Recent news reports highlight how companies that compound drugs, or medicines, may be operating outside necessary oversight by both State and Federal authorities.
On Friday, October 4, 2012, news reports emerged of the New England Compounding Center (NECC) being linked to tainted batches of steroids used for the treatment of back pain and an outbreak of a rare form of fungal meninigitis.
Citing sources, the New York Times reported that health officials estimate that 14,000 patients across the county might have been exposed.
As of October 15, 2012, 15 deaths had been reported. It is believed that up to 23 states and 76 medical facilities may have received tainted drugs. Compounding pharmacies serve a specific role in mixing, or creating rare medications or those made to certain specifications.
In “Ex-Workers at Firm Tied to Pharmacy Had Safety Fears” New York Times reporters S. Tavernise and A. Pollack, describe a corporate culture at NECC that clearly put profits over safety. Specifically, one former employee is identified as remembering the facility put a priority on speed, not quality control.
Allegedly, a popular mantra at the facility was “This line is worth more than all of your lives combined, so don’t stop it.”
Another employee is cited as implicating the company in the highly questionable practice of selling large quantities of medicines to buyers without patients names.
As the public asks how this could happen, The Washington Post, reported that both Federal and State authorities claimed they lacked clear authority to take action earlier despite safety signals pre-dating the recent outbreak. In “Officials say they Lacked Authority Over Pharmacy Involved in Meningitis Outbreak” , Washington Post reporters, L. Sun, S. Kliff and D. Brown, explain that in response to questions over more aggressive action against NECC, officials are claiming they lacked clear authority to act.
Former FDA Commissioner David A. Kessler, is quoted as agreeing that existing legislation is a “murky area” despite existing since 1997. In contrast, other sources are cited as claiming needed authority exists but was not exercised.
The rare fungal strain appears to have contaminated batches of steroid injections used to treat back pain or arthritis. Recepients of mehtlyprednisolone acetate from NECC through their providers are considered at risk. This is an emerging story with alarming results for thousands of patients.
The CDC has identified a number of locations across the United States, depicted in the map above, where facilities reportedly received lots of the recalled Methylpredisolone Acetate from The New England Compounding Center (NECC). A complete list is available here.
Our office is actively investigating cases involving fungal meningitis from use of NECC formulated steroids,mehtlyprednisolone acetate from NECC, and accepting referrals of patients in need of legal representation.