Levine v. Wyeth

• Decision Date: 27 October 2006
• Docket Number: No. 2004-384.,2004-384.
• Citation: 2006 VT 107,944 A.2d 179
• Parties: Diana LEVINE v. WYETH.
• Court: Vermont Supreme Court

944 A.2d 179

2006 VT 107

Diana LEVINE v. WYETH.

No. 2004-384.

Supreme Court of Vermont.

October 27, 2006.

Motion for Reargument Denied December 11, 2006.

Mandate Stayed January 23, 2007.

Granted January 18, 2008.

Richard I. Rubin and Kerry B. DeWolfe of Rubin, Kidney, Myer & DeWolfe, Barre, for Plaintiff-Appellee.

Allan R. Keyes and R. Joseph O'Rourke of Ryan, Smith & Carbine, Ltd., Rutland, and Bert W. Rein, Karyn K. Ablin and Sarah E. Botha of Wiley Rein & Fielding LLP, and Daniel S. Pariser of Arnold & Porter LLP, Washington, D.C., for Defendant-Appellant.

Present: REIBER, C.J., DOOLEY and JOHNSON, JJ., and MORRIS, D.J., and ALLEN, C.J. (Ret.), Specially Assigned.

JOHNSON, J.

¶ 1. Defendant Wyeth, a drug manufacturer, appeals from a jury verdict in favor of plaintiff Diana Levine, who suffered severe injury and the amputation of her arm as a result of being injected with defendant's drug Phenergan. Plaintiff claimed at trial that defendant was negligent and failed to provide adequate warnings of the known dangers of injecting Phenergan directly into a patient's vein. Defendant argues that the trial court should not have allowed the jury to consider plaintiff's claims because the claims conflict with defendant's obligations under federal law regulating prescription drug labels. We hold that there is no conflict between state and federal law that requires preemption of plaintiff's claim. Defendant also raises two claims of error relating to the jury instructions on damages. We hold that the court's rulings on these jury instructions were correct, and we affirm.

¶ 2. In April 2000, plaintiff was injected with defendant's drug Phenergan at Northeast Washington County Community Health, Inc. ("the Health Center"). The drug was administered to treat plaintiff's nausea resulting from a migraine headache. Plaintiff received two injections. The drug was first administered by intramuscular injection. Later the same day, when plaintiff's nausea continued, she received a second dose by a direct intravenous injection into her arm, using a procedure known as "IV push." The second injection resulted in an inadvertent injection of Phenergan into an artery. As a result, the artery was severely damaged, causing gangrene. After several weeks of deterioration, plaintiff's hand and forearm were amputated.

¶ 3. Plaintiff brought a superior court action for negligence and failure-to-warn product liability, alleging that defendant's inadequate warning of the known dangers of direct intravenous injection of Phenergan caused her injuries. During a five-day jury trial, both parties presented expert testimony regarding the adequacy of the warnings defendant placed on Phenergan's label. Plaintiff's experts testified that the label should not have allowed IV push as a means of administration, as it was safer to use other available options, such as intramuscular injection or administration through the tubing of a hanging IV bag. Defendant's expert testified that allowing IV push with instructions cautioning against inadvertent arterial injection was sufficient. The court instructed the jurors that they could consider the FDA's approval of the label in use at the time of plaintiff's injury, but that the label's compliance with FDA requirements did not establish the adequacy of the warning or prevent defendant from adding to or strengthening the warning on the label. At the conclusion of the trial, the jury found in favor of plaintiff on both the negligence and product-liability claims and awarded her $2.4 million in economic damages and $5 million in noneconomic damages. Pursuant to the parties' stipulation, this award was reduced to a total of $6,774,000 to account for pre-judgment interest and plaintiff's recovery in a settlement of a separate action she had filed against the Health Center.

¶ 4. In a summary judgment motion prior to trial, as well as in its timely motion for judgment as a matter of law following trial, both of which the superior court denied, defendant argued that federal law preempted plaintiff's claim. These arguments rested in part on defendant's contention that it had submitted an adequate warning to the FDA, but that the FDA rejected the change because it did not favor strengthening the warning.¹ Plaintiff contended that neither warning would have been adequate. The trial court stated, in its decision on defendant's motion for judgment as a matter of law, that although the FDA had rejected a new warning, the agency's "brief comment" failed to explain its reasoning or demonstrate that it "gave more than passing attention to the issue of whether to use an IV infusion to administer the drug. The proposed labeling change did not address the use of a free-flowing IV bag." The court concluded that there was "no basis for federal preemption" and upheld the jury's verdict.

