Court Opinion

ID: 2961670
Source: CourtListenerOpinion
Date Created: 2015-09-21 20:46:09.06306+00
Date Added: 2024-06-11T11:35:47.299028
License: Public Domain

USCA1 Opinion

	

          January 15, 1993  UNITED STATES COURT OF APPEALS                                FOR THE FIRST CIRCUIT                                 ____________________          No. 92-1278                                      JANE KING,                                Plaintiff, Appellant,                                          v.                                COLLAGEN CORPORATION,                                 Defendant, Appellee.                                 ____________________                     APPEAL FROM THE UNITED STATES DISTRICT COURT                          FOR THE DISTRICT OF MASSACHUSETTS                      [Hon. A. David Mazzone, U.S. District Judge]                                             ___________________                                 ____________________                                        Before                              Torruella, Circuit Judge,                                         _____________                     Aldrich and Campbell, Senior Circuit Judges.                                           _____________________                                _____________________               Clinard J. Hanby, with whom Susan A. Allinger, John O'Quinn,               ________________            _________________  ____________          O'Quinn,  Kerensky &  McAninch,  Michael M.  Essmyer, Michael  M.          ______________________________   ___________________  ___________          Essmyer & Associates, Frank Lynch and LeComte, Emanuelson, Tick &          ____________________  ___________     ___________________________          Doyle, were on brief for appellant.          _____               Bob  Gibbins and  Jeffrey R.  White, were  on brief  for the               ____________      _________________          Association of Trial Lawyers of America, amicus curiae.               Joseph J.  Leghorn, with  whom Peter  T. Wechsler, Warner  &               __________________             __________________  _________          Stackpole, Joe W. Redden, Jr., W. Curtis Webb, and Beck, Redden &          _________  __________________  ______________      ______________          Secrest, were on brief for appellee.          _______               Bruce N. Kuhlik,  Lars Noah, Covington  & Burling, Edwin  H.               _______________   _________  ____________________  _________          Allen,  and Retta M. Riordan,  were on brief  for Health Industry          _____       ________________          Manufacturers Association, amicus curiae.                                 ____________________                                 ____________________                    TORRUELLA,  Circuit Judge.   Jane  King appeals  from a                                _____________          grant  of   summary  judgment   entered  in  favor   of  Collagen          Corporation ("Collagen") by the  United States District Court for          the  District of  Massachusetts.   The district  court determined          that  plaintiff's claims  were  preempted by  the Medical  Device          Amendments of 1976 ("MDA"), 21 U.S.C.   360c et seq.  Because the                                                       _______          district court  correctly construed  the preemption provision  of          the MDA, we affirm.                                        FACTS                                        FACTS                                        _____                    Defendant Collagen manufactures and distributes Zyderm,          a cosmetic medical device used to correct wrinkles and other skin          deformities.   Zyderm treatment consists  of injecting  processed          cow tissue directly  under the  skin.  Zyderm  then supports  the          skin from underneath, smoothing out deformities on the surface of          the skin.  The course of  treatment may run for several weeks and          requires  up  to  six  applications.    Researchers  at  Stanford          University  developed Zyderm  in  the early  1970's and  Collagen          placed it on the market in the early 1980's.                    As a  medical device, Zyderm falls within  the scope of          the MDA and thus must  be approved and regulated by the  Food and          Drug Administration ("FDA").  As a Class III medical device under          the MDA scheme, it is subject to the most extensive pre-marketing          approval  requirements  imposed  by  the  MDA  and  to  similarly          extensive  regulation  post-approval.    The  premarket  approval          process is designed to provide  a "reasonable assurance of . .  .          safety  and  effectiveness" for  medical  devices  which are  too          dangerous  or unknown  to permit  less regulation.   21  U.S.C.            360c(1)(C).  Post-approval regulation is designed to keep the FDA          apprised  of ongoing  safety  findings or  any other  information          about the  device  as it  becomes available.   Id.     360e(e)  &amp;                                                         ___          360i(a).                    Pursuant to the pre-marketing approval process, the FDA          requires applicants to submit proposed labeling, extensive safety          testing  data  and  descriptions  of  manufacturing  methods  and          materials.  Id.   360e(c)(1).   Upon reviewing the materials in a                      ___          comprehensive  manner, the FDA may approve the device for sale or          return the  application to the applicant  for further information          or  testing.    Id.     360e(d)(1).   When  the  FDA  returns  an                          ___          application to the applicant, the FDA must apprise  the applicant          of how to correct all deficiencies.  Id.   360e(d)(2).   Once the                                               ___          device  is  approved,  the  FDA  retains  the power  to  withdraw          approval  of  the product  permanently  or  suspend its  approval          temporarily if it determines that the device has become unsafe or          its labeling inadequate.  Id.   360e(e)(1)(3).  To assist the FDA                                    ___          in  making  these  determinations,  manufacturers  must  maintain          records and make reports  to the FDA on information  pertinent to          the device.   Id.   360i(a).  Zyderm passed through the Class III                        ___          approval process  prior to marketing, and  underwent revisions to          the original approval afterwards.                    Appellant Jane  King sought  Zyderm treatment  in 1987.          Following the normal procedure, Ms. King's physician administered          a  test dose of Zyderm before proceeding with the full treatment.          