Wyeth v. Levine

If all the world's a stage, as Shakespeare professed, then surely one of the great dramas playing in the theater of American jurisprudence is the epic struggle that roils pharmaceutical labeling. Pitting state-law causes of action against a federal agency's regulatory authority, the storylines are stark. Simply put, the labeling issue confronting the Supreme Court this term is: Who decides the adequacy of drug labeling ' the Food and Drug Administration (FDA) or a jury of plaintiff's peers? Both sides have plenty to gain ' and lose.

In 2006, after years of filing amicus briefs, the FDA finally adopted clear rules that set forth its position on the question of the preemptive effect of its labeling determinations. Indeed, the preamble to the 2006 rules states that “the government's long-standing views on preemption” take precedence; namely that, “under existing preemption principles, FDA approval of labeling under the act, whether it be in the old or new format, preempts conflicting or contrary State law.” Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922 (Jan. 24, 2006)(21 C.F.R. pts. 201, 313, 601).

Those hoping that the FDA's forceful pronouncement would make it universally easier to win a preemption defense were quickly disappointed. Following publication of the preamble, state and federal courts continued to show varying amounts of deference to the FDA's position, and confusion reigned over preemption jurisprudence. Two district court cases, decided just six days apart, demonstrate the point.

The two cases were essentially identical: The plaintiffs asserted failure-to-warn labeling claims regarding increased risk of suicide, and the defendants raised the same defenses based on FDA regulations. The contradictory decisions are unvarnished comedy and tragedy; or tragedy and comedy, depending upon your particular side of the preemption debate.

Colacicco v. Apotex, Inc.

The first federal case to address the FDA's 2006 rulemaking, Colacicco v. Apotex, Inc., saw the plaintiff's claims dismissed on preemption grounds. 432 F. Supp. 2d 514 (E.D. Pa. May 25, 2006), aff'd, 521 F.3d 253. In that case, the plaintiff alleged that defendant Apotex failed to warn of the increased risk of suicidal behavior linked to the anti-depressant drug Paxil. Id. at 518. On a motion to dismiss, the defendant argued that to add the warnings the plaintiff claimed were necessary would render the drug misbranded, as the FDA had already rejected increased warnings of suicidal behavior. The court stated that the FDA's view was critical to its analysis because of the deference due an agency's interpretation of its own regulations. Id. at 525. The court held that it should not substitute its view for that of the FDA on medical issues, and deferred to the FDA on the question of whether stronger warnings were required. Id. at 541-542. Thus, the plaintiff's claims were preempted.

Jackson v. Pfizer, Inc.

In the District of Nebraska, however, the court decided essentially the same question in the opposite direction. Jackson v. Pfizer, Inc., 432 F. Supp. 2d 964 (D. Neb. May 31, 2006). In Jackson, the plaintiffs brought a failure-to-warn claim regarding the increased risk of suicidal behavior linked to the anti-depressants Zoloft and Effexor. Id. at 965. As in Colacicco, the defendants argued that, because the FDA had rejected increased warnings of suicidal behavior, the type of warnings the plaintiffs demanded would have rendered the drug misbranded. In reaching its decision, the court gave little deference to the FDA position, noting that FDA regulations are generally minimal standards, and ruled that federal law does not pre-empt Nebraska failure-to-warn claims in the prescription drug context.

Third-Circuit Ruling

Fast-forward two years and little has changed. (The Jackson case settled soon after the district court decision. Dorfman, Quinn, and Brophy, “Presumption of Innocence: FDA's Authority to Regulate the Specifics of Prescription Drug Labeling and the Preemption Debate,” 61 Food & Drug L.J. 585, 619 (2006).) In April 2008, the Third Circuit decided the appeal of the Colacicco case. Colacicco v. Apotex, Inc., 521 F.3d 253 (3d Cir. Pa. 2008) (combined on appeal with McNellis v. Pfizer, 2005 U.S. Dist. LEXIS 37505 (D.N.J. Dec. 29, 2005)). In Colacicco, a panel of the Third Circuit affirmed, 2-1, the Eastern District of Pennsylvania's holding that the plaintiff's failure-to-warn claims were preempted, and reversed the New Jersey District Court that had denied defendant Pfizer's motion for summary judgment on grounds the failure-to-warn claim regarding increased risk of suicidal behavior was preempted by federal law. Id. at 256-57. As noted above, the Pennsylvania court gave substantial deference to the FDA and rejected the argument that the FDA's position was inconsistent with its earlier positions. Id. at 262. The New Jersey court came to the opposite conclusion, holding that the interpretation of the FDA was not entitled to substantial deference and the regulations do not conflict with New Jersey's failure-to-warn laws. Id.

