Missouri Personal Injury Lawyer Blog

For several years, GlaxoSmithKline P.L.C. ignored evidence that its antidepressant, Paxil, may have caused birth defects in Missouri and throughout the nation, according to details emerging from a pharmaceutical liability lawsuit. The claim was filed by a woman who says her 3-year-old son has heart problems because she took Paxil during her pregnancy. Attorneys nationwide who have filed these Paxil lawsuits on behalf of injured clients and their children are alleging that Glaxo, for many years, knew about early tests and research results which all raised issues of concern. In fact, an attorney cited a test where rats that were administered Paxil were more likely to have pups that did not survive past four days.

Warnings relating to Paxil apparently came as early as the 1980s. A scientist warned in an internal memo that "there remains the possibility" that Paxil could cause birth defects in higher doses. But Glaxo ignored those research findings. There are now 600 or more pending cases in the United States, which allege that Glaxo knowingly put Paxil on the market and concealed its risks from consumers in order to boost profits. Paxil, which was approved by the U.S. Food and Drug Administration (FDA) in 1992, generated $942 million in sales just in 2008. Attorneys for Glaxo have denied all allegations and maintain that Paxil has cleared all clinical trials.

Statistics show otherwise. By 1997, within five years of Paxil's approval, Glaxo had received reports of 50 miscarriages or intrauterine deaths. A Glaxo scientist at that point warned that the high number of cases was "an alarming finding." That warning was also ignored by the pharmaceutical company and went unreported to the FDA.

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In 2005, the FDA released a warning on the drug Paxil indicating that the drug increased risks of birth defects when taken during the first three months of pregnancy. Paxil is a selective serotonin reuptake inhibitor (SSRI) given to patients to relieve depression. Other SSRIs included in the report were Celexa, Fluvoxamine, Lexapro, Prozac, Symbyax and Zoloft.

Mothers who had been taking Paxil or other SSRIs after the 20th week of pregnancy were six times more likely to give birth to babies with persistent pulmonary hypertension (PPHN) than pregnant mothers who did not take antidepressants. PPHN is a severe but rare disease that is characterized by abnormal blood flow leading to a lack of oxygen to the baby’s heart and lungs. The condition can be fatal to babies and may cause permanent neurologic damage to survivors.

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Paxil, or paroxetine, is an antidepressant that has been known to cause severe birth defects if taken during pregnancy. The FDA classifies Paxil as a Category D medicine, indicating the level of risk to unborn children. Category D medicines can be given to pregnant women, if the benefits of the drug outweigh the possible risks to the fetus. In the case of Paxil, if a woman is unresponsive to other antidepressants and suffers acute depression, the drug may be prescribed.

Still Paxil poses a prominent risk to babies if mothers take the drug during pregnancy. If taken in early pregnancy, the drug denotes possible heart problems to the fetus and mother ranging from mild to severe and may require surgery. Paxil is also known to cause persistent pulmonary hypertension (PPHN), a condition that affects newborns’ circulation and breathing patterns, preventing oxygen from the heart and lungs. PPHN can be fatal or cause permanent damage to the baby. Paxil can be found in breast milk and can be harmful to feeding babies.

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A recent Paxil lawsuit that took place in Philadelphia gripped the attention of consumers and citizens throughout the United States. According to a philly.com article, this is the first Paxil lawsuit in the plaintiff’s favor; however, it remains uncertain as to how the jury’s distinction of negligence will affect future Paxil cases, especially considering that punitive damages were not awarded.

Based on the article, punitive damages are typically awarded when evidence supports that a company knew about problems with their product, ignored them, or covered them up in order to reap the benefits. Apparently, the jury said that Glaxo had been negligent in not accurately cautioning the pregnant woman’s doctor of the drug’s risk. If Glaxo’s behavior had been deemed outrageous, the family may have been awarded punitive damages as well.

As the first of approximately 600 similar cases against the makers of Paxil, GlaxoSmithKline P.L.C., the jury found that the company was “negligent, but not outrageous” in contributing to heart problems in a 3-year-old whose mother took the anti-depressant drug while she was pregnant. As a result, the family was awarded a $2.5 million judgment that only included compensatory damages. This is considered an encouraging and big win by legal experts for the remaining plaintiffs in Paxil cases. According to the article, the 10-2 jury ruling reflects the decision that the child’s problems were linked to Paxil.

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No one ever expects that tragedy will take its toll on our loved ones. Birth injuries can be some of the most challenging calamities for new parents to endure, with no mention of the physical or mental conditions the child will have to face for the rest of his or her life. These injuries are painful enough on their own, but knowing that a medical professional caused such a birth defect has the potential of adding even more grief.

According to the State of Missouri Department of Health and Senior Services, approximately 1 in 33 infants in the U.S. are brought into this world with a birth defect and almost 6,000 babies die during their first 12 months. It was also noted that the medical costs to treat and provide care for such birth defects amount to around $2 billion a year.

Of course, parents want their child to receive proper and adequate care for a serious condition, whether it is a brain injury, spinal injury, or other birth defect or injury. And children who have suffered such catastrophic injuries deserve the highest standard of medical treatment. Fortunately, with the assistance of an experienced St. Louis birth defect attorney, compensation to help pay for such treatment may be obtained from negligent medical professionals who are responsible for causing the birth injury.

Continue reading "Missouri Birth Defects Can Devastate Families - You Don't Have to Feel Helpless" »