# Brashear v. Pacira Pharmaeuticals, Inc.

> District Court, S.D. Ohio · April 25, 2023

URL: https://www.frixlaw.com/law-library/cases/10382251

## Case

- **Court:** District Court, S.D. Ohio
- **Decided:** April 25, 2023
- **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/10382251

## How later opinions describe it (automated extraction)

- concluding that the “federal statutory scheme amply empowers the FDA to . . . investigate suspected fraud”
- explaining that the FDA can only approve a drug when it determines the drug is “safe for use” as prescribed in the “proposed labeling thereof”
- stating that Ohio Revised Code § 2307.71(15)(b) specifically excludes “manufacturer” from its definition of “supplier”

## 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
After a surgery, Julie Brashear’s doctors gave her an anesthetic called Exparel
to manage her pain. But she thinks the drug made her problems worse. She says it
partially paralyzed her diaphragm, causing long-term breathing trouble. Pacira
Pharmaceuticals made Exparel.
Brashear further believes that Pacira knew Exparel carried a high risk of
injury but failed to warn her or her doctors. She sued. Pacira now moves to dismiss,
arguing Brashear has failed to state a claim. The Court agrees in part.
Because federal regulations preempt certain state law product liability claims,
the Court GRANTS Pacira’s Motion to Dismiss (Doc. 5) as to Brashear’s design
defect, failure-to-warn, and punitive damages claims and DISMISSES those claims
WITH PREJUDICE. The Court further GRANTS Pacira’s Motion to Dismiss (Doc.
5) as to Brashear’s false marketing and supplier liability claims and DISMISSES
those claims WITHOUT PREJUDICE.
Separately, the Court ORDERS Brashear to SHOW CAUSE, no later than
May 12, 2023, why the Court should not dismiss this action as against Pacira
Pharmaceuticals International, Inc. and Pacira Biosciences, Inc. without prejudice

for failure to effect service, or in the alternative why the Court should allow an
extension of time to for Brashear to complete service on these two defendants.
BACKGROUND
When deciding a motion to dismiss for failure to state a claim, the Court
assumes that the complaint’s factual allegations are true. Thus, the Court largely

relies on the facts in Brashear’s Complaint for this decision, but with the caveat that
these facts are not yet established and may never be. Koren v. Neil, No. 1:21-CV-9,
2022 WL 974340, at *1 (S.D. Ohio Mar. 31, 2022).
Brashear had her left shoulder surgically replaced. (Compl., Doc. 1, #3). After
the surgery, her doctors injected Exparel to ease her pain. (Id.). She alleges the
injection paralyzed the left side of her diaphragm. (Id.). Later, she developed

pneumonia and other long-term respiratory issues. (Id.). She thinks Pacira
defectively designed Exparel and did not communicate the risks associated with those
defects to her or her doctors, ultimately leading to her injury. (Id. at #3–4). So she
sued.
Brashear brought claims against three defendants: Pacira Pharmaceuticals,
Inc., Pacira Pharmaceuticals International Inc., and Pacira Biosciences, Inc. (Id. at
#1). To date, Brashear has only served Pacira Pharmaceuticals, Inc—referred to

simply as “Pacira” throughout this Opinion. Brashear’s Complaint contains five
claims, all under Ohio’s Product Liability Act. (Id. at #4, 5, 6). First, she claims
Defendants defectively designed Exparel. (Id. at #4). Second, she claims Defendants
knew that an Exparel injection carried a risk of diaphragmatic injury yet failed to

warn her of this risk. (Id. at #4–5). Third, she claims Defendants falsely marketed
Exparel as a safe and effective medication for post-operative pain management, but
it was not. (Id. at #5). Fourth, she claims that Defendants bear supplier liability for
sending Exparel to market and selling it to physicians. (Id.). Finally, she claims that
Defendants acted maliciously by consciously disregarding her health and safety,
entitling her to punitive damages. (Id. at #6).
Pacira moved to dismiss her Complaint, arguing that FDA regulations preempt

each of her state-law claims. (Doc. 5, #33). Brashear argues otherwise. (Doc. 15).
Pacira has since replied (Doc. 17), and the Motion is ripe for review.
LAW AND ANALYSIS
To survive a motion to dismiss under Fed. R. Civ. P. 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, 555 (2007)). In making that determination, 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) (quoting Directv,
Inc. v. Treesh, 487 F.3d 471, 476 (6th Cir. 2007)) (internal quotation marks omitted).
But that grace only extends so far. A complaint will not meet this standard when it
is wholly comprised of state-law claims preempted by federal law. See, e.g., Robbins,
854 F.3d at 319.
The United States Constitution makes federal law supreme. Accordingly,

