Parents of Five Children Born with Severe Heart Defects
File Personal Injury and Wrongful Death
Lawsuits Against Paxil Maker
Baum Hedlund
FACT SHEET
General information
In 2003, GSK initiated a
retrospective analysis of women, dating back to 1995, who had taken
antidepressants in the first trimester of their pregnancies and had given birth
to children with major congenital malformations. The study found an association
between Paxil and congenital malformations in mothers
taking Paxil in the first trimester.
Another study conducted by
researchers in
In September 2005, GSK sent
out a "Dear Doctor" letter informing physicians throughout the United
States that the results of its analysis showed a higher rate of
"congenital malformations associated with the use of Paxil
as compared to other antidepressants" in infants born to women taking
antidepressants during the first trimester of pregnancy. The most common
malformations for mothers taking Paxil were
cardiovascular, particularly ventricular septal
defects ("VSD").
The FDA has issued three
Public Health Advisories since December 2005 concerning the risk of congenital
heart defects and has changed Paxil's pregnancy
category from C to D, which indicates that "[t]here is positive evidence
of fetal risk." [See Fact Sheet for more information.]
On Wednesday, November 29,
2006, the
"The American Medical
Association estimates that over 1 percent of pregnant women in the
http://www.paxilbirthdefect.com/news.shtml
Sales of antidepressants in
the
http://www.paxilbirthdefect.com/news.shtml
Paxil crosses the placenta, which could
have important implications for the developing fetus.
Serotonin (the
neurotransmitter that Paxil primarily affects) plays
a roll in the fetal development of the heart.
FDA Public Health
Advisories Concerning Paxil Birth Defects
A study using a Swedish
national registry found a 2-fold increased risk of having an infant with a cardiac
defect compared to the entire national registry population.
In another study in the
In March/April 2006 http://www.fda.gov/fdac/departs/2006/206_upd.html#paxil, the FDA updated its data on Paxil and the Risk of Birth Defects, explaining that early
results of two studies "indicate that women who took Paxil
during the first three months of pregnancy were about one and a half to two
times as likely to have a baby with a heart defect as women who received other
antidepressants or women in the general population. Most of the heart defects
reported in these studies were holes in the walls of the chambers of the heart
(atrial and ventricular septal
defects)." The FDA advised "health care professionals not to
prescribe Paxil in women who are in the first three
months of pregnancy or are planning pregnancy, unless other treatment options
are not appropriate."
On July 19, 2006 http://www.fda.gov/cder/drug/advisory/SSRI_PPHN200607.htm , the FDA issued another Public
Health Advisory titled "Treatment Challenges of Depression in
Pregnancy." Ironically, the FDA cites a study that warns of depression
relapse in women who decide to stop taking their antidepressant, which study
has received a great deal of criticism and was the topic of a front-page Wall
Street Journal article exposing the fact that most of the authors of the study
had undisclosed financial ties to antidepressant manufacturers. http://www.paxilbirthdefect.com/news.shtml Notwithstanding, the new advisory
warns of the recent study by Christina Chambers concerning the risk of
pulmonary hypertension in babies born to mothers who took antidepressants in
their third trimester of pregnancy.
Paxil label re Pregnancy
In 2003, the prescribing
information for Paxil stated:
"Pregnancy: Patients
should be advised to notify their physician if they become pregnant or intend
to become pregnant during therapy."
The label also described GSK's animal studies as having "revealed no evidence
of teratogenic effects." ("Teratogen" means any substance with the potential to
cause birth defects.) Paxil was identified as a
Category C drug (Category C drugs are those in which: "Either animal studies
indicate a fetal risk and there are no controlled studies in women, or there
are no available studies in women or animals.) The label also stated:
"There are no adequate and well-controlled studies in pregnant
women." The label further states that Paxil
"should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus."
