//Preemption and medical-product liability

Preemption and medical-product liability

Some of the people who read this blog — both lawyers and injured patients — must respond to preemption defenses in their medical-product litigation. You may want to read Catherine Sharkey’s Field Preemption: Opening the ‘Gates of Escape’ from Tort Law. Here is the abstract:

Richard Epstein remains a (lone) staunch defender of field preemption of state tort laws in drug failure-to-warn and design defect cases. Field preemption blocks state efforts to regulate within that field even where there is no explicit conflict with federal regulation.

Epstein’s position squares with his libertarian predilections. He has decried how concurrent federal and state regulation ratchets up governmental control so that the most intrusive regulator always wins. Moreover, his sharp critique of more moderate conflict preemption approaches, such as my “agency reference model” that harnesses key interpretive tools of administrative law to shed light on the preemption question, follows from his distrust of, and disdain for, the burgeoning administrative state.

Far less examined is the extent to which Epstein’s normative vision of tort law — and how far it deviates from the reality of the expansion of tort liability and rejection of contractual defenses since the 1960s — drives his fervent embrace of field preemption. Seen in this light, field preemption compensates for the systemic errors of tort law.

Framing Epstein’s case for field preemption in this way has two significant implications. First, his critiques of the “agency reference model” are overdetermined. No amount of evidence either that courts are moving in this direction or that they are equipped to scrutinize the administrative regulatory record in deciding whether a state law failure to warn or design defect claim should be foreclosed matters, if the first best position is wholesale eradication of these expansive product liability causes of action.

Second, whereas Epstein has rightly emphasized the high stakes when the issue is whether federal law will preempt state law causes of action that have vastly expanded since the adoption of the Restatement (Second) of Torts in 1966, we might invert the line of inquiry to examine the prospects for adoption of a far more restrictive tort liability standard for drug and device manufacturers, such as the 1998 Restatement (Third) of Products Liability § 6(c). That provision met with a chilly reception in the courts, and most (Epstein included) read this as evidence of the insatiable appetite for ever-expansive state tort liability. But it may well be that the rise of preemption of products liability claims — which incidentally took flight almost at the very same time as the promulgation of the Third Restatement — stunted the evolution of state tort law standards. If that is so, then field preemption is as much to blame for perpetuating the need for a gate of escape from poorly developed concepts of tort liability against drug and device manufacturers.

Source: http://feedproxy.google.com/~r/ConsumerLawPolicyBlog/~3/X00nFYnwcsg/preemption-and-medical-product-liability.html