Key Pre-emption Ruling in Third Circuit

On April 8, 2008, the Third U.S. Circuit Court of Appeals issued a significant decision concerning the authority of federal regulatory agencies to pre-empt state tort claims, Colacicco v. Apotex Inc., No. 6-5148. The decision, authored by the former chief judge of the Third Circuit, holds that when the Food and Drug Administration (the 'FDA') publicly concludes that a specific warning is unnecessary for a prescription pharmaceutical, state tort law cannot supply a cause of action for failure to include the rejected warning in the product's labeling.

The plaintiffs in the two cases consolidated for appeal were the husband and daughter, respectively, of two adults who committed suicide after taking anti-depressant drugs known as selective serotonin reuptake inhibitors ('SSRIs'). The drugs in question were Zoloft', Paxil', and the generic drug containing the active ingredient in Paxil, paroxetine hydrochloride. The plaintiffs argued that, under state law, the manufacturers should have warned physicians of the association between these drugs and an increased risk of suicidal thoughts and behavior ('suicidality'). The FDA, however, had repeatedly rejected the scientific basis for the warning suggested by the plaintiffs. The defendants argued that the FDA's actions pre-empted the plaintiffs' state-law failure-to-warn claims.

The FDA filed an amicus brief in which it argued that the basis for federal pre-emption was not the FDA's labeling guidelines themselves but rather the FDA's broad authority ' and responsibility ' to accept or reject a warning based on its evaluation of the safety and efficacy of the drug and the balancing of its risks and benefits. The court ruled that the FDA's rejection of the warning the plaintiffs proffered pre-empted the plaintiffs' state-law tort actions.

Impact

The ruling is significant because within the last several years federal agencies have increased efforts to pre-empt state-law-based claims challenging their regulatory activities. Colacicco is also significant because other federal and state courts have differed on the pre-emption issue, especially with respect to the effect to be given to the FDA's 'Preemption Preamble' to its 2006 amendments revising drug labeling regulations.

The Preamble states that pre-emption applies, inter alia, to 'claims that a [manufacturer] breached an obligation to warn by failing to include a statement in labeling or in advertising, the substance of which had been proposed to FDA for inclusion in labeling, if that statement was not required by FDA at the time plaintiff claims the [manufacturer] had an obligation to warn.' The Colacicco court concluded that the lack of hearings regarding the Preamble, promulgated in the absence of public notice and comment, may have diminished but did not eliminate the deference given to expressions of administrative agency intent on pre-emption issues.

The Colacicco opinion is, however, a relatively narrow ruling that should not be read to affect most drugs currently on the market. The FDA had actively monitored the possible association between SSRIs and suicide for nearly 20 years, a procedure it does not follow with most drugs. In addition, the court in Colacicco stated that it did not decide whether, in the absence of the FDA's express rejection of a specific warning, the FDA's general review and approval of drug labeling constitutes a minimum safety standard. The Colacicco court further declined to decide the pre-emptive effect of FDA labeling with respect to generic drug manufacturers, who are required under the Hatch-Waxman Act to provide the exact labeling information used by the brand or innovator manufacturer ' no less but, also, no more.

Future

Currently before the U.S. Supreme Court is another pre-emption case to be argued next Term, Diana Levine v. Wyeth, which raises similar but not identical pre-emption issues to those in Colacicco.

In Levine, the plaintiff was injected with a drug, Phenergan', to relieve nausea and dehydration from a severe migraine headache. One of the plaintiff's two injections was administered inadvertently into an artery in her arm instead of a vein. The artery, severely damaged, caused gangrene, requiring the amputation of her hand and forearm. The drug label approved by the FDA warned physicians against the inadvertent arterial injection of the drug. Wyeth had sought to strengthen the warning, but the FDA, without a detailed explanation, required use of the warning in the form it had already approved.

The plaintiff claimed in her suit that the drug should not have been approved for intravenous injection because of the risk of inadvertent arterial damage and its severe consequences. Following trial and a plaintiff's verdict, the Vermont Supreme Court affirmed the verdict and rejected Wyeth's claims that the plaintiff's action was pre-empted by federal law.

The drug industry and plaintiffs' bar are anxiously awaiting the argument and decision in Levine, the second Supreme Court case to consider the pre-emption of state-law-based pharma tort claims under the Food, Drug and Cosmetic Act. The first, Warner-Lambert v. Kent, was recently remanded by an evenly divided Supreme Court. Whether the Court will address all of the issues unresolved in the Third Circuit's Colacicco opinion, however, remains an open question.

Alan Klein is a partner, and Thomas A. Lincoln is an associate, at Duane Morris LLP. Klein ([email protected], 215-979-1150) handles a wide variety of cases with a focus on products liability and toxic torts, including pharmaceuticals and medical and dental devices and equipment. Lincoln ([email protected], 215-979-1146) practices in the areas of products liability, consumer fraud, and commercial litigation.

