Judge Cynthia Rufe recently handed down a new ruling that concerns Zoloft birth defects lawsuits centralized into the multidistrict litigation (MDL) that is proceeding in the U.S. District Court for the Eastern District of Pennsylvania. On June 27, 2014, the Judge decided to exclude the testimony of Dr. Anick Berard, an expert witness on behalf of the plaintiffs.
The Judge deemed Dr. Berard’s methods to be scientifically unsound, in part because Dr. Berard’s peers were of the opinion that her type of epidemiological research did not prove a causal link between Zoloft and birth defects. However, it’s important to note that the exclusion of testimony of one expert witness does not mean that there is no means of establishing a causal link between Zoloft and the serious side effects alleged in the plaintiffs’ complaints.
Dr. Berard’s testimony
As a perinatal pharmacoepidemiologist, Dr. Berard’s area of expertise concerns the impact of drugs such as antidepressants like Zoloft on prenatal development. It is her conclusion that when Zoloft is taken during pregnancy, the baby has a higher risk of birth defects. The plaintiffs’ lawsuits claim that they were not informed of the risks of Zoloft when taken during pregnancy. Earlier, Pfizer moved to exclude the testimony on the basis that it arose from unreliable methods.
According to her expert report, Dr. Berard concluded that selective serotonin reuptake inhibitors (SSRIs) such as Zoloft increased the risk of cardiac defects, craniosynostosis, neural tube defects, pulmonary defects, club foot, persistent pulmonary hypertension of the newborn (PPHN), and many other types of birth defects. To come to her conclusions, Dr. Berard used a forest plot that assembled data from various studies. She then analyzed trends in odds ratios to determine that Zoloft was linked to a higher risk of birth defects, despite the apparent statistical insignificance of the data.
The Judge ruled in favor of Pfizer, finding that Dr. Berard came to her conclusions “without regard to whether the underlying published findings were statistically significant, and without further statistical analysis.” The Judge further ruled that the possible connection between Zoloft and birth defects as evidenced by Dr. Berard’s research was “so weak that one cannot conclude that the risk is greater than that seen in the general population.”
Zoloft litigation against Pfizer
Although the exclusion of Dr. Berard’s testimony does present a setback for the plaintiffs, it’s only part of the process. The issue at the heart of the ruling was not whether Zoloft had any connection at all to the birth defects, but rather whether the association is strong or weak. In fact, the exclusion of Dr. Berard’s testimony during these pre-trial proceedings may work to the plaintiffs’ favor.
Those who filed Zoloft birth defects lawsuits may now attempt to bring in a more credible expert witness to testify on their behalf. The exclusion of this expert witness enables the plaintiffs to build the strongest possible scientific arguments that will help a jury understand the scientific connection between the use of Zoloft during pregnancy and the increased risk of serious, sometimes even life-threatening birth defects.
Researchers at McMasters University in Canada have established a link between a mother’s use of Prozac during pregnancy and childhood obesity and diabetes in her children. The findings, which were reported on June 22, 2014 at the joint meeting of the International Society of Endocrinology and The Endocrine Society, were based on a study of pregnant female rats which were given Prozac.
The findings confirmed that Prozac use during the rats’ pregnancies resulted in higher levels of fat, cholesterol, and inflammation in the livers of the offspring.
Prozac is in a class of selective serotonin reuptake inhibitors known as SSRIs which also include Zoloft, Paxil, Celexa, and Lexapro among others. SSRIs are an extremely popular type of antidepressant that blocks the reuptake of a brain chemical called serotonin, which affects mood and emotional response. The study found that the use of SSRI’s during pregnancy could increase levels of triglycerides, fat, and cholesterol in a developing fetus, which could increase a child’s risk of diabetes and obesity.
The study read in part that the results raised ”new concerns about the long-term metabolic complications in children born to women who take SSRI antidepressants during pregnancy.” While SSRIs have been found to increase the risk of diabetes for the person taking the medication (most recently in a study published in Diabetes Care), this is the first study to investigate the risk of diabetes among Prozac-exposed children.
