Cisson et al v. C.R. Bard, Inc.

Filing 274

MEMORANDUM OPINION AND ORDER (Daubert Motions) granting 91 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Denniz Zolnoun, MD, MPH; granting 94 MOTION by C. R. Bard, Inc. to Exclude the Testimony and Opinions of Dean Alte nhofen, M.D.; granting 98 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Dr. Bob Shull, M.D.; granting 100 MOTION by C. R. Bard, Inc. to Exclude the Opinions and Testimony of Timothy J. Loving, Ph.D. and Janell L. Carroll, Ph. D.; granting in part and denying in part 103 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Plaintiffs' Treating Physicians; granting in part and denying in part 108 MOTION by C. R. Bard, Inc. to Limit the Opinions and Te stimony of Dr. Bernd Klosterhalfen, M.D.; granting in part and denying in part 110 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Lennox Hoyte, M.D.; granting in part and denying in part 113 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of David A. Kessler, M.D.; granting in part and denying in part 127 MOTION by C. R. Bard, Inc. to Exclude the Opinions and Testimony of Anthony B. Brennan, Ph.D; granting in part and denying in part 130 MOTION by C. R. Bard, Inc. to Exclude the Opinions and Testimony of Ahmed El-Ghannam, Ph.D.; granting in part and denying in part 154 MOTION by C. R. Bard, Inc. to Limit the Opinions and Testimony of Julia E. Babensee, Ph.D.; granting in part and denying in part 250 MOTION by Dan Cisson, Donna Cisson to Exclude Opinions and Testimony of Marta Villaraga, Ph.D. and Maureen Reitman, Sc.D. Signed by Judge Joseph R. Goodwin on 6/4/2013. (cc: attys; any unrepresented party) (skh)

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

C. R. BARD, INC.,
PELVIC REPAIR SYSTEM PRODUCTS LIABILITY LITIGATION
MDL No. 2187

_________________________________________
THIS DOCUMENT RELATES TO CIVIL ACTION
NUMBERS:
Cisson, et al. v. C. R. Bard, Inc.
Queen, et al. v. C. R. Bard, Inc.
Rizzo, et al. v. C. R. Bard, Inc.
Jones v. C. R. Bard, Inc.

2:11-cv-00195
2:11-cv-00012
2:10-cv-01224
2:11-cv-00114

MEMORANDUM OPINION AND ORDER
(Daubert Motions)
Pending before the court are C. R. Bard, Inc. (“Bard”)’s Daubert motions:1 Defendant C.
R. Bard, Inc.’s Motion to Limit the Opinions and Testimony of Denniz Zolnoun, M.D., M.P.H.
[Docket 91]; Defendant C. R. Bard, Inc.’s Motion to Exclude the Testimony and Opinions of
Dean Altenhofen, M.D. [Docket 94]; Defendant C. R. Bard, Inc.’s Motion to Exclude the
Opinions and Testimony of Timothy J. Loving, Ph.D. and Janell L. Carroll, Ph.D. [Docket 100];
Defendant C. R. Bard, Inc.’s Motion to Limit the Opinions and Testimony of Dr. Bob Shull,
M.D. [Docket 98]; Defendant C. R. Bard, Inc.’s Motion to Limit the Opinions and Testimony of
Plaintiffs’ Treating Physicians [Docket 103]; Defendant C. R. Bard, Inc.’s Motion to Limit the
Opinions and Testimony of Dr. Bernd Klosterhalfen, M.D. [Docket 108]; Defendant C. R. Bard,

1

In the four bellwether cases noted above, Bard has filed identical Daubert motions in all
bellwether cases, with Jones v. C. R. Bard, Inc., No. 2:11-cv-00114 containing one additional motion
regarding Dr. Lentnek. Except where specifically noted, all docket numbers refer to filings in Cisson v. C.
R. Bard, Inc., No. 2:11-cv-00195, because that is the first case set for trial. However, my rulings apply to
the identical motions filed in all bellwether cases.

Inc.’s Motion to Limit the Opinions and Testimony of Lennox Hoyte, M.D. [Docket 110];
Defendant C. R. Bard, Inc.’s Motion to Limit the Opinions and Testimony of David A. Kessler,
M.D. [Docket 113]; Defendant C. R. Bard, Inc.’s Motion to Exclude the Opinions and Testimony
of Ahmed El-Ghannam, Ph.D. [Docket 130]; Defendant C. R. Bard, Inc.’s Motion to Exclude the
Opinions and Testimony of Anthony B. Brennan, Ph.D. [Docket 127]; Defendant C. R. Bard,
Inc.’s Motion to Limit the Opinions and Testimony of Arnold Lentnek, M.D. [Docket 105];2 and
Defendant C. R. Bard, Inc.’s Motion to Limit the Opinions and Testimony of Julia E. Babensee,
Ph.D. [Docket 154]. Also pending before the court is Plaintiffs’ Motion to Exclude Opinions and
Testimony of Marta Villarraga, Ph.D. and Maureen Reitman, Sc.D. and Brief in Support [Docket
250].
As set forth below, Bard’s motions with respect to Dr. Zolnoun [Docket 91], Dr.
Altenhofen [Docket 94], Dr. Loving and Dr. Carroll [Docket 100] and Dr. Shull [Docket 98] are
GRANTED, Bard’s motions with respect to the treating physicians [Docket 103], Dr.
Klosterhalfen [Docket 108], Dr. Hoyte [Docket 110], Dr. Kessler [Docket 113], Dr. El-Ghannam
[Docket 130], Dr. Brennan [Docket 127], Dr. Lentnek (Jones [Docket 105]), and Dr. Babensee
[Docket 154] are GRANTED in part and DENIED in part, and the plaintiffs’ motion [Docket
250] is GRANTED in part and DENIED in part.
I.

