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.

July 13, 2015

Multiple Research Studies Focus on Zoloft Birth Defects

Major Zoloft Birth Defects

Pfizer has over $2 billion in annual income from Zoloft, one of the most used antidepressant in the United States. However, research studies published in the recent years highlighted a number of birth injury risks associated with it.

A 2012 report in the Human Reproduction journal warned of vertebra and brain deformities in children born to mothers treated with Zoloft when pregnant. This was supported by reports in Neuropsychopharmacology (Chiari type 1 brain malformation, May 2014) and the New England Journal of Medicine (anencephaly, 2007). Zoloft birth defects in a baby may also include developmental delays, fatal lung problem, brain malformations, clubfoot, and heart defects.

A Havard research report claims that Zoloft birth defect in a baby may lead to “two-fold risk of attention deficit hyperactivity disorder.” The drug prescribed to save yet-to-born children from psychological illness of pregnant mothers may result in autism, preterm birth-linked problems, and other birth anomalies when they are born.

The reason for Zoloft birth defect in a baby is traced to ability of the serotonin-inhibitor drug to blind “cell-signaling molecule of a pregnant woman” that impacts physical and mental development of children at the prenatal stage. According to researchers at Johns Hopkins University, Zoloft ingestion during pregnancy hikes autism risk in newborns by three times.

While disfigurement is the most common non-fatal Zoloft birth defect in a baby, the antidepressant may lead to fatal persistent pulmonary hypertension and hypoplastic heart syndrome, which impact oxygen circulation in the body. Cranial defects, including undeveloped vertebra and neural tube, also threaten lives of newborns.

Zoloft Birth Defects Claims Mirror Paxil Lawsuits

Zoloft birth defect lawsuits against Pfizer emulate more than 800 similar claims made against GlaxoSmithKline’s Paxil antidepressant. Similar to the New York-based Pfizer, the London-headquartered Glaxo refuted allegation of defective drug and negligence in warning consumers about potential side effects. However, it relented in the face stiff opposition from consumer groups and legal setbacks over “failure to properly report safety data to regulators.” The manufacturer paid over $3 billion to settle all criminal and civil proceedings pertaining to the allegations.

Interestingly, both Zoloft and Paxil belong to the same class of antidepressants called selective serotonin reuptake inhibitor. Paxil was introduced in 1992, a year after Zoloft was approved. Both drugs were prescribed to treat major depressive disorders and have been linked to identical side effects. In fact, there were many research reports that evaluated both drugs together to review effect of SSRI-class antidepressants when prescribed to pregnant women and attested a number of fatal and non-fatal side effects as common to two medications.

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July 13, 2015

Zoloft Birth Defect Lawsuit Claims Pfizer Knew Pregnancy Risks, But Ignored Side Effects

A lawsuit filed over a Zoloft birth defect in a baby claims that manufacturer Pfizer was aware of the pregnancy-linked side effects of the antidepressant but ignored warnings for commercial gains. According to the evidence presented by a Zoloft lawyer representing the plaintiff, parents of a 11-yer-old boy with heart defects, internal researches apprised the manufacturer of congenital anomalies associated with the drug ingestion by pregnant women. Over 1,000 Zoloft birth defect lawsuits filed across the US legal system unanimous in their claim that Pfizer did not warn consumers or doctors about potential dangers of antidepressant ingestion during pregnancy.

The Zoloft lawyer has presented an excerpt from a May 2014 report prepared by Pfizer researchers. It warns “that newborns of women taking the mood-altering drug were at risk of suffering congenital anomalies.” A Texas doctor testified about the Pfizer internal report suggesting evidence “that Zoloft was clearly a risk factor for birth defects, especially heart defects.”

The internal report submitted to Pfizer hinted at the possibility of heart defects, including atrial septal defect or a hole in the heart, in newborns. It also warned of growth retardation, persistent pulmonary hypertension, congenital heart disorders, and omphalocele or protrusion of liver and intestines, among possible Zoloft birth defects in a baby exposed to Zoloft prior to birth.

