Violette v. Dyonics, Inc. ( 1995 )


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    August 25, 1995   UNITED STATES COURT OF APPEALS
                          FOR THE FIRST CIRCUIT
                                               
    
    No. 94-1291
    
                            RUSSELL VIOLETTE,
                          Plaintiff - Appellee,
    
                                    v.
    
                      SMITH & NEPHEW DYONICS, INC.,
                          Defendant - Appellant.
    
                                               
    
    No. 94-1334
    
                            RUSSELL VIOLETTE,
                          Plaintiff - Appellant,
    
                                    v.
    
                      SMITH & NEPHEW DYONICS, INC.,
                          Defendant - Appellee.
    
                                               
    
                               ERRATA SHEET
    
         The  opinion of  this  court issued  on  August 7,  1995  is
    amended as follows:
    
         The  coversheet should state that  it is an  appeal from the
    United States District Court for the District of Maine.
    
    
                      UNITED STATES COURT OF APPEALS
                          FOR THE FIRST CIRCUIT
                                               
    
    No. 94-1291
    
                            RUSSELL VIOLETTE,
                          Plaintiff - Appellee,
    
                                    v.
    
                      SMITH & NEPHEW DYONICS, INC.,
                          Defendant - Appellant.
    
                                               
    
    No. 94-1334
    
                            RUSSELL VIOLETTE,
                          Plaintiff - Appellant,
    
                                    v.
    
                      SMITH & NEPHEW DYONICS, INC.,
                          Defendant - Appellee.
    
                                               
    
               APPEAL FROM THE UNITED STATES DISTRICT COURT
    
                        FOR THE DISTRICT OF MAINE
    
             [Hon. Eugene W. Beaulieu, U.S. Magistrate Judge]
                                                                      
    
                                               
    
                                  Before
    
                          Boudin, Circuit Judge,
                                                         
                      Aldrich, Senior Circuit Judge,
                                                             
                       and Young,* District Judge.
                                                           
    
                                               
    
         Joseph  J. Leghorn,  with whom  Peter T. Wechsler,  Warner &
                                                                               
    Stackpole, Edward  W. Gould  and Gross,  Minsky, Mogul  & Singal,
                                                                               
    P.A., were on brief for appellant Smith & Nephew Dyonics, Inc.
                  
         Daniel  J. Popeo and Richard A. Samp on brief for Washington
                                                       
    Legal Foundation and Allied Educational Foundation, amici curiae.
                        
                                  
    
    *  Of the District of Massachusetts, sitting by designation.
    
    
         Randall E.  Smith, with  whom  John H.  O'Neil, Jr.,  Smith,
                                                                               
    Elliott, Smith & Garney, P.A., were on brief for appellee Russell
                                           
    Violette.
         Jeffrey  R.  White on  brief  for the  Association  of Trial
                                     
    Lawyers of America, amicus curiae.
    
                                               
    
                              August 7, 1995
                                               
    
                                   -2-
    
    
              YOUNG, District Judge.   Russell Violette  ("Violette")
                        YOUNG, District Judge.
                                             
    
    instituted  this action in the Superior Court in and for Kennebec
    
    County,  Maine, seeking to recover  for damage to  his left wrist
    
    allegedly  caused by the improper  use of a  medical device manu-
    
    factured  by   the  defendant   Smith  &  Nephew   Dyonics,  Inc.
    
    ("Dyonics"), a  Massachusetts corporation.    Dyonics removed  to
    
    federal court, where Violette  ultimately obtained a jury verdict
    
    in the  amount of $250,000.   Dyonics' appeal duly followed.   It
    
    must fail.
    
