Jane King v. Collagen Corporation

III

CONCLUSION au- its exceed not did court district The disbursements directing

thority fund the escrow from claimants refund ICC agree- escrow private established comprised fund was escrow As

ment. deposited with Ruhland monies HTI, purchase for parties Holmes agreement escrow private their indemnity fund intended specifically liabilities contingent HTI’s settling for present in the claimants refund ICC juris- possessed court district litigation, incident fund escrow over diction ICC underlying in the HTI over jurisdiction

action. affirmed, order court district previ- order appellees. costs court, staying by this entered ously fur- ac- escrow disbursements ther case is remanded count, vacated. proceed- court district for further herewith.12

ings consistent Plaintiff, Appellant, KING,

Jane CORPORATION,

COLLAGEN Defendant, Appellee.

No. 92-1278. Appeals, Court States

United Circuit.

First Sept. 1992.

Heard 15, 1993.

Decided Jan. Cir.1992) (issue (1st is unfit F.2d party has demonstrated Since neither and contin- uncertain involves account if "claim escrow review of a residue likelihood anticipated, may occur as refund gent the ICC following events disbursements unripe all”); & claimants, a residue is W.R. Grace any dispute over not occur or indeed Cir.1991). (1st Ass'n EPA, See Massachusetts 364-65 decision. F.2d of Afro- Co. v. Police, Dept., 973 Police Inc. v. Boston American

H31 States District Court for the District of Massachusetts. The district court deter- plaintiff’s preempt- mined that claims were by ed the Medical Device Amendments of (“MDA”), 21 seq. U.S.C. 360c et § correctly Because the district court con- preemption provision strued the MDA, we affirm.

FACTS Collagen Defendant manufactures and Zyderm, distributes a cosmetic medical de- vice used to correct wrinkles and other skin Zyderm deformities. treatment consists of injecting processed directly un- cow tissue supports then der skin. underneath, smoothing skin from out de- formities on the surface of the skin. The may course of treatment run for several requires up applications. weeks and to six University Researchers at Stanford devel- oped Zyderm early 1970’s and Colla- gen placed early it on the market in the 1980’s. device, Zyderm As a medical falls within Hanby, J. with whom Susan A. Clinard scope of the MDA and thus must be O’Quinn,O’Quinn,Kerensky

