Bravelle Lawsuit Survives Motion to Dismiss

Chicago, ILA Bravelle lawsuit has survived a motion from the defendants to dismiss, with a judge finding plaintiffs can revise their claims and file a second amended complaint. The lawsuit involves allegations that some women were given a batch of infertility drug—Bravelle—that had diminished potency and therefore decreased their chances of becoming pregnant.

Plaintiffs allege Ferring should have taken proper steps to ensure its IVF treatment was as effective as marketed. Ferring moved to dismiss the lawsuit, arguing plaintiffs had not proven the actual Bravelle used in their cases was defective, but US District Judge Amy St. Eve refused to fully dismiss the lawsuit, finding that some of the important issues—such as whether Ferring conducted adequate testing and whether it knew about potency issues—will be dealt with during the discovery phase.

Bravelle is used during IVF treatment to stimulate egg maturation. In 2015, Ferring issued a voluntary recall of the drug after stability testing showed decreased potency, which lessened the drug's effectiveness and increased the possibility that women would be given higher doses and were therefore exposed to a higher risk of side effects.

According to court documents, one of the named plaintiffs, Nicole Keith, began the process of IVF treatment in April 2015, when a doctor determined she had "poor egg quality" and would need a donor egg from her sister-in-law. Keith's sister-in-law, Christina Dorris, researched Bravelle and in July 2015, began her daily Bravelle injections to trigger egg growth. Her eggs, however, were also determined to be low quality. As a result, her Bravelle dosage was increased and Dorris experienced side effects.

On August 18, 2015, Keith was implanted with two embryos and began a course of injections and pills but failed to become pregnant. The doctor blamed the low egg quality for Keith not becoming pregnant. Keith alleges the failure to become pregnant was caused by the lower potency Bravelle.

Plaintiffs argue that not only were they less likely to become pregnant than promised as a result of the potency issues, but they paid for out-of-pocket expenses for treatment with Bravelle and other associated costs—including anesthesiologist fees, pre-implantation fees, and medical facility fees—not knowing they were getting an allegedly defective product. They further argue that because they spent between up to $25,000 on the one round of treatment they cannot afford additional treatments.

A lawsuit was filed on behalf of Nicole Keith and other plaintiffs on March 9, 2016. That lawsuit alleges breach of express warranty, unjust enrichment and other violations. Ferring filed a motion to dismiss the lawsuit, which the court granted in part, but also denied in part.

The lawsuit is Nicole Keith et al v. Ferring Pharmaceuticals Inc, case number 1:15-cv-10381, in US District Court for the Eastern District of Illinois.