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  • Biomedical Engineering Expert’s Testimony on Product Warnings Admitted

    Biomedical Engineering Expert’s Testimony on Product Warnings Admitted

    Connie Thacker is one of tens of thousands of individuals who have filed suit against Ethicon for injuries after treatment with Ethicon’s pelvic mesh devices.

    Defendants filed a motion to exclude or limit certain opinions and testimony of Plaintiff Thacker’s expert, Anne H. Wilson, MBA.

    Biomedical Engineering Expert Witness

    Anne Holland Wilson is a biomedical engineer and quality assurance consultant, holding certifications as a Quality Auditor and Quality Engineer.

    She received a Bachelor of Science in Biomedical Engineering from Vanderbilt University in 1985, and a Master of Business Administration from the University of Colorado in 1991.

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

    Discussion by the Court

    Wilson has been designated as an expert in the field of compliance with quality and risk management standards. She is expected to testify that Ethicon failed to meet the “industry standards” for design control processes and risk management.

    Reliability of Wilson’s Testimony

    The Defendants argued that Wilson’s methodology is insufficient because she (1) should have conducted an audit of Ethicon’s systems; (2) failed to consider applicable U.S. standards while inappropriately basing her “industry standards” testimony on inapplicable European standards; and (3) failed to review all relevant case materials in reaching her conclusions.

    Failure to Audit

    The Defendants did not explain, or offer any authority to explain, how conducting an audit is the only reliable methodology available for reviewing the processes Wilson has been asked to review. To the contrary, the Court held that the methodology Wilson used to arrive at her opinions, which involved reviewing Ethicon’s design and risk control documents and evaluating them within the framework of industry standards, was plainly based on “sufficient facts,” and “reliable principles and methods.”

    As Wilson explained in her report, her role in this case involves “addressing the design control and risk management processes of Ethicon.”

    Failure to Review Appropriate Industry Standards

    The Defendants argued that (1) Wilson should not have consulted standards set by the International Organization for Standardization; and (2) she should have consulted applicable FDA regulations in offering testimony on Ethicon’s compliance with “industry standards.”

    To begin with, no party disputes that particular FDA regulations make up a portion of the universe of “industry standards” for design control and risk management processes in the medical device manufacturing industry.

    The Defendants argued that the standards set by the International Organization for Standardization (which are referred to as “ISOs”), however, are not a part of that same universe. However, Wilson’s report stated the opposite— explaining that ISOs were “[t]he primary standards applicable” to Ethicon’s quality and risk management systems at the time Ethicon developed the at-issue devices. She also explained during her deposition that applicable ISOs and FDA regulations are very similar.

    It should be noted that the Defendants failed to offer any evidence or authority stating that ISOs are irrelevant to medical device manufacturers in the United States. Moreover, Wilson’s failure to consider applicable FDA regulations during her review of this case did not render her testimony unreliable. Basically, Wilson plainly opined that ISOs were “[t]he primary standards applicable” to Ethicon’s quality and risk management systems. Because ISOs provided “appropriate validation” for her testimony on Ethicon’s compliance with industry standards, the Court found Wilson’s “industry standards” testimony reliable.

    While Wilson’s testimony may be offered to help define the contours of the duty of care for her common law negligence claim (and for other relevant purposes), such testimony shall not equate compliance or non-compliance with satisfaction or dereliction of the duty of care.

    Failure to Review all Case Materials

    The Defendants first contended that Wilson inappropriately offered “medical opinions” throughout her report. The Defendants did not specify which of Wilson’s opinions are “medical opinions” but rather just cited a page range of Wilson’s report which they argued is “replete” with such opinions.

    Without more specific objections, the Court declined to conduct a line-by-line analysis of the page range cited to determine which of Wilson’s opinions are medical opinions. However, the Court did agree that medical opinions are beyond the scope of Wilson’s qualifications and should be excluded.

    The Defendants finally argued that Wilson’s testimony regarding Ethicon’s Instructions for Use (“IFU”) on the TVT-S device should be excluded. Specifically, the Defendants argued that Wilson is unqualified to offer testimony on IFUs. Wilson is expected to testify that Ethicon’s failure to adequately address certain risks in the TVT-S’s IFU was “a violation of industry practices and international standards.”

    The parties seemed to agree that issues with IFUs relate to risk assessment in the general sense. And the Defendants did not challenge Wilson’s qualifications to testify as an expert on risk assessment. Accordingly, it was apparent to the Court that testimony concerning IFUs directly relates to Wilson’s area of expertise.

    As such, the Court found that Wilson’s familiarity with risk assessment processes in the medical device manufacturing context provides her with sufficient knowledge on IFUs to assist the trier of fact to at least some degree. Wilson is therefore qualified to offer opinions regarding product warnings as a fundamental part of the risk management process in the medical device industry.

    Held

    The Court granted in part and denied in part the Defendants’ motion to exclude or limit the testimony of Plaintiff Connie Thacker’s expert, Anne Wilson, MBA.

    Key Takeaway:

    The Court recognizes that just because Wilson is an expert in one area “does not ipso facto qualify her to testify as an expert in all related areas.” But ultimately, Rule 702 takes a liberal approach to expert witness qualification in that the degree of ‘knowledge, skill, experience, training, or education’ sufficient to qualify an expert witness is only that necessary to ensure that the witness’s testimony ‘assist’ the trier of fact to any degree.

    Please refer to the blogs previously published about this case:

    Urogynecology Expert Witness Testimony about inadequate risk disclosure admitted in medical device product liability action

    Obstetrics and Gynecology Expert’s Testimony on Mesh Porosity and Stiffness Admitted

    Urogynecology Expert’s Opinion on Continuum of Care Admitted

    Obstetrics and Gynecology Expert’s Opinion Regarding the Common Knowledge of Pelvic Surgeons Admitted

    Case Details:

    Case Name: Thacker V. Ethicon Inc.
    Docket Number: 5:20cv50
    Court Name: United States District Court, Kentucky Eastern
    Order Date: July 21, 2025
  • Obstetrics Expert’s Testimony on Brain Damage Limited

    Obstetrics Expert’s Testimony on Brain Damage Limited

    Elizabeth Reyes and her minor daughter G.T. sued the United States, Bronx Lebanon Hospital Center, BronxCare Health System, and two doctors over G.T.’s permanent medical conditions, which the Plaintiffs alleged were caused by mistakes made during Reyes’ labor and delivery and G.T.’s neonatal care.

