Pharma company Glaxo Smith Kline is facing a new lawsuit regarding its troubled diabetes medication, Avandia. The family and estate of Michael James Knight of Texas have filed a wrongful death suit against GSK and several of its related organizations on behalf of Knight. The lawsuit states that GSK and its affiliates had full knowledge of the substantial health risks that Avandia poses to its patients, yet did not take sufficient steps to warn patients of these dangers.
The suit also brings charges of negligence and liability for failing to ensure it was a reasonably safe design, failure to test the drug to ensure it was safe and failure to label it in accordance with its risks. Damages sought by the plaintiffs include wrongful death damages, survivor damages and exemplary damages.
The lawsuit was filed in the Marshall Division of the Eastern District of the State of Texas.
Avandia, like other thiazolidinediones or TZDs, is intended to regulate the blood sugar of patients with type 2 diabetes mellitus, when used in conjunction with diet and exercise changes.
The drug’s effects on heart health have been under scrutiny since 2007, when the FDA ordered GSK to label Avandia with black-box warnings on all packaging. Black-boxing is the FDA’s highest level of safety warning that can be applied. Still, a number of patients who took Avandia before and since have brought suits against the company for the heart damage that the pill has been alleged to cause. Common complaints include charges that the black box warning is far too little labeling for such a serious threat from the medicine, and that the company needs to either stop marketing the drug or label its warnings in a much clearer fashion.
No word has been filed on when proceedings in the Knight case will begin.