Not OT: Watch out, Preemption goes before US Supreme Court

[Guest guest]

" Preemption " means that if the FDA approves it, it must be fine,

regardless of the evidence. If preemption goes into law, consumer

death and injury cases against drug and medical device manufacturers

and food producers could be automatically thrown out by courts.

ALLIANCE FOR HUMAN RESEARCH PROTECTION

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org and http://ahrp.blogspot.com

FYI

The case argued before the Supreme Court on Tuesday, Riegel v.

Medtronic

Inc., pits the very foundation of consumer justice vis a vis large

corporations.

At stake is whether consumers--who are harmed by defective drugs and

devices

that got through the premarketing FDA approval process--have a right

to seek

redress through litigation.

The doctrine of preemption put forth by Troy, (then) chief

counsel of

the FDA, argues that manufacturers whose products gained FDA

marketing

approval are immune from product liability lawsuits. They are immune

solely

because the FDA had given the government license for marketing. Troy

argued

that FDA's license preempts any state statute requiring greater

safety

standards. The doctrine of preemption prevents consumers from

seeking legal

redress for serious injury from defective products licensed by the

FDA--even

if such products were subsequently discovered to cause serious harm--

even

death.

Troy's argument, set forth in 2004, reversed the government's long-

held

position against the preemption doctrine. Since then, the Bush

Administration began to take the manufacturers' side, as it did

before the

Supreme Court on Tuesday.

In the case before the Supreme Court, a deputy solicitor general,

Edwin S.

Kneedler, explained the change in government policy, stating that in

2004,

the F.D.A. " recognized that there would be a serious undermining of

F.D.A.'s

approval authority and its balancing of the risks and benefits if a

state

jury could reweigh those. "

A question in this case, Riegel v. Medtronic Inc., No. 06-179, is

whether

the court will give the government's position the usual deference it

accords

an agency's interpretation of its basic statute.

Greenhouse of The New York Times reports that the arguments

heard

before the Supreme Court on Tuesday, leave the issue in doubt.

Contact: Vera Hassner Sharav

veracare@...

212-595-8974

http://www.nytimes.com/2007/12/05/washington/05bizcourt.html?

ref=health

THE NEW YORK TIMES

Supreme Court Hears Medical Device Case

By LINDA GREENHOUSE December 5, 2007

WASHINGTON Dec. 4 - Whether a federal statute pre-empts state law is

a

familiar issue at the Supreme Court, one the justices will face

multiple

times during the current term alone.

But during an argument on Tuesday, none of the court's many

precedents

appeared to offer a clear path to answering the question in the

latest case:

whether the manufacturer of a medical device approved for sale by

the Food

and Drug Administration can be sued for damages under state law if

the

device injures a patient.

The device at issue was a balloon catheter that burst during an

angioplasty,

causing serious injury to the patient, R. Riegel. He and his

wife,

Donna, sued the manufacturer, Medtronic, which had received approval

to

market the device in 1994, two years before the incident. Two lower

federal

courts in New York dismissed the suit on the ground that the F.D.A.'s

" premarket approval " precluded the imposition of liability under

state law.

The Supreme Court last looked at a medical device case in 1996, when

it

ruled that devices approved by the F.D.A. under a different, more

expedited

process were not shielded from state liability. At that time, the

federal

government itself argued against pre-emption.

But in 2004, the Bush administration reversed the government's

position and

began to take the manufacturers' side, as it did before the justices

on

Tuesday in an argument by a deputy solicitor general, Edwin S.

Kneedler.

Explaining the change in policy, Mr. Kneedler said that in 2004, the

F.D.A.

" recognized that there would be a serious undermining of F.D.A.'s

approval

authority and its balancing of the risks and benefits if a state

jury could

reweigh those. "

A question in this case, Riegel v. Medtronic Inc., No. 06-179, is

whether

the court will give the government's position the usual deference it

accords

an agency's interpretation of its basic statute.

The federal law at issue is the Medical Device Amendments of 1976,

which in

its section on pre-emption bars states from imposing on medical

devices " any

requirement which is different from, or in addition to, any

requirement

applicable under this chapter. "

Beginning with a case in 1992 about warning labels on cigarette

cartons, the

Supreme Court has treated the word " requirement " as including not

only

obligations directly imposed by state laws and regulations, but also

the

award of damages by state tort systems.

For a jury to say, " Well, gee, it should have been done differently

in this

particular situation " is the equivalent of imposing a requirement in

addition to federal approval, Theodore B. Olson, the lawyer

representing

Medtronic, told the justices.

" The F.D.A. is the right place for these decisions to be made and

this

balancing process to occur, " Mr. Olson said, adding that

while " nothing is

perfectly safe, " it would harm consumers to " discourage the

marketing of

products that might save our lives. " Medtronic no longer makes the

balloon

catheter, called Evergreen, involved in the case.

While Mr. Olson's argument clearly found traction with some

justices, most

notably Justice Antonin Scalia, the lawyer for the plaintiffs,

M.

Zieve, was also effective in sowing doubts that " premarket approval "

by the

agency was rigorous enough to justify shielding the manufacturer

from state

liability.

Ms. Zieve, a lawyer with the Public Citizen Litigation Group,

conceded that

the law would prevent a state from imposing its own premarket

approval

process that differs from the federal one. But she said that

premarket

approval was a preliminary judgment of safety and effectiveness that

did not

relieve a manufacturer of an obligation to make a device better and

safer.

Premarket approval was not " irrelevant to the tort suit " but was not

by

itself adequate to invoke pre-emption, Ms. Zieve said.

Several justices, including M. Kennedy, H. Souter and

s, expressed concern about shielding manufacturers during

a

regulatory " hiatus, " after a manufacturer had discovered a problem

with an

approved device but before the F.D.A. had learned of it or taken

action.

" There could be a newly discovered risk that the F.D.A. never knew

about

and, nevertheless, the claim would be pre-empted? " Justice s

asked Mr.

Olson. " Yes, and that's a judgment that Congress made, " the

company's lawyer

replied.

Copyright 2007 The New York Times Company

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