Jon Campisi Jul. 20, 2013, 9:21am


A Texas woman has filed a wrongful death claim against the makers of the generic version

of the antidepressant drug Zoloft over claims that the pharmaceutical led to her infant child’s death two summers ago.

El Paso resident Marisol Smith claims in her federal civil action, filed July 17 at the U.S. District Court in Philadelphia, that soon after delivering her son, Prince Lloyd Tahreek Smith, back on June 27, 2011, the boy was diagnosed with respiratory distress syndrome, patent ductus arteriosis and atrial septal defect with ventricular tachycardia.

The child ended up dying five days later due to pulmonary hemorrhage and intraventricular hemorrhage.

The products liability suit asserts that to this day, Pfizer, which makes Zoloft, and Greenstone LLC, which makes Sertraline, the generic version of the drug, have failed to inform women of childbearing age or those who are already pregnant that they should not take the medication because of the complications that can arise.

Both Pfizer and Greenstone are named as defendants in the complaint, which was filed by attorneys Joseph J. Zonies and Mark Premo-Hopkins, of the Denver firm Reilly Pozner LLP.

According to the lawsuit, the pharmaceutical companies learned early on, back before the drug was sold for human consumption, that Zoloft could cause birth defects, particularly heart defects and fetal death, if taken during pregnancy.

The suit alleges that Sertraline, the generic version of the antidepressant drug, is also hazardous and lacks the proper warnings as to the dangers associated with its use.

Pfizer began selling Zoloft to the public in the early 1990s, the suit says, although the drug company never tested the pharmaceutical’s effects on pregnant women or their unborn children.

And in its promotional activities, the complaint alleges, Pfizer failed to discourage the drug’s use in pregnant women.

“In fact, through a variety of methods, Pfizer and Greenstone actually encouraged doctors to prescribe Zoloft to women of child bearing age, women who were trying to conceive and to pregnant women,” the lawsuit reads. “Pfizer also directly marketed Zoloft to these women.”

Greenstone is listed as lead defendant in this particular case since the plaintiff’s injuries were allegedly caused by her use of the generic form of the drug, which is manufactured by Greenstone.

Zoloft, the name brand drug, was the most prescribed antidepressant by the year 2005, the suit says, with more than 27 million prescriptions filled and $3.3 billion in sales reported nationwide.

The drugmakers, meanwhile, maintain that Zoloft and its generic equivalent carry “accurate, science based and FDA-approved information on benefits and risks, including use in pregnant women, to assist physicians in making appropriate, patient-specific decisions,” said a statement provided by Pfizer spokesman Steve Danehy.

Asked to comment on the merits of Zoloft products liability cases such as the Smith one, Danehy told the Pennsylvania Record in an emailed message that while the company has great sympathy for families dealing with such tragedies, “medical science does not support plaintiffs’ claims about Zoloft and sertraline.

“As recently as December 2011, the FDA issued further guidance regarding the SSRI class of anti-depressants that includes Zoloft, advising health care professionals not to alter their current clinical practice of treating depression during pregnancy,” Danehy continued in his statement. “The Company stands by our medicine and we intend to vigorously defend it.”

As for the plaintiff in this particular case, Smith says that she took Sertraline from 2010 through February 2011, and again from April 2011 until the end of her pregnancy.

The woman initially went off the antidepressant as soon as she learned of her pregnancy in February 2011, but she was placed back on the drug two months later.

On June 30, three days after giving birth to her son at 25 weeks, the boy was diagnosed with the various birth defects.

He ended up suffering from severe pulmonary bleeding, needed to be placed on a ventilator, and had to undergo a blood transfusion.

After suffering the pulmonary hemorrhage, the newborn “continued to deteriorate and ultimately died of his pulmonary hemorrhage and intraventricular hemorrhage on July 2, 2011,” the lawsuit reads.

Smith, the mother, continues to suffer mentally, emotionally and financially as a result of her child’s birth defects and ultimately death, the complaint states.

The suit contains counts of breach of warranty, negligence, strict liability, fraud, negligent misrepresentation, negligence per se, and unjust enrichment.

Smith seeks unspecified compensatory and punitive damages, along with interest, litigation costs and attorneys’ fees.

 

 

 

The federal case number is 2:13-cv-04143-CMR.

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