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An expert who would have testified that the anti-impotence drug Viagra can cause heart attacks did not have enough scientific support for his opinion to let him testify before a jury, an acting New York State Supreme Court justice in Manhattan has ruled. Without the expert’s testimony, Justice Louis B. York concluded in an opinion released last week that the lawsuit, Selig v. Pfizer Inc., 112891/98, should be dismissed because the plaintiff would be unable to establish that taking Viagra caused his heart attack. Attorney Ronald R. Benjamin, who represents plaintiff Robert Selig, said the decision was “wrong on the law and wrong on the facts” and would be appealed. Benjamin said he represents about 30 other metropolitan area men with pending lawsuits claiming adverse medical reactions to Viagra. Selig suffered a heart attack in July 1998 about four to six days after he had last taken Viagra, according to the complaint. All told, he reported taking the drug only three times, with the first time being in April 1998. Before the heart attack, Selig had exhibited no symptoms of cardiac problems, but his treating cardiologist subsequently reported that the attack resulted because he had a “severe blockage” in one of his arteries. In conducting an inquiry into whether Selig’s expert, Dr. George I. Mallis, should be permitted to testify, York acknowledged that his testimony was not based on an “outwardly novel scientific technique.” Instead, he wrote, an inquiry into the reliability of his technique was needed “because his conclusions are allegedly novel.” One of Mallis’s principal reasons for concluding that Viagra could cause a heart attack in someone suffering from cardiac disease was based on research in which he participated. The research involved the long-term impact of drugs that work to inhibit an enzyme called phosphodiesterase. Viagra is a phosphodiesterase inhibitor, as is a drug called milrinone, which was studied by Mallis. He was ready to testify that the results of the milrinone study, showing earlier mortality in patients with severe heart disease, supported a conclusion that Viagra also caused heart attacks in patients with cardiac problems. However, Pfizer Inc., the maker of Viagra, presented an opposing affidavit from a doctor who designed and directed the milrinone study. Dr. Milton Packer concluded that no such connection could be drawn because Viagra worked to inhibit a different strain of the phosphodiesterase (phosphodiesterase-5) than milrinone, which inhibits phosphodiesterase-3. York also observed that Pfizer had presented expert evidence that clinical trials of Viagra revealed no increased risk of heart attacks, and that Mallis had ignored “dozens of clinical studies” supporting that conclusion. SIMILAR CLAIMS PERSIST In an interview, Benjamin countered that the Viagra clinical trials were suspect because they were either performed by Pfizer or entities that had ties to the company. He also pointed to a “consensus document” published by the American College of Cardiology and the American Heart Association, which noted that in its clinical trials Pfizer had studied “only a small fraction of patients with pre-existing heart disease.” Benjamin added that he was aware of pending suits involving Viagra in Chicago and Philadelphia. Susan Yarin, a spokeswoman for Pfizer, declined to comment on pending litigation. Pfizer was represented by David Klingsberg, Steven J. Glickstein, Bert L. Slonim and Maris Veidemanis of New York-based Kaye, Scholer, Fierman, Hays & Handler.

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