Expert Witness Profiler

Tag: Reliable

  • Marketing Expert’s Use of the Market Approach Methodology Affirmed

    Marketing Expert’s Use of the Market Approach Methodology Affirmed

    Plaintiff FireBlok IP Holdings LLC (“FireBlok”) sued Defendants Hilti, Inc. (“Hilti”) and RectorSeal LLC (“RectorSeal”) (together, “Defendants”) and asserted two separate causes of action under the Lanham Act, False Advertising and False Association, based upon Defendants’ use of the UL Certification mark and FM Approval mark on Hilti’s Firestop Box Insert.

    The Firestop Insert is a fire suppression product that is an intumescent box insert designed to help protect electrical outlet boxes in case of a fire. FireBlok’s alleged competing produce is the FireBlok fire suppression gasket.

    FireBlok retained Dr. Alexander V. Krasnikov to testify to damages allegedly sustained by the Defendants’ false advertising and false association.

    Hilti, Inc. and RectorSeal, LLC filed a motion to exclude the testimony of Krasnikov.

    Marketing Expert Witness

    Dr. Alexander V. Krasnikov is a professor at the Quinlan School of Business at Loyola University Chicago, specializing in marketing strategy, analytics, and intellectual property. Since receiving his Ph.D. in marketing in 2007, Krasnikov has continuously researched, published articles, and given lectures on consumer goods marketing and IP strategy.
    Krasnikov has nearly twenty years of experience as a business school professor, teaching undergraduate, graduate, and Ph.D. students about “data analytics, marketing metrics, customer analytics, marketing research, and strategy.”

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

    Discussion by the Court

    Based on his education, experience, and review of the documents produced in litigation, Krasnikov reached three opinions:

    (1) Hilti and RectorSeal’s Profits: From 2008 to 2019, the Defendants’ sales for Firestop Box Inserts reached over $316 million. According to industry- standard profit margins, the Defendants likely net about 31% of this figure ($98 million dollars).

    (2) FireBlok’s Market Share: Without the Defendants’ presence in the market, FireBlok would’ve held 3.82% of the market share for intumescent inserts for electrical outlets and switchboxes. Alternatively, those sales may have evenly split between three major competitors, making FireBlok’s relative market share about 33.3%.

    (3) FireBlok’s Lost Profits: From 2012 to 2019, but now adjusted for inflation, FireBlok lost between $4.2 million and $37 million in profits to the Defendants.

    Qualification

    While it is true that Krasnikov isn’t specifically versed in the fire suppression industry and that he’s never personally prepared a profit/loss statement, the Defendants, however, never explain why those facts matter. Krasnikov commonly analyzes profit/loss statements prepared by third parties and, to the extent necessary, filled gaps in his industry-specific knowledge by relying on FireBlok’s fire suppression expert. If anything, estimating lost profits for fire suppression products is easier than most other industries. An average consumer upset by the (now shocking) price of eggs may choose a cheaper grocery store, use an alternative product, or go without; whereas, professionals in the fire suppression industry must purchase a switchbox and insert to comply with building codes. Therefore, the Court found Krasnikov generally qualified to opine on damages.

    Reliability

    First, in estimating the Defendants’ profits, Krasnikov multiplied their self-reported unit sales by the price per unit (calculating total revenue), then subtracted industry-standard costs as reported in financial and economic databases.

    Second, Krasnikov compared FireBlok’s self-reported 2017–2019 sales to its competitors’ publicly reported annual revenue data for the same timeframe. Finding that two competitors make about thirty-five times FireBlok’s annual revenue for one product category, Krasnikov estimated that FireBlok’s relative market share for intumescent inserts for electrical outlet and switch boxes is roughly 4%.

    Finally, Krasnikov calculated FireBlok’s lost profits by multiplying the Defendants’ unit sales of uncertified products by FireBlok’s market share. So, the Defendants wrongly asserted that Krasnikov relied on insufficient data, “blindly relied” on client information, and failed to support his methodology.

    For one, the Defendants challenged the relevance of their own profitability before FireBlok entered the market in 2016. But without some reason to believe this calculation makes Krasnikov’s conclusions unreliable, the argument does not concern Krasnikov’s methodology. Likewise, to group the remaining arguments by their primary themes, the Defendants maintained that Krasnikov made implausible assumptions and failed to consider key variables.

    It’s true that Krasnikov didn’t consider every variable conceivably affecting market share—such as FireBlok’s manufacturing capacity, profit-sharing agreements, and any promotional discounts in the relevant timeframe. But every analysis makes some assumptions. In this case, the assumptions are supported by reason.

    Krasnikov’s lost profit analysis turns on FireBlok’s past performance in the market. After analyzing manufacturer market power, product offerings and prices over time—and further discussing the market with FireBlok—Krasnikov applied that data to a series of calculations plausibly based on market realities.

    Held

    The Court denied the Defendants’ Daubert motion to exclude the testimony of Plaintiff’s expert Dr. Alexander V. Krasnikov

    Key Takeaway:

    The Defendants objected to Krasnikov’s use of the market approach methodology. The Defendants contended that Krasnikov was required to use either the yardstick or the before-and-after methodology. But the yardstick and the before-and-after methodologies are not the exclusive ways that experts can determine damages. And courts have found the market approach an acceptable methodology.

    Case Details:

    Case Caption: Fireblok IP Holdings, Llc V. Hilti, Inc.
    Docket Number: 3:19cv50122
    Court Name: United States District Court, Illinois Northern
    Order Date: August 04, 2025
  • Fire Investigation Expert’s Testimony About a Missing Orifice Admitted

    Fire Investigation Expert’s Testimony About a Missing Orifice Admitted

    On January 21, 2021, a fire destroyed Jacqueline Flynn’s home located at 7618 Craig Court in Orlando, Florida. The Plaintiff purchased a Thermacell Patio Shield on the day of the fire. Since the Patio Shield was the only energized device in use on the balcony at the time of the fire, the Plaintiff filed her complaint alleging negligence and strict products liability against the Defendants as a result of the Fire.

    The Defendants filed a Daubert motion to exclude the opinions of Plaintiff’s expert John J. Lentini.

    Fire Investigation Expert Witness

    John Joseph Lentini served as a principal member of the NFPA 921 Technical Committee for 20 years and routinely reviews other investigators’ reports to evaluate their compliance with NFPA 921 and other standards. He is the president and principal investigator at his consulting firm.

    Since 1975, he has given expert testimony in over two hundred cases in civil and criminal court in several states and in the Federal Courts.

    Want to know more about the challenges John J. Lentini has faced? Get the full details with our Challenge Study report. 

    Discussion by the Court

    Defendants’ Objections

    The Defendants sought to exclude Lentini’s opinion that the Thermacell Patio Shield experienced a manufacturing defect causing the fire. 

