Carlino, S. v. Ethicon, Inc. ( 2019 )

J-A18035-18
2019 PA Super 114SHARON CARLINO AND CHARLES IN THE SUPERIOR COURT
CARLINO, OF PENNSYLVANIA
v.
ETHICON, INC. AND JOHNSON &
JOHNSON; GYNECARE; SECANT
MEDICAL; SECANT MEDICAL, INC.;
PRODESCO, INC.; AND SECANT
MEDICAL, LLC
APPEAL OF ETHICON, INC. AND
No. 1129 EDA 2016
JOHNSON & JOHNSON
Appeal from the Judgment Entered April 1, 2016
In the Court of Common Pleas of Philadelphia County
Civil Division at No: June Term, 2013, No. 3470
SHARON CARLINO AND CHARLES IN THE SUPERIOR COURT
CARLINO, OF PENNSYLVANIA
v.
ETHICON, INC. AND JOHNSON &
JOHNSON; GYNECARE; SECANT
MEDICAL; SECANT MEDICAL, INC.;
PRODESCO, INC.; AND SECANT
MEDICAL, LLC
APPEAL OF SHARON CARLINO AND
CHARLES CARLINO
No. 1294 EDA 2016
J-A18035-18
Appeal from the Judgment Entered April 1, 2016
In the Court of Common Pleas of Philadelphia County
Civil Division at No: June Term, 2013, No. 3470
BEFORE: STABILE, J., STEVENS*, P.J.E. and STRASSBURGER**, J.
OPINION BY STABILE, J.: FILED APRIL 11, 2019
In this product liability action, Appellants, Ethicon, Inc. and Johnson &
Johnson, Ethicon’s parent company (collectively “Ethicon”), and Appellees,
Sharon and Charles Carlino, appeal and cross-appeal,1 respectively, from a
judgment of $13,500,000.00 entered in favor of the Carlinos in the
Philadelphia Court of Common Pleas. The jury determined that Ms. Carlino
suffered injuries from Ethicon’s defective design of, and failure to provide
adequate warnings about, the TVT device (“TVT”), a medical product used to
treat stress urinary incontinence (“SUI”). The jury also determined that
Ethicon was liable for punitive damages due to its willful and wanton disregard
of Ms. Carlino’s rights. For the reasons articulated below, we affirm.
FACTUAL AND PROCEDURAL HISTORY
Johnson & Johnson has its worldwide headquarters in New Jersey.
Ethicon is a wholly owned subsidiary of Johnson & Johnson with a principal
____________________________________________
* Former Justice specially assigned to the Superior Court.
** Retired Senior Judge assigned to the Superior Court.
1 We consolidated these appeals sua sponte on January 25, 2018.
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place of business in New Jersey. Ethicon worked closely with other entities
and individuals in Pennsylvania to design, test and manufacture the TVT.
SUI is a chronic condition that causes urine to leak involuntarily during
everyday activities such as laughing, coughing, sneezing and exercise.
Transcript (“Tr.”), 1/27 (AM), at 130-31.2 The TVT is a medical device
designed to cure or reduce SUI by supporting the mid-urethra with a tape-like
sling of polypropylene surgical mesh. The mesh is knitted from filaments of
Ethicon’s Prolene polypropylene, a material long used to make surgical
sutures, that is cut into strips to comply with the TVT’s specific shape and
design.3 Plaintiff’s Exhibit (“PTX”) 16 (Instructions for Use) at 26. The mesh
tape works like a hammock, supporting the urethra to stop urinary leakage.
To place the tape, the surgeon makes a small incision in the vagina and then
passes the tape through the incision using two trocars (hollow surgical
needles) to position the tape. Id. at 27. Once placed, only the tape remains
in the body. The tape is not tied to the pelvic structure but instead is held in
place by natural ingrowth of surrounding tissue into the mesh. Id.
____________________________________________
2 Since the entire trial took place in 2016, all subsequent citations to the trial
transcript will only state the month, date and time of day (“AM” or “PM”).
3 It appears that the TVT differs from the Prolift device at issue in Hammons
v. Ethicon, Inc., 190 A.3d 1248 (Pa. Super. 2018). The Carlinos indicate
that the TVT and Prolift device use the same Prolene mesh but are cut to
different specifications. Appellees’ Brief at 23 n.3; see also Kaiser v.
Johnson & Johnson, 334 F. Supp. 2d 923, 941 (N.D. In. 2018) (TVT and
Prolift are “separate but similar” devices).
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The Carlinos reside in New Jersey. In 2005, Ms. Carlino experienced
back pain caused by uterine fibroids and stress urinary incontinence (“SUI”).
Her gynecologist referred her to Dr. Andrew Blechman, a surgeon, who
recommended that she undergo a laparoscopic hysterectomy and bladder
sling procedure to alleviate her pain and SUI. On a consent form signed by
Ms. Carlino and certified by Dr. Blechman, Dr. Blechman informed Ms. Carlino
that the risks of surgery involved “the risk of bleeding, infection, anesthesia
and . . . injury to adjacent organs.” In a separate report, Dr. Blechman stated
that he and Ms. Carlino “discussed the fact that the surgery is no guarantee
that she will be pain-free after the surgery.” On August 18, 2005, Dr.
Blechman implanted a TVT during the bladder sling procedure. The
hysterectomy was effective in alleviating Ms. Carlino’s back pain, and initially
it seemed that the TVT implantation was successful. One year later, on
November 14, 2006, Dr. Blechman reported that Ms. Carlino was “in no acute
distress.” PTX 61 (Carlino medical records), at 12.
In 2007, however, Ms. Carlino felt “something sharp in [her] vagina.”
Tr., 1/27 (PM), at 26-27. Dr. Blechman advised that part of her TVT was
exposed and recommended surgery to revise the mesh and treat her pain.
Id. at 39-40, 45. Ms. Carlino testified that at that point, she understood that
“[the exposure] was a risk of the implantation surgery,” Tr., 1/27 (AM), at
100-01, and that “the mesh was not intended to be exposed in the vagina.”
Tr., 1/27 (PM), at 39-40; see also id. at 45, 72. She called the exposure
“unexpected and concerning,” id. at 44, and believed it was “caus[ing] her
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harm.” Id. at 39-40. She underwent corrective surgery on November 26,
2007.
There was conflicting evidence as to whether Dr. Blechman advised Ms.
Carlino at the time of her corrective surgery that any post-operative
complication was a risk of corrective surgery or a risk posed by the TVT.
Prior to this surgery, he advised Ms. Carlino that surgery involved risks such
as “bleeding, infection, anesthesia and also the possibility of urinary
incontinence in the future.” PTX 61, at 24. After surgery, he appeared to
reach a different conclusion. During a post-surgical appointment with Ms.
Carlino on December 10, 2007, he noted that she “feels okay other than she
has some right lower quadrant pain . . . that she thought may have been
related to the mesh. I do not believe it is so.” PTX 61, at 31. Years later,
during his trial deposition, he appeared to change his views once again. He
testified that “the mesh [he] w[as] leaving behind could still in the future
erode,” indicating that the TVT itself could cause post-operative complications.
Defense Exhibit (“DTX”) 129 (Blechman testimony) at 212:2-6.
In 2010, Ms. Carlino again suffered sharp pain in her vagina. Tr., 1/27
(PM), at 56-59, 76-77. She testified that she “immediately attributed” her
pain to the TVT and knew that this was “not what’s supposed to happen with
bladder slings.” Tr., 1/27 (PM), at 69, 75-77. She reported that her “[b]ladder
sling [was] coming out” and was “uncomfortable during sex.” Id. at 75-77,
78-79; see also DTX-7 (medical form and Ms. Carlino’s handwritten
complaints). Dr. Blechman referred Ms. Carlino to Ellen Conner, a
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urogynecologist, who diagnosed another TVT exposure. DTX-10 (treatment
note).
As was the case with Dr. Blechman in 2007, there was conflicting
evidence as to whether Dr. Conner advised Ms. Carlino in 2010 that her pain
was attributable to the TVT or was simply a risk of surgery. On one hand, Dr.
Conner testified that she explained to Ms. Carlino that “the mesh was causing
her discomfort, that was the most likely cause.” DTX-130 (Conner testimony)
at 30-32. Ms. Carlino testified that she knew this “was not the expected
course,” that the device “wasn’t supposed to have a small part eroding in the
vagina,” that “it needed to be repaired,” and that “[she] had been harmed by
the erosion.” Tr. (1/27 PM), at 72-73, 75-79, 81; Tr., 1/28 (PM), at 104-08.
On the other hand, Dr. Conner’s notes state that she explained that
the risks of surgery were discussed [with Ms. Carlino] and
included . . . hemorrhage, infection, damage to surrounding
organs, erosion of mesh, pain, failure, incontinence . . . I
specifically restated that with implantation of mesh, complications
such as erosion, pain and infection can occur, may require further
surgery, and even then may be difficult to address.
DTX-10035.10. Ms. Carlino signed a consent form that included “erosion of
mesh” as one of multiple risks of surgery. PTX 61, at 42.
On December 17, 2010, Dr. Conner performed corrective surgery to
remove part of the TVT. Tr., 1/27 (AM), at 102-03.
In March 2011, Ms. Carlino declined Dr. Conner’s recommendation to
implant a second mesh sling “[b]ecause [she] had so much trouble with the
first one.” Tr., 1/29 (PM), at 43; see also Tr., 1/29 (AM), at 5-7, 12-14, 21.
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Ms. Carlino’s pain returned in late 2012. In April 2013, Ms. Carlino
viewed a television advertisement describing her symptoms and relating them
to mesh products. Tr., 1/28 (AM), at 112-14. On June 26, 2013, she filed
suit against Ethicon alleging that (1) she suffered injuries from a design defect
in the TVT, and (2) Ethicon failed to adequately warn of the TVT’s medical
risks.
Ethicon raised the statute of limitations as an affirmative defense. In
response, the Carlinos argued that they were not seeking compensation for
pain and suffering suffered in 2007 and 2010 but only for injuries suffered
within two years before June 2013.
In 2014 and 2015, Dr. Blechman examined Ms. Carlino and determined
that her pain and discomfort were chronic conditions, not temporary
byproducts of healing or surgery. Blechman dep., 1/30/16, at 8-16, 34-40.
