The Product Regulation and Liability Review: USA

Introduction to the product liability framework

Product liability in the United States is complex and constantly evolving, governed by distinct legal systems in each of the 50 states and the federal government. Each state has developed its own constitutional and statutory framework and its own common law through decisions by the courts. Owing to the peculiarities of the US federalist system, product liability lawsuits sometimes end up in federal courts, which must nonetheless apply the applicable state's law of product liability. Many industries are heavily regulated by the federal government and federal regulations. All this leads to a complex, interesting, and sometimes confusing, interaction between state and federal law. Fortunately, many of the most important principles of product liability are similar throughout these jurisdictions. This chapter contains an overview of these principles, without purporting to describe every statute, regulation or common-law rule that may apply in a given product liability lawsuit.

As a general matter, US product liability law, in its current state, favours the right of an injured consumer to sue. The litigation environment in the United States for product manufacturers may present greater potential exposure and liability concerns than elsewhere.

Regulatory oversight

The federal government has created a number of administrative agencies to regulate product safety. Among the most prominent are the Consumer Product Safety Commission, which, as the name suggests, oversees the safety of consumer products;2 the Food and Drug Administration (FDA), which, inter alia, regulates the marketing and labelling of food and prescription drugs;3 the National Highway Traffic Safety Administration, which regulates motor vehicle safety;4 the Federal Aviation Administration, which governs all aspects of air transportation;5 the Federal Railroad Administration, which oversees trains and railways;6 and the Occupational Safety and Health Administration, which was created to prevent injuries in the workplace.7 Under certain circumstances, the rules and regulations promulgated by these federal agencies may pre-empt conflicting state law, barring an otherwise viable product liability claim.8 Each state may also have its own laws, agencies and regulations governing some aspects of product safety.

Causes of action

i Strict liability

Strict liability is one of the most common and plaintiff-friendly causes of action. It is recognised in the vast majority of states either through common law or by statute. A plaintiff asserting strict liability need not prove fault by the manufacturer; that is, a manufacturer can be liable even if it acted reasonably in designing and manufacturing the product and followed all applicable procedures and protocols, but nonetheless ended up producing a product later adjudged 'defective'.9

To prevail on a claim of strict liability, a plaintiff must generally show the following elements: the product contained a defect; the defect existed at the time the product left the manufacturer's control; the defect rendered the product unreasonably dangerous; and the defect actually and proximately caused the plaintiff's injuries.10

Generally, there are three types of defects for which a manufacturer may be strictly liable: a defect in manufacture, a defect in design and a defect in labelling.11 To prove a manufacturing defect, a plaintiff must show that a product became unreasonably dangerous because it did not meet manufacturing specifications or deviated from the great majority of otherwise identical products with the same design.12 In determining whether a design defect exists, most courts apply a risk-utility analysis, weighing the benefits and utility of a product's design against its resultant risks.13 Some courts also apply a 'consumer expectations' test, according to which a product's design is defective if the product fails 'to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner'.14

Causation is a necessary element of any strict product liability claim. In toxic tort cases, a plaintiff must prove both 'general causation' – that a particular substance is capable of causing the injury at issue – and 'specific causation' – that the substance did in fact cause the particular injury of this particular plaintiff.15 In all product liability cases, the plaintiff must also prove 'proximate' or 'legal' causation (i.e., that the injury was a reasonably foreseeable consequence of a product defect or wrongful act).16 Notably, a product defect or wrongful act need not be the sole cause of the injury, as long as it is a significant proximate cause. There may well be other contributing causes of the injury.17

Sometimes, a plaintiff will allege that a product defect enhanced, rather than caused, the injury.18 Such claims are commonly referred to as 'enhanced injury', 'second-collision', or 'crashworthiness' claims,19 and are premised on the theory that accidents (e.g., car crashes) are foreseeable with certain products and manufacturers must take reasonable steps to design and produce products that will 'minimise the unavoidable danger'.20 A crashworthiness plaintiff need only show that 'the defective product was the proximate cause of the enhanced injuries – not the proximate cause of the accident itself'.21

ii Negligence

To prove negligence, a plaintiff must show that the defendant owed a duty to the plaintiff; the defendant breached that duty; and the breach actually and proximately caused the plaintiff's injury.22 The primary difference between strict liability and negligence is that the latter requires a showing of fault, while the former does not. It is frequently stated that strict liability focuses on the condition of the product, while negligence focuses on the actual conduct of the manufacturer.23

As a general principle of tort law, every person has a duty to act 'reasonably'. In keeping with this principle, a manufacturer has a duty to design and construct products that are reasonably safe for their foreseeable uses.24 In addition, a non-manufacturing dealer or supplier of a product may have a duty to inspect a product if it knows or has reason to know that the product may be defective.25

Because a reasonable person will obey the law in most circumstances, a violation of a statute or regulation may constitute negligence in itself, or 'negligence per se'.26 The negligence per se doctrine does not impose strict liability, but merely reduces a plaintiff's burden of proof on the elements of duty and breach. A plaintiff who proves negligence per se must still establish that the defendant's statutory violation actually and proximately caused the injury.27

iii Failure to warn

An increasingly popular cause of action in product liability is the failure-to-warn claim, alleging that the manufacturer failed to provide an adequate warning of the dangers associated with its product. These claims may be premised on either strict liability or negligence.28 The exact elements needed to prove a failure-to-warn claim vary between states.29 Generally, however, a plaintiff must show that the manufacturer had a duty to warn and breached that duty, proximately causing the plaintiff's injuries.30

A manufacturer has a duty to warn consumers of dangers associated with the use of its products when the manufacturer knows or should know of such dangers.31 Sometimes, a product will contain a latent defect that does not manifest itself until months or years after the product is first sold. For this reason, a number of states impose a continuing duty on a manufacturer to warn of hazards that become known to the manufacturer after the sale.32 Importantly, many jurisdictions hold that manufacturers have no duty to warn of 'open or obvious' dangers in their products.33

iv Fraud or misrepresentation

A product liability plaintiff may allege that a manufacturer committed fraud or misrepresentation, either through affirmative acts, such as false advertising, or through non-disclosure, such as a failure to disclose a known defect. To prove intentional fraud, a plaintiff must typically establish a false representation (or, in some jurisdictions, omission) of a material fact; 'scienter', in other words, knowledge that the representation is false; intent to mislead; justifiable reliance on the misrepresentation or omission; and damages.34

Although many fraud-based product liability claims are grounded in common law, most states have also promulgated 'consumer protection' statutes that specifically prohibit misrepresentations in advertising, marketing or labelling, and grant private individuals a cause of action for such misrepresentations.35

v Breach of warranty

Actions for a breach of warranty are somewhat unique in the products liability context because they are governed largely by the law of contracts rather than torts. Most states have adopted some version of the Uniform Commercial Code (UCC), Article 2, which applies to contracts for the sale of goods and provides for both express and implied warranties. Implied warranties generate the most product liability litigation. The most important of implied warranties is that of 'merchantability', or fitness for 'ordinary use'.36 The implied warranty of merchantability has been stated to exist in every contract for the sale of goods if the seller is 'a merchant with respect to goods of that kind'.37 Of course, a seller may disclaim any implied warranties, for example, by conspicuously labelling the product 'as is'.38


i Forum

A plaintiff may bring a product liability claim in either state or federal court, although, for various reasons, plaintiffs generally prefer state courts.39 When a plaintiff files suit in state court, the defendant will sometimes 'remove' the case to federal court, provided the requirements for federal jurisdiction are met.40 Federal courts have limited jurisdiction and, broadly, will only hear cases that arise under federal law, such as the US Constitution or federal statutes; cases where the parties are 'diverse', that is, where the plaintiffs and defendants reside in different states, or where a plaintiff is suing a foreign country or foreign citizen; and admiralty cases, which include claims for injuries sustained on vessels on navigable waters.41 Importantly, when a federal court exercises diversity jurisdiction, the court applies federal procedural rules but state substantive law.42 In both state and federal courts, the plaintiff usually will be entitled to a trial by jury, though he or she may elect to try the case before a judge (also called a bench trial).43

The structure of court systems in the United States is as follows. In the federal system, each state contains one or more federal trial courts called 'district courts'. The losing party in the district court may appeal as of right to one of 13 federal appellate courts called 'circuit' courts of appeal.44 A party who loses in the circuit court of appeals may seek review in the US Supreme Court via a petition for a writ of certiorari, although the chances of obtaining review in the Supreme Court are quite low.45 State court systems vary widely as to their organisation, but most have a structure similar to the federal court system, with trial courts of general jurisdiction, intermediate appellate courts and, at the top of the pyramid, a state supreme court that reviews only a small number of cases.46

ii Burden of proof

In most civil cases, including product liability cases, a plaintiff must prove each element of a claim by a preponderance of the evidence.47 This standard 'directs the fact finder to decide whether the existence of a contested fact is more probable than its nonexistence', and 'where evidence weighs evenly on both sides in a controversy, the fact finder must resolve the question against the party who has the burden of proof'.48 In contrast, the defendant usually bears the burden to prove an 'affirmative' defence, such as a statute of limitations.49

iii Defences

Statutes of limitation and repose

A statute of limitations is a law that establishes a time limit for bringing a lawsuit.50 The length of time within which a plaintiff must bring suit (if at all) varies from state to state. Usually, limitation periods range from two to four years and begin to run upon the date the injury occurred or, in a number of states, the date the injury was, or should have been, discovered (the latter is known as the 'discovery rule').51 Some states also have statutes of 'repose', which are laws that bar a claim after a specified time period even if the plaintiff has not yet suffered an injury.52 Statutes of repose are generally longer, more final and less subject to exceptions than statutes of limitation. They usually begin to run from some date unrelated to the injury, such as the date of a product's manufacture.53 Some states do not apply statutes of limitations and repose to claims against the state or government agencies.54

Contributory negligence, assumption of risk and comparative fault

The doctrine of contributory negligence historically barred a plaintiff from any recovery if the plaintiff's own negligence contributed in any way to the injury.55 Closely related to this principle is the 'assumption of risk' doctrine, according to which persons who engage in certain dangerous activities, such as sports, are found to have consented – either directly or by implication – to the risks naturally arising from such activities. They therefore cannot recover for consequent injuries.56 More recently, however, most states have adopted some version of a 'comparative fault' system, either 'pure' or 'modified', in preference to the harsh consequences of the rules of contributory negligence and assumption of risk.57 Under comparative fault, a plaintiff whose negligence contributed to the injury can still obtain a partial recovery in proportion to his or her own fault.58 In a 'pure' comparative fault state, a plaintiff can recover damages even if the plaintiff's percentage of fault exceeds that of the defendant. In a 'modified' comparative fault jurisdiction, a plaintiff cannot recover any damages if the plaintiff's fault exceeds that of the defendant.59

Federal pre-emption and primary jurisdiction

Under the 'Supremacy Clause' of the US Constitution, federal law on the same subject takes precedence over state law.60 This rule of federal 'pre-emption' typically applies in three circumstances: when a federal statute specifically provides for pre-emption (express pre-emption); when federal law directly conflicts with state law and it is impossible to comply with both (conflict pre-emption); and when 'the scope of a federal statute indicates that Congress intended federal law to occupy a field exclusively' (field pre-emption).61 Pre-emption may play a vital role in product liability cases when the defendant's industry is heavily regulated by the federal government, as in the case of the aviation industry or the food and drug industries. For example, an airline may defend against a failure-to-warn claim by arguing that federal law occupies the entire field of aviation safety, thereby pre-empting any state-imposed liability.62 Or a drug manufacturer may defeat a design defect claim by arguing that federal regulations, which take precedence over conflicting state law, prohibited it from changing the design of its drugs.63

Other defences

Product alteration or misuse

Generally, a manufacturer will not be liable for injuries caused by a defective product if the plaintiff used the product 'in a manner which the manufacturer did not intend or reasonably anticipate'.64

State of the art

A manufacturer may rely on the state-of-the-art defence by presenting evidence that the product, even if defective in hindsight, conformed to the technological standards of the time in which it was made.65

Sophisticated user

Under the sophisticated user doctrine, a manufacturer has no duty to warn consumers of dangers associated with a product if the manufacturer reasonably believes that the consumer (e.g., an experienced professional) knows, or should know, of such dangers.66

Learned intermediary doctrine

According to the learned intermediary doctrine, a manufacturer does not have a duty to warn end consumers of product dangers if the manufacturer can reasonably rely on an intermediary, such as a prescribing physician in a pharmaceutical case, to provide such warnings.67 The manufacturer's duty runs solely to the learned intermediary (e.g., the prescribing doctor), not to the end patient or consumer.

