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Expert Witness Insights by Area of Expertise
7 min read
Areas of Expertise :
Medical Devices, Product Liability, Biomedical Engineering, Food And Drug Administration (FDA), Human Factors
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Medical device litigation can involve complex questions about FDA regulatory pathways, federal preemption, product defects, warnings, causation, software, and device-specific technical evidence. This article explains how 510(k) clearance and PMA approval can affect litigation strategy, the roles of medical device experts, and the Rule 702 and Daubert issues that can place expert testimony at risk.
Medical device cases rarely stay simple for long. What may begin as a patient injury claim can quickly involve FDA records, design files, clinical testimony, software updates, adverse event reports, warnings, manufacturing data, and expert challenges.
Modern devices can also involve robotics, sensors, artificial intelligence, connected systems, or cybersecurity issues.
This guide explains what attorneys should know about medical device litigation in 2026, including FDA pathways, federal preemption, expert strategy, discovery priorities, and the reliability problems that can lead to expert exclusion.
Medical device lawsuits may involve several product liability theories, depending on the facts and governing state law. Claims are often easier to evaluate and defend when they connect the alleged injury to a specific defect, warning issue, regulatory failure, or causation theory.
Common theories may include:
As a practical matter, broad claims are often easier to challenge, especially when they do not identify the specific defect, duty, or causal link. A stronger theory identifies the technical problem, ties it to a duty, and connects it to the plaintiff’s injury. That connection is often where expert testimony becomes critical.
Before counsel builds a defect theory, it is important to know how the device reached the market. In practice, the FDA pathway can shape pleadings, discovery, expert selection, preemption arguments, and how the court evaluates the legal theory.
The FDA classifies medical devices by risk. Class I devices are generally lower risk. Class II devices are moderate risk. Class III devices are higher risk and often require more regulatory control. Many Class II devices enter the market through the 510(k) process. Some Class I and Class II devices are exempt from 510(k) requirements, subject to FDA limitations. The 510(k) pathway focuses on whether the device is substantially equivalent to a legally marketed predicate device.
Class III devices generally require Premarket Approval, often called PMA. Through PMA, FDA reviews Class III devices to determine whether the evidence supports safety and effectiveness for the device’s intended use. Because PMA approval involves device-specific federal requirements, it can create major preemption issues in later litigation.
That difference can affect the pleadings, discovery plan, preemption analysis, and expert strategy. A 510(k)-cleared device and a PMA-approved device may call for different pleadings, different discovery, and different expert support. Attorneys should confirm the exact pathway early, before pleadings, discovery, or expert strategy become too difficult to correct.
FDA Regulation
Design Defect
Manufacturing Defects
Safety Warnings
Product Safety
Product Testing
Regulatory Issues
Causation Analysis
Medical device cases rarely stay simple for long. What may begin as a patient injury claim can quickly involve FDA records, design files, clinical testimony, software updates, adverse event reports, warnings, manufacturing data, and expert challenges.
Modern devices can also involve robotics, sensors, artificial intelligence, connected systems, or cybersecurity issues.
This guide explains what attorneys should know about medical device litigation in 2026, including FDA pathways, federal preemption, expert strategy, discovery priorities, and the reliability problems that can lead to expert exclusion.
Medical device lawsuits may involve several product liability theories, depending on the facts and governing state law. Claims are often easier to evaluate and defend when they connect the alleged injury to a specific defect, warning issue, regulatory failure, or causation theory.
Common theories may include:
As a practical matter, broad claims are often easier to challenge, especially when they do not identify the specific defect, duty, or causal link. A stronger theory identifies the technical problem, ties it to a duty, and connects it to the plaintiff’s injury. That connection is often where expert testimony becomes critical.
Before counsel builds a defect theory, it is important to know how the device reached the market. In practice, the FDA pathway can shape pleadings, discovery, expert selection, preemption arguments, and how the court evaluates the legal theory.
The FDA classifies medical devices by risk. Class I devices are generally lower risk. Class II devices are moderate risk. Class III devices are higher risk and often require more regulatory control. Many Class II devices enter the market through the 510(k) process. Some Class I and Class II devices are exempt from 510(k) requirements, subject to FDA limitations. The 510(k) pathway focuses on whether the device is substantially equivalent to a legally marketed predicate device.
Class III devices generally require Premarket Approval, often called PMA. Through PMA, FDA reviews Class III devices to determine whether the evidence supports safety and effectiveness for the device’s intended use. Because PMA approval involves device-specific federal requirements, it can create major preemption issues in later litigation.
