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Category: Compliance Expert Witness

  • Compliance Expert Was Allowed to Opine on Amazon Policy

    Compliance Expert Was Allowed to Opine on Amazon Policy

    ZAGG initiated this action against DVG, TX Trading Inc. (“TX Trading”), and Menachem Mendel Ichilevici (“Ichilevici”) (collectively, “Defendants”), alter egos collectively doing business as Amazon Seller “Mac N’ Cheese,” violated Sections 32 and 43 of the Lanham Act, 15 U.S.C. §§ 1114, 1125(a), by infringing on ZAGG’s trademarks and falsely advertising ZAGG products.

    Plaintiff, ZAGG, Inc., filed a Daubert motion to exclude the report and testimony of DVG’s Amazon policy expert, Rachel Johnson Greer.

    Compliance Expert Witness

    Rachel Johnson Greer worked as a Program Manager at Amazon for five years, overseeing various elements of Amazon’s compliance programs. She has has served as an Amazon compliance consultant since 2015. Greer published a book on Amazon product safety. She has appeared as an “Amazon Product Compliance” speaker at various events from 2016 to 2022.

    Greer received a Master of Business Administration degree from Seattle University.

    Discover more cases with Rachel Johnson Greer as an expert witness by ordering his comprehensive Expert Witness Profile report.

    Discussion by the Court

    I. Qualifications

    ZAGG claimed that Greer is “an unqualified and unreliable witness as to Amazon’s current processes and policies (or any policies after she left in 2017).”

    However, Greer’s experience both as a manager at Amazon and as a consultant to Amazon sellers qualifies her as an expert in the field of “Amazon policy compliance.”

    Despite Greer’s demonstrated experience in the Amazon marketplace, ZAGG attacked her qualifications in four ways. First, ZAGG claimed that none of Greer’s roles at Amazon “involved any of the issues or policies at issue in this case.” But that’s not entirely true. Greer “investigated sellers and vendors for safety and intellectual property infringement,” “managed quality & compliance for Amazon’s own brands,” and “managed the legal compliance of all global imports.”

    Second, ZAGG contended that Greer isn’t qualified because she hasn’t worked at Amazon since 2017 and thus (ZAGG says) isn’t familiar with Amazon’s “current processes and policies.” But ZAGG hasn’t cited any authority for the proposition that an expert must be currently (or even recently) employed by a company whose policies he or she intends to outline.

    Third, ZAGG insisted that “only Amazon itself can testify as to its practices and procedures.” However, courts routinely allow experts who are unaffiliated with a company to testify about that company’s policies or practices if those experts are otherwise qualified to do so. To the extent ZAGG thinks that Amazon would be a better witness, it hasn’t identified any authority that requires the Court to exclude an expert’s testimony simply because a better witness might have been found.

    Finally, ZAGG claimed that Greer is impermissibly trying to “testify on behalf of Amazon.” The Greer Report made it clear that Greer is offering her perspective on Amazon’s policies and practices as an expert who’s navigated the Amazon marketplace for years.

    II. Reliability

    Because Greer is a non-scientific expert testifying about her experience, the relevant question is “how that experience leads to the conclusion reached, why that experience is a sufficient basis for the opinion, and how that experience is reliably applied to the facts.”

    Greer has shown that her opinions about Amazon’s policies and practices are based, in part, on her experience “providing compliance guidance to Amazon sellers regarding Product Policy, Fulfilment by Amazon (‘FBA’) compliance, Amazon’s intellectual property policies, and other Seller Performance issues,” and “providing advisory services on meeting Amazon and regulatory product compliance requirements for consumer goods.”

    Her “opinions in this case are based on her experience working at Amazon and in her Amazon consulting business, Amazon policy documents, publicly available listings of ZAGG products on Amazon.com, and her review of certain documents provided to her by DVG.” That’s more than sufficient for the Court to find her report and testimony reliable under Rule 702.

