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In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation: US District Court : CIVIL PROCEDURE | TORT | FEDERAL PREEMPTION - ICD leads claims preempted by FDCA Medical Device amendments

UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
In re Medtronic, Inc. Sprint Fidelis
Leads Products Liability Litigation,
Multidistrict Litigation
This document relates to: No. 08-1905 (RHK/JSM)
ALL CASES MEMORANDUM OPINION
AND ORDER
Daniel E. Gustafson, Gustafson Gluek, PLLC, Minneapolis, Minnesota, Plaintiffs lead
counsel, Robert K. Shelquist, Lockridge Grindal Nauen P.L.L.P., Minneapolis,
Minnesota, Plaintiffs liaison counsel, Charles S. Zimmerman, Zimmerman Reed PLLP,
Minneapolis, Minnesota, chair of Plaintiffs Steering Committee, on behalf of the
individual Plaintiffs.
Paul R. Dahlberg, Meshbesher & Spence, Ltd., Rochester, Minnesota, James T. Capretz,
Capretz & Associates, Newport Beach, California, for the Third-Party Payor Plaintiffs.
Kenneth S. Geller, Mayer Brown, LLP, Washington, DC, Rick Robinson, Fulbright &
Jaworski, LLP, Washington, DC, George W. Soule, Bowman and Brooke, Minneapolis,
Minnesota, Daniel L. Ring, Mayer Brown, LLP, Chicago, Illinois, for Defendants.
INTRODUCTION
The federal courts are frequently confronted with sympathetic plaintiffs who are,
nevertheless, without remedy by operation of law. Doctrines such as qualified immunity
often shield defendants from liability even when plaintiffs have been injured by the
defendants conduct. As one court has stated, [l]itigants must believe that judges spend
an inordinate amount of time wringing their hands while informing persons who have
been [injured] that the court will do nothing. This is not because judges like to make
1 Congress later amended the Federal Railroad Safety Act to clarify that preemption was
not intended, enabling the plaintiffs claims to proceed. Lundeen, 532 F.3d at 688.
2 Named as defendants in this action are Medtronic, Inc. and two of its wholly owned
subsidiaries, Medtronic International Technology, Inc. and Medtronic Puerto Rico Operations
Co. Because the parties do not differentiate between these three entities, the Court refers to them
collectively as Medtronic.
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litigants feel bad or themselves feel good by expressing sympathy but because it is
important to point out that the absence of a particular remedy . . . does not imply . . . the
lack of a legal wrong. Pacelli v. deVito, 972 F.2d 871, 879 (7th Cir. 1992).
Like qualified immunity, the doctrine of federal preemption also leaves some
plaintiffs without judicial recourse to pursue claims for damages. In one recent example,
hundreds of people injured by the release of noxious gas following a 2002 train
derailment in Minot, North Dakota were left without any remedy because their claims
were preempted by the Federal Railroad Safety Act. See Lundeen v. Canadian Pac. Ry.
Co., 532 F.3d 682, 687 (8th Cir. 2008).1 Medtronic, the Defendant in this multidistrict
litigation,2 asserts the same doctrine here, arguing that Plaintiffs claims sounding in
negligence and strict products liability are preempted by the Medical Device
Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et
seq. Having carefully considered the parties voluminous submissions, the Court agrees.
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BACKGROUND
I. The statutory and regulatory framework and the pre-market approval
process
Every medical device intended for human use is placed into one of three categories
by the Food and Drug Administration (FDA), based on the risks of injury or illness the
device presents; each category is subjected to a different level of FDA scrutiny. See 21
U.S.C. 360c(a)(1); Riegel v. Medtronic, Inc., __ U.S. __, 128 S. Ct. 999, 1003 (2008).
Devices that either support[] or sustain[] human life or present[] a potential
unreasonable risk of illness or injury are categorized as Class III devices. 21 U.S.C.
360c(a)(1)(c)(ii). Class III devices are subject to the greatest level of FDA scrutiny and
must complete a thorough review process with the FDA before they may be marketed.
Buckman Co. v. Plaintiffs Legal Comm., 531 U.S. 341, 344 (2001). Through this
process, known as pre-market approval (PMA), a device maker must provide the FDA
with reasonable assurance that its device is both safe and effective. 21 U.S.C.
360e(d)(2).
The PMA process is a rigorous one. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477
(1996). Manufacturers must submit detailed information regarding the safety and
efficacy of their devices, which the FDA then reviews, spending an average of 1,200
hours on each submission. Id. When analyzing that information, the FDA must weigh
the probable benefit to health from the use of the device against any probable risk of
injury or illness from such use. 21 U.S.C. 360c(a)(2)(C). Accordingly, the FDA
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sometimes grants PMA to potentially life-threatening devices, if they offer great benefits
in light of available alternatives. Riegel, 128 S. Ct. at 1004; accord Heisner ex rel.
Heisner v. Genzyme Corp., No. 08-C-593, 2008 WL 2940811, at *5 (N.D. Ill. July 25,
2008) (Out of practical necessity and the cold calculus of nationwide regulation, the
FDA may be aware of a certain failure rate associated with a medical product and yet
approve it.). The PMA process also requires the FDA to review a devices proposed
labeling to ensure that it is neither false nor misleading. See 21 U.S.C. 360c(a)(2)(B).
If a device receives PMA, the manufacturer may not change its design
specifications, manufacturing processes, labeling, or any other attribute that would affect
the devices safety or efficacy without FDA approval. 21 U.S.C. 360e(d)(6)(A)(i).
Should a manufacturer wish to make such changes, it must submit to the FDA an
application for supplemental PMA, which is evaluated under largely the same criteria as
an initial application. Riegel, 128 S. Ct. at 1005; accord 21 C.F.R. 814.39(c) (All
procedures and actions that apply to an application [for PMA] also apply to PMA
supplements.). In addition, once a device receives PMA, a manufacturer must inform
the FDA when it becomes aware of adverse events in patients using the device. See 21
C.F.R. 803.50, 803.53.
II. The FDCAs express preemption clause
In response to a bevy of state laws regulating medical devices largely enacted due
to the failure of the Dalkon Shield contraceptive in the 1970s, Congress passed the
Medical Device Amendments to the FDCA in 1976. See Riegel, 128 S. Ct. at 1003. The
3 The exception in subsection (b) referred to in Section 360k(a) is irrelevant for present
purposes.
-5-
Medical Device Amendments include an express preemption clause that swept back
some state obligations and imposed a regime of detailed federal oversight. Id. The
preemption clause states:
Except as provided in subsection (b) of this section, no State or political
subdivision of a State may establish or continue in effect with respect to a
device intended for human use any requirement
(1) which is different from, or in addition to, any requirement applicable
under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any
other matter included in a requirement applicable to the device under
this chapter.
21 U.S.C. 360k(a).3
The scope of Section 360k(a) has been the subject of repeated litigation and the
results are, charitably speaking, utterly conflicted. The Supreme Court got into the act in
1996 in Lohr, but did little to clear up the confusion. That wondrously complex
decision, In re Medtronic, Inc. Implantable Defibrillators Litig., 465 F. Supp. 2d 886, 892
(D. Minn. 2006) (Rosenbaum, J.) which has been described by one court of appeals as
fractured in an all but irreconcilable manner, Goodlin v. Medtronic, Inc., 167 F.3d
1367, 1371 (11th Cir. 1999) concluded that the plaintiffs claims for negligence and
strict products liability arising out of the use of a Medtronic pacemaker were not
4 Justice Stevens authored the plurality opinion in Lohr, joined by Justices Kennedy,
Souter, and Ginsburg. Justice OConnor concurred in part and dissented in part, and dissented
from the judgment; she was joined by then-Chief Justice Rehnquist and Justices Scalia and
Thomas. Justice Breyer authored an opinion concurring in part and concurring in the judgment.
