Celino v. Biotronik Inc

UNITED STATES DISTRICT COURT

EASTERN DISTRICT OF LOUISIANA

SAM CELINO SR., ET AL. CIVIL ACTION

VERSUS No. 20-2298

BIOTRONIK, INC. SECTION I

ORDER & REASONS

Barbara Celino (“Barbara”) passed away in 2019 following years of heart-

related medical issues.1 Barbara’s surviving spouse, Sam Celino, Sr., and the couple’s

three sons2 (collectively, the “Celinos”), brought this action individually and on behalf

of Barbara against Biotronik, Inc. (“Biotronik”), a medical device manufacturer. The

Celinos assert a claim under the Louisiana Products Liability Act (“LPLA”) and four

other claims under Louisiana law.3 Biotronik moves to dismiss these claims pursuant

to Federal Rule of Civil Procedure 12(b)(6).4 For the following reasons, the motion is

granted except as to the Celinos’ LPLA ‘design defect’ claim. As explained infra, the

Court will dismiss the motion without prejudice as to that claim only, allowing the

Celinos one final opportunity to amend their complaint.

1 R. Doc. No. 31, at 7 ¶ 10 (First Amended Complaint).

2 The three sons named in the amended complaint are Sam Celino, Jr., Christian

Celino and Colin Celino. Id. at 1 ¶ 1.

3 Id. at 3 ¶ 6. The Celinos have confirmed that they are pursuing only these claims.

R. Doc. No. 39, at 1–2 (the Celinos’ opposition to the instant motion).

4 R. Doc. No. 32-1, at 1 (Biotronik’s Motion to Dismiss).

I. BACKGROUND

According to the amended complaint,5 Barbara suffered from a medical

condition that affected her heart’s ability to properly pump blood.6 Barbara’s

physician, who is not identified in the amended complaint, told her that her condition

would necessitate an implantable electronic defibrillator to regulate her heartbeat.7

Barbara’s doctor recommended a defibrillator manufactured by Biotronik.8 That

5 The amended complaint summarized infra represents the Celinos’ second bite at the

apple. The Court previously dismissed a motion to dismiss, ordering the Celinos to

file an amended complaint that addressed the complaint’s deficiencies. R. Doc. No.

23; see Chiasson v. Medtronic Inc., No. 16-789, 2016 WL 4191837, at *4 (E.D. La. Aug.

9, 2016) (Fallon, J.) (noting the technical complexity of preemption cases, gathering

cases where courts granted leave to amend difficult-to-decipher complaints that failed

to adequately allege a parallel claim, and doing the same). This is not the first time

a Section of this Court has had to allow the Celinos’ counsel to amend a complaint

that contained “unnecessarily repetitive legally conclusive assertions.” Robertson v.

AstraZeneca Pharms., LP, No. 15-438, 2015 WL 5823326, at *1 (E.D. La. Oct. 6, 2015)

(Barbier, J.).

The Court has made every effort to glean the relevant allegations from the amended

complaint—and to address the Celinos’ arguments made in opposition to the motion.

But the Court’s efforts to do so have been hampered by the fact that both documents

are internally inconsistent and lack any meaningful structure. Consequently, despite

the fact that the Celinos are represented by counsel, the Court has been forced to

structure this opinion (and its analysis of the motion) by doing its best to understand

the arguments the Celinos were trying to raise, rather than responding to each

individual point made in their opposition.

The Court will not, however, construe the Celinos’ pleadings liberally, as it would for

a pro se party. They have retained counsel. It is counsel’s responsibility to advocate

for her clients.

6 R. Doc. No. 31, at 7 ¶ 10. For purposes of the instant motion, the Court accepts the

Celinos’ factual allegations as true, except as noted). See Ashcroft v. Iqbal, 556 U.S.

662, 678 (2009) (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)).

7 Id. at 7 ¶¶ 10–11.

8 Id. The device was a “Lumax 340 HF-T.” Id. at 7 ¶ 10.

device was a component in a system that included monitoring software and wires

(“leads”).9 Barbara underwent surgery to implant the device in 2008.10

At some point, “the battery depleted,” and the defibrillator began producing

“unnecessary shocks” that Barbara felt throughout her body.11 This necessitated a

second surgery in which Barbara received a replacement Biotronik defibrillator; that

surgery occurred on October 21, 2013.12

This second defibrillator, however, also experienced problems.13 One of “the

wires or lead14 [sic] had become disconnected and the other lead broke/fractured.”15

This “upon information and belief shortened the ICD device life,” necessitating

9 Id. at 5–7 ¶¶ 9–10.

10 Id. at 7 ¶ 10.

11 Id. at 9 ¶ 15.

12 Id. at 7 ¶ 10. This device was a “Lumax 740 HF-T.” Id.

13 Id. at 9 ¶ 15.

14 The Celinos identify these leads as the “Serox S53,” “Linox SD 65/16,” and “Corox

OTW-75-UP.” Id. at 7 ¶ 10.

15 Id. As explained infra, the Celinos make numerous allegations about ‘the lead’ that

are impossible to connect to any specific item.

further surgery.16 Barbara also “received bad service from Biotronik,” which the

Celinos allege compounded her suffering and constituted a breach of contract.17

Barbara had the second defibrillator replaced with another Lumax 740 HF-T

in April 2019.18 Sadly, Barbara passed away two months later.19 The Celinos allege

that “injuries from the defects and malfunctioning of the Biotronik ICD implanted in

her heart and chest . . . took a toll on [Barbara’s] body,” leading to her death “from

complications due to her complex surgery of having to have [the devices] replaced too

often.”20

The Celinos sued, asserting claims under the LPLA and the Louisiana Unfair

Trade Practices and Consumer Protection Act (“LUTPA”). They also assert

independent claims of “wrongful death,” “survival,” and breach of a service contract.21

16 Id. at 9 ¶ 15. While the relevant allegation’s structure makes it hard to follow, the

Celinos also appear to allege that one or both of these leads somehow “damaged

[Barbara’s] heart because the medical device was supposed to pump blood back into

her her heart Instead [sic] the blood was seeping from her heart; and blood was

accumulating[.]” Id. This statement appears disconnected from the rest of the

allegation (and, indeed, the rest of the amended complaint) which claims that

Barbara died because the second device had to be replaced early due to the

disconnected and fractured leads’ decreasing its life. Id.

The Celinos also allege that “the home monitoring system” associated with this

second device “did not work properly” in that it “never called into Biotronik like it

was supposed to” do when Barbara received “unnecessary shocks.” Id. This

allegation is also confusing, as the Celinos allege that the “first Biotronik ICD,” not

the second, unnecessarily shocked Barbara. Id.

17 Id. The Celinos do not describe the poor customer service, or how it deviated from

any contract.

18 Id. at 7 ¶ 10.

19 Id.

20 Id.

21 See R. Doc. No. 39, at 4–5.

Biotronik argues that the Celinos’ claims under the LPLA should be dismissed

because they (1) are preempted by federal law and (2) fail to comply with the

minimum pleading standards established by the Federal Rules of Civil Procedure.22

Biotronik also argues that the LPLA’s exclusivity provision subsumes the remaining

state-law claims.23

The Celinos contend that their claims are not preempted because the relevant

devices did not undergo the appropriate FDA approval process and, alternatively,

because the LPLA claims parallel federal law, nullifying preemption. They also argue

that, at a minimum, the service contract claim is not subsumed by the LPLA’s

exclusivity provision.

The Court notes that, while the Celinos have dropped their allegation that

“[t]he exact cause of the failure” of the devices “is not yet known or determined,”24 the

amended complaint still offers the Court no real sense of what the Celinos think

happened to Barbara. However, the Court reads the allegation that Barbara “died

from complications due to her complex surgery of having to have her Biotronik ICD

implants replaced too often which took a toll on her body for all these surgeries”25 to

imply that anything that went wrong with one of the devices necessitated one of the

surgeries, and that, without those surgeries, Barbara would not have died. But that

22 R. Doc. No. 32-1, at 11–21.

23 Id. at 21.

24 R. Doc. No. 1-1, at 3 ¶ 13.

25 R. Doc. No. 31, at 7 ¶ 10.

is an implication, not an allegation. And it is difficult to review a complaint that

offers no clear theory of what happened.

