Medical Device Safety Act of 2009 Needs Congressional Approval

medical-device-legislationTuesday, the United States Senate Committee on Health, Education, Labor and Pensions (HELP) heard testimony from patients and medical experts about the effect of the recent United States Supreme Court case known as Riegel v. Medtronic. That decision provides immunity to manufacturers of defective medical devices. Riegel essentially holds that since the FDA approved a medical device, an injured patient cannot sue the manufacturer when she is injured or killed by an allegedly defective device. The Health, Education, Labor and Pensions Committee is considering passage of the Medical Device Safety Act of 2009 which would clarify that FDA approval of certain medical device products does not rob consumers of their right to hold negligent manufacturers responsible in court.

As injury attorneys who have represented thousands of clients injured by defective medical devices and pharmaceuticals, we know the importance of our court system in holding negligent manufacturers responsible. Our regulatory system alone cannot do the work of protecting consumers. The tort system is an important complement to any federal oversight. We call on Congress to pass, and President Obama to sign, the Medical Device Safety Act and to restore the rights of injured patients.

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