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 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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June 25, 2014

Zoloft Birth Defect: Study Warns of Brain Defect in Babies Born to Moms on Antidepressant

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One in five children born to women treated with Zoloft faces the enhanced risk of congenital brain deformities. Prenatal exposure to Zoloft and similar selective serotonin reuptake inhibitor (SSRI) antidepressants is likely to cause potential “Chiari type 1 brain malformation” in babies, a new research study published in the Neuropsychopharmacology journal claims. The report made public on May 19, 2014, is the latest in the line of many findings that link pregnant women taking Zoloft to fatal heart and lung birth defects, developmental problems, and cranial deformities in babies born to them.

The Research Report: 18 Percent Children Face the Risk

Entitled “Chiari I Malformation in Children of Mothers with Depression with and without Prenatal SSRI Exposure,” the report was based on the research conducted by scholars at the University of North Carolina. It highlights the presence of higher risk of brain malformations impacting cognitive coordination in children born to “depressed mothers treated with antidepressants called selective serotonin reuptake inhibitors (SSRIs) during pregnancy.” The risk is six times higher when compared to babies born to pregnant women not treated with antidepressants.

Chiari type 1 malformation refers to deformities in the cerebellum, a vital part of the brain entrusted with regulating human balance and muscle coordination. Malformed brain tissues in the area squeeze the brain stem, obstructing the flow of cerebral fluid to the spinal canal. “Fully 18 percent of the children whose mothers took SSRIs during pregnancy had Chiari type 1 malformations, compared to 3 percent among children whose mothers had no history of depression,” the researchers discovered.

Children born with such defects “might fall down a lot, walk unusually, have trouble grasping items, have poor hand-eye coordination” and likely to have “neck or chest pain, headaches with coughing, excessive drooling, irritation, swallowing difficulty, choking, speaking problem, developmental delays, light sensitivity or blurred vision, numbness, insomnia, or other abnormal feelings in the arms and legs,” the report highlights.

Researches Linking Zoloft Birth Defects to Brain Injury

Risk of cranial deformities and anencephaly in children as a result of Zoloft birth defects. (New England Journal of Medicine, 2007)
Danish researchers claimed link between Zoloft intake by pregnant women and withdrawal syndrome in babies. (Pediatrics journal, March 2010)
Enhanced risk of autism in newborns when pregnant mothers use Zoloft antidepressant. (Times Magazine report, 2011)
Five-fold risk of seizures in babies due to prenatal exposure to Zoloft. (American Journal of Obstetrics and Gynecology, May 2012)
Brain defects, deformities in vertebra, and neurobehavioral syndrome in babies attributed to Zoloft taken by their mothers during pregnancy. (Human Reproduction journal, Oct 2012)
Link between brain hemorrhage in newborns and Zoloft birth defects. (Neurology journal, 2012)
Zoloft birth defects are likely to result in children missing normal development and growth milestones. (US National Academy of Science report, 2012)

The FDA alert on pregnancy-linked Zoloft birth defects came only in 2006, a decade and half after the drug was approved and used by millions. Hundreds of Zoloft birth defect lawsuits have been filed by parents against Pfizer for its failure to inform users about the potential side effects of the antidepressant when used by pregnant women.

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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June 25, 2014June 25, 2014

Zoloft Birth Defects Lawsuit: Mother Sues Hospitals After Son Suffered Brain Injury

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A mother has filed a Zoloft birth injury lawsuit holding two Illinois-based hospitals responsible for the brain injury suffered by her son. Lauren Reed was prescribed Zoloft antidepressant while she was pregnant. Her son Griffin Allen Reed was born with severe respiratory distress, a key Zoloft birth defect side effect, at Anderson Hospital and suffered from brain damage due to lack of oxygen, as doctors failed to timely intubate the baby.

Lauren was treated with Zoloft during her pregnancy unaware that the antidepressant drug could result in birth defects in her child. Doctors at Meridian Ob-Gyn Associates did not take her off from the antidepressant or refer to a perinatologist. Zoloft birth defects led to the birth of the boy with persistent pulmonary hypertension, a disorder that impairs lungs to take over blood-oxygen circulation functions soon after the child is born, and congenital heart deformities.

Griffin was born with a PPHN, and failure on the part of the doctors to provide him with emergency oxygen supply resulted in hypoxic brain injury. The mother has sought $500,000 in addition to legal and medical costs for her son’s disability, pain, suffering, and loss of future earning capacity.

Zoloft Birth Defect Lawsuit: Antidepressant Side Effects

Zoloft SSRI antidepressant was introduced by Pfizer in 1991 to treat depression, anxiety, and obsessive–compulsive disorders. The drug is also marketed in its generic name Sertralin. In 2006, the FDA and Health Canada issued public alerts warning about potential Zoloft birth defect in newborns, if the drug is prescribed to pregnant mothers. Zoloft carries a black box warning for potential suicidal tendency in users.

In 2009, a Danish research study found evidence linking withdrawal symptoms in newborns to the consumption of Sertralin by expectant mothers. It was followed by a study published in the British Medical Journal warning of high risk of heart disorders in babies born with Zoloft birth defects. In 2014, another BMJ report highlighted the potential risk of newborns suffering fatal lung disorders as a consequence of Zoloft birth defect.

A 2012 research report listed a number of possible Zoloft birth defects in babies born to mothers treated with the antidepressant. A compilation of findings reported by over 100 research studies and published in the Human Reproduction journal linked pregnant women using Zoloft antidepressant to heart and lung deformities, cranial and vertebra defects, neurobehavioral disorders, and abnormalities in internal organs in newborns.

According to a 2012 American Journal of Obstetrics and Gynecology report, Zoloft use by pregnant women enhances the risk of their babies suffering from seizure and neurobehavioral problems by five times.

Zoloft Birth Defect Lawsuit

About 600 Zoloft birth defect lawsuits seeking product liability against Pfizer are centralized at the Eastern District Court, Pennsylvania, for pretrial consolidation and coordinated proceeding. Judge Cynthia M. Rufe has been chosen to preside over the federal MDL. Dozens of Zoloft birth defect lawsuits are also awaiting trial in various state courts across the country. At least 25 of these litigations representing families from 18 states are filed in a Missouri court. The first trial date was pushed forward to January 5, 2015, three months from its original schedule, after Pfizer petitioned seeking more time to complete the discovery process.

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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