We informed readers in a prior blog post (please see our October 23 entry) that we would keep them fully apprised of material developments unfolding regarding the nation’s tragic meningitis outbreak that first surfaced last month.
As of the date that post was written, 19 fatalities across the country — including in New Jersey — had been reported. Various media accounts also cited the approximately 250 other persons from multiple states suffering serious infections following their receipt of injections from contaminated vials containing steroids for back and neck pain.
Sadly, those infection-related numbers have risen dramatically since then. Thirty-one personal injury fatalities have now been blamed on the tainted injectable, with health authorities stating that another 424 persons remain infected from an overall population of 14,000 people who received the epidural shots.
The sole source of the contamination — the Massachusetts-based New England Compounding Center (NECC) — has been a central actor from the very beginning of the outbreak. Its doors are now closed; its internal records are being closely scrutinized by federal and state regulators; and its principals have lost their licenses and are already named defendants in a rapidly rising number of medical malpractice, product liability and wrongful death lawsuits. Additionally, injured plaintiffs are attributing negligence to customers of NECC — medical facilities and doctors — in other cases.
And now the fallout is extending to those who were tasked with regulating compounding pharmacies, bodies that have historically been intended as relatively small producers of specialty medications ordered by doctors for patients with unique needs.
NECC unquestionably overstepped that expectation through mass production of drug offerings sold across the country. The Massachusetts director of the Board of Registration in Pharmacy (the entity that regulates all pharmacies in that state) was fired last week for ignoring a complaint from Colorado health officials that NECC was acting as a mass drug manufacturer rather than a small-dose specialty dispenser.
In the wake of the tragedy, a number of critics are demanding that the FDA step up to assume broader regulatory powers over compounding pharmacies.
If you or a loved one has suffered a personal injury that owes to an act of medical malpractice, medical negligence or a product liability matter, please contact Breslin & Breslin for a free consultation.
Source: MedPage Today, “Meningitis: Head of pharmacy board fired,” Michael Smith, Nov. 8, 2012