Shortly  after receiving this test dose, Ms. King suffered muscle                                         -3-          and  joint  pains,  as  well  as  other  symptoms.    Her  doctor          subsequently diagnosed her as having dermatomyositis/polymyositis          ("DM/PM"),  an  autoimmune disease  in  which  the immune  system          attacks skin and muscle tissue as if it were a foreign substance.                    When  Ms. King  received Zyderm,  Zyderm's FDA-approved          labeling contraindicated  use by those with a personal history of          autoimmune  disease.    Since that  time,  however,  the FDA  has          gradually allowed Collagen  to change the labeling as  it related          to  autoimmune   disease.    By   1991,  Zyderm  was   no  longer          contraindicated for persons with a history of autoimmune disease.          The FDA required a warning in 1991, however, that some recipients          have  suffered from  unwanted autoimmune  reactions, but  that no          causal  connection between  Zyderm and  these reactions  has been          shown.                    Ms. King  subsequently filed a first  amended complaint          detailing  seven claims  against Collagen.1   First,  she claimed          that Collagen was strictly liable for her injuries because Zyderm                                        ____________________          1  Ms. King filed suit against Collagen in 1990 alleging that the          test dose  of Zyderm caused her  to develop DM/PM.   Count one of          her suit alleged  that Collagen negligently  tested, manufactured          and  sold  Zyderm.   Count  two  alleged  that Collagen  breached          implied warranties of merchantability.  Count three alleged fraud          and deceit in the sale of Zyderm.               Ms. King  subsequently filed the amended  complaint.  Appellee          contends that Ms. King informed appellee that  she would withdraw          this amended  complaint.   As  such, appellee  never opposed  its          entry.   The district court entered the amended complaint, noting          that  no opposition  was  filed.   The  district court,  however,          proceeded  to grant summary judgment  on the basis  of Ms. King's          original  complaint.    Because the  amended  complaint  contains          essentially similar  claims as  the original complaint,  with few          additions, we will address the claims in the amended complaint.                                          -4-          was unsafe for its intended purpose and unreasonably dangerous to          users.   Second, she alleged that Zyderm was not safe and fit for          the  purpose intended  and therefore  was sold  in breach  of the          warranty  of  merchantability.    Third, Ms.  King  alleged  that          negligence  in the  design,  manufacture, marketing  and sale  of          Zyderm,   including  negligence   in   not  revealing   dangerous          propensities  of the  product, led  to her  injury.   Fourth, she          maintained that  Collagen  misbranded and/or  mislabeled  Zyderm.          Fifth,  she asserted  that  Collagen  made misrepresentations  of          material  fact to Ms. King in selling  Zyderm to her.  Sixth, she          alleged  that  Collagen  failed  to warn  her  of  any  defective          condition.  Finally, Ms.  King alleged that Collagen fraudulently          obtained FDA approval.                    Collagen  moved  for  summary  judgment  shortly  after          Ms. King filed her amended complaint, arguing that FDA regulation          of Zyderm  under the MDA  preempted all  of the causes  of action          alleged  in  the complaint.    The  district  court granted  this          motion, relying on a  similar case from the Southern  District of          Texas.   This case, Stamps v. Collagen Corp., No. H-90-2242, 1991                              ______    ______________          U.S. Dist.  LEXIS 20666 (S.D.  Tex. 1991), held  that plaintiff's          various products liability claims arising out of Zyderm treatment          were preempted by FDA regulation under the MDA.                                    LEGAL ANALYSIS                                    LEGAL ANALYSIS                                    ______________                                          I.                                          I.                    Article  VI of the  Constitution dictates  that federal          law "shall  be the supreme  Law of  the Land; and  the judges  in                                         -5-          every State shall be bound thereby, any Thing in the Constitution          or Laws of any  State notwithstanding."  U.S. Const. art. VI, cl.          2.  State laws  that conflict with federal laws  and regulations,          therefore, are preempted.  E.g., Malone v. White Motor Corp., 435                                     ____  ______    _________________          U.S.  497 (1978).  In determining whether such a conflict exists,          it is well settled that the intent of Congress governs.  That is,          preemption does not occur  unless Congress so intended.   Rice v.                                                                    ____          Santa Fe Elevator Corp., 435 U.S. 497, 504 (1978).          _______________________                    Congress may  express its  intent to preempt  state law          explicitly in the language of the statute.  Jones v. Rath Packing                                                      _____    ____________          Co., 430 U.S. 519,  525 (1977).  Congress may express  its intent          ___          implicitly  by   passing  an  extensive   statutory  scheme  that          extensively  covers the  field of  regulation.   Fidelity Federal                                                           ________________          Sav. &  Loan Ass'n v.  de la  Cuesta, 458 U.S.  141, 153  (1982).          __________________     _____________          Implied preemption  also occurs when a conflict between state and          federal law makes compliance with both  impossible, or when state          law would  frustrate the  purpose and objectives  of the  federal          law.  Id. (citing Florida  Lime & Avocado Growers, Inc.  v. Paul,                ___         _____________________________________     ____          373 U.S. 132, 142-43 (1963); Hines v. Davidowitz, 312 U.S. 52, 67                                       _____    __________          (1941)).                    We are aided in our determination of preemption in this          case  by the Supreme Court's  recent treatment of  the subject in          Cipollone  v. Liggett Group,  Inc., 112 S.  Ct. 2608 (1992).   