Hinkel et al v. St. Jude Medical S.C., Inc.

Filing 35

ORDER AND REASONS: ORDERED that St. Jude Medical, S.C., Inc.'s 22 Motion for Summary Judgment is GRANTED. Signed by Judge Carl Barbier. (gec, )

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA
MELINDA S. HINKEL, ET AL.

CIVIL ACTION

VERSUS

NO: 11-1608

ST. JUDE MEDICAL, S.C., INC.

SECTION: J(5)

ORDER AND REASONS
Before the Court are Defendant’s Motion for Summary Judgment
and Memorandum in Support (Rec. Doc. 22), Plaintiffs’ Memorandum
in Opposition (Rec. Doc. 27), and Defendant’s Reply Memorandum in
Support of its Motion (Rec. Doc. 31).

The motion is before the

court on supporting memoranda and without oral argument.

PROCEDURAL HISTORY AND BACKGROUND FACTS
In June 2009, Plaintiff Melinda Hinkel underwent surgery to
have a medical device called an Eon Mini Implantable Pulse
Generator(“IPG”) implanted in her spine.

The device was

designed to relieve chronic back pain by sending low-intensity
electrical impulses to selectively trigger nerve fibers along her
spinal cord.

Although the surgery was considered successful,

Plaintiff’s back pain reportedly persisted until June 16, 2010,
when she had the IPG device removed and replaced with another
similar spinal chord stimulator.

Approximately one year later, on June 14, 2011, Plaintiff,
along with her husband Brett Hinkel (collectively, “Plaintiffs”),
commenced this action against Defendant St. Jude Medical, S.C.,
Inc. (“St. Jude”) in the 22nd Judicial District Court in St.
Tammany Parish, Louisiana.

In their petition, Plaintiffs alleged

that the Eon Mini IPG System was manufactured by St. Jude, that
it was defective at the time it was purchased, and that it had
continuously malfunctioned during the year it was implanted in
her spine, causing her bodily injury and pain.

Based on these

allegations, Plaintiffs sought damages for past and future
medical expenses, pain and suffering, emotional damages, and loss
of consortium.
On July 8, 2011, St. Jude removed the case to this Court on
the basis of federal diversity jurisdiction.

It answered shortly

thereafter, denying any liability for Plaintiffs’ claimed
injuries and asserting various affirmative defenses.

After

completing discovery, St. Jude filed the instant motion.

PARTIES’ ARGUMENTS
In its motion, St. Jude argues that it cannot be liable for
Plaintiffs’ injuries as a matter of law for principally two
reasons.

First, it argues the record conclusively demonstrates

that it was not the “manufacturer” of the Eon Mini IPG System
alleged to have caused Ms. Hinkel’s injuries, as that term is

defined

under the Louisiana Product Liability Act (“LPLA”).

Instead, it maintains that it merely sold the device to the
surgery center that had implanted it in Ms. Hinkel’s spine.

As

St. Jude explains, the Eon Mini IPG system was manufactured by a
company called Advanced Neuromodulation Systems, Inc. (“ANS”).
While St. Jude Medical, S.C., Inc., and ANS are both wholly-owned
subsidiaries of the same parent company, St. Jude Medical, Inc.,
they are distinct legal entities.

Accordingly, because it was

only a “mere seller” of the allegedly defective product, St. Jude
submits that it cannot be liable for Plaintiffs’ injuries under
the LPLA.
Second, even if it is determined to be a manufacturer of the
device under the LPLA, St. Jude argues that summary judgment is
still proper because each of Plaintiffs’ claims are completely
preempted by federal law.

It explains that the Eon Mini IPG

System is a Class III medical device, as that term is defined by
the Medical Device Amendments to the Food, Drug, and Cosmetics
Act of 1976, and was approved through the Federal Drug
Administration (“FDA”)’s rigorous pre-market approval process.
The Medical Device Amendments include a preemption provision that
expressly preempts any state law imposing requirements different
from, or in addition to, the federal requirements for such
devices.

