Preemption
Preemption Overview
One of a defendant company’s most potent weapons in defending a mass tort is the doctrine of preemption. Federal laws expressly preempt some state-law causes of action relating to mass torts, while other causes of action are impliedly preempted, either because the responsible federal agency has occupied the regulatory field, because the state law presents a substantial obstacle to the accomplishment of a federal objective, or because it would be impossible for a company to comply with both the applicable federal and state law. These preemption doctrines also depend in part on whether the product at issue is a drug or a device, and further (1) if a drug, whether it is branded or generic; and (2) if a device, whether it was approved through the 510(k) clearance or premarket approval process.
Federal Regulation of Drugs and Devices
Drugs and medical devices are regulated by the U.S. Food & Drug Administration. Within the FDA, there are 14 constituent offices and 7 centers. The two centers that feature most prominently in pharmaceutical and medical device litigation are the Center for Drug Evaluation and Research (“CDER”) for pharmaceuticals and the Center for Devices and Radiologic Health (“CDRH”) for devices. Other centers to be familiar with are the Center for Biological Evaluation and Research (“CBER”), the Center for Food Safety and Applied Nutrition (“CFSAN”), and the National Center for Toxicological Research (“NCTR”), the last of which is within the Office of the Chief Scientist, which itself is within the Office of the Commissioner.
An important element of both drug and device litigation is an understanding of current good manufacturing practices (“CGMPs”). CGMPs are the quality-control and risk-management systems for design and monitoring of both manufacturing facilities and the actual processes used in manufacturing. By law, any drug or device that was not made in compliance with CGMPs is “adulterated,” a term of art under federal law. Moreover, CGMPs are not simply common-law standards of care, but instead are statutory and regulatory requirements that impose explicit standard to which manufacturers must adhere.
The CDER regulates both prescription and over-the-counter, brand-name and generic drugs, as well as biological therapeutics—treatments of disease made from living materials or tissues. Perhaps surprisingly, “drugs” under CDER’s purview also includes intrauterine devices, fluoride toothpaste, and sunscreen.
An important concept in drug and device litigation is “misbranding.” A drug or device is misbranded if “its labeling is false or misleading in any particular.”[1]
[1] 21 U.S.C. § 352(a)(1).