Medical Device Law

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Medical Device Law

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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

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Safety, Not Efficacy

• No Regulation of Efficacy
• Safety Only As Regards Direct Hazard
• No Consideration of Danger of Improper Treatment

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Congressional Hearings

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

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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

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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

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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

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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.

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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

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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.

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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

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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

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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?

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Politics of Preemption under the MDA

• When did this become an issue?
• Who was FDA Commissioner?
• Who was President?
• Who were the Presidents Major Supporters?
• What was the FDAs Position on Preemption?
• Why Did Justice OConnor Say We Should not Care
  What the FDA Thinks?

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Medtronic v. Lohr

• What is the device?
• What Class is it?
• How was it approved?
• Does this mean no review at all?
• What are Plaintiffs Claims?

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Type of Preemption?

• What are the types of preemption?
• Which type is at issue here?
• Did the court find that plaintiffs claims were
  preempted?
• Why?

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Justice Breyer

• What was Justice Breyers Approach?
• Would he have reached a different result in this
  case?
• What did he leave open?

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Post Medtronic

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

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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 plaintiffs claims?

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Private Enforcement

• What laws do allow private enforcement?
• Why does the government use these?
• Why not use this for the FDA?
• What was the courts ruling?
• How was the analysis similar to an explicit
  preemption analysis?