*1 RIEGEL, AS ADMINISTRATOR OF INDIVIDUALLY AND v. MEDTRONIC, INC.
ESTATE OF RIEGEL APPEALS FOR CERTIORARI TO THE UNITED STATES COURT OF THE SECOND CIRCUIT February 20, 2008 Argued December 2007 Decided No. 06-179. *2 M. Zieve argued With Allison cause for petitioner. Nelson, L. Brian Scott Wolfman, briefs were her on the Wayne P. Smith.
Theodore B. Olson argued the cause for respondent. Amir C. McGill, D. Matthew him the brief were With Andrew Tayrani, Gossett, Getter, David M. Kenneth S. E. Tauber.
Deputy Kneedler Solicitor General the cause argued amicus curiae affirmance. urging States as United Clement, As were Solicitor General him on brief With Douglas Daryl Attorney Keisler, Joseffer, sistant General Swingle, Meron* and Daniel Letter, N. Sharon of New filed for the State urging reversal were *Briefs of amici curiae *3 York,'Barbara Cuomo, of Attorney General New by York et al. Andrew M. Aronowitz, Solicitor Underwood, General, Deputy Michelle D. Solicitor Solicitors Chang, Assistant General, Dearing and Cecelia and Richard jurisdictions respective General, Attorneys General for their Arkansas, Arizona, Dustin McDaniel of Terry as follows: Goddard of Delaware, Connecticut, Joseph R. Bidden III of Richard Blumenthal of Florida, Columbia, of Mark Singer Bill McCollum Linda of the District of Idaho, Madigan of Illi- Hawaii, of Lisa J. Bennett of Lawrence G. Wasden Iowa, Kansas, Douglas F. Gansler nois, Paul J. Morrison of Tom Miller of Massachusetts, of Minne- Maryland, Coakley of Lori Swanson of Martha Missouri, Mike sota, (Jay) Nixon of Mississippi, Jim Hood of Jeremiah W. Nevada, King K. Gary Montana, Cortez Masto of McGrath of Catherine Ohio, Dakota, Dann of Mexico, Wayne Stenehjem of Marc of New North Carolina, E. Robert Hardy Myers Henry of South Oregon, of D. McMaster Jr., Utah, H. Sorrell Cooper, Tennessee, William Mark L. Shurtleff McGraw, Jr., of Vermont, Washington, Darrell Rob McKenna of V. Wisconsin, J. Crank of and Patrick Virginia, West J. B. Hollen of Van Brendan J. Crim- Wyoming; by David C. Frederick and for AARP et al. mins; by Jeffrey Robert for Justice et al. for the American Association Peterson; of United Consumers Union Flynn and Kathleen for the White Health Savage; for the Public States, Inc., by Heinzerling and Mark Lisa Dowling; Senator Edward Advocacy by Timothy J. and for Institute et al. Kennedy M. et al. B. William Schultz. the Advanced were filed for urging
Briefs of amici curiae affirmance E. Phillips, Daniel by Carter G. Technology Association et al. Medical Davis, Paul J. Malo- Wood, Joyce, Troy, K. Eamon P. Michael W. Rebecca United Carter; ney, for the Chamber of Commerce and William J. opinion delivered the of the Court. Justice Scalia pre-emption We consider whether the clause enacted in the Medical Device Amendments of 1976, U. S. C. 360k, challenging bars safety common-lawclaims and effective- given premarket ness of a approval by medical device (FDA). Drug Food and Administration I A Drug, (FDCA), The Federal Food, and Cosmetic Act Stat. seq., long 1040, as amended, U. S. C. 301 et has re- quired drugs FDA for the introduction of new into statutory the market. Until the enactment at issue here, however, the introduction of new medical devices was left largely supervise they for the States to as saw fit. See Med- (1996). tronic, Lohr, Inc. v. 518 U. 470, S. 475-476 regulatory landscape changed in the 1970’s, 1960’sand complex proliferated devices some failed. Most nota- bly, the Daikon Shield intrauterine device, introduced 1970,was linked to serious infections deaths, and several large pregnancies. to mention a number of Thousands of Bacigal, Litigation: tort claims followed. R. Limits Controversy The Daikon Shield In the view of many, the Daikon Shield failure and its aftermath demon- inability system strated the of tort to man- common-law *4 age dangerous g., the risks associated with e. See, devices. Managing Foote, S. the Medical 151-152 Arms Race adopted regulatory including Several States measures, Cali- requiring premarket fornia, which in 1970 enacted a law Stats, 1573, of medical devices. 1970 Cal. ch. Conrad, TJntereiner, D. Alan Robin S. and Amar by States of America Sarwal; Douglas Lawrence S. Ebner CropLife by for America and et al. Nelson; T. Robert N. Council, Inc., Liability Advisory for the Product Weiner; Popeo and Daniel J. Washington Legal and for the Foundation Samp. Richard A. Preemption Adler, The see also Leflar &
§§ 26670-26693; Preemption Liability Pentad: of Products Claims Federal (iden (1997) n. 66 Medtronic, 691,703, After 64 Tenn. L. Rev. tifying governing as of medical devices state statutes 1976). passage
Congress stepped Device in with of Medical § (MDA), seq.,1which C. 360c et Amendments of 1976 U. S. obligations imposed regime swept back state and some express oversight. The includes an detailed federal MDA pre-emption provision that states: (b)
“Except provided section, this as subsection political of a establish no State or subdivision State respect to a device intended or in effect with continue any requirement— for use human “(1) any re- to, in addition from, which is different chapter quirement applicable device, under this “(2) safety which relates to the effectiveness requirement in a device other matter included or to §360k(a). applicable chapter.” to the device under this (b) permits exception FDA contained subsection exempt local some pre-emption. regime regulatory levels of
The new established various they oversight depending devices, the risks medical present. as elastic I, which includes such devices Class subject gloves, bandages lowest to the and examination labeling “general oversight: as re- such controls,” level of 360c(a)(l)(A); quirements. Device Device FDA, Advice: (all http://www.fda.gov/cdrh/devadvice/3132.html In- Classes, available Feb. ternet materials as visited file). includes such II, which in Clerk of Court’s case Class surgical drapes, powered ibid., wheelchairs devices refer to sections Unqualified seq. numbers hereinafter 360 et S. C. U. *5 subject “special per-
is in addition to controls” such as postmarket formance standards surveillance measures, 360c(a)(l)(B). § receiving oversight
The devices the most federal are those replacement III, Class which heart valves, include implanted pacemaker pulse gen- cerebella stimulators, and supra. erators, FDA, Device Device In Classes, Advice: general, assigned a is III if device to Class it cannot be stringent provide established that a less classification would safety reasonable assurance of effectiveness, “purported represented sup- device is a or to be for use porting sustaining human life or for a use which is of importance preventing impairment substantial of human “presents potential health,” or unreasonable risk of illness 360c(a)(l)(C)(ii). § injury.” Although rigorous regime pre the MDA established a approval grandfathered market III devices, new Class it many already that were on the sold before market. Devices the MDA’seffective date remain on the market until the promulgates, regulation FDA after comment, notice and 360e(b)(l). §§ 360c(f)(l), requiring premarket approval. A provision competitive advantage related seeks limit the grandfathered A not un devices receive. new device need dergo premarket approval if the FDA it is “substan finds tially equivalent” exempt premarket to another device 360c(f)(l)(A). § approval. agency’s review of devices 510(k) § process, equivalence for substantial is known as the describing statutory provision named after the review. through III enter the market Most new Class devices 510(k). example, In FDA authorized the mar 2005,for 510(k) premarket keting granted 3,148 devices under approval just Gross Hutt, Merrill, P. R. & L. 32 devices. 2007). (3d Drug man, Food and Law 992 ed. supra, “rigorous” process. Lohr,
