Bill would shield some drug firms from punitive damages

[Guest guest]

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness and Full Disclosure

www.ahrp.org

FYI

A proposed bill in Congress would be another disincentive for pharmaceutical

companies to disclose drug safety problems.

Those promoting the bill should be asked to disclose their financial ties to

drug companies.

In 2000, a mysterious clause giving Eli Lilly immunity from thousands of

vaccine lawsuits arising from the harm suffered by children from

mercury-laced vaccines had made its way into the Homeland Secruity Act.

This current proposed legislation is being dubbed the " Merck Protection

Provision " inasmuch as it would limit punitive damages from Vioxx and other

hazardous drugs which the FDA had failed to warn about-even though those

hazards were known to the manufacturers.

If enacted this would effectively prevent citizens who suffered preventable

injury from being compensated.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

http://www.philly.com/mld/inquirer/2004/12/26/news/nation/10497841.htm

Bill would shield some drug firms from punitive damages

Philadelphia Inquirer

A provision in medical malpractice legislation would protect manufacturers

that meet FDA standards.

By Steve Goldstein

Inquirer Washington Bureau

on Sun, Dec. 26, 2004

WASHINGTON - As concern grows over the safety of popular painkillers, a

provision in medical malpractice legislation now before Congress apparently

would protect drug manufacturers from punitive damage awards as long as

federal Food and Drug Administration standards are met.

The provision could dramatically affect lawsuits against Merck & Co. Inc.,

whose drug, Vioxx, has been tied to increased risk of heart attack and

stroke.

Although the proposed legislation does not eliminate liability for harm

caused by the drug, analysts are concerned that, if it became law, companies

would not be held fully accountable for negligence. Moreover, there would be

no threat of large punitive awards to deter a company from ignoring warning

signs about a drug.

" This would be an extremely difficult requirement to meet " to sue for

punitive damages, said Lucinda Finley of the Law School of the State

University of New York at Buffalo, who has been researching medical

malpractice and proposed reforms. " You could sort of call this the 'Merck

protection provision.' "

" Lawsuits and punitive damage awards have been the catalyst to getting

dangerous drugs and medical devices off the market, " said Joanne Doroshow,

executive director of the Center for Justice and Democracy, a plaintiffs'

rights advocacy organization. As an example, she cited the 1984 removal from

the market of the Dalkon Shield intrauterine device by manufacturer A.H.

Robins after 11 punitive damage awards totaling about $25 million.

Those who back the legislation, however, argue that drug companies should

not be punished for products that passed muster with the FDA, as long as

they followed FDA rules.

Merck spokesman Tony Plohoros said: " We support the bill and have supported

medical malpractice reform for a long time. "

The controversial provision is in a medical malpractice bill that will be at

the center of debate when the new Senate convenes in January. Republicans,

who have increased their majority to 55, generally favor restrictions on

medical malpractice lawsuits, while Democrats generally oppose such limits.

In March 2003, the House of Representatives passed the bill, which, in

addition to limiting punitive damages, puts a $250,000 cap on jury awards

for pain and suffering caused by medical malpractice and restricts the

contingency fees plaintiffs' lawyers could charge.

But Senate Democrats, who effectively filibustered the bill, claim to still

have enough votes to keep the legislation bottled up. Senate Majority Leader

Bill Frist (R., Tenn.) insists that the strong push for medical malpractice

changes by President Bush may alter the arithmetic.

Two other pieces of legislation under the general heading of tort reform

have a better chance of being enacted into law, according to Senate staff

members.

One is a class-action lawsuit change that would " federalize " most such

lawsuits by taking them out of state courts and putting them under federal

jurisdiction. Proponents of the change say that some states are too quick to

certify class-action lawsuits.

The other would be the culmination of the long-standing negotiation on

asbestos litigation, which seeks to create a gigantic trust fund to pay

victims.

The odds are longer for medical malpractice change, which has pitted the

medical establishment against the Association of Trial Lawyers of America.

