Kilgore et al v. Boston Scientific Corporation
MEMORANDUM OPINION AND ORDER (Defendant's Motion for Summary Judgment) Boston Scientific Corporation's 63 MOTION for Summary Judgment Against Plaintiffs Debra Kilgore and William Kilgore is GRANTED IN PART with respect to the plaintiffs& #039; claims of strict liability for manufacturing defect, strict liability for failure to warn, negligent manufacturing, negligent failure to warn, breach of express warranty, breach of implied warranty of merchantability, breach of implied warranty of fitness for a particular purpose, and fraudulent concealment, and DENIED IN PART with respect to the plaintiffs' claims of strict liability for design defect, negligent design, and loss of consortium. Signed by Judge Joseph R. Goodwin on 10/5/2015. (cc: counsel of record; any unrepresented party) (kp)
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
DEBRA KILGORE and WILLIAM KILGORE,
Civil Action No. 2:13-cv-09171
BOSTON SCIENTIFIC CORP.,
MEMORANDUM OPINION AND ORDER
(Defendant’s Motion for Summary Judgment)
Pending before the court is Defendant Boston Scientific Corp.’s (“BSC”) Motion for
Summary Judgment and Memorandum in Support Against Plaintiffs Debra Kilgore and William
Kilgore (“Motion”) [Docket 63]. As set forth below, BSC’s Motion is GRANTED IN PART with
respect to the plaintiffs’ claims of strict liability for manufacturing defect, strict liability for failure
to warn, negligent manufacturing, negligent failure to warn, breach of express warranty, breach of
implied warranty of merchantability, breach of implied warranty of fitness for a particular purpose,
and fraudulent concealment. BSC’s Motion is DENIED IN PART with respect to the plaintiffs’
claims of strict liability for design defect, negligent design, and loss of consortium.
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
72,000 cases currently pending, approximately 19,000 of which are in the Boston Scientific Corp.
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 trial-ready, 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,
orders.html). This selection process was completed twice, creating two waves of 100 cases, Wave
1 and Wave 2. The Kilgores’ case was selected as a Wave 2 case by the plaintiffs.
Plaintiff Debra Kilgore was surgically implanted with the Advantage Fit System (the
“Advantage Fit”), the Pinnacle Pelvic Floor Repair Kit (the “Pinnacle”), and the Uphold Vaginal
Support System (the “Uphold”) on June 25, 2012. (Short Form Compl. [Docket 1] ¶¶ 8, 10). She
received the surgery at a hospital in Brooksville, Florida. (Id. ¶ 11). Her surgery was performed by
Dr. Harvey Schonwald. (Id. ¶ 12). Ms. Kilgore claims that as a result of implantation of the
Advantage Fit, Pinnacle, and Uphold, she has experienced multiple complications. The plaintiffs
bring the following claims against BSC: strict liability for manufacturing defect, design defect,
and failure to warn; negligence; breaches of express and implied warranties; loss of consortium;
fraudulent concealment; and punitive damages. (Short Form Compl. [Docket 1] ¶ 13).
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).
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. “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. 2:08-md-01968, 2010 WL 2102330, at *7
(S.D. W. Va. May 25, 2010).
If a plaintiff files her claim directly into the MDL in the Southern District of West Virginia,
however, as the Kilgores did in this case, I consult the choice-of-law rules of the state in which the
implantation surgery took place. See Sanchez v. Boston Scientific Corp., 2:12-cv-05762, 2014 WL
202787, at *4 (S.D. W. Va. Jan. 17, 2014) (“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.”). Ms. Kilgore received her implantation surgery in Florida. (Short Form Compl.
[Docket 1] ¶ 11). Thus, the choice-of-law principles of Florida guide this court’s choice-of-law
These principles compel application of Florida law. “In an action for a personal injury, the
local law of the state where the injury occurred determines the rights and liabilities of the parties,
unless, with respect to the particular issue, some other state has a more significant
relationship . . . .” Bishop v. Fla. Specialty Paint Co., 389 So. 2d 999, 1001 (Fla. 1980) (quoting
Restatement (Second) of Conflict of Laws (“Restatement”) § 146); see also id. (quoting
Restatement § 145) (listing factors to consider when determining which state has the most
significant relationship to a dispute).
Here, the plaintiffs are Florida residents. (Short Form Compl. [Docket 1] ¶ 4). In addition,
Ms. Kilgore was implanted with the device and allegedly suffered injury in Florida. (Id. ¶¶ 11, 13).
Accordingly, Florida has the most significant relationship of any state to the occurrence alleged in
this lawsuit and to the parties. Thus, I apply Florida’s substantive law to this case.
