Expert Witness Profiler

Tag: Warning

  • Safety Expert Allowed to Opine on Effectiveness of Warning Signs 

    Safety Expert Allowed to Opine on Effectiveness of Warning Signs 

    Plaintiff Anthony Rebmann sues Astec, Inc. d/b/a Astec of Tennessee and Astec Industries, Inc. (collectively, “Astec”) based on an incident on March 19, 2020, when, in the course of his employment at an asphalt plant, his left hand became entangled in an Astec baghouse screw conveyor. Astec has answered and has also filed a Third-Party Complaint against Rebmann’s employer at the time, Gernatt Asphalt Products, Inc. (“Gernatt”), claiming contribution and negligent training and supervision.

    Astec sought to strike the report of Plaintiff’s life-care expert, Nadeem I. Hussain, M.D. and has also filed motions in limine to exclude the testimony of Plaintiff’s products-warnings (or “human factors”) expert, Gerald M. Goldhaber, Ph.D. and Plaintiff’s products-liability expert Thomas A. Berry, P.E.

    Plaintiff has filed his own motion to exclude or limit the opinions of Astec’s expert, Dennis B. Brickman, P.E.

    Safety Expert Witness

    Dr. Gerald Martin Goldhaber has emerged as the nation’s leading safety warnings and communication expert. He is the publisher of the Goldhaber Warnings Report. His clients have included over 100 of the top 500 corporations in the U.S. Fifty of the top 100 law firms and government agencies, including the FDA (for whom he consulted on a new nutritional label). Goldhaber’s clients have also included the Consumer Product Safety Commission (CPSC) to establish guidelines for products ranging from All Terrain Vehicles (ATV’s) to soda bottles to in-line skates, the USDA for whom he has consulted about potential warnings for sugary products.

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

    Physical Medicine And Rehabilitation Expert Witness

    Dr. Nadeem Imran Hussain is a Physical Medicine & Rehabilitation specialist who has practiced medicine in New York since 2014.

    Hussain is a licensed physician in the state of New York, and he is certified by the American Board of Physical Medicine & Rehabilitation.

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

    Mechanical Engineering Expert Witness

    Dennis Barry Brickman is an industry veteran with over 40 years of mechanical engineering and materials science experience.

    Brickman has developed specialized expertise in the safety of children’s products, outdoor power equipment, tree care machinery, elastic cord products, and automatic door sensor systems.

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

    Engineering Expert Witness

    Thomas Alan Berry holds a Master of Science in Mechanical Engineering from Wichita State University and a Bachelor of Science in Mechanical Engineering from the same institution.

    He has authored at least 15 peer-reviewed papers presented at ASAE/ASABE and ASME conferences between 1985 and 2013, covering topics such as PTO safety, agricultural equipment accidents, forklift tipover risks, pallet truck accidents, mower stability, and gasoline geysering hazards.

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

    Discussion by the Court

    A. Thomas Berry, P.E.

    Plaintiff has retained Thomas Berry, P.E., as an engineering expert in this case. Berry has opined that Astec “knew or should have known of technically and economically feasible design alternatives that would have significantly reduced and/or eliminated the risk to operators without unnecessarily affecting the utility of the [baghouse] machine.”

    Astec sought to exclude Berry’s opinions regarding causation and alternative designs, arguing that he “failed to properly test and validate his opinions, basing them instead on unsupported assumptions.”

    1. Clearance Between Door and Nip/Shear Point

    The first alternative design is to add “clearance between the access door opening and the nip/shear point created by the extremely small distance between the auger flighting and the housing.” According to Berry, “this could be accomplished by raising the edge of the access door opening or providing a grate guard for the lower area of the opening, or by utilizing a left-hand flighted screw that would move the nip area to the back of the auger rather than directly below the access opening.”

    a. Testing

    The Court concluded that Berry did not need to perform testing as to his alternative of raising the edge of the access door opening. Astec’s expert has asserted that “[f]lighted screw augers typically have a close clearance with respect to their housing [because] otherwise, material builds up and does not adequately move near the housing interior structure.” That is sensible and understandable, but the housing in the area at issue appears to be rectangular, containing a cylindrical auger. With that geometry, the Court concluded that no testing would be required to support Berry’s opinion that raising the lower edge of the access door opening could put the pinch/nip point beyond the reach of fingers when the hand is grasping the lower edge of the housing.

    b. Cost

    Astec asserted that Berry has failed to conduct a “meaningful” comparison of the cost versus utility of his proposed alternative designs.

    Plaintiff did not dispute the importance of cost in the analysis. But Plaintiff maintained that the associated costs were zero, nominal, required by industry standards, or otherwise based on Berry’s training, education, and experience.

    As to cost, Berry asserted that raising the lip of the access opening could be provided “at no or little difference in cost.”

    Absent special considerations that are not immediately apparent and that could be the subject of cross-examination, the Court agreed that no further explanation or analysis is necessary for Berry’s opinion that designing or cutting the port in the auger housing to place the lip of the access door at a higher point would carry little or no cost difference.

    c. Efficacy

    Astec also argued that Berry’s report lacks evidence that the proposed alternative designs “could have prevented” Rebmann’s injuries. Plaintiff maintained that the standard is not whether the design would have “prevented” the injury, but whether the design would have resulted in greater safety.

    The Court agreed with Astec that designing the crossover screw with left flighting instead of right flighting would not have been materially safer. Berry asserted that the change “would move the nip area to the back of the auger.”

    Raising the lower edge of the inspection door opening, however, does not suffer from the same problem. Astec correctly observed that Berry’s supplemental report recommends raising the edge by “a few inches” which is not a particularly precise specification. And if “a few inches” means just two or three inches, then Astec may be correct that the modification would not eliminate the risk of entanglement for a hand grasping the bottom edge of the inspection door opening. But the Court is not persuaded that Berry needed to calculate precisely how many inches the edge would have to be raised. It is apparent from the layout and geometry of the inspection door opening that raising the bottom edge by some number of inches—more than two but less than half the height of the inspection door opening—would put the nip/shear point more than a finger’s length away.

    2. Bars on Lower Area of Access Opening, or Grate

    a. Testing

    Similar to the alternative of raising the bottom edge of the inspection door opening, the Court concluded that Berry did not need to test the alternative of adding bars across the lower area of the access opening. This solution is functionally identical to raising the edge of the door opening. The main difference is that that lower area of the access opening would be covered with parallel bars instead of solid metal.

    b. Cost

    Like the alternative of raising the bottom edge of the inspection door opening, Berry asserted that the cost of adding bars would be low; in his view, “less than $10-15.” Astec maintained that Berry’s cost estimate should be excluded for lack of any “meaningful explanation.”

    The Court is not persuaded that more explanation is required; the proposed alternative design appears to involve ordinary components that could be incorporated into the inspection door opening at modest cost.

    c. Efficacy

    Similar to raising the bottom edge of the inspection door opening, adding a sufficient number of bars at the lower area of the opening would put the nip/shear point more than a finger’s length away. Astec argued that dust accumulation in the area would prevent visibility through the bars.

    At his deposition, Berry conceded that dust accumulation between the bars would obstruct visibility if the bars were not cleaned off. Even if not cleaned off, the alternative design is for bars only on the lower area of the access opening; the upper area would still offer views into the enclosure. The Court concluded that Berry can testify to the bars as an alternative design.

