Heard April 15, 2016
action commenced in the Superior Court Department on March 8,
case was tried before Diane M. Kottmyer, J.
Jonathan D. Orent (Dennis A. Costigan with him) for the
T. Adams, of Missouri (Susan M. Donnelly Murphy with him) for
Present: Cypher, Katzmann, & Massing, JJ.
plaintiff Diane Albright, an Ohio resident, brought this
action in the Superior Court against defendant Boston
Scientific Corporation (BSC), a Massachusetts-based company,
seeking damages for injuries that she sustained after having
BSC's "Pinnacle Pelvic Floor Repair" kit
(Pinnacle device) surgically implanted to treat her pelvic
organ prolapse (POP) condition. BSC designed, manufactured, and
marketed the Pinnacle device and sold it to the Ohio hospital
where Albright's surgery took place. After a three-week
trial, a jury found for BSC on Albright's claims of
defective design and inadequate warning.
appeal, Albright challenges the exclusion of the medical
application caution (caution) contained within the 2004
material safety data sheet (MSDS) that had been provided to
BSC by its supplier of the polypropylene material used to
fabricate the mesh in the Pinnacle device. Albright offered
the caution for the limited purpose of showing notice and
knowledge on the part of BSC. Albright also claims error from
the exclusion of two letters that the United States Food and
Drug Administration (FDA) sent to BSC in 2012. We conclude that,
in the context of the case as it unfolded at trial, it was
prejudicial error to exclude the proffered caution and FDA
letters. The judgment in favor of BSC shall therefore be
vacated and the case remanded to the Superior Court for a new
was evidence from which the jury could have found the
2008, Albright had surgery to treat POP symptoms involving
her bladder. Dr. Jay Meyer performed a
procedure that did not involve the implantation of
surgical mesh. Less than twelve months later, Albright
experienced a recurrence of the bulging sensation in her
pelvic area. During a follow-up visit with Dr. Meyer,
Albright reported feeling "something give" in her
pelvis after lifting a heavy table. Dr. Meyer advised
Albright that if she could tolerate this sensation of a bulge
or pressure in her pelvic area, surgery could be avoided.
Albright was not able to do so; she met again with Dr. Meyer,
voicing a desire to have "something done."
Meyer informed Albright of an option to permanently implant a
mesh device in her pelvic cavity to shore up weakened tissue.
Albright agreed. With the aid of an experienced colleague,
Dr. Meyer performed the implant procedure at Mary Rutan
Hospital, located in Bellefontaine, Ohio, on March 9, 2010.
Mary Rutan Hospital had purchased the Pinnacle device from
BSC on May 15, 2009. At the time, Dr. Meyer was pleased with
the surgical outcome, commenting favorably that the Pinnacle
device worked "as advertised."
marketed the Pinnacle device as a safe implant for use in the
treatment of POP. The Pinnacle device is intended to shore up
and repair tissue that holds and supports pelvic organs in
place. The FDA had cleared the device for sale in the United
States pursuant to the agency's § 510(k)
six months, Albright experienced pain and discomfort when
urinating and other "hard-to-describe" pain in her
pelvic area. On examining Albright in September, 2011, Dr.
Meyer found no indication of mesh erosion. He suspected that
Albright might have interstitial cystitis. No diagnosis was
made linking Albright's symptoms and complications to the
mesh. Similar findings were made by Dr. Andrew Hundley during
visits with Albright in 2011 and 2012, and by Dr. Maurice
Chung, a gynecologist who examined Albright in 2012 and 2014.
was also examined by Dr. Niall Galloway, a urologist and
gynecologist affiliated with Emory University, and Dr. John
Steege, a professor in the department of gynecology and
obstetrics at the University of North Carolina. Drs. Galloway
and Steege concluded that Albright was suffering from painful
bladder syndrome and other complications due to the erosion
and degradation of the mesh in her body.