    The Bronx Lebanon Defendants filed a motion to preclude Plaintiffs’ obstetrics expert, Dr. Daryl K. Boffard; Plaintiffs’ anesthesiology expert, Dr. Alexander E. Weingarten; and Plaintiffs’ pediatric neurology expert, Dr. Louis N. Manganas. The United States filed a motion to preclude Drs. Boffard and Manganas.

    Plaintiffs opposed these motions, and for the most part, they satisfied their burden to demonstrate the admissibility of their experts’ testimony under Rule 702 and Daubert. Despite their efforts, the Plaintiffs fell short in backing a few specific opinions.

    Obstetrics and Gynecology Expert Witness

    Dr. Daryl Keith Boffard, M.D., FACOG has been practicing Obstetrics and Gynecology Medicine in the New York metropolitan area since 1981 when he received his medical degree from the University of Medicine and Dentistry in Newark, NJ.

    He was board certified by the American Board of Obstetrics and Gynecology in 1987. Following his residency, he has been the Medical Director at Jersey GYN Associates from 1987 to present date.

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

    Anesthesiology Expert Witness

    Dr. Alexander Eugene Weingarten, M.D., PC is a physician licensed to practice medicine and surgery in the state of New York and board certified in the medical specialty of anesthesiology.

    He became board certified by the American Board of Anesthesiology in October of 1984 and has remained board certified ever since. He limits his practice to the field of anesthesiology. He received his medical degree from S.U.N.Y. Upstate Medical Center in Syracuse.

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

    Pediatric Neurology Expert Witness

    Dr. Louis Nicholas Manganas, M.D., Ph.D. is a pediatric neurologist who specializes in treating a wide range of neurological conditions in children, including hypoxic ischemic encephalopathy, intracerebral hemorrhage, central nervous system infections, developmental delays, and epilepsy.

    After completing his clinical fellowship in Epilepsy at Yale, he joined the Department of Neurology at Stony Brook as faculty. He is currently the Chair of the Department of Neurology at the NYU Grossman Long Island School of Medicine.

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

    Discussion by the Court

    Daryl Boffard

    First, Boffard opined that G.T.’s delivery process caused “cerebral palsy and hemiplegia.” The United States argued that Boffard isn’t qualified to offer an expert opinion on the causes of G.T.’s neurological conditions.

    While Plaintiffs responded that “any person has the knowledge that having an interruption of oxygen for forty-five minutes can damage the brain,” and that “[t]here is nothing unreliable about Plaintiffs’ experts’ theories . . . that the failure to deliver or resuscitate . . . was a substantial contributing factor to the brain damage,” Boffard himself admitted that he’s “not qualified to offer an opinion as it relates to pediatric neurology.”

    However, Boffard’s causation opinion goes beyond merely explaining brain damage; it focuses on specific pediatric neurological conditions that Boffard expressly stated he is not qualified to testify about. So while Boffard may testify that G.T.’s delivery caused brain damage, the Court excluded his opinion that the delivery process caused “cerebral palsy and hemiplegia and the sequelae of these conditions.”  

    Alexander Weingarten

    Weingarten opined that “use of spinal anesthesia . . . was a substantial contributing factor to G.T.’s injuries, including brain damage.”

    The Bronx Lebanon Defendants argued that Weingarten was not qualified to offer a causation opinion in the case. Plaintiffs’ only response was that Weingarten was qualified to opine on the standard of care, but this did not address Defendants’ concern about whether Weingarten was qualified to render an opinion about whether the use of anesthesia caused G.T.’s brain damage. Because Plaintiffs declined to meet Defendants’ critique head-on, the Court deemed this issue conceded. Therefore, the Court excluded Weingarten’s causation opinion.

    Weingarten opined that the use of anesthesia “was a deviation from good and accepted medical practice.” The Bronx Lebanon Defendants argued that this opinion was “speculative and must be excluded” because Weingarten “based his opinions on someone else’s review of the records rather than his own.” Plaintiffs did not respond to this critique in their opposition brief. Consequently, the Court excluded Weingarten’s standard-of-care opinion.

    Held

    The Court granted in part and denied in part the Defendants’ motions to exclude the testimony of Plaintiffs’ experts Daryl K. Boffard and Alexander E. Weingarten.

    Key Takeaway:

    In this case, Plaintiffs declined to meet Defendants’ critique head-on. Numerous courts have held that a Plaintiff’s failure to address an issue in its opposition amounts to a concession or waiver of the argument.

    Case Details:

    Case Caption: G.T. Et Al V. United States Of America
    Docket Number: 1:22cv10901
    Court Name: United States District Court, New York Southern
    Order Date: July 21, 2025
  • Pharmacology Expert’s Testimony About the Purpose and Effect of Illegal Marketing Tactics Excluded

    Pharmacology Expert’s Testimony About the Purpose and Effect of Illegal Marketing Tactics Excluded

    Plaintiff State of Washington alleged that Novo Nordisk Inc. (“NNI”) caused physicians to prescribe its drug, NovoSeven®, to Washington hemophilia patients by: (1) promoting it “off-label” for prophylaxis and “high dose” use; (2) paying kickbacks to physicians; and (3) paying bribes to patients, all of which rendered claims to Medicare and Washington Medicaid false.

    The State of Washington has been investigating this case for almost fifteen years, hoping to find evidence of unlawful conduct that allowed its Medicaid program to recoup money it paid for a medically necessary, life-saving drug.

    Jamie Siegel and Washington State’s expert witness, Dr. Adriane J. Fugh-Berman, opined broadly that NNI’s promotional methods and practices caused physicians and patients to use more NovoSeven, including off-label. NNI filed a Daubert motion to exclude the testimony of Fugh-Berman.

    Pharmacology Expert Witness

    Dr. Adriane J. Fugh-Berman, MD is a Professor of Pharmacology and Physiology with a joint appointment in the Department of Family Medicine at Georgetown University Medical Center.

    She has spent her 35-year academic career researching how pharmaceutical companies market to the medical community, and how that marketing affects the prescription practices of that community.

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

    Discussion by the Court

    To begin with, NNI did not directly challenge Fugh-Berman’s credentials, and it did not argue that she is not an expert in her field. It did emphasize that she self-identifies as an “activist” advocating for “rational prescribing and promoting public health,” and that her opinions have been excluded as irrelevant in other cases.