    Since Greer’s proposed testimony is based on her personal experience working with Amazon’s quality control policies over many years, the Court denied the second aspect of ZAGG’s motion.

    III. Helpfulness

    ZAGG argued that the Greer Report is not helpful because it “contains exclusively fact testimony and is completely devoid of any opinions that go beyond the understanding of an average layperson.”

    However, DVG argued that Greer does much more than just recite Amazon policies and procedures. In saying so, DVG identifies several of Greer’s opinions that (it believes) will help the trier of fact, including:

    • Amazon public-facing policies “are often contradictory or outdated” because “Amazon’s process for changing and updating policies, guidelines and other seller documents on the Amazon Marketplace is a multi-step process that requires internal tickets and up to six approvals.”
    • “Based on her experience at Amazon and in providing consulting services to Amazon sellers, it has always been understood that a “new” item is simply one that is brand-new and unused, free of blemishes, smudges or dirt, and in the original packaging.”

    The Court agreed with DVG that Greer’s report and testimony go well beyond a mere recitation of Amazon’s policies and that her expert analysis of Amazon’s policies and practices would assist the trier of fact. The Court thus denied this third aspect of ZAGG’s motion.

    IV. Opinions & Hearsay

    First, ZAGG said that “it is entirely unclear what ‘opinions’ are being offered by Greer.” ZAGG claimed that the Greer Report is “a hodgepodge of speculative factual assertions made by Greer masquerading as ‘opinions.’”

    However, in making this argument, ZAGG identified several of Greer’s specific opinions—thus belying its claim that it has no way of knowing which opinions Greer plans to offer. (“Greer testified that she is offering only two opinions. First, she testified that: ‘Accordingly, it is my opinion that ZAGG’s conclusion that defendants cannot list ZAGG products as being in new condition is based on an incorrect interpretation of Amazon’s policies that is not used by Amazon in practice.’ Second, she testified that: ‘it is my opinion that defendants’ stickering of ZAGG products comports with Amazon’s policy, as does the marking over the barcode on the lower left of the packaging above.’”)

    Second, ZAGG believed that Greer’s opinions are merely “out-of-court assertions about Amazon’s policies and practices, offered for their truth.”

    The Court held that Greer’s testimony isn’t a mere recounting of the out-of-court statements of others—it’s expert analysis about the industry’s business practices gleaned from her years of experience as an Amazon employee and consultant.

    Held

    The Court denied ZAGG’s motion to exclude the report of DVG’s expert, Rachel Johnson Greer.

    Key Takeaway

    Knowledge of an industry’s business practices is gleaned from years of working within the industry and with its professionals. It is not a recounting of out of court statements of others.

    Case Details:

    Case Caption: Zagg Inc. V. TX Trading, Inc.
    Docket Number: 1:23cv20304
    Court Name: United States District Court, Florida Southern
    Order Date: December 16, 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
  • Compliance Expert’s Testimony on the Hallmarks of a Pill Mill Excluded

    Compliance Expert’s Testimony on the Hallmarks of a Pill Mill Excluded

    Defendant Heather Marks, a nurse practitioner, is charged in a Superseding Indictment with distributing and conspiring (with her former co-defendant, Hemal Mehta, M.D.) to distribute Schedule II controlled substances outside the usual course of professional practice and without a legitimate medical purpose. 

    The Defendant also sought to introduce the testimony of Michael W. Staples, CMBI, as a “Regulatory and Legal Health Care Compliance Expert.”

    Marks has submitted an expert report by Staples, showing that he proposes to testify about (1) the challenges of “Rural Healthcare”; (2) the characteristics of a “Pill Mill” and “bad faith-controlled substance prescribing”; and (3) patient stigma related to controlled substance prescribing and addressing aberrant issues. 

    The government argued that Staples is not qualified to testify as an expert to offer the evidence he proposes to offer and that his proposed testimony is both unreliable and irrelevant.

