Medical Device Law
FDA
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FDA Regulated Devices From the
Beginning
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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
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No Regulation of Efficacy
Safety Only As Regards Direct Hazard
No Consideration of Danger of Improper
Treatment
Congressional Hearings
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Early 1970s
Post-WW II Expansion of Technology
Necessary For ICU and Specialty
Surgery
An Integral Part of Modern Medicine
High Risk Devices
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Pacemakers
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Subject to Catastrophic Failure
Also Bribery Issues
Anesthesia Machines
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Marginally Competent Personnel
The O-Ring
Congress Decides to Regulate Devices
MDA of 1976
Medical Device Amendments
of 1976
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Shifted from Post-Market to Pre-Market
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PMA
Like Drugs
Established Risk Classes
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Class I - Low Risk
Class II - Moderate Risk
Class III - High Risk
Existing Devices
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Grand-fathered in pre-existing Devices
510(k)
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“Substantially equivalent” to a pre-1976 Device
Only gets GMP Review
FDA Was To Evaluate Existing Devices
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No Money
No Political Support
360k(a)
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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.
Exempt requirements
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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—
Exemption Requirements
Continued
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(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.
Exemption Cases
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State Consumer Fraud
State Regulation of Professions
Hearing Aids
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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
Cipollone v. Liggett Group
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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
Preemption v. Regulatory
Compliance
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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?
Politics of Preemption under the
MDA
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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?
Medtronic v. Lohr
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What is the device?
What Class is it?
How was it approved?
Does this mean no review at all?
What are Plaintiff’s Claims?
Type of Preemption?
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What are the types of preemption?
Which type is at issue here?
Did the court find that plaintiff’s claims
were preempted?
Why?
Justice Breyer
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What was Justice Breyer’s Approach?
Would he have reached a different
result in this case?
What did he leave open?
Post Medtronic
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What questions does Medtronic leave
open?
What might you counsel a client?
Based on the notes, is the court hostile
to preemption?
Buckman
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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?
Private Enforcement
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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?