WRAL Investigates

Raleigh woman suing over implanted "homemade" device

Posted October 30, 2014
Updated November 3, 2015

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.


This story is closed for comments.

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  • godwinlisa Nov 4, 2014

    Continued..... will always fully trust him with our daughters care. We are so thankful, but we are so disappointed in WRAL. Your news coverage was a mirror of the magazines on the grocery store isle.

  • godwinlisa Nov 4, 2014

    I've always watched WRAL and believed they were one of the few stations left that reported truthful facts after MUCH investigating. I also believe we are all free to post our thoughts and comments. I have one. One that our family can truthfully report from experience. "The rest of the story" that the reporter failed to mention and/or twisted. I am NOT speaking for the women in this story, but for our beautiful 11 year old daughter who freely runs around actively playing WITH a U-Rod in her to correct the 108 degree curve she had from scoliosis with osteoporosis. And yes…..Dr Lloyd Hey is her extremely skilled surgeon God led us to. He has a God given gift of helping others. After spending endless hours researching our daughters case, he was the ONLY surgeon that was able to help her. Dr. Hey carefully explained every fine detail of the surgery Maggie would have months before the surgery ever took place. Her case was difficult. We knew that full well. We continue to see Dr. Hey and

  • Lucy L. Nov 3, 2014

    I feel so blessed to have found Dr. Hey seven years ago after suffering for years from painful scoliosis. My surgery was extremely successful with no complications. I have referred many satisfied patients to him in the years since. He is a brilliant surgeon as well as a caring individual.
    Good job WRAL. If your goal was to make Dr. Hey look like a quack, you succeeded.
    Nothing could be further from the truth.

  • scoliosispatient52 Nov 3, 2014

    I was extremely disappointed to see the incredibly misleading story about Dr. Hey, and would hate to think that someone who needed back surgery would choose not to see Dr. Hey after reading the story. Dr. Hey was the first orthopedist who was able to offer a solution to my debilitating pain. I had back pain for 16 years due to scoliosis and degenerative disc disease and had not found a doctor that had a solution other than pain medications. I am so very grateful to Dr. Hey for understanding what it would take to give me my life back. My lumbar spine is fused to my pelvis with rods and screws, and I am now six years post-surgery and am essentially pain-free. Dr. Hey is a compassionate and extremely skilled surgeon. I would recommend him to anyone suffering from un-resolved back pain.

  • sbsmith7 Oct 31, 2014

    WRAL shame on you!!! The headline of this article is very misleading. Did you even investigate the story other than what the plaintiff claimed in the court documents?

    Dr. Hey is one of the finest doctors I have ever met. He performed spinal surgery on my child not once, but twice! He always showed the utmost care for not just her but us as a family as well. I have recommended many people to him over the years and my daughter thinks the world of him. He was recommended to is by two other very satisfied patients.

    I'm sorry that Ms. Williams is still having problems with her back. Pain is a terrible adversary. As a rheumatologist she should know better than anyone that if she was incapacitated by medications then she should have had someone with her when her doctor was discussing the procedure. It makes her accusations very questionable.

    WRAL please reconsider before you try to smear someone's good name!!! YOUR headline seems intentionally misleading.

  • chefpexton Oct 31, 2014

    My daughter recently had scoliosis surgery by Dr. Hey. He's a brilliant surgeon who performed a flawless procedure. My daughter whos spine was curved and twisted is now straight as an arrow and recovered in record time. If ever I needed anything spine related, he would be the Dr. I would see.

  • Edward Anderson Oct 31, 2014
    user avatar

    "Between the pain pills and the antibiotics, Williams says she doesn't remember...."

    Since when do antibiotics impair your memory? I'm surprised she's not suing the manufacturer of those!

  • k9sandQtrs Oct 31, 2014

    meds are used "off label" all the time, so it makes sense that medical devices are, too. Still, it should be with full disclosure to the patient and the patient should fully understand what's being done. I really doubt the disclosure and understanding happens as often in human as it does in veterinary medicine.

  • ncprr1 Oct 31, 2014

    View quoted thread

    Kind of exactly what I was thinking. This report is a real hatchet job on this doctor. He must have done something to rub WRAL the wrong way, probably a conservative or something.

    They make it sound like he bought some threaded rod from Home Depot, bent it and installed it in the woman's back.

  • DAP Oct 31, 2014

    There are no 100% guarantees in life, especially in a situation that was already difficult. When you are dealing with damage from an automobile accident, treatment is what we all would like to search for to think we can be completely back to normal. Unfortunately the best of the best surgeons will tell you that you have have to weigh if the risks are worth taking for a chance to see if it will give you some improvement. Some people may get relief, some may stay the same and some may have worse symptoms. This is a chance you take after assessing your situation and if you are willing to take the risks. She is a physician and already knows this to be true. She took a chance on improvement and it didn't work for her. This treatment has worked for others. The assessments may change after they get inside and can see more than an MRI can show. The surgeon does their best job and how your body receives the treatment is out of his hands.