Antidepressant use in pregnancy linked to kids’ health risks

Zoloft MDL

Two new studies have tied antidepressants used during pregnancy to health risks for kids.

The studies looked at a common antidepressant and whether children exposed to its use had an increased risk of complications after birth and even years later. Results from one study indicated that newborns were more likely to require intensive care post-birth if their mothers used selective serotonin reuptake inhibitors (SSRIs) during pregnancy. Also, the second study found that the same children several years later had an increased risk for language and speech disorders.

Previous studies also had found links between SSRIs and these birth complications, however, they were not as reliable.
Having said that, doctors emphasize individualized assessments, and that more harm could occur if SSRIs are not used. Each situation and patient is different and each patient should consult their medical providers based on the specifics of their own health requirements.

Well known SSRIs are Prozac, Paxil, Zoloft and Lexapro.  Each SSRI increases serotonin chemical levels to treat depression.

A study in Sweden looked at just under 750,000 births over a six year period ending in 2012 and found that almost two percent of the children had been exposed to SSRIs while in the womb. The study out of Lund University found that about 14 percent of newborns exposed to SSRIs were admitted to the neonatal intensive care unit (NICU) after birth, compared to about 8 percent of those not exposed to the drug. The study results published in the journal Pediatrics also pointed out that there was an increased risk when mothers took SSRIs late in pregnancy.

Researchers in another study analyzed data on some 56,000 children in Findland, most under the age of 9, to see if those who’d been exposed to SSRIs in the womb were more likely to have cognitive problems.

About 28 percent had been exposed to SSRIs during pregnancy. Another 17 percent were born to mothers who had depression but did not purchase SSRIs during pregnancy. The remaining 55 percent were born to mothers who didn’t take SSRIs and did not have depression.

There were no links between SSRI exposure in the womb and scholastic or motor disorders in the children, according to Dr. Alan Brown at Columbia University in New York City and his colleagues, who included researchers from the University of Turku in Finland.

However, a JAMA Psychiatry report stated that for children whose mothers purchased at least two SSRI prescriptions during pregnancy, the speech and language disorders risk was 37 percent higher when compared to children whose mothers had depression but didn’t take the drugs, and 63 percent higher than for children whose mothers didn’t have depression.
The American College of Obstetricians and Gynecologists and the American Psychiatric Association published in a 2009 joint report that depression and antidepressant medications during pregnancy are linked to negative consequences for newborns.

The organizations believe that some women with mild-to-moderate depression can be treated with psychotherapy alone or with medication. Also, they say there is a need for ongoing discussions between patients’ psychiatrist and obstetrician during pregnancy. It is further recommended not to discontinue use of medications without consulting one’s doctor.

Zoloft MDL Plaintiff wants case remanded to California

Zoloft MDL

Plaintiffs in the Zoloft birth defects multidistrict litigation (MDL) have argued that their case should be transferred from federal court in Philadelphia, PA to California where the distributor of the drug is located.

The case, D.B. v. Pfizer, was originally filed in California state court where several cases against pharmaceutical distributor McKesson Corp. had been consolidated.

The case was removed by Pfizer to the national Zoloft MDL in the U.S. District Court for the Eastern District of Pennsylvania, claiming that McKesson was fraudulently joined.

Plaintiff attorneys for a mother of a child born with a congenital heart defect argue that Pfizer failed to show evidence that McKesson was fraudulently joined and relied only on her complaint.

Plaintiff court documents state that the cause of action was adequately stated since the defendant was located in California, a distributor of the product that the plaintiff used, the product was the proximate cause of the injury, and the product was defective. The documents go on to state that the case should be remanded because the Defendants cannot meet their burden for proving fraudulent joinder.

Pfizer claimed in its opposition to the plaintiff’s motion to remand that Parmley made no allegations in her complaint specifically directed at McKesson.

Pfizer has argued in court documents that throughout the course of the Zoloft birth defect litigation, plaintiffs have not treated McKesson like a real defendant, nor even taken discovery of McKesson.

“If plaintiffs had any intention of making out a case against McKesson, they’d have obtained the records from the pharmacy where the mother plaintiff bought Zoloft and established that McKesson actually distributed that Zoloft,” Pfizer stated in court documents. They further argued that the Plaintiffs did not even name the pharmacy from which the mother claims she purchased the Zoloft.

