The legal framework governing product safety in the USA is discussed below.

Overarching Federal Laws and Regulations

Product safety

The Consumer Product Safety Act of 1972 (CPSA), 15 USC Section 2051 et seq

This legislation established the Consumer Product Safety Commission (CPSC), the independent federal regulatory agency charged with protecting the public from unreasonable risks of harm from consumer products. The CPSC is authorised to develop standards, issue recalls and ban products in the USA under certain circumstances.

The Consumer Product Safety Improvement Act of 2008 (CPSIA), Pub L 110–314, 122 Stat 3016

The CPSIA amended the CPSA. It provided new regulatory and enforcement tools, and authorised the CPSC to create SaferProducts.gov, a website database where the public can file and read complaints about products under the CPSC’s jurisdiction.

Amendment to the Consumer Product Safety Improvement Act of 2008, Pub L 112–28, 125 Stat 273 (2011)

The CPSIA was amended in 2011 to add requirements for SaferProducts.gov, including:

• expanding the information collected in product reports;
• defining the timing for posting the reports to the database; and
• expanding the CPSC’s authority and discretion to enforce product safety laws.

In addition, federal statutes impose safety and labelling requirements for specified products, such as:

• the Flammable Fabrics Act, 15 USC Section 1191 et seq;
• the Labeling of Hazardous Art Materials Act, 15 USC Section 1277;
• the Refrigerator Safety Act, 15 USC Section 1211;
• the Virginia Graeme Baker Pool and Spa Safety Act, 15 USC Section 8001 et seq;
• the Drywall Safety Act of 2012, 5 USC Section 553, 15 USC Sections 2058, 2063; and
• the Portable Fuel Container Act of 2020, 15 USC Section 2056d.

Industry-Specific Laws

Food and drugs

The Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), 21 USC Section 301 et seq

This law charges the Food and Drug Administration (FDA) with ensuring the safety of the USA’s food supply, cosmetics and the safety, efficacy and security of drugs, biological products and medical devices. The law protects the public from adulterated and misbranded products manufactured and sold in the USA.

The Food and Drug Modernization Act of 1997, Pub Law 105–115

The regulation of food, drugs, medical devices and cosmetics was reformed to include:

• off-label use of drugs and medical devices;
• risk-based regulation of medical devices;
• elimination of pre-market approval for food packaging; and
• monitoring healthcare claims for foods.

The Family Smoking Prevention and Tobacco Control Act of 2009 (TCA), Pub L 111–31, 123 Stat 1776

This law authorises the FDA to regulate the manufacture, distribution and marketing of tobacco products in the USA.

Transportation

The Federal Aviation Act of 1958, 49 USC Section 40101 et seq (repealed and recodified in 1994)

The Federal Aviation Act of 1958 established the Federal Aviation Agency (FAA) to provide for the safe and efficient use of national airspace and to regulate safety in the aviation industry.

The National Traffic and Motor Vehicle Safety Act (VSA) of 1966, Pub L 89–563, 80 Stat 718

This law establishes federal motor vehicle safety standards (FMVSS) for all new domestic and imported vehicles, addresses concerns about tyre safety, and requires manufacturers to notify consumers of safety-related defects and pay for the repairs.

The Highway Safety Act of 1970, 23 USC Section 401 et seq

This law established the National Highway Traffic Safety Administration (NHTSA) and charged it with setting and enforcing safety performance standards for motor vehicles and related equipment, and with investigating safety defects in motor vehicles.

The Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act, 49 USC Sections 30101–30170

The TREAD Act requires vehicle and equipment manufacturers to periodically report to the NHTSA safety recalls in the USA and safety campaigns in foreign countries, and to report information that could indicate the existence of a potential safety defect. The Act imposes criminal liability on vehicle manufacturers that intentionally violate reporting requirements.

Toxic substances

The Toxic Substances Control Act of 1976 (TSCA), 15 USC Section 2601 et seq

The TSCA granted the Environmental Protection Agency (EPA) the power to impose reporting, record-keeping and testing requirements, as well as restrictions relating to chemical substances and mixtures. The TSCA addresses the production, importation, use and disposal of specific chemicals. Food, drugs, cosmetics and pesticides are excluded from the TSCA.

The Lautenberg Chemical Safety Act, Pub L 114–182, 130 Stat 448 (2016)

The Lautenberg Act revised the TSCA to permit more rigorous vetting of chemicals before they are allowed on the market, and updated the EPA’s risk analysis for chemicals already on the market, including a risk-based safety standard that excludes cost considerations.

The Asbestos Information Act of 1988, 15 USC Section 2607(f), Pub L 100–577, 102 Stat 2901

This law requires companies that make certain asbestos-containing products to report production to the EPA.

