On April 29, 2013, a Connecticut mother filed a Zoloft birth defects lawsuit against Pfizer, Inc. on behalf of her minor child. The case is one of many that have joined the Zoloft multidistrict litigation (MDL) No. 2342, which is currently proceeding in the U.S. District Court of the Eastern District of Pennsylvania under the Honorable Cynthia M. Rufe.

As part of the MDL, which is a consolidation of cases that share similar allegations, the plaintiff retains her right to an individual trial by jury. She is seeking compensatory, treble, and punitive damages. Treble damages are awarded by the court in certain cases. It effectively triples the amount of the actual damages to be awarded.

Minor child suffers developmental complications

This Zoloft birth defects lawsuit alleges that the minor child suffered from developmental complications as a result of the plaintiff’s use of Zoloft during pregnancy. In December 2005, the plaintiff was prescribed Zoloft, an antidepressant. Neither the label on the product nor the plaintiff’s doctor warned her that the drug had the potential to cause birth defects. According to the complaint, the doctor prescribed the drug in accordance with the defendants’ product information and because of their marketing campaign.

The plaintiff became pregnant while she was using Zoloft. She gave birth on August 1, 2006. Her minor child was immediately diagnosed with bilateral clubfeet. This is a deformity of the feet that causes them to be forced into unnatural positions, which may interfere with mobility. Bilateral means that the child suffers from clubfoot in both feet.

According to the complaint, the minor child’s condition is severe and presumed to be permanent. The child has undergone many different treatments, including castings and splinting, in an attempt to correct the problem. The complaint alleges that the child continues to suffer from severe emotional and physical problems, and that he has been deprived of a normal childhood.The lawsuit notes that the plaintiff has sustained significant financial difficulties due to numerous medical bills and expenses, and the ongoing treatment that her child requires. She is also seeking compensatory damages to cover her lost wages.

Zoloft and birth defects

Clubfoot is just one of the birth defects that Zoloft is alleged to cause when used during pregnancy. The plaintiffs in the Zoloft MDL allege numerous birth defects, including:

·    Atrial septal defects (ASD)
·    Heart defects
·    Craniosynotosis
·    Ventricular septal defects (VSD)
·    Omphalocele
·    Persistent pulmonary hypertension of the newborn (PPHN)

Link between Zoloft and club foot

The association of Zoloft and clubfoot was not mentioned on the product’s label, and the plaintiff would not have taken the drug if the warning had been available, according to the complaint. This lawsuit states that the minor child’s injuries are a direct result of the defendants’ failure to warn of the risks of the drug. The plaintiff further alleges that the defendants misrepresented the product and intentionally withheld vital medical information about Zoloft from patients and healthcare professionals. The claimant contends that Zoloft is defective in design and was not sufficiently tested prior to marketing.

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Extended pre-natal exposure to SSRIs like Zoloft (sertraline) has been associated with an increased risk of serious birth defects such as spina bifida, heart malformations, club foot and others.

The minor plaintiffs were born with these conditions after their mothers took Zoloft during pregnancy. All of the children required corrective surgeries and will need ongoing medical treatment for the remainder of their lives. The claim joins other similar lawsuits that have been lodged in court rooms across the nation, charging Pfizer with failure to warn.

Conditions cited in Zoloft birth defects lawsuit

The plaintiffs hail from various states including Kentucky, New Hampshire and Tennessee. While their hometowns are all different, the allegations against Pfizer remain the same: that the drug maker designed, manufactured and sold a potentially defective medicine without proper safety warnings as to in-utero side effects. Despite medical research and anecdotal evidence suggesting the dangers of SSRIs to the unborn fetus, Pfizer allegedly continued to market their medication as safe to expectant mothers.

Zoloft is one of the most popular antidepressants on the market, and was approved by the FDA in 1991. It is frequently prescribed to treat anxiety disorders, depression and obsessive-compulsive disorder. Reports involving Zoloft side effects in children prompted the FDA to issue a warning about sertraline  in 2006. The agency noted that ingesting Zoloft while pregnant may increase risk of persistent pulmonary hypertension of the newborn (PPHN).

Among the severe and life-altering birth defects cited in this recent lawsuit were:

• Craniosynotostosis
• Pulmonary stenosis
• Hypospadias
• Hypoplastic heart syndrome
• Atrial septal defect (ASD)
• Imperforate anus
• Congenital heart disease
• Club foot
• Cleft lip
• Spina Bifida

Pfizer charged with fraudulent concealment

According to court documents, had the minor plaintiffs’ mothers known about the risks of Zoloft use and pregnancy, they would never have taken the medication and jeopardized the health of their unborn children. Their allegations mirror those of other claims against Pfizer, which contend that the company misled the public, medical community and FDA about the safety of its medication, despite knowledge of pre-natal side effects. A 2007 study published in the British Medical Journal revealed that women who took Zoloft during pregnancy were twice as likely to have children with heart defects such as ASD.

The claimants’ Zoloft lawyer adopts multiple counts against the defendant including negligence, negligent misrepresentation, fraud, deceit by concealment, and breach of implied and express warranty.

One of the minor plaintiffs died as a result of her birth defects which included aortic stenosis and hypoplastic left heart syndrome. Her parents are also charging Pfizer with wrongful death.  The claimants are seeking actual damages in addition to compensation for past and future medical expenses, pain and suffering, loss of companionship, and punitive damages. Though they filed a joint Zoloft birth defects lawsuit, they all demand an individual trial by jury.

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The plaintiff alleges that defendant Pfizer failed to warn consumers that its antidepressant medication, Zoloft, significantly increases the risk of heart malformations and other serious birth defects when taken by pregnant women. The plaintiff’s daughter, who was born in 1995, was diagnosed with a hypoplastic left heart that necessitated several surgeries while she was an infant. Babies who are born with this condition have a severely underdeveloped heart, where the left side is unable to effectively pump blood to the body, forcing the right side to compensate. Surgery and a possible heart transplant are indicated to treat this rare defect.

