The Burlington School District (“BSD” or “Plaintiff”) commenced this action after discovering polychlorinated biphenyls (“PCBs”) at Burlington High School (“BHS”). Defendants Monsanto Co., Solutia, Inc., and Pharmacia LLC (collectively “Monsanto” or “Defendants”) are allegedly successors to the old Monsanto company, which was the primary manufacturer of PCBs in the United States for several decades. BHS was constructed in the 1960s, and testing recently revealed the presence of PCBs in its buildings. The BSD concluded that because of PCB contamination, BHS had to be demolished.
Wendy N. Pearson is a licensed engineer who has worked at Matson & Associates for over 25 years.
Pearson has bachelor’s and master’s degrees in civil engineering and environmental science and engineering. She has also conducted peer-reviewed research relating to environmental contamination, chemical manufacturing industry standards and practices, and chemical releases from manufacturing and industrial facilities.
Dr. Robert Adam Wanat holds an M.S. and a Ph.D. in chemistry from Cornell University. He has more than 30 years’ experience working for major chemical companies overseeing research and development of various chemical products. Since 2018, he has owned his own consulting company which specializes in the development, manufacture, and application of polymers, plastics, materials, and adhesives.
Defendants first argued that opinions about what Monsanto should have known should be excluded. Their contention is that these witnesses’ testimonies about the environmental impacts of PCBs — based in part on information from Monsanto’s own archives — are “mere pronouncements” based on “subjective or speculative opinions” and would constitute a subjective interpretation “based on nothing more than a review of decades-old documents.”
Pearson reviewed the state of the science related to PCBs over several decades, beginning in the 1930s. Pearson also explained the chemical nature of PCBs and what was known about their dangers. She did offer opinions about what Monsanto could have done to expand its knowledge. Those opinions are based on studies that were known in the scientific community and, in certain instances, by Monsanto itself.
As a result, the Court found that Pearson’s testimony is not based on speculation. Nor did it constitute merely subjective narrations. Instead, they appeared to be supported by a substantial documentary record that provided a foundation for their opinions.
Wanat’s report is similarly supported. He will testify about chemical evaporation generally, and with respect to PCBs specifically. He will also reference Monsanto’s documents, including patents and technical bulletins.
II. Standard of Care
Defendants next argued that Pearson’s and Wanat’s opinions regarding industry standards cannot be admitted because they are not supported by sufficient facts, are not based on any methodology, and constitute improper legal conclusions.
Pearson intended to testify that Monsanto defined its own standard of care and failed to live up to that standard. Wanat’s report is more limited, citing Monsanto’s adherence to American Conference of Government Hygienists thresholds.
The Court questioned whether the materials in question establish a standard of care, or whether they instead constitute general statements of corporate responsibility. Regardless of the distinction, the Court found no reason to exclude the testimony of either Pearson or Wanat, insofar as their testimony is based on Monsanto’s own statements about its responsibilities.
Defendants’ final argument is that testimony about the standard of care consisted of improper legal conclusions and stood in the shoes of the jury.
Here, Plaintiff submitted that Wanat will use the term “reasonable” in its “ordinary, non-legal sense.” Defendants have not identified an element of a pending cause of action that would render the term “reasonable” an impermissible legal conclusion. Consequently, the Court declined to bar such testimony.
Held
The Court denied Defendants’ motion to exclude the expert testimony of Wendy Pearson and Robert Wanat.
Key Takeaway
To determine when a question posed to an expert witness calls for an improper legal conclusion, the district court should consider first whether the question tracks the language of the legal principle at issue or of the applicable statute, and second, whether any terms employed have specialized legal meaning.
This is an antitrust action filed by Plaintiffs CareFirst of Maryland, Inc., Group Hospitalization and Medical Services Inc., and CareFirst Bluechoice Inc. (collectively, “CareFirst”) alleging that Defendants Johnson & Johnson and Janssen Biotech, Inc. (collectively, “J&J”) used monopoly power to unlawfully delay the introduction of biosimilar competitors for their drug ustekinumab (sold under the brand name “Stelara”).
J&J filed a motion to exclude the testimony of Plaintiffs’ expert Dr. Aaron S. Kesselheim. J&J sought to exclude both of Kesselheim’s opinions on the grounds that they are unreliable or unhelpful to the jury.
Pharmacoeconomics Expert Witness
Aaron Seth Kesselheim, M.D., J.D., M.P.H., is a Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital.
He is also a Visiting Professor of Law at Yale Law School, and has practiced internal medicine at Brigham and Women’s Hospital for over 20 years. Kesselheim holds an M.D. and J.D. from the University of Pennsylvania as well as an M.P.H. from Harvard. Kesselheim assisted in founding the Center for Bioethics at Harvard Medical School and has published over seven hundred scholarly articles.
Kesselheim’s expert report provides background information and two opinions related to the pricing of pharmaceutical drugs. J&J sought to exclude both opinions on reliability and relevancy grounds as well as background information Kesselheim provided regarding certain “life cycle management” strategies employed in the pharmaceutical industry.
A. Kesselheim’s First Opinion
Kesselheim’s first opinion discussed the historical impacts of “biosimilar competition on the market for biologic drugs” since the passage of the Biologics Price Competition and Innovation Act (BPCIA). Specifically, Kesselheim opined that, in the fifteen years since BPCIA’s passage, “[b]iosimilar competition has an impact on pricing.” Kesselheim bases his first opinion “largely” on two studies he co-authored in 2021 and 2024, which examined two non-Stelara biologies and studied “how market structures altered by the BPCIA affected prices for biologies subject to biosimilar competition.”
