IN THE SUPERIOR COURT OF THE STATE OF DELAWARE
Izabella Shealy, ) ) Plaintiff, ) ) C.A. No.: N21C

- 01

- 068 PEL
v. ) ) Boston Scientific Corporation, ) ) Defendants. )

Submitted: April 8, 2021 Decided: June 1 , 2021

OPINION AND ORDER ON DEFENDANT’S MOTION TO DISMISS

DENIE D IN PART/GRANTED IN PART

Robert J . Leoni, Esquire, Shelby & Leoni, 221 Main Street Wilmington, DE 19804, Attorneys for Plaintiff. Shanin Specter, Esquire , Lee B. Balefsky, Esquire Tracie L. Palmer, Esquire , Kline & Specter, P.C ., 1525 Locust Street Philadelphia, PA 19102 , o f Counsel

- Attorney 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.2 INTRODUCTION Plaintiff, Izabelle Shealy, has brought suit against the D efendant, Boston Scientific Corporation ( “ Boston Scientific ” ), alleging numerous claims sounding in

strict liability, negligence, and breach of various warranties. Plaintiff’s claims arise out of personal injuries she claims to have suffered from a mesh d evice that was surgically implanted in her

. Plaintiff alleges that this mesh device was defectively designed and manufactured by Boston Scientific

. The D efendant has moved to

dismiss the C omplaint on the following grounds : (1) the Complaint fails to satis fy the pleading requirements of the Superior Cour t; (2) the failure to warn claims are barred by the learned intermediary doctrine; (3) any design or manufacturing defect

claim should be dismissed for failure to specify a defect; (4) the breach of warran t y
claim fails because P laintiff has failed to allege how or when the alleged representations of the warranty were made; (5) there is no allegation that the

D efendant’s device was the proximate cause of P laintiff’s injuries; and (6)

P laintiff’s request for punitive damages should be stricken because she has not alleged sufficient facts to support a punitive damages claim under either Delaware

or New York law. The parties appear to agree the substantive law of New York

controls this action. For purposes of this motion the Court will accept that New York3 law applies

. 1 For the reasons set forth below , Boston Scientific’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

P laintiff’s C omplaint, which this court must accept as true in deciding the motion to

dismiss.

Plaintiff is a resident of New York. On January 7, 2019 , P laintiff underwent imp lantation of a pelvic mesh device manufactured by Defendant called the Obtryx

. The surgery was performed in Santa Monica , California. As a result of the implant

P laintiff has suffered pain, erosion, urinary problems, dyspareunia, organ perforation, and v aginal scarring related to complications from Defendant’s product

. This included an additional surgery to remove eroded mesh performed at UCLA Medical Center on July 12, 2019

. Plaintiff’s C omplaint was filed on January 11,

2021. The Complaint asserted claims against Defendant based on Negligence (Count I), Breach of Warranty (Count I I), and Failure to Warn (Count III). Defendant filed a Motion to Dismiss the action on February 23, 2021. The parties have fully briefed the Motion to Dismiss and this Opinion represents the

Court’s decision on that Motion.

1 Plaintiff is a resident of New York. The two medical procedures related to the mesh implant occurred in California. This Court’s re view of California law suggests that the result reached in th is opinion is the same if the Court applied California law to this analysis.4 STANDARD OF REVIEW Under Sup erior Court Rule 12(b)(6), the Court may dismiss a claim for failure to state a claim upon which relief can be granted only where the plaintiff cannot recover under any reasonably conceivable set of circumstances or facts susceptible of proof that may be i nferred from the allegations. The Court accepts the well

- pled allegations of the complaint as true and draws “all reasonable information that logically flow from those allegations in favor of the non

