Carla Muss-Jacobs didn’t give much thought to the tools her surgeon would use to replace her knee. Like most patients, she just wanted to feel better and trusted that any devices in the operating room would be safe.
In her case, the surgeon sliced open her leg and positioned special cutting guides, like carpentry jigs, over her thigh and shin bones to line up his bone saw precisely. The device, called the OtisKnee, was supposed to speed the surgery and the recovery.
Ms. Muss-Jacobs’s recovery was not speedy. In terrible pain after the operation, she eventually underwent a second knee replacement.
As it turned out, the OtisMed Corporation, the maker of the OtisKnee, did not seek clearance from the Food and Drug Administration for its OtisKnee guides before it started selling them. When the company did apply for F.D.A. review, its application was rejected because, the agency said, the company failed to show that the product was safe and effective.
In December, OtisMed and its former chief executive pleaded guilty in Federal District Court in Newark to criminal charges of distributing adulterated medical devices. The Justice Department said the company sold and distributed 18,000 of its OtisKnee devices from 2006 to 2009 without F.D.A. approval.
No one can say with certainty if the OtisKnee device caused Ms. Muss-Jacobs’s problems, but in announcing an $80 million settlement of criminal and civil charges against OtisMed, United States Attorney Paul J. Fishman said patients “should be entitled to trust that the devices their doctors are using are safe, effective, tested and approved.”
An examination of the OtisKnee case shows how easily that trust can be violated in the rapidly evolving world of medical devices, a thriving $110 billion-a-year industry. If not for a whistle-blower, the public might never have learned about the widespread use of a potentially dangerous device that sidestepped regulation. […]
Diana Zuckerman, president of the National Center for Health Research, an F.D.A. watchdog group, said the agency wasn’t doing enough to keep patients safe.
The F.D.A.’s “surveillance system is so flawed and so weak and so subjective and so inadequate,” Ms. Zuckerman said, “that there are no automatic red flags going up when something happens.”