Expert Witness Profiler

Tag: Documents

  • Chemistry Expert Witness’ Testimony Admitted Because He Conducted An Independent Analysis of FDA Regulations

    Chemistry Expert Witness’ Testimony Admitted Because He Conducted An Independent Analysis of FDA Regulations

    Plaintiff Multiple Energy Technologies, LLC (“MET”) accused Under Armour of false advertising in relation to certain products that contain bioceramic powder. MET contended that Under Armour inaccurately claimed that the Federal Food and Drug Administration had determined that those products enhanced recovery.

    Under Armour sells activewear and sleepwear products directly to consumers. This includes the sale of products containing a competing bioceramic product known as celliant, which is manufactured by Hologenix, LLC (“Hologenix”). Under Armour advertises these products separately from their other product offers and as helping to promote recovery, especially for athletes.

    Plaintiff MET brought four claims against Defendant Under Armour, Inc.: violation of the Lanham Act, violation of the Sherman Act, misappropriation of trade secrets; breach of non-disclosure agreement; tortious interference with contract; tortious interference with prospective business expectancies; unjust enrichment; unfair competition; conversion; a claim for an accounting; and a claim for injunctive relief.

    Alberto Gutierrez

    MET’s Lanham Act claim is based principally on certain advertisements for Under Armour products that reference the FDA’s alleged treatment of celliant. The FDA language used in those advertisements originated with Hologenix, the manufacturer of celliant. Hologenix based those statements on its interpretation of the FDA’s June 8, 2017 response to Hologenix’s request for information regarding the FDA’s classification of celliant (the “FDA Letter”).

    MET retained Dr. Alberto Gutierrez to “opine about the classification process by the FDA, the intent of the June 8, 2017 letter from the FDA to Hologenix and the statements made by Under Armour about celliant and the FDA.” Under Armour filed a motion to exclude Gutierrez’s opinions.

    Chemistry Expert Witness

    Alberto Gutierrez worked at the FDA for 25 years in various departments.  At the FDA, Gutierrez was personally involved with the process by which the FDA responds to requests for information pursuant to section 513(g) and in making determinations of what is a medical device that would be regulated by the FDA. Gutierrez is now a consultant who helps device companies navigate the FDA regulatory requirements and provides strategic advice on regulatory issues and helps companies with submissions to the FDA.

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

    Discussion by the Court

    I. Qualification

    First, Under Armour argued that ” Gutierrez is not qualified as an expert to opine on advertising or marketing issues, including the intent of the advertisements in question or the impact of those advertisements on consumers” because his background is in chemistry, he has no experience in advertising or consumer perception, and has never studied nor done any consulting work on the impact of advertisements on consumers. According to Under Armour, Gutierrez’s opinion is “purely speculative” with regard to whether Under Armour adopted a “campaign of deception.” Under Armour also argued that even if Gutierrez is not being offered as a consumer impact expert, his “campaign of deception” opinion is speculative and unreliable and shouldn’t be admitted.

    The Court concluded that Gutierrez is qualified to offer an opinion on Under Armour’s statements about celliant and the FDA. Gutierrez is not being offered as an expert on the intent or consumer impact of advertisements—instead, Gutierrez is being offered “to opine about the classification process by the FDA, the intent of the June 8, 2017 letter from the FDA to Hologenix and the statements made by Under Armour about celliant and the FDA.”

    The Court noted that Gutierrez worked at the FDA for 25 years in various positions, ultimately holding a director position. After his career in the FDA, Gutierrez joined a consulting group that helps companies navigate FDA regulatory requirements.

    Independent Analysis

    Second, Under Armour argued that even if Gutierrez is not qualified as an expert in the field of consumer perception, his report should be excluded because he did not perform any independent analysis. Under Armour argued that Gutierrez “took counsel’s word for it” that Under Armour engaged in a campaign of deception and did not review data related to consumers visiting websites containing the advertisements at issue, how long each website was active, or how many products with celliant Under Armour sold in a given year. Under Armour further argued that the “campaign of deception” opinion is not based on independent analysis.

    However, the Court found that Guttierez did perform sufficient independent analysis. Under Armour objects to Gutuerrez’s statement that Under Armour engaged in a “campaign of deception.” Gutierrez concluded in his report that Under Armour’s statements about celliant were false in light of FDA regulations and practices.