    Lentini presented four opinions in his expert report. First, he stated that the fire started on the second-floor balcony where the Thermacell Patio Shield was located. Second, he explained that if the Thermacell unit catches fire, its components will burn vigorously and act as a capable ignition source for nearby combustibles. Third, he suggested that the most probable cause of the fire is a malfunction of the Thermacell unit due to a manufacturing defect. Fourth, he indicated that the most likely manufacturing defect is the absence of an orifice. Lentini supported each of these opinions with their respective bases.

    Lentini’s Opinions

    Methodology

    To begin with, Lentini conducted experiments to demonstrate that if the orifice was omitted from the Thermacell Patio Shield during manufacturing, a flame would appear near the intake and contact the bottom of the combustible heat box. 

    Once Lentini’s experimentation established that the Patio Shield was a competent ignition source, Lentini ruled out other possible causes for the fire. Lentini opined that the Thermacell Patio Shield was the only thing on the second-floor balcony that could have caused the fire.

    Lentini observed that common sense also suggests the Thermacell Patio Shield caused the fire. He stated, “[i]f there was an electrical failure, it is a major coincidence. . . . Almost astronomically impossible coincidence that a latent [electrical] defect decided to manifest itself during that short period of time that the Thermacell unit was burning for the first time.”

    In summary, Lentini tested the Thermacell unit to see if it could serve as a competent fire source. He found that tipping the unit on its side or dropping it from a patio table height did not produce a reliable fire, ruling out the chance of an accidental fire caused by a gust of wind. Lentini also eliminated the possibility of an electrical fire originating from an outlet, overhead lights, or the television on the patio. He then concluded that a manufacturing defect, such as a missing orifice, allowed enough butane to be released to ignite the device, which broke the glass tabletop and set fire to other combustible materials, including the lounge chairs and cushions. The Court therefore found that Lentini’s methodology is sufficiently reliable to meet Daubert standards.

    Lentini’s Opinions on Origin

    They Defendants sought to exclude Lentini’s opinion that the fire originated on the balcony where the Thermacell unit was located.

    Lentini ruled out electrical causes for the fire, leaving the Patio Shield as the source. Since Lentini’s methodology is sound, the Court held that his conclusion—that the fire started on the balcony at the Thermacell unit—remains valid.

    The Defendants also sought to exclude Lentini’s opinion that Garrett Wienckowski of Orange County Fire Rescue and Patrick Dugan of NEFCO Fire Investigations used generally accepted methods to conclude that the fire started at the location of the Thermacell unit.

    Lentini can rely on Dugan’s report, and in doing so, may explain why these facts and data are the types typically relied upon by experts in his field when forming an opinion, including the reliability of Dugan’s methodology. As for Chief Wienckowski, the Defendants argued that Lentini cannot offer an opinion on his conclusions because the Chief’s opinions are inadmissible.

    The Court previously found that his opinion that the fire started on the second-floor balcony, that it was accidental, and that there is no information suggesting this was an electrical fire, are admissible as lay witness opinions. Lentini may testify on how these lay witness opinions are used in forming his own opinions.

    The Defendants’ next objection is to Lentini’s opinion that credible eyewitnesses placed the origin of the fire on the second-floor balcony. However, the Court denied the Defendants’ motion to exclude an opinion on a point they admitted. 

    Defendants also sought to exclude Lentini’s opinion that there were no other potential sources of ignition on the balcony as unsupported by Dugan’s investigation. The Court overruled the Defendants’ Daubert Motion to exclude the testimony of Dugan, finding his methodology sound.

    Held

    The Court denied the Defendants’ Daubert motion to exclude the opinions of Plaintiff’s expert John J. Lentini.

    Key Takeaway:

    The Defendants seemed to argue that neither Lentini’s opinions nor their supporting bases can be stated with certainty. It is important to note that “certainty is not required to provide expert testimony.”

    Because the Court found Lentini’s opinions on the cause of the fire to be sufficiently reliable and helpful, the Defendants’ request to exclude his opinion that the Thermacell unit will burn vigorously and provide a competent ignition source, and that the likely cause of the fire is a manufacturing defect, is denied.

    Please refer to the blog previously posted about this case:

    Fire Investigation Expert’s Opinion on Damage to the Residence Admitted

    Case Details:

    Case Caption: Flynn V. Thermacell Repellents, Inc. Et Al
    Docket Number: 6:23cv1890
    Court Name: United States District Court, Florida Middle
    Order Date: August 01, 2025
  • Rehabilitation Expert’s Employability Report Partly Admitted

    Rehabilitation Expert’s Employability Report Partly Admitted

    Plaintiff Jean-Claude Franchitti brought retaliation claims against his former employers, Defendants Cognizant Technology Solutions Corp. and Cognizant Technology Solutions U.S. Corporation.

    More specifically, Franchitti alleged that Cognizant terminated his employment because he spoke out against the company’s unlawful efforts to eliminate experienced non-Indian employees in its workforce, questioned the legality of fraudulent visa applications the company was submitting to on behalf of Indian workers, and complained about discrimination.

    Cognizant retained Rona E. Wexler and Richard V. Turner as expert witnesses to testify about Franchitti’s efforts—or lack thereof—to obtain employment following his termination in 2016. Wexler and Turner coauthored a report (the “Wexler and Turner Report”) that presented their opinion that “Dr. Franchitti failed [to] perform[] a reasonably diligent job search since his separation from Cognizant.” 

    To rebut the opinions of Wexler and Turner, Franchitti proposed to call at trial Roberto J. Cavazos, who authored an “Expert Rebuttal Report” (the “Cavazos Report”) in response to the Wexler and Turner Report.

    Each side filed motions to exclude some or all of the testimony of the other side’s experts.

    Vocational Evaluation & Rehabilitation Expert Witnesses

    Rona E. Wexler, M.A., ADVE/D is the President and Founder of Wexler Vocational and Career Consulting LLC. She holds a B.A. in English and Education from Emerson College and an M.A. in Counseling Psychology and Guidance from New York University. She provides vocational/employability evaluations and expert witness services nationwide.

    With over two decades of experience as a Vocational Evaluator, Career Advisor, and Employability Expert, Wexler also brings 12 years of executive recruiting experience, having served as a principal/managing partner and director in two firms.

    Wexler is certified as a Diplomate (ABVE/D) by the American Board of Vocational Experts. She has served on the ABVE Board of Directors and chaired the committee responsible for overseeing the standards and credentialing process from 2015 to 2022.

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

    Richard V. Turner, Ph.D., CRC, IPEC is the Director of Research and Evaluations at Wexler Vocational and Career Consulting LLC. He holds a B.S. in Psychology with a minor in Biology from Kansas State University, an M.A. in Rehabilitation and Counselor Education from The University of Iowa, and a Ph.D. in Rehabilitation Counseling from Southern Illinois University Carbondale. Turner is a Certified Rehabilitation Counselor and received dual training in rehabilitation counseling and clinical mental health.

    Moreover, he has experience in integrated care settings providing rehabilitation and counseling services to individuals with serious mental illness, case management for individuals with disabilities, and vocational evaluation, with particular expertise in standardized testing and assessment.

