
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-
