Even for lawyers, the Federal Register is not the most scintillating read. So it was with a certain resignation that John Brenner sat down at his desk early one evening three years ago to read 76 densely worded pages of new drug labeling regulations issued by the Food and Drug Administra-tion. Brenner, then a drug liability partner at McCarter & En-glish in Newark, remembers thinking, "I need to read this-these are major changes in the labeling rules." He resisted the urge to skip to the last ten pages where the actual changes to the regulations were laid out. Instead, he started slogging through the 65-page preamble, which set forth the agency's rationale for the new rules. At comment 13, Brenner saw something that pulled him up short. "It was like a lightbulb went on," he remembers. Taking the rules with him, he went out into the hallway to hunt down his colleagues. "Have you seen this?" he said to as many lawyers as he could find. "Does it say what I think it says?"
The language that surprised Brenner-and other drug liability lawyers who read it-centered on preemption, or the concept that federal law trumps inconsistent or contradictory state law. In that 2006 preamble, the FDA had stated for the first time in its own regulations that it considered agency approval of a drug label to "preempt conflicting or contrary state law." The dry legal tone belied the blockbuster impact of what came to be known as the "preemption preamble," but drug liability lawyers on both sides of the table knew instantly how big a deal it was. In essence, the FDA was saying that its approval of a drug label immunized the manufacturer from state law-based "failure-to-warn" claims, the most common grounds for drug liability suits. Suddenly, defense lawyers had a potent new weapon against drug liability cases-and plaintiffs lawyers had a big problem.
"It was tectonic," Brenner says. "It opened a whole new front in drug liability cases that every-one thought was moot." Under the Bush administration, the FDA had previously filed amicus briefs arguing for federal preemption in a few cases, but the preamble meant that virtually every failure-to-warn drug case was vulnerable to a preemption defense. While defense lawyers revisited their pending cases to see how they could leverage this gift from the FDA, plaintiffs lawyers were apoplectic, particularly because the preemption language hadn't appeared in the proposal released for public comment prior to issuance of the final rules. (Technically, the preamble is not considered a rule, but rather the agency's interpretation of the rules, so it is not subject to the required notice and comment period.) But there was little that plaintiffs lawyers could do except brace themselves for the barrage of preemption arguments that was sure to come.
Brenner was the first defense lawyer to take advantage of the FDA's rule change. At the time the new regulations came out, he was defending the pharmaceutical company Cephalon, Inc., against a New Jersey state court claim that its painkiller, Actiq, caused the plaintiff to suffer extensive tooth decay. He immediately wrote to the judge asking if he could amend a pending summary judgment motion to add a preemption claim based on the preamble. After getting the go-ahead, Brenner filed his papers. Some days later, he got a call from the judge's law clerk. "Isn't this [preemption] the central issue?" the clerk asked Brenner. "I'd like to think so," Brenner answered. In early March 2006, Brenner got his answer, in a two-page opinion dismissing the case on the grounds that federal labeling law preempted the plaintiff's state-law failure-to-warn claim.
Businesses in a host of industries have benefited from litigation initiatives undertaken by the Bush administration, from its appointment of business-friendly federal judges to the passage of the Class Action Fairness Act, which keeps big class actions out of what are perceived to be plaintiffs-friendly state courts. But no industry has received more presidential protection in the last eight years than the drug business, and no policy has conferred as much of that protection as preemption. Since Brenner's first use of the preemption preamble defense, at least 40 courts have weighed in, according to the Drug and Device Law blog, which is cohosted by drug liability defense lawyers James Beck of Dechert and Mark Herrmann of Jones Day. Another 20 judges have ruled on other FDA preemption issues. Decisions have been about evenly split between plaintiffs and defendants, although in 2008, defendants "have really been on a roll," says Herrmann, with 16 wins and only four losses.
And depending on how the U.S. Supreme Court rules in a case set to be argued November 3, pre-emption could, in fact, spell the end of pharmaceutical tort litigation as we know it. Wyeth v. Levine centers on Diana Levine, a professional guitarist who lost part of her arm to gangrene af-ter being injected with Phenergan, an antinausea medication manufactured by Wyeth. After losing a $6 million jury verdict in Vermont state court and an appeal of that verdict before the Vermont Supreme Court, Wyeth's lawyers will assert before the high court that Levine's failure-to-warn claim is preempted because the FDA approved the drug's label. It's almost impossible to exaggerate the importance of the case. "Levine is pretty much the Super Bowl" for drug liability lawyers, says Brenner, now a partner at Pepper Hamilton in Princeton. If sweeping FDA preemption prevails at the Supreme Court, it could end up being the Bush administration's most profound influence on civil litigation.
