A Case for Industry (and plaintiff council) to follow:

[Guest guest]

September 19, 2008

Drug Label, Maimed Patient and Test for Court

By ADAM LIPTAK

<http://topics.nytimes.com/top/reference/timestopics/people/l/adam_liptak/index.\

html?inline=nyt-per>

MARSHFIELD, Vt. - When Levine starts talking about her rock 'n' roll days,

she plays a little air guitar, mimicking the way she used to handle her electric

bass in bands like the Re-Bops and Duke and the Detours. But Ms. Levine is

missing much of her right arm, which was amputated below the elbow after a

medical disaster.

She sits at her kitchen table, strumming an imaginary guitar with a phantom

hand.

In November, the Supreme Court will hear arguments about whether Ms. Levine may

keep more than $6 million that a Vermont

<http://topics.nytimes.com/top/news/national/usstatesterritoriesandpossessions/v\

ermont/index.html?inline=nyt-geo> jury ordered Wyeth, a pharmaceutical company,

to pay her for failing to warn her adequately about the risks of one of its

drugs. The case, the latest in a brisk parade of similar ones, will help define

the contours of a signature project of the court.

In legal jargon, the cases concern " pre-emption, " a doctrine that can bar

injured consumers like Ms. Levine from suing in state court when the products

that hurt them had met federal standards. The issue is less boring and more

consequential than it sounds, and Ms. Levine's case is shaping up to be the most

important business case of the term.

" Federal pre-emption is the fiercest battle in products liability law today, "

said M. Sharkey, a law professor at New York University

<http://topics.nytimes.com/top/reference/timestopics/organizations/n/new_york_un\

iversity/index.html?inline=nyt-org> . " The court clearly recognizes this, as it

has agreed to hear so many cases and seems eager to give clarity to what has

been, to date, an undisputably muddled area of law. "

A second pre-emption case, this one concerning cigarette labels, is scheduled

for the first argument of the new term, on Oct. 6.

Business groups, often supported by the Bush administration, have vigorously

pursued pre-emption arguments, hoping to build a barrier against many kinds of

injury suits. Plaintiffs' lawyers oppose broad pre-emption doctrines, saying

they short-circuit valid claims arising from terrible injuries.

Ms. Levine is a trim, elegant 62-year-old who now favors three-quarter length

sleeves, just long enough to cover what remains of her right arm. But she

gestures enthusiastically with both arms, and she retains a playful side.

Her house is jammed with whimsical toys - a papier-mâché giraffe, an enormous

telephone receiver. In the control room of her recording studio, there is a copy

of " Hand, Hand, Fingers, Thumb, " a children's book. " It's just sarcasm, " she

explained.

In the spring of 2000, suffering from a migraine, Ms. Levine visited a clinic

near here for a treatment she had received many times: Demerol for the pain and

Wyeth's drug Phenergan for nausea.

" Nothing wrong with either drug, " Ms. Levine said. " They're both safe when given

the right way. "

But if Phenergan is exposed to arterial blood, it causes swift and irreversible

gangrene. For that reason, it is typically administered by intramuscular

injection. According to Ms. Levine's lawyers, using an intravenous drip is

almost entirely safe as well.

This time, though, a physician's assistant used a third method. She injected the

drug into what she thought was a vein, a method known as " IV push. " But the

assistant apparently missed.

In the following weeks, Ms. Levine's hand and forearm turned purple and then

black, and they were amputated in two stages.

The drug's label, approved by the Food and Drug Administration

<http://topics.nytimes.com/top/reference/timestopics/organizations/f/food_and_dr\

ug_administration/index.html?inline=nyt-org> , had warned that " inadvertent

intra-arterial injection " can result in " gangrene requiring amputation. " But it

did not rule out administration of the drug by IV push.

Ms. Levine said no one had discussed the risks of IV push with her, or the only

benefit generally associated with intravenous administration - " more potent and

expeditious antinausea relief, " in the words of Wyeth's brief.

" The benefit-risk is just outrageously ridiculous, " Ms. Levine said. " Any child

could figure this out. "

Faster nausea relief, she said, is not worth the risk of losing an arm.

