Preemption of Drug and Medical Device Claims: A Legal Overview

Summary: The interaction between state tort laws and the federal regulation of medical devices and drugs has been a source of constant litigation in recent years. In the last two decades, the Supreme Court has issued several decisions concerning whether the Federal Food, Drug, and Cosmetic Act (FDCA) preempts state tort law. The results have been mixed: in some cases a person injured by an allegedly defective drug or device is barred from suing a manufacturer, whereas in other cases, the Supreme Court has allowed a lawsuit to proceed. Following these decisions, ambiguities exist concerning the scope of federal preemption in these medical device and drug cases.

Summary: With respect to medical devices, state-law tort claims brought against device makers are restricted by a provision of the FDCA that expressly preempts state "requirements" that are "different from, or in addition to" federal requirements applicable to a device and that "relate[] to the safety or effectiveness of the device." The Supreme Court has generally found that under this provision, the ability of an individual to bring a state-law tort suit alleging certain defects with a medical device can hinge on, among other things, how that device received marketing approval from the Food and Drug Administration (FDA). In Medtronic v. Lohr, the Court found that state-law claims involving "substantially equivalent" medical devices cleared through the § 510(k) process were not barred by the FDCA's express preemption provision. However, in Riegel v. Medtronic, the Court concluded that if the FDA grants approval to a medical device under its more rigorous premarket approval process, the device manufacturer is immune from certain suits under state tort law. The Court has also found in Buckman v. Plaintiff's Legal Committee that state-law tort claims stemming from violations of the FDCA may be impliedly preempted by federal law. Despite these three decisions, questions remain about what state-law tort claims survive federal preemption.

Summary: In contrast to its provisions on medical devices, the FDCA does not contain an express preemption clause with respect to its prescription drug mandates. Nonetheless, the elaborate premarket approval scheme for drugs created by the FDCA has the potential to clash with state tort law, raising questions as to whether these laws may be preempted. The Court has recently handed down three landmark rulings that clarify when the FDCA's drug requirements preempt state tort law. In 2009, the Supreme Court, in Wyeth v. Levine, held that a person hurt by a brand name drug could sue the manufacturer under state tort law for a failure to properly warn about the dangers of the drug. However, in a second case, PLIVA v. Mensing, the Supreme Court ruled that a person hurt by a generic drug could not bring the same failure-to-warn claim because changing the labeling of a generic drug would conflict with federal law that requires a generic drug to be the "same" as its branded equivalent in all material respects, including its labeling. Finally, in Mutual Pharmaceutical v. Bartlett, the question for the Court was whether a person harmed by a generic drug could obtain relief on a theory other than a failure-to-warn claim. The Court held that such claims, much like the failure-to-warn claims in Mensing, by imposing heightened duties that would conflict with the "sameness" requirements of federal law regarding generic drugs, were preempted by the FDCA.

Summary: This report provides background on the doctrine of preemption and the types of state-law tort claims that have been brought against medical device and prescription drug manufacturers. The report also addresses the federal regulation of medical devices and drugs under the FDCA. With that background in mind, the report discusses the major FDCA preemption cases that have been recently issued by the Supreme Court. Finally, the report covers possible judicial and legislative developments that may affect this dynamic area of law.

Federal preemption of state tort law actions brought against drug and medical device manufacturers, which has the legal effect of immunizing manufacturers from tort liability, has been a source of great controversy in recent years. These cases arise when individuals are allegedly harmed by a defective product and sue the manufacturer. The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly allow these injured individuals to bring such a claim, and, accordingly, someone injured by a medical device or drug may be limited to bringing a suit under state tort law in order to obtain compensation for the resulting injuries. For example, an injured plaintiff may allege that a manufacturer was negligent with respect to the design of the drug or device and seek monetary relief for the injuries suffered. However, because of the doctrine of constitutional preemption, a court may dismiss such a claim because the claim is superseded by federal law. The Supreme Court has evaluated medical device and drug preemption cases on a number of occasions over the past two decades, and the results have been mixed: in some instances a person injured by an allegedly dangerous drug or device is barred from suing a manufacturer, whereas in other cases, the Court has allowed a suit to go forward.

In order to explain the major Supreme Court cases in this area of law, this report begins by providing background on three general subject matters. First, the report examines the doctrine of constitutional preemption, the legal basis for determining when a state law must yield to a federal law. From there, the report discusses both the state law and federal laws at issue in the recent Supreme Court FDCA preemption cases. Specifically, the report addresses the types of state-law tort claims that are commonly brought against drug and medical device manufacturers. After discussing preemption and tort liability, the report examines federal law regulating prescription drugs and medical devices. With the background on the general subjects of preemption, tort law, and federal regulation of drugs and devices in mind, the report concludes by examining the major Supreme Court FDCA preemption cases and analyzing possible judicial and legislative developments that may affect this complicated and ever-changing area of law.

Because of the Supremacy Clause found in Article VI of the Constitution, the "Laws of the United States" made in pursuance of the Constitution are by definition "the supreme Law of the Land" "notwithstanding" "the Constitution or the Laws of any State to the Contrary." Under the doctrine of federal preemption, state laws are invalid if they "interfere with, or are contrary to federal law." Accordingly, preemption is a necessary product of a specific federal law's reach, and, in that vein, the Court has repeatedly recognized that the intent of Congress is the "'ultimate touch-stone' in every pre-emption case."

Another principle that sometimes guides the Supreme Court's jurisprudence in preemption cases is the so-called "presumption against preemption." Specifically, the Court in the past has held that in "all pre-emption cases" an assumption exists that "the historic police powers of the States were not to be superseded by [a] Federal Act unless that was the clear and manifest purpose of Congress." Notwithstanding the Court's previous pronouncements regarding the presumption against preemption, in recent terms, the Court arguably appears to be moving away from embracing the presumption. Following Wyeth v. Levine , the presumption has largely been ignored or distinguished away by a majority of the Court over the past four terms. In PLIVA v. Mensing, three Justices joined a portion of Justice Thomas's opinion that argued that the original meaning of the Supremacy Clause "suggests that federal law should be understood to impliedly repeal conflicting state law," a theory that would conflict with the presumption against preemption. Two years later, in Mutual Pharmaceutical v. Bartlett , a majority of the Court, while acknowledging that the preemptive scope of the federal law in question had posed "difficult ... questions" and "repeatedly vexed the Court," still found a state law unconstitutional without discussing the presumption against preemption. As a consequence, the presumption against preemption, formerly called one of the "cornerstones of ... pre-emption jurisprudence," appears to be no longer consistently applied, if not rejected, by the Court.

With these principles in mind, there are two general categories of preemption: express preemption and implied preemption.

The first way in which federal law can foreclose the operation of a state law is by express language in a congressional enactment, often called an express preemption clause. In those instances, determining the scope of the preemption clause is a matter of statutory construction. While the existence of an express preemption clause may imply a relatively straightforward resolution of whether a particular state law is preempted by federal law, express preemption cases can be as complex as implied preemption cases. For example, in a case called Cipollone v. Liggett Group, a very divided Supreme Court interpreted a provision in the Public Health Cigarette Smoking Act of 1969 that barred a state from imposing a "requirement or prohibition based on smoking or health ... with respect to advertising or promotion of any cigarettes." The Court issued three different opinions, none of which garnered a majority of the Justices, and ultimately concluded that the express provision in the 1969 law preempted state negligence and strict liability claims, but did not preempt claims for a breach of an express warranty. Nine years later, in Lorillard Tobacco Co. v. Reilly, a 5-4 ruling, the Court concluded that the same language from the Public Health Cigarette Smoking Act of 1969 preempted a state law banning outdoor cigarette advertising near schools. Together Cipollone and Lorillard illustrate that interpreting express preemption clauses in federal statutes can raise complicated and difficult questions for courts to resolve.

A federal law can also preempt state law even in the absence of an express preemption clause. Courts have recognized two ways in which a federal law can implicitly displace a state law: field preemption and conflict preemption. The latter form of preemption may be further subdivided into impossibility preemption and obstacle preemption.

The Court has struck down state laws when Congress has evidenced a desire to occupy the entire field of regulation, such that there is "no room for the states to supplement it." The classic example of a field preemption case is Rice v. Sante Fe Elevator Corp. , which held that states cannot regulate grain elevators licensed by the federal government because the implicit intent of the underlying federal scheme was to replace a system of dual regulation with a system of exclusive federal licensing. Other examples of where the doctrine of field preemption is implicated include state regulation of the construction of nuclear power plants, the registration of aliens, and foreign affairs.