In 2016, Dr. Michael Margolis, an expert witness for the Carlinos, performed
another examination and found that the mesh remaining on Ms. Carlino’s left
side was roped, contracted, banded, and could be felt through the vaginal
wall. Tr., 1/28 (AM), at 62-72, 85-87. By examining Ms. Carlino, Dr. Margolis
confirmed that the remaining sling material shrunk up and rolled on the left
side, and the right side had palpable scar tissue, where the sling used to be.
Dr. Margolis identified Ms. Carlino’s treatment options as (1) a very invasive
surgical procedure aimed at removing as much remaining material as possible
(though he cautioned that such a surgery would not be successful in removing
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all material), (2) treatment that would destroy the nerves of the vagina, or
(3) pain medication. Id. at 85-88. Dr. Margolis concluded to a reasonable
degree of medical certainty that Ms. Carlino’s symptoms were caused by the
TVT. Id. at 94-98.
As discussed in further detail in our discussion of punitive damages
below, the evidence at trial demonstrated that Ethicon knew that the TVT
poses a high risk of injury but nevertheless continued to market the product,
ignored calls for improvement, and failed to warn physicians of its known and
serious risks.
Ethicon requested a directed verdict on the ground that the action was
time-barred, but the court denied the motion. The court submitted a special
interrogatory to the jury: “Did [Ms.] Carlino know, or should she have known
through the exercise of reasonable diligence, before June 26, 2011, that she
was injured and that it was caused by the conduct of another person?” Tr.,
2/9 (AM), at 87. The jury answered “no.”
On February 10, 2016, the jury returned a verdict for the Carlinos on
their design defect and failure to warn claims, awarding $3,500,000.00 in
compensatory damages (including $250,000.00 for Mr. Carlino’s loss of
consortium) and $10,000,000.00 in punitive damages. Ethicon filed timely
post-trial motions seeking, inter alia, judgment n.o.v. on the basis of the
statute of limitations. The trial court denied Ethicon’s motions and entered
judgment for the Carlinos in the amount of $13,738,119.48, including
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$238,119.48 in delay damages. All parties filed timely notices of appeal, and
all parties and the trial court complied with Pa.R.A.P. 1925. In this Court,
Ethicon raises the following issues:
1. Did the trial court commit legal error by exercising personal
jurisdiction over [Ethicon], even though [Ethicon is neither]
incorporated in nor maintain[s] [its] principal places of business
in Pennsylvania, and even though [the Carlinos’] claims do not
arise from or relate to any of [Ethicon]’s contacts with
Pennsylvania?
2. Did the trial court commit legal error when it denied [Ethicon]’s
directed-verdict and JNOV motions, where [the Carlinos’] claims
were barred by the statute of limitations and [the Carlinos] did
not present legally sufficient evidence that the discovery rule
extended the limitations period?
3. Did the trial court commit reversible error by barring all
evidence from the federal Food and Drug Administration (FDA)
regarding TVT, an FDA-regulated medical device?
4. Did the trial court commit reversible error by striking [Ethicon]’s
examination of Dr. Andrew Blechman, who performed Mrs.
Carlino’s surgery, as a sanction for allegedly violating a pretrial
evidentiary ruling?
5. Did the trial court commit reversible error by refusing to instruct
the jury that [the Carlinos’] design-defect claim required them to
show a safer alternative design to TVT?
6. Did the trial court err when it refused to remit the compensatory
damages award?
7. Did the trial court err when it denied [Ethicon]’s directed-verdict
and JNOV motions as to punitive damages?
Ethicon’s Brief at 3-5. The Carlinos raise one issue in their appeal: “Did the
trial court improperly mold the jury’s verdict to add delay damages based only
on the compensatory portion of the verdict?” Carlinos’ Brief at 4.
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PERSONAL JURISDICTION
Ethicon asserts that the trial court erroneously denied its preliminary
objections to the Carlinos’ Short Form Complaint, in which Ethicon argued that
personal jurisdiction did not exist over Ethicon in Pennsylvania. The Carlinos
respond that Ethicon waived this argument, and in any event, the trial court
properly exercised specific jurisdiction over Ethicon. Based on our reasoning
in Hammons v. Ethicon, Inc., 190 A.3d 1248, 1259-63 (Pa. Super. 2018),
we hold that Ethicon preserved this issue for appeal, and that the trial court
properly exercised specific jurisdiction over Ethicon.
One difference between Hammons and this appeal deserves brief
discussion. The appellee in Hammons argued that Ethicon’s retention of
Vincent Lucente, M.D., a Pennsylvania gynecologist, was a basis for exercising
jurisdiction over Ethicon. Id., 190 A.3d at 1263-64. The Carlinos did not
advance this argument. Nevertheless, the trial court properly exercised
jurisdiction over Ethicon based on other facts also discussed in Hammons,
viz., Ethicon’s substantial role in the production of mesh for the TVT at the
Pennsylvania plant of Secant Medical, Inc. Id. at 1263.
STATUTE OF LIMITATIONS
Ethicon contends that the trial court erred in denying judgment n.o.v.
based on the statute of limitations. We disagree. There was conflicting
evidence on this subject that we must construe in the light most favorable to
the Carlinos. Viewed in this light, the evidence demonstrates that Ms. Carlino
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neither knew nor should have known that the TVT caused her injuries until
2013, less than two years before she filed suit.
There are two bases on which the court can grant judgment n.o.v.:
[O]ne, the movant is entitled to judgment as a matter of law
and/or two, the evidence is such that no two reasonable minds
could disagree that the outcome should have been rendered in
favor of the movant. With the first, the court reviews the record
and concludes that even with all factual inferences decided
adverse to the movant[,] the law nonetheless requires a verdict
in his favor, whereas the second, the court reviews the evidentiary
record and concludes that the evidence was such that a verdict for
the movant was beyond peradventure.
Hammons, 190 A.3d at 1265. In an appeal from the trial court’s decision to
deny judgment n.o.v.,
we must consider the evidence, together with all favorable
inferences drawn therefrom, in a light most favorable to the
verdict winner. Our standard of review when considering motions
for a directed verdict and judgment notwithstanding the verdict
are identical. We will reverse a trial court’s grant or denial of a
judgment notwithstanding the verdict only when we find an abuse
of discretion or an error of law that controlled the outcome of the
case. Further, the standard of review for an appellate court is the
same as that for a trial court.
Id.
Since Ms. Carlino’s treatment and injuries occurred in New Jersey, we
first examine whether New Jersey’s or Pennsylvania’s statute of limitations
applies to this case. Pennsylvania law generally governs the time in which the
plaintiff must commence an action. Unisys Finance Corp. v. U.S. Vision,
Inc., 630 A.2d 55, 58 (Pa. Super. 1993); Gwaltney v. Stone, 564 A.2d 498,
502 (Pa. Super. 1989). When an action accrues in another state, however,
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Pennsylvania applies the other state’s limitation period if it is shorter than
Pennsylvania’s. 42 Pa.C.S.A. § 5521(b).
Ms. Carlino’s action accrued in New Jersey, the site of her treatment
with the TVT device and her injuries, but New Jersey and Pennsylvania provide
the same limitation period (two years) for personal injury actions. N.J.S.A. §
2A:14 -2(a); 42 Pa.C.S.A. § 5524. Moreover, both jurisdictions employ
parallel discovery rules that toll the statute of limitations until the plaintiff
knows or reasonably should know that she suffered injury due to the fault of
another. Kendall v. Hoffman-La Roche, Inc., 36 A.3d 541, 552 (N.J.
2012); Wilson v. El-Daief, 964 A.2d 354, 356 (Pa. 2009). Since both
jurisdictions have the same law, we apply the law of the forum state,
Pennsylvania. Unisys Finance Corp., 630 A.2d at 58.
The Judicial Code provides that limitations periods run from the time the
cause of action accrued. 42 Pa.C.S. § 5502(a). Generally, “a cause of action
accrues, and thus the applicable limitations period begins to run, when an
injury is inflicted.” Wilson, 964 A.2d at 361. “Once a cause of action has
accrued and the prescribed statutory period has run, an injured party is barred
from bringing his cause of action.” Fine v. Checcio, 870 A.2d 850, 857 (Pa.
2005). The discovery rule is an exception to this rule that tolls the statute of
limitations when the plaintiff is reasonably unaware that she has been injured
and that her injury has been caused by another party’s conduct. Fine, 870
A.2d at 859. A cause of action accrues upon “actual or constructive knowledge
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of at least some form of significant harm and of a factual cause linked to
another’s conduct, without the necessity of notice of the full extent of the
injury, the fact of actual negligence, or precise cause.” Wilson, 964 A.2d at
364; see also id. at n.10.
The discovery rule requires the plaintiff to exercise reasonable diligence
in investigating the cause of her injuries. Id. at 363 & n.6. The reasonable
diligence standard
is objective, as the question is not what the plaintiff actually knew
of the injury or its cause, but what he might have known by
exercising the diligence required by law. That being said, the
objective reasonable diligence standard is sufficiently flexible to
take into account the differences between persons and their
capacity to meet certain situations and the circumstances
confronting them at the time in question, and, as such, is to be
applied with reference to individual characteristics.
Under this reasonable diligence standard, a plaintiff’s actions are
examined to determine whether the plaintiff demonstrated those
qualities of attention, knowledge, intelligence and judgment which
society requires of its members for the protection of their own
interest and the interest of others. It is the party that asserts
application of the discovery rule that bears the burden of proving
that reasonable diligence was exercised. Finally, as noted,
because the reasonable diligence determination is fact intensive,
the inquiry is ordinarily a question for the jury.
Nicolaou v. Martin, 195 A.3d 880, 893-94 (Pa. 2018) (citations, quotation
marks and ellipses omitted).
To satisfy her burden under the discovery rule, Ms. Carlino had to
demonstrate that she neither knew nor should have known prior to June 26,
2011 (two years before she filed this action) that the TVT caused her injuries.
Viewing the evidence in the light most favorable to Ms. Carlino, as we must
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do in our review of an order denying judgment n.o.v., we conclude that Ms.
Carlino satisfied her burden.