Children’s safety

Several federal statutes address safety measures for products dangerous to children:

• the Federal Hazardous Substances Act of 1960, 15 USC Section 1261 et seq;
• the Poison Prevention Packaging Act of 1970, 15 USC Section 1471 et seq;
• the Child Safety Protection Act, Pub L 103–267, 108 Stat 722 (1994);
• the Children’s Gasoline Burn Prevention Act, 5 USC Section 553, 15 USC Section 2058 (2008);
• the Child Nicotine Poisoning Prevention Action of 2015, 15 USC Section 1471 et seq;
• the Safe Sleep for Babies Act of 2021, Pub L 117–126, 136 Stat 1208;
• Reese’s Law, Pub L 117–171, 136 Stat 2094 (2022) (mandating federal safety requirements for button cell or coin batteries); and
• the Stop Tip-overs of Unstable, Risky Dressers on Youth (STURDY) Act, HR 2617 (2022) (imposing mandatory furniture tip-over standards).

Consumer protection

The Federal Trade Commission Act (FTCA), 15 USC Section 41 et seq

The FTCA established the Federal Trade Commission (FTC) and empowered it to:

• prevent unfair methods of competition or unfair and deceptive acts and practices affecting commerce;
• seek relief for conduct that harms the public; and
• prescribe rules defining and preventing unfair or deceptive acts or practices.

State laws

Product safety laws at the state level can vary widely and may be enforceable both by private action and through state attorneys general.

The main regulators of product safety in the USA are the CPSC, FAA, FDA, NHTSA, FTC and EPA. Their authority to regulate product and consumer safety is defined by statute.

CPSC

The CPSC regulates consumer products by developing standards and issuing recalls and bans on products in the USA under certain circumstances. Its regulations are set forth in the Code of Federal Regulations (CFR), Title 16.

FAA

The FAA regulates airworthiness standards for aircraft and aircraft equipment. Its regulations can be found in the CFR, Title 14.

FDA

The FDA regulates and safeguards food, cosmetics, drugs, biological products, medical devices and tobacco products. The FDA’s regulations are set forth in the CFR, Title 21.

NHTSA

The NHTSA regulates highway and vehicle safety, establishes and enforces FMVSS, and issues motor vehicle and component part recalls. The NHTSA regulations can be found in the CFR, Title 49.

FTC

The FTC investigates violations and enforces consumer protection laws and federal antitrust laws. FTC rules are published in the CFR, Title 16.

EPA

The EPA regulates chemical products, pesticides, airline emissions, and air and water quality standards. The EPA’s regulations are set forth in the CFR, Title 40.

Corrective action, such as product recalls, can be requested or required by the CPSC, FDA and NHTSA.

CPSC

If the CPSC makes a preliminary determination that a product defect creates a substantial risk of injury, corrective action is required. It classifies product dangers depending on the likelihood and severity of death, injury or illness as either Class A, Class B or Class C Hazards. Each Hazard Class requires corrective action, which may include a recall, public notice and remedies for consumers. Corrective action may also include steps to mitigate a potential hazard, such as changes to design, manufacturing materials, quality control, warnings or marketing, or discontinuing a product.

Companies must work with the CPSC to prepare a plan for communicating a recall to consumers. Requirements for recall notices are set forth in CFR Title 16, Section 1115.27. The CPSC has established the Fast-Track Product Recall Program, under which a company may avoid a preliminary determination by the CPSC that a product creates a substantial risk of injury if it reports the potential defect, meets other requirements for a timely recall, and works with the CPSC to implement a corrective action plan.

FDA

The FDA corrective action is largely voluntary and consists of either correction or recall. The FDA evaluates a potential health hazard based on factors set forth in CFR Title 21, Section 7.41, and assigns a recall classification (Class I, II or III) indicating the product’s relative degree of health hazard. Classes are assigned based on the likelihood and seriousness of a product’s adverse health impact. The company then submits a proposed recall strategy to the FDA consistent with the requirements set forth in CFR Title 21, Section 7.42, and communicates the correction or recall to consumers consistent with the requirements set forth in CFR Title 21, Section 7.49. The FDA will notify the public through its weekly Enforcement Report. See CFR Title 21, Section 7.50.

NHTSA

The NHTSA requires manufacturers to recall motor vehicles and component parts that fail to comply with FMVSS or that contain safety-related defects that pose an unreasonable risk to motor vehicle safety. Manufacturers have three options for correcting a defect: repair, replace or refund. If a recall is required, manufacturers must notify by first-class mail all registered owners and purchasers of the affected vehicles or components. The requirements for notification are set forth in CFR Title 49, Section 577.5.

The notification requirements concerning potential protect safety issues vary by agency.

CPSC

The CPSC mandates risk-based and incident-based reporting. Section 15 of the CPSA requires manufacturers, importers, distributors and retailers to notify the CPSC immediately if they receive information that reasonably supports the conclusion that a product:

• fails to comply with an applicable CPSC safety rule or law enforced by the CPSC;
• contains a defect that could create a substantial product hazard; or
• creates an unreasonable risk of serious injury or death.