The punitive damage awards provision has not attracted as much notice as the

capping on jury awards for noneconomic damages, but it has major

implications for Merck, as well as for Pfizer Inc., manufacturer of

Celebrex.

Merck stopped selling Vioxx on Sept. 30 after the company said the

painkiller increased the risk of heart attack and stroke by more than 100

percent. Earlier, Merck continued to sell Vioxx despite knowledge of its

potential dangers, critics contend.

Merck, headquartered in Whitehouse Station, N.J., has about 12,000 employees

at a huge research center in Montgomery County. Vioxx, Merck's $2.5

billion-a-year medicine for arthritis and acute pain, is one of the

company's five top-selling drugs, accounting for about 11 percent of sales

in 2003.

Pfizer Inc. said earlier this month that a study had found that high doses

of Celebrex taken for long periods were associated with a sharply increased

risk of heart attacks. But the company has not taken the painkiller off the

market, citing other, conflicting research.

Pfizer's decision not to withdraw Celebrex is a gamble, because plaintiffs'

attorneys could say in lawsuits that the company knew of the drug's

potential dangers and continued to sell it. This could result in a claim for

punitive damages - damages intended to punish the wrongdoer - as it could in

Merck's case.

Under this legislation, punitive damages would be barred unless the company

failed to comply with FDA regulations; both Merck and Pfizer met FDA

standards with Vioxx and Celebrex.

Proponents of the bill and the pharmaceutical industry have contended that

manufacturers should not have to pay punitive damages for an FDA-approved

product unless it can be shown that they misled the agency or failed to

follow FDA strictures.

The intent of those drafting this provision, according to Senate staff, is

to protect companies that made good-faith attempts to follow federal

guidelines and to guard against lawsuits resulting from misuse of the drug

by doctors or patients.

Opponents say the reform is worse than the abuse.

" While this will be devastating to injured people, it won't do anything to

help doctors with their insurance problems, but it would get pharmaceutical

companies off the hook for their misconduct, " Doroshow said.

It would also eliminate the deterrent factor, said University of

Pennsylvania law professor T. Struve, who has been researching

medical malpractice reform.

Although victims could still be compensated for economic loss and pain and

suffering, she said, it " may be the case that in order to deter a company

from ignoring warning signs with a blockbuster drug, you need something

more - that's the premise behind punitive damages. "

Contact reporter Steve Goldstein at slgoldstein@... or

202-383-6048

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 and Full Disclosure

www.ahrp.org

FYI

A proposed bill in Congress would be another disincentive for pharmaceutical

companies to disclose drug safety problems.

Those promoting the bill should be asked to disclose their financial ties to

drug companies.

In 2000, a mysterious clause giving Eli Lilly immunity from thousands of

vaccine lawsuits arising from the harm suffered by children from

mercury-laced vaccines had made its way into the Homeland Secruity Act.

This current proposed legislation is being dubbed the " Merck Protection

Provision " inasmuch as it would limit punitive damages from Vioxx and other

hazardous drugs which the FDA had failed to warn about-even though those

hazards were known to the manufacturers.

If enacted this would effectively prevent citizens who suffered preventable

injury from being compensated.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

http://www.philly.com/mld/inquirer/2004/12/26/news/nation/10497841.htm

Bill would shield some drug firms from punitive damages

Philadelphia Inquirer

A provision in medical malpractice legislation would protect manufacturers

that meet FDA standards.

By Steve Goldstein

Inquirer Washington Bureau

on Sun, Dec. 26, 2004

WASHINGTON - As concern grows over the safety of popular painkillers, a

provision in medical malpractice legislation now before Congress apparently

would protect drug manufacturers from punitive damage awards as long as

federal Food and Drug Administration standards are met.

The provision could dramatically affect lawsuits against Merck & Co. Inc.,

whose drug, Vioxx, has been tied to increased risk of heart attack and

stroke.

Although the proposed legislation does not eliminate liability for harm

caused by the drug, analysts are concerned that, if it became law, companies

would not be held fully accountable for negligence. Moreover, there would be

no threat of large punitive awards to deter a company from ignoring warning

signs about a drug.

