The United States Attorney’s Office alleged that Omnicare violated the False Claims Act by failing “to obtain a new prescription” for residents of certain long-term-care facilities “after an old one expired or ran out of refills,” instead continuing to dispense medications through certain computer functionalities.
The Office retained Dr. W. Thomas Smith to review Omnicare’s medication-dispense records from a sample of patients to assess whether Omnicare dispensed non-controlled substances without a valid prescription—as defined by Smith.
Omnicare argued that the testimony from Smith about the requirements of pharmacy law in various states was improper because he testified about matters that are the province of the Court.
Pharmacy Expert Witness
W. Thomas Smith has served as Dean of Health Sciences and Pharmacy at Manchester University (MU) College of Pharmacy, Natural and Health Sciences since 2017. He is active in several pharmacy professional organizations, including the American Association of Colleges of Pharmacy (AACP) and the American Society for Pharmacy Law (ASPL). He also currently serves as chair-elect of AACP’s Council of Deans and sits on the organization’s Board of Directors.
Smith — a duly qualified expert of pharmacology, who teaches pharmacists about how to comply with the law for a living — testified about whether Omnicare’s dispensing practice was consistent with the core pharmacy requirement in a number of states, whose laws required a valid prescription before dispensing drugs.
In applying state-law requirements to his assessment of Omnicare’s drug authorization records, Smith engaged in the type of pharmacist practice that pharmacists are trained to perform in their day-to-day practice.
Of the dispensings Smith identified as invalid, many were based on the fact that there was no authorization — no prescription whatever — for the drug dispensation. As noted above, the existence of a prescription is a federal requirement, and so required no application of state-specific standards. Moreover, Omnicare had the opportunity both to cross-examine Smith and offer its own competing expert — an option it chose not to exercise.
Held
The Court allowed Dr. W. Thomas Smith to testify as an expert about the pharmacy law requirements in different states.
Key Takeaway:
Experts regularly provide opinions related to legal requirements in regulated industries. Smith’s testimony did not usurp the role of the judge since he made no effort to instruct the jury on FCA law.
Case Details:
Case Caption:
United States Of America Ex Rel. Uri Bassan, Et Al V. Omnicare, Inc.
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.”
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.
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.
Plaintiff alleged that his use of the antacid medication Zantac caused him to develop prostate cancer because Zantac’s active ingredient, ranitidine, has been found to degrade N-nitrosodimethylamine (“NDMA”).
Brand Defendants’ filed a motion to exclude Plaintiff’s expert Dr. Steven Bird under Daubert.
Pharmacy Expert Witness
Steven Bird is a lead epidemiologist at the Food and Drug Administration / Center for Drug Evaluation and Research. He is responsible for the science and administration function of the team and to ensure that reviewers provide quality review and consultation to review divisions within established timeframes.
Bird opined that (1) NDMA is a potent carcinogen; and (2) Plaintiff’s exposure to NDMA from Zantac (generic name ranitidine) use was a substantial causative factor for his prostate cancer.
Bird (1) performed a “differential etiology methodology” where he purports to “rule in” ranitidine as a potential cause of Plaintiff’s prostate cancer and to “rule out” other causes, and (2) calculates Plaintiff’s lifetime exposure to NDMA from ranitidine by averaging the NDMA levels from other Plaintiffs’ expired ranitidine tablets and then converting his results to inhaled exposure risk estimates from a study of occupational NDMA exposure in rubber workers. The Brand Defendants argued that Bird’s opinions do not pass muster under Daubert based on his unreliable application of his chosen methodology to reach his specific causation opinion and his use of novel extrapolations to calculate Plaintiff’s NDMA exposure.
Bird’s application of the differential etiology methodology is unreliable because he unreliably “rules in” ranitidine use as a potential cause of Plaintiff’s cancer
Bird rejected all published, peer-reviewed ranitidine epidemiological studies assessing whether ranitidine is associated with prostate cancer—Rossing (2000), Habel (2000), Yoon (2021), Kantor (2021), Wang (2022), and You (2023)—none of which shows a statistically significant increased risk. Bird instead relied on the unpublished, non-peer-reviewed Braunstein manuscript, which examined only a cross-sectional, moment-in-time “snapshot” of cancer patients from Braunstein’s hospital. The Court held that Bird’s methodology of rejecting the published, peer-reviewed ranitidine epidemiology while embracing the unpublished Braunstein study is not reliable or based on scientific principles, and renders his opinion that ranitidine can cause prostate cancer unreliable.
Bird does not reliably “rule out” other potential causes
In terms of ruling out potential causes, Bird conceded he made no attempt to “rule out” Plaintiff’s other risk factors for prostate cancer, in particular Plaintiff’s significant family history of cancer.
The Court accordingly finds that Bird’s failure to do so renders his application of the differential etiology methodology unreliable, and warrants its exclusion.
Bird’s extrapolations from expired ranitidine pills and the Hidajat study are the type of guesswork against which Daubert is meant to shield
Bird purported to calculate (1) Plaintiff’s lifetime NDMA exposure from ranitidine use, and (2) the average and per quartile total NDMA exposure of rubber factory workers in the Hidajat study. Bird then uses these calculations to place Plaintiff within the cancer risk quartiles in the Hidajat study to estimate Plaintiff’s total prostate cancer risk from NDMA exposure.
Using this extrapolation methodology, Bird concluded Plaintiff’s NDMA exposure from ranitidine significantly increased his risk of prostate cancer.
Bird opined that Plaintiff absorbed as much NDMA through his use of ranitidine as the rubber workers in Hidajat’s “Quartile IV” had absorbed in their years of working in UK rubber factories. The Court held that the steps Bird had taken to reach this opinion are not a part of any reliable methodology, let alone a reliable application of any methodology. Indeed, the Zantac MDL Court found that “the number of assumptions and estimations necessary to render the Hidajat study helpful to” an expert’s general causation opinion about ranitidine use was “staggering.”
Held
The Court granted Brand Defendants’ motion to exclude Plaintiff’s expert Steven Bird.
Key Takeaway:
Bird’s methodology of rejecting the published, peer-reviewed ranitidine epidemiology while embracing the unpublished Braunstein study is not reliable or based on scientific principles. Moreover, Bird conceded he made no attempt to “rule out” Plaintiff’s other risk factors for prostate cancer, in particular Plaintiff’s significant family history of cancer. When Bird concluded Plaintiff’s NDMA exposure from ranitidine significantly increased his risk of prostate cancer, the Court held that the steps Bird had taken to reach this opinion are not a part of any reliable methodology, let alone a reliable application of any methodology.
Case Details:
Case Caption:
Wilson V. Boehringer Ingelheim Pharmaceuticals, Inc. Et Al
Docket Number:
22CA000284
Court:
Circuit Court of the Thirteenth Judicial Circuit of Florida, Hillsborough County
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.
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.
