Kaur v. Boston Scientific Corporation ( 2022 )

IN THE SUPERIOR COURT OF THE STATE OF DELAWARE
KULWINDER KAUR, )
)
Plaintiff, )
)
v. ) C.A. No.: N19C-07-117 PEL
)
BOSTON SCIENTIFIC )
CORPORATION (d/b/a/ )
MANSFIELD SCIENTIFIC, INC. )
& MICROVASIVE INC.), )
)
Defendant. )
)
OPINION AND ORDER ON DEFENDANT’S
MOTION FOR SUMMARY JUDGMENT
GRANTED, IN PART, AND DENIED, IN PART
Submitted: February 4, 2022
Decided: May 11, 2022
Robert J. Leoni, Esquire, Shelsby & Leoni, Wilmington, Delaware,
Attorney for Plaintiff.
Colleen D. Shields, Esquire, Eckert, Seamans, Cherin & Mellott, LLC, Wilmington,
Delaware, Attorney for Defendant.
Jones, J.
Kulwinder Kaur (“Kaur” or “Plaintiff”), a resident of California, has brought
the instant products liability action. Plaintiff alleges that she was implanted with a
pelvic mesh device, known as the Obtryx Transobturator Mid-Urethral Sling System
(“Obtryx”), which was manufactured by Boston Scientific Corporation (“BSC” or
“Defendant”). Kaur alleges that the Obtryx was defective and has caused her
physical injuries. Plaintiff has asserted a cause of action for negligence, breach of
warranty and failure to warn. BSC has moved for summary judgment. This is the
Court’s decision on the summary judgment. For the reasons stated herein, BSC’s
motion is GRANTED, in part, and DENIED, in part.
STANDARD OF REVIEW
Under Superior Court Civil Rule 56, a party is entitled to summary judgment
if there is no genuine issue as to any material fact and the moving party is entitled to
a judgment as a matter of law.1 A material issue of fact exists if “a rational finder of
fact could find some material fact that would favor the nonmoving party in a
determining way[.]”2 The factual record on a summary judgment motion must be
viewed in the light most favorable to the non-moving party.3
The initial burden is on the moving party to demonstrate there is no genuine
dispute as to any material fact and that the movant is entitled to judgment as a matter
1
Del. Super. Ct. Civ. R. 56(c).
2
Deloitte LLP v. Flanagan, 2009 WL 5200657, at *3 (Del. Ch. Dec. 29, 2009).
3
Gruwell v. Allstate Ins. Co., 988 A.2d 945, 947 (Del. Super. Ct. 2009).
2
of law.4 If the moving party meets the initial burden, the burden shifts to the non-
moving party to show that a genuine issue of material fact exists.5 “It is not enough
for the opposing party merely to assert the existence of such a disputed issue of
fact… [i]f the facts permit reasonable persons to draw from them but one inference,
the question is ripe for summary judgment.”6 Where a moving party submits an
affidavit in support of a motion for summary judgment, the opposing party must
submit a countervailing affidavit or other evidence, or the moving party’s affidavit
will be presumed to be true.7
APPLICABLE LAW
Delaware follows the “most significant relationship” choice of law approach
from the Restatement (Second) of Conflict of Law.8 This approach “provides that the
law of the state that has the most significant relationship to the occurrence and the
parties under the principles stated in [§] 6 is governing law.”9 Section 6 provides that
the following seven (7) factors are relevant to the choice of law inquiry:
(a) The needs of the interstate and international systems;
(b) The relevant policies of the forum;
(c) The relevant policies of other interested states and the relative
interests of those states in the determination of the particular issue;
(d) The protection of justified expectations;
(e) The basic policies underlying the particular field of law;
(f) Certainty, predictability and uniformity of result; and
4
Brzoska v. Olson, 668 A.2d 1355, 1364 (Del. 1995).
5
Id. (citing Moore v. Sizemore, 405 A.2d 679, 680 (Del. 1979)).
6
Id. (citing Wootten v. Kiger, 226 A.2d 238, 239 (Del. 1967)).
7
Highline Financial Services, Inc. v. Rooney, 1996 WL 663100, at *1 (Del. Super. Ct., Oct. 25, 1996).