Background
These cases are four of several thousand assigned to me by the Judicial Panel on

Multidistrict Litigation and currently set for trial pursuant to Pretrial Order # 32.3 These MDLs
involve use of transvaginal surgical mesh to treat pelvic organ prolapse or stress urinary

2

This motion is filed only with respect to the bellwether plaintiff Carolyn Jones, and the docket
number refers to Jones v. C. R. Bard, Inc., No. 2:11-cv-00114.
3
Originally, there was a fifth case, Smith v. C. R. Bard, No. 2:10-cv-01355, which was terminated
on February 22, 2013 pursuant to a Stipulation of Dismissal/Order.

2

incontinence. The four bellwether cases involve implantation of one or more products, but only
the pelvic organ prolapse products are at issue. The plaintiffs in these cases allege injuries
suffered as a result of Avaulta products implanted in Ms. Cisson, Ms. Queen, Ms. Rizzo, and Ms.
Jones. The Complaints allege the following causes of action: 1) negligence; 2) strict liability –
design defect; 3) strict liability – manufacturing defect; 4) strict liability – failure to warn; 5)
breach of express warranty; 6) breach of implied warranty; 7) loss of consortium; and 8) punitive
damages. (See, e.g., Compl. [Docket 1]). The plaintiffs, as well as Bard, have retained many
experts to render opinions regarding the elements of these causes of action. The instant motions
involve the parties’ efforts to exclude or limit the opinions and testimony of many of these
experts.
II.

Legal Standard
Under Federal Rule of Evidence 702, expert testimony is admissible if it will “help the

trier of fact to understand the evidence or to determine a fact in issue” and (1) is “based upon
sufficient facts or data” and (2) is “the product of reliable principles and methods” which (3) has
been reliably applied “to the facts of the case.” Fed. R. Evid. 702. A two-part test governs the
admissibility of expert testimony. The evidence is admitted if it “rests on a reliable foundation
and is relevant.” Daubert v. Merrell Dow Pharm., 509 U.S. 579, 597 (1993). The proponent of
expert testimony does not have the burden to “prove” anything. He must, however, “come
forward with evidence from which the court can determine that the proffered testimony is
properly admissible.” Maryland Cas. Co. v. Therm-O-Disc, Inc., 137 F.3d 780, 783 (4th Cir.
1998).
The district court is the gatekeeper. It is an important role: “[E]xpert witnesses have the
potential to be both powerful and quite misleading[;]” the court must “ensure that any and all

3

scientific testimony . . . is not only relevant, but reliable.” Cooper v. Smith & Nephew, Inc., 259
F.3d 194, 199 (4th Cir. 2001) (citing Westberry v. Gislaved Gummi AB, 178 F.3d 257, 261 (4th
Cir. 1999) and Daubert, 509 U.S. at 588, 595). I “need not determine that the proffered expert
testimony is irrefutable or certainly correct” – “[a]s with all other admissible evidence, expert
testimony is subject to testing by ‘[v]igorous cross-examination, presentation of contrary
evidence, and careful instruction on the burden of proof.’” United States v. Moreland, 437 F.3d
424, 431 (4th Cir. 2006) (quoting Daubert, 509 U.S. at 596 (alteration in original)); see also
Maryland Cas. Co., 137 F.3d at 783 (noting that “[a]ll Daubert demands is that the trial judge
make a ‘preliminary assessment’ of whether the proffered testimony is both reliable . . . and
helpful”).
Daubert mentions specific factors to guide the overall relevance and reliability
determinations that apply to all expert evidence. They include (1) whether the particular
scientific theory “can be (and has been) tested”; (2) whether the theory “has been subjected to
peer review and publication”; (3) the “known or potential rate of error”; (4) the “existence and
maintenance of standards controlling the technique’s operation”; and (5) whether the technique
has achieved “general acceptance” in the relevant scientific or expert community. United States
v. Crisp, 324 F.3d 261, 266 (4th Cir. 2003) (quoting Daubert, 509 U.S. at 593-94).
Despite these factors, “[t]he inquiry to be undertaken by the district court is ‘a flexible
one’ focusing on the ‘principles and methodology’ employed by the expert, not on the
conclusions reached.” Westberry, 178 F.3d at 261 (quoting Daubert, 509 U.S. at 594-95); see
also Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150 (1999) (“We agree with the Solicitor
General that ‘[t]he factors identified in Daubert may or may not be pertinent in assessing
reliability, depending on the nature of the issue, the expert’s particular expertise, and the subject

4

of his testimony.’”) (citation omitted); see also Crisp, 324 F.3d at 266 (noting “that testing of
reliability should be flexible and that Daubert’s five factors neither necessarily nor exclusively
apply to every expert”).
With respect to relevancy, Daubert also explains:
Expert testimony which does not relate to any issue in the case is not relevant and,
ergo, non-helpful. The consideration has been aptly described by Judge Becker as
one of “fit.” “Fit” is not always obvious, and scientific validity for one purpose is
not necessarily scientific validity for other, unrelated purposes. . . . Rule 702’s
“helpfulness” standard requires a valid scientific connection to the pertinent
inquiry as a precondition to admissibility.
Daubert, 509 U.S. at 591-92 (internal citations and quotation marks omitted).
Finally, in several of the instant Daubert motions, a specific scientific methodology
comes into play, dealing with differential diagnoses or etiologies. “Differential diagnosis, or
differential etiology, is a standard scientific technique of identifying the cause of a medical
problem by eliminating the likely causes until the most probable one is isolated.” Westberry, 178
F.3d at 262. The Fourth Circuit has stated that:
A reliable differential diagnosis typically, though not invariably, is performed
after “physical examinations, the taking of medical histories, and the review of
clinical tests, including laboratory tests,” and generally is accomplished by
determining the possible causes for the patient’s symptoms and then eliminating
each of these potential causes until reaching one that cannot be ruled out or
determining which of those that cannot be excluded is the most likely.
Id. A reliable differential diagnosis passes scrutiny under Daubert. An unreliable differential
diagnosis is another matter:
A differential diagnosis that fails to take serious account of other potential causes
may be so lacking that it cannot provide a reliable basis for an opinion on
causation. However, “[a] medical expert’s causation conclusion should not be
excluded because he or she has failed to rule out every possible alternative cause
of a plaintiff’s illness.” The alternative causes suggested by a defendant “affect
the weight that the jury should give the expert’s testimony and not the
admissibility of that testimony,” unless the expert can offer “no explanation for

5

why she has concluded [an alternative cause offered by the opposing party] was
not the sole cause.”
Id. at 265-66 (internal citations omitted).
III.