St. Jude contends that this provision, as interpreted

by the United States Supreme Court’s decision in Riegel v.

Medtronic, Inc., 552 U.S. 312 (2008), preempts Plaintiffs’
claims.
In opposition, Plaintiffs argue that summary judgment is
improper based on the evidence they have produced.

They cite a

voluntary recall letter dated December 19, 2011, in which St.
Jude purportedly acknowledges complaints about the spinal cord
stimulator at issue, and goes on to state that the company has
“improved [its] manufacturing instructions.”1

Plaintiffs

maintain that this is sufficient to demonstrate that there is at
least a factual issue as to whether St. Jude is actually the
manufacturer of the device at issue, or at least, that it held
itself out as the manufacturer of the device, which is sufficient
to make them a “manufacturer” under the terms of the LPLA.
With respect to St. Jude’s preemption arguments, Plaintiffs
do not appear to dispute that the Eon Mini IPG System is a Class
III medical device under the MDA, or that the device has received
FDA approval.

Instead, under the Supreme Court’s holding in

Riegel, they argue that their claims are not preempted if they
demonstrate a “violation of FDA regulations.”

See id. at 330

(noting that state-law claims are not preempted where they are
“premised on a violation of FDA regulations”).

Plaintiffs argue

that if they can establish any one of the four bases under which
a product is deemed “unreasonably dangerous” under the LPLA, this

1

See Rec. Doc. 27-1.

would essentially be “no different from proving that St. Jude had
deviated from FDA requirements,” which is sufficient to escape
preemption.2
In reply, St. Jude argues that Plaintiffs’ arguments miss
the mark.

First, they argue that the voluntary recall letter

attached to their opposition has not been authenticated and is
thus not proper summary judgment evidence.

They also note that

the letter is not from St. Jude Medical, S.C., Inc., but rather
St. Jude Medical, Inc., which is its parent company.

Regardless,

however, St. Jude argues that Plaintiffs cannot avoid summary
judgment, because they have failed to submit any evidence to
establish that their claims are not preempted by the MDA.

LEGAL STANDARD
Summary judgment is appropriate when “the pleadings, the
discovery and disclosure materials on file, and any affidavits
show that there is no genuine issue as to any material fact and
that the movant is entitled to judgment as a matter of law.”
FED. R. CIV. P. 56(c)(2); Celotex Corp. v. Catrett, 477 U.S. 317,
322–23 (1986); Little v. Liquid Air Corp., 37 F.3d 1069, 1075
(5th Cir. 1994).

A material fact is a fact which, under

applicable law, may alter the outcome of the suit. Anderson v.
Liberty Lobby, Inc., 477 U.S. 242, 248 (1986); Ameristar Jet

2

Plaintiffs’ Memorandum in Opposition, Rec. Doc. 27, p. 6.

Charter, Inc. v. Signal Composites, Inc., 271 F.3d 624, 626 (5th
Cir. 2001).

A dispute is genuine when a reasonable finder of

fact could resolve the issue in favor of either party, based on
the evidence before it. Anderson, 477 U.S. at 250; TIG Ins. Co.
v. Sedgwick James of Wash., 276 F.3d 754, 759 (5th Cir. 2002).
When assessing whether a dispute as to any disputed issue of
material fact exists, the Court considers “all of the evidence in
the record but refrains from making credibility determinations or
weighing the evidence.”

Delta & Pine Land Co. v. Nationwide

Agribusiness Ins. Co., 530 F.3d 395, 398 (5th Cir. 2008).

All

reasonable inferences are drawn in favor of the nonmoving party,
but a party cannot defeat summary judgment with conclusory
allegations or unsubstantiated assertions. Little, 37 F.3d at
1075.