Premarket is a typically a A manufacturer must submit what 477. application. Advice—Premar- FDA, multivolume Device *6 (PMA) http://www.fda.gov/cdrh/devadvice/ Approval ket things, among re- full other pma/printer.html. includes, It safety investigations the device’s ports of studies and of all published reason- or should been that have and effectiveness applicant; of the de- ably a “full statement” known to the be properties the ingredients, and of “components, and vice’s description of the operation”; principle principles “a full of or the for, controls used and in, and the facilities methods used packing in- and processing, relevant, and, when manufacture, components samples re- or device of, device”; such stallation labeling. proposed specimen quired of the and a FDA; 360e(c)(l). appli- approve deciding § whether Before experts, panel may agency it of outside refer to a cation, 814.44(a)(2007), may request § data additional and 21 CFR 360e(c)(l)(G). § manufacturer, reviewing average each spends 1,200 hours The FDA an premarket ap grants application, Lohr, S., 518 U. proval only assurance” is a “reasonable if it finds there § 360e(d). agency “safety The effectiveness,” device’s any probable the use of “weig[h] health from benefit to must injury against probable illness from risk the device 360c(a)(2)(C). may approve § devices It thus such use.” great they great bene present nonetheless offer risks if approved, for exam light It alternatives. fits in of available Exemption procedures, a ple, Humanitarian Device under its failing hearts, with device for children assist ventricular using though the device of children rate even survival and Ra percent. for Devices FDA, Center than 50 was less As Debakey diological Left Ventricular Child Health, VAD Summary Safety Ben Probable System-H030003, sist (2004),http://www.fda.gov/cdrh/pdf3/H030003b.pdf. efit 20 process review premarket includes The safety and labeling. proposed FDA evaluates device’s on the forth of use set the conditions under effectiveness proposed 360c(a)(2)(B), that the must determine label, 360e(d)(l)(A). misleading, labeling nor neither false is completing After may grant deny its review, the FDA premarket § 360e(d). approval. may ap It also condition proval performance on adherence to standards, CFR §861.1(b)(3), upon restrictions sale or distribution, or com pliance §814.82. requirements, with agency other impose device-specific also free by regula restrictions §360j(e)(l). tion.
If approve the FDA pro is unable to a new device in its posed “approvable it indicating form, an send letter” *7 approved that applicant the device could be if the submitted specified agreed information or to certain conditions or re 814.44(e). § Alternatively, agency strictions. CFR may approvable” send a listing grounds “not letter, justify that practical, denial and, where measures that the applicant approvable. could undertake to make the device 814.44(f). § premarket approval,
Once device has received the MDA forbids the permission, manufacturer to make, without FDA changes design specifications, manufacturing processes, la beling, or safety other attribute, affect would 360e(d)(6)(A)(i). § applicant effectiveness. If the wishes to change, make ap such a it submit, must the FDA must prove, application supplemental an premarket approval, for largely to be evaluated under the same criteria as an initial application. 814.39(c). § 360e(d)(6); § 21 CFR premarket approval, subject
After the devices are to re porting § requirements. obligation 360i. These include the investigations to inform the FDA of new clinical or scientific concerning applicant studies the device which the knows of reasonably 814.84(b)(2), § of, should know 21 and to CFR report incidents in which the or con device have caused injury, tributed to death or serious or malfunctioned in a likely manner that would cause or contribute to death or se 803.50(a). injury rious if it recurred, The FDA has power newly premarket approval re withdraw based ported existing ap data or information and must withdraw proval or ineffective it a device is unsafe if determines that § 360e(e)(l); labeling. see also under in its the conditions 360h(e) (recall authority). B Except the facts set forth in this indicated, as otherwise Appeals. opinion appear section in the Court Evergreen Catheter marketed device at issue an Balloon by defendant-respondent III Inc. It is a Class Medtronic, premarket approval the FDA in device that received supplemental approvals changes 1994; label received its 1995and 1996. Riegel coronary angioplasty in 1996, underwent
Charles shortly App. suffering myocardial to Pet. after infarction. right coronary artery diffusely dis- for 56a. His was Cert. Riegel’s heavily Ev- inserted the eased and doctor calcified. coronary artery ergreen patient’s his Balloon into Catheter although attempt artery, label- in an the device’s dilate patients ing with dif- stated use was contraindicated fuse also warned that or calcified stenoses. label beyond pres- its rated burst catheter should not be inflated eight Riegel’s atmospheres. inflated the cath- sure of doctor *8 atmospheres; pressure eter of 10 on fifth times, five to a its Riegel Complaint ruptured. 3. de- inflation, catheter support, veloped placed and a heart on life under- block; was emergency coronary bypass surgery. went April Riegel brought in this lawsuit and his wife Donna District for the Northern 1999, in the United States Court alleged complaint that Med- District of York. Their New designed, and labeled, manufactured tronic’s catheter was law, York common and a manner that violated New permanent Riegel severe and these to suffer defects caused injuries. complaint a number of common-law The raised pre-empted held that the MDA Court claims. Riegel’s District warranty; liability; implied breach claims of strict testing, inspection, design, negligence distribu- in the App. marketing, labeling, sale the catheter. tion, Complaint Pet. for 68a; Cert. 3-4. It also held that pre-empted negligent manufacturing MDA claim insofar as premised theory it was not on the that Medtronic violated App. Finally, federal law. Pet. Cert. 71a. court pre-empted Riegel’s concluded the MDA Donna claim for loss of consortium to the extent it was derivative of the pre-empted Id., at id., claims. see also 68a; 75a.2 Appeals United States Court for the Second Circuit (2006). affirmed these 3d dismissals. F. The court “clearly subject concluded that Medtronic federal, was to the device-specificrequirement adhering to the standards con federally approved” premarket ap tained in its individual, proval application. Riegels’ Id., at 118. The claims were pre-empted they impose because if “would, successful, state requirements that from, differed added to,” device- specific requirements. granted federal Id., at 121. We certiorari.3 5 U. S.
