Healthy Skepticism Library item: 5733
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Publication type: media release
Paxil Birth Defect Lawsuit Filed For Child With Severe Heart Defects
Baum Hedlund ( Los Angeles, California) 2006 Jul 28
http://www.baumhedlundlaw.com
Full text:
Release Date: July 28, 2006
Paxil Birth Defect Lawsuit Filed For Child With Severe Heart Defects
Baum Hedlund, A Professional Corporation
http://www.baumhedlundlaw.com
Philadelphia, PA July 28 2006
Child Born with Severe Heart Birth Defects Sues Paxil-Maker
Two-year-old Adrian Vasquez has undergone three open-heart surgeries and now has a pacemaker. His mother took the antidepressant Paxil throughout her entire pregnancy.
Adrian and his parents, Anthony and Matilda Vasquez of Bedford, Texas, filed a lawsuit today against Philadelphia-based GlaxoSmithKline (“GSK”), the maker of Paxil, in Pennsylvania State Court. The family alleges that Mrs. Vasquez’s ingestion of Paxil during her pregnancy resulted in her son being born with severe heart defects. The Vasquez 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.
According to Baum Hedlund attorney Karen Barth Menzies, who represents the family: “Adrian Vasquez is a tough little boy. The trauma he has endured in his brief two years of life is much more than most of us will ever have to suffer in our entire lifetime. The seriousness of these birth defects are such that, at the very first sign of danger, GSK should have issued a strong warning. Over 1 percent — or 40,000 — pregnant women in the US are taking antidepressants. Given the popularity of Paxil, thousands of babies are at risk.”
During the last month of her pregnancy, Mrs. Vasquez learned, while receiving an ultrasound to determine the sex of her baby, that there was something very wrong with her baby’s heart. When Adrian was born a few weeks later, on April 19, 2004, in Norfolk, Virginia, he had several life-threatening congenital heart defects. His parents were repeatedly told that his chances of survival were low.
During the first year of his life, Adrian underwent three open-heart surgeries (at eight days, five months and 10 months) due to his heart defects. He also underwent at least four cardiac catheterizations, and at least thirty echocardiograms within the first few months of his life.
Adrian is now two years old and, while he is behind in his verbal and motor skills, his health has improved. Adrian will, however, need repeated heart surgeries as he continues to grow and may need artificial replacement valves, and perhaps eventually a heart transplant. His prognosis is unclear. [See Fact Sheet for more information about the Vasquez family.]
The Vasquez family is represented by Baum Hedlund, a national pharmaceutical products liability law firm in Los Angeles, Washington, D.C. and Philadelphia. [See Fact Sheet for more information about Baum Hedlund.]
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 analysis showed a more than 2-fold increase for congenital malformations in women taking Paxil compared to other antidepressants.
Another study conducted by researchers in Denmark and published in Pharmacoepidemology and Drug Safety in 2005, also found an association between Paxil and congenital malformations in mothers taking Paxil in the first trimester.
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.]
FACT SHEET
The Complaint:
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.” Armstrong, Wall St. Journal http://www.paxilbirthdefect.com/news.shtml
Sales of antidepressants in the US last year exceeded $12.5 billion. Armstrong, Wall St. Journal
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:
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.”
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 University of California, San Diego, found a six-fold increased risk of persistent pulmonary hypertension (PPH) in infants born to mothers who took an antidepressant in the last trimester of pregnancy.
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 the Vasquez Family:
Adrian Vasquez was born in Norfolk, Virginia on April 19, 2004 to Anthony and Matilda Vasquez. Adrian is their second child. The Vasquez family now lives in Bedford, Texas. Mr. Vasquez is in the Navy and Matilda stays at home to care for the couple’s sons, ages three and two.
Mrs. Vasquez took Paxil throughout her pregnancy with Adrian. She had asked her doctor if taking Paxil was safe and was assured that the manufacturer did not warn of any serious risks in taking Paxil during pregnancy.
During the last month of her pregnancy with Adrian, Mrs. Vasquez had an ultrasound to determine the sex of her baby. It was during this ultrasound that the doctor discovered that there was something drastically wrong with Adrian’s heart. When he was born a few weeks later, on April 19, 2004, in Norfolk, Virginia, he had several life-threatening congenital heart defects.
Adrian had his first open-heart surgery at eight days. At five months, he underwent his second open-heart surgery, which lasted three hours. His parents were told that his chances of survival were low.
At ten months, in February 2005, Adrian underwent emergency open-heart surgery which took over six hours to complete. Again, Adrian’s parents were told that his chances of survival were slim. It was at this point that a pacemaker was installed. Adrian had to remain in the hospital for over a month and was finally discharged from the hospital on April 3, 2005, just a few weeks before his first birthday.
Although Adrian’s health has improved since the installation of the pacemaker, he will need repeated heart surgeries as he continues to grow. His prognosis is unclear. He still may need artificial replacement valves, and perhaps eventually a heart transplant.
About Baum Hedlund:
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.). The firm currently represents families of children who have suffered birth defects due to their mothers’ use of Paxil during pregnancy.
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, the California State Senate and met with members of the 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.”
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1. 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.
2. Moncrieff and Kirsch, “Efficacy of antidepressants in adults” BMJ July 2005.
3. Kirsch, Moore et al., “Antidepressants and Placebos: Secrets, Revelations, and Unanswered Questions,” Prevention & Treatment, Volume 5, Article 33, posted July 15, 2002.
Robin McCall (rmccall@baumhedlundlaw.com)
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
