
USCA1 Opinion

	




                            UNITED STATES COURT OF APPEALS                                FOR THE FIRST CIRCUIT                                 ____________________          No. 94-1951                             LINDA TALBOTT, ETC., ET AL.,                               Plaintiffs, Appellants,                                          v.                               C.R. BARD, INC., ET AL.,                                Defendants, Appellees.                                 ____________________                     APPEAL FROM THE UNITED STATES DISTRICT COURT                          FOR THE DISTRICT OF MASSACHUSETTS                       [Hon. Mark L. Wolf, U.S. District Judge]                                           ___________________                                 ____________________                                        Before                                 Stahl, Circuit Judge,                                        _____________                         Campbell, Senior Circuit Judge, and                                   ____________________                        John R. Gibson,* Senior Circuit Judge.                                         ____________________                                 ____________________               Jeffrey S. Beeler  with whom Jeffrey  A. Newman and  Newman,               _________________            __________________      _______          Heineman & Itzkowitz were on brief for appellants.          ____________________               Francis C. Lynch with whom Daryl J. Lapp  and Palmer & Dodge               ________________           _____________      ______________          were on brief for appellee C.R. Bard, Inc.               Robert D.  Keefe with whom  Hale and Dorr  was on brief  for               ________________            _____________          appellee David Prigmore.               William H. Kettlewell with whom Dwyer & Collora was on brief               _____________________           _______________          for appellee John Cvinar.               Michael S. Raab,  Attorney, Civil Division, with  whom Frank               _______________                                        _____          W.  Hunger, Assistant Attorney  General, Donald K.  Stern, United          __________                               ________________          States Attorney, Douglas N. Letter, Appellate Litigation Counsel,                           _________________          United  States Department of  Justice, and Margaret  Jane Porter,                                                     _____________________          Chief Counsel,  and Beverly  Rothstein, Attorney,  Food and  Drug                              __________________          Administration,  were  on  brief for  the  United  States, amicus          curiae.                                 ____________________                                   August 14, 1995                                        ____________________               *Of the Eighth Circuit, sitting by designation.                                 ____________________                                          2                      CAMPBELL, Senior Circuit Judge.  Section 360k(a) of                                ____________________            the Medical Device  Amendments ("MDA") to the  Food, Drug and            Cosmetic Act ("FDCA") provides:                      [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                           this chapter 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                           this chapter.            21  U.S.C.     360k(a)  (1988).    This  appeal  presents two            questions: (1) whether  the above provision applies  to state            tort   law  claims   asserted   against   a  medical   device            manufacturer; and (2) if so, whether there is an exception to            the  preemption clause where the manufacturer fails to comply            with the MDA.   We hold that the answers to the two questions            are,  respectively,  yes and  no.   We  therefore  affirm the            district  court's dismissal of this case for failure to state            a claim under Fed. R. Civ. P. 12(b)(6).                                          I.                      It   is  unnecessary  to  set  out  the  facts  and            procedural background at length as these are in  the district            court's comprehensive opinion.   Talbott v. C.R.  Bard, Inc.,                                             _______    ________________            865 F. Supp. 37, 39-52 (D. Mass. 1994) (sections I and II.A).                                         -3-                                          3            To orient  the reader  of this opinion,  we provide  only the            following  brief summary.    On  December  28,  1988,  Eunice            Beavers died  on the  operating table  during an  angioplasty            procedure  when  a  heart catheter  failed  to  deflate while            inserted in one  of her coronary arteries.   Her heirs, Linda            Talbott et al.,  sued the manufacturer of the heart catheter,            C.R. Bard, Inc. ("Bard"), and  two members of its  management            for  wrongful death,  alleging  numerous  state tort  claims:            negligence,  breach  of   express  and  implied   warranties,            punitive damages, negligent infliction of emotional distress,            fraudulent  misrepresentation   and  concealment,   negligent            hiring,  civil  conspiracy,  unfair  trade  practices.    