Monday, November 23, 2009

Zipursky On Preemption "In The Spirit Of Conversation"

Professor Ben Zipursky (Fordham) just published a guest post over at Torts Prof Blog ruminating about why the Supreme Court found preemption in the context of medical devices that had undergone premarket approval in Riegel v. Medtronic, but did not find preemption in the context of prescription drugs on the facts of Wyeth v. Levine. That's an interesting post, and we commend it to you.


We have a couple of reactions to the post, one general and one specific.


First, the general: As you know, we're big believers in preemption at this blog, and we think the Supreme Court should have found preemption in both Riegel and Levine. And we're still optimistic that courts will find preemption in the context of drugs that have regulatory histories more compelling than the Phenergan involved in Levine.


But, in the spirit of conversation, let's think for a minute about whether Congress could reasonably have wanted to create a world in which preemption existed for certain medical devices, but not for drugs. We think it could have, for three reasons.


The first reason is historical accident. States were not regulating drugs very much in 1962, when Congress revamped the drug laws. But by 1976 that had changed, and states were regulating medical devices at the time Congress revamped the device laws - most notably California, which in 1970 enacted a law requiring its own premarket approval of medical devices. The Medical Device Amendments followed close on the heels of the Dalkon Shield controversy, which prompted states to act. With state regulation in the offing, Congress could reasonably have focused on the need for preemption in 1976 in a way that never occurred to it in 1962. This is particularly true with the most cutting edge, and highest risk/highest benefit devices, which after 1976 has to be premarket approved - the type of device at issue in Riegel. Had this been on Congress' radar screen in 1962, it might have done the same thing with PMA drugs.


The second reason for Congress to have distinguished between drugs and devices is grounded in policy. Historically, drug companies have been large. Bringing a new drug to market can take ten years and cost a billion dollars; drug companies have to be big. But historically, device companies were smaller. An orthopedic surgeon could step out into his garage, gin up a valuable implant with the tools he had on hand, and then start a small device company. These smaller companies have fewer resources to withstand the double jeopardy of first running the gauntlet of the FDA's approval maze, and then being second-guessed under the disparate laws of the 50 states. Don't get us wrong - we think such double jeopardy shouldn't be tolerated in either case, but we're not Congress. Perhaps Congress thought that large drug companies did not need the protection of preemption as much as small device companies did. In fact, the Senate said as much back in 1976, mentioning that its consideration was informed by the importance of the small innovative manufacturer in the invention and development of new medical devices.


The third reason is also grounded in policy. The useful life of a drug can be very long. Penicillin was discovered decades ago, but still serves a purpose, and thus is regularly prescribed. And, back in 1962, before Hatch-Waxman, drugs received patent protection for a long time, so drug companies could sell drugs profitably for many years. The useful lives of medical devices are frequently much shorter. It would be uncommon for a medical device invented today to remain state-of-the-art a decade from now. Perhaps Congress thought that drug companies, which could earn profits on their products for a long time, needed the protection of preemption less than device companies, whose products are not profitable for as long.


That's our general reaction to Zipursky; here's the specific.


We don't think that the difference between Levine and Riegel can be explained by calling Levine a "warning" case and Riegel a "design" case. For one thing, Levine did not say anywhere that design defect claims involving prescription drugs would be preempted. And we're not as confident as Prof. Zipursky that Levine should be considered a true "warning" case. After all, plaintiff never did offer an alternative warning in Levine and argued primarily that the drug should not have been used at all for that particular indication. 129 S. Ct. at 1194. Nor did Riegel hold that warning claims involving PMA medical devices escaped preemption - quite the contrary. Riegel specifically held warning claims were preempted. 128 S. Ct. at 1011 ("the MDA would pre-empt a jury determination that the FDA-approved labeling for a [device] violated a state common-law requirement for additional warnings").

Having litigated a lot of device cases in our lives, we don't agree with Prof. Zipurski that "most" device cases involve design defects. Certainly more do than in the drug area, since it's hard to conceptualize how in most drug cases one would change the "design" of a product and still have the same drug. But let's face it, design defect cases are hard - in most places a plaintiff has to have an alternative design that arguably works better, or at least more safely. That's expensive evidence to obtain, if it can be done at all. Warning claims are much easier to bring, since it's easy and cheap to second-guess a label. Thus, even in the device area, we'd say that there are still substantially more warning than design defect cases.

As litigators, we tend to take what courts say at face value. Since Levine and Riegel don 't purport to draw distinctions between warning and design claims, we're not prepared to read in such a distinction. But if we were inclined to psychoanalyze the Court, we would look more to Riegel as involving an off-label use, and Levine involving a labeled use. We could see the Court (although, of course, neither opinion says so) being less inclined to permit liability where a defendant's product caused injury while being used in a way inconsistent with its FDA-approved labeling, and more inclined to permit liability where the product was being used for an intended purpose, but nevertheless resulted in injury. But again, that's only rank speculation unsupported by anything in either opinion - and we think there should be preemption in either case, as long as the FDA considered the risk in question and made a decision about what the label should say about that risk.

But then again, maybe the most relevant distinction is between law professors, who are paid to think about such things, and us practicing lawyers, who aren't.

No comments: