Pinsonneault v. St. Jude Medical, Inc. et al

Filing 117

ORDER - Defendants' motions for summary judgment 97 in 12-CV-1717; ECF No. 96 in 12-CV-1785; and ECF No. 92 in 12-CV-2396 are GRANTED IN PART and DENIED IN PART. The motions are DENIED to the extent that they seek dismissal of plaintiffs& #039; claims alleging that defendants failed to comply with state-law requirements that paralleled federal requirements regarding sterilization. The motions are GRANTED in all other respects. (Written Opinion). Signed by Judge Patrick J. Schiltz on 06/24/14. (BJS)

UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
RICHARD J. PINSONNEAULT,

Case No. 12-CV-1717 (PJS/JSM)

Plaintiff,
v.

ORDER

ST. JUDE MEDICAL, INC. and
PACESETTER, INC.,
Defendants.
JOSEPH D. HOULETTE,

Case No. 12-CV-1785 (PJS/JSM)

Plaintiff,
v.
ST. JUDE MEDICAL, INC. and
PACESETTER, INC.,
Defendants.
GARY ROUSE,

Case No. 12-CV-2396 (PJS/JSM)
Plaintiff,

v.
ST. JUDE MEDICAL, INC. and
PACESETTER, INC.,
Defendants.
Yvonne M. Flaherty, LOCKRIDGE GRINDAL NAUEN PLLP, for plaintiff Richard J.
Pinsonneault.
Charles S. Zimmerman, Ronald S. Goldser, Genevieve M. Zimmerman, and Jason P.
Johnston, ZIMMERMAN REED, PLLP, for plaintiff Joseph D. Houlette.
Daniel E. Gustafson, Karla M. Gluek, and Amanda M. Williams, GUSTAFSON GLUEK
PLLC, for plaintiff Gary Rouse.

Blake Shepard, Jr. and Brian W. Thomson, STINSON LEONARD STREET LLP; Maja
C. Eaton and Rebecca K. Wood, SIDLEY AUSTIN LLP; Daniel L. Ring and Andrew E.
Tauber, MAYER BROWN LLP, for defendants.
Plaintiffs Richard Pinsonneault, Joseph Houlette, and Gary Rouse were all implanted
with Riata defibrillation leads manufactured by defendants St. Jude Medical, Inc. and Pacesetter,
Inc. (collectively “St. Jude”). In December 2011, the Food and Drug Administration (“FDA”)
issued a recall for certain Riata models, including the models that had been implanted in
plaintiffs. Plaintiffs’ leads were later explanted.
Plaintiffs bring claims of strict liability/manufacturing defect, negligent manufacturing,
negligence per se, and negligence res ipsa loquitur. St. Jude moves for summary judgment on the
ground that plaintiffs’ claims are preempted under 21 U.S.C. § 360k(a). For the reasons that
follow, St. Jude’s motion is granted in (large) part and denied in (small) part. Specifically, the
Court grants St. Jude’s motion with respect to all of plaintiffs’ claims, save for their claim that
the leads were not properly sterilized.
I. BACKGROUND
A. The Riata Leads
The Riata leads are component parts of an implantable cardioverter defibrillator (“ICD”)
system used to treat heart arrhythmias. Anderson Decl. ¶¶ 4-5. The leads consist of thin,
insulated wires that connect the ICD to one or more electrodes in, on, or near the patient’s heart.
Anderson Decl. ¶ 6. The leads detect the heart’s electrical signals and transmit this information
to the ICD. Anderson Decl. ¶ 6. The leads also deliver the electrical impulses necessary to
restore or maintain normal heart rhythm. Anderson Decl. ¶ 6.

-2-

The Riata leads are Class III medical devices regulated by the FDA pursuant to the 1976
Medical Device Amendments to the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301
et seq. Class III devices are defined as devices that are “for a use in supporting or sustaining
human life,” that are “for a use which is of substantial importance in preventing impairment of
human health,” or that “present[] a potential unreasonable risk of illness or injury . . . .” 21
U.S.C. § 360c(a)(1)(C). Class III devices are subject to a rigorous safety review by the FDA
known as “premarket approval” (“PMA”). See 21 U.S.C. § 360e; Riegel v. Medtronic, Inc., 552
U.S. 312, 317-20 (2008) (describing the PMA process).
The Riata family of leads evolved from the Ventritex TVL Lead System, to which the
FDA granted PMA on May 10, 1996. Neely Decl. ¶ 6 & Ex. A. Generally speaking, after a
medical device has received PMA, the manufacturer must submit a PMA Supplement to the FDA
before making any change to the device that might that affect the safety or effectiveness of the
device. 21 C.F.R. § 814.39(a). St. Jude submitted numerous PMA Supplements relating to the
Ventritex TVL Lead System.
In March 2002, the FDA approved PMA Supplement 14, which sought approval for a
modified lead under the trade name Riata Series 1500. Neely Decl. ¶ 7 & Ex. B. Over the years,
St. Jude sought approval for further modifications to the Riata leads. By the time that the last of
plaintiffs’ leads was manufactured, St. Jude had submitted (and received approval for) PMA
Supplements 15 through 40. Neely Decl. ¶¶ 9-29; Anderson Decl. ¶ 3. Except when it is
necessary to distinguish between them, the Court will refer to the original PMA and PMA
Supplements 1 through 40 collectively as “the PMA.”

