????最重要的是，此事涉及的公司是一家再三忽視潛在致命后果證據的公司。對20多位參與Norian骨水泥計劃的前員工和外科醫生的采訪實錄，數百頁法庭記錄，以及提交給法庭的公司文件顯示，辛迪斯公司不僅無視關于其藐視規則的多次警告，而且還對科學家的勸告（這種骨水泥可能會導致致命的血液凝塊）置若罔聞。

????美國司法部將矛頭對準了4名位居高位的高級管理人員。按照一個名叫《公司主管責任律例》 （Responsible Corporate Officer Doctrine）的醫療保健法案一款不同尋常的條文，他們均承認自己犯有一項輕罪。他們承認對公司從事未經授權的臨床試驗，以及參與藥品核準標示外營銷（off-label marketing，即推廣產品應用于未經授權的領域）等罪行負責，但并不承認自己參與了犯罪。當時，沒有哪位高管因為這項指控被判入獄（4位高管的律師拒絕讓其當事人接受本文作者的采訪，也不愿就這起案件的事實發表評論）。

????藥品核準標示外營銷是一種非常普遍的現象，以至于在一些藥品和醫療器械制造商看來，這種行為與輕微超速行駛沒什么兩樣。過去10年間，默克（Merck）、輝瑞（Pfizer）、雅培（Abbott Labs）和葛蘭素史克（GlaxoSmithKline）這樣一些醫藥大鱷已經支付了數十億美元的罰金，用來擺平它們因參與藥品核準標示外營銷所受到的指控。但此類案件依然持續發生，部分原因在于潛在的利潤往往超過罰金。

????但這并不是一起典型的藥品核準標示外營銷案例，也不是典型的醫療設備或藥物試驗。在諸如此類的臨床試驗中，病人有時會死亡——但這種實驗只有在告知病人潛在的風險，并征得其同意之后才會進行。檢察官聲稱，辛迪斯公司掩蓋了其骨水泥產品未經授權這一事實，進而剝奪了病人選擇是否愿意成為試驗品的權利。

????辛迪斯案例為司法部門提供了一個前所未有的機會。它終于可以要求相關的公司高管為其行為承擔責任。作為這起訴訟的主要發起人，美國助理檢察官瑪麗?克勞利敦促法庭將這些犯有“腐敗罪行”的高管關進監獄。她說：“這種悍然無視病人安全的行徑理應受到法律允許范圍內所能作出的最高刑罰。”

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????譯者：任文科

????Most of all, this is a story about a company that repeatedly ignored evidence of potential lethal consequences. Interviews with more than 20 former employees and surgeons involved in the Norian project, hundreds of pages of court transcripts, and company documents submitted in the case reveal that Synthes not only disregarded multiple warnings that it was flouting the rules, but also brushed off scientists' cautions that the cement could cause fatal blood clots.

????The Department of Justice targeted four high-ranking executives, all of whom pleaded guilty to a misdemeanor under an unusual provision of health care law called the Responsible Corporate Officer Doctrine. They accepted responsibility for the company's crime of running unauthorized clinical trials and for engaging in off-label marketing, or promoting products for unapproved uses, without conceding that they were involved in the crime. At the time, no executive had ever gone to prison for such a charge. (Lawyers for the four executives declined to make their clients available for interviews or to comment on the facts of the case.)

????Off-label marketing is so common among drug and device makers that it's often dismissed as the equivalent of driving slightly over the speed limit. During the past decade, pharmaceutical behemoths such as Merck (MRK), Pfizer (PFE), Abbott Labs (ABT), and GlaxoSmithKline (GSK) have paid billions in fines to settle charges that they engaged in off-label drug promotion. Yet cases continue to happen, in part because the potential profits often exceed the fines.

????But this wasn't the typical off-label marketing case. Nor was it typical of trials for medical devices or drugs. Patients sometimes die during such clinical trials -- but only after being advised of the risks and then granting their consent. In hiding the unapproved status of the cement, prosecutors argued, Synthes denied patients the right to choose whether they wanted to be test subjects.

????For the Justice Department, the Synthes case posed an unprecedented opportunity. It could finally hold individual businessmen accountable for their actions. Mary Crawley, the assistant U.S. attorney who led the prosecution, urged the court to send the executives to jail for their "venal crime." The "callous disregard of patient safety," she argued, "warrants the highest sentence the law will allow."