DIANA LEVINE V. WYETH - VERMONT SUPREME COURT

Page 1

Levine v. Wyeth (2004-384)

2006 VT 107

[Filed 27-Oct-2006]

NOTICE: This opinion is subject to motions for reargument under V.R.A.P.

40 as well as formal revision before publication in the Vermont Reports.

Readers are requested to notify the Reporter of Decisions, Vermont Supreme

Court, 109 State Street, Montpelier, Vermont 05609-0801 of any errors in

order that corrections may be made before this opinion goes to press.

2006 VT 107

No. 2004-384

Diana Levine

Supreme Court

On Appeal from

Washington Superior Court

Wyeth

October Term, 2005

Geoffrey W. Crawford, J.

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

¶ 1. JOHNSON, J. 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

Page 1 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 2

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 non-economic 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.(FN1) 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 non-economic 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

Page 2 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 3

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 (1992) (quoting Maryland v.

Louisiana, 451 U.S. 725, 746 (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

(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 ("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

(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 (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. 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 (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

Page 3 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 4

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 approval. 21 U.S.C. ¶ 355(a). The FDA must approve the application

unless it fails to meet certain criteria, including whether test results

and other information establish that the drug is "safe for use under the

conditions prescribed, recommended, or suggested in the proposed labeling

thereof," whether there is "substantial evidence that the drug will have

the effect it purports or is represented to have under the conditions of

use prescribed, recommended, or suggested in the proposed labeling

thereof," and whether, "based on a fair evaluation of all material facts,

such labeling is false or misleading in any particular." Id. ¶ 355(d).

¶ 11. "FDA regulations mandate the general format and content of

all sections of labels for all prescription drugs as well as the risk

information each section must contain," and "[f]inal approval of the NDA is

'conditioned upon the applicant incorporating the specified labeling

changes exactly as directed, and upon the applicant submitting to FDA a

copy of the final printed label prior to marketing.' " McNellis v. Pfizer,

Inc., 2005 WL 3752269, at *4 (D.N.J.) (citing 21 C.F.R. ¶¶ 201.56,

201.57, and quoting 21 C.F.R. ¶ 314.105(b)). Once a drug and its label

have been approved, any changes to the label ordinarily require submission

and FDA approval of a "Supplemental NDA."

Id.; 21 C.F.R. ¶ 314.70(b)(2)(v)(A).

¶ 12. If the NDA process and the submission of changes for FDA

approval were the exclusive means of creating and altering prescription

drug labels, this might be a very different case. A key FDA regulation,

however, allows a drug's manufacturer to alter the drug's label without

prior FDA approval when necessary. The regulation provides in relevant

part:

(6) The agency may designate a category of changes for the

purpose of providing that, in the case of a change in such

category, the holder of an approved application may commence

distribution of the drug product involved upon receipt by the

agency of a supplement for the change. These changes

include, but are not limited to:

. . . .

(iii) Changes in the labeling . . . to accomplish any of the

following:

(A) To add or strengthen a contraindication, warning,

precaution, or adverse reaction;

. . . .

(B) To add or strengthen an instruction about dosage and

administration that is intended to increase the safe use of

the drug product[.]

21 C.F.R. ¶ 314.70(c).

Page 4 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 5

¶ 13. Section 314.70(c) creates a specific procedure allowing

drug manufacturers to change labels that are insufficient to protect

consumers, despite their approval by the FDA. "The FDA's approved label .

. . can therefore be said to set the minimum labeling requirement, and not

necessarily the ultimate label where a manufacturer improves the label to

promote greater safety." McNellis, 2005 WL 3752269, at *5. While specific

federal labeling requirements and state common-law duties might otherwise

leave drug manufacturers with conflicting obligations, ¶ 314.70(c) allows

manufacturers to avoid state failure-to-warn claims without violating

federal law. Id. ("[I]t is apparent that prior FDA approval need not be

obtained, nor will a product be deemed mislabeled, if the manufacturer

voluntarily or even unilaterally strengthens the approved warnings,

precautions or potential adverse reactions upon the label pursuant to 21

C.F.R. ¶ 314.70(c)(6)(iii)(A)."). There is thus no conflict between

federal labeling requirements and state failure-to-warn claims. Section

314.70(c) allows, and arguably encourages, manufacturers to add and

strengthen warnings that, despite FDA approval, are insufficient to protect

consumers. State tort claims simply give these manufacturers a concrete

incentive to take this action as quickly as possible.

B. Conflict Preemption in Other Jurisdictions

¶ 14. In light of the leeway created by ¶ 314.70(c) for drug

manufacturers to add warnings, courts have been nearly unanimous in holding

that state failure-to-warn tort claims do not conflict with federal law.

See, e.g., McNellis, 2005 WL 3752269, at *7 ("[T]he FDCA and the FDA's

regulations do not conflict with New Jersey's failure to warn law because

those federal regulations merely set minimum standards with which

manufacturers must comply."). McNellis is the latest in a series of recent

cases addressing this issue as it relates to the anti-depressant Zoloft,

which allegedly increases the risk of suicide in some patients. See id.,

at *7-8 (denying summary judgment and rejecting conflict preemption in

Zoloft case); accord Zikis v. Pfizer, Inc., 2005 WL 1126909, at *2-3 (N.D.

Ill.); Witczak v. Pfizer, Inc., 377 F. Supp. 2d 726, 729-30 (D. Minn.

2005); Motus v. Pfizer, Inc., 127 F. Supp. 2d 1085, 1096-1100 (C.D. Cal.

2000); see also Cartwright v. Pfizer, Inc., 369 F. Supp. 2d 876, 882 (E.D.

Tex. 2005) ("With little exception, courts that have considered this exact

issue have concluded that state failure to warn claims are not preempted by

the FDCA and its attendant regulations."). Contra Needleman v. Pfizer,

Inc., 2004 WL 1773697, at *1 (N.D. Tex.) (granting summary judgment to the

defendant on basis of conflict preemption).

¶ 15. The Zoloft cases are representative of a general rule that

FDA approval of a drug's label does not preempt state failure-to-warn

claims. See, e.g., Eve v. Sandoz Pharm. Corp., 2002 WL 181972, at *1-3

(S.D. Ind.) (rejecting conflict preemption of failure-to-warn claim

regarding the drug Parlodel); Caraker v. Sandoz Pharm. Corp., 172 F. Supp.

2d 1018, 1032 (S.D. Ill. 2001) (same); Bryant v. Hoffman-La Roche, Inc.,

585 S.E.2d 723, 725 (Ga. Ct. App. 2003) (heart medication); Bell v. Lollar,

791 N.E.2d 849, 854-55 (Ind. Ct. App. 2003) (prescription pain medication);

Kurer v. Parke, Davis & Co., 2004 WI App 74, 21, 679 N.W.2d 867 (oral

contraceptive). But see Ehlis v. Shire Richwood, Inc., 233 F. Supp. 2d

1189, 1198 (D.N.D. 2002) (granting summary judgment to defendant on basis

of conflict preemption of claim regarding the drug Adderall).

¶ 16. Defendant cites two cases, Needleman and Ehlis, that

support the preemptive effect of the FDCA in failure-to-warn cases

regarding prescription drug labels. Needleman, 2004 WL 1773697, at *1;

Ehlis, 233 F. Supp. 2d at 1198. Needleman is not particularly helpful

under the circumstances here. Its holding relied on the facts of the

Page 5 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 6

Zoloft litigation, particularly an FDA statement that the warning advocated

by the plaintiff would have been misleading. 2004 WL 1773697, at *1. The

courts in the other Zoloft cases took a different approach to the FDA's

statement, in part because the FDA's statement was not "an official agency

position," and in part because the FDA later retracted its position

regarding the link between Zoloft and suicide. See, e.g., Witczak, 377 F.

