Eghnayem v. Boston Scientific Corporation
MEMORANDUM OPINION AND ORDER (Motion for Summary Judgment) Boston Scientific Corporation's 166 MOTION for Summary Judgment is granted with respect to the plaintiffs' manufacturing defect and warranty claims and denied with respect to the plaintiffs' failure to warn claims. Signed by Judge Joseph R. Goodwin on 10/27/2014. (cc: attys; any unrepresented party) (skh)
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
AMAL EGHNAYEM, et al.,
CIVIL ACTION NO. 2:13-cv-07965
BOSTON SCIENTIFIC CORPORATION,
MEMORANDUM OPINION AND ORDER
(Motion for Summary Judgment)
Pending before the court is Defendant Boston Scientific Corporation’s (“BSC”) Motion
for Summary Judgment [Docket 166]. Responses and replies have been filed, and the motion is
ripe for review. As set forth below, BSC’s Motion for Summary Judgment [Docket 166] is
GRANTED with respect to the plaintiffs’ manufacturing defect and warranty claims and
DENIED with respect to the plaintiffs’ failure to warn claims.
This consolidated 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
over 60,000 cases currently pending, over 13,000 of which are in the Boston Scientific
Corporation MDL, MDL 2326. In this particular case, the four plaintiffs were surgically
implanted with the Pinnacle Pelvic Floor Repair Kit (“the Pinnacle”), a mesh product
manufactured by BSC. (See Pretrial Order # 91 [Docket 10], at 1–2).1 All of the plaintiffs
received their surgeries in Florida. The plaintiffs claim that as a result of implantation of the
Pinnacle, they have experienced “erosion, mesh contraction, infection, fistula, inflammation, scar
tissue, organ perforation, dyspareunia (pain during sexual intercourse), blood loss, neuropathic
and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor
damage, and chronic pelvic pain.” (Id. at 3 (quoting the master complaint)). The plaintiffs allege
negligence, design defect, manufacturing defect, failure to warn, breach of express warranty,
breach of implied warranty, and punitive damages. (Id. at 1-2).
In the instant motion, BSC moves for summary judgment on the plaintiffs’ (1) strict
liability and negligent manufacturing claims; (2) breach of express and implied warranty claims;
and (3) failure to warn claims [Docket 166].
a. Summary Judgment
To obtain summary judgment, the moving party must show that there is no genuine issue
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., Ltd. v. Zenith
Radio Corp., 475 U.S. 574, 587–88 (1986).
I originally consolidated the cases of five plaintiffs implanted with the Pinnacle. (See Pretrial Order # 91 [Docket
10] (naming Eghnayem, Dotres, Nunez, Dubois-Jean, and Betancourt as consolidated plaintiffs)). Four plaintiffs
now remain in this action. (See Order [Docket 35] (removing Dubois-Jean from the consolidated pool)).
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 Felty v. Graves-Humphreys Co., 818
F.2d 1126, 1128 (4th Cir. 1987); Ross v. Comm’ns Satellite Corp., 759 F.2d 355, 365 (4th Cir.
1985), abrogated on other grounds, 490 U.S. 228 (1989).
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
federal or state law. Here, the plaintiffs are Florida residents who were implanted with the
Pinnacle in Florida, but filed their complaints directly into the MDL in the Southern District of
West Virginia. “For cases that originate elsewhere and are directly filed into the MDL, I will
follow the better-reasoned authority that applies the choice-of-law rules of the originating
jurisdiction, which in our case is the state in which the plaintiff was implanted with the product.”
Sanchez v. Boston Scientific Corp., 2:12-cv-05762, 2014 WL 202787, at *4 (S.D. W. Va. Jan. 17,
2014); (see also Pretrial Order # 14, MDL 2326, at 2 (“A ‘Directly Filed Case’ is a case filed in
the Southern District of West Virginia for inclusion in this MDL, but the Southern District of
West Virginia does not necessarily have personal jurisdiction over the parties.”)). Florida is the
originating jurisdiction and the parties agree that the court must consult Florida’s choice-of-law
principles to determine the substantive law applicable to the plaintiffs’ claims.
