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In the third phenylpropanolamine trial nationwide and the first in Pennsylvania, a Philadelphia jury returned a defense verdict for the pharmaceutical company GlaxoSmithKline last week. The 12-member jury in Common Pleas Judge Norman Ackerman’s courtroom 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. The eight-day PPA trial in Sparich v. SmithKline Beecham was the first against Philadelphia-based GlaxoSmithKline (SmithKline Beecham and Glaxo Wellcome merged in 2000 to form GSK). The pharmaceutical company Novartis was the defendant in the three other PPA cases that have been tried, two in Los Angeles (consolidated into one trial) and one in Parsippany, N.J. “It’s clear the jury listened closely to the evidence,” said Detroit attorney Tom Foley of Foley Baron & Metzger, who was one of GSK’s three lawyers at trial. “We’re pleased with their decision.” Reflecting on his loss, plaintiff’s attorney Lee Balefsky of Kline & Specter said the verdict was not a surprise. He said the case had many confounding factors, such as his client’s alcohol use and long-term use of Contac 12 Hour, an over-the-counter decongestant manufactured by GSK that contained PPA and which she contended had caused a stroke she suffered in 1999. Still, Balefsky said the case had established some significant principles for future PPA litigation. For example, Ackerman had refused to strike the plaintiff’s demand for punitive damages as GSK had requested, and one of the company’s experts had conceded that PPA can cause stroke, Balefsky said. “This case doesn’t mean that some other jury will see it differently with another plaintiff,” said Balefsky, who tried the case with Mark Hoffman, also of Kline & Specter. “This is the first step in a long process.” 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. About 285 PPA cases are pending in the Complex Litigation Center in Philadelphia, and a list of cases are scheduled for trial between now and the end of the year, according to court records. The pharmaceutical defendants named in the lawsuits have denied the allegations, according to court documents. The plaintiff at last week’s trial was Nancy Sparich, a Levittown woman who was 47 when she suffered a stroke eight hours after having taken a dose of Contac 12 Hour, Balefsky said Sparich claimed that PPA in the Contac 12 Hour had caused her stroke, and she sought punitive damages, according to court records. The stroke left Sparich, now 53, with permanent weakness in the left side of her body, Balefsky said. 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, Balefsky said. At trial, GSK’s defense was that the company “had acted reasonably at all times with regard to the sale of Contac with PPA,” Foley said. “There was no evidence that Contac with PPA caused her stroke.” Such was the testimony of GSK’s expert witnesses at trial, Foley said. 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 — as Sparich had used it — could have caused her stroke, Foley said. Stephen Gollomp, a local neurologist, evaluated Sparich. He testified that there were other factors that had increased her stroke risk, Foley said. The plaintiff’s experts, stroke neurologist Steven Levine from Mount Sinai Medical Center in New York and neurologist Lee Harris from Abington Memorial Hospital, testified that the PPA was responsible for Sparich’s stroke. Some former and current GSK employees also testified, Balefsky said, and told the jury that the company had knowledge of PPA’s potential to cause stroke as early as the 1980s. After deliberating for three hours April 1, the jurors returned a verdict rejecting Sparich’s claims — that GSK was negligent, that Contac 12 Hour was defective and that the company had breached an implied warranty, the lawyers said. The jurors were not polled, but a party needed to convince at least 10 out of 12 jurors for a verdict in his favor, Foley said. Foley’s co-counsel were Joseph J. McHale of Stradley Ronon Stevens & Young and John A. Anderson of Stoel Rives in Salt Lake City.

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