    NNI sought to exclude Fugh-Berman’s opinions, arguing that she failed to set out sufficient facts and data to support her unreliable analytical methodologies, and failed to reliably apply her principles and methods.

    Discourse Analysis

    NNI specifically challenged Fugh-Berman’s reliance on “discourse analysis” to support her conclusion that NNI’s promotional activities improperly affected prescribing physicians’ judgment when selecting a pharmaceutical to treat a hemophilia patient. Moreover, NNI argued persuasively that discourse analysis was not even mentioned in her Report. The Court therefore precluded any opinion testimony about applying “discourse analysis” unless raised by the defense.

    Patient A’s Use of NovoSeven

    Fugh-Berman has general knowledge from experience and known studies and is qualified to testify generally about physician behavior in prescribing pharmaceuticals, and what can influence that behavior. However, she will not be permitted to testify that NNI’s promotional methods were responsible for “specific increases in the prescribing behavior” of Patient A’s primary physician, Dr. Ronald Louie, or about the effects of the promotions on Patient A. NNI persuasively argued that Fugh-Berman did not review specific “claims data” and “medical records” associated with Patient A’s use of NovoSeven. Fugh-Berman may summarize what benefits the record demonstrates were provided to Louie and Patient A that may have influenced Louie in the way that studies have shown that these types of benefits influence prescription choices. She will not be permitted to testify that these benefits caused Louie to use NovoSeven. This is an ultimate legal conclusion for the jury.

    NNI also objected to Fugh-Berman’s proposed “factual narrative” testimony. It argued that it would be improper for her to offer a speculative editorial about the alleged nefarious global effects of [NNI’s] marketing practices” and its “sway over the medical community” because it is “neither relevant nor reliable.” The Court agreed.

    Fugh-Berman’s report concluded with two paragraphs opining about the purpose and effect of NNI’s allegedly illegal marketing tactics, and specifically about the consequences of the benefits it provided to Louie, Patient A, and his mother. These ultimate conclusions of law are for the jury, and she will not be permitted to so opine. In other words, she cannot characterize the high dosage or prophylaxis use of NovoSeven as “unproven.” She can testify that, generally, based on her experience, scholarship, and training, promotional campaigns have been shown to affect such behavior.

    Held

    The Court granted in part and denied in part NNI’s Daubert motion to exclude Adriane Fugh-Berman’s testimony.

    Key Takeaway:

    No expert shall testify in a form of an advocate editorializing, or present a conclusory narrative akin to attorney argument, rather than as an expert witness.

    Please refer to the blogs previously published about this case:

    Law & Legal Expert Helps Jury Understand Medicaid’s Complex Regulatory Framework

    Hematology Expert’s Opinion on NovoSeven’s Medical Appropriateness Admitted

    Case Details:

    Case Caption: United States ex rel. Siegel V. Novo Nordisk Inc.
    Docket Number: 3:23cv5459
    Court Name: United States District Court, Washington Western
    Order Date: July 16, 2025
  • Law Enforcement Expert’s Testimony on Conspiracy Membership Excluded

    Law Enforcement Expert’s Testimony on Conspiracy Membership Excluded

    The Government charged Xiong Lin with conspiracy to distribute, and to possess with intent to distribute, controlled substances. From approximately May through at least September 2022, Lin allegedly conspired with others—known and unknown—in the District of Massachusetts and elsewhere to distribute cocaine and MDMA.

    Government filed a motion in limine to exclude the testimony of Defendant Xiong Lin’s proposed expert witness, Mr. Craig J. Nicewicz.

    Lin designated Nicewicz to rebut the Government’s anticipated assertion that anyone performing occasional tasks for drug traffickers necessarily knows the scope of the conspiracy. Nicewicz indicated that he has “conducted comprehensive investigations into law enforcement practices, including surveillance tactics, confidential informant reliability, and search and seizure procedures, with a focus on ensuring that Defendants’ constitutional rights are protected.”

    The Government moved to exclude Nicewicz’s testimony on three grounds: (1) Lin’s expert disclosure was untimely and failed to satisfy Rule 16(b)(1)(C); (2) Nicewicz lacked specialized knowledge of drug-trafficking organizations; and (3) his opinions are unreliable and have the potential to confuse the jury.

    Law Enforcement Expert Witness

    Craig J. Nicewicz worked in an administrative or managerial capacity within the United States District Court for the District of Massachusetts for over twenty years.

    When he finally left the Court in 2017, he went on to work as a management analyst for the United States Administrative Office in Washington D.C., where he worked on rewriting nationwide manuals and polices for the U.S. Courts related to staff training and operations within budget constraints. He is currently employed as a private investigator with American Legal Investigative Service.

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

    Discussion by the Court

    Lin contended that Nicewicz’s testimony is necessary to ensure a balanced presentation and prevent the jury from being misled about conspiracy membership.

    The Government first argued that Lin failed to meet the requirements of Federal Rule of Criminal Procedure 16 because his untimely expert disclosure consisted only of a single-page summary and a curriculum vitae omitting any detailed statement of Nicewicz’s opinions, the data he reviewed, or the analytical steps he employed. It next contended that, even if the disclosure were timely, Nicewicz is unqualified to opine on drug-trafficking organizations. Finally, prosecutors warned that admitting Nicewicz’s testimony—lacking methodological rigor—risks confusing the jury.

    Lin conceded that Nicewicz has no specialized training, publications, or peer-reviewed work in the field of narcotics conspiracies and that he only previously testified in a Massachusetts state case as a factual rebuttal witness regarding interviews he conducted. Lin also conceded that Nicewicz has no formal law enforcement training or academic credentials in criminal justice but emphasized his two decades in court administration in the District of Massachusetts and his current work as a private investigator. Nicewicz would not testify about Lin’s specific intent or knowledge, but rather would offer general observations about courier roles in drug cases. Lin maintained that these experiences qualify Nicewicz to challenge the assumption that all couriers knowingly participate in drug conspiracies and that excluding his testimony would permit misleading expert opinions to go unchallenged, risking unfair prejudice.

