Albright v. Boston Scientific Corp.

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15-P-633 Appeals Court
DIANE ALBRIGHT vs. BOSTON SCIENTIFIC CORPORATION.1
No. 15-P-633.
Middlesex. April 15, 2016. - September 13, 2016.
Present: Cypher, Katzmann, & Massing, JJ.
Conflict of Laws. Negligence, Defective product, Design,
Adequacy of warning, Duty to warn. Evidence, Relevancy and
materiality, Rebuttal, Bias. Error, Harmless. Practice,
Civil, Instructions to jury.
Civil action commenced in the Superior Court Department on
March 8, 2012.
The case was tried before Diane M. Kottmyer, J.
Jonathan D. Orent (Dennis A. Costigan with him) for the
plaintiff.
Robert T. Adams, of Missouri (Susan M. Donnelly Murphy with
him) for the defendant.
KATZMANN, J. The plaintiff Diane Albright, an Ohio
resident, brought this action in the Superior Court against
1
Albright's amended complaint asserts claims against John
Doe Corporations 1-50. The judgment entered in the Superior
Court dismissed the action against the John Doe defendants as
well as Boston Scientific Corporation.
2
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.2 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.
On appeal, Albright challenges the exclusion of the medical
application caution (caution) contained within the 2004 material
safety data sheet (MSDS)3 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 2012.4 We conclude that, in the context of
the case as it unfolded at trial, it was prejudicial error to
2
POP occurs when a pelvic organ drops or bulges (i.e.,
prolapses) into the vagina. See Stedman's Medical Dictionary
1573 (28th ed. 2006).
3
A 2007 MSDS that contained an identical caution was
excluded as well.
4
Albright also assigns as error the judge's refusal to give
certain proposed jury instructions, discussed infra.
3
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 trial.
Background. There was evidence from which the jury could
have found the following.5
1. Surgeries. In 2008, Albright had surgery to treat POP
symptoms involving her bladder. Dr. Jay Meyer performed a
procedure6 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."
Dr. Meyer informed Albright of an option to permanently
implant a mesh device in her pelvic cavity to shore up weakened
tissue. Albright agreed.7 With the aid of an experienced
5
We reserve mention of certain evidence for our discussion
of Albright's claims of error.
6
A hysterectomy with anterior-posterior repair of the
vaginal walls using native tissue.
7
Dr. Meyer, who had not previously used the Pinnacle
device, suggested that the procedure be performed by a
4
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."
BSC 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) process.8
2. Postsurgery complications. Within 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.
specialist affiliated with the Ohio State University (at
Columbus) medical center, Dr. Andrew Hundley. Albright asked
Dr. Meyer to do the surgery, citing concerns about traveling to
Columbus, which was some distance from her home.
8
The FDA's review of a medical device for substantial
equivalence is known as the § 510(k) process. Riegel v.
Medtronic, Inc., 552 U.S. 312, 317 (2008). A new medical device
need not undergo a rigorous premarket approval process if the
FDA (as it did here) finds the new device is substantially
equivalent to another device already on the market that is
exempt from premarket approval. Ibid. Devices that enter the
market through the § 510(k) process have not been formally
reviewed by the FDA for safety or efficacy. Id. at 323.
 5
He suspected that Albright might have interstitial cystitis.9 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.
Albright 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.10
3. Trial proceedings. Albright 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
9
More than one expert testified that the terms
"interstitial cystitis" and "painful bladder syndrome" are often
"used interchangeably" in the medical community.
10
At trial, Drs. Galloway and Steege testified as experts
on behalf of Albright.
6
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 law.
a. Design. Compared 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.
Experts 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
7
body.11 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.
Scott 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
11
Rao was also the "core team leader" for BSC's Polyform
mesh kit, which contained the same mesh used in the Pinnacle
device. On occasion, Rao had to address inquiries from
physicians (and others) about mesh shrinkage. In one such
instance, a project manager for the BSC urology group suggested
that BSC "piggyback" on the shrinkage data of a mesh made from a
different manufacturer (Gynemesh) "until we can prove
otherwise." Again, BSC did not perform clinical tests to assess
shrinkage of the mesh in the human body.
