Zoloft Birth Defect Lawsuit: Disclosures Show Pfizer Aware of Side Effects

Reports suggest Pfizer was aware of Zoloft birth defect side effects from an internal assessment, but never accepted it publicly or warned consumers. The management of the antidepressant manufacturer was communicated by one of its drug-safety officials last year over internal findings linking Zoloft to pregnancy-linked newborn deformities. The failure to act on the report and continued denial of any birth defect risk linked to its antidepressant may complicate matters for Pfizer in its defense against over 1,000 Zoloft birth defect lawsuit filings around the country.

In April 2014, a top official of Pfizer’s Worldwide Safety Strategy division, Francesca Kolitsopoulous, proposed label modifications for Zoloft to include warning about potential birth defects following its use during pregnancy. While reviewing research reports, she discovered potential association between the prenatal exposure to the antidepressant and heart, abdominal, intestine, and other deformities in newborns.

Disclosures Dig Dip, Cites 1998 Report

A Zoloft birth defect lawsuit filed in a Philadelphia court a few weeks ago was the first to highlight the revelation to support its claim for $2.4 million in financial damages. The Zoloft lawyer representing the plaintiff has cited “hole in heart, growth retardation, persistent pulmonary hypertension, congenital heart disorders, and omphalocele or protrusion of liver and intestines” among newborn abnormalities linked to the antidepressant in an internal report of Pfizer.

The report dates back to 1998 and was prepared based on review of 50 pregnancy-linked Zoloft birth defect reports by the manufacturer. Pfizer safety monitors reportedly admitted that the antidepressant use by pregnant woman “couldn’t be ruled out as a cause” of congenital defects in babies born to them. They found Zoloft pregnancy side effects as strongly related to newborn abnormalities in at least 16 cases and possibly related in another 25 cases.

Though Pfizer has dismissed the revelation as “cherry-picked data,” the disclosure makes it difficult for the company to reject claims of suppression of information on potential side effect risks.

The incident reminds many Zoloft lawyers about Paxil birth defect lawsuits. GlaxoSmithKline denied allegations of birth defect linked to use of Paxil antidepressant by pregnant mothers until it was investigated by the public authorities following similar disclosures. Glaxo paid $3 billion to the government and $1 billion to 800 plaintiffs to settle claims related to its antidepressant.

Zoloft Birth Defects

Zoloft ranks among the most prescribed antidepressants. However, the drug is named in over 1,000 Zoloft birth defect lawsuit filings that allege the drug caused birth defects in newborns when used by pregnant women. Many research studies have also warned of both fatal and non-fatal injuries in children exposed to the antidepressant at the prenatal stage.

According to researchers from Havard, Zoloft has the potential to result in “two-fold risk of attention deficit hyperactivity disorder” in babies when mothers are treated with the antidepressant during pregnancy.
Chiari type 1 brain malformation are likely to develop in babies due to Zoloft pregnancy side effects, claims Neuropsychopharmacology journal.
Children are likely to born with vertebra and brain abnormalities following Zoloft ingestion by mothers, say reports in Human Reproduction and New England Journal of Medicine.
Autism risk associated with Zoloft birth defects, a fact affirmed by researchersat Johns Hopkins University.
The FDA has warned of persistent pulmonary hypertension in babies linked to antidepressant use by expectant mothers.
Various studies highlight heart defects, developmental delays, and physical deformities.

If you have a claim involving Zoloft birth defect in children, please contact us or call on 1-800-632-1404 for a free evaluation of your potential lawsuit.

November 3, 2015

Heart Defect Label Warning on the Horizon as Zoloft Birth Injury Lawsuit Increase

As Zoloft birth injury lawsuits mount, news reports cite a communication from the FDA to drug manufacturer Pfizer seeking to include the risk of infant heart defects in label warning. Many mothers on behalf of their children have filed a Zoloft birth injury lawsuit claiming serious and fatal heart defects filed across the United States. Plaintiffs claim that they and their innocent children turned victims of the drug side effect in the absence of any pregnancy-linked adverse event warning. Recent court submission by a Zoloft attorney highlights Pfizer was aware of birth injury side effects as early as 1998, but never made it public.

As reported by Bloomberg News, the FDA asked Pfizer in August 2015 to modify safety warnings and add information to Zoloft label warning that “some researchers have discovered risk of congenital cardiac problems in children born to women treated with the antidepressant during pregnancy. The present label talks about “absence of adequate and well-controlled studies involving pregnant women.” The FDA stepped in after a Zoloft birth injury lawsuit quoted some internal memos (between 1998 and 2014) citing how the manufacturer’s staff scientists periodically warned about the potential link between heart defects in newborns and pregnancy side effects of the drug.