The plaintiffs have conceded the following claims: strict liability for manufacturing defect,
negligent manufacturing, and breach of express warranty. (Pls.’ Resp. & Supporting Mem. in
Opp’n to Def.’s Mot. for Summ. J. (“Resp.”) [Docket 77], at 1, 10). Therefore, BSC’s Motion on
these claims is GRANTED. I analyze the remaining claims below.
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. Additionally, “a product may be defective by virtue of a design defect, a
manufacturing defect, or an inadequate warning.” Ferayorni v. Hyundai Motor Co., 711 So. 2d
1167, 1170 (Fla. Dist. Ct. App. 1998).
Under the “government rules defense,”
there is a rebuttable presumption that the product is not defective or unreasonably
dangerous and the manufacturer or seller is not liable if, at the time the specific unit
of the product was sold or delivered to the initial purchaser or user, the aspect of
the product that allegedly caused the harm: (a) Complied with federal or state codes,
statutes, rules, regulations, or standards relevant to the event causing the death or
injury; (b) The codes, statutes, rules, regulations, or standards are designed to
prevent the type of harm that allegedly occurred; and (c) Compliance with the
codes, statutes, rules, regulations, or standards is required as a condition for selling
or distributing the product.
Fla. Stat. § 768.1256(1).
BSC argues that the government rules defense applies in this case because the Federal
Food, Drug, and Cosmetic Act (“FDCA”) is designed to prevent the type of harm that allegedly
occurred, and BSC complied with FDA regulations under the FDCA in clearing the Advantage Fit,
Pinnacle, and Uphold for sale to the public. (Def.’s Mot. for Summ. J. & Mem. of Law in Supp.
(“Mem. in Supp.”) [Docket 63], at 9–11).
In Lewis v. Johnson & Johnson, I held that
[t]he 510(k) process is not a safety statute or administrative regulation. The
Supreme Court has determined that “the 510(k) process is focused on equivalence,
not safety.” [Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996)] (internal quotation
omitted); see also [Riegel v. Medtronic, Inc., 552 U.S. 312, 323 (2008)] (“While
§ 510(k) is focused on equivalence, not safety, premarket approval is focused on
safety, not equivalence.”) (internal quotation omitted).
991 F. Supp. 2d 748, 755 (S.D. W. Va. 2014) (footnote omitted); see also Cisson v. C. R. Bard, Inc.
(In re C. R. Bard, Inc., Pelvic Repair Sys. Prods. Liab. Litig.), No. 2:11-cv-00195, 2013 WL
3821280, at *7 (S.D. W. Va. July 23, 2013) (“The FDA 510(k) process does not go to safety and
effectiveness and does not provide any requirements on its own.”). I also found in Lewis that
section 82.008(a) of the Texas Civil Practice and Remedies Code did not apply because the
product’s “510(k) clearance [did] not relate to its safety or efficacy.” Lewis, 991 F. Supp. 2d at 761;
see also Tex. Civ. Prac. & Rem. Code § 80.008(a) (“[T]here is a rebuttable presumption that the
product manufacturer or seller is not liable for any injury to a claimant caused by some aspect of
the formulation, labeling, or design of a product if the product manufacturer or seller establishes
that the product’s formula, labeling, or design complied with mandatory safety standards or
regulations adopted and promulgated by the federal government, or an agency of the federal
government, that were applicable to the product at the time of manufacture and that governed the
product risk that allegedly caused harm.”) (emphasis added).
Section 768.1256 of the Florida Statutes is nearly identical to the Texas statute at issue in
Lewis. Both statutes provide a rebuttable presumption only when the product complies with
government safety standards. Like I held in Lewis, because the 510(k) process is not “designed to
prevent the type of harm that allegedly occurred,” see Fla. Stat. § 768.1256(1)(b), I FIND that the
government rules defense is inapplicable.
BSC has presented no other argument on design defect. Thus, BSC has failed to meet its
burden of showing the absence of a genuine dispute as to any material fact. See Fed. R. Civ. P.
56(a); Adickes v. S.H. Kress & Co., 398 U.S. 144, 157 (1970), superseded on other grounds by
Celotex Corp. v. Catrett, 477 U.S. 317 (1986). Furthermore, the plaintiff has offered concrete
evidence from which a reasonable juror could return a verdict in her favor. Therefore, BSC’s
Motion on the plaintiffs’ claim of strict liability for design defect is DENIED.
