Hagan, et al. v. Boston Scientific Corporation, et al.

2021 | Cited 0 times | Superior Court of Delaware | May 12, 2021


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



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 s . The Plaintiffs

claim that Connie Hagan had surgery to implant a pelvic mesh device manufactured

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

the failure to state a claim for which relief can be granted. The matter has been fully

GRANTED in part and DENIED in



The background of this case is taken from the factual allegations set forth in

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. 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, 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 : (1) the

-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. limitations, (2) 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 the



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



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 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). 12(b)(6) if 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 act. 13

The plaintiff must also plead and a general averment of failure to discharge that 14



Boston Scientific first asserts that this action should be dismissed because the

personal injury claims are time-barred due to expiration of the statute of

limitations. According to Defendant, Connie Hagan underwent surgery to implant the Uphold device on September 12,

2012. under either Delaware two-year limitations period for products liability actions or

-year limitations period for such actions. It is not necessary for this

Court to determine whether Tennessee or Delaware law controls the statute of

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). Both Tennessee and Delaware apply the so- 15

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]

16 The Tennessee legislature has codified the

person shall accrue on the date of the personal injury, not the date of the negligence

17 Similarly, an injury is sustained under [10

Del. C. § 8119] when the harmful effect first manifests itself and becomes physically

ascertainable. 18

later than [the date of Conn 19

accrual date for inquiry notice of her possible Uphold injury because in October of

2008 (roughly four years prior to Co 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 20 Id. 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

thus expi of her alleged injury before she was even injured and well before she even

contemplated having surgery. 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

21 Instead, the Court held that the date when the statute of


This Court will elect to adopt the well-reasoned holding of Wallace with


Id. 22 Id. decision on the record established in this case thus far and cannot be decided at this

claim, and therefore is not amenable to a decision at this stage.


Boston Scientific has also moved to dismiss Plaintiff 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

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

GRANTED with respect to

23 10 Del. C. § 2-725 Plaintiff Warranty is DISMISSED.

DENIED with respect to

consortium. Counts

I, II, and IV are subsumed and will be analyzed under the framework of the TPLA

for the remainder of this litigation. GRANTED


Defendant has also moved to dismiss Plaintiff product liability claims for

negligence, breach of warranty, and failure to warn based on the Tennessee Product

liability actions, including all actions for personal injury resulting from the

manufacture, construction, design. . . warning, instruction, marketing, packaging, or

24 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

Accordingly, the substance of these claims will be analyzed under the framework of

ility claims.

24 Tenn. Code Ann. § 29-28-102(6) (internal quotations omitted.) 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

25 It is insufficient to claim that there

standard. Instead, the Plaintiff must trace his or her injury to a specific defect of the

product. 26 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

, which performance was below reasonable minimum safety expectations of the ordinary

consumer having ordinary, common knowledge as to its ch 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)( 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 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). - 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

Complaint. 31

The Complaint does, however, not adequately plead that the Uphold which

was surgically implanted within Connie Hagan had a manufacturing defect which

Due to

defects in [] manufacturing [the Uphold] Device was unreasonably dangerous at the

Defendant negligent i manufacturing 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

manufacturer. The Complaint has therefore failed to adequately plead a claim for a

30 -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 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

reason of the manufacturer's failure to provide an adequate warning informing users

33 A plaintiff asserting a TPLA claim based on a

defective warning made the product unreasonably dangerous; and (3) the inadequate

34 Plaintiffs

do not identify any particular warning that Boston Scientific allegedly failed to

bing physician. Nor do they assert any

facts to show these unspecified warnings were inadequate or defective. 35 Plaintiff

claim that the Complaint satisfied this standard because it alleges Scientific consistently underreported and withheld information about the propensity

misrepresented the efficacy and safety of the Product, through various means and

media, actively and intentionally misleading the FDA, the medical community,

36 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 36 t 16 (citing Compl. At ¶ 9). 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.

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

DENIED with respect to this claim on this

basis. However, Plaintiff has plead no facts indicating that the Uphold was


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


Learned Intermediary Doctrine. The Learned Intermediary Doctrine is a legal 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 invo meaningful and complete so as

to be understood by the recipient or an individualized medical judgment that this

treatment or medication is necessary and desir 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 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) ( ) 38 Compl. ¶ 9 (emphasis in original) 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.




Counts I, III, and IV of the Complaint are subsumed by the TPLA, and the

DENIED with respect to these claims.


/s/ Francis J. Jones, Jr. Francis J. Jones, Judge

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