Eghnayem v. Boston Scientific Corporation
Filing
246
MEMORANDUM OPINION AND ORDER (Motions in Limine) for the reasons set forth herein, Boston Scientific Corporation's 197 Initial Motions in Limine are granted in part and denied in part; Boston Scientific Corporation's 214 Motion in Limin e to Exclude Evidence of Dyspareunia is denied without prejudice; Plaintiffs' 199 Omnibus Motions in Limine are denied; and Plaintiff Amal Eghnayem's 221 Motion in Limine # 3 is granted in part and denied in part. Signed by Judge Joseph R. Goodwin on 10/28/2014. (cc: attys; any unrepresented party) (skh)
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
CHARLESTON DIVISION
AMAL EGHNAYEM, et al.,
Plaintiffs,
v.
CIVIL ACTION NO. 2:13-cv-07965
BOSTON SCIENTIFIC CORPORATION,
Defendant.
MEMORANDUM OPINION AND ORDER
(Motions in Limine)
Pending before the court are Boston Scientific Corporation’s (“BSC”) Initial Motions in
Limine [Docket 197], BSC’s Motion in Limine to Exclude Evidence of Dyspareunia [Docket
214], Plaintiffs’ Omnibus Motions in Limine [Docket 199], and Plaintiff Amal Eghnayem’s
Motion in Limine # 3 [Docket 221]. For the reasons set forth below, BSC’s Initial Motions in
Limine [Docket 197] are GRANTED in part and DENIED in part, BSC’s Motion in Limine to
Exclude Evidence of Dyspareunia [Docket 214] is DENIED without prejudice, Plaintiffs’
Omnibus Motions in Limine [Docket 199] are DENIED, and Plaintiff Amal Eghnayem’s Motion
in Limine # 3 [Docket 221] is GRANTED in part and DENIED in part.
I.
Background
This consolidated case resides in one of seven MDLs assigned to me by the Judicial
Panel on Multidistrict Litigation 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 60,000 cases currently pending, over 13,000 of which are in the Boston Scientific
Corporation MDL, MDL 2326. In this particular case, the four plaintiffs were surgically
implanted with the Pinnacle Pelvic Floor Repair Kit (“the Pinnacle”), a mesh product
manufactured by BSC to treat POP. (See Pretrial Order # 91 [Docket 10], at 1–2).1 All of the
plaintiffs received their surgeries in Florida. The plaintiffs claim that as a result of implantation
of the Pinnacle, they have experienced “erosion, mesh contraction, infection, fistula,
inflammation, scar tissue, organ perforation, dyspareunia (pain during sexual intercourse), blood
loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage,
pelvic floor damage, and chronic pelvic pain.” (Id. at 3 (quoting the master complaint)). The
plaintiffs allege negligence, design defect, manufacturing defect, failure to warn, breach of
express warranty, breach of implied warranty, and punitive damages. (Id. at 1–2). The instant
Motions in Limine involve the parties’ efforts to exclude or limit certain evidence, arguments,
and testimony at trial.
II.
BSC’s Motions
1. Motion to Preclude Any Evidence or Argument Regarding Fraud on the
FDA or Alleged Misbranding
BSC seeks to preclude evidence that BSC “withheld information from the FDA, misled
the [FDA], or misbranded their device as FDA-cleared.” (BSC’s Mem. in Supp. of Its Initial
Mots. in Limine (“Def.’s Mem. Supp.”) [Docket 197], at 4). BSC argues that such evidence
would only be relevant to a “fraud-on-the-FDA” claim, which is preempted under Buckman Co.
v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). Based on the court’s rulings on the
inadmissibility of FDA evidence in similar cases, the plaintiffs “[a]gree that any evidence or
argument regarding fraud on the FDA or alleged misbranding should be excluded from this
1
I originally consolidated the cases of five plaintiffs implanted with the Pinnacle. (See Pretrial Order # 91 [Docket
10] (naming Eghnayem, Dotres, Nunez, Dubois-Jean, and Betancourt as consolidated plaintiffs)). Four plaintiffs
now remain in this action. (See Order [Docket 35] (removing Dubois-Jean from consolidated pool)).
2
case.” (Pls.’ Omnibus Resp. to BSC’s Initial Mots. in Limine (“Pls.’ Omnibus Resp.”) [Docket
212], at 1). Because the plaintiffs do not oppose this motion in limine, it is thus GRANTED.
