Nelson et al v. Johnson & Johnson et al

Filing 35

DECISION AND ORDER signed by Chief Judge William C Griesbach on 7/15/2019 Denying 32 Motion to Strike, Granting-in-Part and Denying-in-Part 10 Motion for Partial Summary Judgment, Denying 21 Motion for Leave to File Surreply, and Denying 21 Motion to Strike. The Clerk is directed to schedule a telephone conference to discuss the status of 14 , 18 and 25 pending Motions. (cc: all counsel) (Griesbach, William)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF WISCONSIN

KATHRYN M. NELSON,
Plaintiffs,
v.

Case No. 12-C-472

JOHNSON & JOHNSON and
ETHICON INC.,
Defendants.

DECISION AND ORDER

Plaintiff Kathryn Nelson alleges that she was injured as a result of the implantation of a
Prolift device that is made by Defendants Johnson & Johnson, a New Jersey corporation, and
Ethicon Inc., a New Jersey corporation and subsidiary of Johnson & Johnson. Nelson initiated this
lawsuit in the Eastern District of Wisconsin on May 11, 2012. On June 15, 2012, the case was
conditionally transferred to the Southern District of West Virginia under 28 U.S.C. § 1407 for
coordination and consolidation of pretrial proceedings. Dkt. No. 5. After the case was conditionally
remanded back to the Eastern District of Wisconsin on April 26, 2019, the court held a telephonic
status conference on June 18, 2019, where the parties agreed that two fully-briefed motions were
ready for resolution by this court: 1) Ethicon’s motion for partial summary judgment; and 2)
Nelson’s motion to file a sur-reply or alternatively strike portions of Ethicon’s reply brief. The court
has jurisdiction over the case pursuant to 28 U.S.C. § 1332. For the reasons that follow, Ethicon’s
motion will be granted-in-part and denied-in-part and Nelson’s motion will be denied.

BACKGROUND
In April of 2009, Nelson consulted with an OBGYN, Dr. Thomas Reinardy, regarding
symptoms of pelvic organ prolapse—including cystocele and rectocele—and stress urinary
incontinence. On May 14, 2009, Dr. Reinardy performed a total vaginal hysterectomy on Nelson,
implanted a Prolift device to treat the prolapse, and a TVT-O-Obturator device to treat the urinary
incontinence. Prior to the devices’ implantation, Dr. Reinardy attended two training sessions by
Ethicon regarding both Prolift and TVT-O that demonstrated proper surgical technique and
addressed possible complications. Dr. Reinardy was provided information on the risks and benefits
associated with the use of the Prolift in pelvic organ prolapse repair surgery. In addition, Dr.
Reinardy had received training during his residency program and was aware that the use of mesh
products could result in complications such as pain, erosion, and dyspareunia. Based on his general
practice experience, Dr. Reinardy knew that any pelvic floor surgery involves the risks of
dyspareunia, vaginal scarring, infection, urinary problems, bleeding, inflammation, neuoromuscular
problems, recurrence, failure, or acute and chronic pain. Dr. Reinardy was familiar with the
potential adverse reactions to Prolift and risks associated with implantation stated in Prolift’s
instructions for use (IFU) prior to implanting it in Nelson. Nelson subsequently underwent multiple
surgeries for partial mesh excision of the Prolift on July 22, 2010; January 31, 2011; April 13, 2011;
and October 3, 2011.
LEGAL STANDARD
Summary judgment should be granted when the moving party shows 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 other words, the time and expense of the parties and the court should not
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be wasted on a trial when there are no material facts in dispute, one party is entitled to judgment on
those facts, and thus there is nothing to try. In deciding a motion for summary judgment, all
reasonable inferences are construed in favor of the nonmoving party. Foley v. City of Lafayette, 359
F.3d 925, 928 (7th Cir. 2004). The party opposing the motion for summary judgment must “submit
evidentiary materials that set forth specific facts showing that there is a genuine issue for trial.”
Siegel v. Shell Oil Co., 612 F.3d 932, 937 (7th Cir. 2010) (quoted source and internal quotation
marks omitted). “The nonmoving party must do more than simply show that there is some
metaphysical doubt as to the material facts.” Id. Summary judgment is properly entered against a
party “who fails to make a showing sufficient to establish the existence of an element essential to
the party’s case, and on which that party will bear the burden of proof at trial.” Parent v. Home
Depot U.S.A., Inc., 694 F.3d 919, 922 (7th Cir. 2012) (internal quotation marks omitted) (quoting
Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986)).
ANALYSIS
In its motion for partial summary judgment, Ethicon moves to dismiss the following claims
of Nelson’s Amended Short Form Complaint:
Count I - Negligence; Count II - Strict Liability - Manufacturing Defect; Count III Strict Liability - Failure to Warn; Count IV - Strict Liability - Defective Product;
Count VI - Common Law 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;
and Count XV - Unjust Enrichment.
In her response, Nelson states that she does not oppose dismissal of claims associated with the
implantation of the TVT-O-Obturator product, and Counts II, IV, VII, VIII, X, XI, XII, XIII, and
XV as they relate to the Prolift product. Pl.’s Resp., Dkt No. 12 at 1–2. Consequently, Ethicon’s
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motion will be granted as it relates to those claims. This leaves for determination Ethicon’s motion
for summary judgment on Nelson’s claims for strict liability and negligent failure to warn, fraud and
negligent misrepresentation.
A.

