Sanchez et al v. Boston Scientific Corporation

Filing 153

MEMORANDUM OPINION AND ORDER (Motions in Limine) the 135 OMNIBUS MOTIONS by Rod Sanchez, Roseanne Sanchez in Limine is GRANTED in part and DENIED in part and the 137 OMNIBUS MOTION by Boston Scientific Corporation in Limine is GRANTED in part and DENIED in part. Signed by Judge Joseph R. Goodwin on 2/12/2015. (cc: counsel of record; any unrepresented party) (skh)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION

ROSEANNE SANCHEZ, et al.,
Plaintiffs,
v.

CIVIL ACTION NO. 2:12-cv-05762

BOSTON SCIENTIFIC CORPORATION,
Defendant.

MEMORANDUM OPINION AND ORDER
(Motions in Limine)
Pending before the court are the Plaintiffs’ Omnibus Motion in Limine [Docket 135] and
Boston Scientific Corporation’s Omnibus Motion in Limine [Docket 137]. For the reasons set
forth below, the Plaintiffs’ Omnibus Motion in Limine [Docket 135] is GRANTED in part and
DENIED in part and Boston Scientific Corporation’s Omnibus Motion in Limine [Docket 137]
is GRANTED in part and DENIED in part.
I.

Background
This case resides in one of seven MDLs assigned to me by the Judicial Panel on

Multidistrict Litigation (“MDL”) concerning the use of transvaginal surgical mesh to treat pelvic
organ prolapse (“POP”) and stress urinary incontinence (“SUI”). In the seven MDLs, there are
over 70,000 cases currently pending, over 13,000 of which are in the Boston Scientific
Corporation MDL, MDL 2326. In this particular case, plaintiff Roseanne Sanchez was surgically
implanted with two products manufactured by defendant Boston Scientific Corporation (“BSC”):
the Pinnacle Pelvic Floor Repair Kit (the “Pinnacle”) to treat pelvic organ prolapse and the

Advantage Fit Transvaginal Mid-Urethral Sling System (the “Advantage”) to treat stress urinary
incontinence. (See Pls.’ Mem. in Supp. of Pls.’ Mot. for Partial Summ. J. [Docket 63], at 1).1 The
plaintiffs allege that as a result of implantation of the Pinnacle, Ms. Sanchez experienced several
complications, including vaginal discharge, painful intercourse, bleeding, pelvic pain, and
cramping. (See id.). Their complaint alleges the following causes of action: negligence; strict
liability for design defect; strict liability for manufacturing defect; strict liability for failure to
warn; breach of express warranty; breach of implied warranty; loss of consortium; fraudulent
concealment; and punitive damages. (See Short Form Compl. [Docket 1]).2 The instant motions
in limine involve the parties’ efforts to exclude or limit certain evidence, arguments, and
testimony at trial.
The Plaintiffs’ Motions in Limine
a. Motion in Limine No. 1 – 510(k) Clearance or Lack of FDA Enforcement
Action
The plaintiffs move to preclude any argument, evidence, or testimony relating to the
FDA’s 510(k) clearance process or lack of FDA enforcement with regard to BSC’s mesh
products. My reasoning for excluding evidence of the 510(k) process in general is fully set out in
Lewis v. Johnson & Johnson, --- F. Supp. 2d. ---, No. 2:12-cv-04301, 2014 WL 152374, at *2,
*4-6 (S.D. W. Va. Jan. 15, 2014). I will not rehash it here. I will simply describe relevant
California law and explain why evidence of the 510(k) process should be excluded in this case.
i. California Law
1

The plaintiffs are not pursuing any claims in connection with the Advantage product. (See Pls.’ Opposition to
BSC’s Mot. to Exclude Pls.’ Experts’ Op. that Polypropylene Mid-Urethral Slings are Defective [Docket 112], at 6
n.13).
2

The claims for manufacturing defect in strict liability, breach of express and implied warranties, and fraudulent
concealment have been dismissed. See Sanchez v. Boston Scientific Corp., No. 2:12-cv-05762, 2014 WL 4059214,
at *1 (S.D. W. Va. Aug. 18, 2014).

