Monroe v. Medtronic, Inc. et al
Filing
31
Judge Nathaniel M. Gorton: ORDER entered. MEMORANDUM AND ORDER: For the foregoing reasons, the motion of defendants to dismiss plaintiff's complaint (Docket No. 10 ) is,(a) with respect to Counts III, VII, VIII, IX, XI and the claim pursuant to the Magnuson-Moss Warranty Act in Count V, ALLOWED, but(b) otherwise, DENIED.There will be no further amendments to the complaint.So ordered. (Vieira, Leonardo)
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 1 of 25
United States District Court
District of Massachusetts
)
)
)
)
)
)
)
)
)
)
)
Quanita Monroe,
Plaintiff,
v.
Medtronic, Inc. et al.,
Defendants.
Civil Action No.
20-10144-NMG
MEMORANDUM & ORDER
GORTON, J.
Plaintiff Quanita Monroe (“plaintiff” or “Monroe”) alleges
that Medtronic, Inc. (“Medtronic”), its subsidiaries Covidien LP
and Covidien U.S. Holdings, Inc. (collectively, “Covidien”) and
numerous unknown individuals involved in the manufacturing and
distribution process (collectively, with Medtronic and Covidien,
“defendants”) are liable for her severe internal injuries caused
by a medical mesh product implanted during hernia repair
surgery.
Pending before the Court is defendants’ motion to
dismiss plaintiff’s complaint.
-1-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 2 of 25
I.
Factual Background
Medtronic is a medical device manufacturer based in Ireland
with a United States principal place of business in Minnesota.
In 2015, Medtronic acquired each of the medical device companies
that comprise Covidien, both of which are incorporated in
Delaware and have their principal places of business in
Massachusetts.
Covidien manufactures several different kinds of hernia
mesh, including a polyester surgical mesh known as Parietex
Composite (“PCO”) mesh.
PCO mesh is a two-sided composite mesh
which, like other such meshes, is used to add support to
muscular walls and prevent the recurrence of hernias.
It has a
protective absorbable collagen barrier to prevent tissue
attachment on one side and a polyester textile on the other
side.
Defendants allegedly secured approval to market PCO mesh
from the U.S. Food and Drug Administration (“FDA”) pursuant to a
section of the Food, Drug and Cosmetic Act (“FDCA”) that applies
to devices found to be “substantially equivalent” in design and
function to a device already legally on the market. 21 U.S.C. §
360c(f) and (i).
That process, plaintiff avers, allowed
-2-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 3 of 25
defendants to forego pre-market clinical studies and research
intended to ensure the safety of the product.
Monroe, a resident of Nebraska, alleges that she underwent
surgery to repair an inguinal hernia in May, 2013, during which
PCO mesh manufactured by defendants was implanted.
She alleges
that she suffered from chronic abdominal pain in the months
following the surgery and that she underwent corrective surgery
on an unrecalled date to remove or revise part of the implanted
mesh.
In January, 2017, Monroe claims she went to the emergency
room complaining of severe abdominal pain.
Exploratory surgery
purportedly revealed that the PCO mesh had eroded into her small
intestine, requiring the immediate removal of the mesh and a
portion of her bowel.
Plaintiff contends that, as a result of defendants’
negligent conduct in the manufacturing and distribution of PCO
mesh, she has suffered severe and permanent injuries.
II.
Procedural Background
Plaintiff filed her original complaint in this Court on
January 23, 2020, alleging jurisdiction based upon diversity of
citizenship.
She amended her complaint first in February, 2020,
and then again in April, 2020.
In her second amended complaint
-3-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 4 of 25
(“the complaint”), plaintiff alleges 11 counts against the
defendants: negligence (Count I); strict liability for defective
design (Count II); strict liability for defective manufacturing
(Count III); strict liability for failure to warn (Count IV);
violations of 15 U.S.C. § 2301 et seq. and Neb. Rev. Stat. § 591602 et seq. (Count V); unjust enrichment (Count VI); fraudulent
concealment (Count VII); negligent misrepresentation (Count
VIII); negligence per se in violation of 21 U.S.C. § 33l(e) and
21 C.F.R. § 806.01(a)(l) (Count IX); vicarious liability (Count
X); and punitive damages (Count XI).
Defendants filed their motion to dismiss plaintiff’s
complaint pursuant to Fed. R. Civ. P. 12(b)(6) and 9(b) on May
11, 2020.