Choice-Of-Law
As jurisdiction in this district is based on diversity, the court looks to Wisconsins’ choice-of-

law rules to determine which State’s law applies to Nelson’s claims. GATX Leasing Corp. v. Nat’l
Union Fire Ins. Co., 64 F.3d 1112, 1114 (7th Cir. 1995) (“A federal court sitting in diversity looks
to the conflict-of-laws rules in the state jurisdiction in which it sits in order to choose the
substantive law applicable to the case.”) Under Wisconsin law, “‘the law of the forum should
presumptively apply unless it becomes clear that nonforum contacts are of greater significance.’”
Drinkwater v. Am. Family Mut. Ins. Co., 2006 WI 56, ¶ 40, 290 Wis. 2d 642, 714 N.W.2d 568
(quoting State Farm Mut. Auto Ins. Co. v. Gillette, 2002 WI 31, ¶ 51, 251 Wis. 2d 561, 641 N.W.2d
662).
Here, Wisconsin’s contacts predominate. Nelson lived in Wisconsin when she received the
implant and did not leave the state until after filing her case in Wisconsin. In addition, the surgery
was performed in Wisconsin by a Wisconsin surgeon and nearly all of her follow-up treatment
occurred in Wisconsin. Consequently, the court will apply Wisconsin law to Nelson’s claims.
B.

Count I - Negligence and Count III - Strict Liability - Failure to Warn
As an initial matter, the parties dispute whether the learned intermediary doctrine applies

to Nelson’s claims. “The doctrine holds that the manufacturer of a prescription drug or medical
device fulfills its duty to warn of the product’s risks by informing the prescribing physician of those
risks.” In re Zimmer, NexGen Knee Implant Prod. Liab. Litig., 884 F.3d 746, 751 (7th Cir. 2018).
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Although “neither the Wisconsin Supreme Court nor the state’s intermediate appellate courts have
addressed the doctrine,” id., “there is good reason to think that given the opportunity, the Wisconsin
Supreme Court would join the vast majority of state supreme courts and adopt the
learned-intermediary doctrine for use in defective-warning cases,” id. at 752, and the Seventh
Circuit has predicted that Wisconsin’s Supreme Court would do so. Id. Definitive resolution of this
question, however, is not necessary at this time to resolve Ethicon’s motion for partial summary
judgment.
Ethicon asserts that Nelson’s negligent failure to warn claim and strict liability failure to
warn claim should be dismissed because she cannot prove the failure to warn contributed to her
injury. In addition, Ethicon contends that it had no duty to warn Dr. Reinardy about dangers
generally known to pelvic floor surgeons.
1.