              The relevant prior proceedings and the facts supporting
    
    the  jury's  verdict, see  Data  General  Corp. v.  Grumman  Sys.
                                                                               
    
    Support  Corp.,  
    36 F.3d 1147
    ,  1172  (1st  Cir.  1994), may  be
                            
    
    sketched briefly.   In the summer  of 1991, Violette  experienced
    
    numbness in his hands and consulted Dr. Robert C.G. Hottentot, an
    
    orthopedic surgeon.  Dr.  Hottentot's diagnosis was carpal tunnel
    
    syndrome,  and  Violette  underwent  a  relatively  new  surgical
    
    "endoscopic" procedure involving the insertion of a slotted metal
    
    tube with a camera lens  into the carpal tunnel running  from the
    
    patient's  wrist to his palm.  The surgeon employed the technique
    
    developed  and equipment  manufactured  by Dyonics  known as  the
    
    ECTRA System (the "product"), which consists of an  endoscope and
    
    a  set of  related devices  specifically designed  for endoscopic
    
    carpal ligament release.   The outcome of the  surgery was not as
    
    doctor and patient had hoped -- Violette's ulnar nerve and artery
    
    were severed, resulting  in permanent injury  to the nerve  which
    
    left  his small and  ring fingers curled  up into the  shape of a
    
                                   -3-
    
    
    claw.
    
              Violette's   tort   action   against  Dyonics   alleged
    
    negligence (primarily failure to warn), design defect, and breach
    
    of  warranty.  In its  post-removal Answer, Dyonics asserted four
    
    affirmative  defenses:     1)   the  product  was   designed  and
    
    manufactured using  techniques representing the state  of the art
    
    at the time it was manufactured and sold; 2) any harm to Violette
    
    was  caused  entirely by  the fault  of  third parties  for which
    
    Dyonics  cannot  be held  liable;  3)  Dyonics provided  adequate
    
    instructions and  warnings regarding  the appropriate use  of the
    
    product;  and  4)  "Federal  regulation of  the  subject  product
    
    preempts the present action."
    
              With the parties' consent,  the case proceeded to trial
    
    before  a United States Magistrate  Judge on the  failure to warn
    
    and design  defect theories, Violette having waived his breach of
    
    warranty claim.   At the  close of  Violette's evidence,  Dyonics
    
    moved for directed verdict,  which was denied.  A  renewed motion
    
    for directed verdict, made at the  end of the defense case, and a
    
    motion for judgment notwithstanding the verdict or for new trial,
    
    made after the  jury came back  in Violette's favor,  met with  a
    
    similar fate.   Other than  asserting federal  preemption in  its
    
    answer, Dyonics never  mentioned it again either before or during
    
    the trial.   It surfaced as an allegedly  viable issue only after
    
    the jury returned its verdict.
    
              A.  Preemption
                        A.  Preemption
    
              The thrust of Dyonics' appeal is that provisions of the
    
                                   -4-
    
    
    Federal Food, Drug  and Cosmetic Act of 1938,  21 U.S.C.A.    301
    
    et seq.  (West 1972 &  Supp. 1993), preempt  Violette's state-law
                     
    
    products liability  claims.  Specifically, Dyonics  points to the
    
    Medical Device Amendments  of 1976, 21  U.S.C.A.    351-60  (West
    
    Supp.  1993), as  barring the  claims made  in this  case.1   See
                                                                               
    
    generally Gail  H. Javitt, I've  Got You Under  My Skin --  And I
                                                                               
    
    Can't  Get  Redress: An  Analysis of  Recent Case  Law Addressing
                                                                               
    
    Preemption  of  Manufacturer  Liability  for  Class  III  Medical
                                                                               
    
    Devices, 49  FOOD AND  DRUG L.J.  553 (1994).   It is  simply too
                     
    
    late,  however, for Dyonics to make this argument.  Regardless of
    
    its potential  applicability, and  we express  no opinion  on the
    
    subject, Dyonics  has waived the  preemption issue by  raising it
    
    substantively for the first time after trial.  
    
              The  question  of  waiver  is controlled  by  a  recent
    
    decision of this court, Sweeney v. Westvaco Co., 
    926 F.2d 29
    , 36-
                                                             
    
    41 (1st Cir.), cert. denied, 
    502 U.S. 899
     (1991).  In Sweeney, we
                                                                           
    
    held  that the defendant waived its preemption defense by waiting
    
    to raise it until after the jury had returned an adverse verdict.
    