In          _________     ____________________          Cipollone,  a  victim  of  lung  cancer  sued  several  cigarette          _________          manufacturers for  breach  of warranties  contained in  cigarette          advertisements,  for failure to warn of health hazards related to                                         -6-          smoking, for  fraudulently misrepresenting  those hazards  to the          public, and  for conspiracy  to deprive  the public  of important          health information.   Id. at  2613.  The  cigarette manufacturers                                ___          contended that petitioner's claims  were preempted by the federal          law  requiring  a  health  warning  to  appear on  all  cigarette          advertisements and containers.2  Id. at 2614.                                           ___                    In analyzing  preemption, the Court relied  only on the          specific  language of  the provision  regarding preemption.   The          Court reasoned that "Congress'  enactment of a provision defining          the  preemptive reach  of a statute  implies that  matters beyond          that reach  are not preempted."   Id. at 2618.   The opinion thus                                            ___          analyzed  each of  petitioner's  claims in  light of  the express          language  of the  preemption provision  in the  cigarette warning          statute.                    The plurality held that the provision preempted failure          to warn claims as to advertising practices, but not as to testing          or research practices.   Id. at 2621-22.  The  plurality reasoned                                   ___          that  the  Act only  preempted state  law  claims arising  out of          cigarette advertising and promotion, and that appellant's  claims          arising out of testing and research did not relate to advertising          and promotion.  The  provision preempted petitioner's  fraudulent          misrepresentation  claim  that cigarette  advertising neutralized                                        ____________________          2  That law stated that "[n]o requirement or prohibition based on          smoking or health shall  be imposed under State law  with respect          to the advertising or promotion of any cigarettes the packages of          which are labeled in conformity with the provisions of this Act."          Federal Cigarette Labeling and  Advertising Act of 1965,    5, as          amended by Public Health  Cigarette Smoking Act of 1969,    2, 15          U.S.C.   1334.                                         -7-          the effect of the warning in a similar fashion.   Id. at 2623-24.                                                            ___          The provision, however, did not  preempt fraud claims arising out          of  communication  other than  advertising,  such  as information          required to be disclosed  to an administrative agency, or  out of          fraudulent statements  made in  the advertising but  unrelated to          the health warning.  Id.                               ___                    The plurality  further held that the  provision did not          preempt express  warranty claims, because those  claims arose due          to  the conduct  of  the manufacturers  who  made the  warranties          rather than from state law.  Id. at 2622.  Finally, the plurality                                       ___          held that the provision did not preempt the conspiracy to deprive          the public of material  facts claims, because they did  not arise          out of state  law pertaining  to smoking and  health, but  rather          arose out of a  "duty not to conspire  to commit fraud."  Id.  at                                                                    ___          2624.                    The analysis  of the plurality in  Cipollone guides our                                                       _________          analysis  in this  case.   We  begin by  noting that  the express          preemption provision  in the  MDA, 21  U.S.C.    360k, forecloses          inquiry into  implied preemption, because the  fact that Congress          included it in the MDA implies that matters beyond its  reach are          not preempted.   Further, we  note that  the Cipollone  plurality                                                       _________          carefully construed the preemption provision to extend no further          than its language warranted.   In doing so, the  plurality sought          to pay proper respect  to federal-state relations.  This  concern          arises  out of "the assumption that the historic police powers of          the states [are] not to be superseded by . . . Federal Act unless                                         -8-          that  [is]   the  clear   and  manifest  purpose   of  Congress."          Cipollone, 112 S. Ct. at 2617 (citing Rice, 331 U.S. at 230).  We          _________                             ____          too  will carefully construe the preemption  provision of the MDA          to give due regard to questions of federal-state relations.                                         II.                                         II.                    Bearing  these  principles  in  mind, we  turn  to  the          language of the statute in question.  The MDA states that                       (a) Except as provided in  subsection (b)                      of  this section,  no 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.  Under subsection  (b) of   360k, a  state may          petition  the  FDA  in   certain  circumstances  to  allow  state          requirements to  continue  in force.   Because  no such  petition          affects this  case, we  are concerned  only  with the  preemptive          effect  of  subsection  (a).    Under  subsection  (a),  we  must          determine whether appellant's products liability claims give rise          to  state law requirements in addition to or different from those          mandated by the FDA.                    We  turn  first  to  the  FDA's  own  understanding  of          subsection (a) for guidance.  See Chevron U.S.A., Inc. v. Natural                                        ___ ____________________    _______          Resources Defense  Council, Inc.,  467 U.S. 837  (1984) (agency's          ________________________________                                         -9-          interpretation of its own  statute is controlling so long  as not          contrary  to Congress'  intent).   FDA  regulations provide  that          preemption  does not apply when the FDA has issued no regulations          or  other requirements  specific to  the particular  device.   21          C.F.R.   808.1(d).   In this case,  it is clear that  the FDA has          imposed requirements  on  Zyderm  related  to  labeling,  design,          manufacturing and other aspects of the device pursuant to the MDA          scheme.                    