Strict Liability Failure to Warn Claim

Regarding Nelson’s strict liability failure to warn claim, under Wisconsin’s strict liability
statute, Wis. Stat. § 895.047, a product is defective because of inadequate instructions or warnings
if the plaintiff can show that:
a) The foreseeable risks of harm posed by the product could have been reduced or
avoided by the provision of reasonable instructions or warnings by the manufacturer
and the omissions of the instructions or warnings renders the product not reasonably
safe;
b) The defective condition rendered the product unreasonably dangerous to persons
or property;
c) The defective condition existed at the time the product left the control of the
manufacturer;
d) The product reached the user or consumer without substantial change in the
condition in which it was sold; and
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e) The defective condition was a cause of the claimant’s damages.
Wis. Stat. § 895.047(1)(a)–(e). A manufacturer, however, “does not have a duty to warn about
dangers that are obvious to or readily known by potential users, or so commonly known that it can
reasonably be assumed that users will be familiar with them.” Burton v. Am. Cyanamid, 334 F.
Supp. 3d 949, 958 (E.D. Wis. 2018) (citing Godoy ex rel. Gramling v. E.I. du Pont de Nemours &
Co., 2009 WI 78, ¶ 32, 319 Wis. 2d 91, 768 N.W.2d 674).
Nelson disputes that Wis. Stat. § 895.047 applies to her claim. “The treatment of
section[] . . . 895.047 . . . first appl[ies] to actions or special proceedings that are commenced on the
effective date of this subsection.” 2011 Wis. Act 2, § 45(5). Section 895.047 became effective as
of February 1, 2011, and Nelson did not initiate this lawsuit until May 11, 2012—after it went into
effect. Nelson contends that the retroactive application of § 895.047 would be unconstitutional.
Wisconsin tests “the due-process constitutionality of the retroactive application of state statutes by
asking, first, whether the statute is taking away a ‘vested right’ of the challenger.” Gibson v. Am.
Cyanamid Co., 760 F.3d 600, 609 (7th Cir. 2014) (citing Matthies v. Positive Safety Mfg. Co., 2001
WI 82, ¶¶ 21–23, 244 Wis. 2d 720, 628 N.W.2d 842). “If the answer is that no vested right is at
stake, then the statute satisfies due process and the inquiry ends.” Id.
Here, it does not appear that § 895.047 takes away a vested right, but it is unnecessary to
decide that issue now in any event. This is because even if § 895.047 applies, Ethicon is not entitled
to summary judgment because there is a dispute of fact regarding what Ethicon knew about the
hazards of the Prolift device, whether it warned users about those hazards, and whether it caused
Nelson’s injuries. Regarding the adequacy of Ethicon’s warnings, Nelson produced proposed

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warning language drafted by Ehticon’s Medical Affairs Director Axel Arnaud to be added to a new
version of Prolift’s IFU that was ultimately not added. The proposed language stated:
Early clinical experience has shown that the use of mesh through a vaginal approach
can occasionally/uncommonly lead to complications such as vaginal erosion and
retraction which can result in an anatomical distortion of the vaginal cavity that can
interfere with sexual intercourse. Clinical data suggest the risk of such a
complication is increased in case of associated hysterectomy. This must be taken
in consideration when the procedure is planned in sexually active women.
Dkt. No. 12-1 at 46. In addition, Dr. Daniel Elliott opined in his expert report that “Ethicon . . .
knowingly failed to completely disclose the known risks of prolapse surgery using Prolift to
physicians and patients,” id. at 148, and listed all of the risks that he believes Ethicon knew about
but failed to disclose. Id. at 143–46.
Ethicon contends that Nelson “is required to present case-specific expert testimony to prove
Ehitcon’s warnings were inadequate,” Def.’s Reply, Dkt. No. 13 at 7, and that Dr. Elliott’s expert
opinion is only a general opinion about the alleged inadequacies in Ethicon’s warnings and has no
specific connections or relevance to Nelson’s case. Ethicon, however, cites no case in support of
its contention. “[E]stablishing the existence of a product defect based on failure to warn in the strict
liability context requires analysis of what the manufacturer knew and what potential consumers or
users knew about the hazards of the product at the time that the product left the manufacturer’s
control.” Burton, 334 F. Supp. 3d at 958. Dr. Elliott’s expert testimony does just that: analyzes and
identifies hazards known by Ethicon that were not included in its warnings and were not known by
doctor’s such as Dr. Reinardy. While the general nature of Dr. Elliott’s expert testimony may mean
on its own it is not sufficient to establish causation for purposes of Nelson’s injuries, it is sufficient
to identify hazards that Ethicon failed to warn potential users of Prolift.

