Court Opinion

ID: 195237
Source: CourtListenerOpinion
Date Created: 2011-02-07 02:35:57+00
Date Added: 2024-06-11T09:43:01.279250
License: Public Domain

UNITED STATES COURT OF APPEALS
                    FOR THE FIRST CIRCUIT
                                         

No. 93-1911

                        ELLEN MENDES,

                    Plaintiff, Appellant,

                              v.

                       MEDTRONIC, INC.,

                     Defendant, Appellee.

                                         

         APPEAL FROM THE UNITED STATES DISTRICT COURT

              FOR THE DISTRICT OF MASSACHUSETTS

       [Hon. Edward F. Harrington, U.S. District Judge]
                                                      

                                         

                            Before

                     Selya, Circuit Judge,
                                         
                Bownes, Senior Circuit Judge,
                                            
                   and Cyr, Circuit Judge.
                                         

                                         

John  P. LeGrand, with whom Thomas F. Walsh and  John P. LeGrand &
                                                                  
Associates, P.C. were on brief for appellant.
            
Richard H.  Bakalor, with whom Quirk  & Bakalor, P.C., Michael  W.
                                                                  
Gallagher, Andrea Saunders Barisano, Donahue & Donahue, Dan Jarcho and
                                                              
McKenna & Cuneo were on brief for appellee.
           

                                         

                        March 9, 1994
                                         

          BOWNES,  Senior Circuit  Judge.   In this  products
          BOWNES,  Senior Circuit  Judge.
                                        

liability  action  against the  manufacturer of  an allegedly

defective  pacemaker,   plaintiff-appellant,  Ellen   Mendes,

appeals from an  order granting summary judgment  in favor of

defendant-appellee,  Medtronic,  Inc.    The  district  court

entered  summary judgment  for  Medtronic,  ruling  that  the

express preemption  clause of  the Medical  Device Amendments

(MDA) of the Federal Food,  Drug, and Cosmetic Act (the Act),

21  U.S.C.     360k(a),  preempted plaintiff's  Massachusetts

common law claims.1  We affirm.

                              I.

                          BACKGROUND
                                    

          Congress enacted the MDA to  give the Food and Drug

Administration  (FDA)  comprehensive   control  over  medical

devices  for the  first time.   Slater  v.  Optical Radiation
                                                             

Corp., 961 F.2d  1330, 1331 (7th Cir.), cert.  denied, 113 S.
                                                     

Ct. 327  (1992).  The  MDA reflects Congress's  balancing the

need  for regulation  to protect  public  health against  its

interest  in allowing new and improved devices to be marketed

expeditiously  without the costs attributable to an excess of

regulation.   King v. Collagen Corp., 983  F.2d 1130, 1138-39
                                    

                    

1.  Jurisdiction  is  based   on  diversity  of  citizenship.
Defendant  asserts   and  plaintiff  does  not  dispute  that
Massachusetts  law applies.   We agree that  plaintiff's tort
claims arise under Massachusetts law.

                             -2-
                              2

(1st  Cir.) (Aldrich, J.,  concurring), cert. denied,  114 S.
                                                    

Ct. 84 (1993). 

          Pursuant to  the  MDA, FDA  groups medical  devices

into   three  classes  based  on  the  degree  of  regulation

necessary to assure safety and effectiveness.  See  21 U.S.C.
                                                  

  360c;  H.R. Conf. Rep.  No. 1090, 94th  Cong., 2d  Sess. 55

(1976),  reprinted  in  1976 U.S.C.C.A.N.  1103,  1107.   All
                      

classes  of  devices  are   subject  to  "general  controls,"

including  labeling   requirements  and   good  manufacturing

practices.  See,  e.g., 21 U.S.C.     360i, 360j.   Class III
                      

devices, such as  pacemakers, pose the greatest  risks.  Such

devices  may  be  sold  only  if  FDA  finds  that  they  are

"substantially equivalent"  in design and function to devices

on the market before the MDA became effective in 1976, or--in

the case of  new or improved devices--if FDA grants premarket

approval.    Id.      360c(a)(1)(C),  360e(b);  21  C.F.R.   
                

