968 F. Supp. 2d 411
D. Mass.2013Background
- Defendants Zolot (physician) and Pliner (nurse practitioner) are charged with illegal distribution of methadone, oxycodone, and fentanyl and conspiracy under 21 U.S.C. § 841, with six deaths alleged to be caused by methadone distribution.
- Indictment alleges defendants prescribed drugs despite abuse risks and without legitimate medical purpose, enabling dependency and patient return visits.
- Defendants seek to exclude government experts Baden, Callery, Gilligan, Michna, and Aronoff, and government seeks to exclude Caplan; Warfield and McCarberg offered by defendants.
- Court conducted evidentiary hearings May 28–30, 2013; rulings issued partially denying and partially granting motions to exclude.
- Facts: practice in Needham, MA (2002–2007) involved high patient volumes with cursory exams and high dosages; six listed deaths attributed to methadone intoxication or combinations; sampling issues raised due to postmortem redistribution; issues remain pending Supreme Court guidance in Burrage v. United States.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Causation standard under CSA §841(b) for death-enhancement | Government argues methadone as contributory cause suffices for cause-in-fact | Defendants contend methadone must be a necessary condition, not just contributing | Contributory-cause evidence allowed; final standard pending Burrage ruling (partial) |
| Admissibility of Dr. Callery’s causation opinions | Callery’s opinion that methadone contributed to death is relevant to causation | Contribution theory insufficient to show cause-in-fact | Denied for Callery; the opinions remain admissible under relevance |
| Admissibility of Dr. Baden’s postmortem concentration methodology | PMR-aware analysis using postmortem methadone levels is reliable with totality of evidence | PMR reliance is improper if not contextualized | Denied for five deaths; Curley’s death probationary and to be supplemented after Burrage |
| Admissibility of Dr. Caplan’s cocaine, fentanyl, cardiovascular, sleep apnea, and bipolar-disorder opinions | Caplan’s toxicology-based causation opinions are admissible | Some opinions lack independent basis (cardiovascular, sleep apnea, bipolar) | Denied for cocaine and fentanyl; cardiovascular opinion excluded; sleep apnea/bipolar excluded; opinions limited to independent bases |
| Legitimacy of government standard-of-care evidence in pain management | FSMB Model Policy and BOR policy support standards; physicians’ conduct measured against standard | No binding standard; medical guidelines are not absolute; data may be unreliable | ALLOWED IN PART and DENIED IN PART; some standards admitted, others excluded or deferred for supplementation |
| Reliability of urine drug tests in standard-of-care determinations | UDTs, when used with other data, can aid assessment | UDTs have limitations and should not alone establish misuse | UDTs admissible when used with other clinical data; not solely determinative |
Key Cases Cited
- Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993) (admissibility gatekeeping for scientific evidence)
- United States v. Diaz, 300 F.3d 66 (1st Cir. 2002) (Daubert-based test in First Circuit)
- United States v. De La Cruz, 514 F.3d 121 (1st Cir. 2008) (causation standard under CSA death enhancement)
- Burrage v. United States, 133 S. Ct. 2049 (2013) (contributing-cause vs. but-for causation under CSA)
- Mooney v. United States, 315 F.3d 54 (1st Cir. 2002) (Daubert and reliability framework in First Circuit)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999) (flexible gatekeeping factors for expert testimony)