by Long Island Attorney Paul A. Lauto, Esq.
Alfred Caronia, a big pharma sales representative, was previously found by a lower court to have violated the federal Food and Drug Cosmetic Act in his off label promotion of the drug Xyrem. Although the drug Xyrem is approved by the FDA for narcolepsy, Caronia promoted the drug for off label uses including muscle disorders, fatigue and chronic pain. As a result of his unlawful promotion, Caronia was sentenced to one year probation and 100 hours of community service.
Upon appeal, the 2nd circuit Court of Appeals in NY reversed the lower court decision. In explaining the basis for the reversal Judge Chin stated that, "In the fields of medicine and public health, where information can save lives, it only furthers the public interest to ensure that decisions about the use of prescription drugs, including off label usage, are intelligent and well informed." Judge Chin continued to state, "The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good."
Read the full post at www.liattorney.com/scales-of-justice.html.