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Expert Witness Insights by Area of Expertise
10 min read
Areas of Expertise :
Product Liability, Medical Devices, Pharmaceutical, Food And Drug Administration (FDA), Regulatory Compliance
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Health care is changing rapidly. Medical products increasingly include sophisticated software, connected devices, artificial intelligence, and technologies that generate large volumes of patient data. At the same time, federal policy has encouraged new approaches to medical product development and the use of real-world evidence.
These developments have consequences beyond health care delivery and FDA regulation. They can also affect product liability litigation involving prescription drugs, medical devices, biologics, and certain health-related software.
Expert witnesses have long played an important role in these cases. Depending on the claims and applicable law, experts may address product design, warnings, medical causation, engineering, pharmacology, epidemiology, regulatory matters, or other specialized subjects. As medical products and the evidence surrounding them become more complex, the analysis required of those experts can become more complex as well.
For attorneys handling health care product liability disputes, understanding these developments is increasingly important when selecting experts, developing opinions, and preparing for admissibility challenges.
There is no single health care reform measure that governs modern product liability litigation. Instead, a combination of legislative, regulatory, technological, and evidentiary developments has changed the environment in which medical products are developed, evaluated, monitored, and litigated.
One significant development was the 21st Century Cures Act, enacted in 2016. Among other provisions, the law was designed to accelerate medical product development and expanded FDA initiatives involving modernized clinical trial designs and the use of real-world evidence in certain regulatory decision-making contexts.
The FDA defines real-world data as information relating to patient health status or health care delivery that is routinely collected from various sources. Those sources can include electronic health records, insurance claims, registries, and digital health technologies. Real-world evidence is clinical evidence about a medical product's use and potential benefits or risks derived from analysis of real-world data.
This expanding evidence environment matters to product liability litigation because experts may encounter information that goes well beyond traditional clinical trials and other evidence developed before a product reaches the market.
Relevant materials may include:
More data, however, does not automatically produce a more reliable expert opinion. Experts still need to explain why particular information is appropriate for the question they are addressing and how their methods support their conclusions.
Medical product liability cases increasingly involve complex evidence from real-world data, digital health technologies, AI-enabled devices, FDA regulation, and product-tracing systems. This article explains how these developments affect expert testimony, medical causation, Rule 702 reliability, federal preemption issues, and the selection of appropriately qualified experts for pharmaceutical, device, biologic, and software-related disputes.
FDA Regulation
Healthcare Products
Product Safety
Adverse Event
Causation Analysis
Health Data
Healthcare Technology
Drug Regulation
Health care is changing rapidly. Medical products increasingly include sophisticated software, connected devices, artificial intelligence, and technologies that generate large volumes of patient data. At the same time, federal policy has encouraged new approaches to medical product development and the use of real-world evidence.
These developments have consequences beyond health care delivery and FDA regulation. They can also affect product liability litigation involving prescription drugs, medical devices, biologics, and certain health-related software.
Expert witnesses have long played an important role in these cases. Depending on the claims and applicable law, experts may address product design, warnings, medical causation, engineering, pharmacology, epidemiology, regulatory matters, or other specialized subjects. As medical products and the evidence surrounding them become more complex, the analysis required of those experts can become more complex as well.
For attorneys handling health care product liability disputes, understanding these developments is increasingly important when selecting experts, developing opinions, and preparing for admissibility challenges.
There is no single health care reform measure that governs modern product liability litigation. Instead, a combination of legislative, regulatory, technological, and evidentiary developments has changed the environment in which medical products are developed, evaluated, monitored, and litigated.
One significant development was the 21st Century Cures Act, enacted in 2016. Among other provisions, the law was designed to accelerate medical product development and expanded FDA initiatives involving modernized clinical trial designs and the use of real-world evidence in certain regulatory decision-making contexts.
The FDA defines real-world data as information relating to patient health status or health care delivery that is routinely collected from various sources. Those sources can include electronic health records, insurance claims, registries, and digital health technologies. Real-world evidence is clinical evidence about a medical product's use and potential benefits or risks derived from analysis of real-world data.
