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Abstract

The use of federal preemption in cases involving medical devices is under attack by personal injury attorneys and consumer groups.  The U.S. Supreme Court revisited preemption in a medical device case, Riegel v. Medtronic.  Medmarc teamed with AdvaMed, Medtronic, and other like-minded entities and submitted an amicus curiae brief to defend the use of federal preemption in cases involving medical devices.

For over a decade, federal preemption has been used to obtain claim dismissals and settlements in medical device products liability cases.  Predictably, personal injury lawyers have fought against federal preemption, because it has limited the ability of plaintiffs to bring state law claims against the manufacturers of certain medical devices.  When federal preemption recently came under attack in Riegel, Medmarc joined forces with AdvaMed¹ to support its continued use in medical device products liability cases.

In 1976, Congress passed the Medical Device Amendment (MDA) to the Federal, Food, Drug and Cosmetic Act (21 U.S.C. § 301).  This federal law expanded the authority of the Food and Drug Administration (FDA) to ensure through regulatory oversight that medical devices are safe and effective.  Congress recognized that a national, uniform system of regulation would encourage the emergence of new technologies.²  On the other hand, a system of overlapping federal and state rules could stymie manufacturers and thus undermine the public health.  Accordingly, Congress expressly provided in the MDA that a state law is preempted if it is "different from, or in addition to" any federal regulation related to the "safety or effectiveness" of a medical device.³  This provision of the MDA has become the basis for the federal preemption issue in products liability cases involving medical devices, especially devices surviving the PMA (Pre-Market Approval) process.

Background of Riegel v. Medtronic

At issue in Riegel was whether the MDA "preempts common law tort claims regarding medical devices that have entered the market pursuant to the [FDA's] rigorous premarket approval ("PMA") process."⁴  The case involved an Evergreen Balloon Catheter, a PMA device that doctors use during angioplasty to open patients' clogged arteries.  Charles Riegel sued Medtronic for injuries he suffered when the catheter burst while being used by his physician.  The Evergreen Balloon Catheter was contraindicated for use in a patient like Riegel, who had a diffusely diseased and heavily calcified coronary artery.  Further, contrary to the product's warning label, Riegel's doctor over-inflated the catheter. 

Riegel asserted state law causes of action, including negligent design, testing, inspection, distribution, manufacture, marketing, sale, and labeling; strict liability; breach of express warranty; and breach of implied warranty.  A federal district court dismissed Riegel's claims (except negligent manufacturing and breach of express warranty) by summary judgment on the basis that the MDA preempted Riegel's claims of negligence, strict liability, and breach of implied warranty.

The Second Circuit Court of Appeals agreed.  The Court reasoned that a device approved through the PMA process becomes subject to federal, device-specific requirements contained in its individual, federally approved PMA.  The Court held that a successful state law claim would "result in state 'requirements' that differed from, or added to" the PMA-approved standards.⁵  The Court reasoned that "the liability-creating premise of all of [Riegel's] claims is that the Evergreen Balloon Catheter itself, in its present PMA-approved form, is in some way defective and therefore requires modification."⁶  A finding for Riegel would "represent a finding that the [Catheter] had not adhered to the various state common law duties implicated by those claims" and, thus, the state would be imposing requirements that would conflict with the FDA's conclusion that the device was safe and effective.⁷  Riegel, who asked the Supreme Court to hear the case, argued that FDA approval of the Evergreen Balloon Catheter imposed no device-specific requirements and, thus, state law requirements did not differ from or add to those requirements.  Riegel also argued that the decision unreasonably left patients injured by PMA devices with no way to recover compensation and that Congress never meant for this provision to trump state-law claims.  Medtronic and the U.S. solicitor general, on behalf of the FDA, argued that the Supreme Court need not hear Riegel's appeal because the Second Circuit's decision was correct.  Medtronic argued that premarket approval does establish federal device-specific requirements that preempt conflicting state law requirements and most federal courts of appeals deciding cases regarding PMA devices have held correctly that state law claims that conflict with specific federal requirements of the PMA approval are preempted.⁸  Medtronic argued further that the Second Circuit's decision is consistent with congressional intent and its holding is "quite limited" in that it affects only a very small percentage of Class III devices undergoing the PMA process.

