Brown et al v. Boston Scientific Corporation

Filing 113

MEMORANDUM OPINION AND ORDER (Defendant's Motion for Summary Judgment) BSC's 52 Motion for Summary Judgment is GRANTED IN PART with respect to Ms. Brown's claims for strict liability for manufacturing defect, strict liability for design defect, strict liability for failure to warn, negligent manufacturing, breach of implied warranty of fitness for a particular purpose, and fraudulent concealment, and DENIED IN PART with respect to Ms. Brown's claims for negligent fail ure to warn, negligent design, breach of implied warranty of merchantability, and breach of express warranty, and Mr. Brown's claim for loss of consortium. Signed by Judge Joseph R. Goodwin on 4/29/2015. (cc: counsel of record; any unrepresented party) (ts)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION

SANDRA BROWN & GARY BROWN,
Plaintiff,
v.

Civil Action No. 2:12-cv-01396

BOSTON SCIENTIFIC CORP.,
Defendant.

MEMORANDUM OPINION AND ORDER
(Defendant’s Motion for Summary Judgment)
Pending before the court is defendant Boston Scientific Corporation’s (“BSC”) Motion
for Summary Judgment against plaintiffs Sandra Brown and Gary Brown [Docket 52]. As set
forth below, BSC’s Motion for Summary Judgment is GRANTED IN PART with respect to
Ms. Brown’s claims for strict liability for manufacturing defect, strict liability for design defect,
strict liability for failure to warn, negligent manufacturing, breach of implied warranty of fitness
for a particular purpose, and fraudulent concealment. BSC’s Motion for Summary Judgment is
DENIED IN PART with respect to Ms. Brown’s claims for negligent failure to warn, negligent
design, breach of implied warranty of merchantability, and breach of express warranty, and Mr.
Brown’s claim for loss of consortium.
I. Background
This case resides in one of seven MDLs assigned to me by the Judicial Panel on
Multidistrict Litigation concerning the use of transvaginal surgical mesh to treat pelvic organ
prolapse (“POP”) and stress urinary incontinence (“SUI”). In the seven MDLs, there are more

than 70,000 cases currently pending, approximately 15,000 of which are in the BSC MDL, MDL
2326. In an effort to efficiently and effectively manage this massive MDL, I decided to conduct
pretrial discovery and motions practice on an individualized basis so that once a case is trialready (that is, after the court has ruled on all Daubert motions and summary judgment motions,
among other things), it can then be promptly transferred or remanded to the appropriate district
for trial. To this end, I ordered the plaintiffs and defendant to each select 50 cases, which would
then become part of a “wave” of cases to be prepared for trial and, if necessary, remanded. (See
Pretrial Order # 65, In re: Boston Scientific Corp. Pelvic Repair Sys. Prods. Liab. Litig., No.
2:12-md-002326,

entered

Dec.

19,

2013,

available

at

http://www.wvsd.uscourts.gov/MDL/boston/orders.html). This selection process was completed
twice, creating two waves of 100 cases, Wave 1 and Wave 2. The Browns case was selected as a
Wave 2 case by the plaintiffs.
Plaintiff Sandra Brown was surgically implanted with the Obtryx Transobturator MidUrethral System (the “Obtryx”) and the Uphold Vaginal Support System (the “Uphold”) on
August 16, 2011. (BSC’s Mot. for Summ. J. & Mem. of Law in Supp. (“Mem. in Supp.”)
[Docket 52], at 2). She received the surgery at a hospital in Greensboro, North Carolina. (Id.).
Ms. Brown claims that as a result of implantation of the Obtryx and the Uphold, she has
experienced various injuries. (Pl. Fact Sheet [Docket 52-11], at 7–8). She brings the following
claims against BSC: strict liability for design defect, manufacturing defect, and failure to warn;
negligence; breaches of express and implied warranties; and punitive damages. (Am. Short Form
Compl. [Docket 15], at 4). In the instant motion, BSC moves for summary judgment on the
grounds that “[b]oth [p]laintiffs’ legal theories are without evidentiary or legal support.” (Mem.
in Supp. [Docket 52], at 1).