807.100.   Devices found to be "substantially equivalent" are

entitled to bypass  the premarket approval process  unless or

until  FDA issues  a regulation  specifying  that the  device

undergo the review process. 

          On May 14, 1986, a Medtronic pacemaker, a Class III

device,  was   implanted  into  plaintiff.     Medtronic  had

distributed  the  pacemaker  since  1981  without   premarket

approval   because   no  regulation   specifically   required

premarket approval, and because FDA found the pacemaker to be

                             -3-
                              3

substantially equivalent to pre-MDA pacemakers.  On March 10,

1992, the pacemaker  failed, and plaintiff nearly  died.  The

pacemaker was surgically removed, anda new model implanted.  

          Plaintiff filed a complaint alleging that Medtronic

was negligent  in designing, manufacturing,  and distributing

her pacemaker.  She also included claims alleging Medtronic's

failure  to  provide  adequate warnings,  and  breach  of the

implied  warranty of  merchantability.   Medtronic moved  for

summary  judgment  on the  ground  that 21  U.S.C.    360k(a)

preempted  all of  plaintiff's claims.    The district  court

granted the motion, and plaintiff appealed.2 

                      Standard of Review
                                        

          Our review of a  district court's summary  judgment

decision is plenary.  FDIC v. Anchor Properties, No. 93-1542,
                                               

slip op. at 9  (1st Cir. Jan. 5, 1993).   Summary judgment is

appropriate  when  the  pleadings  and  affidavits  raise  no

                    

2.  On  the  date  the order  granting  summary  judgment was
entered,  plaintiff  moved  to  amend  her  complaint.    The
proposed  amended  complaint  reiterated  the  claims  in her
original complaint and  added causes of action for  breach of
express warranty, negligent infliction of emotional distress,
and  strict liability.  The proposed complaint also clarified
that  she  was  alleging that  her  particular  pacemaker, as
                                              
opposed to  the model,  was  defective.   The district  court
denied the motion to amend after plaintiff filed an appeal of
the  summary  judgment  order.    Plaintiff's  brief  neither
challenges  the district  court's rejection  of her  proposed
amended  complaint, nor  refers specifically  to  any of  the
claims raised solely  in her amended complaint.   Because our
review is limited to the  issues raised on appeal, we confine
our analysis to the claims in the original complaint on which
the district court granted summary judgment.

                             -4-
                              4

genuine issue as  to any material fact, and  the moving party

is entitled to  judgment as a matter  of law.  Id.;  see also
                                                             

Fed. R. Civ. P. 56(c).  

          The  nonmoving party bears the burden of placing at

least  one material fact into dispute  after the moving party

shows  the  absence of  material  fact.    Celotex  Corp.  v.
                                                         

Catrett, 477  U.S. 317, 325  (1986).  Evidence in  the record
       

supports that  plaintiff's pacemaker was defective;  that the

defect caused plaintiff's  injuries; and  that Medtronic  was

aware,  before the pacemaker failed, that the model might not

work properly.  

          Medtronic  asserted  in  its   motion  for  summary

judgment that "[t]here are no genuine issues of material fact

since  even  if   plaintiff  could  prove  all   her  factual

allegations,"  her claims would be preempted.  Medtronic also

stated,  "[f]or  the  purposes  of  its  Motion  for  Summary

Judgment  only,"  that  it  did  not  dispute  the  following
              

allegations of plaintiff:  

          1.   [A]  Medtronic   [pacemaker],  model
          number  5984LP   (the  "device"),   [was]
          implanted  into  [plaintiff] on  May  14,
          1986 . . . . 
          2.   [T]he  device  failed on  March  10,
          1992 . . . .
          3.   This alleged  failure caused  a near
          death  circumstance  and   plaintiff  was
          required to undergo  emergency surgery to
          remove the . . . device . . . .  
          4.   [Plaintiff's]  injuries .  . .  were
          due to  defects in  the labeling,  design
          and manufacture of the device . . . .

                             -5-
                              5

Def.'s Mot. for Summ. J., at 2-3 (emphasis in original).  

