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Child Born with Life-Threatening Persistent Pulmonary Hypertension (PPHN) Sues Paxil-Maker.
First PPHN Paxil Birth Defect Lawsuit Filed
Philadelphia, Pennsylvania, October 16, 2006 -- Eric Jackson 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.
Eric and his parents, Christopher Jackson and Lisa Boden of Denver, Colorado filed a lawsuit today against Philadelphia-based GlaxoSmithKline ("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, Eric 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.
Eric 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.
According to Baum Hedlund attorney Karen Barth Menzies, who represents the family: "Eric 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."
"The American Medical Association estimates that over 1 percent of pregnant women in the US, or more than 40,000, are taking antidepressants."
Sales of antidepressants in the US last year exceeded $12.5 billion.
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.
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 Christina 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. Sandra 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, 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. 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."
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:
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 , 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.
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, 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, the California State Senate and met with members of the U.S. House and Senate regarding the risk of antidepressant induced suicidality. 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." Ms. Menzies just received another state Attorney-of-the-Year nomination from Consumer Attorneys of California.
- Kirsch and Moore, "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.
- Moncrieff and Kirsch, "Efficacy of antidepressants in adults" BMJ July 2005.
- Kirsch, Moore et al., "Antidepressants and Placebos: Secrets, Revelations, and Unanswered Questions," Prevention & Treatment, Volume 5, Article 33, posted July 15, 2002.