PATRICIA L. HAMMONS
ETHICON, INC., JOHNSON & JOHNSON; GYNECARE; SECANT MEDICAL; SECANT MEDICAL, INC.; PRODESCO, INC.; AND SECANT MEDICAL, LLC Appeal of Patricia L. Hammons PATRICIA L. HAMMONS
ETHICON, INC., JOHNSON & JOHNSON; GYNECARE; SECANT MEDICAL; SECANT MEDICAL, INC.; PRODESCO, INC.; AND SECANT MEDICAL, LLC APPEAL OF ETHICON, INC., JOHNSON & JOHNSON; GYNECARE; SECANT MEDICAL; SECANT MEDICAL, INC.; PRODESCO, INC.; AND SECANT MEDICAL, LLC
from the Judgment Entered April 14, 2016 In the Court of
Common Pleas of Philadelphia County Civil Division at No:
3913 MAY TERM 2013
BEFORE: OTT, STABILE, JJ. and STEVENS, [*] P.J.E.
product liability action, Appellants, Ethicon, Inc. and
Johnson & Johnson, Ethicon's parent company
(collectively "Ethicon") and Appellee, Patricia
Hammons ("Hammons"), appeal and cross-appeal,
respectively, from a judgment of $12, 850, 945.18 entered in
favor of Hammons in the Philadelphia Court of Common Pleas.
Hammons alleged that she suffered injuries caused by
Ethicon's negligent design of, and failure to provide
adequate warnings about, the Prolift Kit, a medical product
used to treat prolapsed pelvic organs. Appellants challenge
the trial court's denial of (1) their preliminary
objections alleging lack of specific personal jurisdiction,
(2) their post-trial motions seeking judgment n.o.v. on the
basis of the statute of limitations and Appellee's
failure to present sufficient evidence, (3) their post-trial
motions seeking a new trial based on the trial court's
evidentiary and instructional errors, (4) their post-trial
motions seeking remittitur on the compensatory damage verdict
and vacatur or remittitur of the punitive damage verdict. In
her cross-appeal, Hammons argues that the trial court erred
by awarding delay damages only on the compensatory damage
verdict instead of the entire verdict. We affirm in all
AND PROCEDURAL HISTORY
& Johnson has its worldwide headquarters in New Jersey.
Ethicon is a wholly owned subsidiary of Johnson & Johnson
with a principal place of business in New Jersey. As
discussed in greater detail below, Ethicon worked closely
with other entities and individuals in Pennsylvania to
design, test and manufacture the Prolift Kit
review of the record reveals the following. Pelvic organ
prolapse is a pelvic floor disorder that affects the muscles
and tissues that hold the pelvic organs, including the
bladder, uterus, vagina, small bowel, and rectum, in place.
Due to childbirth, advancing age, or other causes, these
muscles and tissues can weaken, and one or more pelvic organs
"prolapse, " or descend into or outside of the
vaginal canal or anus. Pelvic organ prolapse is accompanied
by a number of other symptoms, including a bulge or feeling
of fullness in the pelvic area, back problems, pain during
sexual intercourse, urinary problems such as leaking of urine
or a chronic urge to urinate, or constipation.
early 2000s, a group of surgeons in France developed Prolift
in an attempt to improve treatment of pelvic repairs. In
2005, Ethicon brought Prolift to market. Prolift includes a
precut piece of surgical mesh and single-use implanting tools
called trocars. The mesh is woven from non-absorbable
polypropylene sutures and is pre-cut into distinct shapes for
anterior, posterior or total pelvic repairs. During
implantation, the mesh is inserted into the patient's
body through the vagina, pulled through the vaginal wall,
placed to support prolapsed pelvic organs and anchored with
mesh "arms" through a woman's bones and muscles
via trocars. Prolift surgery is a quality-of-life decision.
2009, Hammons, a post-menopausal woman who lives with her
boyfriend in Washington, Indiana, was diagnosed with prolapse
of her uterus and bladder. Her physician, Michael Baker,
D.O., recommended surgical repair of her bladder prolapse and
removal of her uterus and ovaries. On May 5, 2009, Hammons
signed a consent form authorizing a total vaginal
hysterectomy and "anterior repair with mesh."
Defense Trial Exhibit ("DTX")-36. The form stated
that Dr. Baker advised Hammons why the procedure was
necessary, "the risks thereof, [and] its advantages and
possible complications . . . ." Id. On the same
date, Dr. Baker performed the surgery and implanted the
Prolift device in Hammons' body to support her organs.
Dr. Baker wrote in his report of the operation, "I
discussed the . . . risk of injury to bowel, bladder or
ureter as well as . . . having pain with intercourse or other
types of pain following surgery. [Hammons] agreed to these
risks and wishes to proceed with surgery despite these
risks." DTX-37 at 208-09. Hammons testified, however,
that Dr. Baker did not tell her prior to surgery that pain
during sexual intercourse was one of the risks of surgery.