The            district court dismissed the complaint  under Fed. R. Civ. P.            12(b)(6), finding  that all the  claims were  preempted by               360k(a) of the MDA.  Plaintiffs now appeal.                                         II.                      To  determine whether  federal  law preempts  state            law, we look to the intent of Congress:  congressional intent            to displace  state law  must be "clear  and manifest"  before            preemption is  found.  Rice  v. Santa Fe Elevator  Corp., 331                                   ____     ________________________            U.S. 218,  230 (1947).   Such intent may be  expressed either            explicitly,  in the  language of  a  statute, or  implicitly,            through  passage  of  a  statutory  scheme  that  extensively            occupies the  field or  where the  purpose and objectives  of            federal law would be frustrated by state law.  Here, Congress                                         -4-                                          4            has manifested its intention an explicit preemption clause,              360k(a).    Thus,  absent  any "general,  inherent  conflict"            between  state and  federal law, we  need only  ascertain the            preemption Congress intended.  Freightliner Corp. v.  Myrick,                                           __________________     ______            115 S. Ct. 1483, 1488 (1995); Cipollone v. Liggett Group, 112                                          _________    _____________            S. Ct. 2608, 2617-18 (1992).   We review the district court's            reading of  the  clause de  novo, taking  all of  plaintiffs'                                    __  ____            factual  averments as  true  and  indulging every  reasonable            inference   in   plaintiffs'  favor.     Garcia   Hotel  Ltd.                                                     ____________________            Partnership v. Ponce Federal Bank,  958 F.2d 15, 17 (1st Cir.            ___________    __________________            1992).            A.   State Tort Law Imposes Requirements                 ___________________________________                      Plaintiffs insist  that the district court erred in            concluding that  state tort  law imposes  a "requirement"  as            that  term it  used  in    360k(a).    Plaintiffs argue  that            Congress  meant  "requirement" to  include  only  the state's            positive  enactments    such  as statutes and  regulations               and not  common law causes  of action.  This  issue, however,            has been resolved  against plaintiffs in this circuit  in two            decisions:   King v. Collagen  Corp., 983 F.2d  1130, 1135-36                         ____    _______________            (1st Cir.), cert. denied, 114 S. Ct. 84 (1993), and Mendes v.                        ____________                            ______            Medtronic, Inc., 18  F.3d 13, 16 (1st  Cir. 1994).  In  both,            _______________            this court has ruled that Congress understood state  tort law            to impose a  "requirement" such as to subject  state tort law            to  the MDA's preemption  clause.   Where the  requirement is                                         -5-                                          5            "different from, or  in addition to" the  requirement imposed            by  the  MDA,  state tort  law  will  be preempted.    A like            construction has  been adopted by  every  other circuit court            that has  considered the  issue.1   Plaintiffs argue  that we            should  overrule  King  and Mendes  as  having  been wrongly-                              ____      ______            decided.    However,  except  in  certain  circumstances  not            present here, the prior decisions of panels of this court may            be overruled only  by the full court en banc.   United States                                                            _____________            v. Newman, 49 F.3d 1, 11 (1st Cir. 1995).  We accordingly, we               ______            hold that state tort law falls within   360k(a).            B.   No Exception For Non-Compliance                 _______________________________                      Plaintiffs next argue that, even assuming   360k(a)            applies to state tort law generally, the district court erred            in holding that it applies where a manufacturer has failed to            comply  with  the  provisions  of  the  MDA  by  fraudulently            obtaining  approval  from the  Food  and  Drug Administration            ("FDA").    Plaintiffs  argue that,  in  enacting    360k(a),            Congress intended to preempt  only state laws that  sought to            impose  liability on manufacturers who were already complying                                            ____________________            1.   See, e.g., Anguiano v. E.I. Du Pont De Nemours & Co., 44                 ___  ____  ________    _____________________________            F.3d  806,  809 (9th  Cir.  1995) (dicta);  Martello  v. CIBA                                                        ________     ____            Vision  Corp., 42  F.3d  1167, 1168  (8th  Cir. 1994),  cert.            _____________                                           _____            denied,  63 U.S.L.W. 3904  (1995); Gile v.  Optical Radiation            ______                             ____     _________________            Corp., 22 F.3d  540, 542 (3d Cir.), cert. denied,  115 S. Ct.            _____                               ____________            429 (1994);  Duncan v.  Iolab Corp., 12  F.3d 194,  195 (11th                         ______     ___________            Cir. 1994) (per  curiam); Stamps v. Collagen Corp.,  984 F.2d                                      ______    ______________            1416, 1420-21 (5th Cir.), cert. denied, 114 S. Ct. 86 (1993);                                      ____________            Slater v. Optical  Radiation Corp., 961 F.2d  1330, 1333 (7th            ______    ________________________            Cir.), cert. denied, 113 S. Ct. 327 (1992).                   ____________                                         -6-                                          6            with the MDA.  Congress did not, plaintiffs assert, intend to            afford  such protection to manufacturers who failed to comply            with  the  provisions  of  the  MDA.   Such  a  result  would            conflict, in plaintiffs'  view, with the MDA's  basic purpose            of  protecting individuals  from  unreasonably dangerous  and            defective medical devices.   Where a manufacturer  has failed            to  comply with the  MDA, state  tort liability  would merely            impose additional state sanctions  for noncompliance with the            MDA.    Here,  plaintiffs argue,  Bard  clearly  violated the            provisions of the  MDA by submitting false data to the FDA in            order to obtain approval of its heart catheters.                      As  the district  court explained, Talbott,  865 F.                                                         _______            Supp. at 41-42, Bard pled  guilty in an earlier proceeding to            a  criminal indictment charging it with conspiring to defraud            the  FDA  in  connection  with  applications  for  pre-market            approval of its heart catheters.  Bard  was eventually forced            to pay civil and criminal fines totaling $61 million.  United                                                                   ______            States v.  C.R. Bard, Inc., 848  F. Supp. 287,  289 (D. Mass.            ______     _______________            1994).   There  is some  dispute  between the  parties as  to            whether Bard's guilty plea  admitted wrongdoing with  respect            to  the  particular  heart catheter  used  in  Mrs. Beavers's            angioplasty.   As this  is a motion  to dismiss,  however, we            accept plaintiffs' version of the facts.  Watterson  v. Page,                                                      _________     ____            987 F.2d 1, 3 (1st Cir. 1993).  Thus, for present purposes we            shall assume that Bard fraudulently obtained approval for the                                         -7-                                          7            heart  catheter by submitting  false information to  the FDA.            The  question is  whether     360k(a)  applies  despite  such            fraudulent activity.                      The  latter issue may already have been resolved in            this  circuit against  plaintiffs.   In  King, the  plaintiff                                                     ____            contended that the manufacturer had fraudulently obtained FDA            approval and that  the MDA's preemption clause  therefore did            not apply.   Judge(now Chief Judge) Torruella, in the opinion            for the court,  did not  reach the  question, construing  the            fraud  claim as essentially a failure to warn claim preempted            by the MDA.  In what was titled a "concurrence," however, the            two other  judges on  the  panel expressed  the opinion  that            there was  no exception  to the  MDA's preemption  clause for            cases in  which the manufacturer  failed to  comply with  the            MDA.    As two  judges of  the  panel took  this view,  it is            arguably now stare decisis.                        If   so,  however,  a   separate  panel  in  Mendes                                                                   ______            overlooked the  fact.  The  plaintiff in Mendes did  not make                                                     ______            the   exception-for-noncompliance   argument  made   by   the            plaintiff in King, arguing  merely that the MDA did not apply                         ____            to state tort law.   However, at the end of  the opinion, the            panel wrote:                      We express no opinion on whether products                      liability  claims are  preempted only  if                      the manufacturer complied with applicable                      FDA regulations.   The complaint contains                      no   allegations  regarding   Medtronic's                      noncompliance with  FDA regulations,  and                                         -8-                                          8                      plaintiff  has offered  no evidence  that                      Medtronic violated  any FDA  requirement.                      