A five-year-old boy and his mother have filed a Zoloft heart defect lawsuit against the makers of a popular antidepressant, alleging that the drug caused the boy to be born with birth defects.
The mother alleges that she was prescribed and took Zoloft during her pregnancy. When her son was born on December 29, 2008, he suffered from birth defects including hypoplastic left heart syndrome, a rare condition in which the left side of the heart fails to develop and the right side must do double duty to supply the body with blood. The child has undergone multiple surgeries as a result.
Zoloft complaint alleges failure to warn
The boy and his mother filed their complaint on August 8, 2014, in the Superior Court of California, in Orange County. The complaint names as defendants Pfizer, Inc., McKesson Corporation, and several other companies that were also allegedly involved in the research, design, development, marketing, and sale of Zoloft.
The complaint sets forth a number of theories of recovery including strict liability based on failure to warn, negligence, breach of warranty, deceit by concealment, and fraud. The mother states that she did not know of the risks in taking Zoloft during pregnancy and that she would not have taken it if she had been informed of the danger.
Zoloft and pregnancy risks not disclosed
Zoloft is the name brand of the drug sertraline, a selective serotonin reuptake inhibitor (SSRI). Zoloft has been prescribed and sold to treat depression in the United States for more than 20 years. In 1991, the FDA approved Zoloft for treatment of depression in adults but it has never approved the drug to treat pregnant women.
According to the plaintiffs’ allegations, the defendants knew, based on animal testing and reports, that using Zoloft in pregnancy resulted in a significantly increased risk of cardiac defects in the babies. They allege that the defendants specifically marketed the drug as safe for use in pregnancy while knowing that to be false.
Zoloft linked to birth defects
The FDA has warned that taking an SSRI during pregnancy can lead to persistent pulmonary hypertension of the newborn (PPHN), a dangerous heart and lung condition. PPHN is rare, occurring in only 1 to 2 out of every 1,000 live births, but it is often fatal or leads to long-term complications. One study found that when mothers took an SSRI after 20 weeks gestation, their newborns were six times more likely to suffer from PPHN.
There are more than 500 federal birth defect lawsuits pending against Pfizer over prenatal use of Zoloft. The cases have been consolidated in multidistrict litigation (MDL) in the Eastern District of Pennsylvania. The lawsuits alleged a variety of injuries, including heart defects like that alleged in the recently-filed lawsuit, and septal defects in which the child is born with holes in the all of the heart. Other birth defects linked to the SSRI include hydrocephalus, anencephaly, spina bifida and cleft palate.
The outcome of the Orange County lawsuit and many other state level Zoloft cases against Pfizer may be affected by the results of the bellwether MDL trials. The first Zoloft bellwether trial is expected to begin in January 2015.
Judge Cynthia M. Rufe, the judge tasked with overseeing the Zoloft birth defects lawsuits pending under multidistrict litigation, has excluded the opinions of three witnesses. Judge Rufe ruled that their testimony did not properly address key issues, including the extent of the link between exposure to Zoloft and birth defects in infants.
On August 12, she did however permit the opinions of the experts in question as to biological plausibility, determining their statements were largely reliable.
The product liability lawsuits of more than 500 plaintiffs have been joined together under multidistrict litigation in the Eastern District of Pennsylvania ─ and that number is likely to rise. The MDL was established on April 17, 2013, under the direction of Judge Rufe.
Multidistrict litigation helps to conserve resources, avoid conflicting rulings and eliminate duplicate discovery.
Plaintiffs share a number of common allegations, including that Zoloft ─ otherwise known as Sertraline ─ knew the drug could cause infants to be born with a number of serious birth defects, but failed to properly warn patients and the medical community.
A select group of plaintiffs were chosen to participate in bellwether trials ─ early trial dates to help both parties gauge jury reaction to key evidence and witness testimony that may be present in a number of cases.
While the first bellwether trial was initially scheduled to begin in November 2014, Pfizer requested a delay, so it will now take place starting in January 2015.