    3. Interlock

    a. Testing

    Berry’s third proposed alternative design would be to provide an interlock system “such that the augers could not operate with the access doors open or [without] a grate guard in place” to prevent contact with the running auger that would “still allow the dust to escape during the clearing operation and would allow visual inspection of the augers and shafts.”

    There appears to be no dispute that interlock technology existed at the time the baghouse was designed and manufactured in the 1980s, But Astec asserted that Berry should have conducted testing to determine whether such a device “would work on the Baghouse.”

    The Court agreed that adding an interlock device would be a “more substantial modification” to the Baghouse, and that the practicality and specifics of installation of an interlock depends on the machine to which it would be applied.

    Although it appeared that it would at least be possible to conduct testing of an interlock system applied to the Baghouse, the Court concluded that the lack of any testing or modeling weighs somewhat against admission of Berry’s opinions on the interlock design.

    b. Cost

    In his report, Berry asserted that integrating “interlocked doors and grate guards” into the Baghouse would cost “approximately $200 per opening.”

    Astec maintained that Bery “gives no explanation, sources, or support” for that assertion.The Court agreed with Astec that further support is necessary for Berry’s price estimate because the cost estimate must consider more than purchase price.

    Astec noted that Conveyor Equipment Manufacturers Association (CEMA) industry manual is “an industry group not focused on regulation (or authorized to regulate) but on voluntary standardization of conveyor design.” Even assuming that the CEMA manual purported to require interlocks for applications like the Baghouse, the manual would not constitute regulatory or binding authority. Thus, the cost of an interlock system remains relevant to the reliability inquiry.

    c. Efficacy

    Perhaps the most important consideration as to the interlock design is whether it would improve safety without negatively impacting maintenance and inspection. Berry and Rebmann both testified that Rebmann needed the crossover screw to be running while he was looking into the inspection door because he needed to determine whether the repair to the screw was successful.

    The Court is unpersuaded on this point. If disabling the proposed interlock were the only way to accomplish the inspection, Plaintiff could argue that the time spent doing so could have called extra attention to the need for caution near the spinning auger. Moreover, disabling the interlock would not have necessarily been the only way for Rebmann to complete his task. One version of the interlock that Berry proposes is that it would prevent the augers from operating unless a grate guard was in place. In that scenario, Rebmann would likely have simply replaced the grate guard, rather than attempting to disable the interlock mechanism. The Court concluded that all of these questions about testing, cost, and efficacy of an interlock system are suitable for cross-examination but are not a basis to exclude Berry’s testimony on that alternative.

    4. Safety Signs

    There appears to be a dispute about whether Astec supplied safety signs on or near the inspection door when the product was delivered to Gernatt in 1984. No warning signs or labels are visible on or near the inspection door in the contemporaneous photographs. However, Astec Vice President George Francisco testified in 2024 that he worked for Astec for over 31 years, and that in his experience during that time, Astec would affix warning labels to areas like the inspection door on the baghouse at issue in this case.

    a. Testing

    Aster’s arguments about the proposed addition of safety signs or warning labels do not appear to include a lack-of-testing criticism. In the context of warning labels, the testing that is often most relevant involves “creating several warning labels that varied with respect only to a single characteristic and then gauging peoples’ reactions to the various labels.”

    Here, in contrast, the inquiry is only the presence or absence of any warning labels at all. Testing might be helpful to determine how long a safety sign would remain attached or visible in a dusty and vibrating environment, but the court does not conclude that such testing was necessary here.

    b. Cost

    Berry asserted that safety signs at each access door could have been provided “at a cost of less than $3 each.” Astec faults that assertion as unsupported by any explanation or sources.

    The Court concluded that no further support is required for the proposition that, at least compared to the total cost of a baghouse, industrial safety signs were relatively inexpensive in the 1980s. Whether special adhesion or paint might be required for equipment in a dusty and vibrating environment would be fair game for cross examination.

    c. Efficacy

    Astec contended that “there is a complete absence of factual support for Berry’s conclusion that the alleged failure to warn was a proximate cause of Plaintiff’s injuries.”

    Astec cited Berry’s testimony stating that he agreed that “it’s reasonable to expect that [warnings on equipment] [are] not going to be read.” Plaintiff countered that “the general concept that not all warnings are followed, does not negate Astec’s responsibility to adequately warn.”

    The Court agreed with Plaintiff on this point; safety signs and placards have long been established as “resulting in greater safety.” The Court’s reasoning below as to Astec’s motion to exclude Plaintiff’s products-warnings expert, Goldhaber, supports this conclusion.

    B. Gerald Goldhaber, Ph.D.

    1. “Unsupported Assumptions” on Effectiveness of Warnings

    Astec contended that Goldhaber’s opinions are “premised on the false narrative that Plaintiff was told to get close to the moving screw to check it.”

    At his deposition, Goldhaber asserted that Robert Rebmann, Anthony Rebmann’s uncle and immediate supervisor, directly ordered Anthony Rebmann to “first clean the dust out, and inspect those augers.”

    The fact that Robert Rebmann agreed that the “check” required the augers to be turning does not prove that he expressly instructed Anthony Rebmann to perform the check. Based on its review of Robert Rebmann and Anthony Rebmann’s testimony, the Court agreed with Astec that there is no support for the proposition that Robert Rebmann expressly instructed to carry out a “check” or “inspection” of the repaired crossover screw (or how to perform that check). The Court therefore agreed to limit Goldhaber’s testimony insofar as he might opine that Rebmann received instructions to put aside his training, background, or common sense.

    Astec has a further criticism about the factual basis for Goldhaber’s report: Astec contended that his opinions “disregard that Plaintiff habitually ignored safety protocols, safety training and safety procedures.” The original report, dated August 8, 2024, did not discuss Rebmann’s prior safety incidents. The Court concluded that, at best, it is debatable whether Rebmann’s prior workplace injuries and a verbal reprimand for failing to wear a hardhat show that he “habitually ignored” safety protocols, training, or procedures. In any case, Goldhaber has addressed Rebmann’s prior safety incidents in the supplemental report.

    2. Goldhaber’s Own Testimony and Writing on Effectiveness

    Astec further argued for exclusion of Goldhaber’s opinion about the effectiveness of warning signs or placards as being “in direct contradiction to his own testimony and work on the effectiveness of warnings.”

    However, the inquiry is not whether warning signage would have made the user aware of a danger of which they were previously unaware. The inquiry is whether a warning would have increased the user’s awareness of the danger. Rebmann testified that if warning signs or labels had been present “it would have made me think about becoming—it would have made me think about coming in close proximity a little bit more.” A jury can assess that testimony, and the Court will not exclude Goldhaber from offering similar testimony.

    3. Warnings Standards as of 1984

    Goldhaber’s report specifically faults Astec for failing to comply with ANSI Z535.4, which lie asserts “has been in effect since 1968.” Astec insisted that “in reality, the first version of the ANSI Z535.4 standard for product safety signs and labels was published in 1991, seven years after the Baghouse was manufactured and delivered to Gernatt.” Plaintiff maintained that ANSI Z35.1-1968 was approved in September 1968 and that the Occupational Safety and Health Administration (OSHA) “adopted this standard in 1971, requiring workplaces to comply with it starting August 31, 1971.”