The evidence demonstrates that on July 19, 2005, Ms. Carlino met with
Dr. Blechman and agreed, after discussing the risks and benefits, to undergo
surgery for fibroids and pelvic pain with implantation of a TVT for stress
incontinence. PTX-61, at 4 (Ms. Carlino’s medical records). Dr. Blechman
informed Ms. Carlino that her surgery involved risks of, inter alia, bleeding,
infection and possible injuries to adjacent organs. Id. He also told her that
there was no guarantee she would be pain-free after surgery. Id. On August
18, 2005, Ms. Carlino underwent surgery, and Dr. Blechman inserted the TVT.
One year later, on November 14, 2006, Dr. Blechman conducted a
routine checkup and concluded that Ms. Carlino had a normal post-surgical
GYN examination and was in no acute distress. Id. at 21.
After another year passed, on November 12, 2007, Ms. Carlino reported
to Dr. Blechman that she felt something sharp in her vagina. Id. at 24. Dr.
Blechman examined Ms. Carlino and found an area of exposed mesh from the
TVT. Id. Dr. Blechman recommended surgical excision of the exposed mesh
and discussed the risks of surgery with Ms. Carlino, including, inter alia,
bleeding, infection and urinary incontinence. Id. On November 26, 2007, Dr.
Blechman performed the surgery.
In a post-surgical examination on December 10, 2007, Dr. Blechman
reported that Ms. Carlino was doing “well” and felt “okay other than . . . some
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right lower quadrant pain that has been there for several weeks or possibly
months that she thought may have been related to the mesh. I do not
believe that it is so.” Id. at 31 (emphasis added).
On July 20, 2010, Ms. Carlino reported to Dr. Blechman that she felt
something sharp in her vagina. Id. at 34. Dr. Blechman examined Ms. Carlino
and referred her to Dr. Conner for further consultation. Id. On October 26,
2010, Dr. Conner detected an area of mesh exposure and pain in the area of
exposure, and she recommended excision and removal. Id. at 39. On
November 23, 2010, Ms. Carlino met with Dr. Conner again and reviewed the
risks of surgery, including but not limited to erosion of mesh and pain. Id.
Dr. Conner specifically advised that with mesh implantation, complications
such as erosion, pain, and infection can occur, may require further surgery
and even then may be difficult to address. Id.
On December 17, 2010, Dr. Conner performed a partial removal and
revision of the vaginal sling. Id. at 49. In post-surgical visits on January 11,
2011 and March 30, 2011, Ms. Carlino told Dr. Conner that she was doing
well, and that her pelvic pain and dyspareunia (pain during sexual intercourse)
had resolved completely. Id. at 37, 39. On April 26, 2011, however, Ms.
Carlino reported to Dr. Conner that she was experiencing pelvic pain and
incontinence. Id. at 50. Due to her previous experience with a synthetic
sling, she did not want to undergo another sling procedure. Nearly one year
later, on March 19, 2012, Ms. Carlino visited Dr. Blechman and informed him
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that she was doing well. Id. at 54. Dr. Blechman performed an examination
and reported that it was normal.
Ms. Carlino’s pain returned in late 2012. In April 2013, Ms. Carlino
viewed a television advertisement describing her symptoms and relating them
to mesh products. She filed suit later that year.
Ethicon makes a spirited argument that the statute of limitations bars
Ms. Carlino’s action as a matter of law. Specifically, Ethicon asserts that in
view of Ms. Carlino’s history of pain in 2007 and 2010, the advice her
physicians gave her on both occasions that the TVT was causing her pain due
to erosion, her decision to have corrective surgery on both occasions, and the
recurrence of her discomfort in March 2011, Ms. Carlino knew or should have
known before June 26, 2011 that the TVT caused her injuries. These are
indeed strong points, but the other evidence described above supports a
different conclusion: she reasonably believed her pain was a risk of surgery.
Because there was conflicting evidence on this subject, the trial court properly
denied Ethicon’s motion for judgment n.o.v.
Nicolaou and Hammons support the conclusion that the statute of
limitations issue fell to the jury. In Nicolaou, the plaintiff suffered a tick bite
in 2001 and underwent four Lyme disease tests over the next several years.
The test results for Lyme disease were negative; instead, she was diagnosed
with multiple sclerosis. In 2009, another health practitioner, Nurse Rhoads,
suggested that the plaintiff’s Lyme disease tests yielded false negatives and
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recommended that the plaintiff undergo a different test. At first, the plaintiff
declined because she lacked health insurance and could not pay for it out of
pocket, but she later agreed to take the test. On February 13, 2010, the test
came back positive for Lyme disease. On February 10, 2012, she filed a
complaint against various medical providers alleging that they were negligent
for failing to diagnose Lyme disease. The trial court granted summary
judgment to the providers. Our Supreme Court summarized the trial court’s
ruling as follows:
The trial court reasoned that prior to [the plaintiff]’s last visit with
Nurse Rhoads on February 1, 2010, [the plaintiff] was aware that
her symptoms arose after a tick bite; that a 2006 MRI indicated
that she had either MS or Lyme disease; that treatment for MS
had been unsuccessful; that Nurse Rhoads believed she probably
had Lyme disease based on her clinical symptoms and prior MRI;
that Nurse Rhoads treated her for Lyme disease by administering
antibiotics, after which [the plaintiff] saw an improvement in her
symptoms; and that Nurse Rhoads had urged [the plaintiff] to
confirm the diagnosis with a different type of Lyme disease test.
The trial court reasoned that not only would a reasonable person
have suspected that [the plaintiff]’s injuries could have been
caused by [the providers’] failure to diagnose and treat her Lyme
disease, but that [the plaintiff] actually suspected such
connection, as demonstrated by her Facebook post, stating that
she suspected she had Lyme disease before she received the
positive test results. Finally, the trial court rejected the contention
that [the plaintiff]’s inability to pay for a fifth Lyme disease test
tolled the statute of limitations, finding that [the plaintiff] “could
have confirmed her suspicion regarding the Lyme disease
diagnosis on or about the December 7, 2009 visit, but she opted
not to.”
Id., 195 A.3d at 886-87.
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Our Supreme Court reversed and remanded for further proceedings,
reasoning that genuine issues of material fact prevented the providers from
obtaining summary judgment under the statute of limitations:
[W]e conclude that it is within the province of a jury to determine
whether an untrained lay person who had been repeatedly and
definitively diagnosed with MS by several previous physicians, had
four prior negative Lyme disease tests, and lacked health
insurance to cover the costs of further diagnostic testing
reasonably should have known that she suffered from Lyme
disease after Nurse Rhoads informed her of a “probable” diagnosis
of that disease based on her clinical symptoms, and when some
of her symptoms improved after taking antibiotics prescribed for
that condition. . . . Moreover, it is for the jury, and not a court, to
determine whether a person in [the plaintiff’s] circumstances
acted reasonably in delaying the administration of a fifth Lyme
disease test to confirm Nurse Rhoads’ probable diagnosis. We
reach this conclusion keeping in mind that the appropriate
formulation of discovery rule jurisprudence applies a reasonable-
diligence requirement, as opposed to an all-vigilance one.
Id. at 895 (quotations and citations omitted).
In a nutshell, despite the evidence pointing to Lyme disease in Nicolau,
other evidence precluded judgment as a matter of law by creating a genuine
issue of material fact as to whether the plaintiff reasonably should have known
that she suffered from Lyme disease more than two years before she filed
suit. Id. Similarly, in the present case, Ms. Carlino’s medical records create
a genuine issue of material fact as to whether she knew or should have known
before June 26, 2011 that the TVT, rather than her surgeries, was the cause
of her pain and incontinence.
In Hammons, we affirmed a judgment against Ethicon in a products
liability action involving the Prolift device. Ethicon argued that the appellee’s
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action was time-barred under Indiana’s two-year statute of limitations. Id.,
190 A.3d at 1268-69. We rejected this argument because the statute of
limitations issue was a “fact-sensitive question” involving the discovery rule
that “was proper for the jury to resolve.” Id. at 1269. Prior to the limitations
period, we reasoned, “two experienced gynecologists failed to diagnose Prolift
as the cause of [Hammons’] injuries. Since they failed to draw a nexus
between Prolift and Hammons’ injuries, the jury could conclude that it was
reasonable for Hammons not to have drawn any connection [herself].” Id.
Analogously, in the case at bar, certain trial testimony indicates that Ms.
Carlino’s physicians identified the TVT as the cause of Ms. Carlino’s problems
in 2007 and 2010, but other medical records suggest that these physicians
told her that her problems were risks of surgery. Therefore, as in Hammons,
the statute of limitations issue was a fact-sensitive question for the jury to
decide.
EXCLUSION OF FDA EVIDENCE
Ethicon argues that it is entitled to a new trial because the trial court
erroneously excluded (1) evidence that the FDA cleared the TVT in 2008
through its section 510(k) clearance process and (2) an FDA publication in
2013 relating to the safety and efficacy of TVT’s. We hold that the trial court
properly excluded this evidence.
Evidence of 510(k) clearance. We review challenges to the trial
court’s evidentiary rulings for an abuse of discretion. U.S. Bank, N.A. v.
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Pautenis, 118 A.3d 386, 391–92 (Pa. Super. 2015). “[D]ecisions on
admissibility are within the sound discretion of the trial court and will not be
overturned absent an abuse of discretion or misapplication of law. In addition,
for a ruling on evidence to constitute reversible error, it must have been
harmful or prejudicial to the complaining party.” Id. Since there is unanimous
agreement among the parties and trial court that New Jersey substantive law
governs this case, we will examine whether evidence of 510(k) clearance is
admissible under New Jersey law.
In 1987, New Jersey passed the Products Liability Act, L. 1987, c. 197,
codified at N.J.S.A. 2A:58C-1 to -11. The purpose of this act was to codify
existing common law and provide “some sense of order and clarity to products
liability cases within New Jersey.” Governor’s Statement to S. 2805; accord
N.J.S.A. 2A:58C-1; see also In re Reglan Litig., 226 N.J. 315, 335, 142
A.3d 725 (2016) (“The PLA is a codification of tort-law principles, where the
state has traditionally exercised its historic police powers”).
