United States District Court, S.D. West Virginia, Charleston Division
December 19, 2016
BEVERLY KIVEL, Plaintiff,
ETHICON, INC., et al., Defendants.
MEMORANDUM OPINION AND ORDER (DEFENDANTS' MOTION
FOR SUMMARY JUDGMENT)
R. Goodwin United States District Judge
before the court is the defendants' Motion for Summary
Judgment [ECF No. 67]. As set forth below, the
defendants' Motion is GRANTED in part
and DENIED in part.
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 the 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 the Ethicon MDL that name only Ethicon, Inc., Ethicon,
LLC, and/or Johnson & Johnson. These cases became 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
I completed this selection process four times and selected
the plaintiff's case as a Wave 1 case.
January 5, 2005, Ms. Kivel was surgically implanted with
Gynemesh/Gynemesh PS (“PS”), a product
manufactured by Ethicon. Am. Short Form Compl. ¶¶
9-10 [ECF No. 22]. Ms. Kivel's surgery occurred at
Regions Hospital in St. Paul, Minnesota. Id. ¶
11. Ms. Kivel claims that as a result of implantation of the
PS, she has experienced multiple complications. She brings
the following claims against Ethicon: negligence, strict
liability manufacturing defect, strict liability failure to
warn, strict liability defective product, strict liability
design defect, common law fraud, fraudulent concealment,
constructive fraud, negligent misrepresentation, negligent
infliction of emotional distress, breach of express and
implied warranties, violation of consumer protection laws,
gross negligence, unjust enrichment, punitive damages, and
discovery rule and tolling. Id. ¶ 13.
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).
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
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
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
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). The plaintiff in
this case originally filed her complaint in the United States
District Court for the District of Minnesota. (See
Compl. & Jury Demand 1 [ECF No. 1]). Accordingly, I must
apply Minnesota's choice- of-law rules.
parties agree, as does the court, that these principles
compel application of Minnesota law to the plaintiff's
claims. Minnesota focuses on two factors in resolving
choice-of-law issues: (1) the maintenance of interstate order
and (2) the advancement of the forum state's interest.
See In re Baycol Prods. Litig., 218 F.R.D. 197, 207
(D. Minn. 2003) (stating that only two factors in
Minnesota's usual five-factor test apply to the
resolution of choice-of-law issues arising under tort law)
(citing Nodak Mut. Ins. Co. v. Am. Family Mut. Ins.
Co., 604 N.W.2d 91, 94-96 (Minn. 2000)).
respect to the first factor, the court should look to the
state with “the most significant contacts with the
facts relevant to the litigation.” Id. Here,
that state is Minnesota, where the plaintiff resides,
underwent implantation surgery, and received follow-up
medical care. (See Am. Short Form Compl. ¶ 4,
¶ 11 [ECF No. 26]; Pl.'s Resp. in Opp. To Def.'s
Mot. For Summ. J. 1-5 [ECF No. 79]). The second factor, which
requires the court to consider “the state law in which
the plaintiff lives and in which the injury occurred, ”
also weighs in favor of applying Minnesota law. See,
e.g., In re Baycol, 218 F.R.D. at 207 (“[A]s the
injury occurred in the state of plaintiff's residence,
the substantive law of the state of plaintiff's residence
should be applied to their claims.”); Foster v. St.
Jude Med., Inc., 229 F.R.D. 599, 605 (D. Minn. 2005)
(“[P]roper consideration of Minnesota's
choice-of-law factors reveals that the law of the state where
the [d]evice was implanted would apply to Plaintiffs'
[products liability] claims.”).
considered both factors in Minnesota's choice-of-law
test, I find that Minnesota law governs the plaintiff's
substantive claims in this case. I now turn to the merits of
the pending motions.
argues it is entitled to summary judgment because the
plaintiff's legal theories are without evidentiary or
legal support. In her Response [ECF No. 77], the plaintiff
withdraws several of the Counts listed in her Amended Short
Form Complaint: Count II, strict liability manufacturing
defect; Count IV, strict liability defective product; Count
VI, Fraud; Count VII, fraudulent concealment; Count VIII,
constructive fraud; Count IX, negligent misrepresentation;
Count X, negligent infliction of emotional distress; Count
XI, breach of express warranty; Count XII breach of implied
warranty; Count XIII, violation of consumer protection laws;
Count XIV, gross negligence; and Count XV, unjust enrichment.
Accordingly, Ethicon's Motion with regard to these claims
is GRANTED. Below, the court applies the
summary judgment standard to each remaining claim.
Statute of Limitations
threshold matter, Ethicon argues that the plaintiff's
remaining strict liability claims are barred by a four-year
statute of limitations. Minn. Stat. Ann. § 541.05, subd.
2. This statute incorporates a discovery rule which provides
that “a cause of action does not accrue until two
elements are satisfied: ‘(1) a cognizable physical
manifestation of the disease or injury, and (2) evidence of a
causal connection between the injury or disease and the
defendant's product, act, or omission.'”
