Preemptive Strike

, The American Lawyer

Defense lawyers also contend that the agency's scientists are in a far better position than juries to determine whether a product is safe. Permitting injured consumers to sue manufacturers over an FDA-approved product, they say, sabotages the agency's authority and forces industry to grapple with an unworkable, chaotic state-by-state patchwork of laws. "Once it's gone through the mandated regulatory process, the industry should be entitled to protection," says John Murphy, managing partner of Kansas City, Missouri's Shook, Hardy & Bacon.

And legally, says James Beck of Dechert, plaintiffs lawyers are on shaky ground when they dis-pute preemption. "From a policy perspective, some of these issues may have some validity, but they're addressed to the wrong branch of government," he says. "Complaints about the power, funding, or relationship with industry of a federal agency like the FDA should be addressed to Congress, which created it, not the courts. States do not have the authority to ignore the [U.S. Constitution's] supremacy clause because they disagree with a position taken by a federal agency or think it is not sufficiently strong."

In the most significant preemption ruling to date, the Supreme Court, in a 8-to-1 decision authored by Justice Antonin Scalia, found that Medtronic was immune from suit under the 1976 Medical Devices Amendments because the FDA had approved the catheter that the plaintiff, Charles Riegel, blamed for his injury. The government, to no one's surprise, had sided with Medtronic; the Justice Department submitted a brief on the FDA's behalf that supported Medtronic's preemption defense.

Defense lawyers say the Court's Riegel ruling is of limited significance because it addressed only a small subset of the device market, and didn't address pharmaceuticals at all. Nevertheless, tort litigation involving devices that underwent the same FDA approval process as Medtronic's catheter are disappearing, says Jones Day's Mark Herrmann. He says that just three of 15 such cases have survived a court ruling on preemption since Riegel, one involving allegations centering on the actions of a manufacturer representative and two others involving warranty claims. Other device cases, Herrmann says, are likely being withdrawn or not being brought at all.

The stakes for both plaintiffs and the pharmaceutical industry are vastly higher in the Levine case, which the Supreme Court will consider this fall. Wyeth Pharmaceuticals is seeking to overturn a $6.8 million Vermont state jury verdict, arguing that Levine's failure to warn claim is preempted because the FDA approved the label on the drug that she alleges caused gangrene to develop in her arm. The FDA has weighed in with a brief arguing for more sweeping preemption protection than even the industry claims, Zieve says. "It's almost like field preemption-‘If it is anywhere in our records, if we saw it on a memo crossing our desks, that's enough for preemption.' "

Levine is "monumental," says Seeger & Weiss's Christopher Seeger, who says he plans to attend the argument November 3. A decision for the defense, Seeger says, "would be so extreme and so anticonsumer-it would be like overturning Roe v. Wade." Public Citizen's Brian Wolfman says that a Bush administration victory in the case would not only wipe out compensation for people injured by faulty drug labeling but also obliterate a major incentive for the pharmaceutical industry to ensure that its drugs are safe.

Defense lawyers take a more measured view. "My gut reaction is that it will be a 5-to-4 or 6-to-3 decision for the defense, with a relatively limited case scope," says Dechert's James Beck.

Still, neither side is taking any chances. Wyeth has bumped its former counsel, Wiley Rein, in favor of Seth Waxman, a partner at Wilmer Cutler Pickering Hale and Dorr, who served as solicitor general under President Bill Clinton. Plaintiffs lawyers are so concerned that they urged Levine to replace Public Citizen's Wolfman, a veteran Supreme Court litigator who filed Levine's opposition to Wyeth's petition for certiorari, with David Frederick, a former assistant to the solicitor general and now partner at Kellogg, Huber, Hansen, Todd, Evans & Figel.

Until the Supreme Court rules in Levine, many drug liability cases are in a holding pattern. Law-yers on both sides say that plaintiffs attorneys are playing it safe, being much more selective about the cases they bring, for fear that their investment of time and money could be mooted by an adverse decision in the Levine case. Judges have also put a hold on some cases, including three involving GlaxoSmithKline's antidepressant Paxil. Defense lawyers, of course, are happy to play the waiting game. They've also been using the specter of a pro-defendant verdict in Levine to push for lower settlements. "Defendants are looking for steep discounts," Seeger says.

For now, both plaintiffs and defense lawyers say that there's plenty of work to keep them busy. "Thus far, we have seen very little impact on our overall caseload," says John Murphy of Shook Hardy, which relies on drug and medical device work for close to 30 percent of its revenues. "A great many people are waiting to see what happens in November."

But in the waning days of the Bush administration, the defense bar is still basking in the warm glow of its policies. Pepper Hamilton's John Brenner says his March 2006 case-the first one to cite the preemption preamble as a defense--stands as the perfect example of its potency. Before 2006, the New Jersey Supreme Court said it didn't see any evidence that the FDA had spoken on preemption. When the preamble appeared, Brenner was able to tell the court that the FDA had spoken. Its policy was unambiguous. The court listened-and dismissed the claim against his client.

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