Notes of Testimony ("N.T."), 12/11/15 (PM), at 32.
20, 2009, Hammons returned to Dr. Baker with complaints of
pinching and sharp pain that caused her to stop engaging in
intimate relations. Dr. Baker noted sexual dysfunction but
did not offer a causal explanation. During the next visit,
Dr. Baker diagnosed Hammons with rectal prolapse, or
rectocele. She sought referral to a different gynecologist,
November 2009, Dr. Lackey diagnosed Hammons with pelvic
pressure and incontinence, rectocele, a tear in the vaginal
septum and dyspareunia (pain during sexual intercourse). In
December 2009, Dr. Lackey surgically repaired the rectocele
by using Hammons' own tissue to provide support for her
rectum. In January 2010, Dr. Lackey told Hammons that she
could resume sexual intercourse. It appears that Hammons did
not visit Dr. Lackey again until January 2012.
August 16, 2011, Hammons signed a form authorizing the
release of her "implant related medical records"
for use in "plaintiff litigation for product
liability." DTX-42; N.T., 12/11/15 (PM), at 63.
January 2012, Hammons returned to Dr. Lackey complaining of
pain during intercourse. Dr. Lackey did not identify Prolift
as the cause of Hammons' discomfort. On August 14, 2012,
Hammons returned to Dr. Lackey complaining of incontinence
and recurrent prolapse. Dr. Lackey referred Hammons to
urogynecologist Michael Heit in Louisville, Kentucky.
August 30, 2012, Dr. Heit diagnosed Hammons with symptoms
caused by implantation of Prolift mesh and recommended
additional surgeries for excision of the mesh and repair of
the entire pelvic floor. In November 2012, Dr. Heit
surgically excised mesh from Hammons' anterior vaginal
wall, repaired two cystotomies (holes in her bladder), placed
a ureteral stent and repaired her recurring rectocele. In
January 2013, Dr. Heit removed the ureteral stent, noting new
penetration of mesh into the left lateral bladder wall. Dr.
Heit surgically removed additional mesh from her bladder. In
all, Dr. Heit performed three surgeries.
continues to suffer from incontinence and pain during
intercourse. Because of pain, and because her vagina is
shortened and rigid with scar tissue, she has abstained from
sex, causing humiliation and impairing her relationship with
31, 2013, Hammons filed a civil complaint against Ethicon in
the Philadelphia Court of Common Pleas ("trial
court") alleging negligence, strict liability and other
torts at May Term, 2013, No. 3913 ("Individual
Docket"). In March 2014, the trial court transferred
Hammons' case to a Mass. Tort Program action, In Re
Pelvic Mesh Litigation, which encompassed all pelvic
mesh cases pending in Philadelphia.
March 31, 2014, the trial court issued a case management
order dividing the Pelvic Mesh Litigation matter
into proceedings on a Master Docket and proceedings on each
plaintiff's Individual Docket. On the Master Docket, all
pelvic mesh plaintiffs collectively were to file a "long
form" complaint alleging facts and causes of action that
applied globally to all pelvic mesh cases, and each defendant
was to file (1) preliminary objections that raised global
objections to all pelvic mesh cases or (2) an answer to the
long form complaint. Within 25 days after the answer to the
long form complaint, each plaintiff was to file a "short
form" complaint on her Individual Docket identifying the
counts of the long form complaint that she incorporated by
reference and asserting any new facts or causes of action not
in the long form complaint. Each defendant could then file
preliminary objections on the Individual Docket raising
objections that applied specifically to the short form
complaint. If the defendant did not file preliminary
objections, an entry of appearance by counsel for the
defendant would constitute a denial of allegations in the
short form complaint and an assertion of all applicable new
matter and defenses.
14, 2014, the plaintiffs filed an eighteen-count long form
complaint on the Master Docket against Ethicon and other
defendants, including Secant Medical, Inc. and Secant Medical
LLC ("Secant"), a manufacturer of surgical mesh
located in Perkasie, Pennsylvania. Among the counts in the
long form complaint were strict liability actions for design
defect, manufacturing defect and failure to warn. The long
form complaint also asserted that personal jurisdiction
existed over Ethicon in Pennsylvania.
21, 2014, the plaintiffs served Ethicon with the long form
complaint. On June 10, 2014, Ethicon filed preliminary
objections to the long form complaint arguing that eleven of
the eighteen counts failed to state a cause of action and
objecting to the lack of specificity of certain averments.
Ethicon did not file any objection to personal jurisdiction.
