NEJM comes out against PMA pre-emption
This article was originally published in The Gray Sheet
Executive Summary
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 Fidelis was withdrawn in 2007 after it showed higher than acceptable fracture rates