    Analysis

    The Court held that Nicewicz’s opinions rest on passive observations rather than on the application of reliable principles to case-specific facts. His curriculum vitae reflects career experience in Court administration, not scientific or technical analysis of criminal networks. Lin has provided no information about the particular facts or data Nicewicz reviewed, nor any detailed outline of analytical steps. His private-investigation work offers no recognized methodology for determining when a courier knows the contents of a delivery. Even if he “observed firsthand countless criminal cases,” that passive experience places him at no greater advantage than the factfinder. Nicewicz’s sole state-court testimony merely rebutted witness statements about interviews he conducted, not membership in a drug conspiracy. 

    Held

    The Court granted the Government’s motion to exclude the testimony of defense expert Craig J. Nicewicz.

    Key Takeaway:

    Defense expert Nicewicz was retained to challenge the assumption that all couriers knowingly participate in drug conspiracies. Nicewicz’s opinions were based on his extensive experience in the federal court system, particularly in criminal trials conducted in the U.S. District of Massachusetts, and his experience as a private investigator.

    However, his private-investigation work offered no recognized methodology for determining when a courier knows the contents of a delivery. Even if he “observed firsthand countless criminal cases,” that passive experience places him at no greater advantage than the factfinder.

    Case Details:

    Case Caption: United States V. Feng Chen and Xiong Lin
    Docket Number: 1:22cr10279
    Court Name: United States District Court, Massachusetts
    Order Date: July 18, 2025
  • Neuroradiology Expert’s Supplemental Report Excluded Because It Adds New Opinions

    Neuroradiology Expert’s Supplemental Report Excluded Because It Adds New Opinions

    Plaintiff, Lori Mendez suffered a head injury while she was shopping at a Hobby Lobby store in Reno on June 5, 2021. It all started when she reached for an item on a shelf that was higher up. The shelves were close together and as Mendez grabbed an item off of the lower shelf, the top shelf came unhooked and crashed down on her head.

    Plaintiff filed a motion to to strike the Defendant’s supplemental expert report of Dr. Saman Hazany, MD, DABR.

    Neuroradiology Expert Witness

    Dr. Saman Hazany is an award‑winning, Harvard‑trained neuroradiologist based in greater Los Angeles, with extensive experience in the care of patients with traumatic brain injury, spinal cord injury, stroke, epilepsy, and brain tumor.

    He holds board certification and the Certificate of Added Qualification (CAQ) in radiology and neuroradiology.

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

    Discussion by the Court

    According to the Court’s scheduling order, the deadline for initial expert reports was March 25, 2024. On that date, Hobby Lobby served Plaintiff with its initial expert disclosure, which disclosed Hazany and included his November 22, 2023 initial expert report. That report listed 29 images that Hazany reviewed. On October 8, 2024, Hobby Lobby served Plaintiff with a supplemental report from Hazany, in which he reviewed an additional seven images. It is undisputed that these seven images were available to Hazany at the time of his initial expert report.

    The Supplemental Report was Untimely

    The Defendants did not appear to dispute that the disclosure was untimely. Because the parties agreed that Hazany had access to the seven images at the time of his initial report, the supplemental report was improper under Rule 26(e).

    Striking is Warranted Under Rule 37

    The Defendant primarily argued that sanctions are not warranted because the improper supplemental report was harmless. However, there is no dispute that the Defendants supplemental report reviews seven images not reviewed at all in the initial report. The supplemental report makes findings and conclusions as to several of these images, such as “No CT evidence for traumatic brain injury,” “Other etiologies including traumatic brain injury are unlikely,” and “No post-traumatic findings.”

    In this case, the deadline for rebuttal expert disclosure was May 22, 2024. The Defendants did not serve the supplemental disclosure until October 8, 2024, which was only 15 days before discovery closed. As Plaintiffs pointed out, this meant that Plaintiff’s rebuttal expert had no opportunity to review and rebut the supplement.

    The Court granted the parties multiple extensions of time during the discovery period, including an extension of the rebuttal expert deadline. Moreover, the prejudice cannot be cured when the discovery is closed.

    Held

    The Court granted the Plaintiff’s motion to strike the Defendant’s supplemental expert report of Dr. Saman Hazany.

    Key Takeaway:

    The late disclosure meant that Plaintiff’s rebuttal expert was not able to review and rebut the new conclusions and opinions present in Hazany’s supplemental report. 

    Any risk of prejudice or surprise cannot be easily be cured at this stage.

    Case Details:

    Case Caption: Mendez V. Hobby Lobby Stores, Inc.
    Docket Number: 3:23cv181
    Court Name: United States District Court, Nevada
    Order Date: July 15, 2025
  • Transportation Safety Expert Barred from Offering Opinions on Kent & Smith’s Safety Culture

    Transportation Safety Expert Barred from Offering Opinions on Kent & Smith’s Safety Culture

    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 Dr. Richard W. Carr as an expert in the fields of trucking industry maintenance practices and trucking fleet and driver management standards. Carr offered opinions regarding alleged deficiencies in Smith’s licensure and driving conduct as well as in the maintenance of the vehicle and other practices by his employer, Kent & Smith Holdings, LLC.

    Plaintiffs filed a motion to exclude Carr’s testimony under the standards set forth in Rule 702 and Daubert.

    Transportation Safety Expert Witness

    Richard W. Carr Ph.D., CDS is the principal of R W Carr, Inc., a Risk Management & Safety Consulting corporation based in Jacksonville, Florida, which primarily serves the transportation industry, construction industry, insurance industry, the legal profession, and the U.S. Government.

    He has also worked as a Special Investigator and Accident Investigation Specialist for the Federal Motor Carrier Safety Administration. He has specialized training from the Federal Motor Carrier Safety Administration, Environmental Protection Agency, Penn State University, Northwestern University, Kennedy Western University, Georgia Tech, the National Nuclear Security Administration, and others.

    Carr holds a Ph.D in Safety Engineering and has served as an expert witness in several cases over the last four years.

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

    Discussion by the Court

    Richard Carr

    Plaintiffs did not challenge Carr’s qualifications but instead maintained that he lacked an adequate basis for the following opinions: (1) Billy Smith was not properly licensed at the time of the incident and failed to report vibrations in the steering wheel; (2) Kent & Smith lacked an adequate preventative maintenance program given their operational conditions; (3) Kent & Smith improperly allowed a plugged tire to remain in use; (4) Kent & Smith failed to retain and secure documentation post-accident relating to the subject vehicle and Smith; and (5) Kent & Smith’s alleged carrier violations four years after the accident are evidence of a culture of committing carrier violations around the time of the accident.