Section 15 reporting requirements are found in CFR Title 16, Section 1115. Section 102 of the Child Safety Protection Act requires companies to report certain choking incidents involving children. Code of Federal Regulations Title 16, Section 1117 details the information that the manufacturer, distributor, retailer and importer should include in the report. Reports under either section must be made within 24 hours of receiving reportable information. If uncertain about whether information is reportable, an entity can conduct an investigation, not to exceed ten working days (with some exceptions). Section 37 of the CPSA requires manufacturers of consumer products to report information about settled or adjudicated civil actions after the third such action is terminated. Section 37 reporting requirements are found in CFR Title 16, Section 1116.

FDA

The FDA’s reporting requirements depend on the product at issue.

Drugs and biologics

Manufacturers, packagers and distributors of marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application are required to report all serious and unexpected adverse drug experiences (as defined by the CFR) associated with the use of their products within 15 days of receipt of this information. Reporting requirements are found at CFR Title 21, Section 310.305.

Biologic manufacturers must report serious and unexpected adverse events within 15 days of learning about the event. Requirements for the report are set forth in CFR Title 21, Section 600.80.

Devices

Manufacturers must report to the FDA within 30 days when they learn that a device has malfunctioned and would likely cause or contribute to causing serious injury or death if the malfunction reoccurs. See CFR Title 21, Section 803.50(a).

Device importers are required to report to the manufacturer of the imported device within 30 days a malfunction that would likely cause or contribute to causing serious injury or death. See CFR Title 21, Section 803.40(b).

Reporting requirements are set forth in CFR Title 21, Sections 803.42, 803.52. Manufacturers are also required to report within five days events requiring remedial action to prevent an unreasonable risk of substantial harm to public health. See CFR Title 21, Section 803.53.

NHTSA

The NHTSA requires risk-based and incident-based reporting.

Vehicle and equipment manufacturers must submit a Defect and Non-Compliance Information Report to the NHTSA within five working days of concluding that the equipment or vehicle poses a danger or fails to comply with FMVSS. Information required in the report is set forth in CFR Title 49, Section 573.6. Pursuant to CFR Title 49, Section 579.11, manufacturers must inform the NHTSA of safety recalls or campaigns in foreign countries within five days of deciding to conduct the recall or receiving notice from a foreign government that action is required.

The TREAD Act requires vehicle and equipment manufacturers to report periodically to the NHTSA on a variety of information that could indicate the existence of a potential product safety defect, and to advise the NHTSA of safety recalls or campaigns in foreign countries. Pursuant to 49 USC Section 30166(f), manufacturers are required to submit to the NHTSA copies of their communications about defects and non-compliance with FMVSS.

Penalties are set by law and imposed by agency or the US Department of Justice.

CPSC

Civil penalties are available if a company violates laws enforced by the CPSC. The maximum amounts allowed are USD120,000 for each violation, and USD17.15 million for any related series of violations. In November 2024, a wall bed manufacturer agreed to pay a USD16.025 million civil penalty for failing to report that its product could detach from the wall and create an unreasonable risk of serious injury to consumers. In January 2025, the CPSC provisionally accepted a settlement with a wearable device manufacturer for a USD12.25 million penalty for failing to report that the device could overheat and cause serious burns on consumers’ wrists.

FAA

The FAA may assess civil penalties up to USD400,000 against persons other than individuals and small businesses, and up to USD50,000 against individuals and small businesses, for violation of a law or statute enforced by the FAA. See 49 USC Section 46301; CFR Title 14, Section 13.18. Generally, the penalty for each violation ranges from USD1,100 to USD27,500, depending on the provision violated and the category of the alleged violator.

FDA

Civil and criminal penalties can be imposed on anyone who violates the FD&C. Civil penalties include warning letters, injunctions, seizure and civil fines. See 21 USC Sections 332, 334, 335b. Criminal penalties include imprisonment for up to one year, a fine of USD1,000, or both. See 21 USC Section 333(a).

The FD&C also imposes enhanced criminal penalties for prescription drug marketing violations, violations related to medical devices, and distribution of human growth hormone. See 21 USC Sections 333(b), 333(e), 333(f).

Civil penalties can also be imposed by the FDA pursuant to CFR Title 21, Section 17 et seq, for failing to submit clinical trial information or submitting false or misleading information. The FDA is also authorised to impose civil penalties for violating the TCA. In September 2024, the FDA filed civil complaints against two brick and mortar retailers and nine online retailers for the sale of unauthorised tobacco products, seeking USD20,678 from each retailer.

NHTSA

The VSA provides for civil penalties of up to USD21,000 per violation, and up to USD105 million for a related series of violations. See 49 USC Section 30165. Submitting false or misleading reports exposes companies to civil penalties of USD5,000 per day, and up to USD1 million for a related series of violations. Criminal penalties for falsifying or withholding information include fines or imprisonment for up to 15 years, or both. In November 2024, the NHTSA announced a consent decree with a vehicle manufacturer for failing to comply with federal recall requirements, which included a USD165 million penalty, the second-largest civil penalty in the NHTSA’s history.

EPA

The EPA can impose civil penalties of up to USD37,500 for violating the TSCA, criminal fines and injunctions. See 15 USC Section 2615. Criminal penalties can include:

• fines ranging from USD50,000 per day for individuals, and up to USD1 million per corporate violation of the TSCA;
• restitution; or
• incarceration ranging from one to 15 years (15 USC Section 2615).

