“They said her spinal fluid, which should be clear, was almost pure pus,” her daughter said.
What happened next is unclear. Either with a tip from a Greenville physician or by the observation of an infectious diseases physician at Duke, the cases of Scyster, now dead, and Conrad, still alive, were put together. Engel, the state epidemiologist, was notified and started to investigate.
On Sept. 27, the South Carolina Board of Pharmacy ordered Urgent Care to close. The pharmacy recalled the methylprednisolone, but it refused to recall other products, which had been shipped to 11 states. On Nov. 15, the FDA issued a nationwide alert against using them.
In early December, the Centers for Disease Control and Prevention described in its newsletter, Morbidity and Mortality Weekly Report, four cases of meningitis and one case of joint infection in North Carolina caused by Exophiala fungus.
Meanwhile, Vivian Conrad spiralled downward.
“It was like her brain was pickled with this infection,” Prestwood said. “She tried to say something, and the words came out jumbled. She knew it was not coming out as she intended. It was very frustrating for her.”
Confined to her bed with only enough balance to get to a bedside commode, she died on Nov. 10, 2003 — 17 months after the injection that infected her.
Legality of compounding
The legal wrangling that followed the 2002 outbreak made clear that making compounded drugs by the hundreds of doses — as Urgent Care did with methylprednisolone — was okay in South Carolina, even though a simple reading of the law might lead one to think otherwise.
South Carolina law allows compounding “in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.” The key idea is that compounders must have a “historical basis” for what they make. They can’t just produce thousands of doses of something and hope someone buys it the way drug companies do.
“Compounding . . . in anticipation of receiving prescriptions without a historical basis . . .is considered manufacturing,” the state law said.
Citing that language, the insurance company that sold a policy to R. Ken Mason Jr., Urgent Care’s supervising pharmacist, argued it shouldn’t have to cover his damages because he was acting as a drug manufacturer, not a compounder. But a federal district court didn’t agree with that argument and neither did the U.S. Court of Appeals for the 4th Circuit.
In the appeals court opinion, J. Harvie Wilkinson III wrote that patient-specific prescriptions weren’t necessary “when a pharmacy produces drugs on the basis of historical data, for physicians’ office administration,” and that historical data don’t have to “be derived from the practitioner who ultimately receives the batch in question.”