Title: Joseph Blunt, Sr. v. Medtronic, Inc.
Citation: 2009 WI 16
Docket Number: 2006AP001506
State: Wisconsin
Issuer: Wisconsin Supreme Court
Date: February 17, 2009

2009 WI 16 
 
SUPREME COURT OF WISCONSIN 
 
 
 
 
CASE NO.: 
2006AP1506 
COMPLETE TITLE: 
 
 
Joseph Blunt, Sr. and Margaret Blunt, 
          Plaintiffs-Appellants-Petitioners, 
 
State of Wisconsin Department of Health and 
Family Services, 
          Subrogated-Plaintiff, 
     v. 
Medtronic, Inc., 
          Defendant-Respondent. 
 
 
 
 
REVIEW OF A COURT OF APPEALS DECISION 
2007 WI App 191 
Reported at:  305 Wis. 2d 354, 738 N.W.2d 143 
(Ct. App. 2007-Published) 
 
 
OPINION FILED: 
February 17, 2009   
SUBMITTED ON BRIEFS: 
        
ORAL ARGUMENT: 
October 7, 2008   
 
 
SOURCE OF APPEAL: 
 
 
COURT: 
Circuit   
 
COUNTY: 
Milwaukee   
 
JUDGE: 
Richard J. Sankovitz   
 
 
 
JUSTICES: 
 
 
CONCURRED: 
BRADLEY, J., concurs (opinion filed). 
ABRAHAMSON, C.J., joins concurrence.   
 
DISSENTED: 
        
 
NOT PARTICIPATING:         
 
 
 
ATTORNEYS: 
 
For the plaintiffs-appellants-petitioners briefs were filed 
by John C. Cabaniss, Thomas Armstrong, and von Briesen & Roper, 
S.C., Milwaukee, and oral argument by John C. Cabaniss. 
 
For the defendant-respondent there was a brief by Michael 
K. Brown, Lisa M. Baird, and Reed Smith LLP, Los Angeles, Cal., 
and Robert H. Friebert and Friebert, Finerty & St. John S.C., 
Milwaukee, and oral argument by Michael K. Brown. 
 
An amicus curiae brief was filed by Stephanie A. Scharf, 
David W. Austin, and Schoeman, Updike, Kaufman & Scharf, 
Chicago, Ill., and Coleen D. Ball, Wauwatosa, on behalf of The 
Product Liability Advisory Council. 
 
 
 
2 
An amicus curiae brief was filed by Anne Berleman Kearney, 
Joseph D. Kearney, and Appellate Consulting Group, Milwaukee, on 
behalf of the Wisconsin Manufacturers & Commerce. 
 
An amicus curiae brief was filed by William C. Gleisner, 
III and the Law Offices of William C. Gleisner, Milwaukee, and 
Rhonda L. Lanford and Habush Habush & Rottier S.C., Madison, on 
behalf of the Wisconsin Association for Justice, and oral 
argument by William C. Gleisner, III. 
 
 
 
 
2009 WI 16
NOTICE 
This opinion is subject to further 
editing and modification.  The final 
version will appear in the bound 
volume of the official reports.   
No.  2006AP1506  
(L.C. No. 
2005CV3879) 
STATE OF WISCONSIN  
 
 
   : 
IN SUPREME COURT 
 
 
Joseph Blunt, Sr. and Margaret Blunt, 
 
          Plaintiffs-Appellants-Petitioners, 
 
State of Wisconsin Department of Health and 
Family Services, 
 
          Subrogated-Plaintiff, 
 
     v. 
 
Medtronic, Inc., 
 
          Defendant-Respondent. 
 
FILED 
 
FEB 17, 2009 
 
David R. Schanker 
Clerk of Supreme Court 
 
 
 
 
 
REVIEW of a decision of the Court of Appeals.  Affirmed.   
 
¶1 
PATIENCE DRAKE ROGGENSACK, J.   We review a decision 
of the court of appeals1 affirming the circuit court's decision2 
granting summary judgment in favor of Medtronic, Inc.  Both the 
circuit court and the court of appeals agreed that the express 
                                                 
1 Blunt v. Medtronic, Inc., 2007 WI App 191, 305 Wis. 2d 
354, 738 N.W.2d 143. 
2 The Honorable Richard J. Sankovitz of Milwaukee County 
presided. 
No. 
2006AP1506   
 
2 
 
preemption provision of the 1976 Medical Device Amendments to 
the Federal Food, Drug and Cosmetic Act, specifically 21 U.S.C. 
§ 360k(a) (2000),3 preempted the negligence, strict liability and 
loss of consortium claims asserted by the plaintiffs, Joseph and 
Margaret Blunt (the Blunts).   
¶2 
Our decision in this case turns on whether the Blunts' 
state law tort claims are preempted by federal law.  In order to 
decide this issue, we must answer three questions.  The first is 
whether 
Medtronic's 
Marquis 
7230 
implantable 
cardioverter 
defibrillator 
(the 
Marquis 7230 defibrillator), which was 
approved 
under 
the 
Food 
and 
Drug 
Administration's 
(FDA) 
premarket approval process, 21 U.S.C. § 360e, met the federal 
"requirement" specific to that device, pursuant to 21 U.S.C. 
§ 360k(a), when it received premarket approval.  The second 
question is whether the Blunts' common law claims, which allege 
negligence, strict liability and loss of consortium, constitute 
state requirements that are "different from, or in addition to," 
the federal requirement.  The third question is whether the 
preemption analysis of Riegel v. Medtronic, Inc., ___ U.S. ___, 
128 S. Ct. 999 (2008), applies to claims against the Marquis 
                                                 
3 All further references to the United States Code are to 
the 2000 version unless otherwise noted. 
No. 
2006AP1506   
 
3 
 
7230 defibrillator, even though supplemental premarket approval4 
was given to a later defibrillator.  Because we conclude that 
the United States Supreme Court's decision in Riegel provides 
definitive direction on these questions,5 we answer all of them 
in the affirmative.  We therefore conclude that § 360k(a) 
preempts the Blunts' claims.  Accordingly, we affirm the 
decision of the court of appeals. 
                                                 
4 "Supplemental 
premarket 
approval," 
or 
"supplemental 
approval," is FDA approval for a device that is similar to a 
device that previously has received premarket approval, where 
the 
manufacturer 
changes 
the 
"design 
specifications, 
manufacturing processes, labeling, or any other attribute, that 
would affect safety or effectiveness."  Riegel v. Medtronic, 
Inc., ___ U.S. ___, 128 S. Ct. 999, 1005 (2008) (citing 21 
U.S.C. § 360e(d)(6)(A)(i)).  In order to obtain "supplemental 
approval," the manufacturer "must submit, and the FDA must 
approve, an application  . . .  to be evaluated under largely 
the same criteria as an initial application" for premarket 
approval.  Id. (citing 21 U.S.C. § 360e(d)(6); 21 C.F.R. 
§ 814.39(c)). 
5 We note that when this case was presented for oral 
argument there were two federal preemption cases pending before 
the United States Supreme Court.  See Good v. Altria Group, 
Inc., 501 F.3d 29 (1st Cir. 2007), cert. granted, ___ U.S. ___, 
128 S. Ct. 1119 (2008); Levine v. Wyeth, 944 A.2d 179 (Vt. 
2006), cert. granted, ___ U.S. ___, 128 S. Ct. 1118 (2008).  
Altria has since been decided.  Altria v. Good, __ U.S. __, 129 
S. Ct. 538 (2008).  Neither case is relevant to our discussion.  
In Altria, the Supreme Court interpreted an express preemption 
provision that is different from the statute interpreted in 
Riegel.  Id. at 548-49.  In Levine, there is no relevant express 
preemption provision, rather the case turns on whether conflict 
preemption applies.  Levine, 944 A.2d at 184.  Neither case 
addresses the FDA premarket approval process at issue here. 
No. 
2006AP1506   
 
