Why We Must Rescind Michigan's Drug Shield Law

[Guest guest]

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

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Baycol, or Vioxx—a few of the sixteen drugs that have been withdrawn because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

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.

Copyright © 2006 Henry Greenspan. Reprinted with permission.

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.

[Guest guest]

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

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

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.

Copyright © 2006 Henry Greenspan. Reprinted with permission.

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.

[Guest guest]

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

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

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.

Copyright © 2006 Henry Greenspan. Reprinted with permission.

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.

[Guest guest]

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

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

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.

Copyright © 2006 Henry Greenspan. Reprinted with permission.

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