Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A
Depakote, Depakene / Depakine (Europe), Depacon, and Stavzor are anti-epilepsy drugs that contain valproic acid, which has been known to cause various birth defects when used by pregnant women. Such possible birth defects include facial deformities, developmental issues, and an increased risk of autism.
The link between these drugs and birth defects have been known since the early 1980's. However, the article "Over 14,000 women took Sanofi epilepsy drug despite fetus risk: ministry" reports that "More than 14,000 pregnant women in France took Sanofi's anti-epilepsy drug, Depakine, between 2007 and 2014.
As a result, hundreds of babies that were exposed to these drugs while in utero were either stillborn, or born with congenital birth defects during these seven years in France, alone.
Sanofi claims that during that time, the information provided to doctors and patients warned of the possibility of physical and mental defects in the children of pregnant women.
However, a preliminary investigation in Paris was recently launched in order to evaluate the truth of this statement by looking into the authorization and marketing of Depakine at the time.
As a result, parents of the children who were born with birth defects due to Depakine exposure are filing lawsuits in France (see note, below). They contend that adequate warnings concerning the possible side effects of the drug were not in place.
The case against Sanofi brought in France is a class-action suit; the first of which has been brought in France that deals with a health issue, according to the article, "Families bring class action against French drug maker Sanofi."
However, any cases filed on behalf of birth defect victims in the United States would be handled individually, rather than as a class-action lawsuit.
In fact, since about the year 2000 all successful drug injury lawsuits have been, by necessity, individual lawsuits for the simple reason that the judges will no longer "certify" any drug injury class action.
This is because despite the fact that the individuals who were harmed used the same drug, they all have varying medical histories, duration of use, side effects, severity of injury, etc. In other words, there are simply too many differences and not enough common ground amongst such individuals to lump them into a class-action suit.
To address these inadequate warnings, updates to the drug's packaging will be made within the next several months to more clearly warn of the drug's dangerous potential for the children of pregnant women.
Additionally, France is responding by setting aside an initial 10 million euros ($10.7 million) for claims concerning injuries suffered from Depakine use.
According to the article, "France sets up fund for Sanofi epilepsy drug victims," Health Minister Marisol Touraine told lawmakers in the lower house of parliament that "The 10 million euros are a starting point...In future years, the sums should be much higher." She also stated, "I regret that Sanofi didn't seek an amicable settlement as a matter of principle. I hope (Sanofi) will change its position."
We will continue to monitor the medical literature and legal news concerning the Depakote litigation and its development, here and abroad.
In the meantime, you can visit our website to learn more about Depakote / Depakene / Depacon / Stavzor. In addition, if you or someone you know have taken one of the aforementioned drugs and gave birth to a child with birth defects, we encourage you to complete our Free Case Evaluation form.
Drug Injury Watch: Side Effects News & Reports
Drug Injury Law: Medical & Legal Information