Product liability lawsuit filed against Digitek manufacturer, distributor
April 17th, 2009 by Jennifer Walker-Journey
Linda Weadock, on behalf of her deceased husband George Weadock, and Willie Criss and Frank Heppel, have filed a $5 million product liability lawsuit against drug maker Actavis and drug distributor Mylan Pharmaceuticals, claiming their heart medication Digitek contained more than twice the active ingredient and caused serious injury or death.
Digitek, a brand of digoxin, is a widely used treatment for various heart conditions such as atrial fibrillation, atrial flutter and heart failure.
According to the complaint, the companies received a warning from the Food and Drug Administration (FDA) that they failed to provide periodic safety reports for the facility where the medication was manufactured. By failing to provide the safety reports, the companies violated their adverse medical event reporting obligations. The FDA also warned that the drugs were being marketed without proper clearance and that at least 26 adverse events with the drug had not been reported.
In 2008, the FDA issued an alert to the public of a recall of Digitek, after it was found that some tablets had been distributed at double the thickness. Those oversized pills were thought to contain double the active ingredient. As a result, some patients experienced digoxin toxicity, which can result in life-threatening complications.
The complaint states, “The recalled Digitek was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended use.” Plaintiffs also contend that Actavis and Mylan Pharmaceuticals “placed tens of thousands of patients, including Decedent, unnecessarily at risk of serious injury and/or death and may have caused them to suffer personal injuries and harm, including medical expenses, anxiety and fear induced from ingesting the defective and misbranded drug.” The plaintiffs are asking for a trial by jury.
Source: The Southeast Texas Record