160 Engineering Ethics: An Industrial Perspective
(1) Any person who violates a provision of section 331 of this
title shall be imprisoned for not more than one year or
fined not more than $1,000, or both.
(2) Notwithstanding the provisions of paragraph (1) of this
section, if any person commits such a violation after a
conviction of him under this section has become final, or
commits such a violation with the intent to defraud or
mislead, such person shall be imprisoned for not more
than three years or fined not more than $10,000, or both.
(USC, 2004)
AN ENGINEERING PERSPECTIVE
After initial PMA approval in 1999, word of complications quickly
spread through EVT, causing several employees to question the safety
of the Ancure device. Early in 2000, after a meeting of a dozen employ-
ees, one engineer e-mailed a memo to a superior proposing that the
handle breaking technique be thoroughly tested, with the problem
reported to FDA for review and approval. Although some testing was
conducted, the technique was not reported to FDA at that time, accord-
ing to court records and accounts by ex-employees.
After only 55 complaints were given to the FDA inspector in July 2000, a
small group of employees decided to take action. In October 2000, seven
employees, later dubbed the Anonymous Seven” in court documents, sent
an anonymous letter to Guidant’s chief compliance officer in Santa Clara,
California, describing their efforts to alert the company to problems through
normal channels. They charged that EVT had failed to report numerous
problems to FDA, and sent a copy of this letter to FDA.This letter launched
the internal EVT investigation, as well as the 3-year investigation by FDA’s
Office of Criminal Investigations and the Federal Bureau of Investigations
(FBI) (Jacobs, 2003; U.S. Attorney, 2003).
In its plea agreement, Guidant agreed to not “initiate contacts with
former employees designated by the government without prior approval of
the government, and, if contacted by such designated individuals, [to] notify
the government of the facts and the substance of such contacts” (Plea, 2003).
REFERENCES
Criminal Information, U.S. v. Endovascular Technologies, Inc., Case No. CR-02-0179 SI, U.S.
District Court (N.D.CA 0609), 2003.
Eichenwald, K., Maker admits it hid problems in artery device. NY Times, A1, June 13, 2003.
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