SARIS, District Judge.
Defendants Joseph Zolot, a physician, and Lisa Pliner, a nurse practitioner, are charged with illegal distribution of methadone, oxycodone, and fentanyl under the Controlled Substances Act ("CSA"), 21 U.S.C. § 841. They are also charged with conspiracy. The indictment alleges that defendants' illegal distribution of methadone resulted in the death of six patients.
Defendants have filed a motion to exclude the opinions of government experts, Dr. Michael Baden and Dr. Richard Callery, that methadone caused or contributed to the six deaths. They have also moved to preclude government experts Dr. Christopher Gilligan, Dr. Edward Michna, and Dr. Gerald Aronoff from testifying that defendants prescribed controlled substances without a legitimate medical purpose and outside the course of usual practice.
The government has moved to exclude the testimony of defendants' expert, Dr. Yale Caplan, that each of the six deaths had other independently sufficient causes of death. They also challenge the opinions of Dr. Carol Warfield and Dr. William McCarberg, who will testify that there were no standards for prescription practices in the field of pain management at the time of defendants' treatment.
After evidentiary hearings on May 28 and 30, 2013, and a review of the record and supplemental affidavits, Defendants' Motion to Exclude Expert Opinion Regarding Causation (Docket No. 125) is
The following background facts, most of which are disputed, are alleged in the indictment.
Dr. Zolot, a licensed physician, operated a medical practice in Needham, Massachusetts. Nurse Pliner was a nurse practitioner licensed to write prescriptions. Defendants issued prescriptions for controlled substances to patients, despite indications that such individuals were potentially abusing, misusing, or illegally distributing these drugs. Between the years 2002-2007, defendants distributed these drugs without a legitimate medical purpose. By providing only cursory examinations and investigations into patient history, defendants were able to see 40-50 patients a day, charging $300 for initial visits and $150 for follow-up visits. By prescribing excessive dosages of highly addictive drugs without a legitimate medical purpose, defendants encouraged drug dependency in order to ensure patients returned for further appointments. The government charges that defendants' illegal distribution practices led to the deaths of six patients
The admission of expert evidence is governed by Federal Rule of Evidence 702, which codified the Supreme Court's holding in Daubert v. Merrell Dow Pharms.,
Fed.R.Evid. 702.
The trial court must determine whether the expert's testimony "both rests on a reliable foundation and is relevant to the task at hand" and whether the expert is qualified. Daubert, 509 U.S. at 597, 113 S.Ct. 2786; Diaz, 300 F.3d at 73. An expert's methodology is the "central focus of a Daubert inquiry," but a court "may evaluate the data offered to support an expert's bottom-line opinions to determine if that data provides adequate support to mark the expert's testimony as reliable." Ruiz-Troche v. Pepsi Cola of P.R. Bottling Co., 161 F.3d 77, 81 (1st Cir.1998).
Daubert itself listed four factors which should guide judges in this determination: (1) whether the theory or technique can be and has been tested; (2) whether the technique has been subject to peer review and publication; (3) the technique's known or potential rate of error; (4) the level of the theory's or technique's acceptance within the relevant discipline. United States v. Mooney, 315 F.3d 54, 62 (1st Cir.2002) (citing Daubert, 509 U.S. at 593-94, 113 S.Ct. 2786). "These factors, however, are not definitive or exhaustive, and the trial judge enjoys broad latitude to use other factors to evaluate reliability." Mooney, 315 F.3d at 62 (citing Kumho Tire Co. v. Carmichael, 526 U.S. 137, 153, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999)).
The Court must, however, keep in mind the Supreme Court's admonition that "[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence." Daubert, 509 U.S. at 596, 113 S.Ct. 2786. If an expert's testimony is within "the range where experts might reasonably differ," the jury, not the trial court, should be the one to "decide among the conflicting views of different experts." Kumho Tire, 526 U.S. at 153, 119 S.Ct. 1167. "Only if the expert's opinion is so fundamentally unsupported that it can offer no assistance to the jury must such testimony be excluded." In re Viagra Prods. Liab. Litig., 572 F.Supp.2d 1071, 1078 (D.Minn.2008) (quoting Bonner v. ISP Techs., 259 F.3d 924, 929-30 (8th Cir.2001)). As the First Circuit has stated:
Ruiz-Troche, 161 F.3d at 85. It is with these principles in mind that the Court assesses the motions.
