Title: Levine v. Wyeth

State: vermont

Issuer: Vermont Supreme Court

Document:

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,