Huggins v. Stryker Corp., 932 F.Supp.2d 972, 984 (D.
Minn. 2013) (quoting Hildebrandt v. Allied Corp.,
839 F.2d 396, 398 (8th Cir. 1987)).
discovery rule requires that the plaintiff suffer only
“some damage” to trigger the statutory clock.
Narum v. Eli Lilly and Co., 914 F.Supp. 317, 320 (D.
Minn. 1996). The discovery rule is not, however,
“intended to provoke the premature commencement of
claims for temporary sickness or discomfort. Rather, the
plaintiffs are entitled to wait until the cause has been
rationally identified.” Hildebrandt, 839 F.2d
at 399 (applying Minnesota law). Ultimately, a
plaintiff's claim accrues when she “is aware of
both her injury and the likely cause of her injury, ”
and “waiting for a more serious injury to develop from
the same cause” will not delay the accrual date.
Klempka v. G.D. Searle & Co., 963 F.2d 168, 170
(8th Cir. 1992).
asserts that Ms. Kivel identified the PS as the cause of her
injury when she reported suffering from pain to Dr. Sharpe,
her implanting physician, on November 16, 2007, approximately
two years after the PS was implanted. Mem. in Sup. 6 [ECF No.
68]. Ms. Kivel testified that she did not attribute her
symptoms to the PS-and, in turn, to Ethicon-until she saw a
television advertisement referring to “the
defectiveness of mesh” in 2011. Kivel Dep. 32:21-33:6,
Nov. 4, 2015 [ECF No. 77-2]. Plaintiff also argues that the
earliest possible date Ms. Kivel could have known that the PS
was causing her problems was when the FDA issued a Public
Health Notification on October 20, 2008. Resp. 6 [ECF No.
77]. The plaintiff asserts that Dr. Sharpe had given Ms.
Kivel no reason to believe that her injuries were caused by
the PS product before that time. Id. at 7. In fact,
Dr. Sharpe testified that, at the time of Ms. Kivel's
November 2007 visit, Dr. Sharpe primarily attributed the
plaintiff's pain to scarring and contracting of an
incision from the implantation surgery and “the
physical findings related to the graft itself were absolutely
unremarkable.” Sharpe Dep. 110:5-111:7, 113:19-21, Dec.
16, 2015 [ECF No. 77-2].
light of the evidence proffered by Ms. Kivel and the
defendants, there is a genuine dispute of material fact as to
when Ms. Kivel was aware of the causal connection between the
PS and her injuries. See Hildebrandt, 839 F.2d at
398 (explaining that the statute of limitations begins to run
with “(1) a cognizable physical manifestation of the
disease or injury, and (2) evidence of a causal connection
between the injury or disease and the defendant's
product, act, or omission”). Accordingly, Ethicon's
Motion for Summary Judgment with regard to statute of
limitations is DENIED.
has adopted the doctrine of strict liability for defective
products set forth in section 402A of the Restatement
(Second) of Torts. See Lee v. Crookston Coca-Cola
Bottling Co., 188 N.W.2d 426, 432 (Minn. 1971);
Kapps v. Biosense Webster, Inc., 813 F.Supp.2d 1128,
1146 (D. Minn. 2011).
(1) One who sells any product in a defective condition
unreasonably dangerous to the user or consumer or to his
property is subject to liability for physical harm thereby
caused to the ultimate user or consumer, or to his property,
(a) the seller is engaged in the business of selling such a
(b) it is expected to and does reach the user or consumer
without substantial change in the condition in which it is
(2) The rule stated in Subsection (1) applies although
(a) the seller has exercised all possible care in the
preparation and sale of his product, and
(b) the user or consumer has not bought the product from or
entered into any contractual relation with the seller.
(Second) of Torts § 402A (Am. Law Inst. 1965). Under
this doctrine, Minnesota “imposes liability, without
proof of negligence or privity of contract, upon a
manufacturer or seller for injury caused by a dangerously
defective product.” Lee, 188 N.W.2d at 432.
Minnesota, a plaintiff bringing a design defect claim under
strict liability must prove, through an objective
“reasonable care balancing test, ” that a
defendant failed to execute reasonable care. Bilotta v.
Kelley Co., Inc., 346 N.W.2d 616, 621-22 (Minn. 1984).
This balancing test requires “a balancing of the
likelihood of harm, and the gravity of harm if it happens,
against the burden of the precaution which would be effective
to avoid the harm.” Id. at 621 (quoting
Holm v. Sponco, 324 N.W.2d 207, 212 (Minn. 1982)).
On one side of the balancing test, a court must consider
“the relative costs and benefits of an allegedly
defective design.” Kapps, 813 F.Supp.2d at
1161. On the other side, a court will weigh “the
relative costs and benefits of one of two different things:
either (1) a proposed alternative design, or (2) the removal
of the challenged product from the market.”
Id. “In almost every design defect case, a
plaintiff will demonstrate a safer design as part of
establishing liability.” Block v. Toyota Motor
Corp., 5 F.Supp.3d 1047, 1067 (D. Minn. 2014). Indeed,
“[o]nly in rare cases, ” will a plaintiff prevail
in her claim by arguing that a product “should be
removed from the market rather than be redesigned.”
