FDA and Big Pharma Gang Up On Joe Citizen //Pringle

[Guest guest]

I thought that Bioshield II had failed to be enacted, but--yet, no consumer

can bring a lawsuit against a drug's maker in a state court for injuries caused

by a drug, EVEN if it is shown that the drug company actively concealed

information about known injuries associated with the drug not only from

consumers, but from the FDA as well. Bush administration is but a pawn of

pharma.

......... " The pharma-FDA complex has to be dismantled and the American people

have to insist on that, otherwise we're going to have disasters like Vioxx that

happen in the future. "

 

FDA and Big Pharma Gang Up On Joe Citizen

 

http://www.lawyersandsettlements.com/articles/preemption.html

 

 

By *Evelyn Pringle*

 

*/Washington, DC:/ Since George W Bush took office, the botched

safety processes at the FDA have had an extremely negative impact on

the nation's public health and tens of thousands of people have died

as a result of its negligent handling of the Vioxx debacle alone.*

 

Americans today can no more trust what's in their medicine cabinets

than could the pioneers in the 1800s who filled their medicine

chests when the snake oil salesmen came to town.

 

 

In its latest stunt, the arrogant FDA

is now apparently claiming

infallibility by telling consumers that

if it says a drug is safe and the warnings on a drug's label are

sufficient, no consumer can bring a lawsuit against a drug's maker in a state

court for injuries caused by a drug, even if it is shown

that the drug company actively concealed information about known injuries

associated with the drug not only from consumers, but from the FDA as well.

 

Throughout the FDA's 100 year history, state consumer protection

laws have played an important role in protecting Americans from

unsafe pharmaceutical products, and consumer protection advocates

are rightfully questioning whether the FDA can or will provide the

same protection.

 

Its no secret that the Bush-FDA is hell-bent on protecting drug

company profits and could care less about protecting consumers from

unsafe drugs. A March 2006 report to Congress issued by the

Government Accountability Office, after an investigation of the FDA

ability to monitor drug safety, said the FDA's performance was

undermined by infighting between drug evaluation administrators

whose allegiance is with industry and the Office of Drug Safety.

 

According to Attorney, *Jim Gottstein*, who recently scored a major

victory in the Alaska Supreme Court protecting patients in state

institutions from forced drugging with psychiatric medications, " the

fact that current leaders of the FDA have taken the extraordinary

step of interjecting the FDA into cases to argue pre-emption, leaves

no doubt that it has abdicated its duty to protect the public from

unsafe drugs in favor of protecting pharmaceutical profits. "

 

State lawmakers are also crying foul over the FDA's arrogant

undermining of state consumer protection laws because under

Executive Order 13132, the FDA is required to consult with state

authorities about the effects of regulations it issues on states. In

the original proposed rule, the FDA specifically said that the

regulation would not preempt state laws so state officials had no

chance to object to the preemption rule.

 

According to the National Conference of State Legislatures, the

preemption language in the preamble to the Final Rule is a thinly

veiled attempt on the part of FDA to confer upon itself authority it

does not have by statute and does not have by way of judicial

ruling. The NCSL called FDA's action an abuse of agency process and

a complete disregard for our dual system of government.

 

According to Baum Hedlund attorney, Karen Barth Menzies, " the FDA's

statement is nothing more than the policy position of appointed

officials with an agenda unrelated to public safety. "

 

" As such, " she says, " it should have zero preemptive effect. "

 

When Congress enacted the Federal Food, Drug, and Cosmetic Act in

1938, it specifically rejected a proposal to include a private right

of action for damages caused by products regulated by the FDA, on

the grounds that a right of action already existed under state

common law.

 

The new FDA preemption rule provides no exceptions even in cases

like Vioxx where the FDA asked the company to change the warning

label based on reports of serious adverse effects, and a drug maker

like Merck refuses to change the label for more than 18 months while

many more patients are killed and injured.

 

In addition, the FDA contends that the agency's approval of the drug

label preempts not only claims related to label warnings but also

claims related to false advertising.

 

Given the on-going heated debate over the FDA's ability to police

the pharmaceutical industry as a whole, critics say it is a

particularly inappropriate time to eliminate the role that private

citizen lawsuits in state courts play.

 

But then again, what can we expect when a President recruits the

agency's top attorney, Daniel Troy, directly from Pfizer's stable of

lawyers. Troy began the administration's preemption war against Joe

Citizen to protect Big Pharma profits as soon as he set up shop at

the FDA, by filing amicus briefs on behalf of drug companies,

including Pfizer.

 

Even though Pfizer had been one of his clients and Troy's firm was

paid over $350,000 for work he performed in the year before he was

appointed chief counsel, Troy agreed to file a brief in support of

Pfizer on behalf of FDA, arguing, unsuccessfully it should be noted,

that state tort claims should be preempted.