2. 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”).
(Def.’s Mem. Supp. [Docket 197], at 6). BSC argues that the MSDS is irrelevant, misleading to
the jury, unfairly prejudicial, and would result in an undue delay and waste of time. (Id.).
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. (Id.). BSC bases this contention on
the deposition testimony of Frank Zakrzewski, corporate representative for Chevron Phillips
Chemical Company. (See id. at 6–8).
Evidence or argument as to the methods by which BSC acquired polypropylene resin is
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
Mem. Op. & Order [Docket 232] (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
3
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
197-3], 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 on this issue is DENIED without prejudice.
3. Motion to Preclude Evidence Concerning Polyethylene Material Safety Data
Sheets
BSC seeks to preclude “testimony and evidence concerning the Material Safety Data
Sheet for Marlex and MarFlex Polyethylenes . . . . as it does not apply to the Phillips Sumika
Marlex Polypropylene contained in Boston Scientific’s Pinnacle device.” (Def.’s Mem. Supp.
[Docket 197], at 9). BSC explains that BSC employees and consultants responded to questions
concerning the polyethelene 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
212], at 4). However, BSC clearly states that polyethylene is not a material used in BSC’s mesh.
(Def.’s Mem. Supp. [Docket 197], at 10). 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.
4
4. Motion to Preclude Evidence of BSC’s Procurement of Polypropylene Resin
BSC seeks to preclude “any evidence concerning BSC’s procurement of polypropylene
resin, including, but not limited to, purchases of Phillips Sumika Marlex HGX-030-01
polypropylene resin from a Chinese distributor in July 2011.” (Def.’s Mem. Supp. [Docket 197],
at 11). BSC argues that BSC’s procurement of polypropylene resin is irrelevant to the plaintiffs’
product defect claims, particularly any evidence regarding polypropylene resin not used in the
manufacture of the plaintiffs’ Pinnacle devices. (Id.). 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 their 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 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.
5. Motion to Preclude Evidence Regarding ProteGen Device
BSC seeks to preclude “any evidence or testimony concerning the Boston Scientific
ProteGen sling [ ], including but not limited to, Boston Scientific’s recall of that product.”
(Def.’s Mem. Supp. [Docket 197], at 13). BSC argues that evidence concerning the ProteGen is
irrelevant, misleading to the jury, unfairly prejudicial, and a cause of undue delay and wasted
time because the ProteGen and the Pinnacle are “not substantially similar.” (Id.). BSC notes that
the two products are made from different materials, use a different surgical technique, involve a
different regulatory history, and are used to treat two different medical conditions. (Id.).
5
In Lewis v. Ethicon, 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 No. 2:12-cv-4301, 2014 WL
505234, at *16 (S.D. W. Va. Feb. 5, 2014) (“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. (See Def.’s Mem. Supp. [Docket 197], at 14).
The ProteGen was a product that BSC developed, sold, and subsequently recalled. (Pls.’
Omnibus Resp. [Docket 212], 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 in the Lewis 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.2
6. Motion to Preclude Evidence of Argument Concerning BSC’s Intent,
Motives, or Ethics
BSC seeks to exclude evidence or testimony of its intent, motives, and ethics. BSC
argues that this evidence or testimony “(A) is irrelevant to the Plaintiffs’ claims; and (B) would
cause confusion, unfair prejudice, and undue waste of time; and (C) is beyond the scope of
Plaintiffs’ experts’ knowledge.” (See Def.’s Mem. Supp. [Docket 197], at 16). I need more
information about the particular piece of evidence or argument being challenged in this motion,
2
This finding is limited by my exclusion of any evidence related to the FDA 510(k) clearance process and
enforcement.
6
and I lack the context needed to properly rule on the matter at this time. Accordingly, BSC’s
motion in limine on this issue is DENIED without prejudice.
7. 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 or argument on its discontinuation of certain pelvic
mesh products, including the Pinnacle.” (Def.’s Mem. Supp. [Docket 197], at 19). BSC argues
that such evidence is irrelevant and has the potential to mislead the jury because it was a business
decision, not a recall. (See id.). The plaintiffs state that they “will not suggest at trial that the
Pinnacle product was recalled or withdrawn.” (Pls.’ Omnibus Resp. [Docket 212], at 11).