II. RULE 12(b)(6) STANDARD

Pursuant to Rule 12(b)(6), a district court may dismiss a complaint or part of

a complaint when a plaintiff fails to set forth well-pleaded factual allegations that

“raise a right to relief above the speculative level.” Twombly, 550 U.S. at 555; see

Cuvillier v. Taylor, 503 F.3d 397, 401 (5th Cir. 2007). The complaint “must contain

sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible

on its face.’” Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 570).26 A claim is

facially plausible “when the plaintiff pleads factual content that allows the court to

draw the reasonable inference that the defendant is liable for the misconduct

alleged.” Id. (citing Twombly, 550 U.S. at 570). If the well-pleaded factual

allegations “do not permit the court to infer more than the mere possibility of

misconduct,” then “the complaint has alleged—but it has not ‘show[n]’—’that the

pleader is entitled to relief.’” Id. at 679 (quoting Fed. R. Civ. Proc. 8(a)(2)) (alteration

in original).

In assessing the complaint, a court must accept all well-pleaded facts as true

and construe all factual allegations in the light most favorable to the plaintiff. Spivey

26 In their opposition, the Celinos argue that Iqbal “is not applicable and has nothing

to do with products liability nor medical devices, nor the FDA nor service contracts

and should not be considered” because it “is about a Pakistani detainee and is a

criminal case.” R. Doc. No. 39, at 23. Iqbal was, in fact, a civil case. See generally

556 U.S. 662 (addressing a Bivens action). And, according to Westlaw, it has been

cited favorably more than 239,850 times. If the Court is wrongly applying Iqbal, it

does so in good company.

v. Robertson, 197 F.3d 772, 774 (5th Cir. 1999); Gentilello v. Rege, 627 F.3d 540, 544

(5th Cir. 2010). However, courts “do not accept as true conclusory allegations,

unwarranted factual inferences, or legal conclusions.” Plotkin v. IP Axess Inc., 407

F.3d 690, 696 (5th Cir. 2005) (citing Southland Sec. Corp. v. INSpire Ins. Solutions,

Inc., 365 F.3d 353, 361 (5th Cir. 2004)). Furthermore, “the Court must typically limit

itself to the contents of the pleadings, including attachments thereto.” Admins. of

the Tulane Educ. Fund v. Biomeasure, Inc., No. 08-5096, 2011 WL 4352299, at *3

(E.D. La. Sept. 16, 2011) (Vance, J.) (citing Collins v. Morgan Stanley Dean Witter,

224 F.3d 496, 498 (5th Cir. 2000)). “Dismissal is appropriate when the complaint ‘on

its face show[s] a bar to relief.’” Cutrer v. McMillan, 308 F. App’x 819, 820 (5th Cir.

2009) (quoting Clark v. Amoco Prod. Co., 794 F.2d 967, 970 (5th Cir. 1986) (alteration

in original)).

III. LAW AND ANALYSIS

A. Louisiana Products Liability Act

Because the Court is sitting in diversity, it is bound by the substantive law of

Louisiana, the forum state. See Learmonth v. Sears, Roebuck & Co., 710 F.3d 249,

258 (5th Cir. 2013). The LPLA “establishes the exclusive theories of liability” under

Louisiana law against manufacturers “for damage caused by their products.” La.

Stat. § 9:2800.52. A product manufacturer is “liable to a claimant for damage

proximately caused by a characteristic of the product that renders the product

unreasonably dangerous when such damage arose from a reasonably anticipated use

of the product by the claimant or another person or entity.” Id. § 9:2800.54(A).

A product is unreasonably dangerous under the LPLA “if and only if” the

product is unreasonably dangerous (1) “in construction or composition,” (2) “in

design,” (3) because of an inadequate warning, or (4) because of nonconformity to an

express warranty. Id. § 2800.54(B). Consequently, the LPLA provides four recovery

theories: construction or composition defect (also known as manufacturing defect),

design defect, inadequate warning, and breach of express warranty. See id.

The Celinos pursue all four of these liability theories.

B. Preemption

The Supreme Court has set forth in detail the standard for federal preemption

of products liability claims based on medical devices covered by the Medical Devices

Amendments of 1976 (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”),

concluding that, in many cases, such claims are expressly preempted. See Riegel v.

Medtronic, Inc., 552 U.S. 312, 330 (2008); Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

Federal preemption is based in the Supremacy Clause of the United States

Constitution. It states: “This Constitution, and the Laws of the United States, which

shall be made in Pursuance thereof . . . shall be the supreme Law of the Land.” U.S.

Const. art. VI, § 2. Therefore, when a state law conflicts with a federal law, the

federal law preempts the state law and negates its effect. See Gade v. Nat’l Solid

Wastes Mgmt. Ass’n, 505 U.S. 88, 106–07 (1992). Federal preemption can be “either

express or implied.” Id. at 98. Express preemption occurs when a federal statute

directly conflicts with state law. See id. Implied preemption, however, arises where

“federal law so thoroughly occupies a legislative field ‘as to make reasonable the

inference that Congress left no room for the States to supplement it,’” Cipollone v.

Liggett Grp., Inc., 505 U.S. 504, 516 (1992) (quoting Fidelity Fed. Sav. & Loan Ass’n

v. de la Cuesta, 458 U.S. 141, 153 (1982)), “where ‘compliance with both federal and

state regulations is a physical impossibility,’” Gade, 505 U.S. at 98 (quoting Fl. Lime

& Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142–43 (1963)), “or where state law

‘stands as an obstacle to the accomplishment and execution of the full purposes and

objectives of Congress.’” Id. (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)).

Before 1976, states supervised the introduction of new medical devices as they

came to market. See Riegel, 552 U.S. at 315–16. But Congress eventually determined

that state supervision was insufficient to manage the risks posed by these devices, so

it enacted the MDA. See id. The MDA centralized the regulation of medical devices

by the U.S. Food and Drug Administration (“FDA”) and further “swept back some

state obligations.” Id.

Devices covered by the MDA are assigned one of three categories based on the

degree of potential risk associated with a given device. 21 U.S.C. § 360c. Class I

devices—those deemed the least ‘risky’—are subject to the least stringent

regulations. Riegel, 552 U.S. at 316 (citing 21 U.S.C. § 360c(a)(1)(A)). Class II devices

are subject to the same requirements as those assigned for Class I, as well as further

“‘special controls’ such as performance standards and postmarket surveillance

measures.” Id. at 316–17 (citing 21 U.S.C. § 360c(a)(1)(B)). Generally, “a device is

assigned to Class III if it cannot be established that a less stringent classification

would provide reasonable assurance of safety and effectiveness, and the device is

‘purported or represented to be for a use in supporting or sustaining human life or for

a use which is of substantial importance in preventing impairment of human health,’

or ‘presents a potential unreasonable risk of illness or injury.’” Id. at 317 (quoting 21

U.S.C. § 360c(a)(1)(C)). Class III devices are highly regulated and must undergo a

rigorous premarket approval process (“PMA process”) prior to release. See id. at 317–

18; Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 343–45 (2001). However,

this process is not required if the application is submitted under § 510(k). See Bass

v. Stryker Corp., 669 F.3d 501, 506–07 (5th Cir. 2012).27

PMA requires that manufacturers provide the FDA with “reasonable

assurance” their devices are both safe and effective. See 21 U.S.C. § 360e(c)(1)(A).

The FDA expends around 1,200 hours reviewing a typical application. See Riegel,

552 U.S. at 318 (citing Lohr, 518 U.S. at 477). Once a Class III device receives PMA,

its manufacturer is forbidden from making any changes to the design specifications,

manufacturing process, labeling, or any other attribute that would affect the

product’s safety or effectiveness, absent supplemental FDA approval. See id. at 319.

