Why We Must Rescind Michigan's Drug Shield Law

February 11, 2006

SSRI-Research@

Fri, 10 Feb 2006 21:25:49 -0500

[sSRI-Research] Why We Must Rescind Michigan's Drug Shield Law

Why We Must Rescind Michigan's Drug Shield Law

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

Lest the public be misled by PhRMa and the FDA, that drug and vaccine

manufacturers need to be protected from frivolous lawsuits, Dr. Henry

Greenspan highlights the issues involved in so-called " tort-reform. "

Drug liability lawsuits are not, as Dr. Greenspan points out, about

whether a drug " has dangers " or, indeed, may cause serious injury or

death. Lawsuits are about a company's " failure to take reasonable and

timely action to make a drug's risks known - above all, to the FDA and

to physicians-when that company became aware of those risks. The goal

of immunizing drug and vaccine manufacturers is to protect them from

the consequences of their deliberate concealing of the hazards they

had knowledge of.

And, as PhRMA spokesman, Alan Goldhammer, let slip, liability is what

leads drug manufacturers to be concerned about safety issues--without

the threat of liability, there will be NO INCENTIVE to worry about

drug safety issues.

" If anyone wants to know what complete legal immunity looks like, it

is here in Michigan. Since the passage of a 1995 law under then

Governor John Engler, Michigan is the only state in the nation in

which citizens are fully prohibited from filing liability claims

against drug companies. The prohibition includes state courts and

federal courts, individual actions and class actions. And so Michigan

citizens (or their survivors) who have been seriously injured or

killed by drugs like Redux ( " fenphen " ), Rezulin, Baycol, or Vioxx-a

few of the sixteen drugs that have been withdrawn because of safety

problems since 1997-have been shut out of court. If the champions of

" tort reform " succeed, all other Americans will be shut out as well.

Former Governor Engler has asserted that the " Michigan model " is

intended to be the law of the land. If it becomes so, the result will

go beyond the savaging of legal rights. What is also at stake, as Alan

Goldhammer told us, is the integrity of drug safety itself. "

Contact: Vera Hassner Sharav

212-595-8974

veracare

http://www.justicecaucus.org/features/drugshieldlaw.htm

Why We Must Rescind Michigan's Drug Shield Law

Guest columnist Henry Greenspan, Ph.D.

At a meeting last June of the prestigious national Institute of

Medicine, Alan Goldhammer winged it. Goldhammer, an associate

vice-president of PhRMA (the Pharmaceutical Research and Manufacturers

Association) was asked by a committee member what incentives drug

companies have to do their own monitoring of drug safety. After

referring to " regulatory obligations " associated with the FDA, Mr.

Goldhammer improvised: " I did note there were a fair number of lawyers

on the committee, " he reflected, and " there is also a liability

concern from the perspectives of the company that also means that they

need to address all safety considerations promptly. "

Obviously unrehearsed, and all the more credible for that, Alan

Goldhammer's comments are worth listening to closely. Because of

liability concerns, drug companies feel " the need to address all

safety concerns promptly. " Legal liability is a major incentive to do so.

To the average citizen, the connection between liability and " safety

considerations " would be self-evident. And yet, for the past several

years, the pharmaceutical industry and its " tort reform " allies have

been working hard to eliminate the very liability to which Mr.

Goldhammer refers. The goal of this movement, coordinated nationally,

is not simply to limit punitive damages or exaggerated claims.

Explicitly stated in position papers and in proposed legislation, the

goal is blanket immunity. If a drug has received initial FDA approval,

its manufacturer is to be shielded, fully and forever.

If anyone wants to know what complete legal immunity looks like, it is

here in Michigan. Since the passage of a 1995 law under then Governor

John Engler, Michigan is the only state in the nation in which

citizens are fully prohibited from filing liability claims against

drug companies. The prohibition includes state courts and federal

courts, individual actions and class actions. And so Michigan citizens

(or their survivors) who have been seriously injured or killed by

drugs like Redux ( " fenphen " ), Rezulin, Baycol, or Vioxx-a few of the

sixteen drugs that have been withdrawn because of safety problems

since 1997-have been shut out of court. If the champions of " tort

reform " succeed, all other Americans will be shut out as well. Former

Governor Engler has asserted that the " Michigan model " is intended to

be the law of the land. If it becomes so, the result will go beyond

the savaging of legal rights. What is also at stake, as Alan

Goldhammer told us, is the integrity of drug safety itself.

Those are the issues. But there have been enough attempts to confuse

us about them that at least some of these should be addressed directly.

