Harter et al v. Johnson & Johnson et al
Filing
119
MEMORANDUM OPINION AND ORDER (Ethion's Motion for Summary Judgment) Ethicon's 84 MOTION for Summary Judgment is GRANTED regarding the following claims: negligent manufacturing (part of Count I), (Count II) strict liability - manufac turing defect, (Count III) strict liability - failure to warn, (Count IV) strict liability - defective product, (Count V) strict liability - design defect, (Count IX) negligent misrepresentation, (Count X) negligent infliction of emotional d istress, (Count XIII) consumer protection, and (Count XV) unjust enrichment; Ethicon's Motion on the following claims is GRANTED for both the Prosima and the TVT-O: common law fraud (Count VI), fraudulent concealment (Count VII), construc tive fraud (Count VIII), and breach of implied warranty of fitness for a particular purpose (Count XII); defendant's Motion for claims related to the TVT-O is GRANTED for the following: (I) negligence and (XIV) gross negligence; Ethicon 39;s Motion on the following claims regarding the Prosima is DENIED: negligence (Count I), breach of express warranty (Count XI), breach of implied warranty of merchantability for defective design or for an inadequate warning (Count XII), and gr oss negligence (Count XIV); and Ethicon's Motion on the following claims regarding the TVT-O is DENIED: breach of express warranty (Count XI), and breach of implied warranty of merchantability for defective design or for an inadequate warning (Count XII), as more fully set forth herein. Signed by Judge Joseph R. Goodwin on 12/15/2016. (cc: counsel of record; any unrepresented party) (ts)
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
BETH HARTER,
Plaintiff,
v.
CIVIL ACTION NO. 2:12-cv-00737
ETHICON, INC., et al.,
Ethicon.
MEMORANDUM OPINION AND ORDER
(Ethicon’s Motion for Summary Judgment)
Pending before the court is Ethicon’s Motion for Partial Summary Judgment
[ECF No. 84]. As set forth below, Ethicon’s Motion is GRANTED in part and DENIED
in part.
I.
Background
This case resides in one of seven MDLs assigned to the court 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 58,000 cases currently pending, approximately
28,000 of which are in Ethicon, Inc. and Johnson & Johnson, Inc. (“Ethicon”) MDL,
MDL 2327. In an effort to efficiently and effectively manage this massive MDL, the
court 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
summary judgment Motions, among other things), it can then be promptly
transferred or remanded to the appropriate district for trial. To this end, the court
ordered the plaintiffs and defendants to submit a joint list of 200 of the oldest cases
in Ethicon MDL that name only Ethicon, Inc., Ethicon, LLC, and/or Johnson &
Johnson. which would then become part of a “wave” of cases to be prepared for trial
and, if necessary, remanded. See Pretrial Order No. 193, In re Ethicon, Inc. Pelvic
Repair Sys. Prods. Liab. Litig., No. 2:12-md-002327, Aug. 19, 2015, available at
http://www.wvsd.uscourts.gov/MDL/Ethicon/orders.html. I completed this process
four times and selected the plaintiff ’s case as a Wave 1 case.
On December 23, 2010, Ms. Harter was surgically implanted with Ethicon’s
Gynecare TVT-Obturator (“TVT-O”) and Gynecare Prosima (“Prosima”), products
manufactured by Ethicon to treat SUI and POP, respectively. Am. Short Form Compl.
¶¶ 9–10 [ECF No. 5]. Ms. Harter’s surgery occurred at Rockingham Memorial
Hospital in Harrisonburg, Virginia. Id. ¶ 11. Ms. Harter claims that as a result of
implantation of these devices she has experienced multiple complications. She
brought the following claims against Ethicon: (I) negligence, (II) strict liability –
manufacturing defect, (III) strict liability – failure to warn, (IV) strict liability –
defective product, (V) strict liability – design defect, (VI) common law fraud,
(VII) fraudulent
concealment,
(VIII) constructive
fraud,
(IX)
negligent
misrepresentation, (X) negligent infliction of emotional distress, (XI) breach of
express warranty; (XII) breach of implied warranty, (XIII) violation of consumer
protection laws, (XIV) gross negligence, (XV) unjust enrichment, (XVI) loss of
2
consortium,1 (XVII) punitive damages, and (XVIII) discovery rule and tolling.
