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A federal magistrate in Alabama has denied defense motions for summary judgment in a products liability action over the lactation-suppressing drug Parlodel, finding that the plaintiffs’ “expert opinions are scientifically reliable and admissible.” The Sept. 21 decision came nine days after an Illinois federal judge reached the opposite conclusion in another Parlodel case and excluded plaintiff’s expert testimony as “scientifically unreliable.” Both suits contended that Parlodel had caused strokes in otherwise healthy young women. In Alabama there are two plaintiffs. One, Ruby Quinn, then 40, delivered a child by cesarean section on Aug. 25, 1993, and began taking Parlodel about a week later. On Sept. 21, she had a stroke. The other plaintiff, Elizabeth Brasher, then 38, delivered a child vaginally on Feb. 15, 1994, and began taking Parlodel shortly thereafter. She suffered a stroke six days later . Brasher v. Sandoz Pharmaceuticals, No. CV-98-TMP-2648-S (N.D. Ala.). In Illinois, plaintiff Alisa Ann Caraker, 24, began taking Parlodel just after giving birth and suffered a disabling stroke six days later, said her lawyer, Denise Dunleavy of New York’s Weitz & Luxenberg. Caraker v. Sandoz Pharmaceuticals, No. 96-CV-4113. All three plaintiffs sued the maker of the drug, Sandoz Pharmaceuticals Corp., which is now part of Novartis A.G. Parlodel had been approved for prevention of lactation in 1981 by the Food and Drug Administration, Dunleavy said. It was taken by new mothers who weren’t breast-feeding. Dunleavy said that the FDA began receiving reports of young women having heart attacks and strokes after using it, and in 1994, under government pressure, Sandoz voluntarily withdrew it from the market as a lactation suppressant. The FDA banned it for that purpose in 1995. Dozens of lawsuits ensued, and initially the defense record was poor. The company settled several cases, and the first to trial wound up in a plaintiff’s verdict. After Sandoz and Ciba-Geigy merged to form Novartis, the newly created company changed its philosophy on litigating Parlodel lawsuits. It began attacking the scientific claims of the plaintiffs, said defense counsel Joe G. Hollingsworth of Washington, D.C.’s Spriggs & Hollingsworth. The defense contended that despite the individual reports of strokes or heart attacks, there was no proof that Parlodel caused strokes in postpartum women. In the most recent cases, the plaintiffs’ experts cited animal studies, case reports, adverse drug reaction reports to the FDA, articles in medical textbooks and literature asserting that Parlodel is a risk factor for stroke because of its vasoconstrictive effects. The defense argued that the opinions of the plaintiffs’ experts on causation were scientifically unreliable under Daubert v. Merrill Dow Pharmaceuticals, 509 U.S. 579 (1993). In Alabama, Magistrate Judge T. Michael Putnam wrote that “Sandoz contends that absent a scientifically appropriate epidemiological study showing an increased risk of stroke associated with Parlodel use, plaintiffs’ experts’ opinions are nothing more than unscientific speculation.” The plaintiffs conceded that a valid study was missing and said one was impossible. “The drug is off the market and the events are so rare,” said Dunleavy, whose firm represents the women in both cases. Putnam agreed with that, writing, “Likewise controlled studies cannot be performed because such would unethically expose test participants to risk or harm or death.” But he wrote that “given the practical unavailability of other forms of scientific evidence, reliance on those that are available is all the more reasonable.” Although epidemiological studies would provide the best proof of association between the drug and strokes, Putnam wrote, “it is not the only scientific basis on which those effects can be predicted.” He added that “there is an abundance of other scientifically reliable evidence” and cited the evidence offered by the plaintiffs’ experts. ILLINOIS OUTCOME In Illinois, the outcome was different. Two plaintiffs’ experts approved in the Alabama case were scheduled to testify — Dr. Kenneth Kulig, a Denver toxicologist, and Dr. Denis Petro, an Arlington, Va., neurologist. But on Sept. 12, District Judge J. Phil Gilbert excluded their testimony. He found their data were “suspect” and their opinions “more like personal opinions.” Gilbert was critical of all the evidence offered by the experts. “The case reports upon which Drs. Kulig and Petro rely make little attempt to isolate or exclude possible alternative causes, lack adequate controls and lack any real analysis,” he wrote. As for the textbooks, Gilbert wrote that although a “fair reading of the majority of the plaintiffs’ medical texts indicate that there is an association between bromocriptine and vasospasm,” that is “quite different” from saying that bromocriptine, the main ingredient in Parlodel, causes strokes.

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