The United States District Court for the Eastern District of Pennsylvania is home to the current consolidated litigation regarding claims of injury related to Zoloft (sertraline), and its alleged dangers to expectant mothers and their unborn children.

Allegations raised in Zoloft birth defects lawsuit

Like hundreds of pregnant women who filed suit against Pfizer, the Washington plaintiff claims she relied on the drug information supplied by the manufacturer, and believed that any risks of taking Zoloft during pregnancy would have been highlighted in the product warning. She further trusted that severe conditions associated with the antidepressant, such as congenital defects, would have been included or emphasized in the prescription information. She is suing Pfizer on several counts, and contends that had she been sufficiently warned about possible Zoloft side effects in children, she would have not taken the drug while carrying her baby. When the minor plaintiff was born, she suffered from life- threatening congenital defects, including a hypoplastic left heart that required extensive medical treatment and multiple operations since her birth.

According to court documents, prior to the mother’s ingestion of Zoloft during pregnancy, Pfizer knew of the birth defects associated with use during gestation from earlier clinical trials and published medical research that confirmed these risks. However, she accuses the defendant of failing to take active measures to adequately warn of or address these threats, instead concealing this vital information on potential dangers to both the medical community and the public at large. Her lawyers also allege that the Zoloft manufacturer had the knowledge and the responsibility to provide health care providers and consumers with stronger warnings regarding the link between Zoloft and birth defects, heart defects, PPHN, craniosynostosis, and other related conditions.

Minor plaintiff suffers extensive permanent injuries

In her Zoloft birth defects lawsuit, the mother says that as a direct result of her Zoloft use while pregnant, her minor child suffered physical injuries, which have caused her substantial pain and suffering since the moment of her birth. The claimants are seeking monetary damages to cover nursing, hospital, pharmacy, rehabilitative and related expenses for the child’s birth defects and injuries; care and lost wages, diminished earning capacity, economic losses, and other damages for which they are entitled to compensation. The lawsuit adopts counts of strict product liability- failure to warn, design defect, negligence, fraud, misrepresentation and suppression, constructive fraud, as well as breach of implied and express warranties.The Washington mother and child are demanding a trial by jury and are requesting compensatory and punitive damages, delay damages, and legal costs in an amount to be determined at trial.

At this time, more than 250 claims against Pfizer have been coordinated in multidistrict litigation and the first case involving Zoloft birth defects is expected to go to trial in 2014.

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A new Zoloft heart defects lawsuit was filed on February 26, 2013 against Pfizer, Inc. This case is currently proceeding in the U.S. District Court of the Eastern District of Pennsylvania before Judge Cynthia M. Rufe. The complaint was filed on behalf of a husband, wife, and their minor child, who was born with birth defects. The mother had taken Zoloft, a drug manufactured by the defendant, during her pregnancy, and the lawsuit alleges that the drug caused the minor child’s severe birth defects. Lance Andrews

Zoloft (sertraline) is a selective serotonin reuptake inhibitor (SSRI), a type of antidepressant. It balances certain chemicals in the brain in an effort to treat depression, anxiety disorders, and similar ailments. However, the medication is increasingly being linked to significant birth defects. Since first being sold in 1992, Zoloft has been used by millions and has provided Pfizer with more than $3 billion in revenue.

Minor plaintiff suffers birth defects

During 2010 and 2011, the mother in this lawsuit was prescribed Zoloft. Her doctor instructed her to continue to take it during her pregnancy because the Zoloft birth defects risk was unknown to them at that time.

The minor child was born in 2011. She was diagnosed with ventricular septal defect (VSD), and a heart murmur. VSD has been linked to the use of Zoloft during pregnancy in several clinical studies. In normal infant development, a hole is present in the atrial wall of the heart. This hole normally closes shortly after birth. Babies born with the VSD congenital heart defect have an atrial wall hole that remains open. This allows the oxygenated blood to mix with the oxygen-depleted blood, placing strain on the heart and lungs. The symptoms of VSD can include:

• Heart murmurs
• Lung infections
• Fatigue
• Tachycardia
• Swelling of the abdomen, legs, and feet
• Bluish nails, skin, and lips

Furthermore, the presence of a VSD heart defect means that the minor child is at risk for long-term medical complications, which may include heart and lung damage, hypertension of the lungs, heart failure, stroke, and atrial fibrillation.

Due to the condition, the minor child underwent a surgical VSD repair when she was eight months old. Given the potential for future medical complications, the minor plaintiff could require life-long medical care as a result of this birth defect.

Zoloft heart defects lawsuit joins MDL

This Zoloft lawsuit is part of a multidistrict litigation (MDL), which consolidated all similar federal cases in April 2012 for the purpose of streamlining the litigation. At that time, more than 90 cases nationwide were grouped into the MDL, and additional lawsuits continue to be added. As part of the MDL, the Utah family retains their right to a separate trial against Pfizer.

Zoloft lawyer alleges failure to warn

The plaintiffs’ lawyer argues that Pfizer failed to adequately warn patients and doctors about the potential Zoloft birth defects risk. According to the complaint, the drug maker has still failed to issue warnings about this risk, and continues to target its marketing toward women. The Zoloft lawyer also alleges that the defendant knew of the risk of birth defects prior to their marketing efforts because of tests conducted on animals. However, the defendant then allegedly failed to conduct further tests to determine safety, and instead began marketing Zoloft to women of childbearing age.

In this Zoloft heart defects lawsuit, the Utah plaintiffs are seeking compensatory damages for past and future medical expenses, loss of earning capacity of the minor child, and all other reasonable fees, as well as punitive damages.

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Zoloft lawsuit alleges Pfizer knew of birth defect risks

In July 2006, the Alaska plaintiff was prescribed Zoloft, which she continued to take during her first trimester of pregnancy.  In May 2008, her child was born with Atrial Septal Defect (ASD), a serious congenital heart defect.   As a result of his condition, the child endured extensive surgical procedures in an attempt to repair the birth defect, and will require medical monitoring for the remainder of his life.

