1

IN THE UNITED STATES DISTRICT COURT

FOR THE WESTERN DISTRICT OF TEXAS

AUSTIN DIVISION

MARY CASTILLO, §

§

Plaintiff, §

§

v. § 1:20-CV-513-RP

§

BOSTON SCIENTIFIC CORPORATION, §

§

Defendant. §

ORDER

Before the Court is Defendant Boston Scientific Corporation’s (“BSC”) motion for 

summary judgment, (Dkt. 47), and Plaintiff Mary Castillo’s (“Castillo”) response, (Dkt. 50), as well as 

Castillo’s motion to limit or exclude the opinions of BSC’s expert, (Dkt. 48), and BSC’s response, 

(Dkt. 49).1 After considering the parties’ arguments, the record, and the relevant law, the Court 

grants in part and denies in part BSC’s motion for summary judgment and grants in part and denies 

in part Castillo’s motion to limit or exclude the opinions of BSC’s expert.

I. FACTUAL BACKGROUND AND PROCEDURAL HISTORY

Castillo, who lives in Texas, sought gynecological care. (Mot. Summ. J., Dkt. 47, at 1–2). The 

physician to whom she was referred, Dr. Amanda White (“White”), recommended a medical device 

called the “Advantage Fit System” (“AFS”), “a polypropylene mesh implant to treat [stress urinary 

incontinence (“SUI”)] resulting from urethral hypermobility and/or intrinsic sphincter deficiency,”

manufactured by BSC. (Id. at 2). A number of physicians’ professional organizations, as well as an 

FDA panel, have stated that devices like the AFS are normally relatively safe and effective. (Id. at 5–

6).

1 Neither party filed a reply to the opposing party’s response.

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One of White’s residents, Dr. Emily Goulet (“Goulet”), “handled the pre-operative 

appointments with Plaintiff where the risks and benefits of the procedure were discussed, in part, to 

establish informed consent for the procedure,” and ultimately implanted the AFS in Castillo on 

November 15, 2011. (Id. at 2–3). The parties dispute the extent to which Goulet was aware of the 

various risks posed by the implantation procedure and by the AFS once implanted. (Compare id., with 

Resp. Mot. Summ. J., Dkt. 50, at 10–11). After Goulet implanted the AFS in Castillo, Castillo asserts 

that the AFS caused her “chronic pelvic pain, vaginal pain, dyspareunia, suprapubic pain, recurrent 

urinary tract infections, and chronic urinary dysfunction (including dysuria, frequency, urgency, and 

urge incontinence).” (Resp. Mot. Summ. J., Dkt. 50, at 8; cf. Mot. Summ. J., Dkt. 47, at 6 (“[Castillo] 

alleges that her implant caused her ‘[u]rinary problems, bowel problems, bleeding, dyspareunia, and 

pain.’”)).

The AFS’s directions for use (“DFU”) note a number of potential risks and complications 

and specify that the AFS should be used only by “clinicians with adequate training and experience” 

and that the clinician should “consult the medical literature” prior to implanting the device. (Id.; see 

also DFU, Def.’s Ex. C, Dkt. 47-3). The parties dispute whether Goulet reviewed the DFU prior to 

the procedure and whether additional contact from a BSC representative would have prompted her 

to review it further. (Compare id. at 3, with Resp. Mot. Summ. J., Dkt. 50, at 10). Castillo, meanwhile,

“relied on Dr. Goulet and Dr. White to choose the best approach for treatment of her SUI, and 

[she] has no criticism of how that treatment was handled.” (Mot. Summ. J., Dkt. 47, at 3). Castillo 

herself did not speak with anyone at BSC and does not recall whether she received any additional 

literature from BSC prior to the AFS’s implantation. (Id.).

This case was collected in a multidistrict litigation (“MDL”) in the Southern District of West 

Virginia, one of several concerning devices similar to the AFS. In re Boston Sci. Corp. Pelvic Repair Sys. 

Prods. Liab. Litig., No. 2:12-md-02326, MDL No. 2326 (S.D.W. Va.). Castillo filed her short form 

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complaint on March 23, 2015, (Dkt. 1), which complements the MDL’s master long form complaint, 

(Dkt. 52-4). On May 12, 2020, this case was transferred to the Western District of Texas and the 

undersigned’s docket. (Dkt. 53; see also Transfer Order, Dkt. 51, at 1 (“For the convenience of the 

parties and in order to promote the final resolution of these cases, it appears to the court that the 

cases would be more expeditiously concluded in the venues from which they arise.”)). Prior to the 

transfer, BSC filed its motion for summary judgment on May 13, 2019, (Dkt. 47), and Castillo filed 

her motion to limit or exclude the opinions of BSC’s expert, (Dkt. 48), the same day.

II. BSC’S MOTION FOR SUMMARY JUDGMENT

A. Legal Standard

Summary judgment is appropriate under Federal Rule of Civil Procedure 56 only “if the 

movant shows that there is no genuine dispute as to any material fact and the movant is entitled to 

judgment as a matter of law.” Fed. R. Civ. P. 56(a). A dispute is genuine only if the evidence is such 

that a reasonable jury could return a verdict for the nonmoving party. Anderson v. Liberty Lobby, Inc., 

477 U.S. 242, 254 (1986). “A fact issue is ‘material’ if its resolution could affect the outcome of the 

action.” Poole v. City of Shreveport, 691 F.3d 624, 627 (5th Cir. 2012).

