What A Difference A Decade+ Makes - Lexology
Thirteen years litigating the same case is a looooong time. Absurdly long. Long enough for an attorney working on the case to go from an associate learning to coax a newborn to sleep, to a partner juggling teen school and soccer commitments. Long enough for lawyers to migrate from Blackberrys and voicemail, to smart phones and instant messages. Long enough for new judges to be appointed by multiple presidential administrations, while erstwhile stalwarts of the bench take senior status or retire. Circle of life. You get the picture.
Perhaps the biggest downside of litigation lasting so long is cost. Litigation is ridiculously expensive, and spending more than a decade litigating one case must really, really add up. But apparently there can be an upside to a slow pace too: With that much time, new evidence can materialize that improves the liability picture.
We saw that happen in the Zofran litigation. Zofran initially was approved as an anti-nausea medication for chemotherapy patients. As it became widely used off-label for morning sickness, the FDA considered, but did not require, pregnancy-related labeling.
Litigation began over alleged birth defects in 2015 and whether the manufacturer should have added warnings about that issue. Then, over the next several years, both sides brought the plaintiffs’ allegations/evidence to the FDA’s attention, and the FDA rejected multiple proposed labeling changes regarding birth defects. Eventually, in 2021, it allowed a label change—...
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