    Smith’s Licensure and Failure to Report Steering Wheel Vibrations

    In his deposition Carr opined that he “did not believe Smith had a valid CDL driver’s license at the time of this accident” because the copy contained in his Kent & Smith driver record had an expiration date of September 5, 2018, with no indication of renewal. Carr admitted, however, that he could not say one way or another whether the license had been renewed and that he had made no independent attempt to verify renewal. In response, Plaintiffs showed that a Class A CDL was issued to Smith on June 18, 2018, with expiration date of September 05, 2024.

    Defendants maintained that Carr nonetheless had an adequate basis to reach his conclusion on Smith’s license status, based on the contents of his Kent & Smith driver’s record. Even if Smith was properly licensed at the time of the accident, the fact that his employer’s records indicated he was not may fall short of the standard of care. Further, they complained that the valid driver’s license is not Bates-stamped and was never produced in discovery.

    The Court agreed that the record provided an adequate basis for Carr to opine that there was no evidence in Kent & Smith’s files at the time of the accident that Billy Smith was properly licensed.

    Plaintiffs argued that Carr assumed based on defense expert Michael Grima’s report that the steering wheel was vibrating and then further assumed from the lack of documentation that Smith felt these vibrations and failed to report them.

    The Court found that Carr is adequately qualified to opine on not just if but how Smith should have reported this effect—by formally recording it in his inspection reports. As he noted, the purpose of the reports was to identify issues so that they could be repaired.

    Inadequate Preventative Maintenance Program

    Carr also criticized Kent & Smith for failing to maintain an adequate preventative maintenance program. He based his assumptions about the lack of adequate maintenance on the extent of wear and tear visible on the tires in photographs. He could not cite an industry standard or state specifically how often Kent & Smith should have been inspecting the tires of its fleet, noting that he did not have a copy of the company’s maintenance schedule. Instead, he described his own experience operating a truck over gravel and how it necessitated replacement of the tires after only 50,000 miles. 

    While Plaintiffs write this off as anecdotal, the Court held that Carr’s experience is highly relevant to the tires at issue and their working conditions, and he applied this lens when reviewing the photographs and maintenance records. 

    Allowing a Plugged Tire to Remain in Use

    Carr noted that the right front steering tire had been plugged at least three times. Plaintiffs challenged this opinion because Carr never conducted a firsthand examination of the subject tire. But Carr reviewed photographs as well as the report of Grima, who found evidence of prior punctures.

    As Defendants noted, “[e]very expert who has reviewed the tire has noted the numerous punctures on the tire, the stone drilling in the tire, and the wear of the tire. These facts are not in dispute.” In other words, Carr’s extrapolation, based on testimony that Plaintiffs failed to refute, that leaving such a tire on the steering axle violated Kent & Smith policy appeared to be on solid footing.

    Failure to Retain and Secure Documentation

    In his deposition Carr pointed to deficiencies in Kent & Smith’s record retention. Plaintiffs then pressed him as to whether any such failures contributed to the accident. Carr responded: “By them not providing documents, it did not contribute to the cause of the accident, but it might have inhibited or changed opinions, or aided in the scope and process of the ongoing litigation related and caused by the accident.” 

    Plaintiffs objected that this opinion was irrelevant because, as Carr admitted, any record retention deficiencies did not cause the accident. But, as he explained, the absence of records could have inhibited investigation of the accident and a discovery of its contributing factors. Additionally, the Court held that Carr is adequately qualified through his industry experience, including a stint as an investigator for the Federal Motor Carrier Safety Administration (“FMCSA”), to reach this opinion.

    Kent & Smith’s Culture

    Finally, Carr asserted in his deposition that Kent & Smith had a “culture” of violating safety regulations based on its record from August 2022 to August 2024. Plaintiffs thus moved to exclude this opinion, arguing that testimony regarding Kent & Smith’s subsequent violations is prohibited under Federal Rule of Evidence 404(b).

    Defendants made no argument in support of the relevance of the subsequent violations. The Court agreed that, even if they were offered for some purpose under Rule 404(b) other than showing Kent & Smith’s bad character, they have no probative value because they occurred four to six years subsequent to the subject accident. The motion is therefore granted to the extent that Carr is prohibited from referencing these violations or opining on Kent & Smith’s safety culture at the time of the accident based on its 2022-2024 record. This limitation, however, did not prevent Carr from opining on Kent & Smith’s compliance with DOT and FMCSA practices at the time of the accident based on other, more contemporaneous records.

    Held

    The Court granted in part and denied in part the Plaintiffs’ Daubert motion to exclude the testimony of Defendants’ expert Richard W. Carr.

    Key Takeaways:

    • Experts are permitted to rely on their own relevant experience—including anecdotal cases. It is the responsibility of opposing counsel to explore the factual basis for the opinion and thus, determine its reliability.
    • An expert may rely on hearsay, including other expert reports, in forming his opinions. Although the Court found that Grima lacked an adequate basis for his main conclusions and that his testimony would not be helpful for the jury, there is no basis to doubt his findings as to the effects that the tire’s condition would have on the vehicle’s operations. Likewise, Carr was adequately qualified to opine on not just if but how Smith should have reported this effect—by formally recording it in his inspection reports.

    Please refer to the blog previously published about this case:

    Tire Expert’s Impact Damage Theory Admitted

    Forensic Pathology Expert’s Conclusions About the Cause of Death Admitted

    Case Details:

    Case Caption: Smith V. China Manufacturers Alliance LLC Et Al
    Docket Number: 2:19cv1111
    Court Name: United States District Court, Louisiana Western
    Order Date: July 16, 2025
  • Accident Reconstruction Expert’s Opinions About Visibility and Conditions at the Scene of the Accident Admitted

    Accident Reconstruction Expert’s Opinions About Visibility and Conditions at the Scene of the Accident Admitted

    This case involves a rear-end collision between Plaintiff Tyler Brown’s sedan and a sprinter van driven by Defendant Nikolay Muzyka.

    The accident occurred during the early morning hours of July 29, 2021. Defendant Muzyka, who was driving in the far right lane, began to slow down as he saw lights from emergency vehicles ahead. As he was slowing down, Defendant moved over two lanes into the far left lane. Plaintiff Brown, who was driving in the far left lane, collided with Defendant causing both cars to turn facing oncoming traffic. 

