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Whistleblower case contends surgical device maker misled FDA — and patients paid the price

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by Sheila Kaplan
STAT
August 15, 2016

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.

“They were labeled, ‘not for cervical spine use,’ and yet in everything about them, including emails from their marketing folks, it makes clear that they were meant to be and were used in the cervical spine,” said Dr. Vikas Saini, president of the Lown Institute, a Boston health care think tank, who has followed the case.

Read the full article here.

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