Sanchez et al v. Boston Scientific Corporation
MEMORANDUM OPINION AND ORDER (Plaintiffs' Motion for Reconsideration) denying 149 MOTION by Rod Sanchez, Roseanne Sanchez for Reconsideration of 148 Memorandum Opinion and Order. Signed by Judge Joseph R. Goodwin on 10/17/2014. (cc: attys; any unrepresented party) (skh)
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA
ROSEANNE SANCHEZ, et al.,
CIVIL ACTION NO. 2:12-cv-05762
BOSTON SCIENTIFIC CORPORATION,
MEMORANDUM OPINION AND ORDER
(Plaintiffs’ Motion for Reconsideration)
Pending before the court is the Plaintiffs’ Motion for Reconsideration [Docket 149]. The
defendant has responded. [Docket 150]. As discussed below, the motion is DENIED.
On September 29, 2014, I entered a memorandum opinion and order resolving the parties’
motions to exclude or limit expert testimony.1 The plaintiffs ask that I reconsider or clarify three
of those rulings. I address each of the rulings below.
Rule 54(b) of the Federal Rules of Civil Procedure governs reconsideration here. See
Fayetteville Investors v. Commercial Builders, Inc., 936 F.2d 1462, 1469–70 (4th Cir. 1991)
1 By this Order, I amend my Memorandum Opinion and Order entered on September 29, 2014 [Docket 148], at page
29 to replace the words “the plaintiffs” with “BSC” and the appropriate verb agreement in the following sentences: (1)
“The plaintiffs argue that Dr. Mays’s opinions are not reliable because they are litigation driven, not scientific, and not
fair and balanced.”; (2) “Next, the plaintiffs contend that Dr. Mays ‘selectively cite[s] several articles’ and ‘fails[s] to
include contrary statements or literature in [his] report.”; (3) “If the plaintiffs take issue with Dr. Mays’s failure to
review or cite particular documents, this goes to the weight of his opinion, not its admissibility, and can be addressed
on cross-examination.”; and (4) “Finally, the plaintiffs argue that Dr. Mays’s opinions are a poor fit and would not be
helpful to a jury because Dr. Mays was not able to correlate degradation to any clinical symptoms in an individual
(finding that the district court properly reconsidered an interlocutory order under Rule 54(b)); In re
Digitek Prods. Liab. Litig., MDL No. 1968, 2010 WL 5396377, at *1 n.2 (S.D. W. Va. Oct. 20,
2010); Bragg v. Robertson, 183 F.R.D. 494, 495–96 (S.D. W. Va. 1998) (stating that “the Court
retains power to amend interlocutory orders to achieve complete justice”). Rule 54(b) states:
[A]ny order or other decision, however, designated, that adjudicates fewer than all
of the claims or the rights and liabilities of fewer than all the parties does not end
the action as to any of the claims or parties and may be revised at any time before
the entry of a judgment adjudicating all the claims and all the parties’ rights and
Fed. R. Civ. P. 54(b). “Notwithstanding that precept, it is improper to file a motion for
reconsideration simply to ask the Court to rethink what the Court had already thought
through—rightly or wrongly.” Mt. Hawley Ins. Co. v. Felman Prod., Inc., No. 3:09-cv-00481,
2010 WL 1404107, at *2 (S.D. W. Va. Mar. 30, 2010).
Additionally, although a “motion for reconsideration under Rule 54(b) is not subject to the
strictures of a Rule 60(b) motion,” this district has been “guided by the general principles of Rule
59(e) and 60(b) in determining whether a Rule 54(b) motion should be granted. Shrewsbury v.
Cyprus Kanawha Corp., 183 F.R.D. 492, 493 (S.D. W. Va. 1998). In that regard, the Fourth
Circuit has recognized three grounds for amending a judgment: “(1) to accommodate an
intervening change in controlling law; (2) to account for new evidence not available at trial; or (3)
to correct a clear error of law or prevent manifest injustice.” Pac. Ins. Co. v. Am. Nat. Fire Ins. Co.,
148 F.3d 396, 403 (4th Cir. 1998). Such motions “may not be used, however, to raise arguments
which could have been raised prior to the issuance of the judgment, nor may they be used to argue
a case under a novel legal theory that the party had the ability to address in the first instance.” Id.
The plaintiffs ask that I reconsider three Daubert rulings in this case, wherein I granted
Boston Scientific Corporation’s (“BSC”) motion to exclude the expert testimony of Dr. Thomas
Barker, Dr. Michael Thomas Margolis, and Dr. Mark Slack. See Sanchez et al. v. Boston Scientific
Corp., No. 2:12-cv-05762, 2014 WL 4851989, at *5–19, *30–32 (S.D. W. Va. Sept. 29, 2014).
