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Ginsberg?s Riegel Dissent: A Hidden Win for Drug Preemption?

By James M. Beck and Mark Herrmann

More on Riegel - this time from one of our recidivist guest posters, Adam Masin at Reed Smith.

He thinks there may be a silver lining for drug defendants in Justice Ginsbeg's anti-preemption dissent.

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Justice Ginsberg, the lone dissenter in Riegel, had a lot of relevant things to say about preemption in the prescription drug context. The surprise is that a lot of it was very good for defendants.

It is admittedly difficult to believe that Justice Ginsberg would someday find that FDA?s prescription drug regulations broadly preempt state law when she refused to find broad preemption in the device context, where there was an express preemption clause. Indeed, the basis of Justice Ginsberg?s dissent was her claim that preemption had been historically rejected in the prescription drug context, and therefore, Congress must not have intended broad preemption in the device context either. In that context, Justice Ginsberg reports that courts considering the question have ?overwhelmingly held that FDA approval of a new drug application does not preempt state tort suits,? citing a list of cases very familiar to readers of this blog, and she concluded that ?[d]ecades of drug regulation thus indicate?that Congress did not regard FDA regulation and state tort claims as mutually exclusive.? None of this sounded very promising.

But then things got much better real fast. Justice Ginsberg says that her opinion ?would hardly render the FDA?s premarket approval?irrelevant to the instant suit.? That?s good news. Then she asserts that her rejection of broad preemption, of the kind found by the majority, ?does not foreclose (through negative implication) any possibility of implied conflict preemption.? That?s really good news. Then she acknowledges that a manufacturer ?may have a dispositive defense if it can identify an actual conflict between the plaintiff?s theory of the case and the FDA?s premarket approval of the device in question.? That?s great news.

Read that line again. Justice Ginsberg has explicitly recognized the possibility that a plaintiff?s theory of the case can conflict with FDA approval and would be preempted under that circumstance. That position, of course, has been the basis of FDA?s position on the preemption of failure-to-warn claims all along - and what we?ve been telling courts on behalf of our clients. The next step is simply to identify the conflict, and the good news there is that, as the Reigel majority recognized, FDA is entitled to a lot of deference about the interpretation of its own regulations under Auer.

So despite her historical report that courts have generally rejected preemption in the drug context (or, more accurately, found no conflict preemption under the facts of their individual cases), Justice Ginsberg really helps push the conflict preemption argument forward, even acknowledging, in a line sure to be repeated by us forever, that ?[t]he process for approving new drugs is at least as rigorous as the premarket approval process for medical devices.?

So if FDA goes through that ?rigorous? process and approves warnings as a result, and interprets its own regulations to disallow different warnings under most circumstances, then a plaintiff surely cannot come to court claiming that a drug manufacturer (or a device manufacturer, for that matter), could or should have said something different. Preemption, after all, is not a complicated defense when federal law prohibits you from doing something different.

Reigel is obviously a big win for manufacturers. Whether Justice Ginsberg?s dissent is a hidden ?win? remains to be seen, of course, but it should at least put to rest any argument that conflict preemption can never bar a plaintiff?s failure-to-warn claim, and it provides us with a lot more good things to say about preemption until the Supreme Court has its say again.

Full post as published by Drug and Device Law on February 20, 2008 (boomark / email).