As of 2016, however, the FDA issued “Black Box” warnings for patients with this client’s medical history, suggesting a severely increased risk for tendon rupture. While urologists in Canada and the European Union typically follow the FDA warnings and provide this information to their patients, urologists in the United States typically do not. The Court of Appeals decided that the lawsuit could go forward without an expert witness because the jury could decide for themselves whether urologists in the United States should give their patients the FDA’s “Black Box” warnings.”

Read the Court of Appeals decision here.