    He further opined that the statements in the documents that he reviewed were “false, deceptive and misleading” because the FDA had not determined that celliant products led to faster recovery, only that the health-related claims made by Hologenix would qualify celliant products as medical devices.

    Moreover, Under Armour, by claiming that Gutierrez is not qualified as an expert on the intent of advertisements, attacked Gutierrez’s conclusions by stating that he “took counsel’s word for it” about Under Armour’s intent to deceive. But the Court held that Gutierrez did not purport to opine on Under Armour’s intent in the advertisements—instead, he concluded based on his knowledge and expertise that the statements were false, not that Under Armour intended to deceive consumers.

    Documents and Conclusions

    Third, Under Armour argued that the documents Gutierrez relied on do not support his conclusions. Additionally, Under Armour objects to the use of the phrase “FDA approval” in Gutierrez’s report and argues that his report should be excluded because he reviewed no documents with that specific claim. 

    However, the Court found that the documents Gutierrez reviewed support his opinions, and any argument that they do not goes to the weight, and not the admissibility, of his opinion.

    Gutierrez’s report states that he reviewed Under Armour product pages from its website and from Amazon, and he also reviewed a letter from the FDA to Holegenix. Additionally, Gutierrez reviewed an article stating that celliant fabric had received “FDA approval” as a medical device.

    Opinions about FDA Regulations

    Fourth, Under Armour argued that Gutierrez’s report contains impermissible legal opinions on the applicability of FDA regulations to the case.

    The Court found that Gutierrez’s opinions about the FDA’s regulations and procedures are relevant and are not legal opinions. Courts frequently admit the type of expert testimony that Gutierrez offers, and the Court sees no issues with admitting his opinions here. 

    The Court held that Gutierrez may testify so long as he does not give an opinion as to what is required under the law.

    Held

    The Court denied Under Armour’s motion to exclude Dr. Alberto Gutierrez’s expert report.

    Key Takeaway:

    Concerns about the documents an expert reviewed go to the weight of the evidence, not the admissibility, and are appropriately addressed in cross-examination. An expert has “good grounds” for relying on documents containing statements regarding the FDA because they are the type of documents an expert reviewing whether statements are consistent with FDA regulations would rely upon. 

    Please refer to the blog previously published about this case:

    Marketing Expert Witness’ Testimony on Consumer Perceptions Excluded Because His Survey is Flawed

    Case Details:

    Case Caption: Multiple Energy Technologies, LLC V. Under Armour, Inc
    Docket Number: 2:20cv664
    Court: United States District Court, Pennsylvania Western
    Order Date: January 13, 2025
  • Telecommunications Expert Witness’ Opinions Regarding 3GPP Availability Admitted

    Telecommunications Expert Witness’ Opinions Regarding 3GPP Availability Admitted

    Plaintiff Wireless Alliance, LLC (“Plaintiff” or “Wireless Alliance”) made certain allegations Defendants AT&T Mobility LLC, AT&T Services, Inc., and AT&T Corp. (“Defendants” or “AT&T”). According to Wireless Alliance, AT&T infringed the following United States patents that relate to improvements to cellular networking systems: United States Patent No. 9,144,106 (the “’106 patent”), 9,565,662 (the “’662 patent”) and 10,045,383 (the “’383 patent”) (collectively, the “Asserted Patents”). Wireless Alliance is the exclusive licensee of the ’106 patent and the ’662 patent, and is the owner by assignment of the ’383 patent.

    Plaintiff argued that Defendants inappropriately used Craig Bishop to establish the public availability of 3GPP documents despite him not having the “specialized or personal knowledge about public availability of 3GPP documents” because he is “a layperson with no connection to the actual documents.” 

    Telecommunications Expert Witness

    Craig Bishop has over 30 years of experience in the telecommunications industry with an extensive knowledge of 3GPP and ETSI specifications and procedures including document handling and publication practices.

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

    Discussion by the Court

    Parties’ Positions

    The crux of Plaintiff’s argument is that Bishop’s “opinion is based on nothing more than his subjective, speculative belief that the information displayed on 3GPP’s website is accurate and indicates when the documents were first made publicly available.”