The Alaska plaintiffs allege that Pfizer was aware of the risks of Zoloft side effects since 1991, but marketed and sold their drug without further testing.  According to court documents, Pfizer encouraged physicians to prescribe Zoloft to women of childbearing age and to women already pregnant.  In September 2005, the manufacturer of Paxil, a drug very similar to Zoloft, revised the product labeling to include warnings of side effects such as cardiac malformations and other birth defects in children caused by use of the drug by mothers during pregnancy.  The plaintiffs claim that Pfizer should have similarly revised Zoloft warnings to include potential birth defect risks.

Congenital defects linked to Zoloft in medical studies

Like other claims against Pfizer, this recent Zoloft lawsuit points out that medical studies have shown a statistically significant increase in congenital defects among children whose mothers ingested Zoloft while pregnant.  The New England Journal of Medicine published a study in 2006, revealing a link between use of Zoloft and congenital heart defects.  One year later, the same journal published research demonstrating that the use of Zoloft during pregnancy increased the risk of congenital fetal heart defects by up to 50 percent.  In August 2010, the journal Clinical Epidemiology published a study finding that Zoloft use by women tripled the risk of congenital fetal heart defects.  Additional research indicates that other Zoloft birth defects risks include defects of the intestines, abdominal organs and cranium.

Across the country, hundreds of parents have filed similar lawsuits over birth defects allegedly caused by Zoloft.  Plaintiffs filing these claims contend that Zoloft has been the cause of their children’s cranial abnormalities, intestinal hernias, clubfoot, spina bifida and other birth defects. Multidistrict litigation (MDL) in U.S. District Court in the Eastern District of Pennsylvania, which consolidates over 250 Zoloft lawsuits, is scheduled to commence its first trial in early 2014.

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Zoloft lawsuit links birth defects to Zoloft

The plaintiff in this case began taking Zoloft as prescribed by her doctor in February, 2010. One month later, she learned she was pregnant. Because she and her physician assumed Zoloft was safe during pregnancy, she continued to take the antidepressant until she gave birth to her son on September 21, 2010. Shortly after birth, the plaintiff’s son was diagnosed with sagittal craniosynostosis.

Craniosynostosis is a skull abnormality typically detected shortly after birth. During normal skull development, bony plates are held together by sutures to ensure the brain has room to grow and develop in utero. Those plates fuse together during the first few months of the newborn’s development, to eventually form the single structure known as the skull.

In the case of craniosynostosis, the plates fuse together prior to the completion of brain development. Brain growth may be impacted, which can result in developmental delays for the child. Craniosynostosis can also lead to an abnormally shaped head and asymmetrical facial features. In some cases, the condition can cause excess pressure on certain areas of the brain.

Surgery required for craniosynostosis

According to the Zoloft lawyer filing this complaint, the newborn child underwent surgery at the age of four months to correct the craniosynostosis, which required four days in the hospital. After surgery, the child was required to wear a protective helmet for six months. The child requires ongoing medical care and monitoring, which his parents claim has taken away his ability to have a normal childhood and life.

In addition, the parents of the child, listed as the plaintiffs on this complaint, have continued to suffer mentally, emotionally and financially as a result of their son’s injuries. The couple claims they have incurred “substantial medical bills” as a result of their son’s condition.

Complaint alleges Zoloft side effects in children

According to this complaint, Pfizer knew of the risks associated with Zoloft and pregnancy before the drug was even introduced to the marketplace. Prior to the initial approval of the drug in 1991, animal studies showed an increased risk to fetuses when Zoloft was given during pregnancy. Despite these findings, Pfizer began marketing their drug to patients and physicians, including women who were pregnant.

Even when independent scientists found a link between Zoloft use during pregnancy and birth defects in children, including heart defects, abdominal deformities and cranial malformations, Pfizer continued to market their drug without any modifications to the warning label. The complaint states that Pfizer still does not provide adequate warning about the risk of cardiac malformations and other birth defects for mothers taking Zoloft during pregnancy.

The plaintiffs and their Zoloft lawyer are seeking compensatory and punitive damages from Pfizer, to compensate them for their pain and suffering, medical bills and their son’s injuries. The complaint joins dozens of others that have made recent Zoloft lawsuit news, including numerous cases coordinated in Pennsylvania district court where this case is proceeding.

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The plaintiff, from Mobile, Alabama, was first prescribed Zoloft for depression prior to becoming pregnant with her daughter in 2006. She was advised by her doctor that she could safely continue the treatment during her pregnancy. Neither the plaintiff or her doctor had been made aware of the risk of any potential birth defects caused by prenatal use of Zoloft. The plaintiff’s daughter was born five weeks prematurely, and diagnosed with Gastroschisis, a type of hernia in which a child’s intestines protrude through a hole in the abdominal wall. The child immediately required surgery to place her intestines back inside her body. She also suffered subsequent hospitalizations and health complications resulting from the condition.

Gastroschisis can lead to respiratory problems and death. It’s one of a number of malformations cited in Zoloft lawsuits pending across the United States. Other birth defects reported in children whose mothers took Zoloft during pregnancy include clubfoot, craniosnyostosis, atrial setpal defect, and tetralogy of fallot.

Pfizer failed to warn expectant mothers

As of the date the Zoloft lawsuit was filed, Pfizer has not informed women of childbearing age, or pregnant women, that they should not take the drug. According to court documents, the company “still targets these women as their primary market” despite not knowing exactly how the drug combats depression.

Early testing showed risk for Zoloft heart defects

An increasing number of Zoloft lawsuits allege Pfizer knew about the risk of birth defects and fetal death before they began selling the drug in 1992. Animal testing repeatedly showed it caused defects, but there were no trials performed on pregnant humans. In advertising campaigns, Pfizer did not discourage the use of Zoloft during pregnancy, and actively encouraged doctors to prescribe it to women of child bearing age – including those trying to conceive.