Economic loss rule

Most states follow some version of the economic loss rule, pursuant to which manufacturers are not liable in strict liability or negligence if a defect causes only 'economic loss'; that is, damage to the product itself, without any other property loss or personal injury.68 In these states, damage to the product itself, such as diminished resale value, may be compensable under principles of contract, but not under tort law.69

Government contractor defence

A contractor hired by the government generally cannot be held liable for performing the contract 'in conformity with specifications established by the government'.70 This may be a form of pre-emption in federal contractor cases.71

Regulatory compliance

Evidence that a product complied with all applicable safety regulations may be helpful to show that the manufacturer acted reasonably in designing and manufacturing the product and that the product was not defective. Importantly, though, this defence, standing alone, will probably not absolve the defendant of liability absolutely.72

Employer immunity

Every state has enacted worker's compensation laws that provide the exclusive means of compensation for job-related injuries and shield employers from any resulting tort liability.73 However, employers can still be held liable for injuries caused by intentional torts or wilful misconduct.74

Lack of privity

Lack of privity (i.e., a direct contractual relationship between the defendant and plaintiff) is usually not a defence to tort claims premised on strict liability, negligence or fraud.75 A showing of privity may be required in some states, however, for a claim premised on a breach of contractual duty, such as breach of warranty.76

iv Personal jurisdiction

No court may exercise power over a defendant in the absence of personal jurisdiction. A defendant wishing to challenge personal jurisdiction must do so promptly at the beginning of the lawsuit, or else risk waiving this defence. The reach of personal jurisdiction is governed by the forum state's deliberately far-reaching 'long-arm' statute77 and the federal constitutional requirements of due process (i.e., whether it is 'fair' to subject someone outside the forum to the forum's legal power). At the most basic level, due process requires that the defendant have at least 'minimum contacts' with the forum state before being subject to personal jurisdiction in that state.78 The law of minimum contacts is constantly evolving, however, and recent US Supreme Court cases have placed stricter requirements on a court's ability to exercise personal jurisdiction over a claim – most notably, the US Supreme Court's 2017 decision in Bristol-Myers Squibb Co v. Superior Court.79 That said, some courts have found that personal jurisdiction will likely exist if a defendant transacts any business in the forum state, perhaps if only through a website, and the lawsuit is related to such a transaction.80 Importantly, a company may always be subject to personal jurisdiction in a state, regardless of what any particular lawsuit alleges, if the company is incorporated in that state or conducts substantial business there such that it is 'fairly regarded as at home' (also known as 'general' personal jurisdiction).81

v Expert witnesses

All jurisdictions in the United States allow expert witnesses – including those with no personal knowledge of the facts – to testify at trial. The use of experts is prevalent in product liability cases. Because the US legal system is adversarial in nature, each party is responsible for hiring its own experts to prove its case, and judges only rarely retain independent experts for assistance.82 As a result, product liability trials will often involve a 'battle of the experts', the outcome of which may dictate the jury's verdict.83

In federal courts, the admission of expert testimony is governed by Federal Rule of Evidence 702 (mirrored in many states' statutes or rules of procedure). Rule 702 allows a qualified expert to testify if the expert's testimony assists the trier of fact; is 'based on sufficient facts or data'; is 'the product of reliable principles and methods'; and involves a reliable application of those 'principles and methods to the facts of the case'.84 Before admitting expert testimony into evidence, the trial judge must ensure that the testimony 'both rests on a reliable foundation and is relevant to the task at hand'.85 Sometimes, a party will seek to bar the other's expert testimony on the grounds that the expert's methodology was scientifically unreliable.

vi Discovery

Parties in civil litigation in the United States are usually entitled to considerably broader discovery than elsewhere. Such discovery can often become time-consuming, expensive and sometimes case-dispositive as a result. In federal courts, discovery is governed by the Federal Rules of Civil Procedure,86 and may be obtained through a number of methods, including depositions, written interrogatories (usually limited to 25), requests for production of documents, requests for inspection of evidence or premises and requests for admissions.87 A party may also move the court to obtain a physical or mental examination of the other party.88

The scope of discovery is extensive. Parties may seek information 'regarding any non-privileged matter that is relevant to any party's claim or defense and proportional to the needs of the case'.89 In considering what discovery is 'proportional' to the needs of the case, courts must weigh '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'.90 Most states have modelled their procedural rules on the federal system and allow for similar methods and scope of discovery.91 Thus, in a product liability suit against a manufacturer, plaintiffs may ask for information on the product's design, prior recalls and other accidents, complaints or lawsuits involving the same type of product.92 Discovery is not limitless, however, and a party may (and usually will) object to requests for information or documents on a number of grounds, including that the requests are overly broad, unduly burdensome, seek irrelevant materials or seek information protected by the attorney–client privilege, attorney work-product doctrine or trade secret privilege.93

Judges in federal and state courts encourage parties to conduct discovery with minimal court supervision and to resolve discovery disputes among themselves. In the federal system, the district court will sometimes appoint a magistrate judge94 to preside over discovery matters. State and federal courts may also appoint a 'special master' to address unique or voluminous discovery issues.95

vii Apportionment

Joint and several liability

According to the principle of joint and several liability that governs product liability cases in many jurisdictions, if multiple defendants are found to be responsible for the plaintiff's injuries, each defendant is liable for the entire amount of damages but has a legal right to seek contribution from other defendants.96 Thus, a plaintiff may join all tortfeasors in one action and choose which one to pursue for recovery.97 It is then up to the defendant to seek (by agreement or legal process) contribution by other defendants. A majority of states have abolished the doctrine of pure joint and several liability in favour of apportioning damages based on each party's percentage of fault.98

Successor liability

Traditionally, a purchaser of a company's assets (rather than stock) is not liable for the seller's liabilities unless the successor company assumed the seller's liabilities via an express or implied agreement; the purchasing company effectively merged with the selling company; the transaction was fraudulent; or the buying company was a mere continuation of the seller.99 Some states have developed an additional exception in product liability cases – the 'product line' theory – according to which successor corporations inherit their predecessors' liability for product defects if they 'undertake the manufacture of the same products as the predecessor'.100 A parent company usually cannot be held liable for the torts of its subsidiary, or vice versa, unless the parent exerts such control over the subsidiary as to make it 'a mere adjunct, instrumentality, or alter ego' of the parent, or some other basis exists to pierce the corporate veil.101

Market share liability

The 'market share' principle of liability, adopted in a minority of states, can be applied if multiple companies produced identical products (e.g., generic drugs) and a plaintiff cannot identify the manufacturer of the particular product that caused the injury. In such cases, the plaintiff may join in the lawsuit all manufacturers of the product at issue. Then, each defendant 'will be held liable for the proportion of the judgment represented by its share of [the] market unless it demonstrates that it could not have made the product which caused plaintiff's injuries'.102 This theory has been sparingly applied by the courts. In the majority of product liability cases, there remains a burden on the plaintiff to prove that he or she was injured by the defendant's specific product.103

Contribution and indemnity

A buyer of goods that are slated for resale may enter into an indemnity agreement with the seller, whereby the seller agrees to indemnify the buyer for third-party product liability claims. Such agreements are generally enforceable and subject to the general contract laws of each state.104

viii Mass tort actions

Class actions

In product liability cases where the amount of damages suffered by each plaintiff is relatively small, a class action is often attractive as the only economically viable option for bringing a lawsuit. In federal courts, a class action may proceed only if the class is 'so numerous that joinder of all members is impracticable'; there are 'questions of law or fact common to the class'; the claims or defences of class representatives are 'typical of the claims or defenses of the class'; and the class representatives and their counsel can 'fairly and adequately protect the interests of the class'.105 Most states have similar requirements for class actions.106

Class actions filed against product manufacturers can be brought on behalf of consumers residing in a single state, multiple states or nationwide. While plaintiffs' counsel often will seek to increase a defendant's exposure by filing a multi-state or nationwide class action, such classes have come under increasingly stringent review in recent years. Specifically, courts have held that variations in state law may predominate over 'common' issues or may create significant manageability problems such that a class action is not superior to other available methods for fairly and efficiently adjudicating the controversy.

One of the most important developments in the law of class actions in the past two decades was the enactment of the Class Action Fairness Act of 2005 (CAFA).107 This statute expanded the scope of federal jurisdiction over class actions, making it easier for defendants to remove such actions from state to federal courts.108

Aggregated mass actions

Under federal law, when multiple civil actions, either class or individual, are filed in different federal districts but involve the same subject matter, these lawsuits may be consolidated in one district court for pretrial proceedings.109 This consolidation is referred to as multidistrict litigation (MDL) and is intended 'to provide centralised management of pretrial proceedings and to ensure their “just and efficient” conduct'.110 Actions may be transferred to an MDL either by a specially created judicial panel or by motion of a party.111 At the conclusion of pretrial proceedings, MDL cases are transferred back to their home districts for trial or other resolution.112 Many states also provide similar mechanisms for aggregating certain actions before a single judge for pretrial proceedings.113 One popular venue for aggregated mass tort actions is the Philadelphia Court of Common Pleas.114

Government actions

Sometimes, a state government (e.g., a state attorney general) will bring a product liability lawsuit against a manufacturer on behalf of the state's citizens.115 As recently explained by the Supreme Court, such lawsuits do not qualify as 'mass actions' under CAFA and thus are not removable to federal court, because they only have a single plaintiff – the state – not the 100 or more required under CAFA.116

ix Damages

Compensatory damages

As a primary method of recovery, most product liability plaintiffs will seek compensatory damages, which include both an economic and non-economic component. Economic or 'special' damages are those that are particular to each plaintiff, including 'out-of-pocket medical expenses, future medical expenses, lost wages and lost earning potential'.117 Non-economic or 'general' damages are those that plaintiffs are generally expected to incur in personal injury cases, such as mental suffering, inconvenience, loss of enjoyment or other losses of lifestyle.118 Some states impose caps on the amount of non-economic damages available to plaintiffs.119

