Expert Witness Profiler

Tag: Reliability

  • Economics Expert Witness’ Improper State-of-Mind Testimony Excluded

    Economics Expert Witness’ Improper State-of-Mind Testimony Excluded

    Plaintiffs Richard Dennis, Port 22, LLC, and Michael Glass asserted Commodity Exchange Act and Sherman Antitrust Act claims, alleging that the Andersons, Inc. and Cargill Incorporated, who were supposed competitors, operated multiple grain storage warehouses in Ohio and collaborated to manipulate prices of soft red winter wheat futures and options contracts on the Chicago Board of Trade. 

    According to the Plaintiff, the Andersons, Inc. sold SRW wheat to the major purchasers in October and November 2017 to suppress demand for physical SRW wheat and then, on November 29, 2017, registered for delivery two thousand certificates of CBOT December 2017 SRW wheat.

    This registration (falsely, Plaintiffs say) signaled that TAI would sell ten million bushels of physical SRW wheat to parties holding long positions in December 2017 SRW wheat futures and caused a marked price decrease in the December 2017 SRW wheat futures contract and widened the spread between the December 2017 and March 2018 SRW wheat futures contracts.

    TAI and Cargill later repurchased some of the shipping certificates TAI had delivered at the decreased prices. Plaintiffs allegedly transacted in December 2017 and March 2018 SRW wheat futures and lost money because of the decreased prices caused by the scheme.

    Plaintiffs’ expert Craig Pirrong opined in relevant part that Defendants artificially depressed prices of the December 2017 and March 2018 SRW wheat futures through a market manipulation that injured Plaintiffs on a class-wide basis; Pirrong also provided a methodology for determining individual damages. Through the report of their expert, Professor Justin McCrary, Defendants purported to challenge the reliability of Pirrong’s studies. Plaintiffs attacked Professor McCrary’s qualifications.

    Economics Expert Witnesses

    Justin McCrary is an “economist with expertise in microeconomics, economic modeling, and statistical method,” who teaches at the Law School at Columbia University. He has taught courses on economic theory econometric theory, antitrust, law and economics, and statistics and is a reviewer for leading peer-reviewed economics journals. He served on the Board of Directors of the American Law and Economics Association and has published papers in prominent economic journals.

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

    Craig Pirrong‘s extensive qualifications includes approximately 30 years of concentrating professionally on competition and manipulation of prices with a focus on Chicago Mercantile Exchange wheat, soybean, and corn futures contracts; publishing a dozen peer-reviewed articles and a book on commodity futures manipulation and pricing; presenting to and consulting with federal agencies on manipulation; and testifying as an expert.

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

    Discussion by the Court

    Professor Justin McCrary

    Plaintiffs argued McCrary: (1) is unqualified to give an opinion in this class action alleging market manipulation in wheat futures and options; (2) tenders opinions that are unreliable because they lack a scientific basis and he has never performed such quantitative work before; and (3) offers irrelevant opinions.

    McCrary’s Qualifications

    Plaintiffs insisted McCrary is unqualified to render an opinion in the realm of the commodity futures market, a conclusion they say is underscored by his professed unfamiliarity with “basic industry terminology” like “front month,” “spot month,” “strong stopper,” and “cash contract.”

    The Court held that Plaintiffs’ surface-level attack on McCrary’s background and education is insufficient to demonstrate his lack of qualification, and the Court declines to exclude McCrary’s opinions, which Plaintiffs do not deny are rooted in statistics and economics, merely because he neither purports to be nor appears to be an expert in commodities futures trading or manipulation.

    Reliability of McCrary’s Opinions

    Plaintiffs argued McCrary’s opinions are unreliable, first, for lacking a scientific basis—because he opines Pirrong’s analyses fail to account for confounding fundamental factors that McCrary himself neither identified nor analyzed to determine any potential impact. But, as Defendants retort, that was not McCrary’s task; neither Daubert nor Rule 702 required McCrary to perform independent studies.

    Although Plaintiffs labelled McCrary’s analysis thin and McCrary a mere mouthpiece for the defense, the Court finds he sufficiently explained the underpinnings for his opinions, which flow from his review of relevant literature, his expertise, experience and knowledge.

    Finally, Plaintiffs attacked an isolated sentence of McCrary’s opinion regarding Pirrong’s event study and further attacked his criticism of Pirrong’s damages model because McCrary had “never worked with” data types he used in performing his calculations. The Court agreed with Defendants that the former argument takes McCrary’s statement out of context , and the latter argument lacks force because Plaintiffs identified no errors in McCrary’s calculations.

    Relevance of McCrary’s Opinions

    Plaintiffs finally briefly recycle most of the foregoing arguments, which the Court already has rejected, into an argument that Professor McCrary’s opinions will not help the trier of fact. Again, the Court disagreed. Although Professor McCrary does regurgitate some record evidence (such as that SRW wheat would be aging between December 2017 and March 2018), he does not merely repeat evidence but adds his opinions to the evidence he recites, including that Pirrong should have accounted for the aging of the wheat and other factors. For these reasons and those set forth above in addressing Plaintiffs’ prior arguments, the Court declines to strike McCrary’s opinions because they are relevant to understanding and analyzing Pirrong’s opinions regarding class certification.

    Craig Pirrong

    Plaintiffs proffered their expert witness, Dr. Craig Pirrong, an economist, who intended to testify that Defendants’ alleged manipulation artificially deflated prices in the December 2017 and March 2018 SRW wheat futures markets and caused damages to the proposed class that are capable of calculation on a class-wide basis. 

    In support, he presented: (1) an event study with regression analysis meant to measure the existence and amount of alleged price-artificiality in the December 2017 and March 2018 SRW futures and options contracts that is attributable to Defendants’ conduct rather than chance or other market factors; and (2) a damages model that takes the output from the event study as an input to calculate a range of aggregate damages. Such models may meet Plaintiffs’ burdens at the class certification stage. 

    A. Pirrong’s Event Study with Regression to Predict “But For” Wheat Prices

    Pirrong first employed an event study with regression analysis intended to predict what prices would have been absent Defendants’ actions and statements. 

    In the context of this case, Pirrong’s regression model uses other grain commodities traded on CBOT as control variables; he estimates the historical relationship among the SRW wheat futures prices and the control variables by using “a control period consisting of data from March 1 to November 29 for the CBOT wheat futures contract for each year from 2005 through 2017.”

    According to Pirrong, the model computes what would have been, but for Defendants’ conduct, the prices for December 2017 and March 2018 SRW wheat futures for each trading day between November 30, 2017 and December 14, 2017. He attributed the difference between his model’s output of estimated prices for December 2017 and March 2018 SRW wheat futures prices and the actual December 2017 and March 2018 SRW wheat futures prices to a “price artificiality” due to Defendant’s conduct. 

    Thought Defendants acknowledged that statistical regression is an established methodology, they argued that Pirrong “employed a ‘reliable methodology in an unreliable way” because the “results” are not “statistically significant” under generally accepted statistical principles and lead to an unacceptably high rate of false positives (predicted price manipulation in years in which none is alleged). They insisted that the study “cannot rule out” other potential causes of the SRW wheat futures price changes and has “dubious predictive value.”

    1. Statistical Significance

    Pirrong himself described p-values as “giving the probability of observing the residual,” which, here, is price artificiality, and conceded that “conventional thresholds” for statistical significance are five percent (0.05) and ten percent (0.1).

    Defendants asserted that p-values above 0.05 indicate unreliable regression study results and emphasize “Pirrong offered no thresholds for determining when his event study results should be considered statistically significant,” despite having agreed that one must “choose a threshold” to “establish statistical significance.”

     The Court is unconvinced that all of his results should be excluded due to some p-values above 0.05, particularly where seven of eleven days (November 30 through December 8, 2017) within the December 2017 SRW wheat contracts regression analysis returned p-values with statistical significance at the five percent level. Nor does the Court find that Pirrong’s non-articulation of a statistical significance threshold warrants blanket exclusion of his results here.

    Second, even if Defendants sought to exclude just dates for which a p-value above 0.05 was returned, the Court under these circumstances declines to adopt a “hard and fast rule” requiring p-values of 0.05 or below, which in essence “evaluates statistical significance as a binary question” where “statistical significance lies at the 4.99% level but not at the 5.01% level.’”

    Pirrong also emphasized that “eminent statisticians” have increasingly criticized the use of statistical significance cutoffs “because it is misleading and leads to erroneous conclusions” and that one should avoid “‘dichotomization as statistically significant or not.’”

    The Court held that Defendants’ arguments go to the weight, rather than the admissibility, of the regression study results. Pirrong’s event study results in the December 2017 and March 2018 SRW Wheat futures contracts are sufficiently reliable for consideration.

    2. Rate of False Positives

    Defendants next asserted Pirrong’s study is undermined by the rate of “false positives,” or instances in which Pirrong’s model predicts price artificiality in years in which no manipulation is alleged. Defendants argued the higher the threshold for statistical significance one accepts as to the event study, the higher the rate of false positives the model returns. Accepting, for example, a 43% threshold for statistical significance (drawn from the highest p-value result Pirrong endorses, 0.43, applied across both the December 2017 and March 2018 studies) suggested price manipulation on 85% of the days for which Plaintiffs did not claim manipulation. 