U.S. District Judge Cynthia Rufe of the Eastern District of Pennsylvania recently ruled in a way that effectively ended the MDL. Rufe’s order closed all but 23 of 300 cases which were against defendants other than Pfizer and co-defendant Wolters Kluwer Health. Rufe’s decision is pending an appeal before the U.S. Court of Appeals for the Third Circuit. The court case has been going on for more than three years.

Rufe’s ruling essentially said while it hasn’t been proven that Zoloft doesn’t cause birth defects, the attempts in court to prove that it does have failed. The judge did state that the scientific evidence to show such proof may not be ready for years and, meanwhile, the litigation must eventually come to an end.

Zoloft MDL plaintiffs appeal dismissal

Zoloft MDL

Plaintiffs in 316 cases involving Zoloft multidistrict litigation have appealed a Pennsylvania federal judge’s decision that had ended their litigation.

Plaintiffs appealed to the U.S. Court of Appeals for the Third Circuit. Their appeal states they disagree with “each and every part” of U.S. District Judge Cynthia Rufe’s decision that dismissed their cases before the Eastern District of Pennsylvania on April 5.

Rufe had opined that although it has not been proven that Zoloft does not cause birth defects, plaintiffs attempts in court have failed to prove that it does.

The MDL once numbered 600 cases before nearly half of the cases had been dismissed last summer. Dr. Nicholas Jewell, a professor of biostatistics at the University of California, Berkeley, was the expert for the remaining, cardiac-related cases. Rufe blocked his testimony as the plaintiff’s general causation expert. This had come after she had previously barred testimony from the plaintiffs’ noncardiac birth-injury expert, Dr. Anick Bérard.

“Dismissal without prejudice under the circumstances of this MDL and in the face of this essential defect of proof would work against the fair administration of justice,” Rufe wrote in her opinion. “The court recognizes that the final scientific verdict as to whether Zoloft can cause birth defects may not be delivered for many years. Nevertheless, plaintiffs chose when to file their cases, and the court concludes that for the plaintiffs who have continued to pursue their claims, the litigation gates must be closed.”

“At the end of the day, plaintiffs have failed to raise a jury question on the necessary predicate to success in any case: that Zoloft was capable of causing their injuries,” she stated.

Rufe wanted Jewell to have explained why he believes that the positive associations between mothers’ use of Zoloft and cardiac birth defects, reported in some studies, are accurate and not the result of statistical flaws or biases. Furthermore, she wanted the expert to reconcile those studies that claimed there was no increased risk of cardiac birth defects with his opinion.

Rufe’s previous opinion regarding Jewell’s testimony was that he “has deviated from or downplayed certain well-established principles of his field, and has inconsistently applied methods and standards to the data so as to support his prior opinion. It is improper for an expert to take a results-driven approach to a question, molding his methodology and selectively relying upon data so as to confirm his preconceived opinion.”

Zoloft MDL judge rules, birth defects cases dismissed

Zoloft MDL

A Pennsylvania federal judge last week dismissed more than 300 lawsuits against Pfizer Inc. that had alleged its antidepressant Zoloft caused birth defects in children born to women who took the drug during pregnancy.

U.S. District Judge Cynthia Rufe in the Eastern District of Pennsylvania said that plaintiffs, whose cases were consolidated in federal court, had not produced enough evidence to scientifically link the drug and birth defects. The decision comes after previous decisions that excluded testimony from key plaintiff expert witnesses. There had been two trials involving Zoloft birth-defect claims in state courts in Philadelphia and Missouri, both of which Pfizer has won. Those cases demanded at least $2.4 million in damages for heart abnormalities in babies.

Judge Rufe wrote in her opinion: “The court recognizes that the final scientific verdict as to whether Zoloft can cause birth defects may not be delivered for many years…Nevertheless, plaintiffs chose when to file their cases, and the court concludes that for the plaintiffs who have continued to pursue their claims, the litigation gates must be closed.”

Zoloft is part of a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. Pfizer has denied acting improperly and said that a number of major medical groups, including the American Heart Association, have supported its position, while Plaintiffs said that the company played down the birth-defect risks of the popular drug in order to boost sales.
New York-based Pfizer earned about $3.3 billion in Zoloft sales in 2005.

The company lost patent protection on the drug the next year and sertraline, the generic, is now made by other drugmakers, including Mylan NV. The drug currently generates about $375 million in revenue for the company or about 0.8 percent of the company’s total sales in 2015.

