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.)