That difference can affect the pleadings, discovery plan, preemption analysis, and expert strategy. A 510(k)-cleared device and a PMA-approved device may call for different pleadings, different discovery, and different expert support. Attorneys should confirm the exact pathway early, before pleadings, discovery, or expert strategy become too difficult to correct.
Preemption can be one of the first issues defense counsel raises, especially when the case involves a PMA-approved device. The Medical Device Amendments include a preemption provision that limits states from imposing requirements on a device that are different from, or in addition to, the specific federal requirements that apply to it. That provision carries the most weight with PMA-approved devices, where FDA has established device-specific requirements through the approval process.
In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the U.S. Supreme Court held that many common-law claims challenging the safety or effectiveness of a PMA-approved device are preempted. Still, preemption does not always end the case. Riegel recognized that § 360k does not preempt claims built on violations of FDA regulations, since those claims run parallel to federal requirements rather than add new obligations to them (552 U.S. at 330). Claims that track an existing federal requirement without creating any new state-law duty may survive preemption, but courts have applied this exception carefully, and how the claim is pleaded matters a great deal.
To be viable, that type of claim should identify an existing federal requirement and explain how the manufacturer allegedly violated it. It cannot create a new state-law duty that goes beyond federal law. For attorneys, the practical point is straightforward: vague allegations are vulnerable. A stronger claim identifies the federal requirement, explains the alleged violation, and connects that violation to the injury.
Medical device cases often turn on technical proof. The right expert, or expert team, can help attorneys evaluate whether the device failed, whether warnings or instructions were adequate, whether the manufacturer followed applicable requirements, and whether the evidence supports causation.
Depending on the facts, common expert roles may include:
The practical question is not just whether the expert is qualified. It is whether the expert fits the exact issue in dispute. A strong résumé helps, but it will not save an opinion that skips over the device records, FDA history, testing data, warnings, software records, or patient-specific facts.
Courts do not admit expert testimony simply because the expert has impressive credentials. Under Federal Rule of Evidence 702, expert testimony must be useful to the factfinder, grounded in enough facts or data, based on reliable methods, and reliably applied to the case facts. The 2023 amendment clarified that the proponent must show these requirements by a preponderance of the evidence.
Daubert also directs courts to examine reliability factors such as testing, peer review, error rate, standards, and general acceptance when those factors fit the testimony.
In medical device litigation, expert opinions may become vulnerable when they rely on:
These issues often surface during deposition or Daubert briefing. A report is easier to defend when it explains the data reviewed, the method used, the limits of the opinion, and the reasoning that connects the evidence to the conclusion.
Discovery should focus on records that show how the device was designed, marketed, cleared, approved, exempted, used, monitored, and investigated after the alleged injury.
Key evidence may include, depending on the device, claims, and available records:
Preserving the actual device can also be critical. If the device is lost, altered, repaired, discarded, or unavailable, attorneys may face more disputes over defect and causation opinions.
Discovery should also match the expert theory. A focused discovery plan gives experts the records they need to avoid speculation and helps attorneys test whether the theory is strong enough before expert reports are due.
Are FDA-cleared or FDA-approved devices immune from lawsuits?
Not automatically, and the answer depends on how the device reached the market. For PMA-approved devices, preemption is typically the first major defense because PMA establishes device-specific federal requirements under 21 U.S.C. § 360k. For 510(k)-cleared devices, courts following Lohr have generally found that the clearance process does not create device-specific requirements, so the same preemption defense is usually much harder to sustain. Even for PMA devices, claims that track existing federal requirements without adding any new obligations may survive, depending on how they are pleaded and the governing law.
What is the difference between 510(k) clearance and PMA approval?
A 510(k) submission focuses on substantial equivalence to a legally marketed predicate device. Through PMA, FDA reviews Class III devices to determine whether the evidence supports safety and effectiveness for the device’s intended use.
Why are experts so important in medical device cases?
Experts help connect technical evidence to legal issues, including design, FDA compliance, warnings, human factors, software issues, clinical causation, and damages. In many cases, more than one expert may be needed.
What makes a medical device expert vulnerable to exclusion?
Common problems include weak methodology, incomplete record review, unsupported causation opinions, failure to address alternative causes, and opinions outside the expert’s discipline.
When should attorneys retain a medical device expert?
