# Brashear v. Pacira Pharmaeuticals, Inc.

> District Court, S.D. Ohio · August 19, 2024

URL: https://www.frixlaw.com/law-library/cases/10665123

## Case

- **Court:** District Court, S.D. Ohio
- **Decided:** August 19, 2024
- **Opinion:** 100trialcourt
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/10665123

## How later opinions describe it (automated extraction)

- 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
- 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)

## Opinion text

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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10665123. Public record. Not legal advice.