II expressly pre-empts only require- Since the MDA any requirement ments “different from, to, addition applicable §360k(a)(l), ... to the device” under federal law, we must determine whether the Federal Government has requirements applicable established to Medtronic’s cathe- Riegels’ so, ter. If we must then determine whether the 2The granted summary judgment District Court later to Medtronic on those of Riegel viz., claims it pre-empted, had found not that Medtronic express warranty breached an negligent manufacturing was comply because it did not App. with federal standards. to Pet. for Cert. It consequently granted 90a. summary judgment as well Donna Rie gel’s derivative Ibid. The Court of Appeals consortium claim. affirmed determinations, these they are not before us. Riegel having died, Riegel petitioner on own Charles Donna is now her *9 Post, p. behalf For and as administrator of her husband’s estate. 804. simplicity’s sake, opinion be terminology of our no draws -distinction Riegel Riegel tween Charles and refers to the the Estate of Charles and claims belonging Riegels. as to the requirements upon York are based New
common-law claims inor ad- respect from, are to the device that “different with safety relate to and that ones, dition the federal to,” 360k(a). § effectiveness. majority question. of this Lohr, In first
We turn provision interpreted pre-emption in a the MDA’s Court regulation “substantially set the FDA informed” manner 808.1(d). § id., at 495; see also S., 518 U. at forth at CFR requirements regulation says are that state 500-501. That Drug pre-empted “only Administra- Food when the regulations specificcounterpart or there tion has established particular specific requirements applicable to a are other 808.1(d). § regula- by the Informed device . . . .” CFR labeling manufacturing and tion, that we concluded federal requirements applicable to almost all medi- across the board neg- pre-empt the common-law claims cal did not devices liability ligence in Lohr. The federal and strict at issue specific requirements, said, we were generic “entirely question they con- in reflected device — generally.” regulation atS., 501. U. cerns about device general federal re- While we disclaimed conclusion general quirements pre-empt, duties never state could pre-emption pre-empted, occurred we held that no never be comparison between in at on a careful the case hand based Id., at 500-501. at issue. federal duties 510(k) though substantial-equivalence review under Even rejected specific, con manufacturer’s Lohr device also § 510(k) imposed device-specific “re tention that entering products quirements.” regarded the fact We 510(k) only long through so be marketed the market pre-1976 they equivalents the relevant remain substantial qualification exemption than a re rather an as a devices (O’Connor, quirement. id., at see also Id., 493-494; dissenting part). concurring part J., “requirements” imposes approval, contrast, Premarket gen- interpreted Lohr. Unlike it in as we under the MDA *10 labeling premarket approval specific eral duties, is to individ exemption ual devices. And it inis no sense an from federal safety safety review—it is Thus, federal review. the attri §510(k) lacking pres butes that Lohr found in review are §510(k) ent equivalence, here. While is “‘focused on not safety,’” Court), (opinion premarket ap id., of the proval safety, equivalence. focused While devices §510(k) through that enter the market have “never been for mally safety efficacy,” under reviewed ibid., MDA grant premarket approval only the FDA after it deter safety mines that a device offers a reasonable assurance § 360e(d). and effectiveness, And FDA while the does not “‘require’” that a device allowed to enter the market as a equivalent any particular any par substantial “take form for requires ticular reason,” U. atS., 493, the FDA a device premarket approval that has received to made with be al specifications most ap no deviations from the in its plication, for the reason the FDA has determined that approved provides safety form a reasonable assurance and effectiveness.
HI question: then, We turn, the second whether Rie- gels’ rely upon “any requirement” common-law claims applicable New York law to the catheter is “different from, or in to,” addition federal and that “re- safety lates to of the or to effectiveness device requirement applicable other matter to the included de- 360k(a). Safety very vice.” effectiveness are sub- jects Riegels’ critical issue claims, common-law so the “requirements” is whether York’stort constitute New duties under the MDA.
A
In
causes
Lohr,
that common-law
five Justices concluded
impose
negligence
liability
“re-
of action for
and strict
do
quirement[s]”
require-
pre-empted
federal
and would be
specific
at 512
S.,
518 U.
ments
to a medical device. See
joined
Rehnquist,
(opinion
J., and
O’Connor,
C.
J.,
JJ.);
con
id.,
J.,
at 503-505
Thomas,
(Breyer,
Scalia
judgment).
curring
part
concurring
adhere to
We
*11
interpreting
have like
In
other
we
that
two
statutes
view.
“requirements”
pre-empting
provision
a
state
wise
that
held
Agrosciences
pre-empted
v. Dow
common-lawduties. Bates
(2005),
to
actions
be
found common-law
LLC,
In the leg- contrary, meaning. of this context normal To the excluding scope pre- islation common-lawduties emption would make little sense. State tort law that re- quires a manufacturer’s catheters but safer, to be hence less approved disrupts effective, than the model the FDA has regulatory federal scheme no than less law the same effect. applied Indeed, one would think tort law, juries negligence strict-liability a under standard, is less deserving preservation. regulation A state statute, or adopted by agency, expected apply a state at could be least analysis applied by experts cost-benefit similar to that many the FDA: How more lives will be saved a device along greater brings greater which, with its effectiveness, jury, only risk of harm? A hand, the other the cost sees dangerous design, of a more and is not concerned with its patients reaped rep- benefits; the who those benefits are not explained resented in court. As *12 Lohr, Breyer Justice implausible “grant it greater is that the MDA was meant to (to power set state or in from, standards ‘different addition standards) single jury to,’ federal to a state than to state acting through legislative officials state administrative lawmaking processes.” perverse S., 518 U. at 504. That required suggested by distinction not or even the broad language Congress chose in the and we will turn MDA,4 not somersaults to create it. point The Riegels § 360k(b), exempt FDA to which authorizes the to “requirements” pre-emption from under circumstances that would
rarely be permits agency met for common-law duties. But a law that an exempt to “requirements” pre-emption suggest certain from that does “requirements” Riegels § 360h(d), no other which exist. The also invoke provides compliance that with certain FDA orders “shall not relieve person liability law.” This that under Federal State indicates But it pre-empted, some claims are not as we held Lohr. state-law since possibly pre-empted, could not mean that all claims are not state-law And it deprive pre-emption that would the of all content. MDA clause provides pre-empted and guidance no as to which claims are state-law which are not.