One testified dispute involves the standard of causation under the CSA. Under § 841(b) of the CSA, a defendant is subject to a sentencing enhancement "if death or
The First Circuit has held, "What is required under the death-enhancing statute is that the government prove cause-in-fact, that is, that the decedent's death was caused in fact by his or her use of drugs that were distributed either by the defendant himself or by others in a conspiracy of which the defendant was a part." United States v. De La Cruz, 514 F.3d 121, 138 (1st Cir.2008). The circuits have split on what constitutes sufficient evidence of causation under § 841(b). The Eighth Circuit has held that the "results from" requirement for an enhanced sentence under § 841(b) is met by demonstrating the illegally distributed drug was a "contributing cause" of death. See United States v. Burrage, 687 F.3d 1015, 1021 (8th Cir. 2012) (citing United States v. Monnier, 412 F.3d 859, 862 (8th Cir.2005)). In contrast, the Seventh Circuit rejected a jury instruction stating that an illegally distributed drug must be "a factor" or "must at least have played a part in the death or in the serious bodily injury" to receive the enhancement. United States v. Hatfield, 591 F.3d 945, 947-48 (7th Cir.2010). The Supreme Court has recently granted certiorari on the question "Whether a person can be convicted for distribution of [controlled substances] causing death utilizing jury instructions which allow a conviction when the [drug] that was distributed `contributed to,' death by `mixed drug intoxication,' but was not the sole cause of death of a person." Burrage v. United States, ___ U.S. ___, 133 S.Ct. 2049, 185 L.Ed.2d 884 (2013). Accordingly, this Court has stayed the trial, with the parties' agreement, until the Supreme Court decides the case. In the interim, the Court will decide certain Daubert issues. However, final resolution of some issues await the Supreme Court's ruling.
Dr. Callery concludes that methadone, combined with other narcotics, caused the death of the six victims listed in the indictment. While not challenging Dr. Callery's qualifications
Fed.R.Evid. 401 states that relevant evidence is that which has "any tendency" to increase or decrease the probability of a fact "of consequence in determining the action." Dr. Callery's opinion that methadone contributed to the six deaths makes it more probable that the methadone distributed by defendants was the cause-in-fact of their deaths. Even under the § 841(b)
To prove that defendants' distribution of methadone was the cause of the patients' deaths, the government seeks to introduce the testimony of Dr. Michael M. Baden, a board certified forensic pathologist.
None of the experts disputes the basic scientific principles governing PMR: "Post-mortem drug redistribution refers to the processes by which the movement of drugs and other chemical poisons between tissues, organs, and body fluids takes place after death ..."
Dr. Baden relied on postmortem blood samples to determine the concentration of methadone in the alleged victims' blood. The blood samples were taken at least one calendar day after death for all patients (Tr. 1-122-23)
Given the variability of postmortem blood concentrations, many scientists have counseled caution regarding the use of postmortem blood to determine a patient's cause of death.
Both government and defense experts relied on a text authored by Randall C. Baselt
The government has presented reliable scientific literature to support its position that pathologists who examine the totality of the circumstances surrounding death may use postmortem drug concentrations in determining cause of death, as long as they account for the effects of PMR in their final analysis.
To evaluate whether the amount of methadone in each patient's blood was lethal, Dr. Baden compared the postmortem blood concentrations to other methadone deaths reported in literature to see if the levels were consistent. (Tr. 1-18, 37, 47, 89). Autopsies revealed the following amounts for the decedents: Campbell 780 ng/mL; Dunphy 470 ng/mL; Curley 400 ng/mL; Bartoloni 950 ng/mL; Poulack 639 ng/mL; Dillon 580 ng/mL. The deceased methadone blood concentrations all fell within both the lethal and therapeutic ranges reported by both Winek and Baselt.
