Tag: Pharmacy

  • Economics Expert Allowed to Testify Despite Lacking Experience in the Pharmaceutical Industry

    Economics Expert Allowed to Testify Despite Lacking Experience in the Pharmaceutical Industry

    Named Plaintiffs Judy Kirkbride and Beeta Lewis are consumers in Ohio and Texas that purchased prescription drugs from The Kroger Company (“Kroger”) in the last several years. They alleged that Kroger, through a deceptive pricing scheme, overcharged them for prescription drugs by misreporting the “usual and customary” (U&C) prices for Plaintiffs’ medications, which resulted in higher copayments. 

    Plaintiffs offered Colin Weir as a damages expert primarily to “explain how classwide damages in this case can be calculated using Kroger’s own records.” After Kroger’s experts opined that, to calculate damages in this action, class members’ claims need to be re-adjudicated over the entirety of a plan year, and that process requires additional data from pharmacy benefit managers (“PBMs”) that may not exist, Plaintiffs proffered the rebuttal expert report of Dr. Susan A. Hayes

    Defendant filed Daubert motions to exclude Colin Weir’s expert report, Susan Hayes’ expert report, and Weir’s rebuttal report.

    Economics Expert Witness

    Colin B. Weir is President at Economics and Technology, Inc., a research and consulting firm specializing in economics, statistics, regulation and public policy. He conducts economic, statistical, and regulatory research and analysis and often testifies as an expert witness before state and federal courts.

    His experience includes work on a variety of issues, including: “calculating economic harm and damage, and analyzing liquidated damages provisions; lost profits; false claims; diminution in value; merger/antitrust analysis; Early Termination Fees (ETFs); Late Fees; determination of Federal Excise Tax burden; and development of macroeconomic analyses quantifying the economic impact of corporate actions upon the US economy and job markets.”

    Get the full story on challenges to Colin Weir’s expert opinions and testimony with an in-depth Challenge Study. 

    Pharmacy Expert Witness

    Dr. Susan Hayes has over 40 years’ experience in the health care consulting, pharmacy benefit management industry. Hayes is the principal, owner, and founder of Pharmacy Investigators and Consultants.

    In addition to her work at Pharmacy Investigators and Consultants, she is an Assistant Professional Practices Professor and the Director of the Health Informatics Masters Degree Program at Roosevelt University, where she teaches two of the graduate level classes. She is also a Certified Registered Pharmacy Technician in Illinois and has authored research that discusses ethical decision-making in the pharmaceutical industry.

    Want to know more about the challenges Susan Hayes has faced? Get the full details with our Challenge Study report. 

    Discussion by the Court

    Motions to Exclude Colin Weir’s Testimony

    Initially, the “price paid by Class Member,” according to Weir, is found in Kroger’s transactional records—a dataset of over 158 million pharmacy transactions of generic prescriptions that occurred between December 1, 2018 and November 30, 2022, in Ohio and Texas, with 38 variables describing each transaction. However, Kroger argued that Weir’s analysis “did not meet the requirements of Rule 702” for several reasons.

    First, Weir allegedly lacked the “specialized knowledge” to answer the specific questions at issue: whether class members can be identified by certain Bank Identification Numbers (“BINs”) and classwide damages determined via a formula using only pricing lists and pharmacy claims data. Second, the formula Weir opines can calculate damages on a classwide basis purportedly comes directly from counsel. Finally, the “simplified methodology” proposed by Weir allegedly “ignores the complex set of payment steps that occur with each pharmacy transaction between third-party payors (“TPPs”), PBMs, pharmacies, and individual customers.”

    Analysis

    Ultimately, Kroger has failed to demonstrate that Weir’s testimony is inadmissible under Rule 702 and Daubert. Specifically, its first argument—that Weir lacks experience in the pharmaceutical industry to offer an admissible expert opinion on damages in this case—is foreclosed by Sixth Circuit precedent because a generally experienced expert’s “unfamiliarity with some specific aspects of the subject at hand merely affect[s] the weight and credibility of [the] testimony, not its admissibility.”

    The Court held that Kroger’s second argument, that Weir’s methodology is unreliable because it relied on assumptions from Plaintiffs’ counsel, likewise missed the mark. Weir explained that his damages framework was based on Plaintiffs’ theory of liability in this case, and “it is entirely appropriate for a damages expert to assume liability for the purposes of his or her opinion.”

    Finally, Defendant attacked Weir’s methodology by questioning his failure to consider certain information regarding class members’ individual drug prescription transactions in making his calculations. The Court held that Kroger’s arguments “go to the factual sufficiency of Weir’s analysis and not to the reliability of his underlying methodology.”

    Motion to Exclude Susan Hayes’ Testimony

    Kroger sought to exclude Hayes’ testimony, arguing that her “experience does not include calculating damages in litigation,” and that “she has no education, training, or experience in economics or accounting, let alone in calculating damages.”