8
most easily oxidized materials, a fact that, in his view, is
important to know for biomaterial design purposes.
Dr. 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
9
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.
b. Warning and directions for use. Albright 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.
Discussion. 1. Ohio products liability law. Based on
accepted conflict of laws principles, the judge ruled that
Albright's substantive claims were controlled by Ohio law and
10
that evidentiary issues were governed by the law of
Massachusetts, the forum State. See Hodas v. Morin, 442 Mass.
544, 549-550 (2004); Feeney v. Dell, Inc., 454 Mass. 192, 206
(2009); Fire Ins. Exch. v. Pring-Wilson, 778 F. Supp. 2d 116,
125 (D. Mass. 2011).12 We therefore provide a brief overview of
Ohio products liability law.
It is a deeply rooted principle in Ohio that a manufacturer
is liable for foreseeable harm stemming from a product defect
that could have been avoided or mitigated by exercising
reasonable care.13 This principle is at the core of the Ohio
Products Liability Act (OPLA), a comprehensive and detailed
statutory plan that employs negligence concepts, such as
foreseeable risk of harm and reasonable care. See Ohio Rev.
12
See generally Restatement (Second) of Conflict of Laws
§ 145 (1971) ("The rights and liabilities of the parties with
respect to an issue in tort are determined by the local law of
the state which, with respect to that issue, has the most
significant relationship to the occurrence and the parties
. . .").
13
In 1908, the Ohio Supreme Court explained the common-law
principle as follows: "[The] defendant in an action for
negligence can be held to respond in damages only for the
immediate and proximate result of the negligent act complained
of, and in determining what is direct or proximate cause, the
rule requires that the injury sustained shall be the natural and
probable consequence of the negligence alleged; that is, such
consequence as under the surrounding circumstances of the
particular case might, and should have been foreseen or
anticipated by the wrongdoer as likely to follow his negligent
act." Miller v. Baltimore & Ohio S.W. R.R., 78 Ohio St. 309,
325 (1908), overruled on other grounds by Schultz v. Barbeton
Glass Co., 4 Ohio St. 3d 131 (1983). See Sutowski v. Eli Lilly
& Co., 82 Ohio St. 3d 347, 351 (1998).
11
Code Ann. §§ 2307.71-2307.80 (West 2004 & Thomson Reuters Supp.
2016).14 The term, "foreseeable risk," as used in the OPLA,
defines the scope of a manufacturer's duty of care, which,
simply put, is to guard against a known risk of harm or risks
that the manufacturer "should recognize while exercising"
reasonable care. Ohio Rev. Code Ann. § 2307.71(A)(6)(b) (Supp.
2016).15 See Ohio Rev. Code Ann. § 2307.75 (Supp. 2016) (design
defect). See also Ohio Rev. Code Ann. § 2307.76 (2004) (warning
defect).
While a manufacturer is not an insurer or guarantor of the
safety of its products, it is nonetheless not free to ignore
recognizable, or reasonably foreseeable, risks to consumers who
use its products as intended. Sutowski v. Eli Lilly & Co., 82
Ohio St. 3d 347, 352 (1998). See Briney v. Sears, Roebuck &
Co., 782 F.2d 585, 587 (6th Cir. 1986) (stating that product
need not be "foolproof"). With this backdrop, we turn to the
specific statutory claims in question.
14
As amended, the OPLA abrogates all common-law product
liability causes of action that accrue after April 7, 2005. See
Doty v. Fellhauer Elec., Inc., 175 Ohio App. 3d 681, 686 (2008).
15
Section 2307.71(A)(6)(b)(i)-(ii) specifies that a
manufacturer should exercise both "[t]he attention, perception,
memory, knowledge, and intelligence that a reasonable
manufacturer should possess" and "[a]ny superior attention,
perception, memory, knowledge, or intelligence that the
manufacturer in question possesses."
12
a. Design claim. For the design claim, Albright had the
burden to show, by a preponderance of the evidence, that when
the Pinnacle device "left the control of [BSC], the foreseeable
risks associated with its design . . . exceeded the benefits."
Ohio Rev. Code Ann. § 2307.75(A). See Welch Sand & Gravel, Inc.
v. O & K Trojan, Inc., 107 Ohio App. 3d 218, 224 (1995).