4 
 
I.  BACKGROUND6 
¶3 
In 2002, Medtronic applied for FDA premarket approval 
to market and distribute its Marquis 7230 defibrillator.  Under 
the Medical Device Amendments, a defibrillator such as the 
Marquis 7230 is a Class III device, subject to the FDA's 
strictest regulation and oversight, because it is "for a use in 
supporting or sustaining human life or for a use which is of 
substantial 
importance 
in 
preventing 
impairment 
of 
human 
health."  21 U.S.C. § 360c(a)(1)(C).  With some exceptions,7 a 
Class III device may not be marketed or distributed without 
premarket approval from the FDA.  Id.  The procedures for 
obtaining premarket approval are outlined in 21 U.S.C. § 360e.  
In Riegel, the United States Supreme Court detailed the 
premarket approval process as follows: 
Premarket approval is a "rigorous" process.  A 
manufacturer 
must 
submit 
what 
is 
typically 
a 
multivolume application.  It includes, among other 
things, full reports of all studies and investigations 
of the device's safety and effectiveness that have 
been published or should reasonably be known to the 
applicant; 
a 
"full 
statement" 
of 
the 
device's 
"components, ingredients, and properties and of the 
principle 
or 
principles 
of 
operation"; 
"a 
full 
description of the methods used in, and the facilities 
                                                 
6 The facts related are undisputed unless otherwise noted.   
7 The Medical Device Amendments grandfathered approval for 
certain Class III devices.  For example, those devices sold 
before the Medical Device Amendments' effective date are not 
required to undergo the premarket approval process.  21 U.S.C. 
§§ 360c(f)(1), 360e(b)(1).  In addition, a manufacturer need not 
obtain 
premarket 
approval 
for 
a 
new 
device 
if 
it 
is 
"substantially equivalent" to a device that is exempt from 
premarket approval.  21 U.S.C. § 360c(f)(1)(A). 
No. 
2006AP1506   
 
5 
 
and controls used for, the manufacture, processing, 
and, when relevant, packing and installation of, such 
device"; samples or device components required by the 
FDA; and a specimen of the proposed labeling.  [21 
U.S.C.] § 360e(c)(1).  Before deciding whether to 
approve the application, the agency may refer it to a 
panel of outside experts, 21 CFR § 814.44(a) (2007), 
and may request additional data from the manufacturer, 
§ 360e(c)(1)(G). 
. . . .  
Once a device has received premarket approval, 
the 
[Medical 
Device 
Amendments] 
forbids 
the 
manufacturer to make, without FDA permission, changes 
in design specifications, manufacturing processes, 
labeling, or any other attribute, that would affect 
safety or effectiveness.  § 360e(d)(6)(A)(i).  If the 
applicant wishes to make such a change, it must 
submit, and the FDA must approve, an application for 
supplemental premarket approval, to be evaluated under 
largely the same criteria as an initial application.  
§ 360e(d)(6); 21 CFR § 814.39(c). 
After premarket approval, the devices are subject 
to reporting requirements.  § 360i.  These include the 
obligation 
to 
inform 
the 
FDA 
of 
new 
clinical 
investigations or scientific studies concerning the 
device which the applicant knows of or reasonably 
should know of, 21 CFR § 814.84(b)(2), and to report 
incidents in which the device may have caused or 
contributed 
to 
death 
or 
serious 
injury, 
or 
malfunctioned in a manner that would likely cause or 
contribute to death or serious injury if it recurred, 
§ 803.50(a).  The FDA has the power to withdraw 
premarket approval based on newly reported data or 
existing information and must withdraw approval if it 
determines that a device is unsafe or ineffective 
under the conditions in its labeling.  § 360e(e)(1); 
see also § 360h(e) (recall authority). 
Riegel, 128 S. Ct. at 1004-05 (some citations omitted). 
¶4 
On December 17, 2002, the FDA provided device-specific 
premarket 
approval 
to 
Medtronic 
for 
its 
Marquis 
7230 
defibrillator.  Subsequent to this approval, as a result of 
No. 
2006AP1506   
 
6 
 
laboratory testing, Medtronic became aware of a potential 
shorting problem with the defibrillator's battery.  This 
shorting problem could cause the defibrillator's battery to 
rapidly discharge, leading to a potentially fatal loss of power 
in the device.8   
¶5 
Medtronic submitted to the FDA a premarket approval 
supplemental application containing three design changes that 
addressed the shorting issue.  On October 23, 2003, the FDA 
approved these changes.9  However, at no relevant time did the 
                                                 
8 The parties do not dispute that this failure rate was on 
the order of 1 in 10,000 and that no device failed outside of 
controlled testing conditions.  For some perspective, consider 
that the FDA, on a prior occasion, had approved "a ventricular 
assist device for children with failing hearts, even though the 
survival rate of children using the device was less than 50 
percent."  Riegel, 128 S. Ct. at 1004. 
9 Both parties agree that the 2002 approval of the 
"original" 
Marquis 
7230 
defibrillator 
was 
itself 
a 
"supplemental" premarket approval of an earlier approved design.  
It appears that there were a number of earlier revisions 
(according to oral argument, either 23 or 29 revisions) to the 
device that also received premarket approvals prior to the 
December 17, 2002 approval of the "original" Marquis 7230.  
Therefore, for the sake of our discussion, we will refer to the 
December 17, 2002 approval as the approval of the "original" 
Marquis 7230, and the October 23, 2003 approval as the approval 
of the supplemental Marquis 7230.  As the United States Supreme 
Court noted, "an application for supplemental premarket approval 
[is] evaluated under largely the same criteria as an initial 
application."  Riegel, 128 S. Ct. at 1005 (citing 21 U.S.C. 
§ 360e(d)(6); 21 CFR § 814.39(c)).   
No. 
2006AP1506   
 
7 
 
FDA withdraw its approval of the original defibrillator,10 and 
following 
the 
supplemental 
premarket 
approval, 
Medtronic 
continued to market and distribute the original defibrillator. 
¶6 
In May of 2004, an original Marquis 7230 defibrillator 
was implanted in Joseph Blunt.  In February of 2005, Medtronic 
advised physicians of the shorting problem.  Less than ten days 
after his physician received notice of this problem, Joseph 
Blunt underwent surgery to remove the device at his doctor's 
suggestion. 
 
However, 
at 
no 
time 
did 
his 
defibrillator 
malfunction. 
¶7 
Following 
the 
second 
surgery, 
the 
Blunts 
sued 
Medtronic, alleging negligence, strict liability and loss of 
consortium based on the second surgery.  Medtronic moved for 
summary judgment, arguing that the Blunts' claims were expressly 
preempted by 21 U.S.C. § 360k(a).  Section 360k(a) is a 
provision of the Medical Device Amendments that provides in 
pertinent part: 
[N]o State or political subdivision of a State may 
establish or continue in effect with respect to a 
device intended for human use any requirement-- 
                                                 
10 In the Blunts' briefs to this Court, they supplemented 
much of their factual background information with citations to 
In re Medtronic, Inc., Implantable Defibrillators Litigation, 
465 F. Supp. 2d 886 (D. Minn. 2006), which also dealt with the 
original Marquis 7230 defibrillator.  However, the claims in 
that case were based on different factual allegations and legal 
theories than those alleged here.  Furthermore, the March 16, 
2006 FDA recall referenced in that case to which the Blunts 
refer did not occur until after Joseph Blunt's surgery. 
No. 
2006AP1506   
 
