National Class Action against Drug-maker for Paxil-induced Suicides in Youth

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[sSRI-Research] National Class Action against Drug-maker for

Paxil-induced Suicides in Youth

 

 

 

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org/cms/

 

FYI

 

Those of the public who attend FDA advisory committee meetings have

witnessed demonstrable indefference to the plight of children who

have suffered severe, life-threatening adverse drug effects. Recent

hearings involved psychostimulants and other psychotropic drugs

prescribed for what is acknowledged a condition not validated by any

scientific criteria--as no reliable diagnostic tools exist to ensure

that healthy children are not falsely " diagnosed " and swept up into a

life of drug dependency.

 

Child psychiatrists shamelessly lobbied against strong warnings about

the validated risks of harm. FDA officials twiddle their thumbs and

shrug off evidence of causal drug-induced cardiac arrest, psychosis

and violent behavior leading to tragedies--as if the children were

mere statistical dots on a chart.

 

One is never quite prepared to witness how doctors sworn to " do no

harm " betray their human and professional responsibility by lobbying

against full public disclosure about the life-threatening risks posed

by widely prescribed drugs. The motivation is likely to be found in

their financial ties to psychotropic drug manufacturers.

 

Betrayed by the medical profession and government oversight agencies,

the public must rely on trial lawyers to stop the irresponsible

marketing of toxic drugs that have triggered lethal behavior--

including suicide--in young children. There is probably no greater

crime than knowingly putting a child's life in danger for financial

gain.

 

Below a press release from the lawfirm, Baum Hedlund, announces it

has filed a class action lawsuit against GlaxoSmithKline charging

the company with fraud, negligence, strict liability, and breach of

warranty in its marketing of Paxil (Seroxat) by concealing the risk

of suicide.

 

Earlier the firm settled a class action lawsuit against Pfizer, the

maker of Zoloft (sertraline).

 

Two children named in the lawsuit:

 

11-year-old Trevor Blain was prescribed Paxil for " separation anxiety

disorder " by his pediatrician in October 2000. He immediately began

having difficulty sleeping and had angry outbursts while on Paxil,

but his family did not make the connection between his deteriorating

behavior and the drug. He continued taking the medication as

prescribed. In early November 2000, Trevor hanged himself with his

dog's leash in the family laundry room. Although he survived the

suicide attempt, he remained comatose for several weeks and died on

December 7, 2000.

 

17-year-old Tonya Brooks was a shy high school student. Her family

doctor diagnosed her with " social anxiety disorder " and prescribed

Paxil in 2004. She became agitated, aggressive and had difficulty

sleeping while taking Paxil. She first attempted suicide by taking an

overdose of Paxil and a sleeping medication, Ambien. She survived the

attempt and two days later gouged a hole in her leg with a pair of

scissors. She was hospitalized for several days.

 

 

" GSK has defrauded the medical profession, the Paxil patient

population, and the general public. "

 

The suit will be closely watched as it promises to widen the net to

reveal a Who's Who among those responsible for a pattern of deception

and corrupt practices in the marketing of a dangerous antidepressant

targeting the pediatric population.

 

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

 

March 23, 2006

FOR IMMEDIATE RELEASE

 

Baum Hedlund

12100 Wilshire Blvd., Ste. 950

Los Angeles, CA 90025

Contact: Robin McCall, Media Relations

Day: (800) 827-0087 or (310) 207-3233

Email: RMcCall

Web: www.baumhedlundlaw.com

 

National Class Action Filed against Drug-maker for Paxil-induced

Suicides in Youths

 

Los Angeles, March 23, 2006 - - The mother of an 11-year old Wichita,

Kansas boy who committed suicide on Paxil and a teenager from

Pflugerville, Texas (a small town outside of Austin) who attempted

suicide while taking Paxil, jointly filed a national class action

lawsuit today in federal court in Philadelphia, Pennsylvania, the

hometown of Paxil-maker, Glaxo SmithKline. The two plaintiffs

theoretically represent all individuals under the age of 18 in the

United States who attempted suicide or the families of individuals

who killed themselves as a result of an adverse reaction to Paxil.

The complaint charges include fraud, negligence, strict liability and

breach of warranty. (See attached Lawsuit Allegations.)

 

The FDA has required all antidepressant manufacturers to place a

black box warning in their labels alerting physicians and patients to

the increased risk of suicidality, which went into effect in January

2005.

 

The Plaintiffs

 

11-year-old Trevor Blain was prescribed Paxil for " separation anxiety

disorder " by his pediatrician in October 2000. He immediately began

having difficulty sleeping and had angry outbursts while on Paxil,

but his family did not make the connection between his deteriorating

behavior and the drug. He continued taking the medication as

prescribed. In early November 2000, Trevor hanged himself with his

dog's leash in the family laundry room. Although he survived the

suicide attempt, he remained comatose for several weeks and died on

December 7, 2000.