Foreseeability "usually depends on the defendant's knowledge."
Menifee v. Ohio Welding Prod., Inc., 15 Ohio St. 3d 75, 77
(1984). The jury must principally focus on a given product's
features so as to understand the product manufacturer's
conscious design choices. OPLA sets out a nonexhaustive list of
factors that a jury may consider in determining whether a design
defect exists. A jury may look to factors such as: (1) the
"nature and magnitude" of the risks connected with the design in
light of the product's "intended" use; (2) the "likely awareness
of product users . . . of those risks"; and (3) the "likelihood"
that the chosen design "would cause harm" in light of the
product's intended use. Ohio Rev. Code Ann. § 2307.75(B)(1)-
(3). The first and third factors are instructive here.
The jury were required to closely scrutinize whether the
mesh design for the Pinnacle device was suitable or appropriate
for its intended use as a surgical implant to treat bladder POP.
Suitability demands close attention to the actual area in the
body where the Pinnacle mesh will remain implanted for many
13
years, not other areas of a patient's body (e.g., the abdomen)
where surgical mesh has historically been used with positive
results. Albright was also required to present evidence of a
practical and feasible alternative mesh design. See Ohio Rev.
Code Ann. § 2307.75(F).16
b. Warning claim. For the warning claim, Albright bore
the burden to show that BSC failed to adequately inform Dr.
Meyer of foreseeable risks associated with the Pinnacle device.
See Seley v. G.D. Searle & Co., 67 Ohio St. 2d 192, 202-203
(1981) (discussing learned intermediary doctrine); In re Meridia
Prod. Liab. Litigation, 328 F. Supp. 2d 791, 811-812 (N.D. Ohio
2004) (listing factors relevant to whether warning for
prescription drug is adequate).17 "Merely mentioning a possible
injury or adverse effect is not necessarily adequate." Id. at
812.
Section 2307.76, which codifies a cause of action for
inadequate warning, focuses the trier of fact on many of the
16
Albright did so, presenting evidence of a lightweight and
smaller mesh containing larger pores, a design that was then
available on the market.
17
The relevant factors include, but are not limited to, the
following: whether the warning adequately indicates the scope
of the danger; whether the warning reasonably communicates the
extent or seriousness of the harm that could result from misuse
of the product; whether the physical aspects of the warning
adequately alert a reasonably prudent person to the danger; and
whether the means to convey the warning are adequate in the
given circumstances. In re Meridia Prod. Liab. Litigation,
supra at 812.
14
same issues applicable to a product design claim. A plaintiff
must prove that the defendant manufacturer "knew or, in the
exercise of reasonable care, should have known about a risk that
is associated with the product and that allegedly caused harm
for which the [plaintiff] seeks . . . compensatory damages," and
that "[t]he manufacturer failed to provide the warning or
instruction that a manufacturer exercising reasonable care would
have provided concerning that risk, [both] in light of the
likelihood that the product would cause harm of the type for
which the [plaintiff] seeks . . . compensatory damages and in
light of the likely seriousness of that harm." Ohio Rev. Code
Ann. § 2307.76(A)(1)(a)-(b). The OPLA, for both design and
warning claims, uses the negligence concepts of reasonable care
and foreseeable risk of harm18 to guide a jury in determining
liability. "A warning is adequate if it reasonably discloses
all inherent risks, and if the product is safe when used as
directed." Phan v. Presrite Corp., 100 Ohio App. 3d 195, 200
(1994). See Seley v. G.D. Searle & Co., 67 Ohio St. 2d at 197-
18
For an illuminating discussion as to foreseeability
generally, see Heng Or v. Edwards, 62 Mass. App. Ct. 475, 486
(2004), where Justice Kaplan described the jury's role in a
negligence case: "[T]he jury tries to reproduce the picture of
what a reasonable person, as of the moment before the negligent
act, would have foreseen as the likely harmful consequences of
that act; alongside this picture the jury is to set the picture
of the actual happening, and then to observe, in a general
sense, how far the harm in fact experienced resembles any of the
harms reasonably to have been foreseen" (footnote omitted).
