*1 Walker v Johnson & Johnson PRODUCTS, WALKERv JOHNSON & JOHNSON VISION INC 13, 1996, July 26, Docket No. 175013.Submitted March at Detroit. Decided appeal sought. at 9:05 A.M. Leave to brought Kim in an action the Oakland Circuit Court Products, Inc., others, alleging Johnson & Johnson Vision and permanent injury right eye she suffered her as the result of the disposal by use of contact lenses manufactured Johnson & John- plaintiff alleged respect negli- son. The with to Johnson & Johnson gent design lenses, negligent and manufacture of the failure to dangers lenses, warn of the associated with the use of contact and warranty. summary dispo- breach of Johnson & Johnson moved for sition on the basis the soft extended-weаr contact lenses were in Class medical devices under the Medical Device Amendments of seq., Food, Drug, USC 360c et of the Federal and (mda), Act, seq., and, accordingly, Cosmetic 21 USC 301 et liability preempted by 360k(a), 360k(a). § claims were The court, Mester, J., granted summary disposition Fred M. for Johnson subject-matter juris- & Johnson on the basis that the court lacked 360k(a) § diction because of and dismissed the other defendants on stipulation parties. plaintiff appealed. of the The Appeals The Court of held: Congress preempt did not intend to state court actions the manufacturers of Class m mediсal devices where the claim is negligent design device, based on the and manufacture of the negligent dangers failure to warn of with associated the use of the device, warranty relating or a breach of a to the device. Accord- ingly, holding subject-matter the trial court erred in that it lacked jurisdiction granting summary disposition for defendant Johnson & Johnson. adoption 1. It is unclear whether intended 360k(a) products liability involving all state actions subject provisions accordingly, devices to the of the it is MDA; proper regulations Drug to look to the of the Food and Administra- tion, body charged the administrative with the enforcement of the provisions guidance interpreting congressional mda, agency’s intent and to defer to the construction of the statute inteipretation unless its of the statute is unreasonable. 217 Mich regulations, 808.1(d), interprets 2. The fda in its 21 CPR only preempting requirements state and local where specific counterpart regulations fda “has or there established specific requirements applicable device other thereby act, making existing divergent under the State or local *2 requirements applicable from, to the in device different or addition rеquirements.” to, specific Drug Food and Administration premarket approval procedure 3. The of Class in medical devices by pursuant 360c(a)(l)(C), 360c(a)(l)(C), the fda specific requirement applicable not a device because applies Further, it to all Class m medical devices. because the mda protect specifically consumers, provides was enacted to mda pursuant any person order that an issued to 460 does relieve from liability law, provide under state or federal and the fails to specific remedy, Congress pre- federal could not have intended to liability empt thereby person state actions and leave a injured by remedy. a Class m medical device without a provides labeling 4. Because the for the of medical devices adequate warnings pre- dangers with directions and where the of a scription practitioners are not known to device licensed to use the plaintiff alleged dangers device and the has that the of the contact they pre- lenses at issue were not well known at the time were her, scribed her claim based on a failure to warn is not “differ- from, requirements imposed ent or in addition tо” the under the requirements. but is rather an action to enforce those Accord- mda, ingly, preempted. the claim based on the failure to warn is not Reversed and remanded. J., concurring result, in the stated that the matter raised Griffin, by appeal holding Medtronic, Lohr,
in this is resolved in v Inc US_. (1996), controlling. which is Congress — — — 1. Statutes Courts Intent Administrative Regulations. determining Congress passing A court in the intent of a statute ambiguous regarding congres- where the itself is silent or statute may regulations agency charged sional intent look to the of the guidance interpreting with the administration of the statute for congressional intent. — — 2. Statutes Medical Device Amendments of Medical Devices purpose The of the Medical Device Amendments of 1976 of the Fed- Food, Drug, protect eral and Cosmetic Act was to consumers from (21 seq.~). unsafe medical devices USC 360c et v & Johnson Johnson
