More than 90 people say GlaxoSmithKline was wrong in selling a diabetes drug without first warning of potential serious side effects from which they or their deceased relatives suffered.
Lead plaintiff Carmen Colon, along with 97 others, filed suit Nov. 12 in St. Clair County against the drug company.
John J. Driscoll of St. Louis, Christopher Cueto of Belleville and Robert L. Salim of Natchitoches, La., will be representing them. The same group of lawyers represented plaintiffs in other, nearly identical complaints filed February, April and May against the company.
Plaintiffs in the November suit claim they used Avandia to treat their type 2 diabetes mellitus, but suffered severe injuries from their ingestion of the drug.
Before the plaintiffs were prescribed the drug, GlaxoSmithKline knew Avandia was associated with a significantly increased risk of heart failure, myocardial ischemia and ischemic events, such as cardiovascular mortality, myocardial infarction and stroke, according to the complaint.
Still, GlaxoSmithKline provided no warnings on the dangers of the drug until Avandia's label was changed on Aug. 14, 2007, to warn of the potential increased risk of heart failure. Again, the label was changed on Nov. 19, 2007, to warn of the potential risk of myocardial ischemia.
However, the plaintiffs say they had already begun taking the medication before warnings were added to the label.
As a result of their ingestion of the drug, plaintiffs say they became ill and were impaired in their health, strength and activity. They also incurred medical costs, lost wages, suffered disabilities and experienced pain, according to the complaint.
The plaintiffs say GlaxoSmithKline should have provided the warnings before the FDA required the company to do so, especially since the company knew that most people with diabetes have risk factors such as high blood pressure and cholesterol that provide a susceptibility for heart disease and stroke. In fact, more than 65 percent of deaths in patients with diabetes are from cardiovascular causes, according to the complaint.
However, GlaxoSmithKline failed to perform adequate tests on the product. If the company had performed enough testing, Avandia would only have been allowed to enter the market with a warning label, the complaint says.
Instead of warning its customers of risks, though, GlaxoSmithKline promoted the drug in an extensive mass media advertising campaign, the suit states.
At the time the plaintiffs took Avandia, there were safer medications on the market, they say.
In the 10-count suit, the plaintiffs are seeking a judgment in excess of $350,000, plus costs, attorney's fees and other relief the court deems just.
St. Clair County Circuit Court case number: 09-L-612.