Nevertheless, BSC’s decision to stop selling the Pinnacle has the potential to be construed as a
subsequent remedial measure. Under Federal Rule of Evidence 407, “[w]hen measures are taken
that would have made an earlier injury or harm less likely to occur, evidence of the subsequent
measures is not admissible to prove: negligence; culpable conduct; a defect in a product or its
design; or a need for a warning or instruction.” Accordingly, BSC’s motion in limine on this
issue is GRANTED.
8. Motion to Preclude Any Evidence or Argument Concerning Foreign
Regulatory Actions
BSC seeks to exclude any evidence or argument 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, and such evidence would be
unduly prejudicial, confusing to the jury, and a waste of time. (See Def.’s Mem. Supp. [Docket
197], at 22).
7
I have previously denied without prejudice a defendant’s motion in limine concerning
evidence of foreign regulatory actions. See Huskey, et al. v. Ethicon, Inc., et al., No. 2:12-cv05201, 2014 WL 3861778, at *2 (S.D. W. Va. Aug. 6, 2014); Bard, 2013 WL 3282926, at *2.
Along with several other motions in limine, I found that granting a motion in limine on this
subject was premature:
I simply cannot make a substantive ruling at this time without knowing the
particular piece of evidence that the plaintiffs seek to introduce or argument that
the plaintiffs seek to make, and the context in which the plaintiffs seek to
introduce such evidence or make such argument. In short, a blanket exclusion of
such evidence, argument or testimony is premature at this time[.]
Id. at *2. At trial, this evidence may be inadmissible because different countries have different
regulatory systems and schemes. This case arises under the laws of the United States, and,
therefore, evidence concerning other countries’ regulatory policies may confuse and mislead the
jury. See Deviner v. Electrolux Motor, AB, et al., 844 F.2d 769, 771 n.2, 773 (11th Cir. 1988)
(finding that district court did not abuse discretion when granting motion in limine to exclude
“Swedish law and statistics” under the rationale that “Swedish Standards are not relevant in a
U.S. product liability case involving a saw sold in the U.S.”).
BSC provides a few examples of evidence related to foreign regulatory actions that the
plaintiffs could possibly introduce at trial. However, the plaintiffs state that their evidence is not
“of any ‘foreign regulatory action’” and “raises no question regarding the applicability or
interpretation of foreign law.” (Pls.’ Omnibus Resp. [Docket 212], at 13). The plaintiffs assert
that their evidence instead “discusses serious health complications associated with these products
and as such, is relevant to and admissible for purposes of establishing BSC’s knowledge, notice
and scienter, as well as the state of the art.” (Id.).
8
As in Bard, I lack the specificity and context needed to properly rule on this matter at this
time. See In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 551–52 (S.D.N.Y. 2004) (“The
Court finds no legal basis upon which now to rule . . . that testimony regarding foreign regulatory
actions is irrelevant as a matter of law in a United States products liability case governed by
American law . . . . Any ruling as to the relevancy of otherwise admissible evidence concerning
foreign regulatory actions therefore would be premature.”). Therefore, BSC’s motion with
respect to this matter is DENIED without prejudice.
9. Motion to Preclude Any Evidence or Argument Concerning BSC’s PostImplant Product Innovations Including LITE Mesh and Colored Mesh
BSC seeks to preclude evidence of “subsequent changes or new product lines developed
in Boston Scientific’s continuing study of its products, after Plaintiffs’ implant date” because
such evidence is (1) inadmissible under Federal Rule of Evidence 407 as a subsequent remedial
measure; (2) irrelevant to the plaintiffs’ product liability claims; and (3) confusing, unfairly
prejudicial, and an undue consumption of time. (Def.’s Mem. Supp. [Docket 197], at 25). BSC
notes that “[t]he exclusion of subsequent remedial measures is designed to encourage
manufacturers to ‘make improvements for greater safety.’” (Id. (citation omitted)). Additionally,
BSC argues that any subsequent product innovation is not relevant to the plaintiffs’ defect claims
because such innovations would not have made a difference with respect to the plaintiffs’ alleged
injuries. (Id. at 26).
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 is better suited to be 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
9
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 on
this issue is DENIED without prejudice.