8 
 
(1) which is different from, or in addition to, 
any requirement applicable under this chapter to the 
device, and 
(2) which relates to the safety or effectiveness 
of the device or to any other matter included in a 
requirement applicable to the device under this 
chapter. 
¶8 
Before the circuit court and court of appeals, 
Medtronic argued that federal premarket approval constituted a 
"requirement applicable under this chapter" to the device, also 
known as a federal "requirement."  21 U.S.C. § 360k(a)(1).  In 
addition, Medtronic argued that the Blunts' state tort claims 
alleging 
negligence 
and 
strict 
liability 
were 
expressly 
preempted 
by 
§ 360k(a)(1) 
because 
they 
constituted 
state 
requirements that were "different from, or in addition to," the 
federal requirement that related "to the safety or effectiveness 
of the device."  § 360k(a).  The Blunts' contentions were 
directly opposite Medtronic's in regard to these two issues. 
¶9 
At the time the circuit court ruled on Medtronic's 
motion, prior to the Supreme Court's decision in Riegel, there 
was a split among federal appellate courts with respect to both 
issues.  Regarding the first issue, most federal circuit court 
decisions had concluded that device-specific premarket approval 
constituted a federal requirement within the meaning of 21 
U.S.C. § 360k(a)(1).  See Riegel v. Medtronic, Inc., 451 F.3d 
104 (2d Cir. 2006), aff'd, ___ U.S. ___, 128 S. Ct. 999 (2008); 
Gomez v. St. Jude Med. Daig Div. Inc., 442 F.3d 919 (5th Cir. 
2006); McMullen v. Medtronic, Inc., 421 F.3d 482 (7th Cir. 
2005), cert. denied, 547 U.S. 1003 (2006); Cupek v. Medtronic, 
No. 
2006AP1506   
 
9 
 
Inc., 405 F.3d 421 (6th Cir. 2005), cert. denied sub nom Knisley 
v. Medtronic, Inc., 546 U.S. 935 (2005); Horn v. Thoratec Corp., 
376 F.3d 163 (3d Cir. 2004); Brooks v. Howmedica, Inc., 273 F.3d 
785 (8th Cir. 2001); Martin v. Medtronic, Inc., 254 F.3d 573 
(5th Cir. 2001); Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 
2000); Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997).  
An opinion of the Eleventh Circuit was the lone exception.  See 
Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir. 1999). 
¶10 With respect to the second issue, a majority of 
federal circuit courts that had addressed the issue also 
concluded that state tort claims that relate to safety or 
effectiveness of the device constituted state requirements 
"different from, or in addition to," the federal requirement, 
and thereby were preempted under 21 U.S.C. § 360k(a).  See 
Riegel, 451 F.3d at 122; Gomez, 442 F.3d at 929-30; McMullen, 
421 F.3d at 488-89; Cupek, 405 F.3d at 424; Horn, 376 F.3d at 
176; Brooks, 273 F.3d at 796; Papike v. Tambrands Inc., 107 F.3d 
737, 741 (9th Cir. 1997).  Again, the Eleventh Circuit's 
decision in Goodlin was the lone exception.  Goodlin, 167 F.3d 
at 1378-79. 
¶11 In its order granting Medtronic's motion for summary 
judgment, the circuit court analyzed these lines of cases, and 
concluded that the reasoning of the majority of the federal 
circuits was more persuasive on both issues:  (1) that device-
specific premarket approval constituted a federal requirement; 
and (2) that state tort claims based on an alleged lack of 
safety in a device that had received premarket approval 
No. 
2006AP1506   
 
10 
 
constituted state requirements "different from, or in addition 
to," the federal requirement.  As a result, because Medtronic's 
original Marquis 7230 had received device-specific premarket 
approval, and because the Blunts' claims sounded in negligence 
and strict liability based on the safety of that device, the 
circuit court held that their claims were preempted by 21 U.S.C. 
§ 360k(a).  Accordingly, the circuit court granted summary 
judgment to Medtronic.  The court of appeals, in affirming the 
circuit 
court, 
essentially 
adopted 
the 
circuit 
court's 
reasoning.11  Blunt, 305 Wis. 2d 354, ¶¶12, 16. 
¶12 We granted review and now affirm. 
II.  DISCUSSION 
A. 
Standard of Review 
¶13 We review a summary judgment decision independently, 
employing the same methodology as the circuit court.  Acuity v. 
Bagadia, 2008 WI 62, ¶12, 310 Wis. 2d 197, 750 N.W.2d 817.  In 
addition, we interpret statutes independently of the circuit 
court and court of appeals, but benefitting from their analyses.  
Richards v. Badger Mut. Ins. Co., 2008 WI 52, ¶14, 309 Wis. 2d 
541, 749 N.W.2d 581.  Finally, whether federal preemption 
applies 
is 
a 
question 
of 
federal 
law 
that 
we 
review 
independently.  Int'l Ass'n of Machinists & Aerospace Workers v. 
U.S. Can Co., 150 Wis. 2d 479, 487, 441 N.W.2d 710 (1989).   
                                                 
11 Judge Fine dissented from the decision of the court of 
appeals. 
No. 
2006AP1506   
 
11 
 
B. 
Riegel v. Medtronic 
¶14 The United States Supreme Court has given significant 
direction with respect to the preemptive effect of 21 U.S.C. 
§ 360k(a) when a defendant in a state law tort claim has 
received device-specific premarket approval for a Class III 
medical device that is alleged to have caused harm.  In its 2008 
decision in Riegel, which was released subsequent to the court 
of appeals' decision in this case, the Supreme Court confirmed 
that device-specific premarket approval of a Class III medical 
device constitutes a federal "requirement" within the meaning of 
§ 360k(a): 
Premarket approval . . . imposes "requirements" 
under the [Medical Device Amendments] . . . .  Unlike 
general 
labeling 
duties, 
premarket 
approval 
is 
specific to individual devices. [Premarket approval] 
is federal safety review.  . . . [T]he FDA may grant 
premarket approval only after it determines that a 
device offers a reasonable assurance of safety and 
effectiveness . . . . [T]he FDA requires a device that 
has received premarket approval to be made with almost 
no deviations from the specifications in its approval 
application, 
for 
the 
reason 
that 
the 
FDA 
has 
determined 
that 
the 
approved 
form 
provides 
a 
reasonable assurance of safety and effectiveness. 
Riegel, 128 S. Ct. at 1007.  In resolving this issue, the Court 
eliminated the split among federal circuits, and adopted the 
position of the majority of the federal courts. 
¶15 With respect to whether 21 U.S.C. § 360k(a) precludes 
state tort claims that relate "to the safety or effectiveness 
of" 
premarket-approved 
devices 
because 
they 
are 
"state 
requirements," Riegel also held that it did.  The Supreme Court 
explained: 
No. 
2006AP1506   
 
12 
 
Absent other 
indication, reference to a State's 
"requirements" includes its common-law duties.  . . . 
[C]ommon-law liability is "premised on the existence 
of a legal duty," and a tort judgment therefore 
establishes that the defendant has violated a state-
law obligation.  . . .  And while the common-law 
remedy is limited to damages, a liability award "'can 
be, indeed is designed to be, a potent method of 
governing conduct and controlling policy.'" 
[With respect to premarket approval], there is 
nothing to contradict this normal meaning.  To the 
contrary, in the context of this legislation excluding 
common-law duties from the scope of pre-emption would 
make little sense.  State tort law that requires a 
manufacturer's [devices] to be safer, but hence less 
effective, than the model the FDA has approved 
disrupts the federal scheme no less than state 
regulatory law to the same effect.  Indeed, one would 
think that tort law, applied by juries under a 
negligence 
or 
strict-liability 
standard, 
is 
less 
deserving of preservation.  A state statute, or a 
regulation adopted by a state agency, could at least 
be expected to apply cost-benefit analysis similar to 
that applied by the experts at the FDA:  How many more 
lives will be saved by a device which, along with its 
greater effectiveness, brings a greater risk of harm?  
A jury, on the other hand, sees only the cost of a 
more dangerous design, and is not concerned with its 
benefits; the patients who reaped those benefits are 
not represented in court.  . . . [I]t is implausible 
that the [Medical Device Amendments] was meant to 
"grant 
greater 
power 
(to 
set 
state 
standards 
'different from, or in addition to' federal standards) 
to a single state jury than to state officials acting 
through state administrative or legislative lawmaking 
processes." That perverse distinction is not required 
or even suggested by the broad language Congress chose 
in the [Medical Device Amendments], and we will not 
turn somersaults to create it. 
Riegel, 128 S. Ct. at 1008 (citations omitted).   
¶16 Again, the Court resolved the federal circuit split, 
adopting the position of the majority of circuits that have 
considered the issue.  In doing so, the Supreme Court noted that 
No. 
2006AP1506   
 
