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Mon, 24 Apr 2006 19:54:55 -0400

[sSRI-Research] Detroit (MI) Free Press - LOCAL COMMENT:

Michigan liability law a prescription for disaster

 

 

 

 

 

 

http://www.freep.com/

 

Detroit Free Press

 

LOCAL COMMENT: Michigan liability law a prescription for disaster

 

BY HENRY GREENSPAN

April 17, 2006

 

 

Henry Greenspan

 

Last week was a good one for plaintiffs in New Jersey. A jury voted,

first,

that Merck committed knowing and " unconscionable " consumer fraud against

doctors and patients in the marketing of Vioxx. The same jury then found

that Merck " willfully and wantonly " withheld important safety data

from the

Food and Drug Administration. For a drug company, this is bad as it

gets. It

is the first time it has happened under current New Jersey law.

 

So what will be the result? The charge against Merck for withholding

information from the FDA opens the company to criminal felony

prosecution if

the U.S. Justice Department wants to get involved. Given the history

of such

matters, however, the chances of that are almost zero.

 

My own review of such cases since the founding of the FDA's Office of

Criminal Investigation in 1992 found not a single instance of felony

prosecution of a pharmaceutical company for fraud against the FDA during a

drug's approval or post-approval process. On that score at least,

Merck and

its former CEO, Raymond Gilmartin, can probably rest easy.

 

Those of us in Michigan, however, cannot rest easy. The New Jersey

verdicts

change nothing regarding the rights of Michigan citizens to have their day

in court. Indeed, our 1996 drug industry immunity law prevents Michigan

citizens from seeking civil redress no matter how grievous and

uncontested a

drug company's behavior.

 

During a panel discussion a few weeks ago in Ann Arbor, University of

Florida Law Professor Lars Noah pointed out that even if the Department of

Justice did find a company guilty of felony fraud for withholding safety

data from the FDA -- and the company confessed -- Michigan law, as

interpreted by the federal courts, would still leave state residents

with no

recourse. Zilch.

 

It is hard to imagine a circumstance more unfair, more patently

absurd. And

yet this is the reality in Michigan, the only state with a full shield law

for drug companies.

 

Defenders of that law continue to argue that there are exceptions. But

really, there are none. If that's not already clear, everything that

follows -- or does not follow -- from the New Jersey verdicts will make it

clear as a bell.

 

Meantime, defenders of Michigan's drug industry immunity are not waiting.

They have been pouring into the state for the past three months, trying to

prop up a shield law that was bankrupt, ethically and economically,

from its

start. They hope to capitalize on our rightful concern about Michigan's

economy to induce Michigan citizens to continue to give up their

rights. But

the bottom line is this: Drug industry immunity is a direct-to-consumer

advertisement that this industry cannot be trusted to do the right thing.

 

House Bill 5527, introduced by state Rep. Ed Gaffney, R-Grosse Pointe

Farms,

would restore both the trust, and the rights that were taken from us

by the

immunity law in 1996.

 

The reality, and the irony, is that the pharmaceutical industry generally

can be trusted and deserves our gratitude. Companies that genuinely

play by

the rules -- and most do -- have nothing to fear from our legal system.

Companies that do not play by the rules ought to fear it.

In our state, however, those companies have no reason to fear anything.

 

And if the " Michigan Model " becomes the law of the land, as its defenders

recommend, then the legal rights already savaged would be joined by a

public

health emergency -- no one would know what information about a drug

could be

trusted -- that is as terrifying as it is inevitable. Just picture a

disaster that dwarfs Vioxx in scale, taking place in a world without civil

liability, without a credible FDA, with no accountability whatsoever.

 

What will become of the industry, and the state's economy, then?

 

HENRY GREENSPAN, Ph.D., teaches social psychology and social ethics at the

University of Michigan, Ann Arbor. Write to him in care of the Free Press

Editorial Page, 600 W. Fort St., Detroit 48226 or oped.

 

2006 Detroit Free Press Inc.

 

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