Treatment with contaminated medicine

Presentation‍

A 40-year-old man with a family history of cervical spondylosis consulted a neurosurgeon about cervical pain and a tingling sensation radiating into the fingers of his right hand. An MRI revealed a small annular tear at C5-6 on the right side without evidence of herniation. The patient was referred to Pain Management (PM) Physician A who performed regularly scheduled epidural steroid injections (ESIs) at C5-6 over the next seven months.

After the last ESI, a second MRI showed a progression in the size of the patient’s C5-6 herniation, and the patient underwent a total disc arthroplasty.

Over the next few months, the patient’s condition improved, and he was advised to increase his activity as tolerated and return on an as-needed basis.

Physician action

On the morning of January 11, a compounding pharmacy sent an email to PM Physician A’s office advising to quarantine specific methylprednisolone acetate (MPA) vials as there was concern for a possible contamination. That afternoon, a subsequent notice was sent by fax marked "URGENT-Voluntary Product Recall" and listed the lot numbers of the affected MPA vials. The staff did not check their messages that day.

On the morning of January 12, the patient came to PM Physician A’s office for a scheduled lumbar facet injection. The contaminated MPA was used in this procedure. The patient tolerated the procedure and was discharged home.

Later that morning, after receiving another message about the urgent recall, PM Physician A and staff began segregating the affected MPA vials. They were under the impression that no one had received any of the contaminated medication. The physician notified all patients about the recall and told them to look for any potential adverse effects.

A week later, a staff member discovered that one of the recalled vials was used on January 12. On January 23, the patient called PM Physician A’s office to report symptoms consistent with meningitis. The patient was advised to go to the emergency department (ED).

In the ED, the patient reported headaches and neck pain. The emergency medicine physician noted the patient to be afebrile. She ordered bloodwork, a CT scan, and a lumbar puncture. The patient was then discharged home.

Over the next three days, the patient returned to the ED twice with similar symptoms. After his last visit on January 26, an epidural blood patch was performed, and the patient was discharged.

After five days of incubation, the blood cultures taken on January 26 were reported as negative. A second blood culture was positive for Bipolaris species, isolated from aerobic bottle. The patient's cerebrospinal fluid culture was reported as negative. The patient was admitted to the hospital where a spinal tap was performed and showed no growth.

The patient received IV antibiotics with the admitting diagnosis of acute cephalgia and acute meningitis. After discussions with the Centers for Disease Control and Prevention, the hospital’s infectious disease physician switched the patient's medication to voriconazole, which improved his symptoms.

After eleven days in the hospital, the patient was discharged with instructions to continue oral voriconazole twice a day for three months. The patient experienced renal dysfunction while hospitalized, but his renal function returned to normal before discharge.

Over the next three months, the patient continued to follow up with the infectious disease physician. The patient reported hallucinations, visual disturbances, sound sensitivity, nausea, short-term memory loss, anxiety, sleeplessness, and overall body discomfort. The symptoms eased when the voriconazole was discontinued after three months of use.

On July 7, the patient came to a rheumatologist reporting stiffness, joint and muscle pain, and swelling in his fingers. After a serological test, the patient was diagnosed with seronegative rheumatoid arthritis (RA) and was prescribed etanercept along with the previously prescribed methotrexate.

Allegations

A lawsuit was filed against PM Physician A alleging negligence in using contaminated medication. This resulted in fungal meningitis and subsequent side effects of its treatment.

Legal implications

The main challenge of this case was the breakdown in communication about the recall notice. This failure led to the tainted medication being used during the patient's procedure.

Consultants for the defense questioned whether the patient did indeed suffer fungal meningitis. Unfortunately, he still underwent anti-fungal therapy, which might have caused issues with his vision, anxiety, and sleep. There was little evidence, however, that the anti-fungal medication exacerbated the patient’s RA.

Staff members with PM Physician A stated that they were unaware of written protocols in their office related to reviewing email or phone messages received after hours or while away. The office manager also stated that the practice did not have policies and procedures about how to handle recalled medications.

However, a practice administrator consultant for the defense argued that the standard of care at the time did not require specific policies for handling each type of phone, email, or fax message. Instead, a broader guideline stating that all messages required a response was a more accepted practice. This consultant also stated that because drug recalls are so rare, so are protocols around how to handle these scenarios.

Disposition

The case was settled on behalf of the pain management specialist.

About communication errors

About failure to follow up

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