# Doucet v. Abbott Laboratories, Inc.

> District Court, E.D. Louisiana · May 29, 2025

URL: https://www.frixlaw.com/law-library/cases/11062605

## Case

- **Court:** District Court, E.D. Louisiana
- **Decided:** May 29, 2025
- **Opinion:** 100trialcourt
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/11062605

## How later opinions describe it (automated extraction)

- finding jurisdiction where defendant had “attempted in [no] way to limit the states in which the [products] could be sold” but instead “had every reason to believe its product would be sold to a nation-wide market, that is, in any or all states”
- noting “ultimate or conclusory facts and conclusions of law” are insufficient to support or defeat even a motion for summary judgment
- stating that a court “may take judicial notice of and consider the public records of the FDA ... without transforming a [motion to dismiss] into a motion for summary judgment.”
- holding that Louisiana Civil Code articles regarding prescription apply in a removed diversity case

## Opinion text

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA

MICHAEL DOUCET CIVIL ACTION

V. NO. 25-405

ABBOTT LABORATORIES, INC., ET AL. SECTION "L"(2)

ORDER & REASONS
There are presently two motions before the Court. The first is a Motion for Lack of Personal
Jurisdiction pursuant to Federal Rule of Civil Procedure 12(b)(2) filed by Defendant Abbott
Laboratories, Inc. (“Abbott”). R. Doc. 11. The second is a Motion to Dismiss for Failure to State
a Claim pursuant to Federal Rule of Civil Procedure 12(b)(6) filed by Defendants Abbott and St.
Jude Medical, LLC (“St. Jude”). R. Doc. 9. Plaintiff Michael Doucet opposes the motions. R. Docs.
32, 33. Defendants Abbott and St. Jude replied. R. Docs. 34, 35. Oral argument was held on
Monday, May 19, 2025. Considering the record, the briefing, the arguments, and the applicable law,
the Court now rules as follows.
I. BACKGROUND

This is a product liability suit concerning the implantation of an allegedly defective medical
device approved by the Food and Drug Administration (the “FDA”). R. Doc. 1-1. On March 27, 2020,
Plaintiff Michael Doucet fell some twenty-five feet down an elevator shaft. R. Doc. 1-2 at 2.
Thereafter, Mr. Doucet underwent multiple surgeries and extensive medical treatment to mend a
bone fracture in his right ankle. Id. at 2-4. After these procedures, Mr. Doucet nevertheless
continued to experience chronic pain in his lower back and extremities. Id. at 4. Mr. Doucet’s
doctor thus recommended him for a study involving a medical device allegedly manufactured by
Defendant Abbott that is designed to manage chronic, intractable pain in the lower body. Id. at 5.
This device, called a Proclaim Dorsal Root Ganglion Stimulator (“DRG Stimulator”), is surgically
implanted in the patient and stimulates a bundle of “DRG” nerves located on the outside of the
spinal cord to alleviate pain. Id. The DRG Stimulator “system” includes an implantable pulse
generator or “IPG,” implantable leads that connect to the IPG, an external charger, and an external

programmer. R. Doc. 9-1 at 12. The IPG and implantable leads work together to send electrical
pulses toward the DRG nerves, which can block or alter pain signals before they reach the brain.
Id.
On October 18, 2022, Mr. Doucet had a DRG Stimulator inserted without complications.
R. Doc. 1-2 at 5-6. Over the next year, he reported to his doctor that the DRG Stimulator was
effective, and his pain had subsided significantly. Id. at 6-7. However, on October 27, 2023, Mr.
Doucet began to complain that he had “some irritation” at his DRG procedure site. Id. at 7. As
such, the doctor informed Mr. Doucet that he would have Abbott reach out to him to discuss the
issues he had been having with the device. Id. at 8. In the meantime, Mr. Doucet alleges the DRG
Stimulator would malfunction, “feeling like it was turning off and on sporadically causing

continuing extreme discomfort and irritation.” Id. On January 16, 2024, Abbott advised Mr.
Doucet that the DRG Stimulator had been recalled. Id. Mr. Doucet subsequently informed his
doctor that he would like the device to be removed as soon as possible. Id. However, as of this
date, it is the Court’s understanding that the device has yet to be removed because Mr. Doucet
claims that he cannot afford to have it medically extracted. Id.
On January 13, 2025, Mr. Doucet filed the present lawsuit in state court against Abbott. Id.
He alleges four causes of action under the Louisiana Products Liability Act, including: (1)
construction or composition defect; (2) design defect; (3) inadequate warning; and (4) breach of
express warranty. Id. at 8-13. He also brings three Louisiana state law claims for: (1) breach of
implied warrant of merchantability and fitness; (2) redhibition; and (3) breach of warranty of
fitness for ordinary use. Id. at 13-15. He requests damages for various injuries, such as past and
future physical pain and suffering; past and future medical expenses; loss of enjoyment of life, etc.
Id. at 15-16. In response, Abbott removed the case to this Court based on diversity jurisdiction. R.

