Where a device receives premarket approval from the federal Food and Drug Administration (“FDA”), state tort law cannot pre-empt or change those requirements. Haddock v. Mentor Texas, L.P., Civil Action No. 3:03-CV-2311-B, U.S. District Court for the Northern District of Texas, Dallas Division, March 25, 2005.
In 1998, Haddock underwent cosmetic surgery to replace her 1983 silicone breast implants with saline implants. Thereafter, in 2002, she underwent another surgery to remove the saline implants. During the 2002 surgery, the surgeon discovered that the right implant had deflated. Haddock commenced an action against Mentor, the manufacturer of the saline implant, claiming that the defective implant caused her to undergo surgery, resulting in deformity and scars and that she incurred medical expenses, pain and suffering. Mentor moved for summary judgment, and the district court granted the motion. It held that the saline implants were a medical device that received premarket approval from the FDA. It held that granting summary judgment was proper because Haddock did not allege or demonstrate that Mentor’s manufacturing, design or labeling was inconsistent with FDA standards and that state tort law could not pre-empt or change the requirements established by the FDA.
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