Opinion Court of the — — Preemption. 3. Actions Federal Devices Medical adoption Device Amendments of the Medical its did not pre- Food, Drug, Act intend and Cosmetic Federal 1976 of the n of Class med- empt the manufacturers actions court negligent design and are based on the the claims devices where ical devices, negligent failure to wаrn of dan- manufacture of devices, war- or a breach of gers with the use associated 360k[a]). (21 ranty relating to the devices Simpson & Downing, Schneider Loria, Kelman, plaintiff. Posner), for Alan B. (by & Freeman Van Dusen Moon, Dickinson, Wright, for the Powell), W. and Robert S. Krause Robert (by defendant. P.J., E. R. and Griffin Post,*
Before: Murphy, JJ. & Johnson Plaintiff filed suit Murphy, PJ. 1 when she suffered *3 Products, Inc.,*
Johnson Vision contact eye using after injury right to her permanent court The trial by defendant. manufactured lenses were defendant against claims plaintiffs found that of Device Amendments by the Medical preempted Food, the Federal seq., 360c et to 21 USC 1976 (mda), and seq., et Act, 21 USC 301 and Cosmetic Drug, summary disposition motion for defendant’s granted subject- court lacks 2.116(C)(4) (the to MCR pursuant reverse and We appeals. Plaintiff jurisdiction). matter remand for trial. * by assignment. Appeals sitting judge, on the Court Circuit 1 Adler, Optometry Irving against Care Dr. First also filed suit Plaintiff However, Eyes Only, Inc., these defendants Centers, Inc. For Your and an order dis- appeal entered parties the trial court this because
not missing plaintiff’s parties’ pursuant against to the them cause of action stipulation for dismissal. App 217 developed alleged
Plaintiff that she a comeal ulcer permanent injury eye right and suffered using her after hydrophilic Acuvue, A, Vistakon etafilcon dis posable (Acuvue lenses), contact lenses contact a product manufactured defendant. Plaintiffs sec complaint ond amended contained claims negligent design for defendant and manufacture of negligent lenses, contact failure to warn of the dangers associated with the use of the lenses, contact warranty.2 and breach of Defendant moved sum for mary disposition pursuant argu 2.116(C)(4), to MCR ing regulated that Acuvue contact lenses are as Class plaintiffs m medical devices under the and that expressly preemрted defendant were by 360k(a), 360k(a). § granted The trial court holding 360k(a) preempted motion, defendant’s plaintiff’s claims. grant
This Court reviews de novo a trial court’s or summary disposition. denial Wakim, Bitar v (1995). Mich reviewing NW2d 583 When summary disposition motion under 2.116(C)(4), MCR we must determine whether the pleadings demonstrate that the defendant was enti- judgment tled to aas matter of law or whether the proofs affidavits and other show that was there no genuine Bitar, issue of material fact. 619-620.
The issue in case this is whether plaintiff’s preempts negligent design and manufacture, negligent implied warn, failure to breach war- that the contact MSA 19.2315. MCL any express warranties, claim Because 440.2314; is a claim plaintiff’s complaint MSA lenses were fit for a for breach of an 19.2314, we will assume that or a claim for breach of an does not implied warranty particular purpose, allege plaintiff’s that defendant breached breach of of implied warranty *4 merchantability, MCL 440.2315; warranty 709 v Johnson & Johnson
Opinion of Court majority ranty against The of fed- defendant. claims considering have held this issue courts and state eral products 360k(a) preempts lia- § all state most or bility against of a Class HI the manufacturer claims Corp, Collagen e.g., 67 v See, Mitchell medical device. Bristol-Myеrs-Squibb 1995); (CA Duvall v 7, F3d 1268 (CA 1995); Medtronic, 4, Mendes v 392 Co, 65 F3d Collagen Corp, Stamps (CA 1994); 1, v 13 Inc, 18 F3d (CA 1993); Medtronic, Inc, 916 v 5, F2d 1416 984 Stefl App, 1996); (Mo Barnes-Hind, v Ambrosio SW2d 879 (1995). The United 70; 625 NYS2d740 Inc, 211 AD2d Eastern and Western Courts for the States District majority adopted Michigan both have Districts of Pacing Systems, position. Strong Inc, v Telectronics 1994), Supp (WD rev’d on other Mich, F 401 891 Kemp 1996); (CA grounds Inc, Pfizer, v 6, F3d 256 Recently, (ED 1993). Supp the Sixth Mich, F majority posi- adopted Appeals Circuit Court of Pacing Systems, Inc, tion. Martin v Telectronics (CA 1995). 6, F3d 39 appellate Michigan has state court no now,
Until
preemptive
published decision the
in a
addressed
liability
products
regard
360k(a)
§
to state
effect of
against
m mеdical
of Class
manufacturers
claims
reject the rea-
consideration, we
After much
devices.