Our holding is  limited to the facts  and                      claims in this case.            Mendes, 18 F.3d  at 19-20 (citations omitted).   The dicta in            ______            Mendes can be  read (and plaintiffs argue should  be read) to            ______            indicate  that  the issue  is  still  open  in this  circuit.            Alternatively, it  might mean only  that the panel  in Mendes                                                                   ______            did not pay close attention to the concurrence in King, since                                                              ____            that  issue  was  not  before  it.    Given  the  uncertainty            regarding the precedential status of the King concurrence, we                                                     ____            shall address the arguments anew, as the district court did.                      We hold that Congress did not intend to provide for            an  exception  to   the  MDA's  preemption  clause   where  a            manufacturer fails to comply  with the provisions of  the MDA            by fraudulently  obtaining approval  of its  device from  the            FDA.  In  so holding, we reach the same result reached by the            King concurrence and by the two circuit courts of appeal that            ____            have expressly  addressed this  exact issue.   See  Reeves v.                                                           ___  ______            Acromed Corp.,  44  F.3d  300,  307 (5th  Cir.)  (finding  no            _____________            exception  to  preemption where  a  manufacturer fraudulently            obtained FDA approval), cert. denied, 115 S. Ct. 2251 (1995);                                    ____________            Michael v. Shiley, 46 F.3d  1316, 1329 (3d Cir. 1995) (same),            _______    ______            petition  for  cert. filed,  63 U.S.L.W.  3874 (U.S.  June 2,            __________________________            1995).                      Section 360k(a) preempts broadly any state tort law            "requirement" that is "different from, or in addition to" the                                         -9-                                          9            comprehensive and detailed requirements  set forth by federal            law.  The terms of the statute make no distinction based upon            whether or not  a manufacturer has in fact  complied with the            federal  standard.     We  find  nothing  to   indicate  that            preemption is  conditional upon satisfactory  compliance with            the  federal  standard.   Section  360k(a)  does  not mention            compliance at all.  As    360k(a) reads, the relevant inquiry            is  simply  whether,  in the  abstract,  the  state  tort law            requirement  is "different  from,  or  in  addition  to"  the            federal  requirement.  If a device manufacturer fails to meet            the  federal  requirements,  it will  be  subject  to federal            penalties as  set forth  in the MDA.   Nothing  in    360k(a)            suggests that the  state requirements are somehow  revived by            this failure to comply with the federal standard.                      Plaintiffs argue  that state tort claims  would not            impose  a  "requirement"  that  is  "different  from,  or  in            addition to"  federal requirements so long as the state judge            instructs the  jury that a  manufacturer's obligations  under            state tort  law were  defined by the  provisions of  the MDA.            Given such  an instruction,  plaintiffs say,  state tort  law            would  not be imposing any additional requirements, but would            only compensate  the victim ex  post for failure to  meet the            MDA  standards.    This  theory  of  cooperative  preemption,            however, was expressly rejected, albeit in dictum, in Mendes:                                                                  ______                      One   way  to   ensure  that   a  [state]                      factfinder applies a  standard not adding                                         -10-                                          10                      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.            Mendes, 18 F.3d at  19 n.4.  It  has also been rejected  by a            ______            number  of other  circuit  courts  of appeal.    See Lohr  v.                                                             ___ ____            Medtronic Inc.,  56 F.3d 1335, 1343 (11th Cir. 1995) (holding            ______________            that "preemption under the MDA cannot be defeated by a common            lawsuit  alleging a violation  of the  statutory standards");            Michael,  46  F.3d at  1329  (holding  that "states  have  no            _______            authority  to  police  .  .  .  compliance  with  the   FDA's            procedures").2                      Allowing  an  exception   for  noncompliance  would            disturb  the balance  Congress struck  between the  competing            goals of  protecting individuals from  unreasonably dangerous            medical devices  and  spurring innovation  by  ensuring  that            device  manufacturers  are  subject  to  uniform,  nationwide            standards.   