In its decision, the Third Circuit concentrated on the facts of the case and noted that the FDA had actively monitored the risk of suicide associated with the drugs for nearly 20 years, concluding that the warnings desired by the plaintiff were without scientific basis and would, therefore, be false and misleading. Id. at 269. Further, a federal agency's action taken pursuant to statutory authority can have the same preemptive effect over state law as do statutes and regulations. Id. at 271. Therefore, the plaintiff's claims were preempted by the FDA actions taken pursuant to its statutory authority. Id. at 271.

The Third Circuit took pains to point out that this holding was limited to the facts of the case and that this decision did not determine whether preemption would apply had the FDA not publicly rejected the substance of the warning sought. Id.

Under the heading “the show must go on,” the District Court for the Southern District of Indiana reinstated a Paxil suicide case that it had dismissed earlier on preemption grounds. Tucker v. Smithkline Beecham Corp., 2008 U.S. Dist. LEXIS 55919 (S.D. Ind. July 18, 2008) (reinstating state law tort claims as not preempted by federal law). On reconsideration, the court said the FDA's opinion on the preemptive effects of its regulations represented a recent and complete reversal of the agency's prior position on preemption and, as a result, gave little deference to the agency's opinion. Moreover, the court reasoned that it had given too little consideration to FDA regulations that allow a manufacturer to modify prescription drug labels unilaterally when the manufacturer has reasonable evidence of a serious hazard. Id. at *2, *18-*19, *28-*29.

The Knipe Case

Borrowing a few pages from the Tucker script, the Eastern District of Pennsylvania had an opportunity to interpret, distinguish, and ultimately not follow the Third Circuit's Colacicco decision. Knipe v. SmithKlineBeecham d/b/a GlaxoSmithKline, 2008 U.S. Dist. LEXIS 67424 (E.D. Pa. Aug. 28, 2008). In this case, after the death of their 16-year-old son, the plaintiffs brought a failure-to-warn claim against GlaxoSmithKline (GSK), alleging GSK breached its state law duty to warn of increased suicide in pediatric patients taking the drug Paxil. GSK moved for summary judgment on federal preemption grounds and relied heavily on the Colacicco decision.

Knipe found that the presumption against preemption was alive and kicking in the Third Circuit despite Colacicco's suggestion that implied conflict preemption inquiry effectively supplants the presumption. Knipe, at *38-39. Knipe looked to the Third Circuit's decision in Fellner v. Tri-Union Seafoods, L.L.C., 2008 U.S. App. LEXIS 17672 (3d Cir. Aug. 19, 2008) wherein the court stated that it does not “lightly infer” preemption where “state compensatory regimes have traditionally played an important role.” Id. at *7. Knipe found these “varying pronouncements” indicative that “general presumption against preemption remains viable” though “the outcome of the case turns ultimately on the existence or non-existence of an actual conflict between state and federal law.” Knipe, 2008 U.S. Dist LEXIS 67424 at *39.

The Knipe court found that Colacicco did not control because Colacicco focused on whether an adult, not pediatric, suicide failure-to-warn claim was preempted. Knipe, 2008 U.S. Dist. LEXIS 67424 at *50. More to the point, the holding in Colacicco, by its terms, was limited to the case where the FDA had “clearly and publicly stated its position,” and in this case the court found there had been no clear and public FDA position. Knipe, 2008 U.S. Dist. LEXIS 67424 at *51, 75. Moreover, the court found an issue of fact as to whether GSK possessed reasonable evidence of an association between increased risk of suicidality and pediatric use of Paxil such that FDA regulations would have required it to update its label prior to FDA approval of such a change. “Mere speculation as to whether the FDA would or would not have approved such a warning is insufficient to create a direct conflict upon which this Court can find preemption.” Knipe, 2008 U.S. Dist. LEXIS 67424 at *93. Like Tucker, the Knipe court also found the FDA preamble to be inconsistent with the FDA's earlier views on preemption and determined it was entitled to little deference. Knipe, 2008 U.S. Dist LEXIS 67424 at *63. Quoting a recent Third Circuit decision, the court dismissed the preamble: “'[F]ederal law capable of preempting is [not]created every time someone acting on behalf of an agency makes a statement or takes an action within the agency's jurisdiction.'” Knipe, 2008 U.S. Dist LEXIS 67424 at *62 (quoting Fellner at *5 (3d Cir. Aug. 19, 2008)).