    Id.  at 37.    Westvaco's  failure to  "alert  the  court to  the
                 
                        
                                  
    
    1  The amendment states in part:  
    
                [N]o  state  .  .  .  may   establish  or
                continue  in effect  with  respect  to  a
                device   intended   for  human   use  any
                requirement  . . .   which  is  different
                from,  or in addition to, any requirement
                applicable  under  this  chapter  to  the
                device,  and . . .  which relates  to the
                safety  or effectiveness of the device. .
                . .
    
    21 U.S.C.   360k(a) (West Supp. 1993).
    
                                   -5-
    
    
    problem" at any  one of  myriad opportunities prior  to the  jury
    
    verdict led us to decline to consider the defense.
    
              So here.  An issue not presented to the trial court may
    
    not be raised for the first time on appeal.  G.D. v. Westmoreland
                                                                               
    
    School Dist., 
    930 F.2d 942
    , 950 (1st Cir. 1991) (plaintiff cannot
                          
    
    raise  on  appeal issue  not  articulated  below); Wallace  Motor
                                                                               
    
    Sales,  Inc. v. American Motor  Sales Corp., 
    780 F.2d 1049
    , 1067
                                                         
    
    (1st Cir.  1985).   Although  Dyonics  pleaded preemption  as  an
    
    affirmative defense in its answer,  it neither developed a record
    
    on the issue  nor pressed it in  any fashion before  the district
    
    court.   Merely mentioning an issue in a pleading is insufficient
    
    to carry a party's burden actually to present a claim or  defense
    
    to the  district  court  before arguing  the  matter  on  appeal.
    
    Cookish v. Cunningham, 
    787 F.2d 1
    , 6 (1st Cir. 1986) (per curiam)
                                   
    
    (allegation  in  pleadings  insufficient  to  preserve  issue  on
    
    appeal); Bratt v. International Business Machines Corp., 
    785 F.2d 352
    , 362  n.1 (1st  Cir. 1986) (breach  of confidentiality  claim
    
    mentioned in complaint but  never pressed deemed waived); Wallace
                                                                               
    
    Motor Sales,  780 F.2d at 1067  (1st Cir. 1985) (issue  raised in
                         
    
    pleadings  but not at trial was not "presented" to district court
    
    and could not  be argued on appeal) (citing In  re Linda Coal and
                                                                               
    
    Supply  Co.  v. L.H.  Haberman  and Son,  
    255 F.2d 653
      [3d Cir.
                                                     
    
    1958]).
    
              Dyonics had ample  opportunity and incentive to  assert
    
    preemption below.  It chose, however, neither to file a motion to
    
    dismiss nor to press for  summary judgment on the issue.   In its
    
                                   -6-
    
    
    Pretrial Memorandum, under the  headings "Facts and Defenses" and
    
    "Controverted  Points of  Law,"  Dyonics asserted  only that  the
    
    endoscopic  carpal  tunnel surgery  was  an  "accepted practice";
    
    that  it  warned  physicians,  including Dr.  Hottentot,  of  the
    
    possibility of injury such as that incurred by Violette; and that
    
    Violette's   claim  was  barred  by  the  "learned  intermediary"
    
    defense.   There  is no mention  of preemption.   Nor did Dyonics
    
    assert preemption  in its  trial brief, its  numerous motions  in
    
    limine,  its two motions for directed verdict, and its motion for
    
    judgment  n.o.v. or for new trial.   See Sweeney, 926 F.2d at 38.
                                                              
    
    For whatever  reason, it is  plain that preemption  flickered but
    
    once,  dimly, on  the radar  screen of  this litigation  and then
    
    disappeared   forever,  abandoned   by  Dyonics,   depriving  the
    
    magistrate  judge  of his  rightful  opportunity  to address  the
    
    question  in the first instance.   To allow  Dyonics to resurrect
    
    the  issue here would undermine  the logic behind  our refusal to
    
    consider issues not  presented below:  Dyonics "cannot  evade the
    
    scrutiny of  the district court . . .  on appeal with a new claim
    
    in order to create essentially a new trial."  Westmoreland School
                                                                               
    
    District, 930 F.2d at 950.  Since this is precisely  what Dyonics
                      
    
    is  attempting, and  as  there are  no exceptional  or particular
    
    circumstances requiring  a detour from the  traditional rule, see
    
    id., the applicability of federal preemption is deemed waived and
                 
    
    we will not examine its applicability to this case.
    