- moving party. ” 2 Under
Delaware law, in order to survive a motion to dismiss for failure to state a claim, a complaint need only give general no t ice of the claim asserted and will not be dismissed unless it is clearly without merit, either as a matter of law or fact. 3 A Court can dismiss for failure to state a claim on which relief can be granted only if “it appears with reasonable certainty that the plaintiff could not prove any set of facts

that would entitle her to relief. ” 4
Under Del. Super. Ct. Civ. Rule 9(b) a plaintiff must plead negligence with particularity. The purpose of Rule 9 ( b) is to apprise the adversary of the acts or omissions by which it is alleged that a duty has been violated so that an opponent is able to prepare a defense. 5 Under Rule 9(b) it is usually necessary to allege only

2 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). 3 Wilen v

. Pollution Control Industries, Inc., Del

. Ch. C.A. No 7254

- NC (Consolid ate). Harnett, V.C

. (Oct 15, 2984)

. 4 Rammuno v

. Cawley , 705 A 2d 1029, 1034 (Del 1998). 5 Chesapeake & Potomac Tel. Co. of Maryland v

. Chesapeake Utilities Corp. , 436 A2d 314, 338 (Del 1981).5 sufficient facts out of which a duty is implied and a general averment of failure to discharge that duty. 6

FAILURE TO WARN CLAIMS Defendant alleges that the learned intermediary doctrine bars all failure to

warn claims contained in Count III of Plaintiff’s Complaint

. 7 Under the learned intermediary doctrine a “medical professional acts as an ‘learned intermediary’

between the manufacturer [of a medical device] and the patient” and the manufacturer is relieved of any responsibility to directly warn the patient. 8 Thus, a manufacturer’s duty to warn in this context only extends to the physic i an

. However , the learned intermediary doctrine does not compel dismissal of claims that war ning

labels were insuffic i ent , since the se c laims are premised on Defendant’s failure to provide proper warnings to Plaintiff’s prescribing medical professionals, and not on Defendant’s failure to warn Plaintiff directly. 9

In the instant case P laintiff has alleged the following in her C omplaint:

• Defendant has known and continue to know that some of the predicate products for the Pelvic Mesh Products had high failure and complication rates, resulting in the recall of some of these predicate Devi ce; that there were and are differences between the Defendant’s Pelvic Mesh Products and some or all of the predicate products, rendering them unsuitable for designation as predicate products; that significant differences exist and exited between the Pelvi c Mesh Products and their predecessors and predicate products, such that the disclosures to the FDA were and are

6 State Farm Fire & Cas., Co v

. Gen. Elec. Co. , 2009 WL 517 7156 (Del

. Super., 2009). 7 Bukowski v. CooperVision Inc., 592 NY.2d 807, 809 (N.Y. App. Div. 1993). 8 Banker v

. Hoehn., 718 N.Y. S

. 2d 438, 440 (N.Y. App. Div. 2000)., 9 9 See Martin v. Hacker., 83 N. Y 2d 1, 9 (N.Y. 1993).6

incomplete and misleading; and that the Pelvic Mesh Products were and are causing numerous patients severe injuries and complications. The Defe ndants suppressed information and failed to accurately and completely disseminate or share this and or critical information with the FDA, health care providers, or the patients. As a result, the Defendants actively and intentionally misled and continue to mislead the public, including the medical community, health care providers and patients, into believing that the Pelvic Mesh products and the procedure for implantation was and are safe and effective, leading to the prescription for and implantation of th e Pelvic Mesh products into the Plaintiff. ( Id. at ¶ 12).

• Causation : After, and as a result of the implantation of the Medical Devi c es, Plaintiff Izabella Shealy suffered serious bodily injuries, including, but not limited to erosion and other injuries sim ilar to the ones described in the FDA’s Public Health Advisory of October 20, 2008. ( ¶ 48).

• Causation : These injuries would not have occurred but for the defective nature of the products implanted and/or Defendant’s wrongful conduct. ( Id. at ¶ 49.)