J&J argued that Kesselheim’s first opinion regarding biosimilar competition generally should be excluded because it merely repeats findings from his two studies on other biologic drugs and makes no effort to reliably extrapolate those findings to Stelara.
The Court held that Kesselheim’s first opinion is grounded in fifteen years of research and peer-reviewed studies examining how biological drug markets respond to biosimilar competition, and Kesselheim clearly applies those industry patterns to a hypothetical but-for scenario. J&J argued that Kesselheim should have performed an analysis beyond repeating the findings of his studies or ran “new regression models” more specific to Stelara. However, Kesselheim’s role is to explain market behavior based on consistent historical experience and thus is not required to have performed new quantitative analysis. Accordingly, any alleged gaps in Kesselheim’s analysis go to weight and can be addressed on cross-examination.
Additionally, Kesselheim’s first opinion is helpful for the jury because it bears directly on what would have happened to Stelara prices absent the alleged anticompetitive conduct. Kesselheim’s first opinion situates Stelara within the broader context of a competitive biologies market, including comparator biologies such as Humira and J&J’s own Remicade. Thus, Kesselheim provided the jury with a framework for understanding how a competitive biologies market typically functions.
B. Kesselheim’s Second Opinion
Kesselheim’s second opinion discussed the likely “effects of biosimilar competition on the ustekinumab market if one or more biosimilars launched in or around September 25, 2023.” Kesselheim opined that if one or more biosimilars launched at that time, “there would have been a meaningful lowering of spending related to this drug by all different categories of payors in the U.S.”
J&J sought to exclude Kesselheim’s second opinion on the grounds that it is unreliable and unhelpful speculation. J&J argued that Kesselheim utilized no specific methodology or analysis to draw his conclusions. According to J&J, Kesselheim’s conclusions rest on analogies to other drugs such as Humira, ignore available evidence from actual biosimilar entry, and amount to impermissible ipse dixit.
Kesselheim’s conclusion that earlier biosimilar entry would have led to a meaningful reduction in Stelara’s net price is grounded in reliable, peer-reviewed research as well as consistent historical experience across biologic drug markets. Kesselheim’s conclusions are not merely speculation, as J&J contended. Rather, in his report, Kesselheim synthesized data from multiple biosimilar launches and explained why Stelara shares salient market characteristics with comparator drugs such as Humira. This is not only reliable expert testimony but also relevant context for the jury to understand how biosimilar entry affects biologic pricing.
Furthermore, the Court is not persuaded by J&J’s argument that Kesselheim’s opinion is faulty because he did not specifically examine the data following the entry of a biosimilar drug to ustekinumab in January 2025. Given the timing of the events in this litigation, such data simply was not available when Kesselheim prepared his report in March 2025.
C. Kesselheim’s Discussion of Life Cycle Management Strategies
Kesselheim opined on how “life cycle management” strategies in the pharmaceutical industry are an important factor affecting biosimilar availability. Kesselheim opined that “life cycle management” strategies is a “broad term” describing “drug manufacturers’ strategic efforts to extend their drugs’ market exclusivities, prolong commercial viability, or strengthen their competitive positions in a market.” J&J sought to exclude these observations on the grounds that they are “not grounded in the facts of this case” and are unhelpful to a jury. J&J argued that these “generalized musings” are untethered to either of CareFirst’s theories of liability in this case and thus would risk misleading the jury by introducing irrelevant industry practices that CareFirst does not allege are unlawful.
The Court held that Kesselheim appropriately draws on his specialized knowledge of industry practices and incentives to provide context for why J&J’s alleged conduct fits within established industry patterns. J&J’s objections that Kesselheim “was not even aware of the biologic manufacturing patents at issue” and “did not review any of the settlements that J&J entered with biosimilar manufacturers” went to the weight, not admissibility.
Held
The Court denied J&J’s motion to exclude the testimony of Dr. Aaron Kesselheim.
Key Takeaway
Kesselheim’s observations on pharmaceutical life cycle management are admissible as reliable and relevant testimony. Kesselheim’s opinions on this issue are grounded in specific academic research examining how branded drug manufacturers use secondary patents and related strategies to extend market exclusivity and delay biosimilar competition. This type of experiential expert testimony does not need to rest on quantitative analysis specific to Stelara to be reliable.
Please refer to the blog previously published about this case:
This is an antitrust action filed by Plaintiffs CareFirst of Maryland, Inc., Group Hospitalization and Medical Services Inc., and CareFirst Bluechoice Inc. (collectively, “CareFirst”) alleging that Defendants Johnson & Johnson and Janssen Biotech, Inc. (collectively, “J&J”) used monopoly power to unlawfully delay the introduction of biosimilar competitors for their drug ustekinumab (sold under the brand name “Stelara”).
CareFirst proffered Todd Clark as a pharmaceutical business expert. However, J&J filed a motion to exclude the testimony of Clark.
Marketing Expert Witness
Todd D. Clark has over thirty years of experience in the pharmaceutical industry. Before founding his own advisory firm, Clark served as Vice President of Business Development and Director of Media Services for Medicus NY, then the world’s largest pharmaceutical marketing firm.