Zoloft, the brand name for sertraline, is classified as a Class C drug by the FDA, indicating a risk of birth defects but no provable link. In 2006, the FDA issued a warning about Zoloft-related heart defects, particularly persistent pulmonary hypertension of the newborn (PPHN).

Zoloft lawsuits say drug is most prescribed depression treatment

Since being launched as a treatment for depression, OCD, panic attacks, PTSD and social anxiety disorder, Zoloft has become one of the biggest names on the anti-depressant market. In 2005, it was the most prescribed anti-depressant, racking up $3.3 billion in sales for Pfizer.

The MDL includes more than 250 pending lawsuits alleging the product is defective, dangerous to health, and lacks proper side effect warnings on the label. Pfizer has denied the allegations, describing the lawsuits as “frivolous,” noting the drug’s successful record on treating depression. In one case, a Zoloft lawyer pointed to clinical studies that call into question the effectiveness of the anti-depressant.

Judge Cynthia Rufe, who is overseeing the MDL, is in the process of selecting 25 Zoloft lawsuits to be considered for early trial dates, with one or more expected to start in September 2014.

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Details of Zoloft class action lawsuit

According to court documents, the California woman started taking Zoloft to treat depression in March 2005. She relied on Pfizer’s representation of Zoloft as a safe drug that benefited people who struggled with depression. She used the prescription drug for a span of three years. During that time, her dosage increased from 50 mg per day to 200 mg per day, but she states that Zoloft didn’t work.

The legal complaint asserts that Pfizer intentionally misled consumers regarding Zoloft’s efficacy. As noted in the lawsuit, Pfizer needed at least two clinical trials to show that Zoloft helped treat depression in order to get FDA approval. Four of the six clinical trials presented to the FDA revealed that Zoloft was as ineffective as a sugar pill. Two of the clinical trials concluded that Zoloft provided a marginal benefit to patients, but those trials allegedly had design flaws and a sampling bias.

The claim further states that Pfizer engaged in deceptive marketing practices that prevented consumers from making an informed decision about using the drug. The Zoloft package label presented the drug as being a very effective treatment for depression and didn’t accurately list the results of the clinical trials. Pfizer allegedly chose to only publish favorable clinical trial results in medical journals while omitting information that could be perceived as negative. The plaintiff contends that Pfizer paid medical ghostwriters to produce promotional articles about Zoloft that were published in medical journals.

Other lawsuits allege link between Zoloft and birth defects

Numerous lawsuits have also raised the allegation that Pfizer failed to adequately warn consumers about the link between Zoloft and birth defects. The claimants assert that Pfizer was aware of Zoloft side effects in children, but didn’t update warning labels and marketing materials to inform consumers about the risks. Plaintiffs who filed lawsuits against the drug maker say that had they known about the potential risks of Zoloft during pregnancy, they would have chosen a safer alternative treatment.

A study published in the New England Journal of Medicine concluded that pregnant women who took Zoloft were more susceptible to having children with persistent pulmonary hypertension of the newborn (PPHN). In 2009, a study in the British Journal of Medicine found that women who ingested Zoloft during the first trimester of pregnancy were twice as likely to have children born with atrial septal defects. Using Zoloft during pregnancy may also increase the risk of children having other serious birth defects such as clubfoot, cleft lip or palate, skull defects, delayed development, and spina bifida.

More than 250 Zoloft lawsuits have been filed in federal courts by families with children who suffer from birth defects. In order to handle the cases more efficiently, they were consolidated into multidistrict litigation (MDL). The pretrial proceedings for the Zoloft cases are being handled in the federal court located in the Eastern District of Pennsylvania. The first trial is scheduled to start by September 12, 2014.

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Heart defects diagnosed after Zoloft use

The plaintiff in this lawsuit states she took Zoloft prior to and during her pregnancy as treatment for the post-partum depression she suffered after the birth of a previous child. Her son was born on December 7, 2004, and diagnosed with congenital heart defects shortly after birth. Specifically, the plaintiff’s son suffered a ventricular septal defect and patent foramen ovale, which have required surgical procedures to correct. The child will also require additional medical care and possible surgeries in the future due to these defects.

Ventricular septal defect is a hole between the two lower chambers of the heart. The hole allows blood to pass between the chambers, which causes oxygen-rich and oxygen-poor blood to mix together in the heart. This results in undue strain on the heart, cardiovascular system and lungs of the child.

Patent foramen ovale is also a hole inside the heart that did not close properly after birth. The hole is most commonly located between the upper chambers of the heart and allows blood to bypass the lungs when the baby is still in the womb and does not need to use its lungs for breathing. The hole usually closes during infancy, but if it fails to close, it is called a patent foramen ovale.

Link between Zoloft and pregnancy well documented

According to this complaint, concerns that Zoloft use during pregnancy leads to birth defects are not new. The complaint states that “based upon the alarming evidence and ‘signals’ that had been accumulating since the 1990s,” Zoloft manufacturer Pfizer should have been well aware of the potential for birth defects linked to this drug. Despite the knowledge, the company never approached the FDA about changing the product label to reflect this warning, the complaint states.

In addition, the complaint accuses Pfizer of providing misleading information about their product, by limiting access to negative data to healthcare professionals. Instead, the company provided only the most favorable evidence regarding the safety and effectiveness of their drug, misrepresenting the true risks associated with Zoloft. The plaintiff’s Zoloft lawyers state the company suppressed information about Zoloft’s adverse effects and promoted positive study outcomes while actively marketing their product.

Plaintiffs seek damages for Zoloft injuries

Without adequate warning, this plaintiff and her physician were unaware of the risks associated with Zoloft and pregnancy when she took the medication as prescribed. As a result of her Zoloft use, the plaintiff alleges that her son has suffered “physically, mentally and emotionally” from his heart defects, requiring multiple hospitalizations, surgeries and medical testing. The plaintiff claims her son will continue to be “deprived of a normal life” as a result of his injuries.