Pursuant to a joint motion of the parties, the case
was stayed in June, 2020, pending a decision of the Judicial
Panel on Multidistrict Litigation (“JPML”) as to whether to
consolidate the case with 11 other pending federal actions
related to Covidien’s hernia mesh products.
In August, 2020,
the JPML declined to consolidate the cases for coordinated
pretrial treatment and defendants subsequently moved to lift the
stay and renew their motion to dismiss.
This Court lifted the
stay in September, 2020, and plaintiff thereafter timely opposed
the motion to dismiss.
-4-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 5 of 25
III. Motion to Dismiss
A.
Legal Standard
To survive a motion to dismiss, a claim must contain
sufficient factual matter, accepted as true, to “state a claim
to relief that is plausible on its face.” Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 570 (2007).
In considering the merits of
a motion to dismiss, the Court may only look to the facts
alleged in the pleadings, documents attached as exhibits or
incorporated by reference and matters of which judicial notice
can be taken. Nollet v. Justices of Trial Court of Mass., 83 F.
Supp. 2d 204, 208 (D. Mass. 2000), aff’d, 228 F.3d 1127 (1st
Cir. 2000).
Furthermore, the Court must accept all factual allegations
in the claim as true and draw all reasonable inferences in the
claimant’s favor. Langadinos v. Am. Airlines, Inc., 199 F.3d 68,
69 (1st Cir. 2000).
If the facts in the claim are sufficient to
state a cause of action, a motion to dismiss must be denied. See
Nollet, 83 F. Supp. 2d at 208.
Although a court must accept as true all the factual
allegations in a claim, that doctrine is not applicable to legal
conclusions. Ashcroft v. Iqbal, 556 U.S. 662 (2009).
recitals of legal elements which are supported by mere
Threadbare
-5-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 6 of 25
conclusory statements do not suffice to state a cause of action.
Id.
B.
Application
1.
Choice of Law
As a preliminary matter, this Court must determine what law
applies to plaintiff’s claims.
In diversity actions, a federal
court must apply the law that would be applied under the choice
of law rules of the forum state. Levin v. Dalva Bros., 459 F.3d
68, 73 (1st Cir. 2006).
In Massachusetts, courts apply a
“functional approach” to choice of law that is “explicitly
guided by the Restatement (Second) of Conflict of Laws (1971).”
Id. at 74.
Under that approach, tort claims are governed by the
law of the state where the injury occurred unless another state
has a more significant relationship to the underlying cause of
action. Watkins v. Omni Life Sci., Inc., 692 F. Supp. 2d 170,
174 (D. Mass. 2010).
The parties conclude that Nebraska law should apply to
plaintiff’s claim and this Court agrees.
The implantation of
the mesh and the subsequent injuries and treatment appear to
have occurred in Nebraska, where plaintiff also resides.
The
only state with any other significant connection to the case is
Massachusetts, where Covidien has its principal place of
-6-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 7 of 25
business, but the cause of action is clearly more closely
related to Nebraska than Massachusetts.
Although choice of law
analysis may be premature at the motion-to-dismiss stage in some
circumstances, here the parties are in agreement and the facts
are sufficiently clear that delay in making such a determination
“would serve no useful purpose.” Foisie v. Worcester Polytechnic
Inst., 967 F.3d 27, 42 (1st Cir. 2020).
Therefore, this Court
will apply Nebraska law.
2.
Strict Liability (Counts II, III and IV)
a. Design Defect
To state a claim of strict liability for a design defect
under Nebraska law, a plaintiff must show that
(1) the defendant placed the product on the market for use
and knew, or in the exercise of reasonable care should have
known, that the product would be used without inspection
for defects; (2) the product was in a defective condition
when it was placed on the market and left the defendant's
possession; (3) the defect is the proximate or a
proximately contributing cause of the plaintiff’s injury
sustained while the product was being used in a way and for
the general purpose for which it was designed and intended;
(4) the defect, if existent, rendered the product
unreasonably dangerous and unsafe for its intended use; and
(5) the plaintiff’s damages were a direct and proximate
result of the alleged defect.
Vallejo v. Amgen, Inc., 2014 U.S. Dist. LEXIS 138455, at *18 (D.
Neb. 2014).
