U.S. District Court, District of Utah
A Utah court granted summary judgment in favor of Aventis in a woman's lawsuit alleging the pharmaceutical company's infertility drug Clomid caused birth defects in her child.
The woman became pregnant months after taking Clomid and gave birth to a child with birth defects. She filed a lawsuit against Aventis claiming that Clomid's labels failed to adequately warn about associated risks.
The court described a citizen's petition twice filed with the U.S. Food and Drug Administration (FDA) asserting that Clomid inhibits cholesterol biosynthesis, increasing the risk of birth defects. FDA reviewed the evidence submitted in the petition as well as other research related to Clomid and found the data insufficient to show a link between the drug and an increased risk of birth defects; specifically, FDA found that the half-life of Clomid is not sufficient to cause significant inhibition of cholesterol synthesis even after multiple rounds of treatment.
The plaintiff's claims relied on reasoning already rejected by the government agency, the court found, and it granted summary judgment in favor of Aventis. A Law360 article described the court's conclusion, noting that FDA has consistently approved Clomid labels that affirmatively reject the plaintiff's theories.
Cerveny v. Sanofi, No. 14-0545 (D. Utah 2016).