Expert Witness Profiler

Tag: Pharmaceutical

  • Pharmacoeconomics Expert’s Pricing Opinions Admitted

    Pharmacoeconomics Expert’s Pricing Opinions Admitted

    This is an antitrust action filed by Plaintiffs CareFirst of Maryland, Inc., Group Hospitalization and Medical Services Inc., and CareFirst Bluechoice Inc. (collectively, “CareFirst”) alleging that Defendants Johnson & Johnson and Janssen Biotech, Inc. (collectively, “J&J”) used monopoly power to unlawfully delay the introduction of biosimilar competitors for their drug ustekinumab (sold under the brand name “Stelara”).

    J&J filed a motion to exclude the testimony of Plaintiffs’ expert Dr. Aaron S. Kesselheim. J&J sought to exclude both of Kesselheim’s opinions on the grounds that they are unreliable or unhelpful to the jury.

    Pharmacoeconomics Expert Witness

    Aaron Seth Kesselheim, M.D., J.D., M.P.H., is a Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital.

    He is also a Visiting Professor of Law at Yale Law School, and has practiced internal medicine at Brigham and Women’s Hospital for over 20 years. Kesselheim holds an M.D. and J.D. from the University of Pennsylvania as well as an M.P.H. from Harvard.  Kesselheim assisted in founding the Center for Bioethics at Harvard Medical School and has published over seven hundred scholarly articles.

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

    Discussion by the Court

    Kesselheim’s expert report provides background information and two opinions related to the pricing of pharmaceutical drugs. J&J sought to exclude both opinions on reliability and relevancy grounds as well as background information Kesselheim provided regarding certain “life cycle management” strategies employed in the pharmaceutical industry.

    A. Kesselheim’s First Opinion

    Kesselheim’s first opinion discussed the historical impacts of “biosimilar competition on the market for biologic drugs” since the passage of the Biologics Price Competition and Innovation Act (BPCIA).  Specifically, Kesselheim opined that, in the fifteen years since BPCIA’s passage, “[b]iosimilar competition has an impact on pricing.” Kesselheim bases his first opinion “largely” on two studies he co-authored in 2021 and 2024, which examined two non-Stelara biologies and studied “how market structures altered by the BPCIA affected prices for biologies subject to biosimilar competition.” 

    J&J argued that Kesselheim’s first opinion regarding biosimilar competition generally should be excluded because it merely repeats findings from his two studies on other biologic drugs and makes no effort to reliably extrapolate those findings to Stelara.

    The Court held that Kesselheim’s first opinion is grounded in fifteen years of research and peer-reviewed studies examining how biological drug markets respond to biosimilar competition, and Kesselheim clearly applies those industry patterns to a hypothetical but-for scenario. J&J argued that Kesselheim should have performed an analysis beyond repeating the findings of his studies or ran “new regression models” more specific to Stelara. However, Kesselheim’s role is to explain market behavior based on consistent historical experience and thus is not required to have performed new quantitative analysis. Accordingly, any alleged gaps in Kesselheim’s analysis go to weight and can be addressed on cross-examination.

    Additionally, Kesselheim’s first opinion is helpful for the jury because it bears directly on what would have happened to Stelara prices absent the alleged anticompetitive conduct. Kesselheim’s first opinion situates Stelara within the broader context of a competitive biologies market, including comparator biologies such as Humira and J&J’s own Remicade. Thus, Kesselheim provided the jury with a framework for understanding how a competitive biologies market typically functions.

    B. Kesselheim’s Second Opinion

    Kesselheim’s second opinion discussed the likely “effects of biosimilar competition on the ustekinumab market if one or more biosimilars launched in or around September 25, 2023.” Kesselheim opined that if one or more biosimilars launched at that time, “there would have been a meaningful lowering of spending related to this drug by all different categories of payors in the U.S.”