          We take these assertions at  face value.  We assume

plaintiff's  factual allegations are true, and we examine the

legal issues in this light.   Medtronic does not contend that

plaintiff's   allegations  fail   to  state  a   claim  under

Massachusetts  law.  The sole  issue addressed by the parties

and the district court is  preemption, which is the key issue

on appeal. 

                             II.

                          PREEMPTION
                                    

          Medtronic  argues  that  the  Act  implicitly   and

expressly  preempts plaintiff's claims.  Congress's intent is

the  touchstone of preemption analysis.  Cipollone v. Liggett
                                                             

Group, 112 S. Ct. 2608,  2617 (1992); King v. Collagen Corp.,
                                                            

983 F.2d at 1133.   State common law claims  may be preempted

along with  state statutes  and regulations,  if Congress  so

intended.  See, e.g., Cipollone, 112 S. Ct. at  2620; King v.
                                                          

E.I. Dupont  de Nemours  & Co., 996  F.2d 1346,  1349-50 (1st
                              

Cir.),  cert.  dismissed, 114  S.  Ct.  490  (1993); King  v.
                                                         

Collagen Corp., 983 F.2d at 1134-35.
              

          "Congress' intent may be  `explicitly stated in the

statute's language  or implicitly contained in  its structure

and purpose.'"  Cipollone, 112  S. Ct. at 2617 (quoting Jones
                                                             

v. Rath  Packing Co.,  430 U.S.  519, 525  (1977)).  The  MDA
                    

                             -6-
                              6

contains  an  express  preemption   provision,  21  U.S.C.   

360k(a), that states, in pertinent part:

          [N]o State or political  subdivision of a
          State may establish or continue in effect
          with  respect to  a  device intended  for
          human use any requirement -- 
               (1)  which is different  from, or in
          addition to,  any requirement  applicable
          under  [the   Federal  Food,   Drug,  and
          Cosmetic Act] to the device, and 
               (2)  which relates to  the safety or
          effectiveness  of  the device  or  to any
          other  matter included  in a  requirement
          applicable  to  the   device  under  [the
          Federal Food, Drug, and Cosmetic Act].  

Congress's intent in  enacting this provision was  to prevent

state requirements from unduly burdening interstate commerce.

See  H.R. Rep.  No.  853,  94th Cong.,  2d  Sess. 45  (1976),
   

reprinted in An Analytical Legislative History of the Medical
                                                             

Device  Amendments of 1976,  app. III, at 45  (Food & Drug L.
                          

Inst.  Series, Daniel  F. O'Keefe,  Jr. &  Robert  A. Spiegel

eds., 1976). 

          We construe this preemption clause with  due regard

for  the interests  of federalism  because  it affects  state

public health regulation.  A federal act will supersede "`the

historic police powers of the states,'" only if that is "`the

clear and  manifest purpose of Congress.'"   King v. Collagen
                                                             

Corp., 983  F.2d at  1134 (quoting Cipollone,  112 S.  Ct. at
                                            

2617); see also  CSX Transp. v. Easterwood, 113  S. Ct. 1732,
                                          

1737 (1993); Greenwood  Trust Co. v. Massachusetts,  971 F.2d
                                                  

                             -7-
                              7

818,  823 (1st  Cir.  1992),  cert. denied,  113  S. Ct.  974
                                          

(1993).

          Viewing   section   306k(a)   in   light  of   this

presumption  against   preemption,  we  have   held  that  it

expresses Congress's  intent to  preempt  certain common  law

claims   because    such   claims    may   establish    state

"requirements."   King v.  Collagen Corp., 983  F.2d at 1138;
                                         

accord  Stamps v.  Collagen Corp.,  984 F.2d 1416,  1420 (5th
                                 

Cir.), cert. denied,  114 S. Ct. 86 (1993);  cf. CSX Transp.,
                                                            

113  S. Ct.  at 1737  (discussing  holding in  Cipollone that
                                                        

"federal  statute barring  additional  `requirement[s] .  . .

`imposed  under  state  law''  pre-empts  common-law  claims"

(citation omitted)).      

