Dr. Carol Roberts didn’t touch the syringe that infected as many as 11 patients with hepatitis C at her clinic near Tampa. A nurse started the epidemic.
But state health officials say that, as medical director, Roberts is ultimately responsible. They have filed two administrative complaints against her, according to the Department of Health website.
Both are connected to the 2009 outbreak of the serious and sometimes fatal infection, which causes liver damage.
Roberts, a prominent advocate for alternative medicine, hosted a radio show in the Tampa Bay area for years until the outbreak focused attention on her controversial views.
Now her clinic, Wellness Works, has filed for bankruptcy and will close July 28, according to Spring Valle, Roberts’s medical assistant. Roberts will move to Naples and work for another physician, Valle said.
Roberts could not be reached for comment Thursday. She has not returned calls from reporters in recent months.
The Florida Board of Medicine will decide on an appropriate penalty, if any. Roberts and DOH prosecutors could negotiate a settlement, or she could request a formal hearing before an administrative law judge. If that happens, it could delay resolution for a year or more.
Brandy Medeiros, a nurse who worked at the clinic, caused a number of patients to contract the virus by reusing syringes and medication vials, according to DOH reports. Medeiros was fired and initially suspended from practice, but earlier this year the state Board of Nursing allowed her to keep her license, on probation.
While Roberts is an M.D., her clinic in Brandon offered alternative treatments that are controversial among many of her peers, especially chelation therapy. A blood-cleansing treatment that is useful in treating heavy-metal poisoning, chelation has sometimes been touted for prevention or treatment of heart disease and other ailments.
Roberts told Health News Florida last year that she is a firm believer in the benefits of chelation to ward off problems from silent heavy metal toxicity.
“Personally, I think everybody should be chelated,” she said. “It has side effects -- positive side effects.”
Many mainstream physicians disagree.
"I'm not aware of any proven health benefit to chelation, except for specific conditions such as iron overload," said Dr. Anne Curtis, a professor at University of South Florida and the chief of cardiovascular disease for USF Heath.
Dr. Jeffrey Bernstein, medical director for the Florida Poison Information Center in Miami, pointed out that the ineffectiveness of chelation makes the outbreak even more tragic.
“That increases the risk-reward ratio," he said. "These people are going to have hepatitis for the rest of their lives, and they got it from a procedure that wasn't going to do them any good.”
In the 1980s, when Florida’s medical board tried to discipline physicians who used chelation treatments in ways they viewed as inappropriate, an appellate court intervened, saying medical professionals had a right to hold unpopular opinions.
The complaints against Roberts, signed by Surgeon General Frank Farmer, detail unsanitary and illegal practices. They also raise the hepatitis C case-count to 11; previous reports had put it at seven, eight or nine as the investigation progressed.
It’s assumed that an infected patient was the source of the virus that was transmitted to others.
One of the DOH complaints deals with a female patient identified only as M.F. On April 22, 2009, M.F. visited Wellness Works seeking hormone therapy. A doctor instructed Medeiros -- identified in the complaints as Nurse B.M. – to give intravenous vitamins to M.F. to boost her energy.
Medeiros “used a syringe and needle combination to draw fluid from each vial. Nurse B.M. did not cleanse the tops of the vials with a sterile alcohol wipe," the complaint says. It also says she used single-use vials “multiple times to administer multiple doses to multiple patients.”
Single-use vials are clearly marked. Because they are intended for one-time use, they do not contain additives that inhibit growth of bacteria and viruses.
A month later, M.F. returned to Wellness Works complaining of pain and vomiting. A month after that, she went to the Mayo Clinic and was diagnosed with hepatitis C.
The complaint in the case also says the patient treatment room did not have a sink, which is a violation of Florida statutes.
The complaint charges Roberts, as the medical director of Wellness Works, with medical malpractice because she “failed to meet the prevailing standard of care by failing to institute, monitor, and use acceptable infection prevention practices.”
The second complaint involves a patient identified as W.G., whom Medeiros administered chelation treatments to from April to June 2008. He later reported symptoms similar to those reported by M.F and was diagnosed with hepatitis C.
W.G., who returned to Wellness Works to receive injections of glutathione to treat the hepatitis, noticed then that the nurse did not discard the contaminated syringe. The patient alerted the Hillsborough County Health Department, which had already heard from Roberts that several of her patients had contracted hepatitis.
During the investigation, several other patients reported that they observed Medeiros re-using needles and syringes, and reported that blood from IV injections had spilled onto towels, work stations and patients’ clothing.
The complaint also says medications were improperly stored at Wellness Works.
-- Marty Clear is an independent journalist in Tampa. Questions or comments should be sent to Editor Carol Gentry.