15
198; Crislip v. TCH Liquidating Co., 52 Ohio St. 3d 251, 255
(1990). This fact-based issue was sharply contested at trial.
2. Evidentiary errors. a. MSDS caution. Albright claims
prejudicial error from the exclusion of the caution on BSC's
polypropylene supplier's MSDS. The MSDS contained the following
"MEDICAL APPLICATION CAUTION":
"Do not use this [polypropylene] material in medical
applications involving permanent implantation in the human
body or permanent contact with internal body fluids or
tissues."
Albright offered the caution to show notice to BSC of a risk in
using polypropylene for its implant device. The judge excluded
the caution on the grounds that Albright had not established its
scientific basis and that the record was inconclusive as to the
rationale of the supplier for including the caution on the MSDS.
In Massachusetts, trial judges have wide discretion in
ruling on the admissibility of evidence, and the judge's
exercise of discretion is afforded much deference. See, e.g.,
Dahms v. Cognex Corp., 455 Mass. 190, 198 (2009). A balancing
principle, however, is that "relevant evidence should be
admitted unless there is a quite satisfactory reason for
excluding it." DeJesus v. Yogel, 404 Mass. 44, 47 (1989),
quoting from Crowe v. Ward, 363 Mass. 85, 88-89 (1973).
We conclude that the MSDS caution was relevant, material
evidence admissible for the limited purpose of showing that BSC,
16
which had received the MSDS well before 2009, had notice or
knowledge of the content of the caution. See McNamara v.
Honeyman, 406 Mass. 43, 55 (1989) (statement admissible to show
that medical staff was alerted to possibility that patient was
suicidal); Pardo v. General Hosp. Corp., 446 Mass. 1, 18 (2006)
(memorandum admissible to show notice and knowledge).
When considered solely for the purpose of demonstrating
notice or the extent of BSC's knowledge, the caution was not
hearsay. See Mass. G. Evid. § 801(c) note (2016) (statement
only hearsay if offered in evidence to prove truth of matter
asserted as opposed to, inter alia, notice or effect of
statement on hearer). This is a long-standing rule in this
Commonwealth. See McNamara v. Honeyman, supra; Pardo v. General
Hosp. Corp., supra.
Though the trial judge was understandably concerned about
the scientific basis of the caution,19 here, where the caution
19
See, e.g., Moore v. Ashland Chem. Inc., 151 F.3d 269, 278
(5th Cir. 1998) (holding that MSDS had limited scientific value
when it was not known what tests were conducted in generating
MSDS); Turner v. Iowa Fire Equip. Co., 229 F.3d 1202, 1209 (8th
Cir. 2000) (holding that MSDS indicating that breathing product
dust may irritate nose and throat and aggravate respiratory
diseases was not sufficient basis for expert opinion where
expert did not rely upon MSDS and "nothing in the record
demonstrate[d] what scientific tests or information [the
manufacturer] used to generate its MSDS"); Johnson v. Arkema,
Inc., 685 F.3d 452, 462-463 (5th Cir. 2012) (concluding that
Federal District Court did not abuse its discretion in
disregarding MSDS where proponent failed to come forth with any
scientific data to support its warning).
17
was not offered to establish causation or as the basis of an
expert opinion but solely for the notice effect it had, or
should have had on BSC, the absence of a scientific foundation
for the MSDS caution is not a bar to admission. See In re C.R.
Bard, Inc., 810 F.3d 913, 923, 925-926 (4th Cir. 2016)
(affirming Federal District Court's conclusion in suit for
design defect and failure to warn that MSDS from polypropylene
manufacturer was admissible as nonhearsay for limited purpose of
showing that statement was made and that defendant was aware of
it). Cf. Sanchez v. Boston Scientific Corp., 38 F. Supp. 3d
727, 743 (S.D. W. Va. 2014), quoting from Cal. Civ. Code
§ 3294(c) ("A reasonable jury could find that by ignoring a
warning on the MSDS and failing to conduct clinical testing,
BSC's actions were 'despicable conduct' with willful and
conscious disregard of the safety of consumers").
