Diana Levine v. Wyeth

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 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
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
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).

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
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
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
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.,
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
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)).

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
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.

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.

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.