    Brwon sued Muzyka for negligence and negligence per se. Brown also sued Aleksei Dulepin—the owner of the sprinter van—and Amload, LLC—Muzyka’s employer. Defendants retained accident reconstructionist, Andrew D. Irwin, as Defendants’ testifying expert. Plaintiff filed a motion to preclude Irwin from offering certain opinions at trial. 

    Accident Reconstruction Expert Witness

    Andrew Damien Irwin is an Accident Reconstructionist with Aperture (formerly Scientific Analysis Inc). He uses his decades of experience to provide expert testimony, making use of aids such as accident site diagrams, maps, charts, and crime scene exhibits.

    He holds a Bachelor of Science in Architectural Engineering from the University of Texas at Austin and has completed specialized study in accident reconstruction at Northwestern University and Texas A&M University.

    Irwin is a member of multiple professional societies, including the National Association of Professional Accident Reconstruction Specialists (NAPARS), Society of Accident Reconstructionist (SOAR), Texas Association of Accident Reconstruction Specialists (TAARS), the American Society of Mechanical Engineers (ASME), and the Society of Automotive Engineers (SAE).

    Want to know more about the challenges Andrew D. Irwin has faced? Get the full details with our Challenge Study report. 

    Discussion by the Court

    Plaintiff asked the Court to prohibit Irwin from offering two categories of opinions. First, Plaintiff argued that Irwin should not be allowed to give his opinions about Plaintiff’s reaction time, considering the visibility and conditions at the time of the collision. Second, Plaintiff asked the Court to preclude Irwin from offering his opinions about Section 545.157 of the Texas Transportation Code, known as Texas’s “Move Over or Slow Down” law.

    Irwin’s Opinions about Visibility and Conditions at the Scene of the Accident are Admissible

    Plaintiff Brown objected to Irwin’s opinions that at the time of the accident “visibility was good” based on an aerial video of the location of the collision taken during the day, roughly two years after the accident.

    Brown argued that because this accident took place around one o’clock in the morning on a dark stretch of highway, Irwin’s opinions are incomplete, irrelevant, misleading, and will cause unfair prejudice if the opinions are based on an illustration of the accident scene that was taken during daylight hours.

    Brown also argued that Irwin’s opinions that there was sufficient visibility for Plaintiff to see and react to the sprinter van’s taillights or flashers and avoid a collision are unsupported speculation and merely Irwin’s subjective belief because Irwin did not perform a looming threshold analysis.

    Analysis

    Plaintiff did not point the Court to any cases holding that the failure to use a looming threshold analysis renders an accident reconstructionist’s testimony unreliable. Defendants argued whether Irwin relied on some incorrect facts or should have examined additional or different data is a valid subject of cross-examination, but it did not render Irwin’s opinions inadmissible. The Court agreed with Defendants.

    Irwin’s failure to perform a looming threshold analysis to account for the “dark-lighted” conditions at the time of the accident similarly concerned the weight of the evidence, not its admissibility. The fact that Irwin’s conclusions might be based on data or assumptions that are contracted by facts in the police report did not render Irwin’s conclusions inadmissible.

    Irwin’s Opinions do not Constitute Impermissible Legal Conclusions

    Plaintiff argued that Irwin offered incorrect opinions about Texas’s Move Over or Slow Down law, which impermissibly invaded the province of the judge and jury.

    What Plaintiff failed to mention is that Plaintiff’s counsel asked Irwin whether Defendant Muzyka followed the Move Over or Slow Down law. In other words, Irwin did not comment on or opine about the law in his expert report.

    While Irwin is not permitted to offer legal conclusions at trial, the Court held that the opinions contained in his expert report did not constitute impermissible legal conclusions.

    Held

    The Court therefore denied the Plaintiff’s motion to limit the opinion testimony of Defendant’s expert Andrew D. Irwin.

    Key Takeaway:

    The reliability of the data and facts underlying Irwin’s opinions concerned the weight of the evidence and is subject to cross-examination. In other words, it did not serve as a basis for excluding Irwin’s ultimate opinions.

    Plaintiff may cross-examine Irwin about whether his failure to use a looming threshold analysis to determine Plaintiff’s perception at night or whether any of the factors he did not account for materially affect his opinions.

    These factors concerned the weight of Irwin’s expert testimony, not its admissibility. The Court found that while Plaintiff may cross-examine Irwin as to these alleged deficiencies, Plaintiff has not established that Irwin’s opinions are unreliable and therefore inadmissible.

    Case Details:

    Case Caption: Brown V. Muzyka Et Al
    Docket Number: 6:23cv474
    Court Name: United States District Court, Texas Western
    Order Date: May 22, 2025
  • Hematology Expert’s Opinion on NovoSeven’s Medical Appropriateness Admitted

    Hematology Expert’s Opinion on NovoSeven’s Medical Appropriateness Admitted

    Plaintiff State of Washington alleged that Novo Nordisk Inc. (“NNI”) caused physicians to prescribe its drug, NovoSeven®, to Washington hemophilia patients by: (1) promoting it “off-label” for prophylaxis and “high dose” use; (2) paying kickbacks to physicians; and (3) paying bribes to patients, all of which rendered claims to Medicare and Washington Medicaid false.

    The State of Washington has been investigating this case for almost fifteen years, hoping to find evidence of unlawful conduct that allowed its Medicaid program to recoup money it paid for a medically necessary, life-saving drug.

    The Plaintiffs Jamie Siegel and the State of Washington filed a motion to exclude the testimony of Defendant Novo Nordisk’s expert witness, Dr. Marilyn J. Manco-Johnson.

    Hematology Expert Witness

    Marilyn J. Manco-Johnson is a board-certified hematologist with fifty (50) years of experience treating and managing patients with hemophilia, including those with inhibitors, and other rare blood disorders.

    She has treated patients, including those with the inhibitor antibodies, with NovoSeven and alternative hemophilia treatments developed by other pharmaceutical companies.

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

    Discussion by the Court

    Manco-Johnson’s report described the history, development, and standard of care applicable to hemophilia treatments. Specifically, she opined that from 2005 to 2015—the period relevant to this case—the prophylactic and high-dose usage of NovoSeven was “safe, effective, and accepted by doctors . . . for certain hemophilia patients with inhibitors.” According to her, NovoSeven was considered “clinically appropriate and an accepted method of treatment.”