          To determine the extent to which plaintiff's claims

are preempted, we  need only identify the preemptive reach of

the  statute's express language.   Cipollone,  112 S.  Ct. at
                                            

2618  (plurality); id. at  2625 (Blackmun, J.,  concurring in
                      

part and dissenting in part).   We thus reject at  the outset

Medtronic's argument that this is an implied preemption case.

See King  v. Collagen  Corp., 983 F.2d  at 1134;  Stamps, 984
                                                        

F.2d at 1420.  When "Congress includes an express  preemption

clause in a statute, judges  ought to limit themselves to the

preemptive  reach  of  that  provision without  essaying  any

further  analysis  under  the  various  theories  of  implied

preemption."  Greenwood Trust, 971 F.2d at 823.  
                             

                             -8-
                              8

          Our first task is to outline the Act's requirements

applicable  to  the   device.    Thereafter,  we   scrutinize

plaintiff's  claims,  to  determine  whether  the  successful

litigation of  any of  them would  "establish or  continue in

effect"  a  "different" or  "addition[al]"  requirement.   21

U.S.C.      360k(a).     This  analysis  determines   whether

plaintiff's  claims  are  preempted.   21  C.F.R.    808.1(d)

(state requirements  are preempted  where "there  are  . .  .

specific requirements applicable to a particular device under

the act").

          The  pacemaker  at  issue is  a  Class  III device.

Although Class III devices are generally subject to stringent

design, manufacturing,  and labeling controls pursuant to the

premarket approval process, 21 C.F.R. pt. 814, FDA  has never

required  that the  pacemaker  model  implanted in  plaintiff

comply  with the  premarket  approval  regulations.    Id.   
                                                          

870.3610(c).   The only requirements under the Act applicable

to  the  device   are  regulations  on  labeling   and  "good

manufacturing practices."  Id. pts. 801, 820.  
                              

          Next, we  examine plaintiff's  claims to  determine

whether their  resolution would  establish or  perpetuate any

requirements under the common law differing from or adding to

the Act's requirements.  The complaint states:  

          Prior  to  May  14,  1986  the  defendant
          Medtronic  Inc.  .  .  .  manufactured  a
          certain device [known] as a pacemaker.

                             -9-
                              9

               As a result of the negligence of the
          defendant,  Medtronic  Inc.,  in control,
          maintenance, inspection, testing, design,
          developing,    servicing,   distribution,
          alteration,  modification,  sale   and/or
          manufacturing of  said device,  and as  a
                                       
          result   of   the  negligence   of   said
          defendant . . . in placing said Medtronic
          pacemaker model #5984LP in the stream  of
          medical care and failing to give adequate
          and  effective  warning   concerning  the
          [foreseeable] dangers in the use of  said
          device, the plaintiff . . . was caused to
          be  injured on  March  10, 1992,  by this
                                                   
          defective pacemaker.
                             
          . . . 
               .  .  .  [I]n  supplying  this  said
                                                   
          device  the  defendant  contended  [that]
                
          said   pacemaker   was    of   good   and
                          
          merchantable quality and that  it was fit
          and  safe for the normal use for which it
          was intended[.]  . . . [S]aid  device was
                                               
          not of merchantable  quality and was  not
          fit for safe and normal use in that . . .
          the defective pacemaker malfunctioned.  
                                 

(Emphasis  added.)   The highlighted  statements allege  that

plaintiff's    particular    pacemaker     was    negligently

manufactured;  the reference  to  the  model  number  of  the

pacemaker  is consistent with  claims that the  label carried

inadequate warnings, and  that the design  of the device  was

defective.  Plaintiff's  complaint thus contains  three types

of claims, each sounding in  negligence and breach of implied

warranty:   design defect, failure to warn, and manufacturing

defect.    The  complaint contains  no  allegation  regarding

Medtronic's compliance  with FDA  regulations, and  plaintiff

has offered no evidence on that issue.