If  the  FDA  has  issued requirements  for  a  device,          subsection (a) prohibits  states from  imposing any  requirements          which differ from or add to the FDA requirements, or which relate          to the  safety or effectiveness  of the device.   A "State .  . .          requirement" in  subsection (a) may emanate  from any requirement          established  by a  state including  statutes,  regulations, court          decisions  or ordinances.   21  C.F.R.    808.1(b); see  also San                                                              _________ ___          Diego Building Trades Council v. Garmon, 359 U.S. 236, 247 (1959)          _____________________________    ______          ("[State]  regulation can  be as  effectively exerted  through an          award of  damages as through some form of preventive relief.  The          obligation  to pay compensation can be, indeed is designed to be,          a potent method of governing conduct and controlling policy.").                    The language  of subsection  (a) and the  definition of          state  requirement promulgated  under it  demonstrate a  field of          preemption  which is broad,  but limited.   Any state requirement          which, in  effect, establishes a new  substantive requirement for          the  device in a regulated  area such as  labeling, is preempted.          21  C.F.R.    808.1(d)(6)(ii).   As  the  Seventh Circuit  noted,                                         -10-          however, subsection (a) of  the MDA does not preempt  such claims          as  negligent  implantation  or  removal of  devices,  or  claims          arising out of contaminated devices.  Slater v. Optical Radiation                                                ______    _________________          Corp.,  961 F.2d 1330, 1334  (7th Cir. 1992),  cert. denied, 1992          _____                                          ____________          U.S. LEXIS 6436 (Oct. 13, 1992).                    Armed with  this understanding  of  subsection (a),  we          will analyze  petitioner's claims  individually to determine  the          effect of the MDA preemption provision on each.                    A.  Strict Liability                        ________________                    Appellant  contends  that  Zyderm  is  unsafe  for  its          intended purpose  and unreasonably  dangerous to users,  and that          Collagen  therefore is liable for any  injuries Zyderm may cause.          Indeed, class III devices such as Zyderm are those that present a          "potential  unreasonable risk  of  illness or  injury" such  that          extensive regulation  is required to ensure  reasonably safe use.          21 U.S.C.   360c(a)(1)(C).   The FDA must evaluate  these devices          with regard to those for  whose use the device is intended.   Id.                                                                        ___            360c(a)(2)(A).    The entire  MDA  scheme  for such  Class  III          devices  as  Zyderm,  therefore,  is  aimed  at  determining  and          regulating  the intended purpose of the device, and at ensuring a          reasonable level of safety for its users.                    It  is clear  that appellant's  strict liability  claim          would impose requirements related to the safety and effectiveness          of  Zyderm.  If successful,  the claim would  require Collagen to          redesign  Zyderm, remove  it from  the market,  or be  subject to          strict liability.   The MDA  does not permit  this.   Appellant's                                         -11-          claim  would  force us  to determine  that  Zyderm is  unsafe and          dangerous, in  opposition to  the contrary determination  made by          the  FDA under the MDA.  Subsection (a) protects manufacturers of          medical devices approved by the FDA under the MDA from such state          law intrusion.                    B.  Breach of Warranty                        __________________                    Appellant  claims  that Collagen  breached  express and          implied  warranties   of  merchantability   and  fitness   for  a          particular purpose.   Appellant's  express warranty  claims arise          out of  the labeling  and packaging of  Zyderm, all of  which are          regulated  by the FDA.  In labeling and packaging, Collagen could          not say any  less than what the FDA  required, and appellee could          only  add   extra  warnings   or  safety  information,   but  not          warranties, without FDA approval.   Appellant's express  warranty          claims therefore  are preempted because any  such warranties only          could  arise  out of  the  FDA-approved  labeling and  packaging.          Allowing  appellant's express  warranty claims  effectively would          impose additional or different requirements on  Zyderm's labeling          and packaging.                    We  note that  the Court's  holding in  Cipollone would                                                            _________          seem to require the opposite result  in this case.  However,  the          warnings at issue  in Cipollone were  different than those  here.                                _________          In  Cipollone, the  statute required  cigarette manufacturers  to              _________          include  a brief  health  warning in  their advertisements;  this          warning did not affect cigarette advertisements in any other way.          The manufacturers  were  free to  make  any claims  they  wished,                                         -12-          including express warranties.  Here, however, the MDA has imposed          much   more   extensive   regulation  upon   class   III   device          manufacturers.   The FDA retains rigid  control over the entirety          of  the labeling  and packaging  of class  III  products, largely          displacing  the  ability  of  manufacturers  to  make  additional          claims.  This high level of control contrasts with  the low level          of control in Cipollone, and ensures  that manufacturers will not                        _________          be held liable for packaging and labeling imposed by the FDA.                    Appellant  also  alleges   that  Collagen  breached  an          implied warranty of merchantability,  and that this breach caused          her injuries.   As an implied  warranty is  a requirement upon  a          product  that  arises exclusively  from  the  operation of  state          contract  law,  this claim  is  preempted expressly  by  the MDA.          Otherwise,  it would  impose  a requirement  additional to  those          imposed under the MDA.                    C.  Negligence                        __________                    Appellant's  third  claim  alleges  negligence  in  the          design, manufacture,  marketing and sale  of Zyderm.   