Drug Enforcement Expert Witness Allowed To Testify Despite Not Being A Pharmacist
Posted on July 25, 2024 by Expert Witness Profiler
Manes is a pharmacy that has served the Van Buren, Arkansas community for nearly 40 years. AmerisourceBergen is a wholesale distributor of pharmaceutical products, including controlled substances. This dispute arises from AmerisourceBergen’s decision to restrict its sale of controlled substances to Manes. Manes sued AmerisourceBergen for breach of contract, tortious interference with Manes’ business expectancies, defamation, and compelled self-defamation.
Both parties sought to exclude some of their opponent’s experts. Manes sought to exclude the testimony of James Place and Deborah Komoroski. AmerisourceBergen sought to exclude the testimony of Jack Teitelman.
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Drug Enforcement Expert Witnesses
James Place has 27 years of experience working for the United States Drug Enforcement Administration and nearly ten years of doing compliance work in the private sector.
Deborah Komorski works for Cencora, Inc., which is AmerisourceBergen’s parent company. She has eight years’ experience as a pharmacist, twenty-five years’ experience as a Drug Control Agent for the State of Connecticut, and thirteen years’ experience doing compliance and diversion control work for private companies.
Jack Teitelmean worked for the DEA as a special agent for 13 years, and he has worked in other law enforcement capacities for an additional 13 years. For the last seven years, he has worked for a private company which he describes as “a leading Veterinary Industry provider of DEA-compliance and controlled-substance anti-diversion solutions.”
Discussion by the Court
James Place
Manes argued that the Court should exclude Place’s opinions because he was not a pharmacist and his expert report contained opinions about “the practice of pharmacy and how a pharmacist fulfills his/her corresponding responsibility.” Additionally, Manes argued that Place should be excluded under Arkansas law because he could not judge whether a medical professional had deviated from the accepted standard of care.
The Court held that the Arkansas statute titled “Plaintiff’s burden of proof” Manes relied on did not apply to this case because Manes is the Plaintiff here and this is not an action for negligence. Also, the statute’s definition of medical care provider does not include a drug distributor like AmerisourceBergen. Moreover, Manes has alleged injuries arising out of AmerisourceBergen’s decision to stop selling it controlled substances instead of a medical injury.
Place’s opinions do not discuss the exercise of pharmacological judgment
The Court found that Place’s testimony discussed the steps a distributor or government agency might take when investigating possible diversion. Place’s opinions did not question the drugs Manes’ pharmacists dispensed; his opinions questioned the steps the pharmacists took to investigate questionable prescriptions based on red flags (such as commonly diverted substances) before filling the prescriptions. This opinion fell within his decades of experience with investigations and compliance in the public and private sectors.
Moreover, Manes argued the following opinion is impermissible: “AmerisourceBergen was justified in questioning Plaintiff’s ability to satisfy its corresponding responsibility for the proper dispensing of controlled substances.” The Court held that Place’s opinion is made from the perspective of an outside investigator, not that of a pharmacist challenging Manes’ pharmacist’s pharmacological judgment.
Some of Manes’ objections are simply disputes over the factual basis for Place’s opinions
Manes took issue with paragraph 39 of Place’s report. That paragraph read, in part, “[p]roper controls can be accomplished by following common sense, sound professional practice, and proper dispensing procedures.”
This paragraph is a direct quote from the DEA’s Pharmacist’s Manual. Manes argued that this is an example of where Place “opines as to what pharmacies and pharmacists should or should not do.” The Court held that the paragraph is an example of what the DEA says what a pharmacist should or should not do. In other words, Manes’ argument missed the mark because it challenged the factual basis for Place’s opinions.
Deborah Komoroski
Manes next asked the Court to exclude Deborah Komorski because she is testifying on matters outside of her experience. Manes made the same argument as above about Arkansas’s standard of care for pharmacists, which the Court rejected for the same reasons stated above: the statute did not apply to this case.
Plaintiff objected to Komoroski’s opinions which discussed AmerisourceBergen’s processes when investigating whether a pharmacist carries out their corresponding responsibility. The Court held that these opinions all fall within her decades-long experience as both a pharmacist and diversion control agent.
Manes argued that not only did Komorski fail to consider all the facts but Komoroski cannot testify as to the applicable standard of care because she never practiced pharmacy in Arkansas. The Court did not find any of these arguments convincing because Komoroski’s opinions did not discuss the standard of care.
Jack Teitelman
AmerisourceBergen argued that because Teitelman failed to review a multitude of key sources of information, his testimony should be excluded because it is “so fundamentally unsupported that it can offer no assistance to the jury.” The Court held that while Teitelman’s report may have more thoroughly listed the documents he relied on, that he might base his opinion on different facts than Place does not render his opinion inadmissible.
AmerisourceBergen argued Teitelman is unaware of the steps in its investigation. However, the Court found that reviewing Teitelman’s report in its entirety reveals that he is aware of various steps AmerisourceBergen took as part of its investigation.
Teitelman’s report attempts to explain how Ruan V. United Statess, 497 U.S. 450 (2022) applies to the way that AmerisourceBergen and the DEA should evaluate a pharmacist’s corresponding responsibility. The Court held that Teitelman’s testimony about Ruan impermissibly ventured into testimony about legal matters because he applied the Ruan case out of its criminal context.
The Court did not agree with AmerisourceBergen that Teitelman’s opinions about AmerisourceBergen’s policies were unreliable because they were purely speculative. AmerisourceBergen primarily argued that because Mr. Teitelman did not have personal knowledge of how AmerisourceBergen’s policies had changed over time, his opinions on the topic should be excluded. However, Teitelman based his opinion in part on his previous work with pharmacies that had a relationship with AmerisourceBergen.
Held
The Court denied Manes’ motion to exclude the testimony of James Place and Deborah Komoroski but granted in part and denied in part AmerisourceBergen ‘s motion to exclude the testimony of Jack Teitelman.
Key Takeaways:
- Place’s opinions all fall within his area of expertise and Arkansas’s statute about the standard of care does not apply in this case. Manes is free to challenge the factual basis of Place’s opinions on cross-examination, but Manes has not identified any reason Place’s testimony is inadmissible.
- As per Rule 703, Teitelman can base his opinion on facts or data he has been made aware of or personally observed.
Case Details:
Case Caption: | Manes’ Pharmacy, Inc. V. Amerisourcebergen Drug Corporation |
Docket Number: | 2:22cv2186 |
Court: | United States District Court, Arkansas Western |
Order Date: | July 23, 2024 |