    Astec cited a post on the ANSI website indicating that ANSI Z535.4’s “initial publication” was in 1991—after the Baghouse was manufactured in 1984.

    The Court accepts that as true, but Astec’s argument on this point fails to account for the fact that ANSI Z535.4’s predecessor is USAS 235.1. And federal regulations incorporated the Z35.1-1968 standard in 1984.

    For all of the above reasons, the Court denied Astec’s motion to exclude Goldhaber’s testimony.

      C. Nadeem Hussain, M.D.

      Astec contended that Hussain’s report is “an entirely new report that fails to contradict, challenge, or rebut Defendant’s corresponding report,” and that it is “not based on any new or previously unavailable information that would trigger a duty for Plaintiff to supplement its report.”

      There is no dispute that Hussain’s report cannot qualify as an initial expert disclosure. Plaintiff’s deadline for initial expert disclosures was August 30, 2024, and Plaintiff submitted Hussain’s report well after that date.

      The Court concluded that Hussain’s report is partly a proper rebuttal and partly and improper new expert report. Insofar as the report violates the discovery rules, the Court considers the following factors below.

      a. Plaintiff’s Explanation

      Plaintiff’s explanation is that he offered Hussain’s report “to contradict or rebut evidence on the same subject matter.”

      The majority of Hussain’s life-care plan did not repel, counteract, or disprove the opposing expert’s diagnostic report. But there are exceptions: Hussain’s inclusion of massage therapy implicitly contradicts the opposing expert’s opinion that it is not medically necessary, and Hussain’s inclusion of costs for prosthetics and related supplies for Rebmaim’s lifetime implicitly challenges the opposing expert’s remark about prosthetic abandonment. This factor is therefore mixed.

      b. Importance of Hussain’s Testimony

      In general, a second life-care plan is not particularly important to Plaintiff’s case. But medical opinions on the necessity or utility of the highest dollar-value treatments are very important to Plaintiff’s damages case. This factor is also mixed.

      c. Prejudice to Astec

      Plaintiff argued that Hussain’s report does not prejudice Astec, particularly because Astec had “an opportunity to rebut his report in writing and did so.”

      Astec maintained that allowing Hussain would result in significant prejudice. The Court is not persuaded that any of the items that Astec lists weigh significantly in favor of striking Hussain’s report. Instructions to the jury can mitigate concerns about giving more weight based on the quantity of evidence. The discovery order can be amended without prejudicing either side. Preparing to oppose a second life-care expert will require some additional expense, but it is not excessive in proportion to all the other expenses in this litigation.

      d. Possibility of Continuance

      Finally, Plaintiff asserted that a continuance is possible because “there is time afforded by the current case management order to complete expert discovery and depositions; and there is no trial date.”

      In December 2024, when Plaintiff filed his opposition to Astec’s motion to strike Hussain’s report, the Court had ordered expert depositions completed by March 15, 2025. Now, in mid-2026, all of the deadlines in that prior order have passed. However, it remains true that there is no trial date set in this case.

      For the reasons discussed above, the Court declined to strike Hussain’s report. The Court instead elects to grant Astec an opportunity to serve a surrebuttal report.

      D. Dennis Brickman, P.E. 

      Plaintiff sought preclusion of Brickman’s March 2025 report, arguing that it is untimely insofar as it contains new information and references.

      The first issues are whether Brickman’s March 2025 report is a timely and proper supplementation. Plaintiff has identified no court order altering the deadline, and because no trial date has been set, Rule 26(a)(3)(B)‘s 30-day deadline has not yet expired.

      The Court therefore rejected Plaintiff’s assertion that Brickman’s March 2025 report is untimely supplementation. The more significant dispute is whether it is proper “supplementation” at all.

      Plaintiff argued that Brickman’s March 2025 report is not supplementation, asserting that Brickman “undertook new work and testing based on information and materials that were equally available to him at the time of his first report.”

      For the reasons above, the Court rejected Astec’s explanations for providing the “supplemental” report. In the Court’s view, Brickman’s March 2025 opinions regarding the AGSCO mesh guard are of limited importance because Berry cited that manufacturer’s product only as an example. The AGSCO product’s one-inch openings might allow a finger to pass through, but a different screen with openings smaller than one inch could be specified. Moreover, even a screen with one-inch openings would have been safer than no screen at all.

      At the same time, Brickman’s March 2025 opinions about reduced visibility from the proposed interlocked mesh guard are more detailed than his opinion on that topic in his October 2024 report. Plaintiff asserted that failure to exclude Brickman’s March 2025 report or related testimony would result in “extreme” prejudice. The Court concluded that any such prejudice can be mitigated by granting Plaintiff the opportunity for a surrebuttal.

        Held

        • The Court denied Astec’s motion in limine to exclude Gerald Goldhaber’s testimony.
        • The Court granted in part and denied in part Astec’s motion in limine to exclude Thomas Berry’s testimony.
        • The Court denied Astec’s motion to strike the expert report of Nadeem Hussain.
        • The Court denied Plaintiff’s motion to preclude the opinions of Dennis Brickman.

        Key Takeaway

        Turning to the question of the proper sanction for failure to conform to the discovery rules, the Court considers (1) the party’s explanation for the failure to comply with the discovery order; (2) the importance of the testimony of the precluded witness; (3) the prejudice suffered by the opposing party as a result of having to prepare to meet the new testimony; and (4) the possibility of a continuance.

        Case Details:

        Case Caption: Rebmann V. Astec, Inc.
        Docket Number: 1:21cv879
        Court Name: United States District Court, New York Western
        Order Date: July 13, 2026

      1. Mechanical Engineering Expert Not Allowed to Opine on Blender Warnings

        Mechanical Engineering Expert Not Allowed to Opine on Blender Warnings

        SharkNinja manufactured the Ninja Professional Plus Blender, model BL610. Cody Ford received the blender as a gift at her bridal shower in February 2023. The blender was in a box and after opening the box, Ford removed the “top pulp tray” which, according to the design, rests on top of the wrapped pitcher that contains the blade assembly. Thinking she was going to grab the pitcher, Ford then reached into the box where she grabbed the blade assembly instead and “severely lacerated her left pinky finger.”

        As a result, Ford sued SharkNinja. In support of her claims, Ford
        hired an engineering expert, Mingxi Zheng. SharkNinja filed a motion to exclude Zheng.

        Mechanical Engineering Expert Witness

        Mingxi Zheng is a licensed professional mechanical engineer in California with a specialty in “metallurgy, fracture mechanics, and failure analysis.”

        She received degrees in materials science and engineering and has worked as a materials scientist and mechanical engineer at various reputable institutions.

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

        Discussion by the Court

        According to Zheng, the blender was defectively designed because it lacked protective covers on a new blade assembly and the warnings included with the blender were insufficient and did not comply with the proper standard for product safety signs and labels.

        SharkNinja contended that Zheng’s design defect opinion should be
        excluded. The Court agreed.

        Zheng concluded that blade guards could have been included without, for example, identifying consumers’ expectations for the packaging of such products, considering the cost of the guards themselves, or accounting for the effects of increasing the time or manpower needed to manufacture and package blenders with blade guards. At most, she offered a cursory comparison to a product that has little in common with the product here beyond that both feature, in substantially different forms, a sharp edge. Zheng did not explain how the scientific method, failure analysis, or root cause analysis methodology helped reach this conclusion.