-3-

B. Discovery
In an initial pretrial scheduling order dated November 1, 2012, Magistrate Judge Mayeron
established March 1, 2013 as the deadline for a first phase of discovery limited to the issue of
preemption. ECF No. 20 at 2.1 To help focus that discovery, Judge Mayeron ordered St. Jude to
serve plaintiffs with its motion for summary judgment on the issue of preemption near the
beginning of the discovery period; plaintiffs’ response to that motion would not be due until after
the first phase of discovery had closed. ECF No. 20 at 4. St. Jude accordingly served plaintiffs
with its preemption motion and supporting documents on November 15, 2012, shortly after
discovery began. Keeling Decl. ¶ 3. As it turned out, however, the parties’ discovery disputes
necessitated a lengthy extension of the discovery schedule.
Because the Riata family of leads originated with PMA Supplement 14, St. Jude
originally took the position that it was required to produce only PMA Supplements 14 through 40
(as well as some associated documents, such as the FDA approval letters). Plaintiffs moved to
compel production of additional documents, and on March 15, 2013, Magistrate Judge Mayeron
ordered St. Jude to produce (among other things) the original Ventritex TVL Lead System PMA
and PMA Supplements 1 through 13. ECF No. 68 at 3 ¶ 2.
Judge Mayeron also ordered that plaintiffs could depose Dave Anderson and Elisabeth
Neely, the St. Jude officers who had submitted declarations in support of St. Jude’s motion for
summary judgment. Specifically, Judge Mayeron allowed plaintiffs to depose Anderson and
Neely “on the topics of what documents (in any form) are available to determine for the Riata

1

Unless otherwise indicated, all citations to the Court’s electronic docket are to the docket
in the Pinsonneault case, No. 12-CV-1717.
-4-

leads used by the plaintiffs, the manufacturing requirements imposed on these leads by the
Federal Food and Drug Administration and defendants’ compliance with those requirements.”
ECF No. 68 at 3 ¶ 1.
Judge Mayeron denied some of plaintiffs’ other document requests as overbroad,
however, observing that plaintiffs were seeking everything from “the birth of the Riata Leads to
the end” and that “this has the appearance of a fishing expedition that is going well beyond what
you have alleged in the complaint.” ECF No. 95 at 5-6. But Judge Mayeron’s denial was
essentially without prejudice. She invited plaintiffs to renew their motion to compel — or
alternatively to serve more focused discovery requests— after taking the depositions of Anderson
and Neely. ECF No. 68 at 3 ¶ 2. Plaintiffs did not object to Judge Mayeron’s March 15, 2013
order.
After deposing Anderson and Neely and obtaining the original PMA and PMA
Supplements 1 through 40, plaintiffs filed another motion to compel. ECF No. 74. Plaintiffs
sought additional documents and sought to compel Anderson and Neely to answer certain
questions that they had been instructed not to answer during their depositions. ECF No. 95 at 6.
The parties’ discovery disputes grew out of a disagreement about whether documents that
St. Jude had not submitted to the FDA were nevertheless relevant to the issue of preemption.
St. Jude argued that, for preemption purposes, the only relevant documents were documents that
had actually been submitted to the FDA during the PMA process — specifically, the PMA and
PMA Supplements. (St. Jude also agreed that the FDA’s approval letters were relevant.)
Plaintiffs sought much more than that, including a broad array of St. Jude’s internal documents
relating to the Riata leads.
-5-

In an October 3, 2013 order, Judge Mayeron granted plaintiffs’ motion in part, ordered
St. Jude to produce some additional documents, and overruled St. Jude’s objections to some of
the deposition questions. ECF No. 95. Once again, Judge Mayeron found that many of
plaintiffs’ discovery requests were “hopelessly” overbroad and that some were too vague to be
enforced. ECF No. 95 at 15-16, 17, 22-23, 28, 29-30. Judge Mayeron generally agreed with
St. Jude that “the only specifications and procedures that are relevant in this case are those set
forth in the applications for PMA approval.” ECF No. 95 at 15-16. Judge Mayeron ordered
St. Jude to respond only to those requests for production that addressed the manufacturing
defects at issue or particular documents referred to in the PMA. ECF No. 95 at 12-13, 21-22.
Judge Mayeron indicated that she considered internal product-specification documents to be
relevant so long as they were referenced or incorporated into the PMAs and PMA Supplements.
ECF No. 95 at 22-23.
In her October 3 order, Judge Mayeron also informed the parties that Phase I discovery
would end on November 1, 2013. ECF No. 95 at 2 ¶ 4. Plaintiffs thus had an entire year to
conduct discovery on the issue of preemption. Plaintiffs did not object to Judge Mayeron’s
October 3 order, nor did plaintiffs seek additional time to take discovery.
II. ANALYSIS
A. Standard of Review
Summary judgment is warranted “if the movant shows that there is no genuine dispute as
to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R.
Civ. P. 56(a). A dispute over a fact is “material” only if its resolution might affect the outcome
of the lawsuit under the substantive law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248
-6-

