HARRISBURG, Pa. -- Under the Medical Device Amendments (MDA), a plaintiffs' claims for breach of implied warranty for alleged insufficient warnings on latex glove packages are preempted by federal requirements for glove labeling, a federal judge ruled March 25 (Jean M. Whitson, et al. v. Safeskin Corp., Inc., et al., No. 3:03cv746, M.D. Pa.).
Jean Whitson filed her complaint in the U.S. District Court for the Middle District of Pennsylvania on Dec. 29, 1997. She argued that she suffers permanent latex hypersensitivity due to seven years of exposure to gloves manufactured by Safeskin Corp. and Johnson & Johnson Medical.
While the case was pending in the latex MDL in the Eastern District of Pennsylvania (MDL No. 1148), presiding Judge Edmund V. Ludwig granted the defendants' motion for summary judgment in part. In a March 9, 2001, order, he ruled that tort claims were time-barred and that her express and implied warranty claims were time-barred as to gloves sold to Whitson's employer before Dec. 27, 1993.
He allowed Whitson's claims related to gloves sold between Dec. 27, 1993, and Dec. 27, 1997, to remain. Upon Whitson's motion for reconsideration, Judge Ludwig vacated his order only as to her loss of consortium claims.
Upon remand to the Middle District of Pennsylvania, Whitson argued that the defendants breached their implied warranties of fitness and merchantability under the Uniform Commercial Code.
The defendants argued that Whitson's claims for breach of implied warranty were preempted by the Food and Drug Administration's specific labeling requirements for latex gloves, published in May 1993. Because Whitson was seeking a determination that the gloves should have contained labeling that differed from this, her claims should be dismissed under the MDA, the defendants said.
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