While acknowledging that a doctor cannot determine the actual level of methadone at the time of death due to postmortem redistribution, Dr. Baden explained that based on these ranges and given the other evidence from the autopsy and witness statements, he could determine methadone intoxication was the cause of death. (Tr. 1-100-01, 112, 139, 167). Indeed, for four of the six deaths Dr. Baden testified that knowing only that methadone was present in the victims' blood and not the specific concentration, he would still opine that the cause of death was methadone intoxication because of the other evidence surrounding the death. (Tr. 1-112, 136, 139, 147, 150-51, 163). For Dillon and Curley's deaths, he did rely on the relatively high levels of methadone in combination with other factors to make his final conclusion. (Tr. 1-153-54, 158).
The defense argues that the overlap between the therapeutic and lethal levels of methadone precludes a reliable conclusion that methadone caused the deaths. It is true that the methadone concentrations of the decedents fall within both the therapeutic and lethal concentration ranges. For this reason, defendants argue it is faulty methodology to determine whether each of these victims had lethal or therapeutic levels of methadone in their blood. Dr. Baden acknowledged that all of the victims' methadone levels could have been within a therapeutic range. (Tr. 1-136, 145, 149, 151, 155, 160). However, based on all the other factors present, he reasonably concluded methadone was the cause of death. (Tr. 1-1-136, 145-46, 149, 151,
Finally, defendants' challenges regarding the location and timing of drawing the samples go to the weight of Dr. Baden's opinion, but not its admissibility. See United States v. MacKay, 715 F.3d 807, 828-30 (10th Cir.2013) (holding sufficient evidence to find doctor's illegal prescription of controlled substances caused victim's death despite conflicting testimony on PMR, noting "[w]hen experts do not reach the same conclusion, the jury is responsible for making credibility determinations, not the court."); Adams v. Johnson & Johnson, 2009 WL 8652948, at *3 (S.D.Ill. July 15, 2009) (allowing evidence of postmortem distribution noting that testimony goes "to the weight and not the admissibility of the evidence sought to be excluded.").
In sum, Dr. Baden has provided sufficiently reliable data to support his opinions that five of the six indicted deaths resulted from methadone intoxication. His methodology is consistent with the current scientific literature recommending that pathologists look to the totality of the circumstances together with postmortem drug concentrations to determine cause of death. The motion to exclude Dr. Baden's opinion with respect to the deaths of Dillon, Campbell, Dunphy, Bartoloni, and Poulack is
With respect to Curley's death, Dr. Baden has used sufficiently reliable methodology and data to opine that Curley's death was caused by a combination of methadone and oxycodone. He opined that evidence of pulmonary edema, (Tr. 1-68), unaccounted-for methadone and oxycodone pills, id., and the presence of methadone and oxycodone in the blood, (Tr. 1-159), lead to his conclusion. However, Dr. Baden's testimony was less than clear as to whether methadone was the but-for cause of death, as opposed to the combination of methadone and oxycodone. (Tr. 1-159). Curley had 400 ng/mL of methadone, at the low end of the lethal range, and 339 ng/mL of oxycodone. Dr. Baden testified that he thought the methadone played a greater role because of the relatively lesser amount of oxycodone and fentanyl present in the bloodstream. (Tr. 1-157, 159-60). Dr. Baden's opinion that methadone along with oxycodone caused Curley's death may be legally sufficient if the Supreme Court decides that a "contributing cause" is sufficient to demonstrate "but for" causation under the CSA. The Court defers ruling on the motion to exclude the expert's opinion regarding Curley's death. The opinion may be supplemented within 30 days after the Burrage opinion is issued.
Defendants challenge the government's charge that methadone was the "but for" cause of the six indicted deaths through the testimony of Dr. Yale Caplan, a board-certified forensic toxicologist. His credentials as a forensic toxicologist are not challenged.