" This would be an extremely difficult requirement to meet " to sue for

punitive damages, said Lucinda Finley of the Law School of the State

University of New York at Buffalo, who has been researching medical

malpractice and proposed reforms. " You could sort of call this the 'Merck

protection provision.' "

" Lawsuits and punitive damage awards have been the catalyst to getting

dangerous drugs and medical devices off the market, " said Joanne Doroshow,

executive director of the Center for Justice and Democracy, a plaintiffs'

rights advocacy organization. As an example, she cited the 1984 removal from

the market of the Dalkon Shield intrauterine device by manufacturer A.H.

Robins after 11 punitive damage awards totaling about $25 million.

Those who back the legislation, however, argue that drug companies should

not be punished for products that passed muster with the FDA, as long as

they followed FDA rules.

Merck spokesman Tony Plohoros said: " We support the bill and have supported

medical malpractice reform for a long time. "

The controversial provision is in a medical malpractice bill that will be at

the center of debate when the new Senate convenes in January. Republicans,

who have increased their majority to 55, generally favor restrictions on

medical malpractice lawsuits, while Democrats generally oppose such limits.

In March 2003, the House of Representatives passed the bill, which, in

addition to limiting punitive damages, puts a $250,000 cap on jury awards

for pain and suffering caused by medical malpractice and restricts the

contingency fees plaintiffs' lawyers could charge.

But Senate Democrats, who effectively filibustered the bill, claim to still

have enough votes to keep the legislation bottled up. Senate Majority Leader

Bill Frist (R., Tenn.) insists that the strong push for medical malpractice

changes by President Bush may alter the arithmetic.

Two other pieces of legislation under the general heading of tort reform

have a better chance of being enacted into law, according to Senate staff

members.

One is a class-action lawsuit change that would " federalize " most such

lawsuits by taking them out of state courts and putting them under federal

jurisdiction. Proponents of the change say that some states are too quick to

certify class-action lawsuits.

The other would be the culmination of the long-standing negotiation on

asbestos litigation, which seeks to create a gigantic trust fund to pay

victims.

The odds are longer for medical malpractice change, which has pitted the

medical establishment against the Association of Trial Lawyers of America.

The punitive damage awards provision has not attracted as much notice as the

capping on jury awards for noneconomic damages, but it has major

implications for Merck, as well as for Pfizer Inc., manufacturer of

Celebrex.

Merck stopped selling Vioxx on Sept. 30 after the company said the

painkiller increased the risk of heart attack and stroke by more than 100

percent. Earlier, Merck continued to sell Vioxx despite knowledge of its

potential dangers, critics contend.

Merck, headquartered in Whitehouse Station, N.J., has about 12,000 employees

at a huge research center in Montgomery County. Vioxx, Merck's $2.5

billion-a-year medicine for arthritis and acute pain, is one of the

company's five top-selling drugs, accounting for about 11 percent of sales

in 2003.

Pfizer Inc. said earlier this month that a study had found that high doses

of Celebrex taken for long periods were associated with a sharply increased

risk of heart attacks. But the company has not taken the painkiller off the

market, citing other, conflicting research.

Pfizer's decision not to withdraw Celebrex is a gamble, because plaintiffs'

attorneys could say in lawsuits that the company knew of the drug's

potential dangers and continued to sell it. This could result in a claim for

punitive damages - damages intended to punish the wrongdoer - as it could in

Merck's case.

Under this legislation, punitive damages would be barred unless the company

failed to comply with FDA regulations; both Merck and Pfizer met FDA

standards with Vioxx and Celebrex.

Proponents of the bill and the pharmaceutical industry have contended that

manufacturers should not have to pay punitive damages for an FDA-approved

product unless it can be shown that they misled the agency or failed to

follow FDA strictures.

The intent of those drafting this provision, according to Senate staff, is

to protect companies that made good-faith attempts to follow federal

guidelines and to guard against lawsuits resulting from misuse of the drug

by doctors or patients.

