical and counseling expenses, attorneys' fees, pre and post-judgment interest.

Dallas attorneys Stephen W. Drinnon, Shelby L. Bobosky, and Meridith C. Constant of The Drinnon Law Firm, P.L.L.C are representing the plaintiff.

U.S District Judge T. John Ward is assigned to the litigation.

The case is expected to be transferred to the multi-district litigation (MDL-1871) pending in the Eastern District of Pennsylvania for pre-trial proceedings.

Jury trial requested.

Case No 2:2009cv00150

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