Talbott v. C.R. Bard, Inc.

Opinion

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).


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                                          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


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                                          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


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                                          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


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                                          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


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                                          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


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                                          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


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                                          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
            ____


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                                          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


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                                          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.
            _______


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                                          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


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                                          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
                                                 ______ ________     ____


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                                          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.
                      _________


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