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II. Legal Standards
A. Summary Judgment
To obtain summary judgment, the moving party must show that there is no genuine
dispute as to any material fact and that the moving party is entitled to judgment as a matter of
law. Fed. R. Civ. P. 56(a). In considering a motion for summary judgment, the court will not
“weigh the evidence and determine the truth of the matter.” Anderson v. Liberty Lobby, Inc., 477
U.S. 242, 249 (1986). Instead, the court will draw any permissible inference from the underlying
facts in the light most favorable to the nonmoving party. Matsushita Elec. Indus. Co. v. Zenith
Radio Corp., 475 U.S. 574, 587–88 (1986).
Although the court will view all underlying facts and inferences in the light most
favorable to the nonmoving party, the nonmoving party nonetheless must offer some “concrete
evidence from which a reasonable juror could return a verdict in his [or her] favor.” Anderson,
477 U.S. at 256. Summary judgment is appropriate when the nonmoving party has the burden of
proof on an essential element of his or her case and does not make, after adequate time for
discovery, a showing sufficient to establish that element. Celotex Corp. v. Catrett, 477 U.S. 317,
322–23 (1986). The nonmoving party must satisfy this burden of proof by offering more than a
mere “scintilla of evidence” in support of his or her position. Anderson, 477 U.S. at 252.
Likewise, conclusory allegations or unsupported speculation, without more, are insufficient to
preclude the granting of a summary judgment motion. See Dash v. Mayweather, 731 F.3d 303,
311 (4th Cir. 2013); Stone v. Liberty Mut. Ins. Co., 105 F.3d 188, 191 (4th Cir. 1997).
B. Choice of Law
Under 28 U.S.C. § 1407, this court has authority to rule on pretrial motions in MDL cases
such as this. The choice of law for these pretrial motions depends on whether they involve

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federal or state law. “When analyzing questions of federal law, the transferee court should apply
the law of the circuit in which it is located. When considering questions of state law, however,
the transferee court must apply the state law that would have applied to the individual cases had
they not been transferred for consolidation.” In re Temporomandibular Joint (TMJ) Implants
Prods. Liab. Litig., 97 F.3d 1050, 1055 (8th Cir. 1996) (internal citations omitted). In cases
based on diversity jurisdiction, the choice-of-law rules to be used are those of the states where
the actions were originally filed. See In re Air Disaster at Ramstein Air Base, Ger., 81 F.3d 570,
576 (5th Cir. 1996) (“Where a transferee court presides over several diversity actions
consolidated under the multidistrict rules, the choice of law rules of each jurisdiction in which
the transferred actions were originally filed must be applied.”); In re Air Crash Disaster Near
Chi., Ill., 644 F.2d 594, 610 (7th Cir. 1981); In re Digitek Prods. Liab. Litig., MDL No. 2:08md-01968, 2010 WL 2102330, at *7 (S.D. W. Va. May 25, 2010). Here, the action was
originally filed in Massachusetts. (Compl. [Docket 1]). Thus, the choice-of-law principles of
Massachusetts guide this court’s choice-of-law analysis.
The choice-of-law principles of Massachusetts compel application of North Carolina law.
Under Massachusetts law, “unless another state has a more significant relationship to the
underlying cause of action, tort claims remain governed by the law of the state in which the
alleged injury occurred.” Geshke v. Crocs, Inc., 889 F. Supp. 2d 253, 260 (D. Mass. 2012) (citing
Watkins v. Omni Life Sci., Inc., 692 F. Supp. 2d 170, 174 (D. Mass. 2010)). Here, the alleged
injury occurred in North Carolina, where Ms. Brown was implanted with the allegedly defective
device. Thus, in the absence of a state with a more significant relationship to the underlying
causes of action, I apply North Carolina’s substantive law to the claims in this case.

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III. Analysis
BSC argues that it is entitled to summary judgment in this case because Ms. Brown’s
claims lack either evidentiary or legal support. Ms. Brown agrees that this court should dismiss
her claims for strict products liability. (Pl.’s Resp. in Opp’n to BSC’s Mot. for Summ. J. & Mem.
of Law in Supp. (“Resp. Mem. in Supp.”) [Docket 72], at 3). Therefore, BSC’s Motion for
Summary Judgment on Ms. Brown’s claims for strict liability for manufacturing defect, strict
liability for design defect, and strict liability for failure to warn is GRANTED. Below, I apply
the summary judgment standard to each remaining claim.
A. Negligent Failure to Warn
Under North Carolina law, “[n]o manufacturer . . . shall be held liable in any product
liability action for a claim based upon inadequate warning or instruction unless the claimant” can
satisfy three requirements. N.C. Gen. Stat. § 99B-5(a). First, the claimant must establish “that the
manufacturer . . . acted unreasonably in failing to provide such warning or instruction.” Id.
Second, the claimant must establish “that the failure to provide adequate warning or instruction
was a proximate cause of the harm for which damages are sought.” Id. Finally, the claimant must
establish either of the following:
(1) At the time the product left the control of the manufacturer . . . , the product,
without an adequate warning or instruction, created an unreasonably dangerous
condition that the manufacturer . . . knew, or in the exercise of ordinary care
should have known, posed a substantial risk of harm to a reasonably foreseeable
claimant[; or] (2) After the product left the control of the manufacturer . . . , the
manufacturer or seller became aware of or in the exercise of ordinary care should
have known that the product posed a substantial risk of harm to a reasonably
foreseeable user or consumer and failed to take reasonable steps to give adequate
warning or instruction or to take other reasonable action under the circumstances.
Id.