In four of the six deaths — Campbell, Dunphy, Bartoloni and Poulack — Dr. Caplan concluded that, to a reasonable degree of scientific certainty, chronic cocaine use was an independently sufficient cause of death. (Tr. 2-71, 73, 75-76, 82, 85, 91). Dr. Caplan described how the presence of benzoylecgonine ("BZE"), the cocaine metabolite, in these victims' bloodstream indicated that cocaine had recently been ingested. (Campbell, 576 ng/mL of BZE; Dunphy, 321 ng/mL of BZE; Bartoloni, 936 ng/mL of BZE; Poulack, 1000 ng/mL of BZE.) None of the victims had the parent cocaine substance in their bloodstream. See Def. Mot. in Limine, Exhs. 17, 19, 22, 23. A person who dies from an acute cocaine intoxication will likely still have cocaine in his system, since the body has not had time to metabolize the drug. (Tr. 2-77, 79). Dr. Caplan explained that a person can die from chronic cocaine use without any cocaine in the bloodstream. (Tr. 2-77, 79).
Dr. Caplan explained that a chronic cocaine death would be accompanied by a number of heart changes or pathological evidence of cardiac distress. (Tr. 2-145, 167). Myocardial hypertrophy, which results in an enlarged heart, is one such pathological symptom of chronic cocaine toxicity leading to sudden death.
Significantly, Dr. Caplan agreed that methadone may have contributed to the four deaths, but in his view it was not the
Given the evidence of BZE and some indications of changes to the heart, there is sufficient data to support Dr. Caplan's conclusion that chronic cocaine toxicity was an independently sufficient cause of death for Campbell, Dunphy, Bartoloni and Poulack. The motion to exclude Dr. Caplan's testimony on this topic is
Dr. Caplan concluded that fentanyl was more likely to have caused Curley's death than methadone, and that, to a reasonable degree of scientific certainty, fentanyl was an independently sufficient cause of death. (Tr. 2-60-61). He opined that Curley's death was a multi-drug overdose. In support of his conclusion, Dr. Caplan noted that fentanyl is eighty times more potent than methadone or oxycodone. (Tr. 2-59-60). He also relied on the high fentanyl-to-norfentanyl ratio in Curley's bloodstream. (Tr. 2-60). Norfentanyl is the metabolite breakdown product
Given Dr. Caplan's qualifications as a toxicologist, defendants have provided sufficiently reliable methodology and data to support Dr. Caplan's conclusion that fentanyl intoxication was an independently sufficient cause of death for Curley. The motion to exclude Dr. Caplan's testimony on this topic is
In the case of Mr. Dunphy, Dr. Caplan concluded that cardiovascular disease was an independently sufficient cause of death, in addition to chronic cocaine use. (Tr. 2-72). He stated that he relied upon the medical examiner's diagnosis to make this determination. (Tr. 2-72). However, he provided no support beyond the medical examiner's diagnosis for his own opinion that cardiovascular disease was independently sufficient to cause death. He presented no independent analysis.
Rule 703 allows an expert to rely on certain "facts or data" if "experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject." Fed.R.Evid. 703. This rule allows experts to rely upon the opinions of other experts to form their own conclusions, if that is common practice in the field. United States v. McGhee, 627 F.3d 454, 460 (1st Cir.2010) ("Experts who testify regularly in court commonly and permissibly rely in some measure on information gathered by other experts."). Nonetheless, "[a] scientist, however well credentialed he may be, is not permitted to be the mouthpiece of a scientist in a different specialty. That would not be responsible science." Dura Auto. Sys. of Ind., Inc. v. CTS Corp., 285 F.3d 609, 614 (7th Cir. 2002).
