IN THE SUPERIOR COURT OF THE STATE OF DELAWARE
CONNIE HAGAN AND ROY DALE
HAGAN, )
)
Plaintiffs, )
) C.A. No.: N20C-10-208 PEL
v. )
)
Boston Scientific Corporation )
(D/B/A Mansfield Scientific, Inc.) )
And Microvasive, Inc., )
)
Defendants. )
Submitted: January 4, 2021
Decided: May 12, 2021
ON DEFENDANT’S MOTION TO DISMISS
DENIED in part / GRANTED in part
OPINION AND ORDER
Robert J. Leoni, Esquire, Shelby & Leoni, 221 Main Street Wilmington, DE 19804,
Attorneys for Plaintiff.
Colleen Shields, Esquire and Alexandra D. Rogin, Esquire Eckert, Seamans, Cherin
& Mellott LLC, 221 Main Street, Stanton, DE 19804, Attorneys for Defendant
Jones, J.
Plaintiffs Connie Hagan and Roy Dale Hagan (collectively, the “Hagans” or
the “Plaintiffs”) have brought the instant products liability claim. The Plaintiffs
claim that Connie Hagan had surgery to implant a pelvic mesh device manufactured
by Defendant Boston Scientific Corp. (“Boston Scientific” or “Defendants”) inside
her in 2012, and that defects in the device have since caused her to suffer physical
injuries. Plaintiff has brough claims for Negligence, Breach of Warranty, Failure to
Warn, and Loss of Consortium. Boston Scientific has filed a Motion to Dismiss (the
“Motion”) the Complaint for failure to meet Delaware’s pleading standards and
failure to state a claim for which relief can be granted. The matter has been fully
briefed, and this Opinion will address the Defendant’s Motion. For the following
reasons, the Defendant’s Motion to Dismiss is GRANTED in part and DENIED in
part.
BACKGROUND
The background of this case is taken from the factual allegations set forth in
Plaintiffs’ Complaint in this action and the exhibits thereto. These allegations are
presumed to be true at the Motion to Dismiss stage of this litigation.
Defendant Boston Scientific Corporation is a Delaware Corporation engaged
in the business of designing, manufacturing, and selling medical devices. 1 One of
the devices produced by Boston Scientific is called the Uphold. The Uphold is a
1
Compl. At ¶ 3.
2
device targeted at women who suffer from pain, discomfort, and stress urinary
incontinence as a result of weakened or damaged vaginal walls.2
Plaintiffs Connie and Roy Dale Hagan are residents of Leoma, Tennessee.3
On or about September 12, 2012, Connie Hagan was implanted with an Uphold that
was designed, manufactured, packaged, labeled and sold by Boston Scientific. 4
Connie received the Uphold implantation with the intention of treating her for stress
urinary incontinence and pelvic organ prolapse.5 The Complaint asserts that after
receiving the implantation, Connie Rae Hagan began to suffer “serious bodily
injuries, including, but not limited to, lower back pain, lower pelvic pain and
pressure, incomplete bladder emptying, dyspareunia, pelvic and bladder pain,
urinary retention, abdominal pain, UTIs, yeast infections, extreme pain, infection of
her internal bodily tissue, urinary problems, nerve damage, and other injuries. . .”6
Connie underwent revision surgery to remove mesh from the Uphold device that had
eroded through her vaginal wall on October 24, 2019.7 Plaintiffs filed the instant
Complaint on October 23, 2020.
Boston Scientific filed the instant Motion to Dismiss on December 4, 2020.
The Motion asserts that the Hagans’ Complaint should be dismissed because: (1) the
Hagans’ claims are time-barred due to the expiration of the relevant statute of
2
Compl. At ¶ 4.
3
Compl. At ¶ 1.
4
Compl. At ¶ 43.
5
Compl. At ¶ 44.
6
Compl. At ¶ 46.
7
Pl. Reply Br. At 1.
3
limitations, (2) the Complaint has failed to plead the Plaintiffs’ claims with
particularity as required by Rules 8(a) and 9(b), and (3) the Complaint has failed to
state a claim upon which relief may be granted. This is the Court’s decision on the
Defendant’s Motion.
