Holizna et al v. Boston Scientific Corporation et al
MEMORANDUM OPINION AND ORDER (Defendant's Motion for Partial Summary Judgment) denying 90 MOTION by Boston Scientific Corporation for Partial Summary Judgment on Punitive Damages Claim. Signed by Judge Joseph R. Goodwin on 5/21/2015. (cc: counsel of record; any unrepresented party) (ts)
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
LAURA ANN HOLIZNA AND KENNETH WADE HOLIZNA,
Civil Action No. 2:12-cv-06173
BOSTON SCIENTIFIC CORP.,
MEMORANDUM OPINION AND ORDER
(Defendant’s Motion for Partial Summary Judgment)
Pending before the court is the defendant’s Motion for Partial Summary Judgment on
Plaintiff Laura Holizna’s Punitive Damages Claim and Memorandum in Support (“Motion”)
[Docket 90]. As set forth below, the defendant’s Motion is DENIED.
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 16,000 of which are in the Boston Scientific
Corporation (“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 trial-ready (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 Holiznas’ case was selected as
a Wave 1 case by the plaintiffs.
The plaintiff, Laura Ann Holizna, was surgically implanted with the Obtryx
Transobturator Mid-Urethral Sling System (the “Obtryx”) and the Pinnacle Pelvic Floor Repair
Kit (the “Pinnacle”) to treat her SUI and POP on March 1, 2010. (See BSC’s Mot. for Partial
Summ. J. on Pl.’s Punitive Damages Claim & Mem. in Supp. (“Mem. in Supp.”) [Docket 90], at
10). Dr. Michael Hulse performed the surgery at a hospital in Canton, Georgia. (Id.). Ms.
Holizna claims that as a result of implantation of the Obtryx and the Pinnacle, she has
experienced multiple complications, including “rectal pain, dyspareunia, colon spasms and
terrible pain with bowel movements. Mesh eroded into her rectum, and she developed a
rectovaginal fistula. . . . She has stress urinary incontinence much worse than she had prior to
implant surgery.” (See Pl. Fact Sheet [Docket 113-6], at 7). She brings the following claims
against BSC: negligence; strict liability for design defect, manufacturing defect, and failure to
warn; breaches of express and implied warranties; and punitive damages. (Compl. [Docket 1], at
18–36). Mr. Holizna brings a claim for loss of consortium. (Id. at 32). In the instant motion, BSC
moves for summary judgment on the grounds that the Holiznas’ claim for punitive damages is
“without evidentiary or legal support.” (Mem. in Supp. [Docket 90], at 1).
Partial Summary Judgment
A partial summary judgment “is merely a pretrial adjudication that certain issues shall be
deemed established for the trial of the case.” Fed. R. Civ. P. 56 advisory committee’s note. A
motion for partial summary judgment is governed by the same standard applied to consideration
of a full motion for summary judgment. See Pettengill v. United States, 867 F. Supp. 380, 381
(E.D. Va. 1994) (citing Gill v. Rollins Protective Servs. Co., 773 F.2d 592, 595 (4th Cir. 1985)).
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. 2:08md-01968, 2010 WL 2102330, at *7 (S.D. W. Va. May 25, 2010). Here, the action was
originally filed in Georgia. (Compl. [Docket 1]). Thus, the choice-of-law principles of Georgia
guide this court’s choice-of-law analysis.
Georgia adheres to the doctrine of lex loci delicti, which dictates that “a tort action is
governed by the substantive law of the state where the tort was committed.” Dowis v. Mud
Slingers, Inc., 621 S.E.2d 413, 414 (Ga. 2005). “The place where the tort was committed, or, ‘the
locus delicti, is the place where the injury sustained was suffered rather than the place where the
act was committed, or, as it is sometimes more generally put, it is the place where the last event
necessary to make an actor liable for an alleged tort takes place.’” Bullard v. MRA Holding, 740
S.E.2d 622, 625 (Ga. 2013) (quoting Risdon Enter., Inc. v. Colemill Enter., Inc., 324 S.E.2d 738,
740 (Ga. 1984)). Ms. Holizna’s alleged injury occurred in Georgia; therefore, Georgia law
governs the plaintiffs’ claims.