The changes to the rules governing pregnancy and lactation labeling information incorporated in 2014 empowers the FDA to request for necessary label changes in the view of perceived health risks for pregnant women. Pfizer sources have confirmed that the FDA request is under consideration. Though the manufacturer still claims that “there is no reliable scientific evidence linking Zoloft and birth defects,” the FDA request underlines what many consumer groups, research reports, and plaintiffs have been highlighting so far.

Internal Memos Cite Heart Defect Birth Injury Risk from Zoloft; Leads to Zoloft Birth Injury Lawsuit

A few weeks ago, a Zoloft attorney representing a $2.4 million claim in a Philadelphia court submitted some portions of a Pfizer internal memo that warns about the possibility of “hole in heart, persistent pulmonary hypertension, and congenital heart disorders” in children born to women ingesting the drug while pregnant. It was taken from a 1998 report prepared by researchers employed by the manufacturer. The report studied 50 Zoloft pregnancy adverse events to conclude that the drug side effects “could not be ruled out” for causing birth injuries, the Zoloft lawyer claims.

Another internal report prepared by Pfizer’s associate director for epidemiology at Worldwide Safety Strategy department and dating back to April 2014 also hinted at Zoloft heart defects in infants. Primarily a review report, it talks about birth deformities impacting heart and other vital organs due to prenatal expose to the antidepressant.

For long, Pfizer is rejecting charges of association between Zoloft antidepressant and birth injury in infants, including heart defects. There are over 1,000 Zoloft lawsuits and more than a dozen research reports claiming various types of congenital birth defects in babies born to mother taking the drug during pregnancy. These documents are support for injured children in a Zoloft birth injury lawsuit.

Zoloft Heart Defects

Research studies and litigant claims associate Zoloft pregnancy side effects to congenital heart defects in new born, including

persistent pulmonary hypertension
non-fatal pulmonary hypertension
plumonary atresia
hypoplastic heart
pulmonary stenosis
heart valve defects
arota compression
opening between right and left atria
fallot tetralogy
arterial defects

Zoloft Birth Injury Lawsuit Updates

The latest FDA suggestion for label changes is viewed as existence of credible link between Zoloft and heart defects in newborns. It could be a potential boost to hundreds of such claims in the court and induce a jury to rule that Pfizer is guilty of hiding safety data to further commercial gains. The manufacturer was successful in defending two Zoloft lawsuits in St. Louis and Philadelphia earlier this year well before the FDA suggestions came into the fore. However, the first federal bellwether trial for a Zoloft birth injury lawsuit is expected in January 2016. I would expect that trial to be influenced by the news.

If you have a claim involving Zoloft birth defect in children, please contact us or call on 1-800-632-1404 for a free evaluation of your potential lawsuit.

October 16, 2014October 16, 2014

Zoloft Birth Defect Lawsuit: An Analysis of Risk Factors

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Zoloft birth defect lawsuits filed in the recent years highlight how antidepressant pregnancy side effects have the potential to ruin a healthy start of life. Expectant mothers go to great lengths shunning food, medicine, habits, and many other things so that the fetal development does not face problems of any kind. But the failure to wean themselves from SSRI antidepressants, such as Zoloft, wrecks their efforts and enhances the risk of birth defects in babies.

About 14 percent of pregnant women in the United States are prescribed antidepressants fearing that their unstable mental condition may impact the prenatal growth of child. But are these drugs safe? Zoloft research studies published over the years challenge the common assumption that children born to depressed mothers face greater harms than the antidepressant drug adverse events. Zoloft causes both fatal and nonfatal side effects that exceed the potential impact of depression on the yet-to-born child. Every Zoloft lawyer pressing his plaintiff’s product liability lawsuit claims that Pfizer is on the wrong side for its failure to inform about the possibility of birth defects linked to the drug.

Havard Study Support Zoloft Birth Defect Lawsuit Claims

According to a recent Havard research report, Zoloft and popular SSRI antidepressants put the unborn child at the double “risk of attention deficit hyperactivity disorder.” The researchers also found a close link between autism in children and Zoloft pregnancy side effects while rejecting claims antidepressant saves unborn babies from harmful effects of depression mothers suffer from.

“Many psychiatrists believe that the risks of the medication are less than the risks of remaining depressed during the pregnancy; however, there has never been a study which has shown a better outcome in women who took medication,” claimed Dr. Alice D. Domar of Harvard Medical School.

Prenatal exposure to antidepressants also results in preterm birth, a cause of significant risk of health short and long-term disorders in both babies and their mothers, concluded the group comprising obstetrics, gynecology, and reproductive experts. The scholars also urged pregnant women to use non-pharmacological treatments, such as counseling, physical exercise, and cognitive therapy, in place of Zoloft and SSRI antidepressants.