Section 4 of this Act, entitled “Adequate product warning or instruction;
rebuttable presumption of adequacy after approval,” prescribes:
In any product liability action the manufacturer or seller shall not
be liable for harm caused by a failure to warn if the product
contains an adequate warning or instruction or, in the case of
dangers a manufacturer or seller discovers or reasonably should
discover after the product leaves its control, if the manufacturer
or seller provides an adequate warning or instruction. An
adequate product warning or instruction is one that a reasonably
prudent person in the same or similar circumstances would have
provided with respect to the danger and that communicates
adequate information on the dangers and safe use of the product,
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taking into account the characteristics of, and the ordinary
knowledge common to, the persons by whom the product is
intended to be used, or in the case of prescription drugs, taking
into account the characteristics of, and the ordinary knowledge
common to, the prescribing physician. If the warning or
instruction given in connection with a drug or device or food or
food additive has been approved or prescribed by the federal
Food and Drug Administration under the “Federal Food, Drug,
and Cosmetic Act,” 52 Stat. 1040, 21 U.S.C. § 301 et seq. or the
“Public Health Service Act,” 58 Stat. 682, 42 U.S.C. § 201 et seq.,
a rebuttable presumption shall arise that the warning or
instruction is adequate. For purposes of this section, the terms
“drug”, “device”, “food”, and “food additive” have the meanings
defined in the “Federal Food, Drug, and Cosmetic Act.”
N.J.S.A. 2A:58C-4 [emphasis added]. By attaching a presumption of
adequacy to FDA-approved warnings, the legislature “recognized the
preeminent role of federal regulation of drugs and medical devices.” Cornett
v. Johnson & Johnson, 211 N.J. 362, 387, 48 A.3d 1041 (2012). The
question before us is whether the 510(k) clearance of TVT is admissible under
N.J.S.A. 2A:58C-4 as the FDA’s “approval” or “prescription” of TVT’s warnings.
Some background on the 510(k) process is necessary. The 510(k)
review process originates from the Medical Device Amendments of 1976
(“MDA”) to the Federal Food, Drug, and Cosmetic Act. The MDA’s purpose
was to “impose[] a regime of detailed federal oversight” of medical devices.
Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). Under the MDA,
certain devices must complete a thorough premarket approval (“PMA”)
process with the FDA before marketing, including all devices that cannot
“provide reasonable assurance of [their] safety and effectiveness” under less
stringent scrutiny, and that are “purported or represented to be for a use in
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supporting or sustaining human life or for a use which is of substantial
importance in preventing impairment of human health” or “present[] a
potential unreasonable risk of illness or injury.” Id. at 317; 21 U.S.C. §
360c(a)(1)(C). The PMA process requires the applicant to demonstrate a
“reasonable assurance” that the device is both “safe and effective under the
conditions of use prescribed, recommended, or suggested in the proposed
labeling thereof.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341,
344 (2001) (quoting 21 U.S.C. § 360e(d)(2)(A), (B)).
An exception to the PMA requirement exists for medical devices that
were already on the market prior to the MDA’s enactment in 1976. These
devices are allowed to remain on the market until the FDA initiates and
completes PMA review for them. See 21 U.S.C. § 360e(b)(1)(A); Buckman,
531 U.S. at 345. In addition, to neutralize any monopolistic power that this
exception might give manufacturers of pre-1976 devices, the MDA allows
other manufacturers to market devices that are “substantially equivalent” to
exempt pre–1976 devices. Id.; 21 U.S.C. § 360e(b)(1)(B). The 510(k)
process is the method by which a manufacturer demonstrates substantial
equivalence. Id.
The Safe Medical Devices Act of 1990 (“SMDA”) further clarified the
510(k) process by codifying the definition of substantial equivalence that the
FDA developed administratively following the MDA’s enactment. 21 U.S.C. §
360c(i). In addition, the SMDA ended the legal necessity to cite a pre-MDA
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predicate device. Thus, devices cleared after the MDA’s enactment could be
used as predicates without construction of a clearance chain back to a pre-
MDA predicate device. 21 U.S.C. § 360c(f).
“The § 510(k) process is focused on equivalence, not safety.”
Medtronic, Inc. v. Lohr, 518 U.S. 470, 492 (1996). The design of the device
does not undergo review during the 510(k) process for safety or efficacy. Id.
at 493. “Substantial equivalence determinations provide little protection to
the public,” because they “simply compare a post–1976 device to a pre–1976
device to ascertain whether the later device is no more dangerous and no less
effective than the earlier device. If the earlier device poses a severe risk or
is ineffective, then the later device may also be risky or ineffective.” Id.The 510(k) process is cursory when compared to strenuous PMA review.
“In contrast to the 1,200 hours necessary to complete a PMA review,” 510(k)
review “is completed in an average of only 20 hours.” Id. at 497. “The
attraction of substantial equivalence to manufacturers is clear. Section 510(k)
notification requires little information, rarely elicits a negative response from
the FDA, and gets processed very quickly.” Id. at 479; see also Riegel v.
Medtronic, Inc., 552 U.S. 312, 323 (2008) (“[w]hile § 510(k) is focused on
equivalence, not safety, premarket approval is focused on safety, not
equivalence”).
Because 510(k) does not focus on safety, many courts have refused to
admit evidence of 510(k) clearance in product liability cases. For example, in
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Kaiser v. Johnson & Johnson, 2018 WL 1358407 (N.D. In. 2018), an action
brought against Ethicon under Indiana law, Ethicon attempted to introduce
evidence of 510(k) proceedings for the Prolift device. The Indiana Product
Liability Act (“ILPA”) provides that “in a product liability action, there is a
rebuttable presumption that the product that caused the physical harm was
not defective . . . when [the product] complied with applicable codes,
standards, regulations, or specifications established, adopted, promulgated,
or approved by the United States . . . or by an agency of the United States.”
Indiana Code § 34-20-5-1(2). The court held that “[b]ecause § 510(k) is
focused on equivalency and not safety, it is not relevant to the application of
the presumption in this case and does not mandate its application.” Id. at
*3. This decision was consistent with rulings by multiple other courts,
including courts in states with rebuttable presumptions similar to Indiana’s.
Id. (citing Eghnayem v. Boston Scientific Corp., 873 F.3d 1304, 1317-19
(11th Cir. 2017) (applying Florida law); Tingey v. Radionics, 193 Fed. Appx.
747, 755 (10th Cir. 2006) (applying Utah law); Adams v. Boston Scientific
Corp., 177 F. Supp. 3d 959 (S.D. W. Va. 2016) (applying Texas law);
Williams v. Boston Scientific Corp., 2016 WL 1448860, at *3 (S.D. W. Va.
2016) (applying Wisconsin law); Lewis v. Johnson & Johnson, 991 F. Supp.
2d 748, 761 (S.D. W. Va. 2014) (applying Texas law)).
The Fourth Circuit’s analysis of the 510(k) process in two recent
decisions—Cisson v. C.R. Bard, Inc. (In re C.R. Bard, Inc.), 810 F.3d 913- 24 -
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(4th Cir. 2016), and Huskey v. Ethicon, Inc., 848 F.3d 151 (4th Cir. 2017)—
deserves our attention as well. In Bard, the Fourth Circuit held that the
district court properly permitted the plaintiff to attack the product’s safety
while precluding the defendant from presenting evidence that it complied with
the 510(k) process. The court reasoned that evidence of the 510(k) process
had limited probative value, because while safety considerations might have
some tangential bearing on the 510(k) process, by far its main thrust is to
determine only whether the product is substantially equivalent to pre-1976
products. Id., 810 F.3d at 921. The court also observed that this evidence
was substantially more prejudicial than probative:
[T]he court stated that bringing in such evidence would result in
a “mini-trial” about (1) the strengths and weaknesses of the
process and (2) whether [the defendant] had in fact made all of
the disclosures it should have made during the process. [The
defendant’s] evidence would have initiated a battle of experts:
[the defendant] was prepared to characterize the review process
as “thorough” and “robust” and the FDA’s clearance of the Avaulta
Plus as “an affirmative safety . . . decision” based on “specific
safety and efficacy findings.” [The plaintiff] was prepared to
argue, as she has done before this Court, that these
characterizations wildly inflate the significance of the process, and
that in any event [the defendant] failed to make necessary
disclosures to the FDA.
All of this, the district court reasoned, presented “the very
substantial dangers of misleading the jury and confusing the
issues.” The court expressed concern that subjecting the jury to
many hours, and possibly days, of complex testimony about
regulatory compliance could lead jurors to erroneously conclude
that regulatory compliance proved product safety. In other words,
having a “mini-trial” could easily inflate the perceived importance
of compliance and distract the jury from the central question
before it—whether [the defendant’s] design was unreasonable
based on any dangers it posed versus the costs required to avoid
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them. While 510(k) clearance might, at least tangentially, say
something about the safety of the cleared product, it does not say
very much that is specific. The vast majority of courts have said
so, and having been thoroughly briefed not only by the parties but
by several amici, we say so again today.
Id. at 921-22.
In Huskey, another case against Ethicon, Ethicon argued that the
district court abused its discretion in excluding evidence of the TVT’s
compliance with the 510(k) process. The Fourth Circuit held that the district
court’s ruling was within its discretion, explaining:
[w]e see no reason to distinguish [Bard] here. The information
Ethicon sought to introduce would, at best, have had
“tangential[]” relevance to the case. This relative lack of
probative value, especially given a possible battle of experts over
the 510(k) process, underscores the risks of confusion and wasted
time that would follow the introduction of this evidence. Ethicon’s
effort to distinguish [Bard] on the ground that the [TVT’s] 510(k)
compliance process actually did focus heavily on safety would only
amplify the risk, as the trial would then likely face a substantial
diversion into just how rigorous those safety considerations were,
how forthcoming Ethicon was to the FDA, and how robust the
510(k) process is.
Id., 848 F.3d at 160-61.
