Texarkana residents file suit against GlaxoSmithKline over Avandia

Michelle Massey, East Texas Bureau Oct. 20, 2008, 7:37am

TEXARKANA, Texas – After being diagnosed with type 2 diabetes in May of 2000, Tommie Norton spent seven years taking the drug Avandia to try to improve control of his blood sugar levels. Now Norton believes the drug caused him to have heart attacks in 2003 and in 2006.

Bowie County residents Tommie and Jeri Norton filed a personal injury suit against Smithkline Beecham Corp., doing business as GlaxoSmithKline, on Oct. 14 in the U.S. District Court of the Eastern District of Texas, Texarkana Division.

Approved in 1999, Avandia is in a class of drugs referred to as Thiazolidinediones 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 suit claims that GlaxoSmithKline did know or should have known that Avandia can cause "heart injury, excessive fluid retention, fluid-overload disease, congestive heart failure, heart attack, liver damage, liver failure, and severe injury to the heart leading to cardiac arrest or death."

According to a Senate Committee report, in 2007, the FDA's safety panel on Avandia stated that the drug caused an estimated 83,000 excess heart attacks since its FDA approval. The complaint also states that GlaxoSmithKline's 2006 analysis and study of the drug showed a 31 percent higher risk of adverse cardiovascular risks.

As a result of the finds, in May 2007, the FDA issued a safety alert advising patients that there is a potentially significant risk of heart attacks and heart-related deaths. In November 2007, GlaxoSmithKline gave the drug a black box warning.

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

The plaintiffs state the drug manufacturer failed to promptly review and submit to the FDA adverse events reporting, failed to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of the post-marketing adverse drug experiences, failed to submit all advertisements and promotions to the FDA, and misbranding a drug through false or misleading advertisements.

The plaintiffs argue that Avandia is defective in design and unreasonably dangerous and thus state that the risks of using Avandia far outweighed the benefits. The complaint accuses the defendants of fraudulent behavior stating they "widely advertised and promoted Avandia as safe and effective medication"

Other causes of action filed against the defendant include failure to warn, breach of implied and express warranty, negligence, violation of the Deceptive Trade Practices Act, negligent misrepresentations, negligence per se by violating the Federal Food Drug and Cosmetic Act, 2, U.S.C. 301, and unjust enrichment.

The plaintiffs are seeking punitive damages, arguing GlaxoSmithKline's conduct was "committed with knowing, conscious, and deliberate disregard for the rights and safety of consumers…"

Further, the complaint states that "GlaxoSmithKline intentionally concealed and/or recklessly failed to disclose to the public, including the Plaintiff herein, the potentially life threatening side effects of Avandia in order to ensure continued and increased sales."

The plaintiffs seek damages for physical and mental pain and suffering, medical expenses, lost income and loss of earning capacity. On behalf of Norton's spouse, Jeri, the suit is seeking damages for loss of consortium for loss of companionship, services, society, and ability of marital associations, mental anguish and suffering.

Houston attorney W. Mark Lanier of the Lanier Law Firm PLLC is representing the plaintiffs in their allegations.

Jury trial requested.

U.S. District Judge David Folsom will preside.

Case No 5:08cv00178

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