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Consumer Warranty Law: 1.6.2.1.1 The review system for medical devices

The Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act set up a system for Food and Drug Administration (FDA) review of medical devices.215 The statute categorizes medical devices as Class III, Class II, or Class I, depending on the risk they pose to consumers. For Class III devices, the ones that pose the greatest risk, the FDA requires pre-market approval, its most rigorous review.

Consumer Warranty Law: 1.6.2.1.3 Express warranty claims

While Riegel did not address express warranty claims, many courts hold that federal law does not preempt an express warranty claim based on voluntary additional statements made by the manufacturer, rather than on FDA-approved statements in the product’s packaging and label.233 However, a court may perceive a conflict with the FDA’s approval of the safety and effectiveness of a device if the plaintiff claims that a manufacturer that complied with the FDA’s requirements breached an express warranty of safety and effectiveness.

Consumer Warranty Law: 1.6.2.1.4 Effect of FDA’s generic manufacturing standards

The Riegel Court reiterated that the generic requirements that the FDA imposes across the board on almost all medical devices, and the review it conducts to determine whether a device qualifies for grandfathering, do not necessarily result in preemption.238 Accordingly, when the plaintiff’s complaint is based on poor manufacturing practices, such as contamination or poor quality control, the court should determine whether the FDA has imposed any device-specific requirements regarding these practices.

Consumer Warranty Law: 1.6.2.2 Prescription Medications

The portion of the Federal Food, Drug, and Cosmetic Act that applies to prescription drugs does not contain an express preemption provision.251 In 2009, the United States Supreme Court held that this Act does not preempt state failure to warn claims regarding name-brand prescription drugs.252 The Court relied heavily on the fact that, even though the FDA had approved the existing label for the medication, the manufacturer could have added a stronger warning once it became aware of side effects.

Consumer Warranty Law: 1.6.2.3 Generic Medications

In 2011, in PLIVA, Inc. v. Mensing,258 the Supreme Court held that the Federal Food, Drug and Cosmetic Act preempts failure to warn claims regarding a generic medication. The Court reiterated that similar claims would not have been preempted if they had been asserted against a name-brand manufacturer,259 but based its ruling on differences in the statutory schemes.

Consumer Warranty Law: 1.6.2.4 Over-the-Counter Medications

Over-the-counter drugs cannot be marketed unless the FDA has approved them as safe and effective for their intended use.274 The statute preempts state requirements that relate to the regulation of non-prescription drugs and are different from, in addition to, or otherwise not identical to a requirement under the federal statute.275 A savings clause states, however, that nothing in the federal statute should be construed to modify or affect any action or the liability of any person under state pr

Consumer Warranty Law: 1.6.2.5 Vaccines

Vaccines are subject to a special preemption regime. The National Childhood Vaccine Injury Act280 sets up a federal no-fault compensation program for vaccine-related injuries. The Supreme Court has held that the statute precludes design defect claims, although claims based on side effects that could have been avoided by proper manufacture or proper warnings may be preserved in some circumstances.281

Consumer Warranty Law: 1.6.2.6 The FDA’s Exclusive Enforcement Authority

The Medical Device Amendments and the prescription, generic, and over-the-counter medication provisions discussed above are all part of the Food, Drug, and Cosmetic Act (FDCA). One provision of that Act states that “all such proceedings . . . for the enforcement, or to restrain violations of, [the Food, Drug, and Cosmetic Act] shall be by and in the name of the United States.”282

Consumer Warranty Law: 1.6.3 Pesticides, Herbicides, and Veterinary Medicines

A second area in which preemption is an issue involves pesticides and herbicides, which are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).287 The statute requires manufacturers to submit information to the Environmental Protection Agency (EPA), which reviews the claims made for the product and approves the label under which the product is to be marketed.