Injunctive relief

In most states, to obtain an injunction, a plaintiff must show that there is no adequate remedy at law and that he or she will suffer irreparable harm in the absence of an injunction.120 Many product liability plaintiffs will not be able to show a need for an injunction because, by virtue of their lawsuits, they are already aware of dangers associated with a particular product defect or inadequate label and will be able to avoid those dangers in the future.121 Some states may allow injunctive relief in the form of medical monitoring when a plaintiff alleges exposure to dangerous substances but cannot prove a physical injury (such as cancer) because the disease has not yet manifested itself.122

Punitive damages

Punitive damages may greatly enhance a plaintiff's monetary recovery in a product liability case. Although states use a variety of different standards to determine the propriety of awarding punitive damages, most will allow such damages only upon a heightened showing of fault, such as intentional wrongdoing or conscious disregard for the safety of others.123 Most states will also require a plaintiff to establish the availability of punitive damages by 'clear and convincing evidence' – a higher standard of proof than the usual 'preponderance of the evidence' standard.124

Criminal prosecutions

Criminal prosecutions against individuals or companies, though possible, are relatively rare in the product liability context. When such prosecutions do occur, they usually target company executives or other high-level individuals for conspiracy, lying to government authorities, or committing other types of fraud or intentional misrepresentation, not for merely introducing a defective product to market.125 Notably, however, the Federal Food, Drug, and Cosmetic Act (FDCA) criminalises even the unintentional production or distribution of 'adulterated or misbranded' food, drugs and cosmetics.126

Year in review

Federal and state courts across the United States issued significant decisions in 2020 related to personal jurisdiction, pre-emption and liability for online sellers. The covid-19 pandemic also engendered important developments in product liability law, as the federal government issued emergency regulations to combat the pandemic and courts interpreted a federal statute that gives immunity to losses related to the administration of medical countermeasures. Although the pandemic delayed jury trials and forced courts and attorneys to adjust to remote work, the multidistrict litigation (MDL) related to the opioid crisis resulted in a significant class action decision that stalled an effort to resolve a significant number of cases brought by cities and counties throughout the country.

i Notable court decisions

Personal jurisdiction in class actions

Although the Supreme Court did not issue any watershed product liability decisions in 2020, three federal courts of appeals grappled with questions left open by the Supreme Court's 2017 Bristol-Myers Squibb Co v. Superior Court decision, which held that California courts lacked personal jurisdiction over the defendant in a mass tort action where the out-of-state plaintiffs' claims did not 'arise out of or relate to' the defendant's California-based activities.127 The Bristol-Myers Court did not address how its decision might impact class actions pending in federal court, but the Fifth, Seventh, and D.C. Circuits have now weighed in on that issue.

In Mussat v. IQVIA, Inc., the Seventh Circuit concluded that 'the principles announced in Bristol-Myers do not apply to . . . a nationwide class action filed in federal court under a federal statute'.128 There, the district court granted the defendant's motion to strike nationwide class allegations, concluding that the court lacked personal jurisdiction over the claims of the out-of-state putative class members.129 In addressing the personal jurisdiction issue, the court of appeals relied heavily on the fact that Bristol-Myers was based on 'settled principles' of personal jurisdiction and, long before that decision was rendered, federal courts routinely allowed nationwide class actions to proceed in states where the defendant was not subject to general jurisdiction.130 The court also emphasised that absent class members are treated as non-parties for purposes of diversity jurisdiction and that the same reasoning should apply for purposes of personal jurisdiction.131 The Fifth Circuit and D.C. Circuit addressed whether a defendant can strike the claims of out-of-state class members for lack of personal jurisdiction at the motion-to-dismiss stage or must wait for class certification. In Molock v. Whole Foods Market Group, Inc., the D.C. Circuit held that it was premature to assess personal jurisdiction over the claims of out-of-state class members before certification because putative class members are not considered parties before a class is certified, and personal jurisdiction 'entails a court's power over the parties before it'.132 Thus, the court deferred ruling on whether Bristol-Myers applies to multistate class actions in federal court. Similarly, in Cruson v. Jackson National Life Insurance Company,133 the Fifth Circuit held that a defendant does not waive the right to challenge personal jurisdiction over the claims of absent class members by not raising that argument in a motion to dismiss, provided that the defendant properly preserves the argument in its answer and through its subsequent litigation conduct. The court reasoned that a defendant cannot waive this argument at the pleading stage because waiver occurs only where an argument is 'available' under Rule 12.134 Citing Molock, the court concluded that this defence is not 'available' at the Rule 12 stage because the non-resident putative class members are 'not yet before the court' and do not become parties until class certification.135 The court held that Bristol-Myers did not alter this rule.136 The Molock and Cruson decisions may make it more difficult for defendants to obtain dismissal at the pleading stage of the claims of non-resident putative class members, though they leave open the question of how courts should assess personal jurisdiction of non-resident class members at the class certification stage. Ultimately, how courts resolve these issues will likely dictate whether product manufacturers will be subject to nationwide class actions in any state, or whether such class actions can only be brought in states in which the defendant is subject to general jurisdiction (i.e., their state of incorporation and principal place of business).


The Ninth Circuit addressed whether federal law pre-empts state law claims against medical device manufacturers in In re Bard IVC Filters Product Liability Litigation, holding that such claims can proceed for devices that are approved under a widely used FDA program.137 The Medical Device Amendments of 1976 (MDA) to the Food, Drug, and Cosmetic Act expressly pre-empt any state requirement that is 'different from, or in addition to,' any requirement applicable to the device under the Act.138 In 1996, in a case involving a device approved through an FDA process known as '510(k) clearance', the Supreme Court held that the MDA's express pre-emption provision did not bar the plaintiff's common law claims because the 510(k) process did not impose device-specific requirements (as required under the MDA to trigger pre-emption).139 In In re Bard, the defendant contended that the MDA pre-empted the plaintiff's common law claims even though the FDA approved its heart filters through the 510(k) process, since that process has changed since 1996 and resulted in the type of device-specific requirements for the defendant's filters that are necessary to trigger pre-emption.140 The Ninth Circuit disagreed, holding that the FDA did not impose the type of specific requirements on the devices that are necessary to trigger pre-emption.141 The Ninth Circuit's rejection of the pre-emption defence affirms that product manufacturers whose devices are approved through the 510(k) process face significant challenges in demonstrating that state-law claims are precluded by the MDA's pre-emption provision. That holding has broad ramifications given that the vast majority of medical devices are approved under the 510(k) process.142

The Supreme Court of Connecticut also issued a significant pre-emption decision in 2020. In Boone v. Boehringer Ingelheim Pharmaceuticals, Inc., the plaintiff took the defendants' anticoagulant drug, Pradaxa (approved by FDA in 2010), to lower the risk of blood clots.143 The plaintiff started taking the drug in November 2010 and then died from severe bleeding in March 2014.144 Later, in 2015, the defendants received FDA approval to sell a 'reversal agent' called Praxbind, which would have lowered the risk of uncontrolled bleeding.145 The plaintiff relied on these facts to support a design defect claim, alleging that the defendants should have sought approval for Praxbind at the same time they sought approval for Pradaxa.146 The defendants contended that federal law pre-empted this claim because marketing Praxbind in 2010 would have violated federal law, since it was not approved at that time.147 The trial court agreed and the Connecticut Supreme Court affirmed, concluding that because there was 'no dispute that Praxbind was not approved by the FDA until 2015, the defendants could not have satisfied their alleged state law duty to the decedent without marketing an unapproved drug in violation of federal law'.148 The court also rejected the plaintiff's argument that brand-name drugs like Pradaxa are subject to a different pre-emption test than generic drugs.149

Online retailer liability

State and federal appellate courts also addressed whether online retailers like Amazon can be considered 'sellers' of third-party products and therefore liable for defects in those products. In Bolger v., LLC, a California appellate court reversed the trial court's grant of summary judgment in favour of the company in a case involving the sale of an allegedly defective battery manufactured by a third-party and sold on Amazon's website. The court held that the 'doctrine of strict liability in California was intended to cut through' the formal definitions of 'seller' and 'distributor' that Amazon relied on to avoid liability.150 Focusing on the purposes of strict liability – to compensate plaintiffs for injuries caused by defective products – the court concluded that Amazon was 'an integral part of the overall producing and marketing enterprise', could be 'the only member of that enterprise reasonably available to the injured plaintiff', and may be 'in the best position to ensure product safety'.151 As the Fifth Circuit observed in McMillan v., Inc. when considering the same issue under Texas law, this question has 'potentially sweeping implications' given the significant growth in online retail (which has only increased as a result of the covid-19 pandemic).152 Given the importance of that issue, the Fifth Circuit certified the question to the Supreme Court of Texas, which accepted the certified question in January 2021.153 As McMillan suggests, state supreme courts and legislatures will likely have the final word on this issue. Indeed, in the wake of the Bolger decision, the California legislature introduced a proposed law that would make it easier for consumers to hold online retailers liable for defective products.154

State product liability law

The New Jersey Supreme Court issued another notable product liability ruling in 2020, holding that the New Jersey Products Liability Act (NJPLA) does not bar claims under the New Jersey Consumer Fraud Act (NJCFA) even if the claim sounds in product liability. In Sun Chemical Corporation v. Fike Corporation, Sun Chemical alleged that Fike made a series of misrepresentations in marketing its fire suppression system and brought a claim under the NJCFA, which has more expansive damages than the NJPLA.155 A federal district court rejected the NJCFA claim, concluding that Sun Chemical could not 'avoid the requirements of the [NJPLA] by artfully crafting its claims under the [NJCFA]'.156 However, the New Jersey Supreme Court (acting on a certified question) held that the two statutes 'are intended to govern different conduct and to provide different remedies for such conduct', which means there is 'no direct and unavoidable conflict between' the NJCFA and NJPLA.157 The court emphasised that the 'nature of the plaintiff's damages does not determine whether the cause of action falls under the [NJCFA or NJPLA]; rather, it is the theory of liability underlying the claim that determines the recoverable damages'.158 Given the larger amount of damages available under the NJCFA, plaintiffs injured in New Jersey will likely recast claims that sound in product liability as consumer protection claims. It remains to be seen whether other state courts will reach similar holdings when assessing the interplay between their respective product liability and consumer protection statutory regimes.

ii Federal laws and regulation

Given the enormous public health challenges posed by the covid-19 pandemic, it is not surprising that 2020 witnessed a massive deployment of federal lawmaking authority to combat the virus. Perhaps the most notable example impacting product manufacturers was the Secretary of Health and Human Services' (HHS) invocation of the Public Readiness and Emergency Preparedness Act (PREP Act).159 The PREP Act, which was enacted in 2005, allows HHS to provide immunity from liability to 'covered persons' for the administration of 'medical countermeasures', which include the manufacture and distribution of drugs or biological products (such as vaccines).160 Several district courts have already interpreted the scope of PREP Act immunity. One court held that the PREP Act declaration 'covers the administration and distribution of products meant to curb the spread of covid-19', but does not 'cover more generally the care received by patients in healthcare facilities'.161 The court concluded that the PREP Act is 'designed to protect those who employ countermeasures, not those who decline to employ them'.162 As a result, the court ruled that the PREP Act did not bar negligence claims brought against a healthcare provider that allegedly failed to respond appropriately (i.e., employ countermeasures) to a covid-19 outbreak.163 Other courts have adopted this more limited view of PREP Act immunity.164 Given the continued spread of covid-19, PREP Act immunity will likely be extensively litigated as long as the HHS declaration remains in effect.

