Top medical journal advises Supreme Court not to bar lawsuits over FDA-approved drugs

August 17, 2008

* " Diana Levine, a Vermont guitarist, lost her right arm below the elbow

after she was injected with Phenergan, a medicine for nausea, and developed

gangrene. She sued the manufacturer " *

*However......*

Top medical journal advises Supreme Court not to bar lawsuits over

FDA-approved drugs By RICARDO ALONSO-ZALDIVAR | Associated Press Writer 5:03

PM EDT, August 15, 2008 WASHINGTON (AP) _ Top doctors at the helm of one of

the nation's most influential medical journals are giving the Supreme Court

some unsolicited legal advice about a major case.

The Food and Drug Administration " is in no position " to guarantee drug

safety, the editors of the New England Journal of Medicine said in a

friend-of-the-court brief. Lawsuits can serve as " a vital deterrent " and

protect consumers if drug companies don't disclose risks.

At issue is Wyeth v. Levine, a case expected to be heard this fall that

could have far-reaching implications for litigation over allegedly harmful

drugs, such as the painkiller Vioxx.

Diana Levine, a Vermont guitarist, lost her right arm below the elbow after

she was injected with Phenergan, a medicine for nausea, and developed

gangrene. She sued the manufacturer, Wyeth, arguing that the company had a

duty to warn consumers that such injections could have devastating

consequences. The courts in her state agreed, awarding her nearly $7

million.

But Wyeth appealed, countering that it was protected from such lawsuits. It

argued that the FDA's judgment could not, in effect, be overruled by a state

court. FDA scientists had weighed the risks and benefits of Phenergan in

approving the drug's prescribing literature, or label, as a guide for

doctors. The FDA was aware of risks associated with injecting some forms of

Phenergan, but the label did not specifically warn about the technique used

with Levine.

Although the FDA is often called " the gold standard " in drug evaluation, the

journal editors urged the justices to be skeptical.

" The FDA alone simply lacks the ability to serve as the sole guarantor of

drug safety, " the doctors said in a brief filed Thursday. Without the

discoveries dredged up by plaintiffs' lawyers through liability litigation,

" the FDA would be stripped of an essential source of information that the

agency has consistently relied on when making its regulatory decisions, and

the American public would be deprived of a vital deterrent against

pharmaceutical company misconduct. "

The medical editors joined 47 state attorneys general and two former FDA

commissioners — David Kessler and Donald Kennedy — in supporting Levine's

position. Kessler served in the Clinton administration and that of George

H.W. Bush. Kennedy served in the Carter administration.

The case is being closely watched because earlier this year the Supreme

Court ruled that manufacturers of FDA-approved medical devices were shielded

from litigation in state courts.

However, David Vladeck, a lawyer representing Kessler and Kennedy, said the

statute that applies to medical devices is different from the law that

governs medications.

" The law in the (devices) case had a pre-emption provision, " said Vladeck.

" Congress has never put a pre-emption provision in the Food and Drug Act. "

Nonetheless, t*he Bush administration is supporting Wyeth's position.*

" FDA considers and approves specific labeling for a drug, and the drug

manufacturer is generally barred from making unilateral changes to the

FDA-approved labeling, " Solicitor General Paul D. Clement wrote in the

administration's brief.

But journal editor Dr. Jeffrey M. Drazen said in an interview that he hoped

arguments over legal distinctions would not obscure the reality that the FDA

is overwhelmed trying to keep up with drug safety problems, which can range

from rare but serious side effects, to shortcomings in manufacturing plants

as far away as China.

" Even if the FDA is doing the best it can, it simply can't see the future

clearly enough to pre-empt manufacturers from litigation, " he said. " The

(court) system represents one of the key defense mechanisms that individuals

have if a manufacturer has not made the risks of a product clear to the

public. "

--

Regards,

Dannemann

former director, National Coalition of Organized Women (NCOW)

www.ProgressiveConvergence.com

917 804-0786

" It requires courage to utter truth; for the higher Truth lifts her voice,

the louder will error scream, until its inarticulate sound is forever

silenced in oblivion " …Mary Baker Eddy, Christian Science

To be removed from list, please hit reply and say " remove " .

------- End of Forwarded Message -------

" Diana Levine, a Vermont guitarist, lost her right arm below the elbow

after she was injected with Phenergan, a medicine for nausea, and

developed gangrene. She sued the manufacturer " However......

Top medical journal advises Supreme Court not to bar lawsuits over FDA-approved drugs

By RICARDO ALONSO-ZALDIVAR | Associated Press Writer 5:03 PM EDT, August 15, 2008 WASHINGTON (AP) _ Top doctors at the helm of one of the nation's most influential medical journals are giving the Supreme Court some unsolicited legal advice about a major case.