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As a threshold matter, BSC argues that, under subsection (c) of the same statute, the
learned intermediary doctrine shields it from liability. (Mem. in Supp. [Docket 52], at 7–8 (citing
N.C. Gen. Stat. § 99B-5(c))). Subsection (c) provides: “[N]o manufacturer . . . shall be liable in a
products liability action for failing to provide a warning or instruction directly to a consumer if
an adequate warning or instruction has been provided to the physician or other legally authorized
person who prescribes or dispenses that prescription drug for the claimant . . . .” N.C. Gen. Stat.
§ 99B-5(c).
While I am not persuaded that the plain language of subsection (c) provides the basis for
application of the learned intermediary doctrine to the instant case, “[t]here are indications that
North Carolina courts would adhere to the learned intermediary doctrine” in matters of product
liability. Baraukas v. Danek Med., Inc., No. 6:97CV00613, 2000 WL 223508, at *4 (M.D.N.C.
Jan. 13, 2000) (citing Foyle ex rel. McMillan v. Lederle Labs., 674 F. Supp. 530, 535–36
(E.D.N.C. 1987)). In fact, in Baraukas, the United States District Court for the Middle District of
North Carolina determined that the learned intermediary doctrine applied where the
manufacturer warned the plaintiff’s physician about bone screws. Id. Accordingly, consistent
with the courts that have addressed this issue before me, I assess Ms. Brown’s negligent failure
to warn claim under the learned intermediary doctrine.
Here, genuine disputes of material fact exist with regard to: (1) whether BSC’s warning
was adequate; and (2) whether the alleged inadequate warning proximately caused the alleged
harm to Ms. Brown. Therefore, BSC’s Motion for Summary Judgment on Ms. Brown’s negligent
failure to warn claim is DENIED.