8
Sinnott v. Thompson, 32 A.3d 351, 354 (Del. 2011).
9
Id. (citing Restatement (Second) of Conflict of Laws §145(1)).
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(g) Ease in the determination and application of the law to be applied.10
….
[W]hen applying the section 6 factors, courts should take into account the
following four contacts:
(a) The place where the injury occurred;
(b) The place where the conduct causing the injury occurred;
(c) The domicile, residence, nationality, place of incorporation and
place of business of the parties; and
(d) The place where the relationship, if any, between the parties is
centered.11
Plaintiff is a citizen of California and all her relevant treatment occurred in
California. As such, California has the most significant interest in having its
substantive law applied to Plaintiff’s claims being that the injury occurred in
California and the relationship between Plaintiff and Defendant is centered in that
state. Thus, this Court will apply the substantive law of California in this case.
UNCONTESTED CLAIMS
Plaintiff does not oppose BSC’s motion for summary judgment claims based
on failure to warn, breach of warranty and manufacturing defect. Therefore, BSC’s
motion for summary judgment as to these claims is GRANTED.
10
Id. (citing Restatement at §6(2)).
11
Id. (citing Restatement at §145(2)).
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DESIGN DEFECT
In a medical device case under California law,12 “the test of negligent design
involves a balancing of the likelihood of harm to be expected from a [product] with
a given design and the gravity of harm if it happens against the burden of the
precaution which would be effective to avoid the harm.”13 “Even if a manufacturer
has done all it reasonably could have done to warn about a risk or hazard related to
a product’s design, a reasonable person could conclude that the magnitude of the
reasonably foreseeable harm as designed outweighed the utility of the product as
designed.”14
Given the inherent nature of the Defendant’s pelvic mesh product, the
consumer expectation test is inapplicable and the relevant analysis is under the risk-
benefit test.15 In evaluating the adequacy of a product’s design under the risk-benefit
test, a jury may consider, among other relevant factors, the gravity of the danger
posed by the challenged design, the likelihood that said danger would occur, the
mechanical feasibility of a safter alternative design, the financial cost of an improved
design, and the adverse consequences to the product and to the consumer that would
12
In a non-medical device case, the consumer expectation test is used. That test proves that “a product may be found
defective in design if the Plaintiff demonstrates that the product failed to perform as safely as an ordinary consumer
would expect when used in an intended or reasonably foreseeable manner.” Barker v. Lull Eng’g Co., 20 Cal. 3d
413, 429 (1978); Shabham v. Johnson & Johnson, 2020 WL 5894590 (C.D. Cal. 2020).
13
Merrill v. Navegar, Inc., 26 Cal. 4th 465, 479 (Cal. 2001).
14
Tucker v. Wright Med. Tec., Inc., 2013 WL 1149717, at *7 (N.D. Cal., Mar. 19, 2013) (citing Chavez v. Glock,
Inc., 207 Cal. App. 4th 1283, 1305 (Ct. App. 2012)).
15
Soule v. General Motors Corp., 882 P.2d 298 (Cal. 1994); Morson v. Superior Court, 90 Cal. App. 4th 775, 793-
95 (Cal. 2001).
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result from an alternative design.16 BSC contends that the Plaintiff has not presented
proof to meet this burden. Specifically, Defendant contends that Plaintiff has no
evidence of a safer alternative design that would have not caused injury.
Viewing the evidence in a light most favorable to Plaintiff, the evidence
supports a design defect claim. Plaintiff has offered the opinions of two board-
certified urogynecologists, Dr. Thomas Margolis and Dr. Bruce Rosenzweig, whose
reports describe the danger posed by the usage of non-medical grade polypropylene
in permanent medical implants in the human body.17 They both also outline the
likelihood those dangers would occur.18
Dr. Rosenzweig has offered a safer alternative design, the usage of medical
grade polypropylene resin in the creation of the mesh used in Obtryx rather than the
use of Marlex polypropylene.19 There is evidence that shows that this alternative
design was not only “mechanically feasible” but it was a product that was available
at the time of Kaur’s implantation in 2013.
Dr. Rosenzweig has offered the opinion that medical grade resin existed at the
time of Ms. Kaur’s implant and using this resin as a basis for the mesh in the Obtryx
would have reduced the injuries of the type suffered specifically by Ms. Kaur. Dr.