Secant also filed preliminary objections seeking dismissal of
the claims under the Biomedical Access Assurance Act, 21
U.S.C. § 1601 et seq. On August 22, 2014, the
trial court sustained Secant's preliminary objections and
dismissed all claims against Secant with prejudice. On
September 2, 2014, the trial court overruled Ethicon's
preliminary objections. On September 23, 2014, Ethicon filed
an answer to the long form complaint with new matter.
October 7, 2014, Hammons filed a short form complaint on her
Individual Docket. On October 28, 2014, Ethicon filed
preliminary objections to the short form complaint asserting
lack of personal jurisdiction. On November 6, 2014, the trial
court entered an order on the Master Docket directing the
parties to take discovery on the jurisdictional issue. On
March 30, 2015, the trial court overruled Ethicon's
motion on the Master Docket to dismiss for lack of personal
jurisdiction and Ethicon's preliminary objections on
Hammons' Individual Docket asserting lack of personal
jurisdiction. The trial court did not provide any explanation
for its ruling.
August 31, 2015, Ethicon moved for summary judgment on the
Individual Docket. Among other arguments, Ethicon claimed
that it was entitled to summary judgment on Hammons'
manufacturing defect claim because there was no evidence that
the Prolift device used in her surgery deviated from its
intended design. On November 24, 2015, the trial court
granted summary judgment to Ethicon on the manufacturing
defect claim and other claims. The court left intact
Hammons' design defect and failure-to-warn claims.
expert witnesses, gynecologist Daniel Elliott, M.D., and
urogynecologist Anne Weber, M.D., testified that Prolift was
defectively designed. Dr. Elliott testified that
Prolift's mesh contains too much suture for implantation
through the wall of the vagina. Prolift also requires
implantation of approximately 260 yards of a plastic material
foreign to the patient's body. Dr. Elliott testified that
the mesh is over-engineered and too heavy and dense, and the
pores of the mesh are too small for the product to perform
properly and as intended. Another expert, Uwe Klinge, M.D.,
opined that Prolift mesh's one millimeter pores were
inadequate. He testified Ethicon should have used a mesh with
pores larger than three millimeters. Plaintiff's Exhibit
("P-") 3401 at 10-15; P-3402 at 12-17; P-3408 at
Elliott also testified that the process of implantation
recommended by Ethicon actually causes Prolift's mesh
pores to collapse. For instance, he explained, pores collapse
because the vagina is a dynamic organ that moves, shifts, and
changes shape with normal movement. Pores also collapse
because implantation requires a physician to pull on the mesh
to guide it through the vagina, the vaginal wall, and pelvic
muscles to anchor it into place. Lastly, pores collapse when
physicians cause tension in the mesh when they pull it under
the bladder. Ethicon knew the vagina and pelvic organs create
an environment different from any other (such as the
abdominal cavity for which the mesh was created) but failed
to modify the Prolift mesh and surgical techniques to account
for the differences. P-3402 at 27-37; P-3407 at 1-7; P-3408,
at 10-17; P-3415 at 6-7.
Elliott testified that implantation of materials foreign to
the body naturally causes chronic foreign body reaction and
inflammatory response, and Prolift causes severe inflammatory
reaction proportional to the large amount of plastic used.
Severe inflammation causes scar tissue formation. Prolift
mesh's small pores and pore collapse impede normal tissue
growth through the pores. The mesh bands and rolls to
exacerbate the inflammatory and scar formation cycle. The
process results in platting or bridging, that is, scar tissue
becomes rigid, contracts and bunches. As the mesh contracts,
it erodes layers of tissue in the vagina and then in
neighboring organs. It can become exposed in the vagina and
damage the bladder, intestines and other organs, which then
might experience dysfunction. Further, mesh that contracts
causes tissue irritation and pulls painfully on the
patient's muscles, causing chronic muscle pain and pelvic
floor muscle spasms. Dr. Elliott testified that the
inflammatory response is chronic and triggers a progressive
cycle of mesh contraction and erosion that causes pain
response and organ dysfunction. He added that pain management
techniques are generally unsuccessful, and that Prolift's
design precludes successful and complete excision without
risk of "severe damage" to the pelvic structures.
P-3401 at 2-13; P-3402, at 12-37.
Elliott and Dr. Weber added that Prolift has limited
effectiveness in repairing prolapse. Dr. Elliott testified
that Ethicon's pre-launch clinical study data indicated
more than a twenty percent rate of prolapse recurrence at
both six and twelve months following Prolift implantation.
Even by Ethicon's predefined criteria, Prolift failed
performance expectations because prolapse recurs frequently
and shortly after implantation. Dr. Weber testified that she
independently analyzed raw clinical data and concluded
Ethicon underreported the true rate of recurrence by ten
percent. Dr. Weber also noted the existence of clinical
experience and studies known to Ethicon that demonstrated
nearly twenty percent of women suffered mesh shrinkage with
pain during intercourse, and another approximately twenty
percent suffered mesh erosions within a year of implantation.