Doc. 1. On May 9, 2025, Mr. Doucet amended his petition and added Defendant St. Jude who joins
in Abbott’s Motion to Dismiss for Failure to State a Claim. R. Docs. 11; 30.
II. PRESENT MOTION
Upon removal of the case to this Court, Abbott filed the present Motion to Dismiss for Lack
of Personal Jurisdiction, and argues that it is subject to neither specific nor general jurisdiction in
Louisiana. R. Doc. 11-1. Additionally, Abbott and St. Jude jointly move to dismiss Mr. Doucet’s
case pursuant to Federal Rule of Civil Procedure 12(b)(6) on the grounds of federal preemption
under the Medical Devices Amendment to the Food, Drug, and Cosmetics Act; failure to state a
claim; and prescription. R. Doc. 9-1. Mr. Doucet generally opposes Abbott and St. Jude’s motions,
highlighting Abbott’s complex corporate structure and the necessity for discovery in order to

properly state a claim. R. Docs. 32, 33. Abbott and St. Jude replied, largely reiterating the
arguments made in their initial motion. R. Docs. 34, 35.
III. LAW & ANALYSIS
The Court begins its analysis by first addressing Abbott’s 12(b)(2) motion and then proceeds
to the merits of Abbott and St. Jude’s arguments on their 12(b)(6) motion.
A. Abbott’s Motion to Dismiss for Lack of Personal Jurisdiction
Federal Rule of Civil Procedure 12(b)(2) confers a right to dismissal of claims against a
defendant where personal jurisdiction is lacking. Indeed, personal jurisdiction is “an essential
element of the jurisdiction of a district court, without which the court is powerless to proceed to
an adjudication.” Ruhrgas AG v. Marathon Oil Co., 526 U.S. 574, 584 (1999) (internal quotation
marks omitted). “When a nonresident defendant moves to dismiss for lack of personal jurisdiction,
the plaintiff bears the burden of establishing the district court’s jurisdiction over the
nonresident.” Jobe v. ATR Mktg., Inc., 87 F.3d 751, 753 (5th Cir. 1996). A plaintiff satisfies this

burden by “presenting a prima facie case for personal jurisdiction.” Colwell Realty Invs., Inc. v.
Triple T Inns of Az., Inc., 785 F.2d 1330, 1333 (5th Cir. 1986). To be clear, “[p]roof by a
preponderance of the evidence is not required” at this stage in the proceedings. Bullion v. Gillespie,
895 F.2d 213, 217 (5th Cir. 1990). In assessing whether the plaintiff has made a prima facie
showing of personal jurisdiction, the allegations made in the complaint “must be taken as true, and
conflicts between the facts contained in the parties’ affidavits must be resolved in the plaintiff’s
favor.” D.J. Invs., Inc. v. Metzeler Motorcycle Tire Agent Gregg, Inc., 754 F.2d 542, 546 (5th Cir.
1985). The court may thus consider affidavits, depositions, and other documentation outside of the
plaintiff’s complaint when determining whether personal jurisdiction exists. Brown v. Flowers
Industries, Inc., 688 F.2d 328, 332 (5th Cir. 1982).

Within the context of diversity cases such as the one at present, a federal district court’s
ability to exercise personal jurisdiction over a defendant residing outside of the state in which it
sits involves a two-part test. See Alpine View Co. v. Atlas Copco AB, 205 F.3d 208, 214 (5th Cir.
2000); Unified Brands, Inc. v. Teders, 868 F. Supp. 2d 572, 577 (S.D. Miss. 2012). First, the court
must assess whether a forum state’s long arm statue permits service of process. Id. Second, the
court must determine whether the assertion of personal jurisdiction over the Defendant violates
due process. Id. Here, Louisiana’s long-arm statute, La. R.S. § 13:3201(B), extends jurisdiction to
the constitutional limit, providing that a court “may exercise personal jurisdiction over a
nonresident on any basis consistent with . . . the Constitution of the United States.” As such, the
“two inquiries fold into one,” and a separate analysis of the Louisiana long-arm statute and due
process is unnecessary. Luv N’ care, Ltd. v. Insta-Mix, Inc., 438 F.3d 465, 469 (5th Cir. 2006).
Rather, the sole question before the court is whether the defendant has meaningful “contacts, ties,
or relations” with Louisiana, such that exercise of jurisdiction against it would not offend