    Compliance Expert Witness

    Michael W. Staples has twenty-five years’ of experience in criminal investigations, regulatory and criminal healthcare investigations, medical standards of care investigations, scope of medical practice investigations, and healthcare regulatory and legal compliance.

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

    Discussion by the Court

    A. “The Challenges of ‘Rural Healthcare’”

    Regarding his first proposed topic, the government argued that Staples is not a medical practitioner of any kind and therefore is not qualified to offer medical opinions, using medical jargon, about the appropriate standard of medical care in any setting. More specifically, the government asserted that Staples is not qualified to opine that the applicable standard of care that applies to medical practitioners in the rural setting is different from that governing medical practitioners in urban settings.

    The Court agreed that Staples cannot offer medical testimony or testify about the medical standard of care per se. Consequently, he cannot offer an opinion that the practice of medicine in a rural setting changes the applicable standard of care—this is a medical issue. Nor may he opine that the rural setting somehow altered the legal requirements for proving a violation. However, insofar as Marks’ defense in this case is that she subjectively believed that she was authorized to issue the prescriptions at issue, because she did so in the usual course of her professional practice and with a legitimate medical purpose, Staples’ testimony about the unique challenges facing medical practitioners in rural areas appeared to have some bearing on whether her belief was objectively reasonable.

    The Court held that while Staples may not offer a medical opinion, his experience and training as a healthcare regulatory consultant, investigator, and expert provided him a sufficient basis to proffer an opinion that the rural setting of Marks’ practice posed significant challenges for providers not found in urban settings.

    B. “Characteristics of a ‘Pill Mill’ and ‘Bad Faith controlled substance prescribing’”

    The Defendants argued that they “should not be foreclosed from asking agents about the hallmarks of a ‘pill mill’ case or the wide swath of conduct that is captured by this particular charging statute.”

    The Court addressed this issue orally at a pretrial conference on August 25, 2021, stating that, insofar as the Defendants wanted to question law enforcement agents about the “hallmarks of a pill mill case,” such testimony “would not be allowed,” as it “gets into the charging decision by the government, which is really no concern of the jury.”

    Staples sought to testify both about the hallmarks of a pill mill and that Marks’ practice did not demonstrate any of the characteristics of a pill mill. The government argued that the first part of the proposed testimony is barred by the Court’s previous ruling, that the second part constituted medical opinion testimony, and that both are irrelevant because the government never intended to argue that Marks’ medical practice was a pill mill. 

    The Court held that Staples will not be permitted to argue about the hallmarks or characteristics of a pill mill or that Marks’ practice did not carry any of these hallmarks. 

    C. Patient “Stigma”

    Marks did not address the issue of “patient stigma” in responding to the government’s motion to exclude. The Court found that this part of Staples’ opinion did not offer an opinion tied to or related to any evidence or issue in this case, appeared to constitute medical opinion, and is simply not relevant. 

    D. Urine Drug Testing

    Regarding Staples’ opinions about the use of urine drug testing as a “tool” to be utilized by medical practitioners but not the “sole basis for diagnosis and treatment decisions” and his long list of factors that may cause a negative drug urine test, the Court found that this testimony steps over the line between lay and medical opinion and is not admissible through Staples. In any event, Marks did not address the government’s argument regarding this portion of Staples’ Report or even attempt to justify its introduction.

    Held

    The Court granted in part and denied in part the government’s motion to exclude the testimony of Michael Staples.

    Key Takeaway:

    Staples’ proposed testimony about the unique challenges posed by the rural setting in which Marks’ practice was situated may be relevant to the objective reasonableness of her prescribing practices. As a result, Staples was allowed to offer limited expert testimony on the “unique circumstances that physicians in rural areas face and how this adversely affects their practice.” 

    Case Details:

    Case Caption: United States V. Marks
    Docket Number: 2:19cr3
    Court Name: United States District Court, Tennessee Middle
    Order Date: September 30, 2025