See Mendes, 18 F.3d at 16;  S. Rep. No. 33, 94th                         ___ ______            Cong., 2d Sess. 5, 12  (1975), reprinted in 1976 U.S.C.C.A.N.                                           ____________                                            ____________________            2.   But cf.  National  Bank of  Commerce  v.  Kimberly-Clark                 _______  ___________________________      ______________            Corp., 38 F.3d 988, 992 (8th Cir. 1994) (holding that "when a            _____            statute only  preempts state requirements  that are different            from  or  in  addition  to  those  imposed  by  federal  law,            plaintiffs  may still  recover  under  state  tort  law  when            defendants fail to  comply with  the federal  requirements");            Slater, 961 F.2d  at 1334 (stating  in dicta that  preemption            ______            under    360k(a) "is limited  to efforts by states  to impose            sanctions for compliance with federal regulations").                                         -11-                                          11            1070, 1074,  1081).   To see  how this  is so,  we need  only            imagine how such an exception  would operate in practice.  If            state tort claims  were allowed to go forward,  a state court            would initially  have to determine  whether the  manufacturer            had  complied  with the  MDA.    If,  as  in this  case,  the            plaintiff  claimed that  the manufacturer  had  defrauded the            FDA, the state court would  need to determine whether the FDA            had in  fact been  defrauded and whether  the FDA  would have            approved the device  absent the fraud.  Under  this scheme, a            device manufacturer could potentially be subject  to numerous            inconsistent interpretations  and  applications  of  the  MDA            across different states,  thus undermining the MDA's  goal of            uniformity.    Moreover,  if  state  courts  erred  in  their            application  of the MDA,  they would effectively  be imposing            requirements  "different  from,  or  in  addition  to"  those            imposed  by federal  law.   See  King, 983  F.2d at  1139-40;                                        ___  ____            Talbott, 865 F. Supp. at 47.            _______                      To avoid the  possibility of disuniform  treatment,            Congress  placed enforcement authority  in the FDA.   The FDA            has the  broad power: to withdraw approval  of a device if it            determines  that  the  device  is  unsafe  or  its  labelling            inadequate, 21  U.S.C.    360e(e); to order  a recall  of the            device,     360h(e); and  to  initiate  criminal prosecutions            against  manufacturers, as it did  in this case against Bard.            Bard, 848 F. Supp. at  287.  Centrally situated and with  the            ____                                         -12-                                          12            requisite expertise,  the  FDA is  in  the best  position  to            determine whether the provisions of the MDA have in fact been            violated and to ensure that  the law is applied in a  uniform            manner.   See Michael,  46 F.3d  at  1329.   Given the  FDA's                      ___ _______            central enforcement role,  the preemptive scope of    360k(a)            becomes clear, as the districtcourt in this case aptly noted:                      As  applied  in  this case,  the  express                      preemption  provided   by  21   U.S.C.                         360k(a) manifests a  decision by Congress                      to replace completely  the private rights                      of action  usually available  under state                      law with  civil and  criminal enforcement                      by the federal government when thoroughly                      regulated  devices such  as Bard's  heart                      catheter,  are  at issue.  This  judgment                      represents  a  permissible   decision  by                      Congress  that the  public interest  will                      best be served by relying exclusively  on                      the  FDA  to  strike the  proper  balance                      between  reasonably  assuring  safety and                      promoting innovation  with regard  to new                      devices that  have the potential  both to                      enhance and injure human health.            Talbott, 865 F. Supp. at 40; see also Reeves, 44 F.3d at 307.            _______                      ___ ____ ______                      The  United States, as  amicus curiae,  argues that            such  reasoning, while  perhaps applicable  in  King, is  not                                                            ____            applicable   in  this  case,  because  the  FDA  has  already            determined that Bard  failed to comply with  the requirements            of the MDA by submitting fraudulent  data to the FDA.   Thus,            the concerns about  disuniformity are not implicated  in this            case.   