Court Opinion

ID: 2963615
Source: CourtListenerOpinion
Date Created: 2015-09-21 21:13:02.143645+00
Date Added: 2024-06-11T15:48:57.775139
License: Public Domain

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.
                      _________

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                                          18