PA Judge backs exclusion of Zoloft birth defect experts

A Pennsylvania state court ruling that two causation experts were excluded in a Zoloft birth defect lawsuit was proper, according to a Philadelphia judge.

The judge based his decision in part upon the fact that one of the experts had also been prevented from testifying in a federal Zoloft multidistrict litigation.

Philadelphia Court of Common Pleas Judge Mark I. Bernstein opinion was a response to the plaintiffs’ appeal in the case of Porter v. SmithKline Beecham. The judge wrote that the plaintiffs’ experts, Dr. Michael Freeman and Dr. Robert Cabrera, came to conclusions that were based on flawed methodology, and that Cabrera’s testimony had already been excluded from Zoloft MDL in federal court in the Eastern District of Pennsylvania.

The plaintiffs in that case are without an expert because its expert, Dr. Nicholas Jewell, was barred from testifying, after Judge Cynthia Rufe ruled.

A summary judgment motion is still pending before Judge Rufe.

Freeman described himself as a forensic epidemiologist, meaning applying epidemiology in the legal setting for evaluating causation, Bernstein wrote explaining the validity of excluding both expert’s testimony. Freeman testified that the application of forensic epidemiology depended on which legal jurisdiction he was in.

Bernstein wrote: “Although Dr. Freeman believes the appropriate standard for a scientific conclusion in the field of ‘forensic’ epidemiology depends on ‘jurisdiction,’ only a legal standard depends on jurisdiction, and proper scientific methodology and conclusions do not vary whether testified to on the Pennsylvania side or the New Jersey side of the Benjamin Franklin Bridge.”

Bernstein contended that lumping different birth defects together in
relation to causation cannot be done, instead it violates standard
epidemiological analysis used for showing an association between a drug and a reaction it causes.

Apparently this was done by Freeman when using omphalocele birth defects. “Dr. Freeman improperly lumps the omphalocele birth defect with digestive system defects and assumes medical literature concerning digestive system defects supports his opinion,” Bernstein said. “However, omphalocele is not a digestive system birth defect.”

Bernstein said other factors such as poor nutrition, drug use, age and smoking also must be considered when analyzing birth defects. The judge explained that Freeman relied on forensic epidemiology, and that Cabrera used the same flawed methodology.

Plaintiffs’ expert excluded in Zoloft birth defects MDL

A U.S. District Judge in Pennsylvania ruled December 3 to exclude the testimony of the plaintiffs’ general causation expert in the Zoloft birth-defect multi-district litigation. The ruling raises serious questions on whether the plaintiffs’ MDL cases are able to move forward.

Hon. Cynthia Rufe of the Eastern District of Pennsylvania denied testimony from causation expert Dr. Nicholas Jewell, a professor of biostatistics at the University of California, Berkeley.

Rufe’s opinion stated that Jewell’s position that maternal use of Zoloft during early pregnancy is capable of causing, or contributing to cause, cardiovascular birth defects is based on unreliable science.

Rufe’s ruling comes after hundreds of non-cardiac birth defect cases in the litigation were dismissed over the summer. The total number of cases were around 600 but have been reduced by nearly half. Jewell was named the expert witness on causation after the dismissal, but now with the ruling finding Jewell’s expert opinion inadmissible, the future of the remaining cases are uncertain. Plaintiffs do not know whether they will be permitted to bring in another expert.

Rufe said that the expert’s opinion was based upon his review and analysis of the medical literature, and his reanalysis of data from published Zoloft studies. Pfizer, the defendant, argued that while the expert’s methods used to draw conclusions may have been correct but he did not apply them in his Zoloft opinions.

Rufe said Jewell would have to explain, as a statistics expert, the basis of his belief as to why the positive associations between mothers’ Zoloft use and cardiac birth defects are accurate and not the result of statistical flaws or biases. Furthermore, she said that Jewell would have to then reconcile those studies that claimed there was no increased risk of cardiac birth defects with his opinion.

Rufe wrote: [Jewell] “has deviated from or downplayed certain well-established principles of his field, and has inconsistently applied methods and standards to the data so as to support his a priori opinion. It is improper for an expert to take a results-driven approach to a question, molding his methodology and selectively relying upon data so as to confirm his preconceived opinion.”