Supplemental review is evaluated under largely the same criteria as the initial

application—distinguishing it from the § 310(k) process discussed supra. See Bass,

669 F.3d at 508.

i. Express Preemption

27 When considering a § 510(k) application, the FDA asks whether a product is

“substantially equivalent” to one that has already been approved. Id. (citing Riegel,

552 U.S. at 317).

To help the FDA maintain regulatory authority over medical devices, Congress

explicitly preempted state oversight by enacting 21 U.S.C. § 360k(a).28 This MDA

provision expressly preempts state-law tort claims for injury caused by a medical

device if “(1) ‘the Federal Government has established requirements applicable to [the

device]’; and (2) the claims are based on state-law requirements that are ‘different

from, or in addition to, the federal ones, and that relate to safety and effectiveness.’”

Bass, 669 F.3d at 507 (quoting Riegel, 552 U.S. at 321–22) (alteration in original,

internal quotation omitted). The Supreme Court has concluded that Class III devices

that undergo the PMA process satisfy the first prong of this analysis because the FDA

requires them “to be made with almost no deviations from the specifications in [the

relevant] approval application,” because it has “determined that the approved form

provides a reasonable assurance of safety and effectiveness.” Riegel, 552 U.S. at 323.

This distinguishes them from Class III products that undergo the § 510(k) process;

those do not get the benefit of preemption because that process “does not impose

federal requirements on a device.” Bass, 669 F.3d at 507 (citing Lohr, 518 U.S. at

493–94).

28 The statute provides, excluding a reference to an exception not relevant here, that:

[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).

Under certain circumstances, though, problems with devices that satisfy the

first prong of the inquiry may still form the basis of a products liability claim. When

a manufacturer of such a device violates FDA regulations, a plaintiff may recover

under state law tort theories provided that those theories “parallel” the federal

violation. Riegel, 552 U.S. at 330. For a claim to be parallel, the state-law duty must

not create any requirements that are different from or greater than the FDA

requirements. See id. “Essentially, in a parallel claim, relief is sought under state

law alleging that certain conduct of the defendant resulted in a breach of a state duty,

that this conduct also resulted in a breach of an FDA-imposed federal regulation, and

that certain damages resulted from this breach.” Chiasson, 2016 WL 4191837, at *4.

“If the Plaintiff fails to properly plead her parallel claim, that is, she pleads a violation

of a state law that imposes different or additional regulations . . . her claim will be

preempted.” Id.

This parallel claim exception to express MDA preemption is narrow, and it is

only one part of the inquiry. See id.; see also Bush v. Thoratec Corp., 837 F. Supp. 2d

603, 608 (E.D. La. 2011) (Fallon, J.) (describing the act of pleading a viable parallel

claim as “threading the needle”). Even if a claim is not expressly preempted by the

MDA, it may still be impliedly preempted under Buckman. 531 U.S. at 352–53.

ii. Implied Preemption

As mentioned, state-law claims not expressly preempted by the MDA are still

impliedly preempted if they “exist solely by virtue” of FDA regulations. Buckman,

531 U.S. at 352–53; see, e.g., In re Taxotere (Docetaxel) Products Liability Litigation,

No. 162740, 2021 WL 1295087, at *2 (E.D. La. Apr. 7, 2021) (Milazzo, J.) (concluding

that a Michigan statute allowing for manufacturer liability in situations where

defendants “[i]ntentionally withhold[] . . . or misrepresent[]” information from the

FDA was preempted under Buckman). Congress granted the FDA the sole authority

to enforce violations of the MDA. See Buckman, 531 U.S. at 347–51. Because the

federal government retains this exclusive authority, private litigants do not have the

ability to sue for noncompliance based solely on FDA regulations. Id. at 353. Put

another way, state law cannot give a plaintiff a right of action to enforce the MDA.

See id. Such claims “exist[] solely by virtue” of the FDA’s requirements, and private

litigants cannot step into a regulatory role explicitly given to the federal government.

Id. at 348–51. Because the FDA has the lone authority to police, deter, and punish

fraud, a private litigant’s enforcement of fraudulent conduct would impede the FDA’s

ability to police such fraud. See id. at 350–51.

But Buckman does not preempt claims of a violation of an independent state-

law duty, nor does it prevent plaintiffs from supporting such claims with evidence

“that [a defendant manufacturer] violated the FDA’s . . . regulations [for medical

devices].” Hughes v. Bos. Sci. Corp., 631 F.3d 762, 775 (5th Cir. 2011) (comparing

Buckman with Lohr and other cases where courts had not applied preemption); see

also Bass, 669 F.3d at 514 (discussing Hughes). For example, a state-law failure to

warn claim based on a manufacturer’s failure to comply with FDA reporting

regulations is not inherently preempted. See Hughes, 631 F.3d at 775.

But such claims are still, of course, vulnerable to express preemption under

the MDA, as articulated in Riegel. See, e.g., id. at 769 (acknowledging that “such a

claim is preempted . . . to the extent that it purports to impose liability despite [a

manufacturer’s] compliance with FDA regulations”). This means that, functionally,

claims asserted regarding relevant devices must “fit through [a] narrow gap available

between both express and implied preemption.” Gavin v. Medtronic, Inc., No. 12-851,

2013 WL 3791612, at *5 (E.D. La. July 19, 2013) (Brown, J.). To do so, the claim

“must allege that a well-recognized duty owed under state law was breached by a

manufacturer’s conduct that violates” FDA regulations. Id. In other words, the

plaintiff must identify a federal requirement and show that the manufacturer did not

comply with that federal requirement. See, e.g., Funk v. Stryker Corp., 631 F.3d 777,

782 (5th Cir. 2011). But they must also show that the violative conduct “would give

rise to a recovery under state law even in the absence of [the relevant FDA

regulations].” Gavin, 2013 WL 3791612, at *5 (quoting Caplinger v. Medtronic, Inc.,

921 F. Supp. 2d 1206, 1215 (W.D. Okla. 2013)) (emphasis added).

The Fifth Circuit has also concluded that a plaintiff must do this in a manner

that “meet[s] the Twombly plausibility standard.” Bass, 669 F.3d at 509. And, of

course, the state-law claims themselves must satisfy that same standard. See Funk,

631 F.3d at 782 (applying Iqbal and rejecting a manufacturing defect claim for failure

to “specify a causal connection between the failure of the specific manufacturing

process and the specific defect in the process that caused the personal injury [and to

describe] . . . how the manufacturing process failed [and] how it deviated from the

FDA approved manufacturing process”). Put another way, both the state law claim

itself and the reasons it survives preemption must satisfy Twombly and Iqbal. See

id. As explained below, the Celinos’ LPLA claims do not do so.

C. The relevant products29 underwent the PMA process, satisfying the

first prong of Riegel.

29 The Celinos’ opposition purports to “narrow down” the scope of the lawsuit “before

discovery,” explaining that “the two (2) Biotronik leads are the problem.” R. Doc. No.

39, at 2. It adds that “[t]he other defective product was the home monitoring system

which is not a Class III device thus, all of defendant’s preemption arguments are moot

with respect to the home monitoring system that did not work or function properly.”

Id. The Court takes this as an indication that the Celinos are only pursuing their

claims with regards to those three products.

Confusingly, though, the statement regarding the monitoring system directly

contradicts the amended complaint, which describes the “Biotronik Patient Home

Monitoring and software” as a “Biotronik FDA Class 3 Medical Device[] in violation

of FDA laws,” R. Doc. No. 31, at 14 ¶ 20, because “[u]pon information and belief the

product failed due to problems and glitches in the software, technical failures in the

software, technical failures by Biotronik with wireless connectivity, including but not

limited to the internet being down or out.” Id. at 16 ¶ 22. The amended complaint

alleges that this violated “21 U.S.C.A § 360c(a)(1)(A).” Id. at 14 ¶ 20. As an aside,

the Court notes that that provision generally defines Class I devices. That seems

irrelevant here—and even if it were not, the provision offers little for Biotronik to

“violate.”