constitutional due process. See Int’l Shoe Co. v. Washington, 326 U.S. 310, 319 (1945).
Personal jurisdiction may be general or specific. Helicopteros Nacionales de Colombia,
S.A. v. Hall, 466 U.S. 408, 414-15 (1984). Where a defendant has “continuous and systematic
general business contacts” with the forum state, the court may exercise “general” jurisdiction over
any action brought against that defendant. Id. Where contacts are less pervasive, the court may still
exercise “specific” jurisdiction “in a suit arising out of or related to the defendant’s contacts with
the forum.” Id. In this case, Mr. Doucet alleges that this Court has both general and specific
jurisdiction over Abbott. Conversely, Abbott maintains that it is not subject to personal jurisdiction
in Louisiana whatsoever, and that due process mandates dismissal of Mr. Doucet’s claims against
it. As explained below, the Court ultimately need not reach the issue of general jurisdiction because

it finds that Mr. Doucet has successfully made a prima facie showing of specific jurisdiction.
a. Mr. Doucet Has Made a Prima Facie Showing of Specific Personal
Jurisdiction.

When addressing specific jurisdiction, federal district courts apply a three-part test to
determine:
(1) whether the defendant has minimum contacts with the forum
state, i.e., whether it purposely directed its activities toward the
forum state or purposefully availed itself of the privileges of
conducting activities there; (2) whether the plaintiff’s cause of
action arises out of or results from the defendant’s forum-related
contacts; and (3) whether the exercise of personal jurisdiction is fair
and reasonable.
Seiferth v. Helicopteros Atuneros, Inc., 472 F.3d 266, 271 (5th Cir. 2006). Upon plaintiff
establishing the first two requirements, the burden then shifts to the defendant to demonstrate that
an exercise of personal jurisdiction would be unfair or unreasonable. Burger King Corp. v.
Rudzewicz, 471 U.S. 462, 477 (1985) (citing World-Wide Volkswagen Corp. v. Woodson, 444 U.S.

286, 292 (1980)).
Particularly relevant to the present motion, the second requirement for specific jurisdiction
focuses on the “affiliation between the forum and the underlying controversy.” Goodyear Dunlop
Tires Operations, S.A. v. Brown, 564 U.S. 915, 919 (2011). Indeed, due process requires a
connection between the defendant’s in-state activities and a plaintiff’s claims; specific jurisdiction
may only be exercised over a non-resident defendant where the defendant’s actions within the
forum state concern the plaintiff’s causes of action. Id. at 930 n.6. “[E]ven regularly occurring
sales of a product in a State do not justify the exercise of jurisdiction over a claim unrelated to
those sales.” Id. In other words, the suit itself must arise out of or relate to the defendant’s contacts
with the forum. See Britsol-Myers Squibb Co. v. Superior Court, 582 U.S. 255, 272 (2017).

Here, Mr. Doucet alleges in his petition that Abbott is subject to specific jurisdiction in this
forum because the company developed, manufactured, and placed its products, including the DRG
Stimulator, into a stream of commerce that included distribution in Louisiana. Such an allegation
invokes the Supreme Court’s “stream of commerce theory,” which has been expressly endorsed
by the Fifth Circuit and stands for the proposition that “[w]here a defendant knowingly benefits
from the availability of a particular state’s market for its products, it is only fitting that the
defendant be amenable to suit in that state.” Luv N’ care, 438 F.3d at 470; see also Oswalt v.
Scripto, Inc., 616 F.2d 191, 199-200 (5th Cir. 1980) (finding jurisdiction where defendant had
“attempted in [no] way to limit the states in which the [products] could be sold” but instead “had
every reason to believe its product would be sold to a nation-wide market, that is, in any or all
states”). However, Abbott takes the position that Mr. Doucet’s claims do not arise out of the
company’s contacts with Louisiana, arguing that it was not the entity responsible for or involved
at all in the manufacturing of the DRG Stimulator. In support, Abbott submits the Declaration of

Timothy Lorinser, the company’s Director of Tax, which states that St. Jude designed and
manufactured the DRG Stimulator, not Abbott. R. Doc. 1-1. Mr. Doucet, on the other hand,
maintains that Abbott indeed manufactured the DRG Stimulator or at least had some role in its
distribution. Furthermore, he attaches his own exhibits that indicate a representative from Abbott
personally reached out to him prior to his implantation procedure, the packaging he received
containing the DRG Stimulator was emblazoned with the word “Abbott,” and the loan device
agreement that he was made to sign stated Abbott would be party to the contract. R. Docs. 32-1;
32-2; 32-3; 32-4; 32-6.
Upon review of the record and the evidence submitted by the parties, the Court is satisfied
that Mr. Doucet has made a prima facie showing of specific jurisdiction. As an initial matter, Mr.

