Brashear v. Pacira Pharmaeuticals, Inc.

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF OHIO

WESTERN DIVISION

JULIE BRASHEAR,

Plaintiff,

Case No. 1:21-cv-700

v.

JUDGE DOUGLAS R. COLE

PACIRA PHARMACEUTICALS,

INC., et al.,

Defendants.

OPINION AND ORDER

Plaintiff Julie Brashear allegedly suffered partial paralysis of her diaphragm

and experienced long-term breathing troubles after receiving an Exparel shot to

manage her pain following shoulder surgery. (Am. Compl., Doc. 26). Based on that

alleged harm, Brashear has sued the manufacturer of Exparel, Defendant Pacira

Pharmaceuticals, Inc., (Pacira), and two related corporate entities, Defendants Pacira

Pharmaceuticals International, Inc., (PPI), and Pacira BioSciences, Inc., (PBI),

raising three distinct products liability claims against each. Defendants have now

moved to dismiss Brashear’s Amended Complaint—all three seek dismissal on the

merits, while PPI and PBI also argue that the Court lacks personal jurisdiction over

them. (See Docs. 34, 35, and 36).

For the reasons provided below, the Court concludes that, on the record

properly before it at this stage, the Court has personal jurisdiction over all parties,

but that Defendants succeed on their arguments directed to the merits. The Court

therefore GRANTS IN PART AND DENIES IN PART PPI’s and PBI’s Motions to

Dismiss (Docs. 35, 36) and GRANTS Pacira’s Motion to Dismiss (Doc. 34). Moreover,

because Brashear has failed to make out any viable products liability claims for the

second time, the Court DISMISSES the action against all Defendants WITH

PREJUDICE.

BACKGROUND1

In November 2019, Brashear had her shoulder surgically replaced, for which

she received an Exparel injection to ease her resulting pain. (Doc. 26 ¶¶ 10–12, #200).

Allegedly because of this injection (and not due to her later-developed pneumonia),

Brashear claims she suffered paralysis of her diaphragm, which led to long-term

breathing issues. (Id. ¶¶ 14, 17, #200–01). Brashear claims Defendants, as the alleged

designers and developers of Exparel, knew that this injury was a substantial risk of

receiving an Exparel injection and that they had a duty to warn her or her physicians

about this risk. (Id. ¶¶ 13, 15–16, #200–01). PPI and PBI dispute Brashear’s

allegation that they took part in the production of Exparel and have both submitted

declarations from employees declaring that neither “develop[ed], produce[d],

design[ed], market[ed], manufacture[d], or suppl[ied]” Exparel. (Doc. 35-1, #350; Doc.

36-1, #369).

1 As this matter is before the Court on Defendants’ motions to dismiss, the Court generally

must accept the well-pleaded allegations in the Amended Complaint as true. Bassett v. Nat’l

Collegiate Athletic Ass’n, 528 F.3d 426, 430 (6th Cir. 2008). For that reason, when relying on

those allegations to recount the case’s background, the Court reminds the reader that they

are just that—allegations. That said, PPI and PBI have moved to dismiss for lack of personal

jurisdiction under Rule 12(b)(2). In reviewing such motions, the Court may consider the

evidence the parties have submitted related to issues of jurisdiction. Theunissen v. Matthews,

935 F.2d 1454, 1458 (6th Cir. 1991). As explained, the Court does not do so. But it flags for

the reader the relevant declarations from PPI and PBI as to the proper scope of their

involvement here.

For her injuries, Brashear sued Pacira, PPI, and PBI on November 8, 2021,

raising four products liability claims (including, as relevant here, a failure-to-warn

claim, a false marketing claim, and a supplier liability claim) as well as a nominally

labeled punitive damages claim. (Compl., Doc. 1). Pacira (the only defendant

Brashear had served at the time) moved to dismiss the Complaint, (Doc. 5), and the

Court granted that motion, (Doc. 19). But the Court dismissed Brashear’s failure-to-

warn, false marketing, and supplier liability claims without prejudice, thereby

providing her an opportunity to replead those claims if she could address the Court’s

concerns. (Id. at #176; 10/12/23, 2:37 PM, Not. Order (granting in part Brashear’s

Motion for Nunc Pro Tunc Order, (Doc. 22))).2

Eventually,3 Brashear filed her Amended Complaint. (Doc. 26). In it, she re-

raised her failure-to-warn, false marketing, and supplier liability claims adding

allegations referring to Defendants’ knowledge of the risks allegedly associated with

Exparel as well as the actions she claims they should have taken. (Doc. 26 ¶¶ 18–44,

#201–04). The Amended Complaint contains no attachments and does not refer to

any documents outside the pleadings. This time around, Brashear also successfully

served PPI and PBI. (Docs. 30, 31).

