Litigation Inoculation

Litigation Inoculation
By Thomas Ginsberg
Inquirer Staff Writer

Joseph Colacicco's wife, Lois, slashed herself to death with razor blades in 2003 while taking the antidepressant Paxil, painting her final thoughts in blood in their bathroom: "Thanks."
"She felt it was over, finally," Colacicco said of his wife's mental torment. "She had no inkling it was because of Paxil. The pharmaceutical companies fooled the public, fooled me, fooled my wife."

Colacicco's accusation stands out not just because it is tragic. His lawsuit has become a front-line case in the Bush administration's efforts to rein in claims against pharmaceutical companies, with tens of millions of dollars at stake on both sides.

Colacicco's claim that GlaxoSmithKline P.L.C. and Apotex Inc., maker of generic Paxil, failed to warn patients in 2003 about Paxil's suicide risks was dismissed last month in U.S. District Court in Philadelphia, where GlaxoSmithKline has a U.S. headquarters.

The dismissal was based partly on the newly articulated argument that the U.S. Food and Drug Administration alone is accountable for what is, and is not, written on prescription-drug warning labels, preempting any judge or jury. Under that principle, an FDA-approved warning label is the last word on safety, and courts shouldn't second-guess it.

Lawyers on both sides say such FDA preemption on prescription-drug warnings, if upheld, could block many "failure to warn" claims against drug companies. Such claims constitute many, although not all, of the infractions alleged in tens of thousands of pharmaceutical liability lawsuits each year.

Since 2000, the FDA had asserted the principle only in legal briefs in isolated lawsuits, not as an agency policy.

Now the principle is codified in the preamble of the FDA's new drug-labeling code, which was published in January and took effect June 30. Brandishing the preamble in recent months, drug companies have papered courtrooms nationwide with motions to dismiss failure-to-warn claims.
Most of the motions have failed. On June 6, New Jersey Superior Court Judge Carol E. Higbee denied Merck & Co. Inc.'s motion seeking dismissal of a Vioxx case, calling the FDA preamble "a political statement." On May 31, U.S. District Judge Joseph Bataillon, in Nebraska, rejected Pfizer Inc.'s motion in a case involving its antidepressant Zoloft, saying that the FDA had contradicted its own past positions and that Congress had never given the agency preemption power over courts in prescription-drug cases.

But on May 25 in Philadelphia, U.S. District Judge Michael M. Baylson threw out Colacicco's claim. In a broad ruling, Baylson said courts should defer to the agency's scientific expertise and regulatory authority. It is this deference that other judges have rejected.

"It is not the function of this court, or for a jury empaneled to decide this case, to substitute its judgment for the FDA's about medical issues," Baylson wrote.

He added: "Ultimately, this court believes it is far more desirable that the important issues presented by this case, indeed tragic in its facts, are better addressed by elected officials, legislative and executive, than by appointed judges."

Colacicco, of Long Beach, N.Y., appealed to the U.S. Court of Appeals for the Third Circuit in Philadelphia, taking the lead in a jurisdictional dispute that attorneys predict will not end until it hits the U.S. Supreme Court.

GlaxoSmithKline, which denies that Paxil led Lois Colacicco to kill herself, "believes the agency is in the best position to know what should or should not be in a label," said Andrew Bayman, a GlaxoSmithKline defense attorney from the Atlanta firm King & Spalding.

But Colacicco's attorneys, Derek Braslow and Harris Pogust of Conshohocken, said the FDA lacked the resources, punitive powers, and political support to protect every patient or prosecute drug companies that obscured data. Pogust noted that the FDA changed the label last year and ordered suicide warnings on Paxil, Zoloft and similar antidepressants.
"We really don't blame the FDA" for safety problems, Pogust said. "But what they're doing now with preemption is outrageous. They have no business in civil litigation."

