Jerome Lew is a Hollywood screenwriter, and what happened to him could have come straight out of a horror film.
In 2009, Lew went to UCLA Medical Center for surgery to relieve numbness and pain in his hands. The operation appeared to be a success. But he later began having trouble speaking. His left eye drooped. He developed severe nerve pain and weakness in his neck, arms, and hands.
Lew concluded that the problem had been caused by an implant fused into his neck. It had never been approved to replace a bone in the neck.
“Jeremy’s injuries from this surgery have been devastating,” said his attorney, Robert Vaage. “His life was ripped away by one surgery and the devices that were used.”
In July, Lew, 52, settled with the University of California for $4.2 million; the manufacturer of the device, Medtronic, also settled for a confidential amount. Both parties denied any wrongdoing.
Yet the legal challenge is not over for Medtronic. The company, one of the world’s largest medical device manufacturers, now faces a whistleblower lawsuit that claims it sought Food and Drug Administration approval for its devices under false pretenses — and that the devices have been regularly used for a purpose that was never intended by regulators. […]
The FDA declined to say whether it believes Medtronic has violated regulations guiding the off-label use of medical devices or other regulations. But a spokeswoman said the device was “cleared explicitly for use in the thoracic and lumbar spine.”
Patient advocates say the case highlights the shortfalls of the regulatory system. Medical devices, unlike prescription drugs, are not subject to clinical trials, as is the case with prescription drugs.
Diana Zuckerman, president of the National Center for Health Research, said more scrutiny in a trial would have made it clear that the Medtronic device was sized to fit in the neck.
“Had it been tested in a clinical trial, the orthopedic surgeon would have said, ‘What the hell, this doesn’t fit in the lumbar spine,’” said Zuckerman.
The FDA “didn’t have any data about safety or effectiveness or even whether it would fit where it was supposed to,” she said. “The truth is, FDA is doing such an inadequate job of reviewing devices that if it weren’t for the lawsuits, even more patients would be harmed.” […]
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