BSC argues that the law of Massachusetts––the place where the alleged misconduct
occurred––is the site of the tortious activity and thus, Massachusetts law applies to the plaintiffs’
punitive damages claim. (See Mem. in Supp. [Docket 90], at 13). According to BSC, the focus of
the punitive damages inquiry is corporate conduct, and such conduct took place, if at all, in
Massachusetts where the products were designed, manufactured, and labeled. (Id.). For support,
BSC points to this court’s ruling in In re Ethicon—where I held that the focus of the punitive
damages inquiry was Ethicon’s corporate conduct, and because that conduct allegedly occurred
in New Jersey, New Jersey law applied. In re Ethicon, Inc., Pelvic Repair Sys. Prods. Liab.
Litig., No. 2:12-cv-4301, 2014 WL 186869, at *10 (S.D. W. Va. Jan. 15, 2014), rev’d on other
grounds, No. 2:12-cv-4301, 2014 WL 457551 (S.D. W. Va. Feb. 3, 2014). BSC also points to
other product liability cases where courts have applied an alternative state’s punitive damages
law based on where the corporate conduct occurred. See Aguirre Cruz v. Ford Motor Co., 435 F.
Supp. 2d 701, 706 (W.D. Tenn. 2006) (applying Michigan law for punitive damages where the
corporate decisions, design of the product, and principal place of business all occurred in
Michigan); Zimmerman v. Novartis Pharm. Corp., 889 F. Supp. 2d 757, 760 (D. Md. 2012)
(applying Tennessee’s “significant relationship” approach to hold that New Jersey punitive
damages law—where the conduct occurred—applied); and Tobin v. AMR Corp., 637 F. Supp. 2d
406, 422 (N.D. Tex. 2009) (applying Texas law for punitive damages where injury occurred in
Illinois but the defendants’ corporate decisions were made in Texas).
BSC’s analysis is flawed. The cases BSC cites are inapposite because they all use the
“most significant relationship” test, while Georgia does not. In In re Ethicon, Inc., this court
applied Texas choice-of-law rules. 2014 WL 186869, at *2–3. Under Texas law, courts apply the
“most significant relationship” test as enunciated by the Restatement (Second) of Conflicts (the
“Restatement”) to each substantive issue. Id. at *9. Tobin also applied the Restatement approach
under Texas law. 637 F. Supp. 2d at 412. Similarly, Aguirre Cruz and Zimmerman applied
Tennessee’s choice-of-law rules, where Tennessee also employs the Restatement’s “most
significant relationship” approach. See Aguirre Cruz, 435 F. Supp. 2d at 704; Zimmerman, 889 F.
Supp. 2d at 760. BSC cites to no authority where a Georgia court—state or federal—has ever
construed lex loci delicti to be the place where the defendant engaged in wrongful conduct.
Instead, Georgia’s choice-of-law principles provide that a tort action is governed by the law of
“the place where the injury sustained was suffered rather than the place where the act was
committed.” Bullard, 740 S.E.2d at 625. Ms. Holizna suffered her alleged injuries in Georgia,
not Massachusetts. Therefore, I FIND that the laws of Georgia apply to the plaintiffs’ punitive
The question before the court is whether the plaintiffs have produced enough evidence to
create a genuine issue of material fact as to whether BSC engaged in culpable conduct that meets
Georgia’s punitive damages standard. Under Georgia law, “[p]unitive damages may be awarded
only in such tort actions in which it is proved by clear and convincing evidence that the
defendant’s actions showed willful misconduct, malice, fraud, wantonness, oppression, or that
entire want of care which would raise the presumption of conscious indifference to
consequences.” Ga. Code Ann. § 51-12-5.1(b). “[P]unitive damages, the purpose of which is to
‘punish, penalize or deter,’ are, as a general rule, improper where a defendant has adhered to [the
relevant] safety regulations.” Stone Man, Inc. v. Green, 435 S.E.2d 205, 206 (Ga. 1993). This is
because “such compliance does tend to show that there is no clear and convincing evidence of
willful misconduct, malice, fraud, wantonness, oppression, or that entire want of care which
would raise the presumption of a conscious indifference to consequences.” Id. However,
regulatory compliance does not “preclude an award of punitive damages where,
notwithstanding the compliance with applicable safety regulations, there is other evidence
showing culpable behavior.” Gen. Motors Corp. v. Moseley, 447 S.E.2d 302, 311 (Ga. 1994),
abrogated on other grounds by Webster v. Boyett, 496 S.E.2d 459 (Ga. 1998).