10. Motion to Preclude Any Evidence or Argument that BSC Owed or Breached
a Duty to Warn the Individual Plaintiffs Directly
BSC seeks to preclude evidence regarding BSC’s duty to directly warn the plaintiffs
about the risks associated with the Pinnacle because in light of Florida’s learned intermediary
doctrine, such evidence is irrelevant. I agree. In Florida, manufacturers of prescription drugs and
ethical drugs that can be administered only under the direction of a physician must “provide an
adequate warning only to the physician, or ‘learned intermediary.’” E.R. Squibb & Sons, Inc. v.
Farnes, 697 So. 2d 825, 827 (Fla. 1997); see also Beale v. Biomet, Inc., 492 F. Supp. 2d 1360,
1368 (S.D. Fla. 2007) (“I agree with our sister Florida district courts, and with the great weight
of authority to conclude that under Florida law, the learned intermediary doctrine applies to
prescription medical devices as well as prescription drugs.”). Accordingly, BSC only owed a
duty to warn the plaintiffs’ physicians of 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. The plaintiffs have agreed not to present evidence on this matter. (See Pls.’ Omnibus
Resp.) [Docket 212], at 18).
The plaintiffs nevertheless ask this court to deny BSC’s motion in limine on this issue
because “evidence of BSC’s warnings through the intermediary to Plaintiffs is directly relevant
to whether Plaintiffs’ implanting physicians ‘would have changed’ their decisions to implant the
10
Pinnacle device.” (Id. at 17). BSC’s motion in limine on the duty to warn the plaintiffs directly
does not affect the admissibility of this evidence. Therefore, I do not find the plaintiffs’ concerns
persuasive. Under Federal Rule of Evidence 402, BSC’s motion on this point is GRANTED. See
Fed. R. Evid. 402 (“Irrelevant evidence is not admissible.”).
11. Motion to Preclude Any Evidence or Argument that BSC Owed or Breached
a Duty to Train Plaintiffs’ Surgeons
BSC moves to preclude evidence on BSC’s duty to train the treating physicians because
such evidence is irrelevant: the plaintiffs have not asserted claims against their implanting
physicians, and Florida does not recognize a duty to train a physician. I have previously denied a
similar motion in the face of these reasons. In Lewis, I ruled that even though Texas 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. See Lewis, 2014 WL 505234, at *5. I see no reason to deviate from this
ruling here. Therefore, BSC’s motion to preclude evidence and argument on the duty to train
physicians is DENIED without prejudice.
12. Motion to Preclude Any Evidence or Argument Concerning Marketing and
Promotional Materials Not Seen by the Individual Plaintiffs or Their
Surgeons
BSC seeks to preclude “marketing materials that some of the Plaintiffs or their
prescribing physicians did not read or see” on the basis that the materials are irrelevant and
unfairly prejudicial. (Def.’s Mem. Supp. [Docket 197], at 33). 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
11
punitive damages. I can address any further disputes about relevancy at trial, when the content
and proffered use of the materials is apparent. Thus, BSC’s motion in limine on this issue is
DENIED without prejudice.
13. Motion to Preclude Product Complaints, Adverse Event Reports, & Medical
Device Reports Concerning [Products Other Than the Pinnacle Pelvic Floor
Repair Kit]. 3
BSC seeks to preclude evidence of product complaints, adverse event reports (“AERs”),
or Medical Device Reports (“MDRs”) for products other than the Pinnacle Pelvic Floor Repair
Kit. BSC argues that such evidence is (1) inadmissible hearsay; (2) irrelevant to causation or
notice; and (3) inadmissibly prejudicial under Rule 403. I have previously refused to exclude
such evidence in the motions stage of MDL litigation on the basis that
there are simply too many factors that might determine whether the product
complaints, AERs, and MDRs might be admissible. Without knowing the specific
contents of any complaints, AERs or MDRs that the plaintiffs may seek to
introduce, or how the plaintiffs might seek to use or introduce these complaints
and reports, I cannot make a substantive ruling at this time. . . . [A] blanket
exclusion of this evidence would be premature.
Bard, 2013 WL 3282926, at *6. This ruling equally applies here.