Dr. Michael Margolis
Dr. Margolis is a pelvic floor surgeon and urogynecologist who seeks to opine as to general
and specific causation. In my Daubert ruling, I excluded several of his opinions because I found
his method to be unreliable. See Sanchez, 2014 WL 4851989, at *10-19. The plaintiffs request
reconsideration of the following decisions.
Dr. Margolis’s Rejection of the Ulmsten and Nilsson Studies2
In my Daubert ruling, I excluded Dr. Margolis’s opinion that polypropylene slings are not
safe and effective because his method was unreliable. See id. at *12. In particular, Dr. Margolis
failed to provide a scientific basis for discounting the Nilsson follow-up study, which supports the
conclusion that polypropylene slings are safe and effective. In their original response to BSC’s
Daubert motion, the plaintiffs contended that Dr. Margolis could not explain his rejection of the
Nilsson study because he was “bound by the confidentiality order entered by this Court in Ethicon”
and because of the “work product privilege related to his role in the Ethicon litigation.” (Pls.’
Resp. re: Margolis [Docket 73], at 9). In their original response, the plaintiffs wrote:
The plaintiffs’ Motion for Reconsideration refers to “the Ulmsten and Nilsson series of studies.” (Pls.’ Mot. for
Recons. [Docket 149], at 3). However, the plaintiffs’ original response to BSC’s Daubert motion only notes the
Nilsson study. (See Pls.’ Resp. & Mem. of Law in Opp’n to Mot. to Exclude Michael Thomas Margolis, M.D. (“Pls.’
Resp. re: Margolis”) [Docket 73], at 9-10). Dr. Margolis’s deposition testimony sheds light on the relationship
between these two studies, where he refers to them as “Ulmsten’s original work and then Nilsson’s followup.”
(Margolis Dep. [Docket 132-2], at 193:19-20). Distinguishing between these two studies is immaterial to my Daubert
ruling on Dr. Margolis and my ruling on the plaintiffs’ Motion for Reconsideration, but I point it out for clarification.
Dr. Margolis strongly disagrees with the reliability of findings in the [Nilsson]
study, citing potential bias in data collection. He was not in a position at his
deposition to offer a detailed analysis supporting his rationale for disagreement
with the conclusions in the Nilsson study. Dr. Margolis holds a very sound basis
for his treatment of the findings in the Nilsson study. His understanding of the
potential bias in findings arises from his knowledge obtained in his role as an
expert witness in the Ethicon mesh cases. During deposition, Dr. Margolis
testified that he did not want to directly or indirectly violate confidentiality orders
and work-product privilege in the Ethicon case. These documents may be
produced in camera or under seal, and the parties continue to meet and confer on
(Id. at 9-10 (internal citations omitted)). However, the plaintiffs never provided the court with
documentation explaining Dr. Margolis’s rejection of the study. The plaintiffs even admit this in
their Motion for Reconsideration, stating “Plaintiffs’ counsel offered to produce the documents in
camera, but failed to do so with the result that the Court did not have the information it needed to
make a determination as to the reliability of Dr. Margolis’s methodology.” (Pls.’ Mot. for Recons.
[Docket 149], at 3).
The plaintiffs filed their original response to BSC’s Daubert motion on January 27, 2014,
yet did not provide the court with this information until their Motion for Reconsideration 8 months
later and after I had entered my ruling. The plaintiffs’ untimeliness is an insufficient ground for
reconsideration. See Pac. Ins. Co. v. Am. Nat. Fire Ins. Co., 148 F.3d 396, 403 (4th Cir. 1998)
(“[T]here are three grounds for amending an earlier judgment: (1) to accommodate an intervening
change in controlling law; (2) to account for new evidence not available at trial; or (3) to correct a
clear error of law or prevent manifest injustice.”). The plaintiffs do not get a second chance to
argue their case.
Failure to Consider Contrary Data
In my Daubert ruling, I excluded several other of Dr. Margolis’s opinions because his
method was unreliable. See Sanchez, 2014 WL 4851989, at *11-18. I found that Dr. Margolis
failed to provide a scientific basis for rejecting studies contrary to his opinions and failed to
provide any scientific support for his other opinions. In their Motion for Reconsideration, the
plaintiffs argue that Dr. Margolis considered contrary literature. (See Pls.’ Motion for Recons.
[Docket 149], at 5). This argument was made in the plaintiffs’ original response. (See Pls.’ Resp.
re: Margolis [Docket 73], at 8). In my Daubert ruling, I did not doubt that Dr. Margolis looked at
contrary studies. I found his method to be unreliable because he failed to provide a scientific basis
for rejecting those studies. Thus, this argument is unavailing.