The party moving for summary judgment bears the initial burden of “informing the district 

court of the basis for its motion[] and identifying those portions of [the record] which it believes 

demonstrate the absence of a genuine issue of material fact.” Celotex Corp. v. Catrett, 477 U.S. 317, 

323 (1986). “[T]he moving party may [also] meet its burden by simply pointing to an absence of 

evidence to support the nonmoving party’s case.” Boudreaux v. Swift Transp. Co., 402 F.3d 536, 544 

(5th Cir. 2005). The burden then shifts to the nonmoving party to establish the existence of a 

genuine issue for trial. Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 585–87 

(1986); Wise v. E.I. Dupont de Nemours & Co., 58 F.3d 193, 195 (5th Cir. 1995). Throughout this 

process, the court must view the evidence in the light most favorable to the nonmovant and draw all 

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inferences in the nonmoving party’s favor. Rosado v. Deters, 5 F.3d 119, 122–23 (5th Cir. 1993). It 

may not make credibility determinations or weigh the evidence. Reeves v. Sanderson Plumbing Prods., 

Inc., 530 U.S. 133, 150 (2000).

Unsubstantiated assertions, improbable inferences, and unsupported speculation are not 

competent summary judgment evidence, and thus are insufficient to defeat a motion for summary 

judgment. Turner v. Baylor Richardson Med. Ctr., 476 F.3d 337, 343 (5th Cir. 2007). Furthermore, the 

nonmoving party is required to identify specific evidence in the record and to articulate the precise 

way that evidence supports his claim. Adams v. Travelers Indem. Co. of Conn., 465 F.3d 156, 164 (5th 

Cir. 2006). Rule 56 allows the court to “consider other materials in the record” in addition to what 

the parties cite as evidence. Fed R. Civ. P. 56(c)(3). But it does not impose a duty on the court to 

“sift through the record in search of evidence” to support the nonmoving party’s opposition to the 

motion for summary judgment. Adams, 465 F.3d at 164.

After the nonmoving party has been given the opportunity to raise a genuine factual issue, if 

no reasonable juror could find in its favor, summary judgment will be granted. Miss. River Basin 

Alliance v. Westphal, 230 F.3d 170, 175 (5th Cir. 2000). When the nonmoving party does not respond, 

the Court treats the facts the moving party has raised as “undisputed for the purposes of the 

motion.” Fed. R. Civ. P. 56(e)(2); Eversley v. MBank Dallas, 843 F.2d 172, 174 (5th Cir. 1988).

B. Analysis

Two initial matters merit discussion. First, Castillo originally brought claims for (I) 

negligence;

2

(II) strict liability for design defect; (III) strict liability for manufacturing defect; (IV) 

strict liability for failure to warn; (V) breach of express warranty; (VI) breach of implied warranty, 

2 While listed as a separate count, this claim is effectively an additional theory of liability for design defect, 

manufacturing defect, failure to warn, breach of express warranty, and breach of implied warranty. (See Long 

Form Compl., Dkt. 52-4, at 17–20).

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(VIII) discovery rule, tolling, and fraudulent concealment; and (IX) punitive damages.3(Short Form 

Compl., Dkt. 1, at 4–5; Long Form Compl., Dkt. 52-4, at 17–32). BSC seeks summary judgment on

counts (I)–(VI), and the fraudulent concealment portion of count (VIII), but “has not independently 

moved for summary judgment” on the discovery rule and tolling parts of count (VIII) or count (IX).

(Mot. Summ. J., Dkt. 47, at 1; see Resp. Mot. Summ. J., Dkt. 50, at 1–2). But Castillo states that she 

“will not pursue, and therefore does not object to the dismissal of,” her claims for (III) strict liability 

for manufacturing defect (“relating solely to a claim related to composition or construction”), (V) 

breach of express warranty, (VI) breach of implied warranty, and the fraudulent concealment part of 

count (VIII). (Resp., Dkt. 50, at 1). The Court concludes that given that Castillo does not oppose 

this aspect of BSC’s motion and “acquiesces in the dismissal” of these claims, there is good cause to 

dismiss those claims. McCracken v. Hardberger, No. SA-06-CA-0988-XR, 2008 WL 11411279, at *2 

(W.D. Tex. July 15, 2008). So, the Court’s analysis below concerns only the remaining claims Castillo 

brings on which BSC seeks summary judgment:

1. (I) and (II), negligence and strict liability for design defect; and

2. (I) and (IV), negligence and strict liability for failure to warn.

Second, the parties agree that Texas law applies to these remaining claims. (Mot. Summ. J., 

Dkt. 47, at 6–7; Resp. Mot. Summ. J., Dkt. 50, at 2). The Court accepts the parties’ reasoning and 

accordingly will apply Texas law when appropriate. See Sanchez v. Boston Sci. Corp., No. 2:12-cv-05762, 

2014 WL 202787, at *3–4 (S.D.W. Va. Jan. 17, 2014).

1. (I) and (II): Design Defect

To prevail on her design defect claims under Texas law, Castillo must prove that “(1) the 

[AFS] was defectively designed so as to render it unreasonably dangerous; (2) a safer alternative 

design existed; and (3) the defect was a producing cause of the injury for which [Castillo] seeks 

3 The counts’ numbering follows the complaints’ numbering. Castillo did not bring a claim for loss of 

consortium, which the complaints numbered “VII.” (Short Form Compl., Dkt. 1, at 5).