2

In California, a manufacturer or retailer may be held strictly liable for placing a defective
product on the market if the plaintiff’s injury results from a reasonably foreseeable use of the
product. Chavez v. Glock, Inc., 144 Cal. Rptr. 2d 326, 342 (Cal. Ct. App. 2012) (citing Soule v.
General Motors Corp., 882 P.2d 298 (Cal. 1994)). Strict product liability may be premised upon
a theory of design defect, manufacturing defect, or failure to warn. Id. With regard to design
defect, California recognizes the consumer expectation test, which focuses on the product’s
failure to perform as safely as an ordinary consumer would expect and the risk benefit test, under
which a product is defective if its “design embodies an excessive preventable danger.” Id. at 34243 (internal quotation marks omitted). Additionally, “the theory underlying a warning defect
cause of action is that the product is dangerous because it lacks adequate warnings or
instructions.” Id. at 343. Clearly, the pivotal issue in products liability cases is the safety of the
product.
ii. Absence of Product Defect
First, BSC argues that evidence of compliance with applicable standards is relevant to the
issue of whether the product is safe or not safe. However, I have repeatedly held that the 510(k)
process does not relate to safety and efficacy of a product; therefore, BSC’s argument has no
merit. Because 510(k) is not a safety regulation, the case underlying BSC’s position is not
determinative here. See O’Neill v. Novartis Consumer Health, Inc., 55 Cal. Rptr. 3d 551 (Cal. Ct.
App. 2007) (regarding procedures for classifying OTC drugs as drugs generally recognized
among qualified experts as safe and effective for use).
iii. Adequacy of BSC’s Warnings
Next, BSC contends that the discourse between BSC and the FDA would be helpful to
3

the jury’s understanding of the content of the warnings the plaintiffs now challenge as
inadequate. Again, I have repeatedly held that the prejudicial value of evidence regarding the
510(k) process far outweighs its probative value. Accordingly, I reject BSC’s argument.
iv. Punitive Damages and BSC’s Conduct
Last, BSC argues that compliance with the FDA’s 510(k) process is also relevant to the
plaintiffs’ punitive damages claims and the reasonableness of BSC’s conduct. However, BSC
fails to identify any controlling California law that would differentiate this case from previous
MDLs. Furthermore, whether or not compliance with non-safety regulations is relevant to
punitive damages in this case, I FIND that 510(k) evidence is inadmissible because of its
potential to confuse the issues and mislead the jury. Accordingly, the plaintiffs’ motion in limine
is GRANTED.
b. Motion in Limine No. 2 – AUGS/SUFU & IUGA
The plaintiffs also move to preclude evidence relating to position statements made by the
American Urogynecologic Society (“AUGS”), the Society of Urodynamics, Female Pelvic
Medicine and Urogenital Reconstruction (“SUFU”), and the International Urogynecological
Association (“IUGA”). I have previously denied motions in limine as to this issue, and I adopt
those rulings here. See Huskey, et al. v. Ethicon, Inc., et al., No. 2:12-cv-05201, 2014 WL
3861778, at *2 (S.D. W. Va. Aug. 6, 2014); Lewis, et al. v. Ethicon, Inc., et al., No. 2:12-cv4301, 2014 WL 505234, at *2 (S.D. W. Va. Feb. 5, 2014). I explained:
First, to the extent that the Position Statement is relied upon by an expert witness,
it may be admissible under the learned treatise exception to the hearsay rule. See
Fed. R. Evid. 803(18). Second, under Rule 703, experts are permitted to rely on
otherwise inadmissible information provided that they “would reasonably rely on
those kinds of facts or data in forming an opinion on the subject.” Fed. R. Evid.
703. Third, Ethicon’s state of mind is relevant to the punitive damages claim, and
4

“[a]n out-of-court statement that is offered to show its effect on the hearer’s state
of mind is not hearsay under Rule 801(c).” United States v. Thompson, 279 F.3d
1043, 1047 (D.C. Cir. 2002). Provided that Ethicon properly introduces this
evidence, the plaintiffs’ motion on this issue is DENIED.
Huskey, 2014 WL 3861778, at *2; see also Lewis, 2014 WL 505234, at *2. Accordingly, in this
case, the plaintiffs’ motion in limine is DENIED.
II.