On to the Supreme Court

The preemption drama that has plagued and delighted pharmaceutical labeling litigants may finally close its sold-out run as the Supreme Court prepares to write what many hope will be the final act. The Court granted certiorari in Wyeth v. Levine, 944 A.2d 179 (Vt. 2006), cert. granted, 552 U.S.__, 128 S. Ct. 1118 (2008), on the question:

whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration (FDA) pursuant to [the] FDA's comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. ' 301 et seq., preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use. Pet. for Cert. in Wyeth v. Levine, No. 06-1249, 127 S. Ct. 2451 (2008).

In this case, the plaintiff, Diana Levine, went to the hospital in April 2000, complaining of a migraine headache. Doctors treated her with an intramuscular injection of Demerol, along with Wyeth's drug Phenergan for the nausea that is a common side effect of Demerol. When the nausea persisted, the doctors injected a second dose of Phenergan directly into her vein by the procedure known as an “IV push.” The second injection, however, inadvertently allowed the Phenergan to enter into her artery, which eventually caused gangrene and ultimately necessitated the amputation of first her hand and later her forearm below the elbow.

After settling with the hospital, the plaintiff sued the defendant in a Vermont superior court for negligence and failure-to-warn product liability, alleging that her injuries were caused by Wyeth's inadequate warnings regarding the known dangers of IV push injection of its drug. During the trial, the plaintiff's experts argued that the warning label should not have allowed the IV push and that other, safer options were available for administering the drug. The defendant's expert argued that the FDA's approved label, cautioning against inadvertent injection into the artery, was sufficient. The jury found in favor of the plaintiff and awarded her $6.7 million.

On appeal, the Vermont Supreme Court considered the issue of whether the trial court erred by “failing to dismiss the plaintiff's claim on the basis that the Food and Drug Administration's approval of the Phenergan label preempted state common law claims that the label was inadequate,” and ruled that the state court claim was not preempted by the FDA approval. Levine, at 183. The court rejected the defendant's argument that it was “impossible to comply with both state and federal law,” since the FDA did not approve the defendant's proposed stronger warning. Id. at 188. The court found that the FDA had not clearly explained its intent behind the decision and that the evidence did not indicate that the FDA wanted to preserve the IV-push method for the drug. Id. at 189.

The court also rejected Wyeth's next contention that “state common law liability for its use of an FDA-approved label presents an obstacle to federal objectives,” citing numerous cases for the proposition that “federal labeling requirements pursuant to the FDCA [Food Drug and Cosmetic Act] create a floor, not a ceiling, for state regulation.” Id. at 190-191. The court also found irrelevant the policy arguments that allowing too many state-court claims in this area of law would make beneficial drugs less available to the public and that eliminating these types of lawsuits would leave the public without any adequate resource if the FDA failed to require stronger warnings on labels. Id. at 191.

Informed of the FDA's 2006 preamble only after oral argument, the Vermont Supreme Court rejected it since the new FDA regulations did not come into effect until June 2006 and because the “FDA statement deserves no deference,” because of the 1962 amendment to the FDCA and 21 CFR ' 314.70(c). Id. at 192-193. The 1962 amendment states that “nothing in the amendments made by this act to the FDCA shall be construed as invalidating any provision of state law.” Id. at 190. Consequently, the court ruled that the FDA could not preempt state laws when they have been expressly preserved by Congress. Id. Additionally, the FDA regulations state that a drug manufacturer may alter a label “to strengthen a contraindication, warning, precaution ' ,” so the court found that the defendant was free to strengthen its warning without FDA approval. Id. at 185 (citing 21 C.F.R. ' 314.70(c)).