• As a result of having the Medical Devise implanted into her, Izabella Shealy has experienced significant mental and physical pain and suffering, and she has sustained permanent inj u ry. ( Id. . at ¶ 50.) At this stage of the proceedings , the above allegations le ad this Court to

conclude that the P laintiff has sufficiently pled a failure to warn claim

. T he Complaint clearly indicates that the Defendant mislead the medical community and

the Plaintiff’s injuries would not have occurred but for the Defendant’s wrong ful

conduct

. B y reasonable inference from the facts alleged , this would include the treating physician electing another product had they not been misled. While the Complaint c ould have been more clearly drafted by containing a specific allegation

that the doctor who implanted the Obtryx would not have done so had they received7 a proper warning , the C omplaint is sufficient ( although barely ) at this stage of the proceedings to withstand a motion to dismiss on the learned intermediary doctrine and the proximate cause requirements that follow from that doctrine. A t t he motion to dismiss stage there is a reasonable set of facts that exist that could place liability against the defendant for failure to warn. Accordingly, Defendant’s Motion to Dismiss is DENIED with respect to the failure to warn claim described in Count III of the Complaint.

BREACH OF WARRANTY CLAIM Defendant next seeks to dismiss Plaintiff’s Count II for breach of warranty. Defendant argues that the Complaint “does not describe any representation that Boston Scientific made to [Plaintiff] or her prescribing physician” or where or how such a represent ation was made

. 10 An express warranty is an “affirmation of fact or promise made by the seller to the buyer which relates to goods and becomes part of the basis of the bargain. ” 11 To state a claim for breach of an express warranty under New York law, a plaintiff must prove “that an express warranty existed, was breached, and that plaintiff had relied on that warranty. ” 12 The Plaintiff must allege where, when or how the alleged pro mise or statement was provided to her or her physicians. 13

10 Def.’s Mot. To Dismiss at 7. 11 N.Y. U.C.C. S 2

- 313(1)(a); S ee Friedman v. Medtronic, Inc. 345 N.Y.S

. 2d 637, 643 (N.Y. App. Div. 1973). 12 Reed v

. Pfizer, Inc ., 839 F

. Supp

. 2d 571, 578 (E.D.N.Y. 2012). 13 Fisher v
. APP PHARMACEUTICALS, LLC, et al ., 783 F .S upp .2 d 424, 431 (S.D.N.Y. 2011)

.8

Plaintiff argues that she has pled the breach of warranty claim adequately , pointing to Paragraph 1 7 of the Complaint

. In that section of the Complaint, she alleges : “Defendant provided incomplete, insufficient, and misleading training and information to physicians, in order to increase the number of physicians utilizing the Pelvic Mesh Products, and thus increased the sales and also leading to the dissemination of inadequate and misleadi ng information to patients, including plaintiff

. ” The P laintiff also points to paragraphs 5

- 8, 24, 25 and 46

- 50 of the Complaint . These paragraphs contain, among other allegations, the following :

• “... these products contain a monofilament polypropylene mesh intended for the treatment of stress urinary incontinence. Despite claims that this material is inert, the emerging scientific evidence suggests that this material is biologically incompatible with human tissue and promotes an immune response in a large su bset of the population receiving Defendant’s Pelvic Mesh Products containing this material. ” ( ¶ 5).

• Defendant’s Pelvic Mesh Products have been and continue to be marketed to the medical community and to patients as safe, effective, reliable, medical device ; implanted by safe and effective, minimally invasive surgical techniques for the treatment of medical conditions, primarily pelvic organ 3 prolapse and stress urinary incontinence, and as safer and more effective as compared to the traditional products an d procedures for treatment, and other competing Pelvic Mesh Products . ( ¶ 6).

• The Defendant has marketed and sold the Pelvic Mesh Products to the medical community at large and patients through carefully planned, multifaceted marketing campaigns and strateg ies. These campaigns and strategies include, but are not limited to, aggressive marketing to health care providers at medical conferences, hospitals, private offices, and include the provision of valuable cash and non

- cash benefits to health care providers . Also utilized9

are documents, brochures, and websites, offering exaggerated and misleading expectations as to the safety and utility of the products. ( ¶ 7).

