SOUTHEAST TEXAS RECORD

TEXARKANA -- The Beaumont law firm Provost Umphrey is representing plaintiffs in a federal lawsuit against GlaxoSmith Kline over the diabetes drug Avandia.

Bowie County resident Kay Leeper and Arkansas resident Fred Lands filed a product liability suit against GlaxoSmithKline on March 25 in the U.S. District Court of the Eastern District of Texas, Texarkana division on behalf of Ima Sue and Fred Lands.

The suit alleges that the drug manufacturer is engaged in persistent fraud by misrepresenting, concealing or failing to disclose information regarding the safety and effectiveness of Avandia.

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

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 65 percent of diabetic people die from heart disease or stroke.

"Cardiovascular disease is the main cause of death in diabetes patients. Thus, it is important that an anti-diabetic agent reduce, or at least not exacerbate the risk of cardiovascular injury," the lawsuit states.

The suit claims that Ima Sue Lands' doctors prescribed Avandia to treat her diabetes without knowing all of the drug's risks. The suit does not disclose whether the deceased died from a heart-related condition.

The plaintiffs argue that Avandia is defective in design and unreasonably dangerous, thus "subjecting users to the risk of cardio thrombotic events or cardiac injury, and other illnesses which exceeded the benefits of the product, and for which other safer products were available."

The suit alleges that the drug was not accompanied by proper or adequate warnings of all adverse effects. In November, the drugs' warnings were amended to state, "Avandia can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart), you cannot be started on Avandia. Avandia is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.

"Avandia may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin. Taking Avandia with insulin or with nitrates is not recommended."

Discussing the drugs benefits and risks, the FDA website states, "People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks."

The suit seeks damages for personal injuries including mental anguish, conscious pain and suffering, economic damages including lost income, medical care, funeral expenses, and wrongful death damages that include loss of society, support, and consortium, mental anguish, and loss of inheritance.

Beaumont attorney Christopher T. Kirchmer of the Provost and Umphrey Law Firm L.L.P is representing the plaintiffs.

Judge David Folsom has referred the case to Magistrate Judge Caroline Craven.

The case is expected to enter the multidistrict litigation recently created and assigned to U.S. Judge Cynthia M. Rufe of the Eastern District of Pennsylvania. There are at least 130 actions currently consolidated into the litigation.

A recent trial funded by the National Heart, Lung and Blood Institute issued results on whether the risk of heart disease could be reduced through the treatment of diabetes. The "ACCORD" trial found that the heart disease risk was due to the lowering of blood sugar and no drug was responsible for serious heart problems.

Case No. 5:08cv00056