A court ultimately must be satisfied that “a reasonable

jury could not return a verdict for the nonmoving party.” Delta,
530 F.3d 399.
If the dispositive issue is one on which the nonmoving party
will bear the burden of proof at trial, the moving party may
satisfy its burden by merely pointing out that the evidence in
the record is insufficient with respect to an essential element
of the nonmoving party's claim.

See Celotex, 477 U.S. at 325.

The burden then shifts to the nonmoving party, who must, by
submitting or referring to evidence, set out specific facts
showing that a genuine issue exists. Id. at 324.

The non-movant

may not rest upon the pleadings, but must identify specific facts

that establish a genuine issue for trial. See, e.g., id. at 325;
Little, 37 F.3d at 1075; Isquith for and on Behalf of Isquith v.
Middle South Utils., Inc., 847 F.2d 186, 198 (5th Cir. 1988).

DISCUSSION
As explained above, St. Jude has advanced two alternative
arguments why summary judgment is proper as to each of
Plaintiffs’ claims: first, because it is not a “manufacturer”
under the LPLA; and second, because all of Plaintiffs’ claims are
preempted by federal law, even if it is deemed to be a
“manufacturer.”

Because the Court agrees with St. Jude’s second

argument, it need not address the first.
A. The Medical Device Amendments
Before turning to substance of St. Jude’s preemption
argument, a brief overview of the federal regulatory scheme
applicable to medical devices may be helpful.

Initially, the

Food, Drug and Cosmetics Act (“FDCA”), 21 U.S.C. § 301, et seq.,
only required FDA approval for the introduction of new drugs into
the market.
(1996).

Medtronic, Inc. v. Lohr, 518 U.S. 470, 475-76

The “introduction of new medical devices was left

largely for the States to supervise as they saw fit.”
552 U.S. at 315.

Riegel,

“The regulatory landscape changed in the 1960s

and 1970s,” however, as the nation witnessed the failure of
several complex medical devices, most notably the Dalkon Shield,

resulting in large numbers of injuries and even deaths.

In 1976,

responding to rising concerns that state regulatory regimes were
demonstrably inadequate, Congress stepped in and passed the
Medical Device Amendments (“MDA”), 21 U.S.C. § 360c, et seq.,
giving the FDA authority to regulate medical devices and
expressly preempting certain state-law regulations.

Id.

The MDA employs a three-part classification scheme for
medical devices, according to the degree of risk the device
presents.

See Lohr, 518 U.S. at 476.

Class I devices, such as

elastic bandages and examination gloves, pose little to no risk
of injury, and are subject only to “general controls” that are
applicable to all devices.

21 U.S.C. § 360c(a)(1)(A).

Devices

receiving the “Class II” designation, such as wheelchairs and
surgical drapes, pose somewhat greater risks.

Manufacturers of

Class II devices must therefore comply with federal performance
regulations known as “special controls.”

Id. § 360c(a)(1)(B).

Both Class I and Class II medical devices can generally be
marketed without prior approval of the FDA.
The Class III designation is reserved for devices designed
to support or sustain human life, or to prevent the impairment of
human health.

Riegel, 552 U.S. at 317.

Because these devices

present “a potential unreasonable risk of illness or injury,”
they are subject to the heaviest federal regulation.
(quoting 21 U.S.C. § 306c(a)(1)(c)(ii)).
8

Id.

Generally, before a

Class III device may be marketed and sold, it must undergo
clinical trials and a detailed and rigorous pre-market approval
process (“PMA”), through which the manufacturer must provide the
FDA with “reasonable assurance of its safety and effectiveness.”
Lohr, 518 U.S. at 477.3

The PMA process requires a manufacturer

to submit detailed information regarding the safety and efficacy
of the device, including full reports of all safety and efficacy
studies or investigations; a “full statement” of the device’s
“components, ingredients, and properties and of the principle or
principles of operation”; “a full description of the methods used
in, and the facilities and controls used for, the manufacture,
processing, and, when relevant, packing and installation of, such
device”; samples of both the device and its component parts; and
the proposed labeling.

