For obvious and compelling reasons, national attention has focused acutely in recent weeks on the tragic meningitis outbreak across the country, which — as of the date this post entry was written — has taken the lives of 19 people and materially sickened about 250 others. Estimates are that as many as 14,000 patients in nearly half of all the states have been potentially exposed to fungal meningitis attributed to a contaminated steroid that was administered for back or neck pain through epidural injection.
New Jersey is among the states that have reported both fatal and non-fatal outcomes in patients who received injections.
In a recent opinion piece for CNN, Dr. Michael Carome, who is deputy director of the Public Citizen’s Health Research Group, offers up a view that renders the outbreak additionally heart rending and disturbing: Carome charges that it was “completely avoidable.”
The steroid medication was made by a compounding pharmacy in Massachusetts. Such entities occupy a special niche domestically, being historically tasked to fill individually tailored prescriptions ordered by doctors for patients with unique needs.
The Massachusetts pharmacy crossed that line several years ago through large-scale drug production of several products, including the injectable steroid.
Although the FDA now states that it lacked authority to monitor such activity (with state pharmacy boards having regulatory oversight over compounding pharmacies), Carome notes that this has never been true. In fact, the agency issued warning letter to the pharmacy nearly six years ago telling it to cease production of medications “marketed for general distribution.”
And then, tragically, it never followed up.
Carome rightfully notes that assigning accountability in this tragic personal injury fiasco will take time and involve many parties. Federal bureaucrats are obviously implicated. So, too, will doctors and hospitals who promoted use of a dangerous drug lacking FDA approval be targeted in medical malpractice and wrongful death litigation.
The list goes on. Lobbyists for compounding pharmacies have fought against regulatory oversight, and state regulators have obviously been lax in their duties.
We will keep readers fully apprised of all material developments that unfold in this nationally gripping story.
If you or a loved one has suffered a personal injury that owes to an act of medical malpractice or hospital negligence, please contact Breslin & Breslin for a free consultation.
Source: CNN, “Deadly meningitis outbreak was completely avoidable,” Michael Carome, Oct. 16, 2012
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