Albright v. Boston Scientific Corp.

NOTICE: All slip opinions and orders are subject to formal
revision and are superseded by the advance sheets and bound
volumes of the Official Reports. If you find a typographical
error or other formal error, please notify the Reporter of
Decisions, Supreme Judicial Court, John Adams Courthouse, 1
Pemberton Square, Suite 2500, Boston, MA, 02108-1750; (617) 557-
1030; SJCReporter@sjc.state.ma.us

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.