Supp. 2d at 730. Here, the FDA has not indicated that a stronger warning

would be misleading, so the reasoning of Needleman appears inapplicable to

this case. Ehlis interpreted ¶ 314.70(c) as allowing unapproved changes

to a label only temporarily, and only under "limited circumstances." 233

F. Supp. 2d at 1197-98. We can find no support for this interpretation in

the language of the regulation, which appears to allow unilateral changes

to drug labels whenever the manufacturer believes it will make the product

safer, and places no limit on the duration of pre-approval warnings unless

the FDA disapproves of the change. 21 C.F.R. ¶ 314.70(c).

¶ 17. Defendant next attempts to draw a comparison to the

regulation of medical devices under the FDCA, citing medical device cases

in which state tort law has been preempted. See Buckman Co. v. Plaintiffs'

Legal Comm., 531 U.S. 341, 348 (2001) (holding that "fraud-on-the-FDA"

claim relating to device regulated by Medical Device Amendments to FDCA was

preempted); Horn v. Thoratec Corp., 376 F.3d 163, 177 (3d Cir. 2004)

(holding that failure-to-warn claim was preempted by Medical Device

Amendments). We find this analogy unpersuasive. Neither Buckman nor Horn

weakens the force of the drug-labeling cases cited above. The claim that

was preempted in Buckman was for "fraud on the FDA," not failure to warn;

the Court held that the presumption against preemption applies only when a

claim implicates " 'the historic primacy of state regulation of health and

safety,' " which is not the case when the claim arises from a federal

statute. 531 U.S. at 347-48 (quoting Medtronic, 518 U.S. at 485).

Plaintiff's negligence and product-liability claims fall squarely within

the scope of traditional state regulation, so it is appropriate to apply

the presumption against preemption here. In Horn, the Third Circuit

relied on an express preemption clause in the FDCA that relates only to

medical devices. 376 F.3d at 176. Because no such clause exists for

prescription drugs, Horn's reasoning does not apply to this case.

¶ 18. Finally, defendant cites a third group of cases relating

generally to the United States Supreme Court's recent use of conflict

preemption in other fields. This argument relies primarily on Geier v.

American Honda Motor Co., 529 U.S. 861 (2000). In Geier, the Court held

that state tort claims based on the production of automobiles without

airbags conflicted with federal regulations making airbags one of several

permissible safety equipment options. 529 U.S. at 881. Geier, however,

rested on the conclusion that the Department of Transportation's intent in

drafting the regulation at issue was to provide a range of different safety

options, thus precluding any state determination that a specific type of

equipment should be required. Id. The history of the regulation at issue

indicated that the agency intended to phase in automobile safety

requirements gradually, allowing the public to choose between mandatory

seatbelt laws at the state level and a federal passive-restraint

requirement. Id. at 880-81. Allowing state tort claims based on the lack

of a particular safety mechanism would have conflicted with both the

agency's phase-in plan and its intent to provide consumers with a range of

safety options. Id. at 881. The Court explicitly stated that in a

different context, an agency could promulgate regulations that provided a

floor, but not a ceiling, for state regulation. Id. at 870.

¶ 19. The FDA's labeling requirements are exactly that type of

regulation. Section 314.70(c) does not allow us to interpret FDA approval

of a drug label as anything but a first step in the process of warning

Page 6 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 7

consumers. When further warnings become necessary, the manufacturer is at

least partially responsible for taking additional action, and if it fails

to do so, it cannot rely on the FDA's continued approval of its labels as a

shield against state tort liability. While a state common-law duty may

encourage departure from a label that the FDA has approved in great detail,

such a duty does not create a conflict with federal requirements because

the FDA and the state share the purpose of encouraging pharmaceutical

companies to alter their drug labels when they are inadequate to protect

consumers. We agree with the significant majority of courts that state

failure-to-warn claims are generally not preempted by federal labeling

requirements.

¶ 20. We must now apply this reasoning to defendant's two

original contentions: (1) notwithstanding the fact that it is generally

possible for manufacturers to comply with both federal and state law

through the procedures created by ¶ 314.70(c), the FDA's specific actions

with respect to Phenergan made it impossible for defendant to comply with

both federal and state law; and (2) even if plaintiff's claim and the cases

cited above do not make it impossible for manufacturers to comply with both

state and federal law, they present an obstacle to federal objectives.

C. Impossibility of Compliance

¶ 21. Defendant contends that in this case, it was impossible to

comply with both state and federal law because the FDA prohibited the use

of a stronger warning with respect to IV-push administration of Phenergan.

This claim is not supported by the evidence defendant presented to the

trial court. The record lacks any evidence that the FDA was concerned that

a stronger warning was not supported by the facts, that such a stronger

warning would distract doctors from other provisions in the drug's label,

or that the warning might lead to less effective administration of the

drug. Instead, defendant essentially relies on two factual assertions: 1)

the FDA approved the label that was in use in 2000; and 2) the FDA, in

reviewing the label for use in a different version of Phenergan, expressed

its opinion of the adequacy of the warning in the original label by

stating, "Retain verbiage in current label." AB 5, 5 n.7

¶ 22. With respect to defendant's first assertion, our analysis

above demonstrates that FDA approval of a particular label does not preempt

a jury finding that the label provided insufficient warning, as defendant

was free under ¶ 314.70(c) to strengthen the warning without prior FDA

approval. Defendant's second assertion depends on the meaning of the

instruction, "[r]etain verbiage in current label." Tort liability for

defendant's failure to strengthen its warning could have created a direct

conflict requiring federal preemption only if the FDA intended the

instruction to prohibit any language strengthening the original warning.

In other words, unless we interpret the FDA's statement as evidence that it

would have rejected any attempt by defendant to strengthen its label

through ¶ 314.70(c), we cannot conclude that it was impossible for

defendant to comply with its state common-law duty without violating

federal law.

¶ 23. Defendant argues that the instruction reflected the FDA's

opinion not only that a stronger warning was unnecessary, but also that it

would have harmed patients by eliminating IV push as an option for

administering Phenergan. The record does not support this interpretation.

Defendant has provided a number of letters exchanged by the FDA and

defendant regarding Phenergan's label, but these letters do not indicate

the FDA's opinion of the value of IV-push administration. Neither the

letters nor any other evidence presented to the jury indicated that the FDA

wished to preserve the use of IV push as a method of administering

Page 7 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 8

Phenergan. Nor can we infer such concern from the agency's instruction to

"[r]etain current verbiage" instead of adopting the proposed warning. The

specific warning the agency rejected in favor of the original label did not

indicate any more clearly than the original label that IV-push

administration was unsafe, which is what plaintiff argued made the original

label inadequate. The FDA could have rejected the new warning for any

number of reasons, including clarity or technical accuracy, without

implicitly prohibiting a stronger warning. Defendant's unsupported

hypothesis that the FDA saw the new warning as harmful seems among the

least likely explanations, as the rejected proposal would not have

eliminated IV push as an option for administering Phenergan.(FN2) With

respect to IV administration, the original label read, "When administering

any irritant drug intravenously it is usually preferable to inject it

through the tubing of an intravenous infusion set that is known to be

functioning satisfactorily," while the proposed label stated, "[i]njection

through a properly running intravenous infusion may enhance the possibility

of detecting arterial placement. In addition, this results in delivery of

a lower concentration of any arteriolar irritant." See supra 4 n.1

(comparing proposed and original warnings). Simply stated, the proposed

warning was different, but not stronger. It was also no longer or more

prominent than the original warning, so it could not have raised a concern

that it might overshadow other warnings on the label or drive doctors away

from prescribing the drug. There is no evidence that the FDA intended to

prohibit defendant from strengthening the Phenergan label pursuant to ¶

314.70(c).(FN3) Thus, we cannot conclude that it was impossible for

defendant to comply with its obligations under both state and federal law.

