Pfizer Zoloft Birth Injury Claims – When is a risk too small to explain?

by John McKiggan

Last month 10 couples filed birth injury lawsuits against Pfizer, who manufactures the antidepressant Zoloft. They claim severe birth injuries suffered by their children are a consequence of the mom’s taking Zoloft during their pregnancy.

Failed to Warn of Risks

The argument is Pfizer failed to warn of the risks to unborn children, and further that Pfizer did not adequately test the product.

According to the lawsuit:

“Pfizer knew from preclinical studies and subsequent published studies that dangerous birth defects were associated with Zoloft use during pregnancy…Pfizer’s failure to disclose this information was willful, wanton, and with intentional disregard to the health and safety of consumers…and caused serious and permanent injuries to minor plaintiffs.”

Mislead Patients and Doctors

It is also alleged that Pfizer deliberately marketed Zoloft to doctors and consumers as “the safest anti-depressant on the market for pregnant mothers.”

Known Suicide Risk

In 2004 Pfizer came under fire for the links between the use of Zoloft and suicidal thoughts and actions by children and teenagers. Since then the F.D.A. requires all antidepressants to display a black box warning stating that they may increase the risk of suicide in youth.

Serious Injuries to Infants

All of the parents participating in the lawsuit have children who were born with life threatening injuries. These include pulmonary stenosis, heart problems, skull defects, malformation of the brain and spinal cord, severe developmental delays along with a host of other issues. Each child had to undergo life-threatening open heart surgery to treat their condition.

Risks Not Important?

Pfizer defends the claim by arguing that the risks were small enough that there was no need for them to warn users. In other words, the company claims that the risks were so small that it wasn’t important to tell expecting Mom’s that their babies might suffer serious heart, brain and neurological injuries if the Mom’s took the medication.

One small risk for Pfizer, one giant risk for a pregnant mother

While Pfizer argues the risks were remote, the fact is the company knew the drug was associated with an increased risk of birth defects.

Patient Must be Informed of Risks

In 1995 the Supreme Court of Canada decided in Hollis v. Dow Corning that in medical negligence cases involving product liability there is subjective standard for informed consent. In other words, what risks would the patient want to know about.

When it comes to something like the health and life of a fetus, and the safety of your baby how remote is too remote? Especially if the condition the Mom is being treated for, depression, may not be life threatening.

Even if the defects were unlikely to occur, shouldn’t mothers be given all of the information and then be allowed to make the decision after knowing the facts?

While the risk might appear small to a large pharmaceutical corporation, it probably does not seem small to a pregnant mother.

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