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On Dec. 16, 2014, a federal grand jury in Boston indicted 14 executives and employees of a Massachusetts compounding pharmacy — including the company’s co-owner and senior pharmacists — on 131 criminal charges in connection with a deadly nationwide fungal meningitis outbreak.[1],[2]
The indictment, which the U.S. attorney’s office in Boston announced on Dec. 17, charged Barry J. Cadden, co-owner and head pharmacist of the now-bankrupt New England Compounding Center (NECC), and NECC’s...
On Dec. 16, 2014, a federal grand jury in Boston indicted 14 executives and employees of a Massachusetts compounding pharmacy — including the company’s co-owner and senior pharmacists — on 131 criminal charges in connection with a deadly nationwide fungal meningitis outbreak.[1],[2]
The indictment, which the U.S. attorney’s office in Boston announced on Dec. 17, charged Barry J. Cadden, co-owner and head pharmacist of the now-bankrupt New England Compounding Center (NECC), and NECC’s supervisory pharmacist Glenn A. Chin with 25 counts of second-degree murder in seven states.[3]
Additional charges against the 14 defendants named in the indictment include racketeering; mail fraud; conspiracy; contempt; and violations of the Food, Drug, and Cosmetic Act, the federal law intended to ensure that drugs are safe and effective.[4]
The federal indictment follows a two-year criminal investigation into the conduct of NECC staff related to the production and distribution of contaminated vials of an anti-inflammatory steroid called methylprednisolone acetate. According to the Centers for Disease Control and Prevention (CDC), 751 patients in 20 states were sickened after receiving injections of the contaminated steroid, and 64 patients died.[5]
The fungal meningitis outbreak
As reported in the December 2012 issue of Worst Pills, Best Pills News, on Sept. 18, 2012, doctors at Vanderbilt University in Nashville, Tenn., diagnosed a rare case of life-threatening fungal meningitis in an otherwise healthy patient. The doctors quickly suspected that the source of the fungus was an injection of steroid medication administered for back pain.[6]
Within a month of the diagnosis of the initial case, the fungal meningitis outbreak exploded to involve 137 cases in 10 states, including 12 deaths. In addition to fungal meningitis, treatment with the contaminated steroid caused other serious infections, including spine and joint infections. Nearly all of the infections were caused by a type of black mold commonly found in soil and outdoor water sources.[7]
The growing outbreak garnered widespread attention in major news media outlets across the country. By late September 2012, epidemiologists from the CDC linked the source of the outbreak to contaminated vials of the steroid produced by NECC. The CDC discovered that a total of approximately 17,500 vials from three contaminated lots of this drug had been shipped by NECC to 75 medical facilities in 23 states. The NECC steroid injections were used to treat more than 13,400 patients with back or peripheral joint pain.[8]
Drug compounding versus manufacturing
Traditional drug compounding involves a local pharmacist combining, mixing or altering ingredients to create a unique, custom medication for an individual patient whose medical needs cannot be met by a standard, commercially available brand-name or generic drug manufactured by a drug company. The active ingredients for compounded drugs may come from drugs produced by pharmaceutical companies or raw ingredients purchased in bulk — frequently in the form of a powder — from various suppliers around the world. The preparation of such individually tailored drugs requires a prescription from a licensed health care provider.
Although the Food and Drug Administration (FDA) has always had the authority to regulate the compounding of drugs, for many years, the agency has used “enforcement discretion” to allow compounding pharmacies to produce drugs without complying with FDA regulations, generally deferring regulatory oversight to state pharmacy boards.
However, over the past two decades, many companies identifying themselves as compounding pharmacies have expanded their reach by engaging in large-scale production of drugs, moving from the narrow role traditionally filled by such pharmacies into a realm involving both drug manufacturing and the distribution of standard drugs. In many cases, the drugs are sold in multiple states.
Public Citizen has long contended that such activities represent illegal drug manufacturing under the guise of pharmacy compounding.
Indictment highlights
The federal indictment of the NECC executives and employees reveals a disturbing pattern of alleged criminal conduct that led to the production and widespread distribution of contaminated steroids that were purportedly sterile and safe for injection in patients. (See box, page 8, for a list of the most egregious charges.)
