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Reps. Fitzpatrick, Slaughter Introduce Device Defect Reform Bills

Reps. Mike Fitzpatrick, R-Pa., and cosponsor Louise Slaughter, D-N.Y., introduced medical device reform bills that would let courts consider product liability suits for PMA-approved devices and require physicians to report to FDA adverse events involving medtech products.

Stimulated by grassroots campaigns by patient advocates who say they were harmed by Bayer HealthCare LLC's Essure sterilization product or gynecologists' use of alleged cancer-spreading power morcellators to clear uterine fibroids, Reps. Mike Fitzpatrick, R-Pa., and Louise Slaughter, D-N.Y., introduced two bills in the House on June 8.

"While many medical devices prove lifesaving, we know that some can cause harm and have devastating consequences on patients," commented Fitzpatrick. "When a medical device is found to be unsafe,...

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