N.T., 12/8/15 (A.M.), at 23-64; P-3401 at 6; P-3402, at
21-24; P-3404 at 18; P-3415 at 7.
Elliott and Dr. Weber concluded that Prolift is unsafe. Dr.
Elliott further testified that Ethicon's product warnings
were inadequate, because they failed to convey all of the
risks of the product, including severe and permanent pain
during sexual intercourse. Dr. Baker, the surgeon who implanted
the Prolift device, testified that he would not have
recommended the product had Ethicon adequately warned him of
its risks. Moreover, Ethicon knew about the risks of the
product before placing it on the market. Prolift's
inventors, Professor Jacquetin and Dr. Cosson, insisted both
before and after Prolift's launch on replacement of the
Prolene/Gynemesh mesh with a safer mesh alternative called
Ultrapro. Dr. Weber agreed that Ultrapro mesh reduced the
risk because it contained less mesh, had larger pores and was
softer in place. Ultrapro's characteristics were thought
to reduce inflammation and scar plating. N.T., 12/7/15
(A.M.), at 57-95; N.T., 12/7/15 (P.M.), at 237-48; P-3401 at
2-3, 9-12; P-3402, at 5-7, 33-35; P-3404, at 9; P-3407 at
8-12; P-3415, at 7-8; P-3417 at 1-4.
parties agreed that Indiana law defines the elements of
Hammons' product liability claims, while New Jersey law
provides the standards for determining punitive
damages.  At the end of a three-week trial, the
trial court denied Ethicon's motion for directed verdict.
On December 21, 2015, the jury returned a verdict that
Ethicon was liable for causing Hammons' injuries and
awarded compensatory damages of $5.5 million. After
additional evidence, argument, and instructions, on December
22, 2015, the jury assessed an additional $7 million in
punitive damages. Both sides filed post-trial motions. The
trial court denied Ethicon's post-trial motions and
granted delay damages upon only the compensatory award rather
than the entire verdict. On May 12, 2016, Hammons filed a
praecipe to enter judgment in the amount of $12, 850, 945.18
on the Individual Docket. Both sides filed timely notices of
appeal and timely Pa.R.A.P. 1925(b) statements of errors
complained of on appeal.
RAISED ON APPEAL
appeal at 1526 EDA 2016, Ethicon raises ten issues that we
have re-ordered for the sake of convenience:
1. Did the trial court commit legal error by exercising
personal jurisdiction over [Ethicon], even though [Ethicon is
not] incorporated in [and does not] maintain [its] principal
place of business in Pennsylvania, and even though
[Hammons'] 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
[Hammons'] claims were barred by the statute of
limitations and [Hammons] did not present legally sufficient
evidence that Indiana's discovery rule extended the
3. Did the trial court commit legal error when it denied
[Ethicon]'s directed-verdict and JNOV motions, where
[Hammons] failed to present legally sufficient evidence that
an inadequacy in Prolift's warnings caused her alleged
4. Did the trial court commit legal error when it denied
[Ethicon]'s directed-verdict and JNOV motions, where
[Hammons] failed to present legally sufficient evidence that
a safer alternative design to the Prolift medical device was
available at the time of her May 2009 implantation?
5. Did the trial court commit reversible error by refusing to
instruct the jury that, to prevail on the design-defect
claim, [Hammons] was required to show a safer alternative
design to Prolift?
6. Did the trial court commit legal error when it denied
[Ethicon]'s directed-verdict and JNOV motions, where
[Hammons] failed to present legally sufficient evidence that
a defect in Prolift, as opposed to potential alternatives,
caused her alleged injuries?
7. Did the trial court commit reversible error by admitting
evidence and allowing argument that [Ethicon] supposedly
spoliated evidence, when there was no showing or finding that
spoliation occurred or that [Hammons] was prejudiced?
8. Did the trial court commit reversible error by instructing
the jury that [Ethicon]'s awareness of any potential
misuse of Prolift by surgeons made them responsible for all
misuses of Prolift, whether or not they were foreseeable?
9. Did the trial court err when it refused to remit the
compensatory damages award?