Dr. Caplan testified that, in his experience, toxicologists regularly rely on the medical examiner's diagnosis to determine "whether a drug or something else may have caused the death." (Tr. 2-72-73). Thus, in rendering his opinion about cocaine, Dr. Caplan may properly rely on heart pathology reports to reach a conclusion that cocaine contributed to the cause
Finally, Dr. Caplan concluded that sleep apnea and bipolar disorder were independently sufficient causes of death for Dennis Dillon, although he had no expertise in these medical areas. Dr. Caplan provided no evidence to support his conclusion that bipolar disorder was independently sufficient to cause death. The motion to exclude this opinion is
Government experts, Drs. Gerald Aronoff, Christopher Gilligan, and Edward Michna, analyzed patient files from defendants' practice and concluded that they prescribed controlled substances for these patients without a legitimate medical purpose and outside the course of usual practice. While not challenging their qualifications, the defendants seek to exclude their opinions because 1) the sources cited by the government do not establish a medical standard for pain management; 2) the experts' conclusions are based on nothing but their own say so; and 3) their opinions are based on unreliable data, particularly urine drug tests. The parties did not seek an evidentiary hearing.
Defendants seek to introduce the testimony of Drs. Carol Warfield
Under § 841 of the CSA, a medical practitioner with a DEA license may be convicted only if he intentionally prescribes a controlled substances for other than "a legitimate medical purpose in the usual course of professional practice." See United States v. Moore, 423 U.S. 122, 124, 96 S.Ct. 335, 46 L.Ed.2d 333 (1975) ("[R]egistered physicians can be prosecuted under § 841 when their activities fall outside the usual course of professional practice."); 21 C.F.R. § 1306.04. "[T]he standard for criminal liability under § 841(a) requires more than proof of a doctor's intentional failure to adhere to the standard of care." United States v. Feingold, 454 F.3d 1001, 1011 (9th Cir.2006). See also United States v. Tran Trong Cuong, 18 F.3d 1132, 1137 (4th Cir.1994) (noting that a criminal conviction "requires more" than a showing of malpractice). Instead, "[a] practitioner becomes a criminal not when he is a bad or negligent physician, but when he ceases to be a physician at all." Feingold, 454 F.3d at 1011.
Nonetheless, courts have held "that it is appropriate in [§ 841 cases] for the jury to consider the practitioner's behavior against the benchmark of acceptable and accepted medical practice." Id. Indeed, "only after assessing the standards to which medical professionals generally hold themselves is it possible to evaluate whether a practitioner's conduct has deviated so far from the `usual course of professional practice' that his actions become criminal." Id. at 1007 (citing United States v. Moore, 423 U.S. 122, 126, 96 S.Ct. 335, 46 L.Ed.2d 333 (1975)). Thus, while a breach of the medical standard of care, without more, is not dispositive in a § 841 case against a physician, the government must present evidence of the standard of care to prove that a doctor is acting without a legitimate medical purpose or outside of the course of usual practice. See United States v. Wexler, 522 F.3d 194, 204 (2d Cir.2008) ("While failure to comply with the standard of care applicable to a medical specialty does not alone provide a basis for concluding that a physician's activities fall outside the usual course of professional practice, it surely is relevant to that determination."); United States v. Chube, 538 F.3d 693, 698 (7th Cir.2008) ("[I]t is impossible sensibly to discuss the question whether a physician was acting outside the usual course of professional practice and without a legitimate medical purpose without mentioning the usual standard of care."); United States v. McIver, 470 F.3d 550, 561 (4th
Courts have upheld convictions where there was sufficient evidence of physician behavior that demonstrated prescription without legitimate medical purpose and outside the bounds of professional practice, including the following situations: United States v. Elder, 682 F.3d 1065, 1071 (8th Cir.2012) (where defendant did not maintain medical files of patients and rarely saw patients himself); United States v. Singh, 390 F.3d 168, 179 (2d Cir.2004) (where physician-defendant developed scheme for nurses to see patients and prescribe controlled substances and signed prescriptions without knowing identity of patients); United States v. Kaplan, 895 F.2d 618, 620-21 (9th Cir.1990) (where physician-defendants' prescriptions were issued without physical examination or medical history, and where defendant issued up to 21 prescriptions in a month); United States v. Bartee, 479 F.2d 484, 489 (10th Cir.1973) (where doctor told patients to fill prescriptions at different drugs stores, used street slang to refer to drugs, knew patients were prone to trade drugs, prescribed excessive dosages of controlled substances, and made no physical examinations).