Riegel, 552 U.S. at 318 (citing 21 U.S.C.

§ 360e(c)(1)).

3

It should be noted that not all Class III devices are
required to undergo the extensive PMA process. The MDA provides
two important exceptions, although neither is pertinent to the
instant case. First, the MDA includes a “grandfather clause”
permitting manufacturers to continue to sell medical devices that
were in existence and being marketed prior to 1976 “to remain on
the market without FDA approval until such time as the FDA
initiates and completes the requisite” pre-market approval. See
Lohr, 518 U.S. at 477-78 (citing 21 U.S.C. § 360e(b)(1)(A); 21
C.F.R. § 814.1(c)(1)). Second, where the device is
“substantially equivalent” to a pre-existing device exempt from
the PMA process, the MDA permits the FDA to approve the device
through a substantially less rigorous approval process referred
to as a § 510(k) approval. Id. (citing 21 U.S.C. §
360e(b)(1)(B)).
9

The FDA conducts an extensive review of the above
information and may also require the manufacturer to submit
additional data before approving the device.

Id. (citing 21

U.S.C. § 360e(c)(1)(G); 21 C.F.R. § 814.44(a)).

The FDA must

“weig[h] any probable benefit to health from the use of the
device against any probable risk of injury or illness from such
use” and may “thus approve devices that present great risks if
they nonetheless offer great benefits in light of available
alternatives.”

Riegel, 552 U.S. at 318 (quoting 21 U.S.C. §

360c(a)(2)(C)).
B.

Federal Preemption

The Supremacy Clause of the United States Constitution
provides that the “Laws of the United States . . . Shall be the
supreme Law of the Land.”

U.S. CONST. Art. VI, cl. 2.

When state

law conflicts with federal law, the state law is without effect
under the Supremacy Clause. Cipollone v. Liggett Group, Inc., 505
U.S. 504, 516 (1992).

However, because of the important

principles of federalism in areas of public health and safety,
the states’ police power will not be preempted by federal law
unless congressional intent to the contrary is clearly expressed.
Hillsborough County, Fla. v. Automated Med. Labs., Inc., 471 U.S.
707, 713 (1985).
In the MDA, Congress clearly indicated its intention to
preempt at least some state laws by including an express
10

preemption clause, which provides:
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).4
In Riegel, the Supreme Court established a two-prong test
for determining whether a plaintiff’s state-law claims are
preempted by MDA § 360k(a).

Under the first prong, the court

must determine the threshold issue of whether the federal
government has “established requirements” applicable to the
device at issue in the plaintiff’s lawsuit.
321-22.

Riegel, 552 U.S. at

If it has, the court must then determine whether the

plaintiff’s state-law claims are based upon state-law
requirements that are “different from, or in addition to” the
federal ones, and that relate to safety and effectiveness.”

4

Id.

Subsection (b) of the statute authorizes the FDA to grant
certain exemptions to state requirements that would otherwise be
pre-empted by subsection (a).

11

If the state requirement is different from or in addition to the
federal requirements, then it is preempted.
The Riegel Court recognized that any device approved under
the PMA process will satisfy the first prong, because through the
process, the FDA establishes detailed and device-specific
requirements that must be satisfied before it will grant
Id. at 322; see also Bass v. Stryker Corp., 669 F.3d

approval.

501, 507 (5th Cir. 2012) (“Devices that are approved through PMA
procedures automatically satisfy the ‘federal requirements’
prong.”).
With respect to the second prong, the Riegel Court confirmed
its earlier holding in Lohr that state-law tort actions are
considered “requirements” that relate to safety and effectiveness
under Section 360k(a) when applied to a medical device that has
undergone the PMA process.
Lohr, 518 U.S. at 512).

Riegel, 553 U.S. at 323-24 (citing

Accordingly, if a state-law tort claim

seeks to impose different or additional requirements than those
established by the FDA, a plaintiff’s claims will necessarily be
preempted.