The plaintiff and her husband, as parents of the injured child, have listed a number of counts in their Zoloft lawsuit, including negligence, product liability and fraud. As a result of their son’s injuries, the couple is seeking compensatory and punitive damages against Pfizer, in excess of $75,000.

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Lawyers on both sides will select cases to be included in this initial discovery group, with all choices made by February 22, 2013. Plaintiffs who have allegedly suffered injuries from Pfizer’s popular antidepressant are typically seeking Zoloft settlements or jury awards to compensate them for medical expenses, lost wages, pain and suffering.

Zoloft lawyers to select 12 initial cases

According to Judge Rufe’s court order, Zoloft lawyers representing plaintiffs and their families will select 12 cases to be included in the group, and must send their list to the defendants on or before February 15, 2013. Lawyers representing manufacturer Pfizer will select 13 cases to be included by February 22, 2013. The judge also outlined the procedure to be followed should any of the selected cases be dismissed.

Once this initial group of Zoloft birth defects lawsuits goes through discovery, the court will choose one or more to go to trial starting in September 2014. These initial “bellwether trials” will serve as test trials, giving Zoloft lawyers clues about how juries may respond to evidence and testimony. Depending on the outcome of these initial trials, Pfizer may be more likely to negotiate Zoloft settlements in the future.

Parents seek Zoloft settlements or jury awards

Zoloft is a selective serotonin reuptake inhibitor (SSRI) antidepressant used by millions of patients who suffer from depression or related problems. Though Pfizer does not warn pregnant women against taking the medication, several studies have linked consumption of Zoloft and other SSRI antidepressants during pregnancy with birth defects.

In 2006, for example, the New England Journal of Medicine published a study showing a causal relationship between the use of SSRIs like Zoloft during pregnancy and babies being born with persistent pulmonary hypertension of a newborn (PPHN). In 2007, a study published in the same journal found that babies born to women who took Zoloft during pregnancy had a 50 percent higher risk of developing heart defects.

JPML consolidates Zoloft birth defects lawsuits

On April 17, 2012, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated 57 federal Zoloft lawsuits into the Eastern District of Pennsylvania. The panel stated that centralization would eliminate duplicative discovery, prevent inconsistent rulings, and conserve the resources of the parties, their counsel, and the judiciary. Since then, more plaintiffs have filed Zoloft birth defects lawsuits, and the litigation continues to grow.

Meanwhile, critics claim that Pfizer failed to warn about the serious risks to unborn children, and should have performed more studies prior to launching the drug to ensure the safety of the public.

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Zoloft marketed directly to pregnant women

Defendant Pfizer began selling Zoloft in the United States in 1992. Before launching their blockbuster drug, Pfizer never tested Zoloft’s effects on pregnant women or their unborn children. Likewise, in the company’s promotional activities, Pfizer did not discourage the use of Zoloft in pregnant women. In fact, through a variety of methods, Pfizer actually encouraged doctors to prescribe Zoloft to women of childbearing age, women who were trying to conceive, and to pregnant women. Pfizer also directly marketed Zoloft to these women.

By 2005, after 13 years on the American market, Zoloft was the most prescribed anti-depressant, with over 27 million prescriptions filled and $3.3 billion in sales.

Minor plaintiff has already undergone six surgeries

According to the plaintiffs’ Zoloft birth defects lawsuit, during pregnancy, the mother plaintiff was prescribed and took Zoloft. Neither she nor her doctor had heard that Zoloft could cause birth defects, so she was told to continue taking the drug after discovering she was pregnant. Two months before her son’s birth, the mother plaintiff was told that her son’s hear had not formed properly and that he would be forced to undergo surgery immediately after birth in order to correct these problems. On March 31, 2004, the mother plaintiff gave birth to her son, the minor plaintiff.

Just six days later, on April 5, 2004, the minor plaintiff had open-heart surgery to repair his defects. Since his birth, the child has had six heart surgeries. In 2001, when the minor plaintiff was almost seven years old, doctors informed his mother that he might need additional heart surgery and a pacemaker to treat his heart dysfunction. His heart monitoring continues and will continue for his entire life. Eventually, he will need a heart transplant to stay alive.

Plaintifs allege fraud, negligence and unjust enrichment

The plaintiffs’ Zoloft birth defects attorney emphasizes that, despite overwhelming consumer complaints, Pfizer has to this day not informed women of childbearing age, women trying to conceive, or pregnant women that they should not take Zoloft. According to the complaint, Pfizer still targets these women as their primary market and has made no effort to enact a Zoloft recall or other such measure.

Through their Zoloft birth defects lawsuit, the plaintiffs charge Pfizer with breach of warranty, negligence, strict liability, fraud, negligent misrepresentation, negligence per se, and unjust enrichment. They demand compensatory and punitive damages, as well as interest, costs of suit, attorneys’ fees, and all such other relief as the Court deems proper.

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Zoloft is the brand name for Sertraline, and is marketed primarily as a treatment for depression. It belongs to a class of antidepressants called selective serotonin reuptake inhibitors (SSRI) which work by increasing the brain’s levels of serotonin, a neurotransmitter associated with mental balance and well-being.

Zoloft and pregnancy

Zoloft is able to cross the placenta during gestation and can cause serious birth defects, including ventricular septal defects, atrial septal defects, hypoplastic left or right heart syndrome, persistent pulmonary hypertension of the newborn (PPHN), Tetralogy of Fallot, limb deformations, spina bifida, cleft palate, and patent ductus arteriosus.

The plaintiff was prescribed Zoloft during her pregnancy, and was allegedly never warned of its potentially dangerous effects. Her son was born in 2007 with a ventricular septal defect, commonly known as a hole in the heart. The condition can cause lifelong health problems. A Zoloft lawyer working for the plaintiff says Pfizer should have known of the potential health problems the drug could cause.

Zoloft lawyer: Numerous studies have demonstrated risks

Zoloft is one of the oldest SSRIs available. In 1991, Pfizer won approval to market Zoloft as an antidepressant. By 2005, it had become the most commonly prescribed antidepressant on the US retail market.