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B. Negligent Design
Under North Carolina law, a plaintiff alleging inadequate design first must prove “that at
the time of its manufacture the manufacturer acted unreasonably in designing or formulating the
product, [and] that this conduct was a proximate cause of the harm for which damages are
sought . . . .” N.C. Gen. Stat. § 99B-6(a). To determine whether BSC acted unreasonably in
designing the Uphold and the Obtryx, North Carolina requires that “the factors to be considered .
. . include, but are not limited to, the following”:
(1) The nature and magnitude of the risks of harm associated with the design or
formulation in light of the intended and reasonably foreseeable uses,
modifications, or alterations of the product[;] (2) The likely awareness of product
users, whether based on warnings, general knowledge, or otherwise, of those risks
of harm[;] (3) The extent to which the design or formulation conformed to any
applicable government standard that was in effect when the product left the
control of its manufacturer[;] (4) The extent to which the labeling for a
prescription or nonprescription drug approved by the United States Food and
Drug Administration conformed to any applicable government or private standard
that was in effect when the product left the control of its manufacturer[;] (5) The
utility of the product, including the performance, safety, and other advantages
associated with that design or formulation[;] (6) The technical, economic, and
practical feasibility of using an alternative design or formulation at the time of
manufacture[;] (7) The nature and magnitude of any foreseeable risks associated
with the alternative design or formulation.
Id. § 99B-6(b). Additionally, a plaintiff must prove one of the following:
(1) At the time the product left the control of the manufacturer, the manufacturer
unreasonably failed to adopt a safer, practical, feasible, and otherwise reasonable
alternative design or formulation that could then have been reasonably adopted
and that would have prevented or substantially reduced the risk of harm without
substantially impairing the usefulness, practicality, or desirability of the product[;
or] (2) At the time the product left the control of the manufacturer, the design or
formulation of the product was so unreasonable that a reasonable person, aware of
the relevant facts, would not use or consume a product of this design.
Id. § 99B-6(a).
Here, genuine disputes of material fact exist with regard to: (1) whether BSC acted
unreasonably in designing the Uphold and the Obtryx, see id. § 99B-6(a); and (2) whether BSC
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unreasonably failed to adopt safer, practical, feasible, and otherwise reasonable alternative
designs, see id. § 99B-6(a)(1), or whether the design or formulation of the products was so
unreasonable that a reasonable person, aware of the relevant facts, would not use them.1 See id. §
99B-6(a)(2).
Therefore, BSC’s Motion for Summary Judgment on Ms. Brown’s negligent design claim
is DENIED.
C. Negligent Manufacturing
To the extent Ms. Brown asserts a claim for negligent manufacture of the Uphold and the
Obtryx, her claim fails because “[t]he record is absolutely devoid of any evidence regarding
[BSC’s] . . . manufacturing process, much less any negligent action or omission that occurred
during those processes.” Carlton v. Goodyear Tire & Rubber Co., 413 F. Supp. 2d 583, 588
(M.D.N.C. 2005). Importantly, “the claim of selection of improper materials is a design defect
claim, not a manufacturing defect claim.” Edwards v. ATRO SpA, 891 F. Supp. 1074, 1078
(E.D.N.C. 1995).
Therefore, BSC’s Motion for Summary Judgment on Ms. Brown’s negligent manufacture
claim is GRANTED.
D. Breach of Implied Warranty of Merchantability
Under North Carolina law, “a warranty that the goods shall be merchantable is implied in
a contract for their sale if the seller is a merchant with respect to goods of that kind.” N.C. Gen.
Stat. § 25-2-314(1). For a good to be “merchantable,” it must
1

BSC argues that the fact that BSC received FDA clearance for its products forecloses the possibility that a
reasonable juror could determine that BSC acted unreasonably in designing the Uphold and the Obtryx. As I have
previously held, however, 510(k) clearance from the FDA is not relevant to state tort law. See, e.g., Sanchez v.
Boston Scientific Corp., 38 F. Supp. 3d 727, 744 (S.D. W. Va. 2014) (“Evidence regarding the 510(k) process poses
a substantial risk of misleading the jury and confusing the issues. That a device has been given clearance through the
FDA’s 510(k) process is not relevant to state tort law.”); Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748, 753–56
(S.D. W. Va. 2014) (same).

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(a) pass without objection in the trade under the contract description; and (b) . . .
[be] of fair average quality within the description; and (c) [be] fit for the ordinary
purposes for which such goods are used; and (d) run, within the variations
permitted by the agreement, of even kind, quality and quantity within each unit
and among all units involved; and (e) [be] adequately contained, packaged, and
labeled as the agreement may require; and (f) conform to the promises or
affirmations of fact made on the container or label if any.
Id. § 25-2-314(2). To establish a claim for breach of implied warranty of merchantability, the
plaintiff must demonstrate: “(1) the goods bought and sold were subject to an implied warranty
of merchantability, (2) the goods were defective at the time of the sale, (3) the defective nature of
the goods caused plaintiff’s injury, and (4) damages were suffered as a result.” Goodman v.
Wenco Foods, Inc., 423 S.E.2d 444, 454 (N.C. 1992).
Because a reasonable juror could determine that BSC negligently designed the Uphold
and the Obtryx, see supra Section III.B, a reasonable juror could likewise find that BSC
breached the implied warranty of merchantability. See N.C. Gen. Stat. § 25-2-314(2)(b).
Therefore, BSC’s Motion for Summary Judgment on Ms. Brown’s breach of implied warranty of
merchantability claim is DENIED.
E. Breach of Implied Warranty of Fitness for a Particular Purpose
Under North Carolina law, “[w]here the seller at the time of contracting has reason to
know any particular purpose for which the goods are required and that the buyer is relying on the
seller's skill or judgment to select or furnish suitable goods,” there is an implied warranty that the
goods shall be fit for such purpose. N.C. Gen. Stat. § 25-2-315. Critically, “[a] ‘particular
purpose’ differs from an ordinary purpose for which the goods are used in that it envisages a
specific use by the buyer which is peculiar to the nature of his business . . . .” Id. cmt. 2. On the
other hand, “the ordinary purposes for which goods are used are those envisaged in the concept
of merchantability and go to uses customarily made of the goods in question.” Id. Here, it is

