Court Opinion

ID: 194490
Source: CourtListenerOpinion
Date Created: 2011-02-07 02:18:22+00
Date Added: 2024-06-11T08:44:55.374368
License: Public Domain

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
                                   

          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)  &
                                                  

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
                                        

                                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.

          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
                                      

          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-