(1986). A dispute over a fact is “genuine” only if “the evidence is such that a reasonable jury
could return a verdict for the nonmoving party.” Id. “The evidence of the non-movant is to be
believed, and all justifiable inferences are to be drawn in his favor.” Id. at 255.
B. General Preemption Principles
The FDCA includes an express preemption clause that provides, in relevant 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 —
(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).
As noted, the Riata leads are Class III medical devices for which St. Jude had to receive
premarket approval (or “PMA”) from the FDA. An applicant for PMA must submit a broad
array of information to the FDA, including “a full statement of the components, ingredients, and
properties and of the principle or principles of operation” of the device and “a full description of
the methods used in, and the facilities and controls used for, the manufacture, processing, and,
when relevant, packing and installation” of the device. 21 U.S.C. § 360e(c)(1). The FDA may
also require the applicant to submit any additional relevant information that the FDA deems
necessary. 21 U.S.C. § 360e(c)(1)(H).

-7-

As the Supreme Court explained in Riegel v. Medtronic, Inc., a device that has received
PMA must “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.” 552 U.S. 312, 323 (2008); see also 21 C.F.R.
§ 814.80 (“A device may not be manufactured, packaged, stored, labeled, distributed, or
advertised in a manner that is inconsistent with any conditions to approval specified in the PMA
approval order for the device.”). For that reason, the Court held that the PMA process imposes
“requirement[s] applicable under this chapter to the device” for purposes of § 360k(a)(1). Riegel,
552 U.S. at 322-23.
The Court further held that state common-law duties impose “requirement[s]” that,
notwithstanding their general nature, are “with respect to” medical devices for purposes of
§ 360k(a). Id. at 323-25. As a result, if the common law of a state imposes a requirement
“different from, or in addition to” the federal requirements imposed through the PMA process,
that common-law requirement is expressly preempted by § 360k(a) (assuming that the
requirement “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” — a provision that is not at issue in
this case). Id. at 330. Therefore, the only kind of state-law claim that is not expressly preempted
by § 360k(a) is a so-called “parallel” claim — that is, a claim alleging that the defendant has
violated a state-law duty that does not differ in any material respect from a federal requirement
applicable to the device. Id.

-8-

C. Plaintiffs’ Claims
Plaintiffs’ Riata leads were approved through the PMA process, and thus there is no
question that federal requirements apply to the leads for purposes of § 360k(a). To escape
preemption, then, plaintiffs’ claims must be based on state-law requirements that are the same as
the applicable federal requirements.
As noted, plaintiffs bring state-law claims of strict liability/manufacturing defect,
negligent manufacturing, negligence per se, and negligence res ipsa loquitur. The basis of all of
these claims is that the Riata leads were defectively manufactured. Specifically, plaintiffs claim
that St. Jude (1) failed to manufacture the leads with uniform insulation thickness;2 (2) failed to
apply a controlled, uniform degree of force when crimping the lead wires; (3) failed to comply
with approved methods and specifications for curing; (4) failed to consistently apply a lubricious
interface between the inner and outer insulation; and (5) failed to comply with approved methods
and specifications for sterilizing.
With respect to the fifth alleged defect — failure to comply with approved methods and
specifications for sterilizing the leads — St. Jude admits that the PMA requires the Riata leads to
be sterilized in a particular manner, but contends that the leads were in fact sterilized in that
manner. Anderson Decl. ¶¶ 15, 18. The Court agrees with plaintiffs, however, that this issue
goes to the merits of plaintiffs’ claims rather than to the issue of preemption and is therefore

