Poste by: Cami McEvers
May 16, 2013: BIRMINGHAM, Alabama -- A Jefferson County woman claims in a lawsuit that she became seriously ill after being injected last year at Brookwood Medical Center with a steroid for back pain that was made by a compounding pharmacy that recalled three batches of a similar drug linked to a deadly outbreak of meningitis.
The lawsuit, originally filed in Jefferson County Circuit Court in April but transferred last week to federal court, names New England Compounding Center and Brookwood Medical Center as defendants.
Efforts to reach an attorney for Brookwood and the compounding center have been unsuccessful.
On May 10, 2012 and again on July 30 Janice Stewart underwent a flouro-directed lumbar epidural block using triamcinolone acetonide at Brookwood Medical Center, according to her lawsuit. Stewart received a letter Oct. 22, 2012 that the hospital had purchased the injectable steroid from New England Compounding Center, the lawsuit states.
From Oct. 30 to Nov. 21 Stewart was in UAB Hospital and it was concluded that she was suffering from meningoencephalitis and she was treated with anti-fungal drugs for the condition, according to the lawsuit.
Meningitis only affects the meninges and meningoencephalitis affects both the meninges and the brain, according to a statement this morning from the Centers for Disease Control and Prevention in response to a question from AL.com . "These are really just descriptive terms and the signs and symptoms can be the same for both," according to the statement.
Stewart's attorney, Steve Heninger, provided a copy of the letter. In it Brookwood states that it does not use NECC's methylprednisolone acetate, the steroid linked to the outbreak. "We have removed all NECC products from our pharmacy shelves and they are no longer being used at our hospital," according to the letter.
"The safety of our patients is a top priority, and we are closely following the guidance set forth by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)," the Brookwood letter to Stewart states.
"At this time, no other NECC drugs have been associated with confirmed cases of fungal meningitis or have been determined to be contaminated. Out of an abundance of caution, the FDA has asked all providers to contact patients who may have received certain medications from this company," the letter states.
The letter states Stewart was receiving the letter because she was identified as a patient who may have received an NECC product at Brookwood after May 21, 2012 called triamcinolone acetonide - an injectable steroid used to treat joint inflammation and other conditions.
"NECC was one of several third-party compounders where Brookwood Medical Center acquired this medication," according to the letter.
The letter goes on to tell Stewart that while the product has not been directly linked to the outbreak, it is important that she is aware of the signs and symptoms of meningitis and other possible infections. The letter gives some of the symptoms of meningitis and other possible infections and urges her to contact her doctor if she suffers from the symptoms.
Brookwood set up a call center to answer patients' questions during normal business hours, according to the letter.
As a result of her illness, Stewart has suffered cognitive and physical impairment and "has been required to have assistance with her normal daily activities and she has been severely and permanently injured and impaired," the lawsuit states.
The lawsuit claims the defendants negligently caused or negligently allowed Stewart to receive contaminated steroid injections. "Defendants negligently failed to take proper steps and precautions to assure the injectable steroid compound was not contaminated with bacteria, fungus or other deleterious agents before providing them for injections or use with patients in general and ... (Stewart), in particular," the lawsuit states.
The lawsuit seeks unspecified compensatory and punitive damages.
Heninger said they know Stewart got questionable injections based on the letter from Brookwood and that she later went into UAB Hospital and was treated for meningoencephalitis. "So I'm connecting the dots," he said.
On Oct. 15 the FDA posted on its website a message to pharmacists and others that as a result of the ongoing NECC investigation a patient with possible meningitis potentially associated with epidural injection triamcinolone acetonide, had been reported to the FDA.
Dr. Mary G. McIntyre, Assistant State Health Officer for Disease Control and Prevention and Acting State Epidemiologist, stated in an email that there were no medications from the first three lots - of methylprednisolone acetate - recalled by NECC that were received by health facilities within the state of Alabama. "There were products received in Alabama from other lots that were recalled by the manufacturer and for which the facilities sent letters to patients out of an abundance of caution," she stated.
Initially only three lots of the drug were recalled, but later all drugs made from the NECC facility in Massachusetts were recalled, according to the CDC.
"Alabama Department of Public Health has no documentation and has received no reports on any patients receiving injections within the State of Alabama who fit the case definition for the fungal meningitis outbreak as defined by CDC," McIntyre stated.
Health officials, however, have reported cases of Alabamians who were infected by injections received from outside the state.
McIntyre pointed to CDC information about general complications associated with spinal injections "that can occur in the absence of contaminated products."
The lawsuit against NECC and Brookwood was transferred to federal court at the request of Brookwood and NECC. The hospital and NECC state in court documents that the lawsuit should be stayed to await its transfer again to a federal court in Massachusetts which has been assigned to oversee the more than 200 federal lawsuits that have been filed nationwide against NECC regarding the tainted drugs.