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Regarding causation, Dr. Reinardy testified in his deposition that had he known about
information contained in the proposed language to be added to Prolift’s IFU or some of the risks
identified in Dr. Elliott’s expert report that were not included in Prolift’s IFU, such as the risk that
the inflammatory reaction caused by implanting Prolift could be severe and chronic causing
permanent pain to the patient, he would not have recommended Prolift to Nelson and would have
treated her conditions through other means. Reinardy Dep. at 44:1–22, 51:7–53:25, Dkt. No. 12-1
at 11, 13–14.
Ethicon argues that Dr. Reinardy’s testimony is not sufficient to create a material dispute
of fact for two reasons: 1) Dr. Reinardy testified that Prolift’s IFU informed him and warned of each
complication that Nelson alleges she suffered as a result of having a Prolift implanted; and 2) Dr.
Reinardy’s responses to hypothetical questions during his deposition are not admissible evidence.
When asked, “Were there any complications that Ms. Nelson experienced that are not listed in the
[IFU] that you’re aware of,” Dr. Reinardy responded, “None that I’m aware of.” Id. at 111:4–7,
Dkt. No. 12-1 at 28. But Dr. Reindary also testified in response to hypothetical questions that if he
had known about the risks identified in those hypotheticals or the proposed Prolift IFU language,
he would not have recommended that Nelson have a Prolift implanted nor would he have
recommended it to anybody:
Q: Had you known in May of 2009, before Ms. Nelson’s surgery, what you know
today about all of the potential risks associated with the Prolift, would you have
recommended the use of the Prolift mesh to Kay Nelson?
[Objection by opposing counsel as to form]
A: The answer is no. What I know today, I wouldn’t recommend it in anybody.

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Id. at 41:22–42:4, Dkt. No. 12-1 at 11. And Nelson testified that she made her decision to have the
Prolift implanted based on the recommendation of Dr. Reinardy. Nelson Depo. at 45:3–7, Dkt. No.
12-1 at 155.
The standard for causation in strict products liability cases is: whether the defect was
a substantial factor in producing the injury . . . . “It need not be the sole factor or the
primary factor, only a ‘substantial factor.’ The phrase ‘substantial factor’ denotes
that the defendants conduct has such an effect in producing the harm as to lead the
trier of fact, as a reasonable person, to regard it as a cause, using that word in the
popular sense. There may be several substantial factors contributing to the same
result.”
Tanner v. Shoupe, 228 Wis. 2d 357, 368–69, 596 N.W.2d 805 (Ct. App. 1999) (quoting Sumnicht
v. Toyota Motor Sales, U.S.A., Inc., 121 Wis. 2d 338, 358, 360 N.W.2d 2 (1984)). Evidence that
the inclusion of language warning of known risks or hazards would alert a doctor’s prescribing
decisions can establish cause in a failure to warn claim. See Forst v. SmithKline Beecham Corp.,
602 F. Supp. 2d 960, 968–69 (E.D. Wis. 2009). There is also a question of the significance of the
risks Ethicon noted in the IFU. Ethicon seems to assume that the mere mention of a possible side
effect is sufficient to insulate it from liability for failure to warn. But if the frequency of the risk is
greater than disclosed, the failure to so state can also give rise to liability. Consequently, based on
Dr. Reinardy’s testimony that the inclusion of this information would have affected his decision,
and consequently Nelson’s decision, regarding the use of Prolift, a reasonable jury viewing the
evidence in a light most favorable towards the plaintiff could conclude that Nelson would not have
sustained her injuries but for Ethicon’s failure to warn about known side effects and hazards.
Ethicon’s arguments that Dr. Reinardy’s responses to hypothetical questions are not
admissible evidence are unsubstantiated. Regarding the lack of foundation for the hypothetical
question, a hypothetical question “must be based on assumptions that have some support in the
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evidence,” though it is not necessary that those assumptions be “uncontroverted.” Schulz v. St.
Mary’s Hospital, 81 Wis. 2d 638, 652, 260 N.W.2d 783 (1978). Here, the hypothetical questions
are supported by the expert testimony of Dr. Elliott regarding particular known risks and hazards
that Ethicon knew about. Regarding relevance, Dr. Reinardy’s responses are relevant as they go to
causation and whether he would have still used or recommended Prolift to Nelson had he known
about these particular side effects.
2.