                             -10-
                              10

          In  her brief,  plaintiff  abandoned  any claim  of

defective  design.3   At  oral argument,  plaintiff contended

that   her   allegations   of   Medtronic's   negligence   in

"alter[ing]"  and  "modif[ying]"   the  device  survived  her

abandonment  of the  design  defect  claims.    According  to

plaintiff,  these claims  allege  that  Medtronic  failed  to

obtain  FDA  approval  prior  to  distributing  the  modified

pacemaker  model implanted in  plaintiff.  It  is undisputed,

however, that FDA cleared the pacemaker for marketing without

approving  the  product  design,  finding  it  "substantially

equivalent" to  pre-MDA devices.   See  42 Fed.  Reg. 42,520,
                                      

42,525  (Aug.  23,  1977)  (preamble  to  final  rule)  ("[A]

determination of substantial equivalence . . . relates to the

fact  that the  product  can  lawfully  be  marketed  without

premarket approval or reclassification."); 21 C.F.R.   807.97

(a  finding of substantial  equivalence "does not  in any way

denote  official approval of  the device").   FDA regulations

                    

3.  Plaintiff's brief states:  
          Ellen Mendes  does  not  claim  that  the
          entire  product   line  from   which  her
          pacemaker was manufactured was defective.
          The claims in  this action do not  allege
          that  the  safety  and  effectiveness  of
          Medtronic, Inc.'s pacemaker device, as it
          was  designed and  approved  by the  FDA,
          caused  Ellen  Mendes's  injuries.    The
          claims in her complaint  allege that Mrs.
          Mendes  was  injured  because  Medtronic,
          Inc.  manufactured  and  distributed this
          specific  pacemaker   device  which   was
          itself  individually  defective  and  the
          direct cause of her injuries.

                             -11-
                              11

have never required that the pacemaker of the model implanted

in plaintiff  receive premarket  approval.   See 21  C.F.R.  
                                                

870.3610(c).   Moreover, plaintiff has not alleged that FDA's

substantial  equivalence finding  was  improper.   Therefore,

plaintiff's product  line alteration and  modification claims

fall from this case.  If the claims are design defect claims,

they have  been abandoned.  And if the claims allege that FDA

failed  to  grant  the device  premarket  approval,  they are

meritless.

          Plaintiff's abandonment of her design defect claims

also  forecloses our consideration  of her argument  that, in

the   absence  of  a  requirement  that  the  device  receive

premarket  approval,  her  design   defect  claims  are   not

preempted.   The  cases  cited by  plaintiff to  support that

argument  are  thus   inapposite.    See,  e.g.,   Larsen  v.
                                                         

Pacesetter Systems, 837  P.2d 1273, 1282 (Haw.  1992) (design
                  

defect  claims are  not preempted  where  FDA never  approved

device  design because device  was found to  be substantially

equivalent  to pre-MDA devices); see also Stamps, 984 F.2d at
                                                

1419, 1421-22  (discussing Moore v. Kimberly-Clark Corp., 867
                                                        

F.2d 243, 246  (5th Cir. 1989) (design defect  claims are not

preempted by  requirements applicable  to tampons,  which are

Class II devices not subject to premarket approval)).

          Plaintiff's  only  remaining   common  law  claims,

sounding   in  negligence   and   breach  of   warranty,  are

                             -12-
                              12

allegations  of  inadequate   warnings  and  a  manufacturing

defect.   In this connection,  the MDA provides that  a state

requirement,  if  different from  or  in addition  to  an FDA

requirement, is preempted only if  it "relates to" the safety

or effectiveness  of the device  or to any  other requirement

under  the Act.  21 U.S.C.    306k(a)(2).  All of plaintiff's

claims relate  to the  pacemaker's safety  and effectiveness.

See Stamps, 984 F.2d at  1422.  Consequently, to complete our
          

preemption analysis,  we must  determine whether  plaintiff's

negligence and implied warranty claims, if  successful, would

impose requirements on Medtronic's pacemaker "different from,

or in addition to" those in the Act.  21 U.S.C.   306k(a)(1).