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

    Economics Expert Witness

    Roberto J. Cavazos, Ph.D. is a professional economist with over 30 years of experience. He holds a bachelor’s degree, a Master of Public Administration, and a Ph.D. from the University of Texas. Basically, his work has focused on labor issues, including lost earnings in litigation matters, labor-management relations for global multinationals, and research and evaluation projects for the U.S. Department of Labor.

    He has served on the faculty of the University of Texas at San Antonio, Florida International University, and Carnegie Mellon University, where he taught graduate-level courses in economics and statistics. He is currently the Analytics Practice Lead at EmployStats, a research firm specializing in economic and statistical analysis for the legal, business, and governmental sectors, and also serves on the faculty of the University of North Texas School of Business.

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

    Discussion by the Court

    Franchitti’s Motion

    Rule 26

    To begin with, Franchitti argued that the co-authors Wexler and Turner report failed to comply with Rule 26(a)(2)(B) of the Federal Rules of Civil Procedure. That Rule requires an expert’s report to disclose “a complete statement of all opinions the witness will express and the basis and reasons for them.” Franchitti contended that the Wexler and Turner Report ran afoul of that requirement because it made no “distinction as to which opinions were attributable to which expert.”

    Allowing Cognizant to call both Wexler and Turner as experts would run afoul of Rule 403 of the Federal Rules of Evidence, which calls for exclusion of evidence “if its probative value is substantially outweighed by a danger of . . . needlessly presenting cumulative evidence.” Accordingly, pursuant to Rule 403, the Court will permit Cognizant to call only Turner and will exclude Wexler from testifying.

    Since Franchitti is entitled to know whether all of the opinions in the Wexler and Turner Report represent the opinions of Cognizant’s testifying expert, Turner, Cognizant was directed to produce a copy of the report to Franchitti with any portions not adopted by Turner as his own struck through.

    Next, Franchitti argued that Turner should not be permitted to testify that Franchitti failed to conduct a “diligent” job search following his termination. The Court agreed. It would not be proper for [an expert] to testify as to whether [a Plaintiff’s] efforts to find comparable employment were ‘reasonable’ because this is an ultimate question . . . which is for the jury to decide. However, Turner may testify as to what a reasonable job search, in his experience, typically consists of, and how Franchitti’s job-search efforts compare.

    Qualification

    Also, Franchitti argued that Wexler and Turner’s opinion as to the amount of time it would have taken Franchitti to find comparable employment should be excluded. Specifically, Franchitti objected to Wexler and Turner’s conclusion that “if Franchitti had exercised a diligent, full-time job search of consistent and diverse activities, in four to six months he would have been hired in an Information Technology Management, Consulting, or similar role.”

    Franchitti complained that Wexler and Turner are neither qualified to offer this opinion, nor provide sufficient support for their conclusion. The Court disagreed. As to qualifications, the Court is satisfied that Turner’s professional experience — including prior expert-witness work — renders him sufficiently qualified to opine on the matter.

    And as to the reliability of Wexler and Turner’s opinion about the duration of a reasonable job search for someone in Franchitti’s position, the Court agreed that Wexler and Turner’s assessment is admissible.

    In short, Wexler and Turner’s use of general studies and their analysis of Franchitti’s age, skill set, labor market, actual job openings in his field, and unemployment rates, taken together, is sufficient. To the extent Franchitti believes otherwise, his remedy is “vigorous cross-examination” and “presentation of contrary evidence.”

    Cognizant’s Motion

    Cognizant sought to exclude the opinions of Cavazos. Applying the Daubert standard, the Court agreed with Cognizant that Cavazos is not qualified to rebut the employability report because he lacks the relevant expertise in recruiting and career counseling or in Franchitti’s industries — that is, information technology and consulting.

    Although Cavazos has a professional and educational background in economics, he has no experience working as a recruiter or career counselor, has neither taken nor taught courses on career counseling or job search efforts, and has never even provided advice on strategies for finding a new job.

    Cavazos’s closest experience to career coaching appears to be in his role as a university professor, “helping students try to get employment and giving them ideas.” However, this limited experience does not qualify him to offer opinions on Turner’s expert analysis of Franchitti’s job search.

    Held

    • The Court granted in part and denied in part Franchitti’s motion to preclude the testimony of Rona E. Wexler and Richard V. Turner.
    • The Court granted Cognizant’s motion to preclude the testimony of Roberto J. Cavazos.

    Key Takeaway:

    Where the co-authors reviewed the same materials and, working together, came to the same opinions and are both prepared to testify to all the opinions in the report, there is no reason why it would be inherently impermissible for them to file a joint report.

    On the other hand, Rule 26(a) may be implicated when it isn’t clear whether both experts adhere to all of the opinions in the report and they do not delineate which opinions belong to which expert so as to impede the opposing party’s preparation of effective cross-examination.

    Case Details:

    Case Caption: Franchitti V. Cognizant Technology Solutions Corporation Et Al
    Docket Number: 1:21cv2174
    Court Name: United States District Court, New York Southern
    Order Date: July 29, 2025
  • Insurance Expert Permitted to Testify Despite Lacking Specific Certifications

    Insurance Expert Permitted to Testify Despite Lacking Specific Certifications

    Plaintiffs Diane Watts, Anthony Watts, and Adam Pizzitola (collectively, “Plaintiffs”) purchased car insurance policies from Defendants Liberty Mutual Personal Insurance Company.

    In relevant part, the policies contained an Optional Transportation Expenses Coverage endorsement which provided that, in the event of an accident, LMPIC would pay the expense of a rental vehicle while repairs were performed on the damaged vehicle. If the vehicle was declared a total loss, then LMPIC would pay for a rental vehicle for the “period of time reasonably required” to replace the total loss vehicle, up to a maximum of 30 days, or $900.

    Each Plaintiff alleged that after a car accident in which they received access to and payment for a rental vehicle, Liberty Mutual Personal Insurance Company and Liberty Mutual Insurance Company prematurely terminated the rental car coverage, despite the contractual obligation to first determine the amount of time a policyholder reasonably needs to replace their totaled vehicle.

    On May 16, 2025, LMIC filed a motion to strike and exclude the opinions of Plaintiffs’ expert Mr. Jay Angoff pursuant to Federal Rule of Civil Procedure 56(c)(2) and Rule of Evidence 702.

    Insurance Expert Witness

    Jay Angoff is an attorney with a long career working in the insurance industry. At various times over the past 40 years, he has served as the Insurance Commissioner for the State of Missouri, as the Deputy Insurance Commissioner for the State of New Jersey, as the Director of the U.S. Health Care Financing Administration’s Private Health Insurance Group, and as the Director of the HHS Office of Consumer Information and Insurance Oversight.

    Want to know more about the challenges Jay Angoff has faced? Get the full details with our Challenge Study report

    Discussion by the Court

    Defendants contended that the Court should strike the Angoff Report under Rule 702 and Daubert because Angoff is not qualified to render the opinions in his report and because Angoff’s opinions are not reliable.