If Colacicco's case doesn't get to the Supreme Court, others are right behind, lawyers noted. Pfizer has filed preemption motions in at least a dozen pending cases involving Zoloft, it said.
In one federal case in Philadelphia, a North Wales couple, Tom and Kathy Woodward, say their 17-year-old daughter, Julie, hanged herself in the family's garage after seven days on Zoloft.

The Woodwards have accused Pfizer of suppressing suicide-risk information, and Tom Woodward scoffed at the idea that the FDA alone could protect the public, offering his own insights as a former marketing-promotions consultant for drug companies.

"I would hear them talk about doctors in a very negative way, about the FDA in a very negative light," said Woodward, owner of a small consulting firm, the Pathway Group. "The FDA is always going to be one, two, three steps behind the drug companies."

Pfizer rejected the claim that Zoloft caused Julie Woodward to take her life in 2003. It insisted the elevated risk of suicide among some patients had not been proved until later, when the FDA responded by changing the label.

"If Pfizer had included a warning of any such association at that time, the Zoloft label would have been false and misleading under federal law," said Malcolm E. Wheeler, Pfizer's Zoloft defense lawyer from the Denver firm Wheeler Trigg Kennedy L.L.P.

Wheeler and Bayman said the FDA preamble was significant because, for the first time, it comprehensively spelled out the FDA position on litigation over drug labels, including excessive warnings.

"Patients may be discouraged from using important, potentially lifesaving treatments if the lawsuit-generated warnings are more severe than the neutral medical and scientific experts at FDA consider warranted," Wheeler said.

Critics scoff at the drug companies' suggestion that, if not for the FDA, they voluntarily would put extra warnings on their products.

"It's a naked power grab for the industry, and I think the courts are seeing through it," said Leslie Brueckner, staff attorney at Trial Lawyers for Public Justice, a Washington-based group that helps plaintiffs suing drug companies.

The sides are divided on the potential impact of preemption, a policy initiated by former FDA chief counsel Daniel Troy, who stepped down in 2004 and returned to corporate defense work.
"This will end failure-to-warn claims," said Pogust, who represents Colacicco and the Woodwards.

One member of Congress, Rep. Maurice Hinchey (D., N.Y.), has introduced legislation to limit the FDA's ability to preempt state consumer-protection laws.

But Wheeler called the fears "a Chicken Little argument." He said preemption would be "helpful" but not significant in reducing lawsuits because it would not affect fraud, faulty-design or negligence claims.

Eric G. Lasker, a pharmaceutical defense lawyer at Spriggs & Hollingsworth in Washington, said preemption would "not do away" with litigation but might provide some relief.

"Prescription-drug litigation now is a huge financial issue, and it's driving a lot of what drug companies have to do," Lasker said.

Colacicco himself said he agreed there were too many "frivolous lawsuits." But the pro-Bush registered Republican and entrepreneur said preemption might go too far.

"I do believe we have to support our pharmaceutical companies. But they have to be true to us, as well," Colacicco said.

Legal Basis for Drug Firms' Motions

Pharmaceutical companies cite the Food and Drug Administration's statement on preemption in its new labeling rules as a basis for dismissing lawsuits that assert the firms failed to warn patients about drug risks.

Excerpts from FDA statement

"FDA believes that State laws conflict with and stand as an obstacle to achievement of the full objectives and purposes of Federal law when they purport to compel a firm to include in labeling or advertising a statement that FDA has considered and found scientifically unsubstantiated."
Court rulings "can erode and disrupt the careful and truthful representation of benefits and risks that prescribers need to make appropriate judgments about drug use."

Example of preemption

The FDA offers six examples of lawsuit claims that it says its rules should preempt. Here is one:
"Claims that a drug sponsor breached an obligation to warn by failing to include in labeling or in advertising a statement, the substance of which FDA has prohibited in labeling or advertising."

Other claims are allowed

"The Supreme Court has held that certain state law requirements that parallel FDA requirements may not be preempted."

SOURCE: U.S. Food and Drug Administration