Allinger, John regulated by the Food and McAninch, Essmyer, M. Michael & Michael (“FDA”). Drug As a Administration Class Houston, Associates, TX, Essmyer M. & scheme, MDA III medical device under the LeComte, Emanuelson, Lynch Frank subject pre- extensive it is to most Boston, MA, brief, Doyle, Tick & were on imposed marketing approval requirements appellant. for similarly extensive Gibbins, Austin, TX, Jeffrey R. Bob premarket regulation post-approval. DC, brief, White, Washington, were on for approval process designed provide America, Lawyers Trial the Ass’n of safety and “reasonable assurance of ... amicus curiae. effectiveness” for medical devices which Leghorn, Joseph J. with whom Peter T. permit dangerous too or unknown Wechsler, Stackpole, Warner & Joe W. 360c(a)(l)(C). regulation. 21 less U.S.C. § Redden, Jr., Webb, Beck, W. Curtis designed regulation is Post-approval TX, Secrest, Houston, Redden & were on safety ongoing keep apprised the FDA brief, appellee. for information about findings other Kuhlik, Noah, Covington Bruce N. Lars Id. it becomes available. device as Allen, Burling, H. and Retta M. & Edwin 360i(a). 360e(e) & §§ DC, brief, Riordan, Washington, were on approval pre-marketing Pursuant Ass’n, Industry for Health Mfrs. amicus requires applicants to FDA process, the curiae. labeling, safety extensive proposed submit descriptions of manufac- testing data and TORRUELLA, Judge, Before Circuit and materials. Id. turing methods CAMPBELL, Circuit ALDRICH Senior 360e(c)(l). Upon reviewing the materials Judges. manner, comprehensive TORRUELLA, Judge. Circuit return the approve the device for sale or applicant for further in- application to the grant King appeals Jane from a of sum- 360e(d)(l). testing. formation or mary judgment entered in of Colla- favor (“Collagen”) application the FDA returns an gen Corporation by the United When first filed subsequently King Ms. apprise must applicant, detailing seven complaint amended all deficiencies. to correct of how applicant First, claimed she Collagen.1 ap- against 360e(d)(2). Once Id. § injuries her strictly with- liable was power FDA retains proved, its intend- unsafe permanently product the because of approval draw unreasonably dangerous if it temporarily approval purpose its ed suspend or Zyderm un- alleged become Second, has that she the that users. determines Id. inadequate. intend- purpose fit for safe safe was mak- in FDA assist of To breach 360e(e)(l)-(3). sold was therefore ed and determinations, manufacturers Third, Ms. merchantability. ing these warranty of reports to make design, records maintain must negligence that King alleged pertinent Zy- FDA on sale of marketing and manufacture, passed 360i(a). Zyderm revealing device. in not negligence derm, including pri- process approval III Class through led product, of the propensities dangerous revisions underwent marketing, and toor that Fourth, maintained she injury. to her afterwards. approval original Zy- mislabeled and/or misbranded Collagen Zyderm Collagen sought King that Fifth, asserted she Jane derm. Appellant Following the normal fact of material misrepresentations treatment made adminis- physician to her. King’s selling Zyderm Ms. procedure, King in to Ms. proceed- before Zyderm Collagen test dose failed alleged tered that Sixth, she Shortly after treatment. the full ing with Final- condition. any defective her of warn King dose, suffered Ms. test receiving this Collagen fraudu- alleged that King ly, Ms. as other as well pains, joint muscle approval. FDA lently obtained diag- subsequently doctor Her symptoms. judgment summary, Collagen moved dermatomyositis/poly- having as her nosed amended filed her King Ms. shortly after dis- an autoimmune (“DM/PM”), myositis regulation FDA that arguing complaint, attacks system immune which ease in preempted all under if it were tissue and muscle skin com- in the alleged of action causes substance. foreign mo- this granted court district plaint. Zy- Zyderm, King received Ms. When from similar case on a tion, relying labeling contraindi- FDA-approved derm’s case, This of Texas. District Southern history personal awith by those use cated H-90-2242, No. Collagen Stamps v. time, that Since disease. autoimmune LEXIS 352421, 1991 U.S.Dist. WL allowed gradually has however, FDA plaintiffs that (S.D.Tex.1991), held labeling as it relat- change the Collagen arising out liability claims products various 1991, Zy- By disease. autoimmune ed preempted were Zyderm treatment longer contraindicated no was derm MDA. dis- history of autoimmune awith persons warning required The FDA ease. ANALYSIS LEGAL recipients have however, some that reac- autoimmune unwanted suffered I. connection be- causal tions, no but dictates the Constitution ofVI Article has been reactions these tween Law supreme “shall be law federal shown. such, appellee never complaint. As Collagen amended in 1990 against King suit filed 1. Ms. court entered entry. The district opposed its Zyderm caused her test dose alleging opposition noting that no complaint, suit of her one Count develop amended DM/PM. however, tested, court, proceed- negligently manu- Collagen The district filed. alleged alleged basis of Count two Zyderm. summary judgment on grant sold factured ed to implied warranties Because complaint. breached original King’s Ms. alleged fraud merchantability. essentially Count three similar complaint contains amended Zyderm. sale of addi- complaint, deceit few original claims tions, the amended subsequently King filed in the amend- the claims Ms. will address King Ms. Appellee contends complaint. complaint. ed would withdraw appellee she informed