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recovery.” In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Prod. Liab. Litig., 888 F.3d 753, 765 (5th 

Cir. 2018) (quoting Casey v. Toyota Motor Eng’g & Mfg. N.A., 770 F.3d 322, 330 (5th Cir. 2014)); see 

also Tex. Civ. Prac. & Rem. Code § 82.005(a). The Court finds that BSC is not entitled to summary 

judgment on these claims.

“Texas law defines a safer alternative design as one that “would have prevented or 

significantly reduced the risk of the claimant’s personal injury . . . without substantially impairing the 

product’s utility,” while remaining “economically and scientifically feasible.” DePuy, 888 F.3d at 765 

& n.6 (quoting Tex. Civ. Prac. & Rem. Code § 82.005(b)). “Consistent with this risk-utility 

framework, a plaintiff ‘must show the safety benefits from [the] proposed design are foreseeably 

greater than the resulting costs, including any diminished usefulness or diminished safety.’” Id. at 

765–66 (quoting Casey, 770 F.3d at 331)).

“The Texas Supreme Court and intermediate courts have held that a ‘substantially different 

product’ cannot constitute a safer alternative design.” Id. at 766. Consequently, Texas courts have 

rejected plaintiffs’ “proposed alternative for failing to perform the discrete kinds of functions for 

which the alleged defective was designed,” as opposed to a “slight difference in degree” of how well 

the intended function is performed. Id. at 767. “Texas’s risk-utility test plainly contemplates that a 

proposed alternative design might reduce a product’s utility—that is, its capacity to perform a 

function for which it was designed—without rendering the alternative an entirely different product.” 

Id.

The parties’ disagreement on this issue centers on factor (2) of the overall design-defect test:

whether the opinion of Castillo’s expert witness, Dr. Bruce Rosenzweig (“Rosenzweig”), that a 

number of safer, feasible alternative designs for the AFS exist is sufficient.

4

(See Resp. Mot. Summ. 

4 In its motion, BSC only presents argument on element (2) of the design-defect test. (See Mot. Summ. J., Dkt. 

47, at 10). Finding that BSC is not entitled to summary judgment on Castillo’s design-defect claims for this 

reason, the Court does not reach the test’s other elements.

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J., Dkt. 50, at 3–4). BSC contends that Castillo “has provided no evidence that any alleged safer 

alternative designs to the [AFS] could have significantly reduced the risk of her claimed injuries 

‘without substantially impairing the [AFS’s] utility,’” characterizing Rosenzweig’s opinion as not 

establishing that “the proffered ‘safer alternative designs’ would have provided the same utility.” 

(Mot. Summ. J., Dkt. 47, at 10). In this view, Castillo “has failed to provide evidence that would 

allow a reasonable factfinder to conclude a safer alternative design existed under Texas law.” (Id.). 

Castillo responds that Rosenzweig’s opinion constitutes sufficient evidence that safer, similarly 

functional alternative designs for the AFS existed to survive summary judgment. (See Resp. Mot. 

Summ. J., Dkt. 50, at 4).

The AFS is a medical device made of “a knitted polypropylene monofilament fiber mesh.”

(Rosenzweig Gen. Rep., Pl.’s Ex. B, Dkt. 50-2, at 7). It was intended for “permanent transvaginal 

implantation” to treat “stress urinary incontinence of pelvic organ prolapse.” (Id.). Rosenzweig 

suggests four specific alternative “designs” for the AFS: (1) “the use of sutures, including delayed 

absorbable sutures like PDS, in a colposuspension procedure, like the Burch,” (2) “an autologous 

fascia sling,” (3) “an allograft sling such as Repliform,” and (4) “a sling with less polypropylene such 

as Ultrapro.” (Rosenzweig Specific Rep., Pl.’s Ex. A, Dkt. 50-1, at 29–30).

Designs (1), (2), and (3) do not satisfy the “substantially different product” rule. See Depuy, 

888 F.3d at 766–67. As Rosenzweig himself indicates, Design (1) is a separate and distinct surgical 

procedure from the implantation of the AFS. (See Rosenzweig Gen. Rep., Pl.’s Ex. B, Dkt. 50-2, at 

11–12). Similarly, designs (2) and (3) are composed of entirely different materials than the AFS: 

biological tissue rather than synthetic material. (Id. at 12–13). Thus, these suggestions as alternative 

designs are a “categorical attack” on the AFS, even though they and the AFS serve “the same 

general purpose”; they are not proposed modifications or improvements of the AFS itself. Depuy, 

888 F.3d at 766 (quoting Brockert v. Wyeth Pharm., Inc., 287 S.W.3d 760, 769 (Tex. App.—Houston 

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[14th Dist.] 2009, no pet.)). “The Texas Supreme Court has held that a plaintiff cannot prove design 

defect by claiming that [the] defendant should have sold an entirely different product.” Brockert, 287 

S.W.3d at 770 (citing Caterpillar, Inc. v. Shears, 911 S.W.2d 379, 384–85 (Tex. 1995)).