Oral Arguments

Oral arguments before the Supreme Court were set for Nov. 3, 2008. In its brief to the Court, Wyeth argues that Levine's state-law tort claims conflict with the regime Congress established, by making it impossible for Wyeth to comply with a purported state-law duty to modify its Phenergan labeling without violating the FDCA. Brief for Petitioner, at 29, Wyeth v. Levine, No. 06-1249, 128 S.Ct. 1118, cert. granted (Jan. 18, 2008). This is so because FDA approval of the drug is conditioned on the manufacturer's exact adoption of any changes to the label as the FDA requires. Id. at 30. The post-approval modification urged by Levine, without FDA authorization, would have violated the FDCA. Id. at 33. The Vermont Supreme Court's reliance upon FDA regulations concerning temporary labeling changes without prior FDA approval was erroneous, since those regulations permit changes without FDA approval when the changes reflect newly acquired information about a drug's risk. Brief for Pet., at 34. In this case, Levine has never suggested that Wyeth had any new information about the risks of IV administration of Phenergan that would warrant a change without FDA approval. Id.

In addition, Wyeth argues that the Vermont law would displace the FDA's expert judgment and substitute the verdicts of lay jurors “who consider drug safety after the fact on a case-by-case basis, focusing on a single patient's catastrophic injury, rather than the potential benefits of the drug to the public as a whole.” Id. at 28, 40.

In her brief to the Court, Levine argues that Congress' long-time acceptance of state failure-to-warn claims against drug manufacturers undermines Wyeth's implied preemption argument. Brief for Respondent, at 26-27, Wyeth v. Levine, No. 06-1249, 128 S.Ct. 1118, cert. granted (Jan. 18, 2008). Congress has expressly preempted state claims against device manufacturers, but has never done so with claims against drug manufacturers. Id. at 27.

Levine will also argue that her claim is not impliedly preempted because Wyeth could comply with both state and federal law. Id. at 31. Wyeth's argument that it would be liable for misbranding if it complied with Vermont's duty to warn of the IV-push risks falls short because a drug is not “misbranded” if it accurately relates the information about the risks of a particular procedure. Id. at 33. Additionally, Wyeth could have labeled its drug with a stronger warning regarding the IV-push injection, pursuant to 21 CFR ' 314.70(c), which does not state that these stronger warnings must be based on “newly discovered risk” information, as Wyeth contends. Id. at 37-40.

Last, Levine argues that, far from posing an “obstacle to the federal regime,” the Vermont law complements federal law by requiring drug manufacturers to provide doctors and patients with information about the known risks of their drugs. Id. at 45. Of note, Levine states that the record contains no evidence that the “FDA ever weighed the risks and benefits of IV-push administration of Phenergan or made a judgment that some benefit of IV-push injection in treating nausea justified its increased risks of gangrene requiring amputation.” Id. at 24, 47.

Numerous groups have submitted amicus briefs in support of both sides of the issue. In support of Petitioner Wyeth, the United States of America (FDA), United States Chamber of Commerce, defense bars, and product liability and pharmaceutical groups have submitted amicus briefs. In support of Respondent Levine, 47 states, members of Congress, and the editors of the New England Journal of Medicine have submitted amicus briefs.

Conclusion

The decision of the Supreme Court in this matter, it is hoped, will lend some consistency to future decisions on the issue of preemption of state tort laws governing pharmaceutical labeling requirements and finally close the curtain on the preemption drama. On the other hand, the Supreme Court's decision may just set up innumerable sequels, to play out in courtrooms near you, by tying its holding to the facts of the case, as did the Third Circuit in Colacicco.

Christopher Thomas is a partner and Kevin Saunders is an associate in the Products Liability Group of Nixon Peabody LLP. They concentrate their practice on product liability defense, personal injury defense, construction disputes and injuries, and First Amendment jurisprudence. Timothy Broshears is an associate in the Business Litigation Group of the firm. His practice involves product liability, franchise, and general commercial litigation. Reach them at [email protected]; [email protected]; and [email protected].