Id. ¶ 13.
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,
Former plaintiff Stuart Harter’s loss-of-consortium claim was previously dismissed with prejudice
by stipulation. See Joint Stip. [ECF No. 39].
1
3
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. The choice of law for these pretrial Motions depends on whether they
concern 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). To determine the applicable state
law for a dispositive Motion, the court generally refers to the choice-of-law rules of
the jurisdiction where the plaintiff first filed her claim. 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
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West Virginia, however, as Ms. Harter did in this case, the court consults the choiceof-law rules of the state where the plaintiff was implanted with the product. See
Sanchez v. Bos. Sci. Corp., No. 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, the
court 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. Harter underwent the Prosima and TVT-O
implantation surgery in Virginia. Thus, the choice-of-law principles of Virginia guide
the court’s choice-of-law analysis.
Virginia adheres to the principle of lex loci delicti for tort actions: the place
where the harm occurred provides the substantive law. Vicente v. Obenauer,
736 F. Supp. 679, 690 (E.D. Va. 1990); see also Jones v. R. S. Jones & Assoc.,
246 S.E.2d 33, 34 (Va. 1993). As stated above, Ms. Harter was implanted with the
two products at issue in Virginia. Thus, the court applies Virginia’s substantive law
to this case.
III.
Analysis
Ethicon argues it is entitled to summary judgment on all of Ms. Harter’s claims
because her legal theories are either without evidentiary or legal support. Mem.
Supp. Mot. Summ. J. 1 [ECF No. 84]. Ms. Harter agrees that this court should dismiss
several of the counts listed in her Amended Short Form Complaint because they are
not recognized by Virginia law or because she is no longer pursing the cause of action.
Pl.’s Resp. Mem. Opp. Mot. Summ. J. 1 [ECF No. 96]. Ms. Harter contends that only
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negligence (Count I), breach of express warranty (Count XI), breach of implied
warranty (Count XII), fraud (Counts VI–VIII), and gross negligence (Count XIV)
survive the Motion. Id.
Accordingly, Ethicon’s Motion with regard to all other claims is GRANTED:
negligent manufacturing (part of Count I); (Count II) strict liability – manufacturing
defect; (Count III) strict liability – failure to warn; (Count IV) strict liability –
defective product; (Count V) strict liability – design defect; (Count IX) negligent
misrepresentation;
(Count
X)
negligent
infliction
of
emotional
distress;
(Count XIII) consumer protection; and (Count XV) unjust enrichment. Below, the
court applies the summary judgment standard to each remaining claim.
A. TVT-O Claims
Ethicon argues that all claims related to the design, manufacture, sale,
marketing, and implantation of the TVT-O should be dismissed because there is no
evidence in the record that the TVT-O caused Ms. Harter any injuries or that the
product was defective or harmful. Def.’s Mem. 4.
Ms. Harter failed to respond to this argument. Additionally, Ms. Harter’s own
expert, Dr. Galloway, testified that he did not find any issues related to Ms. Harter’s
TVT-O in his independent medical examination. Galloway Dep. 102:15-104:1,
Dec. 16, 2015 [ECF No. 85-5]. Ms. Harter has failed to show any genuine dispute of
material fact regarding whether or not she was injured by the TVT-O.
Thus, Ethicon’s Motion for Summary Judgment on all counts which require
proof of harm as to Ms. Harter’s TVT-O claim is GRANTED: (I) negligence,
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(VI) common law fraud, (VII) fraudulent concealment, (VIII) constructive fraud, and
(XIV) gross negligence.
For all other counts regarding the TVT-O, Ethicon’s Motion is DENIED:
(XI) breach of express warranty and (XII) breach of implied warranty.