FTC

The FTC can impose civil penalties for knowing rule violations, including injunctions and fines of up to USD10,000 per violation (15 USC Section 45).

Product liability is derived from state rather than federal law. There can be significant differences between the product liability law of individual states.

The primary causes of action in product liability cases are negligence, strict liability and breach of warranty. Other legal claims that may be applicable to product liability lawsuits include consumer protection, fraud and negligent misrepresentation. Claims can generally be asserted against anyone in the chain of commerce including a manufacturer, seller, distributor or retailer, even if a defendant was unaware of the defect at the time it left its control.

Negligence

A negligence claim focuses on the reasonableness of the defendant’s conduct and whether there was a breach of the duty of care. A defendant owes a duty of reasonable care in its design and manufacturing processes and in its provision of adequate product warnings.

The elements of a negligence claim are the following:

• the defendant owed a duty of care to the plaintiff;
• the defendant breached that duty;
• the breach caused the plaintiff’s injury; and
• the plaintiff sustained injuries or damages.

Strict Liability

Strict liability focuses on the product itself and not on the defendant’s intent or level of care. As such, even if a manufacturer is found to have exercised reasonable care, it may still be found liable under strict liability. Strict liability generally requires a showing that:

• the product was sold in an unreasonably dangerous condition when it left the possession and control of the manufacturer, seller, distributor or retailer;
• the product was materially in the same condition when it reached the plaintiff as it was when it left the defendant’s control; and
• the defect caused the plaintiff’s injury.

Breach of Warranty

Warranty claims may be based on:

• express affirmations of fact or promises made to buyers or lessees relating to the product;
• descriptions or samples of goods; or
• implied warranties of merchantability and for fitness for a particular purpose.

A breach of express warranty arises when a seller makes an express promise to a purchaser that the product will meet a certain standard and it fails to do so. The promises are often found in sales contracts but may exist when there are assurances or descriptions of product quality made to the purchaser.

A breach of implied warranty of merchantability occurs when the product is not fit for the purpose for which it is typically used. The plaintiff typically must prove that the defect in the product rendered it unfit for its ordinary and intended use.

An implied warranty of fitness for a particular purpose may arise where:

• the seller has reason to know of the particular purpose for which the goods are provided;
• the seller has reason to know that the buyer is relying upon its skill or judgement to furnish the appropriate goods; and
• the buyer does in fact rely on the seller’s skill or judgement.

Consumer Protection

Consumer protection statutes are often broad and encompass such business practices as:

• false or misleading advertising or labelling;
• breach of implied warranties;
• misrepresentations; and
• safety violations.

The statute will typically set forth the standard of proof. Many statutes require proof of intent and reliance on the misleading information or misrepresentation.

Fraud

To establish a fraud or intentional misrepresentation claim, a plaintiff must prove that:

• the defendant knowingly made a false or misleading representation about the product to induce the plaintiff into purchasing it;
• the plaintiff relied upon the misrepresentation when purchasing the product; and
• the plaintiff was damaged by the representation.

A finding of fraud or intentional misrepresentation may provide a basis for awarding punitive damages.

Negligent Misrepresentation

To prove a claim of negligent misrepresentation, the plaintiff must prove that:

• there was a false or misleading representation made about the product;
• the defendant should have known that the information was false or misleading;
• the plaintiff relied on the false or misleading representation; and
• the plaintiff was damaged as a result.

Unlike fraud, negligent misrepresentation does not require the plaintiff to prove that the defendant intended to mislead.

Types of Product Defect

Defects in manufacturing, design, packaging and product warnings can all give rise to liability. A manufacturing defect exists where the product differs from its intended design. A design defect exists where the product’s design is defective, such that all products manufactured and sold with the design are defective and foreseeable risks could have been limited or eliminated by a reasonable alternative design. A defective warning involves the failure to disclose foreseeable risks of the product or the failure to adequately warn of the product’s dangers. Failure to warn claims are typically asserted as negligence or strict liability claims.

The test for whether a product is defective varies among the states. Typically, states use the consumer-expectations test, the risk-utility test or a combination of both. Under the consumer-expectations test, a defect exists if the product is unreasonably dangerous, and the danger exceeds what an ordinary consumer would expect (Restatement (Second) of Torts: Product Liability Section 402(a)). Under the risk-utility test, the product is defective if the utility of the product is outweighed by the risk of injury (id).

A person claiming injury resulting from a defective product has standing to bring a product liability claim. The original purchaser of the product is not typically the only one with standing. In a “tort based” warranty action (ie, for personal injuries or property damage other than to the product itself), the plaintiff need not have bought or leased the product directly from the defendant, so long as the plaintiff is a person whom the defendant might reasonably have expected to use, consume or be affected by the product. See Theos & Sons, Inc v Mack Trucks, Inc, 431 Mass 736 (2000).