Doucet has furnished the Court with several materials that he received in connection with his DRG
Stimulator procedure that bear the name “Abbott” and its corresponding corporate logo, rather
than anything to do with St. Jude. Moreover, the premarket approval letter for the DRG Stimulator
submitted by Abbott itself indicates that an “Abbott Medical” was the applicant-manufacturer who
submitted the DRG Stimulator for FDA approval; any mention of St. Jude is notably absent. R.
Doc. 10-3. The Court finds that this documentation seriously undermines Abbott’s representations
of its minimal to non-existent involvement with the device at the manufacturing and production
levels and thus weighs in favor of jurisdiction.
Furthermore, the Court observes that, on its face, there may be some merit to the declaration
made by Abbott’s Tax Director supposedly clarifying that St. Jude is the manufacturer of the DRG
Stimulator. This declaration, however, does not explain why all the product labeling that Mr.
Doucet received indicates Abbott as the company associated with the device––a fact that this Court

must construe in favor of jurisdiction at this stage in the proceedings. D.J. Invs., 754 F.2d at 546
(explaining a conflict in the facts is resolved in plaintiff’s favor when there is a prima facie burden
for personal jurisdiction). Indeed, Abbott has crucially failed to submit any further proof to
substantiate the conclusion that it did not in fact manufacture the device at issue. Rather, it
essentially asks this Court to reach a pre-discovery finding that Abbott is not the entity responsible
and thus not subject to jurisdiction on the basis of its employee’s word alone. The Court refuses to
entertain such a request. A bare-bones assertion––even one made by a purportedly knowledgeable
employee––that is not supported by facts is insufficient to support a motion to dismiss on
jurisdiction grounds at this stage in the proceedings. Galindo v. Precision Am. Corp., 754 F.2d
1212, 1216 (5th Cir. 1985) (noting “ultimate or conclusory facts and conclusions of law” are

insufficient to support or defeat even a motion for summary judgment).
Based on the foregoing, the Court finds that it is premature to conclude at this time that
Abbott had nothing to do with the manufacturing or distribution of the DRG Stimulator in this
matter. There are simply too many lingering questions as to Abbott’s level of involvement with
the device that have yet to be answered in light of its participation throughout the FDA approval
process and the prior representations it made to Mr. Doucet. Furthermore, as noted by the parties
at oral argument, Abbott’s corporate structure appears to be factually complex; thus, its
relationship with St. Jude warrants at least some discovery before Mr. Doucet’s claims are to be
dismissed on jurisdictional grounds. See Kelly v. Syria Shell Petroleum Dev. B.V., 213 F.3d 841,
855 (5th Cir. 2000) (finding discovery designed to support an alter ego theory of personal
jurisdiction is warranted if there are issues of fact that need to be explored). Accordingly, the Court
will construe the factual allegations made in Mr. Doucet’s petition in his favor and concludes he
has made a prima facie showing that Abbott is subject to specific jurisdiction in Louisiana. The

Court does wish to clarify, however, that this finding today does not preclude Abbott from re-
challenging the exercise of personal jurisdiction at a later date and in accordance with the proper
procedure, either following discovery or at trial. DeMelo v. Toche Marine, Inc., 711 F.2d 1260,
1271 n.12 (5th Cir. 1983) (“Eventually, of course, the plaintiff must establish [personal]
jurisdiction by a preponderance of the evidence, either at a pretrial evidentiary hearing or at trial.
But until such a hearing is held, a prima facie showing suffices, notwithstanding any controverting
presentation by the moving party, to defeat the motion.”). But at this time, Mr. Doucet has made
the required prima facie showing of personal jurisdiction.
B. Abbott and St. Jude’s Motion to Dismiss for Failure to State a Claim
The Court now moves on to address Abbott and St. Jude’s Motion to Dismiss for Failure

to State a Claim pursuant to Federal Rule of Civil Procedure 12(b)(6). The motion raises arguments
based on, inter alia, federal preemption and prescription. The Court takes each in turn.
a. Preemption Under § 360k(a) of the Medical Device Amendments
The first issue raised in Abbott and St. Jude’s motion is federal preemption. More precisely,
Abbott and St. Jude argue that § 360k(a) of the Medical Device Amendments prohibits state law
causes of action that impose requirements “different from, or in addition to” requirements already
imposed by the FDA vis-à-vis a regulatory mechanism known as premarket approval. On this
basis, Abbott and St. Jude contend that § 360k(a) expressly preempts Mr. Doucet’s claims under
the Louisiana Products Liability Act and Louisiana redhibition law because they are not premised
upon the FDA’s regulations already in place with respect to the DRG Stimulator, but rather an
entirely different standard of care established by Louisiana law. Before diving into the
complexities of how preemption applies in the context of state law claims involving medical
devices approved by the FDA, the Court will start the analysis by providing a background of the