In Bishop v. Florida Specialty Paint Co., the Florida Supreme Court announced a new
approach for choice of law questions concerning tort: “Instead of clinging to the traditional lex
loci delicti rule, we now adopt the ‘significant relationship[ ] test’ as set forth in the Restatement
(Second) of Conflict of Laws §§ 145-146 (1971)[.]” 389 So. 2d 999, 1001 (Fla. 1980). Florida
courts have continued to adhere to the significant relationship test set forth in Bishop. See e.g.,
Rosado v. DaimlerChrysler Fin. Servs. Trust, 1 So. 3d 1200, 1203 (Fla. Dist. Ct. App. 2009); see
also Connell v. Riggins, 944 So. 2d 1174, 1176 (Fla. Dist. Ct. App. 2006). In adopting this test,
the Bishop court reiterated the language set forth in § 146 of the Restatement, noting that “[t]he
state where the injury occurred would, under most circumstances, be the decisive consideration
in determining the applicable choice of law.” 389 So. 2d at 1001. The plaintiffs here are Florida
residents, underwent Pinnacle device implantation surgery in Florida, and allegedly suffered
injury in Florida. (See Pretrial Order # 91 [Docket 10], at 1). Therefore, I FIND that the
substantive laws of Florida apply to the issues in this case.2
a. Manufacturing Defect Claims
First, BSC argues that the plaintiffs’ strict liability and negligent manufacturing claims
fail for lack of evidence. (BSC’s Mem. of Law in Supp. of Its Mot. for Summ. J. (“Def.’s Mem.
I previously determined that in regard to the plaintiffs’ punitive damages claims, Florida has a more significant
relationship to the issue of punitive damages than Massachusetts. (See Mem. Op. & Order [Docket 232], at 4-9).
Supp.”) [Docket 168], at 2). In its reply, BSC also contends that it is entitled to judgment as a
matter of law on the manufacturing defect claims because the plaintiffs did not respond to BSC’s
motion on this issue. (BSC’s Reply in Supp. of Its Mot. for Summ. J. (“Def.’s Reply”) [Docket
183], at 1). However, the Fourth Circuit rejected this argument in Custer v. Pan American Life
In this case, the plaintiff failed to respond to the defendants’ motion for summary
judgment, despite repeated notices to do so. This failure to respond, however,
does not fulfill the burdens imposed on moving parties by Rule 56. Section (c) of
Rule 56 requires that the moving party establish, in addition to the absence of a
dispute over any material fact, that it is “entitled to a judgment as a matter of
law.” Fed. R. Civ. P. 56(c). Although the failure of a party to respond to a
summary judgment motion may leave uncontroverted those facts established by
the motion, the moving party must still show that the uncontroverted facts entitle
the party to “a judgment as a matter of law.” The failure to respond to the motion
does not automatically accomplish this. Thus, the court, in considering a motion
for summary judgment, must review the motion, even if unopposed, and
determine from what it has before it whether the moving party is entitled to
summary judgment as a matter of law. This duty of the court is restated in section
(e) of the rule, providing, “if the adverse party does not so respond, summary
judgment, if appropriate, shall be entered against the adverse party.” Fed. R. Civ.
P. 56(e) (emphasis added).
27 F.3d 410, 416 (4th Cir. 1993). Therefore, I proceed to consider the merits of BSC’s motion
regarding the plaintiffs’ manufacturing defect claims.
In West v. Caterpillar Tractor, Co., the Supreme Court of Florida adopted Section 402A
of the Restatement (Second) of Torts as the standard for strict liability. 336 So. 2d 80, 87 (Fla.
1976). Accordingly, in Florida,
[i]n order to hold a manufacturer liable on the theory of strict liability in tort, the
user must establish the manufacturer’s relationship to the product in question, the
defect and unreasonably dangerous condition of the product, and the existence of
the proximate causal connection between such condition and the user’s injuries or
Id. at 86-87. A manufacturing defect results from manufacturing flaws caused by a “miscarriage
in the manufacturing process which produces an unintended result.” Cassisi v. Maytag Co., 396
So. 2d 1140, 1145 (Fla. Dist. Ct. App. 1981).
The plaintiffs did not respond to BSC’s motion for summary judgment on this issue, but
even if I consider the allegations in the Master Long Form Complaint, no material fact exists
suggesting that the Pinnacle had manufacturing defects. (See generally Master Long Form
Compl. & Jury Demand, MDL 2326). For example, the plaintiffs allege that “the material from
which the Products are made is biologically incompatible with human tissue” and that the
products were “unreasonably susceptible” to shrinkage, contraction, elongation, and
deformation. (Id. at ¶¶ 27, 30, 31; see also id. at ¶ 36 (including a list of product defects)). These
arguments, however, relate to the Pinnacle’s design and behavior after implantation. The
plaintiffs point to no evidence that there was a “miscarriage” in the Pinnacle’s manufacturing
process “which produce[d] an unintended result.” Cassisi, 396 So. 2d at 1145.