2

Plaintiffs refer to this requirement as the insulation “diameter.” Anderson testified that
“diameter” in this context is nonsensical and that the relevant measurement is “thickness.”
Anderson Dep. 118-19. Plaintiffs respond that “thickness” and “diameter” are equivalent. The
Court agrees with plaintiffs to the extent that plaintiffs’ allegation is that the insulation tube
encasing the wires had to be of a certain uniform thickness.
-9-

beyond the scope of this motion. For that reason, St. Jude’s summary-judgment motion is denied
without prejudice insofar as that motion pertains to plaintiffs’ sterilization claims.3
With respect to the remaining alleged defects, St. Jude offers evidence that the FDA did
not impose the particular requirements that plaintiffs allege were violated. See Anderson Decl.
¶ 13 (no federal requirement that insulation diameters be consistent); id. ¶ 14 (no federal
requirement with respect to curing); id. ¶ 16 (no federal requirement that there be a controlled,
uniform degree of force used when crimping); id. ¶ 17 (no federal requirement that a lubricious
interface be applied between the inner and outer insulation). Because the FDA did not impose
these particular requirements, St. Jude argues, plaintiffs’ state-law claims seek to impose state
requirements “different from, or in addition to” the federal requirements applicable to the leads.
21 U.S.C. § 360k(a)(1). For that reason, says St. Jude, plaintiffs’ claims with respect to these
four alleged defects are preempted.
In response, plaintiffs have filed an affidavit under Fed. R. Civ. P. 56(d) contending that
they have not had sufficient time to take discovery to determine whether there are federal
requirements concerning insulation thickness, crimp force, curing, or lubricious interface.
Plaintiffs also argue that the existing record contains evidence of such federal requirements. The
Court considers each argument in turn.

3

Needless to say, unless plaintiffs obtain evidence that what St. Jude says is untrue — i.e.,
evidence that St. Jude did not, in fact, sterilize the leads in the manner required by the PMA —
plaintiffs should voluntarily withdraw their sterilization claims and not require St. Jude to bring
(and this Court to rule on) another summary-judgment motion. See Fed. R. Civ. P. 11(b)(3)
(prohibiting a lawyer from “later advocating” a factual contention that does not have “evidentiary
support”).
-10-

1. Rule 56(d) Affidavit
Rule 56(d) is designed to ensure that the party opposing summary judgment has had
adequate time for discovery. See Ray v. Am. Airlines, Inc., 609 F.3d 917, 923 (8th Cir. 2010).
Under Rule 56(d), a court may permit additional discovery “[i]f a nonmovant shows by affidavit
or declaration that, for specified reasons, it cannot present facts essential to justify its
opposition . . . .” But the rule “is not a shield that can be raised to block a motion for summary
judgment without even the slightest showing by the opposing party that his opposition is
meritorious.” Willmar Poultry Co. v. Morton-Norwich Prods., Inc., 520 F.2d 289, 297 (8th Cir.
1975). To justify additional discovery, a Rule 56(d) affidavit must set forth “(1) what facts are
sought and how they are to be obtained; (2) how these facts are reasonably expected to raise a
genuine issue of material fact; (3) what efforts the affiant has made to obtain them; and (4) why
the affiant’s efforts were unsuccessful.” Johnson v. United States, 534 F.3d 958, 965 (8th Cir.
2008).
As described earlier, plaintiffs had an entire year — from November 1, 2012 to
November 1, 2013 — to conduct discovery on just one issue: preemption. During the course of
that year, various disputes arose between the parties concerning the proper scope of discovery. In
particular, plaintiffs argued that they were entitled not just to the PMA, but to documents
referenced in the PMA. To resolve these disputes, plaintiffs brought two motions to compel,
which Judge Mayeron granted in part and denied in part. Under the local rules of this District,
plaintiffs had two weeks within which to object to Judge Mayeron’s rulings. D. Minn. L.R.
72.2(a). Plaintiffs did not file any objection to either of Judge Mayeron’s orders. Instead,
plaintiffs waited until after the close of discovery — when their summary-judgment response was
-11-

due — to complain about the lack of discovery. In essence, then, plaintiffs are using their
response to defendants’ summary-judgment motion to attempt to bring an untimely and improper
challenge to Judge Mayeron’s discovery orders. Id. (“A party may not assign as error a defect in
the order not timely objected to.”).
The Court does not credit plaintiffs’ conclusory assertion that the need for additional
discovery only became clear shortly before discovery closed on November 1, 2013. Plaintiffs
had been in possession of St. Jude’s motion for summary judgment for nearly a year by the time
discovery closed. In addition, all of the discovery arguments that plaintiffs are currently making
echo arguments that they made before Judge Mayeron. Indeed, Judge Mayeron agreed with
many of their arguments; in particular, she permitted plaintiffs to discover documents referenced
in the PMA and generally agreed with plaintiffs that such documents are discoverable. See ECF
No. 95 at 18-23. To the extent that Judge Mayeron denied plaintiffs’ requests for such
documents, she did so because she found that plaintiffs’ requests were overbroad and that
plaintiffs had not made any efforts to make them more manageable. Id. at 22-23.
The Court sees no error in Judge Mayeron’s analysis, and plaintiffs do not explain how it
is flawed. Instead, they misleadingly imply that Judge Mayeron categorically denied discovery of
documents referenced in the PMA. See Hr’g Tr. 5-6, Jan. 6, 2014 [ECF No. 116]. That is simply
not true. Plaintiffs’ objections to Judge Mayeron’s orders are therefore not only untimely, but
misleading and meritless. For these reasons alone, the Court denies plaintiffs’ Rule 56(d) request
for additional discovery. See Chambers v. The Travelers Cos., 764 F. Supp. 2d 1071, 1082-83
(D. Minn. 2011) (denying Rule 56(d) request based in part on plaintiff’s failure to object to
discovery orders during nearly a year of discovery), aff’d, 668 F.3d 559 (8th Cir. 2012); Beatty v.
-12-