To satisfy the fourth element, a plaintiff must
allege facts showing that the product was
-7-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 8 of 25
dangerous to an extent beyond that which would be
contemplated by the ordinary consumer who purchases it,
with the ordinary knowledge common to the community as to
its characteristics.
Id. at *18-19 (quoting Freeman v. Hoffman-La Roche, Inc., 260
Neb. 552, 569 (2000)).
Defendants contend that they are entitled to dismissal of
Monroe’s design defect claim because 1) her allegations that the
PCO mesh was unreasonably dangerous or defectively designed are
conclusory and 2) she does not explain how an alleged defect in
the PCO mesh caused her injuries.
Liberally construing Monroe’s complaint, this Court
concludes that she has proffered facts sufficient to state a
strict liability design defect claim.
Monroe satisfies the
first element because she alleged that defendants placed the PCO
mesh on the market and knew that it would be used without
inspection.
She also satisfies the second element by alleging
that the PCO mesh was defective when placed on the market
because the absorbable collagen barrier and unsealed edges fail
to protect against damage caused by the mesh’s polyester textile
component.
With respect to the fourth element, Monroe alleged that the
defects of PCO mesh rendered it unreasonably dangerous and that
the PCO mesh products are “considerably more harmful and
-8-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 9 of 25
inadequate than other meshes or methods for hernia repair.”
To
support such a claim, plaintiff alleges that the PCO mesh causes
a severe inflammatory response even when properly implanted.
She further avers that the mesh, implanted in her according to
defendants’ instructions, eroded into her small intestine and
required surgical removal of part of her bowel.
Those factual
allegations, accepted as true, permit a reasonable inference
that the risk of injury caused by the PCO mesh was greater than
an ordinary consumer would expect.
Finally, Monroe meets the third and fifth elements because
she asserts that the implantation of defendants’ PCO mesh
directly and proximately caused her abdominal pain and the
erosion of a portion of her small intestine.
Citing several
recent cases in which courts have dismissed complaints raising
similar claims, defendants insist that plaintiff is required to
demonstrate precisely how the alleged defect caused her
injuries.
Yet plaintiff’s burden on a motion to dismiss does
not require her to prove such a connection conclusively. See,
e.g., Dye v. Covidien LP, 2020 U.S. Dist. LEXIS 105676, at *12
(S.D. Fla. 2020) (“It would be unreasonable for the Court to
require Plaintiff to plead exactly how the implanted Product is
defective and how it caused his alleged injuries when Plaintiff
has not yet been afforded discovery or the benefit of expert
-9-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 10 of 25
testimony.”).
Rather, it is sufficient that Monroe has alleged
that the PCO mesh was defective and proffered facts to support a
reasonable inference that the defect caused her injuries.
Accordingly, Monroe has stated a plausible theory of
recovery based on a design defect.
b. Manufacturing Defect
Defendants move to dismiss Monroe’s manufacturing defect
claim on the ground that she fails to allege properly the
elements of such a claim.
Manufacturing defects are related to but differ
significantly from design defects.
A design defect exists when
“the product meets the specifications of the manufacturer but
[it] nonetheless poses an unreasonable risk of danger.” Jay v.
Moog Auto., Inc., 264 Neb. 875, 880 (2002).
In contrast, a
manufacturing defect exists when “the product differs from the
plan and specifications of the manufacturer.” Freeman, 260 Neb.
at 569 (citing Rahmig v. Mosley Machinery Co., 226 Neb. 423, 438
(1987)).
Monroe pleads no facts indicating that the PCO mesh used to
repair her hernia differed in any way from defendants’ plan or
specifications for that product.
Instead, plaintiff repeats her
allegations that defendants’ PCO mesh products are defective in
-10-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 11 of 25
their design.
To the extent that plaintiff’s allegations can be
construed as complaining of a manufacturing defect, they are
entirely conclusory and therefore do not suffice to state a
cause of action.
Because plaintiff has not demonstrated that
the PCO mesh deviated from its intended specifications, she has
failed to plead a manufacturing defect claim.
c. Failure to Warn
Under Nebraska law,
[a] manufacturer or other seller is subject to liability
for failing either to warn or adequately to warn about a
risk or hazard inherent in the way a product is designed
that is related to the intended uses as well as the
reasonably foreseeable uses that may be made of the
products it sells.
Vallejo, 2014 U.S. Dist. LEXIS 138455, at *5-6.