As to the materiality of the caution, it is enough to say
that the crux of this case has to do with BSC's "knowledge" (as
of May 15, 2009) of the foreseeable risks connected with its
Pinnacle device. This evidentiary link is obvious when the
caution is considered in the context of disputed factual issues
under the OPLA. The jury might have considered the caution's
implications for BSC under both § 2307.75(A) to determine
"foreseeable risks" (if any) tied to the Pinnacle design and
§ 2307.76(A)(1) to determine the warning that a prudent
18
manufacturer exercising reasonable care would have provided
concerning a risk of harm to Pinnacle users.20 Any concerns
about the jury's possible misuse of the caution for causation
purposes or otherwise could have been addressed by an
appropriate limiting instruction, and, if necessary, by a
tailored statement in the jury charge.
b. FDA letters. Albright also contends that it was
prejudicial error to exclude two letters from the FDA to BSC.
The first letter ordered BSC to conduct a "postmarket
surveillance" study of the Pinnacle device to address concerns
as to the safety and efficacy of the device in treating POP.
The second letter agrees to a request from BSC to suspend its
postmarket surveillance study because it planned to discontinue
the manufacture and marketing of the Pinnacle device in this
country.21 We conclude that, in the unique context of this
lengthy trial, Albright ought to have been allowed to use the
letters for the limited purpose of cross-examining BSC's
witnesses, who had testified, without qualification, that the
Pinnacle device was safe as of the time of trial. Such a
20
Albright had the burden to prove that her surgeons would
have acted differently if provided with adequate warnings. See
Sanchez v. Boston Scientific Corp., supra at 732.
21
As tried, there was no error in excluding a 2011 FDA
public health notification, particularly since such
postimplantation evidence was not relevant to Albright's alleged
injuries or Dr. Meyer's decision to use the Pinnacle device for
Albright's March 9, 2010, implant procedure.
19
limited use, to show bias or to rebut the witness's opinion
testimony, would be reasonable cross-examination. See generally
Mass. G. Evid. § 611(b), (d).
We add that the judge would have been well within her
discretion to exclude all reference to the § 510(k) clearance
(see note 8, supra) because of its potential to mislead the jury
and confuse the issues. "That a device has been given clearance
through the FDA's [§] 510(k) process is not relevant to state
tort law. . . . The prejudicial value of evidence regarding the
[§] 510(k) process far outweighs its probative value." Sanchez
v. Boston Scientific Corp., 38 F. Supp. 3d at 744, quoting from
Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748, 754 (S.D. W.
Va. 2014). However, having permitted BSC to invoke the 510(k)
clearance, it was error to preclude Albright from using the
later-in-time (2012) letters in cross-examination of BSC experts
or employees, who had addressed the FDA clearance, to rebut
BSC's claim that its product was, in essence, "cleared" as a
safe device.
Having concluded that it was error to exclude the MSDS
caution and prohibit Albright's use of the FDA letters for
cross-examination purposes, we must determine whether any error
was harmless or prejudicial.
c. Prejudice. As a broad, general rule, error in the
exclusion of evidence should not be grounds for a new trial
20
unless the error "has injuriously affected the substantial
rights of the parties." G. L. c. 231, § 119. Construing this
statutory text, the Supreme Judicial Court has held that "the
substantial rights of a party are adversely affected when
relevant evidence is erroneously excluded that, viewing the
record in a commonsense way, could have made a material
difference." DeJesus v. Yogel, 404 Mass. at 48. This case, in
our opinion, falls within that narrow band of appellate
decisional law that has ordered a new trial for prejudicial
evidentiary error. See, e.g., Grant v. Lewis/Boyle, Inc., 408
Mass. 269, 274-275 (1990); Peterson v. Foley, 77 Mass. App. Ct.
348, 356-357 (2010).
Here, exclusion of the MSDS caution substantially affected
Albright's rights as, without this key piece of evidence, the
jury did not have a complete picture of the information bearing
on the safety of the Pinnacle device that BSC either knew of or,
in the exercise of reasonable care, should have known about. As
noted above, the state of BSC's knowledge is a crucial aspect of
the foreseeability analysis that underlies the claims in this
case. No other evidence before the jury served a similar
function.