H33 every deprive public important health in Land; judges in State and the of the —Id., at -, any Thing in the thereby, formation. U.S. shall be bound cigarette Laws of State notwith- at 2613. The manufacturers con Constitution Const, VI, cl. 2. State standing.” petitioner’s art. U.S. tended that claims were with federal laws preempted by requiring laws that conflict the federal law therefore, preempted. regulations, warning appear cigarette health on all — Corp., 435 Id., Motor E.g., Malone White advertisements and containers.2 L.Ed.2d 443 at -, U.S. 112 S.Ct. at 2614. a con- determining In whether such analyzing preemption, the Court relied exists, settled that the intent flict it is well language only specific provi- on the is, governs. preemption Congress That preemption. regarding sion The Court rea- so intend- Congress occur unless does not “Congress’ pro- enactment of a soned that Fe 331 ed. Rice v. Elevator Santa defining preemptive reach of a vision 1146, 218, L.Ed. 1447 67 S.Ct. 91 U.S. implies beyond statute that matters (1947). —Id., preempted.” reach are not U.S. at express its intent Congress may -, opinion 112 at The thus S.Ct. 2618. in lan explicitly preempt state law analyzed petitioner’s light claims in each Rath Pack guage of the statute. Jones v. express language preemption of the of the 525, 1305, Co., 519, 97 S.Ct. ing 430 U.S. warning provision cigarette in the statute. (1977). Congress may 1309, 51 L.Ed.2d 604 provision plurality The held that implicitly by passing an express its intent preempted failure to warn claims as to statutory scheme that extensive extensive advertising practices, testing not as to but regulation. Fidelity ly covers the field —Id., practices. U.S. at or research Loan Ass’n v. de la Cues Federal Sav. & -, plu 112 S.Ct. at 2621-22. The 141, 153, 3014, 3022, ta, 458 102 S.Ct. U.S. only preempt the Act rality reasoned that (1982). Implied preemption 73 L.Ed.2d 664 cigarette arising claims out of ed state law a conflict state also occurs when between appel advertising promotion, compliance makes and federal law arising testing out of lant’s claims impossible, both or when state law would advertising relate to research did not purpose objectives of the frustrate peti provision preempted The promotion. (citing federal law. Id. Florida Lime & misrepresentation claim tioner’s fraudulent Paul, Growers, 373 U.S. Avocado Inc. v. advertising cigarette neutralized 132, 142-43, 1210, 1217-18, 10 83 S.Ct. warning in a fashion. effect of the similar (1963); Davidowitz, L.Ed.2d 248 Hines v. —Id., at -, 112 at S.Ct. U.S. 52, 67, 312 U.S. 85 L.Ed. however, not provision, 2623-24. did (1941)). 581 o,ut arising of com preempt fraud claims are aided in our determination of We advertising, such as munication other than by Supreme in preemption this case required to disclosed to subject Court’s recent treatment of agency, or out of fraudulent administrative —Inc., Cipollone Liggett Group, U.S. advertising but un statements made -, 120 L.Ed.2d 407 S.Ct. warning. related to the health lung Cipollone, a victim of can- provi- held that the cigarette plurality manufacturers further cer sued several warranty express ciga- preempt contained in sion did not for breach of warranties claims, due to advertisements, claims arose for failure to warn of because those rette who smoking, the manufacturers health hazards related to conduct of rather than from state fraudulently misrepresenting those haz- made the warranties — -, Id., at 112 S.Ct. at public, conspiracy law. U.S. ards to the Ciga- pro- provisions of this Act.” Federal or with the 2. That law stated "[n]o 1965, 5, smoking Labeling Advertising health shall be § hibition based on imposed Act of rette respect State law with Smoking by Cigarette Health as amended Public advertising any cigarettes promotion 1969, 2, 1334. § Act of 15 U.S.C. § conformity packages of which are labeled in (b) of subsection 360k. Under U.S.C. § held that plurality Finally, the 2622. may petition 360k, a state conspiracy to preempt not did provision re- state to allow circumstances claims, certain facts of material public deprive Because in force. continue quirements law of state out arise not they did because case, arewe affects this petition no health, rath but smoking and pertaining effect preemptive only with concerned conspire to not “duty of a out er arose (a), we (a). subsection — Under subsection at -, Id., U.S. fraud.” commit prod- appellant’s whether must determine law to state give rise liability ucts Cipollone plurality analysis different to or in addition requirements begin We in this case. analysis our guides FDA. by the mandated from those pro preemption express noting that own under- FDA’s first turnWe 360k, fore MDA, 21 U.S.C. vision guidance. (a) for of subsection standing be preemption, implied into inquiry closes Re- U.S.A., v. Natural Inc. Chevron See it in included Congress the fact cause Inc., Council, sources Defense beyond its matters implies 2778, 81 L.Ed.2d 837, 104 S.Ct. Further, note preempted. are not reach statute own interpretation (agency’s carefully con plurality Cipollone contrary to long as controlling so to extend provision preemption strued pro- regulations intent). FDA Congress’ warranted. language than no further when apply not does preemption vide that pay sought to so, plurality doing In or other regulations no issued has FDA relations. to federal-state respect proper de- particular to specific requirements assumption of “the out arises This concern case, it 808.1(d). In this 21 C.F.R. § vice. of the states powers police historic that the require- imposed has FDA that the is clear Federal ... superseded not to be [are] de- labeling, to related ments on and manifest the clear Act unless [is] of aspects and other manufacturing sign, — U.S. Cipollone, Congress.” of purpose scheme. the