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Not Quite Buckman Preemption (Devore v. Pfizer)

By James M. Beck and Mark Herrmann

Our crystal ball is usually cloudy.

Not so when the U.S. Supreme Court split four-to-four and thus affirmed Warner-Lambert v. Kent, 552 U. S. ____ (2008) , by an equally divided court. We confidently predicted that this issue would continue to percolate in the lower courts until the Supreme Court actually resolved it.

And it's percolating.

Just before Thanksgiving, another state appellate court came within inches of reaching the Buckman preemption question. The case is Devore v. Pfizer, No. 4147-4147A-4147B, slip op. (N.Y. App. Div. Nov. 20, 2008) (link here).

There, three Michigan residents were presumably trying to evade their home state's law that restricts product liability claims brought against drug companies. The Michigan plaintiffs thus filed their case against Pfizer (involving its drug Lipitor) in New York state court, asserting that the law of New York -- where Pfizer's headquarters are located -- should govern their claims. The trial court disagreed, applied Michigan law, and dismissed plaintiffs' claims.

The New York Appellate Division affirmed. The court first addressed the choice of law question. Since plaintiffs live and work in Michigan and allegedly suffered their injuries in Michigan, "Michigan has far greater significant contacts wtih the litigation." Id. at 5. The appellate court rejected the federal trial court's reasoning in Carlenstolpe v. Merck & Co., 638 F. Supp. 901 (S.D.N.Y. 1986), that the law of a drug company's home state could apply in this type of situation, and instead followed the later, and "far more persuasive," reasoning of Doe v. Hyland Therapeutics Div., 807 F. Supp. 1117 (S.D.N.Y. 1992).

Michigan law governed the claims of Michigan residents who claimed to have been injured by Lipitor in Michigan.

The next question was whether those claims were barred by the Michigan statute (Mich. Comp. Laws Sec. 600.2946(5)) that bars product liability claims brought against manufacturers of FDA-approved drugs unless (1) the FDA revoked its approval, (2) the manufacturer defrauded the FDA in obtaining approval, or (3) the manufacturer bribed an FDA official to obtain approval.
As readers of this blog know, the second of those exceptions -- fraud on the FDA -- may be preempted under the logic of Buckman Co. v. Plaintiff's Legal Comm., 531 U.S. 341 (2000), leaving only the statutory immunity from liability intact.

The Devore court didn't have to reach that question. "Neither the allegations of plaintiffs' complaints nor any other submissions contained in the record before us suffice to set forth a claim that Pfizer fraudulently obtained the FDA approval on which it relies." Slip op. at 9. And the "bare assertion that Pfizer engaged in deceptive marketing and other fraudulent and/or negligent conduct in the marketing of Lipitor" did not entitle "plaintiffs to proceed with discovery on a claim of fraud in the agency approval process." Id.

The court thus did not have to reach the Buckman preemption question or choose sides between Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), and Desiano v. Warner-Lambert, 467 F.3d 85 (2d Cir. 2006) (which became Warner-Lambert v. Kent in the Supreme Court).

Rather, the Appellate Division simply affirmed dismissal of plaintiffs' claims because plaintiffs had not pleaded facts sufficeint to trigger any possible fraud-on-the-FDA exception.

Don't expect the next plaintiffs to make the same mistake. As night follows day, future plaintiffs will routinely plead that drug companies defrauded the FDA, and later courts will not be able to avoid deciding the preemption question.

There's much more to come.

We guarantee it.

Full post as published by Drug and Device Law on December 01, 2008 (boomark / email).