A number of studies have suggested a significant increase in birth defects associated with taking Zoloft during pregnancy. A 2006 study published in the New England Journal of Medicine showed a direct correlation between babies born with Persistent Pulmonary Hypertension (PPHN) and use of Zoloft by their mothers during pregnancy. The results showed women who took Zoloft after the 20th week of their term were six times more likely to have babies with PPHN than those who did not. PPHN occurs when the newborn’s circulation reverts to a fetal level, and can cause respiratory problems.

In June 2007, the New England Journal of Medicine published another study showing that the risk of cardiac defects in babies whose mothers took Zoloft during pregnancy was 50% higher than those who did not.

Zoloft lawsuit alleges Pfizer failed to warn patients

Zoloft is classified by the FDA as a Class C drug, meaning there is a risk of birth defects but no a provable link. In 2006, after the publication of the the New England Medical Journal study, the FDA issued a warning which suggested a link between Zoloft and PPHN in infants.

All ongoing Zoloft lawsuits allege Pfizer marketed a defective, dangerous product that lacked proper warnings regarding side effects. In August 2011, nineteen Zoloft lawsuits were filed by mothers in West Virginia who allege the drug was the cause of their children’s malformations.

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Zoloft birth defects lawsuits raise similar allegations

Sertraline (brand name: Zoloft) was FDA-approved for the treatment of depression in 1991, and for OCD and panic disorders in the following years. As detailed in the Zoloft birth defects lawsuit, sertraline has never been approved by the U.S. Food and Drug Administration for use in pregnant women. Despite this fact, tens of thousands of women, including the Kentucky plaintiff, were prescribed Zoloft while they were expecting, and were completely unaware of the risks posed to the developing fetus.

The woman’s son was born on February 26, 2007 and was diagnosed with serious congenital defects including patent ductus arteriosus as well as other conditions that have yet to be determined. Because of these birth defects, the child had to undergo potentially life-threatening heart surgery, among other risky procedures.

Similar to other plaintiffs who filed Zoloft lawsuits, the plaintiff contends that Pfizer did not conduct sufficient studies into possible side effects and dangers of sertraline during pregnancy. Her claim insists that before she was prescribed Zoloft, the defendants were aware of studies involving SSRI drugs like sertraline that showed significantly higher rates of abnormalities and birth defects among babies born to mothers who ingested the anti-depressant. But despite this knowledge, the company failed to disclose these dangers.

Sertraline still a popular anti-depressant

The lawsuit further states that the defendant knew or should have known prior to 1996 that use of SSRI medications such as Zoloft during pregnancy resulted in lower gestational age and birth rates, heart malformations, longer hospital stays and lower APGAR scores when compared to non-exposed infants in control groups.  More specifically, the lawsuit claims that Pfizer suggested the risks associated with discontinuing Zoloft were far greater than those associated with ingestion during pregnancy.

As with other Zoloft birth defects lawsuits, the plaintiff claims that damages were a direct and proximate result of Pfizer’s alleged fraudulent misrepresentation and failure to warn.

As of early 2013, there there has been no Zoloft recall. However, the Category C medication may soon be changed to Category D status, which indicates positive evidence of heightened risks of fetal harm.

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Like other cases in the MDL, this plaintiff claims she had no knowledge of the risks of Zoloft side effects in children when she took the medication during pregnancy. The woman alleges that as a result of her Zoloft use, her child was born with serious birth defects.

Zoloft lawsuit involves unspecified birth defects

The recent complaint joined multidistrict litigation in the Eastern District of Pennsylvania on January 11, 2013. The plaintiff states that she took Zoloft during her pregnancy in 2005 to treat anxiety and depression. The medication was taken as prescribed by the plaintiff’s physician, with no knowledge of the potential for birth defects associated with the drug.

The plaintiff was unaware of the dangers because Zoloft manufacturer Pfizer failed to provide adequate warnings about the risk of birth defects on the product label, according to the complaint. Her Zoloft lawyer contends that although Pfizer knew about the dangers of possible birth defects, and the fact that doctors were prescribing the medication to pregnant women, the company failed to provide proper disclosure of the risks to consumers. This failure has been deemed “willful, wanton and with intentional regard to the health and safety of consumers,” according to the lawsuit.

Zoloft litigation continues to grow

This claim joins more than 100 others currently pending in the federal MDL in Pennsylvania. In all of the cases filed, plaintiffs allege Zoloft use led to birth defects in their newborn children. Some of the most common birth defects associated with Zoloft include heart defects, limb abnormalities and abdominal malformations. In some cases, the infants required surgery early in life to correct the defects. Others require ongoing medical treatment.

Like the plaintiff in this complaint, many have turned to a Zoloft lawyer for assistance in pursuing compensation for their children’s injuries. Medical bills, lost wages and other expenses take a financial toll on families. Serious defects also result in stress, anxiety and suffering for the child. Zoloft-related birth defects may indicate medical treatment over the course of many years, which increases the financial and emotional burden on the family.

The plaintiff is seeking punitive and compensatory damages in excess of $75,000. She states that Pfizer’s failure to warn pregnant women about the risk of side effects in their unborn children has resulted in serious birth defects like the ones her daughter suffers. The plaintiff has listed a number of causes of action in her complaint, including negligence, fraudulent misrepresentation and failure to warn. The case will be heard by the judge overseeing the MDL, the Honorable Cynthia M. Rufe.

Zoloft attorney alleges heart defects from SSRI use

The Zoloft side effects lawsuit was filed directly in U.S. District Court in the Eastern District of Pennsylvania on January 4, 2013. The plaintiffs in the complaint claim they were unaware of the risks associated with Zoloft when the mother plaintiff took the drug during her pregnancy. However, they allege drug manufacturer Pfizer did know of the risks and had an obligation to warn the medical community and the general public – an obligation they allegedly did not live up to.