Nebraska courts
have applied the learned intermediary doctrine in products
liability actions involving the warnings for pharmaceutical
products. Id. at *6.
Under that doctrine, a defendant’s duty to
warn is discharged if adequate warnings were provided to the
plaintiff’s healthcare provider rather than to the plaintiff
herself. Id.
The adequacy of specific warnings in the context
of pharmaceutical products is assessed under a “reasonableness”
standard. Id. at 7.
Further, the deficient warnings must be the
cause of the plaintiff’s injuries, meaning that the plaintiff
must demonstrate that “the treating physician would not have
-11-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 12 of 25
prescribed the medical device” if a different warning had been
provided. Langner v. Boston Sci. Corp., 2020 U.S. Dist. LEXIS
222125, at *11 (D. Neb. 2020).
The parties agree that the learned intermediary doctrine
applies to plaintiff’s failure to warn claim.
Plaintiff submits
that the Instructions for Use (“IFU”) did not contain adequate
warnings with respect to the defects and dangers of the PCO
mesh.
Defendants respond, however, that plaintiff has failed to
allege sufficiently 1) that the warnings in the IFU provided to
plaintiff’s physicians were inadequate or 2) how any purported
defect in the warnings caused her injuries.
Defendants’ arguments are unavailing.
First, Monroe
identifies numerous alleged deficiencies with respect to the
warnings in the IFU provided to her physicians.
Although many
of the purported deficiencies relate to unexperienced
complications, plaintiff also alleges that 1) the IFU failed to
warn of risks such as “erosion and migration through adjacent
tissue and viscera,” the primary complication of which she
complains, and 2) the IFU lacked warnings as to the frequency,
severity and duration of complications.
Second, Monroe sufficiently alleges that the defective
warnings caused her injuries by contending that her physician
-12-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 13 of 25
would not have used defendants’ product if proper warnings had
existed.
She maintains that her physician was induced to use
the PCO mesh based on defendants’ representations in the IFU and
that her physician would not have implanted the mesh if proper
warnings had been provided.
Accordingly, Monroe has stated a claim for strict liability
based on a failure to warn.
3.
Negligence (Count I)
To state a claim for negligence in a products liability
case under Nebraska law, a plaintiff must plead the elements of
duty, breach, causation and damages. Jay, 264 Neb. at 880.
The
primary inquiry is “whether the manufacturer’s conduct was
reasonable in view of the foreseeable risk of injury.” Id. at
880.
Here, defendants contend that Monroe has not plead
adequately the elements of breach or causation.
Plaintiff alleges that defendants were negligent in
designing, testing, inspecting, manufacturing, packaging,
labeling, marketing, distributing, and preparing written
instructions and warnings [for PCO mesh products].
Because Monroe has plausibly stated a claim for strict liability
based on a design defect and a failure to warn, this Court
concludes that she has also alleged a claim for negligence. See
Dye, 2020 U.S. Dist. LEXIS 105676, at *25-27 (holding that
-13-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 14 of 25
plaintiff stated a claim for negligent manufacturing where he
also plausibly stated a claim for strict liability design defect
and manufacturing defect).
Insofar as her negligence claim is
based on a manufacturing defect that differs from the product’s
intended design, however, such a claim cannot succeed for the
same reason that her strict liability manufacturing defect claim
fails.
4.
Consumer Protection Violations (Count V)
Monroe alleges that defendants engaged in unfair and
deceptive conduct in violation of two consumer protection laws:
the Magnuson-Moss Warranty Act (“MMWA”), 15 U.S.C. § 2301 et
seq., and the Nebraska Consumer Protection Act (“NCPA”), Neb.
Rev. Stat. § 59-1602 et seq.
Defendants urge this Court to
dismiss both claims as inadequately pled.
The MMWA
affords consumers a private cause of action for violations
of the substantive provisions of the Act and for breach of
a written or implied warranty.
Sanford v. Ektelon/Prince Sports Group, Inc., 1999 U.S. Dist.
LEXIS 17458, at *15 (D. Neb. 1999).
The MMWA does not create a
federal cause of action for personal injury claims based on
breach of warranty.
As a result, plaintiffs must demonstrate a
specific substantive violation of the MMWA to support a claim
-14-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 15 of 25
for personal injuries. Id. at *20-22; Boelens v. Redman Homes,
Inc., 748 F.2d 1058, 1065-66 (5th Cir. 1984).