Finally, preemption can occur when a particular state law conflicts with federal law. A conflict exists most obviously when "compliance with both federal and state regulations is a physical impossibility." The quintessential example of impossibility preemption was provided by the Supreme Court in a case called Florida Lime & Avocado Growers v. Paul . Specifically, the Court, in providing a hypothetical example of what impossibility preemption would look like, stated that a federal law forbidding the picking and marketing of any avocado testing more than 7% oil would preempt for reasons of impossibility a state law excluding from the state any avocado measuring less than 8% oil content. Impossibility preemption has rarely been invoked by the Supreme Court, as impossibility has been described as a "demanding defense" when attempting to defeat the effect of a state law.

Conflict preemption can also occur when a state law serves as an "obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Obstacle preemption ultimately becomes a question regarding how much conflict is tolerable between the state and federal law. The answer to that question rests in the balancing of interests between the degree of impedance to the national purpose and the value of state autonomy in a given context. A clear example of obstacle preemption occurred in Nash v. Florida Industrial Commission, where the Court held that federal unfair labor practice laws preempted a state law denying unemployment benefits to employees that filed an unfair labor practice charge with the National Labor Relations Board. In Nash, the Court reasoned that the financial burden imposed by the state law impedes resorting to federal law as a means to stop an unfair labor practice. Obstacle preemption is perhaps the most difficult of the preemption doctrines to apply because of the "inherent uncertainty in determining Congress's intent to preempt based on an ex post judicial assessment of congressional objectives."

Interaction Between Implied and Express Preemption

While one might assume the existence of an express preemption clause in a statute eliminates the need for a court to examine whether a statute implicitly preempts a state law, the Supreme Court in Geier v. American Honda Motor Co. rejected such an assumption. In that case, Alexis Geier, after suffering severe injuries in a car crash, sued Honda, arguing that the car company had negligently and defectively designed the car without a driver's side airbag that might have protected her. Honda argued that Geier's claim was preempted by a federal motor vehicle safety regulation that allowed car companies the choice of installing an airbag, an automatic seatbelt, or some other passive restraint system.

Justice Breyer, writing for a five-person majority, held that an express preemption clause in the Safety Act containing language that compliance with a federal motor vehicle safety standard did "not exempt any person from liability under the common law" excluded common law tort claims from the statute's preemptive reach. Nonetheless, the Court proceeded to explain that while the savings language removed "tort actions from the scope of the express pre-emption clause," it did not limit the operation of ordinary preemption principles, such as conflict preemption, because to do otherwise would allow states to "impose legal duties that would conflict directly with federal regulatory mandates." In other words, the Court would not apply an overly broad reading of the savings clause to defeat the ordinary operation of a federal regulatory scheme. In examining whether the federal motor vehicle safety standard impliedly preempted state tort law, the Court held Geier's state tort suits preempted on the ground that liability for failing to provide airbags would stand as an obstacle to the purpose of the federal regulation, which was to have a "variety and mix of" passive restraint devices on the market, allowing a gradual phase-in of airbags to the market.

In the wake of Geier , the Court has consistently held that implied preemption principles must be applied even in cases where a federal statute contains a savings clause.

Beyond the question of "what counts as preemption," an important ancillary question is what federal institutions have the authority to preempt state law. The text of the Supremacy Clause implies that Congress, through laws made in pursuance of the Constitution and through treaties made under the authority of the United States, can act to create law that is supreme to state law. Beyond Congress, the Supreme Court has recognized that federal administrative agencies, exercising authority delegated by Congress, may also preempt state law in certain circumstances. Specifically, executive preemption is dependent upon whether administrative action lies within the agency's statutory authority or whether the agency has acted arbitrarily, which may ultimately be a product of how much deference a court is willing to accord an agency's judgment. Moreover, in the narrow areas of law in which federal courts can fashion federal common law rules, such as admiralty law, the Court has allowed such rules to preempt state law.

Tort Liability With Respect to Drugs and Medical Devices

Having discussed the doctrine of constitutional preemption and the different ways a federal law can negate the effect of a state law, in order to properly understand the Supreme Court's FDCA preemption case law and how state tort law can be negated by federal law, it is important to also examine both the state and federal laws at issue in the High Court's cases.

An individual harmed by a product, including a drug or a medical device, can potentially utilize tort law as a means to recover any losses caused by such product. Tort law in the United States is "built on the bedrock of state common law," or judge-created legal norms. While the objectives of tort law are manifold, there are four central principles that underlie the American tort system. First, tort law aims to compensate people for injuries brought about by the wrongdoing of others. Second, beyond compensation, tort law attempts to incentivize safety such that people are deterred from engaging in behaviors that are either intended to harm others or unreasonable enough that they are likely to harm others. Third, tort law rests on the assumption that the payment of monetary damages is the most effective and most efficient way of accomplishing the dual goals of compensation and deterrence. Finally, in cases where an individual's behavior is especially egregious, tort law, through punitive or exemplary damages, allows a person to be punished beyond what is required to compensate a victim.

With these basic principles in mind, when suing a drug manufacturer for an injury caused by its product, plaintiffs typically raise products liability claims sounding in negligence, warranty, fraud, and strict liability. Each theory and its application to medical device and prescription drug litigation will be briefly discussed.

To establish a traditional prima facie negligence case, plaintiffs must prove four basic elements: (1) a duty of care owed to the plaintiff by the defendant; (2) a breach of that duty by the defendant; (3) the defendant's breach was a "proximate cause" of the plaintiff's damages; and (4) a cognizable injury or harm to the plaintiff. Generally, product manufacturers owe a duty of due care to all foreseeable users or others who may be affected by the products, and this duty extends to "all aspects of the product," including the "design, manufacture, inspection, labeling, marketing, and promotion." The level of care must comport with that of a "prudent manufacturer ... under the circumstances of the particular case."

With respect to prescription drug or medical device manufacturers, the duty of due care could be breached in a number of ways. For example, entities that manufacture prescription drugs must ensure that the product contains the appropriate concentration, activity, strength, and purity to prevent injury from the use of such a drug. Likewise, manufacturers of medical devices must exercise reasonable care in the production of their wares to ensure that they are not defective. However, for many adverse incidents resulting from prescription drugs and medical devices, no negligence occurred in crafting the product, as the manufacturer adhered to the standards of care for the industry. Nonetheless, the very nature of the product, even when properly manufactured and distributed, will often entail serious risks, as the product can be misapplied or misused. As a result, with medical devices and prescription drugs, the duty to exercise due care extends to a duty to warn of all possible risks of which the manufacturer knows or should know. Under a well-established rule called the "learned intermediary doctrine," a manufacturer satisfies its duty to warn of dangers associated with the use of a prescription drug or medical device by providing adequate warnings to the medical professional administering the drug or device, and not the ultimate user.

Once a plaintiff harmed by a drug or device establishes that the manufacturer of the article breached a duty to exercise due care, the plaintiff must then establish causation. Proof of causation requires a plaintiff to prove both causation in fact (i.e., that "but for" the defendant's breach the plaintiff's injuries would not have occurred) and causation in law (or proximate causation). Proximate causation is the "legal allocation of responsibility for the injury-causing event," such that a defendant is only responsible for those injuries that are direct and reasonably anticipated, and not those injuries that are unforeseeable or remote. In the context of failure-to-warn lawsuits over drugs and medical devices, in the "vast majority" of jurisdictions where a warning is inadequate, the plaintiff is entitled to a rebuttable presumption that "an adequate warning would have been heeded if one had been given." Nonetheless, proximate cause has been referred to as the "plaintiff's Achilles Heel," as the defendant can rebut the presumption through testimony that a different warning would not have made a difference in the actions of the physician, forcing the plaintiff to then present evidence that the physician would have altered his or her behavior and injury would have been avoided with a different warning. This burden can be quite difficult, and, indeed, proximate cause has been the demise of several lawsuits alleging injuries resulting from a failure to warn about the risks of a drug or medical device.

A breach of a warranty, a legal theory that is equally associated with contract law and tort law, can also be the basis for a products liability claim against a drug or device manufacturer. Liability for a breach of a warranty is premised on the principle that manufacturers implicitly warrant that their products are "fit for the ordinary purposes for which they are used" and "merchantable," in that they are of a sufficient quality. Both of these implied warranties are found in Article Two of the Uniform Commercial Code (UCC), which has been codified in nearly all jurisdictions. To establish a prima facie case for breach of the implied warranty of merchantability, a plaintiff must prove (1) the existence of the warranty, (2) a breach of that warranty, and (3) damages proximately resulting from that breach.