First, I cannot determine whether these materials constitute inadmissible hearsay until I
observe how the plaintiffs use them at trial. In Bard, I found that the materials fell within the
hearsay exceptions provided in Federal Rules of Evidence 803(6) and 803(8) and that “to the
extent an expert might rely upon AERs in reaching certain opinions,” experts can rely on
otherwise inadmissible evidence to reach their opinions. Id. at *5 (citing Mahaney ex rel. Estate
of Kyle v. Novartis Pharms. Corp, 835 F. Supp. 2d 299, 312 (W.D. Ky. 2011)). These same
3
BSC’s Motion in Limine entitles this motion “Motion to Preclude Product Complaints, Adverse Event Reports, and
Medical Device Reports Concerning Patients Other Than Plaintiffs,” but the substance of the motion concerns
reports on “products other than the Pinnacle Pelvic Floor Repair Kit.” (Def.’s Mem. Supp. [Docket 197] at 35). I
review the motion based on its substance, rather than its title.
12
hearsay exceptions might come into play at trial in this case.
Second, contrary to BSC’s position, “courts have held that [AERs and MDRs] may show
notice and provide support for causation,” so long as the evidence of injuries are “substantially
similar to those in the case at bar.” Id. Finally, if it appears that the plaintiffs’ introduction of
AERs and MDRs will create unfair prejudice, BSC should object at that time, informed by the
content of the proffered materials and the context in which they are introduced. For these
reasons, I DENY without prejudice BSC’s motion in limine on this matter.
14. Motion to Preclude Any Evidence or Argument that Pelvic Mesh Can Cause
Complications Not Experienced by the Individual Plaintiffs
BSC moves to preclude any evidence of “medical complications purportedly caused by
Boston Scientific’s devices, but not experienced by Plaintiffs themselves,” such as evidence that
polypropylene mesh causes “gross hematuria, inflammatory myofibrolastic tumors, and cancer.”
(Def.’s Mem. Supp. [Docket 197], at 38). Because none of the plaintiffs has alleged these
injuries, BSC argues that such evidence is irrelevant and unfairly prejudicial.
I agree that evidence of complications that no plaintiff 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 inadequate warning “made the product unreasonably dangerous” and that it “was
a legal cause of the loss, injury, or damage to [the] person for whose injury claim is made.” In re
Standard Jury Instructions in Civil Cases, Report No. 09-10 (Prods. Liab.), 91 So. 3d 785, 799
(Fla. 2012) (providing preliminary approval). Strict liability for defective design also focuses on
the plaintiff’s injuries. See id. (providing that strict liability concerns whether the product’s
13
defect “was a legal cause of the loss, injury, or damage to [the] person for whose injury claim is
made”). With respect to negligence, the concern is also for injuries caused to the claimant. Id. at
800. Accordingly, evidence that the Pinnacle causes injuries not experienced by the plaintiffs has
little value. Moreover, elaborating on injuries that the plaintiffs did not incur risks “needless
presentation of cumulative evidence.” Fed. R. Evid. 403. Therefore, BSC’s motion in limine on
this issue is GRANTED.
15. Motion to Preclude Any Evidence or Argument Concerning Lawsuits
Against Other Manufacturers of Pelvic Mesh Products
On the basis that the evidence is irrelevant, unfairly prejudicial, and misleading to the
jury, BSC moves to preclude any evidence of “complaints or lawsuits against other
manufacturers of pelvic mesh to argue that Boston Scientific’s products were defective,
inadequately labeled, or unreasonably dangerous.” (Def.’s Mem. Supp. [Docket 197], at 40).
Pointing to my previous ruling in Bard, the plaintiffs counter that disputes about admissibility of
this evidence should be reserved for trial if “BSC opens the door on this issue.” (Pls.’ Omnibus
Resp. [Docket 212], at 27).
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].
14
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
of unfair prejudice posed by requiring BSC to attest for lawsuits in which it was not involved.
Accordingly, pursuant to Federal Rule of Evidence 403, I GRANT BSC’s motion in limine on
this issue.
16. Motion to Preclude Any Evidence or Argument Concerning Other Mesh
Lawsuits, Investigations, Claims, Verdicts, and Trials Against BSC
BSC moves to preclude any evidence or argument concerning “other lawsuits, claims,
investigations, regulatory actions, or settlements involving Boston Scientific’s mesh products—
whether or not related to the Pinnacle Pelvic Floor Repair Kit.” (Def.’s Mem. Supp. [Docket
197], at 42). BSC argues that this evidence should be precluded because it is irrelevant under
Federal Rule of Evidence 401, “unfairly prejudicial and confusing” under Federal Rule of
Evidence 403, and inadmissible hearsay. (Id.).