This claim          also is preempted by the  MDA.  If the MDA does nothing  else, it          regulates the  design, manufacture,  sale and marketing  of class          III medical  devices in  an extensive  way.   The  MDA does  this          through the  packaging and  labeling requirements  which directly          affect  the  marketing  and  sale  of  the  product.    The  same          requirements  also  affect  the  design and  manufacture  of  the          product in that these processes  must be approved by the FDA  and          described in the product's packaging and labeling.                                         -13-                    As  the  design,  manufacture, marketing  and  sale  of          Zyderm  is the subject of FDA regulation, the negligence claim is          preempted.    Otherwise,  a  finding of  negligence  would  force          Collagen  to alter  these aspects  of Zyderm  in response  to the          finding  of liability, or be subject to liability.  Either result          impermissibly would  impose  an  additional  or  different  state          requirement upon  the design, manufacture, marketing  and sale of          Zyderm.                    D.  Product Misbranding, Misrepresentation & Failure to                        ___________________________________________________                        Warn                        ____                    Appellant  contends  that   Zyderm  was  misbranded  or          mislabeled.  Misbranding generally occurs when labeling is "false          or misleading"  in any particular. 31 U.S.C.   352(a).  Under the          MDA, the FDA must  reject proposed labeling when the  labeling is          "false or misleading  in any particular."   Id.    360e(d)(2)(D).                                                      ___          As  there  is  no  indication  in  the  record  that  the  Zyderm          administered  to Ms. King was anything  but what the FDA-approved          labeling  said it  would  be,  notwithstanding  appellant's  bald          statements, we find this claim preempted.                    Appellant's fifth and sixth claims of misrepresentation          and failure to warn are preempted for similar reasons.  A finding          that Collagen  misrepresented Zyderm to appellant  would impose a          requirement on  Collagen to change  its packaging or  labeling in          order to  correct the  misrepresentation.   The  failure to  warn          claims similarly challenge the adequacy of Zyderm's FDA-regulated          packaging and labeling.  The MDA forecloses these  claims because          Collagen  cannot  be  forced  to change  Zyderm's  packaging  and                                         -14-          labeling by virtue of these state law damage claims.                    E.  Fraud                        _____                    Appellant's final cause of action alleges that Collagen          fraudulently obtained  FDA approval at the  premarketing stage of          the MDA  process, and asks for  treble damages due to  the fraud.          This cause  of action is  more unclear than  her other  causes of          action.  Collagen  insists that  the claim  originally was  based          upon Mass.  Gen. L. ch. 231,    85J, an antifraud  statute, while          appellant urges that  it was based on a more  general duty not to          deceive.                    Section 85J  provides  that "[w]hoever,  by  deceit  or          fraud,  sells  personal property  shall be  liable  in tort  to a          purchaser in treble the amount of damages sustained by him."  The          language of this statute corresponds to Ms. King's fraud claim in          providing for treble damages.  Because Ms. King has not specified          any  applicable statute, or other  reason why she  is entitled to          treble  damages  under a  general duty  not  to deceive,  we must          conclude that  the fraud claim originally arose under   85J.  The          district  court made the same finding in its memorandum and order          in this case.                    To state a claim  for fraud under   85J,  the plaintiff          must be in  privity with  the seller.   Kourouvacilis v.  General                                                  _____________     _______          Motors Corp., 410 Mass. 706, 575 N.E.2d 734, 735 (1991).  In this          ____________          case,  no  privity existed  between  appellant  and Collagen,  as          Collagen only sold its product directly to appellant's physician.          Thus, as a  matter of Massachusetts law, appellant's  fraud claim                                         -15-          must fail.                    We further note that  the fraud claim is, at  bottom, a          failure to warn claim.  It seeks to show that Collagen had a duty          to  provide  different  information  in  Zyderm's  packaging  and          labeling than that which was  approved by the FDA.  As  such, the          claim is preempted expressly by the MDA.                                      CONCLUSION                                      CONCLUSION                                      __________                    Because  we  have  determined that  the  MDA  expressly          preempts  Ms. King's state law  tort claims, the  judgment of the          district court is affirmed.                            ________                                                      "Concurrence follows"                                         -15-                      ALDRICH,  Senior Circuit Judge, with whom CAMPBELL,                                ____________________            Senior Circuit Judge, joins, concurring.  While we agree with            ____________________            our brother Torruella's result, and a good deal that he says,            we approach this case somewhat differently.  First, a  matter            of  housekeeping.   On  December 13,  1991,  a year  past the            scheduled  date for  completion of  the pleadings,  plaintiff            filed a motion  to allow an amended complaint, accompanied by            the complaint.  On  December 17 she wrote defendant  that she            would withdraw  her motion.  Defendant,  accordingly, did not            oppose.  On December 27 defendant moved for summary judgment.            In opposing defendant's motion for judgment plaintiff made no            mention  of the proposed new complaint, but, in fact, she did            not withdraw  her motion,  and  the court  later allowed  it.            However, the court's ultimate order granting summary judgment            did not mention the amendment.                      At first  blush  we might  agree  with  defendant's            objection  that  there  were  substantive  additions  in  the            amended  complaint,  particularly  with  relation  to  fraud.            