Court Opinion

ID: 196229
Source: CourtListenerOpinion
Date Created: 2011-02-07 03:01:01+00
Date Added: 2024-06-11T13:09:24.831282
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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.

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