Whether a plaintiff can bring derivative damage claims in a product liability action typically depends on the law of the state where the action is filed. For example, a spouse or child may be permitted to bring a loss of consortium claim (for loss of care, guidance and comfort) in certain states. Wrongful death or survivor statutes, which also vary by state law, define when heirs or administrators can bring actions on behalf of the decedent’s estate. Certain states permit claims for emotional distress for individuals who were not physically injured by a product if they were in the “zone of danger” and witnessed someone else being injured.

The time limits within which an action may be brought depend on the cause of action and jurisdiction. Statutes of limitations can range from one to six years. Some states have specific statutes for bringing a product liability action. In the absence of such a statute, the time limit for the cause of action controls this.

Most states have adopted the discovery rule, which means that the statute of limitations will not begin to run until the plaintiff discovers, or reasonably should have discovered, the injury, cause and/or wrongful conduct of the defendant. There is variation in the application of the discovery rule among the states that have adopted it. Many states require discovery of the injury and cause to trigger the statute. Other states require only that the plaintiff discover the injury. Certain states require that the plaintiff discover the facts essential to prove each element of the cause of action.

State Court Jurisdiction

To maintain a suit against the defendant, the court in which the case is brought must have personal jurisdiction over the defendant. Personal jurisdiction includes both general and specific jurisdiction.

General jurisdiction

A state court has general jurisdiction to hear all claims over a party where it is incorporated or has its principal place of business in that state. In 2023, the US Supreme Court in Mallory v Norfolk Southern Railway Co, 600 US 122 (2023) held that state statutes requiring consent to general jurisdiction as a condition for doing business in that state do not violate due process. The court’s ruling opens up the potential for corporations to be sued in any state in which they conduct business.

Specific jurisdiction

Specific jurisdiction only allows a court to hear a particular case against a party. The US Supreme Court in Bristol-Myers Squibb Co v Superior Court of California, 582 US 255 (2017) clarified the scope of specific jurisdiction. Specific jurisdiction requires “an affiliation between the forum and the underlying controversy, principally, [an] activity or an occurrence that takes place in the forum State” (id at 264). Multi-plaintiff product actions with non-resident plaintiffs face jurisdictional hurdles when they are brought in courts of states where the defendant is not headquartered or incorporated and where the alleged incident did not occur.

In 2021, the US Supreme Court further delineated where lawsuits can be filed under the doctrine of personal jurisdiction. The court held that plaintiffs could file suit against a defendant where the defendant had cultivated and served a market in a state, even if there was no direct link between the product causing the injury and the forum state (Ford Motor Company v Montana Eighth Judicial District Court et al, 592 US 351, 362 (2021)).

Federal Court Jurisdiction

Federal courts have “federal question” jurisdiction over cases arising under the US Constitution, federal laws or treaties (28 USC Section 1331). Federal courts also have “diversity jurisdiction” in cases where each plaintiff is from a different state or foreign country than each defendant and the amount in controversy exceeds USD75,000 (28 USC Section 1332(d)). In diversity jurisdiction, the federal court where the suit is filed must have specific jurisdiction over at least one party.

If federal jurisdiction prerequisites are not met, claims must be brought in the state court that has jurisdiction.

In general, there are no pre-action requirements to bring a product liability claim. Many jurisdictions, however, require a party asserting a warranty claim to provide the opposing party reasonable notice of the breach of warranty upon discovering the breach (UCC Section 2-607). The notice requirement exists to provide the allegedly breaching party with an opportunity to cure the breach. The notice requirement is typically not a prerequisite for bringing a breach of warranty claim, but the failure to provide reasonable notice may be asserted as an affirmative defence to the claim. In some jurisdictions, the filing of the lawsuit is sufficient notice to the defendant.

Once an entity “reasonably anticipates” becoming party to a litigation or the target of a governmental investigation, it has a common law duty to preserve all potentially relevant documents and tangible things, including electronically stored information, that may be discoverable in that litigation or investigation.

This duty extends to materials within a party’s possession, custody or control and materials it created, revised, sent, received or changed, and applies regardless of where the party has physical custody of the materials. In product liability cases, parties may also be required to preserve tangible things such as the allegedly defective product.

The standards for appropriate preservation of evidence include reasonableness, proportionality and accessibility. A legal hold should be promptly implemented if it could be credibly argued that either an investigation or litigation involving the materials at issue is likely. Fed R Civ P 37(e) governs the potential consequences if a legal hold is not properly implemented or adhered to.

The scope and timing of discovery in federal court is governed by Fed R Civ P 26. State court discovery rules and practice are similar to the federal rules but often have their own nuances. Rule 26(b)(1) defines the scope of discovery as “any non-privileged matter that is relevant to any party’s claim or defence and proportional to the needs of the case”. Proportionality requires an assessment of “the importance of the issues at stake in the action, the amount in controversy, the parties’ relative access to relevant information, the parties’ resources, the importance of the discovery in resolving the issues, and whether the burden or expense of the proposed discovery outweighs its likely benefit”.