Regardless, the Court will not allow the Celinos to make allegations that directly

contradict their amended complaint—and for the first time in an opposition

memorandum, no less. See Pellegrin v. C.R. Bard, No. 17-12473, 2018 WL 3046570,

at *1 (E.D. La. June 20, 2018) (Vance, J.) (confronting a similar issue in a medical

device case and noting “that it is ‘inappropriate to raise new facts and assert new

claims in an opposition to a motion to dismiss’” (quoting Goodwin v. Hous. Auth. of

New Orleans, No. 11-1397, 2013 WL 3874907, at *9 n.37 (E.D. La. July 23, 2013)

(Morgan, J.)). And, even if it was inclined to do so, leave to amend on this point would

be futile, as the FDA records of which the Court has taken judicial notice indicate

that the home monitoring system software was treated as a Class III device and did

receive both an initial and a supplemental approval from the FDA. See R. Doc. No.

41-6, at 1.

In reviewing the instant motion, then, the Court will assume that the Celinos’

allegations are limited to the leads.

The Celinos contend that their LPLA claims are not subject to express

preemption because the leads did not undergo the PMA process or, in the alternative,

because it is unclear whether the devices in fact underwent that process.

For its part, Biotronik has introduced FDA records indicating that each device

at issue—including the leads—has received premarket approval and/or supplemental

premarket approval—not § 510(k) approval.30 It asks that the Court take judicial

notice of the records.31 Notably, the Celinos have not challenged the legitimacy of

these documents.

Although a court’s review of a Rule 12(b)(6) motion to dismiss is typically

limited to the complaint, a court may also take judicial notice of certain matters,

including “publicly-available documents . . . produced by the FDA.” Funk, 631 F.3d

at 783. And the Fifth Circuit has held that “the determination of whether [a given

Class III device] was subject to the PMA process is a question of law” and that

allegations regarding whether a device underwent the PMA process or did not are

“legal conclusion[s] that [a] district court [is] not required to accept as true.” Bass,

669 F.3d at 507–08.

The Celinos’ argument regarding the devices and their approval process is

inconsistent and conflates the PMA/supplemental approval process with the § 510(k)

process. At bottom, though, the Celinos appear to be arguing they are unsure of

whether the devices underwent PMA approval—and that the Court should deny the

30 See R. Doc. No. 41, at 3; R. Doc. Nos. 41-1, 41-2, 41-3, 41-4, 41-5, 41-6 (each

indicating that the relevant device was not granted expedited review).

31 R. Doc. No. 41, at 3 n.1.

motion to dismiss and allow discovery on the issue.32 The Court does not see why it

should do so, when the FDA records—unchallenged evidence of which the Court can

take judicial notice—make it clear that the devices were approved under the

PMA/supplemental approval regime, not § 510(k).

For that reason, the Court takes judicial notice of the fact that the leads (and

other devices, for that matter) underwent the PMA/supplemental approval process.

Consequently, the first requirement in the Riegel express preemption analysis is

satisfied. 552 U.S. at 323.

D. Each of the Celinos’ LPLA claims is either preempted or

insufficiently alleged to state a claim.

The Court must determine (1) whether a finding of liability on any of the

Celinos’ LPLA theories would impose requirements that are different from or add to

those established by the MDA, satisfying the second prong of Riegel and rendering

them preempted and (2) if not, whether the allegations are sufficient to state a claim

under LPLA. See id. The Court notes that, “[b]ecause of the potential for preemption,

courts [in the Fifth Circuit] have required . . . specificity in pleading parallel claims.”

Chiasson, 2016 WL 4191837, at *4 (citing Funk, 631 F.3d at 782). With that in mind,

the Court will address each of the claims in turn.

i. Defective Construction or Composition

The Celinos first allege that the Biotronik defibrillator system and leads were

unreasonably dangerous in construction or composition (i.e., that Barbara’s death

32 R. Doc. No. 39, at 23–24.

was the result of manufacturing defects).33 The Court concludes that the Celinos’

failure to adequately allege a causal link between violations of FDA manufacturing

regulations that support a LPLA manufacturing defect claim and Barbara’s death

prevents a finding that the claim is parallel. The Court also concludes that, even if

the claim was parallel, it does not meet the minimum pleading requirements under

the LPLA. For either reason, the claim fails.

Under the LPLA, a plaintiff can prove a manufacturing defect if, “at the time

the product left [the] manufacturer’s control, the product deviated in a material way

from the manufacturer’s specifications or performance standards for the product or

from otherwise identical products manufactured by the same manufacturer.” La.

Stat. § 9:2800.55. “This is a narrow and demanding test” because the plaintiff must

show “that the particular product used by the [relevant individual] deviated from its

intended design.” Guidry v. Janssen Pharms., 206 F. Supp. 3d 1187, 1197–98 (E.D.

La. 2016) (Feldman, J.) (emphasis in original). In other words, the plaintiff must

show “what a manufacturer’s specifications or performance standards are for a

particular product” and “how the product in question materially deviated from those

standards so as to render it unreasonably dangerous.” Lyles v. Medtronic Sofamor

Danek, USA, Inc., 871 F.3d 305, 311 (5th Cir. 2017) (quoting Morris v. United Servs.

Auto. Ass’n, 756 So. 2d 549, 558 (La. App. 2 Cir. 2000)). Plaintiffs “must also show

that the alleged defect was the cause-in-fact of [the] injury, as well as the ‘most

probable cause.’” Rhodes v. Covidien LP, No. 18-10667, 2019 WL 2162845, at *3

33 R. Doc. No. 31, at 18 ¶ 30.

(Vance, J.) (quoting Wheat v. Pfizer, Inc., 31 F.3d 340, 342 (5th Cir. 1994)).

Allegations that “merely recite[] the elements” of a claim are inadequate. Aucoin v.

Amneal Pharms., LLC, No. 11-1275, 2012 WL 2990697, at *10 (E.D. La. July 20, 2012)

(Brown, J.).

A successful parallel claim under a manufacturing defect theory requires a

plaintiff to allege a violation of a state-law duty that is parallel to a federal

requirement regarding the manufacturing process. See Rodriguez v. Am. Med. Sys.,

Inc., 597 F. App’x 226, 229–30 (5th Cir. 2014). The plaintiff must explain “how the

manufacturing process failed, or how it deviated from the FDA approved

manufacturing process,” and explain the “causal connection between the failure of

the specific manufacturing process and the specific defect in the process that caused

the personal injury.” Funk, 631 F.3d at 782. Bass v. Stryker Corp, 669 F.3d 501, a

Fifth Circuit case finding an adequately alleged parallel claim, is instructive.

Bass addressed a claim that an FDA-approved Class III hip

implant malfunctioned because of impurities in the manufacturing process.

[The Fifth Circuit] held that the plaintiff did state parallel claims where the

complaint specified which FDA regulations were violated in the manufacturing

process, alleged that the manufacturer had received a warning letter from the

FDA regarding the manufacturing defect, and eventually recalled the implant

due to the defect.

Rodriguez, 597 F. App’x at 230 (discussing Bass, 669 F.3d at 510) (citations omitted).

In Funk v. Stryker Corp., however, the Fifth Circuit “addressed a similar claim

regarding the same hip implant but held that the plaintiff’s pleadings were too

conclusory to state a parallel claim.” Id. (discussing Funk, 631 F.3d at 782). It noted

“that Funk’s complaint did not specify the manufacturing defect, did not specify a

causal connection between a failure of the manufacturing process and a specific defect

in the process that caused the personal injury, and did not specify how the process

deviated from the FDA approved manufacturing process.” Id. (discussing Funk, 631

F.3d at 782).

The Celinos offer a laundry list of regulations that Biotronik allegedly

violated.34 But, as Biotronik notes, the majority of these allegations are little more

than “passing reference[s]” and, crucially, do not explain “how any alleged violations

. . . are parallel to the state-law claims at issue here.”35 As explained supra, a viable

parallel manufacturing defect claim would explain what violation occurred, what

state-law claim is parallel to that violation, and how the violation caused the injury.

