Michigan Liability Law--a Rx for Disaster

[Guest guest]

Michigan Liability Law--a Rx for Disaster

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

FYI

In an opinion piece in the Detroit Free Press, Henry Greenspan,Ph.D.

who teaches social psychology and social ethics at the University of

Michigan, writes about the heated battle o overturn the state's

draconian pharmaceutical freedom from liability law.

" Defenders of Michigan's drug industry immunity 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. "

" 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. "

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

Detroit Free Press

LOCAL COMMENT: Michigan liability law a prescription for disaster

BY HENRY GREENSPAN

April 17, 2006

photo

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, 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@....

Copyright © 2006 Detroit Free Press Inc.

FAIR USE NOTICE: This may contain copyrighted (© ) material the use

of which has not always been specifically authorized by the copyright

owner. Such material is made available for educational purposes, to

advance understanding of human rights, democracy, scientific, moral,

ethical, and social justice issues, etc. It is believed that this

constitutes a 'fair use' of any such copyrighted material as provided

for in Title 17 U.S.C. section 107 of the US Copyright Law. This

material is distributed without profit.