Bard’s Daubert Motions
Bard seeks to exclude or limit the testimony of a total of twelve sets of expert witnesses.

The testimony of eleven of these experts relate to all four bellwether plaintiffs: Denniz Zolnoun,
Dean Altenhofen, Timothy J. Loving and Jannell L. Caroll, Bob Shull, the treating physicians,
Bernd Klosterhalfen, Lennox Hoyte, David A. Kessler, Ahmed El-Ghannam, Anthony B.
Brennan, and Julia E. Babensee. The testimony of the twelfth expert witness, Arnold Lentnek,
relates only to plaintiff Carolyn Jones. Bard’s motions as to each of these experts will be
discussed below.
A.

Denniz Zolnoun, M.D., M.P.H.

The plaintiffs offer Dr. Zolnoun to opine on the general and specific causation of pain in
the plaintiffs by the Avaulta mesh products. Bard argues that Dr. Zolnoun’s opinions are classic
ipse dixit opinions, unsupported by any testing or reliable methodology. As discussed below, Dr.
Zolnoun’s opinions should be excluded in their entirety and accordingly, Bard’s motion to
exclude her opinions is GRANTED.
i.

General Causation Opinions

Dr. Zolnoun sets forth two general causation opinions regarding “mechanisms by which
transvaginal mesh procedures cause nerve injury and neuropathic pain.” (Zolnoun Report
[Docket 91-2], at 3). The first is “a direct insult to a nerve in the pelvis by the trocars used to
place the mesh or the arms of the mesh as they are pulled through the transobturator and
ischiorectal spaces.” (Id.). The second is “caused by the well-established contraction and
retraction of the mesh over time, resulting in entrapment of nerves in scar and fibrosis.” (Id.).
6

Bard argues that Dr. Zolnoun’s general causation opinions are inadmissible because they
are not supported by any reliable basis or methodology. The plaintiffs respond by first arguing
that general causation is not in dispute and therefore a Daubert inquiry is unnecessary, citing
McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1239 (11th Cir. 2005). In McClain, the
Eleventh Circuit noted that:
[T]oxic tort cases usually come in two broad categories: first, those cases in which
the medical community generally recognizes the toxicity of the drug or chemical
at issue, and second, those cases in which the medical community does not
generally recognize the agent as both toxic and causing the injury plaintiff alleges.
Id. The court then listed several examples: “asbestos, which causes asbestosis and mesothelioma;
silica, which causes silicosis; and cigarette smoke, which causes cancer.” Id.; see also n.5
(“There is rarely a reason for a court to consider opinions that medical doctors routinely and
widely recognize as true, like cigarette smoking causes lung cancer and heart disease, too much
alcohol causes cirrhosis to the liver, and that the ingestion of sufficient amounts of arsenic causes
death.”). The court based this idea on Kumho Tire, noting that a “trial court does not need to
waste time with a Daubert hearing where the reliability of an expert’s methods is properly taken
for granted . . . .” Id. at 1239 n.5 (internal quotation marks omitted).
Bard contends that Dr. Zolnoun’s general causation opinions are very much in dispute
among the medical community. I agree. The plaintiffs cite to a number of internal Bard
documents and a FDA white paper, none of which Dr. Zolnoun either cited or reviewed. While
these documents may certainly suggest that Dr. Zolnoun’s general causation opinions are true, it
does not appear from these documents that the medical community generally recognizes them as
true to the same extent that the medical community recognizes that cigarette smoke causes
cancer.

7

The plaintiffs then argue that Dr. Zolnoun’s general causation opinions are based upon a
reliable basis and methodology because she “properly relies on her clinical experience and
relevant, peer-reviewed literature to establish” these opinions. (Pls.’ Resp. in Opp’n to Def.’s
Mot. to Exclude Certain Testimony from Pls.’ Proposed Expert Witness Dr. Denniz Zolnoun,
M.D., M.P.H. [Docket 157], at 7). I disagree. A review of Dr. Zolnoun’s lengthy deposition
transcript shows that her opinions are simply ipse dixit opinions.
For example, with respect to Dr. Zolnoun’s first general causation opinion—that the
trocars and the arms of the mesh cause a direct insult to nerves in the pelvis—Dr. Zolnoun first
testified that it was not the trocars that cause nerve injury, but the mesh arms:
Q.

But you agree in any patient it’s impossible for you to say whether your
opinion is that the symptoms are caused by the mesh itself or by the mesh
procedure, correct?

A.

. . . I could say with reasonable degree of medical certainty that [it] is not
caused primarily by the needle, but it is the track of the mesh and the
contractures that are associated with the mesh.

(Zolnoun Dep. vol. I [Docket 91-3], at 183:7-183:15). With respect to the mesh arms, Dr.
Zolnoun then testified:
Q.

What did you do to arrive at this opinion that the mesh arms are sharp and
have the ability to damage or cut nerves as they are pulled with the
trocars?

A.