The Supreme Court "has allowed juries to assess the prevailing standards of care among medical professionals in cases involving the criminal prosecution of licensed practitioners." Feingold, 454 F.3d at 1007 (citing Moore, 423 U.S. at 126, 96 S.Ct. 335). Cf. United States v. Lovern, 590 F.3d 1095, 1100 (10th Cir.2009) (finding the question "what constitutes usual medical practice" properly remained within the province of the jury, not the government). Thus, to the extent both sides challenge the standard of care espoused by qualified experts "the proper response [is] to present evidence ... of the purported disputes within the medical community." Feingold, 454 F.3d at 1007 n. 1.
The standard of acceptable medical care must ordinarily be established by expert testimony. See Lama v. Borras, 16 F.3d 473, 478 (1st Cir.1994) (holding that "the trier of fact can rarely determine the applicable standard of care without the assistance of expert testimony"); Patel v. Gayes, 984 F.2d 214 (7th Cir.1993) ("holding that treating physicians' testimony regarding general standards of care is "classic" expert testimony"). Cf. Levin v. Dalva Bros., 459 F.3d 68, 79 (1st Cir.2006) ("Expert testimony on industry standards is common fare ...."). In a similar context, doctors commonly rely upon their experience and training to opine as to the medical standard of care. See, e.g., Pages-Ramirez v. Ramirez-Gonzalez, 605 F.3d 109, 116 (1st Cir.2010) (holding in a medical malpractice case that a doctor's "medical education and many years of experience in the field" was a sufficiently "reliable foundation" to testify on medical standard of care).
However, the opinion of an expert, no matter how qualified cannot simply be based on her say so. "[N]othing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert." Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997). The gate-keeping function of the
The government cites certain written standards establishing the standard of medical care in the area of pain management. Dr. Aronoff relies upon the Federation of State Medical Boards' ("FSMB") Model Policy for the Use of Controlled Substances for the Treatment of Pain ("Model Policy"). Drs. Gilligan and Michna rely upon both current and historical versions of "(1) the applicable labels and/or FDA warnings related to methadone products, oxycodone products (including Oxy-Contin), and fentanyl products (including Actiq); (2) the Commonwealth of Massachusetts Board of Registration in Medicine's Prescribing Practices Policy and Guidelines, Policy 89-01 ("BOR Prescribing Practices Policy"); and (3) Responsible Opioid Prescribing by Scott Fishman, M.D." (Def. Mot. in Limine, Exh. 5, 2). The defendants contend that these sources do not establish a medical standard of care.
The government highlights language from the BOR Prescribing Practices Policy demonstrating that the policy was meant to establish a standard of care for pain management physicians. The BOR Prescribing Practices Policy was adopted by the Commonwealth of Massachusetts Board of Registration in Medicine in August 1989. The goal of the policy is to inform "physicians as to the legal requirements upon them and the standards the Board applies in reviewing their prescribing practices." Id. at 2. The policy lists several indications of when a physician is not prescribing medication for a legitimate medical purpose.
The government also relies on defendants' own statements to demonstrate that a medical standard of care existed at the time of defendants' treatment. In defending herself before the medical licensing board, defendant Pliner stated she and Dr. Zolot "understood that [they] had to be vigilant in [their] work with patients in order to prevent possible abuse and diversion of controlled substances." Gov't Opp. Mot. in Limine, Exh. H at 5. Both defendants said they took certain precautions to guard against abuse and diversion of drugs, including random urine testing
Finally, the government relies on the book Responsible Opioid Prescribing by Dr. Fishman was published in 2007. (Def. Mot. in Limine, Exh. 38). The last charged death occurred in 2007. The contents of this book have not been disclosed to the Court. Without knowing what the book states, the Court has no basis for concluding whether the experts can reasonably rely on it for determining the standard of care for the years prior to its publication. The ruling on whether experts may rely upon Dr. Fishman's book is deferred until the government provides evidence that the book reflects medical practices at the time of the treatment described in the indictment.