soning
the federal and
well as the rest of
Martin as
of
preempts
360k(a)
have held
state cases that
liability
man-
most or all state
Instead, we are
devices.
Class HI medical
ufacturers of
rejects
minority
persuaded
view, which
provides
of
blanket
view that
Class
manufacturers
law claims
all state
Corp,
Kennedy Collagen
67 F3d
v
devices.
medical
Ministry
1995);
(CA
Province
Health,
*5
App
710
217 Mich
705
Opinion
the
Court
Shiley Inc,
Ontario v
858 F Supp 1426 (CD Cal, 1994);
Larsen v
Systems,
Pacesetter
Inc,
1;
Hawaii
P2d 1273 (1992), amended
The Supremacy Clause of the United States Consti-
provides
tution
the laws of the United States
“shall
supreme
be the
Law of the
. .
Land;
any
.
Thing
in the Constitution or
any
Laws of
State to the Con-
trary notwithstanding.”
Const,
US
VI,
art
cl 2. Pursu-
ant to
Supremacy
Clause, Congress may preempt
state law. Louisiana Public Service Comm v Federal
Communications Comm,
355,
476 US
368; 106 S Ct
1890;
Opinion Court express preemption If statute contains an Id. plain wording of the clause clause, the the best evi- must be examined because it contains Transpor- preemptive Congress’ dence of intent. CSX 658, 664; 113 S Ct tation, Easterwood, Inc v 507 US question (1993). L Ed 2d 387 The to be 1732; 123 express preemption in instances of is the answered extent to which intended to supra, Cipollone, Kennedy, law. *6 preemption. strong presumption against a There is Cipollone, supra, presumption particu- 523. This larly question strong regulatiоns when the relate to safety, historically have mat- health and which been concern, ters of local and when would remedy preclude state remedies where no federal Ministry Health, exists. of response
The mda was enacted in to concerns safety regarding the of the Daikon Shield and other pacemak- devices, medical such as heart valves and purpose protect Id., ers. 1434.The of the mda was to complex “increasingly consumers from devices which pose inadequately improperly serious risk if tested or designed quoting Rep Id., 94-33, or used.” S No 94th reprinted Cong, (1976), Cong 2d Sess in 1976US Code legislation, introducing & Admin News 1074. In the Kennedy purpose of Senator Edward stated: “The this protect safety legislation is to the health and people legislation . . . American the is written so that always given the the benefit of the doubt is to con- pays sumer. After all it is the consumer who with his health and his life for medical device malfunctions.” Cong (1975). quoting The Id., Rec 10688 encourage was also written to the research and devel- opment improve of medical devices that would longevity people. health and of American Id. The classifies medical devices as Class or I, n, 360c(a). degree danger m devices. USC The posed public the medical device to the determines its classification. Class m medical devices are the heavily dangerous regulated. most and the most The Drug Food and Administration has classified extended wear soft contact lenses as Class medical Generally, devices. 21 CFR 886.5925. Class in devices subject “premarket approval provide reason- safety able assurance [their] and effectiveness.” 21 360c(a)(l)(C). premarket approval, USC To obtain manufacturer of a Class m medical device must sub- application containing, mit a detailed to the FDA but following to, not limited information: information regarding safety and device, effectiveness of the the intended device, use of the the methods used to copies proposed labeling manufacture device, requested device, for the by other information 360e(c)(l)(A)-(G); FDA. 21 CFR 814.20(b)(1)-(12). application The FDA refers each panel prepares report and recommendation. 21 360e(c)(2). accept reject The FDA must either or *7 application days receiving the within 180 after application. 360e(d)(l)(a). Defendant submit- application premarket approval ted an for of Acuvue approved application, contact lenses. The FDA sub- ject approval.” to additional FDA “conditions of There is no indication from the record that defendant failed comply approval with the FDA’s additional conditions. express preemption provision
The MDA contains an
provides
which
as follows:
Walker v Johnson & Johnson
Except
provided
(b)[3]
section,
in subsection
of this
no
political
may
State or
subdivision of a State
establish or
respect
continue in effect with
to a device intended for
—
any requirement
human use
(1)
from,
to, any requirе-
which is different
or in addition
applicable
chapter
device,
ment
under this
to the
(2)
safety
which relates to the
or effectiveness of the
any
requirement
device or to
other matter
included
applicable
chapter.