The plaintiffs additionally argue that, in fact, “Dr. Margolis has scientific bases for giving
many of pro-mesh articles less credibility, including (1) his personal knowledge of payment for
results . . . ; (2) peer-reviewed literature demonstrating that industry sponsored literature is
inherently biased for positive results . . . ; (3) his clinical practice and experience that complication
rates are underreported . . . ; and (4) peer reviewed literature demonstrating patients lost the follow
up at alarming rates . . .” (Pls.’ Mot. for Recons. [Docket 149], at 6 (citations omitted)). In support,
the plaintiffs cite and attach an October 2, 2014 affidavit from Dr. Margolis, where he attempts to
better explain his reasoning and deposition testimony that I found so damaging to his reliability.
(See Margolis Oct. 2, 2014 Aff. [Docket 149-2]).
Motions for reconsideration “may not be used . . . to raise arguments which could have
been raised prior to the issuance of the judgment . . .” See Poole v. Ethicon, Inc., No.
2:12-cv-01978, 2013 WL 6164078, at *2 (S.D. W. Va. Nov. 25, 2013) (internal quotations
omitted) (citation omitted). The plaintiffs already had their chance to raise these arguments in their
original response to BSC’s Daubert motion. See id. at *3 (rejecting motion for reconsideration, in
part, because “the plaintiffs appear to raise arguments that could have been raised prior to the
denial of their motion to remand”).
Therefore, the plaintiff’s Motion for Reconsideration as to Dr. Margolis is DENIED.
Dr. Mark Slack
The plaintiffs seek clarification or reconsideration of the court’s Order as to Dr. Slack’s
opinions only as it pertains to product development and testing. (Pls.’ Motion for Recons. [Docket
149], at 6). In my order, I found that Dr. Slack failed to provide a scientific basis for his opinions
because no regulation or authority requires the particular testing Dr. Slack advocates. See Sanchez,
2014 WL 4851989, at *31. In their Motion for Reconsideration, the plaintiffs argue that Dr. Slack
employed a reliable methodology by applying “a published and peer-reviewed set of standards for
pre-market testing to determine whether BSC properly tested and systematically developed the
design of the Pinnacle prior to launch.” (Pls.’ Motion for Recons. [Docket 149], at 6). The
plaintiffs restate the same five standards from a protocol Dr. Slack helped develop as part of the
International Urogynecological Association (“IUGA”) that they cite in their original briefing –
standards which Dr. Slack failed to include in his expert report.3 The reliability of the IUGA
protocol does not dictate my present decision.
Dr. Slack cites the IUGA article at the beginning of his expert report in the description of his background but does
not attach the text. (See Slack Report [Docket 116-1], at 3). When discussing his opinion on product testing and
design, Dr. Slack never mentions the article or the five standards it describes. At the end of his section on clinical
trials, Dr. Slack lists a variety of things BSC should have done prior to product launch, three of which conform to the
standards from his article. However, without aid from the plaintiffs’ brief, I have no way of knowing that Dr. Slack is
relying on the IUGA article in coming to these conclusions.
Moreover, the plaintiffs have ignored the more significant portion of my order stating that
“[m]uch of Dr. Slack’s export report is a narrative review of corporate documents and his opinions
are riddled with improper testimony regarding BSC’s state of mind and legal conclusions.”
Sanchez, 2014 WL 4851989, at *31. My decision stands based solely on this analysis. Because
“Dr. Slack’s impermissible state of mind opinions permeate his entire expert report,” I need not
delve any further into the issue of whether Dr. Slack relied on scientific standards in coming to his
conclusions regarding product testing and design. Id. Accordingly, the plaintiffs’ motion is
Dr. Thomas Barker
Dr. Barker is a biomedical engineer, seeking to offer expert testimony regarding the effects
of polypropylene mesh inside of the human body. In my Daubert ruling, I excluded several of his
opinions because I found his method to be unreliable. See Sanchez, et al., v. Boston Scientific
Corp., No. 2:12-cv-05762, 2014 WL 4851989, at *5-10 (S.D. W. Va. Sept. 29, 2014). The
plaintiffs request reconsideration of the following decisions.
Dr. Barker based his opinions on a series of mechanical tests that he performed on the
Obtryx and Pinnacle mesh. I found his testing method to be unreliable because he (1) failed to
follow published protocols; (2) used an insufficient sample size; (3) failed to meet peer reviewed
standards; and (4) failed to replicate an in vivo environment. See id. at *6.
I found that Dr. Barker failed to follow the published protocols because he did not use a
saline bath in his testing, which was meant to help replicate the physiological environment of the
human body. See id. at *7. I found this flaw to be especially important, since he seeks to opine
about the behavior of the mesh in vivo. See id.
In their original response to BSC’s Daubert motion, the plaintiffs did not refute BSC’s
allegation that Dr. Barker failed to use a saline bath. (Pls.’ Opp’n to Def. Boston Scientific’s Mot.
& Mem. of Law in Supp. of Its Mot. to Exclude the Ops. & Test. of Thomas H. Barker, Ph.D.