 

17-year-old Tonya Brooks was a shy high school student. Her family

doctor diagnosed her with " social anxiety disorder " and prescribed

Paxil in 2004. She became agitated, aggressive and had difficulty

sleeping while taking Paxil. She first attempted suicide by taking an

overdose of Paxil and a sleeping medication, Ambien. She survived the

attempt and two days later gouged a hole in her leg with a pair of

scissors. She was hospitalized for several days.

 

Tonya is one of six youths featured in a new documentary film

entitled " Prescription: Suicide? " The film will be screened at the

upcoming Beverly Hills Film Festival on April 8, 2006. The

documentary takes an intimate look at children and teens who have

committed suicide or attempted suicide while taking antidepressants

and the impact these tragic events have had on their families.

Tonya's mother, Cheryl Brooks stated: " No parent should have to go

through what we did. " Explaining her horror when she found her

daughter sprawled on the bathroom floor after her suicide attempt,

Mrs. Brooks stated: " [T]here was blood everywhere.... [The

manufacturers of these drugs] should be paying for this. They gave

these medicines to these kids - that's murder... "

http://www.prescriptionsuicide.com/

 

Baum Hedlund partner, Karen Barth Menzies, stated regarding the

lawsuit: " Through our Paxil litigation, we've obtained documents that

show a seriously troubling mentality of profit over safety and a

callous disregard for the welfare of children. That's about as

reprehensible as you can get. Governmental regulators around the

world have now analyzed the actual data from the clinical trials, not

GSK's version of it, and have found an increased risk of suicidality.

Yet the drug companies and their hired mouthpieces in the medical

academic community, including the pediatric arm of the APA [American

Psychiatric Association], continue to downplay the Black Box Warning

as an " over-reaction " by FDA. They continue to try to hide this risk

from parents for the sake of profits. We wanted to make sure the

rights of all of these kids are protected by filing this lawsuit. "

 

The Lawsuit's Allegations

 

Paxil was introduced into the U.S. market on December 29, 1992, and

is a well known antidepressant medication in the same class as

Prozac, Zoloft, Effexor, Celexa and Lexapro (selective serotonin

reuptake inhibitors or " SSRI's " ). Paxil is approved for marketing in

the United States for conditions such as depression, obsessive

compulsive disorder, panic disorder, and " social anxiety disorder. "

It is not approved for pediatric use.

 

Although a number of clinical trials have been conducted in the

pediatric population, Paxil has never been approved by the FDA for

use in children/adolescents because the studies show that the drug

doesn't work. (¶ 18.)

 

The studies show a more than doubling of the risk and in one study,

there was a nearly 6 times increase of suicidal thoughts and behavior

compared to placebo. (¶ 19.)

 

Not until 2002 was it recognized that GSK had been coding suicidal

behavior as " emotional lability, " thus hiding the risk. (¶ 19.)

 

Notwithstanding the clinical trials which showed Paxil to be

ineffective for pediatric patients and associated with an increased

risk of serious, and possibly deadly, side effects, GSK engaged in a

campaign to promote the use of Paxil for use with pediatric patients.

(¶ 20.)

 

GSK, faced with the negative results from the pediatric studies,

began a campaign to reduce the negative impact of this bad study

data. GSK prepared a medical journal article regarding Study 329 that

was not only " ghost written, " but falsely stated that Paxil was

superior to placebo among " four of the parameters, " including one

which was identified as a " primary outcome measure. " In fact, GSK

knew that Paxil was not found to be superior to placebo amongst any

of the " primary outcome measures. " Further, the article stated

that " most adverse effects were not serious, " and failed to list

suicide-related events as " serious. " (¶ 20.)

 

In a document directed to " all sales representatives selling Paxil, "

a GSK manager stated that, according to the " Keller " article, " Paxil

demonstrates REMARKABLE Efficacy and Safety in the treatment of

adolescent depression. " (emphasis in original). The document states

that " the findings of this study provide evidence of the efficacy and

safety of Paxil in the treatment of adolescent depression. " As GSK

well knew, study 329 found Paxil to be neither effective nor safe. (¶

20.)

 

GSK also hired doctors to go around the world and promote the use of

Paxil for pediatric patients by way of " posters " and lectures at

medical conferences. These " posters " and their presenters claimed

that Paxil was effective for treating adolescent depression and free

from serious side effects. In fact, GSK knew that to be false. (¶ 21.)