I mean, it’s obvious. I mean, I’ve seen the propylene mesh. Avaulta mesh
is not something I’ve personally touched, but propylene, polypropylene
mesh comes in a variety of shapes and fashions and, with notable
exception of Gore-Tex, all their edges are very sharp and they’re rigid. . . .

...
Q.

Do you have any basis for your opinion that the mesh arms are sharp and
can serrate nerves as they are pulled through by the trocars that we haven’t
talked about?

A.

Other than the fact that I’ve been dealing with this for six years and I had
to take care of the pain, feel them come through the vagina, and looking at
8

the biomechanics of how they rotate the vagina. Empirical evidence based
on my experience, that’s the only construct I could present.
Q.

Are you relying on any scientific literature as a basis for your opinion that
the mesh arms are sharp and can serrate or tear nerves as they are pulled
through the tissue by the trocars?

A.

I mean, it’s obvious. Those propylene meshes are very rigid and that my
finger on a glove catches, I’m really sorry, but I don’t understand how to
prove this. . . . I’m not sure what scientific proof you’re mentioning, but
these are just daily observation[s] of what the mesh eroding feels like.

(Id. at 185:13-185:21; 188:16-189:16). Finally, Dr. Zolnoun admits that the only mesh she has
touched is mesh that has been implanted for some time:
Q.

And do you agree that you’ve never touched an Avaulta mesh, Avaulta
Solo, Avaulta Plus when it was just coming out of the package?

A.

. . . [N]o, I haven’t. But I do know how they feel because I touch a lot of
them as they are eroding out of the upper vagina, lower vagina, pararectal
space.

Q.

But you’ve never touched one before it was inserted into someone’s body?

A.

No.

...
Q.

This mesh eroding that you’re talking about feeling with your glove, is
that mesh that has been in place for a long period of time?

A.

Sometimes two years, sometimes six months . . .

(Id. at 186:16-187:2; 189:17-189:20). Dr. Zolnoun’s first general causation opinion is therefore
based on nothing more than her personal, unscientific observation and opinion that “it’s obvious”
that mesh arms are sharp and can serrate or tear nerves. This is the type of “subjective,
conclusory approach that cannot reasonably be assessed for reliability” and that Rule 702 is
designed to exclude. Fed. R. Evid. 702 advisory committee’s note.

9

Dr. Zolnoun’s second general causation opinion—that mesh causes nerve injury by the
contraction and retraction of the mesh over time, resulting in entrapment of nerves in scar and
fibrosis—is similarly lacking in any reliable basis and methodology and is simply an ipse dixit
opinion. For example, she testified:
As you stated, I’m not an expert in mesh and traction and contraction. So I cannot
possibly be an expert in amount of scarring because of mesh because that’s not
what I do. But if you ask me as a pain person, then this contraction happens, it’s
obvious. Scarring happens and it happens differently in different setting in
different context.
(Zolnoun Dep. vol. II [Docket 91-4], at 255:11-255:17). Accordingly, I FIND that Dr. Zolnoun’s
general causation opinions should be excluded.
ii.

Specific Causation Opinions

Dr. Zolnoun’s specific causation opinions are based on her general causation opinions. In
other words, her opinion as to each bellwether plaintiff is that the plaintiff suffered nerve injuries
through one or both of the general causation mechanisms discussed supra. Because I found that
Dr. Zolnoun’s general causation opinions are not based on reliable methodology and principles,
her specific causation opinions—based on her general causation opinions—should also be
excluded. See, e.g., In re Bausch & Lomb Inc. Contact Lens Solution Prods. Liab. Litig, MDL
No. 1785, 2010 WL 1727807, at *2 (D.S.C. Apr. 26, 2010) (“[E]stablishing general causation is

10

an essential prerequisite to proving specific causation”).4 Thus, I FIND that Dr. Zolnoun’s
specific causation opinions also should be excluded.
B.

Dean Altenhofen, M.D.

According to the plaintiffs, Dr. Altenhofen will opine on:
(i) his general experience with higher complications and injuries sustained by his
patients following his implantation of certain Bard pelvic mesh products over a
three-year period compared with the complication rates reflected in the published
scientific literature, (ii) his opinion that the IFUs did not adequately disclose to
him all the risks known by Bard when the Avaulta products were launched, (iii)
the Avaulta training he personally received from Bard, and (iv) the erosion rate
communicated to him by a Bard sales representative during the time Defendant
was touting the alleged success rate of its pelvic mesh products.

4

A review of Dr. Zolnoun’s specific causation opinions leads to the same result because they are
based upon the logical fallacy of post hoc ergo propter hoc. For example, Dr. Zolnoun testified:
Q.

And this technique of bedside sensory testing does not tell you what caused the
nerve damage that you believe that you identified through using this clinical
examination, does it?

A.

This technique doesn’t tell me – I just want to make sure I understand here. Does
the technique tell me what caused it? I don’t think that is a question that could be
asked because cause is the index event. So cause and effect is surgery, pain. The
technique doesn’t tell me the mechanism completely, yes, but the cause is
obvious. Some patients didn’t have pain, they had pain after surgery. Some of
them had different kind of pain and they develop completely new kind of pain
after surgery. So the cause was – is obvious. But mechanism, the exam alludes to
plausible mechanism, but doesn’t tell me – confirms that that’s exactly the
mechanism.

Q.

So I just want to make sure I understand. What you’re saying is that if a patient
develops new pain after surgery, then it’s your belief that the surgery caused the
pain?

A.

The procedure was associated with the pain. No procedure, no pain. So the event
was the anteceding event.

