Ferring Class Action Lawsuit Follows IVF Drug Recall

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A proposed class action lawsuit was filed against Ferring Pharmaceuticals Inc. in New Jersey federal court following the company’s recall of the drug Bravelle due to its reduced potency.

Plaintiffs Brandy Rosas and Orly Lazarian claim that they incurred out-of-pocket costs in the tens of thousands of dollars and were never reimbursed following the recall of the fertility drug.

Both women state that they underwent in-vitro fertilization procedures in 2014 using the Bravelle that was later recalled, and neither woman became pregnant.

The plaintiffs say that the company only reimbursed the customers for the cost of the drug, but not any related costs incurred due to the IVF process, the complaint reads.

Ferring voluntarily recalled the drugs from the market that had manufacture dates of March 2014 through October 2015. The fertility drugs allegedly failed to meet specifications for potency requirements, according to the complaint.

Rosas and Lazarian allege that they would not have purchased Bravelle or undergone related IVF procedures with related expenses if they had been aware that the drug was not potent enough to allow pregnancy.

“Ferring knew or should have known the recalled lots were not suitable for use and suffered from decreased potency,” the plaintiffs say.

In October 2015, the company’s spokeswoman, Christy Maginn, released a statement that the company’s internal testing determined that certain Bravelle batches “did not meet potency specifications for their full 24-month shelf life.” Maginn further said that the recall was not safety-related.

Bravelle, which was FDA approved in 2002, works by stimulating the maturation of the egg and multiple follicular development in women who are able to produce eggs on their own, according to the claim.

The reduced potency issue in Bravelle was linked to a deficiency of follicle stimulating hormone (FSH), a prime ingredient in the drug. FSH is naturally secreted by the anterior pituitary gland in the body and is responsible for regulating reproductive processes, development, growth and pubertal maturation, according to the complaint.

“FSH is key when it comes to fertility, as it allows a small group of follicles to grow and develop inside the ovary,” the complaint reads. “Each of these follicles contains an egg, so by increasing the body’s levels of FSH, the chance of the ovaries releasing a ripe egg for fertilization is increased.”

Not only was Bravelle unable to cause conception, the plaintiffs contend, it also caused side effects including hot flashes, headaches, nausea and vaginal bleeding due to its reduced potency.

The plaintiffs are seeking certification of a nationwide Class of patients who purchased the recalled batches of Bravelle.

Several counts were brought forth against Ferring including breach of express warranty, breach of implied warranty, unjust enrichment, and violation of the Magnuson-Moss Warranty Act, as well as violations of various business and consumer protection laws in the plaintiffs’ home states of Texas and Georgia.

The plaintiffs are represented by Allen T. Friedman of Bagolie-Friedman LLC.

The Ferring Pharmaceuticals Bravelle Class Action Lawsuit is Brandy Rosas and Orly Lazarian, et. al. v. Ferring Pharmaceuticals Inc., Case No. 2:16-cv-03137, in the U.S. District Court for the District of New Jersey.