B. Negligence Claims
1. Negligent Failure to Warn (Count I)
In Virginia, a manufacturer has a duty to warn users of known dangers posed
by its products. Micjan v. Wal-Mart Stores, Inc., Civil Action No. 14-855, 2016 WL
4141085, at *11 (W.D. Pa. Aug. 4, 2016). The manufacturer will be subject to liability
when the manufacturer:
(a) knows or has reason to know that the chattel is or is likely
to be dangerous for the use for which it is supplied, and
(b) has no reason to believe that those for whose use the
chattel is supplied will realize its dangerous condition, and
(c) fails to exercise reasonable care to inform them of its
dangerous condition or of the facts which make it likely to
be dangerous.
Micjan, 2016 WL 4141085, at *11 (quoting Featherall v. Firestone Tire & Rubber Co.,
252 S.E.2d 358, 366 (Va. 1979) and Restatement (Second) of Torts § 388 (Am. Law
Inst. 1965)).
Ethicon asks the court to employ the learned intermediary doctrine in
considering Ms. Harter’s failure to warn claim. Def.’s Mem. 8. Ethicon further alleges
that the warnings provided were adequate as a matter of law. Ball v. Takeda Pharm.
Am., Inc., 963 F. Supp. 2d 497, 504 (E.D. Va. 2013), aff’d, 587 F. App’x 78 (4th Cir.
7
2014) (“Courts have routinely held warnings adequate as a matter of law when they
alert a party to the very injury for which the plaintiff seeks relief.”)
Virginia, like many jurisdictions, has adopted the learned intermediary
doctrine. Pfizer v. Jones, 272 S.E.2d 43, 44 (Va. 1980). Manufacturers of prescription
medical products have a duty to warn only the physician rather than the plaintiff of
the risks associated with the product. Id. Thus, manufacturers are shielded from
liability if the manufacturer adequately warned the physician. Talley v. Danek,
7 F. Supp. 2d 725, 730 (E.D. Va. 1998). Under this doctrine, a plaintiff must establish
two elements: (1) the warning was inadequate and (2) the failure to warn affected the
physician’s use of the product thereby injuring the plaintiff. Id. Ethicon’s liability on
this claim depends on whether it adequately warned the implanting physician about
the risks associated with its products. Ms. Harter presented ample evidence
demonstrating genuine disputes of material fact with regard to whether an
inadequate warning caused her injuries. Furthermore, the adequacy of the warning
is a question of fact for the jury. Abbot v. Am. Cyanamid Co., 844 F.2d 1108, 1115
(4th Cir. 1988) (applying Virginia law).
Therefore, Ethicon’s Motion on the negligent failure to warn claim is DENIED
as to Ms. Harter’s claim regarding the Prosima.
2. Negligent Design (Count I)
Under Virginia law, a manufacturer of a product has a duty to exercise
ordinary care when designing a product so that it is reasonably safe for its intended
use. Turner v. Manning, Maxwell & Moore, Inc., 216 Va. 245, 251 (1975). The plaintiff
8
must establish that: “(1) an unreasonably dangerous condition (2) existed when the
goods left [Ethicon’s] hands, that (3) the product was not substantially changed after
time of sale. …[and] (4) demonstrate with “reasonable certainty” that the defect
caused the plaintiff’s injuries.” Hambrick ex rel. Hambrick v. Ken-Bar Mfg. Co., 422
F. Supp. 2d 627, 634 (W.D. Va. 2002).
Ethicon argues that a reasonable alternative design is required for this claim.
Ethicon’s cited cases do not support its argument, and I have found no legal authority
suggesting that a plaintiff must provide evidence of a reasonable alternative design.
Nevertheless, Ms. Harter has provided evidence of reasonable alternative designs
through her experts.
Therefore, Ethicon’s Motion on the negligent failure to warn claim is DENIED
as to Ms. Harter’s claim regarding the Prosima.
C. Fraud Claims
To prevail on a claim of fraud, a plaintiff must show by clear and convincing
evidence both that a defendant intentionally and knowingly made a false
representation or an omission of a material fact with the intent to mislead and that
the plaintiff detrimentally relied upon the misrepresentation or omission. Hitachi
Credit Am. Corp. v. Signet Bank, 166 F.3d 614, 628 (4th Cir. 1999) (applying Virginia
law); see also Van Deusen v. Snead, 441 S.E.2d 207, 209 (Va. 1994).