Ms. Levine settled a lawsuit against the clinic, and she went to trial in

Montpelier, not far from here, against Wyeth. She said Wyeth should have added a

stronger warning to the label that the F.D.A. had approved.

" All they had to do, " Ms. Levine said, " was change the label and say, 'Don't

give it this way.' "

Lawyers for Wyeth said that was not an option, at least in the absence of new

information. " Wyeth could not change Phenergan's labeling to comply with Vermont

law without violating federal law, " they wrote in a brief. Ms. Levine's lawyers

disagreed, saying that tougher warnings were always permissible.

That is the crux of the issue. Do the F.D.A. and other federal regulators set

minimum safety standards that states are free to augment? Or do they make

judgments about the optimal balance between risks and benefits that states must

follow?

In February, in Riegel v. Medtronic, an eight-justice majority of the Supreme

Court ruled that many suits concerning injuries caused by medical devices were

pre-empted by a 1976 federal law, in so many words. Ms. Levine's suit represents

the next frontier.

" Riegel boiled down to statutory interpretation, " said Professor Sharkey, of

N.Y.U. " Levine challenges the court to define the parameters of pre-emption

outside the safe confines of the legislators' text. "

The law at issue in the Levine case does not expressly require pre-emption.

Rather, Wyeth and the F.D.A. argue that the company could not comply with both

federal law, given its requirement that the agency approve drug labels, and the

jury's verdict, which punished Wyeth for not using a different one. That

conflict, they say, amounts to " implied pre-emption. "

The Vermont Supreme Court rejected that argument and upheld the jury's verdict

in 2006. Federal law, the majority ruled, " provides a floor, not a ceiling, for

state regulation. "

Chief Justice L. Reiber, who dissented, wrote: " No drug is without risks.

The F.D.A. balances the risks of a drug against its benefits to maximize the

availability of beneficial treatments.

" A jury does not engage in a measured and multifaceted policy analysis. Rather,

a jury views the safety of the drug through the lens of a single patient who has

already been catastrophically injured. "

But Ms. Levine said that the jury in her case was careful and conscientious and

that Vermonters were not noted for their financial profligacy. The award the

jury gave her, she said, was the result of a hard look at a grave wrong.

" I'm a musician, " she said. " For me, it's catastrophic because it took away my

whole livelihood, my whole way of expressing myself. They lopped off my hand,

and they leveled my career. And it didn't have to happen. "

S. Kalman PhD, RD, CCRC, FACN

Miami Research Associates

Director, Nutrition & Applied Clinical Research

6141 Sunset Drive #301

Miami, FL. 33143

(fax)

www.miamiresearch.com <http://www.miamiresearch.com>

[Guest guest]

>This is story is unreal since Phenergan comes in a

suppository that works immediately to stop nausea. Best, V

September 19, 2008

>

>

> Drug Label, Maimed Patient and Test for Court

>

>

> By ADAM LIPTAK

> <http://topics.nytimes.com/top/reference/timestopics/peopl

> e/l/adam_liptak/index.html?inline=nyt-per>

>

> MARSHFIELD, Vt. - When Levine starts talking about

> her rock 'n' roll days, she plays a little air guitar,

> mimicking the way she used to handle her electric bass in

> bands like the Re-Bops and Duke and the Detours. But Ms.

> Levine is missing much of her right arm, which was

> amputated below the elbow after a medical disaster.

>

> She sits at her kitchen table, strumming an imaginary

> guitar with a phantom hand.

>

> In November, the Supreme Court will hear arguments about

> whether Ms. Levine may keep more than $6 million that a

> Vermont

> <http://topics.nytimes.com/top/news/national/usstatesterri

> toriesandpossessions/vermont/index.html?inline=nyt-geo>

> jury ordered Wyeth, a pharmaceutical company, to pay her

> for failing to warn her adequately about the risks of one

> of its drugs. The case, the latest in a brisk parade of

> similar ones, will help define the contours of a signature

> project of the court.

>

> In legal jargon, the cases concern " pre-emption, " a

> doctrine that can bar injured consumers like Ms. Levine

> from suing in state court when the products that hurt them

> had met federal standards. The issue is less boring and

> more consequential than it sounds, and Ms. Levine's case

> is shaping up to be the most important business case of

> the term.