The lawsuit alleges that prior to the plaintiff’s consumption of Zoloft in 2006, the company knew of potential risks associated with the antidepressant. Studies conducted as early as the 1990s, on both animals and humans, showed a correlation between Zoloft use during pregnancy and birth defects, including heart malformations. Despite the studies, the plaintiff in this complaint asserts that Pfizer “failed and continues to fail to warn and disclose to consumers” the potential for heart defects and other complications associated with Zoloft use during pregnancy.

Plaintiff uses Zoloft for multiple conditions

According to the complaint, the plaintiff mother used Zoloft to treat multiple conditions, including anxiety, depression and a mood disorder. She continued to take Zoloft during her pregnancy in 2006. When her child was born on October 13, 2006, he was diagnosed with heart defects, including a ventricular septal defect and tetralogy of fallot. A ventricular septal defect occurs when there is an improper closure between the lower chambers of the heart. The hole allows oxygenated blood to mix with un-oxygenated blood, which can lead to congestive heart failure. Babies born with this defect often require surgery to repair the holes.

Tetralogy of fallot is a condition characterized by four different heart defects, including the ventricular septal defect and problems with the aorta, right ventricle and overall blood flow. The defect may result in slow development, blue skin and improper feeding. It typically requires surgery to correct the defect and allow normal blood flow to resume.

Damages sought in Zoloft birth defects lawsuit

As a result of the injuries her newborn experienced after her Zoloft use, the mother plaintiff is seeking compensatory and punitive damages. This complaint joins dozens of other Zoloft lawsuits in the Pennsylvania court, alleging birth defects like heart defects, limb abnormalities and abdominal defects.

Past research has shown a significant association between SSRIs and birth defects, including persistent pulmonary hypertension of the newborn (PPHN) and atrial septal defects (ASD). An increasing number of women who have taken Zoloft during pregnancy and given birth to a child with birth defects have sought legal recourse.

No increased risk of infant death for mothers taking SSRIs

A study published on January 2, 2013 by the Journal of the American Medical Association (JAMA) found that the use of selective serotonin reuptake inhibitors (SSRIs), a common class of antidepressant, during pregnancy is not associated with higher rates of stillbirth or infant death. To reach this conclusion, researchers reviewed information from 1.6 million births in a population-based cohort study. Though an initial correlation seemed to exist between SSRIs, like Zoloft, and stillbirth/infant death, once researchers adjusted for variables like depression and previous psychiatric hospitalizations, they concluded that there was no significant link.

Two percent of women take SSRIs

The research team was led by Dr. Olaf Stephansson of Stockholm’s Karolinska Institute. The study’s sample included information from 30,000 women in Denmark, Finland, Iceland, Norway and Sweden who filled prescriptions for SSRI antidepressants between 1996 and 2007. Based on prescription registry information, the researchers also determined that approximately two percent of women used SSRIs, including the popular Prozac, Paxil and Zoloft.

Furthermore, they commented on the fact that 7 to 19 percent of pregnant women living in economically developed countries will experience signs of depression. The study authors stated, “maternal depression is associated with poorer pregnancy outcomes, including increased risk of preterm delivery, which in turn may cause neonatal morbidity and mortality.”

Zoloft lawyer provides options for legal recourse

Other studies have investigated the relationship between SSRIs and pregnancy – and possible Zoloft side effects in children born to those mothers. In 2006, a study published in the New England Journal of Medicine showed a link between SSRI medications, including Zoloft, and persistent pulmonary hypertension of the newborn (PPHN). In 2009, the British Journal of Medicine associated Zoloft and other SSRIs with a congenital heart disease known as atrial septal defects (ASD).

A Zoloft lawyer will often utilize these findings to help build a case to show a definitive link between antidepressant use and a child’s birth defects.

Like other cases around the U.S., the plaintiff will likely join multidistrict litigation (MDL) against defendants Pfizer, Inc.; Roerig, a division of Pfizer, Inc.; and Greenstone, LLC.

SSRI lawsuit originally filed with 18 other plaintiffs

On July 11, 2012, the plaintiff originally filed her complaint with 18 other, unrelated families in the West Virginia Circuit Court for Wayne County. According to her SSRI lawsuit, she filed on behalf of and with her minor child. However, when filing in state court, each plaintiff is required to have a separate civil action number so that each case may be docketed individually. The defendants contested the joint lawsuit on several grounds, specifically due to fraudulent misjoinder – the joining of plaintiffs that have different circumstances and therefore should be tried separately.

Plaintiff claims that Pfizer knew of potential birth defects

The complaint in question, which now proceeds in the U.S. District Court for the Southern District of West Virginia and may soon join the Zoloft MDL, states that the minor was born with congenital birth defects, “as a result of [the mother's] use of Zoloft during her pregnancy.” The plaintiff’s Zoloft birth defects lawyer stated that it would be demonstrated that the, “Defendants knew or should have known that Zoloft causes serious birth defects.”

Case alleges failure to warn and gross negligence

Specifically, the plaintiff’s SSRI lawsuit, and many others like it, claim that Pfizer knew or should have know that exposure to SSRI antidepressants, was associated with Zoloft birth defects such as anencephaly, craniosynostosis, omphalocele, and other serious and life-threatening side effects in children and infants. The case levels counts of strict liability, failure to warn, design defect, negligence, negligent pharmocovigilance, gross negligence, and pecuniary loss.

Zoloft lawyer relates facts of the case

According to the plaintiffs’ complaint, the mother gave birth to the minor plaintiff on July 19, 2008. The baby was born with a ventricular septal defect. Also called a “hole in the heart,” this is a common heart defect that involves an abnormal opening between the heart’s lower chambers.

Babies with this defect may have a bluish tint to the skin due to oxygen-poor blood, often most visible in the lips and fingernails. They may also suffer from:

• Breathlessness
• Swelling in the legs, feet, or abdomen
• Rapid heart rate
• Failure to thrive
• Fatigue

The plaintiffs claim that their daughter has undergone multiple treatments, including but not limited to screenings, testings, and medications, to treat this ventricular deficiency. In addition, she may require surgical intervention in the future.