Consumer Warranty Law: 1.6.4 Boats and Airplanes

The United States Supreme Court unanimously rejected a seller’s claim that the Federal Boat Safety Act preempted common law tort claims by the husband of a woman who fell out of a boat and was killed by the boat’s unguarded propeller blades.305 This important decision holds that an express preemption clause that says that a state “may not establish, continue in effect, or enforce a law or regulation” establishing a performance or other safety standard that is not identical to the federal regulations only preempts statutes and regulations, not

Consumer Warranty Law: 1.6.5.2 Private Suits Seeking Relief Similar to a Recall

Some courts have allowed plaintiffs to seek court-ordered recall-like remedies for defective vehicles or parts, particularly in cases in which a defect is alleged but the plaintiffs or the members of the plaintiff class have not yet suffered injuries as a result of the defect.330 This result is supported by the Motor Vehicle Safety Act itself, which states that a recall conducted pursuant to 49 U.S.C.

Consumer Warranty Law: 1.6.5.3 Primary Jurisdiction

When preemption is not found, a defendant may argue that under the doctrine of primary jurisdiction the court should nonetheless defer to the jurisdiction of the National Highway Traffic Safety Administration in cases involving issues of vehicle safety.

Consumer Warranty Law: 1.6.5.4 Required Statement of Estimated Gas Mileage

Federal law requires manufacturers to disclose estimated gas mileage on the Monroney sticker that must be affixed to every new vehicle sold in the United States.338 The Environmental Protection Agency (EPA), which enforces the statute, has detailed standards regulating how the mileage is to be calculated.339 In addition, the FTC has issued a guide regarding advertisement of fuel economy to consumers.340

Consumer Warranty Law: 1.6.5.5 The Clean Air Act’s Emission Controls

The Clean Air Act has an unusually broad preemption provision stating that “[n]o State or political subdivision thereof shall adopt or attempt to enforce any standard relating to the control of emissions from new motor vehicles or new motor vehicle engines subject to this part.”345 A number of courts have held that this provision does not preempt warranty, fraud, and other claims alleging that the manufacturer used a “defeat device” to prevent a vehicle’s non-compliance with federal emissions standards from being detected.

Consumer Warranty Law: 1.6.6 Consumer Product Safety Act

The Consumer Product Safety Act preempts state safety standards and regulations that prescribe requirements as to performance, composition, contents, design, finish, construction, packaging, or labeling that are designed to deal with the same risk of injury as a federal standard unless the state standard is identical to the federal standard.351 The Act also has a savings clause stating that compliance with consumer product safety rules or orders does not relieve any person from liability at common law or under state statutory law to any other

Consumer Warranty Law: 1.6.7 Energy Efficiency Ratings

For the appliances that it applies to, federal law explicitly preempts any state law that requires disclosure of energy use, energy efficiency, or water use other than the information required by federal law.360 A claim that a manufacturer’s federal disclosure was false is not preempted, however.361

Consumer Warranty Law: 1.6.8.1 Hazardous Substances

The Federal Hazardous Substances Act prohibits state cautionary labeling requirements unless they are identical to federal requirements.364 Taking into account the Supreme Court’s narrow construction of similar language in the Federal Insecticide, Fungicide, and Rodenticide Act,365 a court has held that this statute does not preempt a design defect claim regarding a household cleaner.366 In addition, a consumer can assert a state law claim that ado

Consumer Warranty Law: 1.6.8.2 Food and Tobacco

Neither the Food and Drug Administration’s inaction regarding mercury levels in fish, nor a letter in which it espoused preemption, resulted in preemption of a state failure-to-warn claim.368 State law claims concerning misstatements on a nutritional label are not preempted by the federal nutritional labeling law,369 at least as long as they seek to enforce only the federal requirements.370 Some courts hold that the FDA nutritional labeling rules d

Consumer Warranty Law: 1.6.8.3 Wireless Communications

Federal communications laws do not preempt warranty and consumer protection claims regarding the sale of a cellular telephone that could only work on the provider’s network376 or that allegedly emitted harmful radiation.377 But another court held that federal law preempted warranty and consumer fraud claims based on a wireless carrier’s failure to deliver the promised level of connectivity, on the theory that these claims related to market entry and rates, which the Federal Communications Act sp

Consumer Warranty Law: 1.7.2.1 Requirement of Liberal Construction

The Uniform Commercial Code (UCC) imposes a statutory mandate of liberal construction to promote its underlying purposes and policies.388 This mandate means that the Code’s general requirements of reasonableness and good faith can be more influential in deciding a case than the strict, literal language of the Code. Comment 1 to section 1-103 explicitly recognizes the primacy of policy over strict statutory construction: