A Colorado teenager who ended up in a pain clinic after having her third molars removed at the University of Colorado Denver School of Dental Medicine is preparing to take legal action against the school and the oral surgeon who operated on her without an active license.
Anise Fletcher's notice of claim -- a requirement to preserve her right to file a lawsuit -- alleges she was left with "bone chips" in her gums and nerve damage, according to a story in the Denver Post.
The oral surgeon who did the procedure, Randal James, D.D.S., has applied to the state dental board to reactivate his license. The panel met February 17 to discuss the matter in a closed-door meeting but said they will take no action until at least its next meeting March 17, according to the Post.
Dr. James, a University of Colorado faculty member and longtime Colorado oral surgeon, has practiced in a university clinic for nearly six years with an inactive license, which was allowed under state law until last August. Even after the law was changed, Dr. James continued to work in the Sands House Clinic at the School of Dental Medicine.
And for several years, Dr. James has not had a Drug Enforcement Administration (DEA) registration number, which is required to prescribe narcotics and obtain sedation drugs for certain oral surgeries.
Unlicensed dental students supervised by Dr. James had written prescriptions for narcotics using the federal drug credentials of other faculty members who were not always present. That is a potential violation of federal law, which requires that anyone dispensing controlled substances have a relationship with the patient.
Policy changed
Fletcher, 17, had her third molars removed at the university clinic by Dr. James and an unlicensed resident on August 26, 2009, according to the Post. Records show that during the surgery she was administered fentanyl and midazolam intravenously, and that she left the clinic with prescriptions for Vicodin and Dilaudid, both controlled substances and painkillers. The prescriptions were written with the DEA number of a dentist who was not present.
When Dr. James gave up his active state license, he lost the DEA number required to procure, administer, or dispense controlled substances. Because he does not have a state permit needed to administer IV sedation drugs, the DEA has said it is looking into the school's practices.
Denise Kassebaum, D.D.S., the dental school's dean, said she has changed the policy governing how drugs are dispensed at the university's clinic, a teaching environment for dentists in training. Residents no longer are allowed to use the DEA numbers of faculty without consulting them first, she said.
"There are questions about whether it was an appropriate practice or not," university spokeswoman Jacque Montgomery told DrBicuspid.com. But the "use of sedation drugs does not require a prescription, under our understanding of DEA policy," she noted.
She asserted the drugs were appropriately acquired using the DEA number of either Michael Savage, D.D.S., another faculty member, or the university's institutional DEA number.
DEA spokesman Mike Turner declined to comment on the Colorado case specifically, saying, "We don't want to investigate this case in the media, and some of these issues are very technical."
Federal drug regulations don't explicitly forbid doctors without active licenses from giving patients controlled substances (Code of Federal Regulations, Section 1306). But in general, Turner said, "if a controlled substance needs to be administered to a patient, it's typically done through a prescription or order which a doctor would give to document the need; basically, it says that controlled substances have to be accounted for."
School officials will be meeting with DEA officials to clarify if this practice is legal, Montgomery said.
Fletcher's notice of claim alleges the university "failed to supervise Dr. James properly" and was negligent for allowing him to practice dentistry without an active license and "allowing him to write prescriptions for controlled substances" according to the Post. She is seeking compensation for follow-up surgeries, pain therapy, and suffering.
Dr. James has had an inactive dental license since March 1, 2004. Normally, a dentist with an inactive license cannot practice in Colorado. However, an exception in the state law that existed prior to August 5, 2009, allowed him to work at the dental school, and he continued to work in the clinic and treat patients after the law changed.
Both Dr. James and dental school administrators said they were unaware the law had changed. School administrators were aware, however, that Dr. James did not have a DEA registration number or an active license since 2004.
Dr. James has declined to comment, Montgomery said.
The attorneys for Dr. James and Anise Fletcher could not be reached for comment.
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