Ethicon argues that Ms. Harter cannot succeed on any of her fraud claims
because she did not rely on any alleged misrepresentation by Ethicon. Def.’s Mem.
13–14. Ethicon also asserts that Ms. Harter’s fraud claims are merely repackaged
9
failure-to-warn claims that fail under the learned intermediary doctrine. Reply Supp.
Defs.’ Mot. for Partial Summ. J. 6–7 [ECF No. 97]. Additionally, Ethicon notes that
Virginia law does not allow a plaintiff to establish a fraud claim based on reliance by
a third party. Id. at 7.
Ms. Harter alleges Ethicon misrepresented and concealed facts about the mesh
that Dr. Botticelli, her treating physician, and she relied upon. Resp. 11–12. Based
on this alleged conduct, she argues that a reasonable juror could infer that the
devices’ manufacturers acted with the requisite intent to deceive.
Virginia law requires proof of reliance by the injured party, as opposed to
reliance by a third party, in order to maintain an action for fraud. Rich. Metro. Auth.
v. McDevitt St. Bovis, Inc., 507 S.E.2d 344, 346 (Va. 1998) (noting that fraud claims
require “reliance by the party misled”). Establishing the element of reliance by the
injured party can be “problematic” in the medical device context because any alleged
misrepresentations are typically made to the prescribing doctor or other learned
intermediary. Robert E. Draim, Va. Prac. Series Prods. Liab. § 6:7. Ms. Harter never
interacted with any representative of Ethicon, nor did she read or review any
materials created by Ethicon. Ms. Harter did not look at Ethicon’s website nor does
she remember seeing “any materials with Ethicon’s name printed on it” prior to
surgery. Harter Depo. 22:25-23:24; Harter Resp. 2nd Set Interrog. at 4 [ECF No. 847]. The court has not found any evidence that Ms. Harter “relied” upon, any alleged
misrepresentation by Ethicon, so this element cannot be met and must be dismissed
as a matter of law.
10
Ethicon’s Motion regarding common law fraud (Count VI), fraudulent
concealment (Count VII), and constructive fraud (Count VIII) is GRANTED as to Ms.
Harter’s claim regarding the Prosima.
D. Breach of Warranty Claims
1. Breach of Express Warranty (Count XI)
To recover for breach of warranty, a plaintiff has the burden of showing the
existence of a warranty in addition to a breach. Hitachi Credit Am. Corp., 166 F.3d
at 624. Under Virginia’s codification of the Uniform Commercial Code, Virginia Code
§ 8.2-313(1), an express warranty can be created under the following circumstances:
(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.
Va. Code Ann. § 8.2-313(1). Furthermore, “formal words such as ‘warrant’ or
‘guarantee’” or “a specific intention to make a warranty” are not necessary to create
an express warranty. Id., § 8.2-313(2). Additionally,
Lack of privity between plaintiff and defendant shall be no
defense in any action brought against the manufacturer or
seller of goods to recover damages for breach of warranty,
express or implied, or for negligence, although the plaintiff
did not purchase the goods from the defendant, if the
plaintiff was a person whom the manufacturer or seller
11
might reasonably have expected to use, consume, or be
affected by the goods.
Va. Code Ann. § 8.2-318. The buyer does not necessarily even have to rely on the
seller’s representation for those representations to form the basis of the bargain.
Daughtrey v. Ashe, 413 S.E.2d 336, 338–40 (Va. 1992).
Ethicon focuses its argument on the fact Ms. Harter did not review or rely upon
any information provided by Ethicon. However, “[a]ny description of the goods, other
than the seller’s mere opinion about the product, constitutes part of the basis of the
bargain and is therefore an express warranty. It is unnecessary that the buyer
actually rely upon it.” Martin v. Am. Med. Sys., 116 F.3d 102, 105 (4th Cir. 1997).
Additionally, under Virginia law, privity is not required to establish a breach
of express warranty for claims made by foreseeable users of a product. See Va. Code
Ann. § 8.2-318. Virginia case law further confirms that in the medical device context,
“privity is not required, and there is no need to show that the representations were
made directly to [the plaintiff].” Martin, 116 F.3d at 104–5. Ethicon should have
reasonably anticipated that the direct purchasers, hospitals or doctors, would not be
the user of the product, and instead, it would be women like Ms. Harter who would
ultimately be implanted with its products.