13 
 
under the Medical Device Amendments, "the solicitude for those 
injured by FDA-approved devices . . . was overcome in Congress's 
estimation by solicitude for those who would suffer without new 
medical devices if juries were allowed to apply the tort law of 
50 States to all innovations."  Id. at 1009.   
¶17 The device at issue in Riegel was one for which 
supplemental approval had been issued.  We shall assume for the 
sake of our discussion that it was the latest supplemental 
approval given for that medical device because the Supreme Court 
did not discuss whether a supplemental approval given at a 
subsequent date would have had any effect on an earlier approved 
device sold after a subsequent supplemental approval had issued.  
In the case before us, the original Marquis 7230 defibrillator 
is the subject of the Blunts' claims, and the Marquis 7230 that 
was given supplemental approval is not at issue.  With these 
principles in mind, we now proceed to discuss the Blunts' claims 
in light of Riegel. 
C. 
Riegel and the Blunts' Claims 
¶18 Riegel holds that state tort claims based on injuries 
caused by a Class III medical device that was granted device-
specific premarket approval may be preempted by 21 U.S.C. 
§ 360k(a).  Id.  State tort claims based on such medical devices 
are preempted when they relate "to the safety or effectiveness 
of the device."  Id. at 1007.  In addition, such claims must be 
"different from, or in addition to," the federal requirement of 
premarket approval.  Id. at 1011.   
No. 
2006AP1506   
 
14 
 
¶19 The Blunts contend that Medtronic is liable under 
theories of negligence and strict products liability due to the 
condition of the original Marquis 7230 defibrillator when it was 
implanted into Joseph Blunt.  Premarket approval is specific to 
each individual Class III medical device, and it is the federal 
safety review of each such device.  Id. at 1007.  Accordingly, 
we must determine whether the Blunts' claims of negligence and 
strict products liability relate to the safety of the original 
Marquis 7230 defibrillator.12  Id.  We consider each claim in 
turn.   
¶20 With respect to negligence, the Blunts' complaint 
alleged that "Medtronic was negligent in the design, testing, 
manufacture, marketing, warnings and sale of the [defibrillator] 
which was implanted in plaintiff," and the "negligence of . . . 
Medtronic was a proximate cause of the injuries and damages 
sustained by plaintiffs."  These allegations assert that the 
original Marquis 7230 defibrillator could have been safer to 
use, despite Medtronic's obtaining device-specific premarket 
approval from the FDA, had Medtronic not been negligent.  As a 
                                                 
12 The Blunts also alleged loss of consortium.  That claim 
is derivative of the negligence and strict liability claims made 
by Joseph Blunt.  Peters v. Menard, Inc., 224 Wis. 2d 174, 193 
n.8, 589 N.W.2d 395 (1999) ("[L]oss of consortium claims are 
derivative."); Kottka v. PPG Indus., Inc., 130 Wis. 2d 499, 521, 
388 N.W.2d 160 (1986) ("The claim for a loss of consortium is 
derivative, in the sense that it does not arise unless the other 
spouse has sustained a personal injury.") (citing Fitzgerald v. 
Meissner & Hicks, Inc., 38 Wis. 2d 571, 581, 157 N.W.2d 595 
(1968)).  As a result, the merits of the loss of consortium 
claim would be considered only if one or both of the first two 
claims were viable.   
No. 
2006AP1506   
 
15 
 
result, the Blunts' negligence claim does relate to the safety 
of the original Marquis 7230 defibrillator, as "safety" is used 
in 21 U.S.C. § 360k(a) according to Riegel. 
¶21 With 
respect 
to 
strict 
liability, 
the 
Blunts' 
complaint alleged that:  (1) Medtronic's original Marquis 7230 
defibrillator, "as manufactured, designed, tested, marketed and 
sold by . . . Medtronic[,] was in a defective and unreasonably 
dangerous condition to users when it left the possession and 
control of . . . Medtronic"; (2) Medtronic's original Marquis 
7230 defibrillator "was defective in that it had a potential 
battery shorting mechanism which could cause rapid battery 
depletion thereby rendering the [defibrillator] useless and 
unavailable to shock or pace the heart into a normal rhythm if 
plaintiff suffered a rapid, life threatening heart rhythm 
disturbance"; 
and 
(3) 
"[t]he 
unreasonably 
dangerous 
and 
defective condition of the [defibrillator] was a proximate cause 
of the damages sustained by plaintiffs."   
¶22 Here again, the Blunts assert that, despite receiving 
device-specific premarket approval for the original Marquis 7230 
from the FDA, Medtronic designed and sold a Class III medical 
device that was "defective and unreasonably dangerous."  That 
theory of liability is based on allegations that draw into 
question the safety of a Class III device for which the FDA 
granted device-specific premarket approval.  Therefore, it is a 
claim that relates "to the safety or effectiveness of" such a 
device within the meaning of 21 U.S.C. § 360k(a), as construed 
in Riegel. 
No. 
2006AP1506   
 
16 
 
¶23 We next consider the second step in our Riegel 
analysis:  whether the state law tort claims of negligence and 
strict products liability are requirements "different from, or 
in addition to" the federal requirement.  We begin by noting 
that these tort claims are the same tort claims that the Supreme 
Court held were requirements that were "different from, or in 
addition to," the federal requirement of premarket approval in 
Riegel.  Id. at 1007.   
¶24 As the Supreme Court explained, "[i]n [Medtronic, Inc. 
v.] Lohr, [518 U.S. 470, 512 (1996)] five Justices concluded 
that common-law causes of action for negligence and strict 
liability do impose 'requirement[s]' and would be preempted by 
federal requirements specific to a medical device."  Id.  The 
Supreme Court concluded, "[w]e adhere to that view."  Id.  In so 
doing, the Supreme Court distinguished Lohr, wherein it had 
concluded that the claims made for use of a pacemaker were not 
preempted because the pacemaker was subjected to only a 
"substantial-equivalence review under § 501(k)" by the FDA.13  
Id.  This was not the rigorous review of premarket approval.  
Id.  Stated otherwise, the pacemaker at issue in Lohr had not 
received FDA device-specific premarket approval.  Id.   
                                                 
13 Many medical devices were already on the market when 
Congress enacted the Medical Device Amendments to the Food, Drug 
and Cosmetic Act.  Medtronic, Inc. v. Lohr, 518 U.S. 470, 477-78 
(1996).  Class III devices that were substantially similar to 
those earlier marketed devices could be marketed without the 
rigorous premarket review.  Id. at 478-79.  The pacemaker at 
issue in Lohr was such a device.  Id. at 480.   
No. 
2006AP1506   
 
17 
 
¶25 Here, 
the 
FDA 
granted 
Medtronic 
device-specific 
premarket approval for the original Marquis 7230 defibrillator.  
Accordingly, the state law claims of negligence and strict 
liability do impose requirements that are different from or in 
addition to the federal requirement of premarket approval.  Id.  
Therefore, the only question that was not directly addressed in 
Riegel is whether the FDA supplemental premarket approval of the 
Marquis 7230 defibrillator affects the preemption holdings and 
reasoning of Riegel in regard to the originally approved Marquis 
7230 defibrillator.   
D. 
The Supplemental Approval of the Marquis 7230 
¶26 The Blunts argue that their claims are not preempted 
because when Medtronic obtained supplemental premarket approval 
of its Marquis 7230 defibrillator with the design changes 
addressing the shorting problem, the effect of the FDA's 
premarket 
approval 
of 
the 
original 
defibrillator 
was 
"superseded."14  Stated otherwise, the Blunts contend that after 
Medtronic received supplemental premarket approval for the 
Marquis 7230 and sold its original Marquis 7230, Medtronic sold 
a device that was no longer subject to a federal "requirement."  
                                                 
14 At oral argument, counsel for the Blunts was difficult to 
pin down on what he meant by saying that the original premarket 
approval 
was 
"superseded" 
by 
the 
supplemental 
approval.  
However, 
he 
appeared 
to 
contend 
both 
that 
the 
federal 
requirement evidenced by premarket approval for the original 
Marquis 7230 defibrillator was changed when the supplemental 
approval issued and also that there was no longer a federal 
requirement relating to the sale of the original Marquis 7230.  
We address both concepts.  
No. 
2006AP1506   
 
