Congressman Introduces Law to Abolish Medical Device Companies’ Preemption Defense

06/03/2016 - A new Bill was announced today by Congressman Mike Fitzpatrick which would essentially abolish medical device manufacturers’ preemption defense in product liability cases. Currently, Section 521 of the Federal Food, Drug and Cosmetic Act (21 U.S.C 360k) provides that, “No State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement- (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.” In essence, this statute makes it difficult, if not impossible, for many state law causes of action for defective products to be asserted in courts. Since 2008, when the US Supreme Court rendered its incorrect decision in Riegel vs. Medtronic Inc., thousands of litigants have been prevented or preempted from pursuing their legal rights for injuries received by defective medical devices. Manufacturers have enjoyed virtual immunity from suit for 360k approved devices regardless of whether the products were safe or defective.

The new proposed legislation, titled Ariel Grace’s Law seeks to amend the Federal Food Drug and Cosmetic Act with respect to liability under State and local requirements pertaining to medical devices. The Bill is appropriately named after little Ariel Grace, who died at birth due to the injuries suffered by her and her mother caused by the Essure Sterilization Device. The Bill states as follows:

This Act may be cited as the “Ariel Grace’s Law" 
(a) Amendment- Section 521 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360k) is amended by adding at the end the following:

(b)NO EFFECT ON LIABILITY UNDER STATE LAW - Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the laws of any State.”

(c) EFFECTIVE DATE; APPLICABILITY. - The amendment made by subsection (a) shall

(1) Take effect as if included in the enactments of the Medical Device Amendments of 1976 (Public Law 94-295): and

(2) Apply to any civil action pending or filed on or after the date of the Act.

This bill is historic in that it will allow patients who have been injured by defective medical devices approved pursuant to the 360k Premarket Approval Process to pursue their rights in court and to hold manufacturers of defective devices liable and accountable. Civil litigation is both necessary to compensate patients who have been injured by defective devices and to keep manufacturers in check to ensure that the products they put into commerce are safe. This law will not serve to stifle innovation of new products but simply to ensure products are both effective and safe. Although the law will apply to all medical devices approved by the FDA pursuant to the 360k process, the primary catalyst for the bill were the thousands of women who have suffered and will continue to suffer horrific injuries caused by the Essure device. If the FDA is unwilling to act, Congress must act in its stead.


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