Synthes (USA), 101 Fed. Appx. 645, 646 (8th Cir. 2004) (per curiam) (Rule 56(d) “is designed to
minister to the vigilant, not to those who slumber upon perceptible rights” (citation and
quotations omitted)).
Even if plaintiffs’ Rule 56(d) affidavit was not an improper attempt to circumvent the
scheduling order and the local rules governing discovery disputes, the Court would deny
plaintiffs’ request for more discovery. Plaintiffs’ main complaint is that St. Jude should have
produced each and every document referenced in the PMA. See 21 C.F.R. § 814.3(e) and (g)
(defining the PMA and PMA Supplements to include “all information submitted with or
incorporated by reference therein”). But despite having ample time during discovery to identify
and request such documents, neither plaintiffs’ brief nor their Rule 56(d) affidavit identifies any
such document that they seek to discover, much less explains why any such document is
discoverable. Thus, even if the Court were to agree with plaintiffs that every single document
mentioned in a PMA becomes part of that PMA by virtue of § 814.3, plaintiffs’ Rule 56(d)
affidavit would not entitled them to further discovery.
Plaintiffs had received the original PMA and all 40 relevant PMA Supplements by the
middle of March 2013. ECF No. 71 at 2; Keeling Decl. ¶¶ 3-4, 11. This means that many
months before discovery closed, plaintiffs had the ability to identify every single document that
was incorporated by reference into the PMA.4 After March 2013, plaintiffs were given the
4

Plaintiffs contend that no one at St. Jude really knows what was submitted to the FDA,
thereby seeming to suggest that there may be other documents that are not referenced in the PMA
but are nevertheless part of the PMA because they were submitted to the FDA. But any such
suggestion would be pure speculation, and even if such mystery documents exist, plaintiffs had
ample opportunity to pursue those documents during discovery. Plaintiffs have not described
what steps they could now take to determine whether there were some unknown submissions to
(continued...)
-13-

opportunity to depose two witnesses specifically for the purpose of identifying documents
relevant to preemption. Under these circumstances, plaintiffs should now be able to (1) identify
the specific documents that they need in order to respond to St. Jude’s motion for summary
judgment; (2) cite to the Court precisely where those documents are referred to in the PMA (or
precisely what evidence suggests that those documents were at least submitted to the FDA) so
that the Court can assess plaintiffs’ argument that the information in the documents is
“incorporated by reference” under § 814.3(e) and (g); and (3) cite evidence supporting their
contention that the referenced documents relate in some way to the alleged federal requirements
at issue in this case. Yet plaintiffs make no attempt to do any of these things. Nor do plaintiffs
identify a single additional witness whom they wish to depose. Without providing such
information — which plaintiffs should easily be able to do, given the extensive discovery that
has already taken place — plaintiffs have not come close to showing that they are entitled to
additional discovery.
It should be noted that plaintiffs have attached their last few discovery requests as
exhibits to their Rule 56(d) affidavit. See Flaherty Aff. Exs. F, G, J. But plaintiffs do not discuss
these requests in any substantive way, nor do they indicate whether or how St. Jude responded.
Notably, while one of plaintiffs’ earlier requests seeks particular, identified documents
(Exhibit G), plaintiffs’ final request no longer seeks those documents (Exhibit J), suggesting that
St. Jude produced them at some point before the final request was served. It is therefore entirely
4

(...continued)
the FDA, much less explained why they could not have taken those steps during the year that
they were given to take discovery on the preemption issue. See Johnson, 534 F.3d at 965 (proper
Rule 56(d) affidavit must specify, among other things, how the desired information is to be
obtained).
-14-

