April 6, 2004 - Defense Wins Pennsylvania's First PPA Verdict

In the third phenylpropanolamine (PPA) trial nationwide and the first in Pennsylvania, a Philadelphia jury returned a defense verdict for the pharmaceutical company GlaxoSmithKline (GSK) last week.

The 12-member jury came to the same conclusion that other PPA juries in New Jersey and California have when it rejected claims that a pharmaceutical company had manufactured an unsafe over-the-counter drug containing PPA without label warnings that the chemical had been linked to an increased risk of stroke.

Though the plaintiff lost the case, it is seen as having established some significant principles for future PPA litigation, most notably that a company expert conceded that PPA can cause stroke.

After a 2000 study reported that PPA increased the risk of hemorrhagic stroke (bleeding into the brain) in women, the U.S. Food and Drug Administration asked manufacturers to stop using the chemical in nasal decongestant and appetite-suppressant drugs and warned consumers not to use drugs containing PPA.

There are around 285 PPA cases still pending in the Complex Litigation Center in Philadelphia; many are scheduled for trial between now and the end of the year, according to court records. All pharmaceutical defendants named in the lawsuits have denied the allegations, according to court documents.

In last week's trial, the plaintiff was Nancy Sparich, a woman who was 47 when she suffered a stroke eight hours after having taken a dose of Contac 12 Hour. She claimed the PPA in the Contac 12 Hour had caused her stroke, and she sought punitive damages. The stroke left Sparich, now 53, with permanent weakness in the left side of her body. She had been an assistant manager at a Wawa convenience store but is now unable to work. An expert estimated her total economic loss at $540,000.

At trial, GSK's defense was that the company "had acted reasonably at all times with regard to the sale of Contac with PPA. There was no evidence that Contac with PPA caused her stroke." Ralph Sacco, a stroke neurologist and epidemiologist at Columbia University in New York, testified that published medical literature does not support the contention that a product like Contac 12 Hour could have caused her stroke. A local neurologist testified there were other factors that had increased her stroke risk.


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