BSC’s Motions in Limine
a. Motion to Preclude Any Evidence or Argument Regarding Fraud on the
FDA or Alleged Misbranding
BSC seeks to preclude any evidence of fraud on the FDA or alleged misbranding,

particularly through the plaintiffs’ proffered regulatory expert, Dr. Peggy Pence. The plaintiffs
concede that they will not offer evidence of fraud on the FDA or misbranding, including from
Dr. Pence. Accordingly, BSC’s motion in limine is GRANTED.
b. Motion to Preclude Evidence Concerning Material Safety Data Sheets
(“MSDS”)
BSC seeks to preclude any evidence concerning the Phillips Sumika MSDS, specifically
the Marlex Polypropylene MSDS containing a Medical Application Caution (“the Caution”).
BSC argues that the MSDS is irrelevant, misleading to the jury, unfairly prejudicial, and would
result in an undue delay and waste of time.
I find BSC’s arguments wholly unconvincing. First, BSC contends that the plaintiffs
should be precluded from offering any evidence related to the MSDS because such evidence is
irrelevant to the plaintiffs’ claims and will mislead the jury. BSC bases this contention on the
deposition testimony of Frank Zakrzewski, corporate representative for Chevron Phillips
Chemical Company.
Evidence or argument as to the methods by which BSC acquired polypropylene resin is
5

relevant to both the plaintiffs’ substantive claims and claims for punitive damages. See In re C.
R. Bard, Inc., MDL No. 2187, 2013 WL 3282926, at *3 (S.D. W. Va. June 27, 2013) (denying
Bard’s motion in limine seeking to preclude evidence concerning the same MSDS); see also
Sanchez v. Boston Scientific Corp., No. 2:12-cv-05762, 2014 WL 4059214, at *1 (S.D. W. Va.
Aug. 18, 2014) (denying BSC’s motion for partial summary judgment on the plaintiffs’ punitive
damages claims). The MSDS served as a notification to BSC of the manufacturer’s concerns
about the safety of its product for permanent implantation in the human body. Furthermore, the
Caution in the MSDS is pertinent to BSC’s knowledge of potential safety concerns in its final
product.
BSC attempts to bolster its argument by relying on a deposition that is both vague and
unclear. BSC contends that Mr. Zakrzewski unequivocally states that the Caution was not added
based on any scientific concerns. However, BSC’s particular reading of Mr. Zakrzewski’s
testimony is not an accurate reflection of his opinions. Mr. Zakrzewski clearly indicates he has
no knowledge of who wrote the MSDS or why it was written. (See Zakrzewski Dep. [Docket
137-3], at 45 (“A: I would say that legal had some input into the MSDS, but I don’t know that for
certain because I didn’t write it. Q: Do you know who wrote the MSDS? A: I do not.”)). BSC
improperly conflates Mr. Zakrzewski’s lack of knowledge regarding scientific testing with a
conclusive determination. I have made it clear in this MDL that I find the MSDS to be
sufficiently relevant, and BSC’s arguments do not change my mind. Accordingly, BSC’s motion
in limine is DENIED.