I granted a motion in limine in Lewis to exclude evidence of other mesh lawsuits against
the defendant. See Lewis, 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.
15
Id. I apply this reasoning to the evidence challenged by BSC in the instant motion in limine.
Therefore, I GRANT BSC’s motion on this matter.
17. Motion to Preclude Any Evidence or Argument Concerning Unrelated FDA
Corporate Warnings and 483 Letters, All Pertaining to Cardiac Devices
BSC seeks to preclude evidence of a 2006 corporate warning and FDA 483 letters
because such evidence concerns devices unrelated to pelvic mesh. (Def.’s Mem. Supp. [Docket
197], at 44). BSC argues that “[t]his evidence should be excluded because it is (A) irrelevant, (B)
improper character evidence, and (C) unfairly prejudicial.” (Id.). Based on the court’s rulings on
the inadmissibility of FDA evidence in similar cases, the plaintiffs have stated that they “will not
introduce evidence or arguments regarding BSC’s correspondence with FDA, including 483
corporate warning letters.” (Pls.’ Omnibus Resp. [Docket 212], at 30). Because the plaintiffs do
not oppose this motion in limine, it is thus GRANTED.
18. Motion to Preclude Any Evidence or Argument Concerning the Parties’
Litigation Conduct
BSC moves to preclude evidence or argument concerning the parties’ litigation conduct,
such as:
A) Evidence of mediation or settlement negotiations;
B) Boston Scientific’s designation of any documents as confidential or any
suggestion that Boston Scientific’s actions were improper or an attempt to keep
certain documents secret; and
C) Evidence of Boston Scientific’s litigation conduct and of Court rulings such
as motions in limine or objections during discovery.
(Def.’s Mem. Supp. [Docket 197], at 47). BSC argues that evidence of mediation or settlement
negotiations should be excluded because “such evidence is not admissible to prove liability or
invalidity of the claim or amount” under Federal Rule of Evidence 408. (Id.). BSC contends that
16
evidence concerning the designation of confidential documents, BSC’s litigation conduct, and
court rulings should be excluded under Federal Rules of Evidence 401, 402, and 403.
I have previously ruled on similar motions in limine in other cases. See Bard, 2013 WL
3282926, at *8 (challenging the same three types of evidence); Lewis, 2014 WL 505234, at *9
(ruling on motion in limine to preclude plaintiffs from referring to the designation of documents
as confidential for purposes of discovery).
As for evidence of mediation or settlement negotiations, BSC is correct that “such
evidence is not admissible ‘either to prove or disprove the validity or amount of a disputed claim
or to impeach by a prior inconsistent statement or a contradiction.’ Fed. R. Evid. 408(a).
However, under Rule 408(b), this evidence may be admitted for other purposes.” Bard, 2013 WL
3282926, at *8.
As for evidence concerning BSC’s litigation conduct and court rulings, I think it highly
unlikely that such matters will be permitted, but it is impossible to determine the relevancy of
any argument or evidence concerning these issues at this stage. Accordingly, I FIND that a
blanket exclusion of such evidence and argument would be premature at this time[.]” Id.
Therefore, I DENY without prejudice BSC’s motion in limine with respect to evidence of
mediation or settlement negotiations and evidence concerning BSC’s litigation conduct and court
rulings.
As for evidence concerning the designation of confidential documents, “[w]hether a party
designates a document as confidential during the litigation process is absolutely irrelevant.”
Lewis, 2014 WL 505234, at *7. The jury will be instructed at trial to disregard the confidential
marking on documents. Therefore, I GRANT BSC’s motion in limine with respect to this issue.
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Thus, I GRANT IN PART and DENY IN PART BSC’s motion in limine on this matter.
19. Motion to Preclude Any Evidence or Argument Concerning BSC’s Finances
or Employment Decisions
BSC seeks to preclude any evidence or argument concerning BSC’s finances or
employment decisions because “such evidence is irrelevant to this lawsuit and carries the risk of
jury confusion and unfair prejudice.” (Def.’s Mem. Supp. [Docket 197], at 50). 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 50–51). I note that I denied BSC’s motion for partial summary
judgment on the issue of punitive damages and found that Florida substantive law applies to the
plaintiffs’ punitive damages claims. (See Mem. Op. & Order [Docket 232]).