The Food and Drug Administration " is in no position " to guarantee drug safety, the editors of the New England Journal of Medicine said in a friend-of-the-court brief. Lawsuits can serve as " a vital deterrent " and protect consumers if drug companies don't disclose risks.

At issue is Wyeth v. Levine, a case expected to be heard this fall that could have far-reaching implications for litigation over allegedly harmful drugs, such as the painkiller Vioxx.Diana Levine, a Vermont guitarist, lost her right arm below the elbow after she was injected with Phenergan, a medicine for nausea, and developed gangrene. She sued the manufacturer, Wyeth, arguing that the company

had a duty to warn consumers that such injections could have devastating consequences. The courts in her state agreed, awarding her nearly $7 million. But Wyeth appealed, countering that it was protected from such lawsuits. It argued that the FDA's judgment could not, in effect, be overruled by a state court. FDA scientists had weighed the risks and benefits of Phenergan in approving the drug's prescribing literature, or label, as a guide for doctors. The FDA was aware of risks associated with injecting some forms of Phenergan, but the label did not specifically warn about the technique used with Levine.

Although the FDA is often called " the gold standard " in drug evaluation, the journal editors urged the justices to be skeptical. " The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety, " the doctors said in a brief filed Thursday.

Without the discoveries dredged up by plaintiffs' lawyers through liability litigation, " the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct. "

The medical editors joined 47 state attorneys general and two former FDA commissioners — David Kessler and Donald Kennedy — in supporting Levine's position. Kessler served in the Clinton administration and that of George H.W. Bush. Kennedy served in the Carter administration.

The case is being closely watched because earlier this year the Supreme Court ruled that manufacturers of FDA-approved medical devices were shielded from litigation in state courts.However, David Vladeck, a lawyer representing Kessler and Kennedy, said the statute that applies to medical devices is different from the law that governs

medications. " The law in the (devices) case had a pre-emption provision, " said Vladeck. " Congress has never put a pre-emption provision in the Food and Drug Act. " Nonetheless, the Bush administration is supporting Wyeth's position.

" FDA considers and approves specific labeling for a drug, and the drug manufacturer is generally barred from making unilateral changes to the FDA-approved labeling, " Solicitor General Paul D. Clement wrote in the administration's brief.

But journal editor Dr. Jeffrey M. Drazen said in an interview that he hoped arguments over legal distinctions would not obscure the reality that the FDA is overwhelmed trying to keep up with drug safety problems, which can range from rare but serious side effects, to shortcomings in manufacturing plants as far away as China.

" Even if the FDA is doing the best it can, it simply can't see the future clearly enough to pre-empt manufacturers from litigation, " he said. " The (court)

system represents one of the key defense mechanisms that individuals have if a manufacturer has not made the risks of a product clear to the public. "

-- Regards, Dannemannformer director, National Coalition of Organized Women (NCOW)www.ProgressiveConvergence.com

917 804-0786"It requires courage to utter truth; for the higher Truth lifts her voice, the louder will error scream, until its inarticulate sound is forever silenced in oblivion"…Mary Baker Eddy, Christian Science

To be removed from list, please hit reply and say " remove " .

August 17, 2008

The FDA is an under-funded/over-endowed/totally conflicted/ill-conceived government organization that has failed us miserably. It must be divided and conquered. Vote for anyone who pushes this agenda.--- On Sat, 8/16/08, Stephen Fox <stephen wrote:

Stephen Fox <stephen Top medical journal advises Supreme Court not to bar lawsuits over FDA-approved drugshealth_and_healing Date: Saturday, August 16, 2008, 11:45 PM

*"Diana Levine, a Vermont guitarist, lost her right arm below the elbowafter she was injected with Phenergan, a medicine for nausea, and developedgangrene. She sued the manufacturer" **However.... ..*Top medical journal advises Supreme Court not to bar lawsuits overFDA-approved drugs By RICARDO ALONSO-ZALDIVAR | Associated Press Writer 5:03PM EDT, August 15, 2008 WASHINGTON (AP) _ Top doctors at the helm of one ofthe nation's most influential medical journals are giving the Supreme Courtsome unsolicited legal advice about a major case.The Food and Drug Administration "is in no position" to guarantee drugsafety, the editors of the New England Journal of Medicine said in afriend-of-the- court brief. Lawsuits can serve as "a vital deterrent" andprotect consumers if drug companies don't disclose risks.At issue is Wyeth v. Levine, a case expected to be heard this fall thatcould have