6

c. Motion to Preclude Evidence Concerning Polyethylene Material Safety Data
Sheets
BSC seeks to preclude evidence concerning the polyethylene MSDS because it is
irrelevant. I have previously reviewed an identical motion in limine in Tyree v. Boston Scientific
Corp., No. 2:12-cv-08633, 2014 WL 5445769, at *2 (S.D. W. Va. Oct. 22, 2014). To the extent
that there are differences in fact and exhibits, the court does not find them sufficiently material.
In Tyree, I ruled as follows:
BSC explains that BSC employees and consultants responded to questions
concerning the polyethylene material safety data sheet (“MSDS”) thinking they
were responding to questions concerning the polypropylene MSDS. The plaintiffs
attempt to highlight the fact that the polyethylene MSDS was written in 2001,
three years before the polypropylene MSDS. (Pls.’ Omnibus Resp. [Docket 395],
at 4). However, BSC clearly states that polyethylene is not a material used in
BSC’s mesh. (Id. at 8; BSC’s Reply in Supp. if Its Mot. to Preclude Evidence
Concerning Polyethylene MSDSs [Docket 438], at 1). Evidence related to
materials not present in the device at issue is clearly outside the scope of the
plaintiffs’ claims and irrelevant. Accordingly, BSC’s motion in limine on this
issue is GRANTED.
Id. Therefore, I ADOPT my prior ruling on this issue, as stated in Tyree, and GRANT BSC’s
motion in limine.
d. Motion to Preclude Evidence of BSC’s Procurement of Polypropylene Resin
BSC seeks to preclude evidence of BSC’s procurement of polypropylene resin,
particularly purchases from a Chinese distributor in 2011. I FIND that evidence as to the
methods by which BSC acquired polypropylene resin is potentially relevant as to the plaintiffs’
substantive claims, as well as claims for punitive damages. However, an evidentiary ruling on
this issue depends on the particular content of the evidence and argument, and the context in
which the party seeks to introduce it. I simply cannot make a substantive ruling at this time

7

without additional information. Therefore, a blanket exclusion of such evidence, argument, or
testimony would be premature. Accordingly, BSC’s motion in limine is DENIED.
e. Motion to Preclude Evidence Regarding the ProteGen Device
BSC seeks to preclude evidence regarding the ProteGen device because it is irrelevant,
misleading to the jury, unfairly prejudicial, and will result in an undue delay and waste of time. I
have previously reviewed an identical motion in limine in Tyree. 2014 WL 5445769, at *3. To
the extent that there are differences in fact and exhibits, the court does not find them sufficiently
material. In Tyree, I ruled as follows:
In Lewis, I excluded evidence regarding the recall of the ProteGen sling because it
would require extensive discussion of the FDA 510(k) clearance process, given
that Ethicon used the ProteGen as a regulatory predicate device. See id. (“A
discussion of the 510(k) process, whether in the context of the clearance of a new
device or the recall of a predicate product, presents the danger of unfair prejudice
and confusing the jury.”). Here, BSC did not use the ProteGen as a regulatory
predicate device, a fact that BSC itself points out in its Memorandum in Support.
(See Def.’s Mem. Supp. [Docket 375], at 12). The ProteGen was a product that
BSC developed, sold, and subsequently recalled. (Pls.’ Omnibus Resp. [Docket
395], at 7). An evidentiary ruling on this issue depends on the particular content
of the evidence and argument, and the context in which the party seeks to
introduce it. The context in which the plaintiffs seek to introduce evidence of the
ProteGen is clearly different than that of the Ethicon trial. However, I simply
cannot make a substantive ruling at this time without additional information.
Therefore, a blanket exclusion of such evidence, argument, or testimony would be
premature. Accordingly, BSC’s motion in limine on this issue is DENIED
without prejudice.
Id. Therefore, I ADOPT my prior ruling on this issue, as stated in Tyree, and DENY BSC’s
motion in limine.3

3

This finding is limited by my exclusion of any evidence related to the FDA 510(k) clearance process and
enforcement.

8

f. Motion to Preclude Any Evidence or Argument Concerning BSC’s Intent,
Motives, or Ethics
BSC seeks to preclude any evidence concerning BSC’s intent, motives, and ethics
because it is irrelevant, unfairly prejudicial, an undue waste of time, and beyond the scope of the
plaintiffs’ experts’ knowledge. An evidentiary ruling on this issue depends on the particular
content of the evidence and argument, and the context in which the party seeks to introduce it. I
simply cannot make a substantive ruling at this time without additional information. Therefore, a
blanket exclusion of such evidence, argument, or testimony would be premature. Accordingly,
BSC’s motion in limine is DENIED.
g. Motion to Preclude Any Evidence or Argument Concerning BSC’s Decision
to Stop Selling Pinnacle or Suggesting that the Pinnacle Was Recalled or
Withdrawn
BSC seeks to preclude any evidence of its discontinuation of certain pelvic mesh
products, including the Pinnacle. BSC argues that such evidence is irrelevant and has the
potential to mislead the jury because it was a business decision, not a recall. The plaintiffs
concede that they will not suggest at trial that the Pinnacle product was recalled or withdrawn.
Accordingly, BSC’s motion in limine is GRANTED.
h. Motion to Preclude Any Evidence or Argument Concerning Foreign
Regulatory Actions
BSC seeks to exclude any evidence concerning foreign regulatory actions on BSC’s
pelvic mesh products. BSC argues that such evidence is irrelevant because all of the plaintiffs’
BSC products were implanted in the United States. An evidentiary ruling on this issue depends
on the particular content of the evidence and argument, and the context in which the party seeks
to introduce it. I simply cannot make a substantive ruling at this time without additional
9