D. Obstacle to Congressional Purposes and Objectives

¶ 24. Defendant next contends that state common-law liability

for its use of an FDA-approved label presents an obstacle to federal

objectives. We hold that plaintiff's claim does not interfere with any

objective that can legitimately be ascribed to Congress. We agree with the

reasoning in the cases cited above, supra 14-15, that federal labeling

requirements pursuant to the FDCA create a floor, not a ceiling, for state

regulation. Defendant presents a new FDA rule containing language

disputing this reasoning, but this statement does not alter our conclusion

that there is no conflict between federal objectives and Vermont common

law.

1. The Purposes and Objectives of Congress

¶ 25. In the absence of a conflict that makes it impossible for

a regulated entity to comply with both state and federal law, federal law

will preempt state law only if it "stands as an obstacle to the

accomplishment and execution of the full purposes and objectives of

Congress." Freightliner, 514 U.S. at 287 (quotations omitted). We must

therefore examine what "the full purposes and objectives of Congress" were

with respect to federal labeling requirements for prescription drugs. We

agree with the McNellis court that a system under which "federal

regulations merely set minimum standards with which manufacturers must

comply" is

fully consistent with Congress' primary goal in enacting the

FDCA, which is "to protect consumers from dangerous

products," United States v. Sullivan, 332 U.S. 689, 696

(1948), as well as Congress' stated intent that the FDCA "

'must not weaken the existing laws,' but on the contrary 'it

must strengthen and extend that law's protection of the

consumer.' " United States v. Dotterweich, 320 U.S. 277[,

282] (1943) [quoting S. Rep. No. 152, 75th Cong., 1st Sess.,

Page 8 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 9

p. 1].

2005 WL 3752269, at *7; see also Witczak, 377 F. Supp. 2d at 731 ("Congress

certainly did not intend to bar drug companies from protecting the public

when enacting the FDCA; its goal was to protect the public. . . . Any

contrary interpretation of Congress's intent is perverse.").

¶ 26. In fact, Congress has expressed its purposes clearly, not

only in the general sense that the statute was intended to "protect the

public," but also more specifically, with respect to the FDCA's preemptive

effect. In the 1962 amendments to the FDCA, Congress included a clause

expressly limiting the preemptive effect of the statute: "Nothing in the

amendments made by this Act to the Federal Food, Drug, and Cosmetic Act

shall be construed as invalidating any provision of State law . . . unless

there is a direct and positive conflict between such amendments and such

provision of State law." Drug Amendments of 1962 (Harris Kefauver Act),

Pub. L. No. 87 781, ¶ 202, 76 Stat. 780, 793 (1962).

¶ 27. This amendment essentially removes from our consideration

the question of whether common-law tort claims present an obstacle to the

purposes and objectives of Congress. Congress intended that the FDCA would

leave state law in place except where it created a "direct and positive

conflict" between state and federal law. Drug Amendments ¶ 202. This

language "simply restates the principle that state law is superseded in

cases of an actual conflict with federal law such that 'compliance with

both federal and state regulations is a physical impossibility.' " See S.

Blasting Servs., Inc. v. Wilkes County, 288 F.3d 584, 591 (4th Cir. 2002)

(interpreting "direct and positive conflict" language in the preemption

clause of a federal statute governing explosive materials to allow states

to "impose more stringent requirements than those contained in the federal

regulations") (quoting Hillsborough County v. Automated Med. Labs., Inc.,

471 U.S. 707, 713 (1985)).(FN4) In other words, under any circumstances

where it is possible to comply with both state law and the FDCA, the state

law in question is consistent with the purposes and objectives of Congress.

Thus, our discussion above regarding defendant's impossibility argument,

supra 21-23, provides a complete answer to the question of preemption.

¶ 28. We recognize that our dissenting colleague has reached the

opposite conclusion. There is little to say, beyond what we have already

said, except that we respectfully disagree with his analysis of the FDCA,

the FDA's regulations, and the specific context of this lawsuit. Numerous

courts have concluded, over the course of decades, that the FDCA provides a

floor, not a ceiling, for state regulation. See supra, 14-15. While the

dissent cites favorably the minority view, we agree with the majority view.

There is much to be said for the policy arguments employed by courts

adopting this minority view, including the argument that permitting too

much state activity in this area will make beneficial drugs less available

to consumers. Similarly, there is merit to the majority perspective that

eliminating lawsuits like the one at issue here would leave consumers

without recourse in the event the FDA cannot move quickly enough to require

strengthened warnings when they are appropriate. Our view is that neither

policy argument is relevant here. The plain language of the statute

indicates that Congress did not intend to interfere with state prerogatives

except where doing so is absolutely necessary, see supra, 25-27, and the

plain language of the regulation makes such interference unnecessary here,

see supra, 12-13. This analysis is consistent with the constitutionally

rooted presumption against preemption. To look more broadly at arguments

relying on assumptions about safety and economic efficiency is to apply the

opposite presumption-the presumption that Congress could not possibly have

intended to allow states to intrude on what seems, intuitively, to be an

area of federal expertise. It is neither our responsibility, nor that of

Page 9 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 10

the FDA, to question the policy judgments of Congress. The litigation at

issue here does not pose a direct and positive conflict with federal law,

and thus, there is no basis for federal preemption.

2. The FDA's New Statement on Preemption

¶ 29. Defendant, after oral argument in this case, cited a new

FDA regulation that contains a statement relating to the preemptive effect

of the FDCA. The substance of the regulation changes certain aspects of

labeling requirements for prescription drugs, but these changes are

irrelevant to this appeal because the new rule did not take effect until

June 2006. Food and Drug Administration, Requirements on Content and

Format of Labeling for Human Prescription Drug and Biological Products,

Supplementary Information, 71 Fed. Reg. 3922, 3922 (Jan. 24, 2006). The

rule's "Supplementary Information" section, however, contains a broad

statement regarding the preemption of state common-law failure-to-warn

claims. Id. at 3933-36. In this statement, the FDA asserts that recent

cases rejecting preemption of these claims, including those cited above,

pose an obstacle to the agency's enforcement of the labeling requirements.

Id. Among the interpretations the agency claims are incorrect are: (1)

those rejecting preemption on the basis of ¶ 314.70(c); and (2) those

stating that federal labeling requirements are minimum standards and that

"[s]tate law serves as an appropriate source of supplementary safety

regulation for drugs by encouraging or requiring manufacturers to

disseminate risk information beyond that required by FDA under the act."

Id. at 3934.

¶ 30. We are ordinarily required to defer to an agency's

interpretation of a statute it administers. Chevron, U.S.A., Inc. v.

Natural Res. Def. Council, 467 U.S. 837, 844 (1984) ("We have long

recognized that considerable weight should be accorded to an executive

department's construction of a statutory scheme it is entrusted to

administer . . . ."). Plaintiff, however, urges us not to defer to the

FDA's statement because it "was adopted without the requisite comment

period" and "lack[s] the force of law." Presumably, if we were to credit

plaintiff's argument, we would owe the statement only the limited deference

due to agency statements made outside the agency's rulemaking authority.

See United States v. Mead Corp., 533 U.S. 218, 226-27 (2001) (stating that

Chevron deference applies only "when it appears that Congress delegated

authority to the agency generally to make rules carrying the force of law,

and that the agency interpretation claiming deference was promulgated in

the exercise of that authority"). We need not decide this difficult

question of administrative law, however, because we conclude that

irrespective of the level of deference we might apply, the statement would

not affect the outcome of this appeal.