The widely acknowledged architect of the administration's FDA preemption campaign is Daniel Troy, now general counsel for London-based pharmaceutical giant GlaxoSmithKline plc. In August 2001, Troy was appointed chief counsel of the FDA. A conservative who cut his teeth as a law clerk for then-D.C. Circuit court judge Robert Bork and went on to become a partner at Wiley, Rein & Fielding in Washington, D.C., Troy was the first political appointee in many years to hold the post. (Historically, the FDA chief counsel had been a career civil service law-yer.) He stayed at the agency for only about three years before returning to private practice as a partner in the Washington, D.C., office of Sidley Austin, but in that short time, Troy launched a revolution.
As he later wrote in an opinion piece for Legal Times (a sibling publication of The American Lawyer), Troy believed that product liability litigation was crippling innovation in the pharmaceutical industry-and interfering with rational prescribing decisions for patients. Troy hit upon federal preemption as the key to reform: The FDA's control over drug labelling, he believed, preempted state failure-to-warn claims. (Through a Glaxo spokesperson, Troy declined to comment for this article.)
Troy wasn't the first FDA lawyer to consider preemption an issue. The Clinton administration addressed preemption occasionally, but without an overarching strategy. In an amicus brief in the 1996 Supreme Court case Medtronic Inc. v. Lohr, for instance, the FDA argued that its regulations did not preempt a state tort claim involving a medical device. Later, in Buckman Co. v. Plaintiffs' Legal Committee, the agency took the opposite stance, arguing that states could not reexamine federal regulatory decisions, and so a plaintiff couldn't assert that the defendant had defrauded the FDA in winning approval for a medical device. (In both cases, the justices sided with the agency.)
But beginning with Troy, Bush's FDA has never wavered from its position that federal regulations preempt virtually all state-law pharmaceutical injury claims. In September 2002, Troy made his first move, filing an amicus brief in Motus v. Pfizer, Inc., via the U.S. Department of Justice, which represents the FDA in court. The case, which was before the U.S. Court of Appeals for the Ninth Circuit, centered on the suicide of a man who had been taking Pfizer's popular antidepressant Zoloft. The man's wife argued that the drug company should have included a warning that Zoloft might cause suicidal thoughts. The FDA said the case should be thrown out, because the agency had looked at the question and found no evidence that the danger existed. (The court, however, ended up sidestepping the issue.)
Over the next couple of years, Troy filed several more amicus briefs in similar cases against Pfizer and Apotex Inc., the maker of generic Paxil, another antidepressant. In 2003 Troy submitted a "statement of interest" in Murphree v. Pacesetter, a state-law tort claim in Tennessee state court involving an allegedly defective pacemaker. The next year, he weighed in on Horn v. Thoratec Corp., involving a claim by a Pennsylvania woman that her husband had died due to a defective heart pump. In every instance, Troy argued that the plaintiffs' claims were preempted and that the lawsuits should be thrown out.
Defense lawyers handling similar cases referenced FDA amicus briefs, but at the end of the day, the agency's amicus brief strategy proved only modestly influential. Of the five or so cases in which the FDA argued for preemption, only one court agreed, throwing out a claim against Apotex. Then the FDA changed its tactics. On January 18, 2006, the agency issued its revisions to the Physician Labeling Rule, which included the now-infamous preemption preamble. (Although the preemption preamble was released a little more than a year after Troy left, he is widely acknowl-edged to have written it.) "It was a sea change," says Dechert's James Beck. "It shifted the terms of the debate from a situation in which defendants lost so frequently [that] they rarely raised the issue to almost a fifty-fifty split" in court rulings on whether a case was preempted. Allison Zieve, a lawyer at Public Citizen who handles appeals for medical device and drug liability plaintiffs, concurs with this view: "By 2006, we couldn't keep up with the preemption cases." She says the government's stance has made all the difference. "If the agency had not been willing to support the industry on preemption," she says, "these arguments would not have become popular."
Plaintiffs lawyers and consumer advocates argue that it's not the FDA's job to meddle in private litigation, whether in unsolicited amicus briefs or via the preamble. Bush's FDA is "consciously inserting itself into the tort system," Zieve says. "It's remarkable and inappropriate." She and others also point out that the agency is hardly foolproof, and the rights of people injured by drugs and medical devices to have their grievances heard in court helps keep pharmaceutical compa-nies honest. "The Vioxx settlement involved 50,000 people," says Christopher Seeger, a plain-tiffs lawyer at New York's Seeger Weiss. Seeger served as co-lead counsel in the Vioxx multidistrict litigation. "Where would all those plaintiffs go if they couldn't go to court? I guess they'd just go have their heart attacks and die quietly."
In a 2006 report on drug safety requested by the FDA itself, the Institute of Medicine for the Na-tional Academy of Sciences slammed the agency's drug branch, labeling it "dysfunctional." The institute, which is chartered by Congress to advise the government on scientific and health policy, said the FDA muzzles scientific dissent, inadequately monitors drug safety, and relies too much on drug company dollars. But FDA officials and defense lawyers counter that preemption is both legally sound and justified from a policy standpoint. In a 2003 American Lawyer profile, Troy argued that Congress intended to centralize prescription drug advertisement regulation at the FDA, and as such, courts should defer to the agency's stance that it has exclusive control over all drug labels.
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.