Zoloft caused heart defect, expert to testify at PA jury trial

Plaintiff’s medical causation expert in the national Zoloft litigation has been approved to testify in a Philadelphia, PA State Court by Judge Mark Bernstein. Pursuant to Judge Bernstein’s ruling, Nicholas P. Jewell, Ph.D. may testify as to Zoloft’s causation of heart-related birth defects when taken by pregnant women. Dr. Jewell is a Professor of Biostatistic and Statistics at the University of California, Berkeley School of Public Health. Dr. Jewell’s testimony is expected to apply only to heart defects in babies born to mothers who took the popular SSRI antidepressant Zoloft during pregnancy. Zoloft is manufactured by the defendant, drug company Pfizer. 

Zoloft cases are pending in both State and Federal Courts. The Philadelphia, PA State Court ruling comes before Judge Rufe in the federal Multi-District Litigation (MDL) rules on the admissibility of Dr. Jewell’s expert testimony. 

Judge Bernstein rejected Pfizer’s argument that Dr. Jewell reached his conclusions regarding transposition of the great arteries (TGA) by incorrectly correlating data relating to other birth defects. Rather, Judge Bernstein held that Dr. Jewell was correct in including the other studies because TGA is so rare that only a few studies exist on the birth defect. Judge Bernstein stated in his opinion, “Specific birth defects can be so finely isolated that insufficient numbers exist to ever demonstrate statistically significant results.” He went on to say, “Sometimes proper scientific conclusions must be extrapolated from the available data.” 

Judge Bernstein approved of the Dr. Jewell’s methodology. “Not only was this methodology used by Dr. Jewell, but also used by investigators in peer reviewed published studies, defendant’s experts and Pfizer’s employees,” he held.

Another Plaintiff’s expert, identified in the opinion as “Dr. Abdullah,” ruled out other causes of his TGA. The ruled out causes include other medications, diabetes, gestational diabetes, obesity, smoking, alcohol use, illegal drug use and second hand smoke.

WV Supreme Court affirms dismissal of non-resident Zoloft cases

The West Virginia Supreme Court of Appeals, its single appellate court, has upheld the dismissal of 20 Zoloft lawsuits by the 24th Judicial Circuit Court for Wayne County. The opinion of the WV Supreme Court of Appeals was delivered by Justice Allen Loughry on April 10, 2015. “The petitioners seek a writ of prohibition to prevent the Mass Litigation Panel from enforcing its order entered on October 21, 2014, dismissing them on the basis of forum non conveniens from the underlying personal injury litigation, which involves products liability and negligence claims,” he stated. “Following a careful review of the briefs, the arguments of counsel, the record submitted and the applicable law, we deny the requested writ.”

The lawsuits, filed in 2012 and 2013, have been long embroiled in procedural motions back and forth between the parties.

Originally, lawsuits against Pfizer, the manufacturer of the popular SSRI antidepressant Zoloft, were filed by 19 families in July of 2012. The suits claimed several birth defects were caused by the mothers’ ingestion of Zoloft while pregnant. In August of 2012, Pfizer removed 18 of the cases to the U.S. District Court for the Southern District of West Virginia (federal court). Plaintiffs then moved to remand the cases back to the Wayne County Circuit Court (state court). The motion was granted and Pfizer appealed to the U.S. Court of Appeals for the Fourth Circuit, which ruled that it didn’t have the authority to review the remand order.

Pfizer then filed a motion requesting that the Wayne Circuit Court refer the pending cases to WV’s Mass Litigation Panel. The Mass Litigation Panel was established by the Supreme Court of Appeals of West Virginia to efficiently manage and resolve mass litigation. In September of 2013, Pfizer’s motion was denied.

Then, in October of 2013, six new plaintiffs filed similar a similar Zoloft case against Pfizer in the Wayne County Circuit Court. Five of the six new plaintiffs were not WV residents. Plaintiffs filed a Motion to refer the cases to the Mass Litigation Panel. Pfizer again filed a motion to remove the original 19 families to federal court.

In January of 2014, the two cases were transferred to the Mass Litigation Panel.

In March of 2014, the Panel ruled that the cases were not two separate cases, but instead properly were 25 separate cases and divided them accordingly. Plaintiffs appealed to the Supreme Court of Appeals to prevent the enforcement of the Panel’s order. In May of 2014, the Supreme Court granted Plaintiffs’ motion.