to the device under
this
[21
360k(a).]
Whether Congress
intended to
state law
products liability
express
actions is unclear from the
language
preemption
clause.
If a statute is
silent
ambiguous
or
regarding congressional
intent, a
may
court
look to an agency’s
regulations
gui-
dance in interpreting congressional
intent. Chevron,
USA, Inc v Natural Resources
Counсil, Inc,
Defense
Defendant par- requirement[] applicable “specific ato cess is a agree. federal We cannot While most ticular device.” argu- similar that have and state courts considered premarket approval ments have concluded that process satisfies the fda’s rule preempts agree claims, state we with common-law Kennedy the court in that these courts have failed to group whether Class m medical devices as a consider “particular constitute a device” within the FDA’s can understanding Kennedy, supra, If of that term. premarket approval process specific constitutes particular requirement applicable device, to a then manufacturers of Class m medical devices would be liability from immune claims. However, premarket
it makes little sense to hold that fda’s approval process qualifies requirement аppli- ‘specific as a particular 808.1(d) (emphasis to a cable device.’ CFR added). required All class III devices to obtain premarket approval being before sold in interstate com- 360e; merce. 21 21 CFR 814.1. The fact premarket approval process specific requirements, involves 814, 820, see 21 CFR must be not confused with the premarket approval requirement acting specific itself as a requirement. [Id., 1459.] premarket approval pro-
The conclusion that the requirement specific cess satisfies the that there abe requirement applicable device is also analyzed pre- inconsistent with cases that have emption regard issue with to Class n medical devices: consistently In Class cases courts have focussed [sic] ii specificity requirement
both on the of the federal and the particularity required of the device. . . . courts have [0]ther v Johnson & Johnson Opinion Court specificity 808.1(d) under for Class III devices less overall They required particularity H have than for Class devices. *9 analysis preemption devices, of Class n but have analysis ‘particular’ preemption ignored in the the word hi Class devices. Class n and Class III devices
Such distinctions between
Congress
that
make little sense.
enacted the
to ensure
medical devices were introduced into the
safe and effective
Rep
for a
market. HR Conf
No 1090. There is no reason
analysis
preemption
change depending
to
on the
court’s
[Id.,
in
class of device
issue.
1458-1459.]
