According to a December press release from the Department of Justice (“DOJ”), two compounding pharmacists in Massachusetts were charged with 25 counts of second-degree murder and 14 others were indicted in connection with a 2012 fungal meningitis outbreak resulting from contaminated pharmaceuticals that were manufactured at the New England Compounding Center (“NECC”).
[1] The outbreak was caused by contaminated vials of preservative-free methylprednisolone acetate (“MPA”), which were manufactured by NECC and shipped nationwide. [2] The indictment consisted of 131 criminal counts including second-degree murder, racketeering, mail fraud, conspiracy, contempt, structuring, and violations of the Food, Drug, and Cosmetic Act. [3] The U.S. Centers for Disease Control and Prevention (“CDC”) reported that 751 patients in 20 states were diagnosed with fungal infections after receiving MPA injections from NECC, and that 64 of those patients died as a result. [4]
The indictment alleged that from 2006 until 2012, the defendants knowingly compounded and sold drugs in an unsafe and unsterile manner, while concealing safety issues from regulators. [5] The government also alleged that defendants used expired ingredients, employed improper sterilization practices, and mislabeled drugs. [6] Although the pharmacy supervisor was aware of the presence of bacteria and mold in the pharmacy’s clean facilities, he instructed technicians to prioritize production over disinfecting and fraudulently completed cleaning logs. [7] The indictment also alleges that the supervising pharmacists were aware that administration of such injectable drugs had the potential for fatal results. [8]
NECC represented that it was providing “the highest quality compounded medications” and indicated that it employed a “strictly enforced environmental monitoring program” and a “comprehensive end-product testing program.” [9] To avoid intense regulation and oversight from the FDA, NECC claimed that it operated as a compounding pharmacy, producing drugs pursuant to a valid, patient-specific prescription, when in reality it was operating more like a manufacturer, producing drugs in bulk, which would have required NECC to adhere to strict current Good Manufacturing Practices (“cGMPs”). [10]
As noted in a January publication by Michele L. Adelman, et al, this is not the first time that misbranded or adulterated pharmaceuticals produced by compounding pharmacies have resulted in death or serious injury. [11] Interestingly, however, criminal charges are rarely brought against pharmacists, and a charge of second-degree murder has never been brought to date. [12] Adelman notes that the use of the Racketeer Influenced and Corrupt Organizations Act (“RICO”) to charge 25 acts of second-degree murder as predicate offenses indicates an unprecedented approach to pharmaceutical regulatory violations that may have resulted in patient deaths. [13] RICO statutes are more commonly used to prosecute gang members for drug dealing, illegal gambling, money laundering, and murder; however, this approach marks a bold and unusual choice on the part of the prosecution.
In order to successfully prove a RICO violation, the prosecution “must prove beyond a reasonable doubt that the enterprise affected interstate commerce; that the defendant under consideration associated with the enterprise; that the defendant participated in the conduct of the enterprise’s affairs; and that the defendant’s participation was through a pattern of racketeering activity.” [14] This will not be an easy task, however the prosecution is equipped with allegations that the defendants made misrepresentations to customers about NECC’s production practices; produced drugs in a manner that did not comply with applicable regulations; and failed to properly clean and disinfect NECC’s facilities, all for the common purpose of obtaining money and property. [15] These allegations would show some coordination and communication between the defendants, which is necessary to succeed under the RICO statute. [16]
Another challenge that the prosecution will face will be proving that the defendants acted with “extreme indifference to human life.” The victims resided in a number of different states, each with its own variation on the mental state for second-degree murder. States use a spectrum of standards ranging from “acting in a manner inherently dangerous to human life so recklessly and wantonly as to manifest a mind utterly without regard for human life and social duty and deliberately bent on mischief” to simply “an awareness of a high probability that their conduct would result in death.” [17] In order to succeed across the board, the prosecution will have to satisfy the highest standard.
The December press release from the DOJ indicates NECC’s supervisory pharmacists could face a maximum sentence of life in prison if convicted on all counts. [18] According to Attorney General Eric Holder, “The Department of Justice is taking decisive action to hold these individuals accountable for their alleged participation in this grievous wrongdoing. 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.” [19] Holder’s statement expresses a resolution on behalf of the DOJ “to protect the American people, and to hold wrongdoers accountable to the fullest extent of the law.” [20]
Brian King is a current student at DePaul University College of Law in Chicago. Dr. King holds a PharmD from Purdue University and is a practicing Pharmacist in the Chicago area. He will complete his law degree and certificate in health law in 2017.
References:
1. Press Release, U.S. Attorney’s Office, District of Massachusetts, 14 Indicted in Connection with New England Compounding Center and Nationwide Fungal Meningitis Outbreak (Dec. 17, 2014) (hereafter NECC Press Release), available at http://www.justice.gov/usao-ma/pr/14-indicted-connection-new-england-compounding-center-and-nationwide-fungal-meningitis
2. Id. at ¶2.
3. Id. at ¶3.
4. Id. at ¶2.
5. Indictment, United States v. Cadden et al., 1:14-cr-10363 (D. Mass.) (hereafter Indictment) available at http://www.justice.gov/sites/default/files/usao-ma/pages/attachments/2014/12/30/indictment_signed_final.pdf
6. Id.
7. Id.
8. NECC Press Release, at ¶4.
9. Id. at ¶13.
10. Id.
11. Michele L. Adelman, Business Crimes Perspectives, RICO Indictment of NECC Executives for Acts of Second-Degree Murder (Jan. 26, 2015) (hereafter Adelman), available at http://www.foleyhoag.com/publications/alerts-and-updates/2015/january/rico-indictment-of-necc-executives-for-acts-of-second-degree-murder#ref22
12. Id. at ¶6.
13. Id.
14. United States v. Shifman, 124 F.3d 31, 35 (1st Cir. 1997); Aldeman, supra.
15. Shifman, supra; Adelman, supra.
16. Adelman, at ¶8.
17. Id. at ¶11.
18. NECC Press Release, ¶15.
19. Id.
20. Id.