Because no single opinion received the approval of five Justices, the Courts holding is
somewhat unclear. Justice Breyers concurrence, however, is of the greatest importance. See
Marks v. United States, 430 U.S. 188, 193 (1977) (When a fragmented Court decides a case and
no single rationale explaining the result enjoys the assent of five Justices, the holding of the
Court may be viewed as that position taken by those Members who concurred in the judgments
on the narrowest grounds.) (internal quotation marks and citation omitted).
-6-
preempted by Section 360k(a).4 While Justice Breyer agreed with the Lohr plurality that
the plaintiffs claims were not preempted, he also agreed with the four dissenters that the
Medical Device Amendments ordinarily . . . pre-empt . . . state-law tort action[s]. 518
U.S. at 504-05 (Breyer, J., concurring in part and concurring in the judgment).
Given the uncertainty left in Lohrs wake, in the years that followed courts were
divided over how broadly Section 360k(a) reached in medical-device cases. Compare
Goodlin, 167 F.3d at 1382 (concluding that state tort-law claims regarding alleged defects
in Medtronic pacemaker lead were not preempted) with Kemp v. Medtronic, Inc., 231
F.3d 216, 237 (6th Cir. 2004) (concluding that state tort-law claims regarding the same
types of defects in the same Medtronic pacemaker lead were preempted). Nevertheless,
over time the scales began to tip decidedly in favor of preemption, with more and more
courts ruling that state-law claims concerning FDA-approved medical devices were
indeed preempted. See In re Sulzer Hip Prosthesis & Knee Prosthesis Liab. Litig., 455 F.
Supp. 2d 709, 716 (N.D. Ohio 2006) (canvassing case law and concluding that majority
5 The FDA, which appeared as amicus curiae in Riegel, agreed with the Supreme Courts
decision. See 128 S. Ct. at 1009; see also Should FDA Drug & Medical Device Regulation Bar
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view is that virtually all state law claims seeking to hold a defendant liable for injuries
caused by an FDA-approved medical device are preempted).
Early last year, the Supreme Court confirmed that the prevailing view is the correct
one. In Riegel, the Court held that the plaintiffs state-law claims for strict products
liability, breach of implied warranty, and negligence in the design, testing, inspection,
distribution, labeling, marketing, and sale of an FDA-approved medical device were
preempted under the FDCA. 128 S. Ct. at 1007-10. In reaching that conclusion, the
Court undertook a two-step analysis. First, tracking the language of Section 360k(a), the
Court opined that pre-market approval of a medical device by the FDA imposes
requirements under the FDCA, because the device must be made with almost no
deviations from the specifications in [the PMA] application. Id. at 1007. Second, the
Court opined that permitting the plaintiffs claims to proceed would impose requirements
different from, or in addition to the requirements imposed via the PMA process. Id. In
so holding, the Court noted that
[s]tate tort law that requires a manufacturers [device] 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.
Id. at 1008. Because both prongs of Section 360k(a) had been met, the Court concluded
that the plaintiffs claims were preempted.5
State Liability Claims?: Hearing Before H. Comm. on Oversight & Govt Reform, available at
http://www.hhs.gov/asl/testify/2008/05/t20080514b.html (May 14, 2008) (statement by Randall
W. Lutter, FDA Deputy Commissioner for Policy). However, the FDAs position on preemption
has changed over time. See FDA Amicus Curiae Letter Brief, Horn v. Thoratec Corp., 2004 WL
1143720, at *3 (3rd Cir. May 11, 2004) (noting FDAs position in 1997 that state-law tort claims
concerning FDA-approved devices were not preempted); Medical Devices; Current Good
Manufacturing Practice (CGMP) Final Rule; Quality System Regulation, 61 Fed. Reg. 52,602,
52,603 (Oct. 7, 1996) (same). Currently, the FDA takes the position that PMA approval by the
FDA triggers preemption of a wide array of requirements imposed under state tort law. Horn v.
Thoratec Corp., 376 F.3d 163, 171 n.13 (3rd Cir. 2004).
-8-
In the ten months following Riegel, courts across the country have applied Section
360k(a) broadly, preempting all manner of claims from strict products liability and
negligence, see, e.g., Bausch v. Stryker Corp., No. 08 C 4248, 2008 WL 5157940 (N.D.
Ill. Dec. 9, 2008); Despain v. Bradburn, __ S.W.3d __, 2008 WL 1067202 (Ark. Apr. 10,
2008), to breach of warranty, see Link v. Zimmer Holdings, Inc., __ F. Supp. 2d __, 2008
WL 5047677 (N.D. Ill. Nov. 26, 2008); Blanco v. Baxter Healthcare Corp., 70 Cal. Rptr.
3rd 566 (Cal. Ct. App. 2008), to failure to warn and manufacturing- and design-defect,
see Parker v. Stryker Corp., __ F. Supp. 2d __, 2008 WL 4716879 (D. Colo. Oct. 22,
2008), to negligence per se, see Heisner, 2008 WL 2940811.
Yet Riegel left open a back door for plaintiffs: claims alleging that a manufacturer
failed to adhere to the specifications imposed by a devices PMA are not preempted. Id.
at 1011; accord Stevens v. Pacesetter, Inc., No. 3:07-cv-3812, 2008 WL 2637417, at *1
(D.S.C. Apr. 1, 2008) (noting that a narrow category of claims survive Riegel those
alleging a failure to comply with the federal standards which were established through
the PMA process). Such claims are not preempted because they merely parallel
6 All references hereafter to the Complaint and citations to Compl. mean the Master
Consolidated Complaint for Individuals (Doc. No. 129).
-9-
federal requirements that is, they do not add to or differ from federal requirements,
which is the cornerstone of FDCA preemption. Riegel, 128 S. Ct. at 1011 (citing 21
U.S.C. 360k(a)(1)).
III. Medtronic and the medical devices at issue here
The following allegations, which the Court must accept as true for purposes of the
instant Motion, e.g., Stodghill v. Wellston Sch. Dist., 512 F.3d 472, 476 (8th Cir. 2008),
are set forth in Plaintiffs Master Consolidated Complaint for Individuals.6
Medtronic is a Minnesota corporation with its principal place of business in
Minneapolis. (Compl. 7.) It is one of the worlds largest manufacturers of medical
devices, including implantable cardiac defibrillators (ICDs). (Id. 2.) ICDs are small
devices implanted in patients chests to monitor heart rates and correct heart-rhythm
abnormalities. (Id.) They do so through small wires called leads that on one end are
attached to the ICD and on the other end are attached directly to the patients heart muscle
through a coronary vein. (Id.) If electrodes on the leads detect that the patients heart is
out of rhythm, the ICD sends an electric shock to the heart muscle through the leads in
order to correct the problem. (Id.) ICDs and the leads attached to them are categorized as
Class III devices under the FDCA.
Medtronic has manufactured ICD leads since at least 1992, when it submitted an
application (later approved) for PMA of its Transvene Leads System. (Id. 18.) Since
7 Although no party has explained why Medtronics leads have grown smaller over time,
the Court surmises that it is because a smaller lead takes up less space in a coronary vein, and
therefore restricts less blood flow to the heart.