Two central difficulties arise for plaintiffs asserting a breach of an implied warranty in a products liability suit regarding prescription drugs or medical devices. First, warranty law, because of its partial basis in contract law, retains several legal doctrines from contract law that tend to prevent a consumer of a prescription drug or the user of a medical device from recovering damages from the manufacturer. For example, state contract law, and with it warranty law, commonly requires that a contract term, including an implied warranty, run only to a buyer who is in "privity" (or has a direct relationship) with the seller. The privity requirement can undermine drug or medical device breach of warranty lawsuits, as the manufacturer of a drug or device typically does not have a seller-buyer relationship with the end user, barring recovery. Moreover, under the UCC, an implied warranty may be excluded or modified through the use of a disclaimer that "mention[s] merchantability" and is "conspicuous." Finally, another important defense available to manufacturers against claims of a breach of the implied warranty of merchantability is lack of notice or opportunity to cure the defect. The UCC requires that a plaintiff give the seller notice of the breach of the warranty within a reasonable time after he or she has discovered or should have discovered the breach. If the plaintiff fails to provide notice to the seller, the plaintiff is barred from any remedy.

Second, assuming that the doctrines of privity, disclaimer, and notice do not derail a consumer's lawsuit against a drug or device manufacturer, a claim based on the manufacturer implicitly warranting that the product is fit for ordinary uses may not be applicable in a drug or device case. For example, physicians frequently prescribe drugs or employ medical devices for conditions for which they are not actually approved ("off label use")—conduct that is perfectly legal under federal law. If an injury results because of an off label use, by definition there cannot be a breach of the implied warranty of merchantability, as the drug or device was not used for its intended purpose. More broadly, some have argued that the nature of prescription drugs and sophisticated medical devices removes them entirely from the realm of warranty law, which is typically applied with respect to the sales of ordinary goods and services. Specifically, some courts have held that because drugs and certain devices are not available to the general public, but may only be obtained through a licensed physician, the very nature of the product precludes the imposition of a warranty for fitness for ordinary purposes. After all, each individual who uses a drug or device presents a unique circumstance that makes warranty law a poor vehicle to assign liability to a manufacturer.

Another common basis for a drug or medical device products liability suit is the allegation that the manufacturer engaged in fraud by marketing an unsafe product. For example, a plaintiff could allege fraud exists because a drug manufacturer, through their advertising or package insert, painted an undeservedly favorable picture of their drug and minimized the drug's side effects. To succeed on a fraud claim, the plaintiff must establish six elements: (1) a representation or, where there is a duty to disclose, concealment; (2) which is material; (3) made falsely, with knowledge of its falsity or with reckless disregard for the truth; (4) with the intent to mislead; (5) justifiable reliance upon the representation or concealment; and (6) resulting injury that is proximately caused by the justifiable reliance.

These requirements are often difficult for plaintiffs to meet for several reasons. With respect to affirmative misrepresentations, the plaintiff must establish that the manufacturer made a false representation of material fact, as opposed to merely using broad, vague, or commendatory language. For example, a federal court rejected the argument that a drug manufacturer, in its promotion of Actimmune, engaged material misrepresentations by broadly lauding selected medical journals supportive of a drug when the underlying literature was quite mixed on the value of the drug. In regard to fraudulent concealment claims, the case law generally requires that there be a duty of disclosure. Much like the doctrine of privity in the context of warranty claims, a fraudulent concealment claim must rest upon an independent fiduciary duty owed to the plaintiff by the manufacturer or a confidential relationship between the parties, neither of which will typically exist in a case where a consumer is harmed by a drug or medical device. Most importantly, regardless of whether the claim is based on a fraudulent misrepresentation or a fraudulent concealment, claims of fraud require that the manufacturer had an intent to mislead, which is either not the case in the typical products liability suit or will be very difficult for a plaintiff to prove.

Given the difficulties in pursuing a theory of negligence, breach of warranty, or fraud in a products liability suit regarding drugs or devices, plaintiffs have frequently relied on a newer theory of liability, strict products liability, as the central basis to recover damages for injuries caused by a drug or device. To establish a prima facie strict liability claim in a products liability lawsuit, like a negligence claim, the plaintiff must show that a product harmed the plaintiff and the defendant's conduct caused the plaintiff's harm. However, in contrast to a negligence claim, a plaintiff need not establish that the defendant acted unreasonably in breach of the duty of due care. Instead, strict liability focuses on the condition of the underlying product itself and on the adequacy of the warning. Specifically, in addition to proving injury and causation, the plaintiff asserting a strict liability claim must establish that a manufacturer or distributor sold a product that contained some sort of "defect" that made it "unreasonably dangerous" causing an injury.

The central issue in strict products liability, therefore, is whether a given product is "defective." Generally, a "defect" is a "problem, weakness, omission, or error" that exists in a product and is generally manifested in one of three forms. The first type of defect, a manufacturing defect, arises from a mishap in the manufacturing process, such that the finished product does not conform to the manufacturer's own design specifications. The second type of defect is called a design defect and exists when an entire product line shares a common dangerous characteristic. A design defect can be demonstrated by showing that the risks posed by the product could have been reduced or avoided by a reasonable alternative design. In some cases, the social utility of a product can be so minimal that it is outweighed by the risks it poses, making proof of a reasonable alternative design unnecessary to demonstrate that the product is defective. Finally, the third type of defect, a warning defect, occurs when a manufacturer fails to provide adequate instructions or warnings.

With respect to drugs and medical devices, strict products liability litigation over such products primarily focuses on warning defects. Manufacturing defects, such as when a prescription drug contains an impurity or contaminant, are "legally simple" and tend to affect a small number of people, as errors found in the manufacturing process tend to be corrected. Successful design defect claims for drugs and medical devices are also rare for two primary reasons. First, especially with respect to prescription drugs, design defect challenges are "uncommon" because it is difficult for a plaintiff to show that a drug, which often consists of a simple molecule, can be alternatively designed in a manner that removes an undesirable feature. Second, even if a plaintiff can demonstrate that a drug or device can have a reasonably alternative design, the majority of jurisdictions have adopted "comment k " to section 402A of the Second Restatement of Torts, which limits liability for so-called "unavoidably unsafe products."

Comment k recognizes that some products "are quite incapable" of ever being made safe for their intended and ordinary use. However, because certain "unavoidably unsafe products," which are "especially common in the field of drugs," prevent and alleviate serious health concerns, their value outweighs any risks posed by the product. Accordingly, comment k "exempts" from typical rules of strict liability "unavoidably unsafe products," such that manufacturers are not held liable as long as the product is "properly prepared" and manufacturers properly warn of the inherent dangers associated with the product. Comment k does not explain how courts should go about determining what products are "unavoidably unsafe," and state courts are split on whether drugs and medical devices are per se "unavoidably unsafe" products or whether the determination should be made on a case-by-case basis. Regardless, a majority of courts agree that comment k applies to drugs and medical devices at least in some contexts, which functionally eliminates a design defect theory in favor of manufacturing and warning defect claims.

As a result, drug and device litigation based on a strict products liability theory tends to be premised on an allegation of a defective warning. A warning defect exists when the warnings accompanying a product are insufficient to prevent reasonably foreseeable harm. While a failure-to-warn negligence claim and a strict products liability claim premised on a warning defect stem from distinct legal theories, in practice the two claims are largely assessed under the same standard. In fact, the majority of courts that have interpreted strict products liability defective warning claims have required a consideration of the user's awareness of a danger and the ability of the warning to enlighten the user, factors that underlie whether a manufacturer has a duty to warn a consumer under a traditional negligence claim. Ultimately, the question of whether a manufacturer can be held strictly liable for a warning defect "depends on the standards for determining a duty to warn under a negligence action," which includes the learned intermediary doctrine. As a consequence, regardless of the specific theory asserted, questions of liability stemming from a drug or medical device tend to center on the question of adequacy of the warning attached to the product in question.

Having discussed how state tort law attempts to ensure that medical devices and prescription drugs are safe, to understand how these laws can be displaced by federal law it is essential to delve into the underlying federal laws governing the safety of devices and drugs.

The FDCA contains a comprehensive statutory scheme designed to ensure that medical devices are safe and effective. As part of this scheme, medical devices must meet certain minimum requirements in order to be marketed in the United States. For example, like other medical products, a device cannot be adulterated or misbranded, and there are registration, good manufacturing practices, and labeling requirements. There are also more specific requirements that a device manufacturer must follow based on the level of risk that a device poses to patients from its use or misuse.

