MASSACHUSETTS COMPOUNDING PHARMACY IS IN FEDERAL COURT ON CRIMINAL CHARGES OF RACKETEERING AND HOMICIDE IN FUNGAL MENINGITIS OUTBREAK
It is the next act in a drama which came to pubic attention in 2012.
In 2002, there was a deadly national outbreak of fungal meningitis. The outbreak was linked to steroid injections from a Massachusetts compounding pharmacy. Owners of the pharmacy, the New England Compounding Center (Hereinafter, “NECC”), were among those just arrested in connection with the disaster.
The United States. Centers for Disease Control and Prevention tied 751 cases across 20 states to the steroid injections. A total of 64 people died as a result.
Those who became infected came down with fungal meningitis -- which results in inflammation of the membranes covering the brain and spinal cord. That inflammation, according to health officials, resulted from the spinal injections with a contaminated, preservative-free steroid called methylprednisolone acetate.
The problems came to light when the first cases were reported in fall 2002. Framingham-based NECC voluntarily recalled three lots of the steroid that September. The next month, Massachusetts reported that it had "identified serious deficiencies and significant violations of pharmacy law and regulations that clearly placed the public's health at risk."
In 2013, NECC's owners agreed to create a $100 million fund for victims of the outbreak, about a year after filing for bankruptcy protection under Chapter 11. However, in January, 2013, the compounding pharmacy filed a letter with the Securities and Exchange Commission claiming its cleaning company should share responsibility for the outbreak. UniFirst Corp. acknowledged that it provided "once-a-month cleaning services," but added that the pharmacy's claims are "without merit," the filing says.
In the meantime, federal investigations had, of course, begun. Health officials consistently blamed those behind NECC and its sale and administration subsidiary, Medical Sales Management, for the problem.
This week, an indictment was filed in Boston’s United States District Court. This introduces the potential of incarceration for those charged. The 14 people arrested face an array of charges such as racketeering, conspiracy, mail fraud and the production and sale of both "adulterated" and misbranded drugs.
NECC President Barry Cadden and supervisory pharmacist Glenn Chinn face the second-degree murder charges, which the U.S. Justice Department noted "does not require the government to prove Cadden and Chin had specific intent to kill the 25 patients, but rather that (they) acted with extreme indifference to human life."
"These employees knew they were producing their medication in an unsafe manner and in insanitary conditions, and authorized it to be shipped out anyway -- with fatal results," Attorney General Eric Holder said. "American consumers have a right to know that their medications are safe to use."
The indictment claims that NECC did not comply with cleaning, sterilization and other safety regulations -- and that many who worked there, from its owners to pharmacists -- actively lied about it.
NECC President Barry Cadden, for one, "instructed the ... sales force to falsely represent to customers that NECC was providing the highest quality compounded medications," the indictment states. He and others also allegedly used or approved the use of expired or expiring ingredients and "failed and caused others to fail to properly sterilize drugs," it states.
One pharmacist allegedly told technicians "to prioritize production over cleaning and disinfecting," even telling staffers to "fraudulently complete cleaning logs at the end of the month."
The bottom line is that, according to the government, not enough testing was done to make sure the drugs were safe. When it was, it often indicated problems, according to the indictment. Yet "action-level sampling hits" in 37 out of 38 weeks didn't prompt NECC to re-evaluate, investigate or do something significant about its procedures and practices.
It allegedly simply went for profit over safety, thus, with criminal indifference to human life, creating the crisis.
Attorney Sam’s Take On How Business Decisions Can Land You In Prison
Many people think that crimes done in the course of business, with the exception of obvious white collar crimes such as embezzlement, fraud and the like, are addressed in the civil justice arena.
But, these days, it does not necessarily end there.
These days we see more and more commercial entities being prosecuted for conduct which the government says is “indifferent to human life.” Even if this were not the trend, the idea of a murder charge based on said indifference is nothing new.
The classic example in a simple homicide case, where the defendant is an individual, is firing a gun blindly into someone’s window. The bullet kills someone.
Did the defendant mean to kill or injure that person? Assume there is nothing to indicate that. However, the very firing of the gun into the window demonstrates indifference to human life.
And that is a homicide.
So, in theory at least, it is the same thing.
Of course, there are other charges as well. Again, those charges are not so different from what they would be if the defendant was an individual.
The bottom line, folks, is that it is possible for business decisions and/or mistakes to turn into a criminal case.
To review the stories upon which this blog is based, please go to
http://www.bostonherald.com/news_opinion/local_coverage/2014/12/pharmacy_officials_face_racketeering_charges and http://www.cnn.com/2014/12/17/us/meningitis-outbreak-arrests/