An additional two plaintiffs say GlaxoSmithKline was wrong in selling a diabetes drug without first warning of potential serious side effects, including heart attacks and congestive heart failure, from which they suffered.
LeMario Holton of Illinois and Rita Catherine Rieger of Delaware filed suit Sept. 7 in St. Clair County against the drug company.
John J. Driscoll of The Driscoll Law Firm in St. Louis and Douglas P. Dowd and William T. Dowd of Dowd and Dowd in St. Louis will be representing them.
Driscoll has represented plaintiffs in other complaints filed February, April, May and November against GlaxoSmithKline over Avandia.
Plaintiffs in the suit filed Sept. 7 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 and McKesson knew Avandia was associated with a 51 percent increased risk of cardiovascular problems, such as heart attacks, the complaint alleges.
Still, GlaxoSmithKline and McKesson 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 suffered a number of cardiovascular injuries, including heart attacks and congestive heart failure. In addition, they sustained pain and suffering, lost large sums of money because of their inability to work, incurred permanent disfigurement and disability, incurred medical costs and lost their ability to enjoy life.
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.
However, GlaxoSmithKline and McKesson 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 $250,000, plus costs, attorney's fees and other relief the court deems just.
St. Clair County Circuit Court case number: 11-L-501.