Opponents say the reform is worse than the abuse.

" While this will be devastating to injured people, it won't do anything to

help doctors with their insurance problems, but it would get pharmaceutical

companies off the hook for their misconduct, " Doroshow said.

It would also eliminate the deterrent factor, said University of

Pennsylvania law professor T. Struve, who has been researching

medical malpractice reform.

Although victims could still be compensated for economic loss and pain and

suffering, she said, it " may be the case that in order to deter a company

from ignoring warning signs with a blockbuster drug, you need something

more - that's the premise behind punitive damages. "

Contact reporter Steve Goldstein at slgoldstein@... or

202-383-6048

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 and Full Disclosure

www.ahrp.org

FYI

A proposed bill in Congress would be another disincentive for pharmaceutical

companies to disclose drug safety problems.

Those promoting the bill should be asked to disclose their financial ties to

drug companies.

In 2000, a mysterious clause giving Eli Lilly immunity from thousands of

vaccine lawsuits arising from the harm suffered by children from

mercury-laced vaccines had made its way into the Homeland Secruity Act.

This current proposed legislation is being dubbed the " Merck Protection

Provision " inasmuch as it would limit punitive damages from Vioxx and other

hazardous drugs which the FDA had failed to warn about-even though those

hazards were known to the manufacturers.

If enacted this would effectively prevent citizens who suffered preventable

injury from being compensated.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

http://www.philly.com/mld/inquirer/2004/12/26/news/nation/10497841.htm

Bill would shield some drug firms from punitive damages

Philadelphia Inquirer

A provision in medical malpractice legislation would protect manufacturers

that meet FDA standards.

By Steve Goldstein

Inquirer Washington Bureau

on Sun, Dec. 26, 2004

WASHINGTON - As concern grows over the safety of popular painkillers, a

provision in medical malpractice legislation now before Congress apparently

would protect drug manufacturers from punitive damage awards as long as

federal Food and Drug Administration standards are met.

The provision could dramatically affect lawsuits against Merck & Co. Inc.,

whose drug, Vioxx, has been tied to increased risk of heart attack and

stroke.

Although the proposed legislation does not eliminate liability for harm

caused by the drug, analysts are concerned that, if it became law, companies

would not be held fully accountable for negligence. Moreover, there would be

no threat of large punitive awards to deter a company from ignoring warning

signs about a drug.

" This would be an extremely difficult requirement to meet " to sue for

punitive damages, said Lucinda Finley of the Law School of the State

University of New York at Buffalo, who has been researching medical

malpractice and proposed reforms. " You could sort of call this the 'Merck

protection provision.' "

" Lawsuits and punitive damage awards have been the catalyst to getting

dangerous drugs and medical devices off the market, " said Joanne Doroshow,

executive director of the Center for Justice and Democracy, a plaintiffs'

rights advocacy organization. As an example, she cited the 1984 removal from

the market of the Dalkon Shield intrauterine device by manufacturer A.H.

Robins after 11 punitive damage awards totaling about $25 million.

Those who back the legislation, however, argue that drug companies should

not be punished for products that passed muster with the FDA, as long as

they followed FDA rules.

Merck spokesman Tony Plohoros said: " We support the bill and have supported

medical malpractice reform for a long time. "

The controversial provision is in a medical malpractice bill that will be at

the center of debate when the new Senate convenes in January. Republicans,

who have increased their majority to 55, generally favor restrictions on

medical malpractice lawsuits, while Democrats generally oppose such limits.

In March 2003, the House of Representatives passed the bill, which, in

addition to limiting punitive damages, puts a $250,000 cap on jury awards

for pain and suffering caused by medical malpractice and restricts the

contingency fees plaintiffs' lawyers could charge.

But Senate Democrats, who effectively filibustered the bill, claim to still

have enough votes to keep the legislation bottled up. Senate Majority Leader

Bill Frist (R., Tenn.) insists that the strong push for medical malpractice

changes by President Bush may alter the arithmetic.

Two other pieces of legislation under the general heading of tort reform

have a better chance of being enacted into law, according to Senate staff

members.

