A pharmaceutical company, No Pain, manufactures a drug called Pain Away, one of the strongest prescription opioids available. The FDA has approved Pain Away only for cancer patients, who often suffer from pain that is unresponsive to other opioids. To increase the market share for Pain Away among both federal health care and non-federal health care plan beneficiaries, No Pain sales representatives have been marketing Pain Away to physicians for patients that do not have cancer. In addition, No Pain employees have routinely been misrepresenting to both federal and non-federal health care plans that patients had cancer to get them to pay claims for Pain Away. To date, there is no evidence that either of these practices have resulted in federal health care programs paying claims for Pain Away for non-cancer patients. However, the evidence indicates that No Pain has been successful in getting non-federal health care programs to pay for such claims You are an Assistant U.S. Attorney. Your boss presents you with the foregoing facts, and asks your advice on the following three issues: Your boss is very concerned about No Pain’s conduct, and wants know which, if any, of the following criminal offenses have potential applicability to the company’s conduct: 18 USC 1347 18 U.S.C. 287 18 USC 1343 The Food, Drug, and Cosmetic Act, 21 U.S.C. Part A Your boss is concerned that even if No Pain has criminal liability for any of the foregoing offenses, it may take some time to ultimately get a verdict. Accordingly, your boss wants to know what, if any, criminal, civil, or administrative remedies are available to try to stop No Pain’s ongoing efforts to sell Pain Away to non-cancer patients, or to curtail the payments it receives from such sales, while the government pursues criminal charges against No Pain. While your boss is concerned about No Pain’s efforts to sell Pain Away to non-cancer patients, he also recognizes that Pain Away is critical for cancer patients, and that there is no good alternative to Pain Away for such patients. Accordingly, he does not want to put No Pain out of business. Accordingly, your boss asks you to identify the options, if any, that may exist for holding No Pain criminally accountable that would not subject No Pain to mandatory exclusion.
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