“state laws that conflict with federal law are without effect.” Mut. Pharm. Co., Inc. v.
Bartlett, 570 U.S. 472, 479–80 (2013) (citations and internal quotation marks
omitted). Federal law can expressly or impliedly preempt state law. Yates v. Ortho-
McNeil-Janssen Pharms., Inc., 808 F.3d 281, 293 (6th Cir. 2015). Express preemption
arises when Congress states in a federal statute an intent to displace state law. Altria
Grp., Inc. v. Good, 555 U.S. 70, 76 (2008). Federal law impliedly preempts state law,
on the other hand, in at least two circumstances: “when Congress intends federal law

to occupy the field, or when state law conflicts with a federal statute.” Crosby v. Nat’l
Foreign Trade Council, 530 U.S. 363, 372–73 (2000) (cleaned up). Courts generally
refer to the latter of these two as “conflict preemption.”
Conflict preemption can arise in one of two ways: (1) “when it is impossible for
a private party to comply with both state and federal law,” or (2) when the state law
is “an obstacle to the accomplishment and execution of the full purposes and

objectives of Congress.” Yates, 808 F.3d at 294 (cleaned up) (quoting Crosby, 530 U.S.
at 372–73). Here, Pacira argues that federal law preempts Brashear’s state law
product liability claims based on the impossibility ground of conflict preemption.
Because the parties only discuss impossibility preemption, the Court likewise limits
its analysis to that theory.
Under the impossibility analysis, the question is whether Pacira “could
independently do under federal law” what Brashear’s state-law claims would require
of it.1 See id. at 295 (quoting Mensing, 564 U.S. at 620). To make that determination,

the Court starts by identifying what duty Brashear alleges Pacira had under Ohio
law in developing Exparel with respect to each of Brashear’s claims. Id. at 297. Then,
the Court determines whether any federal law prevented Pacira from performing that
purported duty. Id. at 298. The Court analyzes Brashear’s five claims in the order
they appear in her Complaint.

A. FDA Regulations Preempt Brashear’s Design Defect Claim Under
Ohio Law.
Brashear says that Pacira defectively designed Exparel, leading to her injury.
(Doc. 1, #4). Under Ohio law, a product is defectively designed or formulated if, when
it left the control of its manufacturer, the foreseeable risks associated with its design
or formulation outweighed the benefits of that design or formulation. Ohio Rev. Code
§ 2307.75(A). In other words, Brashear claims Ohio law imposed on Pacira a duty to
make Exparel in a way that ensured any risks of using it for post-surgical pain relief
did not outweigh its pain-relieving benefits. In doing so, Brashear has not specifically
alleged any alternative way Pacira could have designed Exparel to mitigate the risks

1 Brashear argues that the Court should not consider preemption at the motion-to-dismiss
stage. But this Court has done so many times. See, e.g., Heliene, Inc. v. Total Quality
Logistics, LLC, No. 1:18-cv-799, 2019 WL 4737753, at *3 (S.D. Ohio Sept. 27, 2019) (granting
defendant’s motion to dismiss based on federal law preempting plaintiff’s fraud claim);
Cincom Sys., Inc. v. LabWare, Inc., No. 1:18-cv-83, 2021 WL 675437, at *5 (S.D. Ohio Feb. 22,
2021) (granting defendant’s motion to dismiss on the ground that the plaintiff’s common-law
claims were preempted by Ohio law).
she claims existed. (See Doc. 1, #4). Essentially, Brashear just asserts that Pacira
should have made Exparel differently, without suggesting how. But even assuming
that is enough to make out a claim under state law, the problem is that, under federal

law, Pacira could not have made any such changes.
Once the FDA approves a drug, a manufacturer cannot change the drug’s
“qualitative or quantitative formulation of the drug product.” Yates, 808 F.3d at 298
(quoting 21 C.F.R. § 314.70(b)(2)(i)). The FDA considers such a change to be a “major
change” that requires prior approval before a manufacturer can distribute the altered
drug.2 Id. The FDA in 2018 approved Exparel for use as a safe and effective nerve
block for pain relief after shoulder surgeries. (Doc. 5, #39). It was at that point that

Pacira could no longer change Exparel’s formulation. If, after receiving that approval
from the FDA, Pacira were to redesign Exparel (as Brashear suggests it needed to)—
either by changing the recommended dosage or by modifying the composition of the
drug itself—Pacira would have been making a prohibited “major change.” Thus, as
the Sixth Circuit has made clear, Brashear’s post-approval design defect claim is
“preempted by federal law.” Yates, 808 F.3d at 298.