The plaintiff alleges that Ethicon misrepresented facts about the nature of the
risks of their products and that they had been adequately tested. There remains a
genuine dispute of fact regarding the alleged misrepresentations and whether those
alleged misrepresentations support a cause of action for breach of an express
warranty.
12
Therefore, Ethicon’s Motion on the claim for breach of express warranty as to
Ms. Harter’s claims regarding both the Prosima and TVT-O is DENIED.
2. Breach of Implied Warranty (Count XII)
Ethicon argues that Ms. Harter’s implied warranty claims overlap with her
negligence claims and should be dismissed. However, as Ms. Harter noted in her
response, Virginia law allows for both a negligence and a warranty claim to proceed
to trial, despite being “largely identical.” Higgins v. Forest Labs, 48 F. Supp. 3d 878,
883-84 (2014).
a. Implied Warranty of Merchantability – Defective Design
In order to succeed in this claim regarding defective design, a plaintiff must
show that the product contained a “defect that rendered it unreasonably dangerous”
for its ordinary use, and that the “unreasonably dangerous condition” existed when
the product left the seller. Norris v. Excel Indus. Inc., 139 F. Supp. 3d 742, 747 (W.D.
Va. 2015). A plaintiff must also produce evidence of a “suitable alternative design to
a product which is technically feasible and desirable.” Lescs v. Dow Chem. Co., 976 F.
Supp. 393, 399 n.2 (W.D. Va. 1997), aff’d sub nom., Lescs v. William R. Hughes, Inc.,
168 F.3d 482 (4th Cir. 1999).
Ethicon argues that Ms. Harter’s implied warranty claims based on design
defect should be dismissed because Ms. Harter has failed to produce evidence of a
feasible alternative design. Def.’s Mem. 17. However, Ms. Harter has produced
evidence of safer alternative designs for the TVT-O and the Prosima products through
her experts. Dr. Shull and Dr. Botticelli offered alternative designs and procedures
13
including posterior colporrhaphy, abdominal sacrocolpopexies using mesh or mesh
alternatives, native tissue repair, lighter weight mesh, or larger pore mesh, among
others. Shull, M.D. Report 13–4 [ECF No. 91-5]; Botticelli, M.D. Dep., 34:22-38:5,
Dec. 16, 2015 [ECF No. 91-2]. Thus, because there is a genuine dispute of material
fact, the claim survives summary judgment.
Ethicon’s Motion for breach of implied warranty of merchantability for design
defect as to Ms. Harter’s claims regarding both the Prosima and TVT-O is DENIED.
b. Implied Warranty of Merchantability – Inadequate Warning
A product can also be considered “unreasonably dangerous” when it is not
accompanied by adequate warnings. Abbot, 844 F.2d at 1114. The learned
intermediary doctrine can apply to the failure to warn implied warranty claim. See
Talley, 7 F. Supp. 2d at 730-31. As discussed previously, manufacturers are shielded
from liability if the manufacturer adequately warned the physician. Id. at 730.
Ethicon argues that Ms. Harter’s implied warranty claims based on failure to
warn are barred by the learned intermediary doctrine. Nevertheless, because Ms.
Harter has provided ample evidence that the warnings Ethicon provided to her
treating physician were inadequate, the learned intermediary doctrine cannot bar
Ms. Harter’s breach of implied warranty claim at this stage in the litigation.
Ethicon’s Motion for summary judgment for breach of implied warranty of
merchantability for an inadequate warning as to Ms. Harter’s claims regarding both
the Prosima and TVT-O is DENIED.
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c. Implied Warranty of Fitness for a Particular Purpose
The implied warranty of fitness for a particular purpose arises when “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.” Va. Code Ann. § 8.2-315. A “particular purpose” is
one that is different than the ordinary purpose for which the good is generally used.
Id., at cmt. 2. Whether or not there is an implied warranty of fitness for a particular
purpose is generally a question of fact. Bayliner Marine Corp. v. Crow, 509 S.E.2d
499, 503 (Va. 1999).