STANDARD OF REVIEW
Defendant has moved to dismiss this action pursuant to Superior Court
Rules of Civil Procedure 12(b)(6), 8(a), and 9(b).8
Under Superior Court Rule 12(b)(6), the Court may dismiss an action for
failure to state a claim upon which relief can be granted. In order to state a claim
upon which relief can be granted, a plaintiff need only make a “short and plain
statement of the claim showing that the pleader is entitled to relief.”9 However,
“conclusory allegations that lack a factual basis will not survive a motion to dismiss”
under this standard.10 On a Motion to Dismiss under to Rule 12(b)(6), the Court will
accept all well-pled allegations of the Complaint as true and will draw all reasonable
inferences that logically flow from those allegations in favor of the plaintiff as the
non-moving party.11 A Court can dismiss for failure to state a claim under Rule
8
Both the Plaintiffs and Defendant agree that Delaware procedural law and Tennessee substantive law (including
the Tennessee Products Liability Act) apply to the Plaintiffs’ claims. See Pl.’s Response to Def.’s Mot. To Dismiss,
at 8.
9
Supr. Ct. R. 12(b)(6).
10
Shah v. Am. Sols., Inc., N11C-07-196, 2012 WL 1413593, at *2 (Del. Super, Mar. 8, 2012).
11
Tanesha Maretta Williams v. Newark Country Club, 2016 WL 6781221 at 1 (Del.Super., November 2, 2016);
William L. Spence Jr., v. Allison J. Funk, et al., 396 A.2d 967, 968 (Del. 1978); Richard Clinton, et al. v. Enterprise
Rent-a-Car Co., et al., 977 A.2d 892, 895 (Del. 2009).
4
12(b)(6) if “it appears with reasonable certainty that the plaintiff could not prove any
set of facts that would entitle her to relief.”12
Rule 9(b) requires plaintiffs to plead claims for negligence with particularity.
To meet this standard, a plaintiff must include the “time, place, contents of the
alleged [] negligence, as well as the individual accused of committing” the negligent
act.13 The plaintiff must also plead “sufficient facts out of which a duty is implied
and a general averment of failure to discharge that duty.”14
STATUTE OF LIMITATIONS
A. PERSONAL INJURY CLAIMS
Boston Scientific first asserts that this action should be dismissed because the
Plaintiffs’ personal injury claims are time-barred due to expiration of the statute of
limitations. According to Defendant, Plaintiffs’ claims accrued on the date when
Connie Hagan underwent surgery to implant the Uphold device on September 12,
2012. This would mean that the Hagans’ personal injury claims would be barred
under either Delaware’s two-year limitations period for products liability actions or
Tennessee’s one-year limitations period for such actions. It is not necessary for this
Court to determine whether Tennessee or Delaware law controls the statute of
limitations in this action, because the Plaintiffs’ claims will survive a motion to
dismiss under either standard.
12
Rammuno v. Cawley, 705 A 2d 1029, 1034 (Del 1998).
13
TrueBlue, Inc. v. Leeds Equity Partners IV, LP, 2015 WL 5968726, at *6 (Del Super. Sept. 25, 2015).
14
State Farm Fire & Cas. Ins. Co. v. Gen. Elec. Co., 2009 WL 5177156, at *5 (Del. Super. Ct. Dec. 1, 2009).
5
Both Tennessee and Delaware apply the so-called “discovery rule” in order to
determine when a plaintiff’s cause of action accrues.15 The discovery rule “prevents
the anomaly of requiring that a plaintiff [must] file suit prior to knowledge of his
injury or. . . that she sue to vindicate a non-existent wrong, at a time when [the]
injury is unknown and unknowable.”16 The Tennessee legislature has codified the
discovery rule for products liability actions: “[a] cause of action for injury to the
person shall accrue on the date of the personal injury, not the date of the negligence
or the sale of a product.”17 Similarly, in Delaware, “an injury is sustained under [10
Del. C. § 8119] when the harmful effect first manifests itself and becomes physically
ascertainable.”18
Boston Scientific argues that the Hagans’ personal injury claims arose “no
later than [the date of Connie Hagan’s Uphold implant surgery on] September 12,
2012.”19 In Defendant’s view, the date of Connie Hagan’s surgery is the appropriate
accrual date for inquiry notice of her possible Uphold injury because in October of
2008 (roughly four years prior to Connie’s surgery) the Food & Drug Administration
had issued a Public Health Notification describing over 1,000 complaints relating to
pelvic mesh products such as the Uphold.20
15
See Teeters v. Currey, 518 S.W.2d 512, 517 (Tenn. 1974).
16
Id. at 515.
17
Tenn. Ann. Code Sect. 28-3-104(b)(1).
18
Burrell v. AstraZeneca, 2010 WL 370584 (Del. 2020).
19
Def.’s Reply Br., at 6.
20
Id.
