FDA Regulated Devices From the Beginning
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
Safety Only As Regards Direct Hazard
No Consideration of Danger of Improper Treatment
Post-WW II Expansion of Technology
Necessary For ICU and Specialty Surgery
An Integral Part of Modern Medicine
High Risk Devices
Subject to Catastrophic Failure
Also Bribery Issues
Marginally Competent Personnel
Congress Decides to Regulate Devices
MDA of 1976
Medical Device Amendments of 1976
Shifted from Post-Market to Pre-Market
Established Risk Classes
Class I - Low Risk
Class II - Moderate Risk
Class III - High Risk
Grand-fathered in pre-existing Devices
"Substantially equivalent" to a pre-1976 Device
Only gets GMP Review
FDA Was To Evaluate Existing Devices
No Political Support
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.
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
(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.
State Consumer Fraud
State Regulation of Professions
MA set standards for disclosure and marketing of hearing aids
These were challanged as additional requirements under 360k
Court Struck them
MA would need to ask for an exemption under the statutory process
Cipollone v. Liggett Group
Tobacco Labeling Act (1967?)
Required Standard Labels
Said State Could Impose No Other Requirements
Lawyers Knew This Was Preemption Language
Court Found State Tort Claims are Requirements, Thus Are Preempted
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?
Politics of Preemption
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
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?
What are the types of preemption?
Which type is at issue here?
Did the court find that plaintiff's claims were preempted?
What was Justice Breyer's Approach?
Would he have reached a different result in this case?
What did he leave open?
What questions does Medtronic leave open?
What might you counsel a client?
Based on the notes, is the court hostile to preemption?
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?
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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