Apart from fraud, the rest of  the amended complaint contains            six  claims as  against,  originally, two  -- negligence  and            breach of implied warranty.  There was definitely a purported            enlargement  -- a state tort of strict liability, and a claim            of express warranty.  While the negligence alleged is limited            to designing and producing a dangerous product, and  not that            the sample sold  plaintiff was  in some way  a departure  and                                         -16-            individually  defective,  plaintiff   adds  mislabeling   and            misrepresentation, and, finally, failure to warn.                      Taking defendant's now alleged seven sins, we group            them  as  follows.    Strict  liability  (negligent  design),            implied warranty,  negligence,  mislabeling, and  failure  to            warn are really all  of a piece --  failure to warn.   On the            record  it is clear  that had there  been a warning  that the            product  might  cause the  disease  that  plaintiff allegedly            suffered she would have no claim under any of these headings.            On  this basis  there  is thus  no  real enlargement  by  the            amended  complaint.   Express warranty might  be enlargement,            but  there is no basis for  claiming it.3  Finally, fraud and            misrepresentation  are  not  as   newly  put  as  they  look.            Defendant would have it  that the original allegation related            only  to representations  made to  the plaintiff.   Plaintiff            states   that   she   intended   her   language  to   include            misrepresentations  to  the  agency.   Two  of  her  exhibits            seeking  to raise an issue on the motion for summary judgment            bear  this  out.    The  amendment   should  stand,  as  mere            clarification.  However, we read fraud more broadly than does            our brother, and shall return to it later.                      All agree  that there is one basic  issue:  federal            preemption.   Preemption may apply against  state judicial as                                            ____________________            3.  Express  warranty might  have created  a problem  for the            defense of preemption, cf.  Cipollone v. Liggett Group, Inc.,                                   __   _________    ___________________            112 S. Ct. 2608, 2622-23 (1992).                                         -17-            well  as  legislative action,4  Cipollone  v.  Liggett Group,                                            _________      ______________            Inc., 112 S. Ct. 2608 (1992), and may take two forms, express            ____            and implied, with a heavy burden upon the party asserting it.            Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977).  This is            _____    ________________            especially  so when  the  subject is  the  state interest  in            health and safety.   Hillsborough County v. Automated Medical                                 ___________________    _________________            Labs, Inc., 471 U.S.  707, 715, 718-19 (1985).   The question            __________            is Congressional intent.  Wood  v. General Motors Corp.,  865                                      ____     ____________________            F.2d  395, 401 (1st Cir.  1988), cert. denied,  494 U.S. 1065                                             ____________            (1990).   Here, concededly,  the statute's purpose  is health            protection,  but  the  parties  disagree  as  to  its  scope.            Plaintiff  says it  is  directed to  the  individual user  by            keeping harmful  products off the market  and assuring proper            warnings.  Defendant says it is also to benefit the public at            large   by   shielding   regulated    manufacturers   against            inconsistent state regulation, including lawsuits.   If their            legal risks may be too great, worthwhile  medical devices may            be left in the laboratory, to the public's loss.                      Public  health is  a  valid  federal  purpose,  and            Congress   can  reasonably   weigh  possible   loss  to   the            idiosyncratic few  against benefits to the  public generally.            See, e.g.,  Mary Beth Neraas, The  National Childhood Vaccine            ___  ____            Injury  Act of  1986:   A Solution  to the  Vaccine Liability                                            ____________________            4.  A  matter that  may have  troubled the  court in  Wood v.                                                                  ____            General Motors, post.  See, also, 21 C.F.R. 808.1(b).            ______________  ____   ___  ____                                         -18-            Crisis?   63  Wash.  L. Rev.  149  (1988).   The  legislative            history  shows  that  this  was  precisely the  Congressional            intent.     Concededly,  the  U.S.   Code  Congressional  and            Administrative News, 94th  Congress, Second Session,  Vol. 3,            pp. 1070  et seq., Medical  Device Amendments of  1976, shows                      __ ___            the  principal  emphasis  to  be  on  the  protection of  the            individual  user.  But it also shows the intent to "encourage            . . . research and development"  and "permit new and improved            devices to be marketed without delay."  Infra.  Perfection is                                                    _____            impossible  and   a  few  individuals  may   be  denied  full            protection at the cost of benefitting the rest.                      Contained  within the  Senate  Report (94-33)5  are            the following.                           As medicine  progresses, as research                      makes  new  breakthroughs, an  increasing                      number   of   sophisticated,   critically                      important   medical  devices   are  being                      developed  and used in the United States.                      These   devices   hold  the   promise  of                      improving the health and longevity of the                      American  people.  The Committee wants to                      encourage their research and development.                      [1071]                           S. 2368 recognizes the benefits that                      medical  research and  experimentation to                      develop  devices offers  to mankind.   It                      recognizes, too, the need  for regulation                      to  assure that  the public  is protected                      and  that  health professionals  can have                      more  confidence  in  the performance  of                      devices.  [1075]                                            ____________________            5.  The Senate bill was passed in lieu of the House bill.                                         -19-                           The Committee recognizes the rapidly                      changing nature of the  devices field and                      therefore feels that  provisions must  be                      made to  amend standards on the  basis of                      improved  technology  or  new  scientific                      evidence.  Such amendments should be made                      in   an   expedited   fashion   so   that                      appropriate   changes   can  be   rapidly                      implemented.      The  purpose   of  this                      authority  is to  permit new  or improved                      devices to  be marketed without  delay so                      that the public may have  such beneficial                      devices  available to  them  as  soon  as                      possible.  [1083]                      Translating this  into a simple concept, and taking            the difference of  opinion between the parties  to be whether            the FDA  requirements are merely  minimum, or  are the  total            maximum protection afforded  the individual user, we  believe            this  a clear  demonstration of  Congressional choice  of the            latter.   We  further find  that the  comprehensive statutory            language conforms thereto.                      21 U.S.C.   360e(c)(1) provides,                           (1)   Any person  may file  with the                      Secretary  an  application for  premarket                      approval for a class III device.  Such an                      application for a device shall contain --                                 (A)   full   reports  of   all                           information,  published or  known to                           or which should reasonably  be known                           to    the    applicant,   concerning                           investigations which  have been made                           to  show whether or  not such device                           is safe and effective;                                 (B)  a  full statement  of the                           components,     ingredients,     and                           properties and of  the principle  or                           principles  of  operation,  of  such                           device;                                         -20-                                 (C) a full description  of the                           methods used in, and  the facilities                           and    controls   used    for,   the                           manufacture,  processing,  and, when                           relevant,  packing and  installation                           of, such device;                                 (D)  an identifying  reference                           to  any  performance standard  under                           section  360d  of  this title  which                           would be applicable to any aspect of                           such device  if it were  a class  II                           device,    and    either    adequate                           information to show that such aspect                           of  such  device  fully  meets  such                           performance  standard  or   adequate                           information to justify any deviation                           from such standard;                                 (E)   such  samples   of  such                           device and of components  thereof as                           the    Secretary    may   reasonably                           require,   except  that   where  the                           submission   of   such  samples   is                           impracticable or unduly  burdensome,                           the requirement of this subparagraph                           may  be  met  by  the  submission of                           complete information concerning  the                           location of one or more such devices                           readily  available  for  examination                           and testing;                                 (F) specimens  of the labeling                           proposed to be used for such device;                           and                                 (G)  such  other   information                           relevant  to  the subject  matter of                           the  application  as the  Secretary,                           with   the    concurrence   of   the                           appropriate panel under section 360c                           of this title, may require.                      Following these detailed  requirements, and we note            especially subsection (F), comes Section 360k(a).                      [N]o State or political subdivision  of a                      State may establish or continue in effect                                         -21-                      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.            Particularly in the light of the legislative history we  read            this as maximum protection and express preemption, leaving no            need to seek  implications.   As all but  one of  plaintiff's            sustainable  claims  are  premised  on  a  failure  to  warn,            preemption here  is  unavoidable, given  the  subsection  (F)            requirement that labels be reviewed by the FDA.                      It follows that  most of plaintiff's  arguments are            beside  the  mark.   A  few,  however,  may deserve  mention.            Plaintiff claims  that because of the  regulation reported in            21  C.F.R. 814.39(d)(1),  to the  effect that  a manufacturer            "may,"  without  prior approval,  make  certain  changes that            enhance safety, defendant  had a duty to make such  here.  It            is  sufficient to  say that  to interpret  "may"  as "should"            would unravel the entire garment.  Second, citing Silkwood v.                                                              ________            Kerr-McGee Corp.,  464 U.S.  238, 251 (1984),  plaintiff says            ________________            that,  if defendant is correct,  she has no  cause of action.            Given an ambiguity,  this objection is a factor  in statutory            construction, but, of itself,  it cannot create an ambiguity,                                         -22-            or there could never be preemption.   Finally, plaintiff says            that  the  FDA's  preemption  regulation,  21 CFR    808.1(d)            conflicts  with  our result.   When  a  statute is  clear the            agency  interpretation must  give way.   