              No  doubt recognizing  the  apparent  applicability  of
    
    Sweeney v. Westvaco  to the  facts of this  case, Dyonics  argues
                                 
    
                                   -7-
    
    
    that,   in   the   present   circumstances,   preemption   is   a
    
    jurisdictional matter which cannot be waived and may be raised at
    
    any time.   It  relies primarily on  International Longshoremen's
                                                                               
    
    Ass'n v. Davis, 
    476 U.S. 380
     (1986), where the Supreme Court held
                            
    
    that Congress had deprived the  courts of jurisdiction to  decide
    
    cases involving conduct arguably  protected by the National Labor
    
    Relations  Act, and  thus  that the  plaintiff's state-law  fraud
    
    claim  was preempted despite the defendant's failure to raise the
    
    issue until after  the jury's verdict.  See id.  at 398; see also
                                                                               
    
    Sweeney, 926 F.2d  at 37-38.  In Sweeney, however, we pointed out
                                                      
    
    that the Davis principle  stemmed from federal statutes involving
                            
    
    a  "choice-of-forum   rather  than  a   choice-of-law  question."
    
    Sweeney,  926 F.2d at 38 (quoting Davis,  476 U.S. at 391 & n.9).
                                                     
    
    That is,  where  Congress has  designated another  forum for  the
    
    resolution of a certain  class of disputes, such as  the National
    
    Labor  Relations Board  in Davis,  such designation  deprives the
                                              
    
    courts of jurisdiction to  decide those cases.  See  Sweeney, 926
                                                                          
    
    F.2d at 37.  Where,  however, the question is whether  state tort
    
    or   federal   statutory   law   controls,   preemption   is  not
    
    jurisdictional and is subject to  the ordinary rules of appellate
    
    adjudication, including  timely presentment and waiver.   See id.
                                                                               
    
    at  39.  This case  presents a "choice-of-law"  question and thus
    
    falls  squarely within the  latter category.   Preemption  is not
    
    here  jurisdictional, and  was waived  when not presented  in the
    
                                   -8-
    
    
    district court.2
    
              B.  The Jury Verdict
                        B.  The Jury Verdict
    
              Violette claimed generally  that the  ECTRA System  was
    
    "in  a  defective  condition  unreasonably  dangerous," and  that
    
    Dyonics  failed  to  warn  of  the  dangers associated  with  its
    
                        
                                  
    
    2  None of Dyonics' proffered authority addresses the question of
    waiver of  the preemption  issue on  appeal.   See Kennan v.  Dow
                                                                               
    Chemical  Co., 
    717 F. Supp. 799
     (M.D. Fla.  1989); Fitzgerald v.
                                                                            
    Mallinckrodt, Inc., 
    681 F. Supp. 404
     (E.D. Mich. 1987); Ignace v.
                                                                            
    International Playtex, Inc., No.  86-C-480-C, 
    1987 WL 93996
     (W.D.
                                         
    Wis. Aug. 14, 1987).  In each of those cases, the defendants were
    permitted to raise the preemption issue for the first time in the
    context of summary judgment  -- an unremarkable result given  the
    liberal standard for amendments  to pleadings of Fed. R.  Civ. P.
    15(c).  As the time for amending pleadings has  long passed here,
    these cases are inapposite.
              Nor  is a  recent case  of  ours, Mendes  v. Medtronic,
                                                                               
    Inc.,  
    18 F.3d 13
     (1st Cir. 1994),  of any assistance to Dyonics.
                  