    Qualifications

    Defendants argued that Angoff is not qualified to render these opinions because he “lacks any education, training, or experience in the field of accounting or financial advisory, or reinsurance” and has no relevant professional certifications or degrees.

    Though Angoff has not served as an expert specifically on financial statements, given this extensive history upon which he renders his opinions, the Court concluded that he is appropriately qualified in this case. The Defendants’ attacks on Angoff’s lack of qualifications or specific certifications are an appropriate line of inquiry for cross-examination, but such bases do not disqualify him from serving as an expert in this case.

    Reliability

    Sufficiency of the Data

    Defendants argued that Angoff’s opinions related to LMPIC’s reserves are unreliable because they are based on plainly erroneous assumptions and cherry-picked facts.

    Angoff’s opinions are predominantly based off LMPIC’s and LMIC’s 2023 accounting statements, from which Angoff has drawn various conclusions based on his experience in the insurance industry reviewing and analyzing financial statements.

    There is no dispute that the accounting statements and the other record evidence considered by Angoff are a reliable basis on which he could form an opinion. While Defendants contended that Angoff’s opinions are based on mistaken assumptions that account only for net numbers and ignore gross numbers, such a challenge is not an appropriate basis for exclusion at this junction. While it is entirely possible that Angoff’s reading of the accounting statements is incorrect, the Court cannot draw that conclusion because would it be appropriate for the Court to do so.

    Legal Conclusions

    Defendants also argued that Angoff’s opinions that LMPIC’s regulator would not permit it to pay a $45 million judgment and that LMPIC does not “act independently” of LMIC are conclusions without factual basis. Defendants further characterized this second conclusion as a legal opinion.

    The Court agreed that some statements in the report are inadmissible conclusions of law. Angoff may testify regarding what, in his experience, a regulator would consider in analyzing an insurance company’s availability and source of funds to pay a judgment, but not the conclusion of law as to whether LMPIC’s regulator would permit LMPIC to pay a $45 million judgment. Similarly, Agnoff may testify as to industry practice in structuring and operating insurance companies and the relationship created in the reinsurance context, but not the conclusion of law that LMPIC does not “act independently” of LMIC.

    Bias

    Defendants also attacked Angoff as an unreliable expert due to alleged bias. Specially, Defendants argued that, “until recently, [Angoff] was a Plaintiff’s class action lawyer who sued insurance companies for a living, and is not independent of Plaintiffs’ counsel given his prior relationship with them.”

    However, an expert’s bias goes to the weight or credibility of his testimony. As such, the Court held that Angoff’s potential bias does not necessitate his exclusion.

    Held

    The Court denied the Defendant’s motion to strike and exclude the opinions of Plaintiffs’ expert Jay Angoff.

    Key Takeaway:

    As long as an expert’s scientific testimony rests upon ‘good grounds, based on what is known,’ it should be tested by the adversary process—competing expert testimony and active cross-examination—rather than excluded from jurors’ scrutiny for fear that they will not grasp its complexities or satisfactorily weigh its inadequacies.

    Angoff’s report is grounded in his experience regarding insurance companies’ financial statements and regulatory requirements. The report and record together contain sufficient explanation of Angoff’s methodological choices and reasoning to overcome a Daubert challenge in this posture.

    Case Details:

    Case Caption: Watts Et Al V. Liberty Mutual Personal Insurance Company Et Al
    Docket Number: 1:23cv12845
    Court Name: United States District Court, Massachusetts
    Order Date: July 29, 2025
  • Business Valuation Expert’s Testimony on Physicians’ Compensation Admitted

    Business Valuation Expert’s Testimony on Physicians’ Compensation Admitted

    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 State of Washington filed a Daubert motion to exclude the testimony of Defendant NNI’s expert witness, Nicholas J. Janiga. Janiga’s report concluded that the compensation NNI paid to 12 healthcare providers between 2005 and 2016 was consistent with fair market value.

    Washington challenged Janiga’s testimony because “his opinions are not premised on sufficient facts or data, nor are they the product of reliable principles and methods.”

    For instance, Washington objected that Janiga analyzed only 12 physicians, and argued that he should have considered how many other consultants “in a position to prescribe NovoSeven” were paid by NNI. The Court, however, regarded this disagreement over the scope of discovery as merely a matter for cross-examination.

    Business Valuation Expert Witness

    Nicholas J. Janiga is an Accredited Senior Appraiser in Business Valuation by the American Society of Appraisers. He is currently the Managing Director of HealthCare Appraisers, Inc.

    Janiga has extensive knowledge and experience in appraising healthcare business enterprises and medical professionals’ compensation. Moreover, he has extensive experience in analyzing the fair market value of healthcare transactions and arrangements involving the Anti-Kickback Statute (AKS).

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

    Discussion by the Court

    First, Washington argued that Janiga incorrectly assumed that the physicians provided necessary bona fide services. It also claimed Janiga’s opinion omitted other benefits physicians received from NNI, such as expenses for meals, lodging, and travel, and assistance with writing and publishing medical scholarship.

    NNI asked Janiga only to opine about whether the physicians’ compensation was fair market value. He was not asked to, and did not, opine on any other elements of the AKS’ “Safe Harbor.” Although the Court acknowledged that these were valid subjects for cross-examination, it held that they did not warrant disqualifying Janiga merely because of the limited scope of his study.

    Washington also asserted that Janiga’s report did not account for the fact that NNI’s compensation structure is based on a physician’s “geographical sphere of influence.”

    It argued that this compensation structure is improper because physicians may end up receiving work and compensation for the purpose of influencing other physicians. The Court viewed a physician’s influence in the medical community akin to stature and reputation. This is a valid factor in determining a physician’s compensation and affects the weight, not the admissibility, of Janiga’s testimony.

    Finally, Washington argued that Janiga’s report did not mention that Craig Kessler, the Editor-in-Chief of the publication Haemophilia, received “revenue based compensation from that publication whose revenue was enhanced by [NNI’s] purchase of reprints.” Washington additionally contended that NNI directly paid Kessler for his advice on this case. 

    Since Kessler’s advice to NNI on this case pre-dates Washington’s allegations that NNI inappropriately paid Kessler, any compensation he received for his advice is not relevant to Janiga’s opinion that Kessler was compensated at fair market value.

    Held

    The Court denied Washington’s motion to exclude the testimony of Nicholas J. Janiga.

    Key Takeaway:

    Janiga has sufficient expertise and experience appraising healthcare enterprises and compensation arrangements. Basically, his knowledge, background, and opinions about whether NNI compensated the 12 physicians at fair market value satisfy Rule 702‘s requirement in that his testimony will assist the jury in understanding the evidence and determining facts in issue.

    His testimony will be permitted because he is a qualified expert in the healthcare compensation appraisal through education, training, experience, knowledge, and skill, his report is based on sufficient facts or data, and his opinions are the product of the reliable application of principles and methods.