¶ 31. Under Chevron, deference to an agency's interpretation is

appropriate only when a statute is "silent or ambiguous with respect to the

specific issue" the agency has considered; otherwise, "the court, as well

as the agency, must give effect to the unambiguously expressed intent of

Congress." 467 U.S. at 842-43. Moreover, "[t]he judiciary is the final

authority on issues of statutory construction and must reject

administrative constructions which are contrary to clear congressional

intent." Id. at 843 n.9. "If a court, employing traditional tools of

statutory construction, ascertains that Congress had an intention on the

precise question at issue, that intention is the law and must be given

effect." Id. When an agency's interpretation is not the type of

interpretation entitled to Chevron deference, we must still grant it some

respect, but only "a respect proportional to its 'power to persuade.' "

Mead, 533 U.S. at 235 (quoting Skidmore v. Swift & Co., 323 U.S. 134, 140

(1944)).

Page 10 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 11

¶ 32. Under either standard, the FDA's statement deserves no

deference. We have already concluded, supra 26-27, that Congress intended

the FDCA to preempt only those state laws that would make it impossible for

manufacturers to comply with both federal and state requirements. Nothing

in the FDA's new statement alters our conclusion that it would be possible

for defendant to comply with both its federal obligations and the

obligations of state common law. The regulatory framework for prescription

drug labeling allows drug manufacturers to add or strengthen a warning "to

increase the safe use of the drug product" without prior FDA approval. See

supra 10-13 (citing 21 C.F.R. ¶ 314.70(c)(6)(iii)(C)). Even if the new

rule eliminated or altered this provision, the change in the regulation did

not take effect until June 2006.(FN5) Without such a change, it is possible

for manufacturers to comply with both FDA regulations and duties imposed by

state common law, and there is no "direct and positive conflict" between

state and federal law.

¶ 33. The FDA does not attempt to establish such a conflict or

explain the inconsistency between its position and the language of the

preemption amendment. The statement cites the amendment, but then proceeds

as if Congress had not spoken on the issue of preemption. The agency

relies on Geier to support its disregard of Congress's "direct and positive

conflict" language, asserting that "[t]he existence of a legislative

provision addressing pre-emption does not bar the operation of ordinary

principles of implied preemption." 71 Fed. Reg. at 3935 (citing Geier, 529

U.S. at 869). Geier does state that implied preemption applies even when a

statute addresses preemption expressly, 521 U.S. at 869, but it does not

allow courts or agencies to preempt state laws that have been expressly

preserved by Congress. Instead, it simply stands for the proposition that

Congress's intent not to preempt a provision of state law cannot be

inferred from either (1) an express preemption clause that does not include

the state law in question in its scope, or (2) a clause that prevents

regulated entities from using compliance with federal law as a defense in

state common-law suits. Id. at 869-70. According to Geier, the former

clause does not support a negative inference that Congress must have

intended to preserve laws it did not expressly preempt; the latter

indicates only that Congress intended to preserve some common-law claims,

not that it intended to allow even claims that conflict with federal

requirements. Id. But see id. at 870 (stating that even the latter clause

would "preserve[] those actions that seek to establish greater safety than

the minimum safety achieved by a federal regulation intended to provide a

floor").

¶ 34. Here, we are not attempting to infer the effect of

statutory language that only indirectly addresses the specific state law at

issue. Instead, we are interpreting an unambiguous express preemption

clause that specifically preserves the type of state law at issue. Under

these circumstances, ordinary preemption principles must give way to

Congress's intent to preserve state laws that do not create a "direct and

positive conflict" with federal law. Drug Amendments ¶ 202. There is no

such conflict here. Accordingly, the FDA's statement is neither an

authoritative interpretation of an ambiguous statutory provision entitled

to deference, Chevron, 467 U.S. at 842-43, nor a persuasive policy

statement entitled to respect. Mead, 533 U.S. at 235. Plaintiff's claim

does not impose conflicting obligations on defendant or present an obstacle

to the objectives of Congress. We therefore agree with the trial court

that the claim is not preempted by federal law.

II. Apportionment of Damages

¶ 35. Defendant next contends the court erred by failing to

Page 11 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 12

instruct the jury to reduce plaintiff's damages by the amount of fault

attributable to the Health Center. "Reversing a jury verdict based on

allegedly faulty jury instructions is warranted where the party claiming

error establishes that the instructions were erroneous and prejudicial."

Simpson v. Rood, 2005 VT 21, 5, 178 Vt. 474, 872 A.2d 306 (mem.). We hold

that there was no error in the court's failure to require apportionment of

damages between defendant and the Health Center.

¶ 36. Defendant argues that pursuant to Vermont's comparative

negligence statute, a defendant is liable for only the portion of the

plaintiff's damages attributable directly to that defendant's negligence.

12 V.S.A. ¶ 1036. Our traditional rule is that multiple tortfeasors are

jointly and severally liable. See Zaleskie v. Joyce, 133 Vt. 150, 158, 333

A.2d 110, 115 (1975) ("[T]he law of this state . . . permits a plaintiff to

pursue all, or any part, of his recovery from either joint tortfeasor").

According to defendant, ¶ 1036 applies not only under circumstances where

comparative negligence is alleged on the part of the plaintiff, and not

only when multiple defendants are sued in the same action, but also any

time the plaintiff recovers from someone besides the defendant. Thus,

because plaintiff and the Health Center reached a settlement in a separate

lawsuit related to the same injury, defendant claims the jury should have

been required to calculate the Health Center's proportion of causal

negligence and subtract that percentage from the verdict.

¶ 37. Section 1036 states, under the heading of "Comparative

negligence,"

Contributory negligence shall not bar recovery in an action

by any plaintiff, or his legal representative, to recover

damages for negligence resulting in death, personal injury or

property damage, if the negligence was not greater than the

causal total negligence of the defendant or defendants, but

the damage shall be diminished by general verdict in

proportion to the amount of negligence attributed to the

plaintiff. Where recovery is allowed against more than one

defendant, each defendant shall be liable for that proportion

of the total dollar amount awarded as damages in the ratio of

the amount of his causal negligence to the amount of causal

negligence attributed to all defendants against whom recovery

is allowed.

12 V.S.A. ¶ 1036. We interpreted this statute under slightly different

circumstances in Plante v. Johnson, 152 Vt. 270, 565 A.2d 1346 (1989). In

Plante, the defendant resisted joinder of the plaintiffs' claims against

her and a third party, resulting in a joint trial with two separate

verdicts. The jury first returned a verdict against the third party for

the entire amount of the plaintiff's damages, then found against the

defendant for the same amount, and the court consolidated the judgments.

The defendant appealed, arguing that the first verdict made the third

party's share of the fault 100%. She concluded that under ¶ 1036, she

was entitled to a ruling apportioning 100% of the liability for the

plaintiff's damages to the third party. The defendant failed to argue this

point at trial, making a holding regarding ¶ 1036 unnecessary. We

nevertheless examined the statute in depth to demonstrate that our

determination that the defendant was not entitled to apportionment was

"more than a technical omission." Id. at 272, 565 A.2d at 1347. We

concluded that the statute did not apply to the defendant in Plante because

"the statute provides for apportionment among defendants, suggesting that

only those joined in the same action should be considered in apportioning

damages," and "there is no allegation that the plaintiff was negligent in

this case."(FN6) Id. at 273, 565 A.2d at 1347-48.

Page 12 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 13

¶ 38. In reaching this conclusion, we relied in part on the fact

that "the New Hampshire Supreme Court has held that its nearly identical

statute does not apply to create several liability in the absence of an

allegation of negligence on the part of the plaintiff." Id., 565 A.2d at

1348 (citing Lavoie v. Hollinracke, 513 A.2d 316, 319-20 (N.H. 1986)).

Defendant points out that Lavoie has since been overruled, but the decision

overruling it, Nilsson v. Bierman, 839 A.2d 25 (N.H. 2003), relied on a

legislative revision of New Hampshire's statute that placed the concepts of

comparative negligence and apportionment under separate headings. Id. at

29. In the absence of action by the Legislature to amend Vermont's

comparative negligence statute, we see no reason to depart from the

interpretation of ¶ 1036 contained in Plante. The Health Center was not

a party to plaintiff's action against defendant, and defendant does not

allege that plaintiff was comparatively negligent, so ¶ 1036 does not

apply in this case.