Fed R Civ P 34 governs the production of documents and tangible things, whether in physical documents, electronic records and data, records of communications (physical, email, text, recordings, etc), or physical objects such as the product itself. Fed R Civ P 45 addresses the procedures for obtaining documents from a non-party through the service of subpoenas. In a product case, typical non-parties include the plaintiff’s employer, prior owners of the product, and healthcare providers.

Expert witness testimony in federal court is governed by Federal Rules of Evidence 702 and 703. Amendments to Rule 702 that went into effect on 1 December 2023 clarify the standard for the admissibility of expert testimony.

The Amended Rule 702 states that a witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if the proponent demonstrates to the court that it is more likely than not that:

• the expert’s scientific, technical or specialised knowledge helps the trier of fact understand the evidence or determine a fact at issue;
• the testimony is based on sufficient facts or data;
• the testimony is the product of reliable principle and methods; and
• the expert’s opinion reflects a reliable application of the principles and methods to facts of the case.

Rule 703 provides that an expert may base an opinion on facts or data in the case that the expert has been made aware of or personally observed.

While certain information that an expert relies on in forming their opinions may not need to be admissible, if the facts or data would otherwise be inadmissible, the proponent of the opinion may disclose them to the jury only if their probative value in helping the jury evaluate the opinion substantially outweighs their prejudicial effect.

Federal Standard for Admissibility of Expert Testimony

Amended Rule 702 emphasises the judge’s role as gatekeeper for expert testimony and articulates the standard for admission of expert testimony. The amendment clarifies that the party offering expert testimony must establish all criteria by a preponderance of the evidence. In other words, an expert’s methods must be “more likely than not” reliable.

The new language also emphasises the judge’s role in limiting an expert’s opinion to that which reflects a reliable application of the principles and methods to the facts of the case, because jurors may lack the specialised knowledge to make that determination.

Courts assess several factors in determining reliability of an expert’s methodology, including:

• whether the theory is testable;
• whether the theory is subject to peer review and publication;
• whether there is a known or potential error rate; and
• whether the theory is generally accepted in the field.

Courts applying the Daubert standard typically apply additional factors identified by the Ninth Circuit Court of Appeals in Daubert on remand: “whether the experts are proposing to testify about matters growing naturally and directly out of research they have conducted independent of the litigation, or whether they have developed their opinions expressly for purposes of testifying because the former provides important, objective proof that the research comports with the dictates of good science” (Daubert v Merrell Dow Pharm Inc, 43 F3d 1311, 1313 (9th Cir 1995)).

Frye Standard

Some state courts apply the Frye standard rather than Daubert when assessing the admissibility of expert testimony. Expert testimony is admissible under Frye if the expert’s methodology is generally accepted by experts in that particular field. See Frye v United States, 293 F 1013 (DC Cir 1923). Experimental methodology or methodology that is not well recognised is generally not admissible.

The plaintiff who asserts a product liability action bears the burden of proving their claims against the defendant(s). Each element of the claim must be proven by a preponderance of the evidence. The failure to prove any element of a cause of action by a preponderance of the evidence is fatal to the claim. In some states, there is a heightened burden of proof for establishing punitive damages including “clear and convincing evidence” and “beyond a reasonable doubt”. A defendant bears the burden of proving the affirmative defences they raise during the lawsuit.

In some states, plaintiffs are required to prove the existence of a feasible alternative design. See Evans v Daikin North Am, LLC (D Mass 2019).

Product liability cases are typically brought in district court in the federal system and in the state trial courts. Product liability cases are most often tried before juries; however, the parties can agree to proceed with a bench trial before a judge. Some states require the plaintiff to affirmatively claim for jury trial, and the failure to do so may waive the party’s right to a jury trial.

In a jury trial, the judge will preside over the trial and rule on all motions, including those for a directed verdict. A directed verdict motion asserts that the plaintiff has failed to meet their burden of proof at trial.

There are no unique appellate procedures for product liability cases. In federal court cases, a party may appeal a final decision to a regional Circuit Court of Appeal. A decision is final when the court enters a final judgment (either through ruling on a dispositive motion or following a verdict). See Fed R Civ P 58. In some instances, a party may appeal a district court’s ruling through an interlocutory appeal. The Federal Rules of Appellate Procedure and local rules of individual Circuit Courts of Appeal govern the appeal process. The appellate court will issue a ruling based on its review of the record, the parties’ appellate briefs, and oral argument.

To challenge an appellate court ruling (or a state supreme court’s ruling if there is a federal question), a party can file a writ of certiorari to the US Supreme Court. The Supreme Court has discretion to grant or deny such petitions.

In state court, there is typically a trial court, intermediate appellate court and high court. The appellate procedure is governed by the individual state’s rules of appellate procedure.

Affirmative defences to product liability claims are typically governed by state law and vary among jurisdictions. The defendant’s burden of proving an affirmative defence is by a preponderance of the evidence. The following are among the most common affirmative defences to product liability claims.