2 The Court originally dismissed the failure-to-warn claim with prejudice. (Doc. 19, #176).

But Brashear asked the Court to reconsider that order, claiming that she could provide

additional allegations that would plausibly allege that the manufacturer had newly acquired

safety information about Exparel that would have allowed it to initiate the CBE process.

(Doc. 22). So the Court granted leave to replead that claim, as well, by amending the prior

dismissal language to be without prejudice. (10/12/23, 2:37 PM, Not. Order). As discussed

below, the Court concludes that Brashear has failed to make good on that representation.

3 Brashear failed to comply with the Court ordered timeline for filing an amended complaint.

(See 12/7/23 Not. Order; 2/7/24 Not. Order).

Defendants each moved to dismiss the Amended Complaint. PPI and PBI both

moved to dismiss under Rule 12(b)(2) claiming the Court lacked personal jurisdiction

over them. (Doc. 35, #340–44; Doc. 36, #359–63). And they argued in the alternative

that the claims should be dismissed under Rule 12(b)(6) because Brashear’s claims

were barred by the statute of limitations and otherwise did not state plausible claims

for relief. (Doc. 35, #344–47; Doc. 36, #363–66). In support of their personal

jurisdiction arguments, PPI and PBI both attached declarations from employees

disclaiming any responsibility for any part of the Exparel production process. (Doc.

35-1, #350; Doc. 36-1, #369). Pacira, on the other hand, moved to dismiss solely under

Rule 12(b)(6) contending that Brashear’s Amended Complaint is defective for the

same reasons that led the Court to dismiss her original Complaint. (Doc. 34, #243).

Brashear opposed all three motions, (Docs. 39, 40, 41)—attaching unauthenticated

screenshots of websites (to support her newly raised alter-ego theory in support of the

Court’s exercising personal jurisdiction over PPI and PBI) and a case study nowhere

referenced in her Complaint to buttress her allegations about Defendants’ learning

of new risks of Exparel. (Docs. 39-1 to -3, 40-1 to -3, and 41-1). Defendants then

replied. (Docs. 44, 45, and 46). The matter is now ripe.

LEGAL STANDARDS

To survive a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6),

a “complaint must present sufficient facts to ‘state a claim to relief that is plausible

on its face.’” Robbins v. New Cingular Wireless PCS, LLC, 854 F.3d 315, 319 (6th Cir.

2017) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). “A claim has

facial plausibility when the plaintiff pleads factual content that allows the court to

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

alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). In assessing plausibility, the

Court “construe[s] the complaint in the light most favorable to the plaintiff.” Bassett

v. Nat’l Collegiate Athletic Ass’n, 528 F.3d 426, 430 (6th Cir. 2008) (cleaned up). But

while well-pleaded allegations are accepted as true, they are just that—allegations.

A court analyzing a motion to dismiss under Rule 12(b)(6) generally must

confine its review to the pleadings. Armengau v. Cline, 7 F. App’x 336, 343 (6th Cir.

2001). That said, it may properly consider public records or decisions of public

agencies, even on a motion to dismiss. J.P. Silverton Indus. L.P. v. Sohm, 243 F. App’x

82, 86 (6th Cir. 2007). And if “a document is referred to in the pleadings and is

integral to the claims, it may be considered without converting a motion to dismiss

into one for summary judgment.” Com. Money Ctr., Inc. v. Ill. Union Ins., 508 F.3d

327, 335–36 (6th Cir. 2007); Fed. R. Civ. P. 10(c). “These written instruments are

records falling within a narrowly defined class of legally significant documents on

which a party’s action or defense is based. As a result, they often create or define legal

rights or obligations, or define or reflect a change in legal relationships.” Anderson v.

ABF Freight Sys., Inc., No. 1:23-cv-278, 2024 WL 51255, at *9 (S.D. Ohio Jan. 4, 2024)

(cleaned up). “Even so, a court will not credit a document attached to a motion to

dismiss [or other briefing] that is not integral to or referenced in the complaint, or is

otherwise unlike quintessential examples of written instruments—for example, when

the exhibit is unsigned and undated (i.e., lacks self-verifying qualities).” Washington

v. City of Cincinnati, No. 1:23-cv-230, 2024 WL 474403, at *2 (S.D. Ohio Feb. 7, 2024)

(cleaned up).