information. Therefore, a blanket exclusion of such evidence, argument, or testimony would be
premature. Accordingly, BSC’s motion in limine is DENIED.
i. Motion to Preclude Any Evidence or Argument Concerning BSC’s PostImplant Product Innovations Including LITE Mesh and Colored Mesh
BSC seeks to preclude subsequent changes or new product lines developed by BSC after
Ms. Sanchez’s implant date. BSC argues that such evidence is inadmissible as a subsequent
remedial measure and irrelevant. Although it appears that BSC’s motion has merit, as evidence
relating to other devices is outside the scope of the plaintiffs’ design defect claim, this issue
would be better handled at trial, as evidence is presented. Furthermore, evidence of subsequent
remedial measures that is inadmissible to prove “negligence; culpable conduct; a defect in a
product or its design; or a need for warning or instruction,” may be admitted “for another
purpose, such as impeachment or—if disputed—proving ownership, control, or the feasibility of
precautionary measures.” Fed. R. Evid. 407. In other words, the admissibility of such evidence or
argument depends on the context and method by which the plaintiffs seek to introduce it.
Accordingly, BSC’s motion in limine is DENIED.
j. Motion to Preclude Any Evidence or Argument that BSC Owed or Breached
a Duty to Warn Ms. Sanchez Directly
BSC seeks to preclude any evidence that BSC owed or breached a duty to warn the
plaintiff directly because in light of California’s learned intermediary doctrine, such evidence is
irrelevant. In California, manufacturers of prescription drugs and medical devices satisfy their
duty to warn if they provide adequate warnings to prescribing physicians, rather than patients.
See Carlin v. Superior Court, 920 P.2d 1347, 1354 (Cal. 1996) (“[I]n the case of prescription
drugs, the duty to warn runs to the physician, not to the patient.”); Brown v. Superior Court, 751
10

P.2d 470, 477 n.9 (Cal. 1988) (“It is well established that a manufacturer fulfills its duty to warn
if it provides adequate warning to the physician.”). Accordingly, BSC only owed a duty to warn
the plaintiff’s physician about the Pinnacle’s potential risks to patients. Any evidence or
argument that BSC owed or breached a duty to warn the plaintiffs directly is therefore irrelevant,
and BSC’s motion in limine is GRANTED.
k. Motion to Preclude Any Evidence or Argument that BSC Owed or Breached
a Duty to Train Plaintiff’s Surgeons
BSC moves to preclude evidence that BSC owed or beached a duty to train the plaintiff’s
surgeon as irrelevant because the plaintiffs have not asserted claims against the implanting
physician, and California does not recognize a duty to train a physician. I have previously denied
a similar motion in the face of these reasons. In Tyree, I ruled that even though West Virginia
does not recognize a duty to provide training to physicians, evidence or argument related to
physician training might possibly be relevant for some other purpose, depending on the context
and method by which it is introduced. 2014 WL 5445769, at *5. I see no reason to deviate from
this ruling here. Therefore, BSC’s motion in limine is DENIED.
l. Motion to Preclude Any Evidence or Argument Concerning Marketing and
Promotional Materials Not Seen by Ms. Sanchez or Her Surgeons
BSC seeks to exclude marketing materials not seen by Ms. Sanchez or her implanting
physician because they are irrelevant, unfairly prejudicial, and potentially confusing to the jury. I
have rejected this argument before, finding that “[t]hese materials may be relevant to the
plaintiffs’ other claims, including negligence and punitive damages. Bard, 2013 WL 3282926, at
*6 (emphasis added). This finding applies here, where the plaintiffs have claimed negligent
design and have asked for punitive damages. Further disputes about relevancy can be addressed
11