However, Castillo has established, via Rosenzweig’s reports, that whether design (4) is a valid 

safer and functional alternative design for the AFS is a genuinely disputed material fact. Castillo has 

not “proffered extensive evidence” of this alternative design, via Rosenzweig’s reports or otherwise, 

that design (4) would “have reduced [Castillo’s] injuries, would not have affected the product’s 

utility, and would have been economically and technologically feasible.” Lankston v. Ethicon, Inc., No. 

2:12-CV-00755, 2016 WL 5843723, at *3 (S.D.W. Va. Oct. 4, 2016). But the fact that she can point 

to an extant product as an example of the proposed alternative design strongly suggests that the 

design is indeed less harmful, as functional, and as feasible. Cf. Caterpillar, 911 S.W.2d at 384 

(“Because Shears offered no evidence of a safer design for a loader that could perform the same 

tasks as the Caterpillar model 920, we hold that this product is not defectively designed as a matter 

of law.”). A proposed alternative “design need only prove ‘capable of being developed.’” Gen. Motors 

Corp. v. Sanchez, 997 S.W.2d 584, 592 (Tex. 1999) (quoting Boatland of Houston, Inc. v. Bailey, 609 

S.W.2d 743, 748 (Tex. 1980)). Moreover, “qualified expert testimony on the issue suffices . . . if it 

reasonably supports the conclusion that a reasonable alternative design could have been practically 

adopted at the time of sale.” Id. (quoting Restatement (Third) of Torts § 2 cmt. f (Am. Law. Inst. 1998)). 

Rosenzweig’s report may do that here, particularly when inferences are drawn in Castillo’s favor as 

the nonmoving party at this stage. See Rosado, 5 F.3d at 122–23. A jury is well-situated to evaluate his 

testimony against that of BSC’s competing expert. See Reeves, 530 U.S. at 150. Therefore, BSC is not 

entitled to summary judgment on Castillo’s design-defect claims.

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2. (I) and (IV): Failure to Warn

Next, BSC argues that the learned intermediary doctrine bars Castillo’s failure-to-warn claims 

“[w]hether sounding in strict liability, negligence, or breach of express or implied warranties.” (Mot. 

Summ. J., Dkt. 47, at 11). The Court agrees: though the DFU was likely defective, Castillo has not

shown the required causation.

The learned intermediary doctrine applies to medical devices such as the AFS. Porterfield v. 

Ethicon, Inc., 183 F.3d 464, 468 (5th Cir. 1999). “In order to recover for a failure to warn under the 

learned intermediary doctrine, a plaintiff must show: (1) the warning was defective; and (2) the 

failure to warn [the intermediary, i.e., the doctor] was a producing cause of the plaintiff’s condition 

or injury.” Id. But “if the warning to the intermediary was inadequate or misleading, then the 

manufacturer remains liable for injuries sustained by the end user.” Centocor, Inc. v. Hamilton, 372 

S.W.3d 140, 170 (Tex. 2012); cf. id. at 158 (“A prescription drug manufacturer fulfills its duty to warn 

end users of its product’s risks by providing adequate warnings to the intermediaries who prescribe 

the drug and, once fulfilled, it has no further duty to warn the end users directly.”).

a. Adequacy of Warning

“Texas law generally holds that the adequacy of a product’s warning is a question of fact to 

be determined by the jury.” McNeil v. Wyeth, 462 F.3d 364, 368 (5th Cir. 2006). But if the “warning 

specifically mentions the circumstances complained of, the warning is adequate as a matter of law.”

Id. (quoting Rolen v. Burroughs Wellcome Co., 856 S.W.2d 607, 609 (Tex. App.—Waco 1993, writ 

denied)). However, when the warning mentions the circumstances complained of, but is “misleading 

as to the risk level for developing the condition,” the Fifth Circuit has “appl[ied] the default Texas 

rule that adequacy questions go to the jury.” Id. The rationale is that “[w]arning the learned 

intermediary of a much lower risk than the actual risk could render the warning not just misleading, 

but ineffective.” Id.

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BSC maintains that it “adequately warned Dr. Goulet of the risks associated with the device 

at issue, including the very injuries now claimed by Plaintiff” via the DFU included with the AFS.

(Mot. Summ. J., Dkt. 47, at 12). Castillo responds that the DFU was inadequate because it “[did] not 

specifically mention all of Ms. Castillo’s injuries or the specific circumstances that caused her 

injuries, and it reported risks much lower than the actual risks.” (Resp. Mot. Summ. J., Dkt. 50, at 7).

The DFU specifies contraindications; a general warning; precautions to be taken before, 

during, and after implantation; adverse events that “have been reported” after implantation; and 

potential complications that “have been reported as consequences that may occur in a suburethral 

sling procedure.” (DFU, Def.’s Ex. C, Dkt. 47-3, at 3–5, 8). Of these DFU sections, the “potential 

complications” portion is most salient. (Id. at 8). That portion does not specify a likelihood of each 

complication occurring, whether in relative or quantitative terms, beyond that they “may occur.” See

McNeil, 462 F.3d at 368 (“[I]f the manufacturer decides to label a risk as ‘comparatively rare’ and also 

to provide a numerical quantification of that risk, that number must be within a certain degree of 

accuracy.”).