6
The United States District Court for the Western District of Pennsylvania had
the opportunity to address a similar argument previously and rejected it in a case
which parallels the instant litigation. In Wallace v. Boston Scientific Corp., 2018 WL
6981220 (U.S. D.C. W.D. Pa), a plaintiff brought a personal injury lawsuit against
Boston Scientific based on alleged defects in a surgically implanted pelvic mesh
device. Boston Scientific moved to dismiss the case on the theory that the statute of
limitations began to run on the date of the plaintiff’s pelvic mesh surgery and had
thus expired. The Court denied the motion to dismiss on this basis, holding that “By
[Boston Scientific’s] logic, [the plaintiff] arguably would have had reason to know
of her alleged injury before she was even injured and well before she even
contemplated having surgery. . . the defendant’s statute of limitations argument
invites us to find that its product was so notoriously, inherently, and obviously
unsafe that the statute of limitations would begin to run from the moment it was
implanted in the plaintiff.”21 Instead, the Court held that the date when the statute of
limitations began to run was “not amenable to resolution on a motion to dismiss”
and instead was a “question [which could be] better resolved at the summary
judgment stage.”22
This Court will elect to adopt the well-reasoned holding of Wallace with
respect to the instant Motion to Dismiss. Boston Scientific’s argument that the
21
Id.
22
Id.
7
statute of limitations began to run on the date of Connie Hagan’s surgery on the
theory that the Hagans’ had inquiry notice of the Uphold’s defects is rejected. The
issue of when Connie Hagan’s personal injury claims accrued it not amenable to a
decision on the record established in this case thus far and cannot be decided at this
stage of the proceedings. Plaintiffs’ claim for loss of consortium in Count IV of the
Complaint is derivative of the outcome of the Plaintiffs’ underlying personal injury
claim, and therefore is not amenable to a decision at this stage.
B. BREACH OF WARRANTY CLAIMS
Boston Scientific has also moved to dismiss Plaintiffs’ claim for breach of
warranty on the basis that the statute of limitations had expired by the time
Plaintiffs filed their Complaint. Delaware applies a four-year statute of
limitations to breach of warranty claims.23 Breach of warranty claims accrue
upon “tender of delivery. . . regardless of the aggrieved party’s lack of knowledge
of the breach.” Here, the Plaintiffs’ breach of warranty claims accrued on the
date Connie Hagan’s pelvic mesh implantation surgery on September 12, 2012.
The statute of limitations for the breach of warranty claims expired four years
later on September 12, 2016. This was over four years before the Plaintiffs filed
the Complaint in the instant action on October 23, 2020. The statute of limitations
for a breach of warranty claim thus expired before the Plaintiffs initiated this
lawsuit. Accordingly, Boston Scientific’s Motion is GRANTED with respect to
23
10 Del. C. § 2-725
8
Plaintiffs’ claim for breach of warranty, and Plaintiff’s Count III for Breach of
Warranty is DISMISSED.
In summary, the Defendant’s Motion to Dismiss is DENIED with respect to
Plaintiffs’ counts I, II, and IV for personal injury and loss of consortium. Counts
I, II, and IV are subsumed and will be analyzed under the framework of the TPLA
for the remainder of this litigation. Defendant’s Motion to Dismiss is GRANTED
with respect to Plaintiff’s Count III for breach of warranty.
TENNESSEE PRODUCT LIABILITY ACT
Defendant has also moved to dismiss Plaintiffs’ product liability claims for
negligence, breach of warranty, and failure to warn based on the Tennessee Product
Liability Act (“TPLA”.) According to Defendant, “The TPLA governs all product
liability actions, including all actions for personal injury resulting from the
manufacture, construction, design. . . warning, instruction, marketing, packaging, or
labeling or any product.”24 Defendant argues that this means that Plaintiffs’ claims
for negligence and failure to warn are subsumed by the TPLA and that Plaintiffs
therefore cannot make independent claims for negligence, breach of warranty, and
failure to warn based on the allegations in the Complaint. In their response, Plaintiffs
do not dispute Defendant’s argument that the TPLA subsumes these claims.
Accordingly, the substance of these claims will be analyzed under the framework of
the TPLA’s standards for pleading products liability claims.
24
Def.’s Mot. To Dismiss at 9, citing Tenn. Code Ann. § 29-28-102(6) (internal quotations omitted.)
