J-A25038-18

                                2019 PA Super 287


 MARGARET ENGLEMAN                         :   IN THE SUPERIOR COURT OF
                                           :        PENNSYLVANIA
                                           :
              v.                           :
                                           :
                                           :
 ETHICON, INC., AND JOHNSON AND            :
 JOHNSON,                                  :
                                           :   No. 3320 EDA 2017
                    Appellants             :

           Appeal from the Judgment Entered September 12, 2017
    In the Court of Common Pleas of Philadelphia County Civil Division at
                    No(s): March Term, 2014 - No. 05384

 MARGARET ENGLEMAN                         :   IN THE SUPERIOR COURT OF
                                           :        PENNSYLVANIA
                    Appellant              :
                                           :
                                           :
              v.                           :
                                           :
                                           :
 ETHICON, INC. AND JOHNSON &               :   No. 3400 EDA 2017
 JOHNSON                                   :

           Appeal from the Judgment Entered September 12, 2017
    In the Court of Common Pleas of Philadelphia County Civil Division at
                               No(s): 05384


BEFORE: PANELLA, J., DUBOW, J., and KUNSELMAN, J.

DISSENTING STATEMENT BY DUBOW, J.:              FILED SEPTEMBER 20, 2019

      I respectfully dissent from the Majority’s decision to affirm the trial

court. In light of numerous evidentiary errors that the trial court made, I would

reverse the judgment and order a new trial.

      In June 2007, Dr. Bolton implanted into Appellee TVT-Secur, a vaginal

mesh, to alleviate Appellee’s symptoms associated with Stress Urinary
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Incontinence. A month after the surgery, Appellee experienced vaginal pain

and a return of urinary incontinence. Appellee went back to Dr. Bolton, and

three months later, in September 2007, Dr. Bolton surgically removed two

pieces of the exposed vaginal mesh.

     Appellee continued to suffer pain, and her incontinence increased, so

Dr. Bolton referred Appellant to Dr. Joseph Montella. In February 2008, Dr.

Montella removed all but approximately three centimeters of the vaginal

mesh.

     In 2012 and 2013, Appellee’s pelvic pain returned, and Appellee’s new

gynecologist identified additional erosion in Appellee’s vaginal wall. In

December 2013, Dr. Montella performed another procedure to remove the

remaining mesh. Appellee continued to suffer pain and other significant

symptoms.

     In December       2013, Appellee   saw advertisements on       television

describing the symptoms that she was experiencing. Appellee testified that

these commercials connected her symptoms to the vaginal mesh. She filed a

Complaint within two years of viewing the commercials, in October 2014.

     On April 12, 2017, the parties tried the case before a jury, and on April

28, 2017, the jury awarded Appellee $2,500,000 in compensatory damages

and $17,500,000 in punitive damages. Appellants timely filed a Post-Trial

Motion, which the trial court denied. The trial court entered judgment, and

Appellants appealed.




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                       2008 and 2011 FDA Notices

      Seven years elapsed between 2007, when Appellee began to suffer

symptoms from the implantation of Appellants’ vaginal mesh, and 2014, when

Appellee filed her Complaint. As a result, a significant issue in the trial was

whether the Discovery Rule tolled the Statute of Limitations.

      At trial, Appellants attempted to introduce into evidence FDA Notices

that the FDA published on its website in 2008 and 2011. The original notice,

in its title, states “Serious Complications Associated with Transvaginal

Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress

Urinary Incontinence.” Exhibit CTX-D—Exhibits in Support of Defendants’

Proffer   Regarding   FDA   Evidence,   filed   8/30/17,   “FDA   Public   Health

Notification,” 10/20/08 (emphasis added). The notice describes the nature of

the complications, cautioning that the transvaginal mesh was linked to “pain,

urinary problems, and recurrence of prolapse and/or incontinence.” Id. “In

some cases,” according to the FDA, “vaginal scarring and mesh erosion led to

a significant decrease in patient quality of life due to discomfort and pain,

including dyspareunia.” Id.