unclear what documents plaintiffs are currently seeking or why plaintiffs believe they are entitled
to those documents. At this late stage, plaintiffs’ failure to be more specific is inexcusable and
strongly suggests that they are simply grasping at straws. See Gardner v. Howard, 109 F.3d 427,
431 (8th Cir. 1997) (without a “specific showing” of what evidence could be obtained through
further discovery, Rule 56(d) “does not condone a fishing expedition”).
To the extent that plaintiffs may be seeking documents that they cannot identify because
they were neither referenced in the PMA nor submitted to the FDA, the Court agrees with
St. Jude that such documents are not relevant to preemption. Plaintiffs contend that they are
entitled to St. Jude’s purely internal documents by virtue of 21 C.F.R. § 820.70(a), which
requires device manufacturers to develop and document manufacturing processes ensuring that
devices conform to their specifications. Section 820.70 is part of the FDA’s Quality System
Regulation (“QSR”), 21 C.F.R. part 820, which sets forth “Current Good Manufacturing
Practices” (“CGMP”).
Courts have split over whether alleging a violation of the QSR or the CGMPs is sufficient
to state a claim under Fed. R. Civ. P. 12(b)(6). Compare Bausch v. Stryker Corp., 630 F.3d 546,
554-56 (7th Cir. 2010) (holding that alleging a violation of the QSR and CGMPs was sufficient
to state a claim) with In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp.
2d 1147, 1157 (D. Minn. 2009) (holding that the QSR and CGMPs are “simply too generic,
standing alone, to serve as the basis for Plaintiffs’ manufacturing-defect claims”), aff’d, 623 F.3d
1200 (8th Cir. 2010). In this case, however, plaintiffs do not contend that St. Jude violated
§ 820.70(a) or any other part of the QSR. See Hr’g Tr. 16-18, 57-58. To the contrary, plaintiffs
contend that St. Jude complied with § 820.70(a) — and that, as a result, St. Jude must have
-15-

established internal manufacturing specifications, and those internal manufacturing specifications
must be deemed to be federal requirements for purposes of § 360k(a).
The Court disagrees. Plaintiffs have cited no case, and the Court has found none, holding
that purely internal manufacturing specifications constitute federal requirements for purposes of
§ 360k(a). The absence of such case law is not surprising, as such a holding would plainly be at
odds with the fact that the QSR purposely does not prescribe specific manufacturing processes in
order to give manufacturers a measure of flexibility. See Medical Devices; Current Good
Manufacturing Practice (CGMP) Final Rule; Quality System Regulation, 61 Fed. Reg. 52602,
52603 (Oct. 7, 1996).
Moreover, plaintiffs’ argument proves too much. If § 820.70(a) transforms a
manufacturer’s own internal specifications into federal requirements, then all devices regulated
under that provision — not just Class III medical devices subject to the PMA process — would
be subject to detailed and specific federal requirements that would preempt additional or different
state requirements. See 21 C.F.R. § 820.1(a)(1) (“The requirements in this part 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.”);
Gelber v. Stryker Corp., 788 F. Supp. 2d 145, 152 (S.D.N.Y 2011) (“Medical devices in general,
not just Class III devices, are subject to the FDA’s current good manufacturing practice
requirements (CGMP requirements).”). This result would not only be a terrible blow to the
plaintiffs’ bar, but it would be at odds with Medtronic, Inc. v. Lohr, in which the Supreme Court
held that the CGMPs did not preempt state-law claims concerning a Class III device that was
exempt from the PMA process. 518 U.S. 470, 497-501 (1996).
-16-

Finally, plaintiffs also note that federal requirements may exist outside of the PMA
submission, such as in FDA files to which a PMA applicant may refer or in device-specific
conditions or restrictions imposed by the FDA. See ECF No. 105 at 9-10. That may be so, but
plaintiffs cite nothing suggesting that such requirements exist in this case, nor do plaintiffs
explain why they would need discovery into such matters as FDA regulations. In short, plaintiffs
have fallen far short of demonstrating that they are entitled to yet more discovery under
Rule 56(d).
2. Evidence of Requirements
Plaintiffs next argue that there is evidence in the existing record demonstrating that there
are federal requirements relating to insulation thickness, crimp force, curing, and lubricious
interface.5 Before examining the evidence, the Court notes that plaintiffs argue that preemption
is an affirmative defense for which St. Jude bears the burden of proof. See Williams v. Nat’l
Football League, 582 F.3d 863, 880 (8th Cir. 2009). Plaintiffs ignore, however, that St. Jude has
met its burden; it has come forward with evidence that, standing alone, proves by a
preponderance of the evidence that there are no federal requirements with respect to insulation
thickness, crimp force, curing, or lubricious interface. If there are no such federal requirements,
then plaintiffs’ state-law claims would impose requirements “in addition to” the requirements
imposed on the device by virtue of the PMA process. 21 U.S.C. § 360k(a)(1); Riegel, 552 U.S.

5

In their brief, plaintiffs also argued that, if there are no such federal requirements, then
their state-law claims on those subjects cannot be preempted. Plaintiffs withdrew this contention
at oral argument. Hr’g Tr. 54-56. This was wise, as it plainly contradicts § 360k(a) and Riegel.
Under Riegel, there is no doubt that the PMA process imposed federal requirements on the Riata
leads, and any attempt to impose additional requirements is therefore clearly preempted under
§ 360k(a). Plaintiffs’ argument to the contrary was simply an attempt to reargue Riegel.
-17-

at 322-23. In order to prevail, therefore, plaintiffs must cite evidence demonstrating that there
are, in fact, federal requirements on these subjects. The Court now examines plaintiffs’
evidence.6
a. Insulation Thickness
As discussed above, the Riata leads consist of wires that connect an ICD device to
electrodes on or near a patient’s heart. The wires are encased in a silicone tube of insulation that
has four holes or “lumens” bored through it lengthwise to hold the wires. Plaintiffs allege that
St. Jude failed to manufacture this tube with uniform thickness, which led to an increased risk
that the wires would protrude through areas of thin insulation. Pinsonneault Am. Compl. ¶¶ 4850; Houlette Am. Compl. ¶¶ 47-49; Rouse Am. Compl. ¶¶ 46-48.
To support their claim that the leads must be manufactured with uniform insulation
thickness, plaintiffs point to evidence that the PMA required the overall outer-body diameter of