One is a class-action lawsuit change that would " federalize " most such

lawsuits by taking them out of state courts and putting them under federal

jurisdiction. Proponents of the change say that some states are too quick to

certify class-action lawsuits.

The other would be the culmination of the long-standing negotiation on

asbestos litigation, which seeks to create a gigantic trust fund to pay

victims.

The odds are longer for medical malpractice change, which has pitted the

medical establishment against the Association of Trial Lawyers of America.

The punitive damage awards provision has not attracted as much notice as the

capping on jury awards for noneconomic damages, but it has major

implications for Merck, as well as for Pfizer Inc., manufacturer of

Celebrex.

Merck stopped selling Vioxx on Sept. 30 after the company said the

painkiller increased the risk of heart attack and stroke by more than 100

percent. Earlier, Merck continued to sell Vioxx despite knowledge of its

potential dangers, critics contend.

Merck, headquartered in Whitehouse Station, N.J., has about 12,000 employees

at a huge research center in Montgomery County. Vioxx, Merck's $2.5

billion-a-year medicine for arthritis and acute pain, is one of the

company's five top-selling drugs, accounting for about 11 percent of sales

in 2003.

Pfizer Inc. said earlier this month that a study had found that high doses

of Celebrex taken for long periods were associated with a sharply increased

risk of heart attacks. But the company has not taken the painkiller off the

market, citing other, conflicting research.

Pfizer's decision not to withdraw Celebrex is a gamble, because plaintiffs'

attorneys could say in lawsuits that the company knew of the drug's

potential dangers and continued to sell it. This could result in a claim for

punitive damages - damages intended to punish the wrongdoer - as it could in

Merck's case.

Under this legislation, punitive damages would be barred unless the company

failed to comply with FDA regulations; both Merck and Pfizer met FDA

standards with Vioxx and Celebrex.

Proponents of the bill and the pharmaceutical industry have contended that

manufacturers should not have to pay punitive damages for an FDA-approved

product unless it can be shown that they misled the agency or failed to

follow FDA strictures.

The intent of those drafting this provision, according to Senate staff, is

to protect companies that made good-faith attempts to follow federal

guidelines and to guard against lawsuits resulting from misuse of the drug

by doctors or patients.

Opponents say the reform is worse than the abuse.

" While this will be devastating to injured people, it won't do anything to

help doctors with their insurance problems, but it would get pharmaceutical

companies off the hook for their misconduct, " Doroshow said.

It would also eliminate the deterrent factor, said University of

Pennsylvania law professor T. Struve, who has been researching

medical malpractice reform.

Although victims could still be compensated for economic loss and pain and

suffering, she said, it " may be the case that in order to deter a company

from ignoring warning signs with a blockbuster drug, you need something

more - that's the premise behind punitive damages. "

Contact reporter Steve Goldstein at slgoldstein@... or

202-383-6048

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 and Full Disclosure

www.ahrp.org

FYI

A proposed bill in Congress would be another disincentive for pharmaceutical

companies to disclose drug safety problems.

Those promoting the bill should be asked to disclose their financial ties to

drug companies.

In 2000, a mysterious clause giving Eli Lilly immunity from thousands of

vaccine lawsuits arising from the harm suffered by children from

mercury-laced vaccines had made its way into the Homeland Secruity Act.

This current proposed legislation is being dubbed the " Merck Protection

Provision " inasmuch as it would limit punitive damages from Vioxx and other

hazardous drugs which the FDA had failed to warn about-even though those

hazards were known to the manufacturers.

If enacted this would effectively prevent citizens who suffered preventable

injury from being compensated.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

http://www.philly.com/mld/inquirer/2004/12/26/news/nation/10497841.htm

Bill would shield some drug firms from punitive damages

Philadelphia Inquirer

A provision in medical malpractice legislation would protect manufacturers

that meet FDA standards.