If all the world's a stage, as Shakespeare professed, then surely one of the great dramas playing in the theater of American jurisprudence is the epic struggle that roils pharmaceutical labeling. Pitting state-law causes of action against a federal agency's regulatory authority, the storylines are stark. Simply put, the labeling issue confronting the Supreme Court this term is: Who decides the adequacy of drug labeling ' the Food and Drug Administration (FDA) or a jury of plaintiff's peers? Both sides have plenty to gain ' and lose.

In 2006, after years of filing amicus briefs, the FDA finally adopted clear rules that set forth its position on the question of the preemptive effect of its labeling determinations. Indeed, the preamble to the 2006 rules states that “the government's long-standing views on preemption” take precedence; namely that, “under existing preemption principles, FDA approval of labeling under the act, whether it be in the old or new format, preempts conflicting or contrary State law.” Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922 (Jan. 24, 2006)(21 C.F.R. pts. 201, 313, 601).

Those hoping that the FDA's forceful pronouncement would make it universally easier to win a preemption defense were quickly disappointed. Following publication of the preamble, state and federal courts continued to show varying amounts of deference to the FDA's position, and confusion reigned over preemption jurisprudence. Two district court cases, decided just six days apart, demonstrate the point.

The two cases were essentially identical: The plaintiffs asserted failure-to-warn labeling claims regarding increased risk of suicide, and the defendants raised the same defenses based on FDA regulations. The contradictory decisions are unvarnished comedy and tragedy; or tragedy and comedy, depending upon your particular side of the preemption debate.

Colacicco v. Apotex, Inc.

The first federal case to address the FDA's 2006 rulemaking, Colacicco v. Apotex, Inc., saw the plaintiff's claims dismissed on preemption grounds. 432 F. Supp. 2d 514 (E.D. Pa. May 25, 2006), aff'd, 521 F.3d 253. In that case, the plaintiff alleged that defendant Apotex failed to warn of the increased risk of suicidal behavior linked to the anti-depressant drug Paxil. Id. at 518. On a motion to dismiss, the defendant argued that to add the warnings the plaintiff claimed were necessary would render the drug misbranded, as the FDA had already rejected increased warnings of suicidal behavior. The court stated that the FDA's view was critical to its analysis because of the deference due an agency's interpretation of its own regulations. Id. at 525. The court held that it should not substitute its view for that of the FDA on medical issues, and deferred to the FDA on the question of whether stronger warnings were required. Id. at 541-542. Thus, the plaintiff's claims were preempted.

Jackson v. Pfizer, Inc.

In the District of Nebraska, however, the court decided essentially the same question in the opposite direction. Jackson v. Pfizer, Inc. , 432 F. Supp. 2d 964 (D. Neb. May 31, 2006). In Jackson, the plaintiffs brought a failure-to-warn claim regarding the increased risk of suicidal behavior linked to the anti-depressants Zoloft and Effexor. Id. at 965. As in Colacicco, the defendants argued that, because the FDA had rejected increased warnings of suicidal behavior, the type of warnings the plaintiffs demanded would have rendered the drug misbranded. In reaching its decision, the court gave little deference to the FDA position, noting that FDA regulations are generally minimal standards, and ruled that federal law does not pre-empt Nebraska failure-to-warn claims in the prescription drug context.

Third-Circuit Ruling

Fast-forward two years and little has changed. (The Jackson case settled soon after the district court decision. Dorfman, Quinn, and Brophy, “Presumption of Innocence: FDA's Authority to Regulate the Specifics of Prescription Drug Labeling and the Preemption Debate,” 61 Food & Drug L.J. 585, 619 (2006).) In April 2008, the Third Circuit decided the appeal of the Colacicco case. Colacicco v. Apotex, Inc. , 521 F.3d 253 (3d Cir. Pa. 2008) (combined on appeal with McNellis v. Pfizer, 2005 U.S. Dist. LEXIS 37505 (D.N.J. Dec. 29, 2005)). In Colacicco, a panel of the Third Circuit affirmed, 2-1, the Eastern District of Pennsylvania's holding that the plaintiff's failure-to-warn claims were preempted, and reversed the New Jersey District Court that had denied defendant Pfizer's motion for summary judgment on grounds the failure-to-warn claim regarding increased risk of suicidal behavior was preempted by federal law. Id. at 256-57. As noted above, the Pennsylvania court gave substantial deference to the FDA and rejected the argument that the FDA's position was inconsistent with its earlier positions. Id. at 262. The New Jersey court came to the opposite conclusion, holding that the interpretation of the FDA was not entitled to substantial deference and the regulations do not conflict with New Jersey's failure-to-warn laws. Id.