    Adopting a 5% statistical significance level (which would result in statistical significance for the results of just seven days in the December 2017 study and none in the March 2018 study) garners a 19.66% rate of false positives. Defendants argued that these rates of false positives show the event study does not reflect a reliable application of statistical methods to this case.

    Although the explanation regarding false positives is not robust, the Court nevertheless found that Pirrong’s testimony is “closer to shaky than unreliable.”

    B. Pirrong’s Damages Estimates

    Pirrong proffered damages methodologies to calculate individual damages and estimate aggregate class-wide damages using linear programming (the LP model).

    1. Pirrong’s Use of “Permanent Artificiality” in March 2018 SRW Wheat Futures from December 14, 2017 through March 14, 2018

    Defendants first attacked Pirrong’s opinion that the March 2018 SRW wheat futures contract had a permanent fixed artificial price depression of 1.2¢ per bushel from December 14, 2017 to March 14, 2018. Defendants asserted this use of a constant 1.2¢ residual is undermined by Pirrong’s choice to use a day-to-day approach for other transactions, as well as his opinion that publicly available information is immediately incorporated into the SRW futures marketplace.

    Pirrong, though, opined that Defendants “distorted consumption by making excessive deliveries,” only a “fraction” of which they later repurchased, causing immediate consumption of wheat that “should have remained in storage for consumption later.” The effects of their actions “persisted into the indefinite future beyond November 30, 2017,” thus “distorting supply-demand fundamentals far into the future” and causing ongoing effects on prices. This price artificiality, Pirrong asserted, would remain constant after the December 2017 SRW wheat contract expired both because Defendants’ actions in the December contract could not affect prices after the expiration, and in an efficient futures market, the impacts of Defendants’ actions would be reflected in prices quickly and permanently.

    Pirrong’s explanation provides support for his choice. And, despite Defendants’ attack, the Court held that his testimony is not “unsupported ipse dixit” because, rather than “pluck his conclusions out of thin air” he reviewed the identified records, performed studies, and applied his extensive experience in futures markets to reach those conclusions.

    2. Outputs of the Damages Model

    Defendants challenged the LP Model outputs for the model’s reliance “on the daily artificiality residual (i.e., the daily artificiality estimate produced by the event study) to calculate hundreds of thousands of hypothetical possible trade scenarios and conjures a supposed aggregate damage range for class members,” because it “cannot be applied to estimate the loss for any class member,” includes “computational errors that artificially inflate the damages estimate,” and did not “account for characteristics specific to many entities and individuals included in the group Pirrong purports to study,” like intraday traders and traders with offsets.

    The Court held that Pirrong’s calculations, based upon his event studies, are sufficient to meet Plaintiff’s low burden here.

    Defendants’ argument that “the LP model has several computational errors that artificially inflate the damages estimate” did not suggest damages cannot be calculated on a class-wide basis, and the Court is not seeking to calculate actual damages at this stage. As Plaintiffs point out, Defendants’ related argument that Pirrong’s model did not account for the characteristics of certain traders, boils down to an argument that some members of the defined class “ultimately were not harmed” by Defendants conduct, i.e., that their claims “will fail on the merits if and when damages are decided,” which is “a fact generally irrelevant to the district court’s decision on class certification.”

    C. State-of-Mind Opinions and Legal Conclusions by Pirrong

    Defendants argued that “Pirrong, an economist, lacks an analytically sound basis for ostensibly psychological conclusions” about Defendants’ “knowledge or intentions.”

    The Court held that Pirrong properly may testify regarding “conclusions drawn only in his capacity as an economist.” This includes opining on potential economic motives of a party but not testimony of what a party knew because Pirrong is not more qualified than an ordinary juror to make the latter inferences.

    Held

    The Court denied Plaintiffs’ motion to exclude the testimony of Professor Justin McCrary, and the Court granted in part and denied in part the Defendants’ motion to exclude the testimony of Craig Pirrong. 

    Key Takeaways:

    • Professor McCrary neither purports to be nor appears to be an expert in commodities futures trading or manipulation but his opinions are rooted in statistics and economics.
    • The Court, like many others presented with the question, declines to use statistical significance at the five percent level as a proxy for reliability, and thus admissibility, for the purposes of Rule 702 and Daubert. Considering the entire data set presented, Pirrong’s explanations, and the class definition Plaintiffs propose regarding transactions of December 2017 and March 2018 SRW wheat set forth above, Defendants’ arguments go to the weight, rather than the admissibility, of the regression study results. 
    • First, the Court has resolved the related argument regarding p-values, finding they do not render Pirrong’s testimony inadmissibly unreliable, in large part due to Pirrong’s explanation that “sound economic reasoning” indicates the impact of Defendants conduct would not have dispersed within days, despite the p-value results, and the spread was wider than anticipated for the December 2017 through March 2018 SRW wheat futures. Because Defendants’ false positives argument spins off from the p-values discussion and applies an across-the-board 43% threshold for statistical significance not adopted by Pirrong, the Court is disinclined to reach a different result here. Second, Defendants point to no flaws in Pirrong’s inputs to his studies. Defendants may explore false positives or other questions as to Pirrong’s studies through traditional evidentiary mechanisms. 
    • Legal conclusions are inadmissible, while state-of-mind testimony is admissible where helpful to the jury and its probative value is not outweighed by a risk of unfair prejudice. The admissibility of alleged state-of-mind assertions is more nuanced. Direct opinions regarding state of mind are improper, although an expert may testify regarding the consistency of a certain action with a particular state of mind.

    Case Details:

    Case Caption: Dennis V. The Andersons Inc.
    Docket Number: 1:20cv4090
    Court: United States District Court, Illinois Northern
    Order Date: October 07, 2024
  • Accounting Expert Witness’ Approach to Calculating Lost Profits is Accepted in the Relevant Field

    Accounting Expert Witness’ Approach to Calculating Lost Profits is Accepted in the Relevant Field

     

    Plaintiff Dick’s Sporting Goods, Inc. (“DSG”) filed a lawsuit against Defendants Forbes/Cohen Florida Properties, L.P. (“Forbes”) and The Gardens Venture LLC (“Gardens Venture”) (collectively “Defendants”). 

    DSG claimed that Forbes tortiously interfered with its business and contractual relationships, which involved Sears, Roebuck, and Co. (“Sears”) and Transform Operating Stores LLC (“Transform”), specifically regarding the sublease of the second floor of the Sears store at the Gardens Mall (the “Palm Beach Gardens location”). Forbes allegedly refused to sign necessary forms for development applications submitted to the City of Palm Beach Gardens. DSG filed a lawsuit seeking compensatory and punitive damages, including out-of-pocket costs and net cash flows from operations. 

    To support its claim for damages, DSG presented the opinion and reports of accounting expert witness Louis G. Dudney. In response, Forbes retained accounting expert witness James S. Feltman to counter Dudney’s assertions. 

    Defendants filed a Daubert motion to exclude Dudney’s testimony. Meanwhile, DSG filed a motion to exclude specific parts of Feltman’s testimony. 

    Accounting Expert Witnesses 

    Louis G. Dudney, CPA, CFF, has extensive experience across various areas, including operational, financial, valuation, litigation, bankruptcy, and management consulting. His work encompasses financing, mergers and acquisitions, damages analysis, lost profit assessments, business valuations, solvency evaluations, debtor and credit advisory services, as well as corporate investigations. 

    He serves on the Management Committee at AlixPartners and is the Global Leader of the Investigations, Disputes, and Risk practice. Before joining AlixPartners, Dudney was a partner in the Financial Advisory Services Group at PricewaterhouseCoopers. He earned a Bachelor of Business Administration in accounting from The College of William & Mary and is a Certified Public Accountant. Additionally, he holds a certification in Financial Forensics from the American Institute of Certified Public Accountants. 

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

    James S. Feltman is a Managing Director in the Global Restructuring practice at Kroll, LLC. Kroll operates as a global advisor in valuation, corporate finance, investigations, disputes, cybersecurity, compliance, regulatory matters, and other governance-related issues. The firm employs nearly 3,500 professionals across 28 countries. 

    Feltman has qualified and testified as an expert witness in various federal and state courts. He focuses on forensic accounting and fraud investigations, bankruptcy, and solvency. Additionally, he provides expertise in commercial damages, business valuations, investment theory, and federal and state income taxation. He also addresses issues related to abusive tax shelters, accounting ethics and standards, and accounting malpractice. Furthermore, he deals with investment advisory matters and a range of other accounting, financial, and tax-related topics. 

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

    Discussion by the Court 

    A. Defendants’ Motion to Exclude DSG’s Expert, Louis G. Dudney 

    DSG identified Louis G. Dudney as an expert witness on causation. He assessed the damages reasonably attributed to the Defendants’ tortious interference. Dudney submitted an initial expert report in 2021 and a supplemental report in 2024. 

    1. Defendants’ Arguments 

    Defendants contended that Dudney should not testify due to unreliable methodology. They cited several reasons: 

    1. He relied on outdated data. 
    1. He altered the corporate allocation rate in his 2024 report. 
    1. He failed to consider the proper cannibalization rate. 
    1. He used “skewed or ‘cherry-picked’ ex-post data.” 