iii Multi-district litigation

Despite the delays in jury trials and other court proceedings, 2020 was an important year for the MDL pending in the US District Court for the Northern District of Ohio involving claims against pharmaceutical manufacturers and distributors for their alleged roles in the opioid crisis.165 For instance, in November three opioid distributors – McKesson Corp., Cardinal Health Inc. and AmerisourceBergen Drug Corp. – announced a US$21 billion settlement to end litigation with state attorneys general and local government plaintiffs.166

The opioid MDL also saw a significant ruling from the Sixth Circuit concerning a first-of-its-kind 'class' mechanism designed to facilitate the settlement of sprawling product liability claims involving numerous parties and stakeholders.167 Throughout the litigation, the MDL court repeatedly encouraged the local government plaintiffs (consisting of cities and counties) to settle with the defendants.168 To that end, 51 cities and counties moved to certify a 'negotiation' class: a novel procedural device developed by the appointed special master in collaboration with Harvard Law Professor William Rubenstein.169 The motion sought to include every city and county within the United States in the proposed class (approximately 34,458 municipalities).170 The proposed negotiation class provided the following procedural protections: an opt-out for prospective class members; a mathematical formula to allocate the settlement (so that prospective class members could estimate their recovery); and a requirement that any settlement receive super-majority approval from class members.171 The process was designed to eliminate a common impediment to class settlement; namely defendants' reluctance to enter into a settlement that may yield too many opt-outs and follow-on litigation.172 The district court certified the class, finding that it was not coercive (no defendant was forced to negotiate) and non-class members could proceed however they wished in terms of litigation or individual settlements. Only 556 of the 34,458 putative class members opted out.173

On appeal, the Sixth Circuit reversed the decision. It first determined that the defendants had standing to pursue the appeal because, even though they were not forced to negotiate with the class, the presence of the class 'fundamentally alter[ed]' the MDL by combining the entities into a single bloc.174 The court then held that the district court abused its discretion by certifying 'a new form of class action, wholly untethered from Rule 23' of the Federal Rules of Civil Procedure.175 Heeding the Supreme Court's admonitions against judicial inventiveness, the Sixth Circuit stated that 'district courts do not have the liberty to invent a procedure with no basis in the Rule's text, even absent language expressly prohibiting it'.176 It also rejected any comparison to settlement classes because Rule 23(e) permits certification only after a settlement is proposed.177 The court further rejected the district court's framing of the class as an 'issue class' because that characterisation 'papered over' predominance issues, given the disparate state claims.178 As the Sixth Circuit reasoned, the district court could not evade the predominance analysis 'by certifying a negotiation class based upon a few common federal issues, while at the same time empowering the class to negotiate settlement on virtually all claims brought by the class members', including those brought under state and local law.179 Notwithstanding a lengthy dissent focusing on the 'equitable heritage' of Rule 23,180 the Sixth Circuit denied en banc review. The court's rejection of the novel 'negotiation class' marked a victory for defendants, who might face significant pressure to settle if this type of class were to be allowed.


1 Chilton Davis Varner is a senior counsel, Madison Kitchens is a partner and Franklin Sacha is an associate at King & Spalding LLP.

2 See; see also Consumer Product Safety Act, 15 U.S.C. §§2051 et seq.

3 See; see also Food, Drug & Cosmetic Act, 21 U.S.C. §§301 et seq.

4 See; see also National Highway Traffic Safety Administration Authorization Act, 49 U.S.C. §§30101 et seq.

5 See; see also Federal Aviation Act, 49 U.S.C. §§40101 et seq.

6 See; see also 49 U.S.C. §§20101 et seq.

7 See; see also Occupational Safety & Health Act, 29 U.S.C. §651 et seq.

8 See discussion on pre-emption, Section IV.iii.

9 See, e.g., Myrlak v. Port Auth. of N.Y. & N.J., 723 A.2d 45, 52 (N.J. 1999); Greenman v. Yuba Power Prods., Inc., 377 P.2d 897, 900 (Cal. 1963). All participants in the product's chain of distribution may be strictly liable. See Restatement (Second) of Torts §402A, cmt. f (stating that the strict liability rule applies 'to any manufacturer . . ., to any wholesale or retail dealer or distributor, and to the operator of a restaurant'); Simon v. Nortrax N.E., LLC, 941 N.Y.S.2d 706, 708 (App. Div. 2012).

10 See, e.g., Sheehan v. N. Am. Mktg. Corp., 610 F.3d 144, 149 (1st Cir. 2010) (discussing Rhode Island law); Barton v. Adams Rental, Inc., 938 P.2d 532, 536–37 (Colo. 1997); Restatement (Second) of Torts §402A.

11 Labelling defects are discussed in Sections III.iii and III.iv.

12 See Am. Tobacco Co. v. Grinnell, 951 S.W.2d 420, 434 (Tex. 1997) ('[A] plaintiff has a manufacturing defect claim when a finished product deviates, in terms of its construction or quality, from the specifications or planned output in a manner that renders it unreasonably dangerous'); In re Coordinated Latex Glove Litig., 121 Cal. Rptr. 2d 301, 313 (Ct. App. 2002) ('A defective product is one that differs from the manufacturer's intended result or from other ostensibly identical units of the same product line'. (internal quotation marks omitted)); see also Rix v. Gen. Motors Corp., 723 P.2d 195, 200 (Mont. 1986) (defining a manufacturing defect as an imperfection that occurs 'in a typically small percentage of products of a given design as a result of the fallibility of the manufacturing process' (internal quotation marks omitted)).

13 See, e.g., Evans v. Lorillard Tobacco Co., 990 N.E.2d 997, 1012 (Mass. 2013); Warner Fruehauf Trailer Co. v. Boston, 654 A.2d 1272, 1278 (D.C. 1995). States use a variety of factors to determine whether utility outweighs risk, such as (1) the utility of the product to the public as a whole and to the individual user; (2) the nature of the product and the likelihood that it will cause injury; (3) the availability of a safer design; (4) 'the potential for designing and manufacturing the product so that it is safer but remains functional and reasonably priced'; (5) 'the ability of the plaintiff to have avoided injury by careful use of the product'; (6) the degree to which the plaintiff was aware of the product's potential danger; and (7) 'the manufacturer's ability to spread any cost related to improving the safety of the design'. Voss v. Black & Decker Mfg. Co., 450 N.E.2d 204, 208–09 (N.Y. 1983).

14 Perez v. VAS S.p.A., 115 Cal. Rptr. 3d 590, 603–04 (Ct. App. 2010); Delaney v. Deere & Co., 999 P.2d 930, 944–45 (Kan. 2000) (adhering to the consumer-expectations test and discussing the merits of that test as opposed to the risk-utility approach); see also Evans, 990 N.E.2d at 1012 ('The vast majority of States have adopted the risk-utility balancing test . . . rather than the consumer expectations test').

15 See Ranes v. Adams Labs., Inc., 778 N.W.2d 677, 687–88 (Iowa 2010); Richardson v. Union Pac. R.R. Co., 386 S.W.3d 77, 80 (Ark. Ct. App. 2011).

16 Jones v. Detroit Med. Ctr., 806 N.W.2d 304, 305 (Mich. 2011) (defining proximate cause as 'a foreseeable, natural, and probable cause' (internal quotation marks omitted)); Krause v. U.S. Truck Co., 787 S.W.2d 708, 710 (Mo. 1990) ('[F]rom the essential meaning of proximate cause arises the principle that in order for an act to constitute the proximate cause of an injury, some injury, if not the precise one in question, must have been reasonably foreseeable' (internal quotation marks omitted)).

17 See Stull v. Fuqua Indus., Inc., 906 F.2d 1271, 1277 (8th Cir. 1990) (holding that, under Missouri law, a lawnmower manufacturer could be held liable for the plaintiff's injury when the plaintiff 'encountered a swarm of bees just prior to the accident, moved to avoid the bees and then got his foot caught underneath the mower'); Jurado v. W. Gear Works, 619 A.2d 1312, 1318 (N.J. 1993) ('Even if a defect is a contributing or concurring cause, but not the sole cause, of an accident, the manufacturer will be liable').

18 See, e.g., Mazda Motor Corp. v. Lindahl, 706 A.2d 526, 529 (Del. 1998); Larsen, 391 F.2d at 501; Kupetz v. Deere & Co., 644 A.2d 1213, 1218–19 (Pa. Super. Ct. 1994).

19 Mazda Motor Corp., 706 A.2d at 530.

20 Huddell v. Levin, 537 F.2d 726, 735 (3d Cir. 1976); Larsen v. Gen. Motors Corp., 391 F.2d 495, 501–02 (8th Cir. 1968); Farmer v. Int'l Harvester Co., 553 P.2d 1306, 1315 (Idaho 1976) ('[I]t is . . . the manufacturer's duty to design and manufacture its products so as to eliminate unreasonable risks of foreseeable injury in the event of collision or other impact').

21 Mazda Motor Corp., 706 A.2d at 531.

22 See, e.g., Weigle v. SPX Corp., 729 F.3d 724, 731 (7th Cir. 2013) (discussing Indiana law); Glorvigen v. Cirrus Design Corp., 816 N.W.2d 572, 581–82 (Minn. 2012).

23 See, e.g., Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 833 (Neb. 2000).

24 Robinson v. Brandtjen & Kluge, Inc., 500 F.3d 691, 696 (8th Cir. 2007) (discussing South Dakota law); Sexton v. Bell Helmets, Inc., 926 F.2d 331, 335 (4th Cir. 1991) (discussing Kentucky law).

25 Dutchmen Mfg., Inc. v. Reynolds, 891 N.E.2d 1074, 1086 (Ind. Ct. App. 2008); Lind v. Beaman Dodge, Inc., 356 S.W.3d 889, 901 (Tenn. 2011) (stating that a failure-to-inspect action can be maintained only in negligence, not in strict liability); see also Duncan v. Ford Motor Co., 682 S.E.2d 877, 884 (S.C. Ct. App. 2009) ('A manufacturer who incorporates into his product a component made by another has a responsibility to test and inspect such component, and his negligent failure to properly perform such duty renders him liable for injuries proximately caused as a consequence').

26 Restatement (Second) of Torts §288B ('The unexcused violation of a legislative enactment or an administrative regulation which is adopted by the court as defining the standard of conduct of a reasonable man, is negligence in itself'); see also, e.g., Orthopedic Equip. Co. v. Eutsler, 276 F.2d 455, 460 (4th Cir. 1960) (stating that the Federal Food, Drug, and Cosmetic Act 'imposes an absolute duty on manufacturers not to misbrand their products, and the breach of this duty may give rise to civil liability').

27 See Heath v. La Mariana Apartments, 180 P.3d 664, 670 n.3 (N.M. 2008); Sikora v. Wenzel, 727 N.E.2d 1277, 1281 (Ohio 2000); Atl. Mut. Ins. Co. v. Kenney, 591 A.2d 507, 512 (Md. 1991).