Research Findings Boost Filing of Zoloft Birth Defect Lawsuits

The publication of various research reports linking sertraline to birth defects in newborns has accelerated the filing of Zoloft birth defect lawsuits across the United States. Countering the very basic postulate on which the drug operates, researchers blamed the drug for inhibiting serotonin, a neurotransmitter that plays a vital role in emitting brain neuron signals. It blinds the cell-signaling molecule of a pregnant woman, which, in turn, hinders the development of heart, lungs, gut, and cranial features in babies during the prenatal stage. As result, we witness harmful results in babies born to mothers notwithstanding their better eating, sleeping, and freedom from depression assured by Zoloft.

A Johns Hopkins University research report linked the prevalence of autism spectrum disorders in children to Zoloft pregnancy side effects. The study linked prenatal exposure to the drug with three-time higher risk of autism. Developmental delays, including lower language competence, in children may be due to SSRI antidepressant impact during pregnancy, claims a Norwegian study.

Zoloft birth defect lawsuits saw a surge after a series of research findings link the drug to clubfoot, heart defects, other rare congenital disorders, and the fatal lung problem. A number of reports also blame Zoloft pregnancy side effects for newborns scoring low on APGAR scale, a key indicator of their good health and well being immediately after birth.

Contact Zoloft Lawyer for Birth Defect Lawsuit

Parents and children who have suffered from injuries, losses, and disability due to Zoloft side effects have the right to seek compensation for economic and non-economic damages from the drug manufacturer. To know about the process for filing Zoloft birth defect lawsuit and pursue defective medical device product liability claims citing drug maker’s actions and inactions, please contact us or call on 1-800-632-1404 to talk to an experienced Zoloft lawyer.

If your child was born with a birth defect and you or a loved one took Zoloft during the first trimester or pregnancy, please contact us immediately.

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October 1, 2014

Zoloft Birth Defect Lawsuit: Antidepressant Linked to Neural Tube Defects

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With over 500 Zoloft birth defect lawsuits filed and more in the pipeline, the SSRI antidepressant has become a big risk for pregnant women. Researchers, indicting Zoloft pregnancy side effects for heart, cranial, respiratory, and physical deformities in newborns, have brought to light the adverse effects of the antidepressant. Pfizer, which has gained immensely from 30 million Zoloft prescriptions in the last two decades, is facing a number of neural tube birth defect lawsuits linked to the drug.

Zoloft lawyers representing plaintiffs have claimed that newborns died or had to undergo surgical procedure immediately after their births due to the presence of neural tube birth defects, brain malformation, spina bifida, anencephaly, and similar high-risk cranial deformities.

Zoloft Lawsuit: Understanding Neural Tube Birth Defect

The neural tube is responsible for the nervous functions of a fetus during early pregnancy, and it conflates to form the brain and the spinal cord as the prenatal development succeeds. Neural tube defect is likely to occur when openings remain and the tube does not fuse properly. It can be of several types.

Spina Bifida: A type of spinal cord malformation, it refers to bone or tissue openings, such as lumps, dimple, birth mark, or skin abnormalities. There can also be hidden spina bifida occulta in newborns due to Zoloft birth injury effects.
Anencephaly: Referring to absence of major brain parts, it occurs in children born without cerebellum or frontal lobe.
Hydranencephaly: A Zoloft lawsuit filed a few months ago claims death of a baby born “with missing cerebral hemispheres of the brain.”
Tethered Cord Syndrome: It refers to unnecessary tissues attached to the spinal cord and resolution requires surgical intervention.
Encephaloceles: Brain malformations are formed and bulge out through the skull.

Zoloft Neural Tube Birth Defect Studies

In May 2014, Neuropsychopharmacology made public a research report, warning of a six-fold higher risk of “Chiari type 1 brain malformation” in children due to pregnancy side effects of Zoloft. The study, “Chiari Malformation in Children of Mothers with Depression with and without Prenatal SSRI Exposure,” traced the problem to “depressed mothers treated with antidepressants called selective serotonin reuptake inhibitors (SSRIs) during pregnancy.” These malformations block proper formation of the spinal cord and the skull.
An American Medical Association research also warned of the significant risk of neural tube defects in babies born to mothers who have been prescribed Zoloft antidepressant.
According to an October 2012 report in Human Reproduction journal, Zoloft birth defects may result in vertebra and brain deformities.
The American Journal of Obstetrics and Gynecology quoted researchers, highlighting the high risk of seizure in newborns due to Zoloft-linked neural tube defects.
In 2007, the New England Journal of Medicine brought out study findings exposing a close association between anencephaly in newborns and Zoloft birth defects.