¶ 5. Defendant claims the superior court erred by: (1) failing to dismiss 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; (2) failing to instruct the jury to reduce plaintiff's damages by the amount of fault attributable to the Health Center; and (3) failing to instruct the jury to calculate the present value of plaintiff's damages for future noneconomic losses. We reject these claims of error, and we affirm.

I. Federal Preemption

¶ 6. Defendant's principal argument on appeal is that the court should have dismissed plaintiff's claim because it was preempted by federal law. Defendant asserts that any state common law duty to provide a stronger warning about the dangers of administering Phenergan by IV push conflicts with the FDA's approval of the drug's label. As preemption is a question of law, we review the trial court's decision de novo. Office of Child Support v. Sholan, 172 Vt. 619, 620, 782 A.2d 1199, 1202 (2001) (mem.). We hold that the jury's verdict against defendant did not conflict with the FDA's labeling requirements for Phenergan because defendant could have warned against IV-push administration without prior FDA approval, and because federal labeling requirements create a floor, not a ceiling, for state regulation.

¶ 7. The United States Constitution provides that federal law is the supreme law of the land. U.S. Const. art. VI, cl. 2. The Supremacy Clause is the basis for the doctrine of preemption, according to which "state law that conflicts with federal law is `without effect.'" Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992) (quoting Maryland v. Louisiana, 451 U.S. 725, 746, 101 S.Ct. 2114, 68 L.Ed.2d 576 (1981)). In Cipollone, the Court described the relevant analysis for determining whether Congress intended a federal statute to preempt state law:

Congress' intent may be explicitly stated in the statute's language or implicitly contained in its structure and purpose. In the absence of an express congressional command, state law is pre-empted if that law actually conflicts with federal law, or if federal law so thoroughly occupies a legislative field as to make reasonable the inference that Congress left no room for the States to supplement it.

Id. (quotations and citations omitted). Absent clear congressional intent to supersede state law, including state common law duties, there is a presumption against preemption. Medtronic, Inc. v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) ("[B]ecause the States are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly pre-empt state-law causes of action."); Cipollone, 505 U.S. at 516, 112 S.Ct. 2608 ("Consideration of issues arising under the Supremacy Clause `start[s] with the assumption that the historic police powers of the States [are] not to be superseded by ... Federal Act unless that [is] the clear and manifest purpose of Congress.'" (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 91 L.Ed. 1447 (1947))). This presumption has "add[ed] force" when there has been a "long history of tort litigation" in the area of state common law at issue. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449, 125 S.Ct. 1788, 161 L.Ed.2d 687 (2005).

¶ 8. Defendant concedes that Congress has not expressly preempted state tort actions through the Food, Drug and Cosmetics Act (FDCA), 21 U.S.C. §§ 301-399, and that Congress did not intend the FDCA to occupy the entire field of prescription drug regulation. Rather, it asserts that plaintiff's action "actually conflicts with federal law." Cipollone, 505 U.S. at 516, 112 S.Ct. 2608. This requires defendant to show either that "it is impossible for a private party to comply with both state and federal requirements," or that Vermont's common law "stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Freightliner Corp. v. Myrick, 514 U.S. 280, 287, 115 S.Ct. 1483, 131 L.Ed.2d 385 (1995) (quotations and citations omitted).

¶ 9. Defendant presents two alternative bases for its assertion of conflict preemption: (1) in the specific context of the Phenergan label, the FDA was aware of the dangers of IV-push administration and specifically ordered defendant to use the warning it used, making it impossible for defendant to comply with both its state common-law duty and the requirements of federal law; and (2) by penalizing drug companies for using FDA-approved wording on drug labels, state tort claims like plaintiff's present an obstacle to the purpose of the FDA's labeling regulations. Before reaching these issues, we briefly examine the FDA's role in regulating prescription drug labels and the general approach courts have taken to the preemptive effect of federal labeling requirements.

A. Regulatory Background

¶ 10. Prior to distributing a prescription drug such as Phenergan, the manufacturer must submit a New Drug Application (NDA) for FDA...