28 As one court explained, a failure-to-warn claim based on negligence requires proof 'that a manufacturer or distributor did not warn of a particular risk for reasons which fell below the acceptable standard of care', but the 'rules of strict liability require a plaintiff to prove only that the defendant did not adequately warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution'. Carlin v. Superior Court, 920 P.2d 1347, 1351 (Cal. 1996). Many courts, however, do not recognise a distinction between negligence and strict liability in failure-to-warn cases. See, e.g., Ford Motor Co. v. Rushford, 868 N.E.2d 806, 810 (Ind. 2007) ('Under either [strict liability or negligence] a product may be defective . . . where the manufacturer fails in its duty to warn of a danger or instruct on the proper use of the product as to which the average consumer would not be aware'); Adeyinka v. Yankee Fiber Control, Inc., 564 F. Supp. 2d 265, 279 n.17 (S.D.N.Y. 2008) ('[W]here liability is predicated on a failure to warn, New York views negligence and strict liability claims as equivalent'. (internal quotation marks omitted)); Madsen v. Am. Home Prods. Corp., 477 F. Supp. 2d 1025, 1033 n.12 (E.D. Mo. 2007) ('The Iowa Supreme Court has abandoned any distinction between strict liability and negligence in products liability failure-to-warn cases'); Crislip v. TCH Liquidating Co., 556 N.E.2d 1177, 1183 (Ohio 1990) ('[T]he standard imposed upon the defendant in a strict liability claim grounded upon an inadequate warning is the same as that imposed in a negligence claim based upon inadequate warning').

29 In Florida, for example, a plaintiff must show that '(1) the warnings accompanying an item were inadequate, (2) the inadequacy of the warnings caused the plaintiff's injury, and (3) the plaintiff suffered an injury from using the product'. In re Fosamax Prods. Liab. Litig., 707 F.3d 189, 193 (2d Cir. 2013) (discussing Florida law); see also Fontenot v. Taser Int'l, Inc., 736 F.3d 318, 332 (4th Cir. 2013) (stating that, under North Carolina law, 'a claimant bringing a product liability action under a failure to warn theory must establish that the defendant's failure to provide an adequate warning or instruction was a proximate cause of the harm' (internal quotation marks omitted)). In Georgia, the plaintiff must show that 'the defendant had a duty to warn, that the defendant breached that duty, and that the breach proximately caused the plaintiff's injury'. Dietz v. SmithKline Beecham Corp, 598 F.3d 812, 815 (11th Cir. 2010) (discussing Georgia law). Sometimes, a failure-to-warn claim will be incorporated into a design-defect claim, as some states consider an inadequate warning to be a design defect. See Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2474–75 (2013) (discussing New Hampshire law).

30 See, e.g., Dietz, 598 F.3d at 815 (discussing Georgia law); Huggins v. Stryker Corp., 932 F. Supp. 2d 972, 986 (D. Minn. 2013).

31 See, e.g., Chrysler Corp. v. Batten, 450 S.E.2d 208, 211 (Ga. 1994); Bristol-Myers Co. v. Gonzales, 561 S.W.2d 801, 804 (Tex. 1978); Swift v. Serv. Chem., Inc., 310 P.3d 1127, 1131 (Okla. Civ. App. 2013).

32 See Robinson, 500 F.3d at 697–98 (8th Cir. 2007) (discussing South Dakota law); Hunter v. Werner Co., 574 S.E.2d 426, 431 (Ga. Ct. App. 2002) ('A negligent failure to warn claim may arise from a manufacturer's post-sale knowledge acquired months, years, or even decades after the date of the first sale of the product' (internal quotation marks omitted)); see also Restatement (Third) of Torts: Prod. Liab. §10 & cmt. a (discussing post-sale duty to warn, and recognising such a duty 'whether or not the product is defective at the time of original sale'). But see Jablonski v. Ford Motor Co., 955 N.E.2d 1138, 1160–61 (Ill. 2011) (noting that a manufacturer has a continuing duty to warn if it 'knew or should have known of the hazard' at the time of manufacture, but declining to adopt the broader rule in the Restatement (Third) of Torts: Prod. Liab. §10). The post-sale duty to warn may not last indefinitely, however. For example, one court held that a manufacturer of a printing press did not have a post-sale duty to warn of the risk of operating the machine, where the press was manufactured over 60 years before the injury. See Robinson, 500 F.3d at 697–98 ('Whatever the scope of the post-sale duty to warn, it does not extend to warning each individual employee of a company that owns a press some sixty-one years after the sale').

33 See, e.g., Zavala v. Burlington N. Santa Fe Corp., 355 S.W.3d 359, 374 (Tex. App.--El Paso 2011, no pet.); Martino v. Sullivan's of Liberty, Inc., 722 N.Y.S.2d 884, 885 (App. Div. 2001).

34 ReMax N. Atlanta v. Clark, 537 S.E.2d 138, 141 (Ga. Ct. App. 2000); Prospect Dev. Co. v. Bershader, 515 S.E.2d 291, 297 (Va. 1999). Notably, expressions of opinion, 'puffing' (exaggerated praise of a product), or predictions of future performance usually will not amount to fraud. In one recent Georgia case, for example, a manufacturer's representation that the allegedly defective trailers would 'never rust' in their lifetime and 'should have no problem remaining operable for 10 to 14 or 15 years' were 'mere opinions, expectations, and predictions of the future and thus could not serve as the basis for either a fraud or a negligent misrepresentation claim'. Home Depot USA., Inc. v. Wabash Nat'l Corp., 724 S.E.2d 53, 60 n.4 (Ga. Ct. App. 2012).

35 See, e.g., California Consumers Legal Remedies Act, Cal. Civ. Code §1750 et seq.; Florida Deceptive & Unfair Trade Practices Act, Fla. Stat. §501.201 et seq.; New York Deceptive Acts & Practices Act, N.Y. Gen. Bus. Law §349 et seq. Federal law also prohibits food, drug and cosmetic manufacturers from misbranding their products by using 'false or misleading' labels, 21 U.S.C. §§343(a), 352(a), 362(a), but does not grant a private cause of action for such violations, see Adventure Outdoors, Inc. v. Bloomberg, 552 F.3d 1290, 1295 (11th Cir. 2008).

36 UCC §2-314(1); 18 Williston on Contracts §52:78 (4th ed.).

37 UCC §2-314(1). A contract for sale may also contain an implied warranty of 'fitness for a particular purpose' if the seller 'has reason to know any particular purpose for which the goods are required', and the buyer relies 'on the seller's skill or judgment to select or furnish suitable goods'. Id. §315.

38 See UCC §2-316 ('[T]o exclude or modify the implied warranty of merchantability or any part of it the language must mention merchantability and in case of a writing must be conspicuous, and to exclude or modify any implied warranty of fitness the exclusion must be by a writing and conspicuous'); see also, e.g., Wis. Stat. Ann. §402.316 ('Unless the circumstances indicate otherwise, all implied warranties are excluded by expressions like “as is”, “with all faults” or other language which in common understanding calls the buyer's attention to the exclusion of warranties and makes plain that there is no implied warranty').

39 One reason for preferring state courts is that state courts have a reputation for favouring their own citizen-plaintiffs over large, out-of-state corporations. See Paul Rosenthal, 'Improper Joinder: Confronting Plaintiffs' Attempts to Destroy Federal Subject Matter Jurisdiction', 59 Am. U. L. Rev. 49, 57–58 (2009).

40 Federal 'removal' proceedings are governed by 28 U.S.C. §§1441 and 1446.

41 See 28 U.S.C. §1331 (governing federal question jurisdiction); 28 U.S.C. §1332 (governing diversity jurisdiction); 28 U.S.C. §1333 (governing admiralty jurisdiction); see also Admiralty Jurisdiction Extension Act, 46 U.S.C. §30101 and the Death on the High Seas Act, 46 U.S.C. §§30302–30308.

42 Gasperini v. Ctr. for Humanities, Inc., 518 U.S. 415, 426–28 (1996). Classifying a given rule as substantive or procedural 'is sometimes a challenging endeavor'. Id. at 427. Generally, however, 'procedural' rules are those governing the filing of pleadings, motions and discovery (i.e., the Federal Rules of Civil Procedure), while 'substantive' law includes the particular state law on strict liability, negligence, causation and various tort defences.

43 The Seventh Amendment to the US Constitution guarantees the right to a trial by jury in civil cases. U.S. Const. amend. VII. Although this constitutional right applies only in federal courts, see Minneapolis & St. Louis R.R. Co. v. Bombolis, 241 U.S. 211, 217 (1916), a vast majority of states also guarantee the right to a trial by jury in civil cases, see Aftercare of Clark Cnty. v. Justice of Las Vegas Twp., 82 P.3d 931, 933 (Nev. 2004) (discussing the right to a jury trial in Nevada); Eric J Hamilton, 'Federalism and the State Civil Jury Rights', 65 Stan. L. Rev. 851, 855–56 (2013).

44 For example, a party appealing from a decision of a district court in Florida, Georgia or Alabama will appeal to the US Court of Appeals for the Eleventh Circuit, and a party appealing from a district court in New York will appeal to the US Court of Appeals for the Second Circuit.

45 The Supreme Court typically has full discretion over which cases to hear and grants only a tiny fraction of certiorari petitions filed, usually in cases of exceptional importance or in cases of conflict between lower federal courts. For example, during the October 2015 term, the Court had a total of 7,535 cases on the docket, but heard oral argument in only 82 cases and reviewed and decided an additional 145 cases without oral argument. See Statistical Table, 'Supreme Court of the United States – Cases on Docket, Disposed of, and Remaining on Docket at Conclusion of October Terms, 2011 Through 2015', available at

46 There are exceptions. For example, the State of West Virginia does not have an intermediate appellate court and, until recently, there was no 'right' of appeal from the trial court, only a petition of certiorari to the West Virginia Supreme Court of Appeals, which that Court had the discretion to grant or deny. See Victor E Schwartz, 'Sherman Joyce and Cary Silverman, West Virginia as a Judicial Hellhole: Why Businesses Fear Litigating in State Courts', 111 W. Va. L. Rev. 757, 760–61 (2009). In 2010, the Supreme Court of Appeals adopted new rules that allow the Court to decide all appeals on the merits. See W. Va. R. App. P. 21 (effective 1 December 2010) (allowing the Court to decide appeals via a short 'memorandum decision'); id., clerk's cmt. (stating that, under Rule 21, 'every appeal, unless dismissed, will result in a decision on the merits'); see also West Virginia Judiciary, ('In 2010, the Supreme Court [of West Virginia] revised the rules of Appellate Procedure. The revised rules are an effective method of providing a full review and a decision on the merits in all properly prepared and filed appeals').

47 See, e.g., Gann v. Anheuser-Busch, Inc., 394 S.W.3d 83, 86 (Tex. App.--El Paso 2012, no pet.); Lawson v. Honeywell Int'l, Inc., 75 So. 3d 1024, 1027 (Miss. 2011).

48 People v. Taylor, 618 P.2d 1127, 1135 (Colo. 1980); see also In re B.D.-Y., 187 P.3d 594, 598 (Kan. 2008) (defining 'preponderance of the evidence' as 'evidence which is of greater weight or more convincing than the evidence which is offered in opposition to it' (internal quotation marks omitted)).

49 See Pension Trust Fund for Operating Eng'rs v. Mortg. Asset Securitization Transactions, Inc., 730 F.3d 263, 271 (3d Cir. 2013).