(Zolnoun Dep. vol. II [Docket 91-4], at 265:16-266:14) (emphasis added). In short, her specific causation
opinion is based on the idea that because each bellwether plaintiff suffered pain after the mesh surgery,
then the mesh must have caused the pain. A review of Dr. Zolnoun’s expert report and deposition reveals
that the bedside sensory testing she conducted is designed only to find the location and nature of the pain,
not the cause, and that she did not perform a reliable differential diagnosis. Again, this is the type of
“subjective, conclusory approach that cannot reasonably be assessed for reliability” that Rule 702 is
designed to exclude. Fed. R. Evid. 702 advisory committee’s note.

11

(Pls.’ Resp. in Opp’n to Def. Bard’s Mot. to Exclude the Testimony & Ops. of Dean Altenhofen,
M.D. [Docket 149], at 3). Bard argues that Dr. Altenhofen’s opinions regarding complication
rates and injuries are not based on reliable methodology, and that his opinions regarding Bard’s
IFUs, Avaulta training, and statements by Bard sales representatives are irrelevant to the facts of
the bellwether plaintiffs. As discussed below, Dr. Altenhofen’s opinions should be excluded in
their entirety and accordingly, Bard’s motion to exclude his opinions is GRANTED.
i.

Complication Rate Opinion

Dr. Altenhofen opines that from 2006 until 2009, he implanted Avaulta mesh products
into a number of his patients. Of the patients that received Avaulta mesh products, some suffered
complications and injuries that Dr. Altenhofen opines were caused by the mesh products. Using
simple division—the number of patients implanted with Avaulta mesh products divided by the
number of patients that suffered complications—Dr. Altenhofen arrives at his complication rate.
According to the plaintiffs, “Dr. Altenhofen’s opinion based on his clinical experience is
straightforward: these Avaulta products had more severe, repeated, and unusual complications
than the published complications rates in the scientific literature specific to pelvic floor mesh
products.” (Id. at 7).
The fundamental problem with Dr. Altenhofen’s complication rate opinion is that it has
no basis in any reliable methodology. Importantly, Dr. Altenhofen’s complication rate itself has
changed throughout the course of his involvement in this litigation. His initial expert report
indicated that he implanted Avaulta mesh products in 68 of his patients, and of those 68 patients,
16 suffered complications from the mesh products—a complication rate of 23.53%. (Altenhofen
Report [Docket 94-2], at 2). Interestingly, despite a mathematical complication rate of 23.53%,

12

Dr. Altenhofen’s initial expert report also noted that “[m]ore than 30% of my patients developed
injuries and complications that required repair and revision.” (Id. at 3).
During his deposition, Dr. Altenhofen corrected his initial expert report, testifying that he
had 18 patients, not 16, who suffered complications—a complication rate of 26.47%:
Q.

Okay. Now, your report refers to 16 of the 68 patients in which you
implanted an Avaulta product as having some sort of complication,
correct?

A.

Correct. Yes.

Q.

But would you count for me how many patients’ records are in Exhibit 7?

A.

There’s 17 individual patients in this booklet.

Q.

I guess what I’m trying to get at is what is the correct number, 16, 17, or
18?

A.

All right. So there’s one, two, three, four, five, six, seven eight – there’s
18. I’m sorry, there’s 18 in this booklet here.

Q.

Why does your report only refer to 16?

A.

Maybe a miscalculation or a count here. There’s one – may have been a
mistake when we were counting up the numbers here. And then when we
went down, they wanted specifics on here, so it could have been an
oversight.

(Altenhofen Dep. [Docket 94-4], at 135:17-136:11; see also Revised Altenhofen Report [Docket
94-3], at 2).
Most recently, the plaintiffs submitted an errata sheet for Dr. Altenhofen’s deposition,
which further alters Dr. Altenhofen’s complication rate. (See Errata Sheet [Docket 149-1], at 67). For example, several of the 18 patients were ultimately determined not to have an Avaulta
implant, two patient records were determined to be the same patient, and another patient had
subsequent revision surgeries but her medical device implant record could not be located. (See
id.). Considering the errata sheet and as calculated by Bard, 65 patients were implanted with
13

Avaulta products, 14 of which experienced complications, resulting in a complication rate of
21.54%. Further complicating matters, Dr. Altenhofen also provided, in the errata sheet, 21
additional implant records between March 1, 2007 and November 15, 2007 evidencing other
implantations of Avaulta mesh products, without any explanation as to their relevance.
In sum, it is clear that Dr. Altenhofen’s methodology of producing his complication rate
is unreliable, resulting in multiple changes to his expert report on this issue. Accordingly, I
FIND that Dr. Altenhofen’s complication rate opinion should be excluded.
ii.

Opinions Regarding IFUs, Training, and Marketing

Dr. Altenhofen’s other opinions are either outside of his expertise, irrelevant, or outside
the realm of appropriate expert testimony. Dr. Altenhofen seeks to opine on the adequacy of
Bard’s IFUs and training, as well as Bard’s sales representative’s statements regarding the
erosion rate and other complications, pain, and reoperation rates. However, he is simply not
qualified to render opinions on the adequacy of warnings, as he has no “knowledge, skill,
experience, training, or education” in this particular area. Fed. R. Evid. 702. To the extent that
Dr. Altenhofen might opine on Bard’s knowledge, motive, or intent based on corporate
documents, such opinions are not properly the subject of expert testimony because these are lay
matters. Accordingly, I FIND that Dr. Altenhofen’s remaining opinions should be excluded.
C.

Timothy J. Loving, Ph.D. and Janell L. Carroll, Ph.D., C.S.E.