See Bass, 669 F.3d at 510; Rodriguez, 597 F. App’x at 230; Funk, 631 F.3d at 782.

The vast majority of the Celinos’ claims do little more than identify a regulation and

allege that Biotronik violated it. While this may be a “skeletal requirement[] for a

cognizable parallel claim under the LPLA,” it is not “sufficient[ly] specific[] for this

Court to accurately determine whether a successful[] parallel claim may exist.”

Chiasson, 2016 WL 4191837, at *4; see Funk, 631 F.3d at 782 (describing as

“impermissibly conclusory and vague” an allegation that a “hip [prosthesis] contained

a manufacturing defect in that it was manufactured in such a manner that

impurities, residues and bacteria remained on the prosthesis in violation of the FDA

standards and requirements and in violation of the manufacturing processes and

34 See, e.g., R. Doc. No. 31, at 10–12 ¶ 17.

35 R. Doc. No. 32, at 2.

design approved by the FDA”). This amended complaint falls far short of the level of

detail (and clarity) offered in Bass.

The closest the Celinos come is an allegation that “[u]pon information and

belief, Biotronik did not manufacture [Barbara’s] purchased ICD and lead in

accordance with FDA standards where the lead is not to produce more than 1KV/50A

peak output . . . . Plaintiffs believe the Biotronik ICD and lead exceed this output

causing the device to break, fall apart, malfunction, oversensing, over shocking and

depleting the battery and damaging the lead.”36

While the Celinos fail to identify the violated regulations, this is still a fairly

specific allegation; the Court can reasonably conclude the Celinos are arguing that

the lead produced too much power,37 in violation of an FDA regulation. This

argument—that the leads caused the battery to fail—seems irrelevant in light of the

Celinos’ statement in their opposition that their claim extends only to the leads. Still,

the Court might see the argument that this “damage[ed] the lead” as tied to the

Celinos’ allegation that “[t]he lead implanted in Barbara . . . malfunctioned and failed

and ‘fractured’ and the other became disconnected.”38 But see Scianneaux v. St. Jude

Medical S.C., Inc., 961 F. Supp. 2d 808, 813 (E.D. La. 2013) (Vance, J.) (rejecting an

36 R. Doc. No. 31, at 11 ¶ 17. There are other references to FDA regulations regarding

leads, but they are far too vague to be helpful. See, e.g., id. at 12 ¶ 17 (arguing that

Biotronik violated an FDA regulation requiring leads to be compliant with a

particular industry standard but offering no description of the relevant standard or

how it was violated).

37 While the Court is unsure as to how this allegation is consistent with the Celinos’

description of the leads as “steroid releasing,” id. at 6 ¶ 9, it accepts the allegation as

true in reviewing this motion.

38 Id. at 6 ¶ 9.

allegation that “the leads failed” as conclusory). And, while ‘the leads failed’ is

arguably inadequate, it is more substantive than anything else the Celinos offer that

is tied to a violation of an FDA regulation.

But Barbara had three devices installed, each with different leads.39 The

Celinos allege that only one was manufactured in violation of the unnamed FDA

regulation. Which was it? The Celinos do not say.40

And, even if the Court were to ignore that issue, it would still need to identify

a Twiqbal-compliant allegation that this violation is also a violation of LPLA. See,

e.g., id. (“[I]n addition to pleading a violation of FDA regulations, a plaintiff must

plead facts in support of each element of a claim under the LPLA.”). As explained, in

order to state a manufacturing defect claim under the LPLA, the Celinos would need

to identify “[Biotronik’s] specifications or performance standards” for the lead and

explain how the lead “materially deviated from those standards so as to render it

unreasonably dangerous.” Lyles, 871 F.3d at 311 (quotation omitted). On that front,

the Celinos allege (1) “upon information and believes [sic] . . . the . . . leads . . . had a

non-conforming materials [sic] or the parts were either defective in design, process,

constructed improperly and composition,”41 (2) “[u]pon information and belief,

Biotronik has a history of violating FDA laws in manufacturing by using

39 Id. (identifying leads named Setrox, Linox SD, and Corox OTW 75-Up Steroid).

40 The Court suspects they are describing a lead associated with the second installed

device, as an earlier allegation regarding that device mentions that “one of the wires

or lead, had become disconnected and the other lead broke/fractured.” Id. at 9 ¶ 15.

How that relates to power output, the Celinos do not say.

41 Id. at 14 ¶ 20.

Nonconforming material in its Lumax ICDs,”42 (3) “[a]t the time, the products left

Biotronik’s control, the product [sic] deviated in a material way from FDA standards,

specifications, laws and regulations,”43 (4) “[u]pon information and belief, an example

of the Biotronik Lumax ICD system, lead . . . defect can be found in a sampling of the

numerous FDA supplements,”44 (5) “[u]pon information and belief, the Biotronik

products are unreasonably dangerous in construction or composition because their

manufacturing standards are substandard and do not comply with manufacturing

standards of medical devices and component parts as required by the FDA; upon

information and belief the Biotronik products are adulterated,”45 and (6) “[t]he

product was unreasonably dangerous when it left the control of the manufacturer and

did not conform to FDA standard [sic] nor standards of safety under Louisiana law

nor the standard for manufacturing standard and specifications.”46

The amended complaint is, to say the least, “light on factual allegations and

heavy on conclusory statements;” these allegations are far too conclusory to be of any

help. Scianneaux, 961 F. Supp. 2d at 813. Certainly, none can be said to do more

than state the elements of the claim, which is insufficient. Aucoin, 2012 WL 2990697,

at *10. But the Court does not think the allegations go even that far, because they

lack any reference to the Biotronik standard that whichever lead the Celinos are

referencing failed to meet. That is a key component of a manufacturing defect (as

42 Id. at 15 ¶ 21 (emphasis omitted).

43 Id. at 17 ¶ 24.

44 Id. at 17 ¶ 26.

45 Id. at 18 ¶ 30.

46 Id. at 22 ¶ 43.

opposed to design defect, addressed infra) claim. Without it, parallel or not, the

Celinos’ manufacturing defect claim fails. And so it does.

The Celinos’ opposition also offers only conclusory argument suggesting that

the elements of a manufacturing defect claim are adequately alleged.47 Indeed, the

opposition comes close to acknowledging the claim’s deficiency, explaining the Celinos

are “making claims under all theories of recovery under the [LPLA] since discovery

has not commenced.”48 The Celinos emphasize that “[t]he case is at the pleading

stage, not the actual trial.”49

The opposition does purport to identify the particular leads that failed,

explaining that “Barbara[’s] Sprint Quattro leads broke.”50 But this statement makes

little sense, as the Celinos do not allege that Sprint Quattro leads were ever

implanted in Barbara—and FDA records confirm that the Sprint Quattro is not a

Biotronik product.51 And, even if it were the right product, the Celinos have not

alleged that it deviated from Biotronik’s specifications and standards.

47 See, e.g., R. Doc. No. 39, at 5–6 (“The facts stated in Celino’s [sic] petition are not

speculative . . . there is no speculation here; its facts. Proof of the facts is there.”).

48 Id. at 13.

49 Id. at 7.

50 Id. at 14.

51 See U.S. Food & Drug Admin., Premarket Approval (PMA)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?start_search=1&

sortcolumn=do_desc&PAGENUM=500&pmanumber=P920015 (last visited April 28,

2021).

The Court suspects that counsel may have incorrectly altered opposition from one of

the lawsuits she has recently filed against the manufacturer of that device, a different

medical device company. See, e.g., Reddick v. Medtronic, Inc., No. 18-8568, 2021 WL

798294, at *1 (E.D. La. Mar. 2, 2021) (Morgan, J.) (raising allegations about the

“Sprint Quattro Secure Lead”). This “undermine[s] the credibility of . . . counsel, who

Ultimately, the Celinos’ manufacturing defect claim is preempted and fails to

state a claim under the LPLA because it fails to allege a way in which the leads (or

any other Biotronik product) both violated FDA regulations and deviated from

Biotronik’s specifications and standards in a manner that was the proximate cause

of Barbara’s death. The Celinos have already been given leave to amend once.