The Zoloft lawsuit demands strict product liability against Pfizer for hiding safety information to gain quick market share and increase commercial earnings.

Do I Have A Zoloft Birth Defect Lawsuit?

While research reports and Zoloft lawsuits continue to highlight antidepressant side effects, it is no more hidden that Pfizer aggressively marketed the drug without disclosing about its potential side effects. A study by the Tennessee Medicaid reveals that newborns face “five-fold rise in the risk of life-threatening health problems” due to the pregnancy side effects of the drug.

If you have a claim involving Zoloft birth defect in baby, please contact us or call on 1-800-632-1404 for a free evaluation of your potential lawsuit. Our Zoloft lawyer offers to guide you and fight your drug injury litigation for economic and non-economic damages on contingency fee basis.

March 3, 2015

Zoloft Injury Attorney Reports Expert Witness Excluded

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Zoloft Injury Attorney Ed Wallis has reported that a federal judge has excluded an expert witness for those injured due to Zoloft, but Mr. Wallis is still accepting cases for Zoloft, Wellbutrin and Zyban birth defects.

The plaintiffs (who allege Zoloft caused birth defects in unborn children) in an MDL proceeding in Pennsylvania federal district court offered Dr. Anick Bėrard, an epidemiologist, as an expert regarding general causation. In re Zoloft, __ F.Supp.3d __, 2015 WL 314149 (E.D. Pa.). In June 2014, the court excluded Dr. Bėrard’s testimony for several reasons, “including her inattention to the principles of replication and statistical significance, her use of certain principles and methods without demonstrating either that they are recognized by her scientific community or that they should otherwise be considered scientifically valid, . . . and Dr. Bėrard’s failure to reconcile her currently expressed opinions with her prior opinions and her published, peer-reviewed research.” Id. at *1.

The plaintiffs filed a motion for reconsideration, contending the court erred by excluding “a general causation expert for drawing conclusions about causation in the absence of replicated, statistically significant associations.” Id. at *1.

The court denied the plaintiffs’ motion because the court did not hold that there is any such requirement. “Rather, the court set forth its factual findings that epidemiologists, such as Dr. Bėrard, who are examining potential teratogens generally will not draw causal conclusions in the absence of replicated statistically significant findings and application of the Bradford-Hill criteria.” Id. at *2. The Bradford-Hill criteria are well-established causation criteria used by epidemiologists.” Id. at *2.

The court considered statistical significance to be one important indicator of reliable methodology, and then assessed Dr. Bėrard’s methodology under Daubert. Id. at *2. The court concluded that Dr. Bėrard’s methodology did not satisfy Daubert and excluded her opinions.

Despite this setback for injured persons, we remain willing to discuss birth defects associated with Zoloft, Zyban, or Wellbutrin. If you or a loved one took Zoloft during pregnancy and a child was born with a birth defect, please contact us.

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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NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

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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July 22, 2014August 22, 2014

Zoloft Birth Defects Are Possible If Ingested When Pregnant

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As attorneys that are representing children born with birth defects after taking Paxil, Wellbutrin, Zoloft, and Effexor, we wanted to advise that an Ohio woman has filed a lawsuit against GlaxoSmithKline with the client alleging Paxil caused birth defects.

Zoloft Birth Defects Similar to Paxil Birth Defects

In March 2014, Katherine Kiker, an Ohio woman, filed a lawsuit against Smithkline Beecham Corporation d/b/a GlaxoSmithKline claiming that Paxil, the antidepressant she took while she was pregnant, caused severe birth defects to her child. She filed suit in the United States District Court for the Eastern District of Pennsylvania. In the suit, Kiker also named her minor child, C. S., as a plaintiff. According to Kiker, her child has been diagnosed with infant respiratory distress syndrome and ventricular septal defect (VSD). The child alleges per Kiker to continue to suffer from these conditions. Attorneys in the suit have cited several causes of action including but not limited to negligence, failure to warn and fraud. Kiker was seeking compensation for all general and economic damages, lost earnings, medical expenses and punitive damages, as well as all costs associated with pursuing the lawsuit.