In accordance with the deadline set by the case management order, Pfizer filed motions to dismiss the cases of all 21 of the non-resident plaintiffs on the basis of forum non-conveniens. The Panel granted Pfizer’s motion and dismissed 20 of the cases in October 2014. Plaintiffs’ appealed to prevent the dismissals.

The Supreme Court of Appeals found no error in the panel’s decision to dismiss the non-resident families stating, “West Virginia has no real interest in trying non-resident plaintiffs’ claims against non-resident defendants involving causes of action that accrued in states other than West Virginia.”

In her dissent, Judge Davis opined that a Motion to Dismiss two years after a case has been filed was not timely and should have been denied. She states, “The factors relied upon by the defendants to support their motion were obvious from the time the complaints were filed.”

Zoloft MDL Order scheduling 2015 Daubert hearings, 2016 trial

On April 1, 2015, U.S. District Judge Cynthia M. Rufe entered a Scheduling Order, Pretrial Order No. 83., governing the national Zoloft multidistrict litigation (Zoloft MDL) in the United States District Court for the Eastern District of Pennsylvania in Philadelphia, PA.

Zoloft MDL No. 2342 was created by the United States Judicial Panel on Multidistrict Litigation on April 17, 2102, to consolidate lawsuits filed across the country against Pfizer alleging birth defects caused by use of its popular SSRI antidepressant Zoloft and its generic version sertraline. The purpose of the MDL is to eliminate duplicative discovery, prevent inconsistent pretrial rulings, and conserve the resources of the parties, their lawyers, and the judiciary.

IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA

IN RE: ZOLOFT (SERTRALINE HYDROCHLORIDE) PRODUCTS LIABILITY LITIGATION

MDL NO. 2342
12-MD-2342

HON. CYNTHIA M. RUFE

THIS DOCUMENT RELATES TO: ALL ACTIONS

PRETRIAL ORDER NO. 83
SCHEDULING FOR DAUBERT HEARINGS AND INITIAL TRIALS

    AND NOW, this 1st day of April 2015, in recognition that discovery and trial issues are most efficiently handled by the entry of Pretrial Orders, and after Leadership and General Status Conferences, the Court hereby enters this Pretrial Order governing scheduling concerning this MDL, subject to entry of later Pretrial Orders modifying or supplementing this Pretrial Order.

        1. GENERAL CAUSATION DAUBERT MOTIONS: The PSC having served the additional general causation expert report of Dr. Jewell, and Pfizer having served any responsive expert reports on general causation, the following schedule is established for further proceedings directed to Zoloft general causation experts:

May 1, 2015  —  The Court will determine the order in which the Trial Pool cases will be tried.

May 1, 2015  —  Pfizer will complete the deposition of Dr. Jewell.

May 15, 2015  —  Plaintiffs may submit expert reports for injuries not included in the PSC’s reports. If submitted, additional Daubert proceedings will be scheduled by separate Pretrial Order.

May 15, 2015  —  Pfizer’s Daubert motion and opening brief as to Dr. Jewell shall be filed.

May 29, 2015  —  The PSC will complete depositions of Pfizer’s responsive experts.

June 12, 2015  —  Response to Daubert motion shall be filed

June 24, 2015  —  Reply brief in support of Daubert motion shall be filed.

July 7, 2015  —  10:30 a.m. Hearing on Daubert motion begins.

        2. INITIAL TRIAL SCHEDULE: The following schedule is established for further proceedings directed to preparation for initial trials:

June 15, 2015  —  Plaintiffs’ non-causation and case-specific reports shall be served.

August 3, 2015  —  Pfizer’s non-causation and case-specific reports shall be served.

September 7, 2015  —  Expert depositions shall be completed.

September 28, 2015  —  Case-specific Daubert and dispositive motions shall be filed.

October 12, 2015  —  Responses to case-specific Daubert and dispositive motions shall be filed.

October 19, 2015  —  Replies to case-specific Daubert and dispositive motions shall be filed.

November 2, 2015  —  10:30 a.m. Hearing on case-specific Daubert and dispositive motions begins.

November 16, 2015  —  The parties shall exchange witness lists, exhibits, and deposition designations.

November 30, 2015  —  Motions in limine and other non-dispositive and non-Daubert motions shall be filed.

December 7, 2015  —  The parties shall exchange objections to exhibits and deposition designations, and deposition counterdesignations.

