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Medical Device Law

Medical Device Law. FDA. FDA Regulated Devices From the Beginning Hubbard Electrometer Cases Magnetic Healing Cases Original Law Required Proof of Harm Post-Market, not Pre-Market Could Tie the FDA Up in Court for Years. Safety, Not Efficacy. No Regulation of Efficacy

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Medical Device Law

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  1. Medical Device Law

  2. FDA • FDA Regulated Devices From the Beginning • Hubbard Electrometer Cases • Magnetic Healing Cases • Original Law Required Proof of Harm • Post-Market, not Pre-Market • Could Tie the FDA Up in Court for Years

  3. Safety, Not Efficacy • No Regulation of Efficacy • Safety Only As Regards Direct Hazard • No Consideration of Danger of Improper Treatment

  4. Congressional Hearings • Early 1970s • Post-WW II Expansion of Technology • Necessary For ICU and Specialty Surgery • An Integral Part of Modern Medicine

  5. High Risk Devices • Pacemakers • Subject to Catastrophic Failure • Also Bribery Issues • Anesthesia Machines • Marginally Competent Personnel • The O-Ring • Congress Decides to Regulate Devices • MDA of 1976

  6. Medical Device Amendments of 1976 • Shifted from Post-Market to Pre-Market • PMA • Like Drugs • Established Risk Classes • Class I - Low Risk • Class II - Moderate Risk • Class III - High Risk

  7. Existing Devices • Grand-fathered in pre-existing Devices • 510(k) • “Substantially equivalent” to a pre-1976 Device • Only gets GMP Review • FDA Was To Evaluate Existing Devices • No Money • No Political Support

  8. 360k(a) • Except as provided in subsection (b) of this section, no State or political subdivision of a State 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 chapter 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 chapter.

  9. Exempt requirements • Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a) of this section, under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if—

  10. Exemption Requirements Continued • (1) the requirement is more stringent than a requirement under this chapter which would be applicable to the device if an exemption were not in effect under this subsection; or(2) the requirement--(A) is required by compelling local conditions, and(B) compliance with the requirement would not cause the device to be in violation of any applicable requirement under this chapter.

  11. Exemption Cases • State Consumer Fraud • State Regulation of Professions • Hearing Aids • MA set standards for disclosure and marketing of hearing aids • These were challenged as additional requirements under 360k • Court Struck them • MA would need to ask for an exemption under the statutory process

  12. Cipollone v. Liggett Group • Tobacco Labeling Act (1967?) • Required Standard Labels • Said State Could Impose No Other Labeling Requirements • Lawyers Knew This Was Preemption Language • Court Found State Tort Claims Related to Warnings are Requirements that Would Effect Labeling, Thus Are Preempted

  13. Preemption v. Regulatory Compliance • Are they the same? • What are the procedural issues? • Why does state v. federal court matter? • Which would you prefer to have if you are a defense lawyer? • Why?

  14. Politics of Preemption under the MDA • When did this become an issue? • Who was FDA Commissioner? • Who was President? • Who were the President’s Major Supporters? • What was the FDA’s Position on Preemption? • Why Did Justice O’Connor Say We Should not Care What the FDA Thinks?

  15. Medtronic v. Lohr • What is the device? • What Class is it? • How was it approved? • Does this mean no review at all? • What are Plaintiff’s Claims?

  16. Type of Preemption? • What are the types of preemption? • Which type is at issue here? • Did the court find that plaintiff’s claims were preempted? • Why?

  17. Justice Breyer • What was Justice Breyer’s Approach? • Would he have reached a different result in this case? • What did he leave open?

  18. Post Medtronic • What questions does Medtronic leave open? • What might you counsel a client? • Based on the notes, is the court hostile to preemption?

  19. Buckman • What is the device? • Was it approved the first time? • What did the manufacturer do to get it approved? • What was the approved use? • How was it really used? • How did this lead to plaintiff’s claims?

  20. Private Enforcement • What laws do allow private enforcement? • Why does the government use these? • Why not use this for the FDA? • What was the court’s ruling? • How was the analysis similar to an explicit preemption analysis?

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