        SharkNinja also contended that Zheng is not qualified to offer expert testimony regarding the adequacy of the warnings. Ford failed to meet her burden to establish Zheng’s qualifications regarding this opinion because Zheng has no expertise in human factors or product warnings.

        Held

        The Court grant SharkNinja’s motion to exclude Ford’s expert, Mingxi Zheng.

        Key Takeaway

        Courts often require experience or expertise in “human factors engineering” or product warnings to opine on the adequacy of warnings. Zheng has no expertise in human factors or product warnings.

        Case Details:

        Case Caption: Ford V. Sharkninja Operating LLC
        Docket Number: 8:25cv245
        Court Name: United States District Court for the Middle District of Florida, Tampa Division
        Order Date: June 01, 2026
      2. Mechanical Engineering Expert Barred From Testifying for Not Testing Alternative Design

        Mechanical Engineering Expert Barred From Testifying for Not Testing Alternative Design

        Plaintiff Paul Johnson sustained severe injuries while operating a RIDGID K-6200 drain cleaning machine (“subject machine”) at his workplace. He sued the machine manufacturer, Defendant Ridge Tool Company (incorrectly identified as Ridge Tool Manufacturing Company, Inc.), asserting claims for negligence, product liability, and failure to warn.

        Plaintiff brought this lawsuit contending that Defendant manufactured an unreasonably dangerous and defective machine without an appropriate fixed guard that would have prevented Plaintiff from having to hold a rotating cable in his hand that could suddenly twist and kink and pull him. Plaintiff also challenged the adequacy of Defendant’s warnings and argued that personal protective equipment (PPE) was insufficient to protect users from the known hazards associated with this type of drain cleaning machine.

        In support of his claims, Plaintiff relied on two experts, Chad E. Jones, a mechanical engineer, and Cynthia M. Rando, a certified human factors professional. Following the completion of discovery, Defendant filed motions to exclude the testimony of both experts.

        Mechanical Engineering Expert Witness

        Chad E. Jones is a certified machine safety expert who is licensed in seven states and has worked as an engineer since 1996. He has a Bachelor of Science in Mechanical Engineering from Clemson University. Jones has participated in and led industrial accident investigations and participated in in-depth process safety audits. This work has included equipment design, machine safeguarding, cost estimating and safety compliance. He has designed HVAC and plumbing systems for commercial, industrial, and private clients.

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

        Human Factors Expert Witness 

        Cynthia M. Rando is a certified human factors professional who has worked in the human factors field for approximately twenty years. She is Vice President of the Board of Certification in Professional Ergonomics (Human Factors). Rando received her B.S. and M.S. in Human Factors Engineering from Clemson University and an MBA from Northeastern University. She has also served as an associate professor at University of Houston Clearlake providing instruction in Human Factors, Safety and Ergonomics course material.

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

        Discussion by the Court

        Chad Jones

        i. Qualifications

        Defendant argued that Jones was not qualified because, despite being a mechanical engineer, he did not have any experience with the machine at issue or with drum-style drain cleaning machines generally. Defendant also contended that Jones’ purported experience with guarding mechanisms as they relate to industrial machine presses bore no relation to this case, as a machine press was entirely different from a drum-style cleaning machine.

        While Jones’ personal experience with drain cleaners is limited, and he is not familiar with the subject machine, the Court held that his professional experiences qualify him to opine here. Jones is certified as a machinery safety expert and has worked in the area of machine safeguarding since March 2019. True, he may not have actual experience with the particular machine in this case, but he need not be the best expert in the field in order to be qualified.

        ii. Reliability

        Defendant argued that even if Jones’ qualifications pass muster, his opinions are nonetheless unreliable because he failed to perform any testing of his purported reasonable alternative design. Jones opined that Defendant was required to include a fixed guard over the rotating cable to prevent injury. It is undisputed that Jones did not engage in any physical testing of the proposed alternative nor did he conduct any mathematical calculations or models.

        Indeed, Jones conceded that he has not spoken to any users of the equipment or industry professionals nor did he design or test his own fixed guard or physical prototype, use a computer program to design or simulate a fixed guard, perform calculations or drawings to demonstrate how an alternative guard would fit onto the machine, take an exemplar guard and try to apply it to the machine, or perform calculations, modeling, or other analysis to assess if an alternative guard would impact the speed or ability of the cable’s rotation. 

        Plaintiff’s contention that Jones need not test his alternative design is premised upon his assumption that the fixed guard is an “industry standard.” On this point, Plaintiff claimed that three of Defendant’s competitors use a fixed guard and thus the Court should presume this is what the industry requires. But that is too great of a leap in logic.

        Jones did not conduct any type of analysis that would make up for his lack of testing of the proposed alternative design. While Plaintiff contended that Jones included detailed designs, an economic study, preliminary drawings, and his own risk-utility testing, the Court does not find that information on the cited references or anywhere else in the report.

        Cynthia Rando

        After reviewing certain materials and taking Plaintiff’s hand measurements, Rando opined as follows:

        ➢ The primary root cause of the incident involving Plaintiff and the K-6200 Drain Cleaning machine was failure to effectively address hazards created by the design and operation of the K-6200 Drain Cleaning machine through standard design controls.

        ➢ Defendant demonstrated negligence through their failure to effectively assess and control risk and the violation of accepted standards of practice pertaining to risk management and the design for human safety.

        ➢ Additionally, the failure to provide the correct personal protective equipment (PPE), including unsafe recommendations made by Defendant to utilize a “one size” glove that allowed for a loose fit for individuals representing a smaller anthropometric hand size range, introduced unacceptable added risk and significant potential for injury.

        ➢ The reliance on the user manual to provide the necessary information regarding safe operation of the device by Defendant and the expectation that the manual was the hazard control method was negligent. This approach passed the responsibility of safety to the end user despite the awareness of the potential for significant injury based on the design of the equipment and recommended method of operation.

        ➢ The user manual was not written in an easy-to-understand manner, including conflicting safety instructions and recommendations for postures that would create increased risk of injury to the operators.

        ➢ The manual violated ANSI Z535 standards and recommended unsafe operations to the end users but advertised them to be “safe.”

        ➢ These issues represent the root cause and contributing factors to the injury incurred by Plaintiff on August 17, 2019.

        i. Reliability

        Defendant argued that Rando’s opinions on the user manual are irrelevant to the causation analysis and unreliable because she failed to either offer or test any reasonable alternative warnings.

        After reviewing Rando’s expert report, the Court concluded that Rando did not offer a specific opinion about the adequacy of the warning label. Indeed, her opinions as to “Caution and Warnings” are couched in the context of analyzing the user manual which, as noted, Plaintiff did not read.

        Rando never addressed whether the warning label affixed to the machine was inadequate or failed to capture Plaintiff’s attention. Because her opinion focused solely on the user manual Plaintiff never read, the Court held that it is not relevant.

        Even if the Court did interpret Rando’s opinion as encompassing the warning label, her failure to draft or test any proposed alternative warnings still rendered any such opinion unreliable.

        Last, Plaintiff pointed to Rando’s opinion on personal protective equipment (PPE) that Defendant’s standard one size fits all glove—which Plaintiff admittedly did not use here—was unsafe, but that has no bearing on his failure to warn claim. In the end, these “unsafe recommendations” were included in the user manual, which, as already discussed, Plaintiff never read. Therefore, the Court held that her opinion on PPE is similarly irrelevant.