On April 8, 2008, the Third U.S. Circuit Court of Appeals issued a significant decision concerning the authority of federal regulatory agencies to pre-empt state tort claims, Colacicco v. Apotex Inc., No. 6-5148. The decision, authored by the former chief judge of the Third Circuit, holds that when the Food and Drug Administration (the 'FDA') publicly concludes that a specific warning is unnecessary for a prescription pharmaceutical, state tort law cannot supply a cause of action for failure to include the rejected warning in the product's labeling.

The plaintiffs in the two cases consolidated for appeal were the husband and daughter, respectively, of two adults who committed suicide after taking anti-depressant drugs known as selective serotonin reuptake inhibitors ('SSRIs'). The drugs in question were Zoloft', Paxil', and the generic drug containing the active ingredient in Paxil, paroxetine hydrochloride. The plaintiffs argued that, under state law, the manufacturers should have warned physicians of the association between these drugs and an increased risk of suicidal thoughts and behavior ('suicidality'). The FDA, however, had repeatedly rejected the scientific basis for the warning suggested by the plaintiffs. The defendants argued that the FDA's actions pre-empted the plaintiffs' state-law failure-to-warn claims.

The FDA filed an amicus brief in which it argued that the basis for federal pre-emption was not the FDA's labeling guidelines themselves but rather the FDA's broad authority ' and responsibility ' to accept or reject a warning based on its evaluation of the safety and efficacy of the drug and the balancing of its risks and benefits. The court ruled that the FDA's rejection of the warning the plaintiffs proffered pre-empted the plaintiffs' state-law tort actions.

Impact

The ruling is significant because within the last several years federal agencies have increased efforts to pre-empt state-law-based claims challenging their regulatory activities. Colacicco is also significant because other federal and state courts have differed on the pre-emption issue, especially with respect to the effect to be given to the FDA's 'Preemption Preamble' to its 2006 amendments revising drug labeling regulations.

The Preamble states that pre-emption applies, inter alia, to 'claims that a [manufacturer] breached an obligation to warn by failing to include a statement in labeling or in advertising, the substance of which had been proposed to FDA for inclusion in labeling, if that statement was not required by FDA at the time plaintiff claims the [manufacturer] had an obligation to warn.' The Colacicco court concluded that the lack of hearings regarding the Preamble, promulgated in the absence of public notice and comment, may have diminished but did not eliminate the deference given to expressions of administrative agency intent on pre-emption issues.

The Colacicco opinion is, however, a relatively narrow ruling that should not be read to affect most drugs currently on the market. The FDA had actively monitored the possible association between SSRIs and suicide for nearly 20 years, a procedure it does not follow with most drugs. In addition, the court in Colacicco stated that it did not decide whether, in the absence of the FDA's express rejection of a specific warning, the FDA's general review and approval of drug labeling constitutes a minimum safety standard. The Colacicco court further declined to decide the pre-emptive effect of FDA labeling with respect to generic drug manufacturers, who are required under the Hatch-Waxman Act to provide the exact labeling information used by the brand or innovator manufacturer ' no less but, also, no more.

Future

Currently before the U.S. Supreme Court is another pre-emption case to be argued next Term, Diana Levine v. Wyeth, which raises similar but not identical pre-emption issues to those in Colacicco.

In Levine, the plaintiff was injected with a drug, Phenergan', to relieve nausea and dehydration from a severe migraine headache. One of the plaintiff's two injections was administered inadvertently into an artery in her arm instead of a vein. The artery, severely damaged, caused gangrene, requiring the amputation of her hand and forearm. The drug label approved by the FDA warned physicians against the inadvertent arterial injection of the drug. Wyeth had sought to strengthen the warning, but the FDA, without a detailed explanation, required use of the warning in the form it had already approved.

The plaintiff claimed in her suit that the drug should not have been approved for intravenous injection because of the risk of inadvertent arterial damage and its severe consequences. Following trial and a plaintiff's verdict, the Vermont Supreme Court affirmed the verdict and rejected Wyeth's claims that the plaintiff's action was pre-empted by federal law.

The drug industry and plaintiffs' bar are anxiously awaiting the argument and decision in Levine, the second Supreme Court case to consider the pre-emption of state-law-based pharma tort claims under the Food, Drug and Cosmetic Act. The first, Warner-Lambert v. Kent, was recently remanded by an evenly divided Supreme Court. Whether the Court will address all of the issues unresolved in the Third Circuit's Colacicco opinion, however, remains an open question.

Alan Klein is a partner, and Thomas A. Lincoln is an associate, at Duane Morris LLP. Klein ([email protected], 215-979-1150) handles a wide variety of cases with a focus on products liability and toxic torts, including pharmaceuticals and medical and dental devices and equipment. Lincoln ([email protected], 215-979-1146) practices in the areas of products liability, consumer fraud, and commercial litigation.