Zoloft Neural Tube Birth Defect Impacts

Neural tube disorders caused by Zoloft birth defects result in the death of newborns or serious permanent effects. Many a time, there is no solution to it, and parents are left to manage the disorder in their children. While the rate of fatality is high, those live longer face normal development and growth delays. Mental disabilities, nervous system problems, seizures, visual impairment, muscle weakness, and cognitive dysfunctions continue to impact the lives of such children forever.

Parents and children who have suffered from injuries, losses, and disability due to Zoloft side effects have the right to demand compensation for economic and non-economic damages from the drug manufacturer. To know about the process for filing Zoloft lawsuit and pursue defective medical device product liability claims citing drug maker’s actions and inactions, please contact us or call on 1-800-632-1404.

Contact a Zoloft Birth Defect Lawyer Today.

If your child was born with a birth defect and you or a loved one took Zoloft during the first trimester or pregnancy, please contact us immediately.

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April 28, 2014

Zoloft Birth Defect Lawsuit: Things to Know

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With over 600 Zoloft birth defect lawsuits awaiting trial and many more expected, Pfizer’s once bestselling antidepressant is now subject to intense legal scrutiny. The use of Zoloft by pregnant mothers has been linked to serious heart, skull, and lung defects in newborns and even death of babies within hours of birth. Research reports have also highlighted a range of potential Zoloft birth defects in babies exposed to the drug during the prenatal stage.

Zoloft Birth Defect Lawsuit: Decoding the Drug

Zoloft is a selective serotonin reuptake inhibitor antidepressant
Zoloft is prescribed to treat major adult depressive disorders
Sertraline is the key ingredient in Zoloft and acts by inhibiting serotonin neurotransmitter responsible for feeling of wellbeing
Pfizer began marketing Zoloft in 1991
Zoloft became the second highest sold antidepressant in 2011
FDA categorized Zoloft as a pregnancy C class medication
With the expiry of Pfizer’s patent in 2006, the drug is also available in generic form

Zoloft Birth Injury Lawsuit: Research Studies

The April 2014 edition of PLosOne reported that there was a high possibility of pregnant women suffering from preterm labor and delivering babies with several Zoloft birth defects and deformities when treated with the SSRI antidepressant.
A January 2014 report in the British Medical Journal linked use of Zoloft and similar antidepressants during pregnancy to fatal lung disorders, such as PPHN, in babies.
In May 2012, the American Journal of Obstetrics and Gynecology warned of a five-time rise in the risk of newborns suffering from premature birth and seizers, when pregnant mothers treated with Zoloft.
In October 2012, a review of more than 100 research studies reported by the Human Reproduction journal highlighted the hazard of Zoloft birth defects, such as neurobehavioral abnormalities, heart and lung disorders, brain deformities, vertebra defects, and underdeveloped internal organs, due to prenatal exposure of babies to the drug.
In 2012, the US National Academy of Science expressed fear of potential developmental delays in babies due to Zoloft birth defects. In July 2011, a Times Magazine warned of autism in babies born to mothers who had been prescribed Zoloft during pregnancy.
In 2009, a study in the British Medical Journal disapproved of the use of Zoloft by pregnant women, citing the risk of congenital heart disorders in babies born with Zoloft birth defects.

Zoloft Birth Defect Lawsuit: Major Side Effects Impacting Newborns

Persistent pulmonary hypertension or a fatal lung disorder that prevents blood and oxygen circulation in newborns soon after their birth
Heart defects, such as congenital cardiovascular problems, faulty heart valves, hypoplastic heart, septal deformities, and other problems
Skull and brain deformities, including anencephaly, premature skull ossification, seizures, cranial pain, and distorted vision, and sleep disorder
Neurological problems in babies
Autism, delays in growth, and missed developmental milestones
Under developed internal organs, such as spina bifida, vertebra deformities, rectum defects, abdominal malformations, and neural tube defects
External injuries, including cleft lip and palate, abnormal skull, and neo-behavioral syndrome
Withdrawal syndrome

Zoloft Birth Injury Lawsuit: Regulator Warnings

FDA black box warning for suicidal behavior (2005, 2007)
FDA alert for pregnancy-linked Zoloft birth defects (2006)
Health Canada advisory on Zoloft birth defects (2006)
Danish studies warning of withdrawal syndrome in newborns (2009)

Zoloft Birth Defect Lawsuit: The Litigation

Pfizer has been named as the defendant in over 600 Zoloft birth injury lawsuits filed in U.S. courts. Pennsylvania Eastern District Court Judge Cynthia M. Rufe is presiding over pretrial consolidation of all federal Zoloft birth defect lawsuits. Dozens of litigations have also been filed in various state courts. With expert hearing and discovery phase is set to be completed, the first Zoloft birth injury lawsuit is likely to face trial in October 2014.

If your child was born with a birth defect and you or a loved one took Zoloft during the first trimester or pregnancy, please contact us immediately:

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