Is the preemption defense for PMA-approved medical devices in jeopardy?

• Author: Margarce, Joyce B.
• Position: Premarket approval

MOST jurisdictions have held that [section] 360k(a) of the Medical Device Amendments preempts conflicting state common-law claims arising from the design, manufacture, and labeling of a medical device that received pre-market approval. (1) However, the preemption defense may be in further jeopardy. Pending before the United States Supreme Court, and argued on December 4, 2007, is a challenge of the Second Circuit's holding in Riegel v. Medtronic, Inc. (2) The Supreme Court has taken up the following issue:

Does the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. [section] 360k(a), preempt state law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration? (3) Background

On May 10, 1996, Charles Riegel underwent an angioplasty, during which his surgeon attempted to dilate Mr. Riegel's right coronary artery. (4) During the angioplasty, Mr. Riegel's right coronary artery was found to be "diffusely diseased" and "heavily calcified." (5) After his surgeon attempted to remove the calcium deposits and unsuccessfully inserted several balloon catheters, the surgeon was finally able to successfully insert the Evergreen Balloon Catheter. (6) During the final inflation, the Evergreen Balloon Catheter burst. Mr. Riegel lost consciousness, was intubated, and placed on advanced life support. He was immediately taken to have an emergency coronary bypass surgery. Mr. Riegel survived the procedure.

In 1999, Mr. Riegel and his wife filed suit against Medtronic, Inc., the manufacturer of the Evergreen Balloon Catheter, in the Northern District of New York alleging five state common-law causes of action: (1) negligence in the design, testing, inspection, manufacture, distribution, labeling, marketing, and sale of the Evergreen Balloon Catheter; (2) strict liability; (3) breach of express warranty; (4) breach of implied warranty; and (5) loss of consortium. (7)

Medtronic moved for summary judgment based on the affirmative defense of federal preemption pursuant to 21 U.S.C. [section] 360k(a). The FDA approved Medtronic's premarket approval ("PMA") application for the Evergreen Balloon Catheter on August 30, 1994. It subsequently approved two PMA supplements on April 27, 1995 and April 18, 1996, which requested approval for revised labeling of the catheter. Because of this PMA approval, on March 14, 2002, the district court ruled that all of the Riegels' negligence claims (except for the negligent manufacturing claim), the strict liability claim, and breach of implied warranty claim were preempted. Subsequently, Medtronic moved for summary judgment on other grounds on the two remaining claims, negligent manufacturing and breach of express warranty. The district court dismissed both of these claims because they were without factual basis. The Riegels appealed to the Second Circuit challenging both summary judgment rulings; however, they did not challenge the summary judgment dismissal of their breach of express warranty claim. (8)

The Second Circuit Court of Appeals' Decision

The Second Circuit Court of Appeals began its analysis with a discussion of the regulatory structure. In 1976, Congress enacted the Medical Device Amendments ("MDA") which established a regulatory structure to regulate medical devices. (9) The MDA divides medical devices into three classes, depending on the level of risk that the medical device poses. The strictest FDA regulation is reserved for Class III devices, defined as those which (1) are to be used for supporting or sustaining human life or that are of substantial importance in preventing impairment of public health; or (2) present a potential unreasonable risk of illness injury. (10)

Because the Class III device poses the greatest risk, it must undergo premarket approval ("PMA") prior to making the device to provide "reasonable assurance of its safety and effectiveness." (11) The PMA process is lengthy and rigorous. The manufacturer must submit a detailed PMA application that includes, "full reports of all investigations of the safety and effectiveness of the device; a full statement of the components, ingredients, properties, and principles of operation of the device; a full description of the methods used in manufacture and processing of the device; information about performance standards of the device; samples of the device; specimens of the proposed labeling for the device; and any other relevant information." (12) The FDA spends an average of 1,200 hours on each PMA submission. (13) After the application is filed, the FDA has authority to approve, deny, or request modification. (14) As a condition of PMA approval, the FDA may impose other requirements on manufacturers.(15) Once the PMA is approved, the manufacturer must comply with the standards in the PMA approval order. (16) A PMA supplement must be submitted for approval for any changes that the manufacturer believes may affect the safety or effectiveness of the device. (17) Continued approval of the PMA requires the manufacturer to submit detailed post approval reports annually. (18) A manufacturer must also timely submit an "Adverse Reaction Report" or "Device Defect Reporting." (19)