18 
 
Under 
that 
scenario, 
the 
Blunts 
contend, 
no 
federal 
"requirement" existed to preempt their state tort claims.   
¶27 At oral argument, both parties acknowledged, with some 
variation, that:  (1) the "original" Marquis 7230 was either the 
23rd or 29th supplemental premarket-approved device; (2) there 
were 
either five 
or eight supplemental premarket-approved 
defibrillator devices between that original Marquis 7230 and the 
supplemental Marquis 7230 that addressed the potential shorting 
problem; and (3) since the first approval, there have been 
approximately 75 supplemental premarket approvals of the Marquis 
7230 defibrillator. 
¶28 We begin by noting that Congress expressly preempted 
requirements that were different from or in addition to the 
federal requirement of device-specific premarket approval for 
Class III medical devices.  21 U.S.C. § 360k(a); Riegel, 128 
S. Ct. at 1010.  As the Supreme Court explained: 
The [Medical Device Amendments] provide[] that no 
State "may establish or continue in effect with 
respect to a device . . . any requirement" relating to 
safety or effectiveness that is different from, or in 
addition to, federal requirements. 
Riegel, 128 S. Ct. at 1010 (emphasis in original).  Nothing in 
the Medical Device Amendments advises that a device-specific 
approval once given is diminished by a supplemental approval for 
changes in that device without a further act by the FDA.   
¶29 It is beyond dispute that the FDA has the power to 
withdraw premarket approval or to recall a device to which it 
No. 
2006AP1506   
 
19 
 
has given premarket approval.  21 U.S.C. § 360e(e)(1); 21 U.S.C. 
§ 360h(e).  As the Supreme Court noted: 
[t]he FDA has the power to withdraw premarket approval 
based on newly reported data or existing information 
and must withdraw approval if it determines that a 
device is unsafe or ineffective under the conditions 
in its labeling.   
Riegel, 128 S. Ct. at 1005.   
¶30 Under the comprehensive scheme that Congress has 
enacted, withdrawal of the manufacturer's right to market its 
premarket-approved devices is accomplished through affirmative 
acts of the FDA.  There is nothing to suggest that premarket 
approval ceases without FDA action.  For example, federal law 
directs that for the withdrawal or temporary suspension of 
premarket approval "due notice and opportunity for informal 
hearing" must be given.  21 U.S.C. § 360e(e)1.  We also note 
that the FDA has express authority to recall premarket approved 
Class III medical devices when the FDA finds "there is a 
reasonable probability that a device intended for human use 
would cause serious, adverse health consequences or death."  21 
U.S.C. § 360h(e)(1).   
¶31 In addition, Medtronic continued to be obligated to 
comply with the premarket approval reporting requirements with 
respect to the original Marquis 7230 defibrillator, subsequent 
to supplemental premarket approval of the changes to the 
defibrillator.  Riegel, 128 S. Ct. at 1005 (citing 21 U.S.C. 
§ 360i; 21 CFR §§ 814.84(b)(2), 803.50(a)).  The samples of the 
FDA premarket approvals in the record of this case relate: 
No. 
2006AP1506   
 
20 
 
Postapproval reports.  Continued approval of this 
[premarket approval] is contingent upon the submission 
of 
postapproval 
reports 
required 
under 
21 
CFR 
[§] 814.84 at intervals of 1 year from the date of 
approval of the original [premarket approval].   
The content of these premarket approvals is consistent with the 
discussion in Riegel, cited immediately above.  Accordingly, if 
the 
premarket 
approval 
of 
the 
original 
Marquis 
7230 
defibrillator were not ongoing, there would be no need to direct 
Medtronic to report at least annually on the results of further 
use and testing of the device.15   
¶32 We have found nothing in the comprehensive federal 
regulatory scheme that suggests a change in device-specific 
premarket approval of a Class III medical device occurs simply 
because a subsequent device has received supplemental premarket 
approval, and the Blunts have identified no such provision in 
the federal law.  Accordingly, we conclude that the supplemental 
premarket approval that Medtronic received did not affect the 
federal requirement of premarket approval granted to the 
original Marquis 7230 defibrillator. 
¶33 Furthermore, the United States Supreme Court has 
interpreted other federal statutory schemes to which preemption 
arguments have been made in a manner that supports this 
conclusion.  For example, in Geier v. American Honda Motor, 529 
U.S. 861 (2000), the United States Department of Transportation 
                                                 
15 See also 21 U.S.C. § 360e(d)(6) (providing the standards 
for supplemental approvals, without mentioning any effect that 
supplemental approvals may have on prior approvals); 21 CFR 
§ 814.39(c) (same). 
No. 
2006AP1506   
 
21 
 
had required that new automobiles employ at least one of a 
variety 
of 
approved 
passive 
restraint 
systems, 
including 
automatic seatbelts and airbags.  Geier, 529 U.S. at 875-76.  
Geier sued Honda, alleging liability based on a theory that 
Honda had a duty to install airbags, even though the federal 
regulations explicitly permitted other passive restraint systems 
such as automatic seatbelts.  Id. at 881.  The Supreme Court, in 
rejecting Geier's argument, stated: 
In effect, petitioners' tort action depends upon 
its claim that manufacturers had a duty to install an 
airbag . . . .  Such a state law——i.e., a rule of 
state tort law imposing such a duty——by its terms 
would have required manufacturers of all similar cars 
to install airbags rather than other passive restraint 
systems, such as automatic belts or passive interiors 
. . ., even though [the regulation] required only that 
10% of a manufacturer's nationwide fleet be equipped 
with any passive restraint device at all.  
Id.  Since the state tort claims in Geier would have held 
automobile manufacturers liable for manufacturing automobiles 
without airbags and the federal regulations permitted the 
manufacturers to use other restraints, the state tort claims 
were preempted due to conflict preemption, a form of implied 
preemption.16  Id.   
¶34 Applying the reasoning of Geier to this case, we note 
that 
Medtronic 
had 
received FDA device-specific premarket 
                                                 
16 In Geier v. American Honda Motor, 529 U.S. 861 (2000), 
the Supreme Court considered both the express preemption 
provisions in the federal law and implied preemption.  Due to a 
savings clause in the express preemption provision, the Court 
concluded that express preemption did not bar Geier's tort 
claim.  Id. at 868.  There is no savings clause in 21 U.S.C. 
360k(a).   
No. 
2006AP1506   
 
22 
 
approval to sell both the original and the supplemental 
defibrillators.  The Blunts acknowledge this, yet the Blunts' 
tort claims seek to impose liability for selling the original 
Marquis 7230 defibrillator.   
¶35 While the ultimate holding in Geier was based on 
implied preemption and our decision is based on express 
preemption, the facts before us are analogous to the facts in 
Geier because in Geier the federal government approved airbags 
and also other restraints, such as lap and shoulder belts.  Id. 
at 876.  Here, both the original defibrillator and the 
supplemental 
defibrillator 
were 
approved 
by 
the 
federal 
government.   
¶36 In Geier, Honda had installed airbags in some of its 
autos, in conformance with federal regulation; however, Geier 
was injured in an auto that contained lap and shoulder belts, 
also in conformance with federal regulations.  Id. at 865.  
Here, Medtronics sold both defibrillators and Blunt sought 
recovery 
based 
on 
the 
implantation 
of 
the 
original 
defibrillator, which defibrillator was also in conformance with 
the federal regulation.  
¶37 In Geier, the Court upheld a preemption defense for 
the lap and shoulder belts, concluding that because both types 
of restraint had been federally approved, a state tort claim 
would conflict with the federal scheme under which the approvals 
had been granted.  Id. at 886.  Here, we uphold a preemption 
defense, albeit based on express preemption, for the federally 
approved original Marquis 7230 defibrillator.  In so doing, we 
No. 
2006AP1506   
 