 

In internal, unpublished documents, which have been kept from public

and regulatory scrutiny via the stratagem of over-

broad " confidentiality " designations, GSK has made numerous

admissions about Paxil's associated harmful side effects and lack of

effectiveness in children and adolescents. Notwithstanding these

admissions, in flagrant and conscious disregard and indifference, GSK

has denied publicly that such nexus exists, and has failed utterly to

take any measures whatsoever to alert the public, the prescribing

physicians, and the patients who take it, of the incipient dangers

associated with Paxil. (¶ 72.)

 

GSK has defrauded the medical profession, the Paxil patient

population, and the general public in that it, among other acts:

 

(a) Hired a firm to " ghostwrite " an article that was widely

publicized which claimed, falsely, that Paxil was effective and safe

for the treatment of depression with children and adolescents;

 

(b) Hired doctors to present " posters " around the world at medical

conferences which claimed, falsely, that Paxil was effective and safe

for the treatment of depression with children and adolescents;

 

© Fraudulently mischaracterized and miscoded adverse events

involving self-harm with the term " emotional lability " so as to

reduce the number of occurrences and hide their existence from the

public and regulators;

 

(d) Failed to inform the medical and research communities that a

significant number of pediatric patients taking Paxil during clinical

trials attempted acts of self-harm at a rate that was at least twice

that for pediatric patients who took placebo;

 

(e) Fraudulently claimed that Paxil's characteristic side effects of

insomnia, agitation and anxiety were of little or no concern when in

fact these effects are known to be among the most critical and deadly

of the short-term risk factors for self-harm;

 

(f) Fraudulently denied Paxil's association with serious or deadly

thoughts or acts of self-harm when its own investigators informed GSK

(and GSK determined itself) that Paxil was associated with such

conditions;

 

(g) Allowing the use of concomitant medications in clinical trials to

lessen side

 

effects in order to avoid the reporting of treatment-emergent adverse

events, such as akathisia;

 

(h) Aggressively promoted Paxil to doctors for use with pediatric

patients even though Paxil was not, and is not, approved for use with

children and adolescents.

 

(¶ 73.)

 

 

In early 2005, GSK updated Paxil's label to include a " black-box "

warning, which is the strongest warning allowed for by FDA

regulations. That warning states:

 

Suicidality in Children and Adolescents

 

Antidepressants increased the risk of suicidal thinking and behavior

(suicidality) in short-term studies in children and adolescents with

Major Depressive Disorder (MDD) and other psychiatric disorders.

Anyone considering the use of PAXIL or any other antidepressant in a

child or adolescent must balance this risk with the clinical need.

Patients who are started on therapy should be observed closely for

clinical worsening, suicidality, or unusual changes in behavior.

Families and caregivers should be advised of the need for close

observation and communication with the prescriber. PAXIL is not

approved for use in pediatric patients. (See WARNINGS and

PRECAUTIONS -- Pediatric Use)

 

Pooled analysis of short-term (4 to 16 weeks) placebo-controlled

trials of 9 antidepressant drugs (SSRIs and others) in children and

adolescents with major depressive disorder (MDD), obsessive

compulsive disorder (OCD), or other psychiatric disorders (a total of

24 trials involving over 4,400 patients) have revealed a greater risk

of adverse events representing suicidal thinking or behavior

(suicidality) during the first few months of treatment in those

receiving antidepressants. The average risk of such events in

patients receiving antidepressants was 4%, twice the placebo risk of

2%. No suicides occurred in these trials.

 

(¶ 28.)

 

 

About Baum Hedlund and Karen Barth Menzies

 

Baum Hedlund is one of the leading national law firms representing

antidepressant suicide and suicide attempt victims across the

country. The firm represents approximately 50 victims, over one third

of those are children and adolescents.

 

Since 1990, Baum Hedlund has been handling SSRI (selective serotonin

reuptake inhibitors) suicide/violence cases and served on the

Plaintiffs' Steering Committee in the first SSRI-suicide litigation

involving Prozac (the first SSRI approved by the FDA for marketing in

the U.S.).

 

 

Baum Hedlund partner, Karen Barth Menzies, heads the firm's SSRI-

Antidepressant Litigation Department and is Lead Counsel for the

Plaintiffs' Steering Committee (MDL-1574) Paxil Products Liability

Litigation. In addition to her court activities, she has testified

about the dangers of SSRIs before the California State Assembly and

the Food and Drug Administration's Psychopharmacologic Drugs Advisory

Committee and met with members of the House and Senate regarding the

risk of antidepressant induced suicidality. In 2004 Ms. Menzies was

named Lawyer of the Year by Lawyer's Weekly, California Lawyer of the

Year by California Lawyer magazine and in 2005 one of The National

Law Journal's Top 40 Under 40 for her " extraordinary achievements "

and " impressive track record " for " stepping up her fight in the past

few years, advocating that pharmaceutical companies should warn about

the alleged risks of antidepressant drugs. "

 

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Drug-Free School Zone? Just Say NO to Prozac for Children.