Clark’s expert report provided four opinions related to causation, all of which are premised on the assumption that the jury finds J&J’s challenged conduct was unlawful under antitrust law.
A. Clark’s “Reasonable Company” Framework
To begin with, J&J’s first objection applies to all four of Clark’s opinions. J&J argued that Clark’s opinions should be excluded on the ground that they are all predicated on an unreliable framework that Clark utilized in his opinions: what a “reasonable” pharmaceutical company could have done.
However, the Court rejected J&J’s overarching argument that Clark’s “reasonable” pharmaceutical company is unreliable. Basically, Clark’s focus on the conduct of a “reasonable” company reflects a well-established approach in the antitrust context for evaluating corporate decision making.
Clark drew on his more than thirty years of experience to offer a range of business options through the lens of industry practice. This approach falls within the province of acceptable testimony from an experiential expert, and it provides a reliable framework for assisting the jury in understanding the options available to companies in J&J’s position.
That Clark applied this framework to the facts of this case did not render it unreliable, especially since Clark did not purport to give an opinion on what J&J actually knew or would have actually done absent the challenged misconduct.
B. Clark’s First Opinion
Clark’s first opinion is that “[a] reasonable company in J&J’s position had options other than asserting the biosimilar manufacturing patents” that “therefore would have avoided the allegedly anticompetitive actions associated with the Momenta biosimilar patents.”
In his first opinion, Clark offers five alternative options “available to J&J or a reasonable company in the same position that would not have involved asserting the biosimilar manufacturing patents against biosimilar manufacturers and therefore would have avoided the allegedly anticompetitive actions associated with the Momenta biosimilar patents.” The five options that Clark offers are:
1) “a reasonable company in J&J’s position could have chosen not to take possession of the biosimilar manufacturing patents at the time of the Momenta acquisition or to divest them upon completing the acquisition”;
2) “a reasonable company in J&J’s position could have chosen not to maintain rights to the biosimilar manufacturing patents”;
3) “a reasonable company in J&J’s position could have chosen not to assert the biosimilar manufacturing patents”;
4) “a reasonable company in J&J’s position could have licensed the biosimilar manufacturing patents to ustekinumab biosimilar makers without also negotiating delayed market entry”; and
5) “J&J could have chosen to license or divest the biosimilar manufacturing patents to another party.”
J&J argued that each option provided by Clark should be excluded because, generally, they “amount to nothing more than conclusory assertions,” are “unsupported by any methodology,” and would not help the jury because Clark provided options other than “asserting” the Momenta patents yet Plaintiffs have expressly disavowed any challenge to J&J’s assertion of these patents.
The Court is unpersuaded by J&J’s arguments for excluding Clark’s first opinion and the five options he provides therein. Clark is an experiential expert, so his over thirty years of experience provides a foundation for understanding the business incentives around patent ownership and divestiture.
C. Clark’s Second Opinion
As for his second opinion, Clark opined that “biosimilar manufacturers could have obtained FDA approval and launched with labels that carved out ulcerative colitis treatment as covered by the ‘307 patent.”
J&J challenges Clark’s second opinion on the following two grounds: (1) because Clark is not a lawyer, he is unqualified to opine the legal risks of using a labeling carve-out, thereby making his opinion mere speculation; and (2) Clark utilized no specific methodology to conclude that skinny labels could avoid infringement, instead basing his opinion on the fact that the FDA has approved biosimilars with labeling carve-outs in the past.
According to the Court, Clark applied a reasoned, experience-based methodology to answer a business and regulatory question, not a legal one. Any concern that J&J has with his conclusions goes to weight, not admissibility.
J&J’s arguments for the exclusion of Clark’s second opinion mischaracterize the nature of the opinion as well as the methodology applied. First, Clark did not purport to offer a legal opinion about patent infringement or to assess the ultimate “legal risks” of labeling carve-outs, an issue he appropriately acknowledged during his deposition would be addressed by patent counsel.
Here, Clark offers an opinion squarely within his expertise: whether, as a matter of regulatory practice and business risk, reasonable biosimilar manufacturers would have viewed a launch under a labeling carve-out as a viable strategy notwithstanding the ‘307 patent.
Second, Clark’s opinion rests on a sufficiently reliable methodology. His report devotes substantial analysis to the history and mechanics of labeling carve-outs, the FDA’s guidance encouraging such practices, and the real-world experience of biosimilar and generic manufacturers launching under a labeling carve-out.
D. Clark’s Third Opinion
As for his third opinion, Clark opined that “absent the allegedly anticompetitive behavior, there would have been no patent-related barrier to earlier availability of ustekinumab biosimilars.”
J&J challenged Clark’s third opinion as conclusory, arguing that it should be excluded because (1) Clark is not an expert in the pertinent art of biosimilar manufacturing and thus is unqualified, and (2) Clark did not conduct any analysis that would allow him to conclude whether biosimilar manufacturers faced patent-related barriers to entry.
