Lawsuit Says Zoloft Side Effects Caused Cleft Lip, Cleft Palate

Zoloft has been beacon for Pfizer, bringing in billions of dollars each year. It’s a popular antidepressant but is also prescribed for a number of other disorders such as Post-Traumatic Stress Disorder (PTSD). However, many people have claimed lawsuits against Pfizer that Zoloft birth defects allegedly caused permanent, congenital defects in their children.

The latest family to join Zoloft multidistrict litigation (MDL) and sue Pfizer is Patricia Helms and Jose Alfaro, who claim that Helms’ taking of Zoloft while pregnant caused their son to be born with birth defects. Their Zoloft lawsuit was filed on Feb. 12, 2014.

According to the Zoloft lawsuit, the couple welcomed their son to the world on April 17, 2011. He was born “with congenital birth defects known as cleft lip and cleft palate, and other related conditions as a result” of her alleged ingestion of an SSRI (Zoloft) while she was pregnant.

She claims that “had she been adequately warned” about these Zoloft side effects, she never would have taken it while pregnant, especially since there are so many other antidepressants on the market. However, Zoloft was the most prescribed antidepressant in 2005, and victims like this couple claim that Pfizer not only knew about the dangers for pregnant women, but consciously concealed them and actually marketed the drugs specifically for women who were pregnant.

The couple says that their son’s birth defects were allegedly a direct result of her being prescribed the drug. However, it’s also alleged within the Zoloft MDL that prescribing doctors were also in the dark since Pfizer supposedly didn’t warn anyone, including the medical community, about all Zoloft side effects. Zoloft has been available since 1991.

“Under the Food and Drug Administration (FDA) scheme, Defendants had a duty to ensure their warnings to the medical community are and remain accurate and adequate, to conduct safety surveillance of adverse events for the drug, to report any data related to the safety and/or accuracy of the warnings and information disseminated regarding the drug, and to update the label when new safety information was obtained,” the Zoloft birth defect lawsuit states.

The couple says that before Helms became pregnant, Pfizer either knew or should have known about the risks of birth defects, especially considering it had been on the market for 15 years already. They point to preclinical studies undertaken by Pfizer as well as plenty of subsequent research conducted by other parties which all showcase the risk of birth defects. Additionally, they allege that Pfizer knew from their own studies that Zoloft and other SSRIs cross the placenta, exposing the fetus to the drug.

The couple says that Pfizer “failed to fully, truthfully and accurately disclose Zoloft data to the FDA, the plaintiffs and the Mother Plaintiff’s physician, and as a result negligently, intentionally and fraudulently misled the medical community, physicians and Mother Plaintiff’s physicians, and Plaintiff about risks to a fetus associated with the use of Zoloft during pregnancy.”

As more parents file Zoloft lawsuits, a number of recurring birth defects are cited.

Pfizer “had the knowledge, the means, and the duty to provide the medical community and the consuming public with a stronger warning label regarding the association between Zoloft and congenital birth defects, heart defects, PPHN, craniosynostosis, and other related conditions, through all means necessary, including, but not limited to, labeling, continuing education, symposiums, posters, sales calls to doctors, advertisements” and other avenues, the lawsuit states. Instead, this couple alleges that Pfizer prioritized the profitability of Zoloft over the safety of their customers, including pregnant women and their unborn children.

There are cases of children dying due to congenital defects which were allegedly caused by Zoloft use by the mother. In other cases, the birth defects are so severe that a lifetime of medical care and prescriptions (along with the complementary high costs) can be debt-inducing. A child’s birth defects can impact many people.

A Preventable Situation?

The couple alleges that their son’s “serious injuries were the foreseeable and proximate result of (Pfizer’s) acts and/or omissions” and that his birth defects were probably preventable. They also claim that as a direct result of Pfizer’s actions, the whole family has suffered “medical, nursing, hospital, pharmacy, rehabilitative, and related costs and expenses for (their son’s) injuries, care and lost wages, lost earning capacity, economic losses and other damages” for which they say they deserve compensation.

They also state that they have suffered, and will continue to suffer, “great emotional pain, mental anguish and other serious injuries and loss, including loss of consortium, services, support, companionship, society, love and affection.”

The family is suing Pfizer for failure to warn, design defect, negligence, negligent design, fraud/misrepresentation and suppression, constructive fraud, breach of warranties, gross negligence/malice, loss of consortium and pecuniary loss, negligent infliction of emotional distress, and punitive damages.

Was Your Child Harmed by Zoloft?

If you, your mother or partner took Zoloft while pregnant and birth defects were the result, you might qualify for a Zoloft legal claim. You can find out more at the Zoloft Lawsuit & SSRI Lawsuit Antidepressant Birth Defect Class Action Lawsuit Investigation. Once your information is received, a lawyer will contact you for a complimentary Zoloft claim review.