Although the FDCA has always expressly required drugs to be reviewed by the FDA in some manner before going on the market, this was not the case with medical devices. Historically, the regulation of devices was primarily left up to the states. But concerns about the safety of these products spurred Congress to enact the Medical Device Amendments of 1976 (MDA), which amended the FDCA to create a detailed regime for the oversight of medical devices. The MDA established three classes of devices based the degree of control needed to provide assurance of the device's safety and effectiveness. Class I devices are subject to the least amount of oversight. These devices "present no unreasonable risk of illness or injury" and are subject to minimal regulation by "general controls." Class II devices pose a moderate risk to patients, and are subject to general controls as well as certain "special controls" to reduce or mitigate risk. Finally, Class III devices are generally considered the devices with the highest risk and are typically at issue in medical device preemption litigation. These devices are used to support or sustain human life, for a use which is of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Class III devices receive the greatest amount of federal oversight and are generally subject to premarket approval by the FDA.

As noted above, the premarket approval process, often described as rigorous and time-consuming, is generally used for Class III devices, subject to exception. As part of this process, the FDA determines if these devices have a "reasonable assurance of ... safety and effectiveness." A premarket approval application is lengthy and must include, among other things, information regarding proposed labeling; reports of information "concerning investigations which have been made to show whether or not such device is safe and effective"; a description of the manufacturing and processing methods; samples of the device and its components; and information regarding the components, ingredients, and operating principles of the device. An application will be denied approval if "there is a lack of a showing of reasonable assurance that such device is safe [and effective] under the conditions of use" in the proposed labeling; if the methods of manufacturing, processing, packing, or installing the device do not conform to good manufacturing practices; if the proposed labeling is false or misleading; or if the device does not meet performance standards. After a device has received premarket approval, "the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness." All new devices are automatically designated as Class III, and therefore must receive premarket approval unless the device meets one of the exceptions specified under federal law.

Premarket Notification (§ 510(k) Submissions)

One common exception to the requirement for premarket approval is for devices that the FDA has determined under the § 510(k) premarket notification process to be "substantially equivalent" to those already on the market. Class III devices generally require a premarket notification as well as premarket approval. However, some Class III devices may be marketed only with a § 510(k) submission—if the device was introduced after the passage of the MDA in 1976 and is substantially equivalent to a pre-1976 device. The majority of new Class III medical devices reach the marketplace after only a § 510(k) submission, as opposed to the receipt of a premarket approval application.

Under the § 510(k) process, a new device is considered "substantially equivalent" if the FDA makes such a determination based on a comparison of the new device with a "predicate" device. A device is "substantially equivalent" if it has (1) the same intended use and the same technological characteristics as the predicate device, or (2) the same intended use, different technological characteristics, and information and data that demonstrate safety and effectiveness, and does not "raise different questions of safety and effectiveness than the predicate device." In order for a device to be cleared under the § 510(k) process, a manufacturer must submit a premarket notification submission to the FDA. Information generally required to be provided to the FDA as part of this submission includes, among other things, the name and description of the device; proposed labeling and advertisements for the device and directions for its use; and information comparing the device to predicate devices.

It may be noted that medical devices cleared through the § 510(k) pathway tend to receive considerably less scrutiny from the FDA than devices receiving premarket approval. For example, unlike the §510(k) submission, the FDA generally requires clinical data for most premarket approval applications. Other characteristics of the § 510(k) process that make it less rigorous than the premarket approval process include (1) premarket inspections of how devices were manufactured are generally not required by the FDA, and (2) post-market studies are not required by the FDA as a condition of clearance.

The Supreme Court has evaluated three medical device preemption cases, and these cases have arisen in both the express and implied preemption context. With respect to express preemption, the Medical Device Amendments of 1976 (MDA) added a provision to FDCA which states,

... no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement applicable under this Act to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this Act.

The MDA also included an exception to this provision stating that the FDA may, upon application by a state or a political subdivision thereof, exempt state requirements that are "more stringent" than federal ones or state requirements "required by compelling local conditions" if "compliance with the requirement would not cause the device to be in violation of any applicable requirement" under the FDCA. The FDA has also issued regulations that address the scope of the preemption provision. These regulations state, among other things, that the MDA preemption provision "does not extend to "[s]tate or local requirements of general applicability [whose] purpose ... relates either to other products in addition to devices."

The Supreme Court has evaluated the scope of the MDA preemption provision on two occasions in Medtronic v Lohr and Riegel v. Medtronic . The Supreme Court has generally found that under the provision, the ability of an individual to bring a state tort lawsuit alleging certain defects with a medical device can hinge on, among other things, how that device received marketing approval from the FDA. Particularly in light of the most recent case, Riegel v. Medtronic , this provision has been generally viewed as severely limiting the ability of individuals to sue after they have been injured by a defective medical device receiving premarket approval. However, as discussed below, the Supreme Court has recognized that this provision is not a complete bar to state-law tort claims.

In 1996, the Supreme Court first evaluated the scope of the MDA preemption provision in Medtronic v. Lohr . Plaintiffs brought suit against a pacemaker manufacturer, alleging negligence and strict liability claims after a component of the device failed and the patient suffered a heart block that required emergency surgery. The device maker claimed that the plaintiff's suit was preempted under the express preemption provision of the MDA. The pacemaker in question was a Class III medical device that was deemed substantially similar to a predicate device under § 510(k) and, accordingly, had not gone through the premarket approval process. In a fractured opinion, the Court found that the plaintiff's state-law claims were not preempted by the MDA. While a majority of Justices agreed on the outcome of the case, there was disagreement as to the scope of the MDA preemption provision and, in particular, the extent to which the provision preempts state-law tort actions.

The device manufacturer had argued that because the device was cleared under the § 510(k) process, this clearance equates to federally enforceable design requirements that should be immune from the specific state-law claim at issue in these cases. However, the majority of the Court disagreed, opining that the § 510(k) process does not impose requirements regarding the "safety" and "effectiveness" of the device; it merely establishes that the device is equivalent to a device that is already on the market. The Court explained that the FDA did not "'require' Medtronics' pacemaker to take any particular form for any particular reason; the agency simply allowed the pacemaker, as a device substantially equivalent to one that existed [before the MDA] to be marketed without running the gauntlet of the [premarket approval] process." The Court reasoned that the § 510(k) exemption to premarket approval is generally intended to maintain the status quo with respect to marketing medical devices, which included the potential for the manufacturer to be subject to state law negligent design claims.

The patient had argued that even if state-law claims were "requirements" under the MDA preemption provision, the claim was not preempted unless it was "different from or in addition to" these federal requirements. The Court's majority agreed, and indicated that nothing in the MDA denies a state the ability to provide a remedy for violations of common law duties "when those duties parallel federal requirements." The Court noted that FDA regulations confirm this view, and given that Congress had authorized the FDA to exempt state law from federal preemption, the Court found this to be a "sound basis" for relying on the agency's interpretation of the statute.

Despite the conclusion that the plaintiff's state-law tort claims were not preempted by federal law, the majority of Justices in Lohr , in concurring and dissenting opinions, expressly indicated that some types of these state-law claims could nevertheless be preempted by the MDA. This conclusion caused confusion in the lower courts. For example, it was uncertain whether claims brought by plaintiffs injured by devices receiving premarket approval review were preempted under the MDA.

In 2008, the Supreme Court examined the scope of the MDA preemption provision for the second time in Riegel v . Medtronic , holding that state tort law claims for injuries related to a medical device that received premarket approval were preempted by federal law. The device at issue in Riegel was a catheter that had received premarket approval from the FDA to be marketed by Medtronic as a Class III device. Despite the fact that the device's label stated that the device was contraindicated for individuals like the patient, his physician nevertheless used the catheter. After the patient's doctor inflated the catheter beyond the recommended amount, the catheter ruptured and the patient was seriously injured. The patient and his wife filed suit, claiming violations of New York common law. The district court found that these common law claims were preempted by federal law, and the court of appeals affirmed the dismissals. The Supreme Court agreed, and, in an 8-1 decision, held that the MDA expressly preempted the plaintiff's state tort law claims.

To reach its holding, the Court examined two questions in light of the MDA preemption provision: (1) whether the federal government established "requirements" applicable to the device; and second, if so, (2) whether the plaintiffs' common law claims are based on state requirements that are "different from, or in addition to" the federal requirements, "and that relate to safety and effectiveness."

In evaluating the first question, the Court concluded that the federal government had indeed "established requirements applicable to" the catheter. The fact that the catheter had received premarket approval was central to this finding. The Court distinguished its earlier decision in Lohr , where the device at issue had received substantial equivalence review under § 510(k). Under the § 510(k) process, the Court in Lohr explained, the federal requirements at issue were general in nature, and the process is essentially an exemption from safety review. However, the Court in Riegel explained there is a notable difference: the premarket approval process is safety review, and it imposes "requirements" under the MDA that are specific to particular devices. The Court also observed that unlike the § 510(k) process, premarket approval includes formal FDA review, and devices that receive premarket approval may not deviate from the FDA-approved specifications in the approval application.

