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…”
In her Zoloft birth defects lawsuit, a plaintiff alleges her use of the antidepressant during pregnancy led to gastrointestinal defects and autism in her son. Although the son is now over the age of 18, he continues to require care due to incapacitation linked by the plaintiff to her Zoloft use. The plaintiff has also suffered significant economic losses and will continue to do so due to her son’s ongoing medical condition.
According to the complaint, the mother plaintiff was taking Zoloft as prescribed by her physician in 1995, while she was pregnant. At the time, the plaintiff had no knowledge of the potential risks Zoloft could pose to her unborn child. However, prior to FDA approval of Zoloft in 1991, the plaintiff claims Zoloft manufacturer Pfizer was aware of those risks when the company’s preclinical animal studies suggested use of the drug could lead to birth defects.
Pfizer marketed drug despite concerns
Despite this knowledge, Pfizer proceeded to market their drug to the medical community and general public upon its approval. It wasn’t long before concerns were raised over link between possible birth defects and use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy. Zoloft belongs to this category of antidepressants, along with Paxil and Prozac.
In 2005, the manufacturer of Paxil updated the package label to alert users to the possibility of cardiac malformations and other defects when Paxil was taken during pregnancy. Although Zoloft is a similar drug, no such warning was added to the Zoloft label at that time. In fact, it is possible that Pfizer increased their market share of women at childhood-bearing age who were no longer willing to take Paxil during pregnancy because of the new warning.
Plaintiff’s son diagnosed with multiple conditions
The plaintiff’s son was born on August 8, 1995. Shortly after birth, her son was diagnosed with pyloric stenosis, a condition that blocks food from entering the small intestine from the stomach. Symptoms of this condition include projectile vomiting, constant hunger and dehydration. The only treatment for pyloric stenosis is surgery, which the plaintiff’s son underwent when he was just one year old.
In addition to pyloric stenosis, the plaintiff’s son has been diagnosed with autism, which led to significant developmental delays early in life. Autism is a disorder that affects neurodevelopment, affecting social interactions and communication. Children with autism commonly use repetitive motions and may engage in self-destructive behavior like banging their head against a hard surface. Because there is no cure for autism, treatment may be ongoing and may include medication and behavioral interventions.
In 2011, CNN reported on a study involving the Kaiser Permanente database, which suggested that exposure to SSRIs in the womb could increase a child’s risk of an autism diagnosis. First-trimester exposure appeared to carry the highest risk, according to the researchers conducting this particular study. Since that time, evidence linking autism and SSRI use has been mixed. However, lawsuits like this one could increase scrutiny on this particular risk associated with SSRIs, which could lead to additional studies on the subject.
Plaintiff seeks damages from Pfizer
The plaintiff in this Zoloft birth defect lawsuit claims that her son’s condition has deprived him of a normal childhood and life and subjected him to ongoing medical testing and treatment. She is now seeking compensatory and punitive damages from Pfizer, asserting that the company’s insufficient warnings have led to mental, emotional and financial suffering for her, as well as her son.
This case joins a growing list of complaints filed in U.S. District Court for the Eastern District of Pennsylvania, where multidistrict litigation has been established for Zoloft lawsuits. Plaintiffs allege Zoloft use during pregnancy led to birth defects, including heart abnormalities, gastrointestinal defects and limb malformations. The proceedings are currently overseen by the Honorable Judge Cynthia M. Rufe in that court.
- FDA, FDA Drug Safety Communication: Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressant Use During Pregnancy and Reports of a Rare Heart and Lung Condition in Newborn Babies, http://www.fda.gov/Drugs/DrugSafety/ucm283375.htm
- U.S. District Court, Eastern District of Pennsylvania, MDL No. 2342: Zoloft (Sertraline Hydrochloride) Products Liability Litigation, https://www.paed.uscourts.gov/mdl2342.asp
- WebMD, Antidepressants Linked to Birth Defect, http://www.webmd.com/baby/news/20090924/antidepressants-linked-to-birth-defect
- Mayo Clinic, Pyloric Stenosis, http://www.mayoclinic.org/diseases-conditions/pyloric-stenosis/basics/definition/con-20027251
- National Institute of Neurological Disorders and Stroke, Autism Fact Sheet, http://www.ninds.nih.gov/disorders/autism/detail_autism.htm