        Held

        The Court granted the  Defendant’s motions to bar the testimony of Plaintiff’s expert witnesses, Chad Jones and Cynthia Rando.

        Key Takeaway:

        An expert can overcome the lack of testing by adhering to the standards of intellectual rigor demanded in their professional work. However, Jones did not conduct any type of analysis that would make up for his lack of testing of the proposed alternative design. 

        Case Details:

        Case Caption: Johnson V. Ridge Tool Manufacturing Company, Inc.
        Docket Number: 1:21cv1939
        Court Name: United States District Court, Illinois Northern
        Order Date: August 22, 2025
      3. Human Factors Expert’s Opinions on Alternative Warnings Excluded

        Human Factors Expert’s Opinions on Alternative Warnings Excluded

        This case arises out of an alleged design defect and failure to warn regarding a 2017 Toyota Tacoma. Lee Griffin was the primary driver of a 2017 Toyota Tacoma. After Griffin died due to accidental carbon monoxide poisoning from an automobile inadvertently continuing to run in the garage, Caroline Griffin filed suit individually and as executor of Lee Griffin’s estate.

        The Defendants filed a motion to exclude certain opinions offered by the Plaintiff’s proffered human factors and warnings expert, Joellen Gill.

        Human Factors Engineering Expert Witness 

        Joellen Gill, CHFP, CXLT, CSP attended Georgia Tech and Wright State Universities for her undergraduate work, earning a BS in human factors engineering in 1979. Her nearly four-decade career includes 15 years in aerospace and national defense industries as a human factors engineer specializing in safety and risk management.

        Gill started part time at ACS in 1994 after completing a master’s degree in engineering, accepted a full-time position in 2005, then, after obtaining certification as a Human Factors Professional, was lead engineer on her first case just a year later. She is also a licensed tribometrist and a Certified Safety Professional.

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

        Discussion by the Court

        Specifically, the Defendants sought to exclude “opinions regarding alternative warnings or that a different warning would have changed the decedent’s behavior at the time of the subject incident.”

        During her deposition on August 8, 2024, Gill was asked, “In your opinion, what warnings should Toyota have provided for the 2017 Toyota Tacoma?” She responded, in part, “I am not a design engineer. I think it’s improper for me to offer opinions related to specific warnings that should have been provided in a vacuum.” She then explained that her “overarching opinion” was that Toyota adopted a safety strategy that relied on users taking action to protect themselves—something she believed was the least effective method of ensuring safety.

        Later in the deposition, Gill was asked whether she had formed any opinions on whether a different set of warnings or alerts would have changed Lee Griffin’s behavior on the day of the incident. She answered, “I don’t have any specific opinions about other warnings that would have changed his behavior… with respect to leaving his vehicle running inadvertently.”

        However, just twelve days after her deposition, Gill submitted a rebuttal report stating: “If Toyota had wished to give an effective external audible warning, Toyota could have designed the vehicle to blow its horn when left running without the key fob present in the vehicle.” She further asserted, “An effective audible alert would have resulted in Griffin recognizing he had not turned off his vehicle and therefore would have resulted in a change in his behavior.”

        Plaintiff’s Arguments

        The Plaintiff did not claim that these opinions had been disclosed in Gill’s initial report or deposition. Instead, she argued (1) that the statements were part of a timely rebuttal in response to the Defendants’ expert’s opinion regarding the vehicle’s “feedback,” and (2) that any resulting prejudice was due to Toyota scheduling Gill’s deposition before rebuttal reports were due.

        Analysis

        The Plaintiff offered no explanation for Gill’s failure to include these opinions in her initial expert report. Instead, she placed the blame on the Defendants for deposing Gill before the rebuttal reports were filed. However, this timing did not eliminate the prejudice caused by introducing new and improper opinions in a rebuttal report.

        Even if the Defendants had received the rebuttal report beforehand and questioned Gill about its contents, the prejudice from her untimely opinions would have remained.

        Moreover, even assuming for the sake of argument that the opinions were timely, Rule 26 required expert reports to explain not only what conclusions were reached, but also how and why the expert reached them. Gill failed to meet this standard. She offered no reasoning, analysis, or citation to support her claim that a vehicle horn alert would have been “effective” or that it “would have resulted in a change in [Lee Griffin’s] behavior.” As a result, the Court held that these opinions failed to comply with the disclosure requirements under Rule 26.

        Held

        The Court granted the Defendant’s motion to exclude certain opinions offered by the Plaintiff’s proffered human factors and warnings expert, Joellen Gill.

        Key Takeaway:

        Under Rule 26, a witness retained to provide expert testimony must prepare a written report that includes “a complete statement of all opinions the witness will express and the basis and reasons for them.”

        If a party fails to provide information or identify a witness as required by Rule 26(a) or (e), the party is not allowed to use that information or witness to supply evidence on a motion, at a hearing, or at a trial, unless the failure was substantially justified or is harmless.

        Case Details:

        Case Caption: Griffin V. Toyota Motor Corporation Et Al
        Docket Number: 1:23cv3107
        Court Name: United States District Court, Georgia Northern
        Order Date: June 18, 2025

      4. Obstetrics and Gynecology Expert Witness’ Opinions on the Filshie Clip Instructions for Use Admitted

        Obstetrics and Gynecology Expert Witness’ Opinions on the Filshie Clip Instructions for Use Admitted

        Defendants CooperSurgical, Inc., Femcare, Ltd., and Utah Medical Products, Inc. manufacture and distribute birth control devices called Filshie Clips.

        Filshie Clips are 3-5 millimeters wide and are laparoscopically placed on the fallopian tubes. Plaintiffs are individuals who had tubal ligation surgery in 2009 and 2010.

        Plaintiffs Giovanna Bulox and Lorena Ahiri Merlo are sisters. Bulox underwent a tubal ligation procedure, choosing Filshie clips on July 13, 2010. Merlo underwent a tubal ligation procedure through the use of Filshie clips on July 21, 2009. Several years later, both sisters allegedly began to experience discomfort and pain.

        In 2019, doctors removed two migrated Filshie Clips from Bulox’s body, one in her intestinal wall. Plaintiff Merlo had the same pain several years after her surgery, and in 2020, radiology showed the Filshie Clips migrated in her body. An attempt to remove them laparoscopically was unsuccessful; Merlo still has displaced Filshie Clips in her body. Plaintiffs sued Defendants for: (1) design defect; (2) manufacturing defect; (3) failure to warn; (4) strict liability; (5) negligence; (6) violation of consumer protection laws; (7) gross negligence; and (8) exemplary damages.

        Defendants designated Dr. Janesh K. Gupta as a witness to assist their defense but Plaintiffs sought to exclude several of Gupta’s opinions, namely any opinion regarding: (1) Bulox’s medical condition; (2) Merlo’s medical condition; (3) the design and/or manufacture of Filshie Clips; (4) the adequacy of warnings promulgated with Filshie Clips; and (5) FDA regulations or how they apply to Filshie Clips.

        Obstetrics and Gynecology Expert Witness

        Dr. Janesh Gupta is an Honorary Professor of Obstetrics and Gynaecology at Birmingham Women’s and Children’s Hospital.

