[SSRI-Research] [archives] Plaintiffs in Class Action Submit Scathing Response to Paxil is Non-Habit Forming

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[sSRI-Research] [archives] Plaintiffs in Class Action Submit Scathing

Response to " Paxil is Non-Habit Forming "

 

http://www.baumhedlundlaw.com/media/ssri/paxil/Injunction/pr_inj3.htm

 

 

August 21, 2002

Baum Hedlund et al

 

12100 Wilshire Blvd., Suite 950

Los Angeles, CA 90025

Web: www.baumhedlundlaw.com

 

 

Plaintiffs in Class Action Submit Scathing Response to FDA's Intervention

Regarding Court Order Requiring GSK to Pull TV Ads That State Paxil is

Non-Habit Forming

 

 

Los Angeles, August 21, 2002 - - The Plaintiffs in a Nationwide Class Action

lawsuit have filed a scathing response to the FDA's eleventh hour " Statement

of Interest " related to a US District Court's Order that requires GSK to

pull television commercials that claim Paxil is " non-habit forming. "

 

Plaintiffs' request for a preliminary injunction asked the Court to stop GSK

from making three advertising claims in its promotional brochures and

television commercials: 1) that Paxil " may cause mild, usually temporary,

side effects in some individuals; " 2) that " Paxil has been studied both in

short-term and long-term use and is not associated with dependence or

addiction; " and, 3) that " Paxil is non-habit forming. "

 

GSK conceded with the Class Plaintiffs' lawyers prior to the hearing on the

preliminary injunction that it would stop distributing promotional brochures

stating that Paxil " may cause mild, usually temporary side effects in some

individuals " and " Paxil has been studied both in short-term and long-term

use and is not associated with dependence or addiction. " According to Karen

Barth, attorney for the Plaintiffs: " These claims were absolutely false and

misleading on their face, but the FDA did nothing about them. It wasn't the

FDA that got GSK to stop this false and misleading advertising -- it was a

group of Plaintiffs who accomplished this. Where was the FDA when these

false and misleading claims were being made to the consuming public? Can the

consuming public really trust that the FDA is protecting their interests

under these circumstances? If it had been left to the FDA, these

misrepresentations that GSK has now conceded would still be out there. "

 

According to lawyers representing the Class Plaintiffs:

 

" The intervention by the Food & Drug Administration (FDA) to support

GlaxoSmithkline (GSK) before the U.S. District Court in insisting Paxil is

'non habit forming' is illustrative of a continuing problem for the American

consumer. The FDA apparently is more concerned about the welfare of

pharmaceutical companies than consumers. Going to the legal merits of the

Paxil 'habit forming' issue, the court rightly ruled for the plaintiffs

because the operative test for determining the truthfulness of an

advertisement is the context of common usage envisioned by the consumer, in

other words 'plain English.' 'Non Habit forming' to the consumer means

he/she can walk away from the drug at any time without ill effects. The FDA

has lost touch with the American people because the agency has sided with

industry in its esoteric legalisms of 'habit forming' and 'addiction.' The

FDA has joined with industry in its 'double-speak' and distanced itself from

the people in this country who actually view these ads. If the FDA is the

only watchdog as it claims, how is it that it did nothing for nine years on

the Paxil withdrawal crisis as thousands of patients suffered through

withdrawal reactions. The FDA, unfortunately, has been derelict in its duty

to protect the American consumer. How is it that countless articles

appearing in the scientific literature throughout the 1990's documenting the

serious Paxil withdrawal problems also failed to spur the FDA to do its job?

Not even a medical article published by doctors struggling to treat newborn

infants suffering from neonatal Paxil withdrawal could do the trick. Only

lawsuits brought by private citizens, one of which was about to come to

trial, spurred the FDA to issue a 'precaution' on Paxil withdrawal on

December 14, 2001. Even then, the FDA opted to adopt the industry's cryptic

word 'discontinuation,' in its precautionary message to consumers about the

Paxil problem. It is suspicious, too, that the FDA stepped in only after the

court's opinion became a public issue in the media, and not while the legal

arguments were being presented to the court for consideration. On the merits

of the question, no reasonable observer can look at the thousands of Paxil

sufferers attempting to quit the drug and conclude that Paxil 'is not habit

forming.'

 

" Notably, even the FDA's intervention papers filed with the Court just

yesterday admit that 'Paxil causes a discontinuation syndrome.' The fact

that the FDA can concede this point and still assert that the Court was

'wrong' in holding that the 'non-habit forming' language could be misleading

demonstrates one thing above all else. The FDA believes that it can be an

advocate for GlaxoSmithKline, without exceeding its legislatively delegated

authority.

 

" In its rush to defend GSK, the FDA completely failed to notice that the

Court's Order did not conflict with any past action of the FDA. The Court

made it clear that it was not contesting how the drug is classified by

experts, or by the FDA. The Court made it clear that it was not ruling that

Paxil is addictive. The Court merely held, as the courts of this country

have long had the right to do, that the non-habit forming language is likely

to be misleading to the average consumer, and therefore it is not protected

commercial speech.

 

" The FDA is now asserting something that no one has ever asserted before.

The FDA is asserting that it is the supreme arbitrator of what is legally

false and misleading in the eyes of the American consumer. The FDA is

asserting that it has exclusive authority to determine the nature and

limitations of our first amendment rights.

 

" We cannot afford to turn a blind eye towards the unprecedented enormity of

what the FDA has just done. What we are witnessing is nothing less than a

run-away bureaucracy attempt to destroy our constitutional system of checks

and balances. When the day comes that federal bureaucracies, agencies which

are both political by nature and subject to being captured by the industries

they supposedly regulate, can reign supreme over the will of the people, and

the constitution, as those things are represented by state governments and

the courts, it will be a dark, despairing, grievous day.

 

" Our most basic freedoms stand to be lost when the public finds that it

cannot obtain justice in a court of law, because congress has delegated

supreme authority to an agency that neither it, nor the courts can control.

That the members of this agency, especially those members who approved

Paxil, routinely leave the agency for exorbitantly high paying jobs with the

companies whose products they approved, apparently does not matter. That

drug companies routinely sue the FDA themselves to preliminarily enjoin it

from abridging their alleged 'commercial speech' apparently does not matter

either.

 

" While the FDA could take action against a false or misleading

advertisement, there is no requirement that it do so. All government

regulatory actions are discretionary, and limited by the funds allocated to

it for enforcement purposes. Thus, the mere fact that the FDA has authority

to take action against false or misleading advertisements for prescription

drugs does not mean that it will do so in any given case. The Court's ruling

will have NO effect on the FDA, drug formularies, Medicare, physicians or

patients. Indeed, the Court's ruling does nothing more than protect the

health of the consuming public from an advertisement that is false and

misleading.

 

" Contrary to the FDA and GSK's assertions, the courts of this country do not

have to surrender their Article III powers to a federal, political,

captured, bureaucracy. For the sake of the Constitution, for the sake of the

principles of federalism, for the sake of the separation of powers doctrine,

and finally, for the sake of our basic freedoms, courts must be allowed to

do their jobs. The public's already eroded faith in government depends upon

it. "