50 Black's Law Dictionary (9th ed. 2009).

51 For example, Florida provides a four-year limitations period for claims of negligence, fraud or injury to personal property and a two-year limitations period for wrongful death. Fla. Stat. §95.11(3)–(4). Florida's four-year statute of limitations in product liability cases 'begins to run “from the date that the facts giving rise to the cause of action were discovered, or should have been discovered with the exercise of due diligence”'. R.J. Reynolds Tobacco Co. v. Ciccone, 123 So. 3d 604, 610 (Fla. Dist. Ct. App. 2013) (quoting Fla. Stat. §95.031(2)(b)), approved in part, quashed in part on other grounds by 190 So. 3d 1028 (Fla. 2016). California and Oklahoma have a two-year statute of limitations for personal injuries caused by negligence. Cal. Civ. Proc. Code. §335.1; 12 Okla. Stat. Ann. §95.A. And New York and Wisconsin each have a three-year statute of limitations for personal injury. N.Y. C.P.L.R. §214.5; Wis. Stat. Ann. §893.54.

52 See Black's Law Dictionary (9th ed. 2009).

53 As one court explained, '[s]tatutes of limitations promote judicial economy and fairness, but do not create any substantive rights in a defendant to be free from liability'. Anderson v. United States, 46 A.3d 426, 437 (Md. 2012). Statutes of repose, on the other hand, are meant 'to provide an absolute bar to an action or to provide a grant of immunity to a class of potential defendants after a designated time period'. id. at 437–38; see also Combs v. Int'l Ins. Co., 354 F.3d 568, 589 n.11 (6th Cir. 2004) ('[A] statute of limitations might bar an injured plaintiff from bringing a product liability action more than three years after he discovered his injury, whereas a statute of repose would bar the action three years after the manufacturer produced the product'). Like statutes of limitations, statutes of repose differ from state to state. For example, Texas has a 15-year statute of repose for product liability cases. Tex. Civ. Prac. & Rem. Code §16.012(b) ('[A] claimant must commence a products liability action against a manufacturer or seller of a product before the end of 15 years after the date of the sale of the product by the defendant'). In Washington, the statute of repose is 12 years for product liability cases, but may be overcome with evidence that the product's useful safe life is longer than 12 years. Wash. Rev. Code §7.72.060; Lisby v. PACCAR, Inc., 316 P.3d 1097, 1100 (Wash. Ct. App. 2013).

54 See State v. Lombardo Bros. Mason Contractors, Inc., 54 A.3d 1005, 1023–24 (Conn. 2012); Ohio Dep't of Transp. v. Sullivan, 527 N.E.2d 798, 799, 801 (Ohio 1988); Okla. City Mun. Improvement Auth. v. HTB, Inc., 769 P.2d 131, 134 (Okla. 1988).

55 Li v. Yellow Cab Co., 532 P.2d 1226, 1230 (Cal. 1975); Restatement (Second) of Torts §467 ('Except where the defendant has the last clear chance [to avoid injury], the plaintiff's contributory negligence bars recovery against a defendant whose negligent conduct would otherwise make him liable to the plaintiff for the harm sustained by him').

56 Ross v. Clouser, 637 S.W.2d 11, 14 (Mo. 1982); Baccari v. KCOR, Inc., 971 N.Y.S.2d 458, 458 (App. Div. 2013); see also Anderson v. Ceccardi, 451 N.E.2d 780, 783 (Ohio 1983); Simmons v. Porter, 312 P.3d 345, 353 (Kan. 2013) (stating that a 'majority of comparative fault jurisdictions' have modified or abolished the assumption-of-risk doctrine).

57 See McIntyre v. Balentine, 833 S.W.2d 52, 57 (Tenn. 1992).

58 McIntyre, 833 S.W.2d at 57; see also Tegman v. Accident & Med. Investigations, Inc., 75 P.3d 497, 499 n.4 (Wash. 2003) ('Under proportionate liability a negligent party is liable for his or her own proportionate share of fault and no more' (internal quotation marks and alteration omitted)). The plaintiff may even recover a full amount, regardless of fault, if the defendant partly caused the injury through intentional or grossly negligent conduct. See Hampton Tree Farms, Inc. v. Jewett, 974 P.2d 738, 748 (Or. Ct. App. 1999).

59 For example, in Tennessee, a plaintiff may recover 'so long as a plaintiff's negligence remains less than the defendant's negligence . . .; in such a case, plaintiff's damages are to be reduced in proportion to the percentage of the total negligence attributable to the plaintiff'. McIntyre, 833 S.W.2d at 57; see also Brodsky v. Grinnell Haulers, Inc., 853 A.2d 940, 944 (N.J. 2004) ('A plaintiff's contributory negligence does not bar a recovery so long as that negligence 'was not greater than the negligence of the person against whom recovery is sought or was not greater than the combined negligence of the persons against whom recovery is sought'); Wilson v. Image Flooring, LLC, 400 S.W.3d 386, 396 & n.10 (Mo. Ct. App. 2013); Davis v. LeCuyer, 849 N.E.2d 750, 755–56 & n.5 (Ind. Ct. App. 2006).

60 U.S. Const. art. VI, cl. 2; Maryland v. Louisiana, 451 U.S. 725, 746 (1981).

61 Kurns v. R.R. Friction Prods. Corp., 132 S. Ct. 1261, 1265–66 (2012); see also Gade v. Nat'l Solid Wastes Mgmt. Ass'n, 505 U.S. 88, 108 (1992); Patriotic Veterans, Inc. v. Indiana, 736 F.3d 1041, 1049 (7th Cir. 2013). For an example of express pre-emption, see the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360k(a) ('[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement . . . which is different from, or in addition to, any requirement applicable under this chapter to the device').

62 See Montalvo v. Spirit Airlines, 508 F.3d 464, 468 (9th Cir. 2007) (holding that the Federal Aviation Act and the applicable federal regulations pre-empted plaintiff's failure-to-warn claims against various airlines); see also Kurns, 132 S. Ct. at 1264–68 (holding that the federal Locomotive Inspection Act was intended to 'occupy the entire field of regulating locomotive equipment', thereby pre-empting the plaintiff's state-law claims against a locomotive parts manufacturer alleging asbestos-related injuries).

63 See Bartlett, 133 S. Ct. at 2476–77. A state law tort suit brought by a private individual – not just a state statute or regulation – can trigger conflict pre-emption. See id.; Geier v. Am. Honda Motor Co., 529 U.S. 861, 881 (2000).

64 Black v. M & W Gear Co., 269 F.3d 1220, 1234 (10th Cir. 2001) (discussing Oklahoma law). As one judge put it, if 'a plaintiff undertakes to use his power saw as a nail clipper and thereby snips his digits, he will not be heard to complain'. Suter v. San Angelo Foundry & Mach. Co., 406 A.2d 140, 162 (N.J. 1979) (Clifford, J., concurring); see also Jurado, 619 A.2d at 1318 (N.J. 1993); Montgomery Ward & Co. v. Gregg, 554 N.E.2d 1145, 1156 (Ind. Ct. App. 1990); Higgins v. Paul Hardeman, Inc., 457 S.W.2d 943, 948 (Mo. Ct. App. 1970); Brown v. U.S. Stove Co., 484 A.2d 1234, 1241 (N.J. 1984) (holding that a heater manufacturer could be held liable for injuries resulting from the plaintiff's alteration of the heater, as the plaintiff's expert testified that 'it was commonplace to alter these heaters so they could generate more heat than that for which they were originally designed').

65 For example, the Kentucky Products Liability Act provides that, in a product liability action, 'it shall be presumed . . . that the product was not defective if the design, methods of manufacture, and testing conformed to the generally recognized and prevailing standards or the state of the art in existence at the time the design was prepared, and the product was manufactured'. Ky. Rev. Stat. Ann. §411.310(2); see also Iowa Code §668.12 (providing a state-of-the art defence). But see Kelley v. Hedwin Corp., 707 S.E.2d 895, 899 (Ga. Ct. App. 2011) ('A manufacturer's proof of compliance with industry-wide practices, state of the art, or federal regulations does not eliminate conclusively its liability for its design of allegedly defective products' (internal quotation marks omitted)); Murphy v. Chestnut Mountain Lodge, Inc., 464 N.E.2d 818, 823 (Ill. App. Ct. 1984) ('While it is true that the state of the art is not a defence to strict liability, evidence of the existence of feasible alternative designs is relevant and admissible in actions predicated on strict liability as well as those sounding in negligence' (citations omitted)); In re Haw. Fed. Asbestos Cases, 665 F. Supp. 1454, 1457 (D. Haw. 1986) (discussing Hawaii law and stating that the state-of-the-art defence was inadmissible in strict liability cases because 'the product's design is considered at the time of trial not at the time of manufacture').

66 Johnson v. Am. Standard, Inc., 179 P.3d 905, 910–11 (Cal. 2008); Humble Sand & Gravel, Inc. v. Gomez, 146 S.W.3d 170, 183 (Tex. 2004) ('When the foreseeable users of a product have special training, a supplier has no duty to warn of risks that should be obvious to them, even if persons without such training would not appreciate the risks'); Hines v. Remington Arms Co., 648 So. 2d 331, 337 (La. 1994); Restatement (Second) of Torts §388 cmt. k. For example, a chemical manufacturer may have no duty to warn a professional exterminator of dangers related to a commonly used pesticide. Cf., e.g., Johnson, 179 P.3d at 916 (holding that manufacturers of air-conditioning equipment had no duty to warn a heat, ventilation and air-conditioning technician of dangers associated with brazing refrigerant lines and exposure to phosgene gas).

67 See, e.g., Seifried v. Hygenic Corp., 410 S.W.3d 427, 432 (Tex. App.--Houston [1st Dist.] 2013, no pet.) ('[W]hen a drug manufacturer properly warns a prescribing doctor of the dangers of its product, the manufacturer is excused from warning each patient who receives the drug'); see also Bodie v. Purdue Pharma Co., 236 F. App'x 511, 521 (11th Cir. 2007) (holding that, under Alabama's learned intermediary doctrine, an allegedly inadequate drug label was not the proximate cause of the plaintiff's injury because the doctor prescribed the drug based not on the label, but on his own independent knowledge of the drug's risks and benefits). Sometimes the 'learned intermediary' doctrine is also referred to as a 'sophisticated user' intermediary doctrine. See Pfeifer v. John Crane, Inc., 164 Cal. Rptr. 3d 112, 130 (Ct. App. 2013).

68 Home Depot, 724 S.E.2d at 59; Corporex Dev. & Constr. Mgmt., Inc. v. Shook, Inc., 835 N.E.2d 701, 704 (Ohio 2005); Filak v. George, 594 S.E.2d 610, 618 (Va. 2004). As one court explained, economic loss 'means damages for the loss of the value or use of the defective product itself, costs of repair or replacement of the defective product, or the consequent loss of profits, unaccompanied by any claim of personal injury or damage to other property'. Home Depot, 724 S.E.2d at 59. The economic loss rule is usually not a defence to claims of intentional fraud or misrepresentation. Id. at 59; Peterson Grp., Inc. v. PLTQ Lotus Grp., L.P., 417 S.W.3d 46, 62 (Tex. App.--Houston [1st Dist.] 2013, pet. denied); see also Va. Transformer Corp. v. P.D. George Co., 932 F. Supp. 156, 163 (W.D. Va. 1996) (stating that 'the fraud exception to the economic loss rule' applies only to actual fraud, not constructive fraud).