Separately, Brashear seems to allege that Pacira could have just designed its
drug differently in the first place—that is, before the drug received FDA approval.
(Doc. 1, #3–4). But the Yates court addressed that notion, as well. Yates, 808 F.3d at
299. According to the Sixth Circuit, any such “pre-approval” duty is “too attenuated,”

2 Moderate or minor changes have different notice requirements. Yates, 808 F.3d at 298. But
Brashear’s allegations concern Exparel’s chemical ingredients, and any change to that
chemical makeup would be “major.” See id.
because it requires assuming the FDA would have approved the safer design. Id. The
same logic applies here. To the extent that a pre-approval duty exists, Pacira could
not have complied with it without still getting FDA approval through the standard

new drug application process. See id. at 300; 21 U.S.C. § 355(a) (describing the
procedure for new drug applications). Brashear has not specifically alleged facts that
support the hypothetical scenario in which the FDA would have approved a
differently formulated Exparel.
In sum, Brashear’s state law design defect claim presumes that Pacira could
have just changed Exparel’s formulation. This Court finds that it would have been a
violation of FDA regulations for Pacira to make any changes to Exparel’s design

because it had already been approved by the FDA. Accordingly, federal law preempts
Brashear’s design defect claim.
B. FDA Regulations Preempt Brashear’s Failure-To-Warn Claim.
Brashear separately advances a failure-to-warn claim, saying she was injured
because Pacira did not warn her or her doctors about Exparel’s risks. (Doc. 1, #5).

Under Ohio law, a manufacturer has a duty to provide adequate warning of any
reasonably foreseeable risks associated with its product. Ohio Rev. Code § 2307.76.
The Exparel that Brashear received included labeling that warned of the risk of
“persistent or permanent” paralysis. (Doc. 5, #39). Brashear does not say what other
warning Pacira should have provided but mentions several times the term
“diaphragmatic paralysis.” (Doc. 1, #3, 4). This suggests she thinks Pacira should
have changed Exparel’s warning label to include the more specific risk of paralysis of
the diaphragm.
But for the same reason that Pacira could not have changed Exparel’s design

or formulation after the FDA had approved the drug for use, Pacira could not have
changed its warning label—the FDA had already approved it in 2018. (Doc. #5, 38).
And once a drug has been approved, companies like Pacira can only modify their
drug’s labeling in one of two ways: (1) by submitting a supplement to the FDA and
waiting for approval or (2) through the “Changes Being Effected” (“CBE”) process.
Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 581 (6th Cir. 2013) (interpreting FDA labeling
regulations codified at 21 C.F.R. § 314.70).

Since the FDA approved Exparel in 2018, Pacira has warned of Exparel’s risk
of paralysis under the “Warnings and Precautions” part of the Full Prescribing
Information section. (Doc. #5, 39–40). FDA regulations say that any change to this
section of an approved drug also requires a change to the “Recent Major Changes”
part listed in the drug’s Highlights section. See, e.g., 21 C.F.R. §§ 201.57(a)(5), (c)(1)–
(3), (c)(5)–(6); 21 C.F.R. § 314.70(b)(2)(v)(C). And any change to the Highlights section

requires prior FDA approval of a supplement to the drug’s labeling before distribution
can occur. Fulgenzi, 711 F.3d at 581. Pacira could not have independently added
language to Exparel’s warning label to specify the risk of diaphragm paralysis
because it would have needed the FDA’s advanced approval. Thus, federal law
preempts Brashear’s failure-to-warn claim.
Nor does the availability of the CBE process change this result. The CBE
process allows manufacturers to independently “add or strengthen” a drug’s warning
label without waiting for preapproval by the FDA. Mensing, 564 U.S. at 614. But a

drug manufacturer can only use the CBE process to reflect “newly acquired” safety
information. Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1679 (2019).
Additionally, this new information must show “evidence of a causal association”
between the drug and the risk of injury. Id. Newly acquired information includes
data, reports of adverse events, or new analyses not previously submitted to the FDA.
See 21 C.F.R. § 314.3(b).
While the Supreme Court and the Sixth Court have not explicitly discussed

who bears the burden of showing the newly acquired information, other circuits have.
Those courts say the plaintiff must plausibly allege information showing that a
manufacturer would have been able to use the CBE process to change its drug
labeling. See, e.g., Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699, 708–09 (2d Cir.
2019) (ruling that “conclusory and vague allegations” cannot plausibly show the
existence of newly acquired information); In re Celexa and Lexapro Marketing & Sales

