Court Opinion

ID: 2963526
Source: CourtListenerOpinion
Date Created: 2015-09-21 21:11:29.672944+00
Date Added: 2024-06-11T11:42:42.618046
License: Public Domain

USCA1 Opinion

	

          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-