Court Opinion

ID: 2962418
Source: CourtListenerOpinion
Date Created: 2015-09-21 20:57:32.708972+00
Date Added: 2024-06-11T12:40:22.798269
License: Public Domain

USCA1 Opinion

	

                            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.                                          I.                                      BACKGROUND                                      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                                  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.                                         II.                                      PREEMPTION                                      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).              _________    __________                                         -17-                                          17            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.                      _________                                         -18-                                          18