Below is a chart listing the conditions Castillo asserts that she suffered after the AFS’s 

implantation and the notations in the DFU’s “potential complications” portion that most closely 

correspond to them:

5

Castillo’s conditions

(Resp. Mot. Summ. J., Dkt. 50, at 8)

The DFU’s “potential complications”

(DFU, Def.’s Ex. C, Dkt. 47-3, at 8)

chronic pelvic pain pelvic, vaginal pain

vaginal pain pelvic, vaginal pain

dyspareunia dysparenia [sic]

suprapubic pain pelvic, vaginal pain

recurrent urinary tract infections infection

chronic urinary dysfunction (including 

dysuria, frequency, urgency, and urge

incontinence)

irritative voiding symptoms including 

urgency and urge incontinence

urinary retention

recurrent stress urinary incontinence

5 Each entry in the chart is a quote, but the chart omits quotation marks and modifies capitalization.

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While the DFU appears to list each of the conditions Castillo suffered after her AFS’s 

implantation, it states only that each “may occur.” Castillo maintains that the DFU “do[es] not 

sufficiently or adequately advise physicians on the permanence, frequency, or severity of the 

complications that can arise from the use of the devices.” (Resp. Mot. Summ. J., Dkt. 50, at 7). She 

also identifies several conditions, besides the ones from which she suffers, that the AFS could cause 

and that the DFU does not list—in particular, several other harmful “polypropylene mesh 

characteristics” in addition to the overarching point that the polypropylene in the AFS “was not 

intended for use as a permanent implant in the human body.” (Id. at 7–8; see also Rosenzweig Gen. 

Rep., Pl.’s Ex. B, Dkt. 50-2, at 54–556). And she notes that “BSC admits occurrence rates for adverse 

events were not disclosed in their brochures or DFUs.” (Id.).

“The issue therefore is whether there is a genuine issue of material fact as to whether the 

[DFU] was misleading. This must be viewed in terms of significant differences between the 

disclosed risk and the actual risk.” McNeil, 462 F.3d at 369; see also DePuy, 888 F.3d at 773 (“[I]n 

determining whether warnings are adequate as a matter of law, Texas courts subject them to a 

demanding standard of specificity.”). “When the differences in risk” between the levels expressed in 

the DFU and the actual levels “are significant, their potential misleading impact is a question for the 

jury.” McNeil, 462 F.3d at 368 n.4; see also id. (citing Salmon v. Parke, Davis & Co., 520 F.2d 1359, 1363 

(4th Cir. 1975)) (“Other courts have also recognized that warnings that are ‘unreasonably diluted’ 

may be misleading and thus inadequate.”). The DFU makes a limited claim about the potential 

6 “The Mesh Products’ DFUs do not inform the physician that the devices can chemically and biologically 

degrade, shrink, contract, rope, curl, fold, flake, crack, embrittle, stiffen, harden, elongate, or otherwise alter 

inside the human body. . . . The Mesh Products’ DFUs do not inform physicians that a woman’s tissue 

responses to BSC’s meshes can induce a greater foreign body, enhanced inflammatory response, excessive 

scarring, multiple erosions that persist for life, chronic and debilitating pelvic pain and new pain syndromes, 

recurrence, worsening or de novo incontinence, chronic and permanent dyspareunia, new infections, rejection 

of the mesh, permanent sexual dysfunction, defecatory dysfunction, vaginal scarring; wound healing 

problems, or injury to ureters, bladder, and urethra.”

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complications’ likelihood: they “may occur.” But this is in fact a double claim. It states a probability 

of complications occurring—the DFU uses “may,” when it could have used “will” or “are likely to,” 

for example. And it states a prediction of permanency—the DFU’s use of “may occur” suggests that 

the complication may arise, rather than that it may both arise and last for an extended period of 

time.

Whether this disclosed level of risk is significantly different than the actual level of risk, 

when considered in combination with the additional possible complications Castillo identifies that 

the DFU does not list, would be a question of fact for the jury. BSC would be “free to argue, to a 

jury, its view of the proper weight to be given” to Castillo’s assertions of high risk. Id. at 371.

b. Causation

However, to prevail on her failure-to-warn claims, Castillo must present sufficient evidence 

both of the DFU’s inadequacy and that “the inadequate warning was the producing cause of [her] 

injuries.” Centocor, 372 S.W.3d at 170; see also McNeil, 462 F.3d at 372. This is a conjunctive test. The 

Court finds that Castillo does not present sufficient evidence of causation, entitling BSC to summary 

judgment on Castillo’s failure-to-warn claims.

“In the LI context, causation entails two distinct factual predicates: first, that the doctor would 

have read or encountered the adequate warning; and second that the adequate warning would have 

altered his treatment decision for, or risk-related disclosures to, the patient.” DePuy, 888 F.3d at 775. 