December 14, 2015  —  Responses to motions in limine and other non-dispositive and non-Daubert motions shall be filed.

December 18, 2015  —  Replies in support of motions in limine and other nondispositive and non-Daubert motions shall be filed.

December 21, 2015  —  The parties shall exchange objections to deposition counter-designations.

December 22, 2015  —  10:30 a.m. Hearing on motions in limine and other pretrial motions shall be held.

January 11, 2016  —  10:30 a.m. Final Pretrial Conference will be held.

January 19, 2016  —  10:00 a.m. Jury Selection begins.

IT IS SO ORDERED.

BY THE COURT:

CYNTHIA M. RUFE, J.

First Zoloft lawsuit trial continues before jury in St. Louis, MO

The Zoloft lawsuit trial against drug maker Pfizer is continuing before a jury in St. Louis, MO. The lawsuit claims that a young boy, the Plaintiff in the case, suffered several birth defects due to his mother’s ingestion of Zoloft when she was pregnant. While there are many suits against Pfizer alleging similar injuries, this is the first Zoloft birth defects jury trial.

The boy’s mother took Zoloft during her first trimester of pregnancy. The boy was born with numerous heart defects, including transposition of the great arteries (TGA); he has undergone over 25 procedures and multiple operations.

In opening statements, the boy’s lawyer told the jury that adverse events have been reported by patients since 1991 when Zoloft was introduced on the U.S. market. These events included both birth defects and fetal deaths. The lawyer stated that this trend was clearly visible. He described to the jury a Pfizer internal report in which the company admitted the increased risk of heart defects. He stated that despite the known Zoloft birth defects risks, Pfizer failed to change the Zoloft warning label to adequately communicate the risks to physicians and patients.

Currently there are over 1,000 Zoloft lawsuits pending against Pfizer alleging it failed to warn of birth defects risks. Most of the mothers who are involved in these lawsuits took Zoloft during the mid-2000s. In 2005, Zoloft was one of the most popular drugs on the market and Pfizer’s take from Zoloft was about $2.6 billion. Last year, even with generics on the market, Zoloft sales generated approximately $433 million in revenue for Pfizer. 

Drug company GlaxoSmithKline faced a similar lawsuits over their antidepressant Paxil and reportedly paid $1 billion to settle 800 birth defects suits that were filed against it.

The St. Louis Zoloft trial is scheduled to resume on Monday, April 13, 2015.

First trial of a Zoloft birth defects lawsuit has begun

The first Zoloft birth defects trial started today in state court in St. Louis, Missouri. The case is one of more than 1,000 Zoloft lawsuits filed across the country in both state and federal courts against Pfizer, Inc., manufacturer and seller the popular SSRI antidepressant.

The Plaintiff in the case at trial is a boy who at birth suffered Zoloft heart defects for which he has undergone three open heart surgeries. Now at age eleven, he continues to suffer functional impairment and residual disability. Lawyers representing his family claim that Pfizer hid Zoloft birth defects risks so it could market Zoloft as a better alternative for pregnant women suffering from depression. They assert that Pfizer should be held liable for “failing to clearly warn doctors and patients that Zoloft posed an increased risk of birth defects.”

The family’s lawyer claims that Pfizer failed to warn women, including the boy’s mother, of the potential birth defects risks to unborn children that the drug could cause when taken during pregnancy. This failure to warn occurred despite a contraceptive warning included by researchers in Zoloft’s “Core Data Sheet,” an internal file. Pfizer officials admitted that the birth defects warning, “is not in the U.S. label.”

The Zoloft lawsuits are similar to previous suits against GlaxoSmithKline, PC, claiming that its claims that it’s blockbuster SSRI antidepressant drug Paxil caused birth defects. Glaxo agreed to pay settlements in excess $1 billion to compensate injured plaintiffs. Several researchers opine that this class of antidepressants, Selective Serotonin Reuptake Inhibitors, pose a greater risk of heart defects in newborns than non-SSRI antidepressants.

Plaintiffs can present new expert in Zoloft MDL

Plaintiffs in the national Zoloft MDL won a battle over expert testimony last month when Judge Rufe granted their motion for leave to identify and present Dr. Nicholas Jewell as their new general causation expert. The national Zoloft MDL (multidistrict litigation) in the Unites States District Court for the Eastern District of Pennsylvania includes over 600 cases claiming Zoloft use during pregnancy causes birth defects.