relevant statutory and regulatory framework.
In 1976, Congress passed the Medical Devices Amendments (“MDA”) to the Federal Food,
Drug, and Cosmetic Act (“FDCA”), which established a regulatory regime to approve and monitor
the manufacture and sale of medical devices. Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008).
The MDA sets forth three levels of “oversight for medical devices, depending on the risks they
present.” Id. Class I devices are “subject to the lowest level of oversight” such as “labeling
requirements.” Id. (citing 21 U.S.C. § 360c(a)(1)(A)). Class II devices are subject to all of the
Class I requirements and additional “‘special controls such as performance standards and
postmarket surveillance measures.” Id. at 316-17 (quoting 21 U.S.C. § 360c(a)(1)(B)). Class III
devices are subject to the “most federal oversight.” Id. These devices either support or sustain

human life, substantially prevent impairment of human health, or present a potentially
unreasonable risk of injury or illness. Id. (citing 21 U.S.C. § 360c(a)(1)(C)(ii)).
The Food and Drug Administration (“FDA”) subjects all new Class III devices to
premarket approval (“PMA”), at which time the “manufacturer must provide the FDA with a
‘reasonable assurance’ that the device is both safe and effective.” Medtronic, Inc. v. Lohr, 518 U.S.
470, 477 (1996) (quoting 21 U.S.C. § 360e(d)(2)). “Premarket approval is a ‘rigorous process,’”
and the FDA spends “an average of 1,200 hours reviewing each application.” Riegel, 552 U.S. at
317-18 (quoting Lohr, 518 U.S. at 477). Ultimately, to gain premarket approval, the manufacturer
must demonstrate that the device satisfies the statutory standard––a “reasonable assurance of
safety and effectiveness.” See 21 U.S.C. §§ 360c(a)(1)(C), 360e(c). To meet this burden, the
manufacturer:
must submit a detailed PMA application that contains full reports of
all investigations of the safety and effectiveness of the device; a full
statement of the components, ingredients, properties, and principles
of operation of the device; a full description of the methods used in
the manufacture and processing of the device; information about
performance standards of the device; samples of the device;
specimens of the proposed labeling for the device; and any other
relevant information.

Riegel v. Medtronic, Inc., 451 F. 3d 104, 109 (2d Cir. 2006), aff’d, 552 U.S. 312 (2008) (citing 21
U.S.C. § 360e(c)). In analyzing PMA applications, the FDA balances “any probable benefit to
health from the use of the device against any probable risk of injury or illness from such use.”
Riegel, 552 U.S. at 318 (citation omitted). If the agency is not satisfied with the information the
manufacturer provided, it can demand more information. 21 U.S.C. § 360e(c)(1)(G). The agency
can also require a manufacturer to revise the device’s design, manufacturing methods, or labeling
to obtain approval. 21 C.F.R. § 814.44(e). Under the “reasonable assurance of safety and
effectiveness” standard, the agency may “approve devices that present great risks if they
nonetheless offer great benefits in light of available alternatives.” Riegel, 552 U.S. at 318.
Particularly relevant to the present motion, 21 U.S.C. § 360k(a) of the MDA contains an
express preemption clause, providing that no State may establish “any requirement . . . which is
different from, or in addition to” a federal requirement “which relates to the safety or effectiveness
of [a medical device subject to the MDA].” The United States Supreme Court has twice now
interpreted § 360k(a). See Lohr, 518 U.S. at 477; Riegel, 552 U.S. at 317-18. In fact, the Court in
Riegel v. Medtronic, Inc. created a helpful two-part test to determine whether preemption applies
to a plaintiff’s state law claims against a certain medical device. First, the court must determine
whether the federal government has “established requirements applicable to [the medical
device].” Id. at 372. The Fifth Circuit has held that Class III devices subject to PMA
“automatically” satisfy the first prong. Bass v. Stryker Corp., 669 F.3d 501, 507 (5th Cir. 2012).
Second, the court evaluates whether the state law claims are based on “requirements with respect
to the device that are ‘different from, or in addition to,’ the federal ones, and that relate to safety

and effectiveness.” Riegel, 552 U.S. at 321-22 (quoting § 360k(a)). If they are, the state law claim
is preempted. See id.
However, courts have concluded that so-called “parallel” state law claims are not
preempted by § 360k(a). Id. at 330. A state law claim is “parallel” if it “provid[es] a damages
remedy . . . premised on a violation of FDA regulations.” Id. Put more simply, plaintiffs may use
the LPLA or any other state law as a legal mechanism to seek recovery for violations of FDA
regulations that rendered the device at issue “unreasonably dangerous” and ultimately caused them
harm. See Reddick v. Medtronic, Inc., No. 21-30169, 2022 WL 715494, at *3 (5th Cir. Mar. 9,
2022); Scianneaux v. St. Jude Medical S.C., Inc., 961 F.Supp.2d 808, 812 (E.D. La. 2013); Parra
v. Coloplast Corp., No. CV 16-14696, 2017 WL 24794, at *3 (E.D. La. Jan. 3, 2017).