Therefore, the claim will be dismissed with prejudice.

ii. Defective Design

The Celinos also allege the leads were unreasonably dangerous in design.52

They argue that this claim is not preempted despite the FDA’s approval of the devices

because, “upon information and belief,” Biotronik committed fraud during the PMA

process, meaning that the FDA never approved the actual design of the products.53

It is true that Buckman does not prevent plaintiffs from using a ‘fraud against

the FDA’ theory to support an independent state-law claim—only from using it as

independent grounds for a claim. See, e.g., Hughes, 631 F.3d at 775–76. But,

pursuant to Federal Rule of Civil Procedure 9(b), allegations of fraud must be made

with particularity, even when they are made in support of a claim. The parties have

not addressed whether that standard should apply to arguments that a stand-alone

claim is not preempted ‘because’ of a fraud, which appears to be the Celinos’ argument

as to their design defect claim. See Naquin v. Medtronic, No. 20-2401, 2020 WL

is obligated under Rule 11 not to file a pleading containing factual assertions that do

not have evidentiary support or will not have such support after discovery.” Pellegrin,

2018 WL 3046570, at *1.

52 R. Doc. No. 31, at 18 ¶ 31.

53 Id. at 10 ¶ 17.

7060150, at *6 (E.D. La. Dec. 2, 2020) (Ashe, J.) (rejecting as conclusory an allegation

that a similar claim was not preempted because the manufacturer had “not been

truthful about the products that are the subject of this litigations [sic]”).

But the Court need not decide that issue today because, assuming the Celinos’

design defect claim is not preempted, it still falls short of even the relaxed standard

courts sometimes employ to review the sufficiency of LPLA design defect claims.

To prove a design defect claim under the LPLA, the Celinos must show that:

“(1) [t]here existed an alternative design for the product that was capable of

preventing [Barbara’s] damage; and (2) [t]he likelihood that the product’s design

would cause [Barbara’s] damage and the gravity of that damage outweighed the

burden on [Biotronik] of adopting [the] alternative design and the adverse effect, if

any, of such alternative design on the utility of the product.” Johnson v. Teva

Pharms. USA, Inc., 758 F.3d 605, 612 (5th Cir. 2014) (quoting La. Stat. § 9:2800.56).

“The occurrence of an injury does not give rise to the presumption that the design

was unreasonably dangerous.” Fuller v. Eisai, Inc., No. 20-1675, ___ F. Supp. 3d ___,

2021 WL 149122, at *4 (E.D. La. Jan. 15, 2021) (Africk, J.) (quoting Rivers v.

Remington Arms Co., No. 17-17124, 2018 WL 746392, at *4 (E.D. La. Feb. 7, 2018)

(Africk, J.)). Similarly, “[a] conclusory allegation that an alternate design exists will

not suffice.” Rivers, 2018 WL 746392, at *4 (quoting Robertson, 2015 WL 5823326,

at *4).

“However, at least in the context of pharmaceutical [design defect] claims,

courts do not require that plaintiffs ‘plead extremely “detailed factual allegations”’ to

survive a motion to dismiss.” Fuller, 2021 WL 149122, at *5 (quoting Flagg v. Stryker

Corp., 647 F. App’x 314, 317 (5th Cir. 2016) (quoting Iqbal, 556 U.S. at 678)). All that

is needed to satisfy Twombly’s plausibility standard are allegations sufficient “‘to

raise a reasonable expectation that discovery will reveal evidence of’ the necessary

claims or elements.” Flagg, 617 F. App’x at 317 (quoting In re S. Scrap Material Co.,

LLC, 541 F.3d 584, 587 (5th Cir. 2008)).

Nonetheless, some allegation is required, even after Flagg. See, e.g., Lewis v.

Baxter Int’l Inc., No. 16-16391, 2017 WL 661324, at *4 (E.D. La. Feb. 17, 2017)

(Fallon, J.) (concluding that, even in light of the difficulties posed by pre-discovery

dispositive motions in products liability cases, “conclusory allegations” of a design

defect were insufficient); Pellegrin, 2018 WL 3046570, at *5 (similar); see generally

Flagg, 617 F. App’x at 318 (explaining that this relaxed application of Twombly and

Iqbal does not allow “fishing expedition[s]” to proceed to “lengthy and expensive

discovery”). Flagg does not require courts to accept wholly conclusory allegations.

See, e.g., Dubroc v. Bristol-Meyers Squibb, No. 18-833, 2019 WL 3756469, at *4 (M.D.

La. Aug. 8, 2019) (rejecting the notion that Flagg renders conclusory allegations

sufficient). For example, allegations that “there existed an alternative design for the

product that was capable of preventing Plaintiff’s damages with use of other

materials that did not ‘bleed,’” have been found insufficient. Id.

The Celinos repeatedly allege that various Biotronik devices were “defective,”

including at least one lead.54 They explain that “the leads were defective [sic]

54 See, e.g., R. Doc. No. 31, at 4 ¶ 8.

Biotronik did not manufacture the lead in accordance with [sic] FDA’s manufacturing

standards and due to upon [sic] information and belief, Biotronik used defective

materials, defective design, defective construction, and defective software.”55 They

also “alleges [sic] the [sic] upon information and believes [sic] the . . . leads . . . were .

. . defective in design.”56 Finally, they add that “[t]he Biotronik products are

unreasonably dangerous in design because for [sic] the same reasons previously

stated in the previous paragraph and the petition.57 The defective designs include,

defective process designs, defective medical device design . . . and defective software

design, all in violation and in non-conforming [sic] of FDA laws.”58

Those are all conclusory statements, to say the least. But even if they were

not, the Celinos would still fail to state a design defect claim. The only allegation

contained in the amended complaint that even touches upon the elements of a LPLA

design defect claim states, without identifying any particular Biotronik product, that

“[a]lternatives in construction, design, composition, and products existed at he [sic]

time that could have prevented the damage,” and that “[t]he likelihood that

Biotronik’s design and the construction and composition would cause damage and the

gravity of the damage outweighs the burden on the manufacturer to use a different

design, constructor, [sic] or material in composition.”59 At best, this merely recites

55 Id. at 6 ¶ 9.

56 Id. at 14 ¶ 20. See also id. at 17 ¶ 25 (“Upon information and belief, Biotronik’s . .

. lead . . . [was] defective in design[.]”).

57 The Court does not know what those reasons are.

58 Id. at 18 ¶ 31.

59 Id. at 22 ¶ 43.

some of the elements of a LPLA design defect claim—and fails to point to an

alternative design. “Even under the seemingly less rigorous approach to products

liability cases . . . set forth in Flagg, [the Celinos have] still failed to state a claim.”

Dubroc, 2019 WL 3756469, at *4.

The Court has already provided the Celinos one chance to amend their

complaint. And the Celinos are represented by counsel. Under most circumstances,

the Court would be inclined to dismiss this claim with prejudice.

However, in light of Flagg, and out of an abundance of caution, the Court will

allow the Celinos one more opportunity to amend this claim. If they fail to do so

adequately, the claim will be dismissed with prejudice.

iii. Inadequate Warning

The Celinos further contend the Biotronik devices are unreasonably dangerous

because “an adequate warning about the products has not been provided concerning

the numerous problems, and malfunctions of these products and their component

parts in violation of the FDA laws.”60 The Court need not evaluate whether the claim

is preempted because it falls woefully short of the requirements to state such a claim

under the LPLA.

“To successfully maintain a failure-to-warn claim under the LPLA, a plaintiff

must demonstrate that the product in question has a potentially damage-causing

characteristic and that the manufacturer failed to use reasonable care to provide an

adequate warning about this characteristic.” Stahl v. Novartis Pharms. Corp., 283

60 Id. at 19 ¶ 32.

F.3d 254, 264 (5th Cir. 2002) (citing Grenier v. Med. Eng’g Corp., 243 F.3d 200, 205

(5th Cir. 2001)).

