Guidant LLC, a subsidiary of Boston Scientific Corporation, will pay close to $300 million to settle federal charges that it withheld information about short-circuit failures of cardio implants designed to detect and correct abnormal heart rhythms. From the Food and Drug Administration press release:
Today’s entry of a guilty plea by Guidant LLC and the proposed resolution would represent the largest criminal penalty ever imposed on a device manufacturer for violating the Food Drug and Cosmetic Act,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA will continue to commit enforcement resources to seeking this type of criminal resolution and stiff sanctions when device manufacturers fail to adhere to the statutory and regulatory requirements that exist to ensure the safety and efficacy of their products.”
The guilty plea follows a four-year federal investigation into the company’s handling of device failures. The FDA’s approval process for medical devices has recently come under scrutiny from some researchers and lawmakers, who say flawed studies are often used to approve devices.
The nation’s largest association of trial lawyers noted that despite Guidant’s guilty plea, the company is immune from civil claims because of a 2008 Supreme Court decision that said manufacturers could not be held liable for faulty medical devices that had been pre-approved by the FDA. A bill in Congress, the Medical Device Safety Act, would reverse this.
Related: Justice Department: Cardiac Device Maker Failed to Report Safety Problems
[...] Cardio Implant Maker Pleads Guilty for Not Reporting Safety … [...]