    Please refer to the blogs previously published about this case:

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

    Hematology Expert’s Opinion on NovoSeven’s Medical Appropriateness Admitted

    Pharmacology Expert’s Testimony About the Purpose and Effect of Illegal Marketing Tactics Excluded

    Internal Medicine Expert’s Testimony Limited Despite His Physician Behavior Experience

    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 15, 2025
  • Fire Investigation Expert’s Opinion on Damage to the Residence Admitted

    Fire Investigation Expert’s Opinion on Damage to the Residence Admitted

    On January 21, 2021, a fire destroyed Jacqueline Flynn’s home located at 7618 Craig Court in Orlando, Florida. The Plaintiff purchased a Thermacell Patio Shield on the day of the fire. Since the Patio Shield was the only energized device in use on the balcony at the time of the fire, the Plaintiff filed her complaint alleging negligence and strict products liability against the Defendants as a result of the Fire.

    The Defendants, Thermacell Repellants, Inc. and Lowe’s Home Centers, LLC filed a Daubert motion to exclude the opinions of Plaintiff’s fire cause and origin expert, Patrick B. Dugan, under Rule 702.

    Fire Investigation Expert Witness

    Patrick B. Dugan, CFI  is a Certified Fire Investigator through the International Association of Arson Investigators and the National Board on Fire Service Professional Qualifications. He is also a Certified Fire and Explosion Investigator and Certified Vehicle Fire Investigator through the National Association of Fire Investigators. In addition, Dugan holds an HVAC Technician certification through the United States Environmental Protection Agency.

    Dugan retired as Deputy Chief and Platoon Commander of the Schenectady Fire Department in 2002 after a 33-year career. Prior to that, he served as deputy chief of training, fire captain, paramedic lieutenant, and fire lieutenant of the same department.

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

    Discussion by the Court

    Dugan offered several opinions regarding the cause and origin of the
    fire. The site inspection was followed by a laboratory examination of fire debris in July 2021 and January 2024. While Dugan did not find remnants of the Patio Shield, he explained that its components are plastic, metal, and butane, which is highly flammable, and that there could be microscopic ceramic components. Dugan also factored weather conditions into his analysis and determined that an eight-mile-per-hour wind was present and sufficient to spread the fire. He also testified that he found no evidence of an electrical source starting the fire.

    Dugan ruled out arson, noting that the Flynn’s owned the home for 18 years before the fire, there was no mortgage on the residence, they had good credit, and the home had never been on the market for sale. He further noted that all indications were that the fire was accidental and was caused by the Patio Shield. Consequently, he testified that a “heavy fire load” was present in proximity to the Patio Shield, consisting of wicker on the table, cushions on the chairs, and plastic coverings. Dugan did not identify any other ignition source aside from the Patio Shield, causing him to identify the product as the fire source.

    Dugan testified that the burn patterns supported his opinion that the Patio Shield caused the fire. Moreover, he concluded that the fire started at the table area, and debris from the table started to burn and dropped down, catching the floor and chairs on fire. He noted that Chapter 19.4.4.3 of NFPA 921 provides that there are circumstances where the ignition source cannot be identified, but the ignition sequence can be logically inferred.

    Analysis

    The Defendants argued that Dugan did not find remnants of the Patio Shield or PIC Coil. However, this criticism ignored Dugan’s explanation that the components of the Patio Shield are combustible and were easily dispersed by the water suppression efforts. As for the PIC Coil, Flynn testified she did not ignite the PIC Coil, and the Defendants offered no competent evidence to the contrary.

    The Defendants further argued that Dugan’s opinions regarding the cause of the fire should be excluded because he did not remove the outlet to examine it before ruling it out. However, Dugan testified that the outlet was destroyed in the fire.

    The Defendants also sought to exclude Dugan’s statement that the “observations of the witnesses and responding firefighters were also consistent with a fire that began in the area of the product” on the balcony.
    Lieutenant Lizbeth Desio, the first firefighter on the scene, testified that based upon her observations at the scene, there is no indication that the fire began anywhere other than the second-floor patio. Neither party identified the statement of any other witness who observed the location of the fire. LT Desio’s statement that fire was observed emitting from the rear, second-floor, balcony of the home, was consistent with Dugan’s opinion that the first responder concluded the fire began in the area of the product on the balcony. The Court denied the motion to exclude Dugan’s opinion that witnesses and first responders concur with his conclusion.

    Because Dugan inspected the scene and provided a detailed description of the damage caused by the fire, the Court denied the Defendants’ request to exclude Dugan’s opinion that the fire caused extensive smoke, fire, and thermal damage to the interior and exterior of the residence.

    Held

    The Court denied the Defendants’ motion to exclude the testimony of Plaintiff’s fire cause and origin expert, Patrick B. Dugan.

    Key Takeaway:

    Dugan’s investigation and analysis easily satisfied Daubert’s mandate that an expert employ a “sufficiently reliable” methodology. His opinions are based on sufficient facts and data; he did not unjustifiably extrapolate his research to reach an unfounded conclusion; he considered—and ruled out—contradictory data (other known ignition sources); his analysis was based on objective data including burn patterns, weather, timing, and available ignition sources, and Dugan is as careful as an expert would be in conducting professional work outside the context of paid litigation. Basically, the Defendants’ criticism of Dugan’s methodology and resulting opinions goes to the weight that the jury may give such testimony—not its admissibility.

    Case Details:

    Case Caption: Flynn V. Thermacell Repellents, Inc. Et Al
    Docket Number: 6:23cv1890
    Court Name: United States District Court, Florida Middle
    Order Date: July 28, 2025
  • Internal Medicine Expert’s Testimony Limited Despite His Physician Behavior Experience

    Internal Medicine Expert’s Testimony Limited Despite His Physician Behavior Experience

    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.

    Novo Nordisk’s expert, Dr. Anupam B. Jena, a medical doctor who also has a Ph.D. in economics opined that NNI’s “alleged publication strategy” did not cause the submission of false claims for NovoSeven.

    Washington did not challenge Jena’s credentials or expertise, but it did argue that his “causation” opinions were not admissible because (1) they were based on insufficient or mis-stated facts; (2) his methodology was unreliable because though he is not an expert on the independence of medical publications, he makes “assumptions” about the integrity of the publications at issue, while ignoring other evidence particular to the publications and strategies at issue; (3) he opined about areas of medicine and reimbursement that are outside his expertise; and (4) he opined about the law of causation, a matter better left for jury instructions.

    Internal Medicine Expert Witness

    Dr. Anupam B. Jena, MD, PhD, is the Joseph P. Newhouse Professor of Health Care Policy at Harvard Medical School and a physician in the Department of Medicine at Massachusetts General Hospital. He is also a faculty research associate at the National Bureau of Economic Research. As an economist and physician, Jena’s research involves several areas of health economics and policy including the use of natural experiments in health care, the economics of physician behavior and the physician workforce, medical malpractice, the economics of health care productivity, and the economics of medical innovation. 

    Jena graduated Phi Beta Kappa from the Massachusetts Institute of Technology. He received his MD and PhD in Economics from the University of Chicago and completed his residency in internal medicine at Massachusetts General Hospital. He is the host of the Freakonomics, MD podcast, which explores the “hidden side of health care.”