far-reaching implications for litigation over allegedly harmfuldrugs, such as the painkiller Vioxx.Diana Levine, a Vermont guitarist, lost her right arm below the elbow aftershe was injected with Phenergan, a medicine for nausea, and developedgangrene. She sued the manufacturer, Wyeth, arguing that the company had aduty to warn consumers that such injections could have devastatingconsequences. The courts in her state agreed, awarding her nearly $7million.But Wyeth appealed, countering that it was protected from such lawsuits. Itargued that the FDA's judgment could not, in effect, be overruled by a statecourt. FDA scientists had weighed the risks and benefits of Phenergan inapproving the drug's prescribing literature, or label, as a guide fordoctors. The FDA was aware of risks associated with injecting some forms ofPhenergan, but the label did not specifically warn about the technique

usedwith Levine.Although the FDA is often called "the gold standard" in drug evaluation, thejournal editors urged the justices to be skeptical."The FDA alone simply lacks the ability to serve as the sole guarantor ofdrug safety," the doctors said in a brief filed Thursday. Without thediscoveries dredged up by plaintiffs' lawyers through liability litigation,"the FDA would be stripped of an essential source of information that theagency has consistently relied on when making its regulatory decisions, andthe American public would be deprived of a vital deterrent againstpharmaceutical company misconduct."The medical editors joined 47 state attorneys general and two former FDAcommissioners — David Kessler and Donald Kennedy — in supporting Levine'sposition. Kessler served in the Clinton administration and that of GeorgeH.W. Bush. Kennedy served in the Carter administration.The

case is being closely watched because earlier this year the SupremeCourt ruled that manufacturers of FDA-approved medical devices were shieldedfrom litigation in state courts.However, David Vladeck, a lawyer representing Kessler and Kennedy, said thestatute that applies to medical devices is different from the law thatgoverns medications."The law in the (devices) case had a pre-emption provision," said Vladeck."Congress has never put a pre-emption provision in the Food and Drug Act."Nonetheless, t*he Bush administration is supporting Wyeth's position.*"FDA considers and approves specific labeling for a drug, and the drugmanufacturer is generally barred from making unilateral changes to theFDA-approved labeling," Solicitor General Paul D. Clement wrote in theadministration' s brief.But journal editor Dr. Jeffrey M. Drazen said in an interview that he hopedarguments over legal

distinctions would not obscure the reality that the FDAis overwhelmed trying to keep up with drug safety problems, which can rangefrom rare but serious side effects, to shortcomings in manufacturing plantsas far away as China."Even if the FDA is doing the best it can, it simply can't see the futureclearly enough to pre-empt manufacturers from litigation," he said. "The(court) system represents one of the key defense mechanisms that individualshave if a manufacturer has not made the risks of a product clear to thepublic."-- Regards, Dannemannformer director, National Coalition of Organized Women (NCOW)www.ProgressiveConv ergence.com917 804-0786"It requires courage to utter truth; for the higher Truth lifts her voice,the louder will error scream, until its inarticulate sound is foreversilenced in oblivion"…Mary Baker Eddy, Christian ScienceTo be removed

from list, please hit reply and say "remove".------- End of Forwarded Message -------

"Diana Levine, a Vermont guitarist, lost her right arm below the elbow after she was injected with Phenergan, a medicine for nausea, and developed gangrene. She sued the manufacturer" However......

Top medical journal advises Supreme Court not to bar lawsuits over FDA-approved drugs

By RICARDO ALONSO-ZALDIVAR | Associated Press Writer

5:03 PM EDT, August 15, 2008

WASHINGTON (AP) _ Top doctors at the helm of one of the nation's most influential medical journals are giving the Supreme Court some unsolicited legal advice about a major case.The Food and Drug Administration "is in no position" to guarantee drug safety, the editors of the New England Journal of Medicine said in a friend-of-the-court brief. Lawsuits can serve as "a vital deterrent" and protect consumers if drug companies don't disclose risks.At issue is Wyeth v. Levine, a case expected to be heard this fall that could have far-reaching implications for litigation over allegedly harmful drugs, such as the painkiller Vioxx.Diana Levine, a Vermont guitarist, lost her right arm below the elbow after she was injected with Phenergan, a medicine for nausea, and developed gangrene. She sued the manufacturer, Wyeth, arguing that the company had a duty to warn consumers that such injections could have devastating

consequences. The courts in her state agreed, awarding her nearly $7 million.