    However, Washington challenged Manco-Johnson’s report as irrelevant on several grounds. First, it argued that the report did not “mention or analyze the medical necessity” of NovoSeven. Furthermore, it contended that her testimony about the standard of care was also irrelevant, asserting that this “is a case about whether illegal means were used to cause the government to pay for a product that was not medically necessary, as defined by standards particular to the Washington Medicaid program.” Finally, Washington argued that Manco-Johnson should be precluded from testifying about the use of and reference to compendia, since her report does not “mention or evaluate any compendia.”

    Analysis

    First, the Court agreed that Manco-Johnson’s report failed to mention or evaluate any compendia. Any such testimony will therefore be excluded.

    Next, the Court precluded Manco-Johnson from testifying as to whether illegal means caused the off-label use of NovoSeven. Her report does not contain any opinions on this issue.

    Finally, the Court concluded that the standard of care applicable to NovoSeven and its medical appropriateness is relevant to this case. Although she does not use the term “medical necessity,” Manco-Johnson opined that NovoSeven was considered safe, effective, and accepted by doctors. Washington raised both medical necessity and acceptance in its briefing.  While it suggests the standards for medical acceptance and necessity are distinct, this argument goes to the weight, not admissibility, of Manco-Johnson’s testimony.

    Washington has even argued that its claims rest on the alleged unlawful kickbacks, rather than on questions of medical necessity. Nevertheless, there is no dispute that, after several doctors—including Dr. Jeffrey Thompson—and the 2009 Hemophilia Working Group reviewed NovoSeven for medical necessity, Washington Medicaid approved and paid for its use during the relevant period. In fact, Washington has conceded that this payment constitutes evidence of medical necessity.

    Moreover, the Court has authorized an adverse inference instruction, allowing the jury to infer that the lost or destroyed Hospital Corporation of America (HCA) records likely showed that reviewers approved NovoSeven because it was medically necessary. Even so, the jury could still conclude that neither Manco-Johnson and Thompson nor the 2009 Hemophilia Working Group followed the regulatory hierarchy of evidence in determining medical necessity. Consequently, Manco-Johnson’s opinion regarding NovoSeven’s medical appropriateness, acceptance, and standard of care became both relevant and admissible.

    Held

    The Court granted in part and denied in part the State of Washington’s Daubert motion to exclude the testimony of Dr. Marilyn Manco-Johnson.

    Key Takeaway:

    Manco-Johnson has sufficient expertise and experience treating hemophilia patients with inhibitors with NovoSeven for on- and off-label purposes. Her knowledge, background, and testimonial opinions concerning hemophilia and the evolution of treatment modalities over decades satisfy the requirement in Rule 702 that her testimony will assist the jury in understanding the evidence and determining facts in issue. Her testimony will be largely permitted because she is a qualified expert in the medical field through education, training, experience, knowledge, and skill, her report is based on sufficient facts or data, and her opinions are the product of the reliable application of principles and methods.

    Please refer to the blog previously published about this case:

    Law & Legal Expert Helps Jury Understand Medicaid’s Complex Regulatory Framework

    Case Details:

    Case Caption: United States ex rel. Siegel V. Novo Nordisk Inc.
    Docket Number: 3:23cv5459
    Court Name: United States District Court, Washington Western
    Order Date: July 15, 2025
  • Obstetrics and Gynecology Expert’s Opinion Regarding the Common Knowledge of Pelvic Surgeons Admitted

    Obstetrics and Gynecology Expert’s Opinion Regarding the Common Knowledge of Pelvic Surgeons Admitted

    Connie Thacker is one of tens of thousands of individuals who have filed suit against Ethicon for injuries after treatment with Ethicon’s pelvic mesh devices.

    Plaintiff Connie Thacker filed a motion asking the Court to preclude defense expert Dr. John R. Wagner from offering testimony on certain subjects.

    Obstetrics and Gynecology Expert Witness

    Dr. John Raymond Wagner is board-certified in obstetrics and gynecology with a subspecialty board certification in pelvic floor medicine and reconstructive surgery.

    He is a 1987-graduate of The Icahn School of Medicine at Mount Sinai in New York. While at Icahn, he was honored with the Alan F. Guttmacher Award as well as membership into the Alpha Omega Alpha Honor Medical Society.

    Want to know more about the challenges John R. Wagner has faced? Get the full details with our Challenge Study report. 

    Discussion by the Court

    Wagner’s testimony that certain risks of the Prolift and TVT-S devices are widely known by other surgeons

    Thacker argued that Wagner’s testimony that certain risks of the Prolift and TVT-S devices are widely known by other surgeons was unreliable.

    The parties anticipated that Wagner will testify that certain risks involved with using the Prolift and TVT-S devices were commonly known by other surgeons in his field (and thus did not need to be included in Ethicon’s product warnings).

    While Thacker acknowledged that Wagner may properly opine on such risks as he understands them, she contended that he went too far by opining on what risks were commonly known by other surgeons. More specifically, Thacker argued that Wagner cannot testify as to what was commonly known by other surgeons because “Wagner did not conduct any empirical research or interview other physicians to verify the veracity of his opinion.”

    Ultimately, the Court rejected Thacker’s argument and found that Wagner’s testimony that certain risks of the Prolift and TVT-S are widely known by other surgeons is reliable.

    Wagner’s opinion regarding the common knowledge of pelvic surgeons was reliable because it was based on his medical training to become a pelvic surgeon—which is the same training regimen he represents is common to every pelvic surgeon. This training, along with his review of relevant medical literature, provided “appropriate validation,” for Wagner’s opinion concerning the common knowledge of pelvic surgeons and rendered his testimony reliable.

    Wagner’s testimony regarding the properties of the mesh used in the TVT-S and Prolift

    Thacker next argued that Wagner’s testimony regarding the properties of the mesh used in Ethicon’s devices was unreliable. Specifically, Thacker took issue with the reliability of Wagner’s opinion that the mesh involved “is a safe and effective material.” Thacker suggested that this opinion was unreliable because Wagner lacked the appropriate qualifications to form such an opinion: namely, she took issue with his lack of training in biomedical engineering, pathology, epidemiology, or medical device design.