Zoloft birth defects lawsuits
The Plaintiffs’ Steering Committee planned to use the testimony of expert witnesses Dr. Thomas Sadler, Dr. Robert Cabrera and Dr. Michael Levin to determine whether it’s possible that Zoloft could have caused the birth defects alleged by plaintiffs in the MDL.
All of the experts stated that Zoloft can indeed cause the birth defects experienced by children born to pregnant mothers taking the drug during their first trimester. However, Pfizer moved to exclude their testimony, claiming their opinions were not based on sufficient facts or data and are not the result of reliable scientific principles and methods.
“Although the Court has found that the experts at issue have offered scientifically reliable opinions on biological plausibility, that is but one of the Bradford-Hill criteria,” stated Judge Rufe. “Therefore, the Court must examine the extent to which their opinions on human causation address the other Bradford-Hill criteria.”
Witnesses failed to speak on epidemiological data
She noted that the expert witnesses failed to speak on varying epidemiological data. Zoloft has been used by pregnant mothers for 20 years, and as a result the judge noted an enormous amount of epidemiological research has been conducted and published on the drug. Consequently, credible witnesses must address the discrepancies in the epidemiological research.
“Where that body of research does not support the conclusions drawn by the experts, the experts must endeavor to reconcile the inconsistent epidemiological data with their opinions,” Judge Rufe stated. “Here, the experts have given scant attention to the epidemiology research in their reports, and have failed to reconcile inconsistent epidemiological evidence with their opinions on human causation. Only Dr. Sadler makes any effort to reconcile the inconsistent epidemiological research with his opinion, and he provides only an untested hypothesis. The experts’ failure to reconcile inconsistent epidemiological research with their opinions regarding human causation is a significant methodological flaw, undermining their reliability under Daubert.”
Judge Rufe also displayed apprehension surrounding a number of the witnesses’ key points, including the inference from animal data to human statistics. She noted that as high doses of a drug are frequently given in in vitro and live animal studies, it is essential for scientists to consider the dosage.
She said she will not allow an expert witness to testify based on undocumented research, as this type of opinion does not meet the evidentiary requirement of reliability.
A Zoloft side effects lawsuit filed concerning birth defects allegedly caused by antidepressant use during pregnancy has been removed to the U.S. District Court in the Eastern District of Missouri (St. Louis) from the circuit court in the same state where it was filed. The defendant, Pfizer, Inc., intends to seek a transfer of the lawsuit to federal court in Pennsylvania, where hundreds of lawsuits involving Zoloft side effects have been consolidated as part of a larger litigation process.
The two plaintiffs in the case are Cricelda Martinez, an Idaho woman, and her minor child. Martinez claims that she took Zoloft an antidepressant manufactured by the defendant during pregnancy according to the dosage recommended by the manufacturer. The result of ingesting the drug at this time, according to the plaintiff, was that her child was born with a club foot and other birth defects. Treatment for the club foot required costly surgery.
The central allegations in Martinez v. Pfizer, Inc. (case # 4:14-CV-01325) are that Pfizer produced a drug of defective design, that they were negligent in testing and publishing results of tests regarding this drug, that they failed to warn about possible birth defects associated with its use in pregnancy, and that they fraudulently misrepresented to and concealed these risks from medical professionals, potential patients, and the general public.
Zoloft side effects lawsuit one of hundreds filed concerning birth defects
Hundreds of lawsuits have been filed concerning the possible link between Zoloft use during pregnancy and birth defects. Zoloft has been implicated in birth defects including heart problems, congenital skull deformations, omphalcocele (a rare defect in which organs develop outside the fetus’ abdominal wall), cleft lip and palate, club foot, spina bifida, and persistent pulmonary hypertension of the newborn (PPHN).
The complaint in Martinez v. Pfizer, Inc. states that the defendant “knew from preclinical studies and subsequent published studies that dangerous birth defects were associated with [Zoloft] use during pregnancy,” and they did not publish their studies or adequately warn concerning studies that had been carried out. Several studies, some of them with conflicting results, have been published concerning the link between Zoloft and other anti-depressants known as selective serotonin reuptake inhibitors (SSRIs) since Zoloft (the brand name of sertraline chloride) first entered the market in 1991.