B scope pre-emptive The dissent would narrow grounds “requirement” “difficult to be- it is term on Congress all comment, remove would, without lieve that by injured judicial FDA- for consumers means of recourse” (in- (opinion Ginsburg, approved of at Post, devices. J.) omitted). ex- quotation But, as we have ternal marks pre-emption exactly for plained, clause medical what this is by operation a law enacted its terms. The devices does by report by committee need not be seconded g., pain judicial Nat. See, e. Connecticut nullification. It is not Germain, Bank v. 503 U. S. 253-254 job upon congressional speculate If we were motives. our to only text available—the so, however, to do indication injured by suggests that the for those solicitude statute — controlling, FDA-approved dissent finds which the devices, Congress’s solicitude estimation was overcome juries medical devices if those suffer without new who would apply to all law 50 States were allowed tort innovations.5 position supported the
In
the FDA has
us,
the case before
regard
meaning
opinion
of the stat-
to the
taken
our
with
rely
agency
unnecessary
upon
We have
it
ute.
found
clearly
speaks
itself
view
we think the statute
because
point
the statute
we had found
If, however,
at issue.
position
agency’s
ambiguous
current
accorded the
had
post,
8,n.
that—
correct,
the dissent is
see
deference,
seemingly be
would
mere
deference
inasmuch as
Skidmore
*13
might
degree
the
reduced
of deference
be
at issue—the
agency’s
position
See
was different.
earlier
fact that the
(1944);
134
United States
Co.,323 U. S.
Skidmore v.
&
Swift
post,
contention,
(opinion
concur
at
Contrary to Justice Stevens’
argu
this
“advanc[e]”
do not
part
concurring
judgment),
we
ring in
and
upon congres
speculate
if
were
merely suggest
one
ment. We
in the
be found
statute.
for that would
purposes,
the best evidence
sional
(2001);
Corp.,
Hospi-
v. Mead
C Riegels underlying negligence, The contend that the duties strict-liability, implied-warranty pre- are not claims “ ” empted they impose ‘requirements,’ gen- even if because eral common-law duties are not maintained respect “‘with to devices.’” Brief for Petitioner 34-36. Again, majority suggested of this Court otherwise Lohr. J.); Breyer, (opinion S., id., See 518 U. at 504-505 at 514 (opinion joined by Rehnquist, J., C. O’Connor, J., JJ.).6 good The And with reason. Scalia Thomas, Riegels’. opinions joined by dispose Justices asser these five qualify as general tion that were too Lohr held common-law duties disa majority opinion in Lohr also respect duties “with to a device.” conclusion, did “not believe vowed this for it stated that the Court *14 reading. Riegels’ language not bear the of the statute does “may provides or continue no State establish The MDA that requirement” respect . . . in effect to a device with relating safety from, is or different to or effectiveness § 360k(a) (emphasis requirements. to, in addition federal added). depends upon Riegels’ York’s“contin The suit New respect general u[ing] in tort “with to” Med effect” duties suggests Nothing statutory in text tronic’s catheter. apply only requirement pre-empted to that the must only and not to all device, to medical devices relevant general. products in and all actions contrary argument Riegels’ on the text to the rests pre-emption regulation FDA that MDA’s
an which states including “[s]tate or duties, certain clause does not extend to pur requirements general applicability where the local products requirement pose to either other relates (e. general requirements g., such as elec addition to devices (warranty of trical and the Code codes, Uniform Commercial fitness)), practices require to unfair trade which § 808.1(d)(1). to ments are not limited devices.” CFR regulation play assuming a role de Even that this could provide fining pre-emptive scope, un it does not the MDA’s position. agency’s ambiguous support Riegels’ for the reading deference, its own rule is entitled substantial (1997), and the FDA’s Auer U. S. Robbins, see v. put regulation case that the does view forward in this is underlying general care, such as those refer tort duties designed, labeled, that a was the claims in this case device Brief manner, in an unsafe or ineffective or manufactured ac so, That Amicus 27-28. for United States as Curiae regulation cording from excludes FDA, to the because incidentally only requirements pre-emption relate requirements. tort General but not other devices, medical . . necessarily precludes . language statutory regulatory [the MDA’s] S.,U. pre-empted ....” being ever ‘general’ state at 500. *15 prac-
duties of care, unlike fire codes or restrictions on trade “directly regulate” including tices, the device itself, its de- sign. agency’s explanation Id., at 28. We find the less than compelling, general require- since the same could be said of imposed by ments electrical codes, the Uniform Commercial unfair-trade-practice regulation spe- Code, or law, which the cifically pre-emption. excludes from portions
Other support § 808.1, 21 CFR however, 808.1(d)(1) agency’s § application view that no has to this (though failing explain why case still to electrical codes, unfair-trade-practice require Uniform Code, Commercial different). 808.1(b) ments are Section states that the MDA “general pre-empting “having sets forth a rule” state duties (whether by the force and effect of law statute, established decision) regulation, (Emphasis ordinance, or court . . .” . added.) comprehensible This is far sentence more under the 808.1(d)(1) § application FDA’s view that has no here than Riegels’ under the view. areWe aware of no duties estab lished court decision other than common-law duties, are solely we aware noof common-law duties that relate medical devices. Riegels’ reading regula- is also in tension with the misbranding
tion’s statement that adulteration and claims pre-empted they establishing “ha[ve] are when the effect of a requirement specific g., specific substantive for a a device, e. labeling requirement” that is “different from, addition 808.1(d)(6)(h). § requirement. Surely a to,” federal this pre-empt jury means that the MDA would determination FDA-approved labeling pacemaker that the for a violated requirement warnings. a state common-law for additional § Riegels’ reading 808.1(d)(1), however, would allow a escape long mislabeling pre-emption claim for tortious so brought against objects such a claim also other could be than medical devices. 808.1(d)(1) § nothing all,
All in we can to our think that add analysis accepting rejecting but nor confusion. Neither properly regulation consulted proposition be can that this accepting meaning; nor and neither determine the statute’s require- general rejecting between FDA’s distinction regulate only directly regulate and those ments that interpretation regulation incidentally; to alter our fails concerned. of this case is the outcome text insofar as IV only pre-empted requirements under the MDA are State they inor addition from, are “different to the extent 360k(a)(l). imposed federal law. to” the providing a dam- prevent State Thus, 360k does *16 regu- remedy premised of FDA ages on a violation claims for “parallel,” than rather in such a case the duties lations; see requirements. S., 495; at Lohr, 518 U. to, add federal (O’Connor, concurring part in and dissent- id., J., also at 513 recognized that ing part). case in this in The District Court App. pre-empted, Pet. for parallel see claims would not be interpreted here to assert the claims it 70a-71a, Cert. but notwithstand- tort law violated state that Medtronic’s device requirements, see ing compliance relevant federal with the argue Riegels Although their law- now that the id., at 68a. they in parallel contention no such claims, made suit raises they this raise Circuit, nor did their briefs before the Second petition argument decline ad- certiorari. We in their argument here. in the first instance that dress judgment the foregoing Court reasons, For Appeals
Affirmed. concurring Stevens, part concurring Justice the judgment. provision pre-emption in the Medi- significance of the (MDA), 360k, 21 U. S. C. of 1976 Amendments
cal Device
appreciated
fully
many years
was not
until
after it was
example
gen-
enacted.
an
It is
of a
text
statute whose
objective
territory
actually
eral
cover
envisioned
its
frequently
authors.