    J&J sought to exclude Kesselheim’s second opinion on the grounds that it is unreliable and unhelpful speculation. J&J argued that Kesselheim utilized no specific methodology or analysis to draw his conclusions. According to J&J, Kesselheim’s conclusions rest on analogies to other drugs such as Humira, ignore available evidence from actual biosimilar entry, and amount to impermissible ipse dixit.

    Kesselheim’s conclusion that earlier biosimilar entry would have led to a meaningful reduction in Stelara’s net price is grounded in reliable, peer-reviewed research as well as consistent historical experience across biologic drug markets. Kesselheim’s conclusions are not merely speculation, as J&J contended. Rather, in his report, Kesselheim synthesized data from multiple biosimilar launches and explained why Stelara shares salient market characteristics with comparator drugs such as Humira. This is not only reliable expert testimony but also relevant context for the jury to understand how biosimilar entry affects biologic pricing.

    Furthermore, the Court is not persuaded by J&J’s argument that Kesselheim’s opinion is faulty because he did not specifically examine the data following the entry of a biosimilar drug to ustekinumab in January 2025. Given the timing of the events in this litigation, such data simply was not available when Kesselheim prepared his report in March 2025.

    C. Kesselheim’s Discussion of Life Cycle Management Strategies

    Kesselheim opined on how “life cycle management” strategies in the pharmaceutical industry are an important factor affecting biosimilar availability. Kesselheim opined that “life cycle management” strategies is a “broad term” describing “drug manufacturers’ strategic efforts to extend their drugs’ market exclusivities, prolong commercial viability, or strengthen their competitive positions in a market.” J&J sought to exclude these observations on the grounds that they are “not grounded in the facts of this case” and are unhelpful to a jury. J&J argued that these “generalized musings” are untethered to either of CareFirst’s theories of liability in this case and thus would risk misleading the jury by introducing irrelevant industry practices that CareFirst does not allege are unlawful.

    The Court held that Kesselheim appropriately draws on his specialized knowledge of industry practices and incentives to provide context for why J&J’s alleged conduct fits within established industry patterns. J&J’s objections that Kesselheim “was not even aware of the biologic manufacturing patents at issue” and “did not review any of the settlements that J&J entered with biosimilar manufacturers” went to the weight, not admissibility. 

    Held

    The Court denied J&J’s motion to exclude the testimony of Dr. Aaron Kesselheim.

    Key Takeaway

    Kesselheim’s observations on pharmaceutical life cycle management are admissible as reliable and relevant testimony. Kesselheim’s opinions on this issue are grounded in specific academic research examining how branded drug manufacturers use secondary patents and related strategies to extend market exclusivity and delay biosimilar competition. This type of experiential expert testimony does not need to rest on quantitative analysis specific to Stelara to be reliable.

    Please refer to the blog previously published about this case:

    Marketing Expert’s Testimony on Patent-Related Barriers Admitted

    Case Details:

    Case Caption: Carefirst Of Maryland, Inc., Et Al. V. Johnson & Johnson
    Docket Number: 2:23cv629
    Court Name: United States District Court, Virginia Eastern
    Order Date: December 23, 2025
  • Compliance Expert’s Testimony on the Marketability of the Olivetol Excluded

    Compliance Expert’s Testimony on the Marketability of the Olivetol Excluded

    Noramco and Dishman entered into a contract (“the Supply Agreement”) under which Dishman agreed to provide Noramco with a large amount of olivetol, an ingredient used in the manufacture of pharmaceutical products. 

    The Supply Agreement required Dishman to supply Noramco with olivetol manufactured at Dishman’s facilities in India. The Agreement represented that those facilities were “c-GMP compliant,” i.e., compliant with the current Good Manufacturing Practice standards set by the U.S. Food and Drug Administration.

    In February 2020, the European Directorate for the Quality of Medicines & HealthCare (“EQDM”) inspected Dishman’s facility in India where the olivetol was manufactured. The EQDM subsequently informed Dishman on March 19, 2020, that the facility had failed the inspection and was not compliant with cGMP. 

