Fatal Birth Defects May Leave Drugmaker Liable

(CN) - Forest Pharmaceuticals must face claims that its antidepressants Lexapro and Celexa caused a baby to be born with fatal cardiac birth defects, a federal judge ruled.

Erica Atkinson said she had been taking Lexapro and/or Celexa, as prescribed by a doctor, while pregnant in 2010-11. Her daughter Sophia Cowan was born with atrioventricular canal defects in Indiana on July 14, 2011.

The baby died weeks later on Aug. 7, allegedly as a result of the complications.

Atkinson sued the drug's New Jersey-based manufacturers, Forest Research Institute Inc., Forest Laboratories Inc., and Forest Pharmaceuticals Inc., last year.

She claimed that the companies were "involved in developing, labeling, marketing, monitoring, performing regulatory compliance and reporting, performing and/or participating in clinical trials, performing drug surveillance, researching and testing of pharmaceuticals for distribution, sale, and use by the general public, including the drug Lexapro."

The complaint in Camden, N.J., asserts claims for negligence, fraud, wrongful death and other claims, which Atkinson alleges are worth punitive damages.

U.S. District Judge Robert Kugler refused to dismiss the case on June 18 but rejected Atkinson's claim that New Jersey law applies.

"Here, not only did plaintiffs' injuries occur in Indiana, but 'the conduct causing injury in a prescription drug products liability case, including failure to warn and warranty cases, occurs primarily where the injured party was prescribed and ingested the drug,'" the unpublished opinion states, quoting a 2010 ruling in Yocham v. Novartis Pharm. Corp.

While Atkinson filed suit within two years of Sophia's death, her suit may have not timely "commenced," based on her "largely blank" summons on Forest Research, the ruling states.

"Though the summons names Forest Research Institute Inc. as a defendant, it does not include any of the information required by Rule 4(C)," Kugler wrote. "Further, plaintiffs did not include summonses for Forest Laboratories Inc. or Forest Pharmaceuticals Inc."

The court also found a "wrinkle" in the case that neither party had identified.

"Plaintiffs allege that defendants fraudulently concealed the true risks associated with Lexapro and Celexa and that plaintiffs were prevented from discovering information about the safety of these drugs sooner due to defendants' fraudulent concealment of the facts and information that would have allowed plaintiffs to timely discover potential causes of action," Kugler wrote. "In a decision handed down by the Supreme Court of Indiana approximately two weeks ago, the Supreme Court held that the Indiana 'Fraudulent Concealment Statute may apply to toll the Wrongful Death Act's two-year filing period.' Further, because 'a plaintiff is entitled to an entire statutory period after discovery to file his claim, which in the wrongful death context means two years,' it is not at all clear here that plaintiffs' claims are untimely."

Kugler added: "Indeed, as it is unclear exactly when plaintiffs discovered their claims, the court cannot conclude that the limitations period governing plaintiffs' wrongful death claims expired on the two-year anniversary of Sophia's death."

The defendants failed to challenge the timeliness of Atkinson's personal-injury claims, however, so the court deferred ruling on that issue.

Actavis reportedly acquired Forest Laboratories on July 1 in a cash and equity transaction currently valued at about $28 billion, with an anticipated combined revenue of $15 billion.

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