In such
we
cases
have
concluded that
ultimately
provisions
“it is
of our
rather than
laws
principal
legislators by
of our
concerns
which
arewe
governed.” Oncale
Services, Inc.,
v. Sundowner Offshore
(1998). Accordingly,
agree
There is in the of the MDA suggesting Congress thought that state tort remedies had impeded development of medical Nor is there devices. suggest at evidence all to decided injuries Drug the cost of from Food and Administration- approved outweighed “by medical devices was solicitude for juries those who would suffer without new medical devices if apply were allowed tort law 50 to all innova- States Court). (opinion policy tions.” Ante, That is a *17 argument by by Congress. advanced the not As Court, Jus- persuasively explains, overriding pur- the Ginsburg tice pose legislation protection provide of the towas additional existing protections. to not was consumers, to withdraw It regulatory development premarket the then-recent of state regimes explained provision pre-empting that the need for a conflicting Medtronic, v. See Inc. administrative rules. (“[W]hen (1996) (plurality opinion) Lohr, 518 470, U. S. 489 primarily the it concerned with 360k, enacted was regulations problem specific,conflicting of state statutes general by rather common-law than the duties enforced actions”).
332 the such of reaches beyond provision
But language of “require- other encompass types to regimes regulatory administered rules Because common-law ments.” define legal create and like statutes and regulations, judges, “require- qualify them unquestionably some of obligations, Inc., 505 U. S. Group, v. Liggett See Cipollone ments.”1 (“[C]ommon-law (1992) damages opinion) 522 (plurality are premised the sort raised by petitioner actions of that such to say of a and it is difficult duty, existence legal [I]t not ‘requirements prohibitions.’... actions do impose are that to enforce duties essence of the common law negative prohibitions”). affirmative either as “require- rules qualify And not all common-law although that out five Justices ments,”2 correctly points the Court action Lohr concluded that causes of the common-law in that case imposed at issue liability and strict negligence federal require- that were pre-empted “requirements” 1 rules, however, “require juries obey not who are The verdicts those And apply rules, do not make them. ments” of that Juries but kind. device jury’s liability may defendant to alter its finding while a induce a label, “requirement” within the finding or its this does not render be that must meaning requirement “A is a rule law MDA. merely optional an obeyed; event, jury verdict, that motivates an such as a LLC, U. S. requirement.” Agrosciences is not a Bates v. Dow decision grant that the MDA does It is for that reason that set standard single any power to jury’” ‘“a whatsoever I do not federal standard. conforms with or differs from relevant either opinion, quotation the Court’s agree with the colorful but inaccurate ante, at 325. that the S., (plurality opinion) (explaining Cipollone, U. at 523 See §5(b) positive scope of cannot be limited pre-emptive “the fact that pre-empts all common-law that that enactments does not mean section claims analyze petitioner’s common-law proceeding “each of claims” Bates, S., 443- U. pre-empted”); in fact whether it is determine 136v(b) judge- pre-empt U. (noting finding “[7 that a S. C.] nothing about says rules, regulations, as well as statutes made par whether proceeding to determine scope pre-emption,” of that conditions case satisfied the at issue ticular common-law rules *18 pre-emption).
ments to a medical specific device. I with Moreover, agree the Court’s of cogent explanation why the claims are Riegels’ predicated New York common-law duties that constitute with to the at requirements respect device issue that differ from federal relating safety and effective- I ness. therefore join Court’s all of its judgment for Parts opinion except III-A III-B. Ginsburg,
Justice dissenting. Amendments, (MDA The Medical Device of 1976 or Act), Court, Stat. as construed cut into a deeply domain state law. The historically occupied by MDA’s pre- clause, § emption 360k(a), U. S. C. the Court holds, spares medical device manufacturers claims personal injury flaws in a label alleging once for design application or label has design from the gained premarket approval Food and (FDA); Administration a state rem- Drug damages the Court edy, instructs, for persists only claims “premised Ante, on a violation of FDA I 330.1 dis- regulations.” sent from constriction state today’s authority. Congress, 360k(a) view, § did not my intend to effect a radical curtail- ment common-law for suits seeking compensation injuries caused medical designed labeled defectively devices. 360k(a) for reason
Congress’ enacting evident. Until the Federal Government did not engage premarket fill medical devices. Some States acted to regulation their void own for medical by adopting regulatory systems 360k(a) devices. Section to that state responded regulation, to California’s particularly system premarket ap- State initiatives proval devices, medical by preempting 360k(b). absent FDA See permission. holding important
1The Court’s does not reach an issue outside 360k(a) §of where of a preemptive this case: the effect evidence bounds of pre light only the device receives medical device’s defect comes to after approval. market *19 334
I Congress touchstone of “purpose the ultimate is Group, Liggett analysis.” Cipollone Inc., pre-emption v. omitted). (internal (1992) quotation marks 504, 505 U. 516 S. Congress “long presumed not does cava- that have Courts lierly pre-empt Medtronic, Inc. of action.” state-law causes (1996).2 analysis Preemption 470, S. 485 Lohr, v. 518 U. powers police assumption that “the historic starts with the superseded [a]re . . unless that was to be . States purpose Congress.” v. Rice Santa manifest clear and (1947). assump- Corp., “This 218, 331 U. S. 230 Fe Elevator provides balance’ will assurance that 'the federal-state tion Congress unintentionally by or unnecessar- not be disturbed Packing ily 519, Co.,430 U. S. the courts.” v. Rath Jones omitted). (citation (1977) 525 preemption heightened against presumption “where in fields of traditional
federal law is said to bar state action regulation.” Blue York State state New Conference Co., 514 Plans v. Travelers Ins. U. S. Blue Shield Cross & (1995). “primacy reg- of state 645, traditional 655 Given safety,” 518 U. Lohr, S., ulation of matters of health and regulation related assume “that state and local 485, courts regu- normally [those] federal matters can coexist with ... County Hillsborough Medical Labo- lations,” v. Automated Inc., 718 ratories, U. S. containing preemption not auto- clause do
Federal laws against preemption. matically escape presumption See (2005); Agrosciences U. LLC, S. Bates v. Dow preemption us clause tells A Lohr, S., U. at 485. modify supersede law to intended precision, legislative how- In the absence of some extent. determining the substance face the task of ever, courts Court, plurality. Unless part, for a spoke part, In Lohr for the con of Lohr indicated, portions this refer opinion citations otherwise veying opinion of the Court. scope Congress’ displacement of state law. Where preemption open text of a clause is to more than one
plausible reading, ordinarily “accept reading courts pre-emption.” disfavors Bates, S., 544 U. at 449.