By contrast, a motion to dismiss under Rule 12(b)(2) for want of personal

jurisdiction is governed by a slightly different standard. For challenges to personal

jurisdiction, “[t]he plaintiff bears the burden of establishing that [such] jurisdiction

exists.” Theunissen v. Matthews, 935 F.2d 1454, 1458 (6th Cir. 1991). The nature of

the burden turns on how the Court chooses, in its discretion, to handle the motion.

Malone v. Stanley Black & Decker, Inc., 965 F.3d 499, 505 (6th Cir. 2020). Before trial,

a court may decide to resolve the question on the written submissions, to permit

additional discovery, or to hold an evidentiary hearing. Id. If an evidentiary hearing

is held, “the plaintiff may not stand on [her] pleadings but must, by affidavit or

otherwise, set forth specific facts showing that the court has jurisdiction” by a

preponderance-of-the-evidence standard. Theunissen, 935 F.2d at 1458, 1465. But if

the Court “rules on written submissions alone, the burden consists of a prima facie

showing that personal jurisdiction exists.” Schneider v. Hardesty, 669 F.3d 693, 697

(6th Cir. 2012) (cleaned up). And a plaintiff may rely on just her allegations to meet

that prima facie burden. Malone, 965 F.3d at 505. In other words, when the Court

opts not to hold a hearing, it rules on a Rule 12(b)(2) motion without consideration of

any affidavit or declaration contradicting those jurisdictional allegations. Id.

LAW AND ANALYSIS

Because three motions are pending, a roadmap is in order. PPI’s and PBI’s

identical motions raise both personal jurisdiction and merits arguments. Pacira’s

motion, by contrast, addresses just the merits. Under black letter law, “a federal court

generally may not rule on the merits of a case without first determining that it has

jurisdiction over the category of claim in suit (subject-matter jurisdiction) and the

parties (personal jurisdiction).” Morgeson v. Freeman, No. 1:23-cv-269, 2024 WL

1406105, at *3 (S.D. Ohio Apr. 2, 2024) (quoting Sinochem Int’l Co. v. Malaysia Int’l

Shipping Corp., 549 U.S. 422, 430–31 (2007)). So the Court turns first to PPI’s and

PBI’s personal jurisdiction arguments before any other issue. Given the Court finds

Brashear has made out a prima facie case that the Court has personal jurisdiction

over PPI and PBI, it then turns to the merits. Conveniently, PPI and PBI both adopt

and concur with Pacira’s merits briefing. (Doc. 35, #346–47; Doc. 36, #365–66). So the

Court resolves the merits of the claims against all three Defendants in one fell swoop.4

A. Personal Jurisdiction

Begin with personal jurisdiction. Personal jurisdiction comes in two flavors:

general and specific. As all appear to concede, (Doc. 35, #343; Doc. 36, #361–62; see

Doc. 39, #383; Doc. 40, #406), the Court lacks general personal jurisdiction over

Defendants PPI and PBI, as neither is “at home” in Ohio, (Doc. 26 ¶¶ 3–4, #199).

Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 924 (2011). So what

about specific personal jurisdiction? PPI and PBI raise only a single argument about

why the Court lacks specific personal jurisdiction over them: their employees’

declarations establish that they did not engage in any act in this matter that relates

4 Though PPI and PBI also raise statute-of-limitations arguments, the Court declines to

address them because Brashear fails to state a claim for relief. Courser v. Mich. House of

Representatives, 831 F. App’x 161, 180 (6th Cir. 2020).

to the forum state of Ohio. (Doc. 35, #344 (“To the extent plaintiff has attempted to

plead allegations that would satisfy the requirements of specific jurisdiction, those

allegations do not pass muster in light of the evidence presented here that Pacira

BioSciences did not develop, produce, design, market, manufacture, or supply

EXPAREL® either in Ohio or anywhere else.”); Doc. 36, #362–63 (same)).