>

> " Federal pre-emption is the fiercest battle in products

> liability law today, " said M. Sharkey, a law

> professor at New York University

> <http://topics.nytimes.com/top/reference/timestopics/organ

>

izations/n/new_york_university/index.html?inline=nyt-org>

> . " The court clearly recognizes this, as it has agreed to

> hear so many cases and seems eager to give clarity to what

> has been, to date, an undisputably muddled area of law. "

>

> A second pre-emption case, this one concerning cigarette

> labels, is scheduled for the first argument of the new

> term, on Oct. 6.

>

> Business groups, often supported by the Bush

> administration, have vigorously pursued pre-emption

> arguments, hoping to build a barrier against many kinds of

> injury suits. Plaintiffs' lawyers oppose broad pre-emption

> doctrines, saying they short-circuit valid claims arising

> from terrible injuries.

>

> Ms. Levine is a trim, elegant 62-year-old who now favors

> three-quarter length sleeves, just long enough to cover

> what remains of her right arm. But she gestures

> enthusiastically with both arms, and she retains a playful

> side.

>

> Her house is jammed with whimsical toys - a

papier-mâché

> giraffe, an enormous telephone receiver. In the control

> room of her recording studio, there is a copy of " Hand,

> Hand, Fingers, Thumb, " a children's book. " It's just

> sarcasm, " she explained.

>

> In the spring of 2000, suffering from a migraine, Ms.

> Levine visited a clinic near here for a treatment she had

> received many times: Demerol for the pain and Wyeth's drug

> Phenergan for nausea.

>

> " Nothing wrong with either drug, " Ms. Levine said.

> " They're both safe when given the right way. "

>

> But if Phenergan is exposed to arterial blood, it causes

> swift and irreversible gangrene. For that reason, it is

> typically administered by intramuscular injection.

> According to Ms. Levine's lawyers, using an intravenous

> drip is almost entirely safe as well.

>

> This time, though, a physician's assistant used a third

> method. She injected the drug into what she thought was a

> vein, a method known as " IV push. " But the assistant

> apparently missed.

>

> In the following weeks, Ms. Levine's hand and forearm

> turned purple and then black, and they were amputated in

> two stages.

>

> The drug's label, approved by the Food and Drug

> Administration

> <http://topics.nytimes.com/top/reference/timestopics/organ

>

izations/f/food_and_drug_administration/index.html?inline=

> nyt-org> , had warned that " inadvertent intra-arterial

> injection " can result in " gangrene requiring amputation. "

> But it did not rule out administration of the drug by IV

> push.

>

> Ms. Levine said no one had discussed the risks of IV push

> with her, or the only benefit generally associated with

> intravenous administration - " more potent and expeditious

> antinausea relief, " in the words of Wyeth's brief.

>

> " The benefit-risk is just outrageously ridiculous, " Ms.

> Levine said. " Any child could figure this out. "

>

> Faster nausea relief, she said, is not worth the risk of

> losing an arm.

>

> Ms. Levine settled a lawsuit against the clinic, and she

> went to trial in Montpelier, not far from here, against

> Wyeth. She said Wyeth should have added a stronger warning

> to the label that the F.D.A. had approved.

>

> " All they had to do, " Ms. Levine said, " was change the

> label and say, 'Don't give it this way.' "

>

> Lawyers for Wyeth said that was not an option, at least in

> the absence of new information. " Wyeth could not change

> Phenergan's labeling to comply with Vermont law without

> violating federal law, " they wrote in a brief. Ms.

> Levine's lawyers disagreed, saying that tougher warnings

> were always permissible.

>

> That is the crux of the issue. Do the F.D.A. and other

> federal regulators set minimum safety standards that

> states are free to augment? Or do they make judgments

> about the optimal balance between risks and benefits that

> states must follow?

>

> In February, in Riegel v. Medtronic, an eight-justice

> majority of the Supreme Court ruled that many suits

> concerning injuries caused by medical devices were

> pre-empted by a 1976 federal law, in so many words. Ms.

> Levine's suit represents the next frontier.