Lawsuits concerning Zoloft use and birth defects consolidated in PA court
Over 500 lawsuits linking Zoloft and birth defects have been consolidated as part of a multidistrict litigation (MDL) established on April 17, 2012 in the U.S. District Court for the Eastern District of Pennsylvania. The MDL will include cases related to a variety of different birth defects because the discovery process related to Pfizer’s study and market of the drug supposed to have caused them all will be similar in each case. Cases will, however, be tried on an individual basis under Judge Cynthia M. Rufe.
Preliminary (“bellwether”) cases as part of the MDL were slated to begin in November of 2014, though Pfizer successfully petitioned to have the first case pushed back to January of 2015. Judge Rufe has also remanded a small group of cases back to state courts in Missouri and Pennsylvania for reasons having to do with diversity, though Pfizer will seek to have them removed back to the federal level as part of the MDL.
Twelve mothers have filed a Zoloft birth complications lawsuit on behalf of their children against Pfizer, the drug manufacturer, and its distributor, the McKesson Corporation. The lawsuit details a horrendous catalogue of permanent injuries that the children have suffered and the resulting emotional and mental anguish endured by their parents and guardians allegedly due to the mothers’ ingestion of Zoloft during their pregnancies.
The suit, filed May 14, 2014, in Superior Court, Los Angeles County, California, pits the pharmaceutical giant, Pfizer, against a group of plaintiffs who say they should never have been innocently subjected to a product as severely flawed, untested, and unreasonably dangerous as Zoloft.
At the crux of the Zoloft lawsuit is Pfizer’s alleged “vile, base, willful, malicious, oppressive, and fraudulent” behavior in allowing these mothers to use Zoloft when it knew or should have known, that “children were being born with congenital birth defects, heart defects, and other similar conditions to women who took Zoloft during pregnancy”.
Manufacturing a new drug comes with responsibilities
Sertraline chloride, distributed under the brand name Zoloft, is a member of a class of drugs known as “selective serotonin reuptake inhibitors” or SSRI’s. Zoloft was first approved by the FDA in 1991 for the treatment of major depression in adults.
As a new drug, the FDA mandates that a drug manufacturer provide full disclosure of the drug’s chemistry, manufacturing process, pre-market clinical testing, and critically, what risks it might present to the medical community who would prescribe it and to the public who would use it.
Equally important, the Zoloft birth complications lawsuit states that Pfizer had a duty to “ensure its warnings to the medical community…remain accurate, to conduct safety surveillance of adverse events for the drug, to report any data related to the safety and/or accuracy of the warnings and information disseminated regarding the drug, and to update the label when new safety information was obtained”.
Zoloft birth complications lawsuit cites damning studies
In 2005, the FDA issued one of several warning letters to Pfizer citing it for omitting risk information about Zoloft and for placing advertisements that were false and misleading to the public.
In 2006, the New England Journal of Medicine published a study showing a causal relationship between SSRI’s and babies being born with Persistent Pulmonary Hypertension of the Newborn ( “PPHN”), a serious heart defect. In 2007, the same journal published testing results showing a doubling of the risks of septal heart defects when Zoloft was used during pregnancy.
Perhaps most telling, in September 2009, the British Medical Journal published a study that found that Zoloft use during pregnancy tripled the risk of congenital heart defects to the baby.
To this day, the current Zoloft label still does not warn doctors or patients about the increased risk of cardiac malformation and other birth defects seen in babies whose mothers took Zoloft.
Damage to the children and their families incalculable
According to the suit, the plaintiffs demand compensatory, exemplary, punitive, general, and special damages for the minor plaintiffs’ “sustained pain and suffering, mental anguish, and the loss of enjoyment of the pleasures of life without the presence of birth defects…”.
The mothers who ingested Zoloft claim they are entitled to “all damages…including the loss of their children’s love, companionship, comfort, care, assistance, protection, affection, society, moral support, training, guidance, benefits, and services…”