Zoloft pregnancy side effects of concern
Antidepressant use has increased 400 percent over the past 20 years, making the drugs the most commonly prescribed medication in the U.S. for people between 18 and 44 years of age — the childbearing age range for most women.
In a study published in the Oct. 31 issue of Human Reproduction, researchers from several Boston-area hospitals reviewed previously published studies that examined women with depression who took antidepressants while pregnant.
The study read in part that “…First, there is clear and concerning evidence of risk with the use of the SSRI antidepressants by pregnant women, evidence that these drugs lead to worsened pregnancy outcomes. Second, there is no evidence of benefit, no evidence that these drugs lead to better outcomes for moms and babies”.
Many popular antidepressants have been linked to a risk of serious health problems for children exposed to the medication before birth, including septal heart defects, skull malformations, neural tube defects, abdominal defects, spina bifida and other serious injuries.
SSRI risks to the fetus: delayed developmental milestones
Recent studies have also found that antidepressant use in pregnancy may increase the risk of seizure and delay of infant development milestones, such as sitting and walking, as well as an increased risk of persistent pulmonary hypertension in newborns (PPHN), a serious respiratory disorder that may cause insufficient blood flow to the lungs, leading to potentially life-threatening problems.
The review also found evidence of an increase in miscarriages and two potentially dangerous conditions, pregnancy-induced hypertension and preeclampsia, especially if use extends beyond the first trimester.
Premature birth was the “most pressing” obstetrical complication in more than 30 studies the researchers reviewed because, the study authors said, “…we know that babies born before 37 weeks are at risk for many short and long-term health problems.”
“There is enough evidence to strongly recommend that great caution be exercised before prescribing SSRI antidepressants to women who are pregnant or who are attempting to get pregnant…” study co-author Dr. Alice Domar, an OB/GYN at Beth Israel Deaconess Medical Center, said in the press release of the Boston study.
An Iowa mother has filed a Zoloft lawsuit on behalf of her child, who was born with birth defects as an alleged result of her ingestion of the SSRI drug during pregnancy. She asserts that her infant child was born with severe and life threatening congenital health issues due to the negligent behaviors of the defendant.
“Defendants concealed their knowledge of the unreasonably dangerous risks of the ingestion of Zoloft from plaintiffs, their physicians, other consumers, and the medical community,” states the claim. “Specifically, defendants failed to adequately inform consumers and the prescribing medical community about the risk of congenital birth defects associated with the use of Zoloft.”
Claimant used Zoloft during pregnancy
The Zoloft lawsuit alleges that the mother and her physicians did not fully understand the risks associated with antidepressant, because although Pfizer had access to information linking the drug to congenital birth defects, the defendant failed to share this with physicians and consumers.
“Defendants failed to warn physicians and plaintiffs herein adequately about the congenital birth defect risks associated with Zoloft, despite the fact that defendants know that physicians, the medical community, plaintiffs, and others similarly situated relied on defendants to disclose what it knew or should have known from a prudent review of the information that it possessed or to which it had access.”
The plaintiff is suing the defendant on multiple counts, including:
- Count I: Strict Products Liability
- Count II: Breach of Express Warranty
- Count III: Negligence
- Count IV: Negligent Design
- Count V: Negligent Phamraco-Vigilance
- Count VI: Misrepresentation by Omission
- Count VII: Failure to Warn
- Count VIII: Negligent Misrepresentation
- Count IX: Fraud and Misrepresentation
- Count X: Fraud by Concealment
- Count XI: Breach of Implied Warranties
- Count XII: Damages
- Count XIII: Gross Negligence/Malice
Study points to Zoloft birth defects
Medical journal PLOS ONE published a study in March 2014, revealing results indicating that Zoloft side effects may increase the risk of pre-term birth and can cause birth defects. The study was conducted by researchers from a number of medical facilities and universities, including Brigham and Women’s Hospital.
