Contaminated Medicine Believed to Be Source of Nationwide Fungal Meningitis Outbreak
Health officials believe that an outbreak of fungal meningitis originated with contaminated medications from a Massachusetts pharmacy. The outbreak has sickened more than three hundred people in at least eighteen U.S. states, with twenty-four reported deaths. About five percent of the reported cases are in Maryland. The pharmacy that produced the drugs believed to be the source of the infection, according to authorities, has a history of regulatory compliance issues. Lawsuits against the pharmacy have already begun, but some plaintiffs are reportedly also suing their doctors, combining legal theories of products liability and medical negligence.
According to the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), the outbreak originated from contaminated vials of methylprednisolone acetate, a steroid-based medication used in treatment of back pain. As of October 24, 2012, the CDC had received reports of 328 cases in eighteen states. The worst-hit states at the time were Michigan, with eighty cases; and Tennessee, with seventy. Maryland had seventeen reported cases, while Virginia had forty-three and Washington DC apparently had none.
“Meningitis” refers to several types of infections of the spinal cord. Fungal meningitis is rarer than the viral or bacterial varieties, and unlike those types, fungal meningitis is not contagious person-to-person. It is generally transmitted by the introduction of one of several types of fungi to the bloodstream, where it then spreads to the spinal cord. The CDC identified Exserohilum rostratum as the likely culprit in this outbreak. Symptoms include neck stiffness, which is common to most forms of meningitis, headaches, fever, light sensitivity, and nausea. In some cases, it can cause altered mental states. It can be fatal for some patients, particularly those with weakened immune systems.
Health officials identified a pharmacy in Massachusetts, New England Compounding Center (NECC), as the likely source of the contamination in September 2012. The pharmacy recalled three lots of methylprednisolone acetate on September 26. It has since shut down all operations, and healthcare facilities have been advised to inspect any medications obtained from there.
A compounding center differs from a retail pharmacy in that they often formulate custom drugs for specific patients according to doctor instructions. They also provide medications that are subject to shortages and therefore not available to retail pharmacies. The FDA has stated that at least eighty-nine Maryland healthcare facilities obtained drugs from NECC. The risk of a medication error is different in a compounding center, where errors or contamination can occur during the compounding process. NECC has a history of complaints from state and federal health officials, according to news reports
Several people allegedly sickened by methylprednisolone acetate compounded at NECC have filed suit against the company. Some of them have reportedly also sued the doctor or facility that prescribed or administered the drug. This creates an unusual combination of legal theories. A claim against NECC would likely rely on a strict products liability theory, as NECC was the manufacturer of the compounded drug. NECC would therefore be liable for damages caused by a defective product. A claim against a doctor would require evidence of failure to investigate the safety of the medications diligently. Given the alleged history of regulatory problems at the pharmacy, it may be a reasonable claim.
The Maryland attorneys at Lebowitz & Mzhen can assist victims of medication errors, who have been injured by drugs prescribed, dispensed, or administered incorrectly. Contact us today online or at (800) 654-1949 for a free and confidential consultation to discuss your case.
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Maryland Hospital Patients Possibly Affected by Radiology Technician Suspected in Hepatitis C Outbreak, Pharmacy Error Injury Lawyer Blog, August 30, 2012
Drug Manufacturer Recalls Vaccine Due to Expired Ingredients, Pharmacy Error Injury Lawyer Blog, April 6, 2012
Hospitals and Pharmacies Hit by Nationwide Drug Shortages, Pharmacy Error Injury Lawyer Blog, November 3, 2011
Photo credit: 'Microbiologist 01' by James Gathany, Content Providers(s): CDC/ Maryam I. Daneshvar, Ph.D. Transwiki approved by: w:en:User:Dmcdevit [Public domain], via Wikimedia Commons.