Sunday, January 3, 2010

FDA approval process for medical devices criticized

The Food and Drug Administration's approval process for medical devices such as pacemakers and implanted defibrillators has come under fire for failing to adequately consider the safety of such devices. Reporting on a study first published in the Journal of the American Medical Association, the Los Angeles Times observed that cardiovascular devices "are not subjected to rigorous safety and effectiveness research before being approved for use."

These findings are all the more troubling in light of the US Supreme Court's 2008 decision in Riegel v. Medtronic providing immunity from civil lawsuits to manufacturers of such products that are approved by the FDA. In its opinion, the Supreme Court reasoned that the FDA approval process was "rigorous" and thus precluded claims against the manufacturer by those injured by its products. With serious questions now being raised about that approval process, the justification for this decision are now in serious doubt. Unfortunately, patients who receive these devices have little recourse at this time for injuries caused by these defective products, although the Medical Device Patient Safety Act of 2009 pending in the House of Representatives (and supported by the New England Journal of Medicine) offers some hope that the injustice created by this decision can be reversed.

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