10. 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.
raises the following issue in her appeal at 1522 EDA 2016:
"Did the trial court improperly mold the jury's
verdict to add delay damages calculated only on the
compensatory portion of the verdict?" Hammons' Brief
first asserts that the trial court erroneously denied its
preliminary objections to Hammons' Short Form Complaint,
in which Ethicon argued that personal jurisdiction does not
exist over Ethicon in Pennsylvania.In support of this argument,
Ethicon relies on the United States Supreme Court's
recent decision in Bristol-Myers Squibb Co. v. Superior
Court of California, San Francisco County
("Bristol-Myers"), - U.S. -, 137 S.Ct. 1773
(2017), which held that California courts lacked specific
jurisdiction to entertain product liability claims by
nonresidents against a nonresident drug manufacturer, where
the nonresidents were not prescribed the drug in California
and did not purchase, ingest or suffer injury from the drug
there. Hammons responds that Ethicon waived this issue by
failing to raise it in preliminary objections to the Long
Form Complaint on the Master Docket. In any event, Hammons
continues, Bristol-Myers actually supports the
conclusion that "the trial court properly exercised
specific jurisdiction over Ethicon, given Ethicon's
activities in Pennsylvania relating to this case."
Hammons' Supplemental Brief at 1.
conclude that Ethicon did not waive this issue, because the
case management order for pelvic mesh cases did not require
Ethicon to contest personal jurisdiction in preliminary
objections to the Long Form Complaint.
begin with, the case management order was a valid exercise of
the court's authority. In 1992, the Philadelphia Court of
Common Pleas initiated the Mass. Tort Program to deal
efficiently with large numbers of complex but similar tort
cases by coordinating and streamlining pleadings, discovery,
pretrial motions, and trial. The legal foundation for the
Program is Pa.R.Civ.P. 213, which authorizes courts to
consolidate related cases and issue case management orders
for their efficient disposition. See Pa.R.Civ.P.
213(a) ("In actions pending in a county which involve a
common question of law or fact . . . the court on its own
motion . . . may order the actions consolidated and may
make orders that avoid unnecessary cost or delay"). The
case management order in this case—which appears to be
a standard order in all Philadelphia mass tort
cases—fits well within the boundaries of Rule 213(a) by
delineating applicable procedures in pelvic mesh cases.
case management order restricts preliminary objections to the
Long Form Complaint to issues that apply to
all pelvic mesh cases. The question whether
the trial court had personal jurisdiction over Ethicon did
not apply to all pelvic mesh cases. While a
question of personal jurisdiction over Ethicon exists with
regard to out-of-state plaintiffs such as Hammons, it appears
fairly certain personal jurisdiction would exist over Ethicon
in actions brought by plaintiffs who underwent Prolift
surgery in Pennsylvania due to the "affiliation between
the forum and the underlying activity."
Bristol-Myers, 137 S.Ct. at 1781 ("In order for
a court to exercise specific jurisdiction over a claim, there
must be an affiliation between the forum and the underlying
controversy, principally, [an] activity or an occurrence that
takes place in the forum State . . . When there is no such
connection, specific jurisdiction is lacking regardless of
the extent of a defendant's unconnected activities in the
State"). Thus, Ethicon was not required to raise
objections to personal jurisdiction in preliminary objections
to the Long Form Complaint on the Master Docket. Indeed, as
Ethicon observes, it was impossible for Ethicon to challenge
personal jurisdiction in preliminary objections to the Long
Form Complaint, because this complaint "lacked any of
the plaintiff-specific allegations required to assert such
objections—for example, the state where the plaintiff
resides, the state where she had the device implanted, and
the state where the injury occurred . . . When [Hammons]
filed her short-form complaint that added those allegations .
. . [Ethicon] promptly and timely filed their preliminary
objetions to personal jurisdiction." Ethicon's Reply
Brief, at 3.
merits, however, we conclude that personal jurisdiction
exists over Ethicon in this case. The trial court applies the
following standards to preliminary objections asserting lack
of personal jurisdiction:
When preliminary objections, if sustained, would result in
the dismissal of an action, such objections should be
sustained only in cases which are clear and free from doubt.
Moreover, when deciding a motion to dismiss for lack of
personal jurisdiction the court must consider the evidence in
the light most favorable to the non-moving party. A defendant
making a challenge to the court's personal jurisdiction
has, as the moving party, the burden of supporting its
objection to jurisdiction.
De Lage Landen Services, Inc. v. Urban Partnership,
LLC, 906 A.2d 586, 589 (Pa. Super. 2006) (citation
omitted). "Our standard of review of an order of the
trial court overruling . . . preliminary objections is to
determine whether the trial court committed an error of law.
[Furthermore], the appellate court must apply the same
standard as the trial court." Id.
Process Clause of the Fourteenth Amendment to the United
States Constitution limits the authority of a state to
exercise in personam jurisdiction over non-resident
defendants. Burger King Corp. v. Rudzewicz, 471 U.S.
462, 471-72 (1985). The extent to which the Due Process
Clause proscribes jurisdiction depends on the nature and
quality of the defendant's contacts with the forum state.
Id. at 474-76; Kubik v. Letteri, 614 A.2d
1110, 1114 (Pa. 1992). Where a defendant "has
established no meaningful contacts, ties or relations"
with the forum, the Due Process Clause prohibits the exercise
of personal jurisdiction. Burger King, 471 U.S. at
472. However, where a defendant has "purposefully
directed" his activities at the residents of the forum,
he is presumed to have "fair warning" that he may
be called to suit there. Id.