Pfizer fails to provide adequate warnings about Zoloft and pregnancy

The plaintiffs claim that Pfizer was aware of the health risks of using Zoloft during pregnancy, yet failed to warn about them. In fact, in 2005, the FDA warned that the use of some selective serotonin reuptake inhibitor (SSRI) antidepressants like Zoloft in the first three months of pregnancy could increase the risk of heart defects in some babies.

Scientific studies have also found a connection between Zoloft and pregnancy health problems. A 2007 study published in the British Medical Journal found that mothers who took Zoloft during pregnancy were twice as likely to have babies born with a heart defect.

A later study published in the same journal in 2009 showed an increased risk of septal heart defects in newborns exposed to SSRI antidepressants, and a 2010 study in The American Journal of Nursing also concluded that SSRI antidepressants like Zoloft taken during pregnancy could increase risk of congenital heart defects.

Zoloft birth defects lawsuits underway in MDL

The plaintiffs in this case claim that despite having extensive knowledge of the extreme risks associated with Zoloft, as well as the absolute duty to warn users, the defendants never approached the FDA to alter the label for Zoloft, and never warned of the risks of birth defects. They also failed to continually analyze data regarding the safety of the medication.

Hundreds of lawsuits are in progress in the Zoloft MDL in Pennsylvania. Formed on April 17, 2012, the consolidated litigation has been underway for only a short time. The date for the first bellwether trial has been scheduled for September 12, 2014.

Zoloft and birth defects

In 1991, Pfizer received FDA approval to market Zoloft, also known as sertraline, as a prescription drug that can be used to treat adults suffering from depression, anxiety disorders, obsessive-compulsive disorder and panic disorder. Zoloft is classified among the group of antidepressants known as serotonin reuptake inhibitors (SSRIs). Safety studies conducted on animals revealed using Zoloft was associated with an increased risk of babies developing birth defects. Researchers concluded that Zoloft led to a higher production of serotonin – hormone that aids communication between the brain and nervous system – in the body and that this affected pre-natal development.

Serious birth defects linked to Zoloft include congenital heart defects, premature birth, miscarriage, club foot, cleft palate, persistent pulmonary hypertension and developmental delays.

According to the Zoloft birth defects lawsuit, all of the plaintiff mothers used the antidepressant during their respective pregnancies. The Zoloft lawyer states that the minor plaintiffs’ injuries were directly caused by their exposure to the antidepressant during fetal development. The minor plaintiffs were born with or developed medical conditions such as club foot, atrial septal defect, heart valve disorder, cleft lip, brain malformation, abnormal accumulation of fluid in the brain, and underdeveloped organs. The medical conditions required several surgeries and some of the minor plaintiffs will need ongoing treatment for the rest of their lives.

Pfizer accused of negligence in Zoloft birth defects lawsuit

FDA regulations require manufacturers to issue safety warnings about its drugs if there is reasonable evidence linking use of the drug to patient health risks. According to the plaintiffs, even though Pfizer marketed Zoloft as a safe treatment for pregnant women, the drug manufacturer knew or should have known that Zoloft posed serious health risks to those women and their unborn children based on the results of the medical studies.

If Pfizer adequately notified patients about the increased medical risks Zoloft posed to pregnant women, the plaintiff mothers would not have used the anti-depressant and the minor plaintiffs would have not sustained the birth defects, according to the complaint. The damages the plaintiffs incurred as a result of Pfizer’s wrongful conduct include past, present and future medical expenses, loss of earning capacity, as well as pain and suffering. The parent plaintiffs are seeking compensation for loss of companionship, economic support, affection and other damages directly caused by their children’s injuries.

Persistent pulmonary hypertension from Zoloft

Persistent pulmonary hypertension of the newborn, also known as PPHN, is a birth defect that affects an infant’s lungs. According to at least one study, babies born to women who took SSRI antidepressants, including Zoloft, during pregnancy are reportedly six times more likely to develop PPHN than children of women who did not take these drugs. In a child born with persistent pulmonary hypertension from Zoloft, the ductus arterious fails to close as it normally would, and therefore creates abnormally high pressure and blood flow to the lungs. As a result, blood is diverted from the newborn’s lungs, creating short- and long-term effects that can create serious health risks to the child.

Several studies have explored the link between persistent pulmonary hypertension and Zoloft. Research published in the New England Journal of Medicine showed that 12 out of every 1,000 babies born to mothers taking SSRI meds may develop PPHN; the national average is just 2 out of every 1,000 births.

The risk is even greater when pregnant women take Zoloft during the second and/or third trimester. In 2010, a different study was published in the American Journal of Nursing and showed that infants exposed to SSRI antidepressants in utero have a higher rate of birth defects, including atrial septal defects (ASD) and ventrical septal defects (VSD). In 2006, the FDA issued a public warning and labeled Zoloft a Category C medication, meaning that it may harm a fetus if used during pregnancy.

Symptoms of PPHN from Zoloft

Women who take Zoloft during pregnancy may give birth to children with PPHN. These infants are born with a variety of symptoms, which often include tachypnea (rapid breathing), respiratory distress, cyanosis (bluish tint to the skin), heart murmur, low blood-oxygen levels, and rapid heart rate. The long-term effects of persistent pulmonary hypertension may extend to bronchopulmonary dysplasia (permanent damage due to the hardening of the lungs), as well as chronic seizures, breathing problems, hearing problems, and neurological delays.

Zoloft birth defects lawsuit

Some families affected by birth defects, including PPHN from Zoloft, choose to pursue legal action against Pfizer. A Zoloft birth defects lawsuit usually has several purposes, the main goal being compensatory and punitive damages. Compensatory damages compensate these families for medical bills, medical equipment, and other financial burdens directly related to their child’s diagnosis of persistent pulmonary hypertension resulting from Zoloft. Punitive damages, on the other hand, help reimburse for non-monetary injuries, such as a reduced quality of life for the infant and his or her family.