The FDA’s early release of inspection findings regarding a testing lab’s possible involvement in data falsification leading to the subsequent FDA approval of Zolgensma is unusual, pointing to the likelihood that Novartis will face tough scrutiny of its actions – and even stiff fines because of the fraud. Novartis says it hopes to learn from the experience and will work with the FDA to improve, but one analyst alluded to the possibility of a government investigation on the call Novartis held for the investment community. Can Novartis’ corporate officers be held liable for statue violations, regardless of whether they knew of any wrongdoing or participated in any misconduct?