Medmarc Joins Forces to Bolster Preemption

In a 1996 case, Lohr v. Medtronic, Medmarc joined forces with the Health Industry Manufacturers Association (HIMA, AdvaMed's predecessor) to support federal preemption for so-called 510(k) devices, ones that are "substantially equivalent" to devices already on the market.  Together, Medmarc and HIMA submitted an amicus curiae brief to the U.S. Supreme Court, arguing that the FDA's regulation of medical devices preempts state products liability claims and to permit such claims would stifle scientific and technological advancement in the medical device field.

To represent the interests of its policyholders, constituents, and the medical technology and life sciences industry, Medmarc joined forces with AdvaMed and other entities and filed an amicus brief in support of federal preemption in Riegel.  (Click here to access the amicus brief.)  Medmarc is the only insurance company to advocate for the industry in this way.  Medmarc worked through counsel (Carr Maloney P.C., Washington D.C.), Medtronic's outside counsel (Gibson, Dunn & Crutcher LLP), and AdvaMed's counsel (Sidley Austin LLP) to collaborate on the best legal strategy to argue for preemption before the U.S. Supreme Court.

Supreme Court Affirms Use of Preemption

On February 20, 2008, in an 8-1 decision, the U.S. Supreme Court found that federal preemption prohibits state law claims that challenge the safety or effectiveness of a medical device that receives premarket approval from the FDA.⁹  (Click here to access the Court’s opinion.)  The Court's decision hinged, in large part, on its finding that FDA approval of a Class III device through the PMA process does, indeed, impose federal requirements on the device.  Further, a successful state law tort claim would impose requirements on the device that are different from, or in addition to, those already imposed on the device as a result of the PMA process.  Justice Scalia delivered the opinion of the Court, explaining that in accordance with the MDA, state lawsuits are barred since they impose state requirements on devices that are already subject to federal requirements.

Scope of the Decision

It is easy to hype and over-reach in assessing Riegel’s impact.  Important to understand is the fact that Riegel impacts only a narrow slice of medical device claims and lawsuits—specifically, those involving PMA devices.  Most devices do not enter the market through the PMA process.  In the Riegel opinion, the Court noted, "In 2005, for example, the FDA authorized the marketing of 3,148 devices under § 510(k) [the alternative to the PMA process] and granted premarket approval to just 32 devices."¹⁰  The Court’s decision bars state law claims for injuries that result from aspects of the device that are scrutinized during PMA review.  Most claims—suits against non-PMA devices—will still survive, as will claims for manufacturing defects.  Plaintiffs are also free to pursue claims for injuries sustained because devices do not conform to the specifications or safety processes approved during PMA review or because manufacturers deceive regulators by providing false information to attain premarket approval.  As such, Riegel  will likely not represent a sea-change in the medical device products liability landscape, which is important to note in the face of trial lawyer and consumer cries about patients being stripped of their right to sue.

By the same token, it is a mistake to belittle the impact of Riegel simply because it only applies to PMA devices.  Though Riegel only impacts a narrow band of medical device cases, that swath comprises claims that typically have high dollar values, high reserves, high jury values, high exposure and high legal costs.  The reason: PMA devices, by their very nature, tend to be life-supporting and life sustaining.  If they do not work as intended, the result is usually patient death or catastrophic injury.  To the extent that Riegel removes many claims involving PMA devices, the financial impact of their removal—being that they are high severity claims—is much more indicative of Riegel's than is the frequency or mere stick-count of these cases.  For this reason, the affirmation of federal preemption in Riegel is financially significant for a subset of the medical device universe.

¹ AdvaMed is the world's largest medical technology association, representing manufacturers of medical devices, diagnostic products and medical information systems.
2 Brief of the Health Industry Manufacturers Association and Medmarc Insurance Company as Amici Curiae in Support of the Petitioner/Cross-Respondent, Medtronic, Inc., 1996.
³ 21 U.S.C. § 360k(a).
⁴ Riegel v. Medtronic, 451 F.3d 104 (2d Cir. 2006).
⁵ Id, at 119.
⁶ Id, at 122.
⁷ Id.
⁸ A few federal courts throughout the country have held that mere FDA approval of a medical device does not bar individual plaintiffs from pursuing failure to warn cases against Class III devices.
⁹ Riegel v. Medtronic, Inc., 552 U.S. 312 at 312 (2008).
¹⁰ Id at 317.