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A Philadelphia judge refused last week to certify a proposed statewide class action in which women were seeking medical monitoring, linking an increased risk of developing breast cancer to the hormone-replacement drug Prempro. Common Pleas Judge Mark I. Bernstein noted that both plaintiffs’ experts agreed that determining whether a member of the potential class qualified for special medical treatment would require an individual assessment of the risk factors — aside from Prempro use — affecting each woman. Bernstein wrote that the class could include as many as 720,000 Pennsylvania women who used the hormone replacement drug. Because the question of how Prempro would affect a woman’s risk of developing cancer was not common to all proposed class members, class treatment was not appropriate, Bernstein concluded. “In this case of uncontradicted evidence, mostly presented by plaintiff’s expert witness, demonstrates that specialized treatment required by a member of the plaintiff class could only be based on an individual assessment of risk factors other than Prempro use,” Bernstein wrote. The judge said the plaintiffs hadn’t shown they were exposed to a “hazardous substance” — a requirement of demonstrating a medical-monitoring claim — considering evidence that many women are in actual, medical need of Prempro. “Plaintiff’s own expert continues to prescribe the medication characterized as ‘hazardous substance,’” Bernstein observed. “It certainly is not a hazardous substance for those for whom it is a necessary medical treatment, including at least one named plaintiff.” Defense counsel, Mike Scott of Reed Smith, said that Bernstein’s ruling, which interprets Pennsylvania’s requirements for class certification, could be “helpful” to a federal judge in Arkansas who is considering the certification of a proposed national class of Prempro users who also seek medical monitoring. Pennsylvania’s requirements for class certification are similar to the federal courts’ requirements, Scott said. Scott represented the defendant, pharmaceutical giant Wyeth Corp., with Kerry Kearney and Christin Bassett at a three-day hearing on the proposed class certification in January. “This was a case that, on the face of the complaint and on the face of the expert reports, looked like it would be plausible for class certification,” Scott said. “As soon as it became open to cross-examination, it became crystal clear [that] this was nowhere near appropriate for certification… . Medical monitoring was created to deal with poisonous, hazardous substances — not drugs that are recognized as effective products.” Wyeth argued that patients who use Prempro do not need any special monitoring because they are of post-menopausal age — the age at which doctors already recommend that women undergo a mammogram once a year to screen for cancer. The named plaintiffs in Albertson v. Wyeth, Finnegan v. Wyeth and Everette v. Wyeth sought certification of a class of all post-menopausal women in Pennsylvania who took a high dose of Prempro on a daily basis for at least a year prior to July 9, 2002, and who haven’t been diagnosed with breast cancer. Wyeth’s Prempro is a prescription drug that combines estrogen and progestin for post-menopausal hormone therapy, helping to treat symptoms such as hot flashes and vaginal atrophy. It can also help prevent osteoporosis. In July 2002, the National Heart Lung and Blood Institute announced it was stopping a study of the effects of long-term use of Prempro to fight heart disease because the drug’s overall health risks, including invasive breast cancer, exceeded the benefits of the drug, according to the federal Food and Drug Administration’s Web site. The FDA has approved the drug. An expert for the plaintiffs, Nancy Elliott, described a special medical monitoring program that class members allegedly need because of their use of Prempro. The program would have included a yearly mammogram, breast exam and lifestyle counseling, according to the opinion. But Bernstein found that the Elliott’s medical monitoring program was not a program for Prempro users but for any woman with a lifestyle or family history factor that makes her more likely to develop breast cancer. “Women will fall into different categories of risk based upon individual risk factors, irrespective of past Prempro use,” Bernstein wrote. “Dr. Elliott testified: ‘very often Prempro use is not the only risk factor that a woman has.’ Indeed, based on the panoply of risk factors identified by plaintiff’s expert, it is difficult to isolate any woman who would not, in Dr. Elliott’s opinion, qualify for her program. Were it possible to insulate plaintiffs who had no risk factor other than past Prempro use, Dr. Elliot would nonetheless recommend a yearly mammogram and exam.” Bernstein determined the plaintiffs had failed to demonstrate any “distinct” medical regime. “Based on plaintiffs’ experts’ testimony, those women who would need special, necessary monitoring, exclusively due to Prempro use would be a very small subclass of the classes defined in this lawsuit for certification,” Bernstein wrote. Determining that small class would depend on an individual analysis of all risk factors, including breast density and whether Prempro use affected the density, Bernstein concluded. “Accordingly, this court finds that individual questions of law and fact exist with respect to the medical monitoring claim and commonality has not been even prima facie demonstrated.” Martin J. D’Urso, a lead counsel for the proposed class, said Bernstein’s ruling was disappointing, but he and others are “analyzing it carefully before making any related determinations.” He declined to comment further. D’Urso, an attorney at Kohn Swift & Graf, represented the plaintiffs as the class certification hearing in January with Jonathan Auerbach of Berger & Montague, and Marc Auerbach and Nancy Rhoads of Sheller Ludwig & Badey.

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