69 See, e.g., Giddings & Lewis, Inc. v. Indus. Risk Insurers, 348 S.W.3d 729, 738 (Ky. 2011).

70 Banks v. Parish of Jefferson, 108 So. 3d 1208, 1222 (La. Ct. App. 2013).

71 See Boyle v. United Techs. Corp., 487 U.S. 500, 508–11 (1988).

72 Blueflame Gas, Inc. v. Van Hoose, 679 P.2d 579, 591–92 (Colo. 1984); Hernandez v. Badger Constr. Equip. Co., 34 Cal. Rptr. 2d 732, 756–57 (Ct. App. 1994) ('Compliance with regulations, directives or trade custom does not necessarily eliminate negligence but instead simply constitutes evidence for jury consideration with other facts and circumstances'). As one court explained, 'the focus in a strict liability claim is on the product itself, and not on the degree of care employed by the seller or distributor of the product'. Blueflame Gas, Inc., 679 P.2d at 591. Therefore, 'a product may be in a defective condition unreasonably dangerous to the user or consumer notwithstanding the supplier's compliance with a safety regulation related to that product'. id. at 591–92.

73 1 Modern Workers Comp. §100:1; see, e.g., Mich. Comp. Laws §418.131 (providing that Michigan's worker's compensation act 'shall be the employee's exclusive remedy against the employer for a personal injury or occupational disease'); Fla. Stat. §440.11 (stating that an employer's liability under Florida's worker's compensation scheme 'shall be exclusive and in place of all other liability'); see also Boston ex rel. Estate of Jackson v. Publix Super Markets, Inc., 112 So. 3d 654, 656 (Fla. Dist. Ct. App. 2013) ('The worker's compensation statutes provide a strict liability system of compensation for injured workers in which the worker receives the guarantee of rapid compensation for work related injuries but in return is precluded from bringing a common-law negligence action').

74 See, e.g., Lentz v. Young, 536 N.W.2d 451, 457 (Wis. Ct. App. 1995); Mich. Comp. Laws §418.131 (stating that the 'only exception' to the exclusive worker's compensation remedy 'is an intentional tort').

75 See, e.g., Ga. Code Ann. §51-1-11(a) ('[N]o privity is necessary to support a tort action'); Standard Chartered PLC v. Price Waterhouse, 945 P.2d 317, 339 (Ariz. Ct. App. 1996); Jim's Excavating Serv., Inc. v. HKM Assocs., 878 P.2d 248, 253 (Mont. 1994); see also Butler v. Turner, 555 S.E.2d 427, 431 (Ga. 2001) ('When a material fact is wilfully misrepresented to induce another to act and upon which the other acts, a cause of action is created in the injured party, and privity is not necessary to give rise to such a cause of action'); Velazquez v. Decaudin, 854 N.Y.S.2d 163, 167 (App. Div. 2008).

76 See, e.g., Ragone v. Spring Scaffolding, Inc., 848 N.Y.S.2d 230, 233 (N.Y. App. Div. 2007); Blake v. John Doe 1, 623 N.E.2d 1229, 1231–32 (Ohio Ct. App. 1993).

77 See, e.g., N.Y. C.P.L.R. §302 (New York's long-arm statute); Fla. Stat. §48.193 (Florida's long-arm statute); Cal. Civ. Proc. Code §410.10 (California's long-arm statute; allowing the exercise of jurisdiction 'on any basis not inconsistent' with the California Constitution or the US Constitution).

78 Int'l Shoe Co. v. Washington, 326 U.S. 310, 316 (1945); Burger King Corp. v. Rudzewicz, 471 U.S. 462, 474 (1985). For other important Supreme Court cases exploring personal jurisdiction, see Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017); Daimler AG v. Bauman, 134 S. Ct. 746 (2014); Asahi Metal Indus. Co. v. Superior Court, 480 U.S. 102 (1987); World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286 (1980); McGee v. Int'l Life Ins. Co., 355 U.S. 220 (1957).

79 137 S. Ct. 1773 (2017) (holding that California courts lacked personal jurisdiction over the defendant where the out-of-state plaintiffs' claims did not 'arise out of or relate to' the defendant's California-based activities).

80 See Burger King Corp., 471 U.S. at 475–76 (1985) (stating that personal jurisdiction exists where the out-of-state defendant 'deliberately has engaged in significant activities within a State, or has created continuing obligations between himself and residents of the forum' (citations and internal quotation marks omitted)). For example, the Eleventh Circuit held that a New York resident was subject to personal jurisdiction in Florida in a lawsuit alleging a trademark violation where the defendant operated an interactive website selling counterfeit goods and some Florida residents used the website to purchase those goods. Louis Vuitton Malletier, S.A. v. Mosseri, 736 F.3d 1339, 1355–1358 (11th Cir. 2013). One popular test for determining personal jurisdiction in internet cases was formulated in Zippo Mfg. Co. v. Zippo Dot Com, Inc., 952 F. Supp. 1119, 1123–24 (W.D. Pa. 1997). According to Zippo, 'the likelihood that personal jurisdiction can be constitutionally exercised is directly proportionate to the nature and quality of commercial activity that an entity conducts over the Internet'. id. at 1124. Thus, personal jurisdiction will exist where 'the defendant enters into contracts with residents of a foreign jurisdiction that involve the knowing and repeated transmission of computer files over the Internet', but not 'where a defendant has simply posted information on an Internet Web site which is accessible to users in foreign jurisdictions'. id. However, the above 'minimum contacts' standard is relevant only to 'specific' jurisdiction; that is, jurisdiction over a particular lawsuit that arises out of the company's contacts with the state. See Daimler AG, 134 S. Ct. at 754. If a company is incorporated in the forum state or maintains its principal place of business there, it may be subject to 'general' personal jurisdiction, meaning that it will be always subject to suit there, regardless of what any particular lawsuit alleges. See id. at 761.

81 See Daimler AG, 134 S. Ct. at 760.

82 However, see Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387, 1392–93 (D. Or. 1996) (appointing independent experts to advise the court on admissibility of expert testimony in litigation alleging injuries caused by silicone breast implants); see also Fed. R. Evid. 706 (governing court-appointed expert witnesses).

83 See Croskey v. BMW of N. Am., Inc., 532 F.3d 511, 516 (6th Cir. 2008).

84 Fed. R. Evid. 702; see, e.g., Del. R. Evid. 702; N.C. R. Evid. 702(a); Ariz. R. Evid. 702; Ga. Code Ann. §24-7-702(b); see also Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589–90 (1993); Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 147 (1999).

85 Daubert, 509 U.S. at 597. Litigants should be aware that proposed expert testimony must also be disclosed before trial. Fed. R. Civ. P. 26(a)(2). The framework for analysing the admissibility of expert witnesses stems from the 'Daubert trilogy', which consists of Daubert, General Electric Co. v. Joiner, 522 U.S. 136 (1997), and Kumho Tire Co., 526 U.S. 137. See Truck Ins. Exch. v. MagneTek, Inc., 360 F.3d 1206, 1209 (10th Cir. 2004). Daubert instructed the courts to consider four factors in determining the admissibility of expert testimony: whether the expert's theory or technique can be tested; whether the theory has been subjected to peer review and publication; the rate of error in the scientific technique; and whether the technique has been generally accepted in the scientific community. Daubert, 509 U.S. at 593–94. In Joiner, the Supreme Court held that a district court's admission or exclusion of expert testimony under Daubert can be overturned on appeal only if the district court had abused its discretion. Joiner, 522 U.S. at 141–43. In Kumho Tire Co., the Supreme Court held that Daubert applies not only to 'scientific' testimony, but to any expert testimony based on technical or other specialised knowledge. Kumho Tire Co., 526 U.S. at 141. Notably, not all states have adopted the Daubert approach to expert evidence and some continue to apply the earlier, narrower framework enunciated in Frye v. United States, 293 F. 1013 (D.C. Cir. 1923). Under the Frye approach, 'scientific evidence is admissible if the methodology that underlies the evidence has general acceptance in the relevant scientific community'. Grady v. Frito-Lay, Inc., 839 A.2d 1038, 1043–44 (Pa. 2003).

86 See Fed. R. Civ. P. 26–37.

87 Fed. R. Civ. P. 26, 30, 33, 34, 36. Importantly, under the federal rules, a party must make certain initial disclosures without awaiting a discovery request by the opposing party. Fed. R. Civ. P. 26(a).

88 Fed. R. Civ. P. 35.

89 Fed. R. Civ. P. 26(b)(1).

90 Fed. R. Civ. P. 26(b)(1).

91 See, e.g., Ill. St. S. Ct. R. 201 (allowing discovery through 'depositions upon oral examination or written questions, written interrogatories to parties, discovery of documents, objects or tangible things, inspection of real estate, requests to admit and physical and mental examination of persons'); Cal. Civ. Proc. Code §§2017.010, 2019.010.

92 See Smith v. BIC Corp., 869 F.2d 194, 200–201 (3d Cir. 1989); Uitts v. Gen. Motors Corp., 58 F.R.D. 450, 452–53 (E.D. Pa. 1972).

93 See Lamoureux v. Genesis Pharmacy Servs., Inc., 226 F.R.D. 154, 158–59 (D. Conn. 2004); 6 James Wm. Moore et al., Moore's Federal Practice §§26.41, 26.47, 26.60 (3d ed.); see also Martin H. Redish & Colleen McNamara, 'Back to the Future: Discovery Cost Allocation and Modern Procedural Theory', 79 Geo. Wash. L. Rev. 773, 779–80 (2011).

94 Unlike district court judges, circuit court judges and Supreme Court justices, federal magistrate judges (appointed by the subject district court) are not appointed under Article III of the Constitution. They have limited power to try cases, dependent on the consent of both parties. See Roell v. Withrow, 538 U.S. 580, 582 (2003) (stating that federal magistrate judges are authorised 'to conduct “any or all proceedings in a jury or non-jury civil matter and order the entry of judgment in the case”, as long as they are “specially designated . . . by the district court” and are acting “[u]pon the consent of the parties”.' (quoting 28 U.S.C. §636(c)(1)). Nonetheless, discovery matters and disputes in federal courts are frequently referred to magistrate judges.

95 A special master is a person 'specially appointed to help a court with its proceedings'. Black's Law Dictionary (9th ed. 2009). A special master 'may take testimony, hear and rule on discovery disputes, enter temporary orders, and handle other pretrial matters'. id.

96 See, e.g., Sehl v. Neff, 26 A.3d 1130, 1133–34 (Pa. Super. Ct. 2011); State v. Therrien, 830 A.2d 28, 36–37 (Vt. 2003).

97 See Therrien, 830 A.2d at 37.

98 See Jamerson v. Quintero, 313 P.3d 532, 534 (Ariz. Ct. App. 2013) (noting that the Arizona legislature generally abolished joint and several liability and that, 'in the usual case, each defendant “is liable only for the amount of damages allocated to that defendant in direct proportion to that defendant's percentage of fault”' (quoting Ariz. Rev. Stat. §12-2506)).

99 See Aguas Lenders Recovery Grp. v. Suez, S.A., 585 F.3d 696, 702 (2d Cir. 2009) (discussing New York law); Ray v. Alad Corp., 560 P.2d 3, 7 (Cal. 1977). Some courts apply a fifth exception: lack of adequate consideration in the transfer. See Fizzano Bros. Concrete Prods., Inc. v. XLN, Inc., 42 A.3d 951, 954 & n.2 (Pa. 2012).