MDA to pursuant device v. (citing Rice 2617 at -, 112 S.Ct. requirements 218, has issued FDA U.S. If Corp., 331 Elevator Fe Santa (a) states prohibits device, 1447 1152, L.Ed. subsection 1146, 230, 67 S.Ct. dif- which requirements any imposing carefully construe from too will (1947)). We requirements, the FDA give or add MDA from of fer provision preemption effective- safety or federal-state relate or which questions regard to due require- ... A “State the device. ness of relations. (a) may emanate in subsection ment” in- by a state established any requirement II. deci- court statutes, regulations, cluding mind, turn 808.1(b); principles Bearing 21 C.F.R. these ordinances. or sions question. statute Building Trades language of Diego San see also 247, 236, Garmon, states v. Council (1959) (b) L.Ed.2d in subsection (a) Except provided as effectively as can (“[State] subdi- or .section, political no State of this as damages award through an contin- or may establish exerted aof State vision relief. preventive form device through to a some respect in effect with ue be, can compensation pay require- obligation to any use human intended be, method potent designed is indeed ment— poli- controlling conduct governing from, in addition or different which cy.”). this under applicable to, requirement (a) device, of subsection language chapter to promulgat- requirement of state definition safety or effec- relates (2) which preemp- a field it demonstrate ed under any other or to device tiveness Any state broad, limited. but which applica- tion requirement in a matter included effect, establishes which, in requirement chapter. this ble H35 Warranty B. Breach for the device substantive new labeling, is area such regulated in a breached Appellant claims 808.1(d)(6)(h). As 21 C.F.R. preempted. mer- implied warranties of express and however, noted, subsec Circuit the Seventh particular chantability fitness for such preempt (a) MDA does tion warranty express purpose. Appellant’s remov implantation or negligent claims labeling packag- arise out of the claims arising of con devices, claims out al of regulated ing Zyderm, all of which Optical Radi devices. Slater taminated packaging, FDA. by the Cir.1992), (7th 1330, 1334 961 F.2d ation say any less than what Collagen could not — U.S. -, denied, only appellee rt. could required, ce information, safety warnings 121 L.Ed.2d add extra warranties, approval. without but not sub- understanding Armed there- express warranty claims Appellant’s petitioner’s (a), analyze we will section war- any such preempted because fore are individually the effect to determine FDA- out of the only could arise ranties on each. provision preemption of the MDA packaging. Allow- labeling and warranty claims ef- express ing appellant’s Liability differ- impose additional or fectively A. Strict would labeling and Zyderm’s on requirements ent un- Zyderm is contends that Appellant packaging. unreason- purpose and its intended safe for holding in Ci- users, Collagen We note Court’s dangerous to ably require opposite seem pollone would any injuries liable for therefore However, warnings this case. result in Indeed, III devices class cause. than were different Cipollone at issue in “poten- a present those that Zyderm are re- the statute Cipollone, those here. injury” risk illness of tial unreasonable to include quired cigarette manufacturers required is regulation extensive such that in their advertise- warning brief health reasonably use. safe U.S.C. to ensure ciga- not affect ments; warning did this 360c(a)(l)(C). The FDA must evaluate § way. any in other rette advertisements to regard those these devices any free to make were The manufacturers intended. is whose use wished, including express war- they claims MDA scheme 360c(a)(2)(A). The entire however, im- Here, the MDA has ranties. Zyderm, there- III devices for such Class extensive more posed much determining regulat- and fore, at is aimed manufacturers. III device upon class device, and purpose of the ing the intended entirety over rigid control FDA retains safety for level of ensuring a reasonable III of class packaging labeling and its users. ability of largely displacing products, claims. additional to liability make strict manufacturers appellant’s that It is clear contrasts with of high This level control to related impose requirements claim would en- Cipollone, and control in low level If Zyderm. safety and effectiveness held will be manufacturers sures that successful, require the claim Colla- would imposed labeling packaging liable it from redesign Zyderm, remove gen by the FDA. liability. market, subject to strict or be Appel- this. not permit does The MDA Collagen that alleges also Appellant us to determine would force lant’s claim warranty of merchant- implied an breached in dangerous, Zyderm is unsafe her caused breach this ability, and contrary determination warranty a re- opposition is implied As an injuries. Sub- the MDA. exclu- the FDA under that arises by upon product made quirement of medi- of state contract operation (a) protects sively manufacturers from the section by expressly law, preempted claim by the FDA under approved cal devices impose Otherwise, it would the MDA. state law intrusion. MDA from misrepresenta- ing in correct order imposed those requirement additional similarly warn failure to tion. The the MDA. FDA- Zyderm’s challenge adequacy labeling. The Negligence C. packaging regulated Col- because these claims MDA forecloses negli- alleges claim third Appellant’s Zyderm’s change forced lagen cannot be manufacture, market- design, in the gence of these labeling by virtue packaging also This claim Zyderm. sale of ing and damage claims. state law does If the MDA MDA. by preempted design, manu- else, regulates nothing it III marketing of class facture, sale and E.Fraud way. in an extensive

