CHAPTER § 9.05 Preemption

• Jurisdiction: United States

§ 9.05 Preemption

Prescription drug and medical-device manufacturers are required to follow regulations for application and labeling set forth by the United States Food and Drug Administration ("FDA") and promulgated under the Federal Food, Drug, and Cosmetic Act ("FDCA").²⁵⁸ Pursuant to these laws and regulations, prescription drugs and medical devices may only be manufactured and distributed in accordance with specific FDA standards. In most cases, changes to the design, manufacturing standards, and labeling cannot be made without prior FDA approval. Because of FDA's extensive control over virtually every facet of prescription drugs and medical devices, manufacturers of these products often raise the affirmative defense of federal preemption when faced with state-law product-liability claims that seek to hold a company liable despite compliance with FDA's laws and regulations. The essence of the defense is that lay jurors should not be permitted to second-guess FDA's expert decisions on the safety and efficacy of drugs and devices, including the adequacy of their labeling, how they are manufactured, and how they were researched and designed.

The preemption defense, if successful, is a complete defense to most theories of liability under state law. Further, it can be raised at an early stage in the litigation, avoiding entirely the cost of discovery, if successful.

This section provides a brief overview of the preemption defense in the context of pharmaceuticals and medical devices. In addition, this section examines the various sources of preemption defenses, as well as the factual circumstances under which the defense is accepted, and those areas where the law is still developing. The section then examines a unique form of conflict preemption as set forth in the Supreme Court's decision in Buckman Co. v. Plaintiffs' Legal Comm. applicable to claims by private litigants seeking to enforce provisions of the FDCA, which is an increasingly important limit on product-liability claims against manufacturers of medical devices and prescription drugs.

[1] Types of Preemption

The law of preemption originates in the Supremacy Clause of the United States Constitution, which states: "The Constitution and the law of the United States . . . shall be the Supreme Law of the land; and the Judges in every state shall be bound thereby."²⁵⁹ Accordingly, any state law or regulation that contradicts or interferes with federal law is superseded by the federal law.²⁶⁰ For purposes of preemption, "federal law" is broadly defined to include the United States Constitution, federal statutes, federal regulations promulgated by agencies, and actions taken by federal agencies pursuant to their congressionally delegated authority.²⁶¹ "State law" includes state statutes, state regulations, and common-law tort actions.²⁶²

The central question in evaluating a preemption defense is the determination of congressional intent.²⁶³ In this regard, there are two main types of preemption: express and implied. Express preemption occurs when Congress explicitly states its intent that a particular statute invalidates, or preempts, state law in a particular area.²⁶⁴ Implied preemption occurs when Congress has not expressly spoken on the issue of preemption but its intent is "implicitly contained in [a statute's] structure and purpose."²⁶⁵ Implied preemption can occur in two variations: (1) field preemption or (2) conflict preemption. Implied field preemption arises when the scheme of federal regulation in a particular field is "so pervasive as to make reasonable the inference that Congress left no room for the States to supplement it."²⁶⁶ Implied conflict preemption occurs when "compliance with both federal and state regulations is a physical impossibility"²⁶⁷ or when state law "stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress."²⁶⁸

Only where Congress has not made its intent clear will courts apply a general "presumption against preemption."²⁶⁹ Citing federalism and state-sovereignty concerns, courts assume that Congress would not intend to supplant traditional areas of state regulation in the absence of a clear intent to do so. But where Congress expressly declared its intent to supersede state law, the Supremacy Clause mandates that state law is preempted, and there is no role for any "presumption against preemption."²⁷⁰

There is no express-preemption statute supplanting state-law claims against prescription drug manufacturers, so only implied preemption is available. Congress has passed express-preemption provisions governing claims relating to medical devices and over-the-counter drugs. For those products, claims may be expressly or impliedly preempted. In addition, implied preemption may impact all FDA-regulated products where private parties directly seek to enforce provisions of the FDCA, which provides for no private right of action.

[2] Who Decides Preemption?