Returning to the present case, the FDA groups medical devices into
three classes (I, II, and III), and exercises the most strenuous regulatory
oversight over Class III devices. The FDA originally classified Prolene suture
in Class III but reclassified it into Class II in 1990. The FDA also classified
polymeric meshes, the umbrella category for the TVT, within Class II. In 1997,
Ethicon submitted a 510(k) application asserting that the TVT consisted of the
same polypropylene strands that are used to fabricate Prolene’s sutures. In
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1998, the FDA cleared the TVT as a Class II device under 510(k). Ethicon
moved for admission of the TVT’s 510(k) clearance into evidence, but the trial
court denied the motion.
This decision was a proper exercise of the trial court’s discretion.
N.J.S.A. 2A:58C-4 provides that a rebuttable presumption arises that a
product’s warning or instruction is adequate if the FDA has “approved or
prescribed” it. The Products Liability Act does not define these terms, but
when, as here, “the average person would understand the words used in a
statute . . . the terms used in the provision will carry their ordinary, well-
understood meanings . . . To ascertain the ordinary meaning of words used in
a statute, courts typically look to a dictionary.” State v. N.G., 886 A.2d 186,
191 (N.J. Super. A.D. 2005). The definition of “approve” is “to accept as
satisfactory” or “to give formal or official sanction: ratify.” Merriam-Webster
Dictionary (2009). The definition of “prescribe” is “to lay down as a guide,
direction, or rule of action.” Id. During the 510(k) clearance process, the
FDA does not “accept” a warning “as satisfactory” or “lay down” a warning as
a “guide, direction or course of action.” Id. The FDA merely determines
whether the warning is substantially equivalent to other warnings. Huskey,
848 F.3d at 160-61; Bard, 810 F.3d at 921; Kaiser, 2018 WL 1358407, at
*3. Such clearance does not constitute the FDA’s “approval” or “prescription”
of a warning or instruction. Moreover, the foregoing decisions persuade us
that the 510(k) process is, at most, marginally relevant to whether the TVT is
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safe, and any excursion into this subject would have needlessly prolonged an
already lengthy trial and posed considerable risk of confusing the jury.
FDA’s 2013 publication. The trial court denied Ethicon’s motion to
introduce Dr. Denise Elser, an expert witness on urogynecology, to testify
about a 2013 FDA publication entitled “Considerations about Surgical Mesh for
SUI.”4 Court Exhibit 3. In pertinent part, the publication stated:
Mesh sling procedures are currently the most common type of
surgery performed to correct SUI. Based on industry estimates,
there were approximately 250,000 of these procedures performed
in 2010.
While all surgeries for SUI carry some risks, it is important for you
to understand the unique risks and benefits for surgical mesh
slings used in SUI repair.
In order to better understand the use of surgical mesh slings for
SUI and evaluate their safety and effectiveness, the FDA held a
panel meeting of scientific experts (Obstetrics and Gynecology
Devices Panel of the Medical Device Advisory Committee) in
September 2011 and conducted a systematic review of the
published scientific literature from 1996 to 2011. For surgical
mesh slings used for SUI, both the panel and the FDA’s review
found that:
 The safety and effectiveness of multi-incision slings is well-
established in clinical trials that followed patients for up to
one year. Longer follow-up data is available in the
literature, but there are fewer of these long-term
studies compared to studies with one-year follow-up.
. . .
____________________________________________
4The trial court also excluded other FDA publications issued in 2011 and 2012,
but because Ethicon does not object in this Court to the exclusion of these
publications, we have no need to address them.
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 Mesh sling surgeries for SUI have been reported to be
successful in approximately 70 to 80 percent of women at
one year, based on women’s reports and physical exams.
Similar effectiveness outcomes are reported following non-
mesh SUI surgeries.
 The use of mesh slings in transvaginal SUI repair introduces
a risk not present in traditional non-mesh surgery for SUI
repair, which is mesh erosion, also known as extrusion.
 Erosion of mesh slings through the vagina is the most
commonly reported mesh-specific complication from SUI
surgeries with mesh. The average reported rate of mesh
erosion at one year following SUI surgery with mesh is
approximately 2 percent. Mesh erosion is sometimes
treated successfully with vaginal cream or an office
procedure where the exposed piece of mesh is cut. In some
cases of mesh erosion, it may be necessary to return to the
operating room to remove part or all of the mesh.
 The long-term complications of surgical mesh sling
repair for SUI that are reported in the literature are
consistent with the adverse events reported to the
FDA.
 The complications associated with the use of surgical mesh
slings currently on the market for SUI repair are not linked
to a single brand of mesh.
The FDA conducted a review of Medical Device Reports (MDRs)
received from Jan. 1, 2008 through Sept. 30, 2011. During this
time frame the FDA received 1,876 reports of complications
associated with surgical mesh devices used to repair SUI.
The most common complications reported through MDRs for
surgical mesh slings for SUI repair, in descending order of
frequency, include: pain, mesh erosion through the vagina (also
called exposure, extrusion or protrusion), infection, urinary
problems, recurrent incontinence, pain during sexual intercourse
(dyspareunia), bleeding, organ perforation, neuro-muscular
problems and vaginal scarring. Many of these complications
require additional medical intervention, and sometimes require
surgical treatment and/or hospitalization. With the exception of
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mesh erosion, the above complications can occur following a non-
mesh surgical repair for SUI.
Id. (emphasis added). We conclude that the trial court properly excluded this
publication from evidence, albeit for reasons different from those expressed
by the trial court. See Zehner v. Zehner, 195 A.3d 574, 581 n.12 (Pa.
Super. 2018) (appellate court can affirm trial court’s ruling on any basis).
Ethicon highlights the publication’s statement that the FDA considered
multi-incision slings, including TVT’s, safe for seventy to eighty percent of
patients within one year after SUI surgery. This was not relevant to Ms.
Carlino’s action. Her problems began close to two years after her initial
surgery, and the essence of her case was that the TVT was defective due to
its long-term effects, particularly long-term mesh erosion.
Two sentences in the publication touched upon long-term performance,
but both were too vague to have probative value. The first sentence stated
that “longer follow-up data is available in the literature, but there are fewer
of these long-term studies compared to studies with one-year follow-up.”
Court Exhibit 13. What made up this “literature” and “data,” and what these
items concluded about the TVT’s long-term performance, was anyone’s guess.
The second sentence stated, “The long-term complications of surgical mesh
sling repair for SUI that are reported in the literature are consistent with the
adverse events reported to the FDA,” id., such as pain, mesh erosion, urinary
problems, incontinence and other symptoms. The publication did not,
however, identify the pertinent “literature” or the percentage of cases in which
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long-term complications occur. Even assuming these passages had marginal
relevance, their probative value was vastly outweighed by the risks of jury
confusion and time consumed by experts skirmishing over what the FDA
meant by the terms “literature” and “data” and whether the investigation
underlying the publication was sufficiently robust. See also Bard, 810 F.3d
at 921-22 (subjecting jury to hours or days of complex testimony about
regulatory investigation could lead jurors to erroneously infer the product was
safe).
DR. BLECHMAN’S TESTIMONY
The next issue involves the effect that the court’s order precluding the
FDA evidence discussed above had on Dr. Blechman’s second deposition in
this case.
To elaborate, the parties initially took Dr. Blechman’s deposition on June
30, 2015, seven months before trial. DTX-129 (excerpts from June 30, 2015
deposition). In January 2016, shortly before trial, the trial court entered an
order precluding Ethicon from entering the aforementioned FDA evidence. On
January 30, 2016, in the middle of trial, the parties took Dr. Blechman’s
second deposition via videotape, intending to play it for the jury.
On February 2, 2016, the Carlinos moved for sanctions on the ground
that Ethicon’s counsel (1) asked questions during the January 30, 2016
deposition that violated the order precluding FDA evidence and (2) used these
questions to dupe Dr. Blechman into changing his testimony. On February 5,
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2016, the trial court granted the Carlinos’ motion and precluded Ethicon “from
introducing any portion of the cross-examination and recross-examination of
Dr. Blechman from his January 30, 2016 deposition as a sanction for
questioning during that deposition that violated this [c]ourt’s [o]rder
[excluding FDA evidence].” The trial court also precluded the Carlinos from
introducing Dr. Blechman’s re-direct examination.
Ethicon contends that the trial court abused its discretion not only
because the sanction imposed precluded testimony on the FDA evidence, but
also because the sanction precluded it from introducing three other portions
of Dr. Blechman’s testimony unrelated to the FDA evidence. Ethicon argues
preclusion of this testimony entitles it to a new trial. We conclude no relief is
due.
During the January 30, 2016 deposition, Dr. Blechman testified on direct
examination that had he known in 2005 what he now knows about the TVT’s
potential adverse effects, he would not have recommended it for Ms. Carlino
or any other patient. PTX-60, Blechman dep., at 54, 59.
On cross-examination, the following took place:
[COUNSEL FOR ETHICON]: Okay. Do you know that the FDA
cleared the TVT device to be put on the market in 1998?
[COUNSEL FOR THE CARLINOS]: Object. We have a motion in
limine that was granted excluding . . . what the FDA did or didn’t
do.
[COUNSEL FOR ETHICON]: I’m just trying to put things in
perspective . . . [Y]our objection is preserved and it can be
continued for these questions.
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[COUNSEL FOR THE CARLINOS]: It also misstates the facts.
BY [COUNSEL FOR ETHICON]:
Q. Do you know that the TVT was cleared by the FDA? Do you
understand that, Dr. Blechman?
A. I understand that it was cleared by the FDA.
Q. Do you know that the FDA has continuously studied it ever
since?
[COUNSEL FOR THE CARLINOS]: No . . . that’s a false statement.
You know, it’s not admissible because the [c]ourt has ruled it’s
not admissible. So these questions are only designed to educate
the witness, to get him to change his mind about his prior
testimony. It’s just flagrantly abusive and I’m sure when the judge
sees this, he’ll be very unhappy.
BY [COUNSEL FOR ETHICON]:
Q. Dr. Blechman, you can just answer questions unless your
lawyer tells you not to –
A. Okay.
Q. -- and ignore attorney talk. All right?
A. Okay.
Q. Do you know that the TVT has been evaluated by the FDA on
an ongoing basis?
[COUNSEL FOR THE CARLINOS]: Okay. Now I’m going to give
counsel notice that we’re going to seek sanctions for this conduct.
And with each time this question is asked, the sanctions request
is going to be ratcheted upward.
