Judge Dee Benson, U.S. District Court, District of Utah, granted Shook, Hardy & Bacon’s motion for summary judgment for client Aventis regarding its infertility drug Clomid on Wednesday, March 16, 2016.
Plaintiff Victoria Cerveny allegedly took Clomid in September and October 1992. Shortly thereafter, she became pregnant. When her son was born, he was missing two fingers and had a congenital dislocation of his left elbow.
In 2007, a citizen petition was filed with FDA demanding that Clomid include a warning that taking it before conception increases the risk of birth defects, following the theory that Clomid has a long half-life and inhibits cholesterol biosynthesis. In 2009, based on its review of the evidence cited in the petition and its own “independent survey” of the literature, FDA rejected the citizen petition finding that the “reliable scientific evidence does not establish that [Clomid]…carries teratogenic risks when used” as directed. Shortly thereafter, the petitioner filed a motion for reconsideration that was also denied by FDA.
Judge Benson found the Plaintiffs’ claims preempted based on FDA’s denial of the citizen petition and its continuous approval of warnings that stated there was no evidence of an increased risk in humans when used appropriately.
“Since 1967, Clomid’s label has consistently warned about the risk to a fetus if Clomid is ingested during pregnancy,” the judge said. “However, in the nearly five decades Clomid has been used to induce ovulation, the FDA has never required Clomid to carry warnings suggesting birth defects associated with Clomid use prior to pregnancy.”
Partner Eric Swan led the defense for Aventis.
The case name is Cerveny et al v. Sanofi et al.