II preemption The MDA’s clause states: *20 “[N]o political State or subdivision of a State estab- respect lish or continue in effect with to a in- device any requirement— tended for human use “(1) any which is different from, or in to, addition re- quirement applicable chapter under this to the device, and
“(2) safety which relates to the or effectiveness of the device require- or to other matter included in a applicable ment chapter.” to the device under this 21 360k(a). § U. S. C.
“Absent other indication,” the states, Court “reference to ‘requirements’ a State’s includes its common-law duties.” Regarding Ante, at 324. the MDA, however, “other indica- “[ajbsent.” tion” is not Contextual examination of the Act 360k(a)’s “require- convinces me that inclusion of the term prompt ment” sweeping preemption should not of mine-run claims for relief under state tort law.3
A Congress provide safety enacted the MDA “to for the effectiveness of medical devices intended for human use.” very provision, 360k(b), political next allows States and their sub apply exemption requirements divisions to for from the for medical devices by set the FDA stringent” when their own are “more than by “compelling federal or are standards necessitated local conditions.” concerns, prescription This as embodied in indicates solicitude § 360k(a) § 360k(b) legislation regulation. But no more than itself does show that homed in on state common-law suits and meant deny injured parties recourse to them. medical A of high-profile series
90 Stat. 539 (preamble).4 loss injuries that caused extensive device failures among Conspicuous MDA.5 life propelled adoption device, intrauterine Daikon was the Shield these failures in the United million women 2.2 used approximately Dist. In re Northern 1974. See between 1970 States Liability Litigation, Daikon IUD Prods. Cal., Shield ante, at 315. (CA9 1982); Aggressively pro 2d F. Dai control, the effective form of birth moted as safe and and 25 miscarriages linked to 16 deaths kon Shield had been 94-853, 1975. H. R. No. p. middle of Rep. compensa “more than 500 lawsuits early 1976, seeking By than million” more and punitive damages totalling $400 tory Ibid6 attending been Given the publicity had filed. the suits awareness of
Daikon Shield litigation Congress’ consideration, I find infor- time was at the the MDA under Senate, explained: legisla “The Introducing sponsor in the its the bill *21 always given to the the benefit of the doubt is tion is written so that with and his pays who his health consumer. After all it is consumer (1975) (re Cong. Rec. life for medical malfunctions.” 121 10688 device Kennedy). marks of Sen. 5 (1976) See, 94-853, (“Significant defects g., Rep. p. H. No. 8 e. R. voluntary pacemakers, recalls of pacemakers cardiac have necessitated 34 (“Some (1975) 1972.”); 94-33, p. 23,000 Rep. 6 involving units, since S. No. recorded, For exam 10,000injuries resulted death. of which 731 were valves; deaths injuries to heart 89 ple, 512 deaths were attributed and 300 8,000 to intra injuries injuries and pacemakers; 186 10 deaths to heart Waxman) (1976) (remarks Rep. devices.”); Cong. 122 Rec. uterine 5859 (“A 850 tied di 10-year found over deaths FDA death-certificate search (remarks id,., Nel devices.”); of Sen. rectly to 121 at 10689-10690 medical (1996). son). Medtronic, Lohr, 476 v. 518 U. S. See also Inc. inju ultimately of serious linked to “thousands The Daikon Shield was Preemption Regulatory Vladeck, healthy women.” ries to otherwise (2005). 1984, manu 95, 103 By Failure, Pepperdine October L. Rev. cases. 7,700 Shield approximately Daikon litigated had facturer settled or Bankruptcy Daikon Shield Sobol, Story Bending the Law: R. (1991). any sign legislative design pre- mative the absence of of a empt state common-lawtort actions.7 “§ recognizes prevent
The Court that 360k does a State providing damages remedy premised for claims on a regulations.” remedy, violation of FDA Ante, at That 330. although important, help injured by does not consumers de- prove vices that FDA receive but nevertheless un- any safe. compensatory The MDA’sfailure to create federal remedy suggests Congress for such consumers further that broadly preempt did not intend state common-law suits grounded allegations independent requirements. of FDA Congress It is “difficult to believe would, without com- judicial large ment, remove all means of recourse” num- injured by bers of consumers defective medical devices. Corp., Silkwood v. Kerr-McGee U. S. explained:
The former chief counsel to FDA product approval “FDA’sview is that FDA and state liability usually operate independently, tort provid- each ing significant, yet layer protec- distinct, of consumer regulation anticipate tion. FDA aof device cannot protect against safety all risks to individual consumers. regulation thorough product Even the most of a such as identify potential a critical medical fail device problems product. presented by Regulation cannot 7“[Njothing hearings, debates,” in the Reports, the Committee noted, the Lohr plurality “suggest[ed] legislation proponent intended a sweeping pre-emption of traditional common-law remedies against manufacturers If distributors defective devices. result, odd, spectacularly
intended such a its failure even to hint at it is particularly acutely ongoing aware of since Members both Houses were S., Mann, product litigation.” liability at 491. Adler & 518 U. See also *22 Amok, Preemption and Medical Devices: The Courts Run 59 Mo. L. Rev. (1994) 895, (“To 925 common extent that mentioned law tort claims, suggest they it to was not criticize them that needed Rather, regulation place. be barred once it was to note a federal was they protections how for consumers were demonstrated additional needed.”). 338 result that might injuries all possible
protect against all such of Preemption over time. of a device from use of layer a significant the loss of result claims would Lohr Decision: Porter, The .” . . . consumer protection 7, L. J. Drug 52 Food & Position, FDA Perspective (1997). 11 Amicus Curiae Pet. for as Brief for United States
Cf. Systems, Ker Inc. v. Medical Industries in Smiths Cert. Health and of nats, O. T. 17-18; 96-1405, Dept. 1997, pp. No. Service, Advisory Opinion, Health Services, Public Human Hile, Associate from J. Letter 83A-0140/AP, Docket No. Health Women’s Affairs, to National for Regulatory Comm’r 1984).8 construction (Mar. Court’s 8, Network immu broad 360k(a) effect” granting has the “perverse of Congress, in the that, judgment industry “to an entire nity Lohr, S., at 518 U. regulation,” needed more stringent in tort from liability not exemption opinion), (plurality litigation. order certain authority the FDA grant
The MDA does alia, inter that a device “pre- it concludes if, remedial action See position in an amicus brief. recently a new The FDA announced An amicus brief inter as Amicus Curiae 16-24. Brief for United States Skidmore v. most, under entitled, at to deference is preting a statute Corp., States v. Mead (1944). Co., See United & S. 134 323 U. Swift agency position to an weight accorded U. S. 229-233 in its consider thoroughness evident Skidmore upon the “depend[s] under later consistency with earlier reasoning, its ation, validity of its if persuade, power to give it those factors which pronouncements, and all Mead, S., 533 U. S., at 140. See also 323 U. lacking power to control.” alia, “persuasiveness” “consistency” and inter (courts consider, Shalala, U. S. Hospital v. position); GoodSamaritan agency’s an in assess a factor (“[T]he position is (1993) consistency agency’s anof view due.”). long-held the FDA’s Because weight position ing the 360k(a) pre comports with the better effect of preemptive on the limited protections, safety health preemption of state sumption against position is new MDA, the FDA’s history purpose and well as the weight. to little entitled
