Sunday, April 15, 2007

Why Does Preemption Matter?

On Thursday afternoon, the Wall Street Journal called.

Herrmann fielded the call, because Beck had a conflict -- his firm is defending Merck in the Vioxx litigation.

The reporter told us that Judge Randy Wilson is overseeing the Texas statewide coordinated Vioxx proceedings. Judge Wilson had announced that he will soon be dismissing one Vioxx complaint on the ground of federal preemption and staying proceedings in the other 1000 Vioxx cases pending before him to allow appellate review of his preemption decision. Why, the reporter asked, does that matter?

For interested readers, the resulting article was posted on wsj.com (subscription required) on the night of Thursday, April 12, and the article appeared in the print edition of the Journal on Friday, April 13, on page A3.

That inquiry prompted this post. Readers who defend drug products liability cases for a living should pass on this post. It's not aimed at you. It's aimed at casual readers who have the same question that the WSJ did: Why does preemption matter?

We won't talk about the Vioxx litigation in particular, which might cause problems for Beck, but rather just about preemption in the abstract. Why is the preemption defense uniquely important in the pharmaceutical product liability world?

Let us count the ways.

First, preemption is potent. If applicable, the defense eliminates the entire failure-to-warn piece of the plaintiff's case, which typically includes the strict liability, negligence, warranty, and consumer protection act claims that are based on alleged inadequacies in the drug's package insert.

In most pharma products cases, failure-to-warn is the whole ball game.
Plaintiffs routinely plead that the defendant defectively manufactured the drug, but that's hokum. There's almost never evidence of a manufacturing defect. And plaintiffs routinely plead that the defendant defectively designed the drug, but that's hokum, too. Plaintiffs almost never have proof that a prescription pharmaceutical product -- developed over a period of years at a cost of tens (or hundreds) of millions of dollars -- should have been tweaked some way to make it better. Even the most malleable plaintiff's expert typically won't swear that he's ginned up some better formulation of, say, penicillin.

But, unlike manufacturing defect and design defect claims, failure-to-warn is easy to plead and "prove." The alleged sin is the failure to have warned appropriately about whatever side effect a particular plaintiff suffered. If there's no warning about that side effect, then, the plaintiff says, the manufacturer should have included one. If there is a warning about the side effect, then the manufacturer should have made it stronger: the side effect should have been included in the "warnings" or "contraindications" part of the label, instead of in "precautions." Or the warning should have been in a black box. Or the manufacturer should have sent a "dear doctor" letter to all physicians telling them about the risk. Or some aspect of the plaintiff's unique usage of the drug -- a high dose, or long-term use, or something else -- should have been identified. Whatever. It doesn't matter what the drug's label said; if only the label were re-jiggered slightly, then this plaintiff supposedly would not have used the drug and would not have been injured. Failure-to-warn cases are thus a plaintiff's dream -- essentially effortless to plead and "prove."

If the defendant wins the failure-to-warn claims, he's won the whole case. Preemption is potent.

Second, preemption is generic. If a defendant prevails on the ground that failure-to-warn claims are displaced by the FDA's regulation of a drug's labeling, then no plaintiff can win. As to that particular drug, every plaintiff's claim is barred.

And the defense may not be limited to just that particular drug. Depending on how the law plays out, it may be that all failure-to-warn claims based on all prescription drugs' labeling are preempted. That result would largely eliminate product liability claims against the manufacturers of prescription drugs -- which is a consummation devoutly to be wished. It would put the regulation of drug labeling firmly in the hands of the expert FDA, not to be second-guessed later by a lay jury deciding whether to transfer money from a drug company to a sympathetic injured plaintiff.

Third, preemption is a legal question. Most defenses in product liability cases are tied to a particular plaintiff's facts: What did the treating physician say? What dose did the plaintiff ingest? When did the plaintiff take the drug?

But preemption has nothing to do with a particular plaintiff. The only question is whether the FDA regulated the drug's labeling. Some courts will decide that question on a motion to dismiss, before the parties have spent tens (or hundreds) of thousands of dollars on discovery. Because preemption presents a pure question of law, it's an easy and elegant route to victory.

Fourth, preemption is severable. Even if a particular court does not view preemption as a pure question of law, the factual issues underlying preemption are severable from the rest of the case. If a court wants to hear evidence about a drug's labeling history, the discovery into that issue is discrete. The defendant can produce the relatively few documents related to the drug's labeling history, produce a single knowledgeable witness for a deposition (if even that much is needed), the parties can brief the issue, and the court can rule. In the world of product liability litigation, that's a no-muss, no-fuss victory.

In short, there are few defenses that are potent, generic, legal and severable. That's why preemption matters.

(Our more sophisticated readers shouldn't worry that this digression into a basic topic reflects a fundamental change in this blog. No, no; don't you fret. We'll return to the incomprehensible stuff -- choice of law in MDLs, the Reexamination Clause of the Seventh Amendment, heeding presumptions -- in our upcoming posts. We've got your back.)

2 comments:

Henry said...

Thank you for this primer on preemption. Although none of it is new to those of us who have been involved, it does provide one more useful statement of the ethical, logical, and legal bankruptcy that underlies it.

Here in Michigan, where we've lived under a preemption regime since 1996, we know that bankruptcy well. So do 70% of Michigan citizens, who support resscinding our drug industry immunity law. It is not only plaintiffs (and I am neither lawyer nor plantiff) who are tired of feeling like disposable garbage.

This blog always provides insight into the mentality of those whose job it is is to flush their rights, and the realities of their lives, down the toilet.

Sergeant First Class Rick said...

As one of the Vioxx Victims, I can say that this is horrible beyond belief. Preemption is basically a license to kill and maim for profit without being held responsible for those actions when victims and their families need a venue to force Pharmaceutical companies to own up.

Wow talk about crooks(Pharmaceutical companies) gaming the Judicial system to their favor!