      In 2011, the FDA updated its findings and continued to identify as its

target audience health care providers and patients “who are considering or

have received a surgical mesh implant to repair . . . stress urinary

incontinence.” Exhibit CTX-D—Exhibits in Support of Defendants’ Proffer

Regarding FDA Evidence, filed 8/30/17, “FDA Safety Communication,”

7/13/11 (emphasis added).

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J-A25038-18



      Appellants argued to the trial court that these two notices were relevant

to the jury’s determination of the Discovery Rule, i.e., whether a reasonable

person using due diligence would have discovered a link between her injury

and the cause of the injury earlier than Appellee did in this case. The trial

court disagreed and precluded the introduction of the 2008 and 2011 FDA

Notices on two grounds. First, the trial court found that the notices were not

relevant pursuant to Pa.R.E. 402 and 403 because the notices do not “refer to

stress urinary incontinence.” Trial Ct. Op., 1/32/18, at 42. The trial court also

found that the public notices were inadmissible as hearsay. Id. Both of the

court’s findings are incorrect.

      As an initial matter, the trial court is incorrect about the topic of the

notices. Both notices, in fact, refer to Appellee’s condition, Stress Urinary

Incontinence. The notices specifically target patients who suffer from

Appellee’s condition, and they describe the nature and potential severity of

side effects associated with vaginal implantation of surgical mesh.

      Also, the trial court erred in concluding that the FDA Notices were

inadmissible hearsay. Appellants were not attempting to introduce them for

substantive purposes, but rather as evidence that in the public domain was

notice of a link between Appellee’s symptoms and Appellants’ product. In

other words, Appellants were attempting to introduce them for purposes of

applying the Discovery Rule, i.e., as notice to a reasonable person that there

was a link between her symptoms and the vaginal mesh. Because Appellants

were attempting to use the FDA Notices to establish “notice,” not the facts

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contained therein, the trial court erred in concluding that the FDA Notices

constituted inadmissible hearsay.

      The Majority in this case agrees that the trial court erred in finding that

the FDA Notices were hearsay but finds that they were not relevant. The

Majority bases its analysis on the conclusion that Appellee “is not expected to

self-diagnosis [sic].” Maj. Op. at 14. The Majority relies on Nicolaou v.

Martin, 195 A.3d 880 (Pa. 2018), for the proposition that when applying the

Discovery Rule, Appellee is “only charged with the knowledge communicated

to her by the medical professionals who provided treatment and diagnosis.”

Maj. Op. at 14. In other words, the Majority concludes that the FDA notices

are irrelevant because the statute of limitations does not begin to run until a

medical professional provides a plaintiff with information that links the

plaintiff’s injury to the medical cause of that injury.

      To accept the Majority’s interpretation of Nicolaou would result in the

limitations period commencing, in any case involving medical causation, only

when a medical professional informs a patient of a link between the patient’s

condition and the cause of the condition. However, the Supreme Court in

Nicolaou specifically rejects the Majority’s expansive interpretation of the

Discovery Rule. 195 A.3d at 892 (“This Court has recognized that

Pennsylvania’s formulation of the discovery rule represents a more narrow

approach and places a greater burden on plaintiffs[.]”). The Supreme Court

notes further that triggering the limitations period only upon “specific medical

evidence supporting a cause of action” would represent a “groundbreaking

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transformation” in our law. Id. at 892 n. 14 (deferring any reevaluation of the

Discovery Rule to a future case in which the issue is properly preserved).