Hillsborough County,                                                     ___________________            471 U.S. at 714-15.                      A  more  troublesome  issue is  the  claim  labeled            fraud.                                        FRAUD                                        _____                           . . . Defendant Collagen Corporation                      fraudulently obtained FDA approval of the                      Zyderm PMA, product  and labeling,  which                      was  a producing  or  proximate cause  of                      damage    and   injury    to   Plaintiff.                      Defendant . . . further acted to suppress                      the facts, blame injuries or other causes                      that  its  product   (sic)  and   prevent                      disclosure of the true risks.[6]                      Plaintiff  has  a case  in  point.   In  Hurley  v.                                                               ______            Lederle Laboratories Division  of American Cyanamid Co.,  863            _______________________________________________________            F.2d 1173 (5th  Cir. 1988), the  court, though agreeing  with            the  district court that  the FDA regulation  with respect to            defendant's vaccine labeling  was intended to  be preemptive,            remanded.  At issue  was the same tension  between protecting            idiosyncratic individuals  and the public health.   Balancing            these, the Court concluded,                                            ____________________            6.  As  in the  original complaint,  plaintiff  sought treble            damages.    Though  not  mentioned,  presumably  this  demand            invoked Mass. G.L. c. 231,   85J, that awards  treble damages            in certain  cases of "deceit or  fraud."  We do  not read it,            however, as limiting the scope of plaintiff's claims.                                         -23-                      [T]his issue should  be presented to  the                      jury    in    the    form   of    special                      interrogatories, questioning  whether and                      what    information    the   manufacturer                      withheld  from  the   FDA,  if  any,  and                      whether  possession  of this  information                      would have materially altered the content                      of  the  FDA's  warning.    This  special                      procedure  is  justified  by the  federal                      interest in  encouraging manufacturers to                      produce    vaccines,   in    that   those                      manufacturers need some assurance that if                      they     follow     certain    prescribed                      procedures,  such  as  including an  FDA-                      approved warning, they are complying with                      the law.            Id.  at 1180.  With respect, one may wonder how "encouraging"            __            manufacturers  would view the ruling.7   Rather, we side with            the later case  of Papas v. Upjohn  Co., 926 F.2d 1019  (11th                               _____    ___________            Cir. 1991), where the court said, at 1026 n.8,                      To  the extent  that  Hurley purports  to                                            ______                      recognize   an   exception   to   federal                      preemption  of  common law  tort labeling                      claims when the federal  statute involved                      explicitly prohibits  state regulation of                      labeling  and  the  federal   agency  has                      received incomplete  information from the                      manufacturer,  we  reject its  holding at                      least   as  applied   to  FIFRA-regulated                      pesticides.  Given  the FIFRA  regulatory                      scheme, it would be up  to the EPA -- and                      not  a  jury  -- to  determine  first (1)                      ___                      whether  the   information  provided  was                      incomplete or inaccurate; (2) whether the                      omitted information is significant enough                      to mandate a change in the label; and (3)                      how, if  at  all,  the  label  should  be                      corrected.                                            ____________________            7.  Indeed,  we  are reminded  of  the  observation that  the            British  hanged  a  negligent  admiral  "pour  encourager les            autres."  Voltaire, Candide, Ch. 23.                                _______                                         -24-            To prove fraud, plaintiff must show causality.  Surely, where            the FDA  was  authorized to  render  the expert  decision  on            Collagen's  use and labeling, it, and not some jury or judge,            is best suited to determine the factual issues and what their            effect would have been on its original conclusions.  Further,            if the court erred, and incorrectly posited the effect on the            FDA's use and  labeling decision, this  would impose a  state            requirement "which is different from, or in  addition to, any            requirement  applicable  . . . to  the  device."   21  U.S.C.              360k(a).    In addition  to  running afoul  of  the general            principle against implying  personal causes of  action, Royal                                                                    _____            Bus Group, Inc.  v. Realist,  Inc., 933 F.2d  1056 (1st  Cir.            _______________     ______________            1991), plaintiff  would be breaching the federal  dyke in the            absence of its keeper.                      Papas  has  been vacated  and remanded  for further                      _____            consideration in the light of Cipollone, 112 S. Ct. 2608, but                                          _________            we do not believe  this to be a reversal on that  point.  Our            position is  consistent with Cipollone, that  did not preempt                                         _________            fraud found to be  outside the communication targeted  by the            regulation.8  112 S. Ct. at 2623-24.                                            ____________________            8.  Plaintiff    similarly    presents     a    claim     for            misrepresentation, both  to  the public  and  to  plaintiff's            physician.  As the  record shows no statements to  the public            or  physicians that go beyond those approved by the FDA, this            claim collapses into that of fraud on the FDA.                                         -25-