6

Ten days after the close of briefing on St. Jude’s motion and just a few days before the
hearing, plaintiffs filed additional exhibits and an accompanying affidavit. See ECF No. 111.
Plaintiffs did not obtain the Court’s permission for these belated filings, nor did they offer any
explanation to justify their late submission. Because plaintiffs filed these materials in violation
of the briefing schedule and the local rules, the materials are not part of the record, and the Court
will not consider them. ECF No. 96; D. Minn. L.R. 7.1(c)(2).
The Court notes that, even if it did consider these materials, they would not help plaintiffs
avoid summary judgment. Plaintiffs filed these materials well after the close of briefing, and
thus plaintiffs neither cited nor explained the materials in their brief, and the Court has no
independent obligation to scour the materials for evidence that supports plaintiffs’ claims.
See Fed. R. Civ. P. 56(c)(3); Rodgers v. City of Des Moines, 435 F.3d 904, 908 (8th Cir. 2006)
(“Without some guidance, we will not mine a summary judgment record searching for nuggets of
factual disputes to gild a party’s arguments.”). This admonition also applies to plaintiffs’ habit of
repeatedly citing entire depositions and lengthy technical documents without providing pincites.
See, e.g., ECF No. 105 at 9-11. The Court should not have to read an entire deposition to try to
identify what testimony plaintiffs are relying on. That said, the Court has done its best to
examine the record that is properly before it.
-18-

the lead to be .088 inches and the maximum body diameter at the location of the shock electrodes
to be no greater than .105 inches. Anderson Dep. 215-16. Plaintiffs also point to evidence that
the PMA required the insulation tube to be free from nicks and other defects that are greater than
20 percent of the wall thickness. Anderson Dep. 233-34; Flaherty Aff. Ex. N § 8.2.7 Finally, at
oral argument, plaintiffs pointed out that the PMA specifies that the “inner lumen of the lead
shall accept a 0.016 inch tapered, ball-tipped stylet. . . .”8 Hr’g Tr. 39-40; Flaherty Aff. Ex. N
§ 5.1.2.9. Plaintiffs argue that, given these specifications, there is logically and necessarily a
uniform-thickness requirement for the insulation.9
The Court does not agree. The thickness of the insulation depends on the overall
diameter of the lead body as well as on the placement and size of the lumens inside the
insulation. But plaintiffs cite no evidence of any requirement as to the placement of the lumens.
Nor, with respect to three of the four lumens, do plaintiffs cite any evidence of any requirement
as to their size. To the contrary, the record indicates that there are no such requirements. See

7

There is some dispute over whether the document from which these specifications are
taken — which is labeled PS0069 — was actually part of the PMA. There is testimony that it
was submitted to the FDA, however. Anderson Dep. 218 (identifying PS0069 as Neely
exhibit 26); id. at 231 (testifying that Neely 26 was submitted to the FDA). The Court therefore
treats it as part of the PMA for purposes of St. Jude’s motion.
8

Plaintiffs also mentioned an inner-lumen specification in a document entitled QTR 1403.
Hr’g Tr. 44. Plaintiffs did not submit QTR 1403 with their brief in opposition to summary
judgment, however. (As noted earlier, the Court disregards plaintiffs’ late-filed exhibits.) In any
event, based on plaintiffs’ description, the QTR 1403 specification concerns only one of the four
lumens. The Court’s analysis therefore remains the same.
9

Plaintiffs also cite to testimony concerning specifications for insulation thickness. See
Anderson Dep. 119. There is no evidence that those specifications were submitted to the FDA,
however, see Anderson Dep. 122-23, 239, and plaintiffs point to no evidence that they are
contained in a document incorporated by reference in the PMA.
-19-