      Moreover, the nature of the claims pursued in Nicolaou are rather

different from this case. Nicolaou was a medical malpractice case in which

several doctors for many years misdiagnosed the plaintiff’s condition. In July

2009, a nurse practitioner tentatively gave the plaintiff the correct diagnosis

of Lyme Disease and encouraged the plaintiff to undergo a particular test to

confirm the diagnosis. The plaintiff waited seven months to undergo the test,

receiving confirmation that she had Lyme Disease in February 2010. She filed

her malpractice suit within two years of the February 2010 date. The trial court

granted the defendants’ Motion for Summary Judgment on the grounds that

the statute of limitations began to run in July 2009, when the nurse

practitioner gave her a tentative diagnosis of Lyme Disease, and had expired

by the time the plaintiff filed a Complaint in February 2012.

      The issue before the Supreme Court was whether the limitations period

commenced when the nurse provided the plaintiff with a tentative diagnosis

or when the plaintiff received the test results confirming that diagnosis. The

Supreme Court concluded that the commencement of the limitations period

and application of the Discovery Rule were questions for the jury and that,

therefore, the trial court had erred in granting the defendants summary

judgment. Id. at 894-95.

      In this case, Appellee does not assert that doctors misdiagnosed her

condition or erred by failing to link Appellee’s symptoms to the vaginal mesh.

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J-A25038-18



Further, unlike Nicolaou, no question arises that requires a fact finder to

weigh the impact of a tentative medical diagnosis. Therefore, there is no legal

basis to defer commencement of the limitations period until a medical

professional gave Appellee information linking the vaginal mesh to her

symptoms.

      In   fact,   it   was   a   television   commercial,   publicly-disseminated

information, that influenced Appellee to consider a link between the vaginal

mesh and her symptoms. Similarly, the FDA Notices were publicly-

disseminated information suggesting a link and, thus, relevant for the jury to

consider when applying the Discovery Rule.

      The Majority also rejects Appellants’ argument on the relevancy of the

FDA Notices by finding that Appellants are disingenuously arguing that the

FDA notices are relevant for the application of the Discovery Rule, but not

relevant to establish a product defect. Maj. Op. at 15. The issue, however, is

not whether Appellants are disingenuous, but rather whether the trial court

erred in precluding the jury from considering the FDA notices when applying

the Discovery Rule. The fact that the notices contain information that the jury

might also (inappropriately) consider in determining whether the vaginal mesh

was defective is irrelevant to the analysis of whether a reasonable person

would have discovered the link before Appellee discovered it from the

television commercial.

      In sum, I conclude that the FDA Notices were relevant evidence for

purposes of applying the Discovery Rule and the trial court erred in precluding

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J-A25038-18



them from evidence. The notices caution about a linkage between Appellants’

product and symptoms that Appellee suffered. Like the television commercial

that informed Appellee about the linkage, the FDA Notices were publicly

available. The trial court erred in not allowing the jury to consider them.

                 Fraudulent Concealment Jury Instruction

      The trial court included in its jury instruction about the statute of

limitations that “[a]n exception to this also applies if you find that the plaintiff

did not file suit within two years because she was intentionally or mistakenly

misled by the defendant or the defendant’s agents.” Trial Ct. Op. at 15. The

trial court supports its decision to charge the jury on fraudulent concealment

based on the following evidence: “During trial, testimony was elicited that

Plaintiff relied upon Defendants’ statements in the TVT-Secur brochure, Dr.

Bolton’s consent form (wherein he documented his discussion of the risks and

benefits of the procedure) and Dr. Bolton himself as Plaintiff’s learned

intermediary. Specifically, Plaintiff testified that Defendants’ brochure did not

mention erosions or possible need for surgeries to treat complications such as

eroded mesh.” Id.

      A defendant must have committed an affirmative, independent act of

concealment upon which the plaintiff justifiably relied for the doctrine of

fraudulent concealment to apply. Kingston Coal Co. v. Felton Mining Co.,

690 A.2d 284, 291 (Pa. Super. 1997). “Where, through fraud or concealment,

the defendant causes the plaintiff to relax his vigilance or deviate from his

right of inquiry, the defendant is estopped from invoking the bar of the statute

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J-A25038-18



of limitations.” Molineux v. Reed, 532 A.2d 792, 794 (Pa. 1987) (internal

quotation marks, citation omitted). The plaintiff must establish fraud or

concealment with evidence that is clear, precise, and controlling. Id.