(“Pls.’ Resp. re: Barker”) [Docket 89], at 11-13). In fact, the plaintiffs appear to acknowledge this
fact. For example, they stated, “While it is true that Dr. Barker did not use a saline bath in his
mechanical testing, this in no way proves that Dr. Barker’s methodology was flawed.” (Id. at 12
(emphasis added)). The plaintiffs also wrote that “no flaws in methodology can be associated with
Dr. Barker’s failure to use a saline bath in his mechanical testing.” (Id. (emphasis added)).
However, now, in their Motion for Reconsideration, the plaintiffs change their argument
entirely, stating that, in actuality, “Dr. Barker’s testing subjected BSC’s meshes to an identical
saline bath” as the published protocols require. (Pls.’ Mot. for Recons. [Docket 149], at 10). The
plaintiffs attach an October 4, 2014 affidavit from Dr. Barker, where he explains that he did, in
fact, soak the meshes in saline. (See Barker Oct. 4, 2014 Aff. [Docket 149-15], at 1-2). They also
cite to a sentence in Dr. Barker’s expert report where he states, “[a] phosphate buffered saline
solution was used to hydrate each of the Boston Scientific products before testing.” (Barker Report
[Docket 149-16], at 22).
It is unclear to me why the plaintiffs did not raise this argument in their original response. It
is also strange that Dr. Barker himself provided the following deposition testimony:
It goes on to say that, The mesh was allowed to sit in the 37-degree Celsius
saline bath for 10 minutes prior to testing. Correct?
Obviously, in your test the mesh did not sit in any 37-degree Celsius saline
bath prior to testing, is that right?
(Barker Dep. [Docket 71-4], at 197:25-198:8). Under oath, Dr. Barker plainly admits that his mesh
did not sit in a saline bath. Whether this is a misunderstanding on the part of Dr. Barker or on the
part of the plaintiffs, I need not reconcile these inconsistencies. The plaintiffs cannot simply
change their stance by way of a motion for reconsideration. See Pac. Ins. Co., 148 F.3d at 403.
More importantly, even if Dr. Barker did, in fact, soak the mesh in saline, my Daubert
ruling as to Dr. Barker would not change. I still find his method to be unreliable. The use of a saline
bath would not change the fact that his testing also failed to replicate the multi-directional forces of
the female pelvic floor. In their Motion for Reconsideration, the plaintiffs argue that “testing does
not have to replicate the multi-directional forces in the female pelvic floor to arrive at in vivo
conclusions.” (Pls.’ Mot. for Recons. [Docket 149], at 13). In support, the plaintiffs cite to Dr.
Barker’s deposition testimony and new affidavit where he claims that his testing is reflective of the
performance of the mesh in vivo. (See Barker Oct. 4, 2014 Aff. [Docket 149:15], at 4-5; Barker
Dep. [Docket 149-17], at 328:18-330:6). Even so, “it is improper to file a motion for
reconsideration simply to ask the Court to rethink what the Court had already thought
through—rightly or wrongly.” Mt. Hawley Ins. Co., 2010 WL 1404107, at *2. I found ex vivo
mechanical stress tests to be an unreliable basis in forming opinions about the behavior of mesh
inside of the human body. Regardless of the new arguments that the plaintiffs make as to Dr.
Barker’s testing, including those regarding the saline bath or sample size,4 my ultimate conclusion
to exclude Dr. Barker’s testimony is unaffected.
Mechanical Mismatch Opinions
In Sanchez, I found Dr. Barker’s opinions as to the mechanical mismatch between the mesh
and the human body to be unreliable, in part, because he based his elastic modulus calculations of
the mesh on his methodologically flawed and unreliable testing. See Sanchez, 2014 WL 4851989,
at *9. In their Motion for Reconsideration, the plaintiffs now argue that the calculations reached by
Dr. Barker are also available from other sources and are, thus, reliable. The plaintiffs cannot
re-argue their case here. If other sources confirm Dr. Barker’s calculations, the plaintiffs should
have demonstrated that in their original response to BSC’s Daubert motion. See Pac. Ins. Co., 148
F.3d at 403 (stating that motions to amend a judgment “may not be used . . . to raise arguments
which could have been raised prior to the issuance of the judgment . . .”).
Therefore, the Plaintiffs’ Motion for Reconsideration as to Dr. Barker is DENIED.
The court DIRECTS the Clerk to send a copy of this Order to counsel of record and any
ENTER: October 17, 2014
In their Motion for Reconsideration, the plaintiffs make an additional argument about Dr. Barker’s sample size. (See
Pls.’ Motion for Recons. [Docket 149], at 12-13). I need not address this argument because of my finding that his ex
vivo testing provided an unreliable basis for his opinions regarding the mesh’s behavior in vivo.
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