    WA then attempted to equate Defendants’ reliance on Bishop’s report with relying on unauthenticated printouts from the internet by using a declaration from a third party. Defendants countered that this Court had already determined the reliability of Bishop’s opinions regarding 3GPP availability.

    Defendants also argued that Bishop is qualified to opine on 3GPP publication dates based on his extensive experience with 3GPP and ETSI.

    Legal Standards

    An expert witness may provide opinion testimony if “(a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case.”

    Importantly, in a jury trial setting, the Court’s role under Daubert is not to weigh the expert testimony to the point of supplanting the jury’s fact-finding role; instead, the Court’s role is limited to that of a gatekeeper, ensuring that the evidence in dispute is at least sufficiently reliable and relevant to the issue before the jury that it is appropriate for the jury’s consideration.

    Application

    The Court found that Plaintiff’s arguments demonstrated disputes regarding credibility, as opposed to reliability, and accordingly can be properly addressed through vigorous cross-examination and presentation of contrary evidence.

    Held

    The Court denied the Plaintiff’s motion to strike the testimony of Defendants’ expert Craig Bishop.

    Key Takeaway:

    When Plaintiff contended that Bishop has no specialized or personal knowledge about public availability of 3GPP documents, the Court refused to exclude Bishop’s testimony on that basis because Plaintiff’s arguments consisted of credibility attacks.

    Case Details:

    Case Caption: Wireless Alliance, Llc V. At&T Mobility Llc Et Al
    Docket Number: 2:23cv95
    Court: United States District Court, Texas Eastern
    Order Date: October 23, 2024
  • Insurance Expert Witness’ Opinions about California Claims Handling Practices Rejected

    Insurance Expert Witness’ Opinions about California Claims Handling Practices Rejected

    Plaintiff Oxnard Manor LP dba Oxnard Manor Health Center (“Plaintiff”) is a skilled nursing facility. As relevant herein, Defendant Hallmark Specialty Insurance Company (“Defendant”) issued a liability insurance policy to Plaintiff effective from June 1, 2017, to June 1, 2018. Defendant then issued a second liability insurance policy effective June 1, 2018, to June 1, 2019. The policies included coverage for professional liability.

    This insurance coverage action arises from the apparent decision to wrongfully increase business profits at the expense of vulnerable patients’ care and rights through systematic understaffing and underfunding of residential medical care facilities, including the Plaintiff herein, Oxnard Manor LP, doing business as Oxnard Manor Health Center (“Plaintiff” or “Oxnard Manor”).

    The parties each filed motions to exclude expert testimony pertaining to insurance claims handling practices, an issue critical to the Plaintiff’s claim for breach of the implied covenant of good faith and fair dealing.

    Plaintiff moved to exclude the expert testimony of Burl Daniel, whom Defendant designated to rebut opinions offered by Plaintiff’s designated expert, Barry Zalma. Defendant, in turn, moved to exclude the expert testimony of Barry Zalma, whom Plaintiff designated to opine on insurance industry claims-handling custom and practice.

    Insurance Expert Witnesses

    Burl Daniel, CPCU, CIC, CRM entered the Insurance Industry in 1973 and was an Insurance Agency Principal for twenty four years. Attorneys representing policyholders, carriers and/or third parties engage him as a Property and Casualty Insurance Expert Witness.

    He holds a BBA-Insurance from the University of Texas and professional designations of CPCU (Chartered Property Casualty Underwriter), CIC (Certified Insurance Counselor), and CRM (Certified Risk Manager), and licenses as a Property-Casualty Agent and Risk Manager. He has served as a corporate Insurance & Risk Manager, Adjunct Professor of Insurance with two Texas universities.

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

    Barry Zalma has extensive experience in the insurance industry, first as a claims adjuster, then—for several decades thereafter—as an insurance coverage lawyer licensed to practice in California.

     For more than 53 years as a claims person and insurance coverage attorney, Barry Zalma has represented insurers, advised insurers on claims handling, interpreted coverages and testified as an insurance coverage, insurance bad faith, insurance claims handling and insurance fraud expert on behalf of insurers and policy holders’ suing insurers.

    Fortify your strategy by reviewing a Challenge Study detailing grounds for excluding Barry Zalma’s expert testimony.