¶ 39. Defendant argues that whether or not ¶ 1036 applies, we

can depart from our common law and determine that joint and several

liability should no longer prevent apportionment among joint tortfeasors

when one tortfeasor has settled in a previous action. We decline to do so.

In Howard v. Spafford, 132 Vt. 434, 321 A.2d 74 (1974), which also involved

an interpretation of ¶ 1036, we expressed our hesitation to depart from

the rule precluding contribution among joint tortfeasors, preferring not to

"substitute judicial fiat for legislative action." Id. at 435, 321 A.2d at

75. Among the many reasons cited in Howard for adhering to the common law

was the sheer number of alternative schemes adopted by other states. Id.

at 436-37, 321 A.2d at 75-76. This reasoning applies here as well. Our

choice is not between the traditional rule and a uniform new rule, but

rather between a traditional rule and a number of potential new rules or

combinations of rules. The Nilsson court pointed out the divide among

states requiring jury verdicts to be reduced by the dollar amount of the

plaintiff's settlement with a third party (pro tanto), those requiring

verdicts to be reduced by the percentage of the settling party's fault

(proportional share), and those requiring verdicts to be divided among all

joint tortfeasors equally (pro rata). 839 A.2d 30-31. That court pointed

out that while "[t]he American Law Institute favors the proportional share

approach . . . , the overwhelming majority of States reject the

proportional share approach in favor of some version of the pro tanto

approach," and New Hampshire's legislature chose a combination of the two.

Id. at 31 (citations and quotations omitted). It is important to note that

if we were to adopt the majority rule, our decision would have no effect on

this case, as plaintiff and defendant have stipulated to a pro tanto

reduction. Like the New Hampshire court, we will allow the Legislature to

determine which approach is best, if it has not done so already by leaving

¶ 1036 in place after our interpretation in Plante.

III. Present Value of Damages

¶ 40. Finally, defendant contends the court erred by failing to

instruct the jury to calculate the present value of plaintiff's damages for

future non-economic losses, such as pain and suffering. Defendant claims

that the jury's verdict, which granted plaintiff $5 million in non-economic

damages, exceeded the present value of plaintiff's requested amount by

$856,073. In rejecting defendant's proposed instruction, the court pointed

out that defendant failed to provide the jury with expert guidance as to

how present value should be calculated, and that "[j]udges and lawyers are

universally incapable of performing the discount calculations with or

without a calculator and the tables of historic interest rates and

inflationary factors." We agree that it would have been inappropriate to

instruct the jury to make such a calculation under these circumstances.

Page 13 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 14

¶ 41. Even if defendant had presented testimony allowing the

jury to make an informed calculation, we would have upheld the jury's

verdict for several reasons. First, defendant's assertion that the jury

did not take account of the present value of plaintiff's non-economic

damages is pure speculation, as plaintiff's calculation of her economic

damages was presented in terms of its present value, and "the jury was not

required to demonstrate its calculations" with respect to plaintiff's

non-economic damages. Debus v. Grand Union Stores of Vt., 159 Vt. 537,

543, 621 A.2d 1288, 1292 (1993). Second, we limit pre-judgment interest to

economic damages because non-economic damages are "inchoate and rarely

ascertainable at the time of injury." Turcotte v. Estate of LaRose, 153

Vt. 196, 200 n.2, 569 A.2d 1086, 1088 n.2 (1989). These damages become no

less inchoate following a judgment, and we will not require juries to apply

a precise economic calculation to a figure we have identified as inherently

imprecise.

¶ 42. Finally, most jurisdictions and the Restatement (Second)

of Torts reject the concept of requiring juries to make present-value

calculations with respect to non-economic damages. See, e.g., Taylor v.

Denver & Rio Grande W. R.R., 438 F.2d 351, 353 (10th Cir. 1971) (holding

that instruction requiring present-value reduction for pain and suffering

was error and stating that most courts that have considered the issue have

decided "that the better reasoned authority supports the rule that future

pain and suffering should not be reduced to current worth"); Restatement

(Second) of Torts ¶ 913A cmt. a (1979) (stating that while future

pecuniary losses should be reduced to present value, "an award for future

pain and suffering or for emotional distress is not discounted in this

fashion"). But see Olivieri v. Delta S.S. Lines, Inc., 849 F.2d 742,

750-51 (2d Cir. 1988) (stating that "[i]f we were writing on a clean slate,

we might be inclined to accept the view of the other circuits and reject

any discounting of future non pecuniary losses," but previous Second

Circuit holdings required such discounting in some form). Defendant's

reliance on our decision in Parker v. Roberts, 99 Vt. 219, 131 A.2d 21

(1925), is misplaced, as Parker, while it required a jury instruction on

the present value of future losses, did not address the distinction between

pecuniary and non-pecuniary losses. Id. at 224-25, 131 A.2d at 23. The

trial court did not err in refusing to instruct the jury to reduce

plaintiff's non-economic damages to present value.

Affirmed.

___________________________________

Associate Justice

------------------------------------------------------------------------------

Dissenting

¶ 43. REIBER, C.J., dissenting. The overarching issue in this

appeal is whether plaintiff's common-law claim for failure to warn

conflicts with the FDA's regulation of Phenergan, the drug responsible for

plaintiff's injuries. I would conclude that the jury's verdict in this

case conflicts with federal law for two reasons.

¶ 44. First, it would be impossible for defendant Wyeth to

comply with the requirements of both state and federal law. Specifically,

the FDA approved IV administration of Phenergan and required that IV

administration be listed on the Phenergan label. By contrast, plaintiff's

theory of the case required Wyeth either to remove this approved use from

Page 14 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 15

the Phenergan label, add a warning that would directly contradict the

label's indication that IV administration was a safe and effective use, or,

at a minimum, add a warning that only certain types of IV administration

should be used. Thus, compliance with state law in this case would require

Wyeth to eliminate uses of Phenergan approved by the FDA and required to be

included in the Phenergan labeling.

¶ 45. Second, plaintiff's state-law claim conflicts with federal

law in that it poses an obstacle to federal purposes and objectives. In

short, by approving Phenergan for marketing and distribution, the FDA

concluded that the drug-with its approved methods of administration and as

labeled-was both safe and effective. See 21 U.S.C. ¶ 355(d) (listing

criteria for drug approval). In finding defendant liable for failure to

warn, a Vermont jury concluded that the same drug-with its approved methods

of administration and as labeled-was "unreasonably dangerous." See Town of

Bridport v. Sterling Clark Lurton Corp., 166 Vt. 304, 308, 693 A.2d 701,

704 (1997) (to succeed on failure-to-warn claim, plaintiff must show that

"failure to warn made the product unreasonably dangerous and therefore

defective"). These two conclusions are in direct conflict.

¶ 46. For both of these reasons I would conclude that the

state-law cause of action is preempted. I respectfully dissent.

I. Impossibility of Compliance

¶ 47. As explained by the majority, because there is no clause

in the FDCA expressly preempting state law, Wyeth must demonstrate that

preemption is implied by showing either that federal law thoroughly

occupies the regulatory field (a claim that Wyeth does not advance) or that

there is an actual conflict between state and federal law. Actual

conflict, in turn, can be demonstrated in one of two ways: by showing that

it is impossible for the regulated party to comply with both state and

federal law or that state 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 (1995) (quotations

omitted).

¶ 48. The majority in essence concludes that it is not

impossible for Wyeth to comply with both federal and state standards

because Wyeth never sought FDA approval of a "stronger warning" of the type

advocated by plaintiff. According to the majority, because the FDA was not

presented with, and therefore did not explicitly reject, such strengthened

language, there is no reason to presume that the FDA would disapprove.

