Synthes Executives Sentenced to Prison

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  • A former Synthes Inc. executive was sentenced Monday to nine months in prison for his role in the medical-device maker’s promotion of a bone cement for unauthorized uses.
  • Michael Huggins, 54, of West Chester, the former president of Synthes USA, was sentenced to nine months in prison and taken into custody immediately. Thomas Higgins, 55, of Berwyn, former leader of Synthes’ spine division, got the same sentence. John Walsh, 48, of Coatesville, who was in charge of regulatory affairs, got five months.
  • Synthes and its Norian unit agreed last year to plead guilty to charges that between 2002 and 2004 they conspired to conduct unauthorized clinical trials of the Norian bone cement in surgeries to treat vertebral compression fractures of the spine.
  • Inspite of the fact that the prescribing label for the Norian bone cement specifically warned against using it for vertebral compression fractures, because it could cause dangerous blood clots, the warnings were ignored and the trials were conducted.
  • Three patients died on the operating table after spine surgeons used the Synthes product in 2003 and 2004. The Department of Justice hasn’t proved that the cement caused the deaths, but the agency has said the deaths should have raised red flags at Synthes about the product’s safety risks.
  • Synthes and Norian agreed to pay $23.2 million in fines, and Synthes sold Norian to Kensey Nash Corp in an effort to settle the case.
  • Synthes, which has its headquarters in Switzerland and has major operations in the Philadelphia suburbs, has agreed to be acquired by Johnson & Johnson for about $21 billion.
  • The four men pleaded guilty under the responsible corporate officer doctrine according to USA law.
  • Under this doctrine, corporate officers can be found criminally liable if they held positions of authority in which they could have prevented or promptly corrected an alleged corporate violation, but failed to do so.
  • The doctrine is controversial, because it doesn’t require proof that a corporate officer had knowledge or awareness of the alleged wrongdoing.
  • US Justice Department alleged in court papers that the  four men were aware of and participated to some extent in the underlying criminal conduct, and that their conduct caused harm to the public.

Ref:

1. www.justice.gov/usao/pae/News/2011/Nov/synthesexecs_release.pdf

2. www.justice.gov/usao/pae/News/2010/Oct/synthes_release.pdf

 

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