This expanding evidence environment matters to product liability litigation because experts may encounter information that goes well beyond traditional clinical trials and other evidence developed before a product reaches the market.
Relevant materials may include:
More data, however, does not automatically produce a more reliable expert opinion. Experts still need to explain why particular information is appropriate for the question they are addressing and how their methods support their conclusions.
The FDA's approach to real-world evidence continues to develop.
In December 2025, the FDA issued updated final guidance addressing the use of real-world evidence to support regulatory decision-making for medical devices. The guidance explains how FDA evaluates real-world data to determine whether they are of sufficient quality to generate real-world evidence for regulatory decision-making, including an assessment of the relevance and reliability of the real-world data.
The FDA has also developed guidance concerning real-world data and evidence for drugs and biological products.
FDA guidance documents generally describe the agency's current thinking and recommendations. They do not, by themselves, create binding legal obligations, although underlying statutes, regulations, approval conditions, and other applicable requirements may be legally controlling.
These regulatory developments do not create a separate evidentiary standard for civil product liability cases. Regulatory acceptance and courtroom admissibility remain different inquiries.
Still, the growing availability of real-world information can affect the factual record experts encounter in litigation. An expert evaluating an alleged device failure, for example, might need to consider whether registry information, postmarket experience, device-generated information, or other available data are scientifically appropriate for the opinion being offered.
The key question for attorneys is not simply whether data exist. It is whether the expert has used those data reliably.
Federal Rule of Evidence 702 remains central to the admissibility of expert testimony in federal product liability litigation.
The rule was amended effective December 1, 2023. It expressly states that the proponent must demonstrate to the court that it is "more likely than not" that the Rule 702 requirements are satisfied.
Under the current rule, a qualified expert may testify when the proponent demonstrates to the court that it is more likely than not that:
The 2023 amendment also emphasizes the court's responsibility to evaluate whether an expert's conclusions stay within what the expert's methodology can reliably support.
An impressive résumé, substantial clinical experience, or familiarity with FDA-regulated products does not, by itself, establish that every opinion offered by an expert satisfies Rule 702. Experts should be prepared to explain the analytical path connecting the evidence they considered, the methodology they applied, and the conclusions they reached.
Rule 702 directly governs proceedings in federal court. State courts may apply their own evidence rules and expert-admissibility standards, which counsel should evaluate separately.
Causation is often one of the most technically difficult subjects in pharmaceutical and medical device litigation.
Based on the particular claim and governing substantive law, experts may need to address whether a product was capable of causing an alleged injury and whether it caused or contributed to the individual plaintiff's injury.
Depending on the case and the expert's methodology, relevant materials may include clinical research, observational evidence, medical records, exposure information, adverse-event data, and other scientifically appropriate evidence.
The expanding availability of real-world data adds another potential source of information, but it can also introduce methodological challenges.
An association appearing in observational health data does not automatically establish causation. Experts may need to consider confounding variables, selection bias, data quality, missing information, comparison groups, and whether the study design supports the inference being offered.
Consider a hypothetical product liability case in which an expert relies on a patient registry to support an association between a medical device and a particular complication. The existence of that association may be relevant, but the analysis should not end there. The expert may need to address how patients entered the registry, whether important variables are missing, whether there is an appropriate comparison group, and whether other factors could explain the observed result.
For attorneys, the practical question is not simply, "What does the dataset show?" It is also, "What can this dataset reliably establish?"
Digital health is one of the clearest examples of how modern health care is changing the technical issues experts may confront.
The FDA regulates certain software functions that meet the statutory definition of a medical device. Other software functions, including certain clinical decision support functions that satisfy statutory criteria, are excluded from the device definition.
In January 2026, the FDA issued updated final guidance addressing clinical decision support software. The agency also maintains a list of AI-enabled medical devices authorized for marketing in the United States and continues to develop policies and guidance for AI-enabled device software functions.
The FDA notes that its AI-enabled medical device list is not comprehensive and may be updated over time. Attorneys and experts should not treat the list as a complete inventory or as a substitute for analyzing the particular product, software function, intended use, and regulatory history at issue.