    Dudney reduced the projected corporate allocation expenses in the damages analysis.  Dudney says this was done in “accordance with DSG’s updated corporate practice for cost allocation in its pro formas.” Dudney also adopted the cannibalization rate that DSG calculated in his damages model. In his deposition testimony Dudney says he “[used the cannibalization rate] as one of the inputs to evaluate what is the impact and what the best estimate of the impact to Dick’s as a result of [Defendants’] behavior.” 

    Defendants argued the reduction in allocation expenses inflated DSG’s alleged damages. They claimed Dudney improperly relied on information from DSG, making the damages calculation unreliable. 

    2. Plaintiff’s Counter-Argument 

    DSG countered that Defendants had not adequately challenged Dudney’s methodology. Instead, they only criticized certain inputs in his calculations. The Court agreed, noting that the Defendants’ arguments questioned the weight of Dudney’s testimony rather than its admissibility. 

    3. Analysis 

    The Court reviewed Dudney’s deposition and expert reports and determined that he met the Daubert standard. 

    Defendants did not sufficiently challenge the reliability factors required for evaluation. For instance, they argued that he relied on a construction budget from 2015 and that his damages calculation assumed DSG would generate revenue during the COVID-19 pandemic. However, Defendants did not dispute the general acceptance of Dudney’s methodology within the scientific community. 

    Defendants argued that the reduction in allocation expenses “artificially inflates DSG’s alleged damages…and the damages calculation is unreliable because Dudney improperly relied on information provided to him by DSG.” The Court held that Defendants did not challenge the principles and methodologies Dudney applied to get to his conclusions. And it is not improper for an expert to rely on information given to him or made available to him “if experts in the particular field would reasonably rely on those kinds of fact or data.” 

    Also, the Court held that Dudney’s approach to calculating lost profits is accepted in the relevant scientific field. 

    Defendants did not otherwise challenge whether other experts in the field would not have reasonably relied on the facts and or data Dudney relied on. Their remaining objections primarily targeted his conclusions, alleging bias. The Court emphasized that perceived weaknesses in expert testimony should be addressed through vigorous cross-examination, not exclusion. 

    B. DSG’s Motion to Exclude Certain Opinions Offered by Defendants’ Expert, James S. Feltman 

    Defendants identified James S. Feltman as a rebuttal expert. He provided an initial report in 2022 and a supplement in 2024. DSG moved to exclude Feltman’s opinions on mitigating damages. Additionally, DSG sought to preclude Feltman from testifying about third-party demographic data or offering any undisclosed opinions under the Federal Rule of Civil Procedure 26. 

    1. The Third-Party Demographic Data 

    Feltman’s 2024 report included a section on “Target Market Data.” This discussion consisted of data collected from two third-party software systems. DSG argued that Feltman did not analyze the data to establish a cannibalization rate. They pointed out that he admitted he was not an expert in demographic analysis and lacked formal training. DSG asserted that Feltman possessed no specialized knowledge to apply the demographic data in a way that would assist the trier of fact. 

    Defendants countered that Feltman did not need to be a demographer to serve as a rebuttal expert on damages. The Court partially agreed. 

    Feltman was a global advisor in areas such as valuation and corporate finance. He had previously been qualified and testified as an expert in commercial damages. He stated that he had training in analyzing databases and applying them to specific cases. Feltman used resources from two databases, ArcGis and Placer.ai, and applied that information to the facts of this case to reach a conclusion on mitigation of damages. 

    It was acceptable for Feltman to rely on otherwise inadmissible hearsay when forming his opinion, according to Rule 703. However, he could not serve as a conduit for hearsay. Rule 703 specified that if the facts or data were inadmissible, the proponent of the opinion could only disclose them to the jury if their probative value significantly outweighed their prejudicial effect. Defendants did not sufficiently demonstrate how the third-party demographic data met this requirement. 

    Therefore, DSG’s motion regarding the third-party demographic data was granted in part and denied in part. Feltman would be allowed to testify about the conclusions he reached using the data, but the data itself was deemed inadmissible hearsay. 

    2. Feltman’s Opinions on the Mitigation of Damages 

    DSG claimed that Feltman’s opinions on mitigation were based on unreliable methods. Defendants responded that Feltman was a rebuttal expert who relied on publicly available facts and conducted a comparative analysis. The Court agreed with Defendants. DSG did not challenge the methodology used by Feltman; instead, it suggested additional analyses that could have been performed. 

    The Court held that DSG’s objections focused on the weight of the evidence rather than its admissibility. 

    3. Feltman’s Opinions Related to the Sears Bankruptcy and New Opinions at Trial 

    Given the Court’s Supplemental Order on the bankruptcy issue, DSG’s motion regarding Feltman’s opinions on the bankruptcy was denied as moot. The Court resolved the legal implications of the Sears bankruptcy, and no evidence to the contrary would be allowed. 

    DSG’s motion to exclude any new or additional opinions was granted. Defendants were prohibited from presenting new opinions through Feltman’s testimony that DSG had not previously been informed of under Federal Rule of Civil Procedure 26. 

    Held 

    The Court denied the Defendants’ motion to exclude Plaintiff’s accounting expert witness, Louis Dudney’s testimony. 

    The Court granted in part and denied in part the Plaintiff’s motion to exclude certain opinions from Defendants’ accounting expert witness, James Feltman. 

    1. Feltman was prohibited from discussing the legal implications of the bankruptcy as it had already been resolved. 

    2. Feltman was barred from presenting any new opinions that had not been previously disclosed under Rule 26. 

    3. Feltman could provide opinions on the mitigation of damages, but he could not testify to otherwise inadmissible hearsay that he relied  

    Key Takeaway: 

    Plaintiff did not challenge the methodology that Feltman used; instead, it pointed to additional analyses that could have been done. A methodology is not rendered excludable under Daubert if it fails to include every possible test that could have been conducted. 

    Moreover, Rule 702 and Daubert are instructive that the Court’s analysis on a Daubert motion is not of the conclusions, rather the principles and methodologies applied to get to those conclusions. Defendants did not challenge the principles and methodologies Dudney applied to get to his conclusions. And it is not improper for an expert to rely on information given to him or made available to him “if experts in the particular field would reasonably rely on those kinds of fact or data.” 

    Case Details:

    Case caption: Dick’s Sporting Goods, Inc. V. Forbes/Cohen Florida Properties, L.P. Et Al
    Docket Number: 9:20cv80157
    Court: United States District Court for the Southern District of Florida
    Dated: September 9, 2024
  • Technology Expert Witness’ Analysis of Call Detail Records Admitted

    Technology Expert Witness’ Analysis of Call Detail Records Admitted

    This case concerns Defendant’s alleged transmission of illegal robocalls. Plaintiff, Office of the Attorney General, State of Florida, Department of
    Legal Affairs brought this action pursuant to the Telemarketing and
    Consumer Fraud and Abuse Prevention Act. Apparently, Smartbiz courts
    robocaller customers by allowing them to place a high volume of calls in quick
    succession, billing only for the duration of completed calls – sometimes in as little as .6 second increments and ignoring clear indicia of fraudulent call traffic.

    Plaintiff retained Mike Rudolph “as an expert witness to analyze several relevant datasets, specifically: Defendant’s Call Detail Records (“CDRs”), consumer voicemail recordings provided by YouMail, traceback data provided by the Industry Traceback Group (“ITG”), and consumer complaint data provided by the Attorney General.” 

    Defendant filed a motion to strike Rudolph’s expert testimony “because it does not carry the hallmarks of reliability.”

    Defendant argued that Rudolph’s testimony and methods are unreliable because they are based on confidential and proprietary processes, use algorithms and codes to do much of the work, have not been peer reviewed, have an error rate of less than 1% that is inherently suspect, and cite the average length of Defendant’s calls as a metric.

    Technology Expert Witness

    Mike Rudolph is the CTO and Chief Architect of YouMail’s telephony, cybersecurity, and robocall mitigation platforms. Rudolph works directly with Fortune 500 organizations, service providers, and working groups, employing AI, machine learning, and forensic analytics to combat illegal and unwanted calls. Moreover, Rudolph holds over a dozen patents featuring a number of startups and public companies adding intelligence through AI and expert systems to highly scaled platforms in communications, compliance and governance, business process management, activity monitoring, background checks, and consumer advertising.

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

    Discussion by the Court

    Rudolph prepared an Expert Report describing several types of analysis using different methodologies including the following:

    • First, is the behavior call analysis which identifies indicia of fraudulent or otherwise unwanted calls in Defendant’s CDRs and consists of five sections of his Summary of Findings: (1) Analysis of “Snowshoeing” Calling Tactics, (2) Analysis of Low Answer Rates and Short Duration Calls, (3) Analysis of Phone Number Spoofing, (4) Analysis of Recipient Geographic Location, and (5) Analysis of Telemarketing Hours and Do-Not-Call-Registry (DNC) Data.
    • Next, Rudolph analyzed Defendant’s CDRs in conjunction with YouMail Consumer Voice Call Evidence, which consists of call records for calls to YouMail subscribers, recordings of voicemails left by those calls, and transcriptions of those voicemails, identifying examples of calls that Defendant transmitted to YouMail subscribers; third, Rudolph performed an analysis of traceback information to identify patterns in Defendant’s traceback responses to the ITG.
    • Finally, Rudolph analyzed Defendant’s CDRs and YouMail data in conjunction with consumer complaint data supplied by Plaintiff to identify individuals who complained about the types of calls Defendant transmitted. 