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

    Discussion by the Court

    The Court concluded that Jena is qualified to opine on the bulk of topics in his Report, including the reliability of peer-reviewed publications. He has sufficient expertise and experience in the field of physician behavior in connection with writing prescriptions to set out the many factors that can influence treating physicians in their selection of pharmaceuticals to prescribe for their patients.

    While Jena’s testimony was largely permitted because he is a qualified expert in the fields of medicine and economics and his report is based on sufficient facts or data, Jena was barred from opining on the ultimate legal conclusion that the physicians who prescribed NovoSeven did not do so because of the inducements and benefits NNI extended to them or their patients.

    Held

    The Court granted in part and denied in part the Plaintiffs Siegel and Washington’s motion to exclude the testimony of Defendant Novo Nordisk’s expert witness, Dr. Anupam Jena.

    Key Takeaway:

    As a general rule, an expert opinion is not objectionable simply because it embraces an ultimate issue to be decided by the trier of fact. However, an expert cannot opine as to a legal conclusion, or to the ultimate issue of law; instructing the jury on the applicable law is the Court’s distinct and exclusive province.

    Please refer to the blogs previously published about this case:

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

    Hematology Expert’s Opinion on NovoSeven’s Medical Appropriateness Admitted

    Pharmacology Expert’s Testimony About the Purpose and Effect of Illegal Marketing Tactics Excluded

    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 2, 2025
  • Defamation Expert’s Testimony on Economic Damages Excluded

    Defamation Expert’s Testimony on Economic Damages Excluded

    Plaintiff Brian Menge, a former police detective with the City of Highland Park, Michigan, brought a claim against Defendant Khursheed Ash-Shafii, a Highland Park city councilman, alleging that Ash-Shafii unlawfully retaliated against him in violation of the First Amendment because of Menge’s successful settlement of a prior lawsuit against the City. The retaliation consisted of statements published by Ash-Shafii falsely accusing Menge of stealing money from the City’s criminal forfeiture fund while Menge was a police officer there. Menge retained Sameer Somal, to testify to the amount of damages Menge incurred to his income, reputation, and psyche as a result of Ash-Shafii’s false statements.

    The Defendant filed a motion to exclude Somal’s testimony arguing that Somal did not meet the requirements of Rule 702.

    Defamation Expert Witness

    Sameer Singh Somal CFA, CFP®, CAIA is a CFA Charterholder, a CFP® professional, and a Chartered Alternative Investment Analyst. He is the CEO of Blue Ocean Global Technology, a company that assists individuals and entities with building and repairing their online reputation. He has co-authored Continuing Legal Education (CLE) programs about defamation and related topics and is a former member of the Legal Marketing Association (LMA) and the Education Advisory Council (EAC).

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

    Discussion by the Court

    Somal opined that Menge suffered “significant” damages based on Defendant Ash-Shafii’s alleged retaliatory statements. Somal separated the damages into four categories: economic, rehabilitative, reputational, and emotional distress. He determined that Menge suffered at least $283,500 in economic damages.

    Economic Damages

    Ash-Shafii objected first to Somal’s assessment of Menge’s economic damages of $283,500. Somal opined that Menge was entitled to economic damages in that amount based on Somal’s own “conservative estimate” that he lost the opportunity to work over the next three years with between eight and ten attorneys. He reckoned that each of these attorneys would have retained Menge for at least six to eight projects per year for an average of $1,000 per project. Ash-Shafii asserted that this testimony is unreliable because it strays from the facts of the case. He asserted that Somal failed to review certain “Request for Payment” forms that are submitted in indigent criminal cases to obtain payment for Menge’s work on an investigation and did not review Menge’s 2023 tax return.

    While these points may all be grounds for impeachment, the Court held that they do not necessarily fatally undermine the admissibility of Somal’s testimony.

    The problems with Somal’s testimony are more basic. For one, Somal did not appear to be assessing the economic damage to Menge’s investigation business based on any independent body of expertise — that is, based on any knowledge of the legal field in the metro Detroit region. He did not offer any foundation for innate or acquired knowledge of the practices for assignment or retention of investigators in indigent criminal defense cases or the networking customs among defense attorneys. Instead, his conclusions ultimately were based on “estimate[s]” of Menge’s lost work, which he deemed “conservative.” He projected that Menge lost the opportunity to work with between eight and ten attorneys per year, but the source of this estimate is entirely unexplained and does not correspond with any evidence in the record.

    Rehabilitation Damages

    Ash-Shafii next asserted that Somal offered no methodology for his opinion that a twelve-to-eighteen-month rehabilitation campaign, costing approximately $180,000, will be necessary to rehabilitate Menge’s online reputation. He pointed out that the recording of the City Council meeting containing the offending comments only has been viewed approximately 300 times on Facebook, and Somal never searched for references to Menge on Google to determine the extent of the spread of the alleged defamatory statements on the internet.

    However, Ash-Shafii did not appear to take issue with Somal’s qualifications as an expert in the field of online reputation management, and Somal’s report contains a sufficiently clear basis for his $180,000 estimate. He explained that his team would have to conduct ongoing analysis and testing on important “keywords” related to Menge, and as part of their work to rehabilitate his reputation, the team would create “backlinks” — apparently prioritized by search engine algorithms — to more prominently highlight certain favorable results. In his report he quoted a cost of $15,000 a month for twelve months for these tasks. While this number may well be excessive, the Court held that Somal, by dint of his knowledge of the field, is qualified to offer his view.

    While Ash-Shafii faults Somal for failing to assess the extent of the spread of the defamatory content before coming up with this estimate, it did not appear that the amount of work necessary to address harmful online content is dependent on the volume of material circulating on the internet. Moreover, Somal did opine that it was problematic that the alleged defamatory video still was published to Facebook and explained that the fact court documents mentioning the defamatory statement were readily accessible on the internet “adds another layer of complexity to the rehabilitation process.”

    Reputational Damages

    Ash-Shafii also took issue with Somal’s conclusion that Menge is entitled to $550,000 to $750,000 in damages based on more generalized harm to his reputation.

    In his report, Somal stated that “there is no set standard to determine the actual value associated with [reputational damages]” and that calculating damages in this area “is subjective.” He then explained that in his experience, a “solid structure” for assessing damages would consider three “rings”: Menge’s immediate contacts, his prospective contacts, and strangers.

    “Adding the three reputational rings together,” he “calculated and estimated that damages” totaled to “no less than $550,000 – $750,000.” How he calculated a value for each ring is not explained, and his deposition does not shed much further light, but it appeared that the figures may be based on his review of damages awards in other defamation cases.

    The Court held that this opinion suffers from the twin faults of no stated methodology and no factual tether.

    Held

    The Court granted in part and denied in part the Defendant’s motion to exclude testimony of Sameer Somal.

    Key Takeaway:

    Rule 702 requires an expert to articulate some methodological basis before he may present his testimony to a jury. And his work must bear some relation to the facts of the case. The danger of allowing Somal’s opinion based on his calculations is that it could suggest to the jury damages that do not in fact exist.