alleged that the Pinnacle device was defective due to a
flawed design that failed to guard against the foreseeable
risks of harm stemming from the mesh design. She also claimed
that BSC had failed to adequately warn Dr. Meyer of the
foreseeable risks that the Pinnacle device posed to her. BSC
maintained that the Pinnacle device was safe for implantation
inside Albright's body to treat POP. The jury never
reached the disputed factual question whether the Pinnacle
device caused Albright's injuries because of their
finding that Albright had not shown by a preponderance of the
evidence that the device was "defective" under Ohio
to other transvaginal surgical mesh devices on the market in
2009 for the treatment of POP, the Pinnacle device called for
a sizable amount of dense mesh with small "pores"
(i.e., openings in the mesh). The design premise for the
Pinnacle device is that when implanted in the body, its mesh
will promote tissue growth through the mesh pores, and, by
doing so, this new growth will anchor and stabilize the
device in the patient's body. BSC, however, did not
conduct clinical tests to assess mesh shrinkage or
degradation in the body.
for both sides addressed the scientific properties of
BSC's polypropylene mesh. Janice Connor, the clinical
programs director of BSC's urology and women's health
division, testified that her review of scientific literature
confirmed that mesh devices, like the Pinnacle device, were a
safe and effective medical option for women, especially when
compared to native tissue repair surgeries which resulted in
a recurrence rate of thirty to seventy percent. Doreen Rao,
an engineer in BSC's urology group, stated that
polypropylene is "inert" and does not undergo
changes once it is implanted in the human body. On the other
hand, Albright's experts focused on "oxidation,
" the response of tissue cells to the presence of a
foreign body, in this case the implanted Pinnacle device.
Guelcher, a chemical engineering professor and polymer
chemist, explained what happens when tissue cells react to
polypropylene material. Guelcher was among the first to
discover that polypropylene materials, "which were
normally considered stable, " did, in fact, degrade.
Guelcher described this reactive process, testifying that
human cells produce, or secrete, reactive oxygen species,
which "settle on and attach to" the implant. The
response of human cells to implanted material is a
"surface-driven" effect. The cell-generated
reactive oxygen species continuously break down and degrade
the polypropylene mesh until it is destroyed or removed. This
means that the oxidation process results in a "bigger
problem" where there is more polypropylene surface, as
is the case with the Pinnacle device, which uses relatively
more mesh than other POP mesh devices. Guelcher added that
polypropylene is one of the most easily oxidized materials, a
fact that, in his view, is important to know for biomaterial
Thomas Barker, a professor of biomedical engineering at the
university level, also testified for Albright. Dr. Barker
described a further nuance to the chemical reactive process.
Dr. Barker testified that, upon implantation of the mesh
device, human cells populate "dense portions" of
the mesh (i.e., where its fibers are in close proximity to
one another). Tissue cells are activated to "apply
force" and to pull on the mesh material. As a result,
Dr. Barker testified, tissue then grows across mesh
fibers ("fibrotic bridging"), rather than
inside mesh pores, the latter of which is what the
Pinnacle device is intended to promote. This fibrotic
bridging process may form a scar around the implant, which
can cause pain to the patient. Dr. Barker opined that there
was a "mechanical mismatch" between the Pinnacle
device and the anatomical space (the pelvic cavity) where the
device is implanted. As opposed to hernia mesh on the
abdominal wall, the implanted Pinnacle mesh has two
millimeters of soft tissue to protect it from extruding into
the patient's vaginal cavity (a complication about which
Albright complains). This mismatch can lead to foreseeable
biomedical risks, including mesh contracture, mesh shrinkage,
and abrasions. Dr. Donald Ostergard, another of
Albright's expert witnesses, testified at trial that the
Pinnacle device was not appropriate for its intended use to
treat POP because of the volume, weight, and pore size of its
mesh. Albright's experts -- Guelcher, Barker, and
Ostergard -- testified that, prior to marketing the Pinnacle
device, BSC ignored or otherwise failed to account for the
oxidation process as it affects the Pinnacle mesh when
implanted to treat POP.
Warning and directions for use.
presented expert evidence that BSC had failed to warn Dr.
Meyer of the risk that the mesh's density and volume
posed in terms of the frequency, permanence, and potential
severity of complications caused by degradation of the mesh
inside the body. This included painful bladder syndrome and
pudendal neuralgia, as well as the harm that would follow
from a procedure to remove some or all of the mesh to address
such complications. BSC sought to show that the potential or
anticipated risks associated with the Pinnacle device were
fully disclosed in its directions for use (DFU). The DFU for
the Pinnacle device identified incontinence, dyspareunia,
erosion, extrusion, and contracture, among other risks.
BSC's expert, Dr. Matthew Davies, testified that BSC had
adequately warned Dr. Meyer of the risks in using its device.