The plaintiffs offer Dr. Loving and Dr. Carroll (collectively referred to as the
“Relationship Experts”) to opine on the plaintiffs’ damages. According to the plaintiffs, “Dr.
Janell L. Carroll will offer opinions about the impact of the bellwether plaintiffs’ loss in terms of
body image, self-esteem, confidence, sexual drive and the ability to maintain an affectionate
sexual relationship,” and “Dr. Timothy J. Loving will offer opinions about the impact of the

14

bellwether plaintiffs’ loss in terms of how and why the quality of their intimate relationships has
changed, and what affect [sic] that has in terms of self-concept, connections and pain
experienced as a result.” (Pls.’ Resp. in Opp’n to Def.’s Mot. to Exclude the Ops. & Testimony
from Pls.’ Proposed Expert Witnesses Dr. Loving & Dr. Carroll [Docket 150], at 1-3).
Bard argues that the Relationship Experts are not qualified to render opinions regarding
the bellwether plaintiffs or their conditions, and that the opinions of the Relationship Experts
would not assist the jury because:
(1) Plaintiffs can themselves describe how their lives have changed without the
need for expert testimony, (2) the subject matter of the Relationship Experts’
opinions are understandable to the average juror, (3) Dr. Carroll relies on
inadmissible hearsay to draw improper comparisons, and (4) Dr. Loving attempts
to vouch for Plaintiffs’ stories.
(Def. Bard’s Reply Mem. of Law in Supp. of Mot. to Exclude the Ops. & Testimony of Timothy
J. Loving, Ph.D. & Jannell L. Carroll, Ph.D. [Docket 170], at 5 n.5). As discussed below, the
Relationship Experts’ opinions should be excluded in their entirety and accordingly, Bard’s
motion to exclude their opinions is GRANTED.
i.

Opinions that Would not Assist the Jury – Unnecessary for Subject
Matter

Expert testimony which “merely regurgitates factual information that is better presented
directly to the jury rather than through the testimony of an expert witness” is properly excluded.
Hines v. Wyeth, No. 2:04-0690, 2011 WL 2680842, at *5 (S.D. W. Va. July 8, 2011). Parts of the
Relationship Experts’ expert reports merely state what the plaintiffs told them. (See, e.g., Loving
Report [Docket 100-2], at 6-8; Carroll Report [Docket 100-1], at 2, 4-8). Such testimony is better
presented directly to the jury via the bellwether plaintiffs themselves.
To the extent that the Relationship Experts reliably apply scientific literature to the facts
presented to them by the plaintiffs, however, expert testimony on this issue is unnecessary
15

because it is understandable to the average juror. To the extent that the bellwether plaintiffs may
be uncomfortable speaking to the jury about the personal issues and the impact that these issues
have had on their relationships and lives, the average juror will also understand. For example,
Dr. Loving explains the concept of “scripts” in the context of the Queen plaintiffs:
People hold scripts, or expectations, for how social situations are supposed to
progress across a wide variety of settings. . . . People hold sexual scripts as well,
and they tend to be quite powerful in terms of how much they guide people’s
expectations of sexual behavior. . . . Importantly, once we have a script for
specific social situations, it is very difficult to deviate from those scripts. Thus,
it’s no surprise that Wanda and Greg Queen see no point in even beginning the
process of their (and most peoples’) sexual intimacy scripts: it’s just too
frustrating and unfulfilling to not be able to play out that script.
(Loving Report [Docket 100-2], at 15-16; see also Loving Dep. [Docket 100-3], at 201:19202:2). However, this discussion of “scripts” follows from what the Queens told Dr. Loving:
“They both commented that there’s ‘no point’ in touching, or kissing, or rubbing somebody’s
shoulders when you know it can’t go anywhere else.” (Loving Report [Docket 100-2], at 15).
While an average juror may not necessarily fully understand the psychological concept of scripts,
the idea that there is “no point” in certain acts of affection when it cannot lead to sex is
something that can both be explained by the Queens themselves and understood by the average
juror. The Relationship Experts’ depositions and reports are replete with these kinds of opinions.
Accordingly, I FIND that the Relationship Experts’ opinions related to the impact of the
plaintiffs’ loss in terms of their intimate relationships should be excluded.
ii.

Opinions that Would Not Assist the Jury – Not Applied to the Facts of
the Case

Several of the Relationship Experts’ opinions are also appropriately excluded because
they are not applied to the facts of the case. For example, Dr. Carroll seeks to explain to the jury
that:

16

Without professional testimony the jury might look at a plaintiff and tie “sexuality
with attractive body types”. Intimacy, love, expressions of sexuality come in all
body types. It is a mistake to assume sexuality is not important to women of all
body shapes and ages. It is important to all, not just those who may be on
magazine covers.
(Carroll Report [Docket 100-1], at 17). However, Dr. Carroll testified that she has never met or
seen the plaintiffs that she spoke with, that the plaintiffs’ appearances had never been described
to her, and that she only had knowledge of a plaintiff’s physical experience if that plaintiff
offered such information. (Carroll Dep. [Docket 100-5], at 33:2-35:12). Regardless of whether
Dr. Carroll’s opinion is true as a general matter, and regardless of whether the bellwether
plaintiffs do or do not have the “attractive body types” described by her, Dr. Carroll has simply
not applied this stated principle “to the facts of the case.” Fed. R. Evid. 702.
Dr. Loving’s testimony regarding how personal relationships affect morbidity and
mortality—the “life expectancy” testimony that Bard takes issue with—also suffers from a
similar defect. For example, Dr. Loving testified:
Q.

Okay. Well, in term – your point here – and now that I’m talking about it,
I might as well keep going. Your point is that lack of physical intimacy
and lack of physical touch is the reason why these women or people would
have reduced life expectancy?

A.

My point is, right, when you look at large data sets and you look at – and
other types of studies, individuals who experience a lack of physical
intimacy and given what we know about the effects of physical touch on
morbidity as well as long-term health outcomes, that those – those deficits,
if you will, would lead to a reduction in life expectancy, but I’m not – I’m
not proposing a specific amount for a specific individual.

