February 13, 2013
Forty-five Americans are dead and almost 700 have suffered serious infections, resulting, allegedly, from contaminated steroid injections made by a Massachusetts compounding pharmacy, New England Compounding Center (NECC). The injections were distributed to 75 medical facilities in 23 states, which in turn sold thousands of injections to patients.
(Full Disclosure: The author represents patients who received contaminated injections and suffered severe illness.)
Attempts by patients and their families, prosecutors, and regulators to hold responsible parties accountable have created a complex web of multi-faceted litigation occurring simultaneously in multiple jurisdictions.
Litigation Against NECC
The NECC facility, which adjoined a old mattress recycling plant, reportedly contained concerning indicators of a lack of sufficient cleanliness, particularly near supposedly sterile areas. The NECC drugs were reportedly contaminated with a variety of potentially deadly fungi.
In the decade before the outbreak, NECC was reportedly cited for problems with its sterility procedures and was subject of several complaints by state pharmacy boards. On at least three occasions, NECC products were alleged to have caused harm to patients, one leading to a wrongful death lawsuit that NECC settled in 2004.
NECC held itself out as a compounding pharmacy and, as a result, was not considered a traditional drug manufacturer that would have been closely regulated by the Food and Drug Administration (FDA). Compounding pharmacies are typically limited to producing compounded medications for an individual patient pursuant to a specific prescription. Instead of functioning like a traditional compounding pharmacy, NECC reportedly manufactured and shipped injectable steroids to clinics across the nation, sometimes in bulk, and, in many cases, allegedly without specific prescriptions.
Approximately three months after information about the deadly outbreak became public, NECC filed for bankruptcy protection. In light of allegations that NECC’s owners had removed millions of dollars of assets from the company, the bankruptcy court recently issued a temporary restraining order freezing the owners’ assets.
NECC’s attorney also confirmed that a federal grand jury has been investigating possible criminal conduct related to the deadly outbreak.
Clinics Face Questions
The contaminated injections were mostly administered to patients in outpatient clinics. In most instances, the contaminated steroids were injected directly into the patient’s spinal columns to relieve back pain.
The clinics that chose to buy steroids from NECC face significant questions.
In the 1990s, the FDA warned about the risks of compounding pharmacies and the potential for a deadly outbreak from contaminated compounded drugs. The FDA commissioner described compounding as potentially becoming a “shadow industry” of drug manufacturers. Medical industry guidelines encourage providers to do extensive due diligence when dealing with compounders.
The clinics in these cases chose not to buy the drugs from an established traditional drug manufacturer that would be closely monitored by the FDA. Instead, notwithstanding the potential risks known to the medical community of dealing with compounders, clinics chose to buy drugs from NECC, a compounder that had past safety problems and that was apparently exceeding the scope of its license. Significant questions include whether the clinics followed industry rules when deciding to buy injectable drugs from NECC.
The effort to hold responsible partiesaccountable is proceeding on multiple fronts. There are civil, criminal, and regulatory proceedings underway, including:
- Federal civil cases, recently centralized in the District of Massachusetts
- Bankruptcy proceedings in Massachusetts
- State civil cases, mostly against clinics that sold contaminated shots
- Federal grand jury investigation
- State regulatory proceedings
Although there are challenging hurdles in these cases, through coordination and cooperation among participants in various venues, the responsible parties behind this deadly outbreak can be held accountable.