Monroe’s MMWA claim is similar to the one discussed in
Sanford, where the court found that the plaintiff failed to
state a claim under the substantive provisions.
Indeed, her
allegations “are of a generic nature” and “[n]o violations of
[the substantive provisions] are specifically alleged.” Sanford,
1999 U.S. Dist. LEXIS 17458, at *23.
Monroe similarly does not
allege that defendants attempted to disclaim any warranties,
which could indicate a substantive violation.
For those
reasons, Monroe has not stated a claim for a violation of the
MMWA.
Under the NCPA,
[u]nfair methods of competition and unfair or deceptive
acts or practices in the conduct of any trade or commerce
shall be unlawful.
§ 59-1602.
To state a claim of a violation of the NCPA, a
plaintiff must allege that the defendant
(1) engaged in an act or practice that constitutes an
unfair method of competition or a deceptive trade practice
in the conduct of any trade or commerce; (2) that the
defendant’s conduct affected the public interest; (3) that
the plaintiff was injured in its business or property by
[the defendant’s] unfair method of competition or deceptive
trade practice; and (4) that plaintiff suffered damages.
-15-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 16 of 25
Oriental Trading Co., Inc. v. Yagoozon, Inc., 2016 WL 2859603,
at *5 (D. Neb. 2016) (internal quotation marks omitted).
Pursuant to the public interest requirement, the unfair or
deceptive practice complained of must “directly or indirectly
affect[] the people of the State of Nebraska.” Anderson v.
Travelex Ins. Servs., 2019 U.S. Dist. LEXIS 73407, at *9 (D.
Neb. 2019); § 59-1601(2).
Monroe has stated a claim under the NCPA, albeit just
barely.
Liberally construing plaintiff’s complaint, she alleges
that defendants engaged in unfair and deceptive conduct by
creating a product that is purportedly dangerous in its design
and use of polyester and failing to warn about the risks
inherent in the PCO mesh, including its alleged propensity to
cause inflammation and erosion into surrounding tissue.
She
further alleges that those unfair practices led her physicians
to use the PCO mesh to repair her hernia and that the implanted
mesh eroded into her small intestine, causing her damage.
Finally, plaintiff alleged facts sufficient to establish
that defendants’ deceptive practices had an impact on the public
interest.
Her allegations raise a reasonable inference that the
defects in the PCO mesh and accompanying IFU were not limited to
the individual product used in her surgery but rather in all PCO
-16-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 17 of 25
mesh products distributed across the country, including in
Nebraska.
Accordingly, defendants are not entitled to dismissal of
Monroe’s claim under the NCPA.
5.
Unjust Enrichment (Count VI)
Defendants move to dismiss Count VI on the ground that
Monroe has not established that they were unjustly enriched by
her use of the PCO mesh.
Unjust enrichment occurs when “there has been a transfer of
a benefit without adequate legal ground.” Kalkowski v. Neb.
Nat'l Trails Museum Found. Inc., 290 Neb. 798, 806 (2015).
To
state an unjust enrichment claim, a plaintiff must plead that
“[he or she] bestowed a benefit on the defendants and that it
would be unjust to allow the defendants to retain that benefit.”
Abrahamson v. First Nat'l Bank of Holdrege, 2006 U.S. Dist.
LEXIS 20045, at *20 (D. Neb. 2006).
Plaintiff alleges that 1) she paid for defendants’ PCO mesh
to repair her hernia and that defendants accepted payment from
plaintiff and others on her behalf, 2) she did not receive the
safe and effective medical device for which she paid and 3)
defendants’ PCO mesh eroded into her bowel and required surgery
to remove.
Monroe’s allegations are therefore sufficient to
-17-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 18 of 25
raise a reasonable inference that it would be inequitable for
defendants to retain the benefit they received in the form of
payment for the PCO mesh used in her hernia repair operation.
Accordingly, plaintiff has stated a claim for unjust enrichment.
6.
Fraudulent Concealment and Negligent
Misrepresentation (Counts VII and VIII)
Defendants move to dismiss Counts VII and VIII for failure
to meet the heightened pleading requirements of Fed. R. Civ. P.
9(b).
To make a prima facie case for negligent misrepresentation
under Nebraska law, a plaintiff must demonstrate that
(1) a representation was made; (2) the representation was
false; (3) the representation was made recklessly or
negligently as to its truth; (4) the representation was
made with the intention that it should be relied upon; (5)
the representation was relied upon; and (6) damages were
suffered as a consequence.