Second, the Court found that "New York's tort duties constitute 'requirements' under the MDA" and that these requirements were "different from, or in addition to" federal requirements for medical devices. The Court began by noting that five Justices in Lohr concluded that state common law duties could constitute "requirements" that may be preempted by the MDA. It then elaborated on the meaning of the term "requirement" and stated that "[a]bsent other indication, reference to a State's 'requirements' includes its common-law duties." The Court further explained that state liability is "premised on the existence of a legal duty," and that "a tort judgment therefore establishes that the defendant has violated a state-law obligation." While the patient had argued that the state-law claims (e.g., negligence, strict-liability, and implied-warranty claims) are not preempted because these general common-law duties are not maintained "with respect to devices," the Court declined to accept this reasoning. It stated that nothing in the text of the MDA suggests that a preempted state requirement must apply solely to the relevant medical device or to medical devices generally.

Notably, however, the Court also expressly recognized that not all state-law claims are preempted by the MDA preemption provision. The Court reaffirmed its holding in Lohr and reasoned that the MDA express preemption provision "does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case 'parallel,' rather than add to, federal requirements." The Court provided no further analysis as to what types of state duties it had in mind. It also declined to address whether the patient in Riegel raised parallel claims, as the patient did not make that argument in their briefs to the Second Circuit or in their petition for Supreme Court review.

Implied Preemption: Buckman v. Plaintiff's Legal Committee

As noted above, the Supreme Court has concluded that implied preemption principles may still apply even in cases where a federal statute contains an express preemption provision. The concept of implied preemption has arisen in medical device preemption cases in light of the fact that the FDCA contains no explicit private right of action authorizing a person to sue based on injuries suffered because of an unlawfully defective medical product. Further, the FDCA provides that subject to an exception for certain actions that may be brought by a state, "all such proceedings for the enforcement, or to restrain violations of [the FDCA] shall be by and in the name of the United States." Thus, when an individual has brought a state tort claim premised on alleged violations of the FDCA, courts have evaluated whether such claims may go forward, or whether they are, in effect, usurping the FDA's role in enforcing federal requirements and are impliedly preempted by federal law.

In 2001, the Supreme Court in Buckman v. Plaintiff's Legal Committee examined whether federal law preempted state-law tort claims that alleged fraud on the FDA. In this case, plaintiffs with injuries resulting from the use of orthopedic bone screws sued a consulting company that had assisted the manufacturer of the screws in obtaining FDA approval (under the § 510(k) process) to market the devices. The patients alleged that the manufacturer of these screws committed fraud on the FDA by giving the agency misleading information in order to obtain this approval. Plaintiffs argued that had the proper information been provided to the agency, the devices would not have been approved and the plaintiffs would not have been injured.

The Court held that the plaintiffs were barred from bringing an action against the company for noncompliance with federal device requirements. Instead of relying upon the express preemption provision of the MDA to reach this conclusion, the Court found that the state law fraud-on-the-FDA claims were impliedly preempted because they conflicted with the federal scheme for enforcement of the FDCA. The Court opined that federal law authorizes the FDA to address fraud against the agency and allowing this state-law claim to proceed would interfere with federal statutory objectives. The Court observed that the FDCA contains several mechanisms for addressing fraud (e.g., seeking injunctive relief and civil penalties). The High Court further indicated state law fraud-on-the-FDA claims interfere with the FDA's role in policing fraud, and that to force compliance with the agency's regulatory scheme in light of 50 separate state tort law systems would place a burden on applicants that was not envisioned by Congress. The Court also explained that allowing such claims would lead to concern from device applicants that their disclosures to the FDA, while acceptable to the agency, would later be held to be insufficient under state law. Such a finding would incentivize applicants "to submit a deluge of information that the agency neither wants nor needs" and lead to burdens on the agency and delay in the § 510(k) process. The Court also stated that it was expressing no view as to whether the claims were subject to the MDA preemption provision, but did indicate that the existence of the express preemption provision did not interfere with a finding of implied conflict preemption.

Finally, the Court distinguished the Buckman case from its decision in Lohr . The Court explained that besides the fact that Lohr did not directly address the question of implied preemption, the patient's claims in Lohr stemmed from the manufacturer's alleged failure to use reasonable care in the production of the medical device, and not solely from the violation of FDCA disclosure requirements. The Court stated that "although [ Lohr ] can be read to allow certain state-law causes of action that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim."

Future of Preemption and Medical Devices

Following the Lohr , Buckman , and Riegel decisions, the question of whether an individual can bring a state-law tort claim after suffering an injury caused by a medical device can be a complex inquiry with varied results. While the Supreme Court has generally found that under the MDA preemption provision, the ability of an individual to bring a state-law tort suit alleging certain defects with a medical device can turn on how that device received marketing approval from the FDA, (i.e., through either the § 510(k) process or premarket approval), the inquiry is not this straightforward, and questions remain about which state-law tort claims brought against medical device manufacturers are preempted by federal law.

For example, following the Riegel case, lower courts have often concluded that consumers of Class III medical devices are prevented from suing device manufacturers on most state common law claims if the device receives premarket approval. However, as recognized in both the Lohr and Riegel decisions, state-law claims that are "parallel" to federal requirements are not expressly preempted by the MDA preemption provision. As noted above, while the Court in Riegel briefly indicated that parallel claims are those that provide for a "damages remedy for claims premised on a violation of FDA regulations," it did not further address which state-law tort claims survive federal preemption. Several lower courts have grappled with this issue. Additionally, when a plaintiff brings a state-law claim that involves a violation of federal medical device requirements, which may survive under the MDA's express preemption provision, courts nevertheless have struggled with determining whether these claims are impliedly preempted under the Court's reasoning in Buckman .

One case that illustrates some of these issues is Medtronic v. Stengel . This case addresses whether a person can sue a medical device manufacturer under state law for failing to report information about an adverse event to the FDA. In Stengel , a patient was rendered paraplegic by a pain pump that was a Class III device that had received premarket approval. After the FDA approved the pump, but before the plaintiff's injury, the device manufacturer purportedly learned of the issues with the device, but did not notify the FDA. The patient and his wife filed suit under state law, alleging certain negligence and strict liability claims, including a failure-to-warn claim as part of an amended complaint. The Ninth Circuit unanimously held that where, as here, violations of the MDA occur outside of the premarket approval process, the MDA preemption provision does not preempt the state-law claims, as they "parallel" federal duties. The Ninth Circuit further indicated that the patient's claim was different from the plaintiff's claim in Buckman , as the state-law claim was "independent" of the federal device requirements. Other courts of appeal have addressed this issue and reached varying conclusions. Medtronic has appealed this case to the Supreme Court, but the Court has not yet determined whether it will grant review.

Finally, it should be noted that Congress has considered amending the FDCA to clarify the relationship between the federal preemption provision of the MDA and state tort claims. In response to the Supreme Court's decision in Riegel , Representative Pallone and Senator Kennedy introduced H.R. 1346 / S. 540 , the Medical Device Safety Act of 2009. The bill would have effectively overturned Riegel by amending the MDA's express preemption provision to state that "[n]othing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State." The addition of this clause as included in the bill would have taken effect "as if included in the enactment of the [MDA]," and would have "appl[ied] to any civil action pending or filed on or after the date of enactment of" the legislation. The language in H.R. 1346 / S. 540 was incorporated in H.R. 4816 , the Food and Drug Administration Improvement Act of 2010, in the 111 th Congress, which was referred to committee but did not see further action. It appears that similar legislation has not been introduced in the 112 th or 113 th Congress.

Having discussed the various ways the FDCA has been interpreted to preempt state tort claims with respect to medical devices, the report turns to the issue of FDCA preemption and prescription drugs.

Since 1938, there has been a federal system of premarket approval for drugs in the United States. The Kefauver-Harris Drug Amendments of 1962 (Drug Amendments), enacted in the wake of the thalidomide crisis of the early 1960s, revamped the preapproval process for drugs to require that a manufacturer demonstrate that a new drug be both safe and effective for its intended use before the product can be marketed. Under current law, in order to market a new drug, a manufacturer must file a New Drug Application (NDA) with the FDA, which must, among other things, include full reports of investigations into the drug's safety and effectiveness; a list of the drug's components; a full statement of the drug's composition; a description of the manufacturing methods, processing and packing; and "specimens of the labeling proposed to be used for such drug." The FDA will not approve the NDA if it finds, for example, that the reports of testing show that the drug is unsafe or ineffective or if the "proposed labeling" does not make the drug "safe for use under the conditions, prescribed, recommended, or suggested."

