Contaminated Medication Believed to Be Cause of National Fungal Meningitis Outbreak, Including Over Twenty Florida Cases
Federal and state officials believe that a contaminated medication from a Massachusetts pharmacy is responsible for an outbreak of fungal meningitis that has killed at least twenty-four people and sickened more than three hundred. The pharmacy has ceased operations and issued a recall of the medication, and lawsuits against it have already begun. In some cases, victims are suing their health care providers along with the pharmacy in an interesting blend of products liability and medical malpractice theories.
The Centers for Disease Control and Prevention (CDC) has reportedly identified an infectious fungal species, Exserohilum rostratum, in multiple victims. This species can infect the spinal cord, causing fungal meningitis. Unlike the bacterial or viral varieties of meningitis, the fungal kind is not contagious between people. It spreads by direct contact with an infected surface or substance, such as soil, or through direct introduction to the bloodstream, such as through an injection. Symptoms often begin with a sore, stiff neck, and patients can develop headaches, nausea and vomiting, fever, confusion, and photophobia. In some cases, an infection can result in long-term injury or death.
As of October 24, 2012, the CDC and the U.S. Food and Drug Administration (FDA) had received reports of 328 cases of fungal meningitis, including twenty-four fatalities, in eighteen states. Florida has twenty-two reported cases, with three deaths. Vials of the injectable drug methylprednisolone acetate appear to be the source of the infection. The drug is a steroid-based anti-inflammatory prescribed for the treatment of back pain. The vials originated from the New England Compounding Center (NECC) in Framingham, Massachusetts, according to health officials.
NECC announced a recall of three lots of the drug on September 26, and it has reportedly ceased compounding or distributing any medications at its Framingham facility. The FDA issued its own advisory on October 4, asking healthcare providers to follow up with any patients that might have received injections of NECC products on or after May 21, 2012. The Florida Surgeon General further advised patients who may have received a steroid injection from facilities known to have received NECC products to schedule follow-up appointments with those facilities six weeks after the date of the injection, and to remain alert for the warning signs and symptoms of fungal meningitis. The disease usually shows symptoms within six weeks of the initial infection.
The New York Times reported that NECC has had multiple complaints from state health officials since at least 1999. It reportedly received citations for improper documentation of medications regarding patient identity, expiration dates, and more. NECC and its chief pharmacist reached an agreement with Massachusetts health officials in 2006 for one year of probation following numerous complaints beginning in 2004. The state apparently never followed through on the probation, and a state inspector said the company had improved later in 2006.
Lawsuits against NECC have reportedly already started. As a licensed pharmacy, the company has a professional duty to protect patients’ safety. It could face liability for professional negligence, much like medical malpractice, if it breached that duty in a way that caused harm to patients. Similarly, some victims are reportedly suing the doctors or healthcare facilities that ordered the contaminated injections. The pharmacy may also face liability under a products liability theory, based on the allegation that the medication had a manufacturing defect that made it dangerous, and that NECC should be strictly liable for the damage the contaminated medication caused.
The products liability attorneys at Cohn & Smith help recover compensation for people in South Florida who have suffered injuries due to dangerous or defective consumer products. Contact us today online, at (954) 431-8100, or at (305) 624-9186 to schedule a free and confidential consultation with one of our lawyers.
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