Id. at 65-67. Subsequently, Ethicon’s counsel asked, “[B]ased on all the
information that you have received today, including the documents I provided,
looking back in time, if you had all of that information in 2005, would you have
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recommended the use of TVT for your patients?” Id. at 169-70. Dr. Blechman
answered, “Yes.” Id. at 170. Counsel then asked, “Putting yourself back in
2005, but based on the knowledge that you have today, do you still agree that
TVT was a safe and effective treatment for stress urinary incontinence in
women?” Id. at 171. Dr. Blechman answered, “Yes.” Id.
The trial court determined that Ethicon’s counsel violated its order
precluding FDA evidence, and that the appropriate sanction was to preclude
Ethicon from introducing its entire cross-examination and recross-examination
of Dr. Blechman. Trial Ct. Op., 1/3/17, at 34-35. The court explained:
The effect, and the seeming purpose, of [Ethicon’s] counsel’s
question was to confuse Dr. Blechman and cause him to pivot his
testimony so that it would be less favorable to the [Carlinos].
[Counsel] stated as fact that “the TVT has been evaluated by the
FDA on an ongoing basis.” N.T. Dep. Dr. Blechman, June 30,
2016, pp. 64-70. Basically, defense counsel’s strategy was to
present Dr. Blechman with materials that supported Ethicon’s
position that the product was safe, and then to ask him at the end,
based on all this information, looking back in time, if you had been
privy to this information at the time you recommended TVT to Ms.
Carlino, would you have recommended it? Of course the doctor
said yes. Why would being presented with positive studies and
with the idea that the FDA thought that Ethicon’s TVT product was
just fine have changed what he did at the time he recommended
the product in the first place? The salient point is that defense
counsel does not present the entire universe of relevant data.
There is a systematic presentation of positive data, and a
significant overstatement of the FDA’s position, and then a shift
from “knowing this, would you have recommended it?” to
“knowing everything, would you have recommended it?” . . . .
[Ethicon’s counsel] knew that she was transgressing when she
brought the FDA into the matter, and in fact her transgression
went to the heart of why the FDA was to be kept out. She misled
the witness into thinking that the FDA had taken an aggressive,
positive position on TVT, based on years of ongoing evaluation by
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the agency. Then she systematically used that misleading stance,
incorporated into her pool of positive evidence, to undermine Dr.
Blechman’s testimony and to try to turn him against [the
Carlinos]. That is why the metaphor of poison is appropriate here:
[Ethicon’s counsel] tainted every assertion that she coaxed from
Dr. Blechman after her FDA questioning. Doctors are very
deferential to the FDA; they depend on it for many of the decisions
they make in their practice as a matter of routine. To misuse the
FDA’s authority in this manner goes to the heart of why the pretrial
order was in place, and that is why this [c]ourt had to take action.
Id.
As a result of Ethicon interjecting the FDA evidence into its questioning
of Dr. Blechman in direct violation of the trial court’s pre-trial order, Dr.
Blechman changed his testimony from what he said on direct examination
earlier that day. On direct examination, he testified that based on what he
now knew, he would not have recommended the TVT to Ms. Carlino or other
patients. PTX-60 at 54, 59. On cross-examination, after Ethicon’s counsel’s
improper questions suggesting that the FDA “cleared” the TVT, Dr. Blechman
changed his testimony to state that had he known all of the information,
“including the documents [Ethicon’s counsel] provided today,” he would have
recommended the TVT to his patients. Id. at 169-70. Further, he now
testified that the TVT was a safe and effective treatment for SUI. Id. at 171.
We agree with the trial court that Ethicon’s counsel caused this “pivot” in Dr.
Blechman’s position by misleading him to believe that the FDA had approved
the TVT. Trial Ct. Op. at 34-35. The trial court properly excluded this cross-
examination testimony.
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Ethicon argues next that the second and third excerpts excluded by the
sanction precluding Ethicon from introducing any portion of the cross-
examination and recross-examination of Dr. Blechman, were necessary to
refute the Carlinos’ claim that Ethicon failed to warn Dr. Blechman about the
severity of the TVT’s risks. In reality, Ethicon contends, Dr. Blechman testified
on cross-examination that he knew by 2005 that “the risk of dyspareunia . . .
could be permanent” and “severe,” and he “did not need a company like
Ethicon to tell [him] that dyspareunia and pelvic pain were recognized
complications” of a TVT, or that “there would be a chronic foreign body
response” to a TVT. PTX-60 at 91:2-92:3, 126:3-127:15. This argument has
some appeal. The court’s decision to exclude all of Dr. Blechman’s cross- and
recross examination testimony was overbroad. A more appropriate sanction
for Ethicon’s violation of the order excluding FDA evidence would have been
to surgically excise testimony that was attributable to Ethicon’s violation while
admitting the rest into evidence. The testimony in question should have been
admitted because it did not relate to, and was not induced by, Ethicon’s
improper questions about FDA “clearance” of the TVT. Nevertheless, the
exclusion of this testimony was harmless error, because Ethicon was able to
present other testimony on the same subject. Specifically, Dr. Blechman gave
similar testimony during his first deposition on July 30, 2015 that Ethicon
played to the jury on February 3, 2016. DTX-129, at 188-90 (Dr. Blechman
knew in 2005 that the TVT’s risks included dyspareunia and inflammation, and
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that there were no time limits on when these complications could develop).
Thus, Ethicon cannot obtain a new trial due to its inability to demonstrate
prejudice. Rittenhouse v. Hanks, 777 A.2d 1113, 1118-19 (Pa. Super.
2001) (in medical malpractice action by patient’s estate against physician and
hospital, after patient died from liver injury allegedly caused by Eulexin, a
medication used to treat prostate cancer, physician and hospital were not
prejudiced by exclusion of reading of listing in Physician’s Desk Reference
(PDR) for medication and rarity of side effect of liver damage from Eulexin,
because entire PDR listing for Eulexin had been admitted into evidence and
estate’s witnesses had already discussed information contained therein);
Peled v. Meridian Bank, 710 A.2d 620, 626 (Pa. Super. 1998) (exclusion of
records of bank that issued irrevocable letter of credit, in breach of contract
action against advising bank, was harmless error, since similar documents
were admitted that conveyed essentially the same information).
Finally, Ethicon claims that the trial court erred by precluding a fourth
excerpt, Dr. Blechman’s cross-examination testimony that vaginal atrophy
was the cause of Ms. Carlino’s dyspareunia in 2015 instead of the TVT. Once
again, assuming the court committed error, it was harmless in nature because
Ethicon was able to present evidence of vaginal atrophy at other points during
trial. Rittenhouse, Peled, supra. For example, Dr. Elser, Ethicon’s expert,
provided testimony that Ms. Carlino’s medical records from her 2015
examination and previous years demonstrated vaginal atrophy. Tr., 2/5 (AM),
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at 99-100, 109-11. This testimony enabled Ethicon to argue in its closing that
vaginal atrophy caused Ms. Carlino’s dyspareunia in 2015 instead of the TVT.
Tr., 2/9 (PM), at 51-53. Thus, Ethicon cannot obtain relief due to lack of
prejudice. Rittenhouse, Peled, supra.
For these reasons, the trial court’s order precluding Dr. Blechman’s
cross- and recross-examination testimony does not warrant a new trial.
JURY INSTRUCTION ON DESIGN DEFECT
Ethicon posits that the Carlinos’ design defect claim required them to
prove that a safer, feasible alternative design existed for the TVT. The trial
court, Ethicon maintains, erred by instructing the jury that proof of a
reasonable safer alternative design was optional instead of mandatory. We
conclude that the court’s instruction was correct. As we did above, we apply
New Jersey law to this question of substantive law.
“[W]hen a court instructs the jury, the objective is to explain to the jury
how it should approach its task and the factors it should consider in reaching
its verdict.” Tincher v. Omega Flex, Inc., 104 A.3d 328, 351 (Pa. 2014).
The court has broad discretion in its choice of language provided that the
instruction fully and adequately conveys the applicable law. Id. A new trial
is warranted only “if an erroneous jury instruction amounted to a fundamental
error or the record is insufficient to determine whether the error affected the
verdict.” Id.- 38 -
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Under New Jersey law, a plaintiff in a design defect action generally
must provide evidence of a safe and reasonable feasible alternative design.
Smith v. Keller Ladder Co., 645 A.2d 1269, 1271 (N.J. App. Div. 1994)
(risk-utility analysis “ordinarily involves the consideration of available
alternatives”). Smith teaches:
The determination whether a product has been defectively
designed ordinarily involves a “risk-utility analysis,” under which
a manufacturer is held liable only “if the danger posed by the
product outweighs the benefits of the way the product was
designed and marketed.” There are seven factors which the Court
has identified as being relevant to a risk-utility analysis:
1. The usefulness and desirability of the product—its utility to the
user and to the public as a whole.
2. The safety aspects of the product—the likelihood that it will
cause injury, and the probable seriousness of the injury.
3. The availability of a substitute product [that] would meet the
need and not be as unsafe.
4. The manufacturer’s ability to eliminate the unsafe character of
the product without impairing its usefulness or making it too
expensive to maintain its utility.
5. The user’s ability to avoid danger by the exercise of care in the
use of the product.
6. The user’s anticipated awareness of the dangers inherent in the
product and their avoidability, because of general public
knowledge of the obvious condition of the product or of the
existence of suitable warnings or instructions.
7. The feasibility, on the part of the manufacturer, of spreading
the loss by setting the price of the product or carrying liability
insurance.
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Id. at 1270-71. Smith goes on to state that “unless there is some basis for
a jury to find that the risks involved in a product’s use outweigh its utility even
though there is no reasonably feasible alternative design, a plaintiff in a
design-defect case is required to show the existence of a safe and reasonably
feasible alternative to [the] defendant’s product.” Id. at 1271 (citing N.J.S.A.
2A:58C-3(a)(1) (“A manufacturer may not be held liable in a design-defect
product liability action “if ... [a]t the time the product left the control of the
manufacturer, there was not a practical and technically feasible alternative
design that would have prevented the harm without substantially impairing
the reasonably anticipated or intended function of the product”)). Further,
citing the Restatement (Third) of Torts, § 2(b), Smith instructs: “A product is
defective in design when the foreseeable risks of harm posed by the product
could have been reduced by the adoption of a reasonable alternative design
. . . and the omission of the alternative design renders the product not
reasonably safe . . .” Id.