We hear, for example: " All drugs have dangers, many of which cannot be

anticipated until after a drug has been FDA-approved and used widely. "

That is as true as it is irrelevant. Lawsuits are not about whether a

drug " has dangers " or, indeed, may cause serious injury or death.

Lawsuits are about whether a company took reasonable and timely action

to make a drug's risks known - above all, to the FDA and to

physicians-when that company became aware of those risks. Were red

flags appropriately reported? Were studies initiated or even

considered to assess the risk? Were existing studies reviewed and made

public? Or, conversely, was safety information obscured, ignored,

denied, delayed, disguised or-in the most egregious cases-knowingly

suppressed or falsified? Lawsuits are about the failure to

appropriately warn, through any of these means. A company that

responds to danger signals in a reasonable and timely way-and many

companies do--has nothing to fear from the legal system. A company

that does not so respond ought to fear it.

We also hear that FDA surveillance provides safety enough, and tort

liability is unnecessary. Once again, Alan Goldhammer had it right:

Federal regulation and legal liability mutually reinforce drug safety.

Goldhammer's view is shared by most courts, and most experts, on the

matter. Summarizing several earlier decisions, a U.S. District Court

recently wrote that " FDA regulations are generally minimum standards

of conduct, " and an FDA determination about warning " may be sufficient

for federal regulatory purposes but still not be sufficient for state

tort law purposes. " Margaret Porter, when she was FDA Chief Counsel,

asserted that " FDA's view is that FDA product approval and state tort

liability usually operate independently, each providing a significant,

yet distinct, layer of consumer protection. " Another U.S. District

Court recently reiterated that FDA regulations are " minimum standards "

and that " FDA approval does not shield a manufacturer from liability. "

It is important to note that even an ideal FDA-one provided enormously

more resources and enforcement powers than the real FDA today-would

still be dependent on drug companies to flag dangers and disclose risk

data in an appropriate and timely fashion. Thus, even in such utopian

circumstances, tort liability would continue to provide an important

" layer of consumer protection. " In the context of the actual FDA's

resources and powers-the limits of which we have become all too

aware--that protection is nothing short of essential. In late 2002,

the Department of Health and Human Services' Office of Inspector

General conducted a survey of the FDA's own medical reviewers-the

scientists on whom we all rely. Fully two-thirds (66%) of those

reviewers lacked confidence that the agency " adequately monitors the

safety of prescription drugs once they are on the market. " The

scientists' lack of confidence is well founded. In many instances, a

drug is approved on the condition that its manufacturer will pursue

additional ( " post-marketing " ) studies to help resolve remaining safety

concerns. Several recent reviews have determined that less than 40% of

these studies are even initiated (let alone completed) by companies

within the time frame FDA provides. This is the industry that says,

" trust us to do the job. " And yet, far too often, they do not do the job.

That is the primary reason why the majority of Americans do not much

like the pharmaceutical industry right now. In most polls, their

integrity is rated at the same level as big oil and big tobacco in

their worst days. What a terrible irony that those companies whose

products do, indeed, save lives, and make other lives worth living,

are viewed by so many citizens as spiraling to the ethical bottom. So

far, the public still generally trusts the products, the drugs

themselves, if not their manufacturers. But make no mistake. In the

post-Vioxx era, the " big one " has made landfall, and the levees are

broken. When the next storm hits, as it inevitably will within the

present system, recovery is more difficult to imagine . Everything

that remains good and hopeful about this industry depends on public

trust. The increasingly aggressive efforts to absolve drug companies'

legal liability is a virtual admission, a direct-to-consumer

advertisement, that that trust is misplaced.

What happens now in Michigan, therefore, has genuinely national

implications. On one side, there is now strong and bi-partisan effort

to rescind the 1995 shield law. Legislation to restore the rights we

lost--House Bills 4773, 4811, and 5527-has been introduced in the

State House, and most observers believe that there is a good chance of

passage as more and more citizens learn the facts.

Meanwhile, lobbyists from national " tort reform " associations flood

the state--they come from Washington, from Texas, from

Mississippi-trying to prop up a shield law that was bankrupt,

ethically and economically, from the start.

Michigan representatives from across the political spectrum are ready

to fight this onslaught and do the right thing. They deserve, and they

need, our support.

Henry Greenspan, Ph.D., teaches social psychology and social ethics at

the University of Michigan, Ann Arbor.

2006 Henry Greenspan. Reprinted with permission.

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February 12, 2006

Pharmaceutical Industry has used the real need to protect themselves from

frivillous law suits to legalize the production and distribution of poison...I

urge you to think about MERCK and VIOXX...buy puts on their stock....UncBob