Chapter 9 - § 9.1 • PREEMPTION



The defense of preemption2 is a topic that could take up an entire book on its own. It is one of the few areas of product liability law that involves constitutional issues. And, for that reason, with only a few minor exceptions, it is the only topic on which the U.S. Supreme Court routinely issues decisions relevant to Colorado product liability practice. While this section of the book addresses preemption generally — as well as preemption decisions with regards to certain types of products — practitioners and courts should be especially cognizant of the limitations of this section of the book and the need for careful independent research on these subjects for two reasons. First, in light of the enormity of federal regulatory schemes, this book cannot address all federal statutes that may bear on a preemption analysis of any particular product. Second, this area of the law is in constant flux for a wide variety of reasons, and prudence dictates that practitioners and courts make sure that any law they cite on preemption is still good law.

Practice Pointer
Preemption is one of the most complex and ever-shifting topics in product liability law. Careful and up-to-date research on the current state of preemption law is critical.

Under the Supremacy Clause of the U.S. Constitution, any state law that conflicts with the exercise of federal power is preempted.3 This clause provides:

This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.4

As numerous products are highly regulated by the federal government and product liability claims are state law claims, laws that are contrary to such federal laws and regulations are preempted.

There are three types of federal preemption: express preemption, conflict (or impossibility) preemption, and field preemption.5 Express preemption occurs when the U.S. Congress passes a law that explicitly preempts state law.6 For example, the National Childhood Vaccine Injury Act of 1986 (NCVIA) provides:

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.7

Conflict preemption applies when state law conflicts with a federal statute.8 This occurs when it is impossible for the manufacturer to comply with both state and federal law or the state law is an obstacle to accomplishing the purposes and objectives of federal law.9 This type of preemption is sometimes referred to as impossibility preemption, as it places the manufacturer in the impossible position of having its compliance with state law create a violation of federal law. For example, as federal law requires generic drug manufacturers to provide an identical label to the brand name drug label, but as state product liability laws may place a duty on a generic drug manufacturer to provide stronger warnings than as provided in the label of the brand name drug, federal law preempts state law.10

Third, field preemption is found where federal law entirely occupies a field to such an extent that it is reasonable to conclude that Congress left no room for state regulation.11 Field preemption may be inferred if the pervasiveness of the federal regulation precludes state law supplementation or if the federal interest in the field is sufficiently dominant.12 For example, as the federal Locomotive Inspection Act occupies the entire field of regulating locomotive equipment, it creates field preemption that bars all state law product liability actions against manufacturers of locomotive equipment.13

While preemption issues are addressed below by product and federal regulatory scheme (with products regulated by the FDA addressed before other products), practitioners and courts should remain aware of the type of preemption at issue — whether express, conflict, or field.

§ 9.1.1—FDA-Related Preemption Overview And Fraud On FDA Claims

One of the most frequent areas in which preemption issues arise is for products regulated by the U.S. Food and Drug Administration (FDA). FDA oversight and corresponding regulations are some of the most broad and extensive with regards to any products in the United States. The FDA regulates beverages, biologics, cosmetics, dietary supplements, drugs, foods, medical devices, and tobacco products.14

"Fraud on the FDA" style claims are not viable under the doctrine of preemption. A "fraud on the FDA" claim is one in which the plaintiff asserts that a manufacturer's fraudulent representations to the FDA caused the FDA to approve a product for use, and the product in turn caused the plaintiff's injuries.15 As the U.S. Supreme Court has held, due to the robust nature of the federal statutory scheme and the FDA's ability to punish and deter fraud against it, "state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, federal law."16 And, there is no private right of action under the Food, Drug, and Cosmetic Act (FDCA).17

§ 9.1.2—Brand Name Drug Preemption

The issue of preemption regarding drugs usually arises in the context of the labeling of drugs, as the FDA approves the label for the drug that lists warnings.18 As a general matter, federal preemption does not bar state law claims against brand name drugs.19

Congress did not expressly preempt product liability claims against drug manu-facturers.20 In Wyeth v. Levine, the U.S. Supreme Court found that the FDA's approval of drug labels does not create conflict/impossibility preemption.21 The FDA must approve all initial drug labels. However, a brand name drug manufacturer can use the changes-being-effected (CBE) process to change its drug label when necessary, without the FDA's prior approval.22 As the CBE process permits a drug manufacturer "to unilaterally strengthen its warning, . . . the mere fact that the FDA approved [a drug]'s label does not establish that it would have prohibited" a drug manufacturer from unilaterally strengthening its warning.23 Thus, there is no conflict/impossibility preemption for brand name drugs.24 However, if there is "clear evidence that the FDA would not have approved" the warning the plaintiff suggests the defendant should have placed on the label of the drug, the lawsuit is preempted.25

For non-prescription drugs (i.e., over-the-counter medications), the preemption clause in the federal statute specifically preserves product liability actions.26

§ 9.1.3—Generic Drug Preemption

Like brand name drugs, there is no express preemption for generic drugs.27 However, unlike brand name drugs, the label of a generic drug must be identical to the label of the brand name drug.28 A generic drug manufacturer cannot use the CBE process to unilaterally change the label of its drug.29 Accordingly, in PLIVA, Inc. v. Mensing, the U.S. Supreme Court concluded that conflict/impossibility preemption bars claims against generic drug manufacturers, as "state law imposed on the [drug] Manufacturers a duty to attach a safer label to their generic [drug, while federal law] demanded that generic drug labels be the same at all times as the corresponding brand-name drug labels."30 This preemption analysis not only precludes failure to warn claims against a generic drug manufacturer, but also design defect claims31 and breach of warranty claims.32

§ 9.1.4—Medical Device Preemption

The issue of medical device preemption turns upon the type of medical device and the nature of its FDA approval/clearance. Thus, a brief overview of the types of medical devices and their corresponding FDA approval/clearance process is helpful to understand medical device preemption issues.

There are three classes of medical devices: Class I devices (which have the lowest risks and are subject to only general controls, such as elastic bandages and surgical gloves), Class II devices (which have greater risk than Class I devices and are subject to both general and special controls, such as powered wheelchairs, infusion pumps, and surgical drapes), and Class III devices (which are the devices subject to the most regulatory oversight, such as heart valves, implanted cerebella stimulators, and pacemaker pulse generators).33 For Class III devices (as well as certain Class I and II devices), the manufacturer of a new medical device can go through what is referred to as the 510(k) process if the FDA finds the device is substantially equivalent to a previously approved (or grandfathered in) device.34 Otherwise, for Class III devices, "premarket approval" from the FDA is required.35 Premarket approval is a "rigorous process."36

Product liability claims asserted against medical devices that have gone through the "premarket approval" process are generally preempted.37 Product liability claims asserted against medical devices that have gone through the 510(k) process, on the other hand, are not preempted.38

§ 9.1.5—Vaccine Preemption

The National Childhood Vaccine Injury Act of 1986 (NCVIA) set up a no-fault compensation program for those injured by a vaccine.39 NCVIA immunizes vaccine manufacturers from liability for failure to warn if they have complied with all regulatory requirements (including but not limited to warning requirements) and have given the required warning.40 It contains an express preemption clause, which prevents lawsuits based upon unavoidable adverse side effects.41 This preemption clause bars state law design defect claims.42

§ 9.1.6—Tobacco Preemption

The Federal Cigarette Labeling and Advertising Act contains an...

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