NEJM comes out against PMA pre-emption
This article was originally published in The Gray Sheet
Personal injury lawsuits involving PMA-approved products are an "important part of the regulatory framework and very effective in keeping medical devices safe," the editors of the New England Journal of Medicine argue in a March 18 editorial calling for passage of the Medical Device Safety Act. The legislation, reintroduced March 5, would effectively overturn Riegel v. Medtronic, in which the Supreme Court ruled that PMA approval of a device pre-empts state-level litigation (1"The Gray Sheet" March 9, 2009, In Brief). Gregory Curfman, Stephen Morrissey and Jeffrey Drazen argue that "pre-emption will result in medical devices that are less safe for the American people." Riegel has led to thousands of lawsuits being dismissed, they note, citing in particular litigation against Medtronic over its Sprint Fidelis implantable cardioverter defibrillator leads (2"The Gray Sheet" Jan. 12, 2009, p. 3). Fidelis was withdrawn in 2007 after it showed higher than acceptable fracture rates
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Congressional Democrats reintroduced legislation March 5 to reverse last year's U.S. Supreme Court Riegel v. Medtronic decision, which bars, in most cases, state personal injury suits involving PMA-approved devices. The move by Reps. Frank Pallone, Jr., D-NJ, and Henry A. Waxman, D-Calif., and Sens. Edward Kennedy, D-Mass., and Patrick Leahy, D-Vt., immediately followed the high-profile March 4 Wyeth v. Levine Supreme Court decision striking down federal pre-emption of lawsuits against drug makers for failing to properly warn the public of product risks. The Medical Device Safety Act of 2009 would revise language in the 1976 Medical Device Amendments that the high court says expressly pre-empts suits against PMA-approved devices. There is no such language in FDA drug oversight statutes, so the Wyeth decision does not create precedent for device suits. Still, says Waxman, in Wyeth, "the Court noted that these lawsuits 'uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.' The same is true for medical devices." The legislation was introduced for the first time last year, but it is more likely to be signed by a President Obama than a President Bush ("1The Gray Sheet" March 24, 2008, p. 19)
A Minnesota federal judge on Jan. 5 categorically 1dismissed on grounds of federal pre-emption all 21 claims in a multidistrict personal injury lawsuit against Medtronic for its Sprint Fidelis implantable defibrillator leads
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