Fwd: [SSRI-Research] Paxil Litigation Update/October 26, 2003

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BaumHedlund/Paxil Update

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[sSRI-Research] Paxil Litigation Update/October 26, 2003

 

Baum Hedlund

 

Paxil Litigation Update

October 26, 2003

http://www.baumhedlundlaw.com/Paxil/paxilupdate.htm

 

The Baum Hedlund law firm represents class representatives,

members of class action lawsuits and individuals in mass

joinder and individual cases across the country claiming that the

antidepressant drug, Paxil, causes withdrawal symptoms and

dependence in a significant percentage of patients who attempt

to stop taking the drug. The firm also represents families who

have lost loved ones due to Paxil or Zoloft induced suicide and

individuals who have suffered serious suicide attempts caused

by Paxil or Zoloft.

 

The first class action related to Paxil withdrawal was filed by

Baum Hedlund and the law offices of Donald Farber on August

24, 2001. The action originally was filed in state court in Los

Angeles, but was transferred to federal court and consolidated

with another subsequently filed case (by the law offices of Weiss

& Yourman), on September 14, 2001. The consolidated class

action lawsuit sought certification of a nationwide class on

behalf of everyone in the United States who had suffered

withdrawal and dependence as a result of Paxil ingestion.

 

On January 10, 2003, U.S. District Court Judge, Mariana Pfaelzer,

denied Plaintiffs' motion for class certification of the proposed

nationwide class of Paxil withdrawal victims, but gave Plaintiffs

permission to resubmit their motion for class certification. The

Court's primary concern appeared to be the viability of a

multi-state class and the varying laws in the different states.

Judge Pfaelzer stated, however, that: " With this many putative

plaintiffs, Plaintiffs should have no problem forming classes in

other jurisdictions that are large enough to justify the litigation

expenses in other jurisdictions. "

 

On March 24, 2003, Plaintiffs filed their new motion for class

certification which sought to enjoin Paxil's maker (SmithKline

Beecham, dba Glaxo SmithKline, " GSK " ) from making false and

misleading statements in its promotional and advertising

materials and activities regarding Paxil in relation to withdrawal

and dependence. This second motion also sought certification

of a California statewide class to determine, on a class-wide

basis, the issue of whether Paxil causes

dependence/withdrawal symptoms (also known as " general

causation " ).

 

On August 29, 2003, United States District Court Judge,

Marianna Pfaelzer, denied Plaintiffs' motion for class certification

of a California class of Paxil withdrawal victims. Class

certification denial does not hurt the claims of our clients. On

September 12, 2003 we named and joined 248 California

residents who would have been members of the class into a

mass joinder lawsuit.

 

Baum Hedlund has, in conjunction with co-counsel, filed, and

are continuing to file lawsuits related to Paxil

withdrawal/dependency in a number of states throughout the

United States.

 

In the summer of 2002, the class action Plaintiffs in California

sought to preliminarily enjoin GSK from stating in its advertising

and marketing materials that 1) Paxil " is non-habit forming, " 2)

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

individuals, " and 3) " Paxil has been studied both in short-term

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

addiction. " Prior to the hearing on Plaintiffs' preliminary

injunction motion, GSK agreed that it would no longer distribute

the promotional brochures that contained statements 2 and 3

above. The only issue remaining, therefore, was GSK's

television advertisements which claimed that Paxil is " non-habit

forming. "

 

On August 16, 2002, Judge Pfaelzer granted Plaintiffs' motion for

a preliminary injunction and ordered GSK to pull the television

ads in question. Within two business days of the Court's Order,

however, the FDA stepped in to argue that the Court did not have

jurisdiction to second-guess its decision to allow GSK to air the

commercials. (See Plaintiffs' response, Public Opinion Poll and

Declaration of Erin Chemerinksy)

 

On October 10, 2002, Judge Pfaelzer reconsidered her

preliminary injunction order and reversed her ruling based, in

part, on the FDA's representations to the Court that it had given

GSK permission to run the ads and did not believe the

advertisements were misleading. It should be noted that, prior to

the Court's reversal, GSK informed the Court that it was no

longer running the television commercials containing the phrase

" Paxil is non-habit forming. " Judge Pfaelzer also stated in her

Order that GSK and the FDA's legal argument (that the FDA's

decision to allow the ads to run legally prohibits citizens from

obtaining judicial relief) ran " contrary to the grain of other

decisions " and " vitiates, rather than advances, the [food and drug

laws'] purpose of protecting the public. ... . " Judge Pfaelzer also

stated that the FDA and GSK's position " contravenes common

sense. "

 

Plaintiffs and their counsel are happy that their efforts have

resulted in the discontinuation of the above referenced false and

misleading marketing and advertising claims, however, GSK

continues to counter the available data regarding Paxil

withdrawal with marketing messages designed to downplay the

problem.