23 
 
conclude, as did the Supreme Court in Geier, that the federal 
government's approval of the supplemental device did not affect 
the approval of the original device.  Accordingly, a state tort 
claim will be preempted by the original federal approval.17   
¶38 In addition, other courts seem to take for granted 
that a manufacturer often may have a number of different 
supplemental premarket-approved devices on the market at any 
given time.  See, e.g., U.S. ex rel. Gilligan v. Medtronic, 
Inc., 403 F.3d 386, 388 (6th Cir. 2005) (discussing premarket 
approval 
and 
supplemental approval for several pacemakers 
applied for and obtained at the same time); Scott v. CIBA Vision 
Corp., 38 Cal. App. 4th 307 (Cal. Ct. App. 1995) (preempting 
claims for an eye injury that occurred when the wrong solution 
was used with a contact lens after supplemental approval had 
been given to use a red top on the container for that solution 
instead of the earlier approved white top that was used on the 
container of the solution that caused the injury).   
¶39 Finally, supplemental approvals do not necessarily 
occur because newer versions are more safe than predecessor 
versions, but rather, because the law requires premarket 
approval for most changes in design.  For example, under 21 
                                                 
17 Our conclusion that federal approval of the device under 
review is critical to our decision is supported by the reasoning 
in Sprietsma v. Mercury Marine, 537 U.S. 51 (2002).  Even though 
Sprietsma's holding turns on implied preemption, its conclusion 
that preemption did not occur there confirms how important 
federal governmental action is in a preemption analysis.  Id. at 
65-68.  
No. 
2006AP1506   
 
24 
 
C.F.R. § 814.39(a), supplemental approval must be obtained when 
the proposed changes allow for a new use of the device, affect 
the labeling or packaging of the device or require a different 
facility to process the device.  Therefore, we conclude that 
when a manufacturer obtains supplemental approval for a medical 
device, absent further FDA action, prior approvals of the device 
remain valid and accordingly the federal requirement established 
by premarket approval is ongoing.   
¶40 The relevant federal statutes, the FDA's regulations 
and the relevant case law support preemption by the device-
specific premarket approval of the original Marquis 7230 
defibrillator.  Therefore, that premarket approval remained the 
federal requirement that preempts the Blunts' claims under 21 
U.S.C. § 360k(a).  Accordingly, pursuant to 21 U.S.C. § 360k(a), 
as interpreted in Riegel, we conclude that the Blunts' state law 
tort claims are preempted.   
¶41 In an effort to get around the holdings in Riegel, the 
Blunts also contend that the federal statute's use of the word 
"requirement" means that the medical device manufacturer is 
"required" to sell only one version of the device.  The Blunts 
explain that since Medtronic had the option of selling either 
the original Marquis 7230 defibrillator or the supplemental 
Marquis 7230, it was no longer "required" to sell only the 
original defibrillator.  Therefore, they contend that their 
claims that arise from the use of the original Marquis 7230 are 
not preempted.  Stated otherwise, they argue that since there is 
no longer a federal "requirement" that relates solely to the 
No. 
2006AP1506   
 
25 
 
original Marquis 7230, state tort law requirements have no 
federal requirement from which they are "different from, or in 
addition to."  Judge Fine also employed this reasoning in his 
dissent.  Blunt, 305 Wis. 2d 354, ¶22 (Fine, J., dissenting) 
("The Majority asks and answers the wrong question.  [T]he nub 
here is:  Whether Medtronic is protected by the pre-emption 
doctrine when it had the option under federal law of selling two 
approved devices.") (emphasis in original).  We reject this 
argument. 
¶42 Riegel provides a precise meaning for the term, 
"requirement," as used in 21 U.S.C. § 360k(a).  It is not the 
meaning 
suggested 
by 
the 
Blunts. 
 
Through 
the 
federal 
requirement of device-specific premarket approval, "the FDA 
requires a device to be made with almost no deviations from the 
specifications in its approval application."  Riegel, 128 S. Ct. 
at 1007.  That is, "requirement" under § 360k(a) refers to 
safety and efficacy federal requirements that a manufacturer 
must satisfy before its product may be approved and marketed.  
State tort claims based on the safety of a device also are 
"requirements"; however, they are state requirements, rather 
than federal requirements.  For example under Wisconsin law, a 
manufacturer is required to design its device to prevent it from 
being unreasonably dangerous.  See, e.g., Dippel v. Sciano, 37 
Wis. 2d 443, 459, 155 N.W.2d 55 (1967). 
¶43 As a result, the term, "requirement," as it is 
construed 
in 
Riegel, 
encompasses 
both 
federally 
mandated 
No. 
2006AP1506   
 
26 
 
criteria18 for medical devices before they can be marketed and 
sold (a federal requirement) and state tort claims that require 
manufacturers to design their devices with a certain level of 
safety (a state requirement) before they are marketed and sold 
in order to avoid tort liability.  However, under Riegel, the 
term, "requirement," does not mean that a manufacturer is 
"required" to sell one particular approved device among several 
devices that have been given device-specific premarket approval.  
To the contrary, premarket approval does not require the 
manufacturer to sell any premarket approved medical devices at 
all.  Accordingly, the Blunts' arguments do not change our 
conclusion stated above that pursuant to 21 U.S.C. § 360k(a), as 
interpreted in Riegel, the Blunts' state law tort claims are 
preempted.  
III.  CONCLUSION 
¶44 Our decision in this case turns on whether the Blunts' 
state law tort claims are preempted by federal law.  In order to 
decide this issue, we must answer three questions.  The first is 
whether 
Medtronic's 
Marquis 
7230 
implantable 
cardioverter 
defibrillator 
(the 
Marquis 7230 defibrillator), which was 
approved 
under 
the 
Food 
and 
Drug 
Administration's 
(FDA) 
                                                 
18 Not all approvals received under the Medical Device 
Amendments constitute federal "requirements" under 21 U.S.C. 
§ 360k(a), as interpreted in Riegel.  For example, devices that 
receive FDA approval because they are "substantially equivalent" 
to 
premarket 
approval-exempted 
devices 
under 
21 
U.S.C. 
§ 360c(f)(1)(A) are not subject to the federal requirement, and 
tort claims based on such devices are not preempted.  See 
Riegel, 128 S. Ct. at 1007; Lohr, 518 U.S. at 493-94. 
No. 
2006AP1506   
 
27 
 
premarket approval process, 21 U.S.C. § 360e, met the federal 
"requirement" specific to that device, pursuant to 21 U.S.C. 
§ 360k(a), when it received premarket approval.  The second 
question is whether the Blunts' common law claims, which allege 
negligence, strict liability and loss of consortium, constitute 
state requirements that are "different from, or in addition to," 
the federal requirement.  The third question is whether the 
preemption analysis of Riegel applies to claims against the 
Marquis 7230 defibrillator, even though supplemental premarket 
approval was given to a later defibrillator.  Because we 
conclude that the United States Supreme Court's decision in 
Riegel provides definitive direction on these questions, we 
answer all of them in the affirmative.  We therefore conclude 
that § 360k(a) preempts the Blunts' claims.  Accordingly, we 
affirm the decision of the court of appeals.  
By the Court.—The decision of the court of appeals is 
affirmed. 
 