The Court held that Clark’s third opinion concerning patent-related barriers to biosimilar entry is appropriate expert testimony because it does not purport to resolve questions of patent infringement but instead offers an industry-based assessment of the patent landscape absent the alleged misconduct. First, Clark does not opine whether any biosimilar would infringe particular patent claims or analyze biosimilar manufacturing methods—tasks that would require the legal or technical expertise he does not claim to possess. Rather, his opinion is limited to whether, during the relevant period, any patents other than those challenged here would have presented a practical barrier to biosimilar entry once FDA licensure was obtained. Where the record shows that no other unexpired Stelara patents could have delayed competition, Clark’s expertise in pharmaceutical markets is sufficient to support that conclusion.
Second, Clark’s opinion is reliable and is not, contrary to J&J’s argument, unsupported ipse dixit. He grounds his analysis in contemporaneous evidence, including J&J’s own statements, litigation positions, and employee testimony describing the scope and significance of the relevant patents.
E. Clark’s Fourth Opinion
As for his fourth opinion, Clark opined that a “reasonable company in J&J’s position would have launched an ‘authorized biologic’ if only one biosimilar had entered the market following expiration of the ‘734 patent.”
J&J argued Clark’s fourth opinion is (1) not reliable because Clark merely recites record evidence in concluding that J&J would have launched an authorized biologic version of Stelara, and (2) not helpful for the jury because reciting the facts of a case without any analysis does nothing to assist the jury.
Regarding reliability, Clark does not merely summarize J&J’s internal materials. Rather, he synthesizes those materials with his extensive experience in pharmaceutical markets and his review of industry literature to explain why, under well-understood competitive dynamics, a reasonable company in J&J’s position would have had strong incentives to launch an authorized biologic if only a single biosimilar entered the market in September 2023.
Accordingly, because Clark explained the rationale behind his conclusions and applied his specialized knowledge to interpret complex business records and competitive incentives, the Court held that his testimony will help the jury understand when and why companies launch authorized biologics.
F. Due Diligence Process
Finally, the parties disagree over whether the opinions Clark offers in his rebuttal expert report concerning the Momenta acquisition due diligence process are supported. In his rebuttal report, Clark opined that, through its pre-acquisition diligence process, “J&J could draw a connection between [the Momenta manufacturing patents] and the potential to delay follow-on versions of Stelara from reaching the market” at the time it acquired Momenta.
J&J challenged Clark’s opinions about the Momenta acquisition due diligence process as speculative and unsupported.
In response, CareFirst argued that Clark’s opinions on the Momenta acquisition due diligence process are admissible because they are grounded in extensive contemporaneous evidence showing that a reasonable company in J&J’s position could have been prompted to investigate these patents during due diligence.
The Court agreed with CareFirst: J&J’s objections to Clark’s opinions regarding the Momenta acquisition due diligence process go to weight, not admissibility, and are therefore appropriate for cross-examination rather than exclusion. Clark’s rebuttal opinions are grounded in record evidence, and they address what a reasonable company in J&J’s position could have discerned or investigated during the pre-acquisition due diligence process.
Held
The Court denied J&J’s motion to exclude the testimony of Todd Clark.
Key Takeaway:
By explaining what a reasonable company could have done instead of the challenged conduct, Clark’s testimony helps the jury understand the competitive landscape and the range of options available to companies in J&J’s position. As CareFirst notes, Clark does not opine whether a reasonable company in J&J’s position “would choose a particular option, but rather that there were multiple rational business options available” and that “none of those options would unlawfully delay biosimilar entry.”
Thus, Clark’s testimony provided helpful context for the jury to evaluate whether the challenged conduct was exclusionary, and any risk of confusion can be addressed through cross-examination rather than exclusion.
Case Details:
Case Caption:
Carefirst Of Maryland, Inc., Et Al. V. Johnson & Johnson, Et Al
Allstate insured L&J Home Improvements, LLC (“L&J”), which was owned and operated by Julie and Luis Hernandez. In or around 2003, L&J purchased a two-story, wood frame residence built in 1888 that is located at 231 N. Walnut St. in Colorado Springs, Colorado (the “residence”). After the purchase, L&J performed a remodel on the residence in or around 2006. The remodel included an updated electrical system and fixtures.
As part of the remodel, an electrical contractor installed three identical bathroom exhaust/ventilation fan/lights (“fan units”). One fan unit was installed in the upper-level half bath, one fan unit was installed in the lower-level bathroom, and one fan unit was installed in the upper-level bathroom.
A resident, who shared the upper-level bathroom where the fan was located, said that the fan was often left on after bathroom use and the fan had begun to make a noise when turned on several weeks before the incident.
A fire occurred in the residence the evening of February 25, 2021 (the “incident”). The Colorado Springs Fire Department (the “CSFD”) conducted an investigation. The CSFD considered the fan as an ignition source.
Defendant Broan-Nutone manufactured and sold the fan. When the fan was manufactured in the fall of 2005, Broan-Nutone considered itself subject to the following certification requirements created by Underwriters Laboratories (“UL”).
Allstate brought claims against Broan-Nutone for strict product liability, negligence, breach of the implied warranty of merchantability, and breach of the implied warranty of fitness.
On February 9, 2024, Broan-Nutone provided Allstate with its expert disclosures. It listed David Farchione as a non-retained expert who did not need to provide an expert report. Plaintiff filed a motion to exclude the testimony of Farchione.
Product Development Expert Witness
David Farchione has a bachelor’s in engineering from the Milwaukee School of Engineering, where he graduated and entered the workforce in 1996 working for UL in relation to UL product certifications.
