Raleigh woman suing over implanted "homemade" device

A Raleigh woman is suing two medical device companies and trying to sue a spine surgeon, who she says implanted a homemade device in her neck and upper back that he created in his garage.

Posted 9:30 p.m. Oct 30, 2014 — Updated 2:58 p.m. Nov 3, 2015

RALEIGH, N.C. — Editor's Note: A federal judge dismissed Susan Williams' lawsuit against two medical device companies because those companies are under the jurisdiction of the Food and Drug Cosmetic Act.

On October 28, 2015, Dr. Hey provided WRAL with a confidential letter from the North Carolina Medical Board regarding the care of Susan Williams. The letter, dated March 10, 2015, reads “Based on the information available to it, the Board determined there was no violation of the Medical Practice Act and has closed its file."

A Raleigh woman is suing two medical device companies and trying to sue a spine surgeon, who she says implanted a homemade device in her neck and upper back that he created in his garage.

“If he had come to me and said, ‘I’ve created this thing. I’m going to stick it in you,’ I would have said, ‘You’re going to do nothing of the sort,’” said Susan Williams.

Williams, who is a doctor herself and works as a rheumatologist, says she first went to Dr. Lloyd Hey at the Hey Clinic for Scoliosis and Spine Surgery, at 3404 Wake Forest Road in Raleigh, in Spring 2011 after a car wreck made her lifelong back problems even worse. She says she was drawn in by Hey’s personality and experience. But after her surgery, she began experiencing problems.

“I was sick as a dog,” Williams said, adding that she got an infection, had constant pain in her left arm and lost the use of her left hand. Her once-active life came to a halt.

Williams says she just wanted to feel right again, so she opted for a second surgery. Between the pain pills and the antibiotics, Williams says she doesn't remember much prior to that surgery, but she does remember waking up.

“And (Hey) said, ‘This is the first time we’ve ever done this,’ and I said, ‘What?’” Williams recalled.

An X-ray of Williams’ back after her second surgery showed the U-shaped device that was implanted in her body. Hey talked about the surgery on his blog, calling the device the "U-Rod," saying he bent the medical device using a vise he brought from home and a piece of pipe he bought at Lowe's Home Improvement.

Williams says she felt like a guinea pig. Notes from the post-operation, however, show Williams gave consent to the second surgery. She contends she was out of it in the days leading up to the surgery because of pain and medications and contends she was in no condition to provide consent.

Williams’ husband told WRAL Investigates in a statement that he was not told by Hey about the device being used in the surgery.

Hey has since performed the operation on other patients.

“I just want him to stop it,” Williams said. “I just can’t imagine that someone’s who’s taken the oath could do that.”

Williams says that’s why she has filed a lawsuit against several surgical supply companies and the sales representatives she claims helped Hey with his invention.

“A device representative is never, ever supposed to give advice to use something apart from what is in that FDA label,” she said.

In response to the lawsuit, Pioneer and RTI say they should be removed from the lawsuit because “Dr. Hey's deliberate modification of the chrome rods at his home suggests his knowledge that the rods were not … approved for his intended use."

In a statement to WRAL Investigates, a spokeswoman for Zimmer says the company takes pride in training medical professionals about the proper use of its equipment, but "these capable professionals then determine, acting in their best clinical judgment, appropriate applications for our products."

WRAL Investigates reached out to Hey, who said he has used the same u-rod design on other patients and that they had positive outcomes.

"After 20 years here, I think I've earned the trust of thousands of patients I've helped," he said. "I am sorry that Dr. Williams has had a difficult course. I don't experiment on my patients. I am confident I gave Dr. Williams good medical care."

Hey directed WRAL Investigates to his website, which he says lists other patients who had good outcomes with the procedure. Hey says his career was inspired by doctors who "went the extra mile" to help him recover from a badly broken leg as a child.

Hey's attorney, Ike Northup, says FDA regulation is murky on medical devices, but he contends surgeons manipulate implants on a regular basis to fit their patients' needs.

As for Williams, she says she went to another specialist in St. Louis after the device started causing her problems.

“So, he carries on and looks at my X-rays and says, ‘What in the daylights is that?’” Williams recalled.

The surgeon immediately removed two pieces of the u-rod from Williams' neck. There are more surgeries to follow in what has now been three years of medical nightmares.

“Now that I know the whole story, I’m just horrified. I mean, I’m just horrified,” she said.

A federal judge has not yet ruled on whether Hey will be added to the current lawsuit against the medical device companies. Those companies are fighting the move – another sign they're trying to distance themselves from Hey in the case.

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