8 Specifically, models 6930, 6931, 6948, and 6949. (Compl. 21.)
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that time, Medtronic has manufactured several different types of ICD leads, which have
grown progressively smaller in subsequent iterations. (Id. 17-18.)7 For example,
Medtronics Sprint Quattro leads, approved by the FDA in 2001 as part of a PMA
supplement to the Transvene Lead System, measured 2.8 inches wide. (Id. 17, 20, 27.)
Later, in November 2003, Medtronic submitted a PMA supplement for its Sprint Fidelis
leads,8 which measured 2.1 inches wide. (Id. 21.) The FDA granted Medtronics
applications for supplemental PMA of the Sprint Fidelis leads in June 2004. (Id.)
According to Plaintiffs, the Sprint Fidelis leads substantially differ from the Sprint
Quattro leads and were not adequately tested by Medtronic prior to seeking FDA
approval. (Id. 22, 24.) Plaintiffs further claim that the method of manufacturing the
Sprint Fidelis leads, which involves direct resistance spot welding of two different
metals, is prone to damaging them, and that Medtronic knew (but failed to disclose to the
FDA) that such a welding technique was likely to result in the leads failing. (Id. 32,
34.) Finally, Plaintiffs claim that Medtronic failed to take adequate steps to ensure that
the Sprint Fidelis leads were not damaged during production, including failing to perform
adequate testing on the leads components and failing to take corrective action to prevent
lead failures. (Id. 38.)
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In 2006, patients with ICDs using Sprint Fidelis leads began to suffer unnecessary
and painful shocks. (Id. 43.) An investigation by a physician at the Minneapolis Heart
Institute concluded that the shocks were caused by fractures in the leads and that the leads
were failing at a significantly higher rate than the Sprint Quattro leads, a sentiment
echoed by another physician at Cornell University Medical Center in New York. (Id.
43, 45, 49-52.) Plaintiffs claim that upon being confronted with this information,
Medtronic undertook a campaign to defend the Sprint Fidelis leads, even though it knew
that they were unsafe. (Id. 44-61.) As part of that campaign, Medtronic purportedly
delayed filing adverse event reports with the FDA concerning failures of the leads. (Id.
62.)
In May 2007, Medtronic filed a supplemental PMA application containing design
and manufacturing changes to the Sprint Fidelis leads. (Id. 58.) According to Plaintiffs,
Medtronic filed this supplement in order to correct defects endemic to the leads. (Id.)
Yet, Medtronic did not advise the FDA that it was filing the PMA supplement because of
the lead failures and the resulting public health crisis, instead merely informing it that
the proposed changes were intended to make the leads more robust. (Id.) The FDA
approved Medtronics PMA supplement in July 2007, but previously manufactured (and
allegedly defective) Sprint Fidelis leads continued to be shipped to hospitals and
implanted into patients. (Id.)
On September 10, 2007, Medtronic finally filed more than 120 adverse event
reports concerning Sprint Fidelis leads. (Id. 62.) On October 7, 2007, Medtronic
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suspended sales of the leads but did not inform the FDA, doctors, or the public of its
decision, and they continued to be implanted into patients. (Id. 63.) On October 15,
2007, Medtronic recalled the Sprint Fidelis leads, and the FDA issued a Class I recall
shortly thereafter. (Id. 64-65.) A Class I recall is the most serious type of medical
device recall and occurs only when there is a reasonable probability that the use of the
produc[t] will cause serious injury or death. (Id.) At the time of the recall,
approximately 257,000 Sprint Fidelis leads remained implanted in patients. (Id. 69.)
Following the recall, plaintiffs across the country began to file actions against
Medtronic alleging (among other things) claims for negligence, strict products liability,
fraud, and breach of express and implied warranties regarding the Sprint Fidelis leads.
On February 21, 2008, the Judicial Panel on Multidistrict Litigation consolidated 27 of
those actions before the undersigned for coordinated and consolidated pretrial
proceedings, pursuant to 28 U.S.C. 1407. Scores of other cases were later transferred
here as tag along actions. The Court has appointed lead counsel for Plaintiffs and a
steering committee to direct the course of the litigation on their behalf.
Pursuant to the Courts Order dated June 4, 2008 (Doc. No. 115), Plaintiffs
steering committee has now filed a Master Consolidated Complaint against Medtronic
containing 21 claims, each of which is deemed incorporated into the Complaints in the
individual actions pending before the Court in this Multidistrict Litigation. (See id.
9 The 21 claims are: (1) strict liability failure to warn; (2) strict liability
manufacturing defect; (3) negligence; (4) negligence per se; (5) breach of implied warranty; (6)
breach of express warranty; (7) negligent misrepresentation; (8) intentional misrepresentation;
(9) fraud; (10) constructive fraud; (11) violation of the Minnesota False Statements in
Advertising Act; (12) violation of the Minnesota Deceptive Trade Practice Act; (13) violation of
the Minnesota Prevention of Consumer Fraud Act; (14) violation of the Minnesota Senior
Citizen and Handicapped Person Consumer Fraud Act; (15) negligent infliction of emotional
distress; (16) loss of consortium; (17) wrongful death; (18) survival action; (19) medical
monitoring; (20) unjust enrichment; and (21) Medicare Secondary Payer Act.
-13-
17.A.)9 Medtronic now moves to dismiss each of the claims as preempted by the
FDCA.
STANDARD OF REVIEW
The recent Supreme Court case of Bell Atlantic Corp. v. Twombly, 550 U.S. 544,
127 S. Ct. 1955 (2007), sets forth the standard to be applied when evaluating a motion to
dismiss under Rule 12(b)(6). To avoid dismissal, a complaint must include enough facts
to state a claim to relief that is plausible on its face. Id. at 1974. Stated differently, a
plaintiff must plead sufficient facts to provide the grounds of his entitle[ment] to
relief, [which] requires more than labels and conclusions, and [for which] a formulaic
recitation of the elements of a cause of action will not do. Id. at 1964-65 (citation
omitted). Thus, a complaint cannot simply le[ave] open the possibility that a plaintiff
might later establish some set of undisclosed facts to support recovery. Id. at 1968
(citation omitted). Rather, the facts set forth in the complaint must be sufficient to
nudge[] the[] claims across the line from conceivable to plausible. Id. at 1974.
When reviewing a motion to dismiss, the complaint must be liberally construed,
assuming the facts alleged therein as true and drawing all reasonable inferences from
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those facts in the plaintiffs favor. Id. at 1964-65. A complaint should not be dismissed
simply because a court is doubtful that the plaintiff will be able to prove all of the factual
allegations contained therein. Id. Accordingly, a well-pleaded complaint will survive a
motion to dismiss even if it appears that a recovery is very remote and unlikely. Id. at
1965 (citation omitted).
ANALYSIS
Medtronic argues that, following Riegel, each claim in the Complaint is preempted
under Section 360k(a) because it requires a determination that the leads should have
been designed, manufactured, tested, marketed, or labeled differently from the manner
approved by the FDA via the PMA process. (Def. Mem. at 11.) Plaintiffs respond that
Medtronic lost its preemption argument when the Sprint Fidelis leads were recalled and,
in any event, that their claims fall within the narrow window left open by Riegel for
parallel claims. (Mem. in Oppn at 16-32.)
I. The recall does not deprive Medtronic of its preemption argument
Plaintiffs first argue that Medtronic has lost its federal preemption defense
altogether because the recall invalidated the leads PMA. (Mem. in Oppn at 16-18.)