9
To state a claim under the TPLA, a plaintiff must adequately plead “(1) the
product was defective and/or unreasonably dangerous, (2) the defect existed at the
time the product left the manufacturer's control, and (3) the plaintiff's injury was
proximately caused by the defective product.”25 It is insufficient to claim that there
was “something wrong” with the product to adequately state a claim under this
standard. Instead, the Plaintiff must trace his or her injury to a specific defect of the
product.26 While the Plaintiffs’ Complaint does not appear to be specifically tailored
to this standard, it nevertheless pleads sufficient facts to meet it. 27 Read as a whole,
the Complaint gives fair notice of the claims asserted against Defendant and pleads
sufficient facts to state a claim under the TPLA.28
First, the Complaint adequately pleads that the product as issue was defective
and/or unreasonably dangerous. There are two tests under the TPLA to determine
whether a product is defective or unreasonably dangerous. The first test is called the
“consumer expectation test,” which requires a showing that “the product’s
performance was below reasonable minimum safety expectations of the ordinary
consumer having ordinary, common knowledge as to its characteristics.”29 Under
25
Sigler v. Am. Honda Motor Co., 532 F.3d 469, 483 (6th Cir. 2008); Moore v. C.R. Bard, 217 F. Supp. 3d 990, 996
(E.D. Tenn. 2016).
26
Tilden v. Gen. Elec. Co., 2012 WL 1023617 at *3 (E.D. Tenn. Mar. 26, 2012) (emphasis added); Fleming v.
Janssen Pharm., Inc., 186 F. Supp. 3d 826, 835 (W.D. Tenn. 2016).
27
See Higgs v. Gen. Motors Corp., 655 F. Supp. 22, 23 (E.D. Tenn. 1985)( “[I]t makes no difference whether the
complaint is couched in terms of negligence, strict liability or breach of warranty, it has generally been held in the
State of Tennessee that in order for a plaintiff to recover under any theory of product liability, the plaintiff must
establish that the product was defective and unreasonably dangerous at the time the product left the control of the
manufacturer.”)
28
See Otk Associates, LLC, 85 A.3d 696 (Del.Ch. Ct. 2014); see also, In re New Valley Corporation Derivative
Litigation., 2001 WL 563244 (Del. Ch. Ct. Jan. 11, 2001).
29
Jackson v. Gen. Motors Corp., 60 S.W.3d 800, 806 (Tenn. 13 2001).
10
the “prudent-manufacturer test,” the Court “imputes knowledge of the dangerous
condition to the manufacturer, and then asks whether, given that knowledge, a
prudent manufacturer would market the product.” The factual allegations of the
Complaint meet both standards.30 These factual allegations also lead to an inference
that the alleged defects of the Uphold existed at the time that the product left the
manufacturer’s control, and proximately caused the injuries alleged in the
Complaint.31
The Complaint does, however, not adequately plead that the Uphold which
was surgically implanted within Connie Hagan had a manufacturing defect which
caused her subsequent injuries. The Complaint summarily asserts that “Due to
defects in [] manufacturing [the Uphold] Device was unreasonably dangerous at the
time they left Defendant’s control” and that Defendant was “negligent in…
manufacturing” the Uphold, but does not claim that the Uphold which was implanted
within Connie Hagan deviated from the manufacturer’s specifications in any
material way from other units of the product, or plead any specific facts which would
lead to such an inference.32 The Complaint contains no alternative pleading that the
Uphold left Boston Scientific’s possession in a state which was not intended by the
manufacturer. The Complaint has therefore failed to adequately plead a claim for a
30
See Pl.’s Reply to Mot. To Dismiss at 8-9 (describing design and manufacturing defects alleged in the Complaint
in extensive detail.)
31
Additionally, these allegations are sufficiently detailed to satisfy the special pleading standards of Superior Court
Rule of Civil Procedure 9(b).
32
Compl. ¶¶ 57, 63
11
manufacturing defect. Defendant’s Motion is GRANTED to the extent that it asserts
a claim for a manufacturing defect under the TPLA.
Defendant next contends that Plaintiffs have not adequately plead a failure to
warn claim. To plead a failure to warn claim, a plaintiff must allege facts that state
that a product was “in a defective condition or otherwise unreasonably dangerous by
reason of the manufacturer's failure to provide an adequate warning informing users
of the dangers of that product.”33 A plaintiff asserting a TPLA claim based on a
failure to warn theory must show “(1) the warnings at issue were defective; (2) the
defective warning made the product unreasonably dangerous; and (3) the inadequate
labeling proximately caused the claimed injury.”34 In Defendant’s view, “Plaintiffs
do not identify any particular warning that Boston Scientific allegedly failed to
provide to Ms. Hagan’s unidentified prescribing physician. Nor do they assert any
facts to show these unspecified warnings were inadequate or defective.”35 Plaintiffs’
claim that the Complaint satisfied this standard because it alleges “that Boston
Scientific consistently underreported and withheld information about the propensity
of Defendant’s Pelvic Mesh Products to fail and cause injury and complications, and
misrepresented the efficacy and safety of the Product, through various means and
media, actively and intentionally misleading the FDA, the medical community,
patients, and the public at large.”36 These allegations in Plaintiffs’ Complaint,
33
Goins v. Clorox Co., 926 F.2d 559, 561 (6th Cir. 1991) (citations omitted).