medical devices alleges of action cause Appellant’s final through packaging does this MDA fraudulently FDA obtained directly affect requirements which stage premarketing at the approval product. marketing and sale damages for treble and asks process, the de- also affect requirements The same This cause action fraud. due product sign manufacture of ac- causes of her other than more unclear by processes must these origi- claim Collagen insists tion. product’s described ch. upon Mass.Gen.L. nally based labeling. packaging statute, appellant 85J, while antifraud manufacture, marketing design, As the general more on a urges it was based subject of is the and sale duty not to deceive. preempt- claim is negligence regulation, by “[wjhoever, provides 85J Section negligence Otherwise, finding of ed. property fraud, personal sells deceit or aspects these Collagen to alter force would purchaser to a tort be liable shall finding of response to the damages sustained amount of treble the liability. Either subject liability, or be statute corre- language of this him.” addi- impose an impermissibly would result provid- claim in fraud King’s sponds Ms. upon state or different tional King Ms. damages. Because ing for treble manufacture, marketing and design, statute, or applicable specified has not Zyderm. sale to treble why is entitled she other reason de- duty not to general a damages under Misrepresenta- Misbranding, D. Product the fraud ceive, conclude that we must to Warn tion & Failure 85J. under originally arose § claim mis- that was Appellant contends finding in its same the court made district Misbranding gen- mislabeled. branded case. this and order memorandum “false or labeling is when occurs erally 85J, fraud claim for state a To 21 U.S.C. particular. misleading” any the privity with must be plaintiff MDA, FDA must 352(a). Under Motors v. General seller. Kourouvacilis labeling labeling when reject proposed 734, 735 N.E.2d 575 Mass. Corp., 410 any particular.” misleading in is “false or case, be- privity no existed (1991). In no indica- 360e(d)(2)(D). there is As Id. § Collagen Collagen, as appellant and tween adminis- record that the tion in the directly appellant’s product only sold its what anything but King was to Ms. tered Thus, matter Massachu- as a physician. it would said FDA-approved must fail. fraud claim law, appellant’s setts state- be, notwithstanding appellant’s bald ments, preempted. this claim we find is, fraud claim note We further It claim. bottom, warn a failure of mis- sixth claims Appellant’s fifth duty a Collagen had show seeks to to warn and failure representation Zyderm’s finding provide different A for similar reasons. preempted that which labeling than packaging Zyderm to misrepresented such, the As by the FDA. on was impose a appellant would by the MDA. expressly preempted claim is or label- packaging change its Collagen to really piece all a warn are CONCLUSION —failure record it is clear that had warn. On the determined Because we have warning product there been King’s state Ms. expressly preempts plaintiff alleg- might cause the disease claims, of the district judgment tort law have no claim un- edly suffered she would court is affirmed. headings. this basis On der of these ALDRICH, enlargement Senior Circuit BAILEY there thus no real CAMPBELL, H. warranty whom LEVIN Judge, Express with complaint. amended concurring. Judge, joins, Circuit Senior no basis enlargement, but there is might be misrep- Finally, fraud and claiming it.3 brother Torruel- agree with our we While they newly put as are not as resentation says, he we result, good deal that and a la’s it that Defendant would have look. differently. case somewhat approach this represen- allegation only related original De- First, housekeeping. On matter of Plaintiff plaintiff. tations made to 13, 1991, scheduled year past cember language to plain- her pleadings, states that she intended completion of the date for agency. misrepresentations to allow an amended a motion include tiff filed complaint. by the accompanied seeking to raise an complaint, her exhibits Two of defendant that 17 she wrote summary judgment December On on the motion for issue Defen- motion. her she would withdraw should The amendment this out. bear De- dant, oppose. On accordingly, However, did stand, we as mere clarification. summary moved for 27 defendant cember broadly than does our fraud more read motion opposing defendant’s judgment. brother, it later. shall return mention plaintiff made no judgment fact, but, in complaint, proposed agree new All there is one basic motion, Preemption withdraw her she did not preemption. issue: federal However, it. allowed court later judicial as well may apply against state summary granting ultimate order court’s action,4 Liggett Cipollone v. legislative — the amendment. not mention judgment did U.S. -, Inc., Group, (1992), may take two L.Ed.2d 407 agree de- might with At first blush heavy forms, express implied, sub- there were objection that fendant’s asserting it. party Jones upon the burden amended com- stantive additions in 519, 525, Co., Packing v. Rath relation to fraud. particularly with plaint, 1305, 1309, 51 L.Ed.2d fraud, the amended rest of Apart from subject is the especially so when against, This is claims as six complaint contains safety. Hills in health and interest negligence and breach state originally, two— Medical definitely a borough County Automated warranty. There implied 718-19, 707, 715, Inc., of Labs, state tort 471 U.S. enlargement purported —a (1985). 2377-78, 714 express 2371, war- L.Ed.2d liability, and a claim 85 strict S.Ct. lim- negligence alleged is intent. ranty. Congressional the question While is The danger- producing a F.2d designing and 865 ited to Motors v. General Wood sample sold denied, product, Cir.1988), and not 494 ous 395, (1st cert. way departure and in some a plaintiff was L.Ed.2d 782 defective, plaintiff adds misla- individually pur concededly, the statute’s (1990). Here, and, finally, misrepresentation, beling and parties the but protection, pose is health failure to warn. says it is scope. Plaintiff disagree as to its by keeping user to the individual directed alleged seven Taking now defendant’s assur market and products off the harmful sins, as follows. Strict group them it is says warnings. Defendant ing proper design), implied warran- liability (negligent large shield- public the to benefit mislabeling, failure to also and ty, negligence, may the court have troubled prob A matter that warranty might a Express have created 3. See, also, Motors, post. Cipollone preemption, v. General lem for the defense of Wood cf. Inc., - U.S. -, ---, Group, 808.1(b). Liggett C.F.R. (1992). 2608, 2622-23, 120 L.Ed.2d 407 technology or scientific ev- against improved incon- new ing regulated manufacturers be regulation, including lawsuits. idence. amendments should state Such sistent great, may expedited too worth- fashion so that legal If their risks be made an the may be left in im- changes rapidly while medical devices can be appropriate public’s loss. laboratory, purpose The of this authori- plemented. permit ty improved new or devices purpose, is a valid federal Public health delay marketed without so that the to be reasonably possi- weigh can Congress and may have such devices public beneficial against idiosyncratic the few ble loss to possible. available to them soon See, public generally. e.g., the benefits to Mary Beth Neraas, National Childhood ^[1083] 33)5 ting impossible mit keted without denied full But it on sional intent. Vaccine the 94th shows L.Rev. 149 Congressional and Administrative ... medical number of develop that health tant medical devices are people. recognizes, makes new ^[1071] age devices hold Contained within the Senate As medicine S. 2368 new and research assure that Vaccine Congress, Second et health also used their protection seq., shows Injury Act of 1986: rest. research and devices protection shows the intent sophisticated, critically impor- recognizes following. Medical Device Amendments breakthroughs, improved and Liability research and too, professionals can have more delay.” Committee wants to Concededly, the longevity progresses, few individuals development” the need for principal offers to mankind. of the individual United States. public promise precisely at the Infra. Session, Crisis? 63 Wash. devices to be experimentation to legislative the benefits that being developed cost emphasis to be protected A an development. Perfection as research Report “encourage Solution Vol. increasing of benefit- improving and American U.S.Code Congres- encour- history News, These 3, pp. user. “per- mar- (94- It hensive latter. We further between onstration the total maximum thereto. requirements cept, and individual proval for a retary application for 21 U.S.C. § performance nents, ingredients, published or known to or which should used used been 360d of this title tion, of such such device reasonably be known to lation and, cable concerning (B) (C) (D) (A) Translating this Any person when an for, in, statutory user, made to a full statement of full taking the of, principle full parties application identifying are Congressional 360e(c)(l) provides, relevant, reports we believe this class III investigations description is safe aspect the facilities and controls manufacture, merely device; standard protection to be device; show may device shall find which would difference language principles of all of such device packing and instal- into file with whether device. reference to minimum, whether properties premarket ap- under section effective; choice afforded information, a clear which have simple processing, applicant, contain— conforms the be appli- Such an methods compre compo- opinion or not or are opera- dem Sec- if it con any device, II and either ade- were a class performance confidence in the of devices. ^[1075] quate to show such aspect fully meets such of such device recognizes rapidly The Committee adequate in- performance standard or changing nature of the field and devices justify any deviation from formation to provisions feels that must be therefore standard; on such made to amend standards the basis passed bill of the House bill. The Senate lieu