In its decision, the Third Circuit concentrated on the facts of the case and noted that the FDA had actively monitored the risk of suicide associated with the drugs for nearly 20 years, concluding that the warnings desired by the plaintiff were without scientific basis and would, therefore, be false and misleading. Id. at 269. Further, a federal agency's action taken pursuant to statutory authority can have the same preemptive effect over state law as do statutes and regulations. Id. at 271. Therefore, the plaintiff's claims were preempted by the FDA actions taken pursuant to its statutory authority. Id. at 271.

The Third Circuit took pains to point out that this holding was limited to the facts of the case and that this decision did not determine whether preemption would apply had the FDA not publicly rejected the substance of the warning sought. Id.

Under the heading “the show must go on,” the District Court for the Southern District of Indiana reinstated a Paxil suicide case that it had dismissed earlier on preemption grounds. Tucker v. Smithkline Beecham Corp., 2008 U.S. Dist. LEXIS 55919 (S.D. Ind. July 18, 2008) (reinstating state law tort claims as not preempted by federal law). On reconsideration, the court said the FDA's opinion on the preemptive effects of its regulations represented a recent and complete reversal of the agency's prior position on preemption and, as a result, gave little deference to the agency's opinion. Moreover, the court reasoned that it had given too little consideration to FDA regulations that allow a manufacturer to modify prescription drug labels unilaterally when the manufacturer has reasonable evidence of a serious hazard. Id. at *2, *18-*19, *28-*29.

The Knipe Case

Borrowing a few pages from the Tucker script, the Eastern District of Pennsylvania had an opportunity to interpret, distinguish, and ultimately not follow the Third Circuit's Colacicco decision. Knipe v. SmithKlineBeecham d/b/a GlaxoSmithKline, 2008 U.S. Dist. LEXIS 67424 (E.D. Pa. Aug. 28, 2008). In this case, after the death of their 16-year-old son, the plaintiffs brought a failure-to-warn claim against GlaxoSmithKline (GSK), alleging GSK breached its state law duty to warn of increased suicide in pediatric patients taking the drug Paxil. GSK moved for summary judgment on federal preemption grounds and relied heavily on the Colacicco decision.

Knipe found that the presumption against preemption was alive and kicking in the Third Circuit despite Colacicco's suggestion that implied conflict preemption inquiry effectively supplants the presumption. Knipe, at *38-39. Knipe looked to the Third Circuit's decision in Fellner v. Tri-Union Seafoods, L.L.C., 2008 U.S. App. LEXIS 17672 (3d Cir. Aug. 19, 2008) wherein the court stated that it does not “lightly infer” preemption where “state compensatory regimes have traditionally played an important role.” Id. at *7. Knipe found these “varying pronouncements” indicative that “general presumption against preemption remains viable” though “the outcome of the case turns ultimately on the existence or non-existence of an actual conflict between state and federal law.” Knipe, 2008 U.S. Dist LEXIS 67424 at *39.

The Knipe court found that Colacicco did not control because Colacicco focused on whether an adult, not pediatric, suicide failure-to-warn claim was preempted. Knipe, 2008 U.S. Dist. LEXIS 67424 at *50. More to the point, the holding in Colacicco, by its terms, was limited to the case where the FDA had “clearly and publicly stated its position,” and in this case the court found there had been no clear and public FDA position. Knipe, 2008 U.S. Dist. LEXIS 67424 at *51, 75. Moreover, the court found an issue of fact as to whether GSK possessed reasonable evidence of an association between increased risk of suicidality and pediatric use of Paxil such that FDA regulations would have required it to update its label prior to FDA approval of such a change. “Mere speculation as to whether the FDA would or would not have approved such a warning is insufficient to create a direct conflict upon which this Court can find preemption.” Knipe, 2008 U.S. Dist. LEXIS 67424 at *93. Like Tucker, the Knipe court also found the FDA preamble to be inconsistent with the FDA's earlier views on preemption and determined it was entitled to little deference. Knipe, 2008 U.S. Dist LEXIS 67424 at *63. Quoting a recent Third Circuit decision, the court dismissed the preamble: “'[F]ederal law capable of preempting is [not]created every time someone acting on behalf of an agency makes a statement or takes an action within the agency's jurisdiction.'” Knipe, 2008 U.S. Dist LEXIS 67424 at *62 (quoting Fellner at *5 (3d Cir. Aug. 19, 2008)).

