Meningitis Outbreak: Could It Have Been Prevented?
November 15, 2012 Posted By Vanguard Attorneys
A fungal meningitis outbreak has killed 32 people and sickened 461 in 19 states, according to the U.S. Centers for Disease Control and Prevention’s latest report. In Florida alone, there have been 23 cases, including three deaths. A compounding pharmacy in Massachusetts, which distributed pain steroids that later tested positive for contamination, is at the center of an investigation into the deadly outbreak.
“Health officials say as many as 14,000 people received the steroid injections, mostly for back pain,” the Associated Press reports. The fungal infection causes inflammation of the meninges – protective membranes that cover the brain and spinal cord. Anti-fungal medication is used for treatment. But even patients who receive treatment are still at risk of death, brain damage, hearing loss, learning disabilities, speech complications, seizures, and paralysis, according to theMeningitis Foundation of America.
On Nov. 14, a hearing of the U.S. House Energy and Commerce Committee convened to examine the outbreak from the New England Compounding Center’s facility in Framingham, Massachusetts. According to the NECC website, the company has recalled all products shipped in 2012.
The AP article published Nov. 14 showed how the congressional committee charged with investigating the outbreak hammered regulators. “After a tragedy like this, the first question we all ask is: could this have been prevented?” asked Rep. Cliff Stearns, R-Florida’s 6th District, Republican chairman of the oversight and investigations panel. “After an examination of documents produced by the Massachusetts Board of Pharmacy and the U.S. Food and Drug Administration, the answer here appears to be yes.”
A Reuters Newswire article said that in response to these types of questions, Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, “insisted that the FDA lacks clear authority to regulate compounding pharmacies due to conflicting court rulings and other regulatory ambiguities.”
Barry Cadden, co-owner of the NECC, is already exercising his Fifth Amendment rights. In an AP article, he said: “Under advice of counsel, I respectfully decline to answer under basis of my constitutional rights and privileges, including the Fifth Amendment,” he said.