BSC challenges Castillo’s ability to establish the first predicate, contending that because “Goulet did 

not review the DFU before implanting the device at issue into [Castillo]” and “was aware of 

potential risks involved with the procedure,” Castillo cannot establish that the inadequate warning 

was the producing cause of her injuries. (Mot. Summ. J., Dkt. 47, at 14). Castillo responds by 

pointing to Goulet’s testimony that she “sometimes [did] read through [DFUs],” but that she could 

not “recall for this case or at the time regarding this device,” i.e., Castillo’s AFS. (Goulet Dep., Pl.’s 

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Ex. C, Dkt. 50-3, at 73:8–73:11;7 Resp. Mot. Summ. J., Dkt. 50, at 10). When asked if “at some point 

[she] would have reviewed the directions for use for the [AFS], Goulet answered that she was “not 

sure.” (Goulet Dep., Pl.’s Ex. C, Dkt. 50-3, at 73:15–73:19).

The Fifth Circuit’s decision in Pustejovsky v. Pliva, Inc. is instructive. 623 F.3d 271 (5th Cir. 

2010) (applying Texas law). After determining that the plaintiff’s doctor “was not fully aware of the 

risk” of the drug at issue, the court concluded that the plaintiff had not carried her summaryjudgment burden to “show that a proper warning would have changed” the doctor’s decision. Id. at 

277. The doctor “did not recall ever reading the package insert for the drug or consulting the 

Physician’s Desk Reference,” and so the plaintiff “[l]acked any evidence that [the doctor] was aware 

of” the warning. Id. The Fifth Circuit reasoned that the doctor’s “lack of memory, of course, does 

not preclude the possibility that she had read these materials, but neither can it sustain [the 

plaintiff’s] burden” on summary judgment. Id. The plaintiff suggested other ways in which the 

doctor could have learned of an adequate warning but “provided evidentiary support for none of 

them.” Id. The Fifth Circuit arrived at a similar conclusion eight years later in DePuy, considering the 

“discrete evidentiary voids” about whether and how the doctors in that case “actually read or 

encountered defendants’ inadequate warnings” to be dispositive. 888 F.3d at 775.

Similarly, here, assuming that the warning was deficient and that Goulet was not fully aware 

of the risks the AFS posed to Castillo,

8 Castillo has not established that a proper warning would 

have changed Goulet’s decision to offer the AFS. As in Pustejovsky, Goulet did not affirmatively 

testify that she ever reviewed the AFS’s DFU, but rather that she could not recall if she had ever 

7 Unlike other citations in this Order, which refer to CM/ECF-assigned page numbers, citations to deposition 

transcripts refer to the page number printed in the transcript.

8 Goulet testified that she had been unaware, prior to Castillo’s procedure, that “chronic vaginal pain” was “a 

risk associated with the [AFS].” (Goulet Dep., Pl.’s Ex. C, Dkt. 50-3, at 79:2–79:9). Had she been aware, 

Goulet testified, she “wouldn’t have offered the [AFS]” as a treatment. (Id. at 79:10–79:19). She was similarly 

unaware of the other risks that Castillo identified (via Rosenzweig), as described in Part I.B.2.a above. (See id.

at 79:20–80:3, 80:15–81:4, 81:14–81:19, 81:20–82:2, 90:16–91:5).

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done so. While it remains possible that Goulet did review the DFU (whether in general or prior to 

Castillo’s procedure), Castillo has not presented the evidence that Goulet did in fact do so required 

to defeat summary judgment. Hypothetical situations, such as if a BSC representative had specially 

contacted Goulet, do not suffice. See Turner, 476 F.3d at 343. Therefore, BSC is entitled to summary 

judgment on Castillo’s failure-to-warn claims.

III. CASTILLO’S MOTION TO LIMIT OR EXCLUDE THE OPINIONS OF BSC’S 

EXPERT

Separately, Castillo asks the Court to exclude or limit the opinions of Dr. Jennifer Anger 

(“Anger”), BSC’s expert, as to general and specific causation. (Mot. Exclude, Dkt. 48, at 1). The 

Court grants in part and denies in part Castillo’s request, excluding Anger’s opinions on general 

causation, but allowing Anger’s opinions on specific causation to the extent specified in her report.

A. General Causation

Castillo’s first argument is that “Dr. Anger’s general causation opinions [are] outside the 

scope of her Rule 26 designation,” since “BSC designated Dr. Anger only as a case specific expert” 

in its disclosure.9(Id.).

BSC disclosed Anger as a retained expert witness on March 22, 2019. (BSC Rule 26 

Disclosure, Pl.’s Ex. A, Dkt. 48-1, at 3). BSC’s disclosure incorporated Anger’s expert report, (Anger 

Expert Rep., Pl.’s Ex. B, Dkt. 48-2), which, as BSC describes it, “contains nearly 8 pages of opinions 

generally relating to polypropylene mesh midurethral slings and stress urinary incontinence” 

followed by “several pages of opinions specific to [Castillo] as well as a summary of both her general 

9 In the motion now before the Court, BSC contends that Castillo should not have filed a separate challenge 

to Anger’s general causation opinions, per the MDL court’s pretrial order that required a single general 

causation challenge filed in the MDL itself. (Resp. Mot. Exclude, Dkt. 49, at 3); see Boston Sci. Corp., No. 2:12-

md-02326, MDL No. 2326 (S.D.W. Va. filed Oct. 31, 2018) (Pretrial Order # 196, Dkt. 7153). While in the 

context of an MDL, following administrative orders is of paramount importance to ensure the docket does 

not become unwieldy, arguments to this effect are less pressing in the context of an individual case 

transferred from the MDL.