The research team examined information from a variety of medical databases and previous studies to determine that women who ingested antidepressants during their second and third trimesters had an increased risk of premature labor and delivery.
Zoloft lawsuits centralized as multidistrict litigation
Zoloft multidistrict litigation was established on April 17, 2013 in the Eastern District of Pennsylvania. More than 500 products liability lawsuits have been filed under the MDL to date, but that number is expected to increase.
Plaintiffs accuse Pfizer of knowing Zoloft could cause birth defects, but failing to provide adequate warning to patients and the medical community. They believe the defendant misrepresented the drug and continues to misrepresent its safety and efficacy.
A small group of lawsuits have been chosen for early trial dates, as part of coordinated pretrial proceedings. These “bellwether” cases are designed to help both sides measure jury reaction to evidence and testimony that may impact many cases.
The start of the first Zoloft lawsuit trial was recently delayed from November 2014 to January 2015, as Pfizer has requested additional time to prepare their case.
Eight families from across the country have joined to file a Zoloft birth defects lawsuit against Pfizer, Inc, the pharmaceutical giant and its distributor McKesson Corp.
The suit, filed June 2, 2014, in Superior Court of the State of California, Orange County, alleges that the plaintiffs, which include parents and their children, living and deceased, have sustained injury and damages as a result of the negligence, fraud, and failure to warn of the packaging, marketing, promoting, and selling of Zoloft by Pfizer and McKesson. The allegations go on to say that the plaintiffs would not have sustained any injury or damages but for the ingestion of Zoloft during the plaintiffs’ pregnancies.
The plaintiffs include five married couples, three single mothers, and their total of eight children, living and deceased. Of these, five of their children sustained fatal neural tube or neural heart defects, and the three surviving children continue to suffer from a range of severe congenital defects including persistent pulmonary hypertension of the newborn (PPHN), ventricular septal defect, and mitral stenosis.
Zoloft lawsuit alleges that Pfizer knew dangers
The general allegations concern the drug sertraline hydrochloride, which is a member of a class of drugs known as selective serotonin reuptake inhibitors or SSRI’s and was developed to treat major depression in adults. As per the suit, the drug was compounded, designed, developed, packaged, advertised, marketed, tested, and sold by Pfizer under the trade name Zoloft. Zoloft was first approved for use in the US by the FDA in 1991.
The Zoloft lawsuit claims that Pfizer knew, as a New Drug Application applicant that its responsibilities were to accurately disclose any data or information regarding Zoloft’s chemistry, proposed labeling which would include warnings of side effects and risks, test results, and clinical studies because the information would be relied upon by the medical community and the public, including the plaintiffs and their physicians. This information was to be updated accurately and in a timely fashion.
Studies on Zoloft use during pregnancy
In 2006, the New England Journal of Medicine published a study showing a causal relationship between the use of SSRI’s including Zoloft during pregnancy and babies being born with persistent pulmonary hypertension of the newborn (PPHN). The study found that pregnant women who took SSRI’s after the 20th week were six times more likely to have babies with PPHN.
In 2007, the same New England Journal of Medicine found a doubling of the risk of septal heart defects in babies when Zoloft was in the mother’s system while the baby was developing.
In 2009, the British Medical Journal published a study which found that Zoloft use during pregnancy tripled the risk of congenital heart defects to the baby. Studies followed showing risks six and eight times higher for other serious birth defects when a mother ingested Zoloft during pregnancy.
Despite these findings, there are still no warning of increased risks of birth defects on current Zoloft labels.
Compensation demanded for alleged inaction
The lawsuit alleges that Pfizer, knowing what it did to be factual from numerous clinical studies, still willfully caused severe injuries and deaths to the child plaintiffs and incalculable emotional pain, mental anguish, and the loss of support, companionship, and love and affection between a parent and his or her child.
The suit demands compensation for past and future general, economic, and special damages; loss of earnings and impaired earning capacity; medical expenses, pat and future; past and future emotional distress; and punitive and exemplary damages.