On to the Supreme Court

The preemption drama that has plagued and delighted pharmaceutical labeling litigants may finally close its sold-out run as the Supreme Court prepares to write what many hope will be the final act. The Court granted certiorari in Wyeth v. Levine , 944 A.2d 179 (Vt. 2006), cert. granted, 552 U.S.__, 128 S. Ct. 1118 (2008), on the question:

whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration (FDA) pursuant to [the] FDA's comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. ' 301 et seq., preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use. Pet. for Cert. in Wyeth v. Levine, No. 06-1249, 127 S. Ct. 2451 (2008).

In this case, the plaintiff, Diana Levine, went to the hospital in April 2000, complaining of a migraine headache. Doctors treated her with an intramuscular injection of Demerol, along with Wyeth's drug Phenergan for the nausea that is a common side effect of Demerol. When the nausea persisted, the doctors injected a second dose of Phenergan directly into her vein by the procedure known as an “IV push.” The second injection, however, inadvertently allowed the Phenergan to enter into her artery, which eventually caused gangrene and ultimately necessitated the amputation of first her hand and later her forearm below the elbow.

After settling with the hospital, the plaintiff sued the defendant in a Vermont superior court for negligence and failure-to-warn product liability, alleging that her injuries were caused by Wyeth's inadequate warnings regarding the known dangers of IV push injection of its drug. During the trial, the plaintiff's experts argued that the warning label should not have allowed the IV push and that other, safer options were available for administering the drug. The defendant's expert argued that the FDA's approved label, cautioning against inadvertent injection into the artery, was sufficient. The jury found in favor of the plaintiff and awarded her $6.7 million.

On appeal, the Vermont Supreme Court considered the issue of whether the trial court erred by “failing to dismiss the plaintiff's claim on the basis that the Food and Drug Administration's approval of the Phenergan label preempted state common law claims that the label was inadequate,” and ruled that the state court claim was not preempted by the FDA approval. Levine, at 183. The court rejected the defendant's argument that it was “impossible to comply with both state and federal law,” since the FDA did not approve the defendant's proposed stronger warning. Id. at 188. The court found that the FDA had not clearly explained its intent behind the decision and that the evidence did not indicate that the FDA wanted to preserve the IV-push method for the drug. Id. at 189.

The court also rejected Wyeth's next contention that “state common law liability for its use of an FDA-approved label presents an obstacle to federal objectives,” citing numerous cases for the proposition that “federal labeling requirements pursuant to the FDCA [Food Drug and Cosmetic Act] create a floor, not a ceiling, for state regulation.” Id. at 190-191. The court also found irrelevant the policy arguments that allowing too many state-court claims in this area of law would make beneficial drugs less available to the public and that eliminating these types of lawsuits would leave the public without any adequate resource if the FDA failed to require stronger warnings on labels. Id. at 191.

Informed of the FDA's 2006 preamble only after oral argument, the Vermont Supreme Court rejected it since the new FDA regulations did not come into effect until June 2006 and because the “FDA statement deserves no deference,” because of the 1962 amendment to the FDCA and 21 CFR ' 314.70(c). Id. at 192-193. The 1962 amendment states that “nothing in the amendments made by this act to the FDCA shall be construed as invalidating any provision of state law.” Id. at 190. Consequently, the court ruled that the FDA could not preempt state laws when they have been expressly preserved by Congress. Id. Additionally, the FDA regulations state that a drug manufacturer may alter a label “to strengthen a contraindication, warning, precaution ' ,” so the court found that the defendant was free to strengthen its warning without FDA approval. Id. at 185 (citing 21 C.F.R. ' 314.70(c)).