Depending on the disputed issues, experts may need to analyze:
The appropriate expert can depend heavily on the issue being disputed. A physician may be qualified to address clinical practice but not necessarily the design or validation of an algorithm. A software engineer may understand the underlying system but may not be qualified to offer a medical causation opinion.
Depending on the issues in dispute, counsel may need to consider experts from more than one discipline rather than relying on one expert to address every technical question.
FDA regulation can be highly relevant in litigation involving medical products, but regulatory compliance and state-law product liability are distinct legal questions.
Whether federal law preempts a state-law product liability claim can depend on the type of product, its regulatory pathway, the particular state-law duty at issue, and controlling precedent.
For example, in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the U.S. Supreme Court held that the Medical Device Amendments expressly preempted the state-law claims at issue because they would have imposed requirements relating to the device's safety or effectiveness that were different from, or in addition to, federal requirements applicable to a Class III medical device that had received FDA premarket approval.
By contrast, in Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court held that federal drug-labeling law did not preempt the state-law failure-to-warn claim under the circumstances presented in that case.
These decisions illustrate why the interaction between FDA regulation and state-law product liability claims cannot be reduced to a single rule. The preemption analysis depends on the product, regulatory framework, particular claim, and applicable precedent.
Because preemption and the interpretation of governing law are matters for the court, an expert should not tell the court or jury what the law requires or whether a claim is preempted. An appropriately qualified expert may still explain specialized regulatory facts, industry practices, technical requirements, submissions, records, or processes when that testimony is relevant and otherwise admissible.
Modern health care regulation also places increasing emphasis on product traceability.
The Drug Supply Chain Security Act established requirements for an interoperable, electronic system to identify and trace certain prescription drug products at the package level as they move through the pharmaceutical distribution supply chain.
In litigation involving questions about product identity, distribution, or potentially counterfeit or illegitimate products, traceability information may become relevant to the factual investigation.
In an appropriate case, counsel may consider specialists in pharmaceutical distribution, supply-chain systems, manufacturing, or related fields to help analyze records concerning the movement and identity of a product.
Rather than choosing an expert primarily because of broad credentials, counsel should consider whether the expert's actual experience and expertise match the specific issue requiring specialized knowledge.
Useful questions include:
These questions matter both to the strength of the substantive analysis and to potential admissibility challenges.
Health care modernization is changing both medical products and the evidence available to evaluate them. Real-world data, connected technologies, AI-enabled devices, evolving software regulation, and more sophisticated product-tracing systems can all become part of the factual landscape of product liability litigation.
For attorneys, these developments reinforce the importance of selecting experts whose qualifications closely fit the disputed issue and whose reasoning can withstand careful examination. For experts, they highlight the need for transparent methodology, appropriate data, recognition of limitations, and disciplined conclusions.
As medical technology continues to evolve, effective expert testimony may depend not merely on possessing specialized knowledge, but on demonstrating how that knowledge was reliably applied to the specific facts of the case.
Has health care reform made expert witnesses more important in product liability cases?
In some disputes, evolving medical technologies and expanding sources of health data can create additional or more complex specialized issues. Expert testimony may therefore be important when a case involves subjects beyond ordinary lay understanding.
Can experts rely on real-world evidence?
Potentially. The answer depends on the evidence, methodology, purpose of the opinion, governing evidentiary rules, and circumstances of the case. FDA consideration of real-world evidence for regulatory purposes does not automatically make an expert opinion based on that evidence admissible in litigation.
Are AI medical devices regulated by the FDA?
Many are. The FDA regulates software functions that meet the statutory definition of a device and maintains a list of AI-enabled medical devices authorized for marketing. However, the list is not comprehensive, and not every health-related software function qualifies as a medical device.
Does FDA compliance eliminate product liability?
Not necessarily. The legal effect of FDA regulation depends on factors such as the type of product, regulatory pathway, state-law claim, applicable federal statutes, and controlling case law. Federal preemption may restrict certain claims, but the analysis is claim-specific.
What does Rule 702 require of experts?
In federal court, Rule 702 requires more than identifying relevant information. An expert's opinion must rest on sufficient facts or data, reliable principles and methods, and a reliable application of those methods to the case. State-court standards should be evaluated under the applicable jurisdiction's rules.