Even if a state law claim is sufficiently parallel in that it alleges liability based on a
defendant’s failure to comply with FDA-imposed requirements, a district court may still dismiss
it if the claim is “impermissibly conclusory and vague.” Funk v. Stryker Corp., 631 F.3d 777, 782
(5th Cir. 2011). A complaint is insufficient to state a “parallel” products liability claim where it
does not “specify the manufacturing defect,” “specify a causal connection between the failure of
the specific manufacturing process and the specific defect in the process that caused the personal
injury,” or “tell us how the manufacturing process failed, or how it deviated from the FDA
approved manufacturing process.” Id. at 782. Similarly, in Naquin v. Medtronic, Inc., the Fifth
Circuit affirmed the district court’s dismissal of claims for design defect, construction defect,
failure to warn, and breach of express warranty due to inadequate pleading. No. 20-30793, 2021
WL 4848838, at *3 (5th Cir. Oct. 18, 2021). The complaint in that case only “ma[de] numerous
conclusory allegations . . . [without] details as to how a violation of federal regulations” led to a
manufacturing defect, a design defect, or an inadequate warning.

i. Mr. Doucet’s State Law Claims Are Expressly Preempted, But He
May Amend to State Parallel Claims.

In the present motion, Defendants Abbott and St. Jude submit that this Court should take
judicial notice that the DRG Stimulator at issue here is a Class III medical device that went through
premarket approval before the FDA. R. Doc. 10. As such, it takes the position that § 360k(a)’s
express preemption clause is applicable to all of Mr. Doucet’s state law claims. More specifically,
it argues that because Mr. Doucet’s claims explicitly relate to safety and effectiveness and would
require the device to use a different design, different warnings, or a different manufacturing
process than the ones the FDA required through the PMA process, they would impose “different
or additional” state law requirements and thus are expressly preempted. In opposition, Mr. Doucet
asserts that “the LPLA duty is parallel to the duty imposed by federal PMA requirements, and thus,
the DRG System’s marketing and manufacturing implicate relevant laws that are federal in
nature.” Alternatively, Mr. Doucet requests leave to amend in the event that he has not sufficiently
pled “parallel claims.”
After considering the applicable case law, the Court reaches the inescapable conclusion
that Mr. Doucet’s state law claims are expressly preempted by § 360k(a) for the following reasons.
Preliminarily, the Court notes that under a 12(b)(6) analysis, it is typically bound to the allegations
made in a plaintiff’s complaint on a motion to dismiss. This is troublesome for purposes of a
preemption analysis because Mr. Doucet notably does not state that the DRG Stimulator is a Class
III medical device subject to the MDA anywhere in his petition. Federal Rule of Evidence 201,
however, permits a court to take judicial notice of an adjudicative fact “not subject to reasonable
dispute” because the fact is either: “(1) [] generally known within the trial court’s territorial
jurisdiction; or (2) can be accurately and readily determined from sources whose accuracy cannot
reasonably be questioned.” Fed. R. Evid. 201(b); see also Davis v. Toyota Motor Sales, No. 14-

683, 2015 WL 3456656, at *7 (M.D. La. May 29, 2015). Applying that rule to the present case,
the Court will take judicial notice of the fact that the DRG Stimulator was approved by the FDA
vis-à-vis the PMA process and received Class III status. The FDA documentation provided by
Abbott and St. Jude in support bears sufficient indicia of reliability, such that its consideration at
this stage in the proceedings is fair as to all the parties. Indeed, other courts routinely take judicial
notice of PMA approval letters for Class III medical devices when deciding preemption issues at
the motion to dismiss stage. See, e.g., Funk, 631 F.3d at 782-83 (finding that the district court took
appropriate judicial notice of a PMA approval letter); Gavin v. Medtronic, Inc., No. 12-0851, 2013
WL 3791612, at *2-3, *35-37 (E.D. La. July 19, 2013) (taking judicial notice of Class III medical
device’s FDA approval documents); Rollins v. St. Jude Medical, 583 F.Supp.2d 790, 805 (WD.

