Unsafe Practices Lead to Increase in Patients at Risk
News reports indicate that the number of people injured by tainted injections as a result of the New England Compounding Center’s (NECC’s) presumed failure to follow safe compounding practices continues to rise.
All NECC Products Presumed Unsafe
All NECC Products Presumed Unsafe
Now, the FDA is warning physicians to contact patients who have been given any injection made by the New England Compounding Center. Unfortunately, the FDA can’t say how many people will be affected or who exactly may have been exposed.
Symptoms May Not Develop For Months
The problem is, for those exposed to shots contaminated by fungal meningitis, symptoms can take over six weeks to develop. To put this in context, the first meningitis case was reported in Tennessee in late September. Right after that, on Sept. 26, the Massachusetts Board of Pharmacy began an investigation of NECC. The FDA joined in as well. On October 3, NECC surrendered its pharmacy registration. That was also the last day the NECC produced any shots. Unfortunately it appears that patients will continue to get sick from these tainted injections through the holidays.
Total Number of Tainted Shot Exposures Unknown
The total number of cases of exposure to fungal meningitis from NECC’s steroid shots can be estimated. However, the public is now being advised to avoid all other compounded products made by NECC. The total number of units produced by NECC that may have been tainted has not been disclosed. What we do know is that NECC is licensed to sell its products in all 50 states. This is a national concern.
Failed Enforcement of Compounding Practices
The problem may be that while the NECC “states” that it’s produced its compounds according to the strict compounding practices of the U.S. Pharmacopeia, the enforcement of these standards has been ill defined. Without the deterrent effect of strict enforcement, compliance may be viewed by corporations like the NECC as optional.
While “regulation” continues to be a hot button political issue, this tragedy highlights what a failure of regulation looks like. The only recourse for victims of this health crisis is the civil justice system. Lawyers at the DiCello Law Firm have been recognized as leaders in the representation of victims of unsafe drugs and medical devices. Click here to learn about how the DiCello Law Firm is helping victims of the tainted epidural steroid shots
By: Mark DiCello