FDA asks Pfizer to add birth defects to Zoloft warning label

The FDA asked Pfizer in August to add heart defects risks to Zoloft’s safety warnings. In so doing, the drug giant for the first time would have to admit that there are credible studies linking use of its popular SSRI antidepressant during pregnancy to heart defects in newborns. Zoloft’s current label says there are “no adequate and well-controlled” studies of pregnant women. The new warning would acknowledge research findings that there is “an increased risk of congenital cardiac defects” in babies whose mothers took Zoloft during pregnancy.

The request to amend label was part of the FDA’s new content and formatting requirements which, according to a December 2014 FDA press release, “will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.”

“Prescribing decisions during pregnancy and lactation are individualized and involve complex maternal, fetal and infant risk-benefit considerations. The letter category system was overly simplistic and was misinterpreted as a grading system, which gave an over-simplified view of the product risk,” said Sandra Kweder, M.D, deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “The new labeling rule provides for explanations, based on available information, about the potential benefits and risks for the mother, the fetus and the breastfeeding child.”

Despite research findings to the contrary, Pfizer maintains that “there is no difference in birth defect risks between pregnant women who took Zoloft and those who did not.”

According to Bloomberg, Pfizer said, “The new language, which is still in draft form, reflects the extensive science supporting the safety and efficacy of Zoloft, stating a complete review of the scientific evidence finds that there is no difference in birth defect risks between pregnant women who took Zoloft and those who did not.” In short, the company insists that the drug doesn’t cause birth defects and that it adequately warned women and their physicians about Zoloft’s risks.

Pfizer currently faces hundreds of lawsuits filed across the country by parents claiming Zoloft use during pregnancy caused their children to suffer heart defects and other birth defects and that it failed to warn the drug could cause such side effects. The proposed label change could strengthen their claims.

If your child suffered a heart defect after Zoloft use during pregnancy, you may be entitled to recover financial compensation. Contact us now to for a free no-obligation consultation with an experienced Zoloft heart defects lawsuit attorney.

Use the contact request form on this page or call us toll-free at 800-845-6913.

Let us help you recover the compensation you deserve.

Judge gives Zoloft plaintiffs more time to rebut expert’s claims

The multidistrict litigation (MDL) involving Zoloft birth defects lawsuits against drug giant Pfizer has again been delayed. U.S. District Judge Cynthia Rufe of the Eastern Disctrict of Pennsylvania in Philadelphia has continued a Daubert hearing in the Zoloft MDL to September in response to a Pfizer expert’s claimed discovery of alleged data errors in an earlier study of Zoloft heart defects risks.

Defendant Pfizer’s medical Expert, Dr. Stephen E. Kimmel, wrote a report alleging that one of two independent studies claiming that Zoloft increases the risk of heart defects in newborns contains allegedly incorrect data. Kimmel wrote that he contacted the author of the article that appeared in the New England Journal of Medicine.

According to Kimmel’s report, the author of the article later confirmed there were errors and contacted the Journal to issue corrections. Kimmel wrote that the article’s original position of statistical significance supporting claims that Zoloft increased the risk of congenital heart defects was invalid.

Given the recent discovery, Judge Rufe ordered that the remainder of the hearing would be put off until September so the plaintiffs could have the opportunity to conduct more discovery and depositions.

The proceeding, known as a Daubert hearing, allows parties to challenge the admissibility of expert testimony before the start of a trial. There were about 550 cases as of June 1 in the multi district litigation. But in the time leading up to the hearing, dozens of cases had been dismissed without prejudice.

Judge Rufe ruled in May that the plaintiffs had to turn over a report their expert produced in similar litigation involving Prozac. The plaintiffs handed over the report and testimony of Dr. Nicholas Jewell involving a Prozac case in the Western District of North Carolina.

Dr. Jewell is the plaintiffs’ second causation expert used. The first one, Anick Bérard, was rejected after a week-long Daubert hearing last year. It was an unusual move for the judge to allow a second expert to be proffered in the case.

The plaintiff in the Prozac case alleged her son was born with a supracristal ventricular septal defect, a problem in the wall between the left and right sides of the heart. The mother alleged that she had taken Prozac during her pregnancy.

About 60 percent of the cases that are part of the Zoloft litigation involve claims of cardiac defects. Both Zoloft and Prozac are in a class of antidepressant drugs known as selective serotonin reuptake inhibitors (SSRI antidepressants), but the parties disagree about how similarly the drugs operate. Pfizer argues that plaintiffs are trying to hide inconsistencies in the methodologies used in the two different drug cases.