Therefore, the majority reasons, there is no actual conflict between state

and federal law. See ante ¶ 21-22. It is inaccurate, however, to

characterize the requirements imposed by the jury verdict in this case as

merely requiring a "stronger warning." Rather, what plaintiff sought was

an elimination of a use of Phenergan that had been approved by the FDA.

Furthermore, the FDA's rejection of Wyeth's efforts to alter the language

of the warning in 2000 supports Wyeth's claim that the FDA had an

affirmative preference for the language of the original warning.

¶ 49. The crux of plaintiff's claim was not based on the label

warnings per se, but on the approved uses listed there. See, e.g., ante ¶ 3

("Plaintiff's experts testified that the label should not have allowed IV

push as a means of administration . . .."). A review of plaintiff's

complaint and the evidence presented at trial makes clear that the standard

plaintiff sought to establish (i.e., the change to the label that would be

required in light of the jury's finding of liability) was to remove IV

Page 15 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 16

administration-or at least certain types-as an approved use. For example,

plaintiff's complaint asserted that the warnings on the label were

inadequate and that:

[t]he Phenergan sold by defendant is . . . NOT REASONABLY

SAFE FOR INTRAVENOUS ADMINISTRATION because the foreseeable

risks of harm posed by intravenous administration of the drug

are sufficiently great in relation to its foreseeable

theraputic benefits that reasonable health care providers,

knowing of such foreseeable risks and benefits, WOULD NOT

PRESCRIBE THE DRUG INTRAVENOUSLY FOR ANY CLASS OF PATIENTS."

(Emphasis added.) In her appellate brief, plaintiff characterizes the

evidence as revealing "that Wyeth was aware of research indicating that

DIRECT IV ADMINISTRATION OF PHENERGAN WAS UNSAFE." (Emphasis added.)

Plaintiff further refers to expert testimony "that the LABEL SHOULD HAVE

RESTRICTED PHENERGAN TO INTRAMUSCULAR INJECTIOn as this method of

administration presents no risk of inadvertent arterial injection; or,

alternatively, that if IV administration is used, it must be by injecting

the Phenergan into a hanging IV bag, not through a direct IV." (Emphasis

added.)

¶ 50. Here, the FDA clearly addressed the risks attending IV

administration of the drug. The label approved IV administration generally,

and specifically warned of the dangers of direct IV administration,

including inadvertent arterial injection possibly resulting in amputation.

In light of this, it cannot be argued that the FDA did not (1) assess the

risk of IV administration, including direct IV administration and the

associated risk of amputation due to inadvertent arterial injection; (2)

conclude that the benefits of allowing IV administration with appropriate

warnings outweighed the risk; and (3) reach a decision regarding precisely

what warning language should be used. These assessments are, in fact, the

very essence of the FDA's approval and are in furtherance of the federal

objective of advancing public health by balancing the risks and benefits of

new drugs and facilitating their optimal use. See 21 U.S.C. ¶ 355(d)

(listing factors to be considered in approving or refusing new drug

application); 21 U.S.C. ¶ 393(b)(1), (b)(2)(B) (FDA is charged with

promoting public health by acting promptly on new drug applications and

protecting public health by ensuring that new drugs are both safe and

effective).

¶ 51. The majority reconciles this manifest conflict by relying

on 21 C.F.R. ¶ 314.70(c), which allows a drug manufacturer to alter a

label "[t]o add or strengthen a contraindication, warning, precaution, or

adverse reaction" or "add or strengthen an instruction about dosage and

administration" prior to FDA approval.(FN7) On this basis, the majority

concludes that Wyeth "was free under ¶ 314.70(c) to strengthen the

warning without prior FDA approval." Ante ¶ 22. But, it is an

overstatement to claim that manufacturers are "free" to change drug labels

under ¶ 314.70(c). To the contrary, a manufacturer may change a label

only to add or strengthen a warning, not to eliminate an approved use, as

plaintiff would require here. In other words, what plaintiff advocates is

not a stronger warning but language that would directly contradict language

approved and mandated by the FDA.

¶ 52. Further, the apparent purpose of ¶ 314.70(c) is to allow

manufacturers to address newly-discovered risks. See 44 Fed. Reg. 37434,

37447 (June 26, 1979) (allowing supplement to label "whenever possibly

harmful adverse effects associated with the use of the drug are

discovered"). Even courts that conclude that ¶ 314.70(c) provides

manufacturers broad latitude to add warnings to labels acknowledge that

Page 16 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 17

such supplements are aimed at previously unknown and unanalyzed risks. See

McNellis v. Pfizer, Inc., 2005 WL 3752269, at *6 (D.N.J.) (concluding that

¶ 314.70(c) "was promulgated precisely to allow drug manufacturers to

quickly strengthen label warnings when evidence of new side effects [is]

discovered") (citing 30 Fed. Reg. 993 (Jan. 20, 1965)); Kurer v. Parke,

Davis & Co., 2004 WI App 74, 18, 679 N.W.2d 867 (noting that, under ¶

314.70(c), "[d]rug manufacturers can strengthen warnings or petition for

additional warnings when new risk information arises"). Another section of

the regulation makes clear that any changes to a label that exceed the

scope of ¶ 314.70(c) are considered "major changes" that require prior

approval before the drug may be distributed. ¶ 314.70(b), (b)(2)(v). In

short, the regulation does not allow manufacturers to simply reassess and

draw different conclusions regarding the same risks and benefits already

balanced by the FDA. Here, the FDA had already evaluated the risk of

inadvertent arterial injection from direct IV administration of Phenergan,

and had mandated warning language for the label to reflect that risk

assessment.

¶ 53. In addition, any change accomplished under ¶ 314.70(c)

is subject to ultimate FDA review and approval. See ¶ 314.70(c)(7)

(providing that FDA may order manufacturer to cease distribution of drug if

it disapproves supplemental application); see also Needleman v. Pfizer,

Inc., 2004 WL 1773697, at *3 (N.D. Tex. 2004) (noting that changes to label

under ¶ 314.70(c) are temporary and "must later be approved by the FDA").

Thus, any additional or different warnings must ultimately be supported by

scientific research that meets the FDA's standards. Neither a

manufacturer, a state court, nor a state legislature can permanently

substitute its judgment of the risk-benefit analysis for that of the FDA.

¶ 54. At its core, plaintiff's argument in this case was not

that the warnings on the label were inadequate, but that an approved use

(direct IV administration) was in fact unreasonably unsafe. Plaintiff did

not seek to "add or strengthen" a warning or a dosage/administration

instruction, but rather to eliminate an approved use of the drug. This is

a disagreement that cannot be overcome by operation of ¶ 314.70(c).

Plaintiff's claim in this case-that a method of administration of the drug

should be partially if not entirely eliminated from the labeling-represents

a substantive disagreement with FDA policy that goes beyond

labeling/warning issues alone. This disagreement creates opposing

requirements and a manufacturer could not satisfy both at once.

¶ 55. Wyeth argues that even if ¶ 314.70(c) theoretically

allows a manufacturer to make unilateral changes to a drug label, in this

case, the FDA actually rejected Wyeth's attempts in 2000 to change the

warning regarding intra-arterial injection and amputation. The trial court

concluded that the FDA gave only "passing attention" to the risks of IV

administration in 2000. Ante ¶ 4. The majority similarly concludes that

the record does not indicate "that the FDA wished to preserve the use of IV

push as a method of administering Phenergan." Ante ¶ 23. I cannot agree

with this assessment of the record.

¶ 56. Both the original label and Wyeth's proposed alternative

were titled "INADVERTENT INTRA-ARTERIAL INJECTION." On the original label,

the first two sentences of the warning read:

Due to the close proximity of arteries and veins in the areas

most commonly used for intravenous injection, extreme care

should be exercised to avoid perivascular extravasation or

inadvertent intra-arterial injection. Reports compatible

Page 17 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 18

with inadvertent intra-arterial injection of [Phenergan],

usually in conjunction with other drugs intended for

intravenous use, suggest that pain, severe chemical

irritation, severe spasm of distal vessels, and resultant

gangrene requiring amputation are likely under such

circumstances.