party arguing
it is the burden of the
in
Moreover,
preemption
Congress
favor of
to show that
intended
law,
Corp,
to
Silkwood v Kerr-McGee
238, 255;
464 US
104 S Ct
While our оf the conclusion that preemption products of all state provides for blanket majority posi- liability departure claims is a from the our is consistent with tion, holding we believe that Congress intent. Because enacted congressional entirely be con- protect consumers, mda it would interpret pro- trary Congress’ the mda intent to viding for blanket of state liabil- ity of Class ni medical claims manufacturers Congress Moreover, devices. included in the mda a provision stating “[c]ompliance with an order any person shall issued under this section not relieve liability from under Federal or State law.” 21 USC provision 360h(d). Congress’ inclusion of such a pre- is evidence that intended to products liability manufac- serve state pre- turers of Class m medical devices rather than to empt claims. such interpretation
Accepting Congress’ defendant’s enacting 360k(a) intent in would elimi- result any remedy injured by nation of for a consumer effectively Class m medical device and would immu- *10 nize manufacturers of Class m medical devices from by brought injured by claims consumers such devices. Congress This was not the result intended when it history 360k(a). legislative enacted “The of the [Medical Device] Amendments shows an intent to prоtect injuries, consumers from medical device remedy.” Ministry rather than leave them without a supra, interpret Health, 1440. We decline to of immunizing manufacturers of Class m medical by injured brought by devices from claims consumers preemption providing such devices and for blanket products liability against all state claims such manu- specific statutory facturers the absence of more language. Congress nullify “If the intent of were to an body protection entire of state consumer law, and remedy, leave the victims without it would have specifically said so.” Id. v Johnson & Johnson purpose light protecting
In of the MDA con from unsafe medical devices, sumers the fact that provide any remedy Congress did not federal in the compelling MDA is also evidence that did not provide intend to for blanket of state products liability claims the manufacturers of Congress’ regarding mClass medical devices. silence products liability whether it intended to state by enacting signifi the MDA “takes on added light provide any Congress’ cance in failure to fed remedy persons injured by eral such conduct. It is Congress would, difficult to believe that without com judicial ment, remove all means of recourse for those by injured illegal Silkwood, conduct.” 251. As Kennedy, supra, the court noted in 1459: Reading preemption provision in mda’s the manner by advocated the defendant would result in consumers of being Class m devices left without recourse for harm congressional suffered. Such a result in the flies face of protection. legislation: intent behind the consumer 360k(a) preempts Courts that have held that products liability actions manufacturers of m Class devices have also failed to consider the meaning “general applicability” of the words as used 808.1(d)(1). in the context of 21 CFR Id., provides, part: 808.1(d) CFR in relevant requirements There are other State or local that affect preempted 521(a) devices that are not section of the act *11 they ‘requirements appli- 360k(a)] are because not [21 meaning 521(a) cable to a device’ within the of section of following examples of the act. The State or local requirements preempted by regarded that are not section 521 of the act: 217 Mich 521(a) State or
(1) Section does not local purpose requirements general applicability of where the of requirement products in relates either to other addition requirements (e.g., general to devices such as electrical codes, (warranty and the Uniform Commercial Code of fit- practices require- ness)), in or to unfair trade which the [Emphasis ments are not limited to devices. added.] applicability. general State common law is a law of Kennedy, supra, plaintiffs Furthermore, breach warranty implied claim arises under the Uniform Code, 440.2314, Commercial MCL 440.2315; MSA specifically 19.2314,19.2315,and the UCC included example 808.1(d)(1) gen- in 21 CFR as an of a law of applicability. 808.1(d)(1) sup- eral 21 CFR Thus, also ports plaintiffs negligent design our conclusion that negligent manufacture, and warn, failure to implied warranty preempted. breach of сlaims are not argues plaintiffs Defendant failure to warn preempted impose claim is because it would a requirement that is “different from, or addition to” requirements imposed under the mda. We disa- gree. According plaintiff, defendant failed to dispensing include or on the sealed contact lens warning box a of the risk of corneal ulcer associated with the use Acuvue contact lenses. The con- requirements labeling applicable tains that are to all regulated 352(f) medical devices MDA. requires medical devices to have a label with “ade- quate provides directions for but use,” that when such necessary protection directions are “not for the public Secretary promulgate regula- health, the shall exempting drug tions such or device from such requirement.” promulgated regulation The FDA has providing exemption require- labeling an from the *12 v Johnson & Johnson