>

> " Riegel boiled down to statutory interpretation, " said

> Professor Sharkey, of N.Y.U. " Levine challenges the court

> to define the parameters of pre-emption outside the safe

> confines of the legislators' text. "

>

> The law at issue in the Levine case does not expressly

> require pre-emption. Rather, Wyeth and the F.D.A. argue

> that the company could not comply with both federal law,

> given its requirement that the agency approve drug labels,

> and the jury's verdict, which punished Wyeth for not using

> a different one. That conflict, they say, amounts to

> " implied pre-emption. "

>

> The Vermont Supreme Court rejected that argument and

> upheld the jury's verdict in 2006. Federal law, the

> majority ruled, " provides a floor, not a ceiling, for

> state regulation. "

>

> Chief Justice L. Reiber, who dissented, wrote: " No

> drug is without risks. The F.D.A. balances the risks of a

> drug against its benefits to maximize the availability of

> beneficial treatments.

>

> " A jury does not engage in a measured and multifaceted

> policy analysis. Rather, a jury views the safety of the

> drug through the lens of a single patient who has already

> been catastrophically injured. "

>

> But Ms. Levine said that the jury in her case was careful

> and conscientious and that Vermonters were not noted for

> their financial profligacy. The award the jury gave her,

> she said, was the result of a hard look at a grave wrong.

>

> " I'm a musician, " she said. " For me, it's catastrophic

> because it took away my whole livelihood, my whole way of

> expressing myself. They lopped off my hand, and they

> leveled my career. And it didn't have to happen. "

>

>

>

>

>

> S. Kalman PhD, RD, CCRC, FACN

>

> Miami Research Associates

>

> Director, Nutrition & Applied Clinical Research

>

> 6141 Sunset Drive #301

>

> Miami, FL. 33143

>

>

>

> (fax)

>

> www.miamiresearch.com <http://www.miamiresearch.com>

>

>

>

>

>

>

[Guest guest]

>This is story is unreal since Phenergan comes in a

suppository that works immediately to stop nausea. Best, V

September 19, 2008

>

>

> Drug Label, Maimed Patient and Test for Court

>

>

> By ADAM LIPTAK

> <http://topics.nytimes.com/top/reference/timestopics/peopl

> e/l/adam_liptak/index.html?inline=nyt-per>

>

> MARSHFIELD, Vt. - When Levine starts talking about

> her rock 'n' roll days, she plays a little air guitar,

> mimicking the way she used to handle her electric bass in

> bands like the Re-Bops and Duke and the Detours. But Ms.

> Levine is missing much of her right arm, which was

> amputated below the elbow after a medical disaster.

>

> She sits at her kitchen table, strumming an imaginary

> guitar with a phantom hand.

>

> In November, the Supreme Court will hear arguments about

> whether Ms. Levine may keep more than $6 million that a

> Vermont

> <http://topics.nytimes.com/top/news/national/usstatesterri

> toriesandpossessions/vermont/index.html?inline=nyt-geo>

> jury ordered Wyeth, a pharmaceutical company, to pay her

> for failing to warn her adequately about the risks of one

> of its drugs. The case, the latest in a brisk parade of

> similar ones, will help define the contours of a signature

> project of the court.

>

> In legal jargon, the cases concern " pre-emption, " a

> doctrine that can bar injured consumers like Ms. Levine

> from suing in state court when the products that hurt them

> had met federal standards. The issue is less boring and

> more consequential than it sounds, and Ms. Levine's case

> is shaping up to be the most important business case of

> the term.

>

> " Federal pre-emption is the fiercest battle in products

> liability law today, " said M. Sharkey, a law

> professor at New York University

> <http://topics.nytimes.com/top/reference/timestopics/organ

>

izations/n/new_york_university/index.html?inline=nyt-org>

> . " The court clearly recognizes this, as it has agreed to

> hear so many cases and seems eager to give clarity to what

> has been, to date, an undisputably muddled area of law. "

>

> A second pre-emption case, this one concerning cigarette

> labels, is scheduled for the first argument of the new

> term, on Oct. 6.

>

> Business groups, often supported by the Bush

> administration, have vigorously pursued pre-emption

> arguments, hoping to build a barrier against many kinds of

> injury suits. Plaintiffs' lawyers oppose broad pre-emption

> doctrines, saying they short-circuit valid claims arising

> from terrible injuries.

