The complex case heard various allegations that Wyeth allegedly marketed Prempro hormone replacement therapy for off-label purposes, and failed to adequately warn consumers as to the risks associated with using the medication.
As summarized in Civil Justice Magazine (7/23/12), plaintiff Audrey Singleton alleged the Prempro she was prescribed led to the development of breast cancer. Her physician Dr. James Donald testified at trial that had he known the dangers associated with Prempro, he would not have prescribed Prempro to Singleton.
Wyeth, the defendant in the case, put forth various arguments in support of its view that the decision by the lower court originally in favor of the plaintiffs, should be reversed (Audrey Singleton was joined in her lawsuit by her husband Charles). Among its arguments, was that an expert testifying on behalf of the plaintiff undertook unscientific methodology.
However, the Superior Court found the methodology used by Dr. Elizabeth Naftalis to determine a causal relationship between HRT and breast cancer was generally accepted in the scientific community. The Court also found, in a decision written by Judge Jacqueline O. Shogan on behalf of Judge David N. Wecht and Senior Judge James J. Fitzgerald III, that marketing evidence was relevant to illustrate the 'wantonness' of Wyeth's conduct at the time.
"While Dr. Donald testified that he did not prescribe HRT drugs to Singleton based on Wyeth's direct marketing," wrote Judge Shogan, "the representations made by Wyeth's salespeople, his belief that HRT drugs had off-label benefits that led to it being prescribed, and the medical literature and ghost written reviews created at Wyeth's behest were all directly related to Wyeth's promotion of Prempro. Dr. Donald concluded that, had he known the dangers, he would not have prescribed Prempro. As such, there was reliance on Wyeth's promotion of Prempro, both directly and indirectly, and Wyeth's claim that the trial court violated Alabama and Pennsylvania law by imputing a fraud on the market theory is meritless."
READ MORE PREMPRO HRT LEGAL NEWSPrempro was approved by the US Food and Drug Administration (FDA) in 1994 for HRT therapy. Various studies since have identified Prempro as carrying various risks for invasive breast cancer, stroke and Prempro heart attack. However, four years before Prempro was given the FDA nod for HRT therapy, Wyeth (now Pfizer) sought a label change that reflected a claim that Prempro effectively protected AGAINST heart disease.
Health advocates also make the point that Prempro was originally allowed on the market without benefit of a randomized clinical trial.
The Prempro cancer plaintiffs, who hail from Alabama, were awarded $6 million in punitive damages and $4.4 million in compensatory damages, for a total of $10.4 million. Thousands of women have launched Prempro lawsuits over the years, alleging Prempro heart disease and Prempro breast cancer, among other side effects. Such damage claims could potentially increase given the aging Baby Boomers. HRT is usually prescribed to ease hot flashes and related symptoms in menopausal women.