    The batches of olivetol at issue in this case were manufactured by Dishman after the failed inspection. The were shipped by Dishman on March 26, 2020, and received by Noramco on April 2, 2020. After an exchange of emails between the parties regarding the effect of the failed inspection, Noramco rejected the olivetol and sought a refund of the amount Noramco had paid for the product. When Dishman refused to accept the return of the olivetol and to return the funds Noramco had paid for the olivetol, Noramco brought this action seeking damages for breach of contract.

    The Plaintiff, Noramco LLC (“Noramco”), has filed a motion to exclude the opinion testimony of Dr. Rino C. Coladangelo, an expert witness for the Defendant, Dishman USA, Inc. (“Dishman”).

    Compliance Expert Witness

    Dr. Rino Casmira Coladangelo MB BS MRCP is a medical doctor with experience in the field of pharmaceutical compliance.

    He led the global consultancy company Rephine which provided a world class compliance and regulatory service to pharmaceutical companies. His expertise includes regulatory and quality aspects of pharmaceutical manufacture and covers all major global markets.

    Want to know more about the challenges Rino Casmira Coladangelo has faced? Get the full details with our Challenge Study report.

    Discussion by the Court

    To begin with, Noramco challenged Coladangelo’s qualifications as an expert and argued that his reports “lack reliable methodology, are based on unsupported speculation, offer legal conclusions, opine on Plaintiff’s state of mind, and do not establish the expert’s qualifications in the relevant subject matter.” 

    The Limits of Coladangelo’s Qualifications

    From April 2009 until October 2021, Coladangelo served as Chief Executive Officer of Rephine Ltd., a global pharmaceutical consultancy specializing in quality compliance in manufacturing, and regulatory affairs.In that capacity, Coladangelo “led the training and development of the staff and consultants, as well as accreditation of specialty staff.”

    Based on Coladangelo’s experience at Raphine Ltd., the Court found that Coladangelo was qualified to testify as an expert on matters of quality compliance and regulatory affairs in the pharmaceutical industry. However, Coladangelo’s expertise in the field of pharmaceutical quality compliance and regulatory affairs did not qualify him to testify on legal issues or the state of mind of representatives of the opposing party, which are the subjects of much of his expert report.

    In his report, Coladangelo stated that “[t]he supply agreement makes clear that any rejection of material must be made within 30 working days of receipt” and that the actions taken by Noramco “contravene the terms of the agreement.” According to the Court, Coladangelo lacked the qualifications to provide an opinion interpreting the contract in this case, and even if he were qualified to give such an opinion, it would be improper for him to express a legal opinion as to whether Noramco failed to comply with the terms of the Supply Agreement, which is an ultimate issue in this case.

    To the extent Coladangelo purports to offer legal opinions or speculate as to the Noramco representatives’ state of mind, his testimony will be excluded.

    The Reliability of Coladangelo’s Testimony

    First, Coladangelo’s report contains a list of 24 manufacturers of medicinal THC and asserted that “[s]ome of these might have been interested in acquiring the Olivetol batches.” However, aside from the list of THC manufacturers, the report contained no other facts, data, or methodology supporting Coladangelo’s conclusion that all or some number of the listed manufacturers might have been willing to purchase the non-compliant olivetol.

    Second, Coladangelo’s report points to Noramco’s failure to promptly reject the olivetol and its act of sampling the product as causing a reduction in the shelf life and marketability of the olivetol. According to Coladangelo, “[n]on-conformity with the proper protocol would make the material unusable by others.” However, the Court concluded Coladangelo’s naked assertion that non-conformity would make the olivetol unusable by others lacked sufficient support in facts, data, or methodology.

    Third, Coladangelo asserted in his report that the non-cGMP compliant olivetol “could still be used if a Risk Assessment Analysis (RAA) is undertaken.” In support of that assertion, Coladangelo cited certain guidelines from the EQDM and noted that certain other pharmaceutical products have been accepted by Belgian, German, and Brazilian manufacturers following an RAA. 

