National Class Action Filed against Drug-maker for Paxil-induced Suicides in Youths
PATMOM
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
vera...@ahrp.org
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: RMc...@BaumHedlundLaw.com
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;
(c) 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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