 

Physicians in the U.S. are bombarded with marketing messages

designed to minimize concerns surrounding withdrawal. For

instance, GSK uses the term " discontinuation syndrome " rather

than " withdrawal " because it infers " addictive " qualities. In fact,

the term " discontinuation " is not even a legitimate medical term

-- it is not listed in any recognized medical dictionary. GSK's

contrived distinction between " discontinuation " and " withdrawal "

is wholly inconsistent with the language found in foreign labels

for Paxil, wherein GSK acknowledges that Paxil can cause

withdrawal symptoms:

 

Italy: " Withdrawal symptoms may occur if treatment is

discontinued abruptly. Such symptoms ... include: insomnia,

dizziness, sweating, palpitations, nausea, anxiety, irritability,

parasthesia and headache; "

 

UK: " [W]ithdrawal symptoms have been reported on stopping

treatment. ... Dizziness, sensory disturbance (e.g. parasthesia),

anxiety, sleep disturbances (including intense dreams),

agitation, tremor, nausea, sweating and confusion have been

reported following abrupt withdrawal of `Seroxat' [Paxil]; " Ireland:

" Withdrawal reactions have been reported following

discontinuation of `Seroxat' [Paxil], these include dizziness,

sensory disturbance (e.g. paraesthesia), anxiety, sleep

disturbances (including intense dreams), agitation, tremor,

nausea, sweating and confusion; "

 

Netherlands: " [A]brupt discontinuation of Seroxat therapy must

be avoided as this may result in withdrawal symptoms such as

sleep disturbances, sensory disturbances, dizziness, agitation

or anxiety, sweating and nausea; "

 

Spain: " Withdrawal symptoms[.] Discontinuation of paroxetine

administration (especially if it is abrupt) may lead to withdrawal

symptoms such as dizziness, sensory disturbances (including

paraesthesia and sensation of cramps), headache, sleep

disturbances, agitation or anxiety, nausea and sweating; " and

 

France: " Abrupt withdrawal of the treatment may cause, within

one week, symptoms such as dizziness, sensory disorders,

sleep disturbances, agitation and anxiety, asthenia, digestive

disorders and sweating. These signs may persist for 1-2

weeks. "

 

GSK continues to assert that " discontinuation symptoms "

happen with all antidepressants and are " generally mild " and

" self-limiting. " GSK also states in its promotional material: " Is

Paxil addictive? No. Paxil is not a controlled substance. Paxil

belongs to a class of medications called SSRIs, which have not

been shown to be associated with addiction. " However,

according to the World Health Organization publication, " WHO

Drug Information, " Volume 15, No. 1, 2002, concerning the

December 14, 2001 label change: " The Food and Drug

Administration has published a product warning for paroxetine

regarding severe withdrawal symptoms of the kind that could

lead to dependence. "

 

GSK also continues to make statements such as " in most

instances " withdrawal effects are simply " relapse. " (Glamour

Magazine, April 2003.) This is entirely inconsistent with the Paxil

label in Switzerland, which states: " Discontinuation of Seroxat

may lead to discontinuation symptoms. Typical symptoms

include nausea, anxiety, dizziness, sensory disturbances

(including paraesthesia), headache, sweating, agitation, fatigue

and tremor. These symptoms usually start abruptly within a few

days of discontinuation and can be distinguished from relapse

symptoms, which occur later and build up gradually. To prevent

such discontinuation symptoms paroxetine should be

discontinued slowly and with a gradual reduction (maximum

10mg/week). "

 

The truth is, from its inception onto the U.S. market in December

1992 to the present, medical researchers throughout the world

have documented Paxil's propensity to induce dependence/

withdrawal symptoms when patients attempt to reduce or

discontinue taking Paxil. These observations have been

published in an abundance of peer reviewed medical journal

articles. In fact, after a very short time on the market (in 1993), the

Committee on Safety of Medicines ( " CSM " ), the U.K.'s

counterpart to the FDA, reported 78 cases of withdrawal after

discontinuation of Paxil and noted that " such reactions have

been reported more often with [Paxil] than with other SSRI's. "

Although GSK has been aware for the past decade that Paxil can

cause withdrawal, this vital information was not included in the

drug's label. Although GSK was required by the FDA to

strengthen its warning about Paxil withdrawal in December

2001, Plaintiffs allege that it remains inadequate.