International Shoe Co. v. Washington, 326 U.S. 310,
317-18 (1945), the Supreme Court has recognized two types of
personal jurisdiction: general and specific. Id.,
326 U.S. at 317-18. The court has general jurisdiction over a
foreign corporation when its affiliations with the state are
so "continuous and systematic" as to render them
essentially at home in the forum State. Goodyear Dunlop
Tires Operations, S. A. v. Brown, 564 U.S. 915, 919
(2011). "A court with general jurisdiction may hear any
claim against that defendant, even if all the incidents
underlying the claim occurred in a different State."
Bristol-Myers, 137 S.Ct. at 1780. Recently, however,
the United States Supreme Court held that general
jurisdiction will not lie in a state in which neither a
parent corporation nor its subsidiary is incorporated or has
its principal place of business. Daimler AG v.
Bauman, 571 U.S. 117, 134 S.Ct. 746, 762 (2014). The
record does not indicate that any entity within Ethicon's
corporate hierarchy is incorporated in Pennsylvania or has
its principal place of business in Pennsylvania. Therefore,
we need not discuss general jurisdiction concepts further.
general jurisdiction does not exist over a foreign defendant,
it may still be subject to specific jurisdiction in
Pennsylvania pursuant to Pennsylvania's long arm statute,
42 Pa.C.S.A. § 5322 ("Bases of personal
jurisdiction over persons outside this Commonwealth").
Section 5322(a) contains ten paragraphs that specify
particular types of contact with Pennsylvania deemed
sufficient to warrant the exercise of specific jurisdiction.
In addition, Section 5322(b) operates as a "catchall,
" providing that jurisdiction may be exercised over
persons who do not fall within the express provisions of
Section 5322(a) to the fullest extent permitted by the Due
Process Clause of the United States Constitution. Mendel
v. Williams, 53 A.3d 810, 821 (Pa. Super. 2012)
(citation omitted). Regardless, if a defendant's
activities in Pennsylvania only give rise to jurisdiction
under section 5322(a) or (b), the plaintiff's cause of
action is limited to those activities that formed the basis
of jurisdiction. See 42 Pa.C.S.A. § 5322(c)
("when jurisdiction over a person is based solely upon
this section, only a cause of action or other matter arising
from acts enumerated in subsection (a), or from acts forming
the basis of jurisdiction under subsection (b), may be
asserted against him").
jurisdiction enables a court to adjudicate claims arising
from activity that occurs within the forum state's
borders and is "therefore subject to the State's
regulation." Bristol-Myers, 137 S.Ct. at 1780.
There are three requirements for the exercise of specific
jurisdiction. First, the defendant must have
"purposefully availed itself of the privilege of
conducting activities within the forum State or have
purposefully directed its conduct into the forum State."
Id. at 1785. Second, the plaintiff's claim must
"arise out of or relate to" the defendant's
activities in the forum state. Id. Third,
jurisdiction must be fair and reasonable so as not to offend
tradition notions of fair play and substantial justice.
Id. The fairness factors in the third requirement
that a court will consider are "the burden on the
defendant, the forum State's interest in adjudicating the
dispute, the plaintiff's interest in obtaining convenient
and effective relief, the interstate judicial system's
interest in obtaining the most efficient resolution of
controversies, and the shared interest of the several States
in furthering fundamental substantive social policies."
Id. at 1786.
Bristol-Myers, a group of plaintiffs, consisting
mainly of non-California residents, filed a mass tort action
in California state court alleging injuries caused by a blood
thinner drug called Plavix. Id. at 1778. The Supreme
Court held that California did not have personal jurisdiction
over the defendant with regard to claims of the
non-California residents. Id. at 1783. California
did not have general jurisdiction over Bristol-Myers because
the pharmaceutical company was incorporated in Delaware and
headquartered in New York. Id. at 1783-84. Moreover,
California lacked specific jurisdiction because there was no
connection to the non-residents' claims. The nonresidents
did not allege they purchased, ingested or suffered harm from
Plavix in California or received treatment for their injuries
in California. Id. at 1778. Nor did they allege that
they were prescribed Plavix in California or by California
physicians. Id. The mere fact that California
residents were prescribed Plavix or ingested it in
California, or allegedly sustained the same injuries as the
nonresidents, "[did] not allow the State to assert
specific jurisdiction over the nonresidents'
claims." Id. at 1781.