Id.

at 324-25 (holding that state-law claims for

negligence, strict liability, and breach of warranty imposed
requirements that were preempted by the MDA).
C.

Are Plaintiffs’ Claims Preempted under the MDA?

There appears to be little dispute that the Eon Mini IPG
System, a Class III medical device, was granted FDA approval by
12

the FDA on November 21, 2001, and that it has consistently
maintained that approval until the present time.5

Plaintiffs

offer no argument or evidence to rebut St. Jude’s evidence on
this point, and accordingly, the Court finds that the first prong
of the Riegel preemption analysis is clearly met in this case.
As a result, the Court must next determine whether the
second Riegel prong is also met.

Although Plaintiffs do not

specifically enumerate their causes of action in their statecourt, they do appear to acknowledge in their opposition
memorandum that their only claims against St. Jude arise under
the LPLA.6

The LPLA provides “the exclusive theories of

liability for manufacturers for damage caused by their products.”
See La. Rev. Stat. § 9:2800.52.

The LPLA sets forth four

theories under which a device may be deemed “unreasonably
dangerous,” and thus defective:

(1) a defect in construction or

composition; (2) a defect in design; (3) an inadequate warning;
or (4) the failure to comply with an express warranty. See La.
R.S. 9:2800.54(B)(l-4).

The Court must therefore determine

5

See FDA Approval Order re: P010032, Nov. 21, 2001, Rec.
Doc. 22-3, Exh. A; available at
http://www.accessdata.fda.gov/cdrh_docs/pdf/P010032A.pdf; see
also Affidavit of Andrew Johnson, Rec. Doc. 22-3, Exh. 2.
6

The petition states only that “[t]he defendant, St. Jude
Medical, as the manufacturer and distributor of the ‘ANS
Stimulator’ must stand responsible for the damages and injuries
complained of herein.” See State Court Petition, Rec. Doc. 1-2,
p. 2, ¶ 5.
13

whether any of these theories seek to impose requirements
“different from, or in addition to” the applicable federal
standards.
This issue was squarely addressed in a recent decision by a
sister court from the Western District of Louisiana.

In Poole v.

Hologic, Inc., No. 10-314, 2010 WL 3021528 (W.D. La. Jul. 29,
2010), the plaintiff filed suit under the LPLA against the
manufacturer of a Class III medical device called the “NovaSure
machine” after suffering a perforated uterus when the machine
allegedly malfunctioned during a surgical procedure.
2.

Id. at *1-

The plaintiff alleged that the NovaSure machine was

unreasonably dangerous in design; in its construction and
composition; because it did not provide an adequate warning;
because it failed to conform to both an express warranty of
fitness and an implied warranty of fitness; and finally because
the manufacturer’s employees or agents failed to properly and
adequately train the physicians involved on the proper use of the
NovaSure machine.

Id. at *5.

The manufacturer moved for

judgment on the pleadings, and the court granted the motion,
finding that each of the plaintiff’s claims would necessarily
impose requirements that are “different from, or in addition to”
the requirements approved by the FDA and would directly
contravene the FDA’s determination that the device was both “safe
and effective.”

Id.; see also McQuiston v. Boston Scientific
14

Corp., No. 07-1723, 2009 WL 4016120 (W.D. La. Nov. 19, 2009)
(plaintiff's LPLA claims were preempted under the MDA); Rollins
v. St. Jude Med., 583 F. Supp. 2d 790 (W.D. La. 2008) (granting
manufacturer’s motion to dismiss plaintiff’s LPLA claims as
preempted).
Furthermore, even before the Supreme Court’s decision in
Riegel, the Fifth Circuit had generally found LPLA claims to be
preempted by the MDA.

In Gomez v. St. Jude Medical Daig Div.

