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First PPHN Paxil Birth Defect Personal Injury Lawsuit Filed -- Child Sues Paxil-Maker

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First PPHN Paxil Birth Defect Personal Injury Lawsuit Filed -- Child Sues

Paxil-Maker Los Angeles, CA 90025 October 16 2006

First PPHN Paxil Birth Defect Personal Injury Lawsuit Filed -- Child Born with

Life-Threatening Persistent Pulmonary Hypertension (PPHN)

Sues Paxil-Maker

Philadelphia, Pennsylvania, October 16, 2006 -- was born in Denver,

Colorado on October 28, 2004 with severe Persistent Pulmonary Hypertension of

the newborn (PPHN), a life-threatening disorder in which the newborn’s arteries

to the lungs remain constricted after delivery, limiting the amount of blood

flow to the lungs and therefore the amount of oxygen into the bloodstream. 10

percent to 20 percent of infants with PPHN will end up dying even if they

receive treatment.

and his parents, and Boden of Denver, Colorado

filed a lawsuit today against Philadelphia-based GlaxoKline ( " GSK " ), the

maker of Paxil, in Pennsylvania State Court. The family alleges that Ms. Boden’s

ingestion of Paxil during her pregnancy resulted in her son being born with

severe PPHN. The family is seeking an unspecified amount of damages against GSK

for failing to warn about the risks associated with Paxil for pregnant women and

their unborn children. To our knowledge this is the first PPHN Paxil birth

defect lawsuit filed against GSK.

Since his birth, has undergone several medical procedures to save his life.

Immediately after birth he was placed on a ventilator, and was eventually placed

on an oscillating ventilator which he remained on for a month. Thereafter, he

underwent two cardiac catherizations, and a nissen fundoplication procedure to

combat gastral reflux caused by being on a ventilator for an extended period of

time. He remains on oxygen and medications to help him breathe. His mother took

the antidepressant Paxil throughout her entire pregnancy.

is represented by Baum Hedlund, a national pharmaceutical products

liability law firm in Los Angeles, Washington, D.C. and Philadelphia. Baum

Hedlund has the longest track-record in handling SSRI-antidepressant litigation.

[see Fact Sheet for more information about Baum Hedlund.]

According to Baum Hedlund attorney Barth Menzies, who represents the

family: " and his family have endured a terrible ordeal. Based on its

history, we believe that GSK likely had knowledge or, at minimum, should have

known of this very serious risk and warned expectant mothers taking Paxil of

this risk. We will conduct a thorough investigation of what GSK knew, when, and

we will do all we can to vindicate the delicate life of this precious boy. "

--------------------------------------------------------------------------------

FACT SHEET

The Complaint can be seen at http://www.paxilbirthdefect.com/lawsuit.shtml .

General information:

" The American Medical Association estimates that over 1 percent of pregnant

women in the US, or more than 40,000, are taking antidepressants. "

http://www.paxilbirthdefect.com/news.shtml

Sales of antidepressants in the US last year exceeded $12.5 billion.

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.

PPHN

10 percent to 20 percent of infants with PPHN will end up dying even if they

receive treatment.

A recent study published in the New England Journal of Medicine (NEJM) by

Chambers of the University of California, San Diego, found a six-fold

increased risk of persistent pulmonary hypertension (PPHN) in infants born to

mothers who took an antidepressant in the last trimester of pregnancy. (Attached

and linked at www.paxilbirthdefect.com)

According to the lead author: " Based on our findings, we estimate that six to

twelve mothers per thousand who use an SSRI after 20 weeks’ gestation, are

likely to deliver a child with PPHN. "

" This appears to be a very well-conducted study and we find the results to be

very concerning, " said Dr. Kweder, deputy director of the office of new

drugs at the FDA's Center for Drug Evaluation and Research.

Abstract of Chambers study: Persistent pulmonary hypertension of the newborn

(PPHN) is associated with substantial infant mortality and morbidity. A previous

cohort study suggested a possible association between maternal use of the

selective serotonin-reuptake inhibitor (SSRI) fluoxetine late in the third

trimester of pregnancy and the risk of PPHN in the infant. We performed a

case-control study to assess whether PPHN is associated with exposure to SSRIs

during late pregnancy. METHODS: Between 1998 and 2003, we enrolled 377 women

whose infants had PPHN and 836 matched control women and their infants. Maternal

interviews were conducted by nurses, who were blinded to the study hypothesis,

regarding medication use in pregnancy and potential confounders, including

demographic variables and health history. RESULTS: Fourteen infants with PPHN

had been exposed to an SSRI after the completion of the 20th week of gestation,

as compared with six control infants (adjusted odds ratio, 6.1; 95 percent

confidence interval, 2.2 to 16.8). In contrast, neither the use of SSRIs before

the 20th week of gestation nor the use of non-SSRI antidepressant drugs at any

time during pregnancy was associated with an increased risk of PPHN.

CONCLUSIONS: These data support an association between the maternal use of SSRIs

in late pregnancy and PPHN in the offspring; further study of this association

is warranted. These findings should be taken into account in decisions as to

whether to continue the use of SSRIs during pregnancy.

FDA Public Health Advisories Concerning Paxil Birth Defects:

On July 19, 2006

http://www.fda.gov/cder/drug/advisory/SSRI_PPHN200607.htm , the FDA issued a

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 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. "

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.

According to an FDA Public Health Advisory dated December 2005

http://www.fda/gov/cder/drug/advisory/paroxetine200512.htm :

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 US, women who received Paxil in the first trimester of

their pregnancies had a 1.5-fold increased risk of cardiac malformations.

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. "

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 been handling SSRI cases longer than any other law firm. Since

1990 the firm 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.). The firm currently

represents families of children who have suffered birth defects due to their

mothers' use of Paxil during pregnancy.

The firm 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, 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, the

California State Senate and met with members of the U.S. House and Senate

regarding the risk of antidepressant induced suicidality. In 2004 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. " Ms. Menzies just received another

state Attorney-of-the-Year nomination from Consumer Attorneys of California.

http://www.baumhedlundlaw.com/attorneys/karenbarthmenzies.htm

-30-

1. Kirsch and , " The Emperor’s New Drugs: An Analysis of Antidepressant

Medication Data Submitted to the U.S. Food and Drug Administration, " Prevention

& Treatment, Volume 5, Article 23, July 15, 2002.

2. Moncrieff and Kirsch, " Efficacy of antidepressants in adults " BMJ July 2005.

3. Kirsch, et al., " Antidepressants and Placebos: Secrets, Revelations,

and Unanswered Questions, " Prevention & Treatment, Volume 5, Article 33, posted

July 15, 2002. (rmccall@...)

Media Relations Director

Baum Hedlund, A Professional Corporation

12100 Wilshire Boulevard, Suite 950

Los Angeles, CA 90025

Phone : 310-207-3233

Fax : 310-820-7444

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