Under the United  States' scheme,  then, a  plaintiff            would simply need  to prove, not that the manufacturer failed                                         -13-                                          13            to comply with the MDA, but that the FDA had determined  that            the manufacturer failed to comply.                      Although this  may  be a  workable arrangement,  it            still  does  not get  around  the  problem that  neither  the            language of    360k(a) nor  the legislative history  give any            hint   of  congressional  intent  to  create  such  a  unique            exception to  the MDA's preemption clause.  It may or may not            be  that  allowing  injured plaintiffs  to  recover  in state            actions  when  the  FDA has  determined  that  a manufacturer            violated the  MDA would  be a desirable  rule, from  a policy            standpoint.   Congress, however has  not provided for  such a            remedy,  choosing instead to place sole enforcement authority            in the hands of the FDA.  See, e.g., Mendes, 18 F.3d at 19 n.                                      ___  ____  ______            4  (no  federal  private  right  of  action  under the  MDA);            Rodriguez v. SK &  F Co., 833 F.2d 8, 9  (1st Cir. 1987) (per            _________    ___________            curiam) (same).  As the district court aptly noted:                      Congress  could  reasonably  decide  that                      when the  FDA has already  established it                      was defrauded,  private rights  of action                      to recover  damages on behalf  of injured                      individuals are  appropriate.   Where, as                      here, it  is well-established  that there                      is generally  no private right  of action                      to enforce  the MDA, if  Congress intends                      to create  an exception  for fraud  which                      has already been demonstrated by the FDA,                      it should say so clearly.  In view of the                      unqualified language of the MDA's present                      preemption provision, however, this court                      does   not  have   a  proper   basis  for                      inferring  that  such  an  exception  was                      intended.                Talbott, 865 F. Supp. at 47.            _______                                         -14-                                          14                      The absence of a  non-compliance exception does not            mean that individuals injured by noncompliance will always be            without  compensation.    In a  criminal  judgment  against a            manufacturer, a  court may,  as part  of any  sentence, award            restitution to  those harmed.   See 18  U.S.C.    3663(a)(1);                                            ___            Bard,  848 F.  Supp. at  292-93.   While  the district  court            ____            accepted a binding plea agreement from Bard that contained no            restitution  provision,  it  did  so,  in  part,  because  it            erroneously  believed  that civil  proceedings  could provide            appropriate  compensation.  Talbott,  865 F. Supp.  at 47-48;                                        _______            Bard,  848  F. Supp.  at  293.    Courts in  future  criminal            ____            proceedings will, or should, be aware that restitution may be            the only redress  for those harmed by  manufacturers who have            failed to comply with the provisions of the MDA.                      Like  the court below, we cannot find any exception            to   360k(a)  where a manufacturer of a Class  III device has            failed to comply with the requirements of the MDA.            C.   Application of Preemption Clause                 ________________________________                      Having  held  that   the  MDA's  preemption  clause            applies to  state tort law,  whether or not  the manufacturer            has complied  with the  provisions of the  MDA, we  must next            determine  whether the  requirements  imposed by  plaintiffs'            numerous state law claims are "different from, or in addition            to" the ones imposed  by the MDA.  In its  opinion below, the            district  court  did  a  thorough job  of  analyzing  each of                                         -15-                                          15            plaintiffs'  claims,  finding  that   each  of  them  imposed            additional requirements and  was therefore preempted.   As we            agree with  the district  court's analysis and  as we  see no            reason  to repeat  it here,  we adopt  those portions  of the            district court's  opinion.  Talbott,  865 F.  Supp. at  49-52                                        _______            (section II.C);  see In re  San Juan Dupont Plaza  Hotel Fire                             ___ ________________________________________            Litig., 989 F.2d 36, 38 (1st Cir. 1993) (where district judge            ______            produces  a well-reasoned  opinion that  reaches the  correct            result, a reviewing court  should not write at  length merely            to  put matters  in its  own  words).   