    Without some reasoning or methodology to connect the use of an RAA to the olivetol at issue beyond an “implication” or speculation, the Court held that Coladangelo’s conclusion regarding olivetol’s potential use after an RAA lacked the scientific support that Daubert demands.

    The Fit of Coladangelo’s Testimony

    Coladangelo’s expert testimony must help the trier of fact decide (1) the timeliness of Noramco’s rejection and (2) the mitigation of Dishman’s damages.

    On the issue of timely rejection, the Court held that Coladangelo’s opinions, as expressed in his report, are of limited value to the trier of fact. Specifically, the timely rejection issue is primarily a question of contract interpretation as applied to the series of events and correspondence that unfolded between Noramco and Dishman. Moreover, the testimony that Coladangelo is qualified to give on pharmaceutical compliance and regulatory affairs did little to help resolve whether Noramco timely rejected the olivetol at issue.

    On the issue of mitigation of damages, however, the opinions offered by Coladangelo may offer some assistance to the finder of fact in determining whether Noramco’s actions constituted reasonable steps to mitigate Dishman’s damages under the circumstances. In other words, Coladangelo may be able to help the finder of fact understand industry customs and practices for regulatory compliance testing and for opening and resealing tested materials.

    Held

    The Court granted in part and denied in part Noramco’s motion to exclude opinions and testimony of Dr. Rino Casmira Coladangelo.

    Key Takeaway:

    While there are portions of Coladangelo’s report (and, thus, his proposed testimony) that are legitimately within his expertise, much of his report reads like the first closing argument for the Defendant. It appears to be an example of the increasingly common practice of allowing the presentations of expert witnesses to bleed over from expert testimony on discrete factual issues into legal argument on the merits of their proponent’s case. That is decidedly not the role of expert witnesses.

    Case Details:

    Case Caption: Noramco LLC V. Dishman USA, Inc.
    Docket Number: 1:21cv1696
    Court Name: United States District Court, Delaware
    Order Date: October 16, 2025
  • Law & Legal Expert Helps Jury Understand Medicaid’s Complex Regulatory Framework

    Law & Legal Expert Helps Jury Understand Medicaid’s Complex Regulatory Framework

    Plaintiff State of Washington alleged that Novo Nordisk Inc. (“NNI”) caused physicians to prescribe its drug, NovoSeven®, to Washington hemophilia patients by: (1) promoting it “off-label” for prophylaxis and “high dose” use; (2) paying kickbacks to physicians; and (3) paying bribes to patients, all of which rendered claims to Medicare and Washington Medicaid false.

    The State of Washington has been investigating this case for almost fifteen years, hoping to find evidence of unlawful conduct that allowed its Medicaid program to recoup money it paid for a medically necessary, life-saving drug.

    The Plaintiffs Jamie Siegel and the State of Washington filed a motion to exclude the testimony of Defendant Novo Nordisk’s expert witness, Daniel E. Troy.

    Law & Legal Expert Witness

    Daniel E. Troy has been an attorney for 40 years, with 23 years of experience in health care regulation, including three years as Chief Legal Counsel to the FDA and many more in the private sector health industry.

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

    Discussion by the Court

    To begin with, Washington argued that Troy’s opinions were improper legal conclusions about the ultimate issue of law: whether NNI’s marketing practices are protected by the First Amendment or U.S. Food and Drug Administration (“FDA”) regulations. It argued that “can be” is not an opinion at all; it is speculation. Moreover, Washington contended that Troy’s testimony would confuse and mislead the jury about the legality of NNI’s practices, prejudicing it.

    NNI responded that there is well-established precedent that a properly qualified expert with expertise in the regulatory framework or landscape of a highly technical and regulated industry or program, such as Medicaid, can help a jury understand the evidence or determine a fact in issue. It argued that far from unduly prejudicing Washington or confusing the jury, Troy’s testimony will assist the jury in understanding the FDA’s enormously complex regulatory structure, in order to evaluate whether NNI’s conduct was improper.

