Articles Posted in U.S. Court of Appeals for the Third Circuit

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Qui tam relator failed to satisfy the False Claims Act’s materiality requirement in alleging that the manufacturer of a widely-prescribed cancer drug, Avastin, suppressed data that caused doctors to certify incorrectly that Avastin was “reasonable and necessary” for certain at-risk Medicare patients. Avastin is FDA-approved and has accounted for $1.13 billion a year in Medicare reimbursements. The relator, formerly the head of healthcare data analytics for the manufacturer, claimed the company ignored and suppressed data that would have shown that Avastin’s side effects for certain patients were more common and severe than reported and that such analyses would have required the company to file adverse event reports with the FDA, and could have resulted in changes to Avastin’s FDA label. He claimed the company caused physicians to submit Medicare claims that were not “reasonable and necessary.” The Third Circuit affirmed dismissal of the claim, stating the allegations may be true but a False Claims Act suit is not the appropriate way to address them. The manufacturer followed all pertinent statutes and regulations. If those laws and regulations are inadequate to protect patients, it falls to the other branches of government to reform them. View "Petratos v. Genentech Inc" on Justia Law

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Morris worked as a coal miner for nearly 35 years, 19 years underground. Morris’s breathing difficulties caused him to leave work. In 2006, Dr. Cohen diagnosed him with pneumoconiosis (black lung disease). Eighty Four Mining’s physician also examined Morris, but determined that Morris’s breathing difficulties were caused by smoking and that there was no radiographic evidence of pneumoconiosis. In 2008, aPennsylvania Workers’ Compensation Judge denied benefits. Morris did not appeal. Morris’s breathing problems worsened; a doctor put him on oxygen nearly full-time. In 2011, Morris sought Black Lung Benefits Act (BLBA), 30 U.S.C. 901, benefits. He did not rely upon the 2006 report that had been discredited, but on a 2011 arterial blood gas study and pulmonary function testing that supported a finding of black lung disease. In 2013, an ALJ granted BLBA benefits, rejecting a timeliness challenge and reasoning that a denial of black lung benefits due to the repudiation of the claimant’s pneumoconiosis diagnosis renders that diagnosis a “misdiagnosis” and resets the three-year limitations period for subsequent claims. Morris sufficiently established the existence of pneumoconiosis through medical evidence obtained after 2010 and Eighty Four failed to adequately explain why Morris’s years of coal dust exposure were not a substantial cause of his impairment. The Benefits Review Board affirmed, citing judicial estoppel as precluding the timeliness argument. The Third Circuit denied a petition for review. View "Eighty Four Mining Co. v. Morris" on Justia Law