PREEMPTION – PMA DEVICES

KEY POINTS

• When Congress passed the Medical Device Amendments of 1976 (MDA), 21 U. S. C. §360c et seq., it imposed a detailed regime of federal oversight over the approval of medical devices. The MDA was intended to “provide for the safety and effectiveness of medical device[s],” while simultaneously “encourag[ing] the[] research and development” of “sophisticated, critically important” devices.¹
• With patients in mind, and to further this dual goal, Congress gave central authority to the FDA to oversee and regulate medical devices and expressly barred (or “preempted”) individual states from establishing any additional or different requirements that relate to the safety and effectiveness of medical devices. For 40 years, this uniform system has made it possible for millions of Americans each year to benefit from complex and innovative medical devices.
• While on balance the system has been successful, one criticism levied by many neutral observers is that it has not sufficiently promoted innovation; in some cases, Americans are slower to gain access to innovative devices that are in widespread use in advanced healthcare systems around the world. FDA leaders have acknowledged this issue and have expressed a desire to streamline the approval process in various ways.
• In Riegel v. Medtronic, 128 S. Ct. 999 (2008), the Supreme Court followed the clear language of the MDA, holding that lawsuits attempting to impose state-law requirements that were “different from, or in addition to,” the requirements for Premarket Approval (PMA) of a device should be dismissed as expressly preempted. In reaching that conclusion, the Court emphasized that PMA devices are rigorously evaluated by experts at the FDA before approval and must be marketed with “almost no deviations from the specifications in [their] approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness.” Id. at 1007. PMA devices represent less than 2% of all FDA approved devices.
• The express preemption provision of the MDA assures a central standard for device safety, effectiveness, testing, labeling, and marketing of PMA devices, which ultimately protects patients, their safety, and their access to medical innovation. Without express preemption, each State could potentially create its own set of rules for PMA devices, leaving a patchwork of regulations that no company could navigate and that would ultimately harm patient health.

Overview

1. Medical Device Amendments
   
   

   The Medical Device Amendments (MDA) of 1976 to the Federal Food, Drug, and Cosmetic Act (FDCA) extended the FDA’s regulatory authority to medical devices and created a comprehensive regime of detailed federal oversight. In enacting the MDA, Congress sought to ensure that safe and effective medical devices would be readily available to treat patients in need of lifesaving care. To that end, Congress crafted a regulatory framework striking a careful balance between regulation and innovation. According to the Senate Report, the MDA “provide[s] for the safety and effectiveness of medical device[s],” while simultaneously “encourag[ing] the[] research and development” of “sophisticated, critically important” devices.²

   The express preemption provision of the MDA is critical to achieving this dual goal. The provision states:

   “Except as provided in subsection (b) of this section, 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.”

   21 U. S. C. §360k(a).

2. Reigel v. Medtronic
   

   In 2008, the Supreme Court issued its decision in Riegel v. Medtronic, a landmark case addressing the effect of the MDA preemption clause on state-law claims against manufacturers of Premarket Approved (PMA) medical devices.

   The plaintiff in Riegel underwent coronary angioplasty. His right coronary artery was diffusely diseased and heavily calcified, and his doctor used Medtronic’s Evergreen Balloon Catheter in an attempt to dilate it. Plaintiffs alleged that the doctor inflated the catheter to a pressure of 10 atmospheres, at which time it ruptured. The labeling for the catheter expressly stated that use was contraindicated for patients with diffuse or calcified stenosis and warned that the catheter should not be inflated beyond its rated burst pressure of eight atmospheres. Mr. Riegel filed suit against Medtronic, and the district court held that the MDA preempted Mr. Riegel’s state law claims. Plaintiff appealed and the Second Circuit affirmed the district court’s decision. Plaintiff then petitioned for review by the United States Supreme Court.

   In an 8 to 1 decision, the Supreme Court agreed, finding that plaintiffs’ claims were expressly preempted by the MDA because the catheter at issue was a PMA device and Medtronic had complied with all relevant federal requirements. In so holding, the Supreme Court emphasized that PMA devices are rigorously evaluated by the FDA before approval and then must be marketed with “almost no deviations from the specifications in [their] approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness.” Riedel, 128 S. Ct at 1007. The Court also noted that the text of the statute provides strong indication of Congress’s intent to protect patients “who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovation.” Id. at 1009.

3. Remedies Exist for Patients Suffering Device-Related Injuries
   

   MDA express preemption affects only a small subset of medical devices that are approved pursuant to the rigorous PMA process. These devices represent approximately 2% of all devices approved by FDA. Patients who are injured by a PMA device can recover damages from the manufacturer if the device was improperly manufactured.

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