 

The medical literature also points out that Paxil has the highest

incidence of withdrawal reactions, " significantly more frequent

than with other SSRIs. " According to one study involving four

SSRIs (Paxil, Prozac, Zoloft, and Celexa), wherein Paxil was by

far the worst in causing withdrawal effects, the authors stated

that the withdrawal effects seen with Paxil were " not evident in

patients receiving (Prozac), (Zoloft), and (Celexa), suggesting

they are not an SSRI class phenomenon. "

 

A review of the literature shows that, on average, over one-third of

people taking Paxil for any extended period of time experience

withdrawal symptoms, and of those, 21% experience severe

withdrawal symptoms. In the clinical trials of Paxil, a significant

percentage of patients (up to 50% according to some studies)

experienced withdrawal, despite the fact that a tapering regimen

was utilized in those trials. Notwithstanding these alarming

figures, according to a survey conducted in 1997 and published

in the Journal of Clinical Psychiatry, the vast majority of

physicians are not aware of this problem. According to the

authors, " education about discontinuation reactions … is

needed for both psychiatrists and family practice physicians. "

These concerns were echoed in an article published in

December 2000, wherein the author stated that there is

widespread " misdiagnosis of antidepressant discontinuation

symptoms " and " increased professional awareness of

discontinuation symptoms is necessary to prevent misdiagnosis

and inappropriate treatment. " Just last year, the Harvard Mental

Health Letter disclosed that as many as 75% of non-psychiatric

physicians were unaware that Paxil can cause withdrawal

reactions or how to properly diagnose the associated

symptoms.

 

Despite the abundance of data pointing to a problem, GSK has

never prospectively studied the issue of Paxil withdrawal. This is

particularly disconcerting given Paxil's remarkably short half life.

According to one of the few non-confidential documents obtained

by Plaintiffs in this litigation, titled " Draft Guidelines For Abuse

Liability Assessment, " compiled by the Subcommittee on

Guidelines for Abuse Liability Assessment, Drug Abuse Advisory

Committee, Food and Drug Administration, U.S. Public Health

Service states: " In general, rapid onset, short duration drugs

appear to have greater abuse liability than do pharmacologically

similar drugs with slow onset and long duration of actions. "

 

Baum Hedlund and its co-counsel are committed to doing all

they can through whatever procedural tools the legal system

permits to achieve the fairest and most efficient adjudication of

the claims of the thousands of individuals who have suffered

from Paxil withdrawal. So far Paxil cases are filed in California,

Connecticut, Florida, Illinois, Louisiana, Maryland,

Massachusetts, Mississippi, New Mexico, New York, Ohio,

Tennessee, Texas, Washington and Wisconsin.

 

 

 

 

* 248 California Victims File Lawsuit Over Paxil Withdrawal

Reactions - September 12, 2003

* Paxil Withdrawal Victims Respond to GSK's Misleading

Statements About Court's Denial of CA Class Certification -

September 5, 2003

* Judge Denies Class Action Status to California Paxil

Withdrawal Sufferers - Paxil Victims Will File Mass Joinder -

September 3, 2003

* Plaintiffs file new motion for class certification in United States

District Court, Central District of California - March 24, 2003

* Judge denies nationwide Paxil class certification, but permits

Plaintiffs to re-file certification request - January 10, 2003

* Judge reconsiders Paxil makers' request to keep ads on air

claiming the drug is non habit-forming - October 10, 2002

*

Plaintiffs' [Corrected] Reply to Defendant's Opposition to

Plaintiffs' Motion for Class Certification; Memorandum of Points

and Authorities, September 30, 2002

 

