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
       v.                                    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
  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.

       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
  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.

                                     A.
   
       ¶   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
  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
  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.

                                     B.

       ¶   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
       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.

       ¶   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,
  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
       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
  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
  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.

            

            

