Court Revives Fertility-Drug Birth-Defect Claims

(CN) – A federal court should reconsider a Utah couple’s failure-to-warn claims against a pharmaceutical company after its fertility drug supposedly caused their son’s birth defects, the 10th Circuit ruled Tuesday.

U.S. Circuit Judge Robert Bacharach outlined the case’s history in the three-judge panel’s 45-page opinion.

After Victoria and Charles Cerveny’s son, Alexander, was born with a deformity to his left elbow flexor muscles and only three fingers on his left hand, the couple filed a lawsuit against Aventis Inc. Aventis manufactures Clomid, known generically as clomiphene citrate, commonly used to treat infertility. Victoria used Clomid in September and October 1992, before she got pregnant.

The Cervenys asserted claims for failure-to-warn, breach of implied warranty, negligent misrepresentation and fraud.

In 1987, the U.S. Food and Drug Administration stated that, “Clomid may cause fetal harm when administered to pregnant women.”

Aventis also provided a warning label against using the drug during pregnancy. However, the Cervenys argue that Aventis failed to provide a Utah-sufficient warning label about the fetal risks of taking Clomid before pregnancy and one that “unmistakably warned about harm to the fetus” during pregnancy.

Although Victoria did not used Clomid during her pregnancy, she and her husband maintain that the drug has a long half-life and that its inhibition of cholesterol may harm a fetus. They also say they would not have used the drug if the FDA’s 1987 warning had appeared on the label.

A federal judge in Utah found in favor of Aventis, reasoning that the FDA would not have approved the type of warning labels the Cervenys sought.

The 10th Circuit agreed with the lower court’s ruling regarding a warning label about risks before pregnancy.

In 2009, the FDA rejected a citizen petition that asserted virtually identical claims about Clomid’s pre-pregnancy risks to a fetus. This is clear evidence, Bacharach wrote, that the FDA would have rejected the kind of label the Cervenys propose.

“In rejecting [Terence] Mix’s citizen petition, the FDA analyzed claims and data virtually identical to those submitted by the Cervenys,” Bacharach wrote in his 45-page opinion. “Under the standard that would have applied to a change proposed by Aventis, the FDA concluded that warnings were unjustified for risks in taking Clomid prior to pregnancy.”

However, Bacharach added, the court was incorrect to rule that federal pre-emption applied to the Cervenys’ claim regarding a warning label for during-pregnancy risks. Their claim addressed Utah law, and Aventis made its motion for summary judgment based on federal law.

“The district court did not consider whether it could rest on Utah law when deciding a summary judgment motion that had relied solely on federal preemption,” Bacharach wrote. “Because the district court did not consider this question and it has not been fully briefed on appeal, we leave this question for the district court to address on remand.”

Furthermore, the Cervenys’ breach of implied warranty, negligent misrepresentation and fraud claims are all distinguishable from the failure-to-warn claims because they are based “on affirmative misrepresentations rather than on a failure to provide a warning,” though preemption may apply to these claims, as well. Therefore, the district court should consider them on remand.

“We are thrilled that the 10th Circuit has reversed the grant of summary judgment and given the Cervenys the opportunity for their claims to be heard in the district court,” the Cervenys’ attorney, Adam Davis, said in a statement. “The fact that the FDA asked Aventis to strengthen the warnings on the Clomid label in 1987, and that Aventis failed to do so before Mrs. Cerveny used the drug in 1992, is given particular relevance by the Tenth Circuit’s opinion and will be central to our claims at trial.”

Davis is with Wagstaff & Cartmell LLP in Kansas City, Missouri.

Eric Swan from Shook, Hardy & Bacon LLP in Kansas City, Mo., represented Aventis. He could not be reached for comment Tuesday.

U.S. Circuit Judges Gregory Phillips and Carolyn McHugh joined Bacharach on the panel.

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