As an initial matter, I reject BSC’s argument that punitive damages are precluded because
it complied with relevant safety regulations. As I have previously held, the regulations with
which BSC complied are not related to safety and efficacy. See generally Lewis v. Johnson &
Johnson, 991 F. Supp. 2d 748 (S.D. W. Va. 2014), see In re C.R. Bard, Inc., No. 2:10-CV01224, 2013 WL 2432871 (S.D. W. Va. June 4, 2013) (applying Georgia law). BSC contends
that the plaintiff has not produced evidence of any BSC conduct that was so egregious as to
warrant punitive damages. (Mem. in Supp. [Docket 90], at 16–19). BSC points to Dr. Hulse’s
testimony that his patients who were implanted with BSC mesh experience “substantially” less
complications than with other types available for use in his practice, and that Dr. Hulse continues
to use the Obtryx to treat his patients. (Id. at 17).
The plaintiff, on the other hand, relies on my decisions in Hendricks v. Boston Scientific
Corp., 51 F. Supp. 3d 638 (S.D. W. Va. 2014), and Sanchez v. Boston Scientific Corp., 38 F.
Supp. 3d 727 (S.D. W. Va. 2014). She argues that a reasonable jury could find that BSC’s
actions showed willful misconduct, malice, or wantonness because BSC was aware that the
polypropylene used to construct the Obtryx and the Pinnacle was not intended to be permanently
implanted in the human body. (Resp. [Docket 113], at 17). The Obtryx and the Pinnacle are
constructed using a polypropylene resin supplied by Chevron Phillips Chemical Company, LP.
(MSDS [Docket 113-13], at 1). The material safety data sheet (“MSDS”) authored by Chevron
Phillips included the following warning:
MEDICAL APPLICATION CAUTION: Do not use this Chevron Phillips
Chemical Company LP material in medical applications involving permanent
implantation in the human body or permanent contact with internal body fluids or
(Id.). Despite this warning, BSC used Chevron Phillips polypropylene in the Obtryx and the
Additionally, the plaintiff references the written agreement between BSC and its
polypropylene supplier (“the Agreement”), which cautioned BSC to make its own determination
of the safety and suitability of the polypropylene material in its products. (Resp. [Docket 113], at
17). The Agreement provided:
BEFORE USING ANY PSPC POLYPROPYLENE PRODUCT, BOSTON
SCIENTIFIC IS ADVISED AND CAUTIONED TO MAKE ITS OWN
DETERMINATION AND ASSESSMENT OF THE PSPC POLYPROPYLENE
PRODUCT FOR USE BY, FOR OR ON BEHALF OF BOSTON SCIENTIFIC.
IT IS THE ULTIMATE RESPONSIBILITY OF BOSTON SCIENTIFIC TO
ENSURE THAT THE PSPC POLYPROPYLENE PRODUCT IS SUITED TO
BOSTON SCIENTIFIC’S SPECIFIC APPLICATION.
(Chevron Agreement [Docket 113-16], at 1–2).
Despite the MSDS warning and the admonition from BSC’s polypropylene supplier to
conduct its own tests, BSC sponsored no clinical studies on either the Obtryx or the Pinnacle.
(See Clinical Risk/Benefit Analysis (Obtryx Sling System) [Docket 113-19], at 5; Clinical
Risk/Benefit Analysis (Pinnacle) [Docket 113-31], at 10). Furthermore, BSC never warned
through the Directions for Use that the Obtryx and Pinnacle were made of a component—
polypropylene—that was not safe for permanent implantation in the human body. (See Obtryx
DFU [Docket 113-35]; Pinnacle DFU [Docket 113-36]).
In light of this evidence, I FIND that under a clear and convincing standard, a reasonable
juror could find that by ignoring a warning on the MSDS and neglecting to conduct clinical
studies, BSC evinced “willful misconduct, malice, fraud, wantonness, oppression, or that entire
want of care which would raise the presumption of conscious indifference to consequences.” Ga.
Code Ann. § 51-12-5.1(b). Accordingly, BSC’s motion for summary judgment on the issue of
punitive damages is DENIED.
For the reasons discussed above, it is ORDERED that BSC’s Motion [Docket 90] be
The Court DIRECTS the Clerk to send a copy of this Order to counsel of record and any
ENTER: May 21, 2015
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