>

> Ms. Levine is a trim, elegant 62-year-old who now favors

> three-quarter length sleeves, just long enough to cover

> what remains of her right arm. But she gestures

> enthusiastically with both arms, and she retains a playful

> side.

>

> Her house is jammed with whimsical toys - a

papier-mâché

> giraffe, an enormous telephone receiver. In the control

> room of her recording studio, there is a copy of " Hand,

> Hand, Fingers, Thumb, " a children's book. " It's just

> sarcasm, " she explained.

>

> In the spring of 2000, suffering from a migraine, Ms.

> Levine visited a clinic near here for a treatment she had

> received many times: Demerol for the pain and Wyeth's drug

> Phenergan for nausea.

>

> " Nothing wrong with either drug, " Ms. Levine said.

> " They're both safe when given the right way. "

>

> But if Phenergan is exposed to arterial blood, it causes

> swift and irreversible gangrene. For that reason, it is

> typically administered by intramuscular injection.

> According to Ms. Levine's lawyers, using an intravenous

> drip is almost entirely safe as well.

>

> This time, though, a physician's assistant used a third

> method. She injected the drug into what she thought was a

> vein, a method known as " IV push. " But the assistant

> apparently missed.

>

> In the following weeks, Ms. Levine's hand and forearm

> turned purple and then black, and they were amputated in

> two stages.

>

> The drug's label, approved by the Food and Drug

> Administration

> <http://topics.nytimes.com/top/reference/timestopics/organ

>

izations/f/food_and_drug_administration/index.html?inline=

> nyt-org> , had warned that " inadvertent intra-arterial

> injection " can result in " gangrene requiring amputation. "

> But it did not rule out administration of the drug by IV

> push.

>

> Ms. Levine said no one had discussed the risks of IV push

> with her, or the only benefit generally associated with

> intravenous administration - " more potent and expeditious

> antinausea relief, " in the words of Wyeth's brief.

>

> " The benefit-risk is just outrageously ridiculous, " Ms.

> Levine said. " Any child could figure this out. "

>

> Faster nausea relief, she said, is not worth the risk of

> losing an arm.

>

> Ms. Levine settled a lawsuit against the clinic, and she

> went to trial in Montpelier, not far from here, against

> Wyeth. She said Wyeth should have added a stronger warning

> to the label that the F.D.A. had approved.

>

> " All they had to do, " Ms. Levine said, " was change the

> label and say, 'Don't give it this way.' "

>

> Lawyers for Wyeth said that was not an option, at least in

> the absence of new information. " Wyeth could not change

> Phenergan's labeling to comply with Vermont law without

> violating federal law, " they wrote in a brief. Ms.

> Levine's lawyers disagreed, saying that tougher warnings

> were always permissible.

>

> That is the crux of the issue. Do the F.D.A. and other

> federal regulators set minimum safety standards that

> states are free to augment? Or do they make judgments

> about the optimal balance between risks and benefits that

> states must follow?

>

> In February, in Riegel v. Medtronic, an eight-justice

> majority of the Supreme Court ruled that many suits

> concerning injuries caused by medical devices were

> pre-empted by a 1976 federal law, in so many words. Ms.

> Levine's suit represents the next frontier.

>

> " Riegel boiled down to statutory interpretation, " said

> Professor Sharkey, of N.Y.U. " Levine challenges the court

> to define the parameters of pre-emption outside the safe

> confines of the legislators' text. "

>

> The law at issue in the Levine case does not expressly

> require pre-emption. Rather, Wyeth and the F.D.A. argue

> that the company could not comply with both federal law,

> given its requirement that the agency approve drug labels,

> and the jury's verdict, which punished Wyeth for not using

> a different one. That conflict, they say, amounts to

> " implied pre-emption. "

>

> The Vermont Supreme Court rejected that argument and

> upheld the jury's verdict in 2006. Federal law, the

> majority ruled, " provides a floor, not a ceiling, for

> state regulation. "

>

> Chief Justice L. Reiber, who dissented, wrote: " No

> drug is without risks. The F.D.A. balances the risks of a

> drug against its benefits to maximize the availability of

> beneficial treatments.