Louisiana applies the learned intermediary doctrine to medical devices. Willett

v. Baxter Int’l, Inc., 929 F.2d 1094, 1098–99 (5th Cir. 1991). Under that doctrine, a

manufacturer’s obligation to consumers is “fulfilled when the . . . treating physician

is informed of any potential side effects or risks from the [device’s] use so that they

may intelligently decide on its use and advise the patient.” Stahl, 283 F.3d at 267

(quoting McCarthy v. Danek Med., Inc., 65 F. Supp. 2d 410, 413 (E.D. La. 1999)

(Lemelle, J.)). “The premise underlying a failure-to-warn claim in the learned

intermediary context is that the patient is claiming that the manufacturer failed to

adequately warn the treating physician.” Id. at 268 (emphasis retained).

In such circumstances, a medical device may be unreasonably dangerous

because of an inadequate warning if: (1) the defendant failed to warn the plaintiff’s

doctor of a risk associated with the product that was otherwise unknown to the doctor;

and (2) the failure to warn the doctor was both a cause in fact and the proximate

cause of the plaintiff’s injury. Willett, 929 F.2d at 1098. To prove causation, the

plaintiff must show that “a proper warning would have changed the decision of the

treating physician, i.e. that but for the inadequate warning, the treating physician

would not have used . . . the product.” Id. at 1099.

The Celinos allege Biotronik failed to warn Barbara’s doctors “regarding the

unreasonably dangerous and defective products that were implanted and used in the

care and treatment of Barbara Celino, pertaining to the products listed above, subject

to the litigation.”61 They also claim “[t]he labels Biotronik presented to FDA [sic] for

approval by FDA [sic] were not truthful and were misleading.”62

Biotronik argues that this claim must be dismissed because, among other

reasons, the Celinos fail to “allege that, but for the allegedly inadequate warning,

[Barbara’s] doctor would not have used the” Biotronik products—an allegation

required by the learned intermidiary doctrine.63 The Celinos offer the following

response, which the Court reproduces in full:

Defendant’s cite of Stahl, 283 F.3d at 265 pertaining to the Learned

intermediary doctrine does not apply because Biotronik has

documentation and brochures and warranties that state Biotroniks [sic]

products are free of manufacturing defects and Biotronik has stated the

products [sic] life are for [sic] much longer than they actually are.

Biotronik’s medical devices break and malfunction on an ongoing basis.

Biotronik has also provided Biotronik information and advertisements

and brochures that their products have a zero malfunction rate.64

That, as far as the Court can tell, does not address Biotronik’s argument. And

the Celinos’ failure to allege that Barbara’s doctors would not have used the relevant

Biotronik devices had they been properly warned is, in fact, fatal to their claim—as

even Flagg acknowledged. 647 F. App’x at 316, 316 n.3 (citing Stahl, 283 F.3d at 268,

and concluding that the district court “properly dismissed” plaintiff’s failure-to-warn

claim where he “failed to include any allegations about . . . whether [the treating

physician] would have used the [relevant products] if given . . . [an adequate]

61 Id. at 19–20 ¶ 36.

62 Id. at 19 ¶ 32.

63 R. Doc. No. 32-1, at 19.

64 R. Doc. No. 39, at 24–25.

warning, as required under Louisiana law”). The failure-to-warn claim will therefore

be dismissed with prejudice.

iv. Breach of Express Warranty

The Celinos also bring a LPLA claim for breach of an express warranty against

Biotronik.65 To succeed using this theory, a plaintiff must show “(1) the manufacturer

made an express warranty regarding the product, (2) the [decedent] was induced to

use the product because of that warranty, (3) the product failed to conform to that

express warranty, and (4) the [decedent’s] damage was proximately caused because

the express warranty was untrue.” Caboni v. Gen. Motors Corp., 278 F.3d 448, 452

(5th Cir. 2002) (citing La. Stat. § 9:2800.58).

The Celinos argue that the Biotronik devices did not conform to an express

warranty that they “have product life with proven performance.”66 They also point

to a statement by Biotronik that the products were “99% and 100% safe,” with a

malfunction rate of “0% to less than 1% and/or estimated for any part of the

component system.”67

Biotronik argues that express warranty claims under the LPLA are

preempted,68 and that, to the extent this is no longer a categorical rule,69 the Celinos’

claim is inadequate to avoid preemption because it “fails to allege how the alleged

65 R. Doc. No. 31, at 19 ¶ 33.

66 Id. at 8 ¶ 12.

67 Id.

68 R. Doc. No. 41, at 6 (citing Gomez, 442 F.3d at 932).

69 Biotronik acknowledges that Wildman v. Medtronic, Inc., 874 F.3d 862 (5th Cir.

2017), suggests a possible limit to Gomez. Id. at 6 n.3.

breach of warranty also constituted a violation of federal law—the touchstone of a

parallel claim.”70

Biotronik also argues that, even if the claim were not preempted, the Celinos’

“claim fails because they have not sufficiently identified the express warranty they

rely on.”71 Biotronik also notes that “absent from the Amended Complaint are any

allegations that either [Barbara] or her doctor relied upon any alleged express

warranty or that [Barbara’s] alleged damages were caused by any allegedly false

express warranty.72

In response, the Celinos cite Wildman (discussed infra) and argue that it

controls here because “Biotronik had an express warranty Celino was deceived into

believing there was a safe and effective product.”73 The Celinos also argue (again for

the first time in opposition) that “MDT was present in the operating room when the

ICD was implanted and MDT, through their representatives assigns [sic] known as

technicians, followed [Barbara] an [sic].”74 Finally, the Celinos add in opposition that

“[t]he nurses and physicians relied completely on Biotronik, Biotronik is paid for their

services.”75

The Fifth Circuit has previously held that, because the LPLA “requires proof

that ‘the express warranty was untrue,’” it imposes duties that “relate to, and are

70 Id. at 6.

71 Id. at 6 n.3.

72 R. Doc. No. 32-1, at 20.

73 R. Doc. No. 39, at 14–15.

74 Id. at 22.

75 Id.

potentially inconsistent with, the federal regulatory scheme” and is, therefore,

“preempted.” Gomez, 442 F.3d at 932. Indeed, any warranty claim “challeng[ing] a

representation the FDA blessed in the approval process . . . is preempted.” Wildman,

874 F.3d at 868 (citing Gomez, 442 F.3d at 931–32).

The warranty at issue in Gomez was approved during the PMA process. 442

F.3d at 932. In Wildman, though, the relevant warranty went “beyond what the FDA

evaluated in its approval process.” 874 F.3d at 870. Because of this, “[a] verdict

finding that [the manufacturer] misled customers . . . in making this representation

. . . would not undermine any FDA finding concerning the safety of the device.” Id.

Therefore, to the extent the relevant “warranty goes beyond what the FDA

considered,” the claim is not preempted. Id. at 869.

Even following Wildman, though, such claims must still be adequately alleged.

See id. at 870–71. Wildman itself acknowledged that these claims “often fail for other

reasons,” including “a failure to allege the claim with [adequate] particularity.” Id.

at 870. Indeed, despite reversing and remanding the decision below, Wildman

explicitly instructed the district court to review the claim’s sufficiency closely,

including whether the plaintiff “allege[d] reliance on the warranty.” Id. at 871.

As Biotronik notes, the amended complaint (and, for that matter, the Celinos’

opposition to the instant motion), does not identify whether the alleged warranty goes

beyond what the FDA approved. That deficiency alone is fatal, as it means the

Celinos have failed to adequately allege a parallel claim.