That argument does not work under the correct legal standard. For starters,

PPI and PBI have not requested an evidentiary hearing and oppose granting

Brashear additional discovery on personal jurisdiction. (Doc. 45, #463–64; Doc. 46,

#472–73). Accordingly, the Court uses its discretion to rule on personal jurisdiction

based on the written submissions. Malone, 965 F.3d at 505. But that “choice of

procedure ma[kes] [PPI’s and PBI’s respective declarations] irrelevant,” as all

Brashear must do is meet her prima facie burden with the allegations in her Amended

Complaint. Id. PPI’s and PBI’s suggestions to the contrary are meritless as they cite

the wrong standard—the standard that applies when the Court holds an evidentiary

hearing. (Doc. 35, #344; Doc. 36, #362–63). So PPI’s and PBI’s sole challenge to the

Court’s exercising specific jurisdiction over them at this stage of the litigation lacks

support.5 And that means the Court may reach the merits of Brashear’s claims

5 Because PPI and PBI made only one argument about personal jurisdiction based on

declarations the Court may not consider, they have forfeited any other challenge they could

have raised—including that Brashear failed to meet her prima facie burden in her Complaint.

That said, the Court notes that while her allegations on this front are rather thin, there is

enough there for it to conclude that her action arises from PPI’s and PBI’s alleged actions

connected to the forum state of Ohio. Third Nat’l Bank in Nashville v. WEDGE Grp. Inc., 882

F.2d 1087, 1089 (6th Cir. 1989) (noting the key inquiry is whether the defendant’s “conduct

and connection with the forum State are such that he should reasonably anticipate being

haled into court there” (citation omitted)). For example, Brashear alleges PPI and PBI

against them. Thus, the Court denies PPI’s and PBI’s motions to dismiss insofar as

they contend that personal jurisdiction is lacking here (i.e., when moving under Rule

12(b)(2)), as their sole argument turns on evidence not properly before the Court.6

B. The Merits

Next up is whether Brashear’s three products liability claims—her failure-to-

warn, false marketing, and supplier negligence claims—plausibly state claims for

relief. The Court had earlier dismissed each for various reasons: it found that (1) the

failure-to-warn claim was preempted by federal law given Exparel and its labeling

had been approved by the Food and Drug Administration (FDA), (Doc. 19, #167–70);

(2) the marketing claim identified no representations (outside the label) on which

Brashear relied, (id. at #170–72); and (3) the sole basis for her supplier liability claim

appeared to be Exparel’s purported dangerousness, which was preempted by the

participated in the development and production of Exparel—the drug administered to her at

Mercy Health Anderson Hospital in Hamilton County, Ohio, thereby purportedly causing her

injuries in this state. (Doc. 26 ¶¶ 6, 10, 12, #199–200). And Brashear points to PPI’s and PBI’s

alleged failures to provide certain warnings on the product they purportedly produced and to

notify Brashear’s physicians of certain risks, which omissions caused her harm, again in this

state. (Id. ¶¶ 25, 33, 43, #202–04). Taking these allegations in the light most favorable to

Brashear (and especially because PPI and PBI do not argue to the contrary), the Court finds

that Brashear carried her burden (if barely). See Arnold v. CooperSurgical, Inc., 681 F. Supp.

3d 803, 815–18 (S.D. Ohio 2023). Simply, the allegations admit (with some squinting) of

plausible inferences that PPI and PBI engaged in tortious actions with a direct and serious

impact in the state of Ohio, where Exparel was distributed to local medical facilities. Id.; see

Ohio Rev. Code § 2307.382(A)(3). The Court might have reached a different outcome had PPI

and PBI raised different arguments in their motions—but under the party-presentation

principle, the Court is not in the business of making arguments for parties even if the Court

finds the litigation choices “odd.” Gray v. Winton Woods City Sch., No. 1:23-cv-553, 2024 WL

2882645, at *3 (S.D. Ohio June 7, 2024) (citing United States v. Sineneng-Smith, 590 U.S.

371, 375–76 (2020)).

6 Because the Court rejects the sole basis for PPI’s and PBI’s arguments related to personal

jurisdiction, it does not reach Brashear’s non-pleadings-based argument about those entities’

being alter-egos of Pacira. (Doc. 39, #382–83; Doc. 40, #405–06).

FDA’s approving the drug for distribution, (id. at #173–74). The same preemption7

principles leading the Court to dismiss those claims once before now require the same

result again.

1. Failure-to-Warn Claim

Start with the failure-to-warn claim. In it, Brashear attacks the Exparel

warning label. She alleges Defendants learned of new risks associated with Exparel

injections such that they should have changed the drug’s warning label to notify

patients of the potential for diaphragm or lung injuries like those Brashear

experienced. (Doc. 26 ¶¶ 20–23, #201–02). As the Court explained in its prior opinion,

because drug labeling is controlled by federal laws and FDA regulations, state law

causes of action are preempted if it is impossible for a manufacturer to meet its state

law duty of care and its federal obligations. (Doc. 19, #164). This means most failure-

to-warn claims are preempted because drug labeling is highly federally regulated.