In response to the government's position concerning the medical standard of care, defendants argue that there were no binding standards, requirements, or generally accepted practices for how to treat patients with chronic pain at the time of defendants' practice. Articles on the subject of pain management note that the "norms of drug taking and the epidemiology of aberrant drug-taking behavior have not been clearly established. Therefore, clinicians generally lack information to guide assessment of the severity of aberrant clinical occurrences."
The government properly objects to the opinions of Drs. Warfield and McCarberg
The government relies on its Rule 16 disclosures of Dr. Michna's and Dr. Gilligan's testimony as the bases for the reliability of their opinions. Defendants argue these disclosures are deficient. The disclosures provide summaries of the doctors' expected testimony. Dr. Gilligan reviewed thirty patient files and Dr. Michna reviewed sixteen different patient files. For each patient, the summaries state at the outset that both doctors will testify that the defendants' prescription of controlled substances to the patient was "outside the usual course of practice."
Missing from the summaries is sufficient explanation as to the standard of care which should be applied for the treatment of pain when there is problematic behavior by patients. Some of the patient behavior described in these expert disclosures, such as seeking early refills, claiming medication was lost or stolen, and obtaining drugs from other sources, are indicators of "problematic opioid use" described in the BOR Prescribing Practices Policy. See BOR Prescribing Practices Policy at 38. However, the experts do not refer to specific standards in the BOR, or the other sources generally cited by the government, or even provide testimony themselves about accepted medical practice for responding to specific patient behavior. For example, with respect to one patient file, Dr. Gilligan observes that on April 6, 2004, he tested positive for cocaine, positive for methadone which he had not been prescribed, and negative for the oxycodone he was prescribed. On April 12, 2004, he again tested positive for cocaine. In June of 2004, Dr. Zolot notes these two positive cocaine tests and responds by taking the patient off of OxyContin and prescribing methadone. Based on these drug tests, Dr. Gilligan concludes that Zolot violated the standard of medical care by prescribing methadone. However, Dr. Gilligan does not provide testimony regarding the applicable standard of care that should be followed in pain management when a patient has positive drug tests for cocaine.
After reading Dr. Michna's and Dr. Gilligan's summaries, the Court concludes they do not sufficiently articulate the standard of care they are applying to assess defendants' conduct as out of the course of usual practice in responding to the specific patients with problem behavior. They must specifically cite the written standard they are relying on or provide testimony as to the accepted standard in the field. The motion to exclude the opinions of Dr. Michna and Dr. Gilligan is
Dr. Aronoff reviewed twenty-five patient files and did a better job in detailing the patient's history and specifying why the defendants' treatment was deficient, without legitimate medical purpose, and outside the usual course of practice for twenty-two patients. In a conclusion section, he states how defendants' behavior specifically violated the FSMB Model Policy.
This opinion is reliable because it applies the medical standard identified to the evidence elicited from defendants' patient files. The motion to exclude the opinion of Dr. Aronoff is therefore
Finally, defendants challenge the government's expert opinions to the extent they rely on the results of urine drug tests ("UDTs") because the results of such tests were unreliable for making clinical determinations during the relevant time period. At the time of defendants' actions, the results of UDTs had limitations. UDTs could not provide information on specific drug dosage or frequency of use.
Nonetheless, the scientific literature submitted by the defendants demonstrates that, while UDTs had limitations, when used properly in conjunction with other clinical information, they were useful in determining whether a patient is misusing, abusing, or diverting drugs.
The motion to exclude Dr. Aronoff's testimony is
The Motion to Exclude Expert Opinion Regarding Causation (Docket No. 125) is
Therapeutic or Normal Toxic Lethal 0.075-1.10 μg/mL 0.2-2.0 μg/mL 0.4-1.8 μg/mL 75-1100 ng/mL 200-2000 ng/mL 400-1800 ng/mL