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Bravelle Infertility Class Action Lawsuit Going Forward on Negligence Claims

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Chicago, ILWhen the manufacturers of the Bravelle infertility drug temporarily recalled, and stopped selling the product a little more than a year ago over lack of potency, attorneys and legal professionals at the time predicted that plaintiffs would have a bit more of a challenging time bringing a Bravelle lawsuit given that there was no primary safety issue involved. To that end, any Bravelle Infertility Drug lawsuit brought since then has focused on the lack of quality and potency, rather than safety claims.

Indeed, a class action lawsuit brought against Ferring Pharmaceuticals and challenged by the manufacturer will proceed, after a judge granted only partially a motion brought by Ferring for summary judgement.

That means the nationwide class action Bravelle Recall lawsuit can go forward ( Keith, et al v. Ferring Pharmaceuticals, Inc. case no. 1:15-cv-10381 US District Court for the Northern District of Illinois).

In October of last year, when Ferring issued a Bravelle Infertility Drug Recall, it did so due to the results of the Switzerland-based drug maker’s own testing for quality. When it was discovered that certain batches of the fertility drug manufactured in 2014 “did not meet potency specifications for the full 24-month shelf life,” Ferring called a halt to product distribution “until the situation is rectified.”

Industry watchers at the time noted that Ferring had pushed all the right buttons and undertook the necessary protocols to remove the affected lots and temporarily cease distribution – which it did quietly and with little fanfare.

One attorney told Law 360 at the time that would-be plaintiffs would have a difficult time attempting to proceed with failure-to-warn claims, given that the issue had little to do with the potential for physical harm. While the attorney noted that a costly cycle of Bravelle that was insufficiently robust in strength to be effective would prove vexing for the plaintiff, no harm was done.

Another attorney noted at the time one strategy that might be effective in the pursuit of compensation would be the potential for side effects that could pose a health risk for the plaintiff. To that end, plaintiffs could argue that they should not have been made to assume the risk if the efficacy of the product was in doubt.

Fast forward a year. In lawsuits over the Bravelle Infertility Drug Recall, plaintiffs allege that Ferring knew about the lack of potency inherent to its Bravelle product well before the subdued Bravelle recall was initiated in October of last year.

Even without any claims against safety, the prior knowledge card is a big one for plaintiffs, given the costs associated not only for the drug, but the cost for treatments at fertility clinics as well as costs associated with travel, accommodation and time off work. The costs can add up to tens of thousands of dollars, funds which many couples allege it takes years to build up, and is not economically feasible to repeat if a treatment doesn’t work.

Some Bravelle plaintiffs claim to be out as much as $25,000 when all costs are factored in, and are unable – due to financial hardship – to repeat the attempt. For them, the allegation that Ferring knew about the deficient potency long before the Bravelle infertility drug recall, is beyond vexing.

Ferring offered to reimburse patients for the cost of the drug, which is the smallest cost component when all costs are factored in for clinic and clinician costs, time, travel and accommodation. Ferring has not offered to reimburse patients for any other costs beyond the cost of the drug itself.

In April, Ferring moved to have the class action Bravelle Infertility drug lawsuit dismissed. In September, Judge Amy St. Eve of the US District Court for the Northern District noted, in her 31-page ruling that the plaintiffs “have plausibly alleged that all of the Recalled Lots (sic) 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.”


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