Negligent Failure to Warn Claim

For the same reasons, there is also a dispute of fact regarding Ethicon’s failure to warn as
it relates to Nelson’s negligence claim. “In order to grant summary judgment on a negligence claim,
a court must be able to say ‘that no properly instructed, reasonable jury could find based on the facts
presented that the defendant failed to exercise ordinary care.’” Michaels v. Mr. Heater, Inc., 411
F. Supp. 2d 992, 1007 (W.D. Wis. 2006) (quoting Lambrecht v. Estate of Kaczmarczyk, 2001 WI
25, ¶ 2, 241 Wis. 2d 804, 623 N.W.2d 751). “Such scenarios are uncommon, though not
nonexistent.” Id. To the extent Nelson argues the negligence claim is duplicative of the strict
liability claim, “negligence and strict liability are separate avenues of recovery.” Morden v. Cont’l
AG, 2000 WI 51, ¶ 42, 235 Wis. 2d 325, 611 N.W.2d 659. Consequently, as there is a material
dispute of fact as to whether Ehticon’s failure to warn caused Nelson’s injuries, Ethicon’s motion
is denied with respect to Nelson’s failure-to-warn claims.
C.

Count VI - Common Law Fraud
Ethicon asserts, that because it warned of the side effects Nelson alleges to have suffered

and Dr. Reinardy was independently aware of those side effects, Nelson cannot prove that it made
a false misrepresentation. “To prove fraud under Wisconsin law, a plaintiff must demonstrate: 1)
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a misrepresentation; 2) intent to defraud; 3) reliance upon the false representations; and 4)
damages.” Forst, 602 F. Supp. 2d at 971 (E.D. Wis. 2009) (citing Mackenzie v. Miller Brewing Co.,
2001 WI 23, ¶ 18, 241 Wis. 2d 700, 623 N.W.2d 739).

Nondisclosure is actionable as a

misrepresentation when there is a duty to disclose. Tietsworth v. Harley-Davidson, Inc., 2004 WI
32, ¶ 12, 270 Wis. 2d 146, 677 N.W.2d 233 (citing Ollerman v. O’Rourke Co., Inc., 94 Wis. 2d 17,
26, 288 N.W.2d 95 (1980)). “Civil liability for misrepresentation exists when it is ‘foreseeable and
intended that a fraudulent misrepresentation will be repeated to third parties and acted upon by
them.’” Forst, 602 F. Supp. 2d at 971 (quoting State v. Timblin, 2002 WI App 304, ¶ 31, 259 Wis.
2d 299, 657 N.W.2d 89).
As discussed earlier, there is a genuine issue of material fact as to whether Nelson and Dr.
Reinardy relied on Ethicon’s alleged misrepresentations and had they known about side effects that
were not disclosed they would have altered their decision regarding the Prolift device. It is
reasonable for physicians and their patients to rely on information provided by the manufacturer of
a medical device. See id. at 971–72 (“It is wholly foreseeable to a drug manufacturer that its
prescribing and side effect information will be communicated to and relied upon by patients, even
when the drug company only interacts directly with prescribing physicians and not patients. Though
[the drug manufacturer] made no direct representations to the plaintiffs, the plaintiffs based their
decision regarding [the medication] on the information and advice of [the prescribing
physician] . . . . This information in turn, was based upon [the drug manufacturer’s]
representations.”). And Ethicon has “an obligation to warn consumers about the hidden dangers of
their products.” Burton, 334 F. Supp. 3d at 962 (quoting Godoy, 2009 WI 78, ¶ 36 n.5);
RESTATEMENT (SECOND) OF TORTS & 402A, cmt. h (“Where . . . [a manufacturer] has reason to
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anticipate that a danger may result from a particular use, . . . he may be required to give adequate
warning of the danger, and a product sold without such warning is in defective conditions.”).
Accordingly, Ethicon’s motion will be denied as it relates to Nelson’s fraud claim.
D.