Under Florida law, a jury should consider the “financial resources of the defendant” and
“whether the wrongful conduct was motivated solely by unreasonable financial gain,” among
other things, when determining an amount of punitive damages. In re Standard Jury Instructions
In Civil Cases-Report No. 09-01 (Reorganization of the Civil Jury Instructions), 35 So. 3d 666,
793, 798 (Fla. 2010) (alterations omitted) (approving and authorizing for publication the
reorganization of the standard civil jury instructions, including instructions on punitive
damages). Therefore, 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 the amount of punitive
damages. Accordingly, BSC’s motion in limine on this issue is DENIED without prejudice.
20. Motion to Preclude Any Evidence or Argument Concerning Any Plaintiff’s
Implanting Physician’s Decision to Discontinue Using the Pinnacle to Treat
POP
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BSC moves to preclude evidence that Dr. Salom (implanting physician for Ms. Dotres
and Ms. Nunez) and Dr. Gomez-Madrazo (implanting physician for Ms. Betancourt) recently
decided to discontinue use of the Pinnacle and other polypropylene mesh products in their
medical practice for treatment of POP. BSC contends that such evidence would “improperly
suggest” that the doctors’ decisions “imply a defect in the Pinnacle.” (Def.’s Mem. Supp.
[Docket 197], at 52). The plaintiffs respond that the motion should be denied because this
evidence provides a rebuttal to any testimony implying that the doctors “have no concerns
whatsoever with the Pinnacle.” (Pls.’ Omnibus Resp. [Docket 212], at 34).
Given the various ways in which the parties could use this information at trial, I cannot
make a pre-trial substantive ruling on this matter. Moreover, not all of the physicians’ testimony
on this issue casts BSC in a negative light, and as a result, I cannot ascertain the prejudicial
nature of this evidence without knowing the specific testimony that the plaintiffs seek to offer.
(See, e.g., Salom Dep. [Docket 197-16], at 18:12–21 (assenting that his experience with the
Pinnacle sling was “favorable” and that he “enjoy[ed] the delivery system”); Gomez-Madrazo
Dep. [Docket 197-11], at 85:18–21 (confirming that he had a “good” clinical experience with the
Pinnacle)). For these reasons, I DENY without prejudice BSC’s motion in limine concerning
the physicians’ reasons for discontinuing use of the Pinnacle.
21. Motion in Limine to Exclude Evidence of Dyspareunia
BSC seeks to preclude “all evidence and testimony relating to Plaintiff Margarita
Dotres’[s] alleged claim of dyspareunia.” (BSC’s Mot. in Limine to Exclude Evidence of
Dyspareunia [Docket 214], at 1). BSC argues that such evidence is (1) irrelevant to Ms. Dotres’s
active claims; (2) unfairly prejudicial to BSC; and (3) confusing for the jury. (Id.). While I agree
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with BSC’s contention that evidence related to dismissed claims is irrelevant, a blanket exclusion
of dyspareunia would be premature at this time. First, the three other plaintiffs continue to pursue
their dyspareunia claims; therefore, the issue of dyspareunia will be referenced repeatedly
throughout trial. Second, even if I attempt to exclude evidence of dyspareunia solely relating to
Ms. Dotres, the mere mention of dyspareunia is still potentially relevant and necessary to Ms.
Dotres’s claims for pelvic pain generally, as well as her physician’s testimony. (See Pl.’s Resp.
in Opp. to BSC’s Mot. in Limine to Exclude Evidence of Dyspareunia [Docket 223], at 2-3). This
is clearly a matter that can be handled by the court at trial. If necessary, BSC is free to make
clear that Ms. Dotres is not pursuing a claim for dyspareunia. The parties are represented by
experienced and able trial counsel, and I trust that counsel know and intend to abide by the
Federal Rules of Evidence and their agreement. Accordingly, BSC’s motion in limine on this
issue is DENIED without prejudice.
III.