Practices Litig., 779 F.3d 34, 42–43 (1st Cir. 2015) (dismissing plaintiff’s failure-to-
warn claims on preemption grounds because plaintiff did not allege any information
that would have enabled the manufacturer to use the CBE process). This Court
agrees.
Once the FDA has approved a label, the presumption is that the FDA
conducted the necessary vetting and research to confirm that the label accurately
communicates the risks with using the drug. In re Darvocet, Darvon, and
Propoxyphene Products Liability Litigation, 756 F.3d 917, 922 (6th Cir. 2014)
(explaining that the FDA can only approve a drug when it determines the drug is

“safe for use” as prescribed in the “proposed labeling thereof”). To rebut this weighty
presumption, it makes sense to require the party disputing the efficacy of a drug’s
warning label to show exactly why the warning was inadequate and presented a risk
of harm. But if a plaintiff does point to newly acquired information that would have
allowed a manufacturer to use the CBE process to make a label change, courts will
only find impossibility preemption where there is “clear evidence” the FDA would not
have approved the warning required by state law. See Albrecht, 139 S. Ct. at 1676.

Brashear has not met this standard here. (Doc. 1, #4, 5). Rather, Brashear
offers only conclusory allegations that cannot defeat a motion to dismiss. See, e.g.,
Ashcroft, 556 U.S. 662; Twombly, 550 U.S. 555.
Because Brashear has not identified any newly acquired safety information
that would have allowed Pacira to initiate the CBE process, Pacira could not have
changed Exparel’s warning label without first getting FDA approval. Thus, conflict

preemption prevents Brashear from advancing her failure-to-warn claim.
C. Brashear Has Not Plausibly Alleged A False Marketing Claim Because
She Did Not Identify A Statement About Exparel On Which She Relied
Outside The Label.
Brashear says that Pacira improperly marketed Exparel as safe and effective
for use as a post-surgery pain killer. (Doc. 1, #5). To prevail on such a claim, Brashear
must show that: (1) Pacira made a representation as to a material fact concerning
Exparel’s quality or character; (2) Exparel failed to conform to that representation;
(3) Brashear justifiably relied on that representation; and (4) Brashear’s reliance on
that representation was the direct and proximate cause of her injuries. Ace Am. Ins.

Co. v. Gerling & Assocs., Inc., No. 2:19-cv-5627, 2022 WL 4468584, at *5 (S.D. Ohio
Sept. 26, 2022) (interpreting the elements of Ohio Rev. Code § 2307.77).
For a false marketing claim to survive a motion to dismiss, district courts3 in
this circuit have demanded an alleged misrepresentation that is more than a “broad,
all-encompassing statement.” Johnson v. Eisai, Inc., 590 F. Supp. 3d 1053, 1060 (N.D.
Ohio Mar. 9, 2022) (quoting Harris v. Eli Lilly & Co., No. 4:12-cv-2481, 2012 WL
6732725, at *4 (N.D. Ohio Dec. 28, 2012)). And where “there is no representation,”

there can be no nonconformance nor any reliance. Biehl v. B.E.T., Ltd., No. 18-3201,
2018 WL 7502930, at *5 (6th Cir. Oct. 17, 2018) (quoting White v. DePuy, Inc., 718
N.E.2d 450, 485 (Ohio Ct. App. 1998)).
So how does Brashear attempt to show a misrepresentation? She alleges that
Pacira represented to her that Exparel was “safe and effective for use” as a post-
surgical pain reliever. (Doc. 1, #5). But there are two problems with that. First,

Brashear appears to be (again) referring to Exparel’s labeling itself. See 21 U.S.C.
§ 321(k), (m). But if Brashear believes Pacira’s FDA-approved labeling contained
misrepresentations, she runs into the same preemption problems as with her other

3 Granted, this Court in Troyer v. I-Flow Corp. held that a complaint that similarly lacked
any allegation of a specific manufacturer representation nonetheless was sufficiently pled.
No. 1:11-cv-45, 2011 WL 2517031, at *4 (S.D. Ohio June 23, 2011). There, however, the
complaint set forth facts which allowed the Court to “plausibly infer that a representation
was made” and that the product at issue did not conform to it. Id. Brashear has alleged no
such facts here.
claims. See Yates, 808 F.3d at 295. Second, Brashear’s alleged misrepresentation
reads like a “broad, all-encompassing statement,” which is insufficient to survive a
motion to dismiss. See Johnson, 590 F. Supp. 3d at 1060.