But Wyeth appealed, countering that it was protected from such lawsuits. It argued that the FDA's judgment could not, in effect, be overruled by a state court. FDA scientists had weighed the risks and benefits of Phenergan in approving the drug's prescribing literature, or label, as a guide for doctors. The FDA was aware of risks associated with injecting some forms of Phenergan, but the label did not specifically warn about the technique used with Levine.Although the FDA is often called "the gold standard" in drug evaluation, the journal editors urged the justices to be skeptical.."The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety," the doctors said in a brief filed Thursday. Without the discoveries dredged up by plaintiffs' lawyers through liability litigation, "the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory

decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct."The medical editors joined 47 state attorneys general and two former FDA commissioners — David Kessler and Donald Kennedy — in supporting Levine's position. Kessler served in the Clinton administration and that of George H.W. Bush. Kennedy served in the Carter administration.The case is being closely watched because earlier this year the Supreme Court ruled that manufacturers of FDA-approved medical devices were shielded from litigation in state courts.However, David Vladeck, a lawyer representing Kessler and Kennedy, said the statute that applies to medical devices is different from the law that governs medications."The law in the (devices) case had a pre-emption provision," said Vladeck. "Congress has never put a pre-emption provision in the Food and Drug Act."Nonetheless, the Bush

administration is supporting Wyeth's position."FDA considers and approves specific labeling for a drug, and the drug manufacturer is generally barred from making unilateral changes to the FDA-approved labeling," Solicitor General Paul D. Clement wrote in the administration's brief.But journal editor Dr. Jeffrey M. Drazen said in an interview that he hoped arguments over legal distinctions would not obscure the reality that the FDA is overwhelmed trying to keep up with drug safety problems, which can range from rare but serious side effects, to shortcomings in manufacturing plants as far away as China."Even if the FDA is doing the best it can, it simply can't see the future clearly enough to pre-empt manufacturers from litigation," he said. "The (court) system represents one of the key defense mechanisms that individuals have if a manufacturer has not made the risks of a product clear to the

public."-- Regards, Dannemannformer director, National Coalition of Organized Women (NCOW)www.ProgressiveConvergence.com917 804-0786"It requires courage to utter truth; for the higher Truth lifts her voice, the louder will error scream, until its inarticulate sound is forever silenced in oblivion"…Mary Baker Eddy, Christian ScienceTo be removed from list, please hit reply and say "remove".

August 17, 2008

FOR TONY DE ANGELIS:

I like what you are saying, and think it would make a much greater tactical

impact if you would only take the time to post it at my webpost of the same

article at mybarackobama.com:

barackobama.com/page/community/post/stephenfox/gG5HqD

In fact, if you could go one step further and turn it into a 500-800 word

article, of course along the same lines, just with a bit more elaboration,

background, and examples, I would like to publish it widely, like at

opednews.com, transworldnews.com, and other sites. I am members of these

sites and it only takes a few seconds for me to send your idea to hundreds

of thousands, rather than just hundreds of readers, AND I want to make sure

that Obama supporters and all of the 92 groups of which I am a member hear

your comment.

Truly,

Stephen Fox, Contributing Editor, Santa Fe Sun News

> The FDA is an under-funded/over-endowed/totally conflicted/ill-

> conceived government organization that has failed us miserably. It

> must be divided and conquered. Vote for anyone who pushes this agenda.

August 17, 2008

Thanks for your work on this. I do not believe my ideas on this are of great enough impact and they have been repeated many times by those of more influence than I. However, if you think I have something of value to offer, other than an opinion or vote, I would gladly help by doing a webposting to your site.--- On Sun, 8/17/08, Stephen Fox <stephen wrote:

Stephen Fox <stephenRe: Top medical journal advises Supreme Court not to bar lawsuits over FDA-approved drugs Cc: tntstuartDate: Sunday, August 17, 2008, 3:52 PM

FOR TONY DE ANGELIS:I like what you are saying, and think it would make a much greater tactical impact if you would only take the time to post it at my webpost of the same article at mybarackobama. com:barackoba ma.com/page/ community/ post/stephenfox/ gG5HqDIn fact, if you could go one step further and turn it into a 500-800 word article, of course along the same lines, just with a bit more elaboration, background, and examples, I would like to publish it widely, like at opednews.com, transworldnews.. com, and other sites. I am members of these sites and it only takes a few seconds for me to send your idea to hundreds of thousands, rather than just hundreds of readers, AND I want to make sure that Obama supporters and all of the 92 groups of which I am a member hear your

comment.Truly,Stephen Fox, Contributing Editor, Santa Fe Sun News> The FDA is an under-funded/ over-endowed/ totally conflicted/ill-> conceived government organization that has failed us miserably. It > must be divided and conquered. Vote for anyone who pushes this agenda.