    Affirming a grant of  summary judgment to the defendant,  we held
    there that  the  Medical Device  Amendments,  21 U.S.C.     360k,
    preempted plaintiff's common law  negligent failure to warn claim
    against  a  pacemaker  manufacturer because  a  factfinder  could
    impose liability  on such  a claim "applying  standards differing
    from or  adding to  FDA's."   Id.  at 19.   The  language of  the
                                               
    statute and its application in Mendes leave open  the possibility
                                                   
    that a state may impose, establish, or continue burdens identical
    to the  federal standards, leading ineluctably  to the conclusion
    that the statute's preemptive effect  is not jurisdictional.  Had
    Dyonics brought its preemption argument before the district court
    at the proper time,  like the Mendes plaintiff, this  Court could
                                                  
    have reached  the merits.  The  supplemental authorities provided
    by Dyonics --  recent cases  in which district  courts have  held
    that the Medical Device  Amendments preempt state tort  claims --
    merely serve to highlight the proper procedural context  in which
    preemption claims  ought first  be litigated.   See Committee  of
                                                                               
    Dental  Amalgam Alloy  Mfrs. v.  Henry, 
    871 F. Supp. 1278
    , 1285
                                                    
    (S.D. Cal. 1994) (holding on summary judgment that section 360[k]
    preempts California Safe Drinking Water and Toxic Enforcement Act
    of 1986); Talbott v. C.R. Bard, Inc., 
    865 F. Supp. 37
    , 39-40 (D.
                                                  
    Mass. 1994) (holding on motion to dismiss that wrongful death and
    other  state-law causes  of action  preempted by  section 360[k])
    (appeal pending); Feldt v. Mentor Corp.,  No. H-93-2205, slip op.
                                                     
    at 1-2, 10 (S.D. Tex. July 11, 1994) (holding on summary judgment
    that negligence and product liability claims preempted by Medical
    Devices Amendments and FDA regulations).
    
                                   -9-
    
    
    product.  Dyonics  asserts that as matter of  law its product was
    
    free  from defect; that its product was unavoidably unsafe and is
    
    therefore exempt from  strict liability;  that Dyonics  fulfilled
    
    its duty to warn;  that Dyonics cannot be liable  for a surgeon's
    
    selection of a particular procedure; and that  Violette failed to
    
    prove the  product proximately caused his injuries.  Dyonics also
    
    urges that we  reverse because the  magistrate judge declined  to
    
    give  certain jury  instructions.   These arguments  reflect more
    
    hope than experience.
    
              Maine law provides:
    
                One who sells any  goods or products in a
                defective      condition     unreasonably
                dangerous to  the user or  consumer or to
                his property is subject to  liability for
                physical  harm thereby caused to a person
                whom the manufacturer, seller or supplier
                might  reasonably  have expected  to use,
                consume  or be affected  by the goods, or
                to his property, if the seller is engaged
                in the business of selling such a product
                and it is expected  to and does reach the
                user  or   consumer  without  significant
                change in the  condition in  which it  is
                sold.   This section applies although the
                seller has exercised all possible care in
                the  preparation and sale  of his product
                and the  user or consumer  has not bought
                the  product  from  or entered  into  any
                contractual relation with the seller.
    
    ME. REV. STAT. ANN. tit. 14,   221 (West 1980).
    
              Maine  applies the  danger/utility  test  to claims  of
    
    design defects  -- that  is, the finder  of fact  must weigh  the
    
    utility of the product  against the danger it presents.   Guiggey
                                                                               
    
    v. Bombardier, 
    615 A.2d 1169
    ,  1172 (Me. 1992);  St. Germain  v.
                                                                           
    
    Husqvarna Corp.,  
    544 A.2d 1283
    ,  1285  (Me. 1988);  Stanley  v.
                                                                           
    
                                   -10-
    
    
    Schiavi  Mobile  Homes, Inc.,  
    462 A.2d 1144
    ,  1148  (Me. 1983);
                                          
    
    Porter v. Pfizer Hosp. Prod. Group, Inc., 
    783 F. Supp. 1466
    , 1474
                                                      
    
    (D. Me. 1992) (plaintiff cannot prevail on defective design claim
    
    where  he introduced no evidence  that the utility  of the design
    
    was  outweighed  by  the  risks).    This   process  involves  an
    
    examination  of  utility,  risk,  and the  feasibility  of  safer
    
    alternatives.  St.  Germain, 544 A.2d  at 1285 (quoting  Stanley,
                                                                              
    
    462 A.2d at 1148).  The jury's determination that the product was
    
    not safely designed to  carry out its intended use  was supported
    
    by the evidence, and therefore must stand.  
    