Early in the case. Experts can help counsel think through preservation issues, shape discovery, evaluate causation, identify missing records, and reduce admissibility risks.
Preemption can be one of the first issues defense counsel raises, especially when the case involves a PMA-approved device. The Medical Device Amendments include a preemption provision that limits states from imposing requirements on a device that are different from, or in addition to, the specific federal requirements that apply to it. That provision carries the most weight with PMA-approved devices, where FDA has established device-specific requirements through the approval process.
In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the U.S. Supreme Court held that many common-law claims challenging the safety or effectiveness of a PMA-approved device are preempted. Still, preemption does not always end the case. Riegel recognized that § 360k does not preempt claims built on violations of FDA regulations, since those claims run parallel to federal requirements rather than add new obligations to them (552 U.S. at 330). Claims that track an existing federal requirement without creating any new state-law duty may survive preemption, but courts have applied this exception carefully, and how the claim is pleaded matters a great deal.
To be viable, that type of claim should identify an existing federal requirement and explain how the manufacturer allegedly violated it. It cannot create a new state-law duty that goes beyond federal law. For attorneys, the practical point is straightforward: vague allegations are vulnerable. A stronger claim identifies the federal requirement, explains the alleged violation, and connects that violation to the injury.
Medical device cases often turn on technical proof. The right expert, or expert team, can help attorneys evaluate whether the device failed, whether warnings or instructions were adequate, whether the manufacturer followed applicable requirements, and whether the evidence supports causation.
Depending on the facts, common expert roles may include:
The practical question is not just whether the expert is qualified. It is whether the expert fits the exact issue in dispute. A strong résumé helps, but it will not save an opinion that skips over the device records, FDA history, testing data, warnings, software records, or patient-specific facts.
Courts do not admit expert testimony simply because the expert has impressive credentials. Under Federal Rule of Evidence 702, expert testimony must be useful to the factfinder, grounded in enough facts or data, based on reliable methods, and reliably applied to the case facts. The 2023 amendment clarified that the proponent must show these requirements by a preponderance of the evidence.
Daubert also directs courts to examine reliability factors such as testing, peer review, error rate, standards, and general acceptance when those factors fit the testimony.
In medical device litigation, expert opinions may become vulnerable when they rely on:
These issues often surface during deposition or Daubert briefing. A report is easier to defend when it explains the data reviewed, the method used, the limits of the opinion, and the reasoning that connects the evidence to the conclusion.
Discovery should focus on records that show how the device was designed, marketed, cleared, approved, exempted, used, monitored, and investigated after the alleged injury.
Key evidence may include, depending on the device, claims, and available records:
Preserving the actual device can also be critical. If the device is lost, altered, repaired, discarded, or unavailable, attorneys may face more disputes over defect and causation opinions.
Discovery should also match the expert theory. A focused discovery plan gives experts the records they need to avoid speculation and helps attorneys test whether the theory is strong enough before expert reports are due.
Are FDA-cleared or FDA-approved devices immune from lawsuits?
Not automatically, and the answer depends on how the device reached the market. For PMA-approved devices, preemption is typically the first major defense because PMA establishes device-specific federal requirements under 21 U.S.C. § 360k. For 510(k)-cleared devices, courts following Lohr have generally found that the clearance process does not create device-specific requirements, so the same preemption defense is usually much harder to sustain. Even for PMA devices, claims that track existing federal requirements without adding any new obligations may survive, depending on how they are pleaded and the governing law.
What is the difference between 510(k) clearance and PMA approval?
A 510(k) submission focuses on substantial equivalence to a legally marketed predicate device. Through PMA, FDA reviews Class III devices to determine whether the evidence supports safety and effectiveness for the device’s intended use.
Why are experts so important in medical device cases?
Experts help connect technical evidence to legal issues, including design, FDA compliance, warnings, human factors, software issues, clinical causation, and damages. In many cases, more than one expert may be needed.
What makes a medical device expert vulnerable to exclusion?
Common problems include weak methodology, incomplete record review, unsupported causation opinions, failure to address alternative causes, and opinions outside the expert’s discipline.
When should attorneys retain a medical device expert?
Early in the case. Experts can help counsel think through preservation issues, shape discovery, evaluate causation, identify missing records, and reduce admissibility risks.
FDA Regulation
Design Defect
Manufacturing Defects
Safety Warnings
Product Safety
Product Testing
Regulatory Issues
Causation Analysis
Expert Witness Insights by Area of Expertise
Expert Witness Insights by Area of Expertise