On the proposed label, the first sentence of the warning read: "There are

reports of necrosis leading to gangrene, requiring amputation, following

injection of [Phenergan], usually in conjunction with other drugs; the

intravenous route was intended in these cases, but arterial or partial

arterial placement of the needle is now suspect." While the proposed

change to the warning language may not reflect what plaintiff would require

in a warning, it cannot be disputed that Wyeth's proposed alternative

warning (1) placed greater emphasis on the risk of necrosis and amputation

by referencing it in the first sentence, and (2) gave the FDA the

opportunity to consider the specific, alternative warning advanced by

Wyeth, as well as the adequacy of the warning in general. Despite this

opportunity, the FDA mandated that Wyeth retain the language of the

existing warning. The alleged extent of the FDA's consideration of the

issue is not relevant, in my view.

¶ 57. In 2000, the FDA confirmed its assessment that health care

professionals should be permitted to choose IV administration in its

various forms as a means of delivering the drug, where appropriate. Wyeth

could not both list all forms of IV administration as an approved use, as

required by the FDA, and exclude all or some forms of IV administration as

unsafe, as required by the jury's verdict in this case. It would be

impossible to comply with both requirements.

II. Obstacle to Federal Purposes and Objectives

¶ 58. I would further conclude that Wyeth has demonstrated

actual conflict preemption by showing that plaintiff's state-law

failure-to-warn claim poses an obstacle to federal purposes and objectives.

The majority does not address this issue, concluding that Wyeth does not

have the option of proving this form of actual conflict preemption. The

majority reaches this conclusion by relying on the following clause in the

1962 amendments to the FDCA:

Nothing in the Amendments made by this Act to the Federal

Food, Drug, and Cosmetic Act shall be construed as

invalidating any provision of State law . . . unless there is

a direct and positive conflict between such amendments and

such provision of state law.

Ante ¶ 26 (quoting Drug Amendments of 1962 (Harris Kefauver Act), Pub. L.

No. 87 781, ¶ 202, 76 Stat. 780, 793 (1962)). Citing Southern Blasting

Services, Inc. v. Wilkes County, 288 F.3d 584, 591 (4th Cir. 2002), the

majority concludes that the provision "essentially removes from our

consideration the question of whether common-law tort claims present an

obstacle to the purposes and objectives of Congress," because the 1962

provision "simply restates the principle that state law is superseded in

cases of actual conflict with federal law such that compliance with both

federal and state regulations is a physical impossibility." Ante ¶ 27

(internal quotations omitted). "In other words," the majority explains,

"under any circumstances where it is possible to comply with both state law

and the FDCA, the state law in question is consistent with the purposes and

objectives of Congress." Id. Thus, the majority eliminates the

possibility of proving actual conflict preemption independently through the

"obstacle" prong of that standard.

Page 18 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 19

¶ 59. But neither the passage in Southern Blasting on which the

majority relies nor the United States Supreme Court decision (FN8) cited

as authority in that passage provide an explanation or even an affirmative

statement that the phrase "direct and positive conflict" in the 1962

amendment eliminates the "obstacle" prong of the actual conflict preemption

standard. Thus, the majority eliminates one of the two means by which

Wyeth may show actual conflict based on a single, unclearly-reasoned Fourth

Circuit decision that is itself lacking in case law support. There is no

basis for eliminating this prong of the actual conflict standard, and I

disagree with the majority's conclusion to the contrary.(FN9)

¶ 60. Assuming, then, that Wyeth may demonstrate actual conflict

preemption by showing that state law is an obstacle to federal regulatory

purposes and objectives, I believe the facts here support the conclusion

that the state tort-law verdict in this case is preempted. The United

States Supreme Court's decision in Geier v. American Honda Motor Co., 529

U.S. 861 (2000), is controlling on the question of when state law poses an

obstacle to federal purposes and objectives. In that case, the Department

of Transportation had issued a safety standard that required automobile

manufacturers "to equip some but not all of their 1987 vehicles with

passive restraints." Id. at 864-65. Among the optional passive restraints

were air bags. Honda was in compliance with this standard. Nonetheless,

the plaintiff was seriously injured in a car accident while driving a 1987

Honda that was not equipped with an air bag, but with another form of

passive restraint. The plaintiff brought suit, alleging Honda was

negligent in failing to install a driver's-side air bag in the car. Honda

argued that the federal safety standard preempted the plaintiff's state-law

negligence claim. The Supreme Court held that a lawsuit premising

negligence on the failure to install an air bag conflicted with the

objectives of the federal safety standard and was therefore preempted. Id.

at 866.

¶ 61. In reaching this conclusion, the Court noted that the

plaintiff and the dissenting opinion-like the majority in the instant

case-viewed the federal regulation as setting a minimum safety standard

that states were free to supplement or strengthen. Id. at 874. However,

by examining the comments accompanying the regulation, the Court concluded

that a safety standard allowing a choice of passive restraint systems while

not mandating any particular system was a deliberate decision that

reflected a balance of diverse policy concerns. See id. at 875 (noting

that allowing mix of available safety devices available over time would

"lower costs, overcome technical safety problems, encourage technological

development, and win widespread consumer acceptance"). "In sum, . . . the

1984 version of [the safety standard] embodies the Secretary's judgment

that safety would best be promoted if manufacturers installed alternative

protection systems in their fleets rather than one particular system in

every car." Id. at 881 (quotations omitted). Accordingly, the Court

concluded that the tort action sought to impose a duty on manufacturers to

impose air bags, rather than other types of passive restraint systems, and

that this state-law requirement was an obstacle to the federal objective of

allowing a mix of safety devices.

¶ 62. Application of the Supreme Court precedent in Geier

dictates the same result in this case. As with the DOT in Geier, the FDA

is primarily concerned with public safety. The conclusion of what is best

for public safety is arrived at by considering various policy factors that

are sometimes in tension with one another. For example, in developing the

safety regulation at issue in Geier, the DOT considered not only which

passive-restraint systems were safest on an absolute scale, but which were

most cost-effective and which would gain consumer acceptance. Similarly,

Page 19 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 20

here the FDA balances its assessment of a drug's safety against concerns

for the drug's efficacy, taking into account that a safer but less

effective drug is not necessarily best for the public health overall. See

21 U.S.C. ¶ 355(d) (FDA must consider safety and efficacy); 21 U.S.C. ¶

393(b)(1), (b)(2)(B) (FDA's mission is to protect public from unsafe drugs

and to promote public health by approving regulated products in timely

manner). In the specific context oarnings on drug labels, the FDA

considers not only what information to include, but also what to exclude.

As the Eighth Circuit has noted in the medical device context, "[t]here are

. . . a number of sound reasons why the FDA may prefer to limit warnings on

product labels." See Brooks v. Howmedica, Inc., 273 F.3d 785, 796 (8th

Cir. 2001). For example, "warnings about dangers with less basis in

science or fewer hazards could take attention away from those that present

confirmed, higher risks." Id.

¶ 63. No drug is without risks. The FDA balances the risks of a

drug against its benefits to maximize the availability of beneficial

treatments. The FDA's decision in approving a drug, its uses and labeling

reflect consideration of these and other policy factors. While a

state-court jury presumably shares the FDA's concern that drugs on the

market be reasonably safe, the jury does not assess reasonableness in the

context of public health and the associated risk-benefit analysis. A jury

does not engage in a measured and multi-faceted policy analysis. Rather, a

jury views the safety of the drug through the lens of a single patient who

has already been catastrophically injured. Such an approach is virtually

guaranteed to provide different conclusions in different courts about what

is "reasonably safe" than the balancing approach taken by the FDA. In

act, different conclusions were reached in this case.