Building on that assertion, Plaintiffs contend that the federal interest preemption is
intended to protect the PMA process no longer exists because the PMA is no longer
valid. (Id. at 17.) This argument is flawed for several reasons.
First, the argument is predicated on the faulty assumption that the recall
invalidated the leads PMA. Plaintiffs have cited no authority for that proposition, and
10 A simple hypothetical also demonstrates why Plaintiffs assumption is faulty. Imagine
that a medical device received PMA and the manufacturer began to market and distribute it.
Two months later, the manufacturer discovered that an error occurred on the devices assembly
line and all of the devices that had been manufactured and distributed were missing a critical
component. A recall of the already manufactured devices would be appropriate, in order to
remov[e] [the] violative, distributed products from the marketplace. 21 C.F.R. 7.40(a). Yet,
there would be no reason to invalidate the devices PMA if the assembly error were corrected,
then the device could (and would) be manufactured according to the FDA-approved PMA
specifications. In other words, the company could take[] action to prevent the problem from
happening again. http://www.fda.gov/cdrh/recalls/learn.html#1 (last visited January 2, 2009).
-15-
Medtronic correctly notes that the PMA process is governed by a completely separate
statutory and regulatory regime than that governing withdrawal of a PMA a process to
which the Sprint Fidelis leads have never been subjected. Several courts have recognized
this distinction. See, e.g., Theofanis ex rel. Theofanis v. Boston Scientific Corp., No. IP
01-752-C-Y/K, 2003 WL 24049229, at *2 (S.D. Ind. June 24, 2003) (noting that
notwithstanding manufacturers recall of device, the PMA for the [device] has never
been revoked by the FDA); Blanco, 70 Cal. Rptr. 3rd at 580 (The fact the FDA has
implemented a Class I recall does not necessarily mean the FDA has completely removed
the device from the marketplace.). The FDA, too, recognizes the distinction between the
recall of a device and the revocation of a devices PMA it has noted that [w]hen a
company recalls a medical device, it . . . takes action to prevent the problem from
happening again. http://www.fda.gov/cdrh/recalls/learn.html#1 (emphasis added) (last
visited January 2, 2009). There cannot be an again for a recalled device if the recall
invalidated the devices PMA.10
-16-
Second, Plaintiffs argument ignores that PMA for the Sprint Fidelis leads was in
place at the time the leads were implanted. This is what matters, because liability under
Plaintiffs various legal theories hinges upon whether the leads were defective at that
time. See Baker v. St. Jude Med., S.C., Inc., 178 S.W.3d 127, 134 n.5 (Tex. App. 2005)
(rejecting contention that preemption evaporates if the FDA later determines that the
PMA approval was wrongly granted; Whether St. Jude was in compliance with federal
requirements setting the standard of care at the time the alleged tort was committed is the
appropriate issue.) (emphasis added); see also Moore v. Sulzer Orthopedics, Inc., 337 F.
Supp. 2d 1002, 1009-12 (N.D. Ohio 2004) (finding preemption despite device recall);
Theofanis, 2003 WL 24049229, at *5-6 (same); Blanco, 70 Cal. Rptr. 3d at 579 (same).
Third, Plaintiffs argument would fail even if the recall somehow invalidated the
PMA. Plaintiffs correctly note that the federal interest preemption is designed to protect
is the PMA process. (Mem. in Oppn at 17.) But the assertion that this interest would
no longer exist if a PMA were invalidated is wrong preemption necessarily looks
backward (to the time of PMA) rather than forward. Riegel illustrates this point. There,
the PMA process had concluded long before the plaintiffs commenced their lawsuit.
Nevertheless, the Supreme Court recognized that the plaintiffs claims threatened to
interfere with the PMA process because allowing them to proceed would, in essence,
result in retroactive second-guessing of the FDAs decision-making. This logic would
apply with equal force if a PMA were invalidated or withdrawn because, as in Riegel, a
jury confronting such a situation would be required to retroactively question the FDAs
11 There is no dispute that the PMA imposed federal requirements on the Sprint Fidelis
leads. See Riegel, 128 S. Ct. at 1007 (Premarket approval . . . imposes requirements under the
MDA as we interpreted it in Lohr.). The only issue, therefore, is whether Plaintiffs claims
would impose requirements on Medtronic that are different from, or in addition to those
imposed by the PMA (or other federal law). Id.; 21 U.S.C. 360k(a). If so, the claims are
preempted. Id.
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initial decision to approve the medical device at issue. Doing so would interfere with the
PMA process ipso facto.
II. Plaintiffs claims are all preempted
Plaintiffs next argue that they avoid preemption because they have asserted
parallel claims that is, claims that are not different from, or in addition to federal
requirements. The Court cannot agree.11
As noted above, there are 21 claims asserted in the Complaint. Plaintiffs have not
addressed these claims individually but have instead loosely grouped them into
categories, and Medtronic appears to agree that those categories include all of Plaintiffs
claims. Accordingly, the Court will address each category in turn.
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A. Manufacturing-defect claims
Plaintiffs manufacturing-defect claims are based on a simple assertion:
Medtronics defective welds caused the Sprint Fidelis leads to fracture. (Mem. in
Oppn at 21.) The welds purportedly were defective because Medtronic used
inadequate welding techniques that did not comply with the FDAs Current Good
Manufacturing Practices (CGMPs) and Quality System Regulation (QSR). (Id. at 21-
23 (citing, inter alia, Compl. 32-33, 91).) Plaintiffs further allege that Medtronics
testing and quality-assurance protocols were inadequate and failed to comply with the
CGMPs and QSR. (Id. at 22.) Hence, Plaintiffs claim that they are seeking only to
enforce FDA requirements (the CGMPs/QSR) and, as a result, their manufacturing-defect
claims are merely parallel.
Plaintiffs reliance on the CGMPs and QSR, however, does not save these claims
from preemption. It is true that the CGMPs and QSR govern the methods used in, and
the facilities and controls used for, the design, manufacture, packaging, labeling, storage,
installation, and servicing of all finished devices intended for human use. 21 C.F.R.
820.1(a)(1). But they are simply too generic, standing alone, to serve as the basis for
Plaintiffs manufacturing-defect claims. The CGMPs and QSR require manufacturers to
develop their own quality-system controls to ensure that medical devices are safe and
effective for their intended use, and they are inherently flexible. See FDA Device
Advice, Good Manufacturing Practices (CGMP)/Quality System (QS) Regulation,
available at http://www.fda.gov/cdrh/devadvice/32.html#flexibility (last visited January 2,
12 Even where particular methods are called for by the CGMPs and QSR, a manufacturer
may vary from the method specified if the intent of the CGMP requirement can be met by
another method. FDA Device Advice, Good Manufacturing Practices (CGMP)/Quality System
(QS) Regulation, available at http://www.fda.gov/cdrh/devadvice/32.html#flexibility (last visited
January 2, 2009).
-19-
2009) (FDA has identified in the QS regulation the essential elements that a quality
system shall embody for design, production and distribution, without prescribing specific
ways to establish these elements. Because the QS regulation covers a broad spectrum of
devices and production processes, it allows some leeway in the details of quality system
elements.) (emphasis added). The FDA recognizes that the CGMPs and QSR simply
cannot cover, in detail, all of the design, production, and marketing elements for every
medical device in existence. Id. (It is not practical for a regulation to specify details of
quality system elements for such a wide range of products.). Rather, they are intended to
serve only as an umbrella quality system, providing general objectives medicaldevice
manufacturers must seek to achieve. Id. In fact, the CGMPs/QSR provide
specific methods to be used for only a small number of medical devices. In most cases,
it is left to the manufacturer to determine the best methods to obtain quality objectives.