Farchione gained experience in product development, design, manufacture, and failure analysis during his four years working for UL and approximately fifteen years working for Broan. During his career, he has worked in engineering and consulting regarding certifications obtained from UL, which includes certifications specific to exhaust fans, like the Model Fan.
Allstate challenged Farchione’s qualifications to provide an expert opinion that the fan was not defective. Allstate argued that Farchione’s only basis for opining that the fan is not defective is that it is UL certified and that it was designed, built, and evaluated by engineers.
Broan-Nutone did not assert that Farchione was involved in the design, manufacturing, or evaluation of the fan, either through Farchione’s work at UL or his work at Broan-Nutone.
Allstate did not contest Farchione’s qualifications to testify about the UL certification process and how it works, given his experience working at UL and his experience at Broan-Nutone with UL product certification. However, the issue is whether Farchione’s experience with UL certifications allows him to express opinions, drawn only from the UL certification process, that the fan was not defective. The Court found that for Farchione to testify that the fan at issue in this case was not defective would go beyond the “reasonable confines of his subject area.”
Neither Broan-Nutone in its response, or Farchione in his deposition, has explained why Farchione’s UL knowledge allowed him to opine that the fan at issue in this case had no defect. For instance, Farchione did not state that the UL documentation for the fan involved testing for design defects or manufacturing defects.
The Court found that Broan-Nutone has not explained why Farchione is qualified, solely based on his knowledge of the UL certification process, to bridge the gap between a product being “UL certified” and the product being “not defective” without any examination or testing of the fan at issue.
Methodology
Allstate also argued that Farchione’s opinion that the fan was not defective should be excluded because he lacked a reliable methodology for his conclusion.
As the Court has already noted, Farchione did not conduct any testing or evaluation of the fan. As a result, he applied no testing methodology in opining that the fan is not defective. Moreover, neither Farchione nor Defendant identified any methodology that he applied in concluding that, because the fan was UL certified and was designed by engineers, it is not defective.
Allstate challenged the basis for Farchione’s opinion that the fan was “fit for sale,” a conclusion which Farchione reached based on the fact that “[t]here’s been ultimately millions of these [fans] sold over the years. And there’s not any huge issues with these particular problems — or these particular products.” When Allstate asked Farchione to provide more specific figures regarding the number of problems with this model of fan, he stated that “I don’t know how many exactly, but it’s, you know, tens.”
As a result, the Court found that Farchione’s testimony about sales data is not admissible. First, Broan-Nutone failed to establish that data given to Farchione by his (or the Defendant’s) attorneys constitutes the kind of data that would reasonably be relied upon by experts on product defects. Second, Farchione did not identify any other source of data he relied upon. Thus, Farchione’s opinion that the fan is fit for sale, insofar as that opinion relied on sales data, lacked a factual basis.
Held
The Court granted in part and denied in part the Plaintiff’s motion to exclude the testimony of David Farchione.
Key Takeaway:
Farchione was not allowed to testify that the fan was not defective based on the fan’s UL certification or because sales data showed that there were few complaints about the fan.
The Court is not required to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert and may conclude that there is simply too great an analytical gap between the data and the opinion proffered.
This suit arises from a motor vehicle accident that occurred on September 7, 2018, in Vinton, Louisiana. Plaintiffs alleged that Billy Smith was operating a 2016 Kenworth T880 while traveling westbound on Interstate 10 on that date.
The vehicle was outfitted with Chinese-manufactured steel belt radial truck tires, distributed by CMA under the trade name “Double Coin tires.” The accident occurred when Smith’s tires suffered a catastrophic tread/belt separation, overturning the vehicle and severely injuring Smith. Smith passed away on September 4, 2021, and his surviving spouse and four adult children were substituted as Plaintiffs.
Defendants sought to introduce testimony from tire failure expert Joseph L. Grant. Plaintiffs filed a motion to exclude that testimony under the standards set forth in Federal Rule of Evidence 702 and Daubert.
Tire Expert Witness
Joseph Lawrence Grant possesses over thirty years of experience as a forensic tire analyst, along with over fifty years of experience in the tire industry. He has held multiple managerial and directorial positions during his employment with tire manufacturing companies and has been published several times.
Plaintiffs contended that Grant’s testimony is unreliable because: (1) he did not review the tire’s design or manufacturing specifications, (2) there is little evidence supporting his theory of impact damage causing the tire’s failure, and (3) he failed to exclude possible alternative causes.
Review of design and manufacturing specifications
A physical examination of both the tire and its companion tire, as well as each tire’s wheel, allowed Grant to form his opinion on why the tire failed. If the cause of the tire’s failure can be diagnosed through physical examination, the Court held that reviewing the tire’s specifications may not be necessary. In other words, Grant’s findings are not unreliable simply because he reached them without reviewing certain documents.
Challenges to Grant’s impact damage theory
Grant opined that an earlier impact weakened the tire’s durability, and subsequent use of the then damaged tire eventually caused it to fail, leading to the accident at issue.
The Court found Grant’s opinion to be supported because under the Examinations section of his report, Grant observed several detached steel belts and rusted steel cords on the tire. He reasoned that the steel belt detachments resulted from an impact to the tire, which was left either unrepaired or improperly repaired. The steel cords, then left exposed, were able to rust, severely weakening the tire. After prolonged use, the tire ultimately failed.