              Dr. Morton  Kasdan testified that the  product here was
    
    defectively designed  because it required  only approximations in
    
    the initial  placement of  the tube  on the  outside of the  skin
    
    without  being able to  see the ulnar nerve  and artery, and that
    
    when inserted below the  carpal ligament, the knife cuts  through
    
    the  ligament  before  the surgeon  can  see  what  is above  the
    
    ligament.  Dr. Kasdan  also testified that the risk  involved was
    
    enormous and  that the product's  use provided no  benefit beyond
    
    those available with the  safer, proven, alternative technique of
    
    open carpal tunnel surgery.  Dyonics' own expert admitted that he
    
    had   participated   in   the  development   of   an  alternative
    
    "extrabursal"  technique which  sought to  minimize the  risks by
    
    moving the initial placement point  and the cutting line  further
    
    from the ulnar nerve.  Given such testimony, there was sufficient
    
    competent  evidence for the jury to believe and conclude that the
    
    ECTRA  System  was unreasonably  dangerous  and  of little  added
    
                                   -11-
    
    
    utility  compared   to  available   alternatives  --   in  short,
    
    defectively designed.3
    
              The jury's determination that Dyonics failed to provide
    
    adequate  warnings and  directions is  likewise supported  by the
    
    evidence.   A  manufacturer must  provide expected  users of  its
    
    product with warnings of  the risks and "specific directions  for
    
    the product's safe use."  Pottle v. Up-Right, Inc., 
    628 A.2d 672
    ,
                                                                
    
    675 (Me.  1993).  While the  Supreme Judicial Court of  Maine has
    
    not  decided  the  matter,  the general  rule  regarding  medical
    
    devices (and, more frequently and by analogy, prescription drugs)
    
    is that the manufacturer must warn the physician -- the so-called
    
    "learned  intermediary" --  and  not the  patient directly.   See
                                                                               
    
                        
                                  
    
    3   Likewise,  the  evidence of  an  alternative safe  method  of
    surgery defeats  Dyonics' claim  that its product  is unavoidably
    unsafe and therefore exempt from strict liability under comment k
    of  section 402A  of  the Restatement  (Second)  of Torts,  which
    requires a showing  that the  utility or benefit  of the  product
    outweighs its risk  of danger.   See Kearl  v. Lederle Lab.,  218
                                                                         
    Cal.  Rptr.  453,  464  (Ct.  App.  1985)  (court  must  consider
    availability and safety of  alternative products); Belle  Bonfils
                                                                               
    Memorial Blood Bank v. Hansen, 
    665 P.2d 118
    , 123 (Colo. 1983) (en
                                           
    banc) (manufacturer must demonstrate that the "product's benefits
    could  not  be achieved  by a  substitute  product or  in another
    manner"); Toner v. Lederle  Lab., 
    732 P.2d 297
    , 306  (Idaho 1987)
                                              
    (additional element  of comment  k's  requirement of  unavoidable
    risk  is that there must be "no feasible alternative design which
    on  balance accomplishes  the  subject product's  purpose with  a
    lesser risk"); Grundberg  v. Upjohn  Co., 
    813 P.2d 89
    , 93  (Utah
                                                      
    1991) (same).  Even if comment k accurately reflects Maine common
    law -- a point we need  not decide and express no opinion thereon
    --  the refusal  of  the magistrate  judge  to find  the  product
    unavoidably unsafe and exempt from strict liability was not clear
    error.  Salve Regina College v. Russell, 
    499 U.S. 225
    , 233 (1990)
                                                     
    (mixed  questions of fact and  law are reviewed  for clear error;
    "deferential   review"  warranted  when  district  court  "better
    positioned" to  decide  the  issue);  Touch v.  Master  Unit  Die
                                                                               
    Prods., Inc.,  
    43 F.3d 754
    ,  757 (1st Cir.  1995); ICC v.  Holmes
                                                                               
    Transp., Inc., 
    983 F.2d 1122
    , 1128 (1st Cir. 1993).
                           