Id. (emphasis added).12 As the FDA stated when it promulgated the CGMP/QSR final
rule:
Because this regulation must apply to so many different types of devices, the
regulation does not prescribe in detail how a manufacturer must produce a
specific device. Rather, the regulation provides the framework that all
manufacturers must follow by requiring that manufacturers develop and follow
procedures and fill in the details that are appropriate to a given device
according to the current state-of-the-art manufacturing for that specific device.
FDA has made changes to the proposed regulation . . . to provide
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manufacturers with ever greater flexibility in achieving the quality
requirements.
Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality
System Regulation, 61 Fed. Reg. 52,602, 52,603 (Oct. 7, 1996).
The flexibility inherent in the CGMPs and QSR demonstrates why Plaintiffs
manufacturing-defect claims are not parallel. Plaintiffs allege that Medtronics welding
techniques were defective, but they have not pleaded how that welding technique
violated the CGMPs or QSR. This is likely because the CGMPs and QSR do not provide
such a fine level of detail concerning the manufacture of defibrillator leads (or most other
medical devices). In the absence of any specific requirement in the CGMPs/QSR that
Medtronic weld the Sprint Fidelis leads in a certain fashion, holding Medtronic liable for
such a welding defect would impose requirements different from, or in addition to
those under federal law. This is equally true of Plaintiffs allegation that Medtronic used
inadequate testing and quality-assurance methods Plaintiffs simply have not identified
any specific requirements in the CGMPs/QSR that were purportedly violated by
Medtronic. Without any such specified requirement, Plaintiffs necessarily seek to impose
requirements that differ from the CGMPs/QSR.
Plaintiffs failure to allege in detail the federal requirement(s) purportedly violated
by Medtronic also raises the specter of Twombly. Plaintiffs cannot simply incant the
magic words Medtronic violated FDA regulations in order to avoid preemption. See
Parker, 2008 WL 4716879, at *2 (conclusory allegation that device was sold in direct
13 Plaintiffs conclusory allegation that Medtronic failed to manufacture and inspect the
Sprint Fidelis Leads in a manner consistent with, and as prescribed by the FDA-approved
specifications for manufacture and inspection of the Sprint Fidelis Leads (Compl. 103)
similarly fails to pass muster.
-21-
violation of the Code of Federal Regulations insufficient under Twombly to save claim
from FDCA preemption). Hence, their assertion that the Sprint Fidelis leads did not
comply with the CGMPs/QSR is insufficient, without more, to save their claims. See
Heisner, 2008 WL 2940811, at *5-6 (claims preempted under FDCA where plaintiff
failed to provide factual basis for assertion that defendant failed to comply with FDA
regulations); Cottengim v. Mentor Corp., Civ. No. 05-161, 2007 WL 2782885, at *5
(E.D. Ky. Sept. 24, 2007) (rejecting argument that mere allegations that a manufacturing
defect exists is enough to avoid preemption). Under Twombly, Plaintiffs were required
to provide enough factual detail in the Complaint to alert Medtronic of the grounds
upon which their manufacturing-defect claim rests. 127 S. Ct. at 1964-65. Merely
alleging that Medtronic failed to comply with the CGMPs/QSR by using spot welding is
insufficient without some factual detail about why that violates federal standards. Id.
Instead, Plaintiffs were required to point to something in the CGMPs/QSR precluding the
use of spot welding in order to state a manufacturing-defect claim that is plausible on its
face. Id. at 1974.13
Rollins v. St. Jude Medical, __ F. Supp. 2d __, 2008 WL 4661622 (W.D. La. Oct.
20, 2008), provides an example of the types of allegations sufficient to survive
preemption under Twombly. There, the plaintiff alleged that the defendant had failed to
14 At oral argument, Plaintiffs asserted for the first time that they could not plead the
specifications contained in the leads PMA because they have not yet conducted discovery. But
the Court anticipated this at the outset of the case, and Plaintiffs counsel represented to the
Court at that time that no discovery was necessary to resolve the preemption issue. Indeed, at
the initial status conference held on May 28, 2008, the Court specifically asked Plaintiffs
counsel whether discovery was needed before addressing preemption. (See 5/28/08 Tr. at 53-
54.) Counsel made abundantly clear that for purposes of a [Rule] 12(b)(6) motion [on
preemption], no discovery is necessary. (Id. at 54.)
-22-
comply with the devices PMA specifications requiring the device to be packaged with
[its] anchor in vertical position with the bypass tube, neither extending beyond the end of
the tube nor inserted deeply within it, by incorrectly pack[ing] [it] with a .038
guidewire as opposed to the required .035 guidewire. Id. at *8. No similarly detailed
allegations appear in the Complaint here.14
B. Failure-to-warn claims
In their failure-to-warn claims, Plaintiffs allege that Medtronic failed to provide
adequate and timely warnings or instructions regarding the Sprint Fidelis [l]eads.
(Compl. 121.) Specifically, Plaintiffs allege that Medtronic failed to warn physicians
and patients of the defects in the leads prior to announcing the recall on October 15, 2007.
(Mem. in Oppn at 25.) This is a parallel claim, Plaintiffs argue, because the FDA
encourages voluntary recalls and unilateral changes to warning labels and FDA
regulations specifically permit manufacturers to make labeling changes to enhance
product safety, without pre-approval from the FDA. (Id. (citing 21 C.F.R. 814.39).)
But Plaintiffs cannot escape that under their theory of liability, Medtronic would
have been required to provide warnings above and beyond those on the Sprint Fidelis
15 Plaintiffs claim to have broadly allege[d] that Medtronic . . . entirely failed to provide
any warning concerning the Sprint Fidelis leads, including failing to provide any product label
at all. (Mem. in Oppn at 24.) In support, they cite paragraph 121 of the Complaint, which
alleges that Medtronic failed to provide adequate and timely warnings or instructions regarding
the Sprint Fidelis Leads and the known defects. (emphases added). Even under a generous
reading, this allegation in no way suggests that Medtronic failed to provide any warning
whatsoever. If that is what Plaintiffs intended, they could have easily said so.
16 Two days before the hearing on Medtronics Motion, the Supreme Court decided Altria
Group, Inc. v. Good, __ U.S. __, 129 S. Ct. 538 (2008). The Altria Court held that claims under
the Maine Unfair Trade Practices Act were not preempted by the Federal Cigarette Labeling and
Advertising Act. At oral argument, Plaintiffs asserted that, after Altria, their statutory fraud
claims are not subject to preemption. But Altria concerned a statute with a much narrower
preemption clause than Section 360k(a), as Justice Stevens recognized. See id. at 549
(distinguishing Riegel because Section 360k(a) is much broader than the operative language of
the [Cigarette] Labeling Act). Accordingly, the Court concludes that Altria did little to alter its
analysis.
-23-
leads product label a label that was specifically approved by the FDA as part of the
PMA process. See 21 U.S.C. 360c(a)(2)(B). Mandating that a manufacturer provide
warnings beyond those on the device label would impose requirements different from, or
in addition to those approved by the FDA, and are thus preempted. See King v.
Collagen Corp., 983 F.2d 1130, 1136 (1st Cir. 1993).15 Simply put, Section 360k(a)
preempts claims that are, as here, premised on a post-sale duty to warn, where the
plaintiff alleges the defendant was required to provide additional warnings in light of
later-received reports of injury to others caused by the same medical device. In re Sulzer
Hip, 455 F. Supp. 2d at 717 n.10 (emphasis omitted). For the same reasons, claims
alleging that Medtronic should have recalled the Sprint Fidelis leads sooner than it did are
similarly preempted. See, e.g., Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir.