Grant noted that, upon a physical examination, the steel cords were not faulty and were in line with industry standards. Moreover, Grant observed many penetrations within the tire’s tread, indicating that it “had been used in service [in areas] where the tire was subjected to conditions” that would likely cause impact damages to occur.
The Court found fault with Plaintiffs’ assertion that Grant could not identify what caused the impact considering Grant did identify the impact object as having “an [approximately] half-inch diameter.”
While any number of potential impact objects could possess a similar diameter, it is reasonable that an expert like Grant could diagnose impact damage as the cause of a tire’s failure but be unable to identify the particular object that impacted the tire.
Besides, Grant cited several academic papers and guides as authorities supporting his conclusions. Grant listed the case-specific materials he reviewed when forming his opinion. Among them are his physical examination of the tire, companion tire, and their wheels; x-rays and photographs of the tire; the accident report; and Plaintiff’s responses.
Challenges to Grant’s failure to consider alternative causes
Finally, Plaintiffs argued that Grant failed to exclude other potential causes of the tire’s failure. In his report, Grant excluded a design or manufacturing defect from having caused the tire’s failure. He found that the tire complied with federal regulations and industry standards, because it had been tested and stamped. Grant explained that, in order to be sold, all tire must “pass a series of durability standards,” including strength and endurance tests. The subject tire was properly stamped as having passed those tests.
Furthermore, Grant referred to a 2005 NHTSA publication, which stated that “design and manufacturing defects are extremely rare,” because the tire industry has committed decades of research to ensuring functional, defect-free products. Noting this, Grant determined that neither a design or manufacturing defect could have caused the tire’s failure and excluded both as alternative causes. Therefore, the Court found no basis for excluding Grant’s testimony.
Held
The Court denied the Plaintiff’s Daubert motion to exclude the testimony of Joseph L. Grant.
Key Takeaways:
Grant’s findings are not inaccurate simply because he reached them without needing to review certain documents. The Court held that any challenge to his conclusions on this ground is more appropriate for cross-examination.
The Court held that Grant’s finding of impact damage as the cause of the tire’s failure was a reasonable conclusion.
On October 1, 2021, Tate Parker purchased a Tricam Industries, Inc. Gorilla articulated extension ladder (Model GLMPXA-14) from Home Depot in Opelika, Alabama. On February 14, 2022, Parker was injured while using his Tricam ladder to access a residential roof for an insurance-related inspection. At the time of the accident at issue, his job duties included inspecting residential roofs that had endured storm damage.
Parker filed suit against Tricam on January 22, 2024, claiming the ladder was defectively manufactured and designed.
Parker identified an expert witness, Barton C. Prorok, Ph.D., to speak to the issue of the cause of the ladder collapse. Prorok opined that the ladder collapsed because one of the upper side rails was twisted, which allowed a rail lock rod to slip out of the locking hole and the ladder to retract with Parker on it.
Tricam filed a motion to exclude the expert testimony of Prorok, attacking his qualifications given his lack of experience in the ladder industry and attacking his methodology which Tricam argued was unreliable, unscientific, and unhelpful.
Materials Science Expert Witness
Barton C. Prorok, Ph.D., is a materials engineer, metallurgist, and chair of the materials science and engineering department at Auburn University.
He holds a Ph.D. in Materials Science and Engineering from the University of Illinois at Chicago. At Auburn University, he also serves as Director of the Analytical Microscopy Cost Center.
Prorok’s opinions stem, first, from his observation that one of the rails on the subject ladder was twisted upon post-accident inspection. From there, he posits there was a defect in the manufacturing process that caused an upper rail to twist and become distorted. He also believes there is a design defect in the length of the rail lock rods that allowed the rail lock rods to disengage because of the single twisted rail. The combination of the two defects, according to Prorok, caused both upper rails to slip, the upper ladder portion to retract, and the ladder to collapse and fall to the ground.
To begin with, Prorok visually inspected the subject ladder, took measurements, purchased an exemplar ladder for comparison, inspected the site of the accident, and considered eye-witness accounts from Parker and the son of the homeowner.
Analysis
The Court held that Prorok provided no evidence that ladder manufacturers rely on visual inspections or caliper measurements to assess ladder defects. He did not explain how his measurements led to a scientifically reliable methodology. He never conducted tests to determine whether those measurements constituted a defect or unreasonable danger, or caused the ladder collapse. Further, Prorok provided no insight or information supporting his opinion that there was a manufacturing defect that caused the collapse.
Moreocer, he provided no information or opinions about why that twisting could not have occurred for other common sense reasons such as during the ladder’s transit from China to the United States before sale, or during Parker’s storage, and use of the ladder for months on over 100 occasions, or because of the accident itself.
And as to the design defect, Prorok opined that the length of the rail lock rods “is a design flaw that reduces load-carrying capacity, especially when manufacturing variations or normal wear and tear occur.” However, he did not explain what those “manufacturing variations” may be, or what impacts to the ladder there may be from “normal wear and tear.”
As for Prorok’s opinions that the twisting was caused during the metal deformation stage of the manufacturing process, the Court found no evidence about the metal deformation process.
Nor is there any evidence explaining how the upper part of the ladder, post-accident, was observed to be in the fully extended position while the bottom portion was fully retracted if the accident occurred in the manner that Prorok claims it did.
Held
The Court granted Tricam’s motion to exclude the expert testimony of Barton Prorok.