In short, Brashear has not plausibly alleged her false marketing claim because
she has not alleged a material misrepresentation. True, it is possible Brashear
received a misrepresentation outside of the label, and such a claim may well evade
federal preemption. But her Complaint, as currently presented, lacks sufficient facts
to plausibly show that. Therefore, the Court dismisses her claim, but does so without
prejudice to allow her to identify a qualifying misrepresentation if she can.

D. Brashear Has Not Plausibly Alleged Supplier Liability Under Ohio
Law.
Brashear next says the Defendants bear supplier liability for negligently
allowing a dangerous drug to be released to the market and subsequently sold. (Doc.
1, #5). Pacira, the only Defendant so far served, seeks dismissal of this claim by
arguing it manufactures Exparel, making it immune from supplier liability. (Doc. 5,
#56). And indeed, Pacira cannot be both Exparel’s manufacturer and supplier under
Ohio law. See, e.g., Najib v. Meridian Med. Technologies, Inc., 179 F. App’x 257, 262
(6th Cir. 2006) (stating that Ohio Revised Code § 2307.71(15)(b) specifically excludes
“manufacturer” from its definition of “supplier”); Frey v. Novartis Pharms. Corp., 642

F. Supp. 2d 787, 795 (S.D. Ohio 2009) (dismissing plaintiff’s claim for relief under
supplier liability because the drug’s manufacturer fell outside the statutory definition
of “supplier”).
That said, Brashear’s Complaint does not actually say which of the three
Defendants manufactured Exparel. Rather, Brashear’s claims are based on her
pleading in the alternative that Pacira or two other named defendants are liable as

manufacturers or suppliers of Exparel. (Doc. 1, #3; Doc. 15, #142). As a result, exactly
who she is alleging to have manufactured Exparel, versus who she claims supplied
Exparel, is not clear from the Complaint. (Doc. 1, #3, 5). So Pacira’s arguments aside,
it is plausible from the face of the Complaint that Pacira supplies, rather than
manufactures, Exparel. And the same is true for the two unserved defendants—
Pacira Pharmaceuticals International, Inc. and Pacira Biosciences, Inc. Thus, the
manufacture/supplier distinction cannot alone dispose of Brashear’s supplier liability

claim.
That leave the plausibility of the claim itself. To succeed on a supplier liability
claim under Ohio law, a plaintiff must show that the defendant supplier (1) owed the
plaintiff a duty, (2) that the duty was breached, and (3) that the plaintiff’s harm
proximately resulted from that breach. Rees v. W.M. Barr & Co., Inc., 736 F. App’x
119, 129 (6th Cir. 2018).

Brashear has not plausibly alleged a viable claim under that standard here.
Setting aside its legal conclusions, Brashear’s Complaint lacks sufficient facts—other
than Exparel’s alleged defects—to plausibly allege supplier liability. (See Doc. 1, #5).
And to the extent Brashear bases her supplier liability claim on the “dangerousness”
of the Exparel itself, that claim is preempted by federal law for the reasons already
discussed.
Again, Brashear could conceivably allege a supplier liability claim against one
of the three Defendants in a manner not preempted by federal law. For example,
perhaps Pacira negligently contaminated the Exparel while in transit to Brashear, in

turn causing Brashear’s injury. But Brashear’s Complaint contains no allegations—
plausible or not—along those lines. The Court therefore grants Pacira’s Motion to
Dismiss this claim, but again dismisses without prejudice.
E. Ohio Law Precludes Brashear’s Claim For Punitive Damages.
Ohio law does not permit punitive damages against a manufacturer of a drug
if that drug was “manufactured and labeled . . . in accordance with” FDA guidelines.

