Product Liability Federal Preemption in Class III Medical Device Cases By Donna B. DeVaney and Patrick Hamilton I. Introduction proved devices to be used in human Plaintiffs' attorneys litigating The Medical Device Amendments clinical trials. "The application for an ("MDA"), 21 U.S.C. § 360c et seq., to IDE is itself fairly extensive, and the claims involving Class III the Food, Drug and Cosmetic Act, 21 FDA will not approve an IDE if there U.S.C. § 301 et seq., set forth a compre- is reason to believe the device will be medical devices approved hensive regulatory scheme governing ineffective or present unreasonable safety risks to patients. ''7 the sale of medical devices in the through the PMA process United States. The MDA divides Under the third route, manufactur- ers may obtain approval through the medical devices into three classes. FDA's "premarket approval" or Class devices, such as tongue de- will almost certainly face a pressors and elastic bandages, pose "PMA" process, in which "the manu- little or no risk of illness or injury, and facturer must provide the FDA with motion for summary are "subject only to minimal regula- 'reasonable assurance' that the device is both safe and effective. ''s The PMA tion. ''2 judgment based on express Class II devices, such as powered is a "rigorous" process under which wheelchairs and some pregnancy test "[m]anufacturers must submit detailed and implied preemption. kits, are "potentially more harmful," information regarding the safety and efficacy of their devices, which the and manufacturers of such devices "must comply with federal perfor- FDA then reviews, spending an aver- mance regulations known as 'special pacemakers and breast implants--are age of 1,200 hours on each submission. ''9 "devices that either 'presen[t] a poten- Approval of a Class III medical de- controls. '''3 Finally, the most strictly regulated tial risk of illness or injury,' or which vice through the PMA process often begins with an IDE clinical trial. Near devices--Class III devices, such as are 'purported or represented to be for the end of the clinical trial, the manu- use in supporting or sustaining hu- facturer will submit a PMA applica- man life or for a use which is of sub- tion seeking FDA approval to sell the Donna B. DeVaney is a stantial importance in preventing device in the United States. Applica- shareholder with Carlton impairment of human health. '''4 Fields, P.A. in Tampa, Before a manufacturer can market a tions include a summary of the device's safety and effectiveness, in- Fla. Her practice focuses Class III device, it must obtain ap- cluding contraindications, warnings, on representation of proval from the FDA. There are three pharmaceutical and distinct routes to obtain approval. Un- and precautions; detailed device de- scription and manufacturing informa- medical device manufac- der the first route, devices can be sold turers in products liabil- if they are cleared under the so-called tion; performance standards; technical ity cases pending in both 510(k) process, 21 U.S.C. § 360(k), manuals; and package inserts and la- state and federal courts throughout Florida bels. The manufacturer will also pro- which allows manufacturers to sell devices that are "substantially equiva- vide the FDA with information about and the Southeast. Patrick A. Hamilton lent" to a device that pre-dates the the design of its device and its compo- is Of CounseI with nents, including specifications for the MDA. The 510(k) process merely es- Shook, Hardy & Ba- tablishes whether a pre-1976 device various materials used to manufacture and a post-1976 device are equivalent, con L.L.P in Kansas the device. City, Mo. His practice The device may then be reviewed by and places no "requirements" on the focuses on the repre- a panel of non-governmental experts device, sentation of medical such as the Orthopedic and Rehabilita- Under the second route, devices device manufacturers tion Devices Panel ("Panel"), a group representing new technology may be in products liability designated to review and provide the marketed under an investigational claims in state and federal courts across device exemption CIDE"), an experi- FDA with recommendations on PMA the United States. applications for orthopedic devices. mental regimen that allows for unap- Journal of the Kansas Trial Lawyers Association 9
The Panel determines whether the must give way to federal law when matter included in a requirement appli- data submitted by the manufacturer Congress intends a preemptive re- cable to the device under this [Act] .15 meets the safety and effectiveness sult. •2 Congress evidences its intent to criteria required by the FDA and, if so, preempt state law either through ex- Express Preemption A. recommends approval of the manu- press statutory language or by creat- The United States Supreme Court's facturer's PMA application. The FDA ing a federal statutory scheme that decision in Medtronic, Inc. v. Lohr reviews the Panel's suggestions and implies a preemptive intent. 13 (Lohr) provides the framework for often asks that additional information When Congress enacted the MDA preemption analysis under Section be provided to determine whether and gave the FDA the authority to 360k(a). •6 In Lohr, the Supreme Court there is "reasonable assurance that the regulate medical devices, it sought to addressed whether the MDA ex- device is safe and effective for its in- pressly preempted state tort claims protect innovations in device technol- tended use. "1° ogy from being "stifled by unneces- involving a Class III medical device Upon FDA approval of a PMA ap- sary restrictions. "14 To accomplish that approved through the 510(k) process. plication, the medical device can be goal, Congress included in the MDA The Lohr court read section 360k(a) to sold in the United States. Device the following provision, which ex- demand three things: (1) the imposi- pressly preempts certain state law tion of a specific federal requirement manufacturers must then manufacture and market devices in conformity with requirements governing medical de- that (2) applied to a particular device the design, manufacturing and label- and (3) focused on the safety and ef- vices: ing requirements the FDA established. fectiveness of the device. 17 If those They are prohibited from deviating [N]o State or political subdivision of a criteria are satisfied, states are prohib- from these processes in any way that State may establish or continue in effect ited from having "requirements" that would affect the safety or effectiveness with respect to a device intended for are different from or in addition to the of the device. I• human use any requirement-- FDA's requirements regulating the device. Federal Preemption II. (1) which is different from, or in ad- In a fractured opinion (4-4-1), the The affirmative defense of federal dition to, any requirement applicable Lohr court held that section 360k(a) did preemption is a product of our under this [Act] to the device, and not preempt state tort claims involv- nation's dual federal-state system. ing Class III medical devices approved Under the Supremacy Clause of the (2) which relates to the safety or effec- through the 510(k) process because the United States Constitution, state law tiveness of the device or to any other FDA's review of a 510(k) application MONEY Financing that • •,•i}• needs. •:• Increase your cash flow forTR AL expenses! • Develop new cases • Improve working capital ADVANCES •,• Fund operating & expansion needs on your g ES! Reliable financial backing can determine the fate of your case. 3055 112'hAve North East Suite 20 Bellevue,Washington 98004 425-828-415 FAX: 425-828-4161 10 Journal of the Kansas Trial Lawyers Association
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