Comparative/Contributory Negligence

Most states follow comparative negligence principles, which means that the damages awarded will be apportioned based on the parties’ respective percentages of fault. The most common comparative negligence schemes are the pure and modified approaches. Under the pure comparative negligence rule, the plaintiff’s recovery is reduced by their percentage of fault. For example, if the plaintiff is 70% responsible for their damages, their recovery will be reduced by 70%. Under the modified comparative negligence rule, the plaintiff is barred from recovery if they are found more than 50% at fault. A small number of states follow the contributory negligence rule, which means that the plaintiff cannot recover if they are found any amount at fault.

Many states have rules or statutes that further define the scope of the comparative negligence defence. For example, in Massachusetts, the plaintiff’s comparative negligence is not a defence to a breach of implied warranty claim unless the plaintiff voluntarily and unreasonably proceeded to encounter the defect.

Assumption of the Risk

The assumption of the risk defence precludes recovery where a plaintiff voluntarily used a product when they were aware, or should have been aware, of a defect or other risk of harm, and nevertheless proceeded despite having that knowledge.

Material Alteration

The plaintiff is barred from recovery under this defence when it is established that the product was not in materially the same condition at the time of the incident as when it left the control of the defendant, and the alteration or modifications caused the injury.

Unforeseeable Misuse

The plaintiff is barred from recovery when they misuse the product in a manner unforeseeable to the manufacturer or seller, and the misuse causes the injury.

Sophisticated User/Learned Intermediary

The sophisticated user defence protects a manufacturer or product seller from liability for failure to warn when the end user knows or reasonably should know of the product’s risks.

Under the learned intermediary doctrine, a product manufacturer may in some circumstances rely on the knowledge of a “learned intermediary” who has received an appropriate warning. This doctrine is most applicable in the prescription drug and medical device context.

Federal Pre-Emption

Certain state law claims may be pre-empted and barred by a federal statute governing a particular product. Federal law pre-empts state law if:

• it is expressly stated by Congress;
• the state law conflicts with federal law; or
• Congress has indicated that a certain area is not subject to state law.

Product cases in which the defence is typically raised are prescription drug and motor vehicle defect cases.

While compliance with regulatory standards is typically something the jury can consider in assessing the conduct of the defendant, it does not preclude a finding of negligence when reasonable conduct would suggest that additional precautions were warranted. The failure of a manufacturer to comply with applicable federal standards can be evidence of a breach of duty or negligence per se.

Compliance with regulatory standards is relevant to rebut a claim that the manufacturer’s conduct warrants the imposition of exemplary or punitive damages.

Under the “American Rule”, each party is typically responsible for bearing its own litigation costs. There are exceptions to this rule, many of which vary by state. Many state rules allow recovery of certain litigation costs from the losing party. Certain state statutes may allow for recovery of attorney’s fees and litigation costs if a plaintiff prevails in a particular type of claim. For example, under the Massachusetts consumer protection statute (MGL c 93A), a breach of implied warranty is a per se violation of the statute entitling the plaintiff to their attorney’s fees and costs.

The availability of “offers of judgment” under both the federal rules and certain state rules and statutes provides a potential avenue to recovering litigation expenses. Under Fed R Civ P 68, a party can make an offer of judgment to the other party at least 14 days before trial. If the opposing party rejects the offer and the final judgment is less than the offer, the opposing party must pay the litigation costs incurred by the party making the offer incurred after the date of the offer.

Contingency fee arrangements are the typical manner in which injured plaintiffs pursue product liability claims. In these arrangements, the plaintiff’s counsel will receive a percentage of the award or settlement in addition to litigation expenses if there is a recovery. When there is no recovery, the lawyer receives no fee or reimbursement for expenses.

Third-party litigation funding arrangements in which a non-party funds the lawsuit in exchange for a portion of any recovery continues to be a growing trend in personal injury litigation.

Multi-district litigation (MDL) was created by statute and has as its primary purpose establishing a centralised forum where related cases pending in federal court are consolidated so that co-ordinated pretrial proceedings can occur in an efficient and effective manner. Pretrial proceedings include pretrial motions and discovery. The objectives for an MDL proceeding are many, and include reducing litigation costs through more efficient discovery, avoiding conflicting rulings and schedules among court proceedings, streamlining key issues and moving cases towards a resolution – either through trial, motions or settlement. State courts may permit consolidated proceedings involving similar claims of product defect.

Class action proceedings are available in federal court if the prerequisites of Fed R Civ P 23 are met. Product liability and personal injury actions are rarely appropriate for class action proceedings because they require an individualised assessment of causation and injury, making it difficult to satisfy the requirements of Fed R Civ P 23.

In Re: Social Media Adolescent Addiction/Personal Injury Products Liability Litigation, MDL No 3047 (Pending Matter)

This ongoing case exemplifies the recent trend in which traditional product liability theories are applied to personal injuries alleged to have resulted from an intangible product. In this matter, product defect and failure to warn claims are asserted against social media platforms, alleging that platform algorithms are “products” that can lead to addiction and poor mental health outcomes in adolescents. The case has implications for how courts will adapt product liability claims to new technologies and non-physical “products”.