339 sents an public unreasonable of risk substantial harm to the by health” and that notice of the defect “would not itself be sufficient to eliminate the unreasonable risk.” U. S. C. 360h(b)(l)(A). Thus the FDA order the manufacturer repair replace purchase price, the device, it, refund the (e). § 360h(b)(2), cease distribution, or recall the device. prospect The of ameliorative action the FDA, however, support Congress lends no to the conclusion that intended largely preempt oppo state common-law Quite suits. 360h(d) “[compliance site: Section that states with an order any person issued under this section shall not relieve liability provision under Federal or State law.” That antici pates “[court-awarded] damages for economic loss” from remedy which the value of FDA-ordered would be sub tracted. Ibid.9
B regulating enacted the MDA after decades of drugs and food and color Food, additives under Federal Drug, (FDCA), and Cosmetic Act 1040, amended, Stat. as §301 seq. preemption U. S. C. et contains no FDCA § 360k(a) interpretation clause, and thus the Court’s has bearing involving drugs no on tort suits and additives. But 360k(a)’s hardly confinement to medical devices renders ir proper preemption relevant to the construction MDA’s provision long history controls over federal and state drugs public in health and wel additives the interest Congress’ experience drugs regulating fare. additives regulation part provided informed, for, and in the model its of medical devices. I therefore turn to an examination of experience. that § 360h(d) regards unenlightening because it “could not Court “provides all state-law
possibly pre-empted” claims not mean are guidance pre-empted and which are no as to which state-law claims are Ante, op against preemption presumption not.” at n. 4. Given supra, 334-335, clause, construing see preemption erative even Medtronic, its favor. perceived “guidance” against lack should cut new un- drugs required FDCA Starting mar- could be they the FDA before dergo preclearance in the FDCA’s 1052. §505, Nothing Stat. keted. See *24 that FDA preclearance suggested or legislative history text tort from common-law manufacturers drug would immunize suits.10 in 1976, state the MDA the time enacted Congress
By
had
design
for
defects
labeling
claims
drug
common-law
FDA
four decades
nearly
unabated
continued
despite
11
clause
inclusion
a
Congress’
preemption
regulation.
that similar state
concern
was not motivated by
the MDA
medical devices.12
regarding
actions could be mounted
tort
10
for
a federal claim
contrary, the bill
not need to create
To the
did
ex
testified,
right of action
common-law
damages,
“[a]
witnesses
because
”
Com
Senate
on S. 1944 before a Subcommittee
Hearings
isted].
(statement
(1933)
A.
Sess.,
of W.
Commerce,
Cong.,
73d
2d
400
mittee on
Ladds) (“This
id.,
Hines).
(statement
should
of J. A.
act
See
at 403
also
per
respect
with
attempt
modify or
the common law
restate
injuries.”).
sonal
11
defendants,
to state
appears,
preemption
it
raised no
defense
Most
Parke,
g.,
e.
Salmon
drugs. See,
v.
involving FDA-approved
suits
tort
1975) (North
Co.,
law); Reyes v.
(CA4
&
Davis
F. 2d 1359
Carolina
520
Sterling
(CA5 1974) (Texas
Labs.,
law);
v.
Wyeth
1264
498 F. 2d
Hoffman
Sterling
(CA3 1973)
Inc.,
Singer
law);
Drug,
(Pennsylvania
v.
F. 2d 132
485
(CA7
(Indiana
Inc.,
v. Norwich
1972)
law);
McCue
Drug,
288
461 F. 2d
(New
law); Basko
(CA1 1972)
Co.,
Hampshire
Pharmacal
F. 2d
453
1033
(CA2 1969) (Connecticut law);
Inc.,
Parke
Sterling
Drug,
416 F.
417
v.
2d
(CA8 1969) (North
Stromsodt,
law);
&
Dakota
Davis Co. v.
The listed, measures like all MDA, were enacted personal litigation injury with common-law over deféctive products prominent legal part landscape.13 a of the theAt that... exemption products medical devices should receive an from liabil- ity litigation subject new drugs, regulatory scrutiny while to similar agency, the same regime.”); should remain under standard tort law Lohr Decision: FDA Porter, Position, Perspective Drug and 52 Food & (1997) (With 7,11 L. J. of preemption, regulation the “FDA’s devices would entirely weight litigation have been an in private accorded different tort counterpart regulation drugs biologies. disparity than its This justified in- appropriate, agency neither nor nor does the believe it was ....”). by Congress tended pre Drug Congress’ of 1962 reiterated intent not to Amendments empt relying on . . . shall “Nothing claims state law: the amendments any provision of which would be invalidating be construed as State law posi in the there is direct and valid absence such amendments unless law.” provision such of State tive conflict between such amendments and § 202, Stat. 793. required pre- regulations no state enactment,
time of each question, drugs no so additives market against potentially preemption needed a check clause was as conflicting regulatory regimes. for Sen. Ed- See Brief state Kennedy 10. ward et al. Amici Curiae M. when
A as to medical devices different situation existed Congress developed passed the House the MDA. As Report observed: regulation of med-
“In the absence of effective Federal pro- own their devices, ical grams. some States have established regulation comprehensive State The most California, is aware is that which Committee Drug, adopted Food, the Sherman which premarket approval requires This law Cosmetic Law. requires compliance of device devices, of all new medical practices good manufacturing with manufacturers inspection which manu- of establishments authorizes Implementation Law of the Sherman facture devices. requirement de- intrauterine in the has resulted subject premarket in California.” are clearance vices added).14 p. (emphasis Rep. 94-853, 45 H. R. No. premarket regulation devices,
In of medical sum, Congress’ any design suppress in- suits, tort accounts preemption no such clause MDA; clause in the clusion of drugs figures regulating and addi- in earlier federal laws comparable re- control tives, not installed for States had *26 gimes in those areas. 14 of system in its discussion regulatory California’s featured for prime candidate system § as a 360k(a), it also California’s but identified §360k(b). im “[Requirements exemption preemption
an under noted, as an statute,” Report “serve House posed the under the California to be contin Secretary authorize example the should requirements by a State meets (provided any application submitted ued bill).” 94-853, p. 46. Thus Con Rep. H. reported R. No. pursuant to the systems, but approval premarket all gress sought not to terminate state FDA. controlling authority of the systems those under the place rather to
343 c also Congress’ experience casts doubt on regulating drugs §360k(a) Medtronic’s arguments for policy reading pre- 360k(a) state tort empt claims. Section must preempt common-law Medtronic suits, contends, because Congress would not have wanted state juries second-guess FDA’s that medical safe finding device is and effective when used as Brief directed. for 42-49. The Respondent Ante, Court is minded. similarly 324-325.