The FDA's approach to real-world evidence continues to develop.
In December 2025, the FDA issued updated final guidance addressing the use of real-world evidence to support regulatory decision-making for medical devices. The guidance explains how FDA evaluates real-world data to determine whether they are of sufficient quality to generate real-world evidence for regulatory decision-making, including an assessment of the relevance and reliability of the real-world data.
The FDA has also developed guidance concerning real-world data and evidence for drugs and biological products.
FDA guidance documents generally describe the agency's current thinking and recommendations. They do not, by themselves, create binding legal obligations, although underlying statutes, regulations, approval conditions, and other applicable requirements may be legally controlling.
These regulatory developments do not create a separate evidentiary standard for civil product liability cases. Regulatory acceptance and courtroom admissibility remain different inquiries.
Still, the growing availability of real-world information can affect the factual record experts encounter in litigation. An expert evaluating an alleged device failure, for example, might need to consider whether registry information, postmarket experience, device-generated information, or other available data are scientifically appropriate for the opinion being offered.
The key question for attorneys is not simply whether data exist. It is whether the expert has used those data reliably.
Federal Rule of Evidence 702 remains central to the admissibility of expert testimony in federal product liability litigation.
The rule was amended effective December 1, 2023. It expressly states that the proponent must demonstrate to the court that it is "more likely than not" that the Rule 702 requirements are satisfied.
Under the current rule, a qualified expert may testify when the proponent demonstrates to the court that it is more likely than not that:
The 2023 amendment also emphasizes the court's responsibility to evaluate whether an expert's conclusions stay within what the expert's methodology can reliably support.
An impressive résumé, substantial clinical experience, or familiarity with FDA-regulated products does not, by itself, establish that every opinion offered by an expert satisfies Rule 702. Experts should be prepared to explain the analytical path connecting the evidence they considered, the methodology they applied, and the conclusions they reached.
Rule 702 directly governs proceedings in federal court. State courts may apply their own evidence rules and expert-admissibility standards, which counsel should evaluate separately.
Causation is often one of the most technically difficult subjects in pharmaceutical and medical device litigation.
Based on the particular claim and governing substantive law, experts may need to address whether a product was capable of causing an alleged injury and whether it caused or contributed to the individual plaintiff's injury.
Depending on the case and the expert's methodology, relevant materials may include clinical research, observational evidence, medical records, exposure information, adverse-event data, and other scientifically appropriate evidence.
The expanding availability of real-world data adds another potential source of information, but it can also introduce methodological challenges.
An association appearing in observational health data does not automatically establish causation. Experts may need to consider confounding variables, selection bias, data quality, missing information, comparison groups, and whether the study design supports the inference being offered.
Consider a hypothetical product liability case in which an expert relies on a patient registry to support an association between a medical device and a particular complication. The existence of that association may be relevant, but the analysis should not end there. The expert may need to address how patients entered the registry, whether important variables are missing, whether there is an appropriate comparison group, and whether other factors could explain the observed result.
For attorneys, the practical question is not simply, "What does the dataset show?" It is also, "What can this dataset reliably establish?"
Digital health is one of the clearest examples of how modern health care is changing the technical issues experts may confront.
The FDA regulates certain software functions that meet the statutory definition of a medical device. Other software functions, including certain clinical decision support functions that satisfy statutory criteria, are excluded from the device definition.
In January 2026, the FDA issued updated final guidance addressing clinical decision support software. The agency also maintains a list of AI-enabled medical devices authorized for marketing in the United States and continues to develop policies and guidance for AI-enabled device software functions.
The FDA notes that its AI-enabled medical device list is not comprehensive and may be updated over time. Attorneys and experts should not treat the list as a complete inventory or as a substitute for analyzing the particular product, software function, intended use, and regulatory history at issue.
Depending on the disputed issues, experts may need to analyze:
The appropriate expert can depend heavily on the issue being disputed. A physician may be qualified to address clinical practice but not necessarily the design or validation of an algorithm. A software engineer may understand the underlying system but may not be qualified to offer a medical causation opinion.
Depending on the issues in dispute, counsel may need to consider experts from more than one discipline rather than relying on one expert to address every technical question.