    According to Plaintiff, Defendant’s contentions that Rudolph’s methods are unreliable because they use algorithms and have not been peer reviewed are not relevant to the type of expert opinion Rudolph has produced. Defendant relies primarily on factors relevant to scientific testimony to rebut the reliability of Rudolph’s methodology, but Rule 702 does not bar non-scientific expert evidence, and allows expert opinions based on technical or other specialized knowledge.

    This Court found that Defendant’s issues with Rudolph are insufficient to warrant the exclusion of his testimony and are best addressed on cross-examination.

    Held

    The Court denied the Defendant’s Daubert motion to exclude the testimony and report of Mike Rudolph.

    Key Takeaway:

    Rudolph submitted a comprehensive expert report on the relevant datasets, which the Court admitted because the Defendant’s arguments against it were unpersuasive. It was held that the expert’s opinions should not be excluded, but rather be subjected to “vigorous cross-examination” and “presentation of contrary evidence.

    Case Details:

    Case Caption: Office Of The Attorney General, State Of Florida, Department Of Legal Affairs V. Smartbiz Telecom LLC
    Docket Number: 1:22cv23945
    Court: United States District Court, Florida Southern
    Order Date: September 3, 2024
  • Pharmacy Expert Witness’ Testimony Excluded for Rejecting Published, Peer-Reviewed Ranitidine Epidemiology

    Pharmacy Expert Witness’ Testimony Excluded for Rejecting Published, Peer-Reviewed Ranitidine Epidemiology

    Plaintiff alleged that his use of the antacid medication Zantac caused him to develop prostate cancer because Zantac’s active ingredient, ranitidine, has been found to degrade N-nitrosodimethylamine (“NDMA”).

    Brand Defendants’ filed a motion to exclude Plaintiff’s expert Dr. Steven Bird under Daubert.

    Pharmacy Expert Witness

    Steven Bird is a lead epidemiologist at the Food and Drug Administration / Center for Drug Evaluation and Research. He is responsible for the science and administration function of the team and to ensure that reviewers provide quality review and consultation to review divisions within established timeframes.

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

    Discussion by the Court

    Bird opined that (1) NDMA is a potent carcinogen; and (2) Plaintiff’s exposure to NDMA from Zantac (generic name ranitidine) use was a substantial causative factor for his prostate cancer.

    Bird (1) performed a “differential etiology methodology” where he purports to “rule in” ranitidine as a potential cause of Plaintiff’s prostate cancer and to “rule out” other causes, and (2) calculates Plaintiff’s lifetime exposure to NDMA from ranitidine by averaging the NDMA levels from other Plaintiffs’ expired ranitidine tablets and then converting his results to inhaled exposure risk estimates from a study of occupational NDMA exposure in rubber workers. The Brand Defendants argued that Bird’s opinions do not pass muster under Daubert based on his unreliable application of his chosen methodology to reach his specific causation opinion and his use of novel extrapolations to calculate Plaintiff’s NDMA exposure.

    Bird’s application of the differential etiology methodology is unreliable because he unreliably “rules in” ranitidine use as a potential cause of Plaintiff’s cancer

    Bird rejected all published, peer-reviewed ranitidine epidemiological studies assessing whether ranitidine is associated with prostate cancer—Rossing (2000), Habel (2000), Yoon (2021), Kantor (2021), Wang (2022), and You (2023)—none of which shows a statistically significant increased risk. Bird instead relied on the unpublished, non-peer-reviewed Braunstein manuscript, which examined only a cross-sectional, moment-in-time “snapshot” of cancer patients from Braunstein’s hospital. The Court held that Bird’s methodology of rejecting the published, peer-reviewed ranitidine epidemiology while embracing the unpublished Braunstein study is not reliable or based on scientific principles, and renders his opinion that ranitidine can cause prostate cancer unreliable. 

    Bird does not reliably “rule out” other potential causes

    In terms of ruling out potential causes, Bird conceded he made no attempt to “rule out” Plaintiff’s other risk factors for prostate cancer, in particular Plaintiff’s significant family history of cancer.

    The Court accordingly finds that Bird’s failure to do so renders his application of the differential etiology methodology unreliable, and warrants its exclusion.

    Bird’s extrapolations from expired ranitidine pills and the Hidajat study are the type of guesswork against which Daubert is meant to shield

    Bird purported to calculate (1) Plaintiff’s lifetime NDMA exposure from ranitidine use, and (2) the average and per quartile total NDMA exposure of rubber factory workers in the Hidajat study. Bird then uses these calculations to place Plaintiff within the cancer risk quartiles in the Hidajat study to estimate Plaintiff’s total prostate cancer risk from NDMA exposure.

    Using this extrapolation methodology, Bird concluded Plaintiff’s NDMA exposure from ranitidine significantly increased his risk of prostate cancer.

    Bird opined that Plaintiff absorbed as much NDMA through his use of ranitidine as the rubber workers in Hidajat’s “Quartile IV” had absorbed in their years of working in UK rubber factories. The Court held that the steps Bird had taken to reach this opinion are not a part of any reliable methodology, let alone a reliable application of any methodology. Indeed, the Zantac MDL Court found that “the number of assumptions and estimations necessary to render the Hidajat study helpful to” an expert’s general causation opinion about ranitidine use was “staggering.” 

    Held

     The Court granted Brand Defendants’ motion to exclude Plaintiff’s expert Steven Bird.

    Key Takeaway:

    Bird’s methodology of rejecting the published, peer-reviewed ranitidine epidemiology while embracing the unpublished Braunstein study is not reliable or based on scientific principles. Moreover, Bird conceded he made no attempt to “rule out” Plaintiff’s other risk factors for prostate cancer, in particular Plaintiff’s significant family history of cancer. When Bird concluded Plaintiff’s NDMA exposure from ranitidine significantly increased his risk of prostate cancer, the Court held that the steps Bird had taken to reach this opinion are not a part of any reliable methodology, let alone a reliable application of any methodology.

    Case Details:

    Case Caption: Wilson V. Boehringer Ingelheim Pharmaceuticals, Inc. Et Al
    Docket Number: 22CA000284
    Court: Circuit Court of the Thirteenth Judicial Circuit of Florida, Hillsborough County
    Order Date: August 15, 2024
  • Psychology Expert Witness’ Testimony Assessing Causal Factors Leading up to a Suicide Admitted

    Psychology Expert Witness’ Testimony Assessing Causal Factors Leading up to a Suicide Admitted

    This case involved various claims arising from the death of SGT, a minor and former student at St. Marys Middle School in the Camden County School District. Plaintiffs alleged SGT died of suicide because of multiple bullying incidents at the school and Defendants’ failures to adequately respond to and address those incidents and asserted claims under the Americans with Disabilities Act (“ADA”) and Georgia law.

    Plaintiffs retained a psychology expert, Dr. Sheila Crowell, to opine on the causal chain of stressors leading to SGT’s suicide and SGT’s symptoms of ADHD. In her report, Crowell opined SGT experienced stress as a result of actions and inactions by staff at St. Marys Middle School and the cumulative nature of these stressors exceeded the typical level of stress most children encounter. 

    Crowell opined there was a clear precipitating event for SGT’s suicide on November 18, 2019. SGT made “origami rockets” for a classmate on November 15, 2019. The classmate threw the origami rockets in the math classroom, and one got stuck in the ceiling. On November 18, 2019, Jackson sent SGT to the “ownership room” for this incident.

    Crowell opined this event appeared to have been on the forefront of SGT’s mind on the day he died by suicide. In Crowell’s deposition, she detailed a process called “chain analysis.” “A chain analysis is where you go through the chain of events that led to a person harming themselves.”

    Defendants argued Crowell formed her opinions based on information that was narrowly focused on stressors SGT experienced at school, and Crowell did not sufficiently consider stressors outside the school. Defendants asked the Court to exclude Crowell’s opinions.

    Psychology Expert Witness

    Sheila Crowell is a tenured Psychology Professor at the University of Utah. She has been a licensed and practicing psychologist since 2013. Crowell has received funding from the American Foundation for Suicide Prevention and the National Institutes of Health to better understand and prevent suicide. Crowell has produced 115 peer-reviewed and invited publications, of which 30 publications deal directly with the topic of suicide or self-injury. 

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

    Discussion by the Court

    Crowell’s Opinions Are Based on Reliable Methodology

    Defendants argued Crowell’s methodology was not reliable for two reasons. First, Defendants contended Crowell’s opinions are based solely on deposition testimony that was narrowly focused on stressors SGT may have encountered at school. Defendants argued SGT could have encountered other stressors, including discipline at home, interactions with peers outside of school, and SGT’s relationship with his parents, but Crowell did not consider these additional stressors in forming her opinions. Second, Defendants argued Crowell’s “chain analysis” was merely her subjective opinion.