The Plaintiffs’ Motions
1. Plaintiffs’ Omnibus Motion in Limine
a. Motion in Limine No. 1 – The Use of “Standard of Care” Language
The plaintiffs seek to preclude “‘standard of care’ language in relation to any and all
treating physicians’ decisions to implant Plaintiffs with a Pinnacle Pelvic Floor Repair kit (“PFR
Kit”) for treatment of their pelvic organ prolapse.” (Pls.’ Omnibus Mots. in Limine [Docket 199],
at 2). The plaintiffs argue that the use of the term “‘standard of care’ . . . should be limited to
what a reasonable manufacturer would have done when placing a medical device onto the
marketplace,” given that the plaintiffs have not brought any negligence claims against the
treating physicians. (Id. at 2, 4 (emphasis added)). I disagree. Whether the Pinnacle is the
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“standard of care” is highly probative: it goes to the very essence of whether the Pinnacle is
unreasonably dangerous or whether there exists a safer alternative design. If the plaintiffs believe
that the term “standard of care” is confusing or that BSC’s experts have contradicted themselves,
they are free to address those problems at trial through cross-examination. Accordingly, the
plaintiffs’ motion in limine on this issue is DENIED.
b. Motion in Limine No. 2 – AUGS/SUFU & IUGA
The plaintiffs move to preclude evidence relating to position statements made by the
American Urogynecologic Society (“AUGS”) and the Society of Urodynamics, Female Pelvic
Medicine and Urogenital Reconstruction (“SUFU”) and by the International Urogynecological
Association (“IUGA”) concerning mid-urethral slings in the treatment of stress urinary
incontinence (“SUI”). The plaintiffs argue that these statements are irrelevant under Federal Rule
of Evidence 401 and 402 because this case involves POP repair kits. They also argue that the
statements lack a scientific basis and are, thus, not admissible under Federal Rule of Evidence
702 and Daubert v. Merrell Dow Pharms, Inc., 509 U.S. 579 (1993).
First, I do not agree with the plaintiffs that these statements are entirely irrelevant to this
case. The position statements challenged in this motion relate to more than merely mid-urethral
slings in the treatment of SUI. (See, e.g., AUGS & SUFU Position Statement [Docket 199-1], at
2 (stating “[p]olypropylene material is safe and effective as a surgical implant.”); IUGA Position
Statement [Docket 199-2], at 1 (citing to “scientific publications [which] studied all types of
patients, including those with co-morbidities such as prolapse.”).
I have previously denied motions in limine as to this issue. See Huskey, 2014 WL
3861778, at *2; Lewis, 2014 WL 505234, at *2. I explained:
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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 “[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 Lewis, 2014 WL 505234, at *2. Accordingly, in this case,
the plaintiffs’ motion with respect to this issue is DENIED.
2. Plaintiff Amal Eghnayem’s Motion in Limine # 3
The plaintiff, Amal Eghnayem, seeks to preclude testimony or evidence concerning (1)
social media websites; (2) bankruptcy; (3) unrelated medical conditions and procedures; and (4)
prior unrelated injuries because they are irrelevant “to the issues to be determined by the jury.”
(Pl.’s Mot. in Limine # 3 [Docket 221], 1-3). BSC does not intend to offer evidence on Ms.
Eghnayem’s 2001 bankruptcy. (BSC’s Resp. to Pl[.’s] Mot. in Limine # 3 [Docket 228], at 1).
Because BSC does not oppose the plaintiff’s motion in limine with regard to bankruptcy, it is
thus GRANTED. I review the remaining objections in turn.
Next, the plaintiff seeks to exclude all evidence relating to her Facebook account.
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 without additional information. Therefore, a blanket exclusion of
such evidence, argument, or testimony would be premature. Accordingly, the plaintiff’s motion
in limine with regard to social media websites is DENIED without prejudice.
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Lastly, the plaintiff seeks to exclude “any and all evidence of Plaintiff’s unrelated
medical conditions, including medical procedures,” as well as “prior unrelated injuries.” (Pl.’s
Mot. in Limine # 3 [Docket 221], at 2-3). In addition to this motion being overly broad, I FIND
that evidence relating to medical conditions, procedures, and prior injuries is potentially relevant
to the plaintiff’s claims. Therefore, a blanket exclusion of such evidence, argument, or testimony
would be premature. Accordingly, the plaintiff’s motion in limine with regard to medical
conditions, procedures, and prior injuries is DENIED without prejudice.
IV.
Conclusion
For the reasons stated above, BSC’s Initial Motions in Limine [Docket 197] are
GRANTED in part and DENIED in part, BSC’s Motion in Limine to Exclude Evidence of
Dyspareunia [Docket 214] is DENIED without prejudice, Plaintiffs’ Omnibus Motions in
Limine [Docket 199] are DENIED, and Plaintiff Amal Eghnayem’s Motion in Limine # 3
[Docket 221] 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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October 28, 2014
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