¶ 64. The jury in this case was instructed that "[a]

prescription drug is unreasonably dangerous due to inadequate warnings or

instructions if reasonable instructions regarding foreseeable risks of harm

are not provided to the physician and other medical professionals who are

in a position to reduce the risks of harm." Faced with plaintiff's tragic

injuries, the jury concluded that allowing Phenergan to be delivered

through IV administration was "unreasonably dangerous." The jury's verdict

conflicts squarely with the FDA's assessment of precisely the same issue:

whether Phenergan is safe and effective when delivered through IV

administration. The claim is preempted.

¶ 65. For the above reasons, I dissent.

_______________________________________

Chief Justice

------------------------------------------------------------------------------

Footnotes

FN1. The warning on the label that was in use in 2000 read in relevant

part:

INADVERTENT INTRA-ARTERIAL INJECTION: Due to the close

proximity of arteries and veins in the areas most commonly

used for intravenous injection, extreme care should be

exercised to avoid perivascular extravasation or inadvertent

intra-arterial injection. Reports compatible with

inadvertent intra-arterial injection of [Phenergan], usually

in conjunction with other drugs intended for intravenous use,

suggest that pain, severe chemical irritation, severe spasm

Page 20 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 21

of distal vessels, and resultant gangrene requiring

amputation are likely under such circumstances. Intravenous

injection was intended in all the cases reported but

perivascular extravasation or arterial placement of the

needle is now suspect. There is no proven successful

management of this condition after it occurs . . . .

When used intravenously [Phenergan] should be given in a

concentration no greater than 25 mg per ml and at a rate not

to exceed 25 mg per minute. WHEN ADMINISTERING ANY IRRITANT

DRUG INTRAVENOUSLY IT IS USUALLY PREFERABLE TO INJECT IT

THROUGH THE TUBING OF AN INTRAVENOUS INFUSION SET THAT IS

KNOWN TO BE FUNCTIONING SATISFACTORILY.

(Emphasis added.) The revised warning the FDA failed to adopt read in

relevant part:

INADVERTENT INTRA-ARTERIAL INJECTION: There are reports of

necrosis leading to gangrene, requiring amputation, following

injection of [Phenergan], usually in conjunction with other

drugs; the intravenous route was intended in these cases, but

arterial or partial arterial placement of the needle is now

suspect. . . .

There is no established treatment other than prevention:

1. Beware of the close proximity of arteries and veins

at commonly used injection sites and consider the possibility

of aberrant arteries.

2. When used intravenously, [Phenergan] should be given

in a concentration no greater than 25 mg/ml and a rate not to

exceed 25 mg/minute. INJECTION THROUGH A PROPERLY RUNNING

INTRAVENOUS INFUSION MAY ENHANCE THE POSSIBILITY OF DETECTING

ARTERIAL PLACEMENT. IN ADDITION, THIS RESULTS IN DELIVERY OF

A LOWER CONCENTRATION OF ANY ARTERIOLAR IRRITANT.

(Emphasis added.)

FN2. The dissent appears to interpret any warning that would eliminate

IV-push administration as inherently inconsistent with the FDA's approval

of Phenergan for IV administration in general. We see no such

inconsistency, as an approval of a drug for IV administration is not the

same as a conclusion that all methods of IV administration are safe. In

any case, a jury verdict in a failure-to-warn case simply establishes that

the relevant warning was insufficient; it does not mandate a particular

replacement warning. There may have been any number of ways for defendant

to strengthen the Phenergan warning without completely eliminating IV-push

administration. Our purpose in pointing out that the proposed warning the

FDA rejected did not eliminate IV push is simply that rejecting this

warning could not be seen as an affirmative effort by the FDA to preserve

IV push as an option.

FN3. We also reject defendant's argument that it would have been

prosecuted for "misbranding" if it had strengthened the label without prior

approval. See Witczak, 377 F. Supp. 2d at 731, 729 ("[T]he validity and

authority of state law . . . does not depend on speculative hypotheticals"

regarding "assumptions of what the FDA would have done" in response to a

stronger warning.).

FN4. The debate surrounding the amendment helps confirm that it was

Page 21 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 22

intended to preserve the right of states to regulate beyond the federal

requirements of the FDCA. During the floor debate in the House, the

subject of preemption arose several times. First, Congressman Smith of

California expressed concern that the bill, as reported, contained "no

language . . . which says anything to the effect that this particular

measure will not preempt all State food and drug laws," and thus, might

risk interfering with the efforts of some states to make their own,

stricter regulations. 108 Cong. Rec. 21046 (1962) ("[I]t seems to me that

if we are going to pass this law, someone ought to offer an amendment to

make certain that the passage of this bill, which gives all of this power

to the Department of Health, Education, and Welfare and the Food and Drug

Administration, will not preempt any State laws"). Shortly thereafter,

Congressman Harris of Arkansas, the primary House sponsor of the bill,

offered his opinion that "there is nothing in this bill that in any way

preempts the authority and prerogatives of the States." Id. at 21047.

Congressman Schenck of Ohio agreed, stating, "[m]any very helpful State

laws are in effect; many such laws in some instances are even stronger than

Federal laws for the protection of human health in the public interest."

Id. at 21056.

Congressmen Schenck and Harris, despite insisting that the bill as written

would not preempt stronger state laws, eventually supported the "direct and

positive conflict" amendment, and Schenck reiterated that preemption should

not apply in the "many instances where State laws in the area of food and

drugs and health are even stronger than some of the Federal laws." Id. at

21083. Neither the desirability of allowing states to regulate beyond the

FDCA nor the intent of the amendment to protect such regulation from

preemption was called into question during the debate.

FN5. The only alteration the new rule appears to make to ¶ 314.70 is that

changes to the new "Highlights" section of a drug label may not be made

without prior approval. 71 Fed. Reg. at 3934.

FN6. We also listed as an additional reason, not applicable here, that the

third party whose liability was at issue in Plante was held liable under a

different theory of liability that was not clearly within the scope of ¶

1036. Id. at 273, 565 A.2d at 1348.

FN7. This is also the approach employed by the numerous federal district

court decisions cited by the majority. Ante ¶ 14. Because I disagree with

this analysis of the import of ¶ 314.70(c), I do not find these decisions

to be persuasive. Instead, I side with the minority view expressed in

Needleman, which concludes that ¶ 314.70(c) gives manufacturers very little

latitude in unilaterally revising drug labels. Needleman v. Pfizer, Inc.,

2004 WL 1773697, at *3 (N.D. Tex.).

FN8. See Hillsborough v. Automated Med. Labs., 471 U.S. 707, 713 (1985).

The cited passage in Hillsborough does not interpret the phrase "direct and

positive conflict." It merely cites the different forms of preemption,

including the "obstacle" prong. It is worth noting that the federal statute

at issue in Geier v. American Honda Motor Co., 529 U.S. 861 (2000)

(discussed below), contained an even broader savings clause than the 1962

amendment to the FDCA. The provision in Geier stated simply that the

federal safety standard at issue did "not exempt any person from any

liability under common law." Id. at 868.

FN9. Nonetheless, the Court concluded that all ordinary preemption

principles-including actual conflict preemption and the obstacle prong of

the standard-applied. The Court rejected the notion that Congress would so

limit the effect of preemption as to allow an actual conflict with a

federal objective: "Insofar as petitioners' argument would permit

Page 22 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm

Page 23

common-law actions that 'actually conflict' with federal regulations, it

would take from those who would enforce a federal law the very ability to

achieve the law's congressionally mandated objectives that the

Constitution, through the operation of ordinary pre-emption principles,

seeks to protect." Id. at 872.

Page 23 of 23

12/15/2006

file://M:\Litigation Resource Center\2006 GE Newsletter Cases\NOV\Levine v. Wyeth.htm