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Several lawsuits against Pfizer Inc. that claimed Viagra caused heart attacks were dismissed last Thursday by New York’s Appellate Division, First Department. The court affirmed three lower court opinions. The unanimous ruling found that two trial judges had properly precluded expert testimony because it was not based on scientific principles that had gained “general acceptance.” Steven Glickstein of Kaye Scholer, who represented Pfizer, said the court’s decision meant there “wouldn’t be any basis” to file more heart-attack lawsuits. “There’s not scientific evidence that Viagra is harmful,” he said. Glickstein said Pfizer has faced similar suits over the last four years in Texas and California and has prevailed on every occasion. Pfizer, in consultation with the Food and Drug Administration, in 1998 changed the warning label on the drug to include the potential risk to patients with pre-existing cardiovascular disease. Ronald R. Benjamin, who represented the three plaintiffs, described the opinion as “dead wrong” and possibly detrimental to all suits against novel drugs where extensive research on possible side effects is not readily available. He said he would seek leave to appeal to the New York Court of Appeals. The plaintiffs in Selig v. Pfizer Inc., 5897, were three men who suffered heart attacks after taking Viagra, an anti-impotency drug. The lead plaintiff, Robert Selig, allegedly suffered a heart attack about four to six days after he began taking the drug in 1998. Mr. Selig filed suit and appeared before Manhattan Supreme Court Justice Louis B. York. At the outset, the judge ordered an inquiry into testimony to be offered by Mr. Selig’s expert witness, Dr. George I. Mallis. Mallis had planned to testify that Viagra could cause a heart attack in someone suffering from cardiac disease. The doctor’s conclusion was based on research that compared Viagra, which inhibits an enzyme called phosphodiesterase, with milrinone, a drug related to Viagra that is thought to have deleterious effects on patients with heart disease. Although the judge concluded that the expert’s testimony was not based on an “outwardly novel scientific technique,” he said the court needed to assess the reliability of the technique because the expert’s conclusions were allegedly novel. Justice York eventually barred the testimony, saying it did not have enough scientific support, and dismissed the case. The judge also cited clinical trials presented by Pfizer, which showed that using Viagra did not increase the risk of heart attack. The judge found that Dr. Mallis had ignored dozens of studies that supported that conclusion. The First Department, in an unsigned ruling, agreed with Justice York’s reasoning and applied it to two other cases, one that also had been dismissed by Justice York and another dismissed by Manhattan Supreme Court Justice Jane S. Solomon. PLAINTIFF’S BURDEN “In the absence of any clinical data supporting their expert’s theory that there is a causal link between the use of the drug Viagra and heart attacks in men with pre-existing coronary artery disease, it was incumbent upon plaintiffs to set forth other scientific evidence based on accepted principles showing such a causal link,” the appeals panel wrote. The panel also rejected the relationship between milrinone and Viagra, writing that the former, which inhibits phosphodiesterase 3, did not have the same action as Viagra, which primarily inhibits phosphodiesterase 5. The court called another study, which measured responses in human tissue samples, relevant, but concluded it was not sufficient to support a causal link. The study, it said, only showed that further research was warranted. Benjamin said the arguments in favor of dismissing testimony were misplaced because they did not address methodology. Both his expert’s evidence and that of Pfizer were based on acceptable scientific practices, he said, but simply reached different conclusions. Benjamin said that he is preparing another 15 to 20 cases centered on heart attacks. The suits, he said, would rely in part on new studies and different experts, such as epidemiologists. Justices Milton L. Williams, Peter Tom, Ernst H. Rosenberger and Richard W. Wallach made up the First Department panel.

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