• Defendant failed to undertake their duties to properly know the qualities of their product and in representations to Plaintiff and/or to Plaintiff’s healthcare providers, to and concealed and intentionally omitted [] material information ( ¶ 24). 14

• These injuries would not have occurred but for the defective nature of the products implanted and/or Defendant’s wrongful conduct. ( ¶ 49). These allegations , taken together, are sufficient to allege an express breach of warranty claim. Defendant’s Motion to Dismiss is DENIED with respect to the breach of warranty claims detailed in Count II of the Complaint.

REMAINING NELIGENCE CLAIMS Defendant alleges that the remaining negligence claims found in Count I of the Complaint which are not based on a failure to warn theory are not adequately pled. With respect to the design and manufacturing defect claims found in Count I, Defendant maintains that Plaintiff’s allegations fail to establish the existence of a defect or to tie any particular defect to her injuries. According to Defendant, the

Plaintiff does little more than assert the bare element s of a negligence claim

. Plaintiff has alleged the following in her complaint:

• Moreover, these products contain a monofilament polypropylene mesh intended for the treatment of stress urinary incontinence. Despite claims that this material is inert, the emerging scientific evidence suggests that this material is biologically incompa tible with human tissue and promotes an immune response in a large subset of the population receiving Defendant’s Pelvic Mesh Products containing this material. This immune response promotes degradation of the pelvic tissue and can

14 The Complaint contains eleven specific pieces of allegedly omitted material information in this paragraph.10

contribute to the forma tion of severe adverse reactions to the mesh. ( ¶ 5).

• Defendant’s Pelvic Mesh Products have been and continue to be marketed to the medical community and to patients as safe, effective, reliable, medical device; implanted by safe and effective, minimally i nvasive surgical techniques for the treatment of medical conditions, primarily pelvic organ pro lapse and stress urinary incontinence, and as safer and more effective as compared to the traditional products and procedures for treatment, and other competing Pelvic Mesh Products. ( ¶ 6)

• The Defendant has marketed and sold the Pelvic Mesh Products to the medical community at large and patients through carefully planned, multifaceted marketing campaigns and strategies. These campaigns and strategies include, but are not limited to, aggres sive marketing to health care providers at medical conferences, hospitals, private offices, and include the provision of valuable cash and non

- cash benefits to health care providers. Also utilized are documents, brochures, and websites, offering exaggerat ed and misleading expectations as to the safety and utility of the products. ( ¶ 7)

• Contrary to the Defendant’s representations and marketing to the medical community and to the patients themselves, the Defendant’s Pelvic Mesh Products have high failure, i njury, and complication rates, fail to perform as intended, require frequent and often debilitating re

operations, and have caused severe and irreversible injuries, conditions, and damage to a significant number of women, including the Plaintiff, making th em defective under the law. The defects stem from any or all of the following: a. the use of polypropylene material in the Mesh itself and the immune reaction that results, causing adverse reactions and injuries; b. the design of the Pelvic Mesh Device t o be inserted transvaginally into an area of the body with high levels of bacteria, yeast, and fungus that adhere to the mesh causing immune reactions and subsequent tissue breakdown and adverse reactions and injuries; c. biomechanical issues with the desi gn of the mesh that create strong amounts of friction between the mesh and the underlying tissue that subsequently cause that tissue to degrade resulting in injury11 d. the use and design of anchors in the Pelvic Mesh Products which when placed correctly are likely to pass through and injure major nerve routes in the pelvic region. d. degradation of the mesh itself over time which causes the internal tissue to degrade resulting in injury

. e. the welding of the mesh itself during production which creates a to xic substance that contributes to the degradation of the mesh and host tissue alike. f. the design of trocars, as Device to insert the Pelvic Mesh Products into the vagina, are defective because the device requires tissue penetration in nerve rich environ ments which results frequently in the destruction of nerve endings causing pain and other injuries. ( ¶ 8) These allegations, taken together, are sufficient to state claims for failure to warn and sufficiently plead that defects in the Obryx device were t he proximate cause of the Plaintiff’s injuries.