By Steve Goldstein

Inquirer Washington Bureau

on Sun, Dec. 26, 2004

WASHINGTON - As concern grows over the safety of popular painkillers, a

provision in medical malpractice legislation now before Congress apparently

would protect drug manufacturers from punitive damage awards as long as

federal Food and Drug Administration standards are met.

The provision could dramatically affect lawsuits against Merck & Co. Inc.,

whose drug, Vioxx, has been tied to increased risk of heart attack and

stroke.

Although the proposed legislation does not eliminate liability for harm

caused by the drug, analysts are concerned that, if it became law, companies

would not be held fully accountable for negligence. Moreover, there would be

no threat of large punitive awards to deter a company from ignoring warning

signs about a drug.

" This would be an extremely difficult requirement to meet " to sue for

punitive damages, said Lucinda Finley of the Law School of the State

University of New York at Buffalo, who has been researching medical

malpractice and proposed reforms. " You could sort of call this the 'Merck

protection provision.' "

" Lawsuits and punitive damage awards have been the catalyst to getting

dangerous drugs and medical devices off the market, " said Joanne Doroshow,

executive director of the Center for Justice and Democracy, a plaintiffs'

rights advocacy organization. As an example, she cited the 1984 removal from

the market of the Dalkon Shield intrauterine device by manufacturer A.H.

Robins after 11 punitive damage awards totaling about $25 million.

Those who back the legislation, however, argue that drug companies should

not be punished for products that passed muster with the FDA, as long as

they followed FDA rules.

Merck spokesman Tony Plohoros said: " We support the bill and have supported

medical malpractice reform for a long time. "

The controversial provision is in a medical malpractice bill that will be at

the center of debate when the new Senate convenes in January. Republicans,

who have increased their majority to 55, generally favor restrictions on

medical malpractice lawsuits, while Democrats generally oppose such limits.

In March 2003, the House of Representatives passed the bill, which, in

addition to limiting punitive damages, puts a $250,000 cap on jury awards

for pain and suffering caused by medical malpractice and restricts the

contingency fees plaintiffs' lawyers could charge.

But Senate Democrats, who effectively filibustered the bill, claim to still

have enough votes to keep the legislation bottled up. Senate Majority Leader

Bill Frist (R., Tenn.) insists that the strong push for medical malpractice

changes by President Bush may alter the arithmetic.

Two other pieces of legislation under the general heading of tort reform

have a better chance of being enacted into law, according to Senate staff

members.

One is a class-action lawsuit change that would " federalize " most such

lawsuits by taking them out of state courts and putting them under federal

jurisdiction. Proponents of the change say that some states are too quick to

certify class-action lawsuits.

The other would be the culmination of the long-standing negotiation on

asbestos litigation, which seeks to create a gigantic trust fund to pay

victims.

The odds are longer for medical malpractice change, which has pitted the

medical establishment against the Association of Trial Lawyers of America.

The punitive damage awards provision has not attracted as much notice as the

capping on jury awards for noneconomic damages, but it has major

implications for Merck, as well as for Pfizer Inc., manufacturer of

Celebrex.

Merck stopped selling Vioxx on Sept. 30 after the company said the

painkiller increased the risk of heart attack and stroke by more than 100

percent. Earlier, Merck continued to sell Vioxx despite knowledge of its

potential dangers, critics contend.

Merck, headquartered in Whitehouse Station, N.J., has about 12,000 employees

at a huge research center in Montgomery County. Vioxx, Merck's $2.5

billion-a-year medicine for arthritis and acute pain, is one of the

company's five top-selling drugs, accounting for about 11 percent of sales

in 2003.

Pfizer Inc. said earlier this month that a study had found that high doses

of Celebrex taken for long periods were associated with a sharply increased

risk of heart attacks. But the company has not taken the painkiller off the

market, citing other, conflicting research.

Pfizer's decision not to withdraw Celebrex is a gamble, because plaintiffs'

attorneys could say in lawsuits that the company knew of the drug's

potential dangers and continued to sell it. This could result in a claim for

punitive damages - damages intended to punish the wrongdoer - as it could in

Merck's case.