The Court noted, however, that the majority of Class III devices do not go through the PMA process. Instead, devices that are "substantially equivalent" to medical devices in existence prior to 1976 can be marketed and sold without PMA approval. (20) This is known as premarket notification or "[section] 510(k)" process. (21) According to the United States Supreme Court in Lohr, the [section] 510(k) process is, "by no means comparable to the PMA process." (22) "Unlike the PMA process which requires reasonable assurance that the new device is itself safe and effective, and ultimately results in the FDA's 'approval' of the device, the [section] 510(k) process simply requires a manufacturer to show that the device is substantially equivalent ... to a legally marketed device that did not go through the PMA process." (23) A [section] 510(k) device is not considered to be FDA approved. (24) Although the PMA process is estimated to take the FDA 1,200 hours to complete, the [section] 510(k) process is completed in an average of 20 hours. (25) Moreover, a [section] 510(k) device only needs a supplemental submission filed if the device "is about to be significantly changed or modified in design, components, method of manufacturer, or intended use." (26)

The express preemption provision applies to devices that enter the market through both the PMA and [section] 510(k) processes: (27)

[N]o State or political subdivision of the 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 related to the safety and effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. (28)

The Second Circuit Court of Appeals next reviewed the U.S. Supreme Court decision in Medtronic, Inc. v. Lohr. In that case, the Lohrs filed suit seeking damages from an allegedly defective Class III [section] 510(k) cleared pacemaker. (29) The Lohr Court held that none of the Lohrs' claims based on defective design, defective manufacture and failure to warn were preempted by the MDA. (30)

The Riegel Court interpreted Lohr as providing a two step analysis for determining whether a claim is preempted by the MDA. "First, on the federal side of the analysis, courts must consider whether there are any device-specific federal requirements with respect to the device at hand. If so, courts must then turn to the state side to determine whether there would be a conflict between that device-specific federal requirement and any of the liability-creating premises of the plaintiffs' state law tort suit." (31) The Court noted that the majority of circuits have applied this two step analysis and concluded that common-law tort actions as to PMA-approved devices are preempted by the MDA. The Court noted that only the Eleventh Circuit has held the opposite and found that the PMA process does not constitute a federal device-specific requirement and therefore, claims are not preempted. (32)

The Court applied its own two step process for determining if the Riegels' claims are preempted and issued a 2-1 opinion. It first analyzed whether the Evergreen Balloon Catheter is subject to federal device-specific requirements. The Court compared the [section] 510(k) process with the PMA process. First, clearance through the [section] 510(k) process does not equate to a review of the device's safety and effectiveness; in contrast, the PMA process requires reasonable assurance of a device's safety and effectiveness. (33) Second, a [section] 510(k) clearance does not signify that the device has been approved by the FDA; however, PMA clearance does signify FDA approval. Third, the PMA process is a different process, created for devices that were not substantially equivalent to other devices. Finally, the PMA process provides the FDA with the ability to require the device to take a particular form in order to be approved. Also, after a device has received PMA approval, the manufacturer must obtain further FDA approval for any changes that would affect the safety and effectiveness of the device. After considering these differences, the Court concluded that the Evergreen Balloon Catheter was subject to the federal device specific requirements set forth in its PMA application. (34)

The Court rejected the Riegels' position that their failure to warn claim is not subject to a federal device-specific requirement. The Riegels argued that the only federal regulation governing the substance of the catheter's label was the same provision that was at issue in Lohr, which the...