Guidant Investigation Discovers Further Violations
By Jaimee Wolbert
Published on February 24, 2006
A recent inspection by the U.S. Food and Drug Administration revealed that the company failed to obtain the necessary federal approval for changes to its heart defibrillator products. Reports also concluded that Guidant waited more than three years to disclose problems with the defibrillator.
More than seven deaths have been linked to the defective devices, which have also sparked 60 class action lawsuits and nearly 150 individual claims.
In addition to the FDA, Guidant is also facing investigation over its recalls by the U.S. Department of Justice, the Securities and Exchange Commission, and a number of state agencies.
Despite the company's legal troubles, Guidant is set to be acquired by Boston Scientific Corp. for $27.2 billion if the deal is approved by stockholders and regulators.
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