MANUFACTURING DEFECT

To state a claim for a manufacturing defect under New York law, a plaintiff must allege that (1) the product was defective due to error in the manufacturing process and (2) the defect was the proximate cause of P laintiff’s injury. 15 Defendant alleges that any claims premised on a manufacturing defect fail because P laintif f : (1) concedes that the devices at issue were in the condition intended by Boston Scientific when they Boston Scientific’s possession (Compl

. ¶ 18); (2) fails to identify a particular design defect in the device s; and (3) fails to plead that any alleged defect plausibly caused her injuries. Defendant is correct that the P laintiff has alleged that the devices at issue were in the condition intended by Boston

15 Williamson v

. Stryker Corp., 2013 WL 3833081, at 4 (S.D.N.Y. July 23, 2013).12 Scientific when they left Boston Scientific’s possessio n. There is no alternative pleading in the complaint that relates to a manufacturing defect that is premised on an allegation that the Obtryx device was in the condition other then what Boston

Scientific intended when it left the company’s possession

. On this basis , Defendant’s motion to dismiss claims based on a manufacturing defect is

GRANTED

. 16

DESIGN DEFECT To state a cause of action for a design defect, Plaintiff must allege that the product was unreasonabl y dangerous for its intended use and must allege with sufficient specificity how the design of the product was defective. 17 According to

Boston Scientific , Plaintiff has not done this. In paragraph 5 and 6 of the Complaint
(set forth above) plaintiff alle ges that Defendant designed the Obtry x to contain polypropylene, a material they knew was incompatible with tissues found in the

human body

. The C ompla i nt further alleges that Plaintiff’s tissue rejected the Obtry x , causing her injury. The se allegations are sufficient to allege a design defect in the Obtryx

. Defendant’s Motion to Dismiss with respect to Plaintiff’s claim for design defect is DENIED

.

16 See Zetz v

. Boston Scientific , 398 F Supp 3 rd 700 (E.D. Cal 2019). 17 Tears v. Bos. Sic Corp., 344 F Supp 3 rd 500, 510 (S.D.N.Y 2018).13 PUNITIVE DAMAGES CLAIM Plaintiff’s Complaint contains a demand for punitive damages. Defendant seeks to dismiss Plaintiff’s claim for punitive damages. Defendant argues that Plaintiff’s allegations that Boston Scientific acted in a “ wil l ful disregard for Plaintiff’s safety canno t sustain a request for punitive damages ”

. Defendant also seeks to strike Plaintiff’s request for punitive damages on the grounds that the other claims in the Complaint should be dismissed. Plaintiff’s C omplaint specifically alleges the following:

• Despite emerging scientific evidence that polypropylene is incompatible with human tissue, Defendant continues to market the Obtryx to the medical community. (Compl. At ¶ 5

- 6. )

• Contrary to the Defendant’s representations and marketing...the Defendant’s produ cts suffer from high failure, injury, and complication rates, fail to perform as intended, require frequent and often debilitating reoperations, and have caused severe reversible injuries. ( Id. at ¶ 8. )

• The Defendant has chronically underreported and withh eld 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. ( Id. at ¶ . 9

- 10. )

• Defendants “failed to accurately and completely inform the FDA, health providers and the patients. ( Id. at ¶ 11. )

• Defendant continues to mislead the public into believing their products are safe and effective. Id. At the motion to dismiss stage these allegations are sufficient for a punitive damage claim to sur vive , as other causes of action have survived the instant motion14 to dismiss. Defendant’s Motion to Dismiss is DENIED with respect to Plaintiff’s claim for punitive damages.

CONCLUSION In summary, the Defendant’s Motion to Dismiss is GRANTED with respect

for the claims for a manufacturing defect as described above . Defendant’s Motion

to Dismiss is DENIED with respect to all other claims found in the Complaint.

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