        Gupta has published over 175 research papers in scientific journals, book chapters, reviews and books and over 100 lectures and presentations to learned societies in the fields of fetal medicine, benign gynaecology (including abnormal uterine bleeding, fibroids, endometriosis, endometrial hyperplasia), minimal access surgery, induction of labour and abortion. He has received grants from WellBeing of Women, Department of Health National Institute for Health Research (Health Technology Assessment), Medical Research Council and various industry partners.

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

        Discussion by the Court

        Defendants designated Gupta as a witness to assist their defense because he is “an experienced English OB/GYN who has used the Filshie Clip for decades, has both written and reviewed published literature on the Filshie Clip, specifically on Filshie Clip migration, and has since 2012 served as the independent medical consultant for Femcare Ltd.—reviewing complaints and assisting with risk reviews and other studies of the Filshie Clips.”

        The Parties Resolved Several Issues Raised in the Motion

        Plaintiffs argued that Gupta is unqualified to testify about: (1) the injuries sustained by Plaintiffs because he never treated or examined Plaintiffs and did not review their medical records; and (2) Defendants’ FDA compliance because he does not practice medicine in the United States and possesses no knowledge of the FDA regulations or manufacturing or developing a medical device. Plaintiffs continued that Gupta’s opinions are unreliable and unhelpful because he is not an FDA expert yet offers opinions regarding what is a “serious injury” and “reportable event” according to FDA standards, and he did not form his opinions according to objective independent methodology.

        However, Defendants explained that they did not intend to offer several of the objected-to opinions, making them moot. First, “Gupta did not intend
        to provide any specific testimony on Plaintiffs.” Second, Gupta provided no opinion on manufacturing or designing Filshie Clips, but rather he discussed how the design “physiologically accomplishes . . . female sterilization and result in migration,” and he also pointed out that Plaintiffs’ expert had no experience in designing medical devices. Based on the Court’s review, the above issues were denied as moot.

        Third, Defendants have a separate FDA expert and did not intend to use Gupta as such—instead, Gupta discussed his own review of adverse event complaints as Defendants’ independent medical consultant.

        Defendants clarified that “Gupta’s opinions . . . are really about his medical review of adverse event complaints in the context of FDA definitions.” Plaintiffs asserted that this clarification is insufficient because Gupta cannot offer the above testimony without also testifying about Defendants’ FDA compliance. But that is the exact same testimony that they stated that they intended to elicit from him. The Court held that this argument is insufficient for the exclusion of Gupta’s testimony.

        Plaintiffs Failed to Carry their Burden To Exclude Gupta’s Testimony

        Gupta May Testify About Reviewing Adverse Event Complaints

        Plaintiffs argued that Gupta’s opinions regarding his review of reportable events are not backed by any independent methodology and therefore should be excluded. They argued that because Gupta lacked knowledge of the FDA and did not conduct independent research, he “relied only on his subjective interpretation of a definition of ‘serious injury’ provided to him by Femcare to make his determinations regarding serious injuries/reportable events,” which led to inconsistent findings. Plaintiffs also argued that Gupta rejected medical reports and made unfounded assumptions to discount patient reports of migration.

        In his report, Gupta gave a detailed overview of his extensive medical experience and experience as a reviewer and of the applicable FDA regulations. Gupta first ascertained whether there was a serious injury in accordance to the regulatory body definitions and then determined whether there is a reasonable suggestion that the product may have caused the injury.

        Gupta explained that that long-lasting chronic pain, the most common complaint with Filshie Clip migration, requires additional review due to the complexity of pain in the body, which for him, includes searching for additional physiological evidence in the medical history suggesting that the device caused or contributed to the reported problem. The Court held that Plaintiffs’ arguments are insufficient to exclude Gupta’s testimony as
        unreliable. Plaintiffs’ arguments largely relate to the bases of Gupta’s review decisions, not the underlying methodology, and are therefore more suitable for cross examination.

        Gupta May Testify About Filshie Clip Warnings

        Plaintiffs contended that Gupta’s opinions that the Filshie Clip instructions for use (“IFU”) are based on accurate and reliable data is unreliable and unsupported because these opinions are “based on his own erroneous understanding of the language included in the documents and a rate of incidence (0.13%) provided to him by Defendants and not based on any peer-reviewed science or accepted medical principles.”

        The parties disagreed on the underlying facts of Gupta’s opinion that the Filshie Clip IFUs are based on accurate and reliable data. Without deciding the correctness of Gupta’s opinion, the Court found that his opinion is reliable: Gupta has extensive experience with implanting Filshie Clips and reviewing the IFUs—his testimony is based on this experience.

        Held

        The Court denied Plaintiffs’ motion to limit Defendants’ fact and expert witness, Dr. Janesh K. Gupta’s testimony.

        Key Takeaways:

        • Unlike Plaintiffs’ contentions, Gupta has adequate knowledge of the applicable FDA regulations and has educated himself independently of Femcare’s provided material, citing to a wide body of literature in the field of chronic pelvic pain.
        • Gupta has employed his education and experience as a clinical expert who has implanted Filshie Clips for decades and counseled countless patients on the procedure. He also employs his own research, writing, and review of literature in reviewing the warnings for Filshie Clips to come to a conclusion as to whether they adequately warn of clip migration.

        Please refer to the blog previously published about this case:

        Obstetrics and Gynecology Expert Witness Allowed to Testify that Factors Other than Migrated Filshie Clips Caused Plaintiffs’ Injuries

        Case Details:

        Case Caption: Bulox Et Al V. Coopersurgical, Inc. Et Al
        Docket Number: 4:21cv2320
        Court: United States District Court, Texas Southern
        Order Date: February 27, 2025
      5. Human Factors Expert Witness’ Opinion About the Alleged Design Deficiencies of the Boppy Newborn Lounger Admitted

        Human Factors Expert Witness’ Opinion About the Alleged Design Deficiencies of the Boppy Newborn Lounger Admitted

        The Boppy Newborn Lounger (“BNL”) was on the market for nearly sixteen years, and during that time, Boppy sold over 3.3 million BNLs. Boppy’s warnings and marketing made clear that the BNL was intended to give caregivers a place to lay infants down for supervised awake time only, but never for sleeping. As with any product, there were risks associated with improper use, against which Boppy warned and for which Boppy provided instructions concerning safe use.

        On October 2, 2020, Plaintiff Danielle Clark swaddled her infant daughter (“D.B.”) in a blanket that was loosely wrapped around D.B.’s head, but not covering her face. D.B. was then placed “mainly on her side” and in the center of the BNL, which was sitting on the couch. Around 10:30 or 11:00 p.m., Clark fell asleep with her head on the side of the Boppy pillow. When Clark awoke approximately three to four hours later, she found her daughter unresponsive. The decedent was proclaimed dead, and according to the coroner, the cause was “probable asphyxia in the setting of co-sleeping and soft bedding.”

        Plaintiffs alleged that the tragic death of their infant was caused by the BNL. Plaintiffs’ purported expert witness, Dr. Erin Mannen opined that “the design of the Boppy Newborn Lounger resulted in a dangerous biomechanical position that explains the death of [D.B.].” Dr. Ian Noy, also retained by the Plaintiffs, opined that the BNL’s warnings were inadequate.

        Boppy filed motions to exclude the opinions provided by Erin Mannen and Ian Noy.