*

Plaintiffs' Response to Brief of the United States of America and

Opposition to GSK's Motion for Reconsideration, September 12,

2002

* Public Opinion Poll regarding what American's think " non-habit

forming " means

* Declaration of Erwin Chemerinksy Leading authority, expert

and commentator on Constitutional Law, Preeminent Professor

and Scholar

 

 

*

Press Release - August 23, 2002 FDA must submit evidence to

court explaining exactly what it considered and its reasons for

approving Paxil ad containing language " Paxil is non-habit

forming "

 

* Press Release - August 21, 2002 Plaintiffs in Class Action

Submit Response to FDA's Intervention Regarding Court Order

Requiring GSK to Pull TV Ads That State Paxil is Non-Habit

Forming

*

Press Release - August 19, 2002 Judge orders pharmaceutical

giant, Glaxo SmithKline, to pull TV commercials that claim the

antidepressant drug Paxil is non habit-forming

 

*

Court Order Granting Plaintiffs' Motion for Preliminary Injunction -

August 16, 2002

 

*

Memo Decision Re Preliminary Injunction - August 16, 2002

 

*

Press Release July 2, 2002 Representatives of a Nationwide

Class Action Lawsuit Ask Federal Judge to Pull Television Ads

from Nation's Airwaves that Contain Claims that Paxil is Non

Habit-Forming

 

*

Declarations Excerpts from Declarations Submitted in Support of

Preliminary Injunction

 

 

 

*

Plaintiffs' Motion for Preliminary Injunction - June 28, 2002 Notice

of Motion and Motion for Preliminary Injunction

 

 

 

* Consolidated Federal Complaint filed 3/25/2002 (If your name

is not on the consolidated complaint, please do not be

concerned.)

* Press Release of 1/25/2002 17 individuals file first (non-class

action) lawsuit seeking damages against Smithkline Beecham

for severe withdrawal reactions from the antidepressant, Paxil

*

Complaint/Lawsuit filed 1/24/2002

 

 

 

*

Frequently Asked Questions Paxil Withdrawal

Reaction/Dependency Syndrome - Paxil Class Action

 

*

Press Release of 9/14/2001 federal lawsuit (since consolidated

into federal complaint)

 

*

Press Release of 8/24/2001 lawsuit (since consolidated into

federal complaint), Fact Sheet and Complaint

 

 

------

 

Media

 

Addicted to Antidepressants?

The controversy over a pill millions of us are taking

April 2003

Glamour Magazine

 

FDA Counsel's Rise Embodies US Shift

Boston Globe

 

" The pharmaceutical giant Pfizer Inc. was facing last July the kind

of lawsuit that sends shudders through the drug industry. The

suit alleged that Zoloft, the company's top-selling

antidepressant, had backfired and caused a patient to commit

suicide. "

 

 

Paxil Case Explores Drug's Darker Side

Los Angeles Daily Journal

 

Feeling Blah at Work? It May Be Your Job, Not Your Prescription

Wall St. Journal

 

I need a pill RIGHT NOW- Do Users Know the Risks of Popular

Antidepressants?

National Post

 

Disorders Made to Order

MotherJones.com

 

Dangerous Medicine

The American Prospect

 

The Secrets of Seroxat

The BBC's Panorama presents

 

 

 

 

 

PAXIL LABEL CHANGE, December 14, 2001 - - FDA directs

revision to Paxil label, acknowledging Paxil withdrawal

symptoms

 

The most recently approved FDA precaution on Paxil

recommends close monitoring and gradual, rather than, abrupt

discontinuation of the antidepressant. Excerpt from FDA revised

label approved on December 14, 2001, " Patients should be

monitored for these symptoms when discontinuing treatment,

regardless of the indication for which Paxil is being prescribed. A

gradual reduction in the dose rather than abrupt cessation is

recommended whenever possible. "

 

Karen Barth, one of the lead attorneys representing hundreds of

victims suffering dependency/withdrawal syndrome from Paxil

states, " Our effort to get the Paxil warning label revised to reflect

the truth about the withdrawal problems with Paxil began back in

August 2000. That is when we joined attorney Don Farber in

filing a lawsuit in an effort to force SmithKline Beecham to revise

the label for Paxil. Although the language in the revised label, in

our view, should be stronger, we feel the new language is a

definite step in the right direction and we feel vindicated in our

efforts. "