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Latex glove manufacturers chalked up a significant victory last week when a federal judge threw out a products liability suit brought by a health care worker after finding that her implied warranty claims are pre-empted by the federal Medical Device Amendments. In Whitson v. Safeskin Corp., U.S. District Judge James M. Munley of the Middle District of Pennsylvania found that the plaintiff’s claims were barred since she was effectively seeking a determination that the gloves should have carried a warning on their labeling that was “different from, or in addition to, the FDA’s mandated language.” Significantly, Munley also concluded that even if plaintiff Jean Whitson’s claim were not pre-empted, it would still fail because her alleged allergic reaction to the gloves was an “individual idiosyncrasy.” The ruling is a victory for Safeskin’s lawyers, Walter H. Swayze III and Melissa A. Wojtylak of Segal McCambridge Singer & Mahoney. Under Pennsylvania law, Munley said, “a seller cannot be liable for breach of an implied warranty merely because of a harmful effect due to an individual idiosyncrasy on the part of the buyer.” Munley said Pennsylvania courts had also held that an implied warranty claim fails where there is no proof that the product “did anything other than serve its ordinary purpose.” The ordinary purpose of latex gloves, Munley said, is to protect health care workers from contracting blood-borne illnesses. Since Whitson is not claiming that she was exposed to a blood-borne pathogen, but rather that the gloves caused her latex allergy, Munley concluded that “the harm that Ms. Whitson complains of is not a harm that she can recover for under a theory of breach of an implied warranty.” Munley’s ruling is sure to be cited by defense lawyers in other pending latex glove cases because it effectively declares that the gloves are “fit for the ordinary purpose for which they are sold.” Plaintiff’s attorney David S. Shrager of Shrager Spivey & Sachs in Philadelphia said he intends to appeal the decision and that he believes Munley’s analysis misinterprets Pennsylvania products liability law. “This is an issue that is definitely going to have to be taken up by the 3rd Circuit,” Shrager said. On the issue of pre-emption, Munley found that disposable latex patient examination gloves are Class I medical devices that are regulated by the U.S. Food and Drug Administration through the Medical Device Amendments. (Class I devices are “those which pose little or no threat to public health.”) Under FDA regulations, Munley found, state law is pre-empted only when the FDA “has established specific counterpart regulations or . . . other specific requirements applicable to a particular device.” The FDA established specific labeling requirements for latex gloves, Munley found, by issuing a manual in 1993. Munley found that the U.S. Supreme Court’s 1996 decision in Medtronic v. Lohr focused on the pre-emptive effect of the MDA and established a three-factor test for determining whether a claim is pre-empted. Whitson’s claim failed, Munley found, because all three factors were present. For the first factor, Munley said, courts must determine whether the plaintiff is seeking to impose requirements that are “different from, or in addition to,” the federal requirements. Since Whitson complained in her suit that the gloves were sold “without providing adequate warnings,” the first factor was met, Munley found. Likewise, Munley found, the second factor, which focuses on whether the claims “relate to the safety of the medical device,” was also met. For the third factor, Munley said, courts must determine whether the federal regulations are “specific” to a “particular device.” Munley found that that factor, too, was met since the FDA’s glove manual established specific labeling requirements for latex gloves. Shrager argued that general requirements, such as warranty of fitness claims brought under the Uniform Commercial Code, are exempt from federal pre-emption. Whitson’s claim should not be pre-empted, Shrager said, because warranty claims under the UCC are not limited to latex gloves or even to medical devices. Shrager argued that if Munley pre-empted Whitson’s claim, he would be effectively repealing part of Pennsylvania’s law of implied warranty. Munley disagreed, saying the only effect of his ruling was to pre-empt a state law claim “to the extent that it would require defendants to label their latex patient examination gloves in a different manner than that required by the FDA’s glove manual.” The Pennsylvania Supreme Court, Munley noted, has recognized that an implied warranty claim based on an alleged failure to warn may be pre-empted under the MDA. (Copies of the 13-page opinion in Whitson v. Safeskin Corp., PICS No. 04-0496, are available from The Legal Intelligencer . Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information. Some cases are not available until 1 p.m.)

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