House Energy and Commerce Committee's Health Subcommittee held hearings on May 12, 2009 that could lead to the overturning of the Supreme Court decision in Riegel v. Medtronic, Inc., which established that state law tort claims against medical device manufacturers are expressly preempted by federal law.
The hearings are the first step in the legislative process for H.R. 1346, known as the Medical Device Safety Act of 2009. This bill would amend 21 U.S.C. § 360k by adding a new subsection (c) that, as proposed to the subcommittee, reads, "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 law of any State."
Currently, subject to a few exemptions, Section 360k(a) prohibits states from establishing or continuing "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."
Based on its interpretation of Section 360k, the Supreme Court in Riegel held that the Food and Drug Administration's (FDA) pre-market approval process for medical devices preempted state law tort claims against medical device manufacturers.
Now, H.R. 1346 seeks to overturn the Riegel decision by incorporating language into Section 360k that parallels the language contained in another preemption statute that the Supreme Court has already acknowledged as preserving states' product liability actions. According to the Supreme Court in Wyeth v. Levine, Section 379r of Title 21 of the United States Code preempts "certain state requirements concerning over-the-counter medications and cosmetics but expressly preserved product liability actions." Section 379r parallels Section 360k by also prohibiting states from establishing or continuing a requirement that is "different from, in addition to, or that is otherwise not identical with," a requirement established under a number of enumerated federal statutes. However, unlike Section 360k, Section 379r preserves certain state law claims with language that is almost identical to that of H.R. 1346: "Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State."
Therefore, should H.R. 1346 become law, it would lay the foundation for overturning Riegel v. Medtronic. As a result, medical device manufacturers would once again join pharmaceutical drug manufacturers, which recently lost their own argument for preemption, in facing state law tort claims. See also, "The Supreme Court Decides Wyeth v. Levine" on the Supreme Court's decision that the FDA's pre-market approval of pharmaceutical drugs does not preempt state law tort claims.
