Florida Woman Alleges Zoloft Pregnancy Side Effects

Pfizer has once again valued its bottom line over its patients’ health, according to a new Zoloft heart defects lawsuit filed on June 28, 2013, in the United States District Court for the Eastern District of Pennsylvania. A Florida woman alleges that Zoloft pregnancy side effects caused her baby to be born with congenital birth defects. The mother demands unspecified damages for medical bills, loss of consortium and punitive damages.

Due to the increasing number of Zoloft birth defects lawsuits, the U.S. Judicial Panel recently consolidated all such cases in Pennsylvania. Such multidistrict Litigation (MDL) helps eliminate conflicting rulings from multiple forums. MDL may also encourage the parties to settle all their disputes at once, as opposed to reaching piecemeal settlements in different courts scattered throughout the country.

Zoloft heart defects lawsuit facts and allegations

The plaintiff gave birth on September 11, 2006. Doctors diagnosed her baby with severe heart defects, including Patent Foramen Ovale (PFO) and Patent Ductus Arteriosus (PDA). PFO and PDA are commonly referred to as “holes in the heart.” During fetal development, there are small openings between the heart’s left and right upper chambers and between certain blood vessels in the heart. When these openings do not close properly, the patient develops PFO and/or PDA. Some patients may never develop any serious complications; other patients may eventually experience strokes, heart failure and other serious heart problems.

Doctors routinely prescribe sertraline (the chemical name for Zoloft) to thousands of pregnant mothers all across the country. But as early as 1996, just five years after the Food and Drug Administration (FDA) approved Zoloft, researchers uncovered evidence linking SSRI antidepressants to various congenital heart defects.

A number of subsequent studies and other research confirmed the existence of infant heart problems and other Zoloft pregnancy side effects.

• A 2006 study in the New England Journal of Medicine prompted the FDA to issue a warning regarding SSRIs and congenital heart defects. Though it stopped short of issuing a recall, the FDA strongly advised doctors to prescribe SSRIs to pregnant women only in limited circumstances.
• A 2009 Danish study flatly concluded that there was “an increased prevalence of septal heart defects among children whose mothers were prescribed an SSRI in early pregnancy, particularly sertraline and citalopram.”

According to the various lawsuits filed, Pfizer has consistently refused to even acknowledge a possible link between Zoloft and heart defects. In fact, while the Zoloft package insert and instructions does include a generic warning that pregnant women “should not take Zoloft before consulting their physician,” the insert says nothing about the known link between Zoloft and birth defects. Some plaintiffs even cite evidence that Zoloft is no more effective than a placebo as an antidepressant.

Claims for damages

The plaintiff’s Zoloft heart defects lawsuit alleges that Pfizer knowingly committed various wrongful acts.

• Failure to Warn: A drug company has a duty to inform doctors and patients about Adverse Drug Events (ADEs). The plaintiff states that Pfizer failed to issue adequate warnings regarding possible Zoloft pregnancy side effects.
• Design Defect: The plaintiff goes on to allege that there were safer alternative antidepressants available. Pfizer’s failure to consider a safer alternative design renders Zoloft a defective product.
• Negligence: This Zoloft heart defects lawsuit alleges that Pfizer violated the high duty of care that a drug manufacturer owes a patient, and that the violation caused the plaintiff injury.
• Fraud: The lawsuit goes on to claim that Pfizer defrauded patients, by claiming that Zoloft was reasonably safe and effective when the evidence indicated otherwise.

Despite the rising tide of lawsuits and the mounting body of adverse evidence, Pfizer continues to vigorously defend the safety of its SSRI antidepressant, Zoloft.