With regard to negligent manufacturing, although Florida has rejected the notion that
strict products liability and negligence are “functionally equivalent,” the plaintiffs still fail to
offer any evidence of a flaw in the manufacturing process sufficient to show BSC did not act
with reasonable care. See Spencer H. Silverglate, The Restatement (Third) of Torts Products
Liability: The Tension Between Product Design & Product Warnings, 75-DEC Fla. B.J. 10
(2001) (citing High v. Westinghouse Elec. Corp., 610 So. 2d 1259 (Fla. 1992)). Accordingly,
BSC’s motion for summary judgment on the manufacturing defect claims is GRANTED, and
these claims are DISMISSED.
b. Warranty Claims
Next, BSC argues that the plaintiffs’ breach of express and implied warranty claims fail
for lack of privity. (Def.’s Mem. Supp. [Docket 168], at 2). Again, in its reply, BSC contends
that it is entitled to judgment as a matter of law on the warranty claims because the plaintiffs did
not respond to BSC’s motion on the issue. (Def.’s Reply [Docket 183], at 1). I previously
rejected this argument, as discussed above. Therefore, I proceed to consider the merits of BSC’s
motion regarding the plaintiffs’ warranty claims.
Florida recognizes three categories of warranties: (1) express warranty; (2) implied
warranty of merchantability; and (3) implied warranty of fitness for a particular purpose. These
warranties are defined in Sections 672.313, 672.314, and 672.315, Florida Statutes (2012). First,
(1) Express warranties by the seller are created as follows:
(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
F.S.A. § 672.13. Next, Florida Statutes provide that “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.” Id. § 672.14. Lastly,
Where 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 unless
excluded or modified under the next section an implied warranty that the goods
shall be fit for such purpose.
Id. § 672.315.
Under Florida law, “to recover for the breach of a warranty, either express or implied, the
plaintiff must be in privity of contract with the defendant.” T.W.M. v. Am. Med. Sys., Inc., 886 F.
Supp. 842, 844 (N.D. Fla. 1995) (citing Kramer v. Piper Aircraft Corp., 520 So. 2d 37 (Fla.
1988)). In T.W.M., the court explains that a warranty “is fundamentally a contract,” which
requires privity, and that “[a] plaintiff who purchases a product, but does not buy it directly from
the defendant, is not in privity with that defendant.” (Id. (dealing with the purchase of a penile
implant) (citing 1 White & Summers, Uniform Commercial Code § 11-2, at 528 (3d ed. 1988)).
Much like the situation in T.W.M., the present complaint does not allege that the plaintiffs
purchased the Pinnacle directly from BSC or that they contracted with BSC. Had the plaintiffs
responded to BSC’s motion on this issue with additional facts, my decision may have been
different.3 Accordingly, BSC’s motion for summary judgment on the plaintiffs’ warranty claims
is GRANTED, and these claims are DISMISSED.
c. Failure to Warn Claims
Lastly, BSC argues that the plaintiffs’ failure to warn claims are barred by Florida’s
learned intermediary doctrine. In support of this argument, BSC contends that (1) it did not owe
a duty to warn the plaintiffs directly; (2) it provided adequate warnings of the risks associated
with the Pinnacle device; and (3) all four plaintiffs’ treating physicians were aware of the risks
presented in the Pinnacle directions for use (“DFU”). (See Def.’s Mem. Supp. [Docket 168], at 715). While I agree that under the learned intermediary doctrine BSC did not have a duty to warn
the plaintiffs directly, BSC’s remaining two arguments employ circular and unconvincing logic.
For example, in Ocana v. Ford Motor Co., the court discusses the possibility of establishing privity through an
agency relationship. See 992 So. 2d 319, 325-27 (Fla. Dist. Ct. App. 2008). However, the plaintiffs here do not
allege any facts from which I can attempt to ascertain such a relationship.
Florida, like most jurisdictions, follows the learned intermediary doctrine. See E.R.