2005).16
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Furthermore, Medtronic correctly notes that the FDA regulations cited by
Plaintiffs permit a device manufacturer to give certain warnings, but Plaintiffs failure-towarn
theory necessarily requires a showing that Medtronic was required to give those
warnings. And, Plaintiffs have not identified in the Complaint any federal regulation,
rule, or other source of obligation that would require such a warning to be given. In
similar circumstances, the Seventh Circuit held that a failure-to-warn claim was
preempted because it was not parallel to federal requirements:
[21 C.F.R.] Section 814.39 permits a manufacturer to temporarily amend a
warning pending FDA approval of . . . proposed changes. . . . McMullen
discusses at length the fact that Medtronic was allowed and permitted to
issue an interim safety alert while awaiting approval of its amended warning.
He argues that state common law requiring a post-sale warning merely
complements the federal policy of allowing such warnings, and thus is not
preempted. Recall, however, that the MDAs preemption clause provides that
state requirements that are in addition to federal requirements are preempted.
21 U.S.C.. 360k(a). Where a federal requirement permits a course of
conduct and the state makes it obligatory, the states requirement is in
addition to the federal requirement and thus is preempted. Because 814.39
permits, but does not require, a manufacturer to provide interim supplemental
warnings pending approval by the FDA, a common-law duty to provide such
a warning imposes an additional obligation.
McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005) (emphasis added);
accord King, 983 F.2d at 1139 (Aldrich, J., concurring) (Plaintiff claims that because
[Section 814.39 states] that a manufacturer may, without prior approval, make certain
changes that enhance safety, defendant had a duty to make such here. It is sufficient to
say that to interpret may as should would unravel the entire garment.).
-25-
Plaintiffs attempt to remedy this defect by identifying a source for the
requirement that Medtronic provide post-PMA warnings: the FDA approved the
Sprint Fidelis Lead PMA Supplements subject to certain express conditions. (Mem. in
Oppn at 26 n.13 (emphasis in original) (quoting Compl. 23).) However, Plaintiffs
nowhere specified in their brief what those express conditions were, nor did they make
any effort to indicate how those conditions mandated the warnings that Plaintiffs claim
Medtronic failed to provide. Shortly before the hearing on Medtronics Motion, however,
Plaintiffs finally attempted to supply that information, submitting to the Court the FDAs
letter granting PMA to the Sprint Fidelis leads. Plaintiffs now argue that the express
conditions of pre-market approval required Medtronic to advise the FDA of adverse
events in patients using the leads. (See Doc. No. 219, Ex. A.)
But the reporting requirements Plaintiffs point to in the approval letter come from
21 C.F.R. 803.50 and 21 C.F.R. 803.53, regulations that were promulgated by the
FDA in accordance with the FDCA. Stated differently, the PMA conditions did not
impose any new reporting requirements on Medtronic, but simply reiterated Medtronics
already-existing obligations under federal law. Hence, what Plaintiffs are really alleging
is that Medtronic violated the FDCA by failing to inform the FDA in a timely fashion of
adverse lead events. Such a claim necessarily fails, because no private right of action
exists under the FDCA. See Gile v. Optical Radiation Corp., 22 F.3d 540, 544 (3rd Cir.
1994) ([V]iolations of the FDCA do not create private rights of action.); Parker, 2008
WL 4716879, at *3; Alexander v. Smith & Nephew, P.L.C., 98 F. Supp. 2d 1310, 1321
-26-
(N.D. Okla. 2000). Plaintiffs cannot make an end run around this rule by recasting
violations of the FDCA as violations of state common law. See Parker, 2008 WL
4716879, at *3; Lake v. Kardjian, No. 03-1267, 2008 WL 5244823, at *2 (N.Y. Sup. Ct.
Dec. 17, 2008).
It might seem inconsistent with Riegel to conclude that a claim alleging a medicaldevice
manufacturer violated the FDCA is preempted. After all, Riegel expressly
recognized that parallel claims that is, claims premised on a violation of FDA
regulations are not preempted. Id. at 1011. Plaintiffs noted this inconsistency at oral
argument, asserting that if they cannot bring state-law claims for violations of the FDCA,
then there exist no parallel claims that could possibly survive preemption in essence,
different from, or in addition to in Section 360k(a) would be rendered meaningless. If
Congress had intended that result, Plaintiffs argued, it could have easily said so.
But what this argument overlooks is that claims alleging violations of the FDCA
are not preempted because they run afoul of Section 360k(a), which is the type of
preemption addressed in Riegel. Rather, such claims are impliedly preempted by 21
U.S.C. 337(a), which states that all proceedings for the enforcement or to restrain
violations of the FDCA shall be by and in the name of the United States. Hence, the
FDCA leaves no doubt that it is the Federal Government rather than private litigants
[which is] authorized to file suit for noncompliance with the medical device provisions
in the FDCA. Buckman, 531 U.S. at 349 n.4. As a result, when Sections 337(a) and
360k(a) as construed in Buckman and Riegel, respectively are read together, nearly all
17 Naturally, this begs the question: what types of claims alleging defects in an FDAapproved
medical device are not preempted? For one, an adequately pleaded claim that a
specific device was not manufactured in accordance with its PMA specifications can survive
preemption. See Rollins, 2008 WL 4661622, at *8. Similarly, if a state were to pass a statute
providing a remedy for a violation of the FDCA, a claim under such statute would not be
preempted. See Bausch, 2008 WL 5157940, at *4. Notably, there is no such statute at issue here
rather, Plaintiffs claims are based only on generalized common law theories such as strict
liability, negligence, and breach of warranty. Such claims are preempted. Id.
-27-
types of claims concerning FDA-approved medical devices are preempted, including
Plaintiffs failure-to-warn claims here.17
C. Design-defect claims
Plaintiffs design-defect claims allege that (1) after the FDA approved the Sprint
Fidelis leads new and improved design in July 2007, Medtronic should have stopped
selling the original, defective version, and (2) Medtronic should have used the new
and improved design prior to July 2007. (See Mem. in Oppn at 26-27.) The Court
concludes that neither is a parallel claim.
As an initial matter, Plaintiffs design-defect claims would require a jury to find
that the older design of the Sprint Fidelis leads was unsafe. Clearly, such a finding
would usurp the FDAs role in evaluating the safety and effectiveness of the leads and
would interfere with the PMA process. See Riegel v. Medtronic, Inc., No. 99-CV-649,
2002 WL 34234093, at *6 (N.D.N.Y. Mar. 18, 2002) (A finding by a jury in this case
that this design was defective would necessarily impose a standard on Defendant different
from that imposed by the FDA.), affd, 451 F.3d 104 (2d Cir. 1996), affd, 128 S. Ct.
999 (2008).
-28-
But in any event, Plaintiffs have nowhere identified a federal requirement
mandating a manufacturer to stop selling a device when an improved version thereof is
granted PMA. Plaintiffs have cited no federal regulation or other requirement suggesting
that a previously issued PMA is withdrawn or somehow loses its vitality when a device
improvement is granted PMA. Nor does such an assertion make intuitive sense. In many
situations, devices may be improved not because they are unsafe, but simply because a
newer version is better in some fashion just as the Sprint Quattro leads purportedly were
better than Medtronics Transvene Leads. (See Compl. 18-20.)
