Newborn Suffers Heart Problems and Birth Defects from Zoloft

Aida Canales had been interested in taking Zoloft, and when she got pregnant her doctor told her it was safe to start her prescription. Her doctor didn’t know that Zoloft was linked to birth defects. Canales gave birth to her daughter, “EC,” on May 14, 2003 at Rio Grande Regional Hospital in McAllen, Texas. EC was immediately diagnosed with atrio-ventricular septal defect (AVS) and Patent Ductus Arteriosus (PDA), and required surgery at just three months old. 

Open heart surgery on a newborn is risky at best, and caused the baby to be hospitalized for heart and lung failure. Canales filed a Zoloft lawsuit on July 31, 2013, claiming that “to this day, Pfizer (the maker of Zoloft), has not informed women of childbearing age, or prenatal women, that they should not take Zoloft. Pfizer still targets these women as their primary market.” Fortunately, EC survived the surgeries and complications—but other Zoloft babies aren’t so lucky.

According to Canales’ Zoloft lawsuit, Pfizer learned in early animal testing that Zoloft, “if taken during pregnancy, caused birth defects, particularly heart defects and fetal death.” Although Zoloft has been on the market since 1992, “Pfizer never tested Zoloft’s effects on pregnant women or her unborn children.” 

The company hasn’t discouraged use of Zoloft to pregnant women in marketing efforts and in fact, according to Canales, Pfizer “actually encouraged doctors to prescribed Zoloft to women of child bearing age, women who were trying to conceive and pregnant women.” It’s no surprise that by 2005, Zoloft was the most popular anti-depressant on the market. 

While Zoloft is well-known for being an anti-depressant, Pfizer also markets the drug to effectively treat OCD, panic attacks, PTSD and social anxiety disorder. Canales began taking Zoloft when she was only four weeks pregnant, confident in her doctor and that the drug was safe. However, she only took Zoloft for the first trimester of her pregnancy—which studies have shown is the most dangerous time during a pregnancy to take Zoloft. 

EC was born at 38 weeks. According to the Zoloft birth defect lawsuit, the child “continues to suffer physically and emotionally from this birth defect caused by Zoloft. EC continues to have regular doctor exams and testing and has been deprived of having a normal childhood and life. EC has endured substantial medical care, procedures and treatments as a result of this defect.”

As her mother, Canales also “continues to suffer mentally, emotionally and financially as a result of her daughter’s birth defects,” the Zoloft birth defect lawsuit states. She is facing mounting medical bills, and will likely continue to do so for life. 

According to Canales’ lawsuit, “Pfizer knew about these adverse side effects,” and yet did nothing to warn women. Independent scientists began conducting studies on the safety of Zoloft, but “Pfizer could have, but did not, perform these studies.” In fact, “Pfizer did not modify its label to warn of these dangers and…increased its targeted promotion to women of childbearing years to capture the now vulnerable population of women who could no longer take Paxil,” a similar drug that included warnings of birth defects beginning in 2005. 

Canales and other Zoloft birth defect victims claim Pfizer saw an opening to steal Paxil customers because Paxil was doing the right thing in warning women.

Canales’ Request from Pfizer 

Canales says Pfizer “fraudulently concealed these effects and made misrepresentations to the damage and detriment” of her daughter and herself. She’s suing Pfizer for breach of warranty, negligence, strict liability, fraud, negligent misrepresentation, and unjust enrichment. She claims Pfizer has been unjustly enriched from herself and her daughter with full knowledge that she didn’t receive a product “of the quality, nature or fitness” described.

She says Pfizer has violated FDA regulations, and engaged in “misleading and/or reckless advertising and promotion, and misbranding” which has resulted in a lifetime of pain and suffering for herself and her daughter. Some of EC’s birth defects may cause ongoing medical attention, perhaps for life. 

The Zoloft Birth Defect Lawsuit is Aida Canales et al. v. Pfizer Inc., Case No.: 2:13-cv-04420-CMR, in the United States District Court Eastern District of Pennsylvania.