Opinion of the Court “prescription 352(f) ment of 21 USC devices” if certain conditions are met. CFR 801.109. One of the conditions is that the medical device must be one warnings, directions, hazards, “for which and other commonly practitioners information are known to by 801.109(c). licensed law to use the device.” 21 CFR argues danger Plaintiff that the of increased risk of commonly plain- corneal ulcer was not known when prescribed tiff was Acuvue contact lenses and that required defendant therefore was to include a warn- ing package. in the Plaintiffs failure to warn claim is law. not based on state Plaintiffs failure to warn actually negligently claim is a claim that defendant comply requirements labeling failed to with the of the requirements labeling appli- mda as well as regulation. 808.1(d)(2) specifically cable FDA 21 CFR preempt states that “does not State or local requirements equal substantially to, that are or identi- rеquirements imposed by to, cal or under the act.” In Ministry Health, 1439,the court stated that “the MDA would not claims that the manufac- negligently comply regu- turer with the fda’s failed merely finding wrongdoing lations, since a would impose regulations already imposed by those the stat- ute, and would not be ‘different from or in addition imposed by to’ Thus, those the MDA.” to the extent plaintiff’s that failure to warn claim is based on comply defendant’s failure to with the and 21 plaintiff’s merely 801.109, CFR failure to warn claim by seeks to enforce the federal standard established appropriate regulation and the and is FDA preempted. therefore not 808.1(b) sup- Defendant also contends that CFR ports plaintiff’s pre- argument its 217 erupted. 808.1(b), In 21 CFR FDA states “no may political of a State establish State or subdivision any requirement respect in effect with or continue having human use a medical device intended for (whether and effect of law established stat- force regulation, decision).” ute, ordinance, or court To the that the FDA’s inclusion of the words “court extent suggests interprets 360k(a) decision” that the fda preempting plaintiff’s regulation claims, the fda *13 con- every congressional tradicts intent as well as other regulation interprеting 360k(a) § and is not based fda permissible Chevron, on a construction of the statute. supra, 842.
Finally, argues defendant that the United States Supreme Cipollone supports Court’s decision in its argument plaintiff’s preempted. Cipol- that claims are analysis preemptive an lone involved of the effect of Cigarette Labeling Advertising the Federal and Act of Cigarette 1965, successor, and its the Public Health Smoking seq. Act In contrast, 15 USC 1331 et preemptive the instant case involves the effect of 360k(a) accompanying regula- § of the and its Cipollone applicable tions. The statutes in a wеre particular product, applies whereas the to medi- opposed generally specific cal devices to a medical language device. While the of the clauses respective in statutes is it is similar, identical, not language leg- and we conclude that the mda, history, regulations islative and the fda reveal that Congress preempt did not intend to lia- bility manufacturers of Class in medi- cal devices. preparation opinion, prior
After our of this but Supreme release, its the United States Court decided v & Johnson Johnson Concurrence J. Griffin, Medtronic, Lohr, US _; Inc v 116 S Ct Supreme (1996). Lohr, L Ed 2d 700 In held Court does not all state common-law actions the manufacturers of Class m medical case, devices. Unlike the contact lenses this pacemaker, Lohr, medical device in a had not under premarket approval process gone the because it was “substantially equivalent” preexisting found to be medical device and was allowed to avoid the premarket approval process comply and instead with premarket process pursuant a notification to 21 USC previously 360(k). However, reasons stated this reject opinion, we defendant’s claim that premarket approval process “specific constitutes a applicable requirement^ ato device” and preempts plaintiff’s thus claims. We conclude that the reasoning holding applicable and of Lohr is to this supports plaintiff’s and case our conclusion that preempted. claims are not 360k(a), In sum, we conclude that considered in conjunction 360h(d) applicable with 21 USC and the regulations, supports finding did FDA preempt plaintiff’s negligent design not intend to *14 negligent manufacture, warn, failure to and breach of implied warranty claims defendаnt. The Supreme supports holding holding Court’s in Lohr our Accordingly, in this case. we conclude that the trial granting court erred in defendant’s motion for sum- mary disposition pursuant 2.116(C)(4). to MCR jurisdiction.
Reversed and remanded. We retain no Post, J., E. R. concurred. (concurring). J. I In concur the result. Griffin,
my view, Medtronic, Lohr, US _; Inc v 518 116 S Ct 217 J. Concurrence Griffin, L Ed The ratio- (1996), controlling. 2d present nale of Medtronic resolves the issue whether preempts breach state tort implied warranty, design, and failure to negligent arising warn from the use of medical devices that subjected premarket approval process. were to the part, majority’s analysis For the most is moot in light Medtronic, supra.