November 17, 2008
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Case against Stryker involving squeaky hip dismissed in Colorado

A Colorado judge recently dismissed a lawsuit against Stryker Corp. over a squeaky ceramic-on-ceramic hip.

The court determined that since Stryker’s Trident Ceramic Acetabular System has premarketing approval clearance from the FDA, the claims by plaintiff Jama Parker were pre-empted, according to a press release.

In its ruling, the Colorado court cited a Supreme Court decision from earlier this year that addressed the issue of pre-emption. In February, the Supreme Court voted 8-1 to uphold pre-emption in Reigel v. Medtronic. In such cases, pre-emption means that FDA approval of a drug or device supersedes state law claims challenging the safety, efficacy or labeling of that drug or device.

Parker also filed a product liability class action lawsuit against the company in the U.S. District Court for the District of New Jersey for the same device. That case is still pending.

However, pre-emption may be in jeopardy from proposed legislation from Reps. Frank Pallone Jr. (D-N.J.) and Henry Waxman (D-Calif.), according to the press release.

The proposed Medical Device Safety Act would amend the Medical Device Amendments of 1976 to state that FDA approval would not “modify or otherwise affect any action for damages or the liability of any person under state law,” effectively overturning federal pre-emption, according to the press release.