Failure to Warn
To prevail on a claim of failure to warn, a plaintiff must show that the warnings
accompanying the product are inadequate, and that the inadequacy of the warnings proximately
caused the plaintiff’s injury. Hoffmann-La Roche Inc. v. Mason, 27 So. 3d 75, 77 (Fla. Dist. Ct.
Florida follows the learned intermediary doctrine, under which the drug or medical device
manufacturer’s duty to warn is directed to the physician rather than the patient. Felix v. HoffmannLaRoche, Inc., 540 So. 2d 102, 104 (Fla. 1989); see Beale v. Biomet, Inc., 492 F. Supp. 2d 1360,
1368 (S.D. Fla. 2007) (holding learned intermediary doctrine applies to prescription medical
devices as well as prescription drugs); Savage v. Danek Med., Inc., 31 F. Supp. 2d 980, 984 (M.D.
Fla.), aff’d mem., 202 F.3d 288 (11th Cir. 1999) (same).1 Under the learned intermediary doctrine,
any warning read by the physician “means only that the learned intermediary would have
incorporated the additional risk into his decisional calculus.” Thomas v. Hoffman-LaRoche, Inc.,
949 F.2d 806, 814 (5th Cir. 1992) (internal quotation marks omitted) (distinguishing preventablerisk warnings and unavoidable-risk warnings); accord Eck v. Parke, Davis & Co., 256 F.3d 1013,
1021 (10th Cir. 2001); Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992). A plaintiff
must still show that her treating physician would not have implanted the product had the physician
been given an adequate warning. See Hoffmann-La Roche Inc. v. Mason, 27 So. 3d 75, 76 (Fla.
Dist. Ct. App. 2009) (“[The plaintiff] failed to establish that the allegedly deficient warning was
the proximate cause of his injury; therefore, we reverse.”); Boles v. Merck & Co. (In re Fosamax
Prods. Liab. Litig.), 647 F. Supp. 2d 265, 279–82 (S.D.N.Y. 2009); Baker v. Danek Med., 35 F.
Supp. 2d 875, 881 (N.D. Fla. 1998); see also Maley v. Merck & Co. (In re Fosamax Prods. Liab.
Litig.), 688 F. Supp. 2d 259, 265 (S.D.N.Y. 2010) (listing Florida as among the states where the
plaintiff “has the burden of production on this aspect of causation”).
Furthermore, a physician’s failure to read the warning breaks the chain of causation
because the warning would have played no role in the physician’s decision to prescribe the product.
Fields v. Mylan Pharm., Inc., 751 F. Supp. 2d 1260, 1263 (N.D. Fla. 2009).
The plaintiffs argue that the learned intermediary doctrine is an affirmative defense. (Resp. [Docket 77], at 9–10).
Thus, according to the plaintiffs, BSC bears the burden of proof on this issue. (Id. at 10). Although a few Florida courts
have indeed referred to the learned intermediary as an affirmative defense, upon review, I distinguish those cases and
reject such a characterization. See Walls v. Armour Pharmaceutical Co., 832 F. Supp. 1467, 1482 (M.D. Fla. 1993)
(holding that the defendant bore the burden of proof with regard to the learned intermediary doctrine when moving
for judgment as a matter of law under Federal Rule of Civil Procedure 50), aff’d in part, rev’d in part on other grounds
sub nom. Christopher v. Cutter Labs., 53 F.3d 1184 (11th Cir. 1995); MacMorris v. Wyeth, Inc., No. 2:04CV596FTM29DNF, 2005 WL 1528626, at *2 (M.D. Fla. June 27, 2005) (declining to resolve the issue of whether the learned
intermediary doctrine applies at the motion to dismiss stage); Horillo v. Cook, Inc., No. 10-15327, 2012 WL 6553611,
at *3 (11th Cir. Nov. 7, 2012) (referring to the learned intermediary doctrine as an affirmative defense in the context
of a defendant’s ability to “avoid liability by demonstrating the treating physician was otherwise aware of the particular
risk associated with the medical device”).
Here, although Dr. Schonwald, the implanting physician, testified that he “may have” seen
the Pinnacle Directions for Use (“DFU”) before, he also stated that “[h]onestly, I don’t pay
attention to them.” (Schonwald Dep. [Docket 77-3], at 73:20–23). Given his explicit statement that
he does not rely on the DFUs, no amount of additional warnings would have changed Dr.
Schonwald’s course of treatment, and consequently, the plaintiffs cannot establish proximate
causation. See, e.g., Lewis v. Ethicon, Inc. (In re Ethicon, Inc., Pelvic Repair Sys. Prods. Liab.