H39 (E) ty, duty defendant had a to make such samples of such device components say thereof as the Secre- here. It is sufficient that to inter- reasonably require, except tary may pret “may” as “should” would unravel the Second, of such garment. citing the submission Silkwood that where entire unduly bur- samples impracticable or Kerr-McGee densome, requirement 615, 623, (1984), of this sub- plain- 78 L.Ed.2d 443 by the submis- paragraph may that, correct, be met says if tiff defendant she concern- complete information sion of ambigu- of action. an has no cause Given one or more such ing the location of ity, objection statutory, is a factor in for examina- readily available but, itself, devices construction, it cannot create testing; tion and pre- ambiguity, or there could never be labeling pro- (F) emption. Finally, plaintiff says specimens of device; preemption regulation, for such and FDA’s posed to be used CFR 808.1(d) conflicts with our result. When (G) relevant such other information agency interpretation a statute is clear the subject application of the to the matter way. Hillsborough County, give must Secretary, with the concurrence as the 714-15, U.S. at 2375-76. appropriate panel under section of the title, may require. 360c of this A the claim more troublesome issue is fraud. labeled require Following detailed these ments, especially, and we note subsection FRAUD 360k(a).

(F), comes Section of a political State or subdivision [N]o Collagen Corporation ... Defendant or continue in effect State establish approval fraudulently obtained intended for respect with to a device PMA, product labeling, any requirement— human use producing proximate which was from, (1) different addi- which is damage injury to Plaintiff. cause of to, un- any requirement applicable tion suppress Defendant ... further acted to device, and chapter der this to the facts, injuries or other causes blame (sic) product prevent disclo safety or effec- which relates to risks.[6] of the true or to other sure tiveness the device appli- matter included in a Hurley point. has a case in Plaintiff chapter. to the under this cable Division Amer- v. Lederle Laboratories legislative Co., Particularly light (5th Cyanamid F.2d 1173 ican protec- history we read this as maximum Cir.1988), court, though agreeing with leaving no express preemption, tion and the district court that one implications. seek As all but need to respect to defendant’s vaccine prem- claims are plaintiffs sustainable preemptive, to be remanded. was intended warn, preemption here ised on a failure to tension between At issue was same unavoidable, (F) given re- the subsection and the protecting idiosyncratic individuals quirement reviewed these, labels be the Court public Balancing health. FDA. concluded, [Tjhis presented plaintiffs argu- issue should be