Key Takeaway:
Prorok did not produce any literature, reports, or other documentation to support his contention that the accident occurred in the manner that he claims it did. And he tested none of his opinions. Indeed, he performed no testing to duplicate the conditions or manner in which he claims the collapse occurred.
Roger and Reuki Schutt (the “Schutts”) are the owners of a house located at Canton, Massachusetts. On April 24, 2019, the house sustained water damage resulting in the payment of insurance benefits by Safety to the Schutts. The water damage was determined to have originated from a leak in a water filter system manufactured and sold by EcoWater under the tradename Northstar.
On October 23, 2019, the filter system was examined at a joint inspection by experts for both EcoWater and Safety. The sump was observed to have a “throughwall crack extending the entire length of the housing,” as well as “additional cracks.” EcoWater did not use annealing in the production process for its clear sumps. Post-mold annealing is the process of cooling a mold-injected polymer after manufacture.
On April 4, 2022, Plaintiff Safety Insurance Company (“Safety”) filed suit in Massachusetts Superior Court against Defendant EcoWater Systems, LLC (“EcoWater”), asserting its right of subrogation arising from water damage to the property of Roger and Reuki Schutt.
Safety disclosed two experts in support of its case: (1) “appliance failure inspector” expert Thomas Zarek and (2) materials science expert Timothy Kenney.
Zarek opined that the product failed prematurely at the loss location and caused the water damage while Kenney concluded that it was common practice to post-mold anneal these thick wall parts to reduce these residual stresses and improve the performance of the part.
EcoWater filed motions in limine to exclude the opinions and testimony of Thomas Zarek and Timothy Kenney under Rule 702.
Appliances Expert Witness
Thomas Zarek has been employed as an appliance failure inspector since 1997. Regarding his areas of expertise, Zarek holds himself out as a warnings expert, a certified fire and explosion investigator, a certified vehicle fire investigator, and a licensed oil heating inspector and installer. Also, he has taken “a number of courses on appliance failure analysis and on HVAC systems installation,” covering a variety of appliances and materials, including polymers and metals.
Timothy Kenney’s qualifications and experience include a degree in geology, undergraduate engineering courses in materials science, graduate courses in metallurgy, ceramics, and selection of steels, and various publications. Besides, he serves as the Laboratory Director of New Hampshire Materials Laboratory.
NHML provides consulting and technical services in chemical, materials, mechanical design, and industrial processing.
To begin with, Safety’s complaint claimed negligence and breach of warranty based solely on defective manufacture of the filter system. Therefore, the Court held that Zarek’s opinions as they relate to other theories of negligence, such as failure to reasonably warn or defective design, are irrelevant since any expert testimony must therefore be limited to establishing the manufacturing defect claim.
Zarek testified that his conclusions regarding the filter system’s allegedly premature failure are based, at least in part, on his review of EcoWater’s Test ID 4499, which tested canisters similar to the subject sump through a cycle test and hydrostatic test. Yet, the Court found that Zarek himself admitted that he has never performed a cycle test himself for any kind of product and that he does not know what cycle testing is intended to evaluate. As for the hydrostatic testing, Zarek likewise testified that he has never conducted a hydrostatic test on a polymer product or on the styrene acrylonitrile (“SAN”) material used in the subject product, and that the purpose of a hydrostatic test is not to test to failure.
The Court held that Zarek’s lack of relevant experience and knowledge pertaining to the claims alleged makes clear that he is not qualified to offer expert testimony here.
Second, the Court held that Zarek’s opinions reflected little to no expert analysis or review done by Zarek. Several of his proffered opinions merely repeated Kenney’s conclusions, without adding anything more. He stated that he personally did no analysis of the data from the testing performed by Kenney.
Timothy Kenney
In opining that post-mold annealing is a “general industry practice,” Kenney exclusively relied on the ASM International Volume 2 of the Engineered Materials Handbook. The Court held that Kenney himself undermined the relevance of this guidance where he testified that there is a difference between thick-section and heavy wall parts, that the subject sump is a thick-section part, and that the ASM handbook only recommends post-mold annealing for heavy-wall parts and not thick-section parts.
Also, he conceded that he did not conduct any testing to evaluate the effects of post-mold annealing on the product and whether such annealing would have alleviated residual stress, nor has he seen any studies or test reports to that effect.
Moreover, EcoWater also filed a motion for summary judgment seeking to dismiss the case entirely. The Court held that where Safety has no expert support for its claims—which, again, arise exclusively from allegations of negligent manufacture—Safety’s claims cannot survive summary judgment.
Held
To sum it up, the Court granted EcoWater’s motions in limine to exclude Plaintiff’s experts, Thomas Zarek and Timothy Kenney as well as his motion for summary judgment.
Key Takeaway:
In conclusion, the Court held that many of Zarek’s opinions reflected little to no expert analysis or review done by Zarek. While Zarek’s opinions were irrelevant to Safety’s claims regarding negligent manufacture of the filter system, Kenney had no basis to opine as to whether post-mold annealing would have prevented the subject product from failing here, after fourteen years of use.
Case Details:
Case Caption:
Safety Insurance Company Et Al V. Ecowater Systems, Llc
A district judge in Alabama excluded the testimony of the firearms & ballistics expert because he did not offer any evidence to show any of the alleged dangerous conditions in order to support the product liability claims.