Under this legislation, punitive damages would be barred unless the company

failed to comply with FDA regulations; both Merck and Pfizer met FDA

standards with Vioxx and Celebrex.

Proponents of the bill and the pharmaceutical industry have contended that

manufacturers should not have to pay punitive damages for an FDA-approved

product unless it can be shown that they misled the agency or failed to

follow FDA strictures.

The intent of those drafting this provision, according to Senate staff, is

to protect companies that made good-faith attempts to follow federal

guidelines and to guard against lawsuits resulting from misuse of the drug

by doctors or patients.

Opponents say the reform is worse than the abuse.

" While this will be devastating to injured people, it won't do anything to

help doctors with their insurance problems, but it would get pharmaceutical

companies off the hook for their misconduct, " Doroshow said.

It would also eliminate the deterrent factor, said University of

Pennsylvania law professor T. Struve, who has been researching

medical malpractice reform.

Although victims could still be compensated for economic loss and pain and

suffering, she said, it " may be the case that in order to deter a company

from ignoring warning signs with a blockbuster drug, you need something

more - that's the premise behind punitive damages. "

Contact reporter Steve Goldstein at slgoldstein@... or

202-383-6048

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]

But the reason the companies " met FDA standards " is that FDA chose to ignore its

own regulations. I think it is arguable--in fact extremely unlikely-- that

Merck and Pfizer met Food Drug and Cosmetic Act standards.

Meryl Nass, MD

Mount Desert Island Hospital

Bar Harbor, Maine 04609

207 288-5082 ext 220

New home address:

5 andra Road

Southwest Harbor, Maine 04679

phone 207 244-9165

Bill would shield some drug firms from punitive damages

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness and Full Disclosure

www.ahrp.org

FYI

A proposed bill in Congress would be another disincentive for pharmaceutical

companies to disclose drug safety problems.

Those promoting the bill should be asked to disclose their financial ties to

drug companies.

In 2000, a mysterious clause giving Eli Lilly immunity from thousands of

vaccine lawsuits arising from the harm suffered by children from

mercury-laced vaccines had made its way into the Homeland Secruity Act.

This current proposed legislation is being dubbed the " Merck Protection

Provision " inasmuch as it would limit punitive damages from Vioxx and other

hazardous drugs which the FDA had failed to warn about-even though those

hazards were known to the manufacturers.

If enacted this would effectively prevent citizens who suffered preventable

injury from being compensated.

Contact: Vera Hassner Sharav

212-595-8974

veracare@...

http://www.philly.com/mld/inquirer/2004/12/26/news/nation/10497841.htm

Bill would shield some drug firms from punitive damages

Philadelphia Inquirer

A provision in medical malpractice legislation would protect manufacturers

that meet FDA standards.

By Steve Goldstein

Inquirer Washington Bureau

on Sun, Dec. 26, 2004

WASHINGTON - As concern grows over the safety of popular painkillers, a

provision in medical malpractice legislation now before Congress apparently

would protect drug manufacturers from punitive damage awards as long as

federal Food and Drug Administration standards are met.

The provision could dramatically affect lawsuits against Merck & Co. Inc.,

whose drug, Vioxx, has been tied to increased risk of heart attack and

stroke.

Although the proposed legislation does not eliminate liability for harm

caused by the drug, analysts are concerned that, if it became law, companies

would not be held fully accountable for negligence. Moreover, there would be

no threat of large punitive awards to deter a company from ignoring warning

signs about a drug.

" This would be an extremely difficult requirement to meet " to sue for

punitive damages, said Lucinda Finley of the Law School of the State

University of New York at Buffalo, who has been researching medical

malpractice and proposed reforms. " You could sort of call this the 'Merck

protection provision.' "

" Lawsuits and punitive damage awards have been the catalyst to getting

dangerous drugs and medical devices off the market, " said Joanne Doroshow,

executive director of the Center for Justice and Democracy, a plaintiffs'

rights advocacy organization. As an example, she cited the 1984 removal from

the market of the Dalkon Shield intrauterine device by manufacturer A.H.

