Owner of Drugmaker Linked to Meningitis Outbreak Convicted of Racketeering But Acquitted of Murder

On March 22, 2017, a federal jury in Boston, Massachusetts found Barry J. Cadden — co-owner and head pharmacist of the nowbankrupt New England Compounding Center (NECC) located in Framingham, Massachusetts — guilty on more than 50 counts of racketeering and mail fraud charges.[1] The charges were brought in connection with the deadly nationwide fungal meningitis outbreak in 2012 that had been linked to tainted steroid drugs made by Cadden’s company.

However, to the dismay of some survivors of the outbreak, the jury acquitted Cadden on the more serious second-degree murder charges, sparing him a potential life sentence.[2]

According to the Centers for Disease Control and Prevention (CDC), from 2012 to 2014, 753 patients in 20 states had been sickened after receiving injections of the anti-inflammatory steroid methylprednisolone that had been prepared by NECC.[3],[4] Sixty-four of these patients died.

The fungal meningitis nightmare unfolds

On Sept. 18, 2012, doctors at Vanderbilt University in Nashville alerted the Tennessee Department of Public Health that they had diagnosed a rare case of life-threatening fungal meningitis in an otherwise healthy patient.[5],[6],[7] The doctors quickly suspected that the source of the infection was an injection of steroid medication that had been administered for back pain. Thus began one of the most serious infectious disease outbreaks due to contamination of a drug in U.S. history.

In addition to fungal meningitis, treatment with the contaminated steroid caused other serious infections, including spine and joint infections.[8] Nearly all of the infections were caused by a type of black mold commonly found in soil and on plants.[9]

Within a month of the discovery of the initial case, the fungal meningitis outbreak exploded to involve 137 cases in 10 states, including 12 deaths.[10] The growing outbreak garnered widespread attention in major news media outlets across the country. By late September 2012, CDC scientists had linked the source of the outbreak to contaminated vials of the steroid produced by NECC.[11] 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. More than 13,400 people may have been injected with the contaminated NECC steroid drug.[12]

The indictments

In December 2014, a federal grand jury in Boston indicted Cadden and 13 other NECC executives and employees on 131 criminal charges in connection with the fungal meningitis outbreak.[13] The federal indictments followed a two-year criminal investigation into the conduct of NECC staff related to the production and distribution of contaminated vials of methylprednisolone.

The indictment revealed 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. The charges against NECC staff included that they:[14]

• failed to properly sterilize drugs and to verify the effectiveness of NECC’s sterilization process;
• shipped drugs labeled as sterile throughout the country prior to receiving results of tests confirming that the drugs were indeed sterile and, in some instances in which tests showed a lack of sterility, failed to notify customers, institute a recall or investigate the source of the contamination;
• failed to appropriately investigate and address evidence of bacterial and fungal contamination detected in clean rooms used to prepare sterile drugs; and
• committed fraud by selling steroids that were labeled as sterile but were not actually sterile.

Verdicts not unanimous

In a bizarre twist to Cadden’s recent nine-week trial, Boston’s NPR radio station, WBUR, on May 15, 2017, reported that the jurors’ not-guilty verdicts on most of the murder charges apparently had not been unanimous, as is required in federal criminal court cases.[15] The presiding judge, U.S. District Judge Richard Stearns, had instructed the jury that all 12 members must agree that Cadden was either guilty or not guilty before reaching a verdict on each charge.

But the jury’s verdict form recorded the actual number of jurors who voted guilty or not guilty on each charge for which the final verdict was not guilty. Strikingly, a majority of the jurors appear to have voted guilty on 21 of the 25 murder counts, with either eight or nine jurors voting guilty on 18 of those counts.[16] A unanimous not-guilty vote was recorded for only two of the murder charges.

Judge Stearns was the only person — other than the jurors — to see the verdict form before the verdicts were presented in court. Remarkably, he did not seek clarification from the jurors regarding their apparent failure to reach unanimous agreement on most of the second-degree murder charges, as well as some of the other less serious charges.[17] Had he done so, he might have directed the jury to resume deliberations, which may have resulted in unanimous guilty verdicts on some of the murder counts or a mistrial if unanimous agreement was not reached. Because the judge accepted the verdicts, Cadden cannot be retried on the murder charges. Legal experts contacted by WBUR — including lawyers, former prosecutors and a retired federal judge — characterized the circumstances regarding the Cadden verdicts as “unprecedented.”[18]

Trial aftermath

Following the conviction of Cadden after the nine-week trial, the acting U.S. attorney for Massachusetts, William D. Weinreb, said, “This trial revealed that, among other things, Mr. Cadden participated in a massive fraud in which NECC masqueraded as a pharmacy when it was in fact manufacturing drugs. As a result of that, he managed to escape FDA oversight of his actions, and 65 people died. Hundreds of others were injured.”[19]

On June 26, Cadden was sentenced to nine years in prison.[20] Prosecutors had asked for a 35-year sentence. Federal prosecutors also filed a motion in the U.S. District Court in Boston asking Stearns to order Cadden to forfeit $133 million, which represents the estimated profits of NECC’s illegal activities.[21] If the motion is granted, the government would be able to seize Cadden’s multimillion-dollar home, sailboat and other assets.