    Analysis

    The Court agreed with NNI that the bulk of Troy’s testimony will assist the jury and is admissible. This case presents a complexity of issues that requires the jury to understand the regulatory scheme of the government’s oversight of pharmaceuticals through the review of extensive legal briefing spanning the years that this litigation has been pending. However, Troy will not be allowed to testify on how the application of the First Amendment has informed the development of case law in America as it applies to the pharmaceutical industry in its testing and promotion of its drugs.

    The Court held that Troy will be permitted to testify about the marketing role that the dissemination of peer-reviewed studies has in the medical industry for the purpose of acquainting practicing physicians with new pharmaceuticals or new treatment applications of established pharmaceuticals, including off-label uses.

    Basically, Troy’s testimony should discuss industry and regulatory standards when assessing a specific study or article, including the use of the FDA’s nonbinding Good Reprint Practice guidance, and related recommendations.

    Moreover, Troy devoted a significant part of his report to discussing the Konkle Study in the context of the Good Reprint Practice review. This was apparently chosen because Washington cited it as an example of a marketing violation of the AKS.

    As a defense expert, the Court reviewed Troy’s report and his expected trial testimony as rebuttal testimony. Troy will be permitted to go through the Good Reprint Practice guidance and review the record by identifying what NNI did factually to meet the Guidance standards. He will not be permitted to testify that NNI’s activities in connection with the Konkle Report rendered NNI in compliance with the AKS “safe harbor” as this would be testimony an ultimate issue of law.

    Held

    The Court granted in part and denied in part the State of Washington’s Daubert motion to exclude Daniel E. Troy’s testimony.

    Key Takeaway:

    In the Court’s view, Troy’s testimony is not unlike that of an expert physician specialist explaining to a jury the standard of care for a particular procedure by describing the procedure’s steps and then explaining, through reference to the medical records, what steps the allegedly negligent physician took. The expert would not be permitted to testify that, in his opinion, the reviewed physician was or was not negligent.

    Similarly, Troy will be permitted to rebut any evidence produced in Washington’s case in chief regarding its claim that the jury should make a negative inference from the fact NNI rejected the FDA’s request that NNI conduct a Phase III Study. He describes these studies as expensive and explains how other alternatives can be used to demonstrate that NovoSeven is safe and effective, what he calls “real world evidence.”

    Troy will also be permitted to rebut any evidence Washington introduces about free drug samples. He can describe how the FDA regulates this activity, and under what conditions free samples can meet the AKS’s safe harbor requirements, and what the record demonstrates about NNI’s distribution of free samples. He, however, may not testify that NNI complied with the regulations relating to free samples.

    Washington conceded that, as a general rule, an expert’s opinion is not objectionable simply because it embraces an ultimate issue to be decided by the trier of fact. However, it argued persuasively that an expert cannot offer a legal conclusion or opine on an ultimate issue of law.

    Case Details:

    Case Caption: United States ex rel. Siegel V. Novo Nordisk Inc.
    Docket Number: 3:23cv5459
    Court Name: United States District Court, Washington Western
    Order Date: July 14, 2025
  • Court refuses to exclude Pharmaceutical Expert Witness’ Opinions Regarding Breadth of Asserted Claims

    Court refuses to exclude Pharmaceutical Expert Witness’ Opinions Regarding Breadth of Asserted Claims

    A district judge in Florida refused to exclude the testimony of a pharmaceutical expert witness despite allegations of fundamental flaws in the assumptions on which her calculations are based.

    Defendant Aveva Drug Delivery Systems, Inc. of an Abbreviated New Drug Application (“ANDA”) No. 217221 to the U.S. Food and Drug Administration (“FDA”) sought approval to manufacture and sell a Lidocaine Topical System, 1.8% product (“Defendants’ ANDA Product”), a generic version of Scilex Pharmaceuticals Inc.’s ZTLIDO® (lidocaine topical system) 1.8% (“ZTlido®”), prior to the expiration of U.S. Patent Nos. 9,283,174 (the “’174 patent”), 9,925,264 (the “’264 patent”), and 9,931,403 (the “’403 patent”) (collectively “the Asserted Patents”).