Smith & Wesson Brands, Inc, et al v Estados Unidos Mexicanos, 23-1141 (Decided 5 June 2025)

In March 2024, the US Supreme Court heard oral arguments on the appeal of a First Circuit decision that the Protection of Lawful Commerce in Arms Act (PLCAA) did not immunise manufacturers from claims by Mexico that they were responsible for supplying cartels with firearms through their advertisements and failure to the stop the flow of firearms from their downstream dealers to the cartels. Mexico argued that its claims fall within a narrow exception to the statute that prohibits firearms manufacturers from claiming immunity if they have committed violations of state or federal law applicable to the sale or marketing of firearms. The US Supreme Court held that Mexico’s complaint did not plausibly allege that the manufacturers aided and abetted unlawful sales by gun dealers and the PLCAA barred the lawsuit.

Bondi v VanDerStok, 145 S Ct 857 (2025)

In March 2025, the US Supreme Court upheld a Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) rule interpreting the Gun Control Act of 1968 to cover “ghost guns”, firearms without serial numbers that are unregulated and untraceable. In a 7-2 decision, the court ruled that the ATF is authorised to regulate weapons parts and unfinished components that can be “readily converted” into functional firearms. This case is expected to assist federal, state and local governments in combating gun violence, and may result in future rule-making or legislation addressing gun safety and regulation.

Nuclear Verdicts

Nuclear verdicts, or jury verdicts that exceed USD10 million, have seen a marked increase over the past decade. Shifting juror attitudes and demographics, litigation tactics that inflate case values and seek high punitive damages, and social inflation have exposed product manufacturers to greater risk of significant adverse verdicts. 

Nuclear verdicts are typically driven by a jury’s determination on the value of non-economic and punitive damages. Non-economic damages can be distinguished from damages that can be verified or reasonably calculated, such as past and future medical costs or lost earnings. Some jurisdictions in the USA have laws that cap punitive damages, but amount and the circumstances under which these damages may be limited vary by state. Nuclear verdicts have tended to be more prevalent in certain jurisdictions, which has made them target forums for plaintiffs to initiate litigation. The nuclear verdict potential can impact a product manufacturer’s viability and the development of new products. Product manufacturers should be aware of the risk of a nuclear verdict in almost any personal injury case and plan to mitigate that potential with well-developed defences for trial.

Public Health-Related Litigation and Settlements

Lawsuits relating to public health issues continue to be a significant source of litigation across the USA.

Ultra-processed foods are being targeted in litigation as addictive to children and allegedly causing chronic disease. In December 2024, a lawsuit was filed in state court against 11 manufacturers accusing the manufacturers of using aggressive marketing to sell addictive substances. Scientific support for the legal theories and causation are expected to be significant issues in the prosecution and defence of the claims.

Claims relating to PFAS (so-called forever chemicals) typically involve claims relating to water supply contamination, environmental harm, or exposure to PFAS through the use of certain products. PFAS litigation also involves state actors, and billions of dollars in settlements have been paid through the end of 2024. The scope of these settlements and role of state actors reflect the trend of litigation directed against product makers associated with public health issues impacting significant populations.

Other examples of public health-related litigation include tobacco control, gun violence and lead paint.

Artificial Intelligence (AI)

Recent years have seen a significant increase in the use of generative AI globally and across industries, which has raised numerous legal and ethical considerations. Law firms and businesses continue to navigate how to utilise the enormous potential of AI while appropriately implementing it to address concerns, including professional ethics compliance and the adequate safeguarding of private client data.

The speed of AI’s development, implementation and adoption present challenges to existing legal and regulatory regimes, as does its nature as a non-physical “product” with generative capabilities. The Unites States currently has no legislation or comprehensive regulatory regime to address AI. Policy has been primarily advanced through Executive Orders, and continues to evolve. In this environment, courts will be asked to adapt traditional legal principles to claims that blame AI systems for adverse outcomes. Notable affected areas include:

• consumer protection (AI misleading consumers);
• data protection, privacy and IP (what data can be used by AI or to train AI); and
• cybersecurity issues (misuse/abuse of AI tools).

Given the evolution of policy priorities on AI and their expected impact on the development and implementation of AI systems, private sector companies utilising AI should monitor these developments.

Legal Challenges to Federal Agency Discretion After Chevron

On 28 June 2024, the US Supreme Court overturned Chevron USA Inc v Natural Resources Defense Council Inc, a 40-year-old precedent under which courts generally deferred to federal agency interpretations of ambiguous statutes under their purview, so long as the interpretation was reasonable. This approach was discarded in Loper Bright v Raimondo and Relentless v Dept of Commerce. Courts may now exercise their independent judgement when deciding whether a federal agency has appropriately exercised its authority, and are no longer required to defer to an agency’s interpretation of an ambiguous statute. This ruling does not call into question past decisions that relied on the Chevron framework.

The policy implications of removing the “interpretive methodology” of Chevron are significant. Federal agencies will face more challenges to their statutory interpretations, and challengers will have a better chance of prevailing without courts affording deference to an agency’s interpretation. The abrogation of Chevron will impact regulatory issues and their adjudication across industries as well as expand the role of the courts in this process.