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
DENIED 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,
of 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.
INTRODUCTION
Plaintiff, Izabelle Shealy, has brought suit against the Defendant, 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 device that was
surgically implanted in her. Plaintiff alleges that this mesh device was defectively
designed and manufactured by Boston Scientific. The Defendant has moved to
dismiss the Complaint on the following grounds: (1) the Complaint fails to satisfy
the pleading requirements of the Superior Court; (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 warranty
claim fails because Plaintiff has failed to allege how or when the alleged
representations of the warranty were made; (5) there is no allegation that the
Defendant’s device was the proximate cause of Plaintiff’s injuries; and (6)
Plaintiff’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 York
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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
Plaintiff’s Complaint, which this court must accept as true in deciding the motion to
dismiss.
Plaintiff is a resident of New York. On January 7, 2019, Plaintiff underwent
implantation 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
Plaintiff has suffered pain, erosion, urinary problems, dyspareunia, organ
perforation, and vaginal 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 Complaint was filed on January 11,
2021. The Complaint asserted claims against Defendant based on Negligence (Count
I), Breach of Warranty (Count II), 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 review of California law suggests that the result reached in this opinion is the same if the Court applied
California law to this analysis.
3
STANDARD OF REVIEW
Under Superior 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 inferred 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 notice 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 (Consolidate). 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).
4
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 physician. However,
the learned intermediary doctrine does not compel dismissal of claims that warning
labels were insufficient, since these claims 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 Plaintiff has alleged the following in her Complaint:
• 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 Device; 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 Pelvic
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 5177156 (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).,
99
See Martin v. Hacker., 83 N. Y 2d 1, 9 (N.Y. 1993).
5
incomplete and misleading; and that the Pelvic Mesh
Products were and are causing numerous patients severe
injuries and complications. The Defendants 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 the Pelvic Mesh products into the
Plaintiff. (Id. at ¶ 12).
• Causation: After, and as a result of the implantation of the
Medical Devices, Plaintiff Izabella Shealy suffered serious
bodily injuries, including, but not limited to erosion and
other injuries similar 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 injury. (Id.. at ¶ 50.)
At this stage of the proceedings, the above allegations lead this Court to
conclude that the Plaintiff has sufficiently pled a failure to warn claim. The
Complaint clearly indicates that the Defendant mislead the medical community and
the Plaintiff’s injuries would not have occurred but for the Defendant’s wrongful
conduct. By reasonable inference from the facts alleged, this would include the
treating physician electing another product had they not been misled. While the
Complaint could have been more clearly drafted by containing a specific allegation
that the doctor who implanted the Obtryx would not have done so had they received
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a proper warning, the Complaint 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. At the 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 representation 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 promise 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); See 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.Supp.2d 424, 431 (S.D.N.Y. 2011).
7
Plaintiff argues that she has pled the breach of warranty claim adequately,
pointing to Paragraph 17 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 misleading information to patients, including
plaintiff.” The Plaintiff 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 subset 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 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, 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 utilized
8
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 elements 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 incompatible 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.
9
contribute to the formation 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
invasive surgical techniques for the treatment of medical conditions,
primarily pelvic organ prolapse 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, 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 utilized are documents, brochures, and websites,
offering exaggerated 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, injury, 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 them 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 to 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 design 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
injury
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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 toxic 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 environments 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 the 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 Plaintiff’s injury.15 Defendant
alleges that any claims premised on a manufacturing defect fail because Plaintiff:
(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 devices; and (3) fails to plead that any
alleged defect plausibly caused her injuries. Defendant is correct that the Plaintiff
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).
11
Scientific when they left Boston Scientific’s possession. 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 unreasonably 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 alleges that Defendant designed the Obtryx to contain
polypropylene, a material they knew was incompatible with tissues found in the
human body. The Complaint further alleges that Plaintiff’s tissue rejected the
Obtryx, causing her injury. These 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 3rd 700 (E.D. Cal 2019).
17
Tears v. Bos. Sic Corp., 344 F Supp 3rd 500, 510 (S.D.N.Y 2018).
12
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 “willful disregard for
Plaintiff’s safety cannot 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 Complaint 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 products 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 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. (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 survive, as other causes of action have survived the instant motion
13
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
cc: File&ServeXpress
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