It follows that most special interrogato- few, form of jury A howev- ments are beside the mark. ries, infor- questioning whether and what er, may deserve mention. Plaintiff manufacturer withheld regulation reported in mation the that because of the FDA, possession any, if and whether 814.39(d)(1), effect that a C.F.R. materially have prior approv- of this information would “may,” without manufacturer of the FDA’s warn- al, safe- altered the content changes that enhance make certain it, sought or fraud.” We do not read original complaint, plaintiff cases of “deceit however, 6. As in the mentioned, pre- damages. Though limiting scope plaintiff’s hot treble 231, sumably Mass.G.L. c. this demand invoked claims. 85J, damages in certain that awards treble v. action, Group, Inc. Real- Bus. Royal justified procedure special This ing. Cir.1991), (1st plain- Inc., ist, F.2d encouraging interest federal by the dike breaching federal be vaccines, tiff would produce manufacturers keeper. its absence some as- need manufacturers those pre- certain and remanded they follow that if vacated Papas has been surance including light procedures, consideration further scribed — comply- -, they are 112 S.Ct. warning, U.S. FDA-approved Cipollone, to be a reversal not believe the law. do ing with but we position is consistent point. Our on may wonder one respect, at 1180. With fraud preempt not that did Cipollone, would manufacturers “encouraging” how tar- the communication outside to be found Rather, side with we ruling.7 view — at regulation.8 by the geted Co., 926 Upjohn Papas v. later case 2623-24. -, at Cir.1991), the court (11th where F.2d 1019 said, n. at 1026 purports Hurley extent