          The common law, no less than agency regulations and

statutes,  can impose "requirements" on a manufacturer.  King
                                                             

v. Collagen  Corp., 983 F.2d  at 1135;  see also 21  C.F.R.  
                                                

808.1(b)  (MDA   preempts  any  state   requirement  "whether

established  by  statute,  ordinance,  regulation,  or  court

decision").   The  tort  and  implied  warranty  theories  of

products liability are regulatory in that the "`obligation to

pay compensation can  be . . .  a potent method  of governing

conduct and controlling  policy.'"  Cipollone, 112  S. Ct. at
                                             

2620  (quoting San Diego Bldg. Trades  Council v. Garmon, 359
                                                        

U.S. 236, 247 (1959)).  Products liability "regulation" under

the common law imposes requirements by case law precedent.   

                             -13-
                              13

          Comparing the requirements imposed  by the Act with

plaintiff's claims, we  hold that her negligence  and implied

warranty   claims   premised  on   inadequate   warnings  are

preempted.    FDA  regulates the  content  and  appearance of

prescription  medical  device   labels,  including  pacemaker

labels.    21  C.F.R.      801.1,  801.15,  801.109.    These

regulations, which were in effect when plaintiff's particular

pacemaker  was  implanted,  exempt   such  devices  from  the

requirement that there be directions to a layperson on how to

use the product safely, if the package describes, inter alia,
                                                            

"any relevant  hazards, contraindications, side  effects, and

precautions" for the prescribing physician.  Id.   801.109.
                                                

          Plaintiff's implied warranty  and negligent failure

to warn  claims are premised  on the  manufacturer's duty  to

disclose  to  a  physician any  latent,  foreseeable  dangers

associated with the use of a prescription  product.  Knowlton
                                                             

v.  Deseret Medical, Inc., 930 F.2d  116, 120 & n.2 (1st Cir.
                         

1991) (discussing Massachusetts law).  Although this standard

resembles the FDA requirement, the two may differ as applied.

See Jones, 430 U.S. at  526 (in determining preemption issue,
         

it is necessary  "to consider the relationship  between state

and federal  laws as  they are  interpreted and  applied, not

merely as they are written").  Applying Massachusetts  law, a

factfinder  could find a  label deficient that  complies with

FDA requirements.   MacDonald v.  Ortho Pharmaceutical Corp.,
                                                            

                             -14-
                              14

475 N.E.2d 65,  70-71 (Mass.) (holding that  "compliance with

FDA requirements, though  admissible to  demonstrate lack  of

negligence,   is  not  conclusive  on  this  issue,  just  as

violation of FDA requirements is evidence, but not conclusive

evidence, of negligence"), cert. denied, 474 U.S. 920 (1985).
                                       

Such a  finding would  establish a  standard for an  adequate

warning "in  addition to"  the requirements  applicable under

the Act.      

          Similarly,   plaintiff's   negligent  manufacturing

claim (including her  allegations of negligent manufacturing,

control,   maintenance,   inspection,   testing,   servicing,

distribution,  and sale  of the device)  is preempted  by FDA

regulations  on good manufacturing  practices.  21  C.F.R.   

820.1-820.198.   Medtronic's  duty under  the  common law  of

negligence  is to use reasonable care in inspecting, testing,

and  producing  pacemakers.   This  standard  and  FDA's good

manufacturing practices  impose analogous, but  not identical

duties.    FDA's  good  manufacturing  practices  regulations

require manufacturers to develop and implement "appropriate,"

"adequate,"   or   "sufficient"  quality   control,   quality

assurance,   personnel   training,   environmental  controls,

equipment maintenance,  testing, inspection, and  storage and

distribution  procedures, to assure that devices are safe and

effective.   See, e.g., id.     820.1, 820.5, 820.20, 820.25.
                           

The quality assurance requirement, for example, mandates that

                             -15-
                              15

manufacturers  devise and  implement  a  protocol to  ensure,

among other things,  that all components, labels,  packaging,

and  finished devices are  inspected, and either  approved or

rejected.    Id.     820.20(a).    A  factfinder  could  find
                

liability  on  plaintiff's  negligent  manufacturing  claims,

applying standards differing from or adding to FDA's.   

