Supreme Court Botches Preemption Case

by Greg Conko on March 4, 2009 · 7 comments

in Healthcare, Legal, Regulation

The Supreme Court handed down its decision this morning in the Wyeth v. Levine federal preemption case, holding, by a 6-3 majority, that “Federal law does not pre-empt [plaintiff Diana] Levine’s claim that [the Wyeth drug] Phenergan’s label did not contain an adequate warning about the IV-push method of administration.” Justice Stevens wrote the majority opinion, joined by Justices Kennedy, Souter, Ginsburg, and Breyr, and with Justice Thomas concurring in the judgment. Justice Alito wrote a compelling dissenting opinion, joined by Chief Justice Roberts and Justice Scalia. Guest blogger Bert Rein and I separately commented on the case here, here, here, and here.

According to Justice Stevens’ majority opinion, “The history of the [Food Drug and Cosmetics Act] shows that Congress did not intend to pre-empt state-law failure-to-warn actions.” Fair enough, but this isn’t a typical failure-to-warn case. As Justice Alito’s dissent notes, Ms. Levine alleged not only that the warning on Phenergan’s label wasn’t strong enough, but that Phenergan was “not reasonably safe for intravenous administration,” and that Phenergan’s label should have indicated that the drug “should not be used intravenously.” But, that’s a question regarding FDA’s approval of the product for that use, not merely the sufficiency of the warning.

Consequently, the decision reaches to the very core of FDA’s statutory competence. FDA made a regulatory decision that the benefits of IV injection outweighed the risks, and the agency permitted the product to be labeled accordingly. Furthermore, there are no allegations that Wyeth hid any information about the risks of IV injection, nor that any new information regarding the risks of IV injection have arisen that would call that decision into question since FDA made it. So, letting a Vermont jury penalize Wyeth for not ruling out IV injection on Phenergan’s label is tantamount to letting a group of laymen over-rule FDA’s expert opinion regarding safety.

It would have been one thing if new evidence of risk had arisen since FDA approved the label, or if Wyeth were accused of hiding information from the FDA or mis-representing the data it did provide. In such a case, exposing a drug manufacturer to tort liability would not be over-riding FDA’s expert judgment. But that is decidedly not the case here. Indeed, the negligent act that actually caused Ms. Levine’s unfortunate injury was not an IV push injection into a vein, but the physician’s assistant’s botched administration. The physician’s assistant injected Phenergan into Ms. Levine’s artery, in direct contravention of six label warnings against arterial injection. More or sterner warnings against arterial injection would not have prevented Ms. Levine’s injury.

Thus, the Supreme Court could have and should have held in Wyeth’s favor with a narrowly tailored opinion confined to the facts of this case. Doing so would not have insulated wrong-doers from punishment, but would have recognized that Congress gave FDA statutory authority over questions of safety and efficacy because it believed that only a federal expert body could effectively balance the benefits and risks of new medicines. So, not only is the majority’s decision bad policy, it’s also bad law.

Ray Orbach March 4, 2009 at 9:40 am

It's sad to see that the Supreme Court didn't take the facts into consideration. By that I mean that the nurse srewed up, not Wyeth

Alex Harris March 5, 2009 at 5:28 am

I agree that the facts of the case should have led to a narrower ruling – and, indeed, that it should never have gotten up to the US Supreme Court at all.

But I'm not sure I agree with the pro-preemption view in this case. I think there's something to be said for state tort law being independent of the FDA – in both directions. The FDA is pretty bad at making judgments about the safety of drugs. Libertarians have long pointed out that the tort system, alone, would do a much better job.

Unfortunately, we don't have the tort system alone; we have both. On the one hand, this poses a problem of two layers of regulation – which is pretty much always worse than one. The e-commerce context shows this pretty well:

But, if we assume that the tort system almost always gets things right and the FDA rarely does, then we shouldn't have too many complaints when the FDA lets a drug that causes injury slip through and the tort system lets the injured patient sue. We want the tort system to operate in this way. Libertarians recognize that there is no such thing as perfect safety (in a way the FDA does not). When a product injures someone, the right response is not more prospective regulation (which bans or delays the introduction of or increases the cost of lots of great products too) but rather to compensate the victim for the injuries caused by the product. This restores the victim to the place she would have been had she never used the product and it sets the incentives exactly right. The manufacturer internalizes the costs it imposes on people injured by its products. It weighs those costs against the benefits of continued production. Unlike prospective regulation, if the benefits outweigh the costs (as they surely would in this case), the manufacturer will continue making the product.

I worry that if the Court adopted federal preemption, then politicians and voters would no longer have the safety net of the tort system and would call for the FDA to increasingly scrutinize drugs and outlaw every one that has any potential to harm anyone. On the other hand, finding no preemption demonstrates that the FDA is far from infallible. (Unfortunately, it only demonstrates it in one direction, and not in the context of the much more common and deadly – but invisible – Type I errors.)

Mar March 15, 2009 at 12:55 pm

The Supreme Court ruled correctly. Big business has high priced lawyers, politicians and the media. The little guy only has the law suit. It is as simple as that. Lawyers just complicate everything because that is there life.

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