    Plaintiffs alleged that the Defendants’ ANDA Product will be marketed as a generic competing product to ZTlido®, a product developed by Plaintiffs for the relief of pain associated with post-herpetic neuralgia (PHN) in adults.

    This patent infringement arises from Aveva’s notification to Scilex Pharmaceuticals Inc. by Notice Letter dated May 10, 2022, that it had filed an Abbreviated New Drug Application (“ANDA”) No. 217221.

    Defendant Aveva proffered expert witness Dr. Maureen Donovan who stated that that the claims of the Asserted Patents were extremely broad, and therefore that they were not enabled because it would require undue experimentation to practice the claims.

    Plaintiffs filed a motion to strike Donovan’s opinions and analysis regarding the breadth of the asserted claims from consideration at the bench trial in this case. Plaintiffs also accused her of improper supplementation and bolstering under Rule 26 in a separate motion.

    Pharmaceutical Expert Witness

    Maureen Donovan is a Professor of Pharmaceutical Sciences and Experimental Therapeutics at the University of Iowa College of Pharmacy. Donovan holds a Ph.D. in Pharmaceutics from the University of Minnesota College of Pharmacy and has over forty years of experience conducting research and consulting with companies in the field of pharmaceutical sciences.

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

    Discussion by the Court

    Rule 702

    Plaintiffs argued that Donovan’s exemplary calculations, analysis of the breadth of the claimed concentration ranges, and her opinions relying thereon did not meet the requirements of Rule 702. Plaintiffs added there were fundamental flaws in the assumptions on which her calculations are
    based.

    As to experience and qualifications, Plaintiffs did not contend that Donovan was not sufficiently qualified to offer her proffered opinions in this case.

    The Court determined that the proper remedy for any potential weaknesses identified is vigorous cross-examination and confrontation. In other words, Plaintiffs were not precluded from challenging the reliability of Donovan’s opinions at the bench trial. In conclusion, the Court may disregard any expert testimony at trial, if it “turns out not to meet the standard of reliability established by Rule 702.”

    Rule 26

    In a separate motion, Plaintiffs alleged that Donovan altered her written opinion to better align her opinion with another expert’s findings.

    Donovan, having discovered an error in her calculations, was required to correct her findings. Defendants argued that the corrections favored Plaintiffs’ position.

    The Court held that the revisions were both substantially justified and
    harmless. The Defendants filed Donovan’s amended report well before the 30-day deadline contemplated for pretrial disclosures under Rule 26(a)(3). The Court, therefore, denied Plaintiffs’ arguments on the grounds
    that any violation, should one exist, was substantially justified under the circumstances. Moreover, Defendants have both offered Plaintiffs the opportunity to re-depose Donovan and will not oppose supplemental reports from Plaintiffs’ expert.

    The Court added that the decision not to exclude Donovan’s corrected report in no way prevented Plaintiffs from vigorously cross-examining her on her alleged mistakes.

    Held

    The Court denied both motions to exclude the testimony of Defendants’ expert Maureen Donovan.

    Key Takeaway:

    The Court determined that the proper remedy for any potential weaknesses identified is vigorous cross-examination and confrontation. In other words, Plaintiffs were not precluded from challenging the reliability of Donovan’s opinions at the bench trial and the decision not to exclude Donovan’s corrected report in no way prevented Plaintiffs from vigorously cross-examining her on her alleged mistakes.

    Case Details:

    Case Caption: Scilex Pharmaceuticals, Inc. Et Al V. Aveva Drug Delivery Systems, Inc., Et Al
    Docket Number: 0:22cv61192
    Court: United States District Court, Florida Southern
    Order Dates: May 15, 2024 and May 23, 2024