Bristol-Myers' decision to contract with a California
company to distribute the drug nationally did not provide a
sufficient basis for personal jurisdiction. Id. at
1783. The Court ruled that a defendant's contract with a
distributor in the forum state is not itself enough to
establish personal jurisdiction in the State. Id. It
noted that there was no allegation that the defendant engaged
in relevant acts together with the distributor in California,
or that the defendant was derivatively liable for the
distributor's conduct. Id.
short, what was needed-and what was missing-was suit-related
conduct, i.e., a connection between the forum and
the specific claims at issue, "principally, an activity
or occurrence that takes place in the forum State."
Id. at 1781. "[A]ll the conduct giving rise to
the nonresidents' claims occurred elsewhere."
Id. at 1782.
Court rejected the California Supreme Court's
"sliding scale" theory establishing personal
jurisdiction. Under this approach, "the strength of the
requisite connection between the forum and the specific
claims at issue is relaxed if the defendant has extensive
forum contacts that are unrelated to those claims."
Id. What the California court did "resembles a
loose and spurious form of general jurisdiction."
Id. For specific jurisdiction, a defendant's
general connections with the forum state are not enough.
connection between Ethicon and Pennsylvania is considerably
stronger than the connection between Bristol-Myers and
California. Ethicon supervised the design and manufacturing
process of pelvic mesh in Pennsylvania in collaboration with
Secant Medical, Inc., a Bucks County company. Ethicon also
worked closely with an Allentown, Pennsylvania physician,
Vincent Lucente, M.D., in developing Prolift. Both of these
factors support the exercise of specific jurisdiction over
Ethicon in Pennsylvania.
elaborate, Hammons claims that she suffered bodily injuries
due to the properties of the mesh that Ethicon used in its
transvaginal mesh product, Prolift. She contends that Ethicon
defectively designed and manufactured the mesh with
polypropylene material that was toxic, dense and inelastic.
Because of its defective design, she asserts, the mesh caused
scar plating, erosion of mesh into her pelvic organs, and
extensive personal injuries. The record illustrates that
Ethicon worked together with Secant in Pennsylvania to
design, test and manufacture the Prolift mesh.
high-level officials of Secant provided affidavits (R.R.
266b-278b) that Ethicon provided all material specifications
for the weaving of mesh at Secant's Pennsylvania plant,
including specifications concerning the mesh's
elasticity, mass, and density, the specifications at the
center of Hammons' claims. Ethicon delivered
polypropylene filament to Secant in Pennsylvania.
Id. Secant knitted the filament into large rolls of
mesh in, and tested samples for, compliance with
Ethicon's specifications. Id. Ethicon received
the rolls of mesh from Pennsylvania and processed them
further. Id. Emails between Ethicon and Secant
officials demonstrate that Ethicon repeatedly communicated
its requirements for mesh design and development,
manufacturing, quality control, testing, and certification to
Secant—all issues central to this litigation. The
emails also show that Ethicon employees visited Secant's
plant in Pennsylvania on multiple occasions to observe the
mesh production process. This evidence establishes an
affiliation between Pennsylvania and Hammons' cause of
action against Ethicon for defective design of the Prolift
device. Bristol-Myers, 137 S.Ct. at 1781.
evidence also shows that Ethicon relied heavily on
an Allentown, Pennsylvania gynecologist, Vincent Lucente,
M.D., for the development, study, and marketing of Prolift.
N.T., 12/8/15 (AM), at 19-60. Ethicon retained Dr. Lucente as
its investigator for three important clinical studies that
Ethicon funded concerning the outcomes and safety of Prolift
mesh: the Gynemesh PS study of Prolift's mesh materials,
the U.S. TVM study of the Prolift prototype, and the Lucente
IIS study. Hammons' Trial Exhibits 750, 2299, 3404, 3410,
3416. Dr. Lucente's role was so important to
Ethicon's development of Prolift that Ethicon employees
traveled to Pennsylvania in February 2006 to meet with Dr.
Lucente for guidance concerning the marketing and development
strategy for Prolift. Id. Dr. Lucente advised it
would be a "disaster" for a woman to need revision
surgery with Prolift. Hammons' Trial Exhibit 3404. At
Ethicon's behest, Dr. Lucente interceded on Ethicon's
behalf to persuade the American College of Obstetricians and
Gynecologists to remove a designation of these mesh
procedures as "experimental." Hammons' Trial
Exhibits 2299, 3416. Ethicon paid Dr. Lucente over $1.7
million for his services in Pennsylvania, services that were
relevant to Hammons' claims. Hammons' Trial Exhibit
3404. This evidence too provides an affiliation between
Pennsylvania and Hammons' design defect claim, thus
permitting exercise of specific jurisdiction over Ethicon in
Pennsylvania. Bristol-Myers, 137 S.Ct. at 1781;
see also Cortina, 2017 WL 2793808 at *3 (two
pharmaceutical companies were subject to specific
jurisdiction in California based on clinical trials conducted
in California that were relevant to plaintiff's claims
and part of "causal chain" that led to
plaintiff's injury); Symbolstix, LLC v. Smarty Ears,
LLC, 152 F.Supp.3d 1027, 1036 (N.D. Ohio 2015) (in
copyright infringement action in Ohio, specific jurisdiction
existed over Texas company that sold educational mobile
device applications, where company's contacts with speech
pathologists in Ohio were central to its product development
and marketing strategies).
