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Editor: Marc Jay Bern
Profession: Defective Medical Device Lawyer

Category: Medtronic News

Medical Device Safety Act of 2008 is aimed at overturning a Supreme Court ruling granting medical device manufacturers immunity from product liability lawsuits.

The new legislation, introduced by democratic lawmakers, would reverse the Supreme Court's decision denying victim's rights to legal recourse, giving medical device makers blanket immunity for the life of the product.

"Congress should pass this legislation to help protect patients from defective and dangerous medical devices," said Rep. Frank Pallone, D-N.J., in a statement.

The legislation is in response to a February ruling by the Supreme Court in Donna Riegel vs. Medtronic Inc., in which the high court held the pre-emption clause in the Medical Device Amendments of 1976 bars common law claims challenging the safety and effectiveness of medical devices that have received premarket approval from the FDA.

The case involved the rupturing of a heart catheter during a 1996 operation. The patient - who is now deceased - and his wife, filed suit against the company claiming the medical device was designed labeled and manufactured in a manned that violated N.Y. common law.

Both U.S. district court and the 2nd U.S. Circuit Court of Appeals upheld the pre-emption common law.