But the for process new is at least as approving drugs rigorous for medical premarket approval de- process vices.15 Courts that have considered the have question that FDA held of a new overwhelmingly approval drug appli- cation does not state tort preempt suits.16 Decades of drug 15 process approving preclinical a new drug begins with labora tory and testing. sponsor animal drug of the new then submits an investigational application drug new seeking FDA to test drug § 355(i) (2000 U. Supp. V); humans. See 21 S. C. ed. and 21 CFR § 312.1 seq. et generally proceed Clinical trials in phases three involving successively larger groups patients: subjects to 80 phase I; no subjects II; more than phase several hundred and several hundred subjects phase to several thousand III. 21 CFR 312.21. After com pleting trials, sponsor drug clinical application files a new contain alia, inter ing, reports investigations” showing “drug “full whether the effective”; safe for composition; use and . .. the drug’s description drug’s manufacturing, processing, packaging; proposed and the 355(b)(1) (2000 V). labeling ed., drug. Supp. for the U. S. C. 16See, Prods., Inc., g., e. 528, Tobin v. Astra Pharmaceutical 993 F. 2d (CA6 Pharmaceuticals, Labs., v. Searle Searle 1993); Hill Div. of 537-538 Inc., (CA8 Liability Litiga In re Prods. 1064,1068 1989); 884 F. Vioxx 2d tion, (ED Zyprexa In re 776, 2007); Prods. Supp. 501 F. 2d 788-789 La. (EDNY 2007); Liability Litigation, Weiss Supp. 230, F. v. 2d 275-278 Fujisawa Co., (ED 2006); Pharmaceutical 666, Ky. Supp. 464 F. 2d (ED Perry Corp., 678, v. Novartis Pharma. Supp. 456 F. 2d 685-687 Pa. Inc., 2006); 2819046, Pfizer, (JBS), McNellis v. Civ. 2006 WL No. 05-1286 Inc., (D. 964, Pfizer, Jackson v. J., 2006); Sept. 29, Supp. 432 F. 2d *5 N. Pharmaceutical, Inc., (Neb. v. Par 2006); Laisure-Radke Supp. 426 F. Inc., (WD Pfizer, 2006); Supp. 2d Witczak v. 377 F. 2d Wash. (Minn. Inc., Pfizer, 726,732 8104,2005 Zikis 2005); v. C WL No. 04 *27 344 Medtronic’s indicate, argument, to contrary thus
regulation tort and state FDA regard regulation did not exclusive. mutually claims
III § 360k(a) state automatic bar to to as an read Refusing render the FDA’s pre would hardly common-law tort claims device application market Medtronic’s medical First, a provi to the instant suit. “pre-emption irrelevant itself, (through negative implica not foreclose sion, does Geier tion) conflict implied preemption.” possibility Co., (2000) American Motor Honda 861, U. S. 869 529 v. omitted). also (brackets marks See and internal quotation Myrick, Freightliner Corp. 280, 288-289 v. 514 U. S. have a dis- device manufacturer may medical
Accordingly, (ND Inc., 876, 2d Ill., May 9, 2005); Cartwright Pfizer, Supp. 369 F. v. *3 (ED IP 2005); Corp., No. Eve v. Pharmaceutical 885-886 Tex. Sandoz (SD 28, 2002); 98-1429-C-Y/S, 181972, Ind., v. *1 Jan. Caraker 2002 WL (SD 2001); 1018,1044 Supp. 2d Ill. Corp., Sandoz Pharmaceuticals 172 F. (CD 2000); Inc., 1085,1087 Kociemba Pfizer, Supp. v. F. 2d Cal. Motus 127 (Minn. 1988). Co., But see Supp. 1293,1299-1300 D. & F. v. G. Searle (2006) discussing labeling regulations Reg. (preamble to 71 Fed. 3933-3936 drug recently adopted labeling FDA’s view that federal Marketing laws); In preempt conflicting state re Bextra Celebrex CRB, 2006 Liability M: Litigation, Practices Prod. No. 05-1699 Sales Inc., (ND 2374742, Cal., 16, 2006); Apotex, v. Aug. *10 Colacicco WL (ED Inc., Civ. 514, 2006); v. No. Supp. Pa. Needleman F. 2d 537-538 Pfizer (ND Tex., 6, 2004); Aug. Dusek 3:03-CV-3074-N, 1773697,*5 A. 2004 WL (SD Tex., H-02-3559,2004 2191804, Feb. Inc., *10 A. WL v. No. Civ. Pfizer rule). 2004). (2008) 20, Reg. (preamble proposed But Fed. cf. 73 Wyeth, 183 Vt. in Levine v. This Court will address the issue soon cert, question presented (2006), post, p. 1161. The granted, A. 2d im drug labeling judgments prescription in that case is: “Whether (‘FDA’) Drug Administration the Food and posed on manufacturers efficacy authority under safety and comprehensive pursuant FDA’s §301 seq., preempt Food, Act, 21 S. C. et Cosmetic U. Drug, and Federal theory different premised on the liability claims product law reasonably safe necessary drugs make labeling judgments were 06-1249, p. Levine, i. T. No. Wyeth v. O. Pet. for Cert. in use.” *28 positive identify it defense if can an actual conflict between theory plaintiff’s premarket of the case and the FDA’s approval question. currently postured, of the device in As presents up this case no occasion take this issue for Med- 360k(a) § exclusively argue tronic relies and does not con- preemption. flict
Second, a medical device manufacturer be entitled to interpose regulatory compliance a on the defense based approval premarket application. FDA’s of the Most States regulatory compliance regard dispositive, do not treat but jury. it as one factor to be taken into account See Sharkey, Regulatory Preemption FDA Federalism Action: in Pharmaceutical Cases in Courts, State Versus Federal Pol’y J. & 1013, Law also See Restatement (Third) 16(a) Apr. (Proposed of Torts Final Draft No. 2005). present In States, those manufacturer could FDA’s of its device it medical as evidence that used design product. labeling due care of the 360k(a) reading The Court’s broad saves the manufac- urge turer from Instead, need to these re- defenses. gardless strength plaintiff’s will be case, suits authority ab barred initio. The or- constriction of state today by Congress dered was not at odds mandated and is safety. purpose: protect with the MDA’scentral consumer §360k(a) For the stated, reasons I would does hold preempt Riegel’s I would therefore reverse suit. judgment part. Appeals relevant Court