La. 2008) (stating that a court “may take judicial notice of and consider the public records of the
FDA ... without transforming a [motion to dismiss] into a motion for summary judgment.”).
With no dispute then that the DRG Stimulator at issue here is a Class III medical device,
whether preemption applies pursuant § 360k(a) of the MDA becomes a straightforward inquiry.
Given Class III medical devices automatically satisfy the first prong of the Riegel test, the pivotal
question is to what extent Mr. Doucet’s state law claims create requirements “different from, or in
addition to” the relevant FDA requirements. On similar facts to those presently before the Court
in this case, the Fifth Circuit and other courts have consistently held that generically-pled LPLA
and other redhibition claims premised upon substantive Louisiana law alone do not pass muster
under the Riegel test and thus are expressly preempted under § 360k(a) because they impose
“requirement[s]” that related to the “safety and effectiveness” of a device that has already been
approved by the FDA. Rodriguez v. Am. Med. Sys., Inc., 597 F. App’x 226, 229 (5th Cir. 2014)
(affirming district court’s dismissal of complaint involving Class III medical device on preemption

grounds); Greene v. Nevro Corp., No. 23-CV-1648-JWD-RLB, 2025 WL 369682, at *7 (M.D. La.
Jan. 31, 2025) (dismissing plaintiff’s LPLA claims involving a spinal stimulator on preemption
grounds); Parra v. Coloplast Corp., No. CV 16-14696, 2017 WL 24794, at *4 (E.D. La. Jan. 3,
2017) (dismissing plaintiff’s LPLA claims on preemption). Reddick v. Medtronic, Inc., 2022 WL
715494, at *3 (affirming dismissal of LPLA claims because “all four claims impose requirements
that relate to the safety and effectiveness of the device”); Gavin, 2013 WL 3791612, at *15
(dismissing plaintiff’s state law inadequate warning, strict liability and negligence, redhibition,
and warranty claims as preempted). Accordingly, the Court finds that it is well-settled law the
MDA expressly preempts Mr. Doucet’s claims, making them ripe for dismissal.1
But as the Court noted previously, the Fifth Circuit has opened the door to “parallel”

claims––state law claims for damages “premised on a violation of FDA regulations.” See,
e.g., Rodriguez, 597 F. App’x at 228 (“Section 360k does not prevent a State from providing a
damages remedy for claims premised on a violation of FDA regulations; the state duties in such a
case ‘parallel,’ rather than add to, federal requirements.”); Gomez, 442 F.3d at 932 (“[A] lawsuit
that simply parallels or enforces the federal regulatory requirements without ‘threatening’ or
interfering with them is not preempted.”). The problem here though is that Mr. Doucet’s state law

1 Alternatively, Abbott and St. Jude contend that Mr. Doucet’s state law claims are impliedly preempted by the
MDA. The basis of their argument is that in enacting the FDCA, Congress declined to create a private cause of action
and required that any action to enforce the FDCA “shall be by and in the name of the United States,” thus mandating
that the FDCA and its implementing regulations be “enforced exclusively by the Federal Government. 21 U.S.C. §
337(a); Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341, 352 (2001). However, the Court need not reach this issue
because the express preemption provision under § 360k(a) plainly applies to the present facts as clarified by the
aforementioned case law.
claims cannot be considered “parallel” as pled because he does not explicitly allege any violations
of FDA regulations. Instead, his petition merely states generic allegations that the DRG Stimulator
is defective without mention of the FDA or any specific requirements applicable to device that
were imposed per the PMA process.

Rather than dismissing this case outright, however, the Court will give Mr. Doucet an
opportunity to amend his petition in order to properly plead “parallel” claims. This outcome
comports with this Court’s prior decisions under similar facts involving preemption under the
MDA. Cenac v. Hubbell, No. 09-3686, 2010 WL 4174573, at *3 (E.D. La. Oct. 21, 2010) (granting
plaintiff two opportunities to amend and clarify her parallel claim); Bush v. Thoratec Corp., 837
F. Supp. 2d 603, 609 (2011) (granting plaintiff leave to amend the complaint to attempt to “thread
the needle” and state a cognizable parallel claim). For example, in Chiasson v. Medtronic Inc, the
plaintiffs sued a manufacturer of a Class III medical device and brought three causes of action
under the LPLA and a redhibition claim, which were all clearly preempted by the MDA. No. CV
16-3552, 2016 WL 4191837, at *4 (E.D. La. Aug. 9, 2016). But the court ultimately decided not

to dismiss their claims and instead held:
Because of the complex nature of this area of law and in the interest
of justice, this Court has given plaintiffs in similar cases an
opportunity to amend their complaints to clarify the parallel claim,
specifically to plead a violation of state law, a parallel violation of a
federal regulation, and the connection between that violation and the
Plaintiff’s injury.