With respect to the proposed labeling for a drug, the FDA must find that the labeling "contain a summary of the essential scientific information needed for the safe and effective use of the drug" and is neither "promotional in tone nor false or misleading ... " For all prescription drugs, the label must include, among other information, details regarding how the drug should be administered, the proper dosage of the drug, and any contraindications, warnings, or adverse reactions related to the drug. A label describing the contraindications would include descriptions of situations where the drug should not be used because the "risk clearly outweighs any possible benefit."

Once the FDA has approved a NDA, the agency places the drug at issue on a public list of approved drugs. The drugs on this list are known as "listed drugs," and the list is required to be updated every 30 days. The law requires post-market surveillance of the drug by the government, necessitating the FDA to withdraw approval of a new drug if it finds that the drug is unsafe, or there is a lack of substantial evidence that the drug is effective. Likewise, a manufacturer is not absolved of all responsibility once a drug has been approved by the FDA, as a manufacturer must comply with the FDCA's Good Manufacturing Practices, report any "adverse events" to the FDA, and periodically submit any new information that may affect the FDA's previous conclusions about the safety, effectiveness, or labeling of the drug. Nonetheless, the manufacturer generally may not make changes to the drug, including "[c]hanges in labeling," without first submitting a supplemental application to the FDA and securing the agency's prior approval for the change. Importantly, however, under the FDA's so called "changes being effected" or CBE regulation, a manufacturer can add or strengthen a warning without prior approval by the FDA, a "narrow" exception to the general rule that labeling changes require the FDA's prior approval.

Generally, when a drug manufacturer invents a drug, the manufacturer obtains a patent which provides the "pioneer" drug maker with a limited period of time to exclusively manufacture or use the invention. The quid pro quo for the exclusivity period created by patent law is that the manufacturer is required to disclose the invention so that others can one day make and use the underlying product. Normally, when a patent expires, anyone is free to make and use the invention. However, with respect to drugs, the FDCA requires the FDA to grant premarket approval to a particular manufacturer before a drug can be marketed. Following the passage of the Drug Amendments, the only way a drug manufacturer who wanted to market a copy of a drug approved after 1962 whose patent had expired was to submit a NDA and repeat the costly clinical trials that the inventor of the original drug had already undertaken. As a consequence, the FDCA's NDA process could functionally prohibit manufacturers from entering a market and competing with the pioneer manufacturer.

To alleviate the problems created by the Drug Amendments, the Drug Price Competition and Patent Term Restoration Act of 1984, or as it is more commonly known, the Hatch-Waxman Act, created the modern generic drug infrastructure. The act created a new type of application for drug marketing approval, the abbreviated new drug application (ANDA), which allows a third party or "generic" manufacturer to show that its drug formulation is a therapeutically equivalent copy of the one being marketed by the originator. An ANDA generally must include "information to show that the new drug is bioequivalent to the listed drug," and "information to show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug." The generic applicant is not required to conduct its own safety and effectiveness testing, but is permitted to rely upon the safety and effectiveness evidence presented in the NDA for the listed drug. The FDA may withdraw approval of an ANDA for a generic drug if it finds that the labeling for the generic drug "is no longer consistent with that for the listed drug." The current NDA holder of a brand-name drug may change a drug's labeling, but a generic drug manufacturer cannot and must ensure that its labeling remains the same as the labeling for the listed drug.

In contrast to its provisions on medical devices, the FDCA does not contain an express preemption clause with respect to its prescription drug mandates. Nonetheless, the elaborate premarket approval scheme for drugs created by the FDCA has the potential to clash with state tort law, raising questions as to whether federal drug law preempts state tort law. On one hand, as discussed above, state tort law, depending on the specific theory pursued, could result in a manufacturer paying damages for marketing a prescription drug that has been approved by the FDA on the theory that the underlying product is unreasonably dangerous or has an insufficient warning or was fraudulently marketed. After all, common law tort doctrines typically do not treat compliance with a regulation as a bar to liability. Moreover, the Supreme Court, in both Lohr and Riegel , has acknowledged that a jury's verdict in a tort lawsuit can function just like a law passed by a state legislature or an administrative order issued by a governor in creating obligations that a manufacturer must obey. On the other hand, the FDCA with its premarket approval process generally requires the FDA to approve a drug's chemical makeup and warnings before the product can be marketed to the public, and presumably a drug that has been approved by the FDA is both safe and effective within the meaning of the FDCA and has the appropriate warnings to ensure the product is not misbranded in violation of the FDCA. Accordingly, state tort law has the potential to second guess the determinations made by the FDA, by allowing a jury to impose liability for manufacturing a drug whose composition and warnings have been approved by the federal agency.

Despite the potential for conflict between the FDCA's premarket approval process for drugs and state tort law, for much of the FDA's history the issue of federal drug law's preemptive effect on state tort claims was unresolved, and more exacting state tort law standards of care were generally seen by the courts as operating concurrently with federal requirements. However, beginning in 2004, the FDA began arguing that its prescription drug labeling regulations preempted injured plaintiffs' common law tort claims. In 2006, the FDA, in a lengthy preamble to regulations on drug labeling, stated its belief that under "existing preemption principles" product liability claims challenging the safety and efficacy of a FDA-approved label "would be preempted." Specifically, the FDA argued while the FDCA "contains no express preemption provision for drugs," the act, in giving the agency "comprehensive authority over drug safety, effectiveness, and labeling," implicitly preempted tort claims that functionally regulated the field of drug labeling. Moreover, the FDA, in the 2006 preamble, argued that the state tort laws challenging the adequacy of a drug label that had been approved by the agency both stood as "an obstacle to the achievement of the full objectives and purposes" of federal law and made it impossible for manufacturers to simultaneously comply with the FDCA's rules against mislabeling and adjusting a product's label and the duty imposed by state tort law to make the label safer. With the FDA asserting the position that the agency's labeling requirements for drugs established optimal, as opposed to minimal, standards from which state law could not deviate, the position was ripe for a challenge to the Supreme Court. The Court, beginning in 2009, handed down three landmark rulings that clarified when the FDCA's drug requirements preempt state tort law.

In 2009, Wyeth v. Levine became the first Supreme Court case to explore whether the FDCA's drug requirements preempted state tort law, ultimately finding the state tort claim at issue not preempted. The underlying facts of Levine were these: Diana Levine—a bass, guitar and piano player and author of children's music—visited a clinic to receive treatment for severe headache-related nausea and was given the brand name drug Phenergan. According to the federally approved label for Phenergan, the drug could be administered in one of three ways: (1) intra-muscularly; (2) through an intravenous (IV) drip, where it is mixed with saline and descends slowly through a catheter into the patient's vein; or (3) through what is called an IV push, where the drug is injected directly into the patient's vein. The latter method of administration poses significant risks in that if the drug is injected into an artery, the corrosive nature of the drug can cause severe chemical irritation and damage to the tissue, risking irreversible gangrene. The FDA was aware of the risks posed by the IV push method of administering Phenergan, but instead of prohibiting the IV push method, the FDA opted to require that the drug's label merely warn of the danger of gangrene and amputation following an inadvertent intra-arterial injection. The IV push method was used to administer Phenergan to Ms. Levine, and an error in administration resulted in the musician developing gangrene, ultimately forcing doctors to amputate her hand and forearm. Ms. Levine, after suing the clinic and the physician's assistant who administered Phenergan, received a $700,000 settlement. Ms. Levine also sued the maker of Phenergan, Wyeth Pharmaceuticals, in a Vermont state court, arguing that the warning labels on the product were insufficient under common law negligence and strict-liability theories. Wyeth defended the suit by arguing that the state tort claims were preempted by federal law. The state courts rejected Wyeth's preemption argument, and after Ms. Levine won a jury verdict of $6.7 million against Wyeth, the pharmaceutical giant appealed. The Supreme Court granted certiorari to hear the case in 2008 and issued its ruling in March 2009.

In a 6-3 ruling, the Supreme Court, with Justice Stevens the author, held that none of Ms. Levine's state tort claims were preempted by federal law. At the Supreme Court, Wyeth focused on a conflict preemption argument—that is, that the state tort duty was both (1) impossible to comply with simultaneously with the federal law and (2) an obstacle to the objects and purposes of federal drug law. With respect to Wyeth's first argument, the Supreme Court found that the FDA's CBE regulation precluded any preemption based on impossibility. According to Justice Stevens's opinion, the CBE regulation allowed a brand name drug manufacturer when presented with "newly acquired information" about a drug, including "new analyses of previously submitted data," to make "changes to its label before receiving the agency's approval," including adding to or strengthening a warning. The Levine opinion noted that Wyeth had received evidence of 20 incidents resulting from IV push administration of Phenergan before Ms. Levine's injury, giving them the basis to unilaterally strengthen the warning and making it possible for the drug manufacturer to both comply with the duty imposed by state tort law to strengthen Phenergan's warning and to comply with federal drug law. The Court noted that while the FDA retains the authority to reject any labeling changes made pursuant to the CBE regulation, barring any "clear evidence that the FDA would not have approved a change to Phenergan's label," the Court could not conclude that it was impossible for Wyeth to comply with both federal and state requirements.