Ethicon argues that Ms. Harter has failed to allege a “particular purpose” for
which the Prosima and TVT-O were to be used. I agree. The record is void of any
evidence that would permit a reasonable juror to infer that the Prosima and TVT-O
were being used for anything other than their ordinary use – to treat POP and SUI,
respectively.
Accordingly, Ethicon’s Motion for breach of implied warranty of fitness for a
particular purpose as to Ms. Harter’s claims regarding both the Prosima and TVT-O
is GRANTED.
E. Gross Negligence (Count XIV)
Gross negligence in Virginia requires “an unusual and marked departure from
the routine performance of business activities.” Hamilton v. Boddie-Noell Enters.,
Inc., 88 F. Supp. 3d 588, 592 (W.D. Va. 2015) (internal quotations omitted). A plaintiff
must prove that the defendant acted with “an utter disregard of prudence that
15
amounts to a complete neglect of the safety of another person that would ‘shock fairminded persons.” Id. (internal quotations omitted). Gross negligence, however,
requires proof of negligence of a degree less than “willful recklessness.” Griffin v.
Shively, 315 S.E.2d 210, 213 (1984) (citing Ferguson v. Ferguson, 181 S.E.2d 648, 651
(Va. 1971)). Generally, gross negligence is an issue for a jury to resolve; it only
becomes a question of law when “reasonable minds could not differ.” Id. at 212.
Ethicon argue that Ms. Harter has not met the elements of this claim, namely
that she failed to present evidence of conduct that represented “an unusual and
marked departure” from normal business practices. Def.’s Mem. 16.
Ms. Harter contends that much of Ethicon’s conduct was intentional, which is
a higher standard than what is required to satisfy gross negligence. Resp. 12-3. Ms.
Harter contends, inter alia, that Ethicon knew of the risks the mesh posed to patients
and did not exercise its regular due diligence in designing and developing the product.
Id. Through her experts, Ms. Harter asserts that Ethicon knew of the risks associated
with the use of mesh, and that it posed no advantage over traditional native tissue
repair, and Ethicon promoted the product nonetheless. Resp. 12. Ms. Harter also
points to the allegations in Dr. Shull’s expert report. Shull Expert Report 2-3
[ECF No. 91-4].
Here, genuine disputes of material fact exist with regard to whether Ethicon
acted with gross negligence. Ethicon’s Motion for Summary Judgment on the claim
for gross negligence is DENIED as to Ms. Harter’s claim regarding the Prosima.
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IV.
Conclusion
For the reasons discussed above, it is ORDERED that Ethicon’s Partial Motion
for Summary Judgment [ECF No. 84] is GRANTED in part and DENIED in part. As
Ms. Harter has conceded these claims, Ethicon’s Motion is GRANTED regarding the
following claims: negligent manufacturing (part of Count I); (Count II) strict liability
– manufacturing defect; (Count III) strict liability – failure to warn; (Count IV) strict
liability – defective product; (Count V) strict liability – design defect; (Count IX)
negligent misrepresentation; (Count X) negligent infliction of emotional distress;
(Count XIII) consumer protection; and (Count XV) unjust enrichment.
Ethicon’s Partial Motion on the following claims is GRANTED for both the
Prosima and the TVT-O: common law fraud (Count VI), fraudulent concealment
(Count VII), constructive fraud (Count VIII), and breach of implied warranty of
fitness for a particular purpose (Count XII). Additionally, defendant’s Motion for
claims related to the TVT-O is GRANTED for the following: (I) negligence and (XIV)
gross negligence.
Ethicon’s Motion on the following claims regarding the Prosima is DENIED:
negligence (Count I), breach of express warranty (Count XI), breach of implied
warranty of merchantability for defective design or for an inadequate warning
(Count XII), and gross negligence (Count XIV). Ethicon’s Motion on the following
claims regarding the TVT-O is DENIED: breach of express warranty (Count XI), and
breach of implied warranty of merchantability for defective design or for an
inadequate warning (Count XII).
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The Court DIRECTS the Clerk to send a copy of this Order to counsel of record
and any unrepresented party.
ENTER:
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December 15, 2016
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