100 Huff v. Shopsmith, Inc., 786 So. 2d 383, 387 (Miss. 2001); see also Ray, 560 P.2d at 11; Dawejko v. Jorgensen Steel Co., 434 A.2d 106, 110 (Pa. Super. Ct. 1981). Companies usually handle this issue through a contractual provision.

101 Duff v. Southern Ry. Co., 496 So. 2d 760, 762 (Ala. 1986); see also Robinson v. Terex Corp., 439 F.3d 465, 468 (8th Cir. 2006) ('A parent corporation is generally not liable for the debts of its subsidiaries, and the doctrine of piercing the fiction of corporate identity should be applied with great caution'); IDS Life Ins. Co. v. SunAmerica Life Ins. Co., 136 F.3d 537, 540 (7th Cir. 1998); John S. Allee et al., Product Liability §2.02[18] (2008).

102 Sindell v. Abbott Labs., 607 P.2d 924, 936–37 (Cal. 1980).

103 See, e.g., Holcomb v. Ga. Pac., LLC, 289 P.3d 188, 197 (Nev. 2012); Sutowski v. Eli Lilly & Co., 696 N.E.2d 187, 192 (Ohio 1998); Namm v. Charles E. Frosst & Co., 427 A.2d 1121, 1125 (N.J. Super. Ct. App. Div. 1981); see also Wood v. Eli Lilly & Co., 38 F.3d 510, 513–14 (10th Cir. 1994) (applying Oklahoma law); Mulcahy v. Eli Lilly & Co., 386 N.W.2d 67, 75–76 (Iowa 1986).

104 See Bradley v. Earl B. Feiden, Inc., 8 N.Y.3d 265, 274–75 (2007) ('When the intent is clear, an indemnification agreement will be enforced even if it provides indemnity for one's own or a third party's negligence'); Deminsky v. Arlington Plastics Mach., 657 N.W.2d 411, 420–21 (Wis. 2003) ('[A]greements to indemnify a party against its own negligence must be strictly construed, but so long as that standard is met, such agreements are valid').

105 Fed. R. Civ. P. 23(a).

106 See, e.g., Ala. R. Civ. P. 23; 735 Ill. Comp. Stat. §5/2-801.

107 28 U.S.C. §1332(d).

108 See Standard Fire Ins. Co. v. Knowles, 133 S. Ct. 1345, 1348 (2013) ('CAFA provides the federal district courts with 'original jurisdiction' to hear a 'class action' if the class has more than 100 members, the parties are minimally diverse, and the 'matter in controversy exceeds the sum or value of $5,000,000' (quoting 28 U.S.C. §1332(d)(2), (d)(5)(B))); see also Progressive W. Ins. Co. v. Preciado, 479 F.3d 1014, 1015 (9th Cir. 2007).

109 See 28 U.S.C. §1407.

110 United States ex rel. Pogue v. Diabetes Treatment Ctrs. of Am., Inc., 238 F. Supp. 2d 270, 273 (D.D.C. 2002).

111 28 U.S.C. §1407(c); In re Phenylpropanolamine (PPA) Prods. Liab. Litig., 460 F.3d 1217, 1230 (9th Cir. 2006).

112 See 28 U.S.C. §1407(a).

113 See Cal. Rule of Court 3.541 et seq.; Or. R. Civ. P. 32.K.

115 See Fla. Stat. §501.207(1)(c) (authorising state authorities to bring an actual-damages lawsuit on behalf of one or more consumers for a violation of Florida's Deceptive & Unfair Trade Practices Act); see also, e.g., Mississippi ex rel. Hood v. AU Optronics Corp., 134 S. Ct. 736, 740–41 (2014) (discussing a product liability action brought by the state on behalf of its citizens under Mississippi law).

116 AU Optronics Corp., 134 S. Ct. at 741–46.

117 See, e.g., Meals ex rel. Meals v. Ford Motor Co., 417 S.W.3d 414, 419 (Tenn. 2013); Kaiser v. Hardin, 953 So. 2d 802, 810 (La. 2007). Special damages may be determined with relative certainty and may only be awarded based on proof. See Kaiser, 953 So. 2d at 810.

118 See, e.g., Jenkins v. State ex rel. Dep't of Transp. & Dev., 993 So. 2d 749, 767 (La. Ct. App. 2008); Meals, 417 S.W.3d at 420; Meerscheidt v. State, 931 P.2d 220, 224 (Wyo. 1997); Restatement (Second) of Torts §904. Non-economic damages are difficult to quantify and plaintiffs are not required to prove their exact value. See, e.g., Meals, 417 S.W.3d at 420.

119 See, e.g., Mich. Comp. Laws §600.2946a (imposing a US$280,000 or US$500,000 cap on non-economic damages in product liability actions); Md. Code Ann. §11-108(b)(2) (imposing a US$500,000 cap on non-economic damages in actions for personal injury or wrongful death).

120 See Buetow v. A.L.S. Enters., Inc., 650 F.3d 1178, 1183 (8th Cir. 2011) (discussing Minnesota law); Levisa Coal Co. v. Consolidation Coal Co., 662 S.E.2d 44, 53 (Va. 2008); Sadat v. Am. Motors Corp., 470 N.E.2d 997, 1002–03 (Ill. 1984).

121 See Daniel S. Wittenberg, 'Impacts of the FDASIA and Recent Food and Drug Law Litigation', 2013 WL 5293063, at *9 (Aspatore 2013).

122 See, e.g., Stead v. F.E. Myers Co., Div. of McNeil Corp., 785 F. Supp. 56, 57 (D. Vt. 1990); Bocook v. Ashland Oil, Inc., 819 F. Supp. 530, 537 (S.D.W. Va. 1993) (stating that Kentucky would allow recovery for medical monitoring if the plaintiff shows 'some present physical harm, however slight'); John S. Allee et al., Product Liability §11.02[2A] (2008); Am. L. Prod. Liab. 3d §60:15.

123 For example, in Missouri, punitive damages may be awarded in a product liability suit 'if the jury finds that the defendant knew of the defect and danger of the product at the time it sold the product, and that the defendant thereby showed complete indifference to or conscious disregard for the safety of others'. See Sch. Dist. of Independence, Mo., No. 30 v. US Gypsum Co., 750 S.W.2d 442, 446 (Mo. Ct. App. 1988); see also Ehrhardt v. Brunswick, Inc., 231 Cal. Rptr. 60, 64 (Ct. App. 1986) ('Punitive damages may be awarded in a product liability action if it is shown that the defendant placed a product on the market in conscious disregard of the safety of consumers and others'). In Maryland, punitive damages may be awarded only if 'the plaintiff has established that the defendant's conduct was characterized by evil motive, intent to injure, ill will, or fraud, i.e., “actual malice”.' Owens-Illinois, Inc. v. Zenobia, 601 A.2d 633, 652 (Md. 1992); see also Masaki v. Gen. Motors Corp., 780 P.2d 566, 571 (Haw. 1989) ('[T]o justify an award of punitive damages, a positive element of conscious wrongdoing is always required. Thus, punitive damages are not awarded for mere inadvertence, mistake, or errors of judgment'. (citations and internal quotation marks omitted)). And, in New York, a plaintiff may obtain punitive damages by proving 'willful or wanton conduct which demonstrates a conscious disregard of the rights of others or conduct so reckless as to amount to such disregard'. Dubecky v. S2 Yachts, Inc., 651 N.Y.S.2d 602, 604 (App. Div. 1996) (internal quotation marks omitted).

124 See Ala. Code §6-11-20; Smith v. Brown & Williamson Tobacco Corp., 410 S.W.3d 623, 630 (Mo. 2013); Johnson v. Johnson, 747 S.E.2d 518, 523 n.4 (Ga. Ct. App. 2013).

125 See, e.g., 18 U.S.C. §1001 (criminalising the making of false statements in government matters); 49 U.S.C. §30170 (imposing enhanced criminal penalties for making false statements related to car defects).

126 See 21 U.S.C. §331(a)–(c), (k); United States v. Park, 421 U.S. 658, 672–73 (1975) (stating that the FDCA does not 'make criminal liability turn on awareness of some wrongdoing or conscious fraud' (internal quotation marks omitted)).

127 137 S. Ct. 1773 (2017).

128 953 F.3d 441, 443 (7th Cir. 2020).

129 id. at 443.

130 id. at 443–46.

131 id. at 447.

132 id. at 422 (quotation marks omitted).

133 954 F.3d 240 (5th Cir. 2020).

134 id. at 250.

135 id.

136 id. at 251.

137 969 F.3d 1067 (9th Cir. 2020).

138 Id. at 1072 (quoting 21 U.S.C. § 360k(a)) (alterations omitted).

139 Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996).

140 In re Bard IVC Filters Prod. Liab. Litig., 969 F.3d at 1074.

141 id. at 1075–76.

142 See FDA, Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernise FDA's 510(k) program to advance the review of the safety and effectiveness of medical devices (26 November 2018), available at (510(k) pathway represents '82 percent of the total devices cleared or approved').

143 335 Conn. 547, 551, 239 A.3d 1175, 1178–79 (2020).

144 id. at 551, 239 A.3d at 1179.

145 id. at 575–76, 239 A.3d at 1192–93.

146 id.

147 id. at 580, 239 A.3d at 1195.

148 id.

149 id. at 580–81, 239 A.3d at 1195–96.

150 Bolger v., LLC, 53 Cal. App. 5th 431, 456, 267 Cal. Rptr. 3d 601, 619 (2020), review denied (Nov. 18, 2020).

151 id. at 447–53, 267 Cal Rptr. 3d at 612–17.

152 McMillan v., Inc., 983 F.3d 194, 196 (5th Cir. 2020).

153 id.

154 See Alison Frankel, Amazon backs proposed Calif. Product liability law for online sellers (with conditions), Reuters, 25 August 2020,

155 243 N.J. 319, 326, 235 A.3d 145, 149.

156 id. at 326, 235 A.3d at 149.

157 id. at 335–36, 235 A.3d at 154.

158 id. at 339, 235 A.3d at 156.

159 42 U.S.C. § 247d; see also 85 Fed. Reg. No. 52, Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19 (17 March 2020), available at

160 85 Fed. Reg. No. 52, Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19 (17 March 2020), available at

161 Estate of Maglioli v. Andover Subacute Rehab. Ctr. I, No. CV 20-6605 (KM)(ESK), 2020 WL 4671091, at *9 (D.N.J. Aug. 12, 2020).

162 id.

163 id.

164 See, e.g., Lutz v. Big Blue Healthcare, Inc., No. 2:20-CV-2316-HLT-JPO, 2020 WL 4815100, at *7 (D. Kan. Aug. 19, 2020) ('Suffice it to say that the Court is not convinced that a facility using covered countermeasures somewhere in the facility is sufficient to invoke the PREP Act as to all claims that arise in that facility.').

165 In re: Nat'l Prescription Opiate Litig., No. 1:17-md-02804 (N.D. Ohio).

166 Kevin Stawicki, 'McKesson, 2 Other Distributors Ink $21B Opioid Settlement',, 3 November 2020, available at

167 In re Nat'l Prescription Opiate Litig., 976 F.3d 664 (6th Cir. 2020).

168 id. at 667.

169 id. at 667–68.

170 id.

171 id. at 667–69.

172 id. at 668.

173 id. at 669.

174 id. at 670.

175 id. at 672.

176 id. at 671 (quotation marks omitted).

177 id. at 672–73.

178 id. at 675.

179 id. at 676.

180 id. at 677 (Moore, J., dissenting).

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