Ferring Pharmaceuticals Inc. of Parsippany faces a growing number of suits over alleged manufacturing defects that reduced the efficacy of its fertility drug, Bravelle.
The suits stem from the company’s voluntary recall of Bravelle made between March 2014 and October 2015. The recalls were made after the company’s internal quality monitoring revealed that certain lots of the drug did not meet its potency specifications.
Three suits were filed against the company in the District of New Jersey on Nov. 10 and two others were filed in early October. Additional suits against Ferring over Bravelle are pending in the Southern District of Texas, the Northern District of Illinois, and in state court in Los Angeles.
One of the suits was filed on behalf of third-party payers by the American Federation of State, County and Municipal Employees, District Council 47 Health and Welfare Fund. The other suits were brought by individuals.
Bravelle, approved by the Food and Drug Administration in 2002, stimulates ovulation and is often used in conjunction with fertility treatments such as in vitro fertilization. Plaintiffs say they would not have incurred the considerable expense of in vitro fertilization if they knew Bravelle was not effective.
The recall began in the U.S. and Canada and ultimately was expanded to cover the entire world, the suits claim. Eventually Bravelle was withdrawn from the market worldwide.
According to the suits, Ferring cut the price of Bravelle by 50 percent in 2014 in hopes of increasing market share. Bravelle is made with the urine of post-menopausal women, but similar drugs that are synthetic in origin are more effective, the plaintiffs claim. With profit margins reduced, Ferring sought to reduce production costs by incorporating shortcuts that exacerbated potency and stability issues, the suits claim. Ferring received numerous complaints from doctors and patients concerning the effectiveness of Bravelle, but did not take steps to correct the problem, the suits claim.
The suits bring claims for negligence, failure to warn, defective manufacturing and breach of express and implied warranty. The plaintiffs seek compensation for medical expenses, lost wages, pain and discomfort, emotional distress and loss of consortium.
Bravelle users must self-inject with the drug twice daily for up to 12 days, a painful process that can cause local reactions such as bruising, redness and welling. Plaintiffs would not have suffered those side effects if they knew Bravelle was not top quality, they claim.
The New Jersey suits are brought by David Krangle of Alonso Krangle in Melville, New York. Lorna Dotro of Coughlin Duffy in Morristown represents Ferring in some of the suits. Neither one returned a call.
After the recall in 2015, users of Bravelle were invited to seek reimbursement for out-of-pocket costs related to use of the drug, but Ferring did not offer to reimburse third-party payers for their out-of-pocket costs.
The plaintiffs claim that the reimbursement program constitutes assumption by Ferring of responsibility concerning Bravelle’s potency, and they seek a ruling that Ferring is judicially estopped from arguing that it bears no responsibility for those warranties.
In the Illinois case, a federal judge denied a defense motion to dismiss in September 2016, finding that the plaintiffs ”have plausibly alleged that all of the recalled lots were sub-potent or had the potential to be sub-potent” and that the plaintiffs’ allegations “raise a reasonable inference that Defendant knew about the sub-potency issues well before October 2015.”