Additionally, “a statute of limitations that is tolled by virtue of fraudulent

concealment begins to run when the injured party knows or reasonably should

know of his injury and its cause.” Fine v. Checcio, 870 A.2d 850, 861 (Pa.

2005).

       Generally, this fraudulent act occurs subsequent to the allegedly tortious

act claimed by the plaintiff, as it is the defendant’s effort to conceal the alleged

tort that will toll the limitations period. See, e.g., Kingston Coal Co., 690

A.2d at 291 (deeming the fraudulent concealment doctrine irrelevant where

defendants took no subsequent actions to dissuade plaintiffs from their right

of inquiry). In my view, however, none of the evidence cited by the trial court

constitutes subsequent, independent acts by Appellants to conceal their

allegedly tortious behavior such that Appellee would relax her vigilance in the

face of ongoing post-surgical complications. Moreover, although the trial court

suggests that Appellants concealed the risk of erosion from Dr. Bolton, the

court fails to identify any specific information known to Appellants at the time

of Appellee’s surgery that Appellants concealed.1

____________________________________________


1 The Majority, sua sponte, argues that Appellants waived this issue because
Appellant fails to reference to or quote from any authority. Maj. Op. at 30. I
disagree with the Majority’s conclusion that Appellants waived the issue. The
Appellants sufficiently briefed the issue on pages 26-34 of their appellate Brief.


                                           -9-
J-A25038-18




                  Admissibility of Studies from Australia

      The trial court permitted Appellee to introduce into evidence complaints

that Appellants began to receive in Australia about the vaginal mesh, as well

as a “quality block” that Appellants placed on the product in September 2007,

three months after Appellee’s doctor implanted the vaginal mesh. Trial Ct.

Op. at 45.

      The trial court found the evidence relevant to support Appellee’s failure

to warn and design defect claims under the New Jersey Products Liability Act,

N.J.S.A. 2A:58C-1. Id. In particular, the trial court found that “evidence of

the complaints in Australia is relevant to show that [Appellants] were aware

of the risks associated with the TVT-Secur, but failed to take action and

adequately warn [Appellants’] physicians of these issues.” Id at 46. The trial

court fails to consider, however, that physicians in Australia did not complain

about the vaginal mesh until September 2007, three months after Dr. Bolton

implanted the vaginal mesh. Because this evidence does not imply that

Appellants knew about the problems when Appellee had the surgery, this

evidence is not relevant to establish Appellee’s claims.

                     Feasability of Alternative Design

      I also disagree with the Majority’s analysis that Appellants are precluded

from challenging the jury’s verdict on a design defect claim because Appellants

did not challenge the jury’s verdict on the failure to warn claim. The Majority

concludes that even if the trial court erred regarding its decisions on the design

                                     - 10 -
J-A25038-18



defect claim, Appellants have not challenged any of the trial court’s decisions

on Appellee’s failure to warn claim, and this claim supports the jury verdict.

Maj. Op. at 32.

      Appellants, however, challenged the trial court’s decision regarding the

failure to warn claim. In particular, Appellants challenged the trial court’s

decision to admit the evidence of the complaints from doctors in Australia

even though the doctors did not complain until after Appellee’s doctor

implanted the vaginal mesh. Statement of Questions Involved, paragraph 4.

The trial court found this evidence to be relevant because “evidence of

complaints is relevant to [Appellee’s] failure to warn and design defect claims

under the NJPLA, 2A:58C. Tr. Ct. Op. at p.45-46.         Thus, Appellants have

challenged an evidentiary ruling of the trial court on Appellee’s failure to warn

claim, and we must address Appellants’ challenges to the trial court’s decisions

on the design defect claim.

                                  Conclusion

      As a result of these erroneous evidentiary rulings, I would reverse the

decision of the trial court.




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