Inc., 442 F.3d 919 (5th Cir. 2006), the plaintiff sued the
manufacturer of a Class III medical device called the Angio-Seal,
asserting that the product was defective under the LPLA due to
its unreasonably dangerous design, for its failure to include an
adequate warning, and for its failure to conform to an express
warranty.7

Employing essentially the same two-prong test that

the Supreme Court subsequently adopted in Riegel, the Fifth
Circuit reasoned that the plaintiff’s LPLA claims amounted to a
“state-law challenge” to the federally countenanced requirements
for the device, and thus found them completely preempted by
Section 360k(a).

Id. at 930-32.

Here, just as in Gomez and Poole, Plaintiffs’ LPLA claims
seek to impose liability on St. Jude, notwithstanding the Eon
Mini IPG System’s compliance with the design and manufacturing

7

The Plaintiff also asserted various other non-LPLA
claims, which are not relevant to the instant case.
15

specifications and labeling requirements approved by the FDA
during the PMA process.

Because these claims necessarily impose

requirements that are different from or in addition to those
required by the federal regulatory scheme, they are clearly
preempted by the MDA.
Plaintiffs seek to escape this result by recasting their
claims as what have often been referred to as “parallel” claims.
The Gomez court recognized that a “lawsuit that simply parallels
or enforces the federal regulatory requirements without
‘threatening’ or interfering with them is not preempted” under
Section 360k.

Id. at 932; see also Riegel, 552 U.S. at 330

(noting that a state-law claim would not be preempted if it was
“premised on a violation of FDA regulations”).

Accordingly,

courts have permitted state-law actions to proceed when they
allege that a defendant failed to comply with the FDA-approved
specifications for the device.

See, e.g., Martin v. Medtronic,

Inc., 254 F.3d 573, 585 (5th Cir. 2001) (affirming district
court’s refusal to dismiss claims asserting failure to comply
with the FDA’s PMA-approved requirements).
Here, however, Plaintiffs’ petition includes no allegation
that directly or impliedly asserts that St. Jude failed to
manufacture or sell the Eon Mini IPG device in compliance with
the specifications approved by the FDA during the PMA process.
Instead, Plaintiffs’ argument, as the Court appreciates it, is
16

that the LPLA’s standards for liability are somehow the same as
the federal requirements established by the PMA process.
Proceeding on this assumption, they assert that if they can
establish any one of the four bases under which a product is
deemed “unreasonably dangerous” under the LPLA, this would
essentially be “no different from proving that St. Jude had
deviated from FDA requirements.”8
Plaintiffs have cited no authority for this bold contention,
however, and as noted above, the cases that have addressed the
issue have quite clearly found the opposite to be true.

It is

clear that any claim based on the Eon Mini IPG System’s
construction or composition, design, warnings, or express
warranties would each specifically impose requirements different
from or in addition to the FDA-approved requirements for the
device.
For instance, were Plaintiffs to prove that the Eon Mini IPG
System was defective due to the construction or composition of
the system, they would essentially be challenging the
construction, composition, and manufacturing process that the FDA
approved for the device.

As the Supreme Court noted in Riegel, a

PMA application must include a complete statement of the device’s
“components, ingredients, and properties and of the principle or
principles of operation,” as well as “a full description of the
8

Plaintiffs’ Memorandum in Opposition, Rec. Doc. 27, p. 6.
17

methods used in, and the facilities and controls used for, the
manufacture, processing, and, when relevant, packing and
installation of, such device.”

552 U.S. at 318.

Allowing

Plaintiffs to proceed on this theory would enforce standards
distinct from the federally approved requirements, rather than
merely enforcing the same construction or composition
specifications approved by the FDA.
The same is also true for any claim asserting that the Eon
Mini System was defective due to inadequate warnings or its
failure to comply with an express warranty.

As the Fifth Circuit

has noted, in order to establish that the device was defective
due to breach of an express warranty under the LPLA, a plaintiff
must prove that the representations made regarding the device
were untrue.
9:2800.58).