Last year, Plaintiffs’ original general causation expert, Dr. Anick Berard, was excluded by Judge Rufe after Daubert hearings. Plaintiffs appealed Dr. Berard’s exclusion and requested leave to introduce another expert. Defendant Pfizer, manufacturer of the SSRI antidepressant Zoloft, vehemently objected. In her recent Opinion, Judge Rufe found that Pfizer would not be harmed by the introduction of the new expert. She indicated that Pfizer could be prejudiced slightly, but would be in the same position as if the new expert had been presented earlier. She also found that there was no evidence that the Plaintiffs acted in bad faith.

Plaintiffs new expert is Dr. Nicholas Jewell. He holds a Ph.D. from the University of Edinburgh and is author of the textbook Statistics of Epidemiology. Dr. Jewell has been a Professor at the University of California, Berkeley in the School of Public Health, Department of Statistics, Division of Biostatistics for 33 years. Dr. Jewell was able to review existing studies that were in evidence at the initial Daubert hearing and the results of studies that were not available at the time Dr. Berard authored her report. It is likely that his proposed testimony will go only to the causation of heart defects for the unborn children whose mothers used Zoloft during pregnancy. At present, 60% of the more than 600 Zoloft lawsuits in the MDL deal with heart defects and cardiac problems.

Judge Rufe had considerable discretion in ruling on Plaintiffs’ Motion to present a new expert. Federal Rules provide that MDL courts must be given wide latitude due to the complexities of the litigation. There were five factors reviewed by Judge Rufe in determining whether to grant Plaintiffs’ Motion. The Judge first looked at whether the Defendant, Pfizer, would be prejudiced or surprised. The Judge indicated in her ruling that it was very likely that Dr. Jewell would testify in cases outside of the MDL and Pzifer would have to prepare for those cases and likely already was preparing to defend against Jewell’s testimony. The second factor dealt with the ability of Pfizer to cure the prejudice. The ruling stated that Dr. Jewell still had to be approved through Daubert hearings and again Pfizer likely already was preparing for this expert. Third, the judge looked at whether permitting the new expert would cause a disruption of the orderly and efficient trial. The Judge reasoned that even though new Daubert hearings will cause a delay, this MDL has moved along expeditiously through the diligence and cooperation of counsel. There also had to be a determination as to whether Plaintiffs were acting in bad faith. The Opinion states that there was no evidence of attorneys for Plaintiffs acting in bad faith. Finally, the Court had to look at the importance of the evidence.  Judge Rufe found that the importance of the potential testimony of Dr. Jewell to the Plaintiffs outweighed Pfizer’s objections.

The national Zoloft MDL cases continue to move forward. Dates for new Daubert hearings have not yet been set.

Zoloft MDL Daubert ruling excluding experts led to Stay Order

Recently, in the Multi-District Litigation against drug manufacturer Pfizer, Inc. claiming Zoloft birth defects (the Zoloft MDL), presiding Judge Cynthia Rufe excluded plaintiffs’ experts Dr. Anick Berard, a perinatal pharmacoepdemiologist, Dr. Thomas Sadler, an embryologist, Dr. Robert Cabrera, a teratologist and Dr. Michael Levin, a molecular development biologist. Judge Rufe excluded these experts after a Daubert Hearing wherein the court examined the methodology of the experts intending to testify. The pending litigation claims that the SSRI antidepressant Zoloft, manufactured by Pfizer, causes birth defects when used during pregnancy.

There currently is a stay on Zoloft MDL proceedings in the federal court for the Eastern District of Pennsylvania in Philadelphia, PA due to rulings by Judge Rufe. However, both plaintiffs and defendant have Motions pending. Plaintiffs have moved to present new witnesses on the issue of causation. Plaintiffs are attempting to present the testimony of Dr. Nicholas Jewell, a biostatistical professor at the University of California, Berkley. Dr. Jewell is anticipated to provide testimony that “in utero exposure to Zoloft can cause congenital heart defects.” Plaintiffs alternatively are also asking for leave to voluntarily dismiss their claims without prejudice so that they may pursue their Zoloft birth defects claims later, when the proof is more viable. Judge Rufe is scheduled to decide on whether to admit Dr. Jewell’s expert testimony on November 18, 2014.