at trial, when the content and proffered use of the materials is apparent. Thus, BSC’s motion in
limine is DENIED.
m. Motion to Preclude Product Complaints, Adverse Event Reports, and
Medical Device Reports Concerning Patients Other than Ms. Sanchez
BSC seeks to exclude product complaints, adverse event reports, and medical device
reports concerning patients other than Ms. Sanchez because they are inadmissible hearsay and
irrelevant. An evidentiary ruling on this issue depends on the particular content of the evidence
and argument, and the context in which the party seeks to introduce it. I simply cannot make a
substantive ruling at this time without additional information. Therefore, a blanket exclusion of
such evidence, argument, or testimony would be premature. Accordingly, BSC’s motion in
limine is DENIED.
n. Motion to Preclude Any Evidence or Argument that Pelvic Mesh Can Cause
Complications Not Experienced by Ms. Sanchez
BSC moves to preclude any evidence that mesh can cause complications not experienced
by Ms. Sanchez because it is irrelevant and unfairly prejudicial. Evidence of complications that
the plaintiff has not experienced is irrelevant and lacking in probative value. For the claims that
require evidence of injury (strict liability for failure to warn, strict liability for design defect, and
negligence), only the injuries experienced by the complainant are relevant. Strict liability for
failure to warn, for instance, requires the plaintiff to show that the failure to provide an adequate
warning of danger was a cause of injury to the plaintiff. See California Civil Jury Instructions
9.00.7 (West 2014). Strict liability for defective design also focuses on the plaintiff’s injuries.
See id. 9.00.5 (requiring that the defect in design be a cause of injury to the plaintiff). Similarly,
with respect to negligence, the concern is for injuries caused to the claimant. Id. 9.19 (“The
12

negligence of the defendant was a cause of injury and damage to the plaintiff.”). Accordingly,
evidence that the Pinnacle causes injuries not experienced by the plaintiff has little value.
Moreover, elaborating on injuries that the plaintiff did not incur risks “needless presentation of
cumulative evidence.” Fed. R. Evid. 403. Therefore, BSC’s motion in limine is GRANTED.
o. Motion to Preclude Any Evidence or Argument Concerning Lawsuits
Against Other Manufacturers of Pelvic Mesh
BSC seeks to exclude evidence of lawsuits against other manufacturers of pelvic mesh
because it is irrelevant, unfairly prejudicial, and will mislead the jury. Pointing to my previous
ruling in Bard, the plaintiffs counter that disputes about admissibility of this evidence should be
reserved for trial to the extent BSC opens the door on this issue. The use of motions in limine
that lack specificity and are without context have led the court in the past to defer judgment on
several evidentiary issues, including this one. See Bard, 2013 WL 3282926, at *2. Having gained
greater familiarity, however, the court was confident in substantively ruling on the admissibility
of other lawsuits against the same defendant in Lewis:
[E]vidence of lawsuits is generally considered inadmissible hearsay. . . . Further,
evidence of other lawsuits and the factual allegations therein is inadmissible under
Rule 403. Although other lawsuits may ultimately show that the [product] is
defective, the jury must still find that the [product] caused [the plaintiff’s]
injuries. Evidence of other lawsuits is likely to confuse and mislead the jury from
that task, and it is highly prejudicial to [the defendant].
2014 WL 505234, at *6. I find this rationale, as applied to exclude lawsuits against the same
defendant, to be exceedingly appropriate here, where the plaintiffs seek to introduce evidence of
lawsuits against other manufacturers. Even assuming evidence about lawsuits brought against
other manufacturers has some relevance to the present case, the relevance is dwarfed by the risk