    Analysis

    Kroger does not dispute that Hayes is qualified to opine about PBMs or the PBM industry standards and practices generally.

    This Court likewise found Hayes qualified to offer expert opinions regarding PBM practices. Drawing on her decades-long experience in auditing PBMs, she has provided helpful testimony to this Court that rests on a “reliable foundation” and is “relevant to the task at hand.”

    Held

    The Court found that Plaintiffs have satisfied the requirements of Federal Rule of Evidence 702 to admit the expert testimony of Colin B. Weir and Dr. Susan A. Hayes.

    Key Takeaway:

    • Furthermore, Kroger’s argument that Weir’s methodology “is based solely on assumptions provided by Plaintiffs’ counsel” is unpersuasive, because “experts may permissibly rely on assumptions about underlying facts that are stated to them by the client.”
    • Moreover, Rule 702 only requires that an expert have specialized knowledge that “will help the trier of fact to understand the evidence or to determine a fact in issue,” not all facts at issue.

    Case Details:

    Case Caption: Kirkbride V. The Kroger Co.
    Docket Number: 2:21cv22
    Court Name: United States District Court, Ohio Southern
    Order Date: April 09, 2025
  • Pharmacy Expert Witness Barred from Offering Legal Opinions

    Pharmacy Expert Witness Barred from Offering Legal Opinions

    This lawsuit arises from the State of Missouri enacting a law forbidding pharmacists from contacting a prescribing doctor or patient “to dispute the efficacy of ivermectin tablets or hydroxychloroquine sulfate tablets for human use” unless the doctor or patient asks the pharmacist about these drugs’ efficacy first. A pharmacist who violates the statute by alerting a doctor or patient that the FDA has not approved either drug to treat a particular disease may be professionally disciplined, including potentially losing her license. But a pharmacist who on her own initiative contacts a doctor or patient to tout the efficacy of either drug for a purpose the FDA has not approved faces no such sanction. Plaintiff, a pharmacist, contended that the statute violated the First Amendment.

    Dennis K. McAllister is a pharmacist Defendants have retained to offer expert testimony. After reviewing McAllister’s expert report, Plaintiff filed a motion to exclude his opinions that offered legal opinion and legal analysis.

    It is his opinion that the societal interests at stake include protecting the prescriberpatient relationship, guarding the public from possible harassment, ensuring appropriate professional competence from pharmacists, and promoting public trust in the pharmacy profession and the practice of medicine.

    The prescriber-patient relationship requires individual assessment and personalized care after examination by a doctor or medical professional. This relationship involves a level of time, trust, and sharing of information that is critical for society and the health of individual patients. According to McAllister, the statute protects this relationship by limiting the way pharmacists may interact with patients or doctors.

    Pharmacy Expert Witness

    Dennis K. McAllister is the founder of McAllisteRx Consulting LLC. He has been Director of Pharmacy in three hospitals. He is consultant and expert with years of experience in the areas of pharmacy standard of care, negligence, pharmacy laws and regulations, pharmacy automation and development of innovative practice models.

    McAllister served on the Arizona State Board of Pharmacy for 23 years, and as its president four times. Moreover, he served on the Executive Committee of the National Association of Boards of Pharmacy (NABP) for 6 years, and as its president in 2005-2006.

    Discover more cases with Dennis McAllister as an expert witness by ordering his comprehensive Expert Witness Profile report.

    Discussion by the Court

    In response, Defendants extolled McAllister’s expert qualifications as a pharmacist and noted that it is permissible for an expert to opine on industry standards and practices.

    But Defendants did not dispute that Eighth Circuit law prohibits a pharmacist from interpreting statutes or offering legal opinions and analysis. Nor could they, because it is firmly established that an expert may not testify as to legal issues or express legal opinions.

    Held

    The Court granted Plaintiff’s motion to exclude McAllister ‘s opinions. The Court barred McAllister from testifying that : (1) the statute protects the prescriber-patient relationship by “limiting the way pharmacists may interact with patients or doctors;” (2) “the statute identifies an area where” the goal of public trust in pharmacists “may be furthered;” or (3) “the law furthers the important societal interests and interests of the profession of ensuring accurate, reliable, consistent, and authoritative information is conveyed, protecting the prescriber-patient relationship, ensuring appropriate professional competence for pharmacists, and promoting public trust in the pharmacy profession and the practice of medicine.”

    Key Takeaway:

    Expert testimony on legal matters is not admissible because matters of law are for the trial judge. In other words, a district court may exclude the testimony of an expert if it finds that such testimony constitutes an impermissible instruction on the law.

    Case Details:

    Case Caption: Stock V. Gray Et Al
    Docket Number: 2:22cv4104
    Court: United States District Court, Missouri Western
    Order Date: May 23, 2024