>

> " A jury does not engage in a measured and multifaceted

> policy analysis. Rather, a jury views the safety of the

> drug through the lens of a single patient who has already

> been catastrophically injured. "

>

> But Ms. Levine said that the jury in her case was careful

> and conscientious and that Vermonters were not noted for

> their financial profligacy. The award the jury gave her,

> she said, was the result of a hard look at a grave wrong.

>

> " I'm a musician, " she said. " For me, it's catastrophic

> because it took away my whole livelihood, my whole way of

> expressing myself. They lopped off my hand, and they

> leveled my career. And it didn't have to happen. "

>

>

>

>

>

> S. Kalman PhD, RD, CCRC, FACN

>

> Miami Research Associates

>

> Director, Nutrition & Applied Clinical Research

>

> 6141 Sunset Drive #301

>

> Miami, FL. 33143

>

>

>

> (fax)

>

> www.miamiresearch.com <http://www.miamiresearch.com>

>

>

>

>

>

>

[Guest guest]

>This is story is unreal since Phenergan comes in a

suppository that works immediately to stop nausea. Best, V

September 19, 2008

>

>

> Drug Label, Maimed Patient and Test for Court

>

>

> By ADAM LIPTAK

> <http://topics.nytimes.com/top/reference/timestopics/peopl

> e/l/adam_liptak/index.html?inline=nyt-per>

>

> MARSHFIELD, Vt. - When Levine starts talking about

> her rock 'n' roll days, she plays a little air guitar,

> mimicking the way she used to handle her electric bass in

> bands like the Re-Bops and Duke and the Detours. But Ms.

> Levine is missing much of her right arm, which was

> amputated below the elbow after a medical disaster.

>

> She sits at her kitchen table, strumming an imaginary

> guitar with a phantom hand.

>

> In November, the Supreme Court will hear arguments about

> whether Ms. Levine may keep more than $6 million that a

> Vermont

> <http://topics.nytimes.com/top/news/national/usstatesterri

> toriesandpossessions/vermont/index.html?inline=nyt-geo>

> jury ordered Wyeth, a pharmaceutical company, to pay her

> for failing to warn her adequately about the risks of one

> of its drugs. The case, the latest in a brisk parade of

> similar ones, will help define the contours of a signature

> project of the court.

>

> In legal jargon, the cases concern " pre-emption, " a

> doctrine that can bar injured consumers like Ms. Levine

> from suing in state court when the products that hurt them

> had met federal standards. The issue is less boring and

> more consequential than it sounds, and Ms. Levine's case

> is shaping up to be the most important business case of

> the term.

>

> " Federal pre-emption is the fiercest battle in products

> liability law today, " said M. Sharkey, a law

> professor at New York University

> <http://topics.nytimes.com/top/reference/timestopics/organ

>

izations/n/new_york_university/index.html?inline=nyt-org>

> . " The court clearly recognizes this, as it has agreed to

> hear so many cases and seems eager to give clarity to what

> has been, to date, an undisputably muddled area of law. "

>

> A second pre-emption case, this one concerning cigarette

> labels, is scheduled for the first argument of the new

> term, on Oct. 6.

>

> Business groups, often supported by the Bush

> administration, have vigorously pursued pre-emption

> arguments, hoping to build a barrier against many kinds of

> injury suits. Plaintiffs' lawyers oppose broad pre-emption

> doctrines, saying they short-circuit valid claims arising

> from terrible injuries.

>

> Ms. Levine is a trim, elegant 62-year-old who now favors

> three-quarter length sleeves, just long enough to cover

> what remains of her right arm. But she gestures

> enthusiastically with both arms, and she retains a playful

> side.

>

> Her house is jammed with whimsical toys - a

papier-mâché

> giraffe, an enormous telephone receiver. In the control

> room of her recording studio, there is a copy of " Hand,

> Hand, Fingers, Thumb, " a children's book. " It's just

> sarcasm, " she explained.

>

> In the spring of 2000, suffering from a migraine, Ms.

> Levine visited a clinic near here for a treatment she had

> received many times: Demerol for the pain and Wyeth's drug

> Phenergan for nausea.

>

> " Nothing wrong with either drug, " Ms. Levine said.

> " They're both safe when given the right way. "

>

> But if Phenergan is exposed to arterial blood, it causes

> swift and irreversible gangrene. For that reason, it is

> typically administered by intramuscular injection.