Squibb & Sons v. Farnes, 697 So. 2d 825, 827 (Fla. 1997) (stating that Florida law requires the
manufacturer of prescription drugs provide an adequate warning only to the physician, or
“learned intermediary”). Under that doctrine, the drug or medical device manufacturer’s duty to
warn is directed to the physician rather than the patient. Upjohn Co. v. MacMurdo, 562 So. 2d
680, 683 (Fla. 1990) (citing Felix v. Hoffmann-LaRoche, Inc., 540 So. 2d 102, 104 (Fla. 1989)).4
Although typically a question of fact, the adequacy of warnings “can become a question of law
where the warning is accurate, clear, and unambiguous.” Felix, 540 So. 2d at 105. Furthermore,
the “causal link between a patient’s injury and the alleged failure to warn is broken when the
prescribing physician had ‘substantially the same’ knowledge as an adequate warning from the
manufacturer should have communicated to him.” Beale, 492 F. Supp. at 1365 (quoting
Christopher v. Cutter Labs., 53 F.3d 1184, 1192 (11th Cir. 1995)). Consequently, the questions
become whether BSC’s warnings were adequate and whether the plaintiffs’ physicians were truly
“learned intermediaries.” See id. at 1368-71.
i. Adequacy of Warnings
BSC argues that the Pinnacle DFU was adequate because it “advises physicians of the
very injuries for which Plaintiffs seek recovery.” (Def.’s Mem. Supp. [Docket 168], at 9). In its
reply, BSC notes that it would be “unreasonable” to hold BSC liable for not characterizing the
injuries warned of in a certain way. (Def.’s Reply [Docket 183], at 7 (citing Upjohn, 562 So. 3d
at 683)). Although BSC’s reasonableness argument has some merit, it is not sufficient to sustain
a motion for summary judgment. The plaintiffs have presented evidence that “at least some of
I note that in Beale v. Biomet, Inc., the Southern District of Florida held that the learned intermediary doctrine
applies to prescription medical devices as well as prescription drugs. 492 F. Supp. 2d 1360, 1368 (S.D. Fla. 2007).
the complications suffered by these Plaintiffs were not identified in the Pinnacle DFU at all.”
(Pls.’ Resp. in Opp. to BSC’s Mot. for Summ. J. (“Pls.’ Resp.”) [Docket 178], at 4). The
plaintiffs also point out the presence of potentially “qualifying language,” which, in the
plaintiffs’ view, minimizes the presented risks and renders the entire DFU inadequate. (See id. at
7-8). Accordingly, I FIND that the plaintiffs have presented sufficient evidence on the adequacy
of BSC’s warnings to show that there is a genuine dispute of material fact.
ii. Proximate Cause
BSC also asserts that the plaintiffs cannot establish proximate cause because all three
treating physicians had knowledge of the risks warned of in the Pinnacle DFU. However, I agree
with the plaintiffs’ response that BSC’s “circular logic is self-defeating” because there is no
evidence that the treating physicians knew of any risks other than those warned of in the DFU.
(Pls.’ Resp. [Docket 178], at 13). In its Memorandum in Support, BSC quotes testimony from
each treating physician indicating that he read and relied on the DFU. (See Def.’s Mem. Supp.
[Docket 168], at 12-15). Ms. Betancourt’s physician, Dr. Emilio Gomez-Madrazo, even testified
that he had no criticisms of the DFU at the time of Ms. Betancourt’s implantation. (See id. at 13).
Nevertheless, this testimony fails to support BSC’s argument for two reasons. First, I have
already determined that there is a genuine issue of material fact as to the adequacy of the DFU.
Therefore, the fact that the physicians had knowledge of the risks in the DFU does not
necessarily mean they had knowledge of all pertinent risks. Second, the plaintiffs’ response
includes unequivocal statements from all three physicians indicating that had they known then
what they know now, they would not have chosen to use the Pinnacle for these plaintiffs.
Accordingly, I FIND that the plaintiffs have presented sufficient evidence of proximate cause to
show that there is a genuine issue of material fact. Therefore, BSC’s motion for summary
judgment on the failure to warn claims is DENIED.
For the reasons discussed above, BSC’s motion for summary judgment is GRANTED
with respect to the plaintiffs’ manufacturing defect and warranty claims and DENIED with
respect to the plaintiffs’ failure to warn claims.
The court DIRECTS the Clerk to send a copy of this Order to counsel of record and any
October 27, 2014
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