        Human Factors Expert Witness

        Ian Noy has a Ph.D. and M.S. in industrial engineering from the University of Toronto. He is a distinguished human factors and ergonomics consultant and forensic expert with extensive background in innovative and
        applied safety research, industrial engineering, behavioral sciences, and science management.

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

        Mechanical Engineering Expert Witness

        Erin M. Mannen earned a Ph.D. in Mechanical Engineering from the University of Kansas in 2014, completed a Postdoctoral Fellowship in the Center for Orthopaedic Biomechanics within the Department of Mechanical and Materials Engineering at the University of Denver in 2017, and has been researching biomechanics for over 14 years.

        She is currently employed full-time as an assistant professor in the Mechanical and Biomedical Engineering Department at Boise State University in Boise, Idaho.

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

        Discussion by the Court

        Noy’s Report

        Boppy has moved to exclude the report of Plaintiffs’ expert witness, Ian Noy. Most of Boppy’s challenges do not relate to Noy’s qualifications or the relevance of his opinions, but rather, the reliability of his methodology. Specifically, Boppy takes issue with the following: (1) his failure to supply an alternative warning; (2) his reliance on the American National Standard Institute’s (“ANSI”) safety standards; (3) his failure to consider evidence regarding Clark’s refusal to follow the BNL’s warnings; and (4) his opinions about the design of the BNL.

        His failure to supply an alternative warning

        Boppy argued that an expert testifying on the inadequacy of a product’s warning is required to draft an adequate alternative warning. In the absence of a proposed alternative, Boppy argued, Noy’s opinions are unreliable. 

        Here, Noy was made personally aware of the label’s content through examining the BNL at issue. After examining the BNL and consulting a myriad of other materials, Noy highlighted alleged design deficiencies in the BNL’s safety alert signs on the product and its carrying case.

        Noy appeared to suggest that, for example, the alternative proposed warning would include a safety label with no busy background, the font would be larger, there would be a distinction made between suffocation hazard and positional asphyxia hazard, there would be a description provided as to the nature and severity of hazards, and there would be a more effective message prohibiting “chin-on-chest” and providing contrasting symbols for “chin-on-chest” and “chin-off-chest” positions. 

        The Court found that “it would be simplistic to view [Noy’s] failure to ‘draft’ an alternative warning as being fatal to his opinion,” in light of the reasoning gleaned from his report and his expertise in human factors engineering.

        His reliance on the American National Standard Institute’s (“ANSI”) safety standards

        Boppy also challenged Noy’s reliance on standards from the American National Standards Institute (“ANSI”). According to Boppy, there is no ANSI standard that applies to the BNL or any baby lounging products.

        It is noteworthy that Noy’s  report summarizes ANSI Z535’s key requirements, and uses those requirements to outline the deficiencies in BNL’s warning label. According to the Court, this is not a situation where an expert is attempting to substitute scientific methodology for their personal observations.

        Boppy also challenged Noy’s reliance on ANSI standards as a substitute for user testing. 

        The Court held that Noy’s opinions are not unreliable just because his report offered a comparative analysis based on ANSI standards, rather than results from user testing on the BNL’s warnings. While having expert testimony on this point would certainly aid Plaintiffs in proving causation, it is not essential for Daubert purposes.

        His failure to consider evidence regarding Clark’s refusal to follow the BNL’s warnings

        Boppy argued that Noy’s opinion is unreliable because he failed to consider evidence regarding Clark’s failure to follow the BNL’s warnings. The Court is unconvinced. In his deposition, Noy stated that Clark’s deposition was made available to him when he generated his expert report. Additionally, Noy confirmed that he knew Clark did not read the BNL’s labels. 

        His opinions about the design of the BNL

        Boppy contended that Noy’s “report is littered with statements” that offer opinions about the BNL’s design, a topic which Noy is not qualified to speak on.

        Boppy specifically takes issue with Noy’s statements about the hazard control hierarchy. According to Noy, the hazard control hierarchy is “a widely accepted process for eliminating or mitigating hazards through prioritized intervention strategies.” 

        As a human factors expert, the Court held that Noy can incorporate the hazard control hierarchy, a theory “[d]eveloped within the fields of safety and human factors,” into his expert report. Moreover, Noy can acknowledge that, for example, Boppy did not explore design alternatives and that Boppy did not conduct studies to inform safe product design, without opining on the biomechanical or related mechanism design defects in the BNL. 

        Mannen’s Report

        Boppy filed a motion to exclude Erin Mannen’s expert report, which relates to the alleged design defects of the BNL. Boppy argued that Mannen (1) failed to consider the material facts of this case, (2) her opinions violate Rule 26, (3) she is not qualified to opine on cause of death, and (4) her opinion fails to account for alternative causes.

        She failed to consider the material facts of this case

        According to Boppy, Mannen failed to consider the facts and circumstances surrounding D.B.’s death. It is true that Mannen did not review Clark’s deposition before writing her report. Mannen did, however, consider Plaintiff’s Complaint, the autopsy report, photos of the reenactment of the incident, and the coroners file which contained the Howard County Police report.

        Mannen explained that even taking into consideration the unsafe sleeping practices exercised by Clark, the BNL’s defective design was a substantial factor in D.B.’s death.

        Boppy also takes issue with Mannen’s report being premised on an infant’s “ideal body position” in the product, when here, D.B. was placed on her side. When confronted with this discrepancy, Mannen explained that she “understand[s] that there was a blanket, and . . . that the baby was partially on her side, but that [did not] change the fact that even in an ideal body position, [she had] identified all these hazards in the [BNL].”

        Mannen believes that there are inherent hazards in the BNL’s design, even if there is no misuse of the product or unsafe sleeping practices employed. The Court held that Mannen’s opinions are not deprived of a sound factual basis just because her opinion hones the BNL’s alleged inherent design flaws.

        Her Opinions Violate Rule 26

        According to Boppy, Mannen’s report should be excluded under Rule 26 because she has not shared information about the underlying incidents, products, and manufacturers included in the 2019 and 2022 U.S. Consumer Product Safety Commission (“CPSC”) studies her report relies on. In her report, Mannen concluded that, “[b]ecause of the similarities in the designs of inclined sleep products and the Boppy Newborn Lounger Pillow products . . . the concepts from our published in vivo biomechanics studies can be applied to the Boppy Newborn Lounger Pillow.” This is problematic, Boppy argued, because Mannen has refused to disclose the products involved in the studies. With the products left unidentified, Boppy states that it is “left to simply take her word for it,” that the unidentified products are similar to the BNL. 

        While Mannen cannot disclose the “incidents, products, and manufacturers” in her previous studies, the 2022 CPSC study provides photos of the sample pillows that were studied, and descriptions of the sample pillows, including their shape, mass, overall diameter or height and length, tube circumference or width, and thickness, as well as their cover and filler material. Albeit the 2019 CPSC study does not similarly provide photos of the fourteen inclined sleep products that were evaluated. However, Mannen’s report summarizes the sample measurements and characteristics of the products.

        Thus, Boppy is not simply left to take Mannen’s word for it—Boppy has within its possession sufficient information to challenge Mannen’s assertion that the sample products are functionally similar to the BNL. The Court held that Boppy can surely critique Mannen’s opinions and attempt to distinguish the sample products tested in the 2019 and 2022 studies from the BNL on cross-examination. But exclusion of her testimony under Rule 26(a) is not appropriate in this case.