    Moreover, with proper foundation, calculating Menge’s economic damages would not necessarily even require expert testimony. Trial witnesses could testify about the effects of Ash-Shafii’s defamation on Menge’s businesses and his attorney can develop testimony about the size of his business and the comparative reduction in revenue.

    Case Details:

    Case Caption: Menge V. Shafii Et Al
    Docket Number: 2:23cv11339
    Court Name: United States District Court, Michigan Eastern
    Order Date: July 22, 2025
  • Economics Expert’s Testimony on Anti-Discounting Policies Admitted

    Economics Expert’s Testimony on Anti-Discounting Policies Admitted

    Plaintiffs sued Amazon.com, Inc., claiming that the company violated the Sherman Act. They contended that Amazon denied customers the “benefits of lower prices and fees” that would arise in a competitive market; and they said Amazon did so by imposing on third-party sellers “Most Favored Nation” policies that cause customers to pay supra-competitive prices. 

    Plaintiffs’ economics expert Dr. Parag A. Pathak, Ph.D. concluded that Amazon’s anti-discounting policies and practices collectively function as a Platform Most Favored Nation (PMFN) restraint.

    According to Pathak, Amazon is the largest online marketplace in the United States, with a market share of around 72% in the Online Retail Marketplaces Market. He added that Amazon’s conduct prevents price competition with other online retailers, which in turn allows Amazon to charge “monopoly referral fees—i.e., the price of connecting merchants and consumers to each other and completing the sales transaction between them.”

    Amazon filed a motion to exclude Pathak’s expert testimony.

    Economics Expert Witness

    Dr. Parag A. Pathak, Ph.D. is the Class of 1922 Professor of Economics at Massachusetts Institute of Technology. He is also a Research Associate at the National Bureau of Economic Research (NBER) and is the founding Director of the NBER’s working group on market design. 

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

    Discussion by the Court

    Pathak explained that microeconomic modeling shows that, “all else equal, a marketplace with market power (like Amazon) sets higher fees when merchants are constrained by an anti-discounting policy than when they are not.” He said that in this situation, “because merchants cannot discount prices, marketplaces have no reason to discount fees. Instead, the presence of the anti-discounting policy incentivizes the marketplace to increase fees.”

    The company challenged Pathak’s methodology, arguing that (1) the model Pathak used is not generally accepted in the field of economics; (2) the model has an extraordinary error rate; (3) the model rests upon unreliable and unfounded assumptions; and (4) the model ignores heterogeneity in sellers’ business strategies. Amazon also contended that Pathak’s regression analyses are unreliable because the data sample is too small, and that his regressions do not show a relationship between fees and prices.

    General Acceptance of Economic Model

    Amazon contended that Pathak’s methodology, derived from a 2016 paper by Andre Boik and Kenneth S. Corts, is unreliable because the model used is not widely accepted in the field of economics.

    The company asserted that there are no standards for applying the model beyond simplified assumptions and it does not reflect a generally accepted consensus in the field of economics. 

    The Court held that Pathak’s application of the Boik-Corts model to Amazon’s transactional data did not render his opinion unreliable. After all, Amazon did not point the Court to any economic literature describing flaws or errors in the model. 

    Moreover, Amazon’s contention that Pathak improperly extended the Boik-Corts model to the facts of this case is unavailing. Pathak said that he applied the Boik-Corts model to transactional data provided by Amazon to assess the impact of the company’s anti-discounting policies. He analyzed about 236 million individual items sold on Amazon from May 2017 to July 2023 across 30 different categories.

    In sum, Pathak took a peer-reviewed economic model and applied that model to transactional data provided by Amazon.

    Error Rate

    Amazon asserted that Pathak’s model has a 100% false positive rate because it always concludes that a PMFN is inflating all fees and prices even when analyzing data when no PMFN was in effect.

    In his rebuttal report, Pathak explained that the Boiks-Corts model “is not a test of whether a PMFN exists, and it does not return ‘positive’ or ‘negative’ results.”

    Pathak stated that he reviewed the record, and the facts supported his conclusion that Amazon’s anti-discounting policies constituted a class-wide PMFN.  In his report, Pathak explained the facts that lead him to reach this conclusion.

    That Pathak’s model assumed the existence of a PMFN did not automatically render it unreliable. The Court held that Pathak reviewed the facts and explained his basis for concluding that Amazon’s anti-discounting policies act as a PMFN. Thus, Amazon’s argument did not show that the economic model Pathak used is unreliable. 

    The Model’s Underlying Assumptions

    Amazon asserted that Pathak “assumes without justification” that Amazon’s policies and practices constitute a PMFN. Amazon added that Pathak’s opinion of class-wide injury and damages contains too many assumptions and was not supported by real-world evidence. 

    Pathak evaluated (1) the Price Parity Clause, (2) the Select Competitor Featured Offer Disqualification program, (3) the Marketplace Fair Pricing Provision, (4) Amazon’s Standard for Brands, and (5) the Seller Code of Conduct. He discussed these policies, described how Amazon enforced them, and assessed their impact on merchant and consumer conduct.

    The Court held that Amazon’s contention—that Pathak’s model was unreliable because its underlying assumptions did not reflect reality—was unpersuasive.

    Heterogeneity in Sellers’ Business Practices

    Amazon contended that Pathak’s methodology did not account for “focal point” pricing—i.e., a practice in which sellers commonly set prices ending with certain values such as $0.99. 

    Focal point pricing occurs when retailers set prices at “focal points,” such as prices ending in 99 cents or a round number. 

    Pathak made it clear in his rebuttal report that “The possibility of focal point pricing behavior does not affect [his] conclusion that all or virtually all class members were harmed by the conduct. This is because virtually all class members made enough purchases to have overpaid on at least one of them, even if they were not harmed on purchases of focally-priced items of merchandise.”

    Thus, Pathak accounts for focal point pricing and reasonably explains why focal point pricing does not impact his determinations.

    Reliability of Pathak’s Regressions Analyses

    Amazon contended that Pathak’s regression analyses are unreliable because they rely on a small, unrepresentative data sample.

    Pathak studied how Amazon’s fees affected merchandise prices by analyzing price changes following Amazon’s partial fee reduction in 2019 for four product categories: Baby, Health & Personal Care, Beauty, and Furniture. He stated that the results from his analyses confirmed the model’s predictions: lower fees lead to lower prices. He used a difference-in-difference econometric model to compare the prices of individual goods sold on Amazon to other online marketplaces like Walmart. Pathak said that his analysis “supplements and supports the findings of the economic model.”

    In 2019, Amazon lowered its fees in four categories of products: Baby, Health & Personal Care, Beauty, and Furniture. Pathak said that this change applied to a subset of goods within these categories. He explained that he analyzed these fee changes, separately and collectively, to empirically assess whether the change in fees had an impact on product pricing.

    In his rebuttal report, Pathak emphasized that he did not “cherry-pick subsets of the data.” He said that he “analyzed all available prices in every category where a fee reduction occurred.” 

