H.R. 6381: Will Congress Strip Class III Medical Device Manufacturers of Their Pre-Emption Defenses?

The plaintiffs in Riegel filed a civil lawsuit against Medtronic, Inc. in which they claimed that a balloon catheter that ruptured during the course of an angioplasty was negligently and defectively designed, tested, manufactured, and labeled. Prior to the incident, Medtronic, Inc. sought and obtained premarket approval from the Food and Drug Administration (FDA) to market this catheter as a Class III medical device under the MDA. The “rigorous” premarket approval process requires the manufacturer to submit an application that contains, among other things, detailed information on the device’s safety and effectiveness. The FDA spends an average of 1,200 hours reviewing each premarket approval application and only grants premarket approval if it finds there is a reasonable assurance of the device’s safety and effectiveness. 21 U.S.C. § 360e(d). More information on the premarket approval process can be found on the FDA’s website.

The MDA expressly pre-empts States from establishing any “requirement” relating to the “safety or effectiveness” of a medical device that is “different from, or in addition to, any requirement” for the device that has been established pursuant to the MDA. 21 U.S.C. § 360k(a). In Riegel, the Supreme Court held that this clause pre-empts State common-law claims challenging the safety and effectiveness of a medical that received premarket approval.  Specifically, the Court held that products liability claims are pre-empted by the MDA to the extent they are based upon or seek to impose safety requirements for the device’s design and labeling that are different from or in addition to the federal requirements applicable to the device. Justice Ginsburg, the lone dissenter to this opinion, argued, among other things, that Congress did not intend section 360k(a) to effect such a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices. The entire Riegel opinion can be found here.

On June 26, 2008, Rep. Frank Pallone, Jr. introduced a bill in the House of Representatives entitled the Medical Device Safety Act of 2008. A supporter of this bill stated that it was intended to “address the Supreme Court’s flawed decision in Riegel v. Medtronic that completely ignored Congressional intent regarding the ability of injured patients to hold medical device manufacturers accountable for their injuries.” Additional comments can be found at here. This bill attempted to undo Riegel by qualifying the broad pre-emption language upon which it was based. The operative language in this bill provided that “Nothing in this section [360k] shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.”

This bill can be viewed in its entirety here.

Seventy one cosponsors from various states across the country endorsed the House bill and an identical bill was introduced in the Senate by Senator Kennedy of Massachusetts on July 31, 2008.

The Senate bill can be viewed here.

The Senate bill was read twice and then referred to the Committee on Health, Education, Labor, and Pensions the same day. The Senate bill is currently in committee and no major actions have been taken as of the date it was introduced. Similarly, the House bill was referred to the Committee on Energy and Commerce on June 26, 2008 and then referred to the Subcommittee on Health the same day. No major action has been taken since. Thus, it appears that legislative attempts to curtail the scope of the MDA’s pre-emption clause in the wake of Riegel have lost momentum.

While these bills have sat in committee, many Federal and state courts have dismissed various tort claims brought against medical device manufacturers alleging that Class III medical devices that were given premarket approval by the FDA pursuant to Riegel. Shortly after Reigel, the Supreme Court decided Wyeth v. Levine, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009). In Wyeth, the Supreme Court held that the FDCA’s labeling requirements for prescription drugs labels do not impliedly pre-empt State common-law failure to warn claims alleging that additional warnings should have been included on the label. The Wyeth Court pointed out that the Food, Drug, and Cosmetic Act (FDCA), unlike the MDA, does not contain a clause that expressly pre-empts any State law attempts to impose additional safety requirements. The Court reasoned that Congress’ silence in this regard could only be construed as stemming from a judgment that State law suits are not obstacles to the FDCA’s objectives. The full Wyeth opinion can be found here. Thus, absent renewed legislative vigor or a retreat by the Supreme Court, it appears that Riegel will continue to provide medical device manufacturers with a complete defense to many state law products liability and negligence actions.