 

He later justified writing the brief by claiming that he did not

become involved in the case until after the 1-year period in which

government employees may not participate in cases involving former

clients. In hindsight, the 1-year grace period reportedly expired

less than a month before Troy agreed to go to bat for his former client.

 

In stark contrast to Troy's pro drug company stance, in a 1996

speech, the Clinton appointed FDA chief counsel, Margaret Jane

Porter, said the FDA had a " longstanding presumption against

preemption " and that " FDA's view is that FDA product approval and

state tort liability usually operate independently, each providing a

significant, yet distinct, layer of consumer protection. "

 

When simply filing amicus briefs did not work because no judge

accepted the FDA's at best feeble and at worst ridiculous arguments,

in January 2006, the FDA added the preamble to the new drug labeling

rules stating that the Food, Drug and Cosmetic Act " pre-empts

conflicting or contrary state law. "

 

Judges are having mixed reactions to the FDA's preemption position.

In a stinging rebuke, New Jersey judge, Carol Higbee, during a June

6, 2006 hearing involving Vioxx lawsuits, called the Final Rule's

preamble " a political statement by the FDA. "

 

As for the claim that state lawsuits should be preempted, she said,

" It is contrary to the U.S. Supreme Court's decisions. It is

contrary to all the law on preemption. "

 

" In addition to being contrary to the law of the land, " she stated,

" it is also contrary to the Constitution of the United States. "

 

She ended her comments by telling Merck's Vioxx attorneys, " And I am

not going to allow you to use it. "

 

On June 2, 2006, the Associated Press reported that a federal judge

had refused to dismiss a lawsuit filed against Pfizer and Wyeth, on

behalf of the parents of an 11-year-old boy who committed suicide

after taking the antidepressants Zoloft and Effexor.

 

The judge rejected the preemption argument stating: " Federal

labeling laws are minimum standards; they do not necessarily shield

manufacturers from state law liability. "

 

" Defendant's pre-emption argument ultimately fails because Congress

has not expressed a specific intent to pre-empt state

consumer-protection laws in the area of prescription-drug labeling, "

the court said.

 

" In the absence of Congress's express statement, " the judge stated,

" defendant must overcome the presumption against implying

congressional pre-emptive intent. It has not done so. "

 

In what can only be viewed as a rare ruling, In Bextra and Celebrex,

on August 16, 2006, the US District Court for the Northern District

of California dismissed the state law failure-to-warn claims saying

they conflict with the FDA's determination of the proper warning and

pose an obstacle to the full accomplishment of the objectives of the

Food, Drug and Cosmetic Act.

 

The court attempted to justify the FDA's " 180-degree reversal of its

prior position " on preemption, by noting that an agency's view may

change over time and especially with a change in administration.

 

But in New Jersey on September 29, 2006, a federal district court in

McNellis v Pfizer Inc, refused to allow the preemption defense and

based on the fact that the text of FDA regulations had remained

unchanged for years, ruled that the regulations did not conflict

with New Jersey's failure-to-warn laws.

 

The court also said that FDA regulations allow increased warnings

when new risks emerge and that the Food, Drug and Cosmetic Act does

not contain a preemption clause.

 

Following the McNellis decision, on October 16, 2006, a federal

court in Pennsylvania refused to grant the drug maker's preemption

motion in Perry v Novartis Pharma Corp, noting concerns about the

effectiveness of the FDA's monitoring of recently approved drugs,

making the availability of state tort suits an " important backstop

to the federal regulatory scheme. "

 

On October 5, 2006, the 2nd Circuit Court of Appeals was also

critical of the FDA's preemptive reach stating, " [W]hatever

deference would be owed to an agency's view ... an agency cannot

supply, on Congress's behalf, the clear legislative statement of

intent required to overcome the presumption against preemption, " in

Desiano v Warner-Lambert et al.

 

Three weeks later, on October 28, 2006, the Associated Press

reported another state court victory against preemption in a case

where Wyeth was ordered to pay nearly $6.8 million to a Vermont

women after the Vermont Supreme Court upheld a lower court's ruling.

 

The court's decision said federal labeling requirements " create a

floor, not a ceiling " for state regulation, noting that the FDA

regulations allow drug companies to go beyond required warnings.

 

" When further warnings become necessary, the manufacturer is at

least partially responsible for taking additional action, and if it

fails to do so, it cannot rely on the FDA's continued approval of

its labels as a shield against state tort liability, " the court wrote.

 

Peter Lurie, deputy director of the health research group at Public

Citizen, told the Associated Press that the case appeared to mark a

push-back against efforts by the industry, the administration and

the FDA to preempt state regulation of prescription drugs.

 

" If you have a wide enough berth that you can strengthen the label, "

he said, " you can't use the FDA-approved label as an automatic

protection against lawsuits. "

 

Since May 2006, all eyes in the legal field have been on the appeal

in the case of Colacicco v Apotex, Inc, -- F Supp 2d --, 2006 WL

1443357 (ED Pa), in the 3rd Circuit Court of Appeals, where the

lower court ruled against a man whose wife committed suicide after

taking Paxil.