The Court likewise rejected Wyeth's argument that requiring compliance with a state-law duty to provide a stronger warning about IV push administration would obstruct the "purposes and objectives of federal drug labeling regulation." For Wyeth, Congress's purpose in crafting the federal pre-market approval process for drugs was to "entrust an expert agency to make drug labeling decisions that strike the balance between competing objectives," making the FDCA both the floor and ceiling for drug regulation. Relying on Geier , Wyeth contended that a state tort claim based on the inadequacy of a label served as an obstacle to a federal regime trying to account for various competing interests. The Court rejected this argument, however, concluding that Congress, in crafting the FDCA, recognized that state tort law remedies "further consumer protection by motivating manufacturers to produce safe and effective drugs and to give adequate warnings." Additionally, the majority opinion reasoned that if Congress wanted to preempt state tort claims with the FDCA's drug provisions, it could have done so with an express preemption clause, as Congress had done in the medical device context. Congress's silence on the issue was "powerful evidence" to the Court that Congress did not intend FDA oversight to be "the exclusive means of ensuring drug safety and effectiveness." Moreover, the Court distinguished Geier . Unlike in Geier , where the regulation in question went through formal rulemaking and was a consistent position of the agency, in Levine the only regulatory guidance indicating that federal drug law preempted state tort claims came in the form of the 2006 preamble, a position that not only contradicted earlier statements by the FDA, but also was not subject to notice and comment rulemaking before being issued. In other words, the Court did not find that the FDA's recently adopted position deserved any deference, and the Court affirmed the decision of the lower state courts finding no preemption.

Two concurring opinions were issued in Levine, both of which have largely guided the case law in this area. Justice Breyer, following the approach of his majority opinion in Geier , wrote separately to note that it was possible for state tort law to "interfere with the FDA's" objectives, and therefore be preempted. For Justice Breyer, the problem for the defendant in Levine was that the FDA had not issued "lawful specific regulations" describing why labeling requirements serve as both a floor and a ceiling creating a preemptive effect, but instead relied on the 2006 preamble. In other words, Justice Breyer, relying on an obstacle preemption theory, signaled a clear approach for future administrations to, through the issuance of formal administrative rulemaking, bar state tort claims against manufacturers of FDA approved drugs.

Justice Thomas, on the other hand, took a far different approach than Justice Breyer. Thomas wrote separately, noting that while he agreed with the majority's conclusion on the issue of impossibility preemption, he did not agree with the premise that there was a constitutional basis for Wyeth's obstacle or "purposes and objectives" preemption argument. For Thomas, under the Supremacy Clause only federal laws "made in pursuance of the Constitution" preempted state laws, meaning that the law must be passed by both houses of Congress and signed by the President. For Justice Thomas, the "purposes and objectives" preemption doctrine invites the Court to broadly look at "federal policy objectives, legislative history, or generalized notions of congressional purposes that are not contained in the text of the federal law" that was passed by Congress and signed by the President. Accordingly, the Court, by trying to divine the "purposes and objectives" of certain legislation to determine the preemptive effect of a law, strayed from text of the Supremacy Clause. In short, Justice Thomas, in his concurrence in Levine , announced that he would not join an opinion that relied on obstacle preemption because of the theory's tendency to "facilitat[e] freewheeling, extratextual, and broad evaluations of the 'purposes and objectives' embodied within federal law."

The Court returned to the issue of preemption and prescription drugs two years after Levine in PLIVA v. Mensing. In the wake of Levine , a majority of lower courts reasoned that Levine , which was concerned with a brand name or listed drug, was equally applicable to generic drugs and that failure-to-warn claims were not preempted absent "clear evidence" that the FDA would have rejected a stronger warning. In Mensing, the Supreme Court rejected how the lower courts had interpreted Levine with respect to generic drugs. Mensing involved the consolidation of two cases in which the plaintiffs were prescribed the brand name drug Reglan but were dispensed the generic drug metoclopramide by their pharmacists in order to treat a digestive track disorder. One of the side effects of long-term metoclopramide use is the development of tardive dyskinesia, a severe neurological disorder. In light of this side effect, over the years, the FDA approved several changes to Reglan's labeling to increase the strength of its warnings about tardive dyskinesia, culminating in 2009 with a "black box" warning that "[t]reatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases." Prior to the development of the stronger labels, the plaintiffs in Mensing were dispensed the metoclopramide and each developed tardive dyskinesia after taking the drug for several years. The plaintiffs sued the manufacturers of the generic drug, arguing that the manufacturer had breached its duty of due care by failing to change its warning label "despite mounting evidence that long term metoclopramide use carries a risk of tardive dyskinesia far greater than that indicated on the label." The manufacturers defended on preemption grounds.

Justice Thomas, writing for a majority that included the three Levine dissenters and Justice Kennedy, held that the FDCA's requirements for generic drugs implicitly preempted state failure-to-warn claims for impossibility reasons. Deferring to the FDA's views, the Court held that FDA regulations prevented generic manufacturers from "independently changing" a generic drug's safety label, and accordingly, a state tort duty requiring a generic manufacturer to strengthen the drug's label was impossible to comply with while simultaneously adhering to the federal "sameness" requirement for generic drugs. In so concluding, the majority rejected the argument that the generic manufacturer had to prove that the FDA would have rejected a suggested change to make the generic label safer because imposing such a requirement could theoretically defeat any impossibility claim because Congress could always be petitioned to amend a law that conflicted with a state tort duty. Instead, Mensing concluded that "when a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes." Thus, for the five-Justice majority, Mensing was distinguishable from Levine in that federal law permitted manufacturers of brand name drugs to unilaterally strengthen the warning without advance approval from the FDA.

Two years after Mensing, the Supreme Court again revisited the topic of preemption and prescription drugs in Mutual Pharmaceutical v. Bartlett. The case involved Karen Bartlett, a 53-year-old New Hampshire woman, who, after taking sulindac, a generic drug non-steroidal anti-inflammatory drug (NSAID), to treat her shoulder pain, developed a hypersensitivity reaction called Stevens-Johnson Syndrome, a rare but known side-effect to taking a NSAID. At the time Ms. Bartlett was prescribed sulindac, the drug's label did not specifically warn about Stevens-Johnson syndrome. Ultimately, Ms. Bartlett suffered severe burns, resulting in permanent near-blindness and extreme damage to her lungs. As a consequence, Ms. Bartlett filed suit against the manufacturer of the generic drug in a New Hampshire court, arguing that the manufacturer failed to properly warn about the dangers of the drug and, under a strict liability theory, the drug was defectively designed. The trial judge dismissed the plaintiff's failure-to-warn claim, but the strict liability claim went to a jury, which ultimately awarded Ms. Bartlett over $21 million in damages. The pharmaceutical company argued on appeal to the Supreme Court that Ms. Bartlett's strict liability claims, just like the failure-to-warn claims in Mensing , were preempted by the federal sameness requirement for generic drugs.

The Supreme Court, in another 5-4 ruling, agreed with the generic manufacturer of sulindac and held that the strict liability claim at issue in Bartlett imposed a duty that would conflict with the federal sameness requirements. In so ruling, Justice Alito, writing for the Court, rejected two central arguments made by the plaintiff. First, the Court dismissed the argument that state strict liability law did not impose a duty on the manufacturer, but instead merely reallocated the risks imposed as a result of an "unreasonably dangerous" product from the consumer to the manufacturer. The Court examined the underlying state law from New Hampshire and concluded that the state law did indeed impose a "substantive duty" on the manufacturer not to produce an "unreasonably dangerous" product. Specifically, the Court noted that New Hampshire strict liability law, at least in the context of prescription drugs, ultimately mirrors the failure-to-warn claims at issue in Mensing. The reason for the similarity is because New Hampshire, like many states, employs a "risk utility approach" to determine whether a product is defectively designed and "unreasonably dangerous," an approach that requires an evaluation of the usefulness of the product and risk of danger posed by the product. With respect to prescription drugs, and especially with respect to sulindac, a one-molecule drug, redesigning the drug is impossible. Recognizing this, New Hampshire, like the majority of other states, had adopted comment k to § 402A of the Restatement (Second) of Torts and allows prescription drug manufacturers to avoid liability when the drug was accompanied by an adequate warning. In other words, the underlying claim, despite being described as a strict liability claim, functioned just like an ordinary negligent failure-to-warn claim, making Bartlett indistinguishable from Mensing .