To the pre- federal exception to

recognize an labeling tort law of common

emption involved statute federal when the regulation of la- prohibits state explicitly Thomas and CHRONIAK Pauline re- agency has the federal beling Plaintiffs, Appellees, Pugliese, incomplete ceived v. at manufacturer, holding its reject CORP. INVESTMENT GOLDEN FIFRA-regulated pes- applied least Defendants, Roberts, Armand regulatory the FIFRA Given ticides. Appellants. EPA—and up to the scheme, it would (1) first wheth- determine jury not Plaintiff, PUGLIESE, Appellee, Thomas —to was incom- provided er the information v. inaccurate; (2) omit- whether plete or CORP. INVESTMENT GOLDEN enough to significant ted information Defendants, Roberts, Armand label; and change in the mandate Appellants. all, be correct- how, if label should Plaintiff, ed. PUGLIESE, Appellant, Thomas fraud, show causal- must plaintiff prove To was autho- ity. Surely, where CORP. INVESTMENT GOLDEN on Colla- expert render the decision rized to Defendants, Roberts, Armand it, labeling, some gen’s use and Cases). (Two Appellees determine suited to judge, best jury 92-1121, 91-2343, 92- Nos. their effect and what issues the factual 92-1318. conclusions. original on have been would erred, incorrectly Appeals, Court of Further, States if the court United use Circuit. on the FDA’s First posited the effect impose a state decision, this would July 1992. Heard from, different “which is 19, 1993. Jan. Decided ... to, applicable any requirement addition 360k(a). In 21 U.S.C. device.” to the general running afoul

addition causes implying personal against

principle misrep- similarly presents claima Indeed, 8. Plaintiff the observation reminded of we are 7. resentation, plaintiff's public and to both negligent hanged a admiral British no statements record shows As physician. Voltaire, Can- encourager Ies autres.” "pour go beyond those physicians public or dide, Ch. FDA, collapses into this claim FDA. of fraud on

Case Details

Case Name: Jane King v. Collagen Corporation

Court Name: Court of Appeals for the First Circuit

Date Published: Jan 15, 1993

Citation: 983 F.2d 1130

Docket Number: 92-1278

Court Abbreviation: 1st Cir.