Block, 5 F.Supp.3d at 1067; Kallio v. Ford Motor
Co., 407 N.W.2d 92, 96-7 (Minn. 1987).
Motion seeks summary judgment on the plaintiff's design
defect claims on the basis that the plaintiff has neither
shown the existence of a safer alternative design nor
presented evidence to show that the PS was so dangerous that
it should have been removed from the market. The plaintiff,
however, has proffered evidence of an alternative design and
has produced evidence that the purported safer alternative
designs would have reduced Ms. Kivel's injuries, would
not have affected the product's utility, and would have
been economically and technologically feasible. Accordingly,
the court finds that there remains a genuine dispute of
material fact regarding the existence of a safer alternative
design under Minnesota law. Ethicon's Motion on the
plaintiff's strict liability design defect claim is
Failure to Warn
like many jurisdictions, has adopted the learned intermediary
doctrine, which applies to strict liability claims.
Kapps, 813 F.Supp.2d at 1152 (citing Mulder v.
Parke Davis & Co., 181 N.W.2d 882, 885 n.1 (Minn.
1970)). Under this doctrine, “a maker of drugs or
medical devices has a duty to warn only doctors (the learned
intermediaries)-and not patients-about the dangers associated
with a drug or medical device.” Id. Therefore,
a strict liability claim fails when a medical-device
manufacturer provides an adequate warning to a
plaintiff's doctor. Id. A strict liability claim
will also fail if a plaintiff fails to prove that the
allegedly inadequate warning caused the plaintiff's
injures; the causal chain is broken when a doctor (1) is
fully aware of the information that a medical-device
manufacturer “wrongly failed to provide” and (2)
the doctor “would have taken the same action even if
the defendant had included that information in the
warning.” Id. (citing Cornfeldt v.
Tongen, 262 N.W.2d 684, 698 (Minn. 1977)). Both the
adequacy of the warning and causation are questions of fact
to be resolved by the jury. Balder v. Haley, 399
N.W.2d 77, 81 (Minn. 1987).
the plaintiff has offered evidence from which a reasonable
juror could return a verdict in her favor, and genuine
disputes of material fact exist with regard to (1) whether
Ethicon's warning was adequate, and (2) whether the
alleged inadequate warning proximately caused the alleged
harm to Ms. Kivel. Therefore, Ethicon's Motion for
Summary Judgment on Ms. Kivel's strict liability for
failure to warn claim is DENIED.
Minnesota law, “[t]he distinction between strict
liability and negligence in design-defect and failure-to-warn
cases is that in strict liability, knowledge of the condition
of the product and the risks involved in that condition will
be imputed to the manufacturer, whereas in negligence these
elements must be proven. Bilotta v. Kelley Co., 346
N.W.2d 616, 622 (Minn. 1984). Ultimately, however,
“with respect to failure-to-warn and design-defect
claims, the theories of negligence and strict liability are
effectively merged into a single theory of products
liability” once it goes to a jury. Kapps, 813
F.Supp.2d at 1146 (citing Bilotta, 346 N.W.2d at
Ethicon argues only that summary judgment is proper on these
claims because the claims are duplicative of the strict
liability claims. As discussed above, the plaintiff has
proffered sufficient evidence regarding the alleged existence
of a safer alternative design and lack of an adequate
warning. Additionally, the plaintiff's negligence claims
are not contingent on the outcome of her strict liability
claims; they are independent claims and not merged into a
single theory until they go to the jury. Ethicon's Motion
regarding the plaintiff's negligence claims is
Punitive Damages and Discovery Rule & Tolling
asserts that its Motion challenges all of the plaintiff's
claims, which include punitive damages and discovery rule and
tolling. Mot. Summ. J., at 1. Ethicon, however, does not
present any arguments regarding these claims. The court will
not make arguments for Ethicon. Accordingly, Ethicon's
Motion regarding the plaintiff's claims for punitive
damages and discovery rule and tolling is
reasons discussed above, it is ORDERED that
Ethicon's Motion for Summary Judgment [ECF No. 67] is
GRANTED in part and DENIED in
part. As the plaintiff has conceded these claims,
Ethicon's Motion is GRANTED with regard
to the plaintiff's claims for: Count II, strict liability
manufacturing defect; Count IV, strict liability defective
product; Count VI, Fraud; Count VII, fraudulent concealment;
Count VIII, constructive fraud; Count IX, negligent
misrepresentation; Count X, negligent infliction of emotional
distress; Count XI, breach of express warranty; Count XII
breach of implied warranty; Count XIII, violation of consumer
protection laws; Count XIV, gross negligence; and Count XV,
unjust enrichment. Ethicon's Motion regarding the
plaintiffs strict liability design defect, strict liability
failure to warn and negligence claims is
Court DIRECTS the Clerk to send a copy of
this Order to counsel of record and any unrepresented party.