State lawsuits may proceed against medical device manufacturers.

• Author: Gerberry, Robert A.
• Position: Case Note

1. INTRODUCTION II. MEDICAL DEVICE AMENDMENTS III. PREEMPTION IV. FACTS OF LOHR

   1. District Court

   2. Eleventh Circuit Court of Appeals

   3. Supreme Court

   1. Negligent Design Claims Under Section 510(k)

   2. "Requirement" Under Section 360k(a)

   3. Breyer's Concurrence

   4. Dissent V. LOHR'S IMPACT ON THE MEDICAL DEVICE INDUSTRY VI. CONCLUSION

   Premarket approval is supposed to benefit consumers, not create a rose

   garden, free from liability, for manufacturers.(1)

1. INTRODUCTION

   After laying her daughter down to sleep, Lora Lohr began to feel as if she was losing consciousness. When Lohr, a cardiac technician, reached for her pulse she found none. At the hospital, her physician discovered that she was suffering from complete heart block.(2) The wire in her pacemaker had failed to deliver the necessary impulses to her heart.(3) As Lohr stated "the device that was supposed to keep me alive almost killed me."(4) After three years of painful surgeries and complications, Lohr sued the pacemaker's manufacturer, Medtronic, for the cost of her medical treatment.(5) Medtronic refused to pay these claims and Lohr filed a tort liability suit in the State of Florida.(6)

   After the United States Supreme Court's landmark decision in Cipollone v. Liggett Group Inc.,(7) medical device manufacturers have successfully asserted federal preemption as a defense against state product liability suits. Many federal courts have upheld this defense in common law actions brought against medical device manufacturers.(8) Although these courts agree about the existence of the preemption defense, they have disagreed about its scope.(9) In Medtronic v. Lohr, the Supreme Court attempted to resolve this dispute by defining the scope of the preemption defense applicable under the Medical Device Amendments.(10) In fashioning its decision, the Court balanced the need to protect public health against the desire to encourage medical innovation.

   This comment discusses the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Act and its effect on the marketing of medical products. Part II examines the statutory language of the MDA and its regulatory impact on medical devices. Part III explores the history of the preemption doctrine established by the Supreme Court in Cipollone. Part IV delineates the facts and procedural history of Medtronic v. Lohr and analyzes the effect of this case on the federal preemption of state common law suits. Finally, Part V assesses the impact of this decision on the medical device industry and the expansiveness of the preemption doctrine.

2. MEDICAL DEVICE AMENDMENTS

   The Medical Device Amendments (MDA) of the Federal Food, Drug and Cosmetic Act of 1976 govern the regulation of medical devices.(11) Congress enacted the MDA "to provide for the safety and effectiveness of medical devices intended for human use. . . ."(12) Prior to these amendments, the FDA lacked the ability to review the safety of medical devices before their entry into the market.(13) In the early 1970s, an intrauterine device (IUD) called the Dalkon shield caused thousands of women to suffer toxic shock, infertility, and pelvic infections due to a design defect.(14) However, by the time the Federal Drug Administration (FDA) became aware of these injuries, these devices had already inflicted permanent physical damage.(15) To correct this system, Congress enacted the MDA to protect consumers before these dangerous products reached the market.(16)

   The MDA classifies medical devices into three different categories based upon the level of regulation or control necessary to provide a reasonable assurance of safety to society. Every medical device is subject to general controls that require reporting and record keeping procedures and establish adequate labeling standards.(17) Class I devices pose little or no threat to public health or safety and are subject to only general controls.(18) Class II devices are subject to general and special controls.(19) Special controls include performance standards, postmarket surveillance, patient registries and other guidelines.(20) The MDA subjects Class III devices to special scrutiny because, although they aim to support or sustain human life, Class III devices exist within the human body and present an "unreasonable risk of illness or injury" if not properly regulated.(21)