Count IX - Negligent Misrepresentation
Ethicon contends that Nelson’s negligent misrepresentation claim should be dismissed

because it is duplicative of the failure to warn claim and Nelson cannot establish that Ethicon made
an untrue representation of fact. “[U]nder Wisconsin law, negligent misrepresentation has four
elements: (1) a representation of fact made by the defendant, (2) the representation of fact is untrue,
(3) the defendant was negligent in making the representation of fact, and (4) plaintiff’s belief that
the representation was true and reliance thereupon to plaintiff’s damage.” Chevron Chem. Co. v.
Deloitte & Touche, 168 Wis. 2d 323, 331–32, 483 N.W.2d 314 (Ct. App. 1992), aff’d and
remanded, 176 Wis. 2d 935, 501 N.W.2d 15 (1993). As discussed earlier, the nondisclosure here
is actionable as a misrepresentation. Additionally, the claim is not duplicative of Nelson’s failure
to warn claim as Nelson, relying on Dr. Elliott’s expert report, alleges Ethicon made affirmative
misrepresentations about the Prolift product—such as that the Prolift mesh system will restore
normal function—and not just that Ethicon omitted information, as is the case with Nelson’s failureto-warn claims. Consequently, Ethicon’s motion will be denied with respect to Nelson’s negligent
misrepresentation claim.
E.

Nelson’s Motion for Leave to File Sur-Reply Brief or Alternatively Strike Ethicon’s
New Arguments and Authority and Ethicon’s Motion To Strike Nelson’s Notice of
Supplemental Authority and Proposed Sur-Reply Brief
Nelson filed a motion to file a sur-reply to Ethicon’s reply brief or in the alternative strike

portions of Ethicon’s reply because Ethicon raised new arguments and authority in support of its
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motion. Nelson also filed a notice of supplemental authority. Ethicon subsequently filed a motion
to strike’s Nelson’s motion and notice of supplemental authority. In order to avoid further delay
and costs, and because the court is able to resolve Ethicon’s motion based on the briefs, the motions
will be denied.
CONCLUSION
For the foregoing reasons, Ethicon’s Motion for Partial Summary Judgment (Dkt. No. 10)
is GRANTED-IN-PART and DENIED-IN-PART. The motion is GRANTED with respect to
all claims associated with the implantation of the TVT-O-Obturator product and Counts II, IV, VII,
VIII, X, XI, XII, XIII, and XV as they relate to the Prolift product and DENIED in all other
respects. Nelson’s Motion For Leave to File a Sur-Reply or Alternatively Strike Ethicon’s New
Arguments and Authority (Dkt. No. 21) and Ethicon’s Motion to Strike Plaintiff’s Notice of
Supplemental Authority and Plaintiff’s “Response” to Motion for Partial Summary Judgment (Dkt.
No. 32) are DENIED. The Clerk is directed to schedule a telephone conference to discuss the status
of the remaining pending motions, Dkt. Nos. 14, 18, and 25.
SO ORDERED this 15th day of July, 2019.
s/ William C. Griesbach
William C. Griesbach, Chief Judge
United States District Court

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