(Loving Dep. [Docket 100-3], at 102:8-102:20). Dr. Loving’s “life expectancy” opinion is
effectively that because the plaintiffs engage in less physical intimacy subsequent to the meshrelated complications than they engaged in prior to the complications, there will be some
reduction of life expectancy for the plaintiffs. Regardless of whether Dr. Loving’s opinion is true

17

as a general matter, however, this general opinion has not been applied “to the facts of the case”
such that it would assist the jury. Fed. R. Evid. 702. Accordingly, I FIND that such opinions
should be excluded.
iii.

Causation Opinions

Parts of the Relationship Experts’ reports allude to discussions of causation. (See, e.g.,
Carroll Report [Docket 100-1], at 2) (“Based on my expertise, the implantation of the vaginal
mesh product significantly contributed to all of these losses.”). As noted previously, it appears
that the plaintiffs offer the Relationship Experts solely on the issue of damages. To the extent
that the Relationship Experts were offered to opine as to causation, they have not shown that
they are qualified to render such opinions, nor have they offered any basis—much less a reliable
one—for these opinions. Accordingly, I FIND that any causation opinions by Dr. Loving or Dr.
Carroll should be excluded.
D.

Bob Shull, M.D.

According to the plaintiffs, “Dr. Shull holds the opinion that the transvaginal
implantation of Bard’s Avaulta Solo and Plus products are inappropriate for use in women for a
variety [of] reasons . . . .” (Pls.’ Resp. in Opp’n to Def. Bard’s Mot. to Limit the Expert Opinions
& Testimony of Dr. Bob Shull [Docket 151], at 2-3). Dr. Shull’s expert report, however,
suggests that he is offering opinions on much more than just the issue of whether transvaginal
implantation of the Avaulta products are inappropriate. For example, his expert report includes,
but is not limited to, discussions as to: (1) whether proper and sufficient clinical trials were
conducted; (2) whether there was a scientific basis for the use of an armed, transvaginally placed
polypropylene mesh; (3) whether Bard knew about potential problems with the use of

18

polypropylene in the vagina; (4) whether Bard informed doctors of safety concerns, and; (5)
whether Bard acted irresponsibly in the recruitment, training, and monitoring of surgeons.
Bard takes issue with several categories of opinions that are set forth in Dr. Shull’s expert
report: (1) opinions related to Bard’s knowledge, state of mind, alleged bad acts or failures to act,
and corporate conduct and ethics; (2) opinions related to product warnings; (3) opinions related
to product design, testing, and materials; and (4) opinions related to product marketing and
training. As discussed below, Dr. Shull’s opinions as to these issues should be excluded and
accordingly, Bard’s motion to exclude his opinions is GRANTED.
i.

Opinions Related to Bard’s Knowledge, State of Mind, Alleged Bad Acts,
Failures to Act, and Corporate Conduct and Ethics

A significant portion of the first forty pages of Dr. Shull’s expert report discusses Bard’s
knowledge, state of mind, alleged bad acts, failures to act, and corporate conduct and ethics. Dr.
Shull opines, for example, that “Bard, in fact, recognized the problems created by not having
clinical data supporting the use of the Avaulta products.” (Shull Report [Docket 98-2], at 4). He
then opines that “[p]atient safety . . . should have been the highest priority for Bard, not the ‘first
to be cut.’ It is also unethical for a company to withhold relevant clinical information from
physicians . . . .” (Id. at 5; see also, e.g., id. at 10) (“Bard also knew that the amount of mesh –
the ‘mesh load’ – and the material characteristics . . . would be an issue with their products.”);
(id. at 10-11) (“Bard justified the development of mesh kits based on the inaccurate perception of
high recurrence rates when traditional reconstructive procedures using native tissue repair were
performed.”); (id. at 14) (“Bard documents show that the company recognized the need to have
large pores (3-5mm) to avoid contraction and what is described as ‘scar plate formation.’”); (id.)
(“I see no evidence that Bard . . . addressed the question of synthetic material surface area used
as a function of risks and benefits.”); (id. at 14-15) (“Bard . . . documents demonstrate [that it
19

was] aware of shrinkage and contraction when tissue comes in contact with the polypropylene
and xenograft materials.”).
Similar statements are pervasive throughout the first forty pages of Dr. Shull’s expert
report. For example, Section II is titled “Bard did not inform doctors of safety concerns,” Section
III is titled “Bard acted irresponsibly in the recruitment, training, and monitoring of surgeons,”
Section IV is titled “Bard sales representatives appear to be giving medical advice, both in the
operating room and in the management of complications,” and Section V is titled “Bard seems to
lack concern for the individual woman’s health and safety, focusing instead simply on sales.”
(See id. at 24-40).
While an expert may testify as to a review of internal corporate documents solely for the
purpose of explaining the basis for his or her opinions—assuming the opinions are otherwise
admissible—Bard’s knowledge, state of mind, alleged bad acts, failures to act, or other matters
related to corporate conduct and ethics are not appropriate subjects of expert testimony because
opinions on these matters will not assist the jury. See, e.g., In re Rezulin Prods. Liab. Litig., 309
F. Supp. 2d 531, 547 (S.D.N.Y. 2004) (“Inferences about the intent or motive of parties or others
lie outside the bounds of expert testimony . . . the question of intent is a classic jury question and
not one for the experts.”) (internal quotation marks omitted); In re Fosamax Prods. Liab. Litig.,
645 F. Supp. 2d 164, 192 (S.D.N.Y. 2009) (precluding testimony as to “the knowledge,
motivations, intent, state of mind, or purposes of” a company and its employees because it “is
not a proper subject for expert or even lay testimony”). Accordingly, I FIND that Dr. Shull’s
opinions related to Bard’s knowledge, state of mind, alleged bad acts, failures to act, and
corporate conduct and ethics should be excluded.