 
 
No.  2006AP1506.awb 
 
1 
 
 
¶45 ANN WALSH BRADLEY, J.   (concurring in the judgment).  
I write separately in order to express my concern that the 
United States Supreme Court's interpretation of the 1976 Medical 
Device Amendments does not adequately protect the safety of the 
citizens of Wisconsin.  See Riegel v. Medtronic, Inc., __ U.S. 
__, 128 S. Ct. 999 (2008).  With one stroke of a pen, it has 
diminished 
the 
states' 
traditional 
authority 
over 
the 
development of the common law and substituted instead mandatory 
adherence to a regulatory standard that may be substandard.  I 
do not believe that such adherence was mandated by the express 
language of the amendments, although I acknowledge that I am 
bound by the Supreme Court's interpretation. 
¶46 I also write separately because I disagree with the 
majority's reliance on Geier v. American Honda Motor Co., Inc., 
529 U.S. 861 (2000).  The Geier case turns on implied 
preemption.  Nevertheless, the majority uses Geier to conclude 
that the Blunt's tort claims must be dismissed based on express 
preemption.1  Because express preemption and implied preemption 
                                                 
1 The majority misconstrues the Blunts' arguments.  The 
Blunts argue that their tort claims are not state requirements 
"different from, or in addition to" federal requirements because 
Medtronic had the option of selling one of two approved devices.  
Thus, the Blunts assert that Medtronic was allowed to——but was 
not required to——sell the allegedly defective device that was 
implanted in Joseph Blunt. 
No.  2006AP1506.awb 
 
2 
 
are distinct legal theories based on different facts and 
analysis, Geier does not support the majority's determination in 
this case. 
I 
¶47 The purpose of the federal Medical Devices Amendments 
of 1976, 21 U.S.C. § 360 et seq., was "to provide for the safety 
and effectiveness of medical devices intended for human use[.]"  
90 Stat. 539 (1976) (preamble); see also Medtronic, Inc. v. 
Lohr, 518 U.S. 470, 474 (1996).  In response to public health 
disasters involving unsafe medical devices such as the infamous 
Dalkon Shield, Congress determined that these devices should be 
more stringently regulated than most products.  Riegel, __ U.S. 
at __, 128 S. Ct. at 1003.   
¶48 It is the responsibility of the state legislature and 
courts to develop a tort system that protects the health and 
safety of the citizens they serve.  The United States Supreme 
Court has "long presumed that Congress does not cavalierly pre-
empt state-law causes of action."  Lohr, 518 U.S. at 485.  "[A]s 
a rule," the United States Supreme Court "should be and [is] 
reluctant to federalize matters traditionally covered by state 
                                                                                                                                                             
The majority addresses the Blunts' argument only as an 
afterthought.  See majority op., ¶¶41-43.  Instead, the majority 
focuses on an argument never advanced by the Blunts, that is, 
whether 
supplemental 
approval 
of 
a 
subsequent 
device 
extinguished the prior device's Food and Drug Administration 
(FDA) approval.  See majority op., ¶¶26-40.  This is an argument 
that does not appear in the Blunts' brief, and that counsel for 
the Blunts specifically disclaimed during oral argument.  See 
Wisconsin 
Court 
System, 
Supreme 
Court 
Oral 
Arguments, 
http://wicourts.gov/opinions/soralarguments.htm 
(search 
"Party 
name" for "Blunt"; then follow "Playback" link) at 19:15.  
No.  2006AP1506.awb 
 
3 
 
common law."  Patterson v. McLean Credit Union, 491 U.S. 164, 
183 (1989) 
(superseded 
by 
statute) 
(quotations 
omitted).  
Instead, the Court "start[s] with the assumption that the 
historic police powers of the States were not to be superseded 
by the Federal Act unless that was the clear and manifest 
purpose of Congress."  Lohr, 518 U.S. at 485 (quotations 
omitted).   
¶49 The Medical Device Amendments provide that no State 
may "establish or continue in effect . . . any requirement" that 
is "different from, or in addition to" the federal requirements 
and "which relates to the safety or effectiveness of the 
device[.]"  21 U.S.C. § 360k(a).  In 1996, the Court stated that 
"it would take language much plainer than the text of § 360k(a) 
to convince us that Congress intended that result [that state 
tort claims are preempted]."  Lohr, 518 U.S. at 487. 
¶50 However, 12 years later, with precisely the same 
language in force, the Court concluded that the language was 
apparently plain enough.  The Court determined that state tort 
law claims are state "requirements" and that the express 
language of § 360k(a) preempts them.  Riegel, __ U.S. at __, 128 
S. Ct. at 1008. 
¶51 Despite basing its conclusion on a determination that 
the language is plain, the Court turned to the policy reasons 
supporting its determination.  The policy reason cited by the 
Supreme Court in favor of preemption is that it is better for 
one centralized agency——the Food and Drug Administration (FDA)——
No.  2006AP1506.awb 
 
4 
 
to do the necessary cost-benefit analysis in determining whether 
a device is safe enough for the market: 
It is not our job to speculate upon congressional 
motives.  If we were to do so, however, the only 
indication 
available——the 
text 
of 
the 
statute——
suggests that the solicitude for those injured by FDA-
approved 
devices . . . was 
overcome 
in 
Congress's 
estimation by solicitude for those who would suffer 
without new medical devices if juries were allowed to 
apply the tort law of 50 States to all innovations.2 
Riegel, __ U.S. at __, 128 S. Ct. at 1009.3     
¶52 This is a policy rationale that may be meritorious if 
the premarket approval process provided at least minimum 
assurances of safety.  It presumes that the FDA premarket 
                                                 
2 Concurring in the judgment, Justice Stevens stated: 
There is nothing in the preenactment history of the 
[Medical Device Amendments] suggesting that Congress 
thought 
state 
tort 
remedies 
had 
impeded 
the 
development of medical devices.  Nor is there any 
evidence at all to suggest that Congress decided that 
the 
cost 
of 
injuries 
from 
Food 
and 
Drug 
Administration-approved medical devices was outweighed 
"by solicitude for those who would suffer without new 
medical devices if juries were allowed to apply the 
tort law of 50 States to all innovations."  That is a 
policy 
argument 
advanced 
by 
the 
Court, 
not 
by 
Congress. 
Riegel v. Medtronic, Inc., __ U.S. __, 128 S. Ct. 999, 1012 
(2008) (Stevens, J., concurring in part and concurring in the 
judgment) (citations omitted).   
3 A recent law review article closely tracks this rationale, 
declaring that "preemption is necessary to ensure that federal 
regulatory agencies, like the Food and Drug Administration 
(FDA), 
are 
the 
only 
governmental 
actors 
able 
to 
impose 
requirements on manufacturers——thereby ensuring a nationally 
standardized system of safety regulations without myriad local 
variations."  Note, Preemption of State Common Law Claims, 122 
Harv. L. Rev. 405, 405 (2008). 
No.  2006AP1506.awb 
 
5 
 
approval process is indeed rigorous and that the devices 
approved are safe for use.  Recent reporting on the FDA calls 
these presumptions into question. 
¶53 Recently, there has been a flood of criticism directed 
at the FDA approval process, much of the criticism coming from 
whistleblowers within the FDA itself.  It is not at all apparent 
that the FDA approval process actually guarantees a minimum 
level of safety for medical devices.  A January 2009 letter from 
nine FDA scientists could not be more clear: "The purpose of 
this letter is to inform you that the scientific review process 
for medical devices at FDA has been corrupted and distorted by 
current FDA managers, thereby placing the American people at 
risk."  Letter from nine FDA scientists (names redacted), to 
John D. Podesta, Presidential Transition Team 1 (Jan. 7, 2009).    
¶54 The letter charges managers of the Center for Devices 
and Radiological Health (CDRH) with "corrupting and distorting 
the 
scientific 
evaluation 
of 
medical 
devices, 
and 
. . .  
interfering with our responsibility to ensure the safety and 
effectiveness of medical devices before they are used on the 
American public."  Id.  The scientists further explained: 
Managers at CDRH have ignored the law and ordered 
physicians and scientists to assess medical devices 
employing unsound evaluation methods, and to accept 
non-scientific, nor clinically validated, safety and 
effectiveness evidence and conclusions, as the basis 
of device clearance and approval.  Managers . . . have 
ignored serious safety and effectiveness concerns of 
FDA experts.  Managers have ordered, intimidated, and 
coerced FDA experts to modify scientific evaluations, 
conclusions and recommendations in violation of the 
laws, rules and regulations and to accept clinical and 
technical data that is not scientifically valid nor 
No.  2006AP1506.awb 
 