Relevant here, once the FDA approves a drug label, as it did for Exparel in 2018, (Doc.

26 ¶ 20, #201), the label can be modified in only two ways: the manufacturer’s seeking

approval from the FDA directly or using the “Changes Being Effected” (CBE) process

to make changes without waiting for approval. Fulgenzi v. PLIVA, Inc., 711 F.3d 578,

581 (6th Cir. 2013).

7 Brashear indirectly re-raises her previously rejected argument that the Court cannot

analyze preemption at the motion-to-dismiss stage. (See Doc. 41, #428 (arguing that it should

be resolved after discovery)). Preemption is a legal question that can and should be resolved

as early in the litigation as possible, as plaintiffs “are not entitled to discovery on preempted

claims.” Utts v. Bristol-Myers Squibb Co., 251 F. Supp. 3d 644, 673 (S.D.N.Y. 2017).

Brashear cannot rely on the first route—Defendants’ failure to seek approval

from the FDA to alter the label to add other risks—as a basis for alleging a viable

Ohio law failure-to-warn claim. (Doc. 26 ¶ 22, #202). That is because Defendants’ duty

to seek FDA approval of its labeling (and changes thereto) is established by federal

law via authority the FDA exercises under the Federal Food, Drug, and Cosmetic Act

of 1938 (FDCA). FDCA § 502, 21 U.S.C. § 352; 21 C.F.R. § 314.70(b). And “‘[t]he FDCA

leaves no doubt that it is the Federal Government rather than private litigants who

[is] authorized to file suit for noncompliance’ with its substantive provisions.” Loreto

v. Procter & Gamble Co., 515 F. App’x 576, 578 (6th Cir. 2013) (quoting Buckman Co.

v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001)). So “under principles of

implied preemption, private litigants may not bring a state-law claim against a

defendant when the state-law claim is in substance (even if not in form) a claim for

violating the FDCA.” Id. at 579 (cleaned up). Simply, “[i]f the claim would not exist

in the absence of the FDCA, it is impliedly preempted.” Id.

Applying those principles here, it becomes clear that Brashear’s failure-to-

warn claim (to the extent her theory of liability turns on Defendants’ alleged

obligation to seek FDA approval for a change in label) implicitly seeks to enforce a

duty that arises (if at all) under the FDCA and therefore is preempted. Namely, were

Brashear claiming that under Ohio law, Defendants had a duty to warn Exparel users

about diaphragmatic paralysis by seeking FDA approval to add such a warning to its

label, she implicitly would be using a state-law tort suit to enforce the FDCA’s

labeling provisions against Defendants. That regulatory-noncompliance theory of

liability cannot exist without the FDCA and its corresponding regulations. And that

means the FDCA (along with its implied bar on private enforcement) impliedly

preempts any state-law claim relying on it. Loreto, 515 F. App’x at 577. In short,

Brashear cannot maintain a failure-to-warn claim arising from an allegation that

Defendants improperly failed to seek FDA approval for a label change, as the FDCA

impliedly preempts such a state-law effort to prosecute regulatory noncompliance.

Brashear cannot rely on the CBE process either. As explained before, (Doc. 19,

#169), a manufacturer can employ the CBE process to add a new warning, or to

strengthen an existing one, without approval only if the manufacturer receives

“newly acquired” safety information. Merck Sharp & Dohme Corp. v. Albrecht, 587

U.S. 299, 314–15 (2019). Despite claiming in an earlier filing that she could provide

new allegations to that effect, (see Doc. 22), Brashear has pointed to no facts that

plausibly suggests such new information exists. True, her Amended Complaint

conclusorily asserts that Defendants learned of new risks. (Doc. 26 ¶ 21, #201). But

that is no more than an unadorned, “formulaic recitation of [one of] the elements of

[her] cause of action[, which] will not do.” Iqbal, 556 U.S. at 678 (citation omitted).

She tries to avoid this result by citing a 2018 paper (raised for the first time in her

response brief) about the risks of diaphragm injuries associated with shoulder

injections (though the paper does not mention Exparel itself). (Doc. 41, #426–27). But

Brashear neither references this paper in her Amended Complaint nor explains why

such evidence is properly before the Court on the motion to dismiss. As explained,

subject to only narrow exceptions, none of which apply here, the Court may not

consider such outside-the-pleadings evidence at this stage of the litigation.