13

of unfair prejudice posed by requiring BSC to attest for lawsuits in which it was not involved.
Accordingly, pursuant to Rule 403, I GRANT BSC’s motion in limine.
p. Motion to Preclude Any Evidence or Argument Concerning Other Mesh
Lawsuits, Investigations, Claims, Verdicts, and Trials Against BSC
BSC seeks to exclude evidence of other mesh lawsuits, investigations, claims, verdicts,
and trials against BSC because it is irrelevant, inadmissible hearsay, and unfairly prejudicial. I
granted a motion in limine in Lewis to exclude evidence of other mesh lawsuits against the
defendant. See 2014 WL 505234, at *5-6. I noted that “evidence of lawsuits is generally
considered inadmissible hearsay[,]” and ultimately excluded the evidence on Rule 403 grounds. I
explained:
[E]vidence of other lawsuits and the factual allegations therein is inadmissible
under Rule 403. Although other lawsuits may ultimately show that the [product]
is defective, the jury must still find that the [product] caused [the plaintiff’s]
injuries. Evidence of other lawsuits is likely to confuse and mislead the jury from
that task, and it is highly prejudicial to [the defendant]. Accordingly, Ethicon’s
motion on this issue is GRANTED.
Id. I apply this reasoning to the evidence challenged by BSC here. Therefore, I GRANT BSC’s
motion in limine.
q. Motion to Preclude Any Evidence or Argument Concerning Unrelated FDA
Corporate Warning and 483 Letters, All Pertaining to Cardiac Devices
BSC seeks to exclude evidence a 2006 corporate warning and FDA 483 letters
concerning unrelated cardiac devices because they are irrelevant, improper character evidence,
and unfairly prejudicial. The plaintiffs concede that they will not introduce evidence regarding
BSC’s correspondence with the FDA. Accordingly, BSC’s motion in limine is GRANTED.

14

r. Motion to Preclude Any Evidence or Argument Concerning Parties’
Litigation Conduct
BSC seeks to exclude evidence of the parties’ litigation conduct. An evidentiary ruling on
this issue depends on the particular content of the evidence and argument, and the context in
which the party seeks to introduce it. I simply cannot make a substantive ruling at this time
without additional information. Therefore, a blanket exclusion of such evidence, argument, or
testimony would be premature. Accordingly, BSC’s motion in limine is DENIED.
s. Motion to Preclude Any Evidence or Argument Concerning BSC’s Finances
or Employment Decisions.
BSC seeks to exclude evidence of BSC’s net worth, profits, employee compensation and
other employment issues because it is irrelevant and unfairly prejudicial. I have previously
reviewed an identical motion in limine in Tyree. 2014 WL 5445769, at *9. To the extent that
there are differences in fact and exhibits, the court does not find them sufficiently material. In
Tyree, I ruled as follows:
BSC argues that the plaintiffs are attempting to “[paint] [BSC] as a bad actor
improperly motivated by profit” and “induce the jury to render a verdict simply
because Boston Scientific is a large company with significant resources[.]” (Id. at
46–47). I note that I denied BSC’s motion for summary judgment on the issue of
punitive damages. (See Mem. Op. & Order [Docket 425]). Therefore, consistent
with my finding in Bard, I FIND that evidence of BSC’s finances or employment
decisions may be relevant as to the amount of punitive damages. See 2013 WL
3282926, at *15. Furthermore, to the extent that certain financial information
“[paints] [BSC] as a bad actor improperly motivated by profit,” it may be relevant
to the question of liability for punitive damages. See id. at 12, 15 (denying Bard’s
motions in limine as to Bard’s financial information or condition and as to Bard’s
intent, motives, and ethics). Accordingly, BSC’s motion in limine on this issue is
DENIED without prejudice.
Id. Therefore, I ADOPT my prior ruling on this issue, as stated in Tyree, and DENY BSC’s
motion in limine.
15

III.

Conclusion
For the reasons set forth above, the Plaintiffs’ Omnibus Motion in Limine [Docket 135] is

GRANTED in part and DENIED in part, and Boston Scientific Corporation’s Omnibus
Motion in Limine [Docket 137] is GRANTED in part and DENIED in part.
The court DIRECTS the Clerk to send a copy of this Order to counsel of record and any
unrepresented party.
ENTER:

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February 12, 2015