The FDA has changed Paxil's pregnancy category from C to D (Category D:
"There is positive evidence of fetal risk, but there may be certain situations
where the benefit might outweigh the risk [life-threatening or serious diseases
where other drugs are ineffective or carry a greater risk].)
Other Complications
of Taking Paxil During
Pregnancy
A study published in
Teratology Society Abstracts in 2005 reported that women who took Paxil were more likely than those who were not exposed to
have an infant with omphalocele (a fetal malformation
in which variable amounts of abdominal contents protrude into the base of the
umbilical cord) and craniosynostosis (the early
closing of one or more of the sutures of an infant's head, resulting in
malformation of the skull). The strongest effect was reported to be with Paxil.
A recent study published in
the New England Journal of Medicine (NEJM) by Christina Chambers of the
About the Families
1) Hannah Grace Mobley
(Case no. December2006 000049): When Hannah Mobley was born on October 17,
2002, in Dunbar, West Virginia, she was suffering from a complex condition
involving several associated congenital heart defects referred to collectively
as Tetralogy of Fallot. These
problems included a Ventricular Septal Defect (VSD),
Pulmonary Obstruction, Overriding Aorta and hypertrophy.
Beginning from the time
that Hannah was born, she went through several life-threatening procedures. In
November, 2002, she had her first of several surgeries to place a shunt in her
heart. At six months old, she had her second surgery which attempted to correct
her pulmonary artery. A few months later, she had a surgery to insert a feeding
tube in an effort to help her gain weight. Finally, in June, 2004 she was sent
to Children's Hospital in
2) Taylor Danielle
Mobley (Case no. December2006 000050): When Taylor Mobley was born on October
17, 2002, in Dunbar, West Virginia, she was suffering from a life-threatening
congenital heart defect, Ventricular Septal Defect
("VSD").
Shortly after birth,
Plaintiffs are informed and
believe and thereon allege that, as
3) Kenndyl
Gueldenzoph (Case no. December2006 000052): When Kenndyl Gueldenzoph was born on
September 26, 2004, in Toledo, Ohio, she was suffering from a congenital heart
defect called hypoplastic left heart syndrome, a
condition where the left side of the heart -- including the aorta, aortic
valve, left ventricle and mitral valve -- is
underdeveloped.
The day after Kenndyl was born, it became
apparent to her physicians and parents that
something was wrong. She was diagnosed with a
heart defect and eventually transferred to Mott Children's Hospital were she
had open heart surgery to place a shunt in her heart. After the surgery, she
was placed on Extra-Corporeal Membrane Oxygenation ("ECMO"). ECMO is
a life support system that is used when a baby or child has a condition which
prevents the lungs from working properly, i.e. transferring oxygen into the
blood and removing carbon dioxide. It is also used to support patients who have
heart failure. After a week on ECMO, Kenndyl's
condition had improved enough that she was taken off of ECMO. Unfortunately, Kenndyl was not strong enough to survive on her own and she
died a few hours later.
4) Keagan
Hargitt (Case no. December2006 000048): When Keagan Hargitt was born on
January 14, 2002, in Omaha, Nebraska, he was suffering from a congenital heart
defect called hypoplastic left heart syndrome, a
condition where the left side of the heart -- including the aorta, aortic
valve, left ventricle and mitral valve -- is
underdeveloped.
Shortly after Keagan was born, the doctors detected what they first
believed to be a heart murmur. Hours later, Keagan
underwent a catheterization to help the physicians determine what was wrong
with his heart. He was then diagnosed with hypoplastic
left heart syndrome. Thereafter, he had three additional surgeries trying to
correct the serious defects with his heart and lungs so that he might survive.
When he was just three weeks old, it became clear that his condition was more
that he could overcome and Keagan died on February 7,
2002.
5) Mark Fromm (Case no.
December2006 000055): When Mark was born on February 2, 2005, in
Westerville, OH, he was suffering from Tricuspid Atresia,
Ventricular Septal Defect (VSD) and pulmonary stenosis - all life-threatening congenital heart defects.