Plaintiffs have similarly failed to identify any federal requirement to support their
assertion that [u]pon receiving notice of the defect, Medtronic had a duty to take
reasonable steps to improve the safety of the Sprint Fidelis leads. (Mem. in Oppn at
27.) They do cite in the Complaint a host of regulations concerning Medtronics post-sale
reporting requirements. (See Compl. 87-90, 95-96.) But none of those regulations
even remotely suggests an obligation on Medtronics part to improve the Sprint Fidelis
leads upon learning that patients were experiencing problems. Once again, the best
Plaintiffs point to is their allegation that the leads were granted PMA subject to certain
express conditions. (Mem. in Oppn at 27 (quoting Compl. 23).) Yet, Plaintiffs have
pointed to nothing in those conditions requiring Medtronic to improve the leads. Without
any specific federal requirement that Medtronic take steps to improve the safety of the
leads upon receiving adverse-event reports, Plaintiffs seek to impose conditions on
Medtronic different from, or in addition to those under federal law.
18 In any event, it is the FDAs task to determine whether medical devices are adulterated,
and only the FDA may take action with respect to adulterated products. Gile, 22 F.3d at 544.
No private cause of action exists against Medtronic for selling adulterated devices, no matter
how the claim may be styled. See id.; Parker, 2008 WL 4716879, at *3; Talbott v. C.R. Bard,
Inc., 865 F. Supp. 37, 50 (D. Mass. 1994), affd, 63 F.3d 25 (1st Cir. 1995); but see Purcel v.
Advanced Bionics Corp., Civ. No. 3:07-CV-1777, 2008 WL 3874713, at *3-4 (N.D. Tex. Aug.
13, 2008).
-29-
Plaintiffs also argue that their design-defect claims are parallel because the leads
were adulterated under federal law. (Mem. in Oppn at 28.) Such an assertion,
however, necessarily rests on Plaintiffs claim that the leads were negligently
manufactured. (See id. (asserting that Medtronic failed to meet FDA design control
requirements).) Indeed, 21 U.S.C. 351(h) states, in pertinent part, that a Class III
medical device is adulterated only if the methods used in, or the facilities or controls
used for, its manufacture, packing, storage, or installation are not in conformity with the
CGMPs/QSR. Because Plaintiffs manufacturing-defect claims are preempted (see supra
at 18-22), this derivative assertion is also preempted. See Gile, 22 F.3d at 544 ([T]o the
extent Giles adulteration claim is derivative of her other claims for inadequate design,
manufacture, and warnings, she cannot overcome a finding of preemption merely by
claiming that the product was adulterated.); Parker, 2008 WL 4716879, at *3 (noting that
plaintiffs claims were not saved [from preemption] merely by being recast as violations
of the federal adulteration and misbranding statutes).18
Simply put, Plaintiffs have not pointed to any federal requirements parallel to
those they seek to foist onto Medtronic in their design-defect claims. The claims are
preempted.
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D. Negligence per se claims
Plaintiffs negligence per se claims track their manufacturing-defect claims.
Indeed, Plaintiffs admit that these claims incorporate[] the factual allegations of the
ordinary negligence claims to allege that Medtronic violated the CGMPs and QSRs,
thereby resulting in defects in the leads. (Mem. in Oppn at 29-30.) The claims,
therefore, are preempted for the same reasons that the manufacturing-defect claims are
preempted.
The negligence per se claims are also preempted for another reason. A claim of
negligence per se simply adopts the standard of care imposed by a statute or regulation as
the standard against which the defendants conduct is evaluated. See Restatement
(Second) of Torts 286 (1965). Stated differently, negligence is the breach of a legal
duty, and under a negligence per se theory, the measure of that legal duty comes from a
statute (rather than the common law). For example, assume that a state statute sets a
speed limit of 40 miles per hour, and the defendant violates that speed limit and, as a
result, crashes into the plaintiffs car. The plaintiff can press a claim for negligence per
se, adopting the statutory standard of care (no driving in excess of 40 miles per hour) as
the standard to be applied to the defendants conduct. See, e.g., Elder v. Allstate Ins. Co.,
341 F. Supp. 2d 1095, 1099-1100 (D. Minn. 2004) (Kyle, J.).
With this understanding of the foundations for negligence per se, it becomes clear
why it cannot apply here. [T]he negligence per se doctrine . . . is not a magic
transforming formula that automatically creates a private right of action for the civil
19 Plaintiffs also allege that Medtronic violated its obligation not to violate the law by
selling misbranded and adulterated Sprint Fidelis leads. (Compl. 139-40.) Besides
merely paralleling the design-defect and failure-to-warn claims, such claims are also impliedly
preempted under 21 U.S.C. 337(a) and Buckman.
-31-
enforcement, in tort law, of every statute. Talley v. Danek Med., Inc., 179 F.3d 154, 158
(4th Cir. 1999). In other words, the doctrine simply sets the standard of care where an
underlying common law cause of action [already] exists. Elder, 341 F. Supp. 2d at 1100.
Here, Plaintiffs seek to re-cast their negligence claims as claims for negligence per se,
relying on the CGMPs/QSR to provide the requisite standard of care. (See Mem. in
Oppn at 29-30.) But all of Plaintiffs negligence claims are preempted, as discussed
above. Accordingly, the negligence per se claims cannot stand, because there exists no
claim onto which the standard of care from the CGMPs/QSR can be grafted.19
E. Breach of warranty
Plaintiffs allege that Medtronic breached implied warranties by selling the Sprint
Fidelis leads in a defective condition. (Compl. 145-46.) They further allege that
Medtronic expressly warranted that the leads were safe and effective and that Medtronic
breached this express warranty because the leads were unsafe. (Id. 149-52.) The
Court concludes that these claims, too, are preempted.
As for the implied-warranty claims, Plaintiffs ignore that the Riegel plaintiffs
alleged a claim for breach of implied warranty and the Supreme Court affirmed the
dismissal of that claim on preemption grounds. 128 S. Ct. at 1005-06. Such a claim
would require a jury to determine that Medtronic impliedly warranted that the Sprint
20 Plaintiffs note that Lohr and In re Guidant Corp. Implantable Defibrillators Products
Liability Litigation, MDL No. 05-1708, 2007 WL 1725289, at *9 (D. Minn. June 12, 2007)
(Frank, J.), held that implied-warranty claims were not preempted by the FDCA. The Court
concludes that neither case controls in light of the more-recent decision in Riegel.
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Fidelis leads were safe and effective and that Medtronic breached that implied warranty
i.e., a jury would have to find that the leads were unsafe in their design or manufacture.
Such a determination clearly would interfere with the PMA process. See Riegel v.
Medtronic, Inc., 451 F.3d at 121 (We . . . conclude that the Riegels claim[] for . . .
breach of implied warranty . . . would, if successful, impose state requirements that
differed from, or added to, the PMA-approved standards for the [device].), affd, 128 S.
Ct. 999 (2008); Richman v. W.L. Gore & Assocs., Inc. 988 F. Supp. 753, 758 (S.D.N.Y.
1997) ([T]he plaintiffs claim for breach of implied warranty [would] impose safety and
effectiveness requirements that are different from, or in addition to, those established
under FDA regulations.); Talbott v. C.R. Bard, Inc., 865 F. Supp. 37, 51 (D. Mass.
1994), affd, 63 F.3d 25 (1st Cir. 1995) (same).
