Indiana has been one of the hardest-hit states in a nationwide fungal meningitis outbreak that has caused more than three hundred illnesses and over twenty deaths in eighteen states. Health officials believe an injectable medication from a Massachusetts pharmacy is the source of the infection. The pharmacy has recalled the medicine and ceased its facility’s operations. It is already facing lawsuits from victims alleging injury from a defective product, and Indiana state officials are seeking to suspend its license. Some victims may also be pursuing causes of action for medical negligence against the doctors and healthcare facilities that prescribed or administered the allegedly contaminated drugs.
At least forty-three reported cases, out of a national total, so far, of 328, are in Indiana. Three of the Indiana patients have died. The total death toll, as of October 25, 2012, is twenty-four. Investigations by the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have determined that the fungal infection came from injections of methylprednisolone acetate, a steroid-based anti-inflammatory medication used to treat back pain. Authorities traced contaminated vials to the New England Compounding Center (NECC) in Framingham, Massachusetts. They suspect that the contamination occurred during the compounding process.
Victims are suffering from fungal meningitis, an infection affecting the spinal cord. Other types of meningitis may result from communicable viral or bacterial infections, but fungal meningitis is not contagious between people. It usually develops when an infectious fungus species gets into the bloodstream, such as through an injection, and spreads to the victim’s spine. The CDC believes it has identified the fungal species Exserohilum rostratum in at least fifty-two patients. The disease can be fatal, particularly in patients with compromised immune systems, and it can cause severe headaches, nausea, light sensitivity, and disorientation.
NECC voluntarily recalled three lots of methyprednisolone acetate on September 26, 2012. The FDA issued an advisory on October 4 to all medical professionals in the country to withhold and retain all NECC products in their inventories. It also advised them to follow up with patients who received an injection of an NECC product on or after May 21, 2012. NECC has reportedly ceased business operations at its Framingham facility while the investigation is ongoing. According to the New York Times, the company has a history of regulatory complaints. The Indiana Attorney General’s Office filed a claim with the state’s Board of Pharmacy the morning of Friday, October 26, requesting suspension of NECC’s pharmacy license.
Some victims of the outbreak have already filed lawsuits against NECC. As a “compounding center,” NECC faces somewhat different risks than a typical retail pharmacy. Compounding centers often deal with hard-to-find drugs, and they compound customized medications for individual patients. Claims against NECC may rely on a strict products liability theory, alleging that the contaminated drugs contained a manufacturing defect. As a state-licensed pharmacy, NECC also has a professional duty of care in the preparation of prescriptions, and a breach of this duty could lead to liability for medical negligence. Doctors and other medical professionals could face similar liability if plaintiffs can prove that they were negligent in prescribing or administering the contaminated drugs.
The personal injury attorneys at Parr Richey Frandsen Patterson Kruse represent the interests of Indiana accident victims and their families, helping them to obtain compensation for their damages. To schedule a free and confidential consultation with one of our lawyers, contact us today online or at (888) 532-7766.
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Indiana Department of Health Says 2010 Had Highest Number of Reported Medical Errors in Five Years of Collecting Data, Indiana Injury Lawyer Blog, August 13, 2012
Photo credit: ‘FDA microbiologist working in a biosafety laboratory tests for high risk pathogens in food’ by The U.S. Food and Drug Administration (FDA_Lab_Irvine_3405) [Public domain or Public domain], via Wikimedia Commons.