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WASHINGTON STATE BREAST-IMPLANT RULING IS REVERSED.

The Ninth U.S. Circuit Court of Appeals has reversed a ruling against a plaintiff in a breast-implant case, holding the district judge erred in deciding to give the jury instructions based on the law of negligence rather than strict liability.

In Transue v. Aesthetech Corp. et al. (01-35773), Lana Transue sued Aesthetech, Bristol-Myers Squibb and other defendants over her silicone-gel breast implants, which she claimed leaked and injured her before they were removed and replaced by saline-filled implants.

BMS, a Delaware corporation, had the case transferred to federal court. It was then transferred to federal court in Alabama to be included in multi-district litigation, but Transue opted out and her case was remanded to the Western District of Washington.

U.S. District Judge Robert Lasnik told the jury it would have to find BMS failed to use ordinary care in designing and manufacturing the implants as well as issuing warnings.

The jury found for BMS, and Transue appealed.

The Ninth Circuit panel reversed on the basis of the jury instructions.

Washington state law does not put all breast implants under the protection afforded unavoidably unsafe products by comment k of the Restatement (Second) of Torts, U.S. District Judge Dean Pregerson wrote for the panel.

"It appears that the issue of whether a breast implant, specifically, is a 'medical device or product' that is unavoidably unsafe and therefore receives comment k exemption has not been directly addressed by Washington courts," Pregerson wrote.

He said the devices do appear to be covered by Washington courts' interpretation of comment k, but the exemption applies only if the product is "properly prepared."

This case alleges a manufacturing defect, so strict liability applies and negligence needn't be proved, Pregerson said, quoting another court as saying a "drug that has a manufacturing defect is, by definition, not 'unavoidably unsafe'."
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Publication:Liability & Insurance Week
Date:Sep 2, 2003
Words:305
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