    Crowell’s opinions are based solely on deposition testimony that was narrowly focused on stressors SGT may have encountered at school

    Crowell’s report and deposition testimony demonstrated that she reviewed numerous documents to determine which stressors contributed to SGT’s suicide. In addition to depositions from school administrators, Crowell considered SGT’s suicide note, SGT’s suicide video, an interview with SGT’s brother, and Plaintiff Kohn’s deposition.

    Crowell’s report and testimony showed that although she considered information about other stressors from outside of school, like SGT’s home life and parental discipline, she determined those stressors were not “proximal stressors” on the day of SGT’s suicide.

    The Court did not find that Defendants have shown Crowell’s opinions were improperly based on insufficient information.

    Crowell’s “chain analysis” was merely her subjective opinion

    The Court held that the Defendants’ second challenge regarding the reliability of Crowell’s chain analysis methodology is also unconvincing.

    Crowell has sufficiently explained the connection between her training and experience and her opinion that actions and inactions by staff at St. Marys Middle School likely increased SGT’s vulnerability to mental health struggles and led to SGT’s suicide. Defendants have not shown Crowell’s chain analysis is based on an unreliable methodology.

    Crowell relied on her training and experience as a clinical and research psychologist when she performed a chain analysis in this case. Crowell identified several documents she reviewed related to this case, including depositions, a forensic interview, and an academic article focused on youth suicide. After reviewing those materials, Crowell noted there was no evidence of any mental health support for SGT or any efforts to protect him from bullying.

    Crowell’s Opinions Will Assist the Trier of Fact

    Defendants argued causation is the “[t]he legal issue” in this case, and Crowell’s opinions would not assist the trier of fact in resolving that issue. According to the Defendants, Crowell’s opinions focused only on what happened immediately before the suicide, not long-term stressors, and, therefore, her opinions will not help the jury determine whether and to what extent other events could have contributed to SGT’s death.

    Defendants’ contention that Crowell’s opinions will not assist the trier of fact is unconvincing. The Court held that Crowell’s opinions concern the relevant time period for assessing causal factors leading up to a suicide and self-harm generally, and, specifically, concern the proximal stressors that may have contributed to SGT’s suicide. Crowell’s opinions on these topics arise from her specialized training and experience in psychology and assessing risk of self-harm and suicide (with special focus on risks for adolescents). Crowell’s opinions concern a core issue in this case—the cause of SGT’s suicide—and the opinions concern topics likely beyond the understanding of the lay person.

    Held

    The Court denied the Defendants’ motion to exclude the testimony of Sheila Crowell.

    Key Takeaway:

    • Crowell identified the “ownership room” incident as a clear precipitating event for SGT’s suicide, particularly because the “ownership room” probably had negative historical meaning for SGT. Crowell noted the “ownership room” incident occurred in the context of ongoing academic struggles.
    • Crowell’s opinions concern a core issue in this case—the cause of SGT’s suicide—and the opinions concern topics likely beyond the understanding of the lay person. Therefore, Crowell’s opinions would be helpful to the trier of fact.

    Case Details:

    Case Caption: Kohn Et Al V. Camden County School District Et Al
    Docket Number: 2:21cv108
    Court: United States District Court, Georgia Southern
    Order Date: August 21, 2024

  • Court Limits Transportation Safety Expert Witness’ Testimony After he Fails to Identify a Safety Rule Violation

    Court Limits Transportation Safety Expert Witness’ Testimony After he Fails to Identify a Safety Rule Violation

    A district judge in Pennsylvania limited the Transportation Safety Expert’s testimony about the Defendant’s failure to review safety and compliance data.

    Defendant Gateway Freight Systems, Inc., on behalf of Defendant Tempel Steel, retained Defendant Foxway Transportation, Inc. to transport a shipment of Tempel’s product from Tempel’s Canadian location to two locations in Pennsylvania.

    On October 20, 2019, Darlene L. Allen was driving her Mitsubishi Mirage on SR-17 in Tioga County, New York, when she hit a deer. At the time of the accident, Allen had her minor children T.G.A. and Z.D.A. as passengers in the rear seats. Volodymyr Frolyak, an employee of Foxway driving a Foxway-owned Freightliner, was traveling behind Allen and collided with her Mitsubishi. As a result of these accidents, Allen’s children, T.G.A. and Z.D.A. tragically lost their lives.

    Plaintiff Robert C. Allen, co-administrator of the estates of T.G.A and Z.D.A, disclosed Kenneth Lacey for the first time attempting to support his partial motion for summary judgment concerning claims of direct negligence, including negligent entrustment, against Gateway.

    According to the Report, Plaintiff engaged Lacey to specifically determine the
    following:

    1. Did Foxway’s programs comply with both Federal and State regulations and were otherwise consistent with the transportation industry safety, operational, and compliance program and practice standards
    2. If the motor carriers’ programs safety, compliance programs were deficient did these failures contribute, or otherwise directly result in this crash
    3. Did Gateway fail to properly screen, entrust and supervise any party moving product on its behalf
    4. Where there were failures by Gateway to properly screen and supervise motor carriers’ and did these failures contribute, or otherwise directly result in this crash

    Defendant Gateway filed a motion to exclude Kenneth Lacey’s opinion as per the grounds of Rule 702 and the Daubert standard.

    Transportation Safety Expert Witness

    Kenneth Lacey is a safety and operational consultant at KJL Safety and Claims Services LLC, Collegeville, PA.

    As a safety consultant, his job entails working with transportation companies of varying degrees of sizes having commercial motor vehicles operating on highways within the United States and Canada, to establish and improve their safety programs and overall safety performance.

    He had been retained in this case as a transportation safety expert witness to use his education, experience, and expertise with Motor Carriers, Transportation Brokerage, and Transportation Logistics operations and services, his previous experience as the person responsible for negotiating and education, experience, and expertise with the application of the Federal Motor Carrier Safety Regulations (“FMCSRs”), Uniform Commercial Drivers Manual (“UCDM”) and Safe Commercial Motor Vehicle Operations.

    Gain a comprehensive understanding of Kenneth Lacey’s qualifications and casework history with his Expert Witness Profile report.

    Discussion by the Court

    Kenneth Lacey criticized Gateway for neglecting to ensure Foxway’s compliance with safety regulations. He pointed out that Gateway didn’t conduct adequate checks on Foxway’s safety record, including crashes and violations. Despite entrusting Foxway with numerous shipments, Gateway didn’t follow customary vetting procedures. Lacey highlighted that Frolyak, the driver, had previous speeding violations unknown to Gateway. He faulted Gateway for not utilizing monitoring services like Carrier 411, which could have alerted them to to crashes, moving violations, and disqualified driver violations involving Foxway. Lacey recommended Gateway should have implemented a corrective plan or terminated Foxway’s services due to their history of crashes and violations. He concluded that Gateway’s failure to review safety and compliance data directly caused the crash.

    A. Qualification

    Defendant Gateway argued that Lacey lacked the qualifications to testify on liability, causation, or negligence, especially regarding brokers.

    The Court held that Lacey’s background as a safety and operational consultant in both motor carriers and brokerages qualified him. The Court asserted that Lacey’s broader experience in the transportation industry met the Third Circuit’s criteria for expertise. Gateway’s argument was that extensive experience in the transportation industry regarding driver safety, training, and compliance initiatives was insufficient unless Lacey had worked with brokers specifically. Put into the context of the facts of this case, an individual in such a role at Foxway, a motor carrier, would necessarily have experience regarding the practices and customs of Gateway, a broker, in the selection of motor carriers.

    B. Reliability

    Gateway argued that Lacey, despite possessing requisite qualifications, offered opinions which were unclear, conclusory, speculative, and unreliable, thereby warranting exclusion.

    In his report, Lacey refrained from determining whether specific safety rules were violated in causing the crash, a point Gateway emphasized as a flaw in his methodology. Allen countered that Lacey’s expertise in brokerage industry standards justified his testimony, even without identifying statutory violations. The Court acknowledged the relevance of industry practices in determining negligence standards but upheld the requirement to avoid interpreting statutes.

    However, the Court shared Gateway’s concern about Lacey’s methodology, considering the disconnect between Lacey’s methodology—which included identifying violations—and his conclusion—which did not mention any such violations—rendered those conclusions unreliable. For instance, Lacey suggested that Foxway “likely had to reduce its insurance due to being denied loads from shippers actually checking Foxway’s safety rating and refusing to use them.” The Court held that there was nothing in Lacey’s report to support this logical leap. Moreover, Lacey did not explain why, even if Gateway had been more closely monitoring Foxway, it would have been inappropriate for Gateway to continue to retain Foxway to deliver shipments. Lacey did not offer any context for any of the prior Foxway violations or accidents.

    Ultimately, the Court found that Lacey’s report lacked specificity and failed to demonstrate how Gateway’s actions directly caused the crash.

    C. Fit

    Gateway argued that Lacey’s opinion should be excluded because it is unduly prejudicial and not tied to the facts of the case.

    The Court focused on the only possibly admissible opinion from Lacey, which stated that it is consistent with industry standards for brokers to continually monitor the safety records of motor carriers. The Court found that Lacey’s opinion that it is common practice in the transportation industry to continually monitor safety records using third-party vendors, safety scores, and other sources is plainly relevant, and helpful to a jury tasked with determining what Gateway should have known about Foxway’s safety record.