6 
 
obtained in accordance with legal requirements . . . .  
These same managers have knowingly tried to avoid 
transparency and accountability by failing to properly 
document the basis of their non-scientific decisions 
in administrative records.  
Id. at 2.  The letter concludes that the current FDA approval 
process is "a clear and silent danger to the American public."  
Id. at 3. 
¶55 As one example of the FDA's ineffectiveness in 
ensuring basic device safety, the FDA scientists point to the 
1998 approval of a mammography computer-aided detection device.  
Id.  The scientists charge that the FDA approved the device even 
though there was no clinical evidence of improved cancer 
detection.  Id.  Further, the FDA carried out no post-marketing 
reassessment of approved devices and "ignor[ed] accumulating 
clinical evidence provided by independent research publications 
revealing that these devices were ineffective and potentially 
harmful when used in clinical practice."  Id.   
¶56 Congress is aware of some of the problems within the 
FDA, and the House Committee on Energy and Commerce conducted an 
investigation on the matter in October of 2008.  As a result of 
its findings, the Committee sent a letter to the Commissioner of 
the 
FDA, 
stating 
that 
the 
Committee 
"recently 
received 
compelling evidence of serious wrongdoing in connection with 
FDA's review, clearance, and approval process of medical 
devices."4  The letter states that FDA scientists "supplied 
                                                 
4 Letter 
from 
Representative 
John 
D. 
Dingell 
and 
Representative 
Bart 
Stupak, 
Chairmen, 
U.S. 
House 
of 
Representatives Committee on Energy and Commerce, to the 
Honorable Andrew C. von Eschenbach, Commissioner, U.S. Food and 
Drug Administration 1 (Nov. 17, 2008). 
No.  2006AP1506.awb 
 
7 
 
substantial 
evidence 
demonstrating 
that 
medical 
devices 
submitted for FDA review . . . have been received and/or cleared 
or approved in violation of agency regulation and guidance 
mandated to assure safety and effectiveness."5     
¶57 The preemption doctrine should not be employed to 
allow for the normal standard of care to be substandard care.  I 
conclude, as I must, that Riegel controls and that the Blunts' 
tort claims are preempted.6  However, the result may be no 
meaningful protection for Wisconsin patients.   
II 
¶58 I also write separately to express my disagreement 
with the majority's discussion of Geier v. American Honda Motor 
Co., Inc., 529 U.S. 861 (2000).  See majority op., ¶¶33-37.  The 
                                                 
5 Id.  
6 Tort law claims are not preempted, however, to the extent 
that they seek damages for a manufacturer's violation of federal 
requirements: 
Where a state cause of action seeks to enforce [a 
federal] requirement, that claim does not impose a 
requirement that is "different from, or in addition 
to," requirements under federal law.  To be sure, the 
threat of a damages remedy will give manufacturers an 
additional cause to comply, but the requirements 
imposed on them under state and federal law do not 
differ.  Section 360k does not preclude States from 
imposing different or additional remedies, but only 
different or additional requirements. 
Medtronic, Inc. v. Lohr, 518 U.S. 470, 513 (1996) (O'Connor, J., 
concurring in part and dissenting in part) (emphasis in 
original); see also Riegel, 128 S. Ct. at 1011 ("§ 360k does not 
prevent a State from providing a damages remedy for claims 
premised on a violation of FDA regulations; the state duties in 
such 
a 
case 
'parallel,' 
rather 
than 
add 
to, 
federal 
requirements."). 
No.  2006AP1506.awb 
 
8 
 
basis for the majority's conclusion in this case (and for the 
Supreme Court's conclusion in Riegel) is express preemption.  
Yet, Geier is a case that turns on conflict preemption, a form 
of implied preemption.7  Because the cases turn on distinct legal 
theories, 
I do not find Geier relevant to the court's 
determination in this case.  
¶59 Express preemption and implied preemption are separate 
legal theories, based on distinct factual inquiries.  Express 
preemption is exactly what it sounds like——the text of a 
congressional enactment explicitly provides that state law 
claims are preempted.  See English v. Gen. Elec. Co., 496 U.S. 
72, 79 (1990).  Implied preemption, however, comes in several 
stripes and involves a more nuanced analysis.   
¶60 One 
form 
of 
implied 
preemption 
is 
"conflict 
preemption."  Under this doctrine, a particular state law is 
preempted because of an "actual conflict" with a federal 
regulation——even in the absence of a broad congressional mandate 
to preempt all state law in the area.  See id.  State law is 
preempted due to a conflict with federal law when it is 
impossible for a party to simultaneously comply with state and 
federal requirements, or when the state law "stands as an 
                                                 
7 In fact, in Geier the Court determined that a Department 
of Transportation safety standard did not expressly preempt 
state tort law claims.  Geier v. Am. Honda Motor Co., Inc., 529 
U.S. 861, 868 (2000).  However, based on the Department's 
comments which accompanied the standards and the drafting 
history, the Court determined that the claim was nonetheless 
preempted under the doctrine of implied preemption.  Id. at 874. 
 
No.  2006AP1506.awb 
 
9 
 
obstacle to the accomplishment and execution of the full 
purposes and objectives of Congress."  Id.   
¶61 The majority appears to suggest that a case about 
implied preemption lends support to the majority's express 
preemption analysis.  That is, the Blunts' claims are expressly 
preempted because the facts of the case are "analogous" to the 
facts in a case regarding a different Congressional act and in 
which a different preemption doctrine applies.  Majority op., 
¶35.  This cannot be.  Because the majority here takes a 
superficial approach to the facts and the law in Geier, it 
misses the essence of that case and misapplies its holding. 
¶62 In Geier, the Supreme Court determined that the 
plaintiff's state tort law claim was impliedly preempted via the 
doctrine of conflict preemption. 529 U.S. at 874.  Geier had 
filed a tort action against Honda, alleging negligence for 
failure to install an airbag in her car.  Id. at 865.  The Court 
examined the Federal Motor Vehicle Safety Standards, promulgated 
by the Department of Transportation, to determine whether they 
preempted 
Geier's 
claim. 
 
The 
safety 
standards 
required 
automobile manufacturers to equip some——but not all——of their 
vehicles with airbags.  Id. 
¶63 In determining that Geier's claim was impliedly 
preempted, the Court looked to the comments and drafting history 
of the safety standards to determine the Department's intent.  
Id. at 874-79.  In creating the safety standards, the Department 
had "rejected a proposed . . . 'all airbag' standard because of 
safety concerns (perceived or real) associated with airbags[.]"  
No.  2006AP1506.awb 
 
10 
 
Id. at 879.  Instead, the Department determined that "a mix of 
devices would help develop data on comparative effectiveness 
[and] would allow the industry time to overcome the safety 
problems and 
the 
high 
production 
costs 
associated 
with 
airbags[.]" 
 
Id. 
 
The 
safety 
standards 
reflected 
the 
Department's "policy judgment that safety would best be promoted 
if manufacturers installed alternative protection systems in 
their fleets rather than one particular system in every car."  
Id. at 881 (emphasis in original).   
¶64 In Geier, the Court concluded the Department made an 
affirmative determination that it did not want manufacturers to 
install airbags in all of their automobiles.  Because Geier's 
tort claim would require manufacturers to install airbags in all 
of their automobiles or risk liability, the state tort claim 
actually conflicted with the accomplishment of a federal 
objective.  Therefore, it was impliedly preempted.  See id.     
¶65 In this case, the facts in the record do not support a 
finding of implied preemption.  At the time that Blunt received 
the 
allegedly 
defective 
defibrillator, 
the 
FDA 
permitted 
Medtronic 
to 
market 
both 
the 
original 
and 
the 
improved 
defibrillator.  Majority op., ¶32.  There is no indication in 
the record, however, that the FDA made an affirmative decision 
that its policy objectives would be best served if Medtronic 
sold both types of defibrillators at once.  Without such 
affirmative 
determination, 
state 
tort 
law 
claims 
do 
not 
frustrate the accomplishment of the FDA's objective and are not 
preempted under the doctrine of conflict preemption.   
No.  2006AP1506.awb 
 
11 
 
¶66 For the above reason, I determine that the reasoning 
of Geier is inapt in this case.  Because I do not agree with the 
majority's blending of preemption doctrines, I respectfully 
concur.   
¶67 I am authorized to state that SHIRLEY S. ABRAHAMSON, 
C.J. joins this concurrence. 
 
 
 
No.  2006AP1506.awb 
 
 
 
1