34
Moore, 217 F. Supp. 3d at 995
35
Def.’s Mot. To Dismiss at 14.
36
Pl.’s Reply to Mot. To Dismiss at 16 (citing Compl. At ¶ 9).
12
especially those allegations relating to the underreporting of injuries do the use of
the product, are sufficient to adequately plead a claim for failure to warn under the
Tennessee Act.
Defendant’s Motion to Dismiss also argues that Plaintiffs failed to adequately
plead a claim for breach of warranty. As discussed supra, the statute of limitations
for a breach of warranty claim expired before the Hagans filed their Complaint.
Since the statue of limitations on the breach of warranty claim has expired, the Court
will not address whether Plaintiff has adequately stated a claim for breach of
warranty in this Opinion.
In summary, Plaintiff has adequately plead a claim for violation of the TPLA.
While the allegations in the Complaint may not have been specifically tailored to the
TPLA, the Complaint nevertheless states facts sufficient to allege a breach of the
statute. Defendant’s Motion to Dismiss is DENIED with respect to this claim on this
basis. However, Plaintiff has plead no facts indicating that the Uphold was
defectively manufactured, and Defendant’s Motion to Dismiss is GRANTED with
respect to any manufacturing defect claim under the framework of the TPLA. Since
the claim for breach of warranty is time-barred due to expiration of the statute of
limitations, the Court will not address the parties’ arguments on this issue.
LEARNED INTERMEDIARY DOCTRINE
Defendant next moves to dismiss the Hagans’ Complaint based on the
Learned Intermediary Doctrine. The Learned Intermediary Doctrine is a legal
13
principle which holds that a manufacturer’s duty to warn runs to the physician who
prescribes a medication or treatment regimen, rather than an individual patient or the
general public. The Doctrine acts as an affirmative defense which protects
manufacturers from liability when the physician who prescribed a treatment regimen
was independently aware of the risks involved in the device’s use. For the Doctrine
to apply, however, “there must be either a warning – meaningful and complete so as
to be understood by the recipient – or an individualized medical judgment that this
treatment or medication is necessary and desirable for this patient.” The issue of
whether adequate warnings were issued is factual and is usually resolved by the trier
of fact.37
In their Complaint, the Plaintiffs allege the following:
The Defendant has consistently underreported and
withheld information about the propensity of Defendant’s
Pelvic Mesh Products to fail and cause injury and
complications, and have misrepresented the efficacy and
safety of the Product, through various means and media,
actively and intentionally misleading the FDA, the medical
community, patients, and the public at large.38
While these allegations could have been fleshed out in greater detail and
would have been stronger had they included a claim that the surgeon who implanted
the Uphold device would not have done so if her or she had received an adequate
warning, they are nevertheless sufficient to plead a claim for failure to provide an
37
See Restatement (Third) of Torts: Prods. Liab. § 2 cmt. i, illus. 11, at 31 (1998) (“Whether the warning actually
given was reasonable in the circumstances is to be decided by the trier of fact.”)
38
Compl. ¶ 9 (emphasis in original)
14
adequate warning to Connie Hagans’ treating physicians at this stage of this
litigation. It is possible that Boston Scientific will be able to demonstrate that the
physicians in question received an adequate warning following full discovery. At
that point, Boston Scientific may re-assert an affirmative defense based on the
Learned Intermediary Doctrine with the benefit of a fully-developed factual record.
At the Motion to Dismiss stage, this basis for dismissal is DENIED.
CONCLUSION
For the reasons stated above, Defendant’s Motion to Dismiss is GRANTED
with respect to Plaintiff’s Count II for breach of warranty as this claim is time-barred.
Counts I, III, and IV of the Complaint are subsumed by the TPLA, and the
Defendant’s Motion to Dismiss is DENIED with respect to these claims.
IT IS SO ORDERED.
/s/ Francis J. Jones, Jr.
Francis J. Jones, Judge
cc: File&ServeXpress
15