Plaintiff James Andrew Scott, II filed a complaint against Remington Arms Company, LLC (“Remington”) alleging that defects in the trigger mechanism for a Remington Model 770 bolt-action rifle caused it to fire unexpectedly, resulting in the death of his daughter, Alyssa Brooke Scott.
On November 13, 2017, 15-year-old Alyssa and her godmother Christal Davis went deer hunting together. After Alyssa and Davis decided to end the hunt, Davis closed the rifle’s bolt and tied a nylon rope through the trigger guard to lower the rifle to Alyssa. Davis testified that she tied the rope behind the trigger and made sure there was no slack in the knot. Alyssa told Davis that she turned on the rifle’s manual safety switch before she handed over the gun, but Davis does not remember personally checking the position of the safety before she began to lower the rifle from the deer stand.
Davis lowered the rifle with the muzzle pointing down and the rope fastened through the trigger guard. About halfway down, the gun fired and the bullet struck and killed Alyssa.
Before the Court is Remington’s combined motion to exclude the opinions of Plaintiff’s proffered liability expert, Jerry Morris and motion for summary judgment.
Firearms & Ballistics Expert Witness
Jerry Morris has been a gunsmith for 51 years and has worked on hundreds of makes and models of firearms, serviced over 10,000 firearms,” and taught classes on gunsmithing. His expert report represented that he “had extensive knowledge and experience with the Remington 770 rifle, and the trigger system in particular.”
Remington argued that Morris’ affidavit is a violation of Rule 26 since it was untimely under the existing scheduling order and consisted of new reasoning and opinions.
The Court held that Scott “was not allowed to use [the Morris affidavit] to supply evidence on a motion, at a hearing, or at a trial, unless the failure was substantially justified or is harmless.”
But Scott did not argue that the failure to timely disclose this evidence was substantially justified or harmless, despite being given the opportunity to do so. Instead, Scott stuck to his argument that the evidence was an expansion or elaboration of Morris’ previous testimony, which the Court rejected.
The Court held that the affidavit did not qualify as a supplementation under Rule 26(e) because it went well beyond correcting or completing inaccuracies or omissions in the original expert report.
Rule 702
Remington challenged all of Morris’ opinions. First, Remington contended that he was not qualified to offer his defect opinion and that this opinion was not based on any reliable method-based testing, literature, observations, or experience. Second, Remington argued that Morris’ causation opinion was not supported by any testing, the evidence in this case, or his personal experience.
1. Qualification
Morris based his opinion on the manufacturing process of the Model 770’s trigger and sear. He claimed that Remington uses “inferior powdered metal in the components of the trigger system” and that the rough sear contact was unpredictable and inconsistent.
The Court held that Morris may know a lot about guns, but there is no evidence that he ever investigated or studied the materials in the Model 770 trigger mechanism. He has not designed any fire controls or fire control components and has not reviewed any manufacturing or design records related to the Model 770 rifle. In fact, he admitted that he has only repaired two 770 rifles and cleaned about a dozen in his long history as a gunsmith. And as to this particular gun, he did not measure the sear engagement or contact points between the trigger and sear since he did not have the proper tools. In other words, Morris was not qualified to offer an opinion on the metallurgical properties or design process of the trigger or sear in the Remington Model 770 rifle.
2. Reliability
The Court held that even if Morris had the qualifications to offer his opinions, they would fail the reliability prong of the Daubert inquiry.
To begin with, Morris did not provide any measurements or objective observations of rough contact points or surfaces between the sear and trigger in the rifle at issue here. In fact, he admitted that he did not have the tools to measure them. Likewise, when Morris offered the opinion that the low and inconsistent trigger pull forces he documented resulted from a chipped trigger or rough contact points between the trigger and sear, his testimony merely assumed the presence of a chipped trigger or rough contact points without any evidence supporting that assumption.
The Court found that Morris did not perform any testing or offer any evidence to show that any of the alleged dangerous conditions—“powdered metal” trigger components, rough sear contact points, a chipped trigger, or inconsistent trigger pull weights—caused the rifle to fire without activating the trigger.
3. Assisting the Trier of Fact
The Court found that Morris’ theory that the gun could have bumped the tree as it was lowered to the ground lacked evidence; instead, the uncontroverted evidence from the single surviving eyewitness is that the gun did not bump the tree.
The Court concluded that multiple portions of Morris’ opinions were not based on facts in evidence, and thus would not assist the trier of fact.
With the exclusion of Morris’ expert opinions, Remington contended that Scott did not offer sufficient evidence to support his product liability claims. The Court agreed and entered final judgment in favor of Remington and against Scott.
Held
The Court granted Defendant’s motion to exclude the opinions of Plaintiff’s proffered liability expert, Jerry Morris.
Key Takeaway:
Morris based his defect and causation opinions on the materials and process Remington used to manufacture the trigger and sear. The Court excluded his opinions because he did not produce any literature, reports, or other documentation to support his contention that the Model 770’s components are inferior to other fire controls using different processes or materials. Importantly, he did not provide any testing, explanation, or other support for his theory that using hardened forged steel would create a more consistent contact point between the sear and the trigger. Instead, there is simply no explanation in the record for the methodology he used in reaching his conclusions. Morris has not designed any fire controls or fire control components and has not reviewed any manufacturing or design records related to the Model 770 rifle.