    
                                   -12-
    
    
    Knowlton v. Deseret  Medical, Inc.,  
    930 F.2d 116
    ,  120 n.2  (1st
                                                
    
    Cir.   1991)   (in   failure-to-warn   suit    against   catheter
    
    manufacturer, we noted that  it "is generally accepted that  in a
    
    case involving medical products prescribed or used by a physician
    
    or trained medical personnel, the  warning runs to the  physician
    
    not the  patient"); Phelps v.  Sherwood Medical Indus.,  
    836 F.2d 296
    , 299, 302  (7th Cir. 1987)  (heart catheter manufacturer  has
    
    duty to  warn physicians);  Brooks v. Medtronic,  Inc., 
    750 F.2d 1227
    , 1232  (4th Cir. 1984)  (pacemaker manufacturer has  duty to
    
    warn physician, not patient); Desmarais v. Dow Corning Corp., 
    712 F. Supp. 13
    ,  17 & n.5  (D. Conn.  1989) (manufacturer of  breast
    
    implants has duty to  warn physician); cf. Garside v.  Osco Drug,
                                                                               
    
    Inc.,  
    976 F.2d 77
    , 80  (1st  Cir.  1992) (where  product  is a
                  
    
    prescription  drug, duty to warn  runs to physician).   Dr. Chow,
    
    Dyonics' ECTRA System instructor,  admitted that in May of  1991,
    
    when the equipment was purchased by Dr. Hottentot's practice, the
    
    extrabursal  technique was being taught at seminars put on by the
    
    ECTRA faculty.  Both Dr. Chow and Jan Cook, the associate product
    
    manager for Dyonics, admitted  that the extrabursal technique was
    
    safer and  easier to learn and  to teach.  Dr.  Hottentot was not
    
    provided with any materials referring to this safer  technique or
    
    given adequate warnings of  the real potential for complications.
    
    On this record, we conclude that the jury had sufficient basis to
    
    find Dyonics in breach of its duty to warn.
    
              Dyonics argues that  a failure to  warn claim will  not
    
    lie  under Maine law where the risk of danger associated with the
    
                                   -13-
    
    
    use  of the product  was obvious to  the user, citing  Lorfano v.
                                                                            
    
    Dura  Stone Steps, Inc., 
    569 A.2d 195
    , 197  (Me. 1990) ("dangers
                                     
    
    posed by the use of steps without a handrail are patently obvious
    
    and  equally apparent  to  all").   A high-technology,  precision
    
    medical device  is, needless to say,  a far cry from  a handrail.
    
    Moreover,  while a physician cannot be held liable for an adverse
    
    outcome  simply because the result  could have been  avoided by a
    
    different selection as between two reasonable procedures, Roberts
                                                                               
    
    v.  Tardif,  
    417 A.2d 444
    ,  448  (Me.  1980),  here  there  was
                        
    
    sufficient  evidence  that   use    of   the  ECTRA  System   was
    
    unreasonably   dangerous  without  further   warnings  or  proper
    
    instructional  materials.    A   jury  could  conclude  that  Dr.
    
    Hottentot's uninformed choice of the product was not a reasonable
    
    selection of an alternative  surgical procedure, thus  insulating
    
    Dyonics  from liability.  Any  extension of Roberts  to protect a
                                                                 
    
    manufacturer in Dyonics' position is unwarranted.
    
                A  jury verdict may be set  aside "only if [it] is so
    
    seriously mistaken, so  clearly against the law  or the evidence,
    
    as to constitute a  miscarriage of justice."  Levesque  v. Anchor
                                                                               
    
    Motor Freight,Inc.,  
    832 F.2d 702
    , 703 (1st  Cir. 1987).  Such is
                                
    
    not the case here.
    
