Biotech Torts - Winter 2002

Medical Device Law

FDA

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

Congressional Hearings

Early 1970s

Post-WW II Expansion of Technology

Necessary For ICU and Specialty Surgery

An Integral Part of Modern Medicine

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

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

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

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.

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-

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.

Exemption Cases

State Consumer Fraud

State Regulation of Professions

Hearing Aids

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?

Why?

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?

Why?

Justice Breyer

What was Justice Breyer's Approach?

Would he have reached a different result in this case?

What did he leave open?

Post Medtronic

What questions does Medtronic leave open?

What might you counsel a client?

Based on the notes, is the court hostile to preemption?

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?

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?