Plaintiffs in Michigan Allege Depakote Birth Defects in Lawsuit

Port Huron, MIYet another Depakote lawsuit has been filed by a handful of plaintiffs alleging valproate, a drug prescribed to treat epileptic seizures and symptoms stemming from bipolar disorder, was responsible for the emergence of various birth defects in their children.

Depakote was initially approved by the US Food and Drug Administration (FDA) in 1983. Since that time studies have emerged suggesting a link between valproate (Depakote) and various Depakote birth defects.

The latest lawsuit, according to the Madison Country Record (8/29/12) was filed August 3 in St. Clair County Court. Lead plaintiff Nathanael Rymsza claims that his children, together with those of six other plaintiffs in the case, have suffered various Depakote side effects.

Specific birth defects identified in the Depakote lawsuit including spina bifida, cleft palate, cleft lip, limb and digital deformities, facial dysmorphism, mental developmental delays, genitourinary malformations and heart defects. The lawsuit alleges the birth defects occurred after the mothers of various infants ingested Depakote during their pregnancies.

A common thread weaving throughout many Depakote lawsuits is the allegation that defendant Abbott Laboratories—the manufacturer of Depakote—either knew, or should have known of the dangers associated with valproate when used by expectant mothers, but failed to adequately warn doctors or their patients as to the risk.

"Even now, when medical science has proven beyond all doubt that one out of every eight or ten babies whose mothers take Depakote during the first weeks of pregnancy will suffer some form of major congenital anomaly, Abbott refuses to state that risk on its product label, instead obliquely referring to a misleading statistic regarding a single specific defect," the suit states.

The FDA issued a safety warning about Depakote birth defects in 2009.

The perceived wisdom to take a holiday from drugs while pregnant is a hotly debated topic, driven by the need for the medication by the expectant mother v. the potential for harm to a fetus. Plaintiffs state that had they known of the potential dangers they would have been better informed and could have made more appropriate choices given their unique situation and beliefs.

Depakote birth defects can result in a lifetime of emotional and physical health issues for the child, together with unquantified guilt on the part of the mother having ingested valproate without knowing the risks.

The lawsuit (Case # 12-L-403) claims children of the seven plaintiffs have suffered severe and permanent injuries and experienced physical impairment, disfigurement, pain and suffering.
While many physical deformities can be surgically repaired over time, the procedures can be costly. The emotional impact to a child having to go through childhood and adolescence with an obvious physical deformity can be incalculable.