Pfizer report proposed Zoloft birth defect warnings

A scientist connected with Pfizer Inc. warned the company about a potential link between its SSRI antidepressant drug Zoloft and birth defects, according to a report cited by Bloomberg. The document, released as part of an ongoing Philadelphia Zoloft lawsuit, further recommended changes to the drug’s safety warning, the news service reported.

There are more than 1,000 lawsuits against Pfizer alleging that the company sold Zoloft knowing that it could cause heart complications in newborns.

The Pfizer drug safety official involved in the report had recommended last year that Zoloft change its warning labels. This was going on while the company publicly stated Zoloft was not proven to cause congenital heart problems.

Francesca Kolitsopoulous, who was an associate director in Pfizer’s epidemiology group and safety unit, said in the internal company report that she reviewed published studies showing a connection between Pfizer’s medicine and cardiac malformations which could be causal.

Her report from April 2014 concluded that researches had found links between Zoloft and septal heart defects (holes in the heart). Kolitsopoulous proposed changing the drug’s warning label to add the findings of some of the researchers she had reviewed where potential links between the drug’s use and birth defects were

Furthermore, an October 1998 report that was also made public in the Philadelphia case, found 25 cases involving congenital abnormalities or other “adverse events” were possibly related to Zoloft use.

A review of the side effect reports showed that at least 16 cases where there was no obvious cause for the birth defect other than the mother’s use of Zoloft, the documents showed.

The company, which made $3.3 billion in Zoloft sales in 2005, successfully defended its first trial last April in St. Louis. The jury sided with Pfizer and against the claim that Zoloft caused a boy to have three open-heart surgeries and a pacemaker implanted.

However, the St. Louis trial verdict was before this document came out as a result of the ongoing case in Philadelphia where plaintiff claims her cardiac defect, a hole in her heart, was because of her bipolar mother’s use of Zoloft. Her family is seeking at least $2.4 million in damages to cover her future medical expenses.

Pfizer lawyers get to see Zoloft MDL expert’s past report

The federal judge overseeing Zoloft birth defect litigation in the national Zoloft multidistrict litigation (MDL) ruled that the defendant drug company could see an expert’s report from another case that is also underway. However, access to the report is not likely to matter much.

Plaintiff lawyers alleging Zoloft caused birth defects in babies born to mothers using the SSRI antidepressant will have to turn over the same expert’s report used in a similar lawsuit alleging birth defects from using Prozac.

U.S. District Judge Cynthia Rufe of the Eastern District of Pennsylvania in Philadelphia ruled that both the report and testimony given by Dr. Nicholas Jewell in the Prozac case in the Western District of North Carolina must be turned over by Thursday. Judge Rufe is presiding over at least 600 cases brought against Pfizer, which makes Zoloft. The cases had been consolidated in a multidistrict litigation (MDL) in her court.

The North Carolina suit, however, was brought by a single plaintiff against Eli Lilly & Co., which makes Prozac. The two cases share several of the same plaintiffs lawyers.

Dr. Jewell is the second expert the plaintiffs have used in the national Zoloft MDL. Their first causation expert, Anick Bérard, was thrown out after a Daubert hearing. Daubert hearings allow parties to challenge the testimony of expert witnesses before the start of a trial.

The hearing challenging Jewell’s conclusions is set for July 7 and is likely to last a week. Jewell’s area of expertise is cardiovascular defects. The use of a second expert witness after the first one has been tossed is considered an unusual strategy for a plaintiff, but in this case the court found that the lawyers for the plaintiffs had acted in good faith.

Plaintiff attorneys associated with both Zoloft and Prozac cases argued that its depositions and report are confidential and fall under a protective order. However, the judge agreed with Pfizer’s motion to compel argument that the plaintiff’s contentions were implausible: “Dr. Jewell is a general causation expert who presents a statistical analysis of data. He typically does not review or discuss plaintiff-specific information or medical records and has not done so in this matter. His opinions in the Prozac litigation, as they are in this litigation, are presumably based primarily upon publicly available, peer-reviewed literature,” the Pfizer motion stated.

Judge Rufe ordered the plaintiffs to turn over the report with portions redacted to protect personal health information. The majority of the Zoloft cases allege heart defects in babies.