    Moreover, whether the results are statistically significant is testable. Pathak noted that he tested for statistical significance using measures such as the t-statistic. There is nothing to suggest that Pathak selected the data in a biased manner; instead, he appears to have analyzed all the data available to him. Moreover, the Court held that Pathak performed these regression analyses on available empirical data to corroborate the conclusion of his economic modeling.

    Held

    The Court denied Amazon’s motion to exclude testimony of Dr. Parag A. Pathak, Ph.D.

    Key Takeaway:

    The Daubert inquiry is flexible, and the listed factors do not apply equally to every type of expert testimony. Here, Pathak’s conclusions are capable of being tested. And his opinions “are supported by rational explanations which [a] reasonable [person] might accept, and none of his methods strike the court as novel or extreme.” 

    Case Details:

    Case Caption: De Coster Et Al V. Amazon.Com Inc
    Docket Number: 2:21cv693
    Court Name: United States District Court, Washington Western
    Order Date: July 01, 2025
  • Biomedical Engineering Expert’s Testimony on Product Warnings Admitted

    Biomedical Engineering Expert’s Testimony on Product Warnings Admitted

    Connie Thacker is one of tens of thousands of individuals who have filed suit against Ethicon for injuries after treatment with Ethicon’s pelvic mesh devices.

    Defendants filed a motion to exclude or limit certain opinions and testimony of Plaintiff Thacker’s expert, Anne H. Wilson, MBA.

    Biomedical Engineering Expert Witness

    Anne Holland Wilson is a biomedical engineer and quality assurance consultant, holding certifications as a Quality Auditor and Quality Engineer.

    She received a Bachelor of Science in Biomedical Engineering from Vanderbilt University in 1985, and a Master of Business Administration from the University of Colorado in 1991.

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

    Discussion by the Court

    Wilson has been designated as an expert in the field of compliance with quality and risk management standards. She is expected to testify that Ethicon failed to meet the “industry standards” for design control processes and risk management.

    Reliability of Wilson’s Testimony

    The Defendants argued that Wilson’s methodology is insufficient because she (1) should have conducted an audit of Ethicon’s systems; (2) failed to consider applicable U.S. standards while inappropriately basing her “industry standards” testimony on inapplicable European standards; and (3) failed to review all relevant case materials in reaching her conclusions.

    Failure to Audit

    The Defendants did not explain, or offer any authority to explain, how conducting an audit is the only reliable methodology available for reviewing the processes Wilson has been asked to review. To the contrary, the Court held that the methodology Wilson used to arrive at her opinions, which involved reviewing Ethicon’s design and risk control documents and evaluating them within the framework of industry standards, was plainly based on “sufficient facts,” and “reliable principles and methods.”

    As Wilson explained in her report, her role in this case involves “addressing the design control and risk management processes of Ethicon.”

    Failure to Review Appropriate Industry Standards

    The Defendants argued that (1) Wilson should not have consulted standards set by the International Organization for Standardization; and (2) she should have consulted applicable FDA regulations in offering testimony on Ethicon’s compliance with “industry standards.”

    To begin with, no party disputes that particular FDA regulations make up a portion of the universe of “industry standards” for design control and risk management processes in the medical device manufacturing industry.

    The Defendants argued that the standards set by the International Organization for Standardization (which are referred to as “ISOs”), however, are not a part of that same universe. However, Wilson’s report stated the opposite— explaining that ISOs were “[t]he primary standards applicable” to Ethicon’s quality and risk management systems at the time Ethicon developed the at-issue devices. She also explained during her deposition that applicable ISOs and FDA regulations are very similar.

    It should be noted that the Defendants failed to offer any evidence or authority stating that ISOs are irrelevant to medical device manufacturers in the United States. Moreover, Wilson’s failure to consider applicable FDA regulations during her review of this case did not render her testimony unreliable. Basically, Wilson plainly opined that ISOs were “[t]he primary standards applicable” to Ethicon’s quality and risk management systems. Because ISOs provided “appropriate validation” for her testimony on Ethicon’s compliance with industry standards, the Court found Wilson’s “industry standards” testimony reliable.

    While Wilson’s testimony may be offered to help define the contours of the duty of care for her common law negligence claim (and for other relevant purposes), such testimony shall not equate compliance or non-compliance with satisfaction or dereliction of the duty of care.

    Failure to Review all Case Materials

    The Defendants first contended that Wilson inappropriately offered “medical opinions” throughout her report. The Defendants did not specify which of Wilson’s opinions are “medical opinions” but rather just cited a page range of Wilson’s report which they argued is “replete” with such opinions.

    Without more specific objections, the Court declined to conduct a line-by-line analysis of the page range cited to determine which of Wilson’s opinions are medical opinions. However, the Court did agree that medical opinions are beyond the scope of Wilson’s qualifications and should be excluded.

    The Defendants finally argued that Wilson’s testimony regarding Ethicon’s Instructions for Use (“IFU”) on the TVT-S device should be excluded. Specifically, the Defendants argued that Wilson is unqualified to offer testimony on IFUs. Wilson is expected to testify that Ethicon’s failure to adequately address certain risks in the TVT-S’s IFU was “a violation of industry practices and international standards.”

    The parties seemed to agree that issues with IFUs relate to risk assessment in the general sense. And the Defendants did not challenge Wilson’s qualifications to testify as an expert on risk assessment. Accordingly, it was apparent to the Court that testimony concerning IFUs directly relates to Wilson’s area of expertise.

    As such, the Court found that Wilson’s familiarity with risk assessment processes in the medical device manufacturing context provides her with sufficient knowledge on IFUs to assist the trier of fact to at least some degree. Wilson is therefore qualified to offer opinions regarding product warnings as a fundamental part of the risk management process in the medical device industry.

    Held

    The Court granted in part and denied in part the Defendants’ motion to exclude or limit the testimony of Plaintiff Connie Thacker’s expert, Anne Wilson, MBA.

    Key Takeaway:

    The Court recognizes that just because Wilson is an expert in one area “does not ipso facto qualify her to testify as an expert in all related areas.” But ultimately, Rule 702 takes a liberal approach to expert witness qualification in that the degree of ‘knowledge, skill, experience, training, or education’ sufficient to qualify an expert witness is only that necessary to ensure that the witness’s testimony ‘assist’ the trier of fact to any degree.

    Please refer to the blogs previously published about this case:

    Urogynecology Expert Witness Testimony about inadequate risk disclosure admitted in medical device product liability action

    Obstetrics and Gynecology Expert’s Testimony on Mesh Porosity and Stiffness Admitted

    Urogynecology Expert’s Opinion on Continuum of Care Admitted

    Obstetrics and Gynecology Expert’s Opinion Regarding the Common Knowledge of Pelvic Surgeons Admitted

    Case Details:

    Case Name: Thacker V. Ethicon Inc.
    Docket Number: 5:20cv50
    Court Name: United States District Court, Kentucky Eastern
    Order Date: July 21, 2025