16
Barker v. Lull Engineering Co., 573 P.2d 443 (Cal. 1978).
17
See, Exhibit “P” to Plaintiff’s Response to Defendant’s Motion for Summary Judgment at 49-53; Exhibit “Q” of
Plaintiff’s Response to Defendant’s Motion for Summary Judgment at 10-12.
18
Id.19
Marlex polypropylene resin was used by BSC to manufacture the polypropylene mesh contained in the BSC mesh
products.
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Margolis has opined that the defects of the Obtryx, bulleted in his report, were the
cause of Ms. Kaur’s injuries. The defects outlined in Dr. Margolis’ report, to which
he attributes Ms. Kaur’s injuries, were the same defects of the Obtryx Dr.
Rosenzweig opined would have been corrected by usage of the medical grade resin,
namely degradation. These reports in combination meet Plaintiff’s burden.
Viewing the evidence in a light most favorable to Plaintiff, there exist a
genuine issue of material fact as to whether Plaintiff has a viable design detect claim.
Therefore, Defendant’s motion for summary judgment on Plaintiff’s design defect
claim is DENIED.
PUNITIVE DAMAGES CLAIM
Under California law, punitive damages are available in tort claims where it
is proven by “‘clear and convincing’ evidence that the defendant is ‘guilty’ of
‘oppression, fraud, or malice[.]’”20 “Malice” is defined as “conduct which is
intended by the defendant to cause injury to the plaintiff or despicable conduct which
is carried on by the defendant with a willful and conscious disregard of the rights or
safety of others.”21 California courts have held that corporations cannot have the
mental requisite necessary to award punitive damages.22 A Plaintiff seeking punitive
damages from a corporation must prove malice on behalf of the corporation’s
20
Sanchez v. Bos. Sci. Corp., 38 F.Supp.3d 727, 739 (S.D.W.Va. 2014) (citing Cal. Civ. Code § 3294(a). See also
Boeken v. Philip Morris Inc., 127 Cal.App.4th 1640, 26 Cal.Rptr.3d 638, 67 (Ct.App.2005).
21
Cal. Civ.Code § 3294(c)(1).
22
Ayat v. Society Air France, 2007 WL 1100315 (N.D. Cal., Apr. 11, 2007).
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employees.23 This requires a showing that corporate leaders acted with such intent.24
For punitive damages in a product liability action, Plaintiff must provide evidence
that “the Defendant placed a product on the market in a conscious disregard of the
safety of consumers and others.”25 The amount of damages is a fact question, first
committed to the discretion of the jury and next to the discretion of the trial judge
on a motion for new trial.26
Viewing the evidence in a light most favorable to the Plaintiff, there exists a
genuine issue of material fact as to whether BSC engaged in conduct justifying an
award of punitive damages.27 The evidence supporting the claim includes in part:
• Defendant knew its resin supplier was hesitant to supply
polypropylene resin for implantation into the human body and
in response to this hesitation moved its business to a different
supplier.
• BSC presented data on the mesh in the Obtryx to physicians
and the public that it had already been told was implausible.
Therefore, BSC’s motion for summary judgment on the punitive
damages is DENIED.
23
Id.24
Id.25
Ehrhardt v. Brunswick Inc., 186 Cal. App 3d 734, 741 (Cal. 1986).
26
Izell v. Union Carbide Corp. 231 Cal. App 4th 962 (Cal. 2014).
27
Defendant maintains that its compliance with FDA standards precludes an award of punitive damages. While
compliance with FDA standards may be a relevant factor in a punitive damages analysis, California law is clear that
it is not a total bar. Buell-Wilson v. Ford Motor Company, 141 Cal.App.4th 525, 565 (Cal. App. 2007). I also reject
at this point BSC’s argument that there has been no evidence presented that Defendant’s corporate leadership
consciously desired to harm them. There has certainly been evidence presented to date that, at certain levels, BSC
acted in such a way to justify an award of punitive damages. Whether these actions were done at the appropriate
corporate level to impose punitive damages is an issue requiring a more fully developed trial record.
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IT IS SO ORDERED.
/s/ Francis J. Jones, Jr.
Francis J. Jones, Jr. Judge
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