Id. With this case law in mind, the Court in this instance will not depart from its prior reasoning
and gives Mr. Doucet a chance to plead claims that can survive preemption. Mr. Doucet must be
sure to plead his parallel claims with specificity––particularly the federal regulation that he alleges
Abbott and St. Jude breached; the parallel state claim; and its causal nexus to his injuries. Id.
Should he fail to do so, Defendants may re-raise their motion to dismiss on preemption grounds.2
b. The Court Will Not Dismiss Mr. Doucet’s LPLA Claims on the Basis of
Prescription at This Stage in the Proceedings.

Lastly, Abbott and St. Jude argue in the alternative that Mr. Doucet’s LPLA claims should
be dismissed on the basis of prescription. A federal court sitting in diversity must apply state law
to issues of prescription. Calhoun v. Ford, 625 F.2d 576, 577 (5th Cir. 1980); see also Mullen v.
Sears, Roebuck, & Co., 887 F.2d 615 (5th Cir. 1989) (holding that Louisiana Civil Code articles
regarding prescription apply in a removed diversity case). It is undisputed that Mr. Doucet’s four
products liability claims are governed by the Louisiana Products Liability Act. Delictual actions,
such as those found in the LPLA, are subject to a prescriptive period of one year under Article
3492 of the Louisiana Civil Code. “[The prescription of delictual actions] commences to run from
the day injury or damage is sustained.” La. Civ. Code Ann. art. 3492 (2016). In Louisiana, damages
are considered sustained “only when [the damage] has manifested itself with sufficient certainty
to support accrual of a cause of action.” Cole v. Celotex Corp., 620 So.2d 1154, 1156 (La.
1993) (citing McCray v. New England Ins. Co., 579, So.2d 1156 (La. App. 2 Cir. 1991)).
Here, Abbott and St. Jude contend that Mr. Doucet’s LPLA claims arose in October of
2023 when he began experiencing irritation at the DRG Stimulator implant site. Mr. Doucet would
thus have had until October 2024 to file his claims under the applicable one-year prescriptive

period. His state court petition, however, was filed on January 13, 2025. In opposition, Mr. Doucet
argues that prescription began to run on January 16, 2024 when Abbott informed him that the DRG
Stimulator had been recalled, which would make his January 13, 2025 filing timely.

2 Because Abbott and St. Jude’s arguments based on the exclusivity of LPLA claims and an alleged failure to
satisfy federal pleading standards are necessarily related to the preemption question, the Court will reserve any ruling
on these issues until Mr. Doucet properly pleads a cognizable parallel claim.
Considering the applicable standard under a 12(b)(6) motion, the Court is required to
construe all factual allegations contained in the petition and draw all reasonable inferences in the
light most favorable to Mr. Doucet. Baker v. Putnal, 75 F.3d 190, 196 (5th Cir. 1996). As such,
the Court must presume at this time that Mr. Doucet’s LPLA claims arose on January 16, 2024––

the date he was informed of the recall as alleged. To be clear, Mr. Doucet’s claims may very indeed
well be prescribed, but the facts presented on the face of the petition are sufficient to entitle the
parties to discovery. Mr. Doucet notably had several post-operative discussions with his doctor
about the DRG Stimulator leading up to the purported complications. Without discovering the
content of these interactions, the Court finds that Abbott and St. Jude cannot present sufficient
evidence to foreclose Mr. Doucet’s claims as a matter of law. Chiasson, 2016 WL 4191837, at *6
(denying defendant’s prescription argument on a 12(b)(6) because “the accrual of a cause of action
and the reasonableness of delay in filing suit often hinge on the testimony of the plaintiff and his
or her doctor); see also Guidry v. Aventis Pharmaceuticals, Inc., 418 F. Supp. 2d 835 (M.D. La.
2006). However, after the parties have had an opportunity to discover such matters, Abbott and St.

Jude may re-raise their prescription argument.
IV. CONCLUSION
For the foregoing reasons;
IT IS HEREBY ORDERED that Abbott’s Motion to Dismiss for Lack of Personal
Jurisdiction, R. Doc. 11, is DENIED.
IT IS FURTHER ORDERED that Abbott and St. Jude’s Motion to Dismiss for Failure to
State a Claim, R. Doc. 9, is DENIED without prejudice. This Court will grant Mr. Doucet leave to
amend his petition as explained above. He will have 30 days from the issuance of this Order to file his
amended complaint. Failure to do so will result in the dismissal of his case.
New Orleans, Louisiana on this 29th day of May, 2025.

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/11062605. Public record. Not legal advice.