It has long been understood that preemption is an issue of law for courts, not juries, to resolve.²⁷¹ That understanding received a jolt in 2017 when a panel of the Third Circuit—dismissing decades of binding precedent as "offhand statements"—concluded that implied conflict preemption is a question of fact that must be answered by a jury.²⁷²

That sojourn from the norm, at least in the Third Circuit, was short-lived. In 2019, the Supreme Court issued its opinion in Merck v. Albrecht, ruling that the preemption question "is a legal one for the judge, not a jury."²⁷³ Whatever factual questions might exist as part of that legal analysis are "subsumed within an already tightly circumscribed legal analysis" decided by the judge.²⁷⁴ Accordingly, as it had been prior to Albrecht, the question of implied preemption—regardless of the product at issue—is a question of law that should be decided by a judge, likely at the stage of dispositive motion practice.

[3] Federal Preemption in Pharmaceutical Drug Cases

There is no express-preemption provision governing claims against prescription drug manufacturers. However, manufacturers may still contend that the Supremacy Clause bars state-law claims where it "is impossible for a private party to comply with both state and federal requirements."²⁷⁵ In this context, prescription drugs are extensively regulated by FDA, and this authority may, in certain circumstances, impliedly preempt any common-law tort claims that conflict with that authority. The contours of implied preemption in the context of pharmaceutical cases has been shaped by four Supreme Court cases discussed in more detail below.

This section explores the instances in which implied preemption might attach under these cases. It then explores one area in which Congress has expressly preempted State law: over-the-counter medications.

[a] Implied Preemption of Prescription-Drug Claims

Congress has not enacted an express-preemption provision covering prescription drugs.²⁷⁶ As a result, prescription-drug manufacturers must argue that Congress intended FDA's regulation over prescription drugs to impliedly preempt common-law claims.²⁷⁷ The U.S. Supreme Court has explored the parameters of federal preemption in the context of prescription drugs in four cases, Wyeth v. Levine, PLIVA, Inc. v. Mensing, Mutual Pharm. Co., Inc. v. Bartlett, and most recently, Merck v. Albrecht.²⁷⁸ Beginning with Levine, the Court acknowledged that given the right factual circumstances, FDA regulation of prescription pharmaceuticals might impliedly preempt state law. The Court then clarified the scope of implied conflict preemption in Mensing, Bartlett, and now Albrecht, but has left many questions open for lower courts to untangle. The result is that federal preemption in the context of prescription drugs is highly factsensitive and riddled with seemingly inconsistent decisions and exceptions.

[i] Pre-Levine Case Law

Prior to the Supreme Court's decision in Levine, preemption had consistently been raised as a defense in pharmaceutical litigation. However, acceptance of the defense in the courts had been inconsistent.²⁷⁹. Some courts held that FDA's labeling requirements represented only minimum standards that could be supplemented by common-law duties, thereby necessarily defeating the preemption defense.²⁸⁰ Other courts relied on the Changes Being Effected ("CBE") supplement regulation for the proposition that pharmaceutical manufacturers are permitted to "add [ ] or strengthen[] a contraindication, warning, precaution, or adverse reaction" "before FDA approval" and, thus, state and federal requirements do not conflict.²⁸¹ A CBE supplement does not require prior FDA approval, but is permitted for only certain labeling changes, and is appropriate only to "reflect newly acquired information."²⁸²

In contrast, courts accepting the preemption argument recognized the importance of a uniform federal system and that state-law claims often pose a conflict to federal authority. For example, the Third Circuit acknowledged FDA's position that "the imposition of liability under state law for defendants' alleged failure to warn would interfere with FDA's accomplishment of regulatory objectives."²⁸³ Other courts acknowledged that FDA's laws and regulations are not minimum standards, and that the existence of the CBE regulation alone does not prevent a finding of preemption.²⁸⁴

A regulatory event spurred an intense debate in the courts regarding preemption in prescription drug cases. In January 2006, FDA issued changes to the regulations concerning prescription-drug labeling.²⁸⁵ As part of the final rule, FDA issued a formal statement of its position on preemption in pharmaceutical product-liability cases. In what is known as the "Preemption Preamble," FDA expressed its "long standing view"²⁸⁶ that preemption applies where state tort laws "conflict with and stand as an obstacle to achievement of the full objectives and purposes of Federal law."²⁸⁷ Thus, according to FDA, "under...