But even if it were a parallel claim, the Celinos have still failed to allege what

the LPLA requires—that the warranty induced Barbara or her doctor to use the

relevant products. The amended complaint itself offers little on the point. The

opposition includes three statements that are conceivably relevant. First, the Celinos

claim that “Biotronik had an express warranty Celino was deceived into believing

there was a safe and effective product.”76 But, even if the Court were to read “Celino”

as ‘Barbara and her doctors,’ this statement tells the Court nothing about what

Barbara or her doctor would have done if no warranty was offered.

Second, the Celinos claim “MDT was present in the operating room when the

ICD was implanted and MDT, through their representatives assigns [sic] known as

technicians, followed [Barbara] an [sic].”77 The Court believes ‘MDT’ is a reference to

Medtronic, an unrelated manufacturer of similar devices against whom the Celinos’

counsel has brought numerous lawsuits. But even if the Court reads “MDT” to mean

“Biotronik,” this allegation also fails to suggest any inducement. It is therefore

inadequate.

Finally, the Celinos add in opposition that “[t]he nurses and physicians relied

completely on Biotronik, Biotronik is paid for their services.”78 While this statement

includes the word “relied,” it is far too vague to be of any use.

76 R. Doc. No. 39, at 14–15.

77 Id. at 22.

78 Id.

Because the Celinos have not adequately established a parallel claim and

because they did not allege reliance on any warranty, their claim fails. It will be

dismissed with prejudice.

E. Remaining State-Law Claims

i. LUTPA, “wrongful death,” and “survival action”

The Celinos next contend Biotronik violated the Louisiana Unfair Trade

Practice and Consumer Protection Law (“LUTPA”) because it engaged in deceptive

behavior.79 Specifically, they contend that Biotronik intentionally manufactured,

sold, distributed, and marketed products with knowledge that consumers would be

exposed to serious danger.80 Biotronik responds that these claims are subsumed by

the LPLA.81 In opposition, the Celinos “acknowledge that the [LPLA] is the exclusive

remedy for the products,” and offer no response to Biotronik’s argument except as to

their breach of contract claim, discussed infra.82

The LUTPA prohibits “[u]nfair methods of competition and unfair or deceptive

acts or practices in the conduct of any trade or commerce.” La. Stat. § 51:1405(A).

But the passage of the LPLA altered a claimant’s ability to recover under the LUTPA.

La. Stat. § 9:2800.52. The LPLA “establishes the exclusive theories of liability for

manufacturers for damage caused by their products.” Id. Courts consistently hold

that the LPLA bars plaintiffs from making a claim against a manufacturer for

79 R. Doc. No. 31, at 25 ¶ 51.

80 Id. at 26 ¶ 52.

81 R. Doc. No. 32-1, at 21.

82 R. Doc. No. 39, at 1.

damage caused by a product under LUTPA. See Johnson, 758 F.3d at 615–616; see

also, e.g., Reddick, 2020 WL 2759077, at *4 (holding that the LPLA bars LUTPA

claims).

There is no dispute that Biotronik is a manufacturer, nor that the Celinos are

alleging damage caused by Biotronik products. Consequently, the Celinos’ LUTPA

claim is subsumed by the LPLA.83

iii. Breach of Contract

The Celinos finally argue Biotronik breached a service contract it entered into

with Barbara, though they “[do] not have possession of the contract.”84 “This service

contract [was] at least a three-party contract that included the now shuttered and

closed doctor’s clinic and the doctor that was located in St. Tammany Parish.”85 The

Celinos allege that “[u]pon information and belief this service contract states that it

will provide 24 hour/7days [sic] a week monitoring services and patients [sic] services

and home health services to . . . [Barbara].”86 This was to include “patient services

for any of patients [sic] needs, concerns, complaints, or need for medical attention

that may arise during the monitoring of her heart and heart condition.”87 The Celinos

83 Similarly, because the LPLA established the exclusive theories of liability against

manufacturers for damage caused by their products, the Celinos’ survival action and

wrongful death action—to the extent that these are independent claims—are also

dismissed. See Jefferson v. Lead Indus. Ass’n, 106 F.3d 1245, 1250–51 (5th Cir. 1997)

(holding that a plaintiff cannot recover from a manufacturer for damage caused by a

product on the basis of any theory of liability not set forth in the LPLA).

84 R. Doc. No. 31, at 23 ¶ 46.

85 Id. at 23 ¶ 46.

86 Id.

87 Id.

allege that Biotronik provided “bad service” that constantly disrupted Barbara’s

life.88 However, they offer no detail, except that Barbara “failed to get the proper

services as per the contract and as per the price she was paying for the services”89

and that “Biotronik failed to perform its service obligations and continuously

breached the contracts and their obligations to [Barbara] and/or her third-party

doctors.”90

Biotronik argues that the Celinos do not identify “any action or inaction by

Biotronik that constituted a breach of contract.”91 It describes the allegations as

conclusory, distinguishing the instant claim from a similar one alleged in Reddick,

where the court held a plaintiff sufficiently pleaded a breach of contract claim.92

Under Louisiana law, an obligation “is a legal relationship whereby a person .

. . is bound to render a performance in favor of another.” La. Civ. Code art. 1756.

When an obligor fails to perform a conventional obligation, she is liable for the

damages caused by that failure. Id. art. 1994. To recover, a plaintiff must prove: “(1)

the obligor’s undertaking [of] an obligation to perform, (2) the obligor failed to perform

the obligation (the breach), and (3) the failure to perform resulted in damages to the

obligee.” Favrot v. Favrot, 68 So. 3d 1099, 1108–09 (La. App. 4 Cir. 2011).

88 Id. at 24 ¶ 46.

89 Id. at 24 ¶ 47.

90 Id. at 25 ¶ 49.

91 R. Doc. No. 41, at 7.

92 Id. (citing 2020 WL 2759077, at *7).

Because this breach of contract claim is not based on damage caused by

Biotronik’s product but by Biotronik’s allegedly inadequate service, the Court will

assume arguendo that it is not barred by the LPLA. See La. Stat. § 9:2800.52.

However, Biotronik is correct that the allegations here are inadequate to

support a claim. In Reddick, the plaintiffs offered examples of actions that breached

the alleged agreement. Id. at *10 (denying motion to dismiss where the plaintiff

alleged failure to provide “24 hour and seven day a week . . . technical support relating

to the [relevant device]”). Here, the Celinos do not identify how Biotronik failed to

perform the obligations listed in the alleged service agreement—or what those

obligations were. See La. Civ. Code art. 1994. While the Celinos claim Barbara

received “bad” service, they offer nothing more—not even an allegation that the

service was not, in fact, around-the-clock. Their bare assertions “amount to nothing

more than a formulaic recitation of the elements” of a breach of contract

claim. Iqbal, 556 U.S. at 681 (quotation omitted). The claim will therefore be

dismissed with prejudice.

IV. CONCLUSION

The Celinos have failed to state a non-preempted claim upon which relief can

be granted. While leave to amend shall be freely given “when justice so requires,”

Fed. R. Civ. Proc. 15(a)(2), it is “by no means automatic.” Hutcheson v. Dallas Cty.,

___ F.3d ___, 2021 WL 1344002, at *5 (5th Cir. Apr. 12, 2021) (quoting Ashe v. Corley,

992 F.2d 540, 542 (5th Cir. 1992)). The Celinos were “already provided . . . an

opportunity to amend . . . and the amended complaint is still deficient.” Id. However,

given the nature of design defect claims, and out of an abundance of caution, the

Celinos will be given one more opportunity to adequately state that claim only.

Therefore,

IT IS ORDERED that Biotronik’s motion to dismiss is GRANTED IN PART

and DISMISSED WITHOUT PREJUDICE IN PART; all claims addressed above

except for the claim of a LPLA violation premised on a design defect are DISMISSED

WITH PREJUDICE.

IT IS FURTHER ORDERED that the Celinos may file an amended

complaint as to the design defect theory only. That amended complaint shall be filed

no later than MAY 14, 2021. The Court will not consider other claims.

New Orleans, Louisiana, April 28, 2021.

LANGE M. AFRICK

UNITED STATES DISTRICT JUDGE

AO