Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The House Energy and Commerce Health Subcommittee continues to debate the Medical Device Safety Act of 2009, with the announcement of a June 18 hearing on the matter. The bill proposes to overturn the Supreme Court ruling of Riegel v. Medtronic, Inc., which prevents consumers who have been hurt by defective medical devices to sue the device’s maker if the devices have been approved by the Food and Drug Administration (FDA). The class includes medical devices such as cardiac defibrillators, pacemakers, replacement heart valves, coronary artery stents and pre-filled syringes.

According to an internal FDA document, senior officials with the agency’s Center for Devices and Radiological Health (CDRH), which is charged with overseeing the safety of medical devices, made a decision to ignore the Good Laboratory Practice (GLP) regulation and as a result put patients’ lives at risk.

The controversy stems from a new classification of medical devices that resulted from a federal loophole that allowed products that are “substantially equivalent” to combinations of other products marketed before 1976 to be sold. As a result, hundreds of new “Class C” devices were approved and made available for use.

Class C is the FDA’s most risky category and includes heart defibrillators from Medtronic Inc. In 2007, Medtronic suspended the sale of its Sprint Fidelis Defibrillator leads that are used on Medtronic implantable defibrillators, after reports of deaths and injuries to patients with the defibrillators with leads that had fractured or broken causing the defibrillators to shock inappropriately or not at all.

The debate will continue in Congress with the June 18th hearing.

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