Oral Arguments

Oral arguments before the Supreme Court were set for Nov. 3, 2008. In its brief to the Court, Wyeth argues that Levine's state-law tort claims conflict with the regime Congress established, by making it impossible for Wyeth to comply with a purported state-law duty to modify its Phenergan labeling without violating the FDCA. Brief for Petitioner, at 29, Wyeth v. Levine , No. 06-1249, 128 S.Ct. 1118, cert. granted (Jan. 18, 2008). This is so because FDA approval of the drug is conditioned on the manufacturer's exact adoption of any changes to the label as the FDA requires. Id. at 30. The post-approval modification urged by Levine, without FDA authorization, would have violated the FDCA. Id. at 33. The Vermont Supreme Court's reliance upon FDA regulations concerning temporary labeling changes without prior FDA approval was erroneous, since those regulations permit changes without FDA approval when the changes reflect newly acquired information about a drug's risk. Brief for Pet., at 34. In this case, Levine has never suggested that Wyeth had any new information about the risks of IV administration of Phenergan that would warrant a change without FDA approval. Id.

In addition, Wyeth argues that the Vermont law would displace the FDA's expert judgment and substitute the verdicts of lay jurors “who consider drug safety after the fact on a case-by-case basis, focusing on a single patient's catastrophic injury, rather than the potential benefits of the drug to the public as a whole.” Id. at 28, 40.

In her brief to the Court, Levine argues that Congress' long-time acceptance of state failure-to-warn claims against drug manufacturers undermines Wyeth's implied preemption argument. Brief for Respondent, at 26-27, Wyeth v. Levine , No. 06-1249, 128 S.Ct. 1118, cert. granted (Jan. 18, 2008). Congress has expressly preempted state claims against device manufacturers, but has never done so with claims against drug manufacturers. Id. at 27.

Levine will also argue that her claim is not impliedly preempted because Wyeth could comply with both state and federal law. Id. at 31. Wyeth's argument that it would be liable for misbranding if it complied with Vermont's duty to warn of the IV-push risks falls short because a drug is not “misbranded” if it accurately relates the information about the risks of a particular procedure. Id. at 33. Additionally, Wyeth could have labeled its drug with a stronger warning regarding the IV-push injection, pursuant to 21 CFR ' 314.70(c), which does not state that these stronger warnings must be based on “newly discovered risk” information, as Wyeth contends. Id. at 37-40.

Last, Levine argues that, far from posing an “obstacle to the federal regime,” the Vermont law complements federal law by requiring drug manufacturers to provide doctors and patients with information about the known risks of their drugs. Id. at 45. Of note, Levine states that the record contains no evidence that the “FDA ever weighed the risks and benefits of IV-push administration of Phenergan or made a judgment that some benefit of IV-push injection in treating nausea justified its increased risks of gangrene requiring amputation.” Id. at 24, 47.

Numerous groups have submitted amicus briefs in support of both sides of the issue. In support of Petitioner Wyeth, the United States of America (FDA), United States Chamber of Commerce, defense bars, and product liability and pharmaceutical groups have submitted amicus briefs. In support of Respondent Levine, 47 states, members of Congress, and the editors of the New England Journal of Medicine have submitted amicus briefs.

Conclusion

The decision of the Supreme Court in this matter, it is hoped, will lend some consistency to future decisions on the issue of preemption of state tort laws governing pharmaceutical labeling requirements and finally close the curtain on the preemption drama. On the other hand, the Supreme Court's decision may just set up innumerable sequels, to play out in courtrooms near you, by tying its holding to the facts of the case, as did the Third Circuit in Colacicco.

Christopher Thomas is a partner and Kevin Saunders is an associate in the Products Liability Group of Nixon Peabody LLP. They concentrate their practice on product liability defense, personal injury defense, construction disputes and injuries, and First Amendment jurisprudence. Timothy Broshears is an associate in the Business Litigation Group of the firm. His practice involves product liability, franchise, and general commercial litigation. Reach them at [email protected]; [email protected]; and [email protected].