Here, the trial court instructed the jury:
The plaintiff is also required to prove the existence in August 2005
of a reasonably feasible alternate design unless the risk[s]
involved in the TVT’s use outweigh its utility even though there is
no reasonably feasible . . . alternative design. A design defect
exists if the foreseeable risk of harm posed by the TVT could have
been reduced or avoided by the adoption of a reasonable safer
design and the omission of the alternate design renders the
product not reasonably safe.
You are to decide whether the safety benefits from altering the
design as proposed by plaintiff were greater than the resulting
cost or disadvantage caused by the proposed design, including
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any diminished usefulness or diminished safety. If the failure to
incorporate a practical and technically feasible safer alternate
design made the TVT not reasonably safe, then the TVT was
designed in a defective . . . manner . . . If, on the other hand,
plaintiff has not proven there existed a practical and technically
feasible safer alternative or if you find that the TVT as designed
was reasonably safe, then the product was not designed in a
defective manner.
Tr., 2/9 (AM), at 55-56. The first paragraph of these instructions is
substantively identical to the test articulated in Smith. See id. at 1271. The
second paragraph of instructions is entirely consistent with the risk-utility
analysis defined in Smith. Id. at 1270-71. The jury instruction correctly
described the operative standards under New Jersey law.
We note that the Carlinos introduced evidence that reasonably feasible
alternatives to the TVT design were available in 2005. Dr. Klinge testified that
Ethicon could have used either (1) macroporous Ultrapro or Vypro as the mesh
in the TVT; (2) a different polymer; or (3) the different technique of laser-
cutting mesh. The Carlinos’ counsel fairly argued this evidence to the jury in
closing argument. Tr., 2/9 (AM), at 107-12; Tr., 2/9 (PM), at 59-69.
Accordingly, Ethicon’s objection to the jury instruction on design defect
is devoid of merit.
AMOUNT OF COMPENSATORY DAMAGES
Ethicon argues that the trial court abused its discretion by denying
Ethicon’s post-trial motion for remittitur of the compensatory damage verdict
of $3.5 million. The trial court upheld the verdict based on Ms. Carlino’s
chronic pain, inability to have sex and emotional harm from the physical pain,
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and the effect her injury has had on her marriage. Trial Ct. Op. at 50-51. We
conclude that the trial court acted within its discretion.
While New Jersey law prescribes what items of compensatory damage
are available, Pennsylvania law governs the procedural issue of remittitur.
Remittitur is the “procedural [process] by which an excessive verdict of the
jury is reduced.” Hammons, 190 A.3d at 1285. Pennsylvania applies its own
procedural laws when it is serving as the forum state. Id.
As we observed in Hammons,
[u]nder Pennsylvania law, the decision to grant a remittitur
depends on whether the award of compensatory damages lies
beyond “the uncertain limits of fair and reasonable compensation”
or whether the verdict “so shocks the conscience as to suggest
that the jury was influenced by partiality, prejudice, mistake, or
corruption.” Potochnick v. Perry, 861 A.2d 277, 285 (Pa. Super.
2004). This standard is highly deferential, because the trial judge
serves not as finder of fact but as impartial courtroom authority
with obligation to give great respect to the jury’s function. Ferrer
v. Trustees of Univ. of Pennsylvania, [] 825 A.2d 591, 611
([Pa.] 2002). If the compensatory award is excessive, any
remittitur must fix “the highest amount any jury could properly
award.” Neal v. Bavarian Motors, 882 A.2d 1022, 1028 (Pa.
Super. 2005). That amount “must necessarily be as high—and
may well be higher—than the level the court would have deemed
appropriate if working on a clean slate.” Id. This Court is not free
to substitute its judgment for that of the fact finder. “Rather, it is
our task to determine whether the lower court committed a ‘clear’
or ‘gross’ abuse of discretion when conducting its initial evaluation
of a defendant’s request for remittitur.” Dubose v. Quinlan, 125
A.3d 1231, 1244 (Pa. Super. 2015) (citation omitted).
Id. at 1285-86. Moreover,
[e]ach personal injury case “is unique and dependent on its own
special circumstances.” Kemp v. Philadelphia Transportation
Co., [] 361 A.2d 362, 364 ([Pa. Super.] 1976). Thus,
noneconomic loss must be measured by experience rather than
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any mathematical formula. Martin v. Soblotney, [] 466 A.2d
1022, 1025 ([Pa.] 1983) (“it is immediately apparent that there is
no logical or experiential correlation between the monetary value
of medical services required to treat a given injury and the
quantum of pain and suffering endured as a result of that injury”).
For this reason, the law entrusts jurors, as the impartial acting
voice of the community, to quantify noneconomic loss and
compensation. Nelson v. Airco Welders Supply, 107 A.3d 146,
161 (Pa. Super. 2014).
Id. at 1286.
The trial court instructed the jury in detail that Ms. Carlino sought
compensation for past and future pain, suffering, disability, impairment, and
loss of enjoyment of life, and Mr. Carlino sought compensation for loss of
consortium. Tr., 2/9 (AM), at 66-70, 73. The court also stated that if the jury
determined that Ms. Carlino was entitled to damages for future pain and
suffering, her life expectancy today was 27 years. Id. at 70. Ethicon did not
object to these instructions.
The evidence permitted the jury to conclude that Ms. Carlino has
suffered severe pain in her pelvic region since late 2012. Tr., 1/29 (PM), at
20-21; Tr., 1/27 (AM), at 106. She still has more than 80% of the mesh inside
her and suffers significant pain at the site of the implant. Dr. Blechman, Dr.
Margolis, and Ethicon’s expert Dr. Elser confirmed her symptoms through
examination. They testified that she has a recurring throbbing sensation
where mesh was excised. She also has developed “pulling” across her right
leg and pain, and her incontinence has worsened. Tr., 1/28 (AM), at 26-29,
60-87; Blechman dep., 1/30, at 8-16, 34-40. Her pain is irreversible and will
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last the rest of her life, which is expected to be 27 more years, and she will
never again be able to have normal sexual relations with her husband. She
avoids intercourse with her husband because of her dyspareunia, and when
they have sex, it only lasts seconds, causing embarrassment and humiliation.
Her pain and sexual dysfunction have become a recurring topic of conversation
between her and her husband. Tr., 1/27 (AM), at 103-12, 118-19; Tr., 1/28
(AM), at 64-72; Tr., 1/29 (PM), at 20-21. Her condition carries a lifelong risk
of future surgeries if the TVT becomes exposed in the vagina again. Tr., 1/28
(AM), at 36-44. Collectively, this evidence demonstrates Ms. Carlino suffered
considerable physical disfigurement, pain, suffering, embarrassment, and loss
of life’s pleasures, and she will continue to suffer these injuries for the
remainder of her life. The court acted within its discretion under these
circumstances by determining that the verdict did not shock its conscience.
As it did in Hammons, Ethicon asks us to remit the verdict by comparing
Ms. Carlino’s damages with the plaintiffs’ injuries in Smalls v. Pittsburgh–
Corning Corp., 843 A.2d 410 (Pa. Super. 2004), and Hartner v. Home
Depot USA, Inc., 836 A.2d 924 (Pa. Super. 2003). In Smalls, an action
against a manufacturer for asbestos exposure, we remitted a $2 million verdict
for pain and suffering because the evidence demonstrated only that a
sedentary, seventy-four-year-old man with a twenty-year smoking habit and
additional diseases unrelated to asbestos exposure (cirrhosis, chronic
obstruction pulmonary disease, anemia, abdominal and colon conditions, and
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previously contracted pneumonia) became winded after moderate exercise
and no longer was as active around the house as he once was. Id., 843 A.2d
at 417. In Hartner, we remitted a $1 million verdict where the plaintiff
sustained a knee injury and undertook physical therapy but had no stiffness
or swelling during examination and used the gym three or four days a week.
She did not seek employer accommodations nor was there indication of
necessity for ongoing treatment. Id., 836 A.2d at 930. The evidence
demonstrates that Ms. Carlino has suffered, and will continue to suffer for
another 27 years, considerably more physical and emotional trauma from the
TVT than the plaintiff in Smalls suffered from asbestos exposure or the
plaintiff in Hartner suffered from her knee injury.
Ethicon complains that the Carlinos “made no effort to quantify the
severity or duration of damage[s] through evidence that she had been
diagnosed with or treated for any emotional condition.” Ethicon’s Brief at 53.
The evidence permitted the jury to conclude that Ms. Carlino suffers from a
life-long condition accompanied by severe pain, suffering, loss of life’s
pleasures and embarrassment. Moreover, the law does not allow her to
“quantify” her injuries. To the contrary, the law specifically prohibits counsel
from “estimating or suggesting to a jury the amount of damages to be
awarded, especially for pain and suffering in a personal injury case.” Clark
v. Philadelphia College of Osteopathic Medicine, 693 A.2d 202, 206 (Pa.
Super. 1997). “The verdict in an action of tort should be a deduction drawn
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by the jury from the evidence.” Nelson v. Airco Welders Supply, 107 A.3d
146, 162 (Pa. Super. 2014) (granting new trial on damages because counsel
suggested formula for calculating noneconomic damages).
PUNITIVE DAMAGES
Ethicon seeks judgment n.o.v. on the punitive damage verdict on
several grounds. We hold that the trial court properly denied judgment n.o.v.
There are two bases on which the court can grant judgment n.o.v.:
[O]ne, the movant is entitled to judgment as a matter of law
and/or two, the evidence is such that no two reasonable minds
could disagree that the outcome should have been rendered in
favor of the movant. With the first, the court reviews the record
and concludes that even with all factual inferences decided
adverse to the movant[,] the law nonetheless requires a verdict
in his favor, whereas the second, the court reviews the evidentiary
record and concludes that the evidence was such that a verdict for
the movant was beyond peradventure.