 

Joseph Colacicco file a lawsuit against both drug makers alleging

that his wife committed suicide in October 2003, just 21 days after

she began taking Paxil for mild depression with claims of wrongful

death, negligence and a failure to warn her doctor of a link between

Paxil and an increased risk of suicide.

 

In moving for dismissal, Paxil maker, GlaxoSmithKline, and Paxil

generic maker, Apotex, relied on the FDA's position that state

failure-to-warn claims are preempted.

 

The judge ruled that the defendants were entitled to a dismissal of

all claims because the FDA controls the content of warnings and

requires generic drug makers to use the same labeling as approved

for the drug's original maker.

 

In this case, the judge on his own initiative, asked the FDA to

submit an amicus brief. And in response, on the tax payer's dime,

the FDA wrote a brief asking the court to rule against the American

citizen and dismiss the lawsuit against the drug companies.

 

In fact the FDA was the strongest supporter of preemption in this

case because according to the attorneys handling the case, Glaxo

itself barely addressed the preemption issue during oral arguments

on the motion.

 

In a decision that experts predict may end up before the US Supreme

Court, the judge ended up dismissing the claims without ever

considering whether the FDA regulations pose a conflict to the

plaintiff's state tort claims.

 

Attorneys Derek Braslow, Harris Pogust and Matthew Leckman from the

Conshohocken,

Pennsylvania firm of Pogust & Braslow are representing the plaintiff

in the case.

 

Attorney, Harris Pogust, says the judge's ruling " could potentially

do away with all failure-to-warn pharmaceutical cases "

 

The FDA action he notes, " does not seem to be a public health

concern as much as a political concern. "

 

According to Mr Braslow, " the Judge readily admits that he did not

analyze whether there is or was a conflict between state law and

federal law and surmises that he probably would not find a conflict

if he actually did the analysis. "

 

" But, the Judge explained, " he said, " that it doesn't matter - if

the FDA says there is preemption, then there must be preemption. Far

be it for a Judge to interpret the law. "

 

" The Bush-era FDA, " Mr Braslow notes, " in a complete reversal of the

position it took in its 2000 rule proposal, has now officially

cemented its role as a pawn for the pharmaceutical industry. "

 

" It was not that long ago, " Mr Braslow points out, " that the FDA

came forward with amicus briefs on behalf of the consumer in

prescription drug litigation. "

 

" Now, " Mr Braslow says, " an argument first put forward in a couple

Zoloft suicide cases, has become the primary argument in every

prescription drug case, and could, " he warns, " potentially, mean the

end for anyone seeking recourse from injuries resulting from

prescription drugs, no matter how fraudulent the drug company's

conduct. "

 

" Make no mistake, " he states, " the position taken by the Bush-era

FDA is an attempt by the current administration to achieve tort

reform for the benefit of big pharma and at the expense of the

injured consumer, without the consent of Congress. "

 

" The Bush-era FDA takes this position, " he warns, " unconcerned by

the reality that preemption would allow drug companies to peddle

their drugs with impunity and avoid being justifiably called into

court for deceiving the public about the safety and effectiveness of

those drugs. "

 

" Notwithstanding the FDA's position on preemption, " Mr Braslow says,

" courts examining this issue, if they take any time to actually look

at the FDA regulations in question, would realize that there is no

conflict between federal drug regulations and state tort claims. "

 

" Federal drug regulations specifically mandate drug companies to

strengthen their drug's label, " he explains, " as soon as there is

reasonable evidence of an association of a serious hazard with their

drug. "

 

" A state tort claim, " Mr Braslow points out, " does not force a drug

company to take any action that is not already permitted by federal

regulations. "

 

" Because federal regulations for prescription drugs are minimum

standards, " he notes, " federal regulations can never conflict with a

state common law claim. "

 

" The District Court erred, " he states, " in abdicating to FDA legal

opinion, as opposed to interpreting the law. "

 

" What the Colacicco court did, " he says, " was improperly abdicate to

the FDA's legal opinion. "

 

Critics say its time for the FDA to get back to protecting consumers

from dangerous products, rather than protecting the profits of the

pharmaceutical industry. According to career scientist, Dr David

Graham, in a 2005 interview with Jeanne Lenzer in the journal Public

Library of Science, " The pharma-FDA complex has to be dismantled and

the American people have to insist on that, otherwise we're going to

have disasters like Vioxx that happen in the future. "

 

 

 

 

Beware the needle; check http://www.whale.to/vaccine/quotes3.html to see why...

" If people let the government decide what foods they eat and what medicines they

take, their bodies will soon be in as sorry a state as the souls who live under

tyranny. " - Thomas Jefferson

 

Mudville Rose

 

 

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