        She is not qualified to opine on cause of death

        Boppy also contended that Mannen’s report offers an opinion on D.B.’s cause of death.

        Boppy asserts that by stating that “the design of the Newborn Lounger Pillow resulted in a dangerous biomechanical position that is capable of causing suffocation and/or positional asphyxia, like in the death of [D.B.],” Mannen impliedly offered a medical causation opinion.

        As a biomechanical expert, the Court held that Mannen can attest to the design deficiencies in the BNL she believes contributed to D.B. rolling and suffocating.

        Her opinion fails to account for alternative causes

        Boppy expressed its dissatisfaction with Mannen’s failure to consider alternative causes—namely, the blanket, the side-lying, co-sleeping, and misuse of the BNL on the couch. In her rebuttal report, Mannen addressed the foregoing biomechanical problems that Boppy’s expert states played a role in D.B.’s death and offers her dissent. 

        These alleged contributors to D.B.’s ultimate suffocation certainly may prove problematic for Plaintiffs. That said, the Court held that Boppy can press Mannen on the extent to which these alleged biomechanical problems contributed to D.B.’s movement and ultimate suffocation at trial.

        Held

        • The Court denied Plaintiffs’ motion to exclude the opinions provided by Dr. Ian Noy.
        • The Court denied Plaintiffs’ motion to exclude the opinions provided by Dr. Erin Mannen.

        Key Takeaway:

        The Daubert inquiry is a flexible one. Where, as here, an expert’s qualifications are clear and their methodology is sound, “helpful, legitimate expert testimony reaches the jury.”

        Boppy’s qualms with Noy and Mannen’s opinion will no doubt be addressed on cross-examination.

        Case Details:

        Case Caption: Clark Et Al V. The Boppy Company, Llc Et Al
        Docket Number: 1:22cv2120
        Court: United States District Court, Indiana Southern
        Order Date: November 06, 2024
      6. Consumer Product Safety Expert Witness’ Testimony About the Availability of Pop-up Warning Technology Excluded

        Consumer Product Safety Expert Witness’ Testimony About the Availability of Pop-up Warning Technology Excluded

        On June 20, 2015 at approximately 1:00 am, Thomas Power was using the Elitebook while at a 24-hour gym with the computer balanced directly on his lap. After using the computer for approximately 20-60 minutes, the laptop exploded into flame, burning Power’s legs.  He sustained serious injuries, including burns requiring a skin graft, hydrotherapy, catheterization, and intravenous antibiotics. After the accident, Power claims that he began to experience urinary and bowel incontinence.

        Plaintiff Power, via counsel, brought this suit against Defendant, the Hewlett-Packard Company (“HP”), seeking monetary relief for injuries he suffered as a result of his HP-brand laptop catching fire while on his lap. The Defendant filed a motion to exclude the remaining testimony of Plaintiff’s only remaining proffered expert, William F. Kitzes.

        Consumer Product Safety Expert Witness

        William F. Kitzes has over 35 years of safety management experience at the U. S. Consumer Product Safety Commission, the Institute for Safety Analysis and Consumer Safety Associates, where he currently serves as Principal Safety Analyst and Product Safety Manager. He is a Board Certified Product Safety Manager and Hazard Control Manager, and holds a Certificate in Safety Management from the American Society of Safety Engineers.  He has testified in over 100 trials in 28 states, Canada and Australia.

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

        Discussion by the Court

        Kitzes prepared an expert report opining, among other things, that HP had, by late 2007, developed a battery authentication system for certain laptops to identify ‘counterfeit’ battery packs, yet the HP EliteBook that Power had been using on the day of the fire did not include such a system.

        According to the Defendant, Kitzes’”sole source” of methodology for that opinion was “a document [that] Kitzes claimed to have found on HP.com… published on September 29, 2020—over ten years after the manufacture” of the at-issue laptop computer.

        In attacking the notion that the referenced document existed at the time of the laptop’s explosion, the Defendant submitted an affidavit signed by an HP representative averring that the at-issue document had in fact been created on or about September 29, 2020, and therefore could not have been in existence when the fire occurred. The Court concluded at that time that the affidavit offered by the Defendant failed to comply with the requirements of Fed. R. Civ. P. 56(c)(4).

        At the same time, the Court held that,

        “if the sole source of Kitzes’ opinion about the existence of pop-up technology was a document whose contents, as relevant here and as indicated by uncontroverted evidence, postdates the manufacture of the at-issue computer by twelve years,” “then the Court would likely determine that the methodology underlying [Kitzes’ proffered opinion testimony] was unreliable and prevent him from testifying as to it.”

        Availability of Pop-up Warning Technology

        After being granted leave to file a supplemental brief reaffirming its Motion for Summary Judgment and supplementing its Motion in Limine seeking to exclude Kitzes’ testimony, Defendant filed such supplemental brief which included a new affidavit, this time sworn by Wesley Dale, a Computing Operations Lead at HP with personal knowledge of the availability of pop-up warning technology for HP laptop computers and of the existence of the referenced document on HP.com.

        Within the affidavit, the affiant swore upon personal knowledge and expertise that the pop-up technology and documentation did not exist prior to September 29, 2020. As such, the Dale affidavit met the personal knowledge requirement under Fed. R. Civ. P. 56(c)(4).

        The Court concluded that the Dale affidavit sufficiently proved that the document upon which Kitzes relied in stating his conclusion that the pop-up warning technology was available to HP in 2007 is unreliable, as that “HP.com” page and content did not exist until 2020, far after Power’s laptop exploded.

        Neither party disputed that the sole source of Kitzes’ belief that the pop-up authentication technology existed at the time of the at-issue computer’s manufacture was one document that Kitzes referenced. And HP has provided uncontroverted evidence, in the form of a Rule-compliant affidavit supported by multiple exhibits, demonstrating that the document relied upon by Kitzes did not exist on the HP.com webpage until September 2020. The Plaintiff failed to make a convincing argument as to why, despite the evidence provided by the Defendant, the document would have been created in late 2007, then deleted, then reposted in 2020.

        Amendment to Federal Rule of Evidence 702

        The Court would have come to the above conclusion in any event but does so especially in light of the amendment to FRE 702 that became effective on December 1, 2023. The amendment to the Rule does two things: first, it clarifies that expert testimony is not to be considered presumably admissible, but is instead subject to a preponderance of the evidence standard; and second, it emphasizes that a court must evaluate the reliability of an expert’s conclusions drawn from his or her methodology, not just the methodology itself.

        Held

        The Court granted Defendant’s motion to exclude the testimony of William F. Kitzes, J.D. as to the existence of pop-up warning technology at the time that Power’s laptop exploded.

        Key Takeaway:

        After evaluating Kitzes’ conclusion drawn from his methodology—i.e., his conclusion that the pop-up authentication technology existed at the time of the explosion because a document could have existed on a website in 2015, even though there is no evidence that it existed prior to 2020—the Court concludes that that conclusion is speculative at best, and legally and factually unreliable.

        Case Details:

        Case Caption: Power V. Hewlett-Packard Company
        Docket Number: 2:17cv154
        Court: United States District Court for the Western District of Pennsylvania
        Order Date: July 19, 2024