The MSDS caution would have linked the scientific expert
testimony and opinions of Guelcher and Barker regarding the
reactive process of human tissue to surgically implanted mesh of
21
the volume and type used in the Pinnacle device to the primary
concepts that were to guide the jury's determination of
liability under the OPLA. With respect to the design claim, the
jury could have used the caution in conjunction with the expert
oxidation evidence to assess BSC's evaluation of the risks and
benefits connected with the design of the Pinnacle device.22 The
caution is also material to the warning claim. The
ramifications of the caution in light of Albright's expert
evidence would have been essential for the jury's ability to
determine whether BSC exercised reasonable care in warning about
the foreseeable risks associated with the Pinnacle device.
In short, much of Albright's case depended on the limited
admissibility of the MSDS caution to show notice on the part of
BSC as to the unsuitability of polypropylene material for
permanent implantation in the human body, particularly for use
in the pelvic cavity. The MSDS caution was not cumulative of
other evidence in the case, including the unredacted portions of
the MSDS document that were admitted in evidence. BSC's
challenge to the caution (that it was added at the insistence of
legal counsel in response to liability concerns) goes to the
22
The jury could consider the cautionary warning as it
pertained to the intended permanent implantation of the Pinnacle
device in the human body where it would be in constant contact
with internal body fluids and tissues and the extent to which
BSC reasonably explored the likelihood that its chosen design
would cause harm when used as intended.
22
weight of the caution, not its limited admissibility to show
notice and knowledge. See Sacco v. Roupenian, 409 Mass. 25, 28-
30 (1990); Beal Bank, SSB v. Eurich, 444 Mass. 813, 815-816
(2005).
Further, the prejudice stemming from the exclusion of the
caution was exacerbated by the inclusion of the FDA's clearance
of the Pinnacle device in 2008, a point that BSC's counsel
emphasized in closing argument.23 The judge also injected the
issue of FDA approval into the trial, delivering a preliminary
instruction informing the jury that the FDA had "cleared" the
Pinnacle device for sale in this country in accordance with its
§ 510(k) process. The repeated reference to the FDA's clearance
aided BSC's defense, and handicapped Albright's case, on the
central product safety issue in the case. Against this trial
backdrop, the MSDS caution and the FDA letters added necessary
context to the § 510(k) clearance. The exclusion of this
evidence therefore left the jury with an incomplete picture of
the events in question. See note 18, supra.
23
Outside the presence of the jury, the judge admonished
BSC's counsel for "exceed[ing] the permissible scope of argument
on the FDA by referring to the fact that the [Pinnacle device]
was cleared and all of these other [surgical mesh-related]
products were cleared." The judge determined that it was
necessary to instruct the jury that they "may not consider the
fact that the Pinnacle was cleared by the FDA as evidence that
the Pinnacle was a safe or effective medical device."
23
3. Other claims of error. Based on our disposition here,
there is no need to resolve Albright's claims respecting the
judge's refusal to instruct the jury on the "heeding
presumption" and a manufacturer's postsale duty to warn. We
address them only briefly to provide guidance in the event that
these issues arise again at any retrial.
a. Postsale duty to warn. There was little (if any)
evidence at trial to suggest that BSC became aware of a new risk
associated with the Pinnacle device subsequent to the March,
2010, implant procedure. While a manufacturer has a postsale
duty to warn under Ohio Rev. Code Ann. § 2307.76(A)(2), the
trial record did not warrant a further instruction on a postsale
duty, particularly where the trial judge had delivered a proper
instruction concerning BSC's duty to warn under Ohio law and the
factors that the jury should consider in determining whether the
warning and directions for use were adequate.
b. Heeding presumption. Albright contests the judge's
refusal to instruct the jury that they could presume that an
adequate product warning by BSC would have been followed by the
surgeon who performed the implant procedure. Should this issue
arise at a retrial, we would expect the parties to provide
guidance to the trial judge as to the propriety of such an
instruction based on well-settled Ohio law. See Seley v. G.D.
24
Searle & Co., 67 Ohio St. 2d at 200; Miller v. ALZA Corp., 759
F. Supp. 2d 929, 936 (S.D. Ohio2010).
Conclusion. The judgment is vacated and the case remanded
to the Superior Court for proceedings consistent with this
opinion.
So ordered.