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and case specific opinions,” (Resp. Mot. Exclude, Dkt. 49, at 2–3). BSC notes that it “makes no 

delineation between ‘general’ and ‘case-specific’ expert witnesses.” (Id. at 2). Its disclosure lists Anger 

only as a “retained expert witness[]” and refers to the attached expert report. (BSC Rule 26 

Disclosure, Pl.’s Ex. A, Dkt. 48-1, at 3).

At a previous point in the MDL from which this case was transferred, the plaintiffs moved 

to exclude Anger’s general causation opinions. Boston Sci. Corp., No. 2:12-md-02326, MDL No. 2326 

(S.D.W. Va. filed Jan. 11, 2018) (Mot, Dkt. 4828). The court granted the plaintiffs’ motion on the 

ground that “the time for expert disclosure ha[d] passed and Dr. Anger was disclosed only as a 

specific causation expert.” Id. (S.D.W. Va. filed May 29, 2018) (Order, Dkt. 6040, at 5); see also id.

(“While Dr. Anger is permitted to rely on the general causation opinions proffered by experts who 

are properly designated to offer such opinions when forming her case-specific opinions relating to 

particular plaintiffs, she may not exceed the bounds of her designation by offering these opinions 

herself.”).

In the next “wave” of cases, the plaintiffs again moved to exclude Anger’s opinions. Id.

(S.D.W. Va. filed Oct. 18, 2018) (Mot., Dkt. 7003). The court did not rule on the motion, and the 

plaintiffs adopted that motion and the reply they had previously filed for the subsequent wave, 

which included this case. Id. (S.D.W. Va. filed May 13, 2019) (Notice, Dkt. 8060). BSC did the same 

for its response to plaintiffs’ motion. Id. (S.D.W. Va. filed May 28, 2019) (Notice, Dkt. 8147).

The first portion of Anger’s expert report in this case, which contains her general opinions, 

is nearly identical to the iteration of Anger’s expert report that the MDL court considered when it 

granted the MDL plaintiffs’ motion to exclude. Compare id. (S.D.W. Va. filed Jan. 11, 2018) (Anger 

Expert Rep., Pl.’s Ex. 1, Dkt. 4828-1, at 2–9), with (Anger Expert Rep., Pl.’s Ex. B, Dkt. 48-2, at 2–

9). Indeed, BSC’s arguments against Castillo’s motion in this case overlap substantially with its 

arguments against the MDL plaintiffs’ motion to exclude. Compare Boston Sci. Corp., No. 2:12-mdCase 1:20-cv-00513-RP Document 62 Filed 05/28/20 Page 15 of 19
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02326, MDL No. 2326 (S.D.W. Va. filed Feb. 1, 2018) (Resp. Mot. Exclude, Dkt. 4970, at 3–8), with

(Resp. Mot. Exclude, Dkt. 49, at 4–11). The Court sees no reason to deviate from the MDL court’s 

order on the previous iteration, which prohibited Anger from offering general causation testimony, 

including those opinions listed in her expert report in this case under the headings “Urinary 

Incontinence: Condition and Treatment,” “Midurethral Slings,” and “Midurethral Slings Are the 

Standard of Care in Treatment of SUI.” Boston Sci. Corp., No. 2:12-md-02326, MDL No. 2326

(Order, Dkt. 6040, at 4–5); (see Anger Expert Rep., Pl.’s Ex. B, Dkt. 48-2, at 2–9). While BSC 

maintains that Castillo’s arguments concerning its expert disclosure “lack[] any muster,” it does not 

provide any basis for departing from the MDL court’s ruling on a nearly identical record. (Resp. 

Mot. Exclude, Dkt. 49, at 3).

Reaching a contrary result would contravene the law of the case doctrine, which applies to 

cases transferred from MDLs. See McKay v. Novartis Pharm. Corp., 751 F.3d 694, 703–05 (5th Cir. 

2014). “The law of the case doctrine requires that courts not revisit the determinations of an earlier 

court unless (i) the evidence on a subsequent trial was substantially different, (ii) controlling 

authority has since made a contrary decision of the law applicable to such issues, or (iii) the decision 

was clearly erroneous and would work . . . manifest injustice.” Id. at 703 (quoting In re Ford Motor Co., 

591 F.3d 406, 411–12 (5th Cir. 2009)). The Fifth Circuit has held that allowing parties “to relitigate 

in the remand court issues decided by the MDL court with arguments that could have been raised 

but were not would ‘frustrate the purposes of centralized pretrial proceedings.’” Id. at 705 (quoting 

Ford Motor Co., 591 F.3d at 411). Transferee courts are well within their discretion to refuse to 

reconsider the MDL court’s rulings. Id. Consequently, finding none of the defects justifying 

reconsideration that the Fifth Circuit has identified, the Court will exercise that discretion here and 

exclude Anger’s general causation opinions in accordance with the MDL court’s previous ruling.

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B. Specific Causation

Next, Castillo argues that Anger’s opinions concerning specific causation, as expressed in her 

expert report, are insufficiently detailed, violating Federal Rule of Civil Procedure 26(a)(2)(B). (Mot. 

Exclude, Dkt. 48, at 8–10). 

In federal court, “an expert witness must produce all data she has considered in reaching her 

conclusions.” Biestek v. Berryhill, 139 S. Ct. 1148, 1154 (2019) (citing Fed. R. Civ. P. 26(a)(2)(B)). 