Paxil is a brand name that GSK has used in its marketing of the generic medicine Paroxetine, one of several drugs known as selective seratin reuptake inhibitors. The use of the drug was for adults only but never for pregnant women. The plaintiff in this case asserted that she took Paxil as prescribed by her doctor while she was pregnant with C.S. Kiker claims that during her pregnancy, GSK knew that Paxil posed a propound risk of cardiac birth defects in babies whose mothers had taken Paxil while pregnant.

Just two years ago, according to the lawsuit, the United States Department of Justice announced that GSK had agreed to plead guilty and pay Three Billion dollars in punitive damages to resolve both federal and civil allegations regarding the company’s illegal promotion of the drug. The lawsuit contends that GSK promoted Paxil to pregnant women, in fact suggesting that it was safer than other similar medications, such as Prozac and Zoloft.

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.

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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.

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April 28, 2014

Zoloft Birth Defect Lawsuits Move Forward as Researchers Make More Side Effect Claims

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Treating pregnant women with SSRI antidepressant Zoloft may result in serious birth defects in children. The antidepressant drug exposure during the prenatal stage caused life-threatening Zoloft birth defect in newborns, including fatal lung disorders, brain malformations, heart defects, and neural tube flaws. More than 600 Zoloft birth defect lawsuits linking the antidepressant to birth defects have been filed throughout the United States and the number is growing fast.

Introduced by Pfizer in 1991, Zoloft is claimed to be an effective medication for obsessive-compulsive disorders, stress, anxiety, and depression in adults. However, a number of research studies and reports, contrary to the manufacture’s claim, have established that the drug side effects during pregnancy result in life-threatening Zoloft birth defects, including

lung disorder, such as persistent pulmonary hypertension (pphn)
heart defects, such as pulmonary vessels deformities, valve defect, atrioventricular opening, septal imperfection, and hypoplastic syndrome
brain and skull malformations, such as absence of brain parts, anencephaly, skull improperly developed, and cranial deformities
neurological problems caused by skull deformities, such as seizures, sleeping and vision disorders, cranial pain, and brain disorders
autism and developmental delays
other deformities, such as clubfoot, cleft lip, spina bifida, non-formation of internal parts, cleft palate, premature skull ossification, and neural tube defects

FDA and Health Canada Warnings on Zoloft Birth Defect Side Effects

A number of reports published between 2002 and 2006 hinted at a potential link between Zoloft and birth defect in newborns. In February 2006, the New England Journal of Medicine made public a research report, warning of 600 percent rise in fatal lung disorder PPHN in babies born to pregnant women using Zoloft and other SSRI antidepressants. The study investigated 377 newborn PPHN cases in four U.S. cities between 1998 and 2003.

The report triggered warnings by Health Canada and the FDA. In March 2006, the Canadian regulator advised women “pregnant or intend to become pregnant” to avoid Zoloft and other SSRI antidepressants “due to potential risks to the baby.”

In July 2006, the FDA issued a public health alert warning about pregnancy-linked Zoloft birth defects. “Infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were six times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy,” said the FDA announcement.

New Research Study Links Zoloft to Preterm Birth Risk, Injuries

A recent Zoloft birth defect study published in the PLosOne medical journal warned of preterm birth risk and related deformities following the use of the SSRI antidepressant during pregnancy. Reported in the last week of March 2014, the research led by experts from Brigham and Women’s Hospital highlighted a high incidence of preterm labor and child birth among women treated with Zoloft and other SSRI antidepressants after the first pregnancy trimester.

The study looked into a range of medical databases and 41 individual research reports linked to antidepressant use during pregnancy. It also warned of Zoloft birth defects, including deformities, defects, and malformations, following birth of babies prior to their fullest prenatal development.

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