> According to Ms. Levine's lawyers, using an intravenous

> drip is almost entirely safe as well.

>

> This time, though, a physician's assistant used a third

> method. She injected the drug into what she thought was a

> vein, a method known as " IV push. " But the assistant

> apparently missed.

>

> In the following weeks, Ms. Levine's hand and forearm

> turned purple and then black, and they were amputated in

> two stages.

>

> The drug's label, approved by the Food and Drug

> Administration

> <http://topics.nytimes.com/top/reference/timestopics/organ

>

izations/f/food_and_drug_administration/index.html?inline=

> nyt-org> , had warned that " inadvertent intra-arterial

> injection " can result in " gangrene requiring amputation. "

> But it did not rule out administration of the drug by IV

> push.

>

> Ms. Levine said no one had discussed the risks of IV push

> with her, or the only benefit generally associated with

> intravenous administration - " more potent and expeditious

> antinausea relief, " in the words of Wyeth's brief.

>

> " The benefit-risk is just outrageously ridiculous, " Ms.

> Levine said. " Any child could figure this out. "

>

> Faster nausea relief, she said, is not worth the risk of

> losing an arm.

>

> Ms. Levine settled a lawsuit against the clinic, and she

> went to trial in Montpelier, not far from here, against

> Wyeth. She said Wyeth should have added a stronger warning

> to the label that the F.D.A. had approved.

>

> " All they had to do, " Ms. Levine said, " was change the

> label and say, 'Don't give it this way.' "

>

> Lawyers for Wyeth said that was not an option, at least in

> the absence of new information. " Wyeth could not change

> Phenergan's labeling to comply with Vermont law without

> violating federal law, " they wrote in a brief. Ms.

> Levine's lawyers disagreed, saying that tougher warnings

> were always permissible.

>

> That is the crux of the issue. Do the F.D.A. and other

> federal regulators set minimum safety standards that

> states are free to augment? Or do they make judgments

> about the optimal balance between risks and benefits that

> states must follow?

>

> In February, in Riegel v. Medtronic, an eight-justice

> majority of the Supreme Court ruled that many suits

> concerning injuries caused by medical devices were

> pre-empted by a 1976 federal law, in so many words. Ms.

> Levine's suit represents the next frontier.

>

> " Riegel boiled down to statutory interpretation, " said

> Professor Sharkey, of N.Y.U. " Levine challenges the court

> to define the parameters of pre-emption outside the safe

> confines of the legislators' text. "

>

> The law at issue in the Levine case does not expressly

> require pre-emption. Rather, Wyeth and the F.D.A. argue

> that the company could not comply with both federal law,

> given its requirement that the agency approve drug labels,

> and the jury's verdict, which punished Wyeth for not using

> a different one. That conflict, they say, amounts to

> " implied pre-emption. "

>

> The Vermont Supreme Court rejected that argument and

> upheld the jury's verdict in 2006. Federal law, the

> majority ruled, " provides a floor, not a ceiling, for

> state regulation. "

>

> Chief Justice L. Reiber, who dissented, wrote: " No

> drug is without risks. The F.D.A. balances the risks of a

> drug against its benefits to maximize the availability of

> beneficial treatments.

>

> " A jury does not engage in a measured and multifaceted

> policy analysis. Rather, a jury views the safety of the

> drug through the lens of a single patient who has already

> been catastrophically injured. "

>

> But Ms. Levine said that the jury in her case was careful

> and conscientious and that Vermonters were not noted for

> their financial profligacy. The award the jury gave her,

> she said, was the result of a hard look at a grave wrong.

>

> " I'm a musician, " she said. " For me, it's catastrophic

> because it took away my whole livelihood, my whole way of

> expressing myself. They lopped off my hand, and they

> leveled my career. And it didn't have to happen. "

>

>

>

>

>

> S. Kalman PhD, RD, CCRC, FACN

>

> Miami Research Associates

>

> Director, Nutrition & Applied Clinical Research

>

> 6141 Sunset Drive #301

>

> Miami, FL. 33143

>

>

>

> (fax)

>

> www.miamiresearch.com <http://www.miamiresearch.com>

>

>

>

>

>

>