“Expert reports under Rule 26 must be ‘detailed and complete,’ not ‘sketchy and vague.’” Harmon v. 

Georgia Gulf Lake Charles L.L.C., 476 F. App’x 31, 36 (5th Cir. 2012) (quoting Fed. R. Civ. P. 26 

advisory committee’s note to 1993 amendment). “Whether an expert report is sufficiently complete, 

detailed, and in compliance with the Rules so that surprise is eliminated, unnecessary depositions are 

avoided, and costs are reduced depends on the nature of the expert testimony and the opinions 

expressed.” Charles v. Sanchez, No. EP-13-CV-00193-DCG, 2015 WL 808417, at *16 (W.D. Tex. Feb. 

24, 2015). “[T]here will be instances in which testimony—although qualifying as opinion testimony 

that requires an expert report—is not so complicated that it requires something extensive. Because 

expert testimony can vary widely according to the subject matter of the litigation, the issues in a case, 

and the nature of the opinions themselves, it is difficult to generalize about how detailed an expert’s 

report should be.” Norris v. United States, No. 3:11-CV-1351-D, 2012 WL 1231804, at *2 (N.D. Tex. 

Apr. 12, 2012). Here, Castillo challenges two aspects of Anger’s expert report that Rule 26(a)(2)(B) 

requires: “a complete statement of all opinions the witness will express and the basis and reasons for 

them” and “the facts or data considered by the witness in forming them.”

Anger’s expert report contains both of these elements and thus satisfies Rule 26(a)(2)(B)’s 

requirements. First, she details the aspects of Castillo’s medical records that give rise to her 

conclusions. (Anger Expert Rep., Pl.’s Ex. B, Dkt. 48-2, at 9–13). Second, she explains her opinions 

about the conditions Castillo suffered and how she derived those opinions. (Id. at 12–13). Castillo 

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complains of Anger’s explanations’ relative brevity, (see Mot. Exclude, Dkt. 48, at 9), but the Court 

finds that the explanations, though brief, nonetheless satisfy Rule 26’s requirements. See, e.g., Norris, 

2012 WL 1231804, at *2 (“Although Dr. Coburn’s report is brief and lacks certain detail that 

plaintiffs might have preferred to have obtained without taking his deposition, the court cannot say 

that the report fails to satisfy the requirement that it contain ‘a complete statement of all opinions 

the witness will express and the basis and reasons for them.’”); cf. Honey-Love v. United States, 664 F. 

App’x 358, 361 (5th Cir. 2016) (finding expert report deficient when it did not specifically reference 

medical records and provided no basis or reasons for opinions).

Nothing in the specific causation portion of Anger’s report is “sketchy or vague,” Castillo 

“will not be ambushed at trial by the opinions expressed in the report,” and if Anger “testifies at 

trial, [she] will be limited to the opinions expressed in the report.” Charles, 2015 WL 808417, at *16. 

Moreover, as BSC notes, Castillo already had the opportunity to depose Anger and scrutinize the 

bases for her opinions, (see Resp. Mot. Exclude, Dkt. 49, at 11), weakening Castillo’s arguments that 

the written report is lacking. See Carlton v. Freer Inv. Grp., Ltd., No. 5:15-CV-946-DAE, 2017 WL 

11046201, at *16 (W.D. Tex. Aug. 8, 2017) (“Defendants having been afforded ample notice of [the 

expert’s] opinions . . . and extensive cross-examination on those opinions, this testimony does not 

represent the type of ambush at trial which Rule 26(a) is designed to prevent.”). Accordingly, the 

Court will not exclude Anger’s specific causation opinions on this basis—the only basis Castillo 

offers to exclude them.

IV. CONCLUSION

For the reasons discussed above, IT IS ORDERED that BSC’s motion for summary 

judgment, (Dkt. 47), is GRANTED IN PART AND DENIED IN PART. It is GRANTED as 

to Castillo’s failure-to-warn claims, counts (I) and (IV). It is DENIED as to Castillo’s design-defect 

claims, counts (I) and (II).

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IT IS FURTHER ORDERED that Castillo’s failure-to-warn claims, counts (I) and (IV), 

are DISMISSED.

IT IS FURTHER ORDERED that Castillo’s claims in counts (III) strict liability for 

manufacturing defect (“relating solely to a claim related to composition or construction”), (V) 

breach of express warranty, and (VI) breach of implied warranty, as well as the fraudulent 

concealment part of count (VIII), are DISMISSED.

IT IS FINALLY ORDERED that Castillo’s motion to limit or exclude the opinions of 

BSC’s expert, (Dkt. 48), is GRANTED IN PART AND DENIED IN PART. It is GRANTED

as to Anger’s opinions on general causation, which are excluded, consistent with the MDL court’s 

previous order. See Boston Sci. Corp., No. 2:12-md-02326, MDL No. 2326 (Order, Dkt. 6040, at 4–5).

It is DENIED as to Anger’s opinions on specific causation, which are admissible to the extent 

disclosed in her expert report. (See Anger Expert Rep., Pl.’s Ex. B, Dkt. 48-2).

SIGNED on May 28, 2020.

_____________________________________

ROBERT PITMAN

UNITED STATES DISTRICT JUDGE

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