Litig.), No. 2:12-cv-4301, 2014 WL 186869, at *4 (S.D. W. Va. Jan. 15, 2014) (“Although Dr.
Boreham read the [DFU] at one time, she admits that she did not rely on it when she prescribed
the [mesh product] for Ms. Lewis. . . . Therefore, there is no evidence that any additional or
stronger warnings on the [DFU] would have prevented Ms. Lewis’s injuries.” (citations omitted)),
rev’d in part on other grounds sub nom. Lewis v. Ethicon, Inc. (In re Ethicon, Inc.), No. 2:12-cv4301, 2014 WL 457551 (S.D. W. Va. Feb. 3, 2014), aff’d sub nom. Lewis v. Johnson & Johnson,
No. 14-1244, --- F. App’x ---, 2015 WL 860371 (4th Cir. Mar. 2, 2015).
Therefore, BSC’s Motion on the plaintiffs’ claim of strict liability for failure to warn is
In a negligence suit, the plaintiff must establish (1) duty; (2) breach of duty; (3) causation;
and (4) damages. Kayfetz v. A.M. Best Roofing, Inc., 832 So. 2d 784, 786 (Fla. Dist. Ct. App. 2002);
see Clay Elec. Co-op, Inc. v. Johnson, 873 So. 2d 1182, 1185 (Fla. 2003) (citing W. Page Keeton
et al., Prosser and Keaton on the Law of Torts 164–65 (W. Page Keeton ed., 5th ed. 1984)).
As explained earlier, the government rules defense does not apply to the plaintiffs’ design
defect claim, whether based on strict liability or negligence, and BSC has failed to meet its
summary judgment burden. See supra Part III.A.1. Therefore, BSC’s Motion on the plaintiffs’
claim of negligent design is DENIED.
Negligent Failure to Warn
As explained earlier, no amount of additional warnings would have changed Dr.
Schonwald’s course of action, and consequently, the plaintiffs cannot establish proximate
causation. See supra Part III.A.2. Therefore, BSC’s Motion on the plaintiffs’ claim of negligent
failure to warn is GRANTED.
Breach of Implied Warranties
The Supreme Court of Florida has “abolished the no-privity, breach of implied warranty
cause of action for personal injury upon its adoption of the doctrine of strict liability in tort.”
Kramer v. Piper Aircraft Corp., 520 So. 2d 37, 39 (Fla. 1988). “A plaintiff who purchases a
product, but does not buy it directly from the defendant, is not in privity with that defendant.”
T.W.M. v. Am. Med. Sys., Inc., 886 F. Supp. 2d 842, 844 (N.D. Fla. 1995).
Here, the plaintiffs have not presented any evidence that they are in privity with BSC.
Therefore, BSC’s Motion on the plaintiffs’ claims of breach of implied warranty of merchantability
and breach of implied warranty of fitness for a particular purpose is GRANTED.
The plaintiffs’ Short Form Complaint raises fraudulent concealment only as a safeguard to
toll the statute of limitations. (See Short Form Compl. [Docket 1] ¶ 13 (“Count VIII – Discovery
Rule, Tolling and Fraudulent Concealment”)). Likewise, the Master Complaint does not discuss
fraudulent concealment independent of the statute of limitations. (See Master Long Form Compl.
& Jury Demand, MDL No. 2326, ¶¶ 89–92). Therefore, to the extent that the plaintiffs intended to
bring a separate claim of fraudulent concealment, BSC’s Motion regarding that claim is
Loss of Consortium
Loss of consortium is a derivative right, and a spouse may recover only if there is an
underlying cause of action against the same defendant. Gates v. Foley, 247 So. 2d 40, 45 (Fla.
1971); see Busby v. Winn & Lovett Miami, Inc., 80 So. 2d 675, 676 (Fla. 1955).
Because at least one of Ms. Kilgore’s claims survives, Mr. Kilgore’s claim of loss of
consortium also survives. Therefore, BSC’s Motion on the plaintiffs’ claim of loss of consortium
For the reasons discussed above, it is ORDERED that BSC’s Motion [Docket 63] be
GRANTED IN PART with respect to the plaintiffs’ claims of strict liability for manufacturing
defect, strict liability for failure to warn, negligent manufacturing, negligent failure to warn, breach
of express warranty, breach of implied warranty of merchantability, breach of implied warranty of
fitness for a particular purpose, and fraudulent concealment, and DENIED IN PART with respect
to the plaintiffs’ claims of strict liability for design defect, negligent design, and loss of consortium.
The Court DIRECTS the Clerk to send a copy of this Order to counsel of record and any
October 5, 2015
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