We hold  that  all of            plaintiffs' claims are preempted by   360k(a).                      We   note,  briefly,  that  the  Third  Circuit  in            Michael, 46 F.3d at 1328, 1331, though agreeing in large part            _______            with our analysis, has held that claims for breach of express            warranty  and fraudulent advertising  are not preempted  by              360k(a).   The latter claim is  not present in this  case, as            plaintiffs' fraudulent  misrepresentation claim  is based  on            statements made to  the FDA, a claim which  the Michael court                                                            _______            agreed  is  preempted.   Id.  at  1329.   The  former  claim,                                     ___            however, is  present in  this case,  and the  Third Circuit's            position  appears  to  be inconsistent  with  this  circuit's            position as  set forth in King, 983 F.2d  at 1135.  We affirm                                      ____            the  district   court's  finding  that   plaintiffs'  express            warranty  claim  is  preempted,  as  that  result  accurately            reflects the  law in this  circuit.  Accord Martello  v. CIBA                                                 ______ ________     ____                                         -16-                                          16            Vision Corp.,  42 F.3d at 1167, 1169 (8th  Cir. 1994).  As we            ____________            noted previously, prior decisions by panels of this court may            be overruled only  by the full court sitting  en banc, absent            exceptional  circumstances not present here.  Newman, 49 F.3d                                                          ______            at 11.3            D.   Remaining Claims                 ________________                      Plaintiffs  advance  a   number  of  constitutional            arguments  challenging Congress' power to enact   360k(a) and            to displace state tort law.  We have reviewed these arguments            and find them it be without merit.                                         III.                      Because  all of plaintiffs' claims are preempted by               360k(a)  of  the  MDA,  we  affirm  the  district  court's            dismissal of this suit.  We end with  this quotation from the            district court's opinion:                      This is  a particularly poignant  case in                      which  the heirs  of  a  woman  who  died                      during angioplasty are being found not to                      have the  right to seek  compensation for                                            ____________________            3.   After oral argument, plaintiffs brought to our attention            Lohr, 56  F.3d at  1335, in which  an Eleventh  Circuit panel            ____            held  that  a  plaintiff's  negligent  design  and  negligent            failure to warn claims were not preempted  by   360k(a).  The            court in Lohr, however, explicitly  based its holding on  the                     ____            fact that  the device  in question had  not gone  through the            pre-market approval process, but instead was marketed under              510(k) as  "substantially equivalent" to  an existing device.            Lohr is thus distinguishable from cases, like this one, where            ____            the  device was  subject to  the  premarket approval  ("PMA")            process,  as  the Lohr  court  itself  noted.   Id.  at  1347                              ____                          ___            ("Appellee's heavy reliance on . . .  King . . . is misplaced                                                  ____            because the device at issue  in [that case] had undergone the            full PMA process before it entered the market.").                                         -17-                                          17                      the   damages   they   have   undoubtedly                      suffered.  The  government has vigorously                      enforced  the  applicable   criminal  and                      civil laws.   Nevertheless  this decision                      may  cause  some,   including  those  who                      enacted  the  law,  to  question  whether                      complete preemption of  private rights of                      action  is  the most  fair  and effective                      means   of   balancing   the  legitimate,                      competing    interests    of    promoting                      innovation  and  reasonably  assuring the                      safety of complex medical devices.  It is                      axiomatic, however, that  the courts must                      faithfully give effect  to the intentions                      of   Congress  when   they  are   clearly                      expressed by  statute, as they  have been                      in  this  case.   Defendants'  motion  to                      dismiss, therefore, must be granted.            Talbott, 865 F. Supp. at 40.            _______                      Affirmed.                      _________                                         -18-                                          18
