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Latex glove manufacturers chalked up a significant victory last weekwhen a federal judge threw out a products liability suit brought by ahealth care worker after finding that her implied warranty claims arepre-empted by the federal Medical Device Amendments. In Whitson v. Safeskin Corp., U.S. District Judge James M. Munley of theMiddle District of Pennsylvania found that the plaintiff’s claims werebarred since she was effectively seeking a determination that the glovesshould have carried a warning on their labeling that was “differentfrom, or in addition to, the FDA’s mandated language.” Significantly, Munley also concluded that even if plaintiff JeanWhitson’s claim were not pre-empted, it would still fail because heralleged allergic reaction to the gloves was an “individualidiosyncrasy.” The ruling is a victory for Safeskin’s lawyers, Walter H. Swayze III andMelissa A. Wojtylak of Segal McCambridge Singer & Mahoney. Under Pennsylvania law, Munley said, “a seller cannot be liable forbreach of an implied warranty merely because of a harmful effect due toan individual idiosyncrasy on the part of the buyer.” Munley said Pennsylvania courts had also held that an implied warrantyclaim fails where there is no proof that the product “did anything otherthan serve its ordinary purpose.” The ordinary purpose of latex gloves, Munley said, is to protect healthcare workers from contracting blood-borne illnesses. Since Whitson is not claiming that she was exposed to a blood-bornepathogen, but rather that the gloves caused her latex allergy, Munleyconcluded that “the harm that Ms. Whitson complains of is not a harmthat she can recover for under a theory of breach of an impliedwarranty.” Munley’s ruling is sure to be cited by defense lawyers in other pendinglatex 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 inPhiladelphia said he intends to appeal the decision and that he believesMunley’s analysis misinterprets Pennsylvania products liability law. “This is an issue that is definitely going to have to be taken up by the3rd Circuit,” Shrager said. On the issue of pre-emption, Munley found that disposable latex patientexamination gloves are Class I medical devices that are regulated by theU.S. Food and Drug Administration through the Medical Device Amendments.(Class I devices are “those which pose little or no threat to publichealth.”) Under FDA regulations, Munley found, state law is pre-empted only whenthe FDA “has established specific counterpart regulations or … otherspecific 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 athree-factor test for determining whether a claim is pre-empted. Whitson’s claim failed, Munley found, because all three factors werepresent. For the first factor, Munley said, courts must determine whether theplaintiff is seeking to impose requirements that are “different from, orin addition to,” the federal requirements. Since Whitson complained in her suit that the gloves were sold “withoutproviding adequate warnings,” the first factor was met, Munley found. Likewise, Munley found, the second factor, which focuses on whether theclaims “relate to the safety of the medical device,” was also met. For the third factor, Munley said, courts must determine whether thefederal regulations are “specific” to a “particular device.” Munleyfound that that factor, too, was met since the FDA’s glove manualestablished specific labeling requirements for latex gloves. Shrager argued that general requirements, such as warranty of fitnessclaims brought under the Uniform Commercial Code, are exempt fromfederal pre-emption. Whitson’s claim should not be pre-empted, Shrager said, because warrantyclaims under the UCC are not limited to latex gloves or even to medicaldevices. Shrager argued that if Munley pre-empted Whitson’s claim, he would beeffectively repealing part of Pennsylvania’s law of implied warranty.Munley disagreed, saying the only effect of his ruling was to pre-empt astate law claim “to the extent that it would require defendants to labeltheir latex patient examination gloves in a different manner than thatrequired by the FDA’s glove manual.” The Pennsylvania Supreme Court, Munley noted, has recognized that animplied warranty claim based on an alleged failure to warn may bepre-empted under the MDA.

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