Second, the Court rejected the argument that impossibility preemption was inapplicable because a generic drug manufacturer could either "stop selling" its product or pay monetary damages under state law, and by taking either action, comply with both the federal "sameness" requirement and the duty imposed by state tort law. For the Court, the "stop selling" rationale would make impossibility preemption "all but meaningless," because the idea of it being impossible to abide by a state and federal law simultaneously usually presupposes some sort of affirmative conduct, such as selling a product. For example, in the Florida Lime & Avocado Growers hypothetical, if the stop selling rationale governed impossibility claims, it would have been possible for an avocado grower to simultaneously comply with a state's mandate to sell high oil avocados and a federal mandate to produce only low oil avocados by simply not selling avocados in that state. The same stop selling logic would have likewise led to an opposite conclusion in Mensing.

Two dissenting opinions were filed in Bartlett , one by Justice Breyer and one by Justice Sotomayor .

Future of Preemption Issues and the Food, Drug, and Cosmetic Act

The Broad Principles of Levine, Mensing, and Bartlett

Having issued three opinions on preemption and prescription drugs in the last five terms, the Supreme Court appears to have limited two routes for federal drug law to impliedly preempt state tort law, while dramatically expanding another avenue for implied preemption. Specifically, Levine foreclosed field preemption as a viable theory for drug manufacturers to defeat state tort claims, as a six-member majority of the Court recognized that state tort law generally serves to complement federal drug law. Moreover, Justice Breyer's concurrence in Levine and dissent in Bartlett signal that there could be a majority on the Court that would find state tort law serves as an "obstacle to the purposes and objectives" of federal drug law only if the FDA issues a regulation worthy of deference. However, in Mensing and Bartlett , the Court appears to have breathed new life into impossibility preemption, a theory previously reserved to hypothetical examples in the High Court's opinions. After Mensing , when an entity cannot independently satisfy both a state law requirement and federal law requirement without receiving "special permission" from the federal government, the state law must yield. Bartlett further expanded the impossibility defense by rejecting a long-time defense to conflict preemption that no conflict exists when a defendant can choose not to act or pay a state law fine—that is, the stop-selling theory.

Collectively, after Levine, Mensing, and Bartlett , state failure-to-warn claims against a manufacturer of a brand name prescription drug are not preempted by federal drug law, but state failure-to-warn and strict liability claims premised on complying with a state law duty against a generic drug manufacturer are preempted. This result alone is significant, as generic medicines reportedly account for nearly 80% of all prescriptions dispensed in the United States and are growing at a rapid pace. Additionally, the independence principle enunciated in Mensing and reaffirmed in Bartlett lends to the conclusion that tort claims predicated on the chemical makeup of an approved drug, regardless of whether the drug is generic or brand name, would be preempted by the FDCA. After all, under current law no drug manufacturer can unilaterally change a drug, as the "altered chemical would be a new drug that would require its own NDA to be marketed." Even more broadly, the principles enunciated in Mensing and Bartlett could potentially be applied to other contexts in which the law requires approval by the government before a product can be marketed, including with respect to the § 510(k) approval of medical devices, or conceivably to any other area of federal law that similarly imposes a process where the government evaluates the safety or effectiveness of a product before it can be sold.

Potential Changes to the Generic Sameness Requirement

While the broad principles of Mensing and Bartlett with respect to impossibility preemption may have immense implications to a host of different areas of law, the underlying rationale for impossibility preemption of failure-to-warn claims in the generic drug context—the federal sameness requirement—may be altered in the near future. A few weeks after Bartlett was issued, the FDA indicated that it plans to issue a "Notice of Proposed Rulemaking" with respect to the labeling of generic drugs. Specifically, the FDA states that the proposed revisions, which may be issued as soon as September 2013, will "create parity between NDA holders and ANDA holders with respect to submission of CBE labeling requirements." In other words, the FDA intends to allow generic manufacturers the ability to unilaterally update the labeling of a generic drug, which in theory would eliminate the underlying rationale for Mensing by making it possible to simultaneously comply with state tort duties and federal drug law. Nonetheless, eliminating the federal sameness requirement may be difficult to legally accomplish through a change in regulation given the statutory requirement that proposed labeling for a generic drug generally be the "same as the labeling approved for" a listed drug. That statutory basis can be eliminated by Congress, as some bills have proposed doing, but such legislation may raise policy questions as to the wisdom of requiring generic manufacturers, who by definition are relying on others' safety data in marketing their products, to make unilateral determinations that the FDA's original judgments regarding the labeling of the brand name product should be overridden.

Another legislative solution to those who are disappointed with the outcomes of Mensing and Bartlett was hinted at near the end of the majority opinion in Bartlett . Specifically, Justice Alito's opinion lamented the lack of any explicit guidance from Congress with respect to the preemptive effect of the FDCA's prescription drug provisions, going so far as to say the Court "would welcome Congress' 'explicit' resolution of the difficult pre-emption questions that arise in the prescription drug context." The Court cites the explicit preemption clauses found in the FDCA with respect to vaccines and so-called "express non-preemption" clauses found in the FDCA's over-the-counter drugs provisions as examples of explicit language that Congress could add to the statute. However, the addition of language that explicitly states that state tort claims are not preempted by the FDCA may do little to alter the results of Mensing and Bartlett , as the Court has held that the existence of an express preemption clause or a savings clause does not prevent the Court from examining whether a law impliedly preempts state law.

Other Developing Areas Regarding Preemption and Prescription Drugs

Assuming Mensing and Bartlett remain good law, several areas of legal dispute may allow the Court to revisit the issue of preemption and prescription drugs in the near future. For example, a circuit split has developed on whether federal law preempts a tort claim that a generic drug manufacturer has a duty to update a drug's label to match the brand name drug. In the context of Mensing and Bartlett, the generic sameness requirement imposed a requirement of inaction on the manufacturer without prior federal approval of a labeling change, but the same logic requires the generic label to match the pioneer's label at all times. On one hand, state-law tort law could impose an independent duty on a manufacturer to update a generic's label which, unlike in Mensing and Bartlett, would be possible to satisfy while simultaneously obeying the federal sameness requirement. On the other hand, a state duty that mirrors a federal requirement sounds very similar to the claim that was preempted in Buckman , as Congress intended the FDCA and the requirements imposed by the law to be enforced "exclusively by the Federal Government."

The specific issue of whether failure to update claims can proceed may ultimately be of little consequence, as a state claim based on a failure to update would have to prove that not updating the generic label during the time the sameness requirement was violated was the proximate cause of a plaintiff's injuries, seemingly a difficult task for any plaintiff injured by a prescription drug. Nonetheless, failure to update claims raises the specter of a broader issue—much like in the medical device context—as to whether state-law claims that are parallel to the duties imposed by the FDCA's drug provisions or FDA drug regulations are implicitly preempted by federal law.

Beyond the issue of whether parallel state-law claims are preempted, another issue that the Court may need to resolve is whether state law allowing for punitive damages for a failure-to-warn claim against a brand-name manufacturer are preempted. Courts have also split on whether a tort law claim alleging that a generic manufacturer has a duty to communicate with customers about dangers not on a drug label is preempted. In other words, Bartlett will likely not be the last time the Supreme Court delves into the difficult issues prompted by state tort claims, federal drug law, and constitutional preemption.

Question: What characterizes the relationship between state tort laws and the federal regulation of medical devices and drugs?

Answer: The interaction between state tort laws and the federal regulation of medical devices and drugs has been a source of constant litigation in recent years.

Question: What decisions has the Supreme Court issued on this question?

Answer: In the last two decades, the Supreme Court has issued several decisions concerning whether the Federal Food, Drug, and Cosmetic Act (FDCA) preempts state tort law.

Question: What have been the results of these decisions?

Answer: The results have been mixed: in some cases a person injured by an allegedly defective drug or device is barred from suing a manufacturer, whereas in other cases, the Supreme Court has allowed a lawsuit to proceed.

Question: What is the implication of these decisions?

Answer: Following these decisions, ambiguities exist concerning the scope of federal preemption in these medical device and drug cases.

Question: What does this report provide background on?

Answer: This report provides background on the doctrine of preemption and the types of state-law tort claims that have been brought against medical device and prescription drug manufacturers.

Question: What does the report address regarding FDCA?

Answer: The report also addresses the federal regulation of medical devices and drugs under the FDCA. With that background in mind, the report discusses the major FDCA preemption cases that have been recently issued by the Supreme Court.

Question: What does the report address regarding developments that may affect law?

Answer: Finally, the report covers possible judicial and legislative developments that may affect this dynamic area of law.

Tort Liability With Respect to Drugs and Medical Devices