Hammons, 190 A.3d at 1265. In an appeal from the trial court’s decision to
deny judgment n.o.v.,
we must consider the evidence, together with all favorable
inferences drawn therefrom, in a light most favorable to the
verdict winner. Our standard of review when considering motions
for a directed verdict and judgment notwithstanding the verdict
are identical. We will reverse a trial court’s grant or denial of a
judgment notwithstanding the verdict only when we find an abuse
of discretion or an error of law that controlled the outcome of the
case. Further, the standard of review for an appellate court is the
same as that for a trial court.
Id. (citation omitted).
New Jersey allows punitive damages if the plaintiff demonstrates that
the defendant acted with “wanton and willful disregard” of her rights and that
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these acts caused her injuries. N.J. Stat. § 2A:15–5.12(a). Wanton and willful
disregard is “a deliberate act or omission with knowledge of a high degree of
probability of harm to another and reckless indifference to the consequences
of such act or omission.” N.J. Stat. § 2A:15–5.10. The standard of proof is
“clear and convincing evidence.” N.J. Stat. § 2A:15–5.12(a). The jury may
consider all evidence relevant to the defendant’s misconduct and the plaintiff’s
injuries, such as:
(1) the likelihood, at the relevant time, that serious harm would
arise from the defendant’s conduct;
(2) the defendant’s awareness of reckless disregard of the
likelihood that the serious harm at issue would arise from
the defendant’s conduct;
(3) the conduct of the defendant upon learning that its initial
conduct would likely cause harm; and
(4) the duration of the conduct or any concealment of it by the
defendant.
N.J. Stat. § 2A:15–5.12(b).
When a plaintiff contends that a defectively designed medical device
caused her injuries, the question of punitive damages “may turn on whether
the manufacturer wantonly disregarded a high probability that injury would
occur once the defect manifested itself in the situation that the plaintiff
encountered.” Zakrocki v. Ford Motor Co., 2009 WL 2243986 (N.J. Super.
App. Div. July 29, 2009). When a plaintiff asserts that a failure to warn caused
her injuries, punitive damages are appropriate “where the manufacturer knew
of the dangers created by its product and failed to warn users of serious health
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hazards.” Gross v. Gynecare, 2016 WL 1192556, at *26 (N.J. Super. App.
Div. 2016), certification denied, 228 N.J. 430, 157 A.3d 847 (2016).
The Carlinos presented the testimony of experts Bruce Rosenzweig,
M.D. and Uwe Klinge, M.D. to establish that the TVT is defective because it
poses a high risk of catastrophic injury to patients and that Ethicon sold the
TVT without adequate warnings. The testimony of Ethicon’s medical director,
Piet Hinoul, M.D., corroborated the same points. These witnesses testified
that using mesh in transvaginal implantation created a high risk of injury. One
piece of mesh is constructed from 80 feet of suture material knitted together
so that it is heavy and thick. At the same time, the mesh has pores that are
too small to allow the body to heal properly around and through mesh. The
TVT mesh frays and sheds plastic particles because Ethicon used a machine
to cut the mesh into the TVT’s precise shape. The implantation procedure and
subsequent normal activities put tension on the mesh and collapsed its pore
structure. Transvaginal implantation increases the rates of TVT degradation
and of infection relative to other locations in the body, in light of the higher
amount of bacteria and the oxidation processes that occur in the vagina.
Hinoul admitted that Ethicon knew about these risks at the time it launched
the TVT. PTX-19, Hinoul dep. (1/13/14), at 551-55, 773-79, 807, 917-20,
1045-50, 1106-26; PTX-19, Hinoul dep. (1/15/14), at 1717-31; PTX-30,
Klinge dep. (11/4/15), at 16-114, 263-64; PTX-1, Rosenzweig dep.
(12/22/15), at 72-204; PTX-42, Weisberg dep. (5/31/13), at 460-74.
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Dr. Rosenzweig acknowledged that temporary inflammatory reaction
and scar tissue formation is normal with any surgery. But as he explained,
the weight, thickness, and degradation of the TVT trigger a harmful permanent
cycle of severe inflammatory reaction and scar tissue formation. Because the
pores of the mesh are small, tissue does not grow normally but forms firm
scarring known as scar plating or fibriotic bridging. As fibriotic bridging occurs,
the mesh contracts and bunches, and the vagina becomes scarred and
shortened. Firm scar tissue causes friction, irritation, pain from nerve
constriction, and otherwise impedes the proper functioning of the vagina. Dr.
Rosenzweig added that these processes can irritate nerves, causing vaginal
and muscular pain and dyspareunia, which can lead to sexual dysfunction. If
the mesh obstructs the urethra, the patient can develop new urinary
symptoms, such as frequency, urgency, pain with urination and voiding
dysfunction. The mesh can also cause fistulas and erode layers of tissue in
the vagina and neighboring organs, as occurred in Ms. Carlino’s case. PTX-
30, Klinge dep. at 16-114; PTX-1, Rosenzweig dep. at 72-204, 721-26.
Research in the International Urogynecology Journal demonstrates that
mesh exposure in the vagina occurred in 19% of cases. Injuries from the TVT
required additional “very difficult” surgeries, and “about 30 percent of women
will require more than one surgery to treat mesh complications,” but there is
no way to excise mesh completely. Tr., 2/8 (AM), at 112-22; PTX-19 Hinoul
dep. (3/28/14), at 115-21; PTX-1, Rosenzweig dep. at 787-91.
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The TVT has a high rate of failure. Ethicon’s medical director, Hinoul,
admitted that the rate of the TVT’s long-term success as a treatment for
incontinence was around 66% to 68%. Ethicon, however, officially reported
the success rate as over 90%. Tr., 2/8 (AM), at 101; PTX-19, Hinoul dep.
(1/13/14), at 114-18.
The Instructions For Use (“IFU”) in use at the time of Ms. Carlino’s initial
surgery in 2005 listed transitory local irritation and transitory foreign body
response among its potential adverse reactions. Ethicon’s IFU provided no
warning about the risks of foreign body reaction, fibriotic bridging, mesh
shrinkage, vaginal scarring, vaginal perforation, nerve damage, chronic pain,
dyspareunia, or complications requiring mesh removal. Dr. Rosenzweig
testified that Ethicon should have warned that the TVT is cytotoxic, and that
it causes a severe inflammatory reaction because of the amount of foreign
material introduced in the body. He testified that Ethicon should have warned
about the TVT’s substantial degradation, small pore size, and pore collapse.
He also testified that Ethicon should have warned about the risks of serious
injuries, and about the severity, frequency, or permanency of those injuries.
PTX-1, Rosenzweig dep., at 205-46. Dr. Rosenzweig also testified that Ethicon
knew about alternatives to the TVT that were both available and safer for
implantation in humans, and Ethicon’s failure to utilize available alternative
designs rendered the TVT unreasonably unsafe. Id. at 99-101, 200-01, 940-
41.
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The evidence demonstrates that Ethicon knowingly understated the
risks of the TVT in all six versions of the IFU published between 2000 and
2015. The IFU’s adverse reactions section did not change during that time,
and it failed to acknowledge new information Ethicon was obtaining from
treaters and its own researchers on adverse effects associated with the TVT.
Id. In addition, Ethicon consistently and misleadingly informed physicians
that the TVT produced few adverse results and was intentionally evasive about
common complications. PTX-19, Hinoul dep. (1/14/14), at 1157-1208; PTX-
1, Rosenzweig dep., at 210-46; PTX-42 Weisberg dep. (5/31/13) at 398-410,
968-69; PTX-42, Weisberg dep. (11/12/15), at 207-49, 311-26; PTX-42,
Weisberg dep. (11/13/15), at 587-92.
Ms. Carlino testified that Dr. Blechman did not explain crucial risks of
the TVT before she consented to surgery but only warned her about the risks
of surgery and anesthesia. Tr., 1/27 (AM), at 63-72, 95-97. In turn, Dr.
Blechman testified that he expected Ethicon’s IFU to list the adverse reactions
of which Ethicon was aware, but Ethicon did not warn about the TVT’s risk for
causing severe and permanent injury. Further, Dr. Margolis testified that
Ethicon’s failure to warn about these risks of common and severe
complications also caused Ms. Carlino’s permanent injuries. Tr., 1/27 (AM),
at 118-19; Tr., 1/28 (AM), at 34-36, 79-98; Tr., 2/2 (PM), at 4-20. In
reaching these conclusions, Dr. Margolis excluded all other causes of Ms.
Carlino’s injuries. Tr., 1/28 (AM), at 91-96.
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Taken as a whole, and viewed in the light most favorable to the verdict
winner, this evidence permitted the jury to find Ethicon acted with wanton and
willful disregard of Ms. Carlino’s rights and that this conduct caused her
injuries. The evidence showed that Ethicon knew that the TVT could cause
permanent vaginal and muscular pain and sexual dysfunction, because of its
mesh weight, pore size, pore collapse, and particle loss. Despite this
knowledge, Ethicon promoted the TVT for patients who sought to fix SUI,
knowingly understated the risks of the TVT in its IFU, and consistently misled
physicians that the TVT produced few adverse results. PTX-1, Rosenzweig
dep., at 210-46; PTX-42, Weisberg dep. (5/31/2013) at 398-410; PTX-42,
Weisberg dep. (11/12/15-11/13/15) at 207-49, 311-26; PTX-42, Weisberg
dep. (11/15/15) at 587-92; PTX-19, Hinoul dep. (1/14/14) at 1157-1208.
Ethicon insists that punitive damages are unavailable because (1) the
FDA granted 510(k) clearance of the TVT device, and (2) the FDA issued a
publication in 2013 that “the safety and effectiveness of multi-incision slings
is well-established.” We held above that the trial court properly excluded this
evidence. Since it was inadmissible, it cannot protect Ethicon from an award
of punitive damages.
DELAY DAMAGES
In their cross-appeal, the Carlinos argue that the trial court should have
awarded delay damages on the punitive damage portion of the verdict instead
of on the compensatory portion only. We rejected this argument in
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Hammons, and we reject it here for the same reasons. Id., 190 A.3d at
1289-91.
Judgment affirmed. Ethicon’s Application To Strike Supplemental Trial
Court Record denied.
Judge Strassburger did not participate in the consideration or decision
of this case.
Judgment Entered.
Joseph D. Seletyn, Esq.
Prothonotary
Date: 4/11/19
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