Olsen v. Nelnet, Inc., 392 F. Supp. 3d 1006, 1019 (D. Neb.
2019).
Similarly, to state a claim for fraudulent concealment
under Nebraska law, a plaintiff must show that
(1) the defendant had a duty to disclose a material fact;
(2) the defendant, with knowledge of the material fact,
concealed the fact; (3) the material fact was not within
the plaintiff’s reasonably diligent attention, observation,
and judgment; (4) the defendant concealed the fact with the
intention that the plaintiff act in response to the
concealment or suppression; (5) the plaintiff, reasonably
relying on the fact or facts as the plaintiff believed them
-18-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 19 of 25
to be as the result of the concealment, acted or withheld
action; and (6) the plaintiff was damaged by the
plaintiff’s action or inaction in response to the
concealment.
Knights of Columbus Council 3152 v. KFS Bd, Inc., 280 Neb. 904,
925-26 (2010).
Under the Federal Rules, a party alleging fraud
must state with particularity the circumstances constituting
fraud. Fed. R. Civ. P. 9(b).
To satisfy that requirement, a
complaint “must plead the who, what, where, when, and how of the
alleged fraud” and conclusory allegations of fraudulent or
deceptive conduct are insufficient. Gray v. Wiese, 2016 U.S.
Dist. LEXIS 113870, at *8-9 (D. Neb. 2016) (internal quotations
omitted).
Because negligent representation is “a subspecies of
fraud,” the particularity rule applies to both negligent
misrepresentation and fraudulent concealment claims. Superior
Servs. v. Universal Warranty Corp., 2016 U.S. Dist. LEXIS 66756,
at *16-18 (D. Neb. 2016).
Monroe fails to state a claim for either fraudulent
concealment or negligent misrepresentation under the heightened
pleading requirements of Fed. R. Civ. P. 9(b).
She makes only
vague allegations that defendants concealed or misrepresented
the “serious side effects” of the PCO mesh and that it “had not
been adequately tested.”
She also makes no attempt to specify
the timeframe and manner in which the misrepresentations were
-19-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 20 of 25
made, alleging that defendants concealed “the true defective
nature” of the PCO mesh “[a]t all relevant times.”
Such vague
recitation of the elements of each claim is insufficient “to
allow a party to quickly and specifically respond to a
potentially damaging allegation” as required by Rule 9(b).
Olsen, 392 F. Supp. 3d at 1020.
Accordingly, Monroe has failed
to state a claim of either fraudulent concealment or negligent
misrepresentation.
7.
Negligence Per Se (Count IX)
Monroe contends that defendants are negligent per se for
“failure to establish or maintain certain records, or make
certain reports, with respect to medical devices” in violation
of 21 U.S.C. § 331(e) and for “[f]ailure to report in writing to
FDA a correction, removal, and/or discontinuation of a device
conducted to reduce a risk to health posed by the device” in
violation of 21 C.F.R. § 806.01(a)(1).
The Nebraska Supreme Court has repeatedly held that
the violation of a regulation or statute is not negligence
per se, but may be evidence of negligence to be considered
with all the other evidence in the case.
Certain Underwriters at Lloyd's v. Southern Pride Trucking,
Inc., 301 F. Supp. 3d 949, 959 (D. Neb. 2018) (quoting Scheele
v. Rains, 292 Neb. 974, 982 (2016)).
-20-
Accordingly, although
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 21 of 25
defendants’ alleged violations may be evidence of negligence,
they cannot constitute negligence per se and thus Monroe’s claim
is not viable.
Even if the violation of a statute or regulation did
constitute negligence per se under Nebraska law, plaintiff’s
allegations are wholly conclusory and unsupported by sufficient
facts.
Therefore, Monroe’s negligence per se claims will be
dismissed.
8.
Vicarious Liability (Count X)
Under the doctrine of respondeat superior,
an employer may be held vicariously liable for the
negligence or intentional torts of its employee, provided
the employee was acting within the scope of the employer's
business.
Pearce v. Werner Enters., Inc., 116 F. Supp. 3d 948, 953 (D.
Neb. 2015).
Defendants urge dismissal of Monroe’s vicarious liability
claim because it rests on the validity of her other claims, all
of which must fail according to defendants.
