On 24 June 2013, in Mutual Pharmaceutical Co. v. Bartlett, No. 12-142, 570 U.S. __ (2013), the United States Supreme Court held that generic manufacturers cannot be liable for state tort design-defect claims because federal law prevents them from changing a drug’s design. According to the Court, because the Food, Drug, and Cosmetic Act (FDCA) requires a generic drug manufacturer to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based, it would be impossible for a generic manufacturer to comply with a state-law duty that would require a change in the drug’s composition. The court held that the plaintiff’s state tort claims in this case were thus pre-empted. The court’s decision extends the reasoning of its 2011 decision, PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), where the court held that federal law pre-empts state tort-law failure-to-warn claims.

The court's reasoning

In Bartlett, the plaintiff developed toxic epidermal necrolysis—a rare and serious skin condition—as a result of ingesting a generic form of sulindac, an oral tablet. The plaintiff brought suit against the generic manufacturer under New Hampshire tort law, claiming strict product liability failure-to-warn and design defect. Her failure-to-warn claim was dismissed, but the jury awarded over US$21 million in damages on the design-defect claim. On appeal, the First Circuit Court of Appeals affirmed, declining to extend Mensing to the plaintiff’s designdefect claim and suggesting that generic manufacturers could comply with both federal and state law by simply taking the drug off the market. The manufacturer then sought a writ of certiorari.

The Supreme Court reversed in a 5-4 decision. As the majority explained, New Hampshire’s strict-liability tort regime requires manufacturers to ensure that their products are not unreasonably dangerous, either by altering the drug’s design or the drug’s warning label. But both of those are prohibited under federal law: FDCA regulations for generic drugs require the active ingredients, route of administration, dosage form, strength, and labeling to be identical to the brand-name drug in order to receive approval as a generic. It thus would be impossible for manufacturers to comply with both their statelaw and federal-law duties, meaning that the state-law tort claim was preempted: “When federal law forbids an action that state law The court majority also rejected the First Circuit’s “stop-selling” theory, explaining that the court of appeals’ rationale would render impossibility pre-emption meaningless: the court’s prior “pre-emption cases presume that an actor . . . is not required to cease acting altogether in order to avoid liability.”

The dissents

Four Justices dissented in two separate opinions. In the first, Justice Breyer, joined by Justice Kagan, suggested that the U.S. Food and Drug Administration (FDA) has an inconsistent approach to its views on pre-emption in cases involving pharmaceuticals, such that the courts should not give the agency deference when it comes to pre-emption. Justice Breyer’s dissent also considered briefly FDA’s historical tradition of allowing state laws to complement its own regulation, the lack of a pre-emption clause, and a general belief that removing this drug from the market—or requiring penalties in the form of tort damages—would not have a serious impact on the federal statutory scheme.

In the second dissent, Justice Sotomayor, joined by Justice Ginsburg, argued that the court failed to apply its own pre-emption principles, pointing to Wyeth v. Levine, 555 U.S. 555 (2009), which held that failure-to-warn claims against brand-name manufacturers are not pre-empted by the FDCA. Justice Sotomayor also pointed to the savings clause of the FDCA, which explicitly says the FDCA should not be construed to invalidate any provision of state law absent a direct positive conflict, and to the absence of a pre-emption provision in the FDCA. More broadly, the Sotomayor dissent expressed concern that the majority’s ruling would leave consumers like the petitioner without any remedy, rendering generic manufacturers essentially “free from common-law liability.”

Implications

The impact of this decision, in which the court has reinforced a dual-liability system for generic and brandname drugs, likely will be significant, extending beyond the legal theories governing pharmaceutical product liability cases. The Bartlett decision can be expected to affect the practice of medicine, the practice of pharmacy, and the actions of patients, as well as the commercial decisions made by drug manufacturers. Among other things, the virtual lack of liability against generic manufacturers for warning and (at least certain) design-defect claims may make doctors more inclined to prescribe brand-name drugs and to insist (as permitted under most state laws) that there be no generic substitution for that prescription. Patients similarly may be more prone to ask their doctors to prescribe brand-name drugs and also to exercise their rights (again, as provided for in most state pharmacy laws) to instruct pharmacists not to dispense a generic substitute. Even though most state laws already provide for “dispense as written” or “brand name only” prescriptions and allow patients to refuse generic substitution, the lack of tort liability on the part of generic manufacturers may spur efforts to strengthen or expand those laws, such as by removing the financial penalties involved (typically by way of a higher co-pay) for not using a generic product.

There also may be an increase in the number of courts seeking to impose “innovator liability" on brand-name manufacturers for injuries caused by generic products. Since Mensing, some courts have expanded traditional notions of tort liability in an effort to afford injured patients a right of recovery. For example, in Wyeth Inc. v. Weeks, 2013 WL 135733, __ So.3d __ (Ala. Jan. 11, 2013), the Supreme Court of Alabama held that under Alabama law, defective labeling of a brand-name prescription drug manufacturer’s product may render the brand-name manufacturer liable for fraud or misrepresentation for injuries caused by a competitor’s generic product. In so ruling, the Weeks court abandoned the traditional requirement of product liability law that an injured plaintiff actually consume, ingest or be exposed to a product manufactured by the defendant. After Mensing and now Bartlett, the Weeks case may represent a new and troubling trend.

Further, the reasoning underlying the Bartlett decision may lead plaintiffs to assert design-defect claims based on permitted differences between generic and brand-name products. Although, as the Bartlett court noted, the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based, what the decision did not address is the fact that brand and generic drugs are not required to be identical: FDA regulations allow generic drugs in certain circumstances to contain different inactive ingredients than the brand-name product, and even the requirement for the same active ingredient permits differences in the polymorphic form—i.e., the structure or solid state form—of the active molecule. Additionally, FDA may allow the generic version of a drug-device combination product (such as an auto-injector, a spring-loaded syringe that delivers a drug) to incorporate a delivery device that differs in design from the brand-name product. Plaintiffs may thus try to evade Bartlett by requires, the state law is ‘without effect.’” arguing that the alleged injury is traceable to an allowable difference in the generic product. It remains to be seen whether adequate scientific support for such theories of causality can be developed.

Finally, with generic manufacturers theoretically “liability-free” for design and warning defect claims and brandname manufacturers facing increased liability, one should expect an impact on manufacturers’ commercial decisions. Broader liability exposure may be reflected in brand-name product pricing, and may influence decisions on whether to withdraw a product from the market, and whether to seek withdrawal of FDA approval for products no longer marketed. The Bartlett and Mensing decisions also have implications for the already complicated interactions between brand-name and generic manufacturers in negotiating shared Risk Evaluation and Mitigation Strategy (REMS) programs, which the FDCA requires when generic versions of certain drugs with serious risks come to market.

Mensing and Bartlett may not, however, impact manufacturers’ actions and decisions in the long term. Even before Bartlett, FDA was facing increasing pressure from some consumer groups and Democratic Senators to address the implications of Mensing. Earlier this year, for example, FDA announced that it was considering revisions to its regulations to allow generic drug manufacturers to change their products’ labeling in certain circumstances. Such a change in the regulation, which would allow broader differences in labeling between a generic and brand-name product, may in turn eliminate pre-emption of failure-to-warn claims against generic drug manufacturers and may affect design-defect claims, as well.