The 10,000 pound gorilla: federal preemption in class III medical device cases.

• Author: DeVaney, Donna B.

Federal preemption is a powerful defense for device manufacturers in Class III medical device cases. The majority of federal appellate courts around this country have ruled in favor of device manufacturers based on this defense, and they have gone on to dismiss plaintiffs' state law tort claims with prejudice. However, the 11th Circuit sits alone like an island on the subject, having issued an opinion where it found no federal preemption in a Class III medical device case. Because neither the U.S. Supreme Court nor the Florida Supreme Court has issued opinions on the subject, and Florida courts are not bound by decisions out of the 11th Circuit, the defense of federal preemption can still be a powerful tool for the defense in this state. Therefore, it is imperative that defense counsel representing device manufacturers in Florida understand this defense and continue to stay abreast of cases decided not only in Florida, but throughout the country.

Class III Medical Devices

The Medical Device Amendments (MDA), 21 U.S.C. [section] 360c et seq., to the Food, Drug and Cosmetic Act, 21 U.S.C. [section] 301 et seq., set forth a comprehensive regulatory scheme governing the sale of medical devices in the U.S. (1) The MDA divides medical devices into three classes. Class I devices, such as tongue depressors and elastic bandages, pose little or no risk of illness or injury, and are "subject only to minimal regulation." (2) Class II devices, such as powered wheel chairs and some pregnancy test kits, are "potentially more harmful," and manufacturers of such devices "must comply with federal performance regulations known as 'special controls.'" (3) Finally, the most strictly regulated devices--Class III devices, such as pacemakers and breast implants--are "devices that either 'presen[t] a potential risk of illness or injury,' or which are 'purported or represented to be for use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health.'" (4)

Before a manufacturer can market a Class III device, it must obtain approval from the FDA. There are three distinct routes to obtain approval. Under the first route, devices can be sold if they are cleared under the 510(k) process, 21 U.S.C. [section] 360(k), which allows manufacturers to sell devices that are "substantially equivalent" to a device that pre-dates the MDA. The 510(k) process merely establishes whether a pre-1976 device and a post-1976 device are equivalent, and places no "requirements" on the device. (5)

Under the second route, devices representing new technology may be marketed under an investigational device exemption (IDE), an experimental regimen that allows for unapproved devices to be used in human clinical trials. (6) "The application for an IDE is itself fairly extensive, and the FDA will not approve an IDE if there is reason to believe the device will be ineffective or present unreasonable safety risks to patients." (7)

Under the third route, manufacturers may obtain approval through the FDA's "premarket approval" or "PMA" process, in which "the manufacturer must provide the FDA with 'reasonable assurance' that the device is both safe and effective." (8) The PMA is a "rigorous" process under which "[m]anufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission." (9)

Approval of a Class III medical device through the PMA process often begins with an IDE clinical trial. Near the end of the clinical trial, the manufacturer will submit a PMA application seeking FDA approval to sell the device in the U.S. Applications include a summary of the device's safety and effectiveness, including contraindications, warnings, and precautions; detailed device description and manufacturing information; performance standards; technical manuals; and package inserts and labels. The manufacturer will also provide the FDA with information about the design of its device and its components, including specifications for the various materials used to manufacture the device.

The device may then be reviewed by a panel of nongovernmental experts such as the Orthopedic and Rehabilitation Devices Panel, a group designated to review and provide the FDA with recommendations on PMA applications for orthopedic devices. The panel determines whether the data submitted by the manufacturer meets the safety and effectiveness criteria required by the FDA and, if so, recommends approval of the manufacturer's PMA application. The FDA reviews the panel's suggestions and often asks that additional information be provided to determine whether there is "reasonable assurance that the device is safe and effective for its intended use." (10)

Upon FDA approval of a PMA application, the medical device can be sold in the U.S. Device manufacturers must then manufacture and market devices in conformity with the design, manufacturing, and labeling requirements the FDA established. They are prohibited from deviating from these processes in any way that would affect the safety or effectiveness of the device. (11)

Federal Preemption

The affirmative defense of federal preemption is a product of our nation's dual federal-state system. Under the supremacy clause of the U.S. Constitution, state law must give way to federal law when Congress intends a preemptive result. (12) Congress evidences its intent to preempt state law either through express statutory language or by creating a federal statutory scheme that implies a preemptive intent. (13)

When Congress enacted the MDA and gave the FDA the authority to regulate medical devices, it sought to protect innovations in device technology from being "stifled by unnecessary restrictions." (14) To accomplish that goal, Congress included in the MDA the following provision, which expressly preempts certain state law requirements governing medical devices:

[N]o [s]tate or political subdivision of a [s]tate 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 [Act] 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 [Act]. (15) (emphasis added)

Express Preemption

The U.S. Supreme Court's decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), provides the framework for preemption analysis under [section] 360k(a). In Lohr, the Supreme Court addressed whether the MDA expressly preempted state tort claims involving a Class III medical device approved through the 510(k) process. The Lohr court read [section] 360k(a) to demand three things: 1) the imposition of a specific federal requirement that; 2) applied to a particular device; and 3) focused on the safety and effectiveness of the device. (16) If those criteria are satisfied, states are prohibited from having...