Robins after 11 punitive damage awards totaling about $25 million.

Those who back the legislation, however, argue that drug companies should

not be punished for products that passed muster with the FDA, as long as

they followed FDA rules.

Merck spokesman Tony Plohoros said: " We support the bill and have supported

medical malpractice reform for a long time. "

The controversial provision is in a medical malpractice bill that will be at

the center of debate when the new Senate convenes in January. Republicans,

who have increased their majority to 55, generally favor restrictions on

medical malpractice lawsuits, while Democrats generally oppose such limits.

In March 2003, the House of Representatives passed the bill, which, in

addition to limiting punitive damages, puts a $250,000 cap on jury awards

for pain and suffering caused by medical malpractice and restricts the

contingency fees plaintiffs' lawyers could charge.

But Senate Democrats, who effectively filibustered the bill, claim to still

have enough votes to keep the legislation bottled up. Senate Majority Leader

Bill Frist (R., Tenn.) insists that the strong push for medical malpractice

changes by President Bush may alter the arithmetic.

Two other pieces of legislation under the general heading of tort reform

have a better chance of being enacted into law, according to Senate staff

members.

One is a class-action lawsuit change that would " federalize " most such

lawsuits by taking them out of state courts and putting them under federal

jurisdiction. Proponents of the change say that some states are too quick to

certify class-action lawsuits.

The other would be the culmination of the long-standing negotiation on

asbestos litigation, which seeks to create a gigantic trust fund to pay

victims.

The odds are longer for medical malpractice change, which has pitted the

medical establishment against the Association of Trial Lawyers of America.

The punitive damage awards provision has not attracted as much notice as the

capping on jury awards for noneconomic damages, but it has major

implications for Merck, as well as for Pfizer Inc., manufacturer of

Celebrex.

Merck stopped selling Vioxx on Sept. 30 after the company said the

painkiller increased the risk of heart attack and stroke by more than 100

percent. Earlier, Merck continued to sell Vioxx despite knowledge of its

potential dangers, critics contend.

Merck, headquartered in Whitehouse Station, N.J., has about 12,000 employees

at a huge research center in Montgomery County. Vioxx, Merck's $2.5

billion-a-year medicine for arthritis and acute pain, is one of the

company's five top-selling drugs, accounting for about 11 percent of sales

in 2003.

Pfizer Inc. said earlier this month that a study had found that high doses

of Celebrex taken for long periods were associated with a sharply increased

risk of heart attacks. But the company has not taken the painkiller off the

market, citing other, conflicting research.

Pfizer's decision not to withdraw Celebrex is a gamble, because plaintiffs'

attorneys could say in lawsuits that the company knew of the drug's

potential dangers and continued to sell it. This could result in a claim for

punitive damages - damages intended to punish the wrongdoer - as it could in

Merck's case.

Under this legislation, punitive damages would be barred unless the company

failed to comply with FDA regulations; both Merck and Pfizer met FDA

standards with Vioxx and Celebrex.

Proponents of the bill and the pharmaceutical industry have contended that

manufacturers should not have to pay punitive damages for an FDA-approved

product unless it can be shown that they misled the agency or failed to

follow FDA strictures.

The intent of those drafting this provision, according to Senate staff, is

to protect companies that made good-faith attempts to follow federal

guidelines and to guard against lawsuits resulting from misuse of the drug

by doctors or patients.

Opponents say the reform is worse than the abuse.

" While this will be devastating to injured people, it won't do anything to

help doctors with their insurance problems, but it would get pharmaceutical

companies off the hook for their misconduct, " Doroshow said.

It would also eliminate the deterrent factor, said University of

Pennsylvania law professor T. Struve, who has been researching

medical malpractice reform.

Although victims could still be compensated for economic loss and pain and

suffering, she said, it " may be the case that in order to deter a company

from ignoring warning signs with a blockbuster drug, you need something more

- that's the premise behind punitive damages. "

Contact reporter Steve Goldstein at slgoldstein@... or

202-383-6048

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