Armengau, 7 F. App’x at 343. And that leaves Brashear with only her conclusory

assertion that Defendants learned of new risks associated with Exparel. At the risk

of undue repetition, such conclusory assertions do not suffice to overcome the Rule

12(b)(6) hurdle, and the claim must be dismissed.8

2. False Marketing Claim

Brashear’s second claim—her false marketing claim—also fails for the reasons

the Court previously explained. In the prior Opinion and Order, the Court held that,

to the extent Brashear was claiming that the information on the label itself included

misrepresentations, such claim was preempted by FDA regulations and the drug

approval process. (Doc. 19, #171–72). And the Court further explained that Brashear

had failed to allege any misrepresentations outside the drug’s label,

misrepresentations that might not be subject to preemption. (Id. at #172).

Brashear’s repleaded false marketing claim suffers from the same fatal

defect—she cites only representations Defendants made on Exparel’s label as the

basis for her claim that she was misled into believing that the drug was safe and

effective for pain management. (Doc. 26, ¶¶ 30–35, #202–03; Doc. 41, #429

(acknowledging that “[i]n addition to Exparel’s label, Plaintiff relied on her doctor’s

8 The Court also notes that Brashear’s claim would not have survived even had her Complaint

expressly referenced this paper. The article involves a single patient case study that, as noted

above, does not reference Exparel at all—in fact, it mentions a different drug (ropivacaine).

(Doc. 41-1, #434). An n=1 case study that does not even clearly apply to the drug in question

does not permit of a plausible inference that such a paper constitutes newly acquired

information serving as evidence establishing a causal link between the drug in question and

the alleged risk of harm. Albrecht, 587 U.S. at 305 (citing 21 C.F.R. § 314.70(c)(6)(iii)(A)).

understanding of Exparel’s use and safety”)). As the Court already noted, that runs

headlong into preemption. The FDA has the responsibility for policing labels—not

private consumers, and particularly not through state-law tort suits. So Brashear

cannot maintain a false marketing cause of action that turns on any

(mis)representations in a label the FDA approved under federal laws and regulations.

Yates v. Ortho-McNeil-Janssen Pharms., Inc., 808 F.3d 281, 295 (6th Cir. 2015).

Therefore, this claim must be dismissed as preempted.

3. Supplier Liability Claim

Last up is Brashear’s supplier liability claim, in which she alleges that

Defendants negligently permitted Exparel to be used for shoulder surgeries even

though the drug “was not safe for those procedures.” (Doc. 26 ¶¶ 41–42, #203–04).

But that constitutes a “stop-selling” argument based on the perceived dangerousness

of Exparel. And the Court concluded that federal drug laws and regulations

preempted an argument of that nature. (Doc. 19, #173–74). Nothing in the caselaw

has changed on that front since the Court’s earlier decision. Mut. Pharm. Co. v.

Bartlett, 570 U.S. 472, 488 (2013) (rejecting a stop-selling theory as a means to comply

with both a state tort law duty of care and the corresponding federal drug laws). As

Brashear fails even to address the preemption issue latent in this stop-selling

argument, (see Doc. 41, #430–31), the Court adheres to its previous determination

that Brashear may not challenge the “dangerousness” of Exparel to maintain her

supplier liability claim. The claim also must be dismissed as preempted.

CONCLUSION

As explained above, Brashear’s second crack at a viable theory in this case

fares no better than her first. Though she has satisfied (if barely) her prima facie

burden to show that the Court has jurisdiction over PPI and PBI, her Amended

Complaint repleads the same state-law tort claims that the Court previously held

were preempted, without having cured (or frankly even addressed) any of the defects

the Court previously identified. As a result, the Court GRANTS IN PART (to the

extent they seek dismissal under Rule 12(b)(6)) AND DENIES IN PART (to the

extent they seek dismissal under Rule 12(b)(2)), PPI’s and PBI’s Motions to Dismiss

(Docs. 35, 36) and GRANTS Pacira’s Motion to Dismiss (Doc. 34). Moreover, because

this is the second time Brashear has failed to clear the Rule 12 hurdle on the merits

of her claims, the Court DISMISSES the action against all Defendants WITH

PREJUDICE.

The Court DIRECTS the Clerk to enter judgment and to TERMINATE this

case on its docket.

SO ORDERED.

August 19, 2024 .

DATE DOUGLAS R. COLE

UNITED STATES DISTRICT JUDGE

15