          Plaintiff's   implied   warranty  claim   is   also

preempted  by   FDA's  good   manufacturing  practices.     A

factfinder considering that claim could find Medtronic liable

if  a  manufacturing  defect rendered  plaintiff's  pacemaker

unreasonably dangerous.  See Mass.  Gen. L. ch. 106,   2-314;
                            

Colter v.  Barber-Greene Co.,  525 N.E.2d  1305, 1313  (Mass.
                            

1988) (noting that  Massachusetts law on implied  warranty is

"congruent,  in all  material respects,  with the  principles

expressed in Restatement (Second) of Torts   402A (1965), the

Restatement's definition of  a seller's strict liability  for

harm suffered by a user  or consumer of a seller's product").

This  means that under  Massachusetts law Medtronic  could be

found  liable even  if it  meticulously  followed FDA's  good

manufacturing practices.    For  these  reasons,  plaintiff's

breach of implied warranty claim is preempted.4

                    

4.  One way  to ensure that  a factfinder applies  a standard
not  adding  to  or  differing  from FDA  regulations  is  to
supplant the common law standard with FDA's requirements.  We
find  nothing  to  support  that  Congress  intended  such  a
radical, unwieldy form  of preemption, however,  particularly
where Congress  did not intend  to create a private  right of
action under the  Federal Food, Drug, and Cosmetic  Act.  See
                                                             

                             -16-
                              16

          Plaintiff argues that her  claims are not preempted

because  she  is  alleging  that  her  particular  device  is

defective.   This claim, according to plaintiff, is analogous

to  a claim that the device is contaminated.  She argues that

her claims are not preempted because King v.  Collagen Corp.,
                                                            

983 F.2d at 1134-35, excised claims arising from contaminated

devices from the body of claims preempted by the MDA.

          Plaintiff's argument is based on a misunderstanding

of our  remarks in King v. Collagen  Corp., 983 F.2d at 1134-
                                          

35.  We stated:

          The  language  of   [the  MDA  preemption
          clause] .  . . demonstrate[s] a  field of
          preemption which  is broad,  but limited.
          Any state  requirement which,  in effect,
          establishes a new substantive requirement
          for  the device in  a regulated area such
          as labeling,  is preempted.  21  C.F.R.  
          808.1(d)(6)(ii).  As  the Seventh Circuit
          noted,  however,  [the clause]  does  not
          preempt   such   claims    as   negligent
          implantation  or removal  of devices,  or
          claims   arising   out   of  contaminated
                                                   
          devices.
                 

Id.  (emphasis added)  (citing  Slater v.  Optical  Radiation
                                                             

Corp., 961 F.2d at 1334).
     

          The sentence regarding contaminated devices follows

our statement that "[a]ny state requirement which, in effect,

establishes a new substantive requirement for the device in a

regulated  area such as labeling, is preempted."  Plaintiff's

claims   in  this  case,   if  successful,   would  establish

                    

Rodriguez v. SK & F Co., 833 F.2d 8, 9 (1st Cir. 1987).  
                       

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requirements  in  areas  that FDA  already  regulates,  i.e.,
                                                            

labeling and manufacturing.  Accordingly,  this is not a case

where  plaintiff may  maintain  a  claim  arising out  of  an

individually defective device.   We need not  address in this

case  which,  if  any, "claims  arising  out  of contaminated

devices" might not be preempted.  

          We express no opinion on whether products liability

claims are preempted  only if the manufacturer  complied with

applicable FDA regulations.   See  Reiter v.  Zimmer, 830  F.
                                                    

Supp. 199, 204 (S.D.N.Y. 1993) (refusing to extend preemptive

reach  of MDA to  negligence claim against  manufacturer that

allegedly  violated FDA  requirements); see also  Slater, 961
                                                        

F.2d at  1334 (scope of  preemption under MDA "is  limited to

efforts by  states to  impose sanctions  for compliance  with

federal regulations").  The complaint contains no allegations

regarding Medtronic's noncompliance with FDA regulations, and

plaintiff has offered no evidence that Medtronic violated any

FDA requirement.   Our  holding is limited  to the  facts and

claims in this case.

          For  the  foregoing  reasons,  the  order  granting

summary judgment for defendant is 

          Affirmed.
                   

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