Defendant Pfizer asking for a 2nd time to present a summary judgment motion. Pfizer is opposed to the voluntary dismissal as it feels it will previal if their motion for summary judgment is heard and ruled upon. Pfizer has moved that all 526 pending cases be dismissed on summary judgment because all four of plaintiffs’ causation experts were excluded pursuant to Judge Rufe’s Daubert rulings.

Missouri Zoloft lawsuit remanded to MO state court

Twenty–five plaintiffs won a remand Order transferring their Missouri Zoloft lawsuit back to state court after their Missouri claims were removed to federal court at the request of Zoloft drug maker, Pfizer, Inc. Pfizer sought to have the lawsuit consolidated with hundreds of other Zoloft birth defects lawsuits in the national Zoloft MDL in the U.S. District Court for the Eastern District of Pennsylvania in Philadelphia PA, Hon. Cynthia Rufe presiding. The plaintiffs argued that their lawsuit should be heard by a state court because it lacks diversity jurisdiction, Pfizer’s alleged basis for removal.

Judge Rufe ruled that Missouri courts properly have jurisdiction over the claims. Missouri law allows multiple plaintiffs to file one lawsuit together even though they may have separate injuries. Pfizer argued that a defendant was fraudulently joined by the Plaintiffs to destroy diversity jurisdiction and thereby keep the case out of federal court. The Judge ruled against Pfizer on that claim and remanded the cases back to Missouri.

The Missouri Zoloft lawsuit claims that the mothers’ use of Zoloft in pregnacy caused their children to be born with various birth defects, including club foot, cleft palate, heart defects, omphalocele, and more. The lawsuit claims that Pfizer knew Zoloft would cross the border in the placenta and should have warned physicians and patients about Zoloft birth defects risks.

Pretrial orders delay Zoloft MDL as MO cases set for trial

Judge Cynthia M. Rufe has entered two new pretrial Orders in the Zoloft MDL currently pending in the Eastern District of Pennsylvania in Philadelphia, PA. The Zoloft MDL contains over 400 cases against the drug manufacturer Pfizer, the makers of the Selective Serotonin Reuptake Inhibitor (SSRI) Zoloft. The plaintiffs in these pending lawsuits all allege that Zoloft taken while pregnant caused significant congenital birth defects in their children.

The Orders have caused the indefinite delay of bellwether trial dates of the Zoloft cases as they are putting the litigation on hold for at least 30 days. In Order Number 68 a status conference scheduled for September 12, 2014 has been canceled due to court unavailability and will have to be rescheduled. Order Number 69 has ordered that all proceedings in the matter be stayed or stopped for an additional 30 days or until further order of the court. The trial date previously had been pushed from November 2014 to January 2015 at the request of Pfizer. 

Zoloft litigation in Missouri continues to progress toward trial in the 22nd Judicial Circuit Court for the City of St. Louis, MO.  A jury trial of the first Missouri Zoloft lawsuit is scheduled to begin in February 2015.

13 new Zoloft birth defects lawsuits filed in West Virginia

Thirteen more families have filed suit against Pfizer, Inc., the manufacturer of the SSRI antidepressant drug Zoloft, and its subsidiary Roerig. The lawsuits claim birth defects suffered by plaintiff’s minor children were caused by taking Zoloft during pregnancy pursuant to doctor’s directions. Greenstone, LLC, the manufacturer of the generic version of Zoloft (sertraline), also was named in the suits.

The suits join several other lawsuits filed in the Wayne County Circuit Court of West Virginia, Judge James H. Young, Jr. presiding. These cases are separate from the Zoloft Multidistrict litigation (MDL) that currently is pending in Federal District Court for the Eastern District of Pennsylvania in Philadelphia, PA.

The plaintiffs make several claims in the pending actions. They claim that Pfizer knew or should have known about the risks to unborn fetuses associated with taking Zoloft during pregnancy. Further, they state that Zoloft is a defective drug; dangerous to human health; unfit and unsuitable to be marketed and sold; and lacks the proper warnings as to the dangers associated with its use.

Each minor child named in the lawsuits claims to have suffered a congenital birth defect as a direct result of exposure to Zoloft in utero. These include atrial septal defects (ASD), multiple holes in the heart, persistent pulmonary hypertension of the newborn (PPHN), neural tube defects, craniofacial defects and other malformations.

Plaintiffs in the Zoloft lawsuits are seeking compensatory and punitive damages with pre and post judgment interest.