    Held:

    The Court granted Gateway’s motion to exclude Kenneth Lacey, except as to his opinion that industry standards imposed upon Gateway a continuing obligation to conduct ongoing “safety and compliance data reviews.”

    Key Takeaway:

    Defendant’s motion to exclude Lacey was partially granted, allowing his testimony only with regard to the industry standard of ongoing safety and compliance reviews, which was deemed crucial for assessing Gateway’s obligations regarding Foxway’s safety record. Thus, while recognizing Lacey’s qualifications, the Court concluded that his broader assertions lacked the necessary specificity and evidentiary support to be admissible in their entirety

    Case Details:

     Case Caption:  Allen V. Foxway Transportation, Inc. Et Al
     Docket Number:  4:21cv156
     Court:  United States District Court, Pennsylvania Middle
    (Williamsport)
     Order Date:  February 1, 2024
  • Law Enforcement Expert Witness’ Testimony on the Police Officers’ Conduct Admitted

    Law Enforcement Expert Witness’ Testimony on the Police Officers’ Conduct Admitted

    A district judge in Louisiana admitted a law enforcement expert’s testimony summarizing police procedures.

    Cortez alleged that on November 21, 2019, his wife had called 911 and requested that police be dispatched so she could leave their residence without incident because Cortez was in an agitated mood. Cortez averred that an altercation had ensued after Deputies Reese and Custard arrived on the scene.

    Plaintiff brought this lawsuit to pursue claims of excessive force in violation of the Fourteenth Amendment; a cover up by Jefferson Parish Sheriff’s Office employees; and ongoing physical and psychological injuries.

    Defendants Deputy Custard, Deputy Reese, and Sheriff Lopinto asserted that the claims alleged were frivolous, groundless, and unreasonable.

    Defendants offered the testimony of Kerry Najolia to summarize police procedures and to analyze whether the Deputies met those standards. Plaintiff filed a motion to exclude eight of Najolia’s opinions contending they were inadmissible as per Daubert and Rule 702.

    Law Enforcement Expert Witness

    Kerry Najolia has been qualified as, and has testified as, an expert on police practice, procedure, training, police officer survival/defensive tactics, police use of force, and police canines in numerous Louisiana state and federal courts. He has worked in various divisions in law enforcement, which includes patrol, investigations, Training and SWAT.

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

    Discussion by the Court

    The eight opinions in question found that the deputies’ actions were “authorized,” “consistent with their training” and “consistent with departmental policy, procedures, and protocols” at various stages of their interaction with Plaintiff. In support of his motion, Plaintiff argued that: (1) Najolia would need to repeat inadmissible hearsay at trial to explain these opinions (2) Najolia’s testimony is irrelevant, and (3) Najolia’s methodology is unreliable.

    Najolia Will Not Need to Repeat Inadmissible Hearsay at Trial

    Plaintiff argued that Najolia’s opinions about the Deputies’ use of force must be excluded because Najolia will necessarily need to repeat hearsay testimony at trial to express these opinions. He added that Najolia largely relies on an Offense Report written by Deputy Reese, who has not been deposed, for his understanding of the foundational facts of the case.

    Plaintiff did not dispute that Najolia may express opinions in his expert report that are based, in part, on facts contained in an inadmissible report such as the Offense Report. Rather, he contended that Najolia will need to describe Deputy Reese’s hearsay statements at trial. Since, Defendants’ witness list noted that Deputy Reese will testify at trial, the Court held that Najolia may properly refer to her testimony after Deputy Reese testifies.

    Najolia’s Opinions Do Not Constitute Improper Legal Conclusions

    Plaintiff contended that Najoila will improperly invade the duty of the factfinder by offering conclusions on legal issues.

    The eight opinions Plaintiff sought to exclude were tied to the police policies and procedures at issue. The opinions described various actions of the deputies as “consistent with their training” “appropriate” and “in accordance with the deputies training.” This language showed that Najolia intended to opine on whether the Deputies “comported with applicable policies and procedures.” The Court held that such testimony was permissible but Najolia will not be allowed to opine on the ultimate issues of whether the officer’s actions were generally “reasonable” under the applicable legal standard.

    Plaintiff’s Concerns About Najolia’s Assumption of Facts were Properly Addressed on Cross-Examination, Not By Exclusion of His Testimony

    Plaintiff argued that Najolia’s opinions should be excluded because his methodology was unreliable. Najolia, Plaintiff contended, improperly relied on the Defendants’ version of the facts while ignoring other record evidence. The Court held that this this argument was unavailing since Plaintiff’s concerns that Najolia’s opinions were based on incorrect and one-sided facts could be addressed at trial on cross-examination. These questions relate to the “bases” of Najolia’s opinions, and thus go to the “weight to be assigned that opinion rather than its admissibility.”

    Held

    The Court denied Plaintiff’s motion to exclude and held that Najolia may testify as to whether the Defendant Deputies acted in accordance with applicable policing standards, protocols, and trainings.

    Key Takeaway:

    Under Federal Rule of Evidence 704, an expert’s “opinion is not objectionable just because it embraces an ultimate issue.” Louisiana District Court has previously permitted Najolia to opine on whether police officers’ conduct was in accordance with specific policing standards. The eight opinions Plaintiff sought to exclude were tied to the police policies and procedures at issue and hence were permissible. Despite Plaintiff’s concerns that Najolia’s opinions are based on incorrect and one-sided facts, the Court held that Najolia’s testimony will be properly offered to summarize police procedures and
    to analyze whether the Deputies met those standards.

    Case Details:

    Case Caption: Cortez V. Custard Et Al
    Docket Number: 2:20cv3110
    Court Name: United States District Court, Louisiana Eastern
    Order Date: June 10, 2024
  • Court refuses to exclude Pharmaceutical Expert Witness’ Opinions Regarding Breadth of Asserted Claims

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

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

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

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

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

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

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

    Pharmaceutical Expert Witness

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

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

    Discussion by the Court

    Rule 702

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

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

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

    Rule 26

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

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

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

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

    Held

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

    Key Takeaway:

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

    Case Details:

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

  • Defendant’s Objections against the Accounting Expert Witness’ Damages Calculations Overruled

    Defendant’s Objections against the Accounting Expert Witness’ Damages Calculations Overruled

    A district judge in North Carolina refused to exclude the accounting expert witness’ calculations of the Defendants’ revenues and profits earned in connection with their sales.

    Plaintiff and Defendants sell heat transfer systems to industrial customers. In 2016, Plaintiff sued Defendants for trade secret misappropriation, breach of contract, unfair competition, and patent claims. That litigation terminated with a 2018 settlement agreement. According to that agreement, Defendants assigned to Plaintiff patents related to the design of a first-generation Fluid Tracing System (“FTS”) product and pledged specifically to “remove all reference to the [FTS] on its web pages and advertisements and cease all use of any materials referencing the [FTS].”  Defendants also agreed not to sell products into the Sulphur field for an exclusionary period of three years, with exceptions granted for four contracts allegedly in place at the time the settlement agreement was executed (i.e., the “excepted contracts”).

    Following the settlement, Defendants developed a new heat transfer product, FTS Generation 2 (“Gen. 2”). As required under the settlement agreement, Defendants amended their marketing materials to remove references to the first-generation FTS.  Nonetheless, some of Defendants’ post-settlement marketing materials continued to depict FTS Gen. 1. Following the development of FTS Gen. 2, Defendants disseminated a chart indicating that the second-generation product performs better than FTS Gen. 1. Purporting to avail themselves of the excepted contracts provision of the 2018 settlement agreement, Defendants also sold their Gen. 2 product into the Sulphur field.

    Plaintiff again sued Defendants in 2021, raising claims of false advertising and false designation of origin under the Lanham Act; racketeering under RICO; common law fraud, civil conspiracy, and breach of contract; and unfair and deceptive trade practices under North Carolina Law.

    Expert Testimony

    Plaintiff retained Glenn Newman as an expert to calculate the revenues and profits earned by Defendants in connection with their sales into the Sulphur field and sales of FTS Gen. 2 products after the effective date of the settlement agreement. Defendants offered Carson Hannah, an employee of QMax Industries, LLC, to opine on tests he designed and performed in 2019 (before Plaintiff instituted this litigation) showing that Defendants’ Gen. 2 product performs better than the Gen. 1 product for which Plaintiff holds the patent. Each party moves to exclude the other’s expert under Federal Rule of Evidence 702. 

    Accounting Expert Witness

    Glenn Newman, a forensic accountant, has provided a variety of financial consulting and accounting services to attorneys, insurance companies, governmental agencies and public and private corporations since 1980. Newman has served as a Neutral and Special Master and has held numerous leadership positions with the American Institute of CPAs.

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

    Discussion by the Court

    Defendants moved to exclude Newman’s testimony as unreliable because he failed to establish a causal link between his damages calculations and Defendants’ alleged wrongdoing. Plaintiff contended that Hannah’s report has not “been subjected to peer review and publication,” and is not falsifiable because Hannah failed to record the amount of heat-transfer compound used.