Anderson Dep. 216 (“We don’t specify the lumen in that way. I mean, you could say
theoretically the lumen can’t be larger than the maximum diameter. That would be a logical
argument but that is not one of our specifications.”); Id. at 218 (“Q. And is there something in
this document that tells us how big the lumens are going to be . . . ? A. No.”).
Because the spacing and size of the lumens can vary (at least with respect to three of the
four lumens), the insulation could be any thickness at any particular point. The only limit is the
outer-body diameter requirement for the entire lead, but that simply sets a maximum diameter for
the insulation; it does not require that the insulation be uniform or that it be of any particular
thickness between the outer edge of the insulation and a lumen encasing a wire. Nor is it true, as
plaintiffs argue, that the prohibition on nicks or other defects greater than 20 percent of the wall
thickness necessarily means that the insulation must be a particular thickness. A percentage, by
its nature, can apply to any number. The prohibition on nicks simply means that, whatever the
dimensions of the insulation in any particular lead, any nick or other defect cannot exceed
20 percent of that dimension.
Plaintiffs also contend that St. Jude provided the FDA with a sample lead as part of the
PMA application, and that the dimensions of that sample lead — including the dimensions of the
insulation — thereafter became federal requirements. But plaintiffs cite no evidence that St. Jude
provided a sample lead with its PMA application, much less evidence that any such sample had a
uniform insulation thickness. See ECF No. 105 at 11. The statute and regulations do not require
manufacturers to submit samples; instead, the FDA is authorized to request samples, which the
FDA may or may not do in connection with any particular application. See 21 U.S.C.
§ 360e(c)(1)(E) (PMA application shall contain “such samples of such device and of components
-20-

thereof as the Secretary may reasonably require” (emphasis added)); 21 C.F.R. § 814.20(b)(9)
(PMA application shall include “[o]ne or more samples of the device and its components, if
requested by FDA” (emphasis added)). In sum, there is no evidence in the record that the FDA
required that the Riata leads be made with uniform insulation thickness. As a result, plaintiffs’
claims that the leads were defectively manufactured because the insulation was not of a uniform
thickness are preempted.
b. Crimp Force
Plaintiffs allege that St. Jude failed to apply a “controlled, uniform degree of force” when
crimping the lead wires, which resulted in insecure crimps over the length of the leads.
Pinsonneault Am. Compl. ¶ 53; Houlette Am. Compl. ¶ 52; Rouse Am. Compl. ¶ 51. To support
their claim that the FDA imposed such a requirement, plaintiffs offer a “crimp schedule” which
refers to crimp depth “[r]equirement[s].” Flaherty Aff. Ex. Q at 0000007. Plaintiffs cite no
evidence that this document is part of the PMA, however.
Setting that aside, the only competent testimony before the Court is that the required
crimp depths can be achieved with a range of forces and that there is no requirement for a
controlled, uniform degree of force when crimping. Anderson Dep. 287. Plaintiffs contend that
“[t]hat doesn’t sound right,” Hr’g Tr. 52, and that “[o]f course, the force applied to the crimp is
directly proportional to the resulting crimp depth,” ECF No. 105 at 11. Plaintiffs’ claims could
only be viable, however, if the crimp had to be a particular depth. But that is not the case; the
crimp schedule allows for a range of permissible depths. Flaherty Aff. Ex. Q at 0000007.
Because there is no evidence of any requirement for a controlled, uniform degree of force when

-21-

crimping, plaintiffs’ claims that the leads were defective because of the failure to use a
controlled, uniform degree of force are preempted.
c. Curing and Lubricious Interface
Finally, plaintiffs allege that St. Jude failed to follow approved methods and
specifications for curing and that St. Jude inconsistently applied a lubricious interface between
the inner and outer insulation. Pinsonneault Am. Compl. ¶¶ 51-52; Houlette Am. Compl. ¶¶ 5051; Rouse Am. Compl. ¶¶ 49-50. But plaintiffs admitted at oral argument that they have no
evidence of any federal requirements as to curing or lubricious interface. Hr’g Tr. 49 (admitting
that plaintiffs have no evidence of a requirement regarding the curing process); Hr’g Tr. 58-59
(admitting that plaintiffs have no evidence of a requirement regarding lubricious interface).
Moreover, the only evidence in the record is that the leads do not have a lubricious interface
between the inner and outer insulation. Anderson Dep. 176-77. Consequently, plaintiffs’ claims
that the leads were defective because St. Jude failed to follow specifications regarding curing and
the application of a lubricious interface are preempted.
For these reasons, the Court grants summary judgment to St. Jude on all of plaintiffs’
claims, except for plaintiffs’ claims that their leads were not sterilized in the manner required by
the PMA.
ORDER
Based on the foregoing, and on all of the files, records, and proceedings herein, IT IS
HEREBY ORDERED THAT:

-22-

1.

Defendants’ motions for summary judgment [ECF No. 97 in 12-CV-1717; ECF
No. 96 in 12-CV-1785; and ECF No. 92 in 12-CV-2396] are GRANTED IN
PART and DENIED IN PART.

2.

The motions are DENIED to the extent that they seek dismissal of plaintiffs’
claims alleging that defendants failed to comply with state-law requirements that
paralleled federal requirements regarding sterilization.

3.

The motions are GRANTED in all other respects.

Dated: June 24 , 2014

s/Patrick J. Schiltz
Patrick J. Schiltz
United States District Judge

-23-