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undisputed that the Obtryx and the Uphold were sold for their ordinary purpose—to treat SUI
and POP—and not a particular purpose native to Ms. Brown’s circumstances. See Foyle ex rel.
McMillan v. Lederle Labs., 674 F. Supp. 530, 535 (E.D.N.C. 1987) (“In the present case the DPT
vaccine had the ordinary purpose of preventing the contraction of disease. There was no
particular purpose, native to the plaintiff's position, that would implicate the implied warranty for
a particular purpose.”).
Therefore, BSC’s Motion for Summary Judgment on Ms. Brown’s breach of implied
warranty of fitness for a particular purpose claim is GRANTED.
F. Breach of Express Warranty
Under section 25-2-313 of the North Carolina General Statutes, express warranties are
created by the seller in the following ways:
(a) Any affirmation of fact or promise made by the seller to the buyer which
relates to the goods and becomes part of the basis of the bargain creates an
express warranty that the goods shall conform to the affirmation or promise[;] (b)
Any description of the goods which is made part of the basis of the bargain
creates an express warranty that the goods shall conform to the description[;] (c)
Any sample or model which is made part of the basis of the bargain creates an
express warranty that the whole of the goods shall conform to the sample or
model.
Accordingly, any actionable express warranty under North Carolina law must turn on a statement
that is the “basis of the bargain.”
BSC argues that because Ms. Brown herself did not receive any materials from BSC, she
could not have relied on any statement regarding the Obtryx or the Uphold. (Mem. in Supp.
[Docket 52], at 17). North Carolina law, however, provides that Ms. Brown need not prove
contractual privity for her express warranty claim to survive. Alberti v. Manufactured Homes,
Inc., 407 S.E.2d 819, 825 (N.C. 1991) (“[O]ur case law has recognized that a direct contractual
relationship in the sale of the product itself is not a prerequisite to recovery for breach of express
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warranty against the manufacturer.”). Accordingly, without more, BSC has failed to meet its
initial burden of demonstrating the absence of a genuine issue of material fact. See Celotex Corp.
v. Catrett, 477 U.S. 317, 323 (1986) (“[A] party seeking summary judgment always bears the
initial responsibility of informing the district court of the basis for its motion, and identifying
those portions of ‘the pleadings, depositions, answers to interrogatories, and admissions on file,
together with the affidavits, if any,’ which it believes demonstrate the absence of a genuine issue
of material fact.”).
Therefore, BSC’s Motion for Summary Judgment on Ms. Brown’s breach of express
warranty claim is DENIED.
G. Fraudulent Concealment
Ms. Brown’s Amended Short Form Complaint raises fraudulent concealment only as a
safeguard to toll the statute of limitations. (Am. Short Form Compl. [Docket 15], at 4 (“Count
VIII – Discovery Rule, Tolling and Fraudulent Concealment”)). Likewise, the Master Complaint
does not discuss fraudulent concealment independent of the statute of limitations. Accordingly,
to the extent a fraudulent concealment claim has been raised at the summary judgment stage,
BSC’s Motion for Summary Judgment on Ms. Brown’s fraudulent concealment claim is
GRANTED.
H. Loss of Consortium
BSC contends that it is entitled to summary judgment on Mr. Brown’s loss of consortium
claim because loss of consortium is a derivative claim that cannot survive without Ms. Brown’s
claims. While an accurate statement of the law, because Ms. Brown’s claims for negligent failure
to warn, negligent design, breach of express warranty, and breach of implied warranty of

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merchantability survive summary judgment, so does Mr. Brown’s loss of consortium claim.
BSC’s Motion for Summary Judgment on this claim is DENIED.
IV. Conclusion
For the reasons discussed above, it is ORDERED that BSC’s Motion for Summary
Judgment [Docket 52] is GRANTED IN PART with respect to Ms. Brown’s claims for strict
liability for manufacturing defect, strict liability for design defect, strict liability for failure to
warn, negligent manufacturing, breach of implied warranty of fitness for a particular purpose,
and fraudulent concealment, and DENIED IN PART with respect to Ms. Brown’s claims for
negligent failure to warn, negligent design, breach of implied warranty of merchantability, and
breach of express warranty, and Mr. Brown’s claim for loss of consortium.
The Court DIRECTS the Clerk to send a copy of this Order to counsel of record and any
unrepresented party.
ENTER: April 29, 2015

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