Public Citizen’s Health Research Group applauds the aggressive action taken by the Justice Department in charging and prosecuting Cadden and other NECC staff. These actions finally hold accountable the individuals who played the primary role in causing this public health catastrophe.

References

[1] Bidgood J. Compounding pharmacy owner not guilty of murder after 60 meningitis deaths. March 22, 2017. The New York Times. https://www.nytimes.com/2017/03/22/us/meningitis-new-england-compounding-center-barry-cadden.html. Accessed June 19, 2017.

[2] Ibid.

[3] Centers for Disease Control and Prevention. Multistate outbreak of fungal meningitis and other infections –resources for clinicians. Updated October 30, 2015. https://www.cdc.gov/hai/outbreaks/clinicians/index.html. Accessed June 19, 2017.

[4] Centers for Disease Control and Prevention. Multistate outbreak of fungal meningitis and other Infections – case count. Last updated October 29, 2013. http://www.cdc.gov/hai/outbreaks/meningitis-map-large.html#casecount_table. Accessed June 17, 2017.

[5] Kainer M, Wiese AD, Benedict K, et al. Multistate outbreak of fungal infection associated with injection of methylprednisolone acetate solution from a single compounding pharmacy — United States, 2012. Morb Mortal Wkly Rep. 2012; 61(41):839-842.

[6] Pettit AC, Kropski JA, Castilho JL, et al. The index case for the fungal meningitis outbreak in the United States. N Engl J Med. 2012;367(22):2119-2125.

[7] Kauffman CA, Pappas PG, Patterson TF. Fungal infections associated with contaminated methylprednisolone injections. Engl J Med. 2013;368(26):2495-2500.

[8] Centers for Disease Control and Prevention. Multistate outbreak of fungal meningitis and other infections – case count. Updated October 30, 2015. http://www.cdc.gov/hai/outbreaks/meningitis-map-large.html#casecount_table. Accessed June 19, 2017.

[9] Centers for Disease Control and Prevention. Multistate outbreak of fungal meningitis and other infections –resources for laboratories. Updated October 30, 2015. https://www.cdc.gov/hai/outbreaks/laboratory/index.html. Accessed June 19, 2017.

[10] Kainer M, Wiese AD, Benedict K, et al. Multistate outbreak of fungal infection associated with injection of methylprednisolone acetate solution from a single compounding pharmacy — United States, 2012. Morb Mortal Wkly Rep. 2012; 61(41):839-842.

[11] Ibid.

[12] Kauffman CA, Pappas PG, Patterson TF. Fungal infections associated with contaminated methylprednisolone injections. Engl J Med. 2013;368(26):2495-2500.

[13] 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 June 17, 2017.

[14] 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 June 17, 2017.

[15] Boeri D. Judge told jurors in meningitis outbreak case to be unanimous — but verdict form shows division. May 15, 2015. WBUR. http://www.wbur.org/news/2017/05/15/necc-cadden-jury-verdict-form. Accessed June 17, 2017.

[16] U.S. District Court, District of Massachusetts. Case 1:14-cr-10363-RGS, Document 990. Jury verdict form. Filed March 22, 2017. https://d279m997dpfwgl.cloudfront.net/wp/2017/05/Cadden-Verdict-Form.pdf. Accessed June 17, 2017.

[17] Boeri D. Judge told jurors in meningitis outbreak case to be unanimous — but verdict form shows division. May 15, 2015. WBUR. http://www.wbur.org/news/2017/05/15/necc-cadden-jury-verdict-form. Accessed June 17, 2017.

[18] Ibid.

[19] Bidgood J. Compounding pharmacy owner not guilty of murder after 60 meningitis deaths. March 22, 2017. The New York Times. https://www.nytimes.com/2017/03/22/us/meningitis-new-england-compounding-center-barry-cadden.html. Accessed June 17, 2017.

[20] Arsenault M, Ellement JR. Pharmacist in meningitis outbreak that killed dozens gets 9 years in prison. June 26, 2017. The Boston Globe. https://www.bostonglobe.com/metro/2017/06/26/feds-cadden-should-pay-for-fungal-meningitis-outbreak/kwet31ZTnsT4lpq4WRzkXO/story.html. Accessed July 6, 2017.

[21] Roche W. NECC: Prosecutors seek $132.8 million from Cadden. June 13, 2017. Milford Daily News. http://www.milforddailynews.com/news/20170613/necc-prosecutors-seek-1328-million-from-cadden. Accessed June 17, 2017.