these reasons, the trial court correctly denied Ethicon's
motion to dismiss this action for lack of personal
argues that the trial court erred in denying its post-trial
motions seeking judgment n.o.v. on the ground that
Hammons' action is time-barred under Indiana's
two-year statute of limitations. Hammons counters that
following her May 2009 surgery, Dr. Baker and Dr. Lackey
failed to discover over the next several years that Prolift
caused her injuries, and since these experienced physicians
could not detect the problem, neither could she. She asserts
that she only became aware that Prolift caused her injuries
when Dr. Heit diagnosed the problem on August 30, 2012, less
than two years before May 31, 2013, the date she filed suit.
appellate court, we must decide issues such as this by
construing the evidence in the light most favorable to the
verdict winner, Hammons. Construed in this light, the
evidence establishes that August 16, 2011 was the earliest
date on which Hammons had notice that Prolift caused her
injuries.Since this was less than two years before
Hammons filed suit, Ethicon's statute of limitation
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
Menkowitz v. Peerless Publications, Inc., 176 A.3d
968, 976-77 (Pa. Super. 2017) (en banc) (citation
omitted). 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. at 977 (citation omitted).
Indiana Products Liability Act ("IPLA") imposes
liability upon a seller for physical harm caused by a
"product in a defective condition unreasonably dangerous
to any user or consumer" when:
(1) the user or consumer is in the class of persons that the
seller should reasonably foresee as being subject to the harm
caused by the defective condition;
(2) the seller is engaged in the business of selling the
(3) the product is expected to and does reach the user or
consumer without substantial alteration in the condition in
which the product is sold by the person sought to be held
liable under this article.
Ind. Code § 34-20-2-1. In an action for design defect,
"the party making the claim must establish that the
manufacturer or seller failed to exercise reasonable care
under the circumstances in designing the product." Ind.
Code § 34-20-2-2. For purposes of a design defect claim,
[a] product is in a defective condition under [IPLA] if, at
the time it is conveyed by the seller to another party, it is
in a condition:
(1) not contemplated by reasonable persons among those
considered expected users or consumers of the product; and
(2) that will be unreasonably dangerous to the expected user
or consumer when used in reasonably expectable ways of
handling or consumption.
Ind. Code § 34-20-4-1.
action for failure to provide adequate warnings, a product is
defective if the seller fails to: "(1) properly package
or label the product to give reasonable warnings of danger
about the product; or (2) give reasonably complete
instructions on proper use of the product; when the seller,
by exercising reasonable diligence, could have made such
warnings or instructions available to the user or
consumer." Ind. Code § 34-20-4-2. The plaintiff
must show the manufacturer "failed to exercise
reasonable care under the circumstances . . . in providing
the warnings or instructions." Ind. Code §
IPLA provides that the defendant may raise defenses to
product liability claims. Ind. Code §§ 34-20-6-1
and 34-20-6-2. The burden of proving any defense is upon the
defendant. Ind. Code § 34-20-6-2.
Code § 34-20-3-1 provides that "any product
liability action in which the theory of liability is
negligence or strict liability in tort . . . must be
commenced within two (2) years after the cause of action
accrues . . ." Although the statute does not define
"accrues, " Indiana courts have adopted a
"discovery rule" under which "the two-year
statute of limitations begins to run from the date the
plaintiff knew or should have discovered that she suffered an
injury or impingement, and that it was caused by the product
or act of another." Degussa Corp. v. Mullens,
744 N.E.2d 407, 410 (Ind. 2001). "[C]ase law regarding
medical malpractice claims is instructive" in Indiana
product liability cases, "because medical and diagnostic
issues are common between the two actions, the statute of
limitations for both claims is two years, and discovery is
sometimes at issue in determining whether the respective
statutes of limitation have been triggered."
Degussa, the leading Indiana case on this subject,
the plaintiff suspected that workplace chemicals caused her
persistent cough. On March 17, 1992, her primary care
physician diagnosed her with bronchitis and told her that the
cough might have several causes, including the workplace. On
March 26, 1992, a specialist, Dr. Reihman, told the plaintiff
that it was possible that work-related chemical exposure only
was triggering an injury caused by something else. In June
1992, after performing tests, Dr. Reihman observed, "The
etiology of [the plaintiff's] chronic airflow obstruction
and its relationship to her work environment remains
unclear." At ...