In 2005, Guidant Corporation, a maker of
medical cardiac devices, revealed that many of its defibrillators had an
electrical defect that might cause them to fail when needed to interrupt an
erratic and possibly fatal heart rhythm. Guidant was forced to recall more than
100,000 implantable heart devices, including three models of defibrillators
with similar electrical flaws that were tied to at least seven patient deaths.
One of the most troubling aspects of the
recall came into view when it was revealed that Guidant had known about the
electrical problem for at least 3 years after two physicians in Minneapolis,
Dr. Maron and Dr. Hauser, told the company about the problem and urged Guidant
to alert physicians about the device defect so they could check their patients
and implants new models. Guidant made no effort to communicate the problem to
physicians nationwide, or to the Food and drug Administration (FDA) that has a
clear procedure for when a company should make a legal written declaration
about known problems with a medical product. When the company failed to act on
their message and take their advice the physicians contacted other physicians
and The New York Times. The resulting story and outcry quickly forced Guidant to
reveal the problem with its devices and communicate the problem to physicians
nationwide.
In the ensuing investigation, as panel of
medical experts came to conclusion that Guidant had deliberately kept its
faulty cardiac devices on the market without considering the medical impact and
had knowingly failed to alert doctors and patients when the devices started to
malfunction. Once legal proceeding were started against the company, internal
documents further revealed that a consultant to Guidant had informed the
company’s top executives that he believed it had a clear ethical obligation to
inform physicians about heart device defects and he urged the company to begin
a recall process informing them that their decision to withhold such data was
highly questionable. He also noted that Guidant had a clear conflict of
interest that would naturally lead it (and other companies) to disclose product
failures only when absolutely necessary. So, if a tragedy occurred—which it
did—Guidant’s actions would be viewed in the worst possible light possible; it
is always in a company’s best interest to expose its dirty laundry.
This proved true when Guidant faced a product
liability lawsuit filed in Texas by patients who received Guidant
defibrillators and then faced a federal lawsuit in Minnesota that claimed the
company had acted criminally when it knowingly sold potentially flawed
defibrillators. Guidant had to pay hundreds of millions in damages to patients,
and after intense negotiation with the Justice Department, it reached an
agreement to plead guilty to two “misdemeanors” that related to problems
concerning the completeness and accuracy of its filings with the FDA and to pay
a $296 million fine—the largest ever imposed upon a medical device company.
In April 2010, however, responding to ongoing
criticism by the Minneapolis physicians who first revealed the problem that the
fine was not enough to punish the company for its criminal actions, a federal
judge in Minnesota rejected the plea agreement. The judge said that the deal
did not hold Guidant sufficiently accountable for its criminal conduct in
knowingly selling potentially flawed defibrillators and that prosecutors should
have sought probation for Guidant and its new owner, Boston Scientific.
Possible criminal charges against the executives who had orchestrated the
cover-up were also suggested by some parties. While on probation, the company
would be required to take certain steps to ensure such unethical and illegal
behavior did not happen again, such as by putting in place strict new ethical
communication guidelines, an ethics ombudsman to take charge of the decision
about when to communicate product defects, and charitable activities by Guidant
to improve medical care among minority patients. The company announced it would
support such steps and that it would put in place the performance programs
necessary to ensure its managers would never make such unethical and illegal
decisions again.
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