   A medical device manufacturer may introduce its product to the market under three different procedures stipulated by the FDA: 1) premarket approval (PMA); 2) premarket notification; or 3) the investigational device exemption. Generally, before a new Class III device can be placed on the market, it must meet premarket approval standards.(22) The manufacturer must prove the safety and efficacy of the device to the FDA before receiving approval to market the product.(23) Under the premarket notification exemption, devices which were on market before May 28, 1976 need not meet general PMA requirements.(24) If a device is labeled "substantially equivalent," a limited form of review exists whereby a manufacturer must submit an application for premarket notification as specified in section 510(k) of the MDA.(25) Premarket notification procedures require a manufacturer to submit an application at least ninety days prior to introducing a device to the market.(26) The FDA then makes a determination of whether the device qualifies as "substantially equivalent."(27) Eighty to ninety percent of medical devices receive approval under the premarket notification standard.(28) In 1990, Congress enacted the Safe Medical Device Act to stiffen the requirements for companies seeking to market their products under the loophole created by section 510(k).(29) The new rules require manufacturers to include a 510(k) statement or 510(k) summary along with garnering Class III certification in order to market a device as "substantially equivalent."(30)

   Many differences exist between the premarket notification process and the PMA procedure. The premarket notification process typically entails twenty hours to complete, while the PMA, process requires 1,200 hours.(31) In addition, the PMA process requires the device to be tested by a panel of experts for safety and effectiveness.(32) In contrast, the premarket notification demands only raw data to support the assertion that the device is "substantially equivalent" to a device which existed prior to 1976.(33) This shortcut permits a device to be marketed without ever being reviewed or approved by the FDA. This loophole allows a medical device manufacturer to secure the preemptive powers of the MDA without ever being subjected to the regulatory controls established by this law

   Under the investigational device exemption, a manufacturer allows physicians to test medical devices in clinical trials before introducing these products to the market. The FDA classifies these products under the investigational device exemption (IDE).(34) The IDE process is designed to encourage innovation in order to develop new medical devices. Recently, the Sixth Circuit, in Martin v. Telectronics Pacing Systems, held that a plaintiff's product liability claims were preempted by the MDA under section 360k(a).(35) Due to the specific rules for products approved under the IDE, the Sixth Circuit held that state claims relating to these devices should be preempted by conflicting federal requirements.(36) To foster the creation of new medical devices, the IDE procedure allows products to be marketed without being subjected to the rigorous PMA process. This encourages innovation, but fails to provide the safeguards pledged in enacting the MDA.

3. PREEMPTION

   The Supremacy Clause of the Constitution provides that the laws of the United States "shall be the Supreme Law of the Land; and the judges in every State shall be bound thereby, anything in the Constitution or Laws of any state to the contrary notwithstanding."(37) The intent behind the preemption doctrine was to provide uniform laws and regulations for individuals and businesses across the country. To avoid conflicting sets of rules, a state law which imposes different standards than a federal law will be preempted. However, the police powers granted to the states under the Constitution will not be preempted absent "the clear and manifest purpose of Congress to do So."(38)

   Prior to the 1980s, few courts allowed the preemption defense to invalidate state product liability Suits.(39) Then, in the landmark case of Cipollone v. Liggett Group, the Supreme Court ruled that a federal law governing advertising on cigarette packages preempted state actions based on claims that manufacturers failed to warn smokers about the danger of this activity.(40) In Cipollone, the son of a deceased smoker challenged the Third Circuit's preemption of his state tort claim. The Federal Cigarette Labeling and Advertising Act of 1965 stated that it would be a violation of this law "to fail to disclose, clearly and prominently, in all advertising and on every pack, box, carton or container [of cigarettes] that cigarette smoking is dangerous to health and may cause death from cancer and other diseases."(41) This act also included an explicit preemption provision.(42) However, this provision "merely prohibited state and federal rulemaking bodies from mandating particular cautionary statements" and did not preempt state law damage actions.(43)

   In 1969, Congress modified the preemption section of the 1965 law. The new section read: "No requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provisions of this Act."(44) By enacting a statutory provision explicitly preempting state law, the Cipollone Court needed to look no further than the express language of the statute to infer preemption.(45) The 1969 Act banned not only "statements relating to smoking, but requirement[s] or...