              Finally,  the magistrate  judge committed  no error  by
    
    refusing to give two proposed jury instructions.   Dyonics sought
    
    an instruction, based on Roberts, supra, that a manufacturer of a
                                                     
    
    medical device cannot be  held liable merely because  the surgeon
    
    could have pursued  an alternate course of treatment  and thereby
    
                                   -14-
    
    
    avoided the injury.  As noted above, such an extension of Roberts
                                                                               
    
    is unwarranted in this  case.  Dyonics also sought  the following
    
    instruction, citing May v. Dafoe, 
    611 P.2d 1275
    , 1278 (Wash. App.
                                              
    
    1980):
    
                A manufacturer of medical products is not
                responsible   for   the   education   and
                training  of  doctors  who  may  use  its
                product.       The   responsibility   for
                determining whether  an individual doctor
                is  sufficiently  skilled and  trained to
                use  a particular  product lies  with the
                doctor   himself   or  herself   and  the
                facilities where they practice.
    
    Such instruction  was unnecessary in this  failure to warn-design
    
    defect  case  and,  in  any  event,  the  refusal  to  give  this
    
    instruction caused  no prejudice  to Dyonics since  Dr. Hottentot
    
    followed the product instructions  he had been given.   See Davet
                                                                               
    
    v. Maccarone,  
    973 F.2d 22
    , 26 (1st Cir. 1992) ("An error in jury
                          
    
    instructions will  warrant reversal  of a  judgment  only if  the
    
    error is determined to  have been prejudicial, based on  a review
    
    of the record as a whole").
    
              For these reasons, the Amended Judgment entered in this
    
    action  on March  17, 1994,  pursuant to  the jury's  verdict, is
    
    affirmed.4
                      
    
                        
                                  
    
    4  Violette also  cross-appealed, requesting reversal of numerous
    rulings  of the magistrate judge  in the event  we had determined
    that Dyonics was entitled to  a new trial.  As Dyonics is  not so
    entitled,  there is no need  to address the  issues raised by the
    cross-appeal, and it is dismissed as moot.
    
                                   -15-
    
    

Document Info

DocketNumber: 94-1291

Filed Date: 8/7/1995

Precedential Status: Precedential

Modified Date: 12/21/2014

Authorities (27)

Longshoremen v. Davis , 476 U.S. 380 ( 1986 )

Data General v. Grumman Systems , 36 F.3d 1147 ( 1994 )

Touch v. Master Unit Die , 43 F.3d 754 ( 1995 )

in-the-matter-of-linda-coal-and-supply-company-a-corporation-alleged , 255 F.2d 653 ( 1958 )

Walter R. Brooks, Jr. v. Medtronic, Inc., a Corporation, ... , 750 F.2d 1227 ( 1984 )

wallace-motor-sales-inc-ralph-e-wallace-and-third-party-v-american , 780 F.2d 1049 ( 1985 )

Robert Bratt v. International Business MacHines Corporation , 785 F.2d 352 ( 1986 )

Dennis R. Cookish v. Michael Cunningham, Warden, New ... , 787 F.2d 1 ( 1986 )

David A. Levesque v. Anchor Motor Freight, Inc. , 832 F.2d 702 ( 1987 )

Roger N. Phelps v. Sherwood Medical Industries and Argyle ... , 836 F.2d 296 ( 1987 )

Dolores Sweeney v. Westvaco Company, Dolores Sweeney v. ... , 926 F.2d 29 ( 1991 )

prod.liab.rep.(cch)p 12,804 Mark T. Knowlton v. Deseret ... , 930 F.2d 116 ( 1991 )

G.D. Etc. v. Westmoreland School District , 930 F.2d 942 ( 1991 )

Richard F. Davet v. Enrico MacCarone , 973 F.2d 22 ( 1992 )

prod.liab.rep. (Cch) P 13,309 Milissa Garside v. Osco Drug, ... , 976 F.2d 77 ( 1992 )

fed-carr-cas-p-83804-interstate-commerce-commission-v-holmes , 983 F.2d 1122 ( 1993 )

Ellen Mendes v. Medtronic, Inc. , 18 F.3d 13 ( 1994 )

May v. Dafoe , 25 Wash. App. 575 ( 1980 )

Toner v. Lederle Laboratories , 112 Idaho 328 ( 1987 )

Belle Bonfils Memorial Blood Bank v. Hansen , 665 P.2d 118 ( 1983 )

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