WISCONSIN SUPREME COURT FINDS PRODUCT LIABILITY CLAIMS RELATED TO A PMA MEDICAL DEVICE PREEMPTED

On February 17, 2009, the Wisconsin Supreme Court issued a decision finding that state common law product liability claims related to Medtronic’s Marquis 7230 implantable cardioverter defibrillator (“Marquis 7230 defibrillator”) are preempted by the Medical Device Amendments to the Food, Drug and Cosmetic Act (“FDCA”). Blunt et al. v. Medtronic, Inc., No. 2006AP1506 (Wis., Feb. 17, 2009). This is the first medical device preemption decision by a state supreme court since the United States Supreme Court’s 2008 decision in Riegel v. Medtronic, 128 S. Ct. 999 (2008).

Background

In 2002, Medtronic submitted an application to the Food and Drug Administration (“FDA”) requesting pre-market approval (“PMA”) to market and distribute its Marquis 7230 defibrillator, a Class III medical device. The PMA process requires a manufacturer to provide the FDA with “reasonable assurance” that the device is both safe and effective. This rigorous process involves submitting detailed information to the FDA, which the FDA analyzes to weigh the device’s probable health benefits against its probable risk of injury. Once a product obtains PMA, the manufacturer cannot change its design specifications, manufacturing processes, labeling, or any other attribute that would affect the device’s safety or efficacy without FDA approval.

On December 17, 2002, the FDA granted device-specific PMA to the Marquis 7230 defibrillator (“original PMA”). Subsequent to receiving the original PMA, Medtronic learned of a potential shorting problem with the battery. A supplemental PMA application containing three design changes related to the shorting issue was submitted. This supplemental application received FDA approval on October 23, 2003 (“supplemental PMA”). The FDA did not withdraw the original PMA, and physicians proceeded to implant Marquis 7230 defibrillators approved under both the original PMA and the supplemental PMA.

In May 2004, a Marquis 7230 defibrillator approved under the original PMA was implanted in James Blunt. In February 2005, Medtronic advised physicians of the shorting problem. Although Blunt’s defibrillator never malfunctioned, he underwent surgery to remove the defibrillator at the recommendation of his physician. Following the second surgery, Blunt and his wife sued Medtronic, asserting claims for negligence, strict liability and loss of consortium. Medtronic argued that the Blunts’ claims were preempted because the Marquis 7230 defibrillator had received PMA.

All Claims Preempted

In Riegel, the Supreme Court held that state-law claims related to medical devices that received PMA were expressly preempted because the PMA imposes device-specific requirements under the FDCA. The Court concluded that state law claims that effectively impose requirements “different from or in addition to” those requirements are preempted. The Court added that claims alleging that a manufacturer failed to adhere to the requirements imposed by the product’s PMA are not preempted.

Applying Riegel, the Wisconsin Supreme Court found that the Marquis 7230 defibrillator’s PMA was a device-specific federal requirement and that the Blunts’ common law tort claims attempted to impose state law requirements that were “different from or in addition to” federal requirements. The court then addressed whether the Riegel preemption analysis applies to claims where a supplemental PMA is given to a later version of the originally approved device.

The Blunts argued that preemption did not apply to their claims because “when Medtronic obtained supplemental [PMA] of its Marquis 7230 defibrillator with the design changes addressing the shorting problem, the effect of the FDA’s [PMA] of the original defibrillator was ‘superseded’.” The Wisconsin Supreme Court rejected this argument, finding that the Medical Device Amendments do not indicate that a device-specific approval is diminished by a supplemental approval for changes in a device absent a further act by the FDA. The FDA has the power to withdraw the prior PMA or to recall devices designed or manufactured under the prior PMA, and it had not taken either action at the time Blunt received the Marquis 7230 defibrillator. As a result, the Blunts’ common law claims were preempted under Riegel and the Medical Device Amendments to the FDCA.

What This Means for Medical Device Companies

Under current law, claims related to PMA devices are preempted absent a factually supported allegation that the manufacturer violated the PMA specifications or requirements. There is a strong argument that preemption extends to devices where a supplemental PMA is obtained, and “absent further FDA action, prior approvals of the device remain valid.” This decision is significant because supplemental PMAs are commonly applied for and granted for various reasons in an industry where there are constant new device designs and modifications. The Riegel and Marquis 7230 Defibrillator decisions do not provide preemption for devices approved and marketed under the FDA’s less rigorous section 510(k) approval process.

Possible Preemption Amendment

Justice Ann Walsh Bradley drafted a concurring decision that may add more fuel to arguments that the Medical Device Amendments should be amended to abolish preemption. While acknowledging that the Wisconsin Supreme Court is bound by Riegel, the concurring decision states that Riegel “does not adequately protect the safety of the citizens of Wisconsin”, and cites the “flood of criticism directed at the FDA approval process”, including a January 2009 letter from nine FDA scientists to the Presidential Transition Team alleging corruption in the scientific evaluation of medical devices. In 2008, bills were introduced in both the Senate (S. 3398) and the House (H.R. 6381) to effectively overrule Riegel and abolish the preemption of state law tort claims related to medical devices that have PMA. One of the co-sponsors of S. 3398 was President Barack Obama.

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