How Medtronic v. Lohr has redefined medical device regulation and litigation.

• Author: Tumidolsky, Rachel

State law tort claims will no longer be preempted by the Medical Devices Amendments, and manufacturers now are faced with state product liability

MEDICAL devices have improved the lives of millions of people, as the medical device industry has grown tremendously during this century. Approximately 11 million people are implanted with medical devices.(1) The Food and Drug Administration, through power granted by Congress in the Food, Drug and Cosmetic Act, has been given the task of ensuring that medical devices are safe for consumers. In the past, if a medical device manufacturer showed compliance with the FDA regulations, the manufacturer could argue successfully that an injured plaintiff's claims were preempted by federal law.

But now, thanks to the U.S. Supreme Court's 1996 decision in Medtronic Inc. v. Lohr,(2) injured consumers have expanded power to bring suits against manufacturers for damages rooted in common law tradition and to fight the preemption defense. Not only is this new threat of liability a benefit to individuals injured by medical devices, but medical device manufacturers now have a greater incentive to produce products that are safer and of higher quality.

Since the FDA began exercising its regulatory power two decades ago, it has not escaped criticism of its methods for approving medical devices. Given the recent attention to medical devices in the wake of Medtronic, it is prime time to re-examine the FDA's role and duty to ensure public safety in this field. Equally important, the role of the FDA in writing regulations intended to guide manufacturers producing devices, as well as the ability of those regulations to allow preemption of such claims, need to be examined.

MEDICAL DEVICE AMENDMENTS

Prior to the 1976 Medical Device Amendment, the FDA did not regulate medical devices until after market distribution.(3) The statutory definition of "medical device" is comprehensive. Essentially, any item promote, d for a medical purpose that does not rely on chemical action to achieve its intended effect is considered to be a medical device. 21 U.S.C. [sections] 321(h). This broad definition gives the FDA jurisdiction over a wide variety of products, from chewing gum that contains an abrasive food additive for its anti-plaque properties, to software that analyzes the output of a cardiac monitor.(4)

Spurred by the increased technological complexity of devices and mounting disclosures of shortcomings involving pacemakers, intrauterine devices and intraocular lenses, Congress responded by enacting the MDA to, in the words of the statute's preamble, "provide for the safety and effectiveness of medical devices intended for human use." The MDA embraced a balanced and comprehensive regulatory scheme intended to (1) assure public protection against unsafe and ineffective devices, (2) ensure that health practitioners could be confident about the medical equipment they prescribed for their patients, and (3) provide market protection for pioneers of new medical technologies.(5)

Congress faced a daunting challenge of filling the legislative void, especially given the tremendous variety of medical devices. Some, such as bedpans, present minor and obvious risks and need not require premarket approval. On the other hand, implanted devices, such as pacemakers, present enormous potential risks.(6) To meet the challenges and provide the FDA with enough flexibility to regulate appropriately, Congress created a three-class system for categorizing medical devices.

Class I devices are subject to only minimal regulation by "general controls," which include actions related to adulteration, misbranding, banning, premarket notification, reporting, registration, restrictions on sale or distribution, record keeping, labeling, reporting of adverse experiences, and good manufacturing practices (GMPs). GMPs cover quality control, personnel training, inspection, distribution and numerous other aspects of the manufacturing process. Failure to comply with these regulations, which also apply to devices in Classes II and III, renders a device "adulterated" and subjects the device, as well as the responsible person, to regulatory action.(7)

Class II devices can require that performance standards be met because Class I controls alone are not adequate and because there is sufficient information available about the device for the FDA to develop a mandatory standard.(8) Tampons, for example, are a Class II device.

Class III devices require premarket approval (PMA) because Class I controls are not adequate and the Class II standards cannot be met because insufficient information exists to promulgate a standard for the particular device. Class III devices, for instance, include silicone gel-filled breast implants, most pacemakers and their component parts, penile implants, and most other prosthetic and implantable devices. Each manufacturer of a Class III device must secure a PMA in order to sell the device. In effect, the premarket approval process grants individuals a license to manufacture an individual device.(9) PMA requires manufacturers to demonstrate the safety and effectiveness of the device to the FDA's satisfaction. It also ensures that devices with the greatest potential risk are not marketed until their safety and effectiveness have been satisfactorily demonstrated through lab or clinical testing. Preamendment devices are assigned to the least regulated class that is sufficient to provide reasonable assurance of safety and effectiveness.(10)

Some devices are marketed under an investigational device exemption (IDE), which is an FDA-approved experiment that allows an unapproved device to be used in human beings in order to collect data. The manufacturer is exempted from typical premarket approval obligations and other MDA demands during the term of the IDE.(11)

Congress realized that medical devices in existence at the time the MDA was enacted could not be withdrawn or recalled from the market while the FDA completed PMA analysis for each of those devices, because the devices were in use. Had the FDA suspended devices already on the market, it would have been faced with a huge backlog of devices awaiting approval--both new devices and those already on the market. It instead directed the FDA to develop an inventory of devices being sold, to place the devices into one of the three classes, and eventually to regulate the devices. Congress could have "grandfathered" devices already on the market, but it chose not to do so.(12) Instead, it established a provision permitting devices that are "substantially equivalent" to pre-existing devices to avoid the PMA process.(13)

The term "substantial equivalence" is not defined. Congress apparently intended it to accommodate changes in a device that do not affect its safety.(14)

The PMA process, called the "510(k) mechanism" or "premarket notification," was meant to be a short-term solution. Congress...