    Discussion by the Court

    Plaintiff’s Motion to Exclude the Expert Testimony of Burl Daniel

    Plaintiff made three arguments as to why Daniel’s testimony should be excluded: first, that his testimony was not based on sufficient facts or data; second, that his testimony was unreliable because it lacked a supporting methodology; and third, that he offered impermissible, non-rebuttal opinions outside the scope of Zalma’s testimony. 

    Burl Daniel’s Factual Bases

    Plaintiff first contended that Daniel’s report should be excluded because Daniel purportedly largely relied on the deposition testimony of Defendant’s 30(b)(6) witness in formulating his opinions. Although far from clear from his rebuttal report, Daniel has attested under oath to considering over 21,000 pages of documents, and it is not the Court’s role to engage in credibility determinations.

    In any event, as Plaintiff explained with respect to its own witness, Zalma, an expert’s purported failure to “address (or review)” material “that purportedly undermine[s] some of his opinions or assumptions does not make his testimony excludable” but instead provides “grounds for cross-examination.” The Court declined to exclude Daniel’s opinions on this basis.

    Burl Daniel’s Methodology

    Plaintiff also argued that Daniel lacked any “discernable methodology” for his opinions. In particular, Plaintiff noted that Daniel did not refer to “California insurance claims handling or investigation standards” and that he otherwise “lacked sufficient knowledge or experience” to support his conclusions.

    As an initial matter, Daniel’s report does not make clear what bases he has to opine on California claims handling practices. Standing alone, Daniel’s curriculum vitae indicates that his experience as an insurance agent occurred within the state of Texas; although he has also worked as an insurance expert witness for approximately twenty years, the curriculum vitae does not make clear how this experience equips him to opine on California insurance custom and practice.

    Notwithstanding, Daniel provided scant explanation or analysis to explain the basis of his opinions and did not indicate any methodology he used to arrive at his conclusions. Daniel concluded that Defendant’s investigation and analysis was reasonable under the circumstances of the claim as per insurance industry and California practice standards. Yet, Daniel did not provide any analysis to substantiate this conclusion.

    In short, Daniel did not provide any explanation or analysis that could enable the Court to ensure that his expert opinion “both rests on a reliable foundation and is relevant to the task at hand.”

    Legal Conclusions

    Daniel’s opinions about Defendant’s claim handling process must be excluded for the additional reason that they encroach the role of the jury by reaching the ultimate issue in this case: whether Defendant acted in bad faith. Daniel’s opinions pertained to Plaintiff’s claim for breach of the implied covenant of good faith and fair dealing.

     It would be proper for Daniel to offer testimony that could support his conclusion that “Hallmark met its duty of good faith and fair dealing.” It was, however, plainly improper for him to offer only that legal conclusion. 

    The Scope of Daniel’s Testimony

    Plaintiff also argued that Daniel should be precluded from opining on certain warranties Plaintiff purportedly made in its insurance application on the grounds that this opinion fell outside the scope of Zalma’s report and was irrelevant.

    The Court concluded that Daniel’s opinion “that the answers and information Robin provided on the application were warranties” and that “any inaccuracies or misrepresentations could serve as grounds to void coverage from inception,” is too generalized and speculative to be helpful to a jury. 

    Daniel did not set forth any facts that could support a conclusion that Defendant considered this issue in handling Plaintiff’s claim. Defendant contends in opposition that “[a] routine step in claims-handling, which necessarily includes analyzing the insurance policy, is reviewing the application.” While this may be so, Daniel simply concluded that Defendant’s investigation of Plaintiff’s claim was reasonable without analyzing the claims-handling process.

    Defendant’s Motion to Exclude the Expert Testimony of Barry Zalma

    Defendant advanced three arguments as to why Zalma’s testimony was not reliable: first, that his opinions lacked sufficient factual bases; second, that they lacked a reliable methodology; and third, that they were inadmissible legal opinions.

    Zalma’s Factual Bases

    Defendant challenged Zalma’s testimony on the grounds that he reviewed only twenty-two documents rather than “all documents produced in this action.” Defendant contended that “Zalma did not have all relevant documents and, therefore, all relevant facts.” The Court held that Zalma’s report indicates that he reviewed various documents, including certain of Defendant’s claim notes, internal best practices documents, the policies at issue in this action, and certain correspondence between the parties. Henceforth, it constituted grounds for cross-examining Zalma at trial, not excluding his testimony.