    Defendants’ Motion to Exclude Newman

    They argued that a damages expert must establish causation by tracing ill-gotten gains to wrongdoing alleged in the complaint. Defendants contended that for an expert report to be admissible to prove disgorgement of profits under the Lanham Act, the expert must do more than assume a correlation between the alleged wrongdoing and the profits; the expert must instead examine causation between the alleged wrongdoing and the estimate of damages.

    The Court held that the Plaintiffs retained Newman to opine on merely damages; not causation.

    Defendants argued that an expert’s opinion as to damages must be causally related to the alleged harm. Assuming (as the Defendants might) that the jury accepts Plaintiff’s contention that the parties are direct competitors in a two-supplier market, the Court held that Newman’s disgorgement analysis is “causally related to the alleged harm.”

    Defendants added that the astronomical amount of profits Newman contended the Defendants owe intensified the unreliability of Newman’s opinion. The Court held that the Defendants’ objection concerned the weight accorded to Newman’s testimony, not its admissibility.

    Defendants argued that Newman’s report was unreliable because it did not apportion damages amounts to each of Plaintiff’s claims. According to the Defendant, an expert’s “failure to apportion the disgorgement of profits as to each claim renders his opinion unreliable because there is no way for the factfinder to differentiate which profits are attributable to which claims.”

    The Court recognized the merit of Defendants’ claim that Newman’s disgorgement analysis had the potential to mislead a jury, citing the Plaintiff’s lack of entitlement to a disgorgement remedy on all their claims. The Court will address this issue if it materializes at trial. However, the Court denied Defendants’ motion to exclude.

    Plaintiff’s Motion to Exclude Hannah

    Defendants offered Hannah, a QMax employee, to opine regarding a test that he performed to compare the performance of the Gen. 1 and Gen. 2 FTS products.

    Hannah only had to provide a disclosure stating “the subject matter on which [he] is expected to present evidence” and “a summary of the facts and opinions to which [he] is expected to testify” because he is a Rule 26(a)(2)(C) witness.

    Plaintiff moved to exclude Hannah on the basis that his conclusions “were not based on sufficient facts or data and were not the product of reliable principles and methods.”

    In 2019, before Plaintiff brought this suit, Hannah conducted a test apparently showing that Defendants’ Gen. 2 FTS product performed between 5% and 15% better (in terms of heat transfer) than the Gen. 1 FTS product. Hannah’s Rule 26(a)(2)(C) report did not contain any data from this test. When he conducted this test, Hannah failed to record the total amount of heat-transfer compound used to connect the FTS products to their respective process pipes, which could affect the performance of the FTS products. Hannah admitted that, based on his 26(a)(2)(C) report alone, it would be impossible to evaluate or recreate his analysis.

    Since Hannah’s report did not contain the data on which he based his conclusion, Plaintiff contended that “Hannah’s opinions are based on no facts or data—nevermind sufficient ones—and must therefore be excluded.”

    The Court held that the spreadsheets produced by Defendants in response to Plaintiff’s discovery requests, which apparently contain the data underlying the 2019 tests belied the Plaintiff’s contention that no such data existed.

    Also, the Court held that “vigorous cross-examination” and “presentation of contrary evidence” at trial instead of the Court’s gatekeeping function should address the the reliability of Hannah’s conclusions.

    Held

    The Court denied the parties’ motions to exclude. The Court held that the parties’ critiques were not without merit, but they ultimately concerned the weight, not the admissibility, of the relevant testimony. 

    Key Takeaways:

    • As per Daubert, that district court reliability assessments should focus “solely on principles and methodology, not on the conclusions that they generate” when Defendants added that the astronomical amount of profits Newman contended the Defendants owe intensified the unreliability of Newman’s opinion.
    • Peer review and publication—while one indicator of reliability—is hardly a requirement for admissibility under Daubert‘s gloss on Rule 702. 

    Case Details:

    Case Caption: Controls Southeast, Inc. V. Qmax Industries, Inc. Et Al
    Docket Number: 3:21cv302
    Court Name: United States District Court, North Carolina Western
    Order Date: May 14, 2024
  • Epidemiology Expert Witness’ General Causation Opinion Rejected

    Epidemiology Expert Witness’ General Causation Opinion Rejected

    This is a multidistrict litigation (“MDL”) in which over 5,000 individual Plaintiffs allege that they developed Parkinson’s disease because of their exposure to an herbicide, paraquat dichloride (“paraquat”). Paraquat is a restricted-use quaternary ammonium herbicide that is used to control weeds in farming operations and other settings around the United States. Defendants, Syngenta Crop Protection, LLC and Syngenta AG (collectively “Syngenta”), currently manufacture and distribute paraquat for use in the United States, whereas Defendant, Chevron U.S.A., Inc. (“Chevron”), manufactured and distributed paraquat until 1986.

    Facts of the Case

    Dr. Martin Wells serves as Plaintiffs’ sole expert witness on the critical issue of general causation, offering an opinion that occupational exposure to paraquat can cause Parkinson’s disease. Defendants filed a motion to exclude Wells’ proffered testimony which raised complex issues related to the study of epidemiology and the scientific methodologies of systematic review and meta-analysis. Defendants’ motion is brought in four of the six member cases that were selected for case-specific discovery in the Court’s April 13, 2022 order. These four cases have gone through fact and expert discovery and now serve as this MDL’s first set of trial selection cases.

    Plaintiffs retained Martin Wells to “analyze the epidemiological evidence relating the association and causation of the occupational exposure of paraquat to the onset of Parkinson’s disease.” To accomplish this task, Wells conducted a meta-analysis of seven epidemiological studies that measured a potential association between paraquat and Parkinson’s disease. Wells determined, based on this meta-analysis, that there was a “near tripling of PD occurrence in [study] participants occupationally exposed to paraquat.” 

    After establishing a positive association between occupational exposure to paraquat and Parkinson’s disease, Wells conducted a weight of the evidence review to determine whether the association was attributable to a causal relationship. He found that it was and drew the following conclusions: (i) the available epidemiological evidence supports a causal relationship between paraquat and Parkinson’s disease; and (ii) the trial selection Plaintiffs fit the exposure and diagnostic criteria of the seven studies in his meta-analysis, meaning that they were at “near tripl[e]” the risk of developing Parkinson’s disease. 

    Epidemiology Expert Witness' General Causation Opinion Rejected

    Epidemiology Expert Witness

    Dr. Martin Wells boasts of an impressive career as an academic, researcher, and prolific publisher in the fields of biostatistics and epidemiology. He received his Ph.D. in Mathematics from the University of California in 1987 and became an Assistant Professor at Cornell University that same year. Furthermore, Wells currently serves as a Professor of Clinical Epidemiology and Health Services Research at Weill Medical School and as the Chair of the Department of Statistics and Data Science at Cornell. Moreover, he has published 250 scholarly articles on statistics, human health, and other topics and has received research grants from numerous governmental and non-governmental institutions, including the U.S. Department of Agriculture, the U.S. Army, and the National Institutes of Health. 

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

    Discussion by the Court

    Legal Standard

    In his own words, Wells offers an opinion that “the available epidemiological evidence supports a causal relationship between occupational paraquat exposure and PD.”

    The admissibility of expert testimony under the Federal Rules of Evidence is governed by the well-known and oft-cited standards of Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993). Under Rule 702, “[a] witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if the proponent demonstrates to the court that it is more likely than not that:

    (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’s opinion reflects a reliable application of the principles and methods to the facts of the case.”

    Amended Rule 702

    This amended version of Rule 702 took effect on December 1, 2023, after the Parties submitted their briefing. The Advisory Committee on the Rules of Evidence explained that the amendment does not “impose[] any new, specific procedures.”

    Rather, the amendment emphasized that the proponent bears the burden of demonstrating compliance with Rule 702 by a preponderance of the evidence, and that “each expert opinion must stay within the bounds of what can be concluded from a reliable application of the expert’s basis and methodology.” 

    The Advisory Committee cautions that “expert testimony may not be admitted unless the proponent demonstrates to the court that it is more likely than not that the proffered testimony meets the admissibility requirements set forth in [Rule 702].”

     In providing this instruction, the Advisory Committee noted that some courts had “incorrect[ly]” held that an expert’s basis of opinion and application of her methodology were questions of weight, not admissibility. The Advisory Committee thus appears to have found that courts had erroneously admitted unreliable expert testimony based on the assumption that the jury would properly judge reliability by assigning appropriate weight to an expert’s opinion.

    Bradford Hill Analysis

    To judge causation, researchers ordinarily consider how the following nine “Bradford Hill” factors (named after the British epidemiologist and statistician, Sir Austin Bradford Hill) apply to an observed association:

    (1) temporal relationship (the exposure must occur before the disease develops);

    (2) strength of association (the higher the RR or OR, the greater the likelihood that the relationship is causal);

    (3) dose-response relationship (whether a higher dose increases the incidence or severity of the disease);

    (4) replication of findings (whether research findings have been replicated in different populations with consistent results);

    (5) biological plausibility (whether the association is consistent with current biological knowledge about the disease);

    (6) consideration of alternative explanations (whether the research has properly accounted for bias and confounding variables);

    (7) cessation of exposure (whether the cessation of exposure reduces the risk of disease);

    (8) specificity of association (an association is specific and more likely to be causal if the exposure is associated with only a single or a small number of diseases); and

    (9) consistency with other knowledge (whether a causal inference is consistent with relevant general knowledge or data).