Beginning from the time
that Mark was born, he has gone through two life-threatening surgeries. First,
when Mark was just seven weeks old, a shunt was placed in his heart. This
procedure was followed by a bidirectional Glenn procedure when Mark was nine
months old. This procedure in an open heart surgery that is
used to prepare the heart for the Fontan procedure,
which Mark is scheduled to have next year.
How Effective are Antidepressants?
There is a general
consensus that doctors must weigh the benefits of drug treatment versus the
risks. In order to do a proper risk benefit analysis, a doctor must be aware of
the degree of effectiveness of the drug - not just drug company hype. Is the
drug extremely effective or only marginally effective? Doctors know the drug was
approved by the FDA, but do they know the FDA's standards for approving a drug
as effective?
In an analysis of efficacy
data submitted to the FDA between 1987 and 1999 for six of the most popular
selective serotonin reuptake inhibitor (SSRI) antidepressants, including Paxil, 75 to 80% of the response to medication was
duplicated in placebo groups.1 These data
were the basis on which the medications were approved by the FDA. The researchers
explained that the "small difference between the drug response and the
placebo response has been a 'dirty little secret' known to researchers who
conduct clinical trials, FDA reviewers, and a small group of critics who
analyzed the published data ..."2 Yet another recent
meta-analysis found that SSRIs have "no
clinically meaningful advantage over placebo."3
FDA approval of these drugs
implies that the data were strong enough and reliable enough to warrant
approval, however, as one FDA memo illustrates, the FDA's standards for
approving antidepressants as effective are not robust: "Approval [of the
antidepressant] may ... come under attack by constituencies that do not believe
the agency is as demanding as it ought to be in regard to its standards for
establishing the efficacy of antidepressant drug products."
Complicating the
risk/benefit analysis further is industry-exaggerated prevalence of illness. Is
the mother really suffering from clinical depression or has pharmaceutical
marketing done such a tremendous job at "selling sickness" that a
pregnant woman who is feeling "down in the dumps" is immediately
prescribed a drug that could cause very serious harm to her unborn child. http://bmj.bmjjournals.com/cgi/content/full/324/7342/886
About Baum Hedlund
Baum Hedlund
has the longest track-record handling SSRI antidepressant litigation, having
litigated over 3,000 antidepressant cases in the past 16 years. The firm has
five plaintiff attorneys specifically dedicated to litigating the SSRI
antidepressant cases.
Since 1990 Baum Hedlund has been handling antidepressant-SSRI (selective
serotonin reuptake inhibitors) cases and served on the Plaintiffs' Steering
Committee in the early 1990s in the first SSRI-suicide litigation involving
Prozac (the first SSRI approved by the FDA for marketing in the U.S.).
Baum Hedlund
also represents dozens of antidepressant suicide and suicide attempt victims
across the country. They have handled SSRI-induced suicide / violence
litigation involving Prozac, Paxil and Zoloft.
For more than a decade Baum
Hedlund partner, Karen Barth Menzies
has been handling SSRI-antidepressant cases. She is Lead Counsel and a member
of the Plaintiffs' Steering Committee in charge of the multi-district
litigation re Paxil Products Liability Litigation.
She led the legal team which successfully defeated Pfizer's (maker of Zoloft)
and the FDA's preemption arguments in a number of cases.
In addition to her court
activities Ms. Menzies has testified about the
dangers of SSRIs before the FDA's Psychopharmacologic
Drugs Advisory Committee (and is schedule to speak again on Dec. 13, 2006
before the same committee about the suicide risk of antidepressants in adults)
and the California State Senate. She met with members of the House and Senate
regarding the risk of antidepressant-induced suicidality
and assisted in a congressional investigation regarding same. In 2004 Karen was
named Lawyer of the Year by Lawyer's Weekly USA, 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 "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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