Monroe v. Novartis Pharms. Corp., 29 F. Supp. 3d 1115, 1129 (S.D. Ohio 2014)
(quoting Ohio Rev. Code § 2307.80(C)(1)). While the Ohio statute provides a narrow
exception where a plaintiff can show by a preponderance of the evidence that the
manufacturer fraudulently withheld from the FDA information related to the
plaintiff’s alleged harm (see id.), the Supreme Court has held that federal law
preempts such “state-law fraud-on-the-FDA claims.” Buckman Co. v. Plaintiffs’ Legal

Comm., 531 U.S. 341, 348–49 (2001) (concluding that the “federal statutory scheme
amply empowers the FDA to . . . investigate suspected fraud”).
The Sixth Circuit expanded on Buckman and recognized that a plaintiff’s
state-law fraud claim against the FDA is preempted “unless some federal agency” has
already found some fraud on the FDA. In re Aredia & Zometa Prods. Liab. Litig., 352
F. App’x 994, 995 (6th Cir. 2009). Brashear’s claim for punitive damages under Ohio
law thus only works if the FDA (or some other federal agency) has already discovered
that Pacira made some sort of fraudulent representation about Exparel. Monroe, 29
F. Supp. 3d at 1130. Brashear has provided no facts plausibly showing Pacira
fraudulently withheld information from the FDA relating to her injury. She also does

not say that the FDA or any other federal agency has identified such fraud. As a
result, Brashear’s claim for punitive damages is preempted.
Because Pacira manufactured Exparel according to FDA requirements,4 Pacira
is not subject to punitive damages.
F. Brashear Must Show Cause Why The Court Should Not Dismiss Pacira
Pharmaceuticals International, Inc., and Pacira Biosciences, Inc., For
Failure To Timely Serve.
As previously stated, Brashear only served Pacira Pharmaceuticals, Inc. But
Brashear’s Complaint also names two other defendants—Pacira Pharmaceuticals
International, Inc., and Pacira Biosciences, Inc.
In general, a plaintiff must serve a defendant within 90 days after filing the
complaint unless “the plaintiff shows good cause for the failure.” Fed. R. Civ. P. 4(m).
Otherwise, a Court may dismiss that defendant “on motion” from a party or on its

own after giving notice to the plaintiff. Id; see also Byrd v. Stone, 94 F.3d 217, 219
(6th Cir. 1996) (explaining that the Federal Rules of Civil Procedure require dismissal
without a showing of good cause to justify the failure to effect timely service). Thus,
after Brashear filed her Complaint on November 8, 2021, she needed to serve the two

4 The FDA initially approved Pacira’s new drug application in 2011. In 2018, the FDA
approved Exparel for use as a post-operative nerve block to provide pain relief after shoulder
surgeries. (Doc. 5, #38, 39).
defendants within ninety days or request an extension to do so. Now almost a year
and a half later, Brashear has done neither.
The Sixth Circuit prefers that this Court give Brashear “notice and an

opportunity to perfect service.” Pullen v. Broughton, 2023 WL 2384438, at *5 (S.D.
Ohio Mar. 7, 2023) (quoting Wesley v. Cuyahoga Cnty. Sheriff’s Dep’t, No. 1:19-cv-
1232, 2021 WL 1895007, at *3 (N.D. Ohio Mar. 18, 2021)). Therefore, the Court
ORDERS Brashear to SHOW CAUSE, no later than May 12, 2023, why the Court
should not dismiss this action as against Pacira Pharmaceuticals International, Inc.,
and Pacira Biosciences, Inc., without prejudice for failure to effect service, or in the
alternative explain why the Court should allow an extension of time to perfect such

service.
CONCLUSION
The main issue here was whether Pacira could “independently do under federal
law” what Brashear’s state-law claims required of it. Brashear has not provided
sufficient facts showing that Pacira could. Because federal regulations preempt

certain state law product liability claims, the Court GRANTS Pacira’s Motion to
Dismiss (Doc. 5) as to Brashear’s design defect, failure-to-warn, and punitive
damages claims and DISMISSES those claims WITH PREJUDICE. The Court
further GRANTS Pacira’s Motion to Dismiss (Doc. 5) as to Brashear’s false
marketing and supplier liability claims and DISMISSES those claims WITHOUT
PREJUDICE.
Separately, the Court ORDERS Brashear to SHOW CAUSE, no later than
May 12, 2023, why the Court should not dismiss this action as against Pacira
Pharmaceuticals International, Inc., and Pacira Biosciences, Inc., without prejudice
for failure to effect service, or in the alternative explain why the Court should allow
an extension of time to perfect service on those defendants. Failure to comply with
this Order may result in dismissal of those two defendants.
SO ORDERED.
April 25, 2023
DATE DOUGLAS R. COLE
UNITED STATES DISTRICT JUDGE

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10382251. Public record. Not legal advice.