    After establishing a positive association, Wells conducted a Bradford Hill analysis to determine whether occupational exposure to paraquat was causally related to Parkinson’s disease. Wells discussed six of the nine Bradford Hill factors (strength of association, consistency, temporality, dose-response, experimental evidence regarding the cessation of exposure, and specificity) in his first report, and assumed that the other three factors (biological plausibility, coherence, and analogy) were satisfied based on the report of Plaintiffs’ toxicology expert. He appears to have found that the six factors he evaluated were all satisfied, and on that basis, concluded that “drawing general causal inferences related to occupational paraquat exposure and PD is merited.”

    Legal Analysis

    A. Qualifications

    Defendants first attacked Wells on the basis that he was not qualified to offer an opinion about the causal relationship between occupational paraquat exposure and Parkinson’s disease. This argument purported to show that although Wells possessed impressive credentials as a statistician, his qualifications were limited to just that type of work—calculating a summary risk estimate from a pre-selected universe of epidemiological studies.

    The Court held that Wells is not just a statistician; he is a professor of epidemiology with an impressive record of scholarly publications on epidemiological issues. As such, he is well-equipped to judge the relative quality of the epidemiological studies at issue.

    Simply put, as a biostatistician and epidemiologist, Wells is well qualified to offer a general causation opinion based on a Bradford Hill analysis and to evaluate the relative quality of epidemiological studies relevant to the causation question at issue. 

    B. Reliability
    1. The Scope of Dr. Wells’ General Causation Opinion

    An epidemiological causation assessment ordinarily proceeds in two steps: (i) a determination of whether a disease is associated with exposure to a particular agent; and (ii) if a positive association is found, a Bradford Hill analysis to determine whether the association is the result of a cause-and-effect relationship. At a high level, Wells followed these steps as well. First, he surveyed the epidemiological literature and established a positive association by conducting a meta-analysis of seven case-control studies that examined a possible association between paraquat exposure and Parkinson’s disease. Second, he conducted a Bradford Hill/weight of the evidence analysis to determine whether the totality of the evidence supported a causal relationship between occupational paraquat exposure and Parkinson’s disease. Wells then offered the opinion that the elevated odds ratio from his meta-analysis applied to the four trial selection Plaintiffs, Mr. Richter, Mr. Burgener, Mr. Fuller, and Mr. Coward. 

    Wells offered an expert opinion that “occupational” paraquat exposure was causally related to Parkinson’s disease. Any exposure that did not qualify as “occupational” is therefore not within the scope of his opinion. The Court observed that Wells redefined “occupational” exposure no less than three times, creating more questions than answers about the types of paraquat exposures that, according to him, can cause Parkinson’s disease.

    2. Wells’ Meta-Analysis

    Wells’ violations of the rules of meta-analysis are evident from the very beginning of his process. One of the initial steps in a meta-analysis involves the search for relevant studies that are then further analyzed for potential inclusion in the analysis. Wells’ first report is entirely devoid of a search narrative that would allow other researchers to validate his process.

    The next methodological red flag in Wells’ meta-analysis is that until he submitted his rebuttal report, he failed to clearly articulate the inclusion/exclusion criteria that purportedly governed a study’s eligibility for his analysis. Indeed, Wells testified at his first deposition that he reviewed the relevant studies “holistically” to determine “whether or not [they were] reliable enough for inclusion.” This “holistic” approach was neither reduced to writing, nor did it offer any discernible objective criteria that would allow others to replicate Wells’ eligibility determinations.

    Moreover, Wells relied on an evolving set of quality criteria to determine which studies ultimately warranted inclusion in his meta-analysis. This alone undermines the methodological soundness of his qualitative evaluation of the literature.

    Another methodological issue in Wells’ meta-analysis concerned his apparent failure to follow even his own articulated reliability standards. Wells appeared to have violated this guideline for the most important study in his meta-analysis, Liou (1997).

    The Court took no position on the relative merit of the various epidemiological studies at issue in Wells’ analysis. Indeed, the Court did not find Wells’ meta-analysis unreliable because it excluded van der Mark (2014), Shrestha (2020), or any other relevant study for that matter. Rather, Wells’ meta-analysis did not pass muster under Rule 702 because its methodology was unclear, inconsistently applied, not replicable, and at times transparently reverse-engineered.

    3. Dr. Wells’ Weight of the Evidence / Bradford Hill Analysis
    a. General Observations

    After he generated his odds ratio of 2.8, Wells conducted a “weight of the evidence” review utilizing the Bradford Hill framework to determine whether the association was attributable to a cause-and-effect relationship between occupational paraquat exposure and Parkinson’s disease. This analysis involved the “combination of two methods”—weight of the evidence review and application of the Bradford Hill factors. Although this approach is generally reliable, there is “very little” circuit-level authority guiding its application in toxic tort cases.

    In short, experts in toxic tort actions commonly employ this methodology to answer complex epidemiological causation questions. Because of its widespread adoption in the scientific community and in other litigations, the general reliability of this approach is not in dispute.  However, the method gives researchers significant flexibility to decide how to analyze the evidence and weight each Bradford Hill factor in relation to the others.  An expert could “theoretically assign the most weight to only a few factors, or draw conclusions about one factor based on a particular combination of evidence.”  So, while the methodology offers the benefit of flexibility, it is vulnerable to results-driven analysis, which, of course, raises significant reliability concerns.

    b. The Reliability of Dr. Wells’ Bradford Hill Analysis

     Wells’ weight of the evidence/Bradford Hill analysis is a textbook example of the type of standardless presentation of evidence that courts have cautioned against. The most obvious methodological defect is the absence of any discernible weighting methodology. Neither Wells’ first report nor his rebuttal report offer any explanation of the relative weight or importance assigned to each of the six Bradford Hill factors he analyzed.

    c. Isolation from the Scientific Community

    This Court has focused, as it must, on the methodological soundness of Wells’ analyses in support of his conclusions, not the conclusions themselves. However, the line between methodology and conclusion is “not always an easy [one] to draw.”

    Daubert expressly addressed the importance of independent validation of an expert’s opinion when it observed that “[w]idespread acceptance can be an important factor in ruling particular evidence admissible.”  The Advisory Committee on the Federal Rules of Evidence therefore cautions that “when an expert purports to apply principles and methods in accordance with professional standards, and yet reaches a conclusion that other experts in the field would not reach, the trial court may fairly suspect that the principles and methods have not been faithfully applied.”

    In conclusion, Wells’ causation theory has not been adopted or independently validated in any peer-reviewed scientific analysis outside of this litigation. 

    4. Dr. Wells’ Plaintiff-specific Opinions

    Wells’ third and final proffered opinion concerned the individual Plaintiffs in the four trial selection cases, Mr. Burgener, Mr. Coward, Mr. Fuller, and Mr. Richter. According to Wells, “these individuals fit the inclusion criteria in the referenced seven studies in my meta-analysis.” As a result, “[t]he elevated odds ratio of 2.8[] and the [Bradford] Hill criteria apply to these individuals.”

    This opinion will be excluded because it is not severable from Wells’ meta-analysis and his weight of the evidence/Bradford Hill analysis. Plaintiffs conceded this point at the Daubert hearing by noting that Wells’ meta-analysis is “critical for specific causation.” Moreover, without testimony concerning (i) a positive association between occupational paraquat exposure and Parkinson’s disease, and (ii) a causal relationship between occupational paraquat exposure and Parkinson’s disease, there is no testimony for Wells to give as it pertains to the four trial selection Plaintiffs. 

    Held

     To sum it up, the Court concluded that Martin Wells’ proffered opinions were not admissible under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993).

    Key Takeaways:

    • Moreover, in addition to the Bradford Hill factors of strength of association, consistency, and temporality (which he also considered in Monroe), Wells discusses experimental evidence related to the cessation of exposure, evidence of a dose-response relationship, and specificity. Nonetheless, the Court is not persuaded that his discussion of these considerations pushes his testimony beyond the limits of his qualifications as a biostatistician and epidemiologist. Furthermore, Wells’ Bradford Hill analysis is appropriately limited to the epidemiological studies he reviewed. He does not purport to venture into the realm of toxicology or other disciplines that are beyond his area of expertise.
    • Wells’ reliance on an unwritten, “holistic” methodology presents an ideal example of “because I said so” expertise that is impermissible under Rule 702. Wells insisted that he “ha[s] the credentials to do this” and that he “had a process that [he] followed.” But these assurances, without more, do not show that Wells faithfully applied the necessary steps of his chosen methodology as Daubert requires.
    • Against the backdrop of Wells’ departure from the most basic methodological requirements of a weight of the evidence review, it is not surprising that his analysis reveals extensive selection bias. Wells appears to have fallen prey to the temptations of selection bias in his discussion of several Bradford Hill factors, most notably those concerning a dose-response relationship and strength of association.

    Case Details:

    Case Caption: Richter v. Syngenta AG (In re Paraquat Prods. Liab. Litig.)
    Docket Number: 3:21md3004
    Court Name: United States District Court, Illinois Southern
    Order Date: April 17, 2024