    The Court found that Wagner’s testimony regarding the properties of the mesh used in Ethicon’s devices was reliable due to Wagner’s “extensive clinical experience, combined with his review of peer-reviewed literature, qualifies [him] to opine on mesh’s reaction to and effect on the human body.”

    Held

    The Court denied the Plaintiff’s motion to exclude or limit the testimony of defense expert John Wagner.

    Key Takeaway:

    Wagner is more than qualified to opine on mesh’s reaction to and effect on the human body considering his extensive clinical experience, combined with his review of peer-reviewed literature. Wagner’s opinion regarding the common knowledge of pelvic surgeons is also reliable because it is based on his medical training to become a pelvic surgeon—which is the same training regimen he represents is common to every pelvic surgeon. 

    Please refer to the blogs previously published about this case:

    Urogynecology Expert Witness Testimony about inadequate risk disclosure admitted in medical device product liability action

    Obstetrics and Gynecology Expert’s Testimony on Mesh Porosity and Stiffness Admitted

    Urogynecology Expert’s Opinion on Continuum of Care Admitted

    Case Details:

    Case Caption: Thacker V. Ethicon Inc.
    Docket Number: 5:20cv50
    Court Name: United States District Court, Kentucky Eastern
    Order Date: July 08, 2025
  • Law & Legal Expert Helps Jury Understand Medicaid’s Complex Regulatory Framework

    Law & Legal Expert Helps Jury Understand Medicaid’s Complex Regulatory Framework

    Plaintiff State of Washington alleged that Novo Nordisk Inc. (“NNI”) caused physicians to prescribe its drug, NovoSeven®, to Washington hemophilia patients by: (1) promoting it “off-label” for prophylaxis and “high dose” use; (2) paying kickbacks to physicians; and (3) paying bribes to patients, all of which rendered claims to Medicare and Washington Medicaid false.

    The State of Washington has been investigating this case for almost fifteen years, hoping to find evidence of unlawful conduct that allowed its Medicaid program to recoup money it paid for a medically necessary, life-saving drug.

    The Plaintiffs Jamie Siegel and the State of Washington filed a motion to exclude the testimony of Defendant Novo Nordisk’s expert witness, Daniel E. Troy.

    Law & Legal Expert Witness

    Daniel E. Troy has been an attorney for 40 years, with 23 years of experience in health care regulation, including three years as Chief Legal Counsel to the FDA and many more in the private sector health industry.

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

    Discussion by the Court

    To begin with, Washington argued that Troy’s opinions were improper legal conclusions about the ultimate issue of law: whether NNI’s marketing practices are protected by the First Amendment or U.S. Food and Drug Administration (“FDA”) regulations. It argued that “can be” is not an opinion at all; it is speculation. Moreover, Washington contended that Troy’s testimony would confuse and mislead the jury about the legality of NNI’s practices, prejudicing it.

    NNI responded that there is well-established precedent that a properly qualified expert with expertise in the regulatory framework or landscape of a highly technical and regulated industry or program, such as Medicaid, can help a jury understand the evidence or determine a fact in issue. It argued that far from unduly prejudicing Washington or confusing the jury, Troy’s testimony will assist the jury in understanding the FDA’s enormously complex regulatory structure, in order to evaluate whether NNI’s conduct was improper.

    Analysis

    The Court agreed with NNI that the bulk of Troy’s testimony will assist the jury and is admissible. This case presents a complexity of issues that requires the jury to understand the regulatory scheme of the government’s oversight of pharmaceuticals through the review of extensive legal briefing spanning the years that this litigation has been pending. However, Troy will not be allowed to testify on how the application of the First Amendment has informed the development of case law in America as it applies to the pharmaceutical industry in its testing and promotion of its drugs.

    The Court held that Troy will be permitted to testify about the marketing role that the dissemination of peer-reviewed studies has in the medical industry for the purpose of acquainting practicing physicians with new pharmaceuticals or new treatment applications of established pharmaceuticals, including off-label uses.

    Basically, Troy’s testimony should discuss industry and regulatory standards when assessing a specific study or article, including the use of the FDA’s nonbinding Good Reprint Practice guidance, and related recommendations.

    Moreover, Troy devoted a significant part of his report to discussing the Konkle Study in the context of the Good Reprint Practice review. This was apparently chosen because Washington cited it as an example of a marketing violation of the AKS.

    As a defense expert, the Court reviewed Troy’s report and his expected trial testimony as rebuttal testimony. Troy will be permitted to go through the Good Reprint Practice guidance and review the record by identifying what NNI did factually to meet the Guidance standards. He will not be permitted to testify that NNI’s activities in connection with the Konkle Report rendered NNI in compliance with the AKS “safe harbor” as this would be testimony an ultimate issue of law.

    Held

    The Court granted in part and denied in part the State of Washington’s Daubert motion to exclude Daniel E. Troy’s testimony.

    Key Takeaway:

    In the Court’s view, Troy’s testimony is not unlike that of an expert physician specialist explaining to a jury the standard of care for a particular procedure by describing the procedure’s steps and then explaining, through reference to the medical records, what steps the allegedly negligent physician took. The expert would not be permitted to testify that, in his opinion, the reviewed physician was or was not negligent.

    Similarly, Troy will be permitted to rebut any evidence produced in Washington’s case in chief regarding its claim that the jury should make a negative inference from the fact NNI rejected the FDA’s request that NNI conduct a Phase III Study. He describes these studies as expensive and explains how other alternatives can be used to demonstrate that NovoSeven is safe and effective, what he calls “real world evidence.”

    Troy will also be permitted to rebut any evidence Washington introduces about free drug samples. He can describe how the FDA regulates this activity, and under what conditions free samples can meet the AKS’s safe harbor requirements, and what the record demonstrates about NNI’s distribution of free samples. He, however, may not testify that NNI complied with the regulations relating to free samples.

    Washington conceded that, as a general rule, an expert’s opinion is not objectionable simply because it embraces an ultimate issue to be decided by the trier of fact. However, it argued persuasively that an expert cannot offer a legal conclusion or opine on an ultimate issue of law.

    Case Details:

    Case Caption: United States ex rel. Siegel V. Novo Nordisk Inc.
    Docket Number: 3:23cv5459
    Court Name: United States District Court, Washington Western
    Order Date: July 14, 2025