FDA regulation can be highly relevant in litigation involving medical products, but regulatory compliance and state-law product liability are distinct legal questions.
Whether federal law preempts a state-law product liability claim can depend on the type of product, its regulatory pathway, the particular state-law duty at issue, and controlling precedent.
For example, in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the U.S. Supreme Court held that the Medical Device Amendments expressly preempted the state-law claims at issue because they would have imposed requirements relating to the device's safety or effectiveness that were different from, or in addition to, federal requirements applicable to a Class III medical device that had received FDA premarket approval.
By contrast, in Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court held that federal drug-labeling law did not preempt the state-law failure-to-warn claim under the circumstances presented in that case.
These decisions illustrate why the interaction between FDA regulation and state-law product liability claims cannot be reduced to a single rule. The preemption analysis depends on the product, regulatory framework, particular claim, and applicable precedent.
Because preemption and the interpretation of governing law are matters for the court, an expert should not tell the court or jury what the law requires or whether a claim is preempted. An appropriately qualified expert may still explain specialized regulatory facts, industry practices, technical requirements, submissions, records, or processes when that testimony is relevant and otherwise admissible.
Modern health care regulation also places increasing emphasis on product traceability.
The Drug Supply Chain Security Act established requirements for an interoperable, electronic system to identify and trace certain prescription drug products at the package level as they move through the pharmaceutical distribution supply chain.
In litigation involving questions about product identity, distribution, or potentially counterfeit or illegitimate products, traceability information may become relevant to the factual investigation.
In an appropriate case, counsel may consider specialists in pharmaceutical distribution, supply-chain systems, manufacturing, or related fields to help analyze records concerning the movement and identity of a product.
Rather than choosing an expert primarily because of broad credentials, counsel should consider whether the expert's actual experience and expertise match the specific issue requiring specialized knowledge.
Useful questions include:
These questions matter both to the strength of the substantive analysis and to potential admissibility challenges.
Health care modernization is changing both medical products and the evidence available to evaluate them. Real-world data, connected technologies, AI-enabled devices, evolving software regulation, and more sophisticated product-tracing systems can all become part of the factual landscape of product liability litigation.
For attorneys, these developments reinforce the importance of selecting experts whose qualifications closely fit the disputed issue and whose reasoning can withstand careful examination. For experts, they highlight the need for transparent methodology, appropriate data, recognition of limitations, and disciplined conclusions.
As medical technology continues to evolve, effective expert testimony may depend not merely on possessing specialized knowledge, but on demonstrating how that knowledge was reliably applied to the specific facts of the case.
Has health care reform made expert witnesses more important in product liability cases?
In some disputes, evolving medical technologies and expanding sources of health data can create additional or more complex specialized issues. Expert testimony may therefore be important when a case involves subjects beyond ordinary lay understanding.
Can experts rely on real-world evidence?
Potentially. The answer depends on the evidence, methodology, purpose of the opinion, governing evidentiary rules, and circumstances of the case. FDA consideration of real-world evidence for regulatory purposes does not automatically make an expert opinion based on that evidence admissible in litigation.
Are AI medical devices regulated by the FDA?
Many are. The FDA regulates software functions that meet the statutory definition of a device and maintains a list of AI-enabled medical devices authorized for marketing. However, the list is not comprehensive, and not every health-related software function qualifies as a medical device.
Does FDA compliance eliminate product liability?
Not necessarily. The legal effect of FDA regulation depends on factors such as the type of product, regulatory pathway, state-law claim, applicable federal statutes, and controlling case law. Federal preemption may restrict certain claims, but the analysis is claim-specific.
What does Rule 702 require of experts?
In federal court, Rule 702 requires more than identifying relevant information. An expert's opinion must rest on sufficient facts or data, reliable principles and methods, and a reliable application of those methods to the case. State-court standards should be evaluated under the applicable jurisdiction's rules.
FDA Regulation
Healthcare Products
Product Safety
Adverse Event
Causation Analysis
Health Data
Healthcare Technology
Drug Regulation
Expert Witness Insights by Area of Expertise
Expert Witness Insights by Area of Expertise