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Rebutting the implied-preemption defense: in products suits, drug companies are seeking immunity under theories of implied preemption. Their arguments are flawed.

Article Excerpt
For more than a century, patients who have been injured by drugs and medical devices have sued manufacturers tot breach of common law duties. (1) In the early 1990s, medical device manufacturers began to argue that the law regulating their products immunized them from liability by expressly preempting state law damages claims. They premised this argument on a provision of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act (FDCA), enacted to preempt certain state and local regulation of medical devices. The argument has met with mixed success. (2)

The FDCA contains no express preemption provision regarding prescription drugs, and, until recently, drug companies have not typically raised a preemption defense in products cases. Now, however, drug manufacturers are arguing, with increasing frequency, that federal law preempts state law suits.

Thus far, drug manufacturers have used this argument only with respect to failure-to-warn claims. Yet their theory, if adopted, would support broad immunity from products liability suits. This implied-preemption argument has several flaws, however, and the companies' attempts to evade responsibility for injuries caused by their products should fail.

Damages suits for drug-related injuries are generally based on theories of negligence or strict liability, for product defects or inadequate warnings. Relying on the FDA's marketing approval for new drugs, which includes scrutiny of clinical trials, manufacturing processes, and labeling, a company arguing that state law claims are preempted will focus on implied conflict preemption. The argument may be either that complying with both federal regulations and state laws is impossible, or that complying with the state laws would frustrate the purposes of the federal regulation.

A defendant arguing "impossibility" would not claim that it was physically impossible to provide the warning that the plaintiff alleges state law required. Instead, it would claim that FDA regulations prohibited the company from providing the warning and that, if the drug company had provided it anyway, the FDA would have considered the product misbranded and taken enforcement action against it.

In making these arguments, the company may claim either that the common law duties on which a claim is based establish a conflict or that a plaintiff verdict would impose duties that would conflict with federal law. In the latter case, for example, the defendant might suggest that a verdict finding that the company failed to warn of a known risk associated with its product is equivalent to a state law requirement that it add such a warning to the product's label.

However, a plaintiff verdict requires only that the defendant pay damages, not that it alter its product or label. (3) Indeed, a core principle of strict products liability is that although some potentially dangerous products will cause harm on occasion, it benefits society as a whole to keep them on the market and to compensate injured parties through the tort system. (4) Nonetheless, to fashion a preemption defense, defendants tend to overstate the regulatory effect of a plaintiff verdict. (5)

Presumption against preemption

In these cases, a presumption against preemption applies and may be overcome only by "clear and manifest" congressional intent to the contrary. (6) When Congress was considering the legislation that it ultimately enacted as the FDCA of 1938, it made clear its intention with regard to the effect on state-law damages claims: Congress specifically rejected a proposal to include a private right of action for damages caused by faulty or unsafe products that are regulated under the FDCA because such a right of action already existed under state common law. (7)

The notion that when Congress declined to provide a federal private right of action because state law already provided one, it approved a regulatory scheme that impliedly preempted those state remedies, is illogical. (8) Thus, it is not surprising that, since the...

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