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It’s hard to find a political constituency for the preemption defense. Liberals want to permit plaintiffs to sue; conservatives believe in federalism, and so don’t think the federal government should lightly override state law. What’s a defense lawyer to do?
Be smart, and be careful. We’ve recently posted on the need for defendants to pick their fights carefully when litigating the preemption defense.
So why raise this defense in the Zyprexa litigation? Judge Jack Weinstein has built a reputation over the decades for using the judicial system to try to solve broad social problems. (Some people love him for that and some hate him for that — but it’s his reputation, and everyone knows it.) Judge Weinstein would be about the last guy on the planet to hold that it’s the job of the FDA — not judges and juries — to protect patients from the dangers associated with prescription drugs.
What were the defense lawyers thinking? Are our friends Tony Vale and Rachel Weil at Pepper Hamilton nuts?
We’re pleased to report that they’re not nuts. But we’re less pleased to report on the preemption decision that Judge Weinstein handed down in the Zyprexa MDL on Monday.
Eli Lilly raised preemption only gently in the Zyprexa litigation, in the context of federal question removal. Judge Weinstein then entered a series of orders over time, requiring Lilly to brief more and more preemption-related issues. When the judge orders, you listen, so preemption eventually came to the fore.
Judge Weinstein’s preemption decision is a long one. In re Zyprexa Prods. Liab. Litig., No. 04-MD-1596, 06-CV-1729, 2007 U.S. Dist. LEXIS 42641 (E.D.N.Y. June 11, 2007). And, as usual, we have to tread lightly here. If we try to distinguish a case in one direction today, we’re sure to regret those words when we’re representing some new client tomorrow.
But here’s what Judge Weinstein thinks. First, he fundamentally agrees with us that preemption is a good idea:
“Were the courts in a position to rely on the adequacy and candor of
representations to the FDA and of robustness of inquiry and decisions of the FDA, a desirable result would be to apply preemption, excluding the state tort law relied upon by present plaintiffs.”
Id. at *14. Eureka! He gets it!
Sadly, however, the judge thinks that “the FDA’s own research is limited and that it relies heavily on self-motivated representations and studies by the pharmaceutical industry.” Id. In that world, says the judge, tort law serves a purpose.
But if Judge Weinstein’s right, wouldn’t the answer be to fix the FDA? If the FDA is underfunded, fund it. If the FDA must do research, enable it. If the FDA needs more power to obtain information from drug companies, empower it.
But what’s not the answer? Create a world in which, first, the experts at the FDA dictate the contents of drug labeling and, later, lay juries sitting in courtrooms with injured plaintiffs second-guess those decisions, declare warnings to be inadequate, and award money damages. That’s nuts.
Nuts it is. Judge Weinstein notes a strong presumption against federal preemption. Id. at *102. (As we’ve posted previously, Supreme Court precedent doesn’t compel the finding of a presumption against preemption in the context of implied preemption. But no one’s listening to us yet.)
Judge Weinstein does not think the Preemption Preamble is entitled to Chevron deference, and he thinks the FDA’s purportedly inconsistent views on preemption undercut the authority of the Preamble. Id. at *107. (We’ve posted on that, too, and the FDA has been far more consistent than the plaintiff’s bar gives it credit for.)
Judge Weinstein doesn’t see a clear finding of legislative intent to preempt state tort law. Id. at *110. He’s persuaded by the dictum in Desiano that dismisses the Preemption Preamble. Id. He sees no actual conflict between plaintiff’s claims and federal law. Id. at *115. (There’s lots of room for commentary here, but whatever we write would come back to haunt us. In your cases, think hard about the existence of actual conflict.)
And, remarkably, “a jury verdict finding Lilly negligent for failure to warn of Zyprexa’s risks would not compel the company to do anything.” Id. at *116. (We thought that had been decided in Cipollone. Since about 1970, jury verdicts have expressly been meant to be regulatory, compelling defendants to act. And a verdict that a warning is inadequate would be paraded, rightly or wrongly, as offensive collateral estoppel in later cases. Sane defendants do not ignore the compulsion of jury verdicts.)
Judge Weinstein will, however, presumably allow the FDA’s assessment of drug labeling into evidence at trial, since the “jury may be guided by the parties’ experts as well as the more neutral expert opinion of the FDA, which approved the warning.” Id. at *128. (Small comfort there.)
The Zyprexa decision also grapples with statute of limitations and learned intermediary issues under the laws of Florida, Pennsylvania, and North Carolina. But you’re on your own to read that stuff. We’ve spent way too long at the computer, typing, today.
That was the week that was, from A to Z.
Happy Father’s Day, gents!