Gomez, 442 F.3d at 932 (citing LA. REV. STAT. §
A jury hearing a breach of express warranty claim

would thus be required to determine whether St. Jude’s
representations regarding the Eon Mini System – including the
FDA-approved label, warnings, and instructions for use – were
false.

Such a determination would clearly undermine the federal

regulatory scheme.

The same is true should Plaintiffs wish to

proceed on a failure to warn theory.

The FDA approved the

product’s warnings based on its evaluation of the results of the
extensive clinical trials and safety studies required during the
PMA process.

To permit a jury to decide that these warnings are
18

inadequate under Louisiana law would effectively “displace the
FDA’s exclusive role and expertise in this area and risk imposing
inconsistent obligations” on manufacturers of PMA-approved
devices.

Id. at 930.

As such, neither of these theories simply

enforce federal requirements, as Plaintiffs suggest.
Finally, were Plaintiffs to maintain a claim that the Eon
Mini IPG System was “unreasonably dangerous” because of a
defective design, they would have to prove that an alternative
design existed and that St. Jude’s choice not to adopt this
alternative design was unreasonable under the circumstances.
LA. REV. STAT. § 9:2800.56.

See

Rather than mirroring federal

requirements, this would allow the state to directly contradict
the FDA’s determination that the approved design of the Eon Mini
IPG System was both “safe and effective.”

Poole, 2010 WL

3021528, at *5; see also Gomez, 442 F.3d at 930 (“The FDA studied
the Angio-Seal design through the PMA process and approved it.
To permit a jury to second-guess the Angio-Seal design by
applying the Louisiana statutory standard for unreasonably
dangerous design would risk interference with the
federally-approved design standards and criteria.”).
Based on the foregoing analysis, the Court finds that each
of Plaintiffs’ LPLA claims would at least potentially place St.
Jude in the precarious position of choosing whether it should
comply with federal or state requirements, but without the option
19

of satisfying both, which is a result the Supremacy Clause does
not permit. The Court therefore finds that Plaintiffs’ claims are
entirely preempted under Section 360k of the MDA.9
Perhaps anticipating this conclusion, Plaintiffs
alternatively request leave to amend their petition to allege
that “St. Jude deviated from FDA requirements in connection with
the manufacture and sale” of the Eon Mini IPG System.10
Plaintiffs have been well aware that St. Jude intended to assert
a preemption defense since at least July 27, 2011, when it was
raised in its Answer.11

Nevertheless, not once did they ever

move to amend their Complaint to include the allegation that St.
Jude deviated from FDA requirements in manufacturing this device,
opting instead to make the request in the final line of their
opposition to St. Jude’s motion for summary judgment.12

Absent

any such allegation in their Complaint, and finding no competent
evidence supporting the notion that such a deviation ever
occurred, the Court will not entertain Plaintiffs’ last-minute

9

Under Louisiana law, “a loss of consortium action is a
derivative claim of the primary victim’s injuries.” Ferrell v.
Fireman's Fund Ins. Co., 696 So. 2d 569, 575 (La. 1974). Thus,
because the Court finds that Mrs. Hinkel’s claims are preempted,
Mr. Hinkel’s loss of consortium claims are barred, as well.
10

Plaintiffs’ Memorandum in Opposition, Rec. Doc. 27, p.

11

See Defendant’s Answer, Rec. Doc. 11.

12

Plaintiffs’ Memorandum in Opposition, Rec. Doc. 27, p.

7.

7.
20

request to recast their suit as a “parallel claim” in order to
avoid preemption.

See McQuiston, 2009 WL 4016120 at *7 (denying

plaintiff’s request for leave to amend in same procedural
posture).

St. Jude’s motion will therefore be granted.

CONCLUSION
Accordingly, for the reasons expressed above, IT IS ORDERED
that St. Jude’s Motion for Summary Judgment (Rec. Doc. 22) is
hereby GRANTED.
New Orleans, Louisiana, this 23rd day of April, 2012.

CARL J. BARBIER
UNITED STATES DISTRICT COURT

21