Medtronic v. Lohr: state lawsuits may proceed against medical device manufacturers.

I. INTRODUCTION II. MEDICAL DEVICE AMENDMENTS III. PREEMPTION IV. FACTS OF LOHR A. District Court B. Eleventh Circuit Court of Appeals C. 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) I. 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. II. 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. …