    Defendant also contended that Zalma’s opinions are unreliable because, in preparing them, he viewed documents that Plaintiff purportedly did not provide to Defendant. In any event, as with the documents Zalma did not consider, to the extent this material undermines the credibility of Zalma’s opinions, Defendant may cross-examine him at trial on this matter.

    Finally, Defendant raised various substantive criticisms of Zalma’s opinions. The Court held that Defendant’s arguments about Defendant’s choice of defense counsel, Plaintiff’s request for admission responses, Defendant’s investigation, and whether Zalma considered whether any exclusions might bar coverage “go to the weight of the testimony and its credibility, not its admissibility.”

    Zalma’s Methodology

    Defendant next contended that Zalma’s opinions lacked a reliable methodology because they incorporated standards set forth in California Fair Claims Settlement Practices Regulations and California Insurance Code. Defendant asserted that “Zalma’s opinions are almost entirely based on non-existent legal standards and legal standards that are expressly inapplicable to the case at bar.”

    Zalma appeared to have Identified the Relevant Standards for Claims Handling

    The Court noted that Zalma has extensive experience in the insurance industry, first as a claims adjuster, then—for several decades thereafter—as an insurance coverage lawyer licensed to practice in California. This experience forms “a sufficient foundation of reliability for his testimony.”

    As for Zalma’s invocation of various California statutory provisions, the Court cannot conclude, as Defendant urges, that these provisions are entirely “inapplicable.”

    First, Zalma opined—and Defendant did not dispute—that Defendant incorporated certain of the California Fair Claims Settlement Practices Regulations into its own Best Practices for Healthcare Claims. Second, relying on his industry experience, Zalma opined that it is the custom and practice of insurers doing business in California to treat these regulations as minimum standards for interactions with insureds. Zalma appeared to have identified the relevant standards for claims handling and applied those standards to the facts before him.

    Defendant Mischaracterized One of Zalma’s Opinions

    As for the two opinions Defendant contended were based on “non-existent/inaccurate legal principles,” Defendant mischaracterized one of Zalma’s opinions, which in fact stated that it is industry custom and practice to “[m]eet, and preferably exceed, the minimum standards,”not, as Defendant represents, “that an adjuster has the obligation to exceed standards.” To the extent Defendant disagrees with this aspirational statement, it may cross-examine Zalma about it at trial.

    As for Zalma’s opinion regarding providing coverage “to the satisfaction of the insured,” in light of Plaintiff’s concession that Zalma “confirmed it was a misstatement,” the Court questions why the parties have engaged in motion practice regarding this issue. Because the parties and Zalma all agree that this specific opinion is erroneous, the Court concluded that it is unhelpful and irrelevant.

    Defendant’s contention that Zalma’s “analysis and resulting opinions are based on an egregiously incomplete and incorrect factual foundation,” essentially repackages its prior argument that Zalma’s opinion must be excluded because he did not review certain purportedly relevant documents and did review certain other, purportedly irrelevant, documents. For the reasons already stated above, however, Rule 702 does not impose such a rigid requirement under these circumstances.

    Held

    The Court granted the Plaintiff’s motion to exclude the testimony of Burl Daniel in full. However, Defendant’s motion against Barry Zalma was granted only to the extent that it sought to exclude testimony that it is the custom and practice in the insurance industry to adjust claims “to the satisfaction of the insured.”

    Key Takeaways:

    • Daniel did not provide any analysis to substantiate this conclusion. His report failed to identify any purportedly reasonable actions Defendant took to investigate and analyze. As per Rule 702, his statement was merely conclusory absent an explanation of what steps Defendant took and when.
    • Daniel simply concluded that Defendant’s investigation of Plaintiff’s claim was reasonable without analyzing the claims-handling process. Testimony that Defendant could theoretically have concluded the policy was void from inception and denied coverage to Plaintiff on that basis risks confusing the jury where there is no indication that Defendant ever considered doing so.
    • Zalma relied on his extensive industry experience and invoked various California statutory provisions. According to the Court, Zalma appeared to have identified the relevant standards for claims handling and applied those standards to the facts before him.

    Case Details:

    Case Caption: Oxnard Manor Et Al V. Hallmark Specialty Insurance Company Et Al
    Docket Number: 2:23cv1322
    Court Name: United States District Court, California Central
    Order Date:  April 2, 2024