Plaintiffs cite 21 C.F.R. 808.1(d)(1) to argue that their implied-warranty claims
are not preempted. That regulation states that requirements of general applicability
such as general electric codes, and the Uniform Commercial Code (warranty of fitness)
are not preempted under Section 360k(a). Id. (emphasis added). But the Riegel
plaintiffs made this same argument, and the Supreme Court rejected it, holding that the
regulation fail[ed] to alter [the Courts] interpretation of Section 360k(a). This Court
perceives no reason to deviate from that ruling here.20
21 The Supreme Court did not opine on express-warranty claims in Riegel, because the
plaintiffs did not challenge the dismissal of those claims on appeal.
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The Court also believes that the express-warranty claims are preempted for the
same reason as the implied-warranty claims.21 Such claims are based on an allegation that
the leads were represented as safe in both the product label and in publications, . . . the
internet, and other communications intended for physicians, medical patients, and the
general public but were not. (See Compl. 149-50.) A jury finding in Plaintiffs
favor on such claims, therefore, would be required to conclude that the Sprint Fidelis
leads were unsafe. As the safety and effectiveness of the leads are matters solely for the
FDA, and because the FDA determined that the leads were safe and effective when
granting PMA, these claims are preempted. See, e.g. Gomez v. St. Jude Med. Daig Div.
Inc., 442 F.3d 919, 932 (5th Cir. 2006) (express-warranty claim preempted under FDCA);
Enlow v. St. Jude Med., Inc., 210 F. Supp. 2d 853, 862 (W.D. Ky. 2001) (same); Lake,
2008 WL 5244823, at *1-2 (same). Simply put, claims such as these, which require[] a
manufacturers [device] to be safer, but hence less effective, than the model the FDA has
approved, necessarily disrupt[] the federal scheme and must be preempted. Riegel,
128 S. Ct. at 1008.
F. The remaining claims
While the parties apparently agree that all of Plaintiffs claims fall into the five
categories discussed above, that is not entirely clear to the Court. Claims such as loss of
consortium (Count 16) and unjust enrichment (Count 20) do not appear to fit neatly into
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any of the aforementioned categories. Nevertheless, the Court agrees with Medtronic that
any claims in the Complaint not addressed above are derivative of Plaintiffs other claims
and hence cannot stand. See, e.g., Riegel, 128 S. Ct. at 1006 (affirming dismissal of lossof-
consortium claim on preemption grounds because it was derivative of the pre-empted
claims); Talbott, 865 F. Supp. at 52 (claims for negligent infliction of emotional distress,
violation of Massachusetts consumer-protection statute, and fraudulent misrepresentation
preempted); see also Pa. Employees Benefit Trust Fund v. Zeneca Inc., 499 F.3d 239,
251-52 & n.12 (3rd Cir. 2007) (FDCA preempted derivative claims under state consumerprotection
statute and for unjust enrichment predicated on allegedly misleading
advertising of prescription drug).
The analysis above also requires the dismissal of the claims in the Master
Consolidated Complaint for Third-Party Payors. The claims in that Complaint parallel
those in the Master Consolidated Complaint for Individuals and seek to recover sums paid
by insurance companies (and others) on behalf of individuals who had Sprint Fidelis leads
implanted. In the absence of any viable claim by the individual Plaintiffs, these claims
also fail.
G. The Court will dismiss the Complaints with prejudice
Having concluded that all of Plaintiffs claims are preempted, the Court must next
determine whether to dismiss those claims with or without prejudice. For several reasons,
the Court concludes that dismissal with prejudice is appropriate.
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First, this is not Plaintiffs only bite at the pleading apple. The Complaint is, in
essence, an Amended Complaint filed in each and every one of the cases in this
multidistrict litigation. (See supra at 12-13.)
Second, Plaintiffs nowhere requested leave to amend the Complaint in the event
the Court were to determine that their claims are preempted. The Court need not grant
leave to replead sua sponte when Plaintiffs never requested such relief, not even in the
alternative. See Confederate Meml Assn, Inc. v. Hines, 995 F.2d 295, 299 (D.C. Cir.
1993); Gunderson v. ADM Investor Servs., Inc., Nos. C96-3148, C96-3151, 1997 WL
570453, at *11 (N.D. Iowa Apr. 17, 1997) (rejecting the notion that a party putting
forward inadequate pleading must automatically be given leave to amend when the court
finds that the opposing partys Rule 12(b)(6) motion should be granted).
Third, the Complaint was filed after extensive preparation by Plaintiffs steering
committee, which is made up of more than a dozen experienced products-liability lawyers
well versed in Riegel, Buckman, and the nuances of federal preemption, and only after
the preemption issue was raised by Medtronic and by the Court. See In re Career Educ.
Corp. Sec. Litig., No. 03 C 8884, 2007 U.S. Dist. LEXIS 23635, at *36 (N.D. Ill. Mar. 29,
2007) (dismissal with prejudice appropriate where there have been ample opportunities
to research and plead sufficient claims). Indeed, the Complaint is suffused with
immense detail regarding the Sprint Fidelis leads and sprawls across 59 pages and 252
paragraphs. In the Courts estimation, if Plaintiffs were aware of sufficient facts in order
to avoid preemption, they would have already pleaded them.
22 Nor does the Court believe it would be appropriate for Plaintiffs to simply change the
theory of their case now by alleging, for example, that Medtronic did not comply with the
specifications in the PMA when manufacturing the leads. Cf. Humphreys v. Roche Biomedical
Labs., Inc., 990 F.2d 1078, 1082 (8th Cir. 1993) (noting that the right to amend a complaint
under Federal Rule of Civil Procedure 15(a) terminates when the complaint is dismissed; a
district court does not abuse its discretion in refusing to allow amendment of pleading to change
the theory of a case if the amendment is offered after summary judgment has been granted
against the party, and no valid reason is shown for the failure to present the new theory at an
earlier time).
-36-
Fourth, and finally, the Court does not believe that repleading, even with leave to
take limited discovery, would remedy the defects in the Complaint. The theory of
Plaintiffs case is that Medtronic did not adequately manufacture the Sprint Fidelis leads,
not because it failed to comply with the specifications in the leads PMA, but rather
because the manufacturing methods Medtronic opted to used rendered all of the leads
defective. In other words, Plaintiffs claims are predicated on a defect in the method of
manufacture approved by the FDA when it granted the leads PMA. For the reasons set
forth above, such claims are by their very nature preempted under Section 360k(a).22
CONCLUSION
As in Pacelli, the Court recognizes that at least some Plaintiffs have suffered
injuries from using Sprint Fidelis leads, and the Court is not unsympathetic to their plight.
But Plaintiffs assert claims for which the Court simply cannot provide a remedy.
Congress has decided to limit medical-device manufacturers liability in order to spur
innovation, even though individuals are sometimes injured when using medical devices.
Plaintiffs remedy, therefore, lies with Congress, and not with this Court (or any other
court).
-37-
Based on the foregoing, and all the files, records, and proceedings herein, IT IS
ORDERED that Medtronics Motion to Dismiss the Master Consolidated Complaint for
Individuals (Doc. No. 151) and Medtronics Motion to Dismiss the Master Consolidated
Complaint for Third-Party Payors (Doc. No. 149) are GRANTED. The Master
Consolidated Complaint for Individuals (Doc. No. 129) and the Master Consolidated
Complaint for Third-Party Payors (Doc. No. 130) are DISMISSED WITH
PREJUDICE.
Dated: January 5, 2009 s/Richard H. Kyle
RICHARD H. KYLE
United States District Judge
 

 
 
 

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