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Charges Against New England Compounding Center (NECC) Staff[9]
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The indictment emphasized NECC’s primary business as “high-risk compounding,” involving the use of nonsterile ingredients to produce sterile pharmaceuticals.[10] It alleged that Cadden instructed the company’s sales force to “falsely represent to [health care providers] that NECC was providing the highest quality compounded medications,” when in fact the company’s staff was not adhering to standard safety guidelines.[11]
The second-degree murder charges against Cadden and Chin were made under the Racketeer Influenced and Corrupt Organizations Act. Under this law and depending on particular state laws, prosecutors will not have to prove that the defendants intended to kill the 25 patients. They have to prove only that Cadden and Chin acted with extreme indifference to human life.[12]
For example, with respect to patients who died in Tennessee, the state with the second-highest number of fungal meningitis cases during the outbreak, the indictment stated that the defendants acted “with an awareness that their conduct was reasonably certain to cause death, and unlawfully killed” seven individuals.[13]
Commenting on the indictment, U.S. Attorney General Eric Holder stated:
[T]hese 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. … Actions like the ones alleged in this case display not only a reckless disregard for health and safety regulations, but also an extreme and appalling indifference to human life.[14]
Public Citizen’s Health Research Group applauds the aggressive action taken by the Justice Department in charging the NECC executives and employees. These federal criminal charges finally begin to hold accountable the individuals who played the primary role in causing this public health catastrophe, which resulted in so many deaths and serious injuries. It is imperative that the Justice Department, together with the FDA, investigate and prosecute other companies that place patients at great risk by producing potentially tainted drugs in unsanitary conditions and selling them to health care providers.
References
[1] Department of Justice. 14 indicted in connection with New England Compounding Center and nationwide fungal meningitis outbreak. December 17, 2014. http://www.justice.gov/opa/pr/14-indicted-connection-new-england-compounding-center-and-nationwide-fungal-meningitis. Accessed January 13, 2015.
[2] United States District Court, District of Massachusetts. Grand jury indictment in the case of United States of America v. Barry J. Cadden et al. Filed December 16, 2014. http://www.justice.gov/sites/default/files/opa/press-releases/attachments/2014/12/17/necc-indictment.pdf. Accessed January 13, 2015.
[3] Department of Justice. 14 indicted in connection with New England Compounding Center and nationwide fungal meningitis outbreak. December 17, 2014. http://www.justice.gov/opa/pr/14-indicted-connection-new-england-compounding-center-and-nationwide-fungal-meningitis. Accessed January 13, 2015.
[4] Ibid.
[5] Centers for Disease Control and Prevention. Multistate outbreak of fungal meningitis and other Infections – case count. Last updated October 23, 2013. http://www.cdc.gov/hai/outbreaks/meningitis-map-large.html#casecount_table. Accessed January 14, 2015.
[6] Fungal meningitis outbreak highlights the dangers of compounding pharmacies. December 2013. Worst Pills, Best Pills News. /newsletters/view/824, Accessed January 14, 2015.
[7] An ongoing public health catastrophe: Public Citizen continues work on fungal meningitis outbreak. Health Letter. September 2013. http://www.citizen.org/Page.aspx?pid=6080. Accessed January 14, 2015.
[8] An ongoing public health catastrophe: Public Citizen continues work on fungal meningitis outbreak. September 2013. Health Letter. http://www.citizen.org/Page.aspx?pid=6080. Accessed January 14, 2015.
[9] United States District Court, District of Massachusetts. Grand jury indictment in the case of United States of America v. Barry J. Cadden et al. Filed December 16, 2014. http://www.justice.gov/sites/default/files/opa/press-releases/attachments/2014/12/17/necc-indictment.pdf. Accessed January 13, 2015.
[10] United States District Court, District of Massachusetts. Grand jury indictment in the case of United States of America v. Barry J. Cadden et al. Filed December 16, 2014. http://www.justice.gov/sites/default/files/opa/press-releases/attachments/2014/12/17/necc-indictment.pdf. Accessed January 13, 2015.
[11] Ibid.
[12] Department of Justice. 14 indicted in connection with New England Compounding Center and nationwide fungal meningitis outbreak. December 17, 2014. http://www.justice.gov/opa/pr/14-indicted-connection-new-england-compounding-center-and-nationwide-fungal-meningitis. Accessed January 13, 2015.
[13] United States District Court, District of Massachusetts. Grand jury indictment in the case of United States of America v. Barry J. Cadden et al. Filed December 16, 2014. http://www.justice.gov/sites/default/files/opa/press-releases/attachments/2014/12/17/necc-indictment.pdf. Accessed January 13, 2015.
[14] Department of Justice. 14 indicted in connection with New England Compounding Center and nationwide fungal meningitis outbreak. December 17, 2014. http://www.justice.gov/opa/pr/14-indicted-connection-new-england-compounding-center-and-nationwide-fungal-meningitis. Accessed January 13, 2015.
