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When the risk of harm from taking a prescription medication is beyond the pale of reasonability — frankly, the manufacturer should have known about it — and when the warning about such an increased risk either is nonexistent or is inadequate, the injured patient may be entitled to compensation to recover medical expenses and other damages.

So when medical science finds an association between fetal exposure to certain antidepressants and increased risks of harm to the baby, amid some questions about the “clinical significance” of such an association, the debate has no bearing on one’s right to bring suit.

Children born with certain malformations, whose mothers took a selective serotonin reuptake inhibitor antidepressant while they were pregnant, may have a case for recoverable damages. And that is a fact even if scientists fail to come to grips with the families’ reality until the cows come home.

The April edition of the Journal of Clinical Psychiatry published two studies that delved into the effect of prenatal antidepressant exposure on the health of the baby. The researchers were from the Women’s Mood and Anxiety Clinic: Reproductive Transitions at the Psychiatry Department of the Toronto-based Sunnybrook Health Sciences Centre.

One of the two analyses unearthed thousands of studies, examined hundreds of them and, based on independent reviews of study quality, selected 27 articles. Researchers found, “Overall, antidepressants do not appear to be associated with an increased risk of congenital malformations, but statistical significance was found for cardiovascular malformations,” according to the study’s abstract. In this analysis, the authors wrote, “Data on use of any antidepressant, including fluoxetine (Prozac) and paroxetine (Paxil) specifically, were extracted.”

The other study focused on whether there was a relationship between prenatal antidepressant exposure and the incidence of “poor neonatal adaptation syndrome (PNAS) or individual clinical signs (respiratory distress and tremors),” as the abstract read. Twelve studies were plucked from the stacks for this one.

A thematically significant aside (probably not clinically significant), the November-December 2005 issue of the Canadian Pharmacists Journal referred to previous PNAS investigation. Authors wrote, “Some studies have described a ‘poor neonatal adaptation’ syndrome in newborns whose mothers have taken tricyclic, SSRI, or SNRI antidepressants near term.” That was 2,000-freaking-5! This risk has been bandied about for years.

Back to our second recent study: A conclusion of the PNAS study released in April read, “An increased risk of PNAS exists in infants exposed to antidepressant medication during pregnancy; respiratory distress and tremors also show associations.”

The Journal of Clinical Psychiatry issued a statement about these analyses. Summarizing the antidepressant studies, a part of the statement read, “Results did reveal some negative effects of antidepressant exposure, including an increase in risk for poor neonatal adaptation syndrome (PNAS) and the individual signs of respiratory distress and tremors in infants. The authors identified a significant association between cardiovascular birth defects and exposure to any antidepressant during pregnancy, but they question its clinical significance.”

About “significance” — in a universal sense of the term …

One of the Toronto-based researchers, Dr. Lori E. Ross from the Centre for Addiction and Mental Health in Toronto, said in the statement, “We hope physicians will use this research to provide expectant mothers with the best available evidence to inform this decision, and work with them to develop a treatment plan that works for them and their families.”

Shouldn’t someone be held accountable for not ensuring that important information, such as the aforementioned, was disseminated sooner — both to patients with the medication and to health care professionals who also can inform the patients and make prescription decisions? When pregnant women are not informed of the increased risks that they are taking, and serious harm is the outcome, then the unfortunate event is indeed “significant” in the word’s broader meaning.

Plaintiffs in Paxil lawsuits or in other litigation against manufacturers of selective serotonin reuptake inhibitor antidepressants — such as Zoloft, Celexa, Lexapro, Prozac, Luvox and Viibryd — want to hold accountable corporations that should have known about the unreasonable increased risks of these drugs and should have distributed proper warnings.

When selective serotonin reuptake inhibitor side effects compromise the life of a newborn, the victim and the victim’s family do not have to suffer silently. They can hire an attorney skilled in handling pharmaceutical injury lawsuits who will fight for their rights.

The debate about the effects of prenatal SSRI exposure is not settled. But there have been legal settlements throughout the intellectual discourse, the latter of which has been going on for a while. Parents and their affected children do not have the time to wait for the dénouement of this meeting of the medical-scientific minds.

For instance, the FDA in 2006 — ahem, 2006 — reacting to a study published that year in The New England Journal of Medicine, “asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN,” persistent pulmonary hypertension. An FDA public health advisory described PPHN as a “life-threatening lung condition that occurs soon after birth of the newborn.” The FDA explained then that the study showed “PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant.”

The FDA has since sat on the fence about the risks of fetal exposure to selective serotonin reuptake inhibitor antidepressants. Nevertheless, the victims of an uninformed increased risk do not have to join the FDA on that fence.

Let the scientists debate the clinical and statistical significance. And let the victims recognize that their suffering is most significant, beyond the empirical sense, and is perhaps an entitlement to compensation.

Washington can be neutral. Victims can hire a lawyer and pursue the justice they deserve.

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The pharmaceutical injury attorneys at Reich & Binstock ( offer a free consultation to anyone who believes he, she or a loved one has suffered complications that may be related to fetal exposure to SSRI antidepressants. The law firm may be reached at 1-866-LAW-2400.

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