A federal judge in Utah has rejected claims made by a woman who allegedly took Clomid before pregnancy and gave birth to a boy with 2 missing fingers, that labels of the fertility drug failed to adequately warn about the risk of birth defects.
What’s the Problem?
March 21, 2016 – U.S. District Judge Dee Benson said that the U.S. Food & Drug Administration (FDA) twice rejected a citizen’s petition to add warnings to Clomid’s labeling indicating that it may increase the risk of birth defects when taken prior to conception, according to Law360.
Judge Benson determined the petitions’ argument that Clomid has a long half-life and blocks cholesterol biosynthesis, leading to an increased risk for birth defects, was the same theory presented by plaintiff Victoria Cerveny in her complaint.
FDA concluded that there is insufficient data to demonstrate a link between the use of Clomid before conception and an increased risk of birth defects. Specifically, the agency found that research showed that any half-life of Clomid isn’t sufficient to cause “significant inhibition of cholesterol synthesis” even after multiple rounds of treatment, according to Benson.
The judge went on to say that when a citizen’s petition is filed after an alleged injury which addresses the same failure to warn claim as a plaintiff’s, FDA’s denial of the petition can be evidence to support a drugmaker’s preemption defense.
According to the lawsuit, Cerveny took Clomid in 2002, years before the citizen’s petitions were denied in 2007 and 2009.
“If the FDA concluded in 2009 and 2012 that Clomid is not a significant inhibitor of cholesterol, and if used as directed Clomid does not pose a risk of causing birth defects, the court cannot say the FDA would have approved a contrary warning prior to 1992,” Benson said. “The FDA’s denial of the plaintiffs’ theories embodied in Mix’s citizen petitions is clear evidence that the FDA would not have permitted Aventis to strengthen Clomid’s label prior to 1992.”
Benson also noted that the FDA has consistently approved Clomid labeling that includes rejections of Cerverny’s theories:
“Since 1967, Clomid’s label has consistently warned about the risk to a fetus if Clomid is ingested during pregnancy. 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.”
Cerveny used Clomid until she found out she was pregnant after her 2nd round of treatment, according to the lawsuit. She later gave birth to a son, Alexander, who was delivered without an index or pinky finger on his left hand, as well as with “a congenital dislocation of the left radial head.”
Cerveny argued that Alexander’s birth defects were the result of Clomid remaining in her body during conception and while his organs were developing in the womb, Benson said. The lawsuit is: Cerveny et al v. Sanofi et al., case number 2:14-cv-00545, in the U.S. District Court for the District of Utah.