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A fertility drug manufactured by Ferring Pharmaceuticals, Bravelle received FDA approval in 2002. To help women become pregnant, this treatment genetically known as urofollitropin includes a follicle-stimulating hormone and luteinizing hormone activity, which, in turn, stimulate the ovaries to help them produce eggs.
However, in September 2015, Ferring announced a recall after several lots were found to have reduced potency, which lessens its effect. While the company has since compensated those who purchased the drug any time in 2014 and 2015, patients who had to pay several out-of-pocket medical expenses say this isn’t enough.
The recall concerned lots during this period, which contained drugs that had lost their potency before the expiration date and had less of an effect. In response, Ferring sent out letters to patients about this voluntary recall and decided to remove all lots from the U.S. market. At the time, they further reimbursed patients who had purchased the fertility drug from March 2014 through October 2015.
Prior to the recall, Ferring had conducted tests, which showed that certain batches were losing potency quicker than expected. But, at the same time, women unaware they had purchased these defective batches found they weren’t becoming pregnant and, as a result, had their doctors up the dosage, increasing their risk of exposure to potential side effects.
Bravelle continues to remain on the market, although Ferring doesn’t mention its past potency problems on its website, nor does the company provide patients with a way to determine if they still have a recalled drug.
As of 2017, patients have started filing lawsuits at the local level against Ferring. Claims allege Ferring didn’t take appropriate steps to ensure Bravelle was safe and effective for its intended use, failing to live up to its express and implied warranties. Further, plaintiffs:
- Have requested reimbursement for the full IVF cycle – up to $14,000 – claiming that they wouldn’t have undergone the procedure if they knew the drug wasn’t going to work.
- Claim the higher dosage exposed them to greater health risks, such as blood clots, birth defects, ovarian torsion, and ovarian hyper-stimulation syndrome.
- Have requested reimbursement not just for the drug but also for the full IVF or intrauterine insemination treatment and all other out-of-pocket expenses.
In response, Ferring filed a motion to dismiss the lawsuits at the end of 2016, claiming the plaintiffs could not prove the Bravelle involved in their treatments was part of the recalled lots. In certain states, courts have approved Ferring’s motion.