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A medical-monitoring claim can continue against Wyeth Inc. over a hormone-replacement drug it manufactured and distributed, a judge has ruled in the Commerce Case Management Program, denying the defendant’s preliminary objections. Philadelphia Common Pleas Judge Albert W. Sheppard Jr. ruled in Albertson v. Wyeth Inc. that the plaintiffs had stated a viable claim that use of the drug Prempro increased their risk of breast cancer. “Plaintiffs have sufficiently alleged that they are at a significantly increased risk of harm for developing breast cancer and have also pleaded with sufficiency that the monitoring regime is different from that normally recommended,” Sheppard said. However, Sheppard said the plaintiffs had no claim under Pennsylvania’s Unfair Trade Practices and Consumer Protection Law that Wyeth intentionally misrepresented the drug in direct-to-consumer mailings. Sheppard said the U.S. Food and Drug Administration granted Wyeth’s petition to market Prempro in 1994 to be prescribed to post-menopausal women. In July 2002, the plaintiffs claim, about 6 million American women were taking Prempro. The plaintiffs claim it is the best-selling hormone-replacement therapy drug in the country. Wyeth’s marketing efforts for the drug have been directed to doctors and in significant direct-to-consumer efforts, Sheppard said. While certain of those marketing materials made statements to the contrary, the plaintiffs claimed, the risks of taking Prempro far outweighed the benefits. A prematurely terminated Women’s Health Initiative study by the National Heart, Lung and Blood Institute showed that after five years of use, the risks associated with the use of Prempro outweighed any benefits, according to the complaint. The risk of invasive breast cancer increased 26 percent after the use of Prempro for an average of 5.2 years, according to the WHI study. In July 2002, Wyeth acknowledged the significant risks of breast cancer and cardiovascular disease associated with the use of Prempro, Sheppard said. That same month it changed its warning labels and scaled back its marketing of the drug, he said. It also created an amended package insert. Three complaints were filed against Wyeth in July 2002; they were consolidated early this year into one complaint. The complaint asserts five counts against Wyeth, including one for medical monitoring and one for violation of the UTPCPL. Wyeth filed preliminary objections in the nature of a demurrer. Wyeth argued that the plaintiffs failed to meet the criteria the state Supreme Court established for stating a claim for medical monitoring in its decision in Redland Soccer Club Inc. v. Department of the Army in 1997. Under the test, a plaintiff must prove:

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