Because this Court
has already determined that several of Monroe’s claims will
survive the motion to dismiss, it will not dismiss her claim for
vicarious liability on that basis.
-21-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 22 of 25
Liberally construing Monroe’s complaint, she has stated a
claim of vicarious liability.
She avers that any alleged
actions or omissions of defendants were committed by their
agents or employees within the scope of their employment and
with the full authorization or ratification of defendants.
Her
factual allegations raise the reasonable inference that the
manufacturing, advertising and distribution of the PCO mesh of
which Monroe complains was conducted by defendants’ agents or
employees within the scope of their employment.
Accordingly,
defendants are not entitled to dismissal of Monroe’s claim for
vicarious liability.
9.
Punitive Damages (Count XI)
Finally, defendants urge this Court to dismiss plaintiff’s
claim for punitive damages.
It is well-established that
Nebraska law does not permit a plaintiff to obtain punitive
damages over and above full compensation for the
plaintiff’s injuries.
Golnick v. Callender, 290 Neb. 395, 404 (2015); see also State
ex rel. Cherry v. Burns, 258 Neb. 216, 226 (1999) (“[P]unitive
damages contravene Neb. Const. art. 7, § 5, and are not
allowed.”)
-22-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 23 of 25
Monroe attempts to preserve her claim for punitive damages
by highlighting that the United States Supreme Court has held
that punitive damages are recoverable under 42 U.S.C. § 1983
when the defendant's conduct is shown to be motivated by
evil motive or intent, or when it involves reckless or
callous indifference to the federally protected rights of
others.
Burns, 258 Neb. at 227.
and without merit.
Plaintiff’s argument is both perplexing
She brings no claim under § 1983 or any
other federal civil rights law and thus the cited exception to
Nebraska’s prohibition on punitive damages does not apply.
Accordingly, Monroe can prove no set of facts that would entitle
her to punitive damages and her claim in that regard will be
dismissed.
IV.
Leave to Amend Complaint
In her memorandum in opposition to defendants’ motion to
dismiss, Monroe requests that, if any of her claims are
dismissed, she be granted leave to amend her complaint.
Under the Federal Rules of Civil Procedure, leave to amend
should be “freely give[n]” in instances in which “justice so
requires.” Fed. R. Civ. P. 15(a)(2).
A district court may deny
such a request, however, when it is characterized by “undue
delay, bad faith, futility, [or] the absence of due diligence on
the movant’s part.” Nikitine v. Wilmington Trust Co., 715 F.3d
-23-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 24 of 25
388, 390 (1st Cir. 2013).
Plaintiffs have the burden to
demonstrate why a court should allow leave to amend. See Newman
v. Metro. Life Ins. Co., 2013 U.S. Dist. LEXIS 32286, at *31 (D.
Mass. 2013).
This Court sees no reason to allow plaintiff leave to amend
her complaint any further.
She has already amended her
complaint twice and has failed to provide a proposed amended
complaint or proffer any basis for yet another amendment. See
id.(denying leave to amend where plaintiff “failed to provide a
proposed amended complaint or articulate the basis for [her]
additional claims”); Upshaw v. Andrade, 2011 U.S. Dist. LEXIS
91985, at *5 (D. Mass. 2011) (finding a plaintiff’s motions for
leave to amend “deficient because they fail to attach a proposed
amended complaint”); Noonan v. Wonderland Greyhound Park Realty
LLC, 723 F. Supp. 2d 298, 344 n.117 (D. Mass. 2010) (explaining
that “in the event [the plaintiff] seeks leave to amend . . . ,
he must file the proper motion for leave with supporting legal
authority, see LR. 7.1, and attach a copy of the proposed
amended complaint”).
-24-
Case 1:20-cv-10144-NMG Document 31 Filed 01/06/21 Page 25 of 25
ORDER
For the foregoing reasons, the motion of defendants to
dismiss plaintiff’s complaint (Docket No. 10) is,
(a)
with respect to Counts III, VII, VIII, IX, XI and the
claim pursuant to the Magnuson-Moss Warranty Act in
Count V, ALLOWED, but
(b)
otherwise, DENIED.
There will be no further amendments to the complaint.
So ordered.
/s/ Nathaniel M. Gorton
Nathaniel M. Gorton
United States District Judge
Dated January 6, 2021
-25-
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?