20

ii.

Opinions Related to Product Warnings

Dr. Shull opines that Bard failed to inform doctors of safety concerns related to the
Avaulta mesh products. (Shull Report [Docket 98-2], at 24-29). However, Dr. Shull does not
provide a reliable basis for his opinions of what Bard should have done with respect to its
warnings. For example, Dr. Shull’s expert report opines:
Bard knew that pain could be a significant postoperative problem when these
products are utilized in vaginal surgery, and yet it is not even mentioned in
Avaulta 510(K) applications, labeling, or physician and patient education
materials. . . . Pain as a result of the trocar placed armed mesh kits is often lifealtering and can be permanent. Bard . . . should have investigated and resolved a
complication of this magnitude prior to marketing a permanent implanted medical
device.
(Id. at 26). Strikingly absent from this discussion is any basis for Dr. Shull’s opinion of what
Bard “should have” done. This is likely the result of Dr. Shull’s lack of expertise in the specific
area of warnings and labels for medical devices:
Q.

. . . But would you agree that you are not an expert in developing warnings
and labels for medical devices?

A.

I have never developed a warning or a label. I don’t intend to do that. And
I don’t know the process for doing it, so I would not claim to be an expert
in that area.

(Shull Dep. vol. I [Docket 98-3], at 115:1-115:7; see also id. at 64:12-64:16 (no familiarity with
federal regulations regarding IFUs); Shull Dep. vol. II [Docket 98-4], at 348:11-350:25 (no
familiarity with whether FDA or other manufacturers’ IFUs include supporting data)). Despite
his stellar qualifications as a urogynecologist, Dr. Shull is unqualified to testify on the specific
issue of product warnings, as evidenced by his lack of familiarity with the process. To the extent
that Dr. Shull seeks to opine that surgeons did not receive adequate warnings from Bard, he is
similarly unqualified to do so. Accordingly, I FIND that Dr. Shull’s opinions related to Avaulta
product warnings should be excluded.
21

iii.

Opinions Related to Product Design, Testing, and Materials

With respect to Dr. Shull’s opinions related to product design, testing, and materials,
Bard argues that (1) Dr. Shull lacks qualifications to render opinions on such issues; (2) Dr.
Shull’s opinions on such issues are not based on sufficient data and are unreliable; and (3) Dr.
Shull’s opinions on such issues will not assist the jury.
Dr. Shull is qualified to render opinions on such issues. A witness may be “qualified as
an expert by knowledge, skill, experience, training, or education.” Fed. R. Evid. 702. Dr. Shull’s
extensive experience with pelvic floor disorders and the use of mesh to treat such disorders
qualifies him to render opinions on such issues, notwithstanding his lack of expertise in the
particular areas of product design or biomaterials.
However, Dr. Shull’s opinions on the issues of product design, testing, and materials
have no reliable basis. A review of Dr. Shull’s expert report reveals that his opinions are largely
based on (1) his personal experiences and observations and (2) internal Bard documents. For
example, he testified:
Q.

Your opinions as to what may have occurred with the mesh implanted in
these women, whose records you reviewed, those opinions are based only
on the medical records and the depositions, perhaps, of the treating
physicians, correct?

A.

No, that isn’t correct.

Q.

What else is it –

A.

My – my conclusions are based on my professional experience, my
professional education, my examination of women who have had
complications of surgery, my interviews with them, with their spouses, my
examination of them, my operating on them, in addition to the information
provided in these records. So, otherwise, you would be presuming I’m
making – drawing a conclusion disassociated with anything else in my
background of knowledge and experience, and that isn’t true.

22

(Shull Dep. vol. I [Docket 98-3], at 196:15-197:8). Dr. Shull further states that “the source of my
words for describing [that mesh can saw into tissue] are based in large part on a clinical practice
of managing women who have similar symptoms and physical findings.” (Shull Dep. vol. II
[Docket 98-4], at 227:22-227:25). “[A] bold statement of the experts’ qualifications, conclusions,
and assurances of reliability are not enough to satisfy the Daubert standard.” In re Bausch &
Lomb, Inc., 2009 WL 2750462, at *10 (quoting Doe 2 v. Ortho-Clinical Diagnostics, Inc., 440 F.
Supp. 2d 465, 471 (M.D.N.C. 2006)).
With respect to his “sawing effect” opinion, Dr. Shull relies on his experience and one
specific observation, and Dr. Shull testified that he “can’t say that [the mesh] actually sawed into
the [tissue]” in that case. (Shull Dep. vol. II [Docket 98-4], at 229:10-229:14). The plaintiffs
appear to use Dr. Shull’s qualifications as a means for arguing that his opinions are reliable. Just
because an expert may be “qualified . . . by knowledge, skill, experience, training or education”
does not necessarily mean that the opinion that the expert offers is “the product of reliable
principles and methods” or that the expert “has reliably applied the principles and methods to the
facts of the case.” Fed. R. Evid. 702.
Dr. Shull’s deposition testimony also reveals that his opinions have not been applied “to
the facts of the case.” Fed. R. Evid. 702. For example, with respect to whether Avaulta products
shrink, Dr. Shull testified:
Q.

You’re basing that on a document you read that was furnished to you by
the Plaintiffs’ attorneys, correct?

A.

That’s accurate.

Q.

You’ve done no independent assessment of that?

A.

I have not tested any Avaulta product.

23

Q.

And you’re not qualified to test Avaulta products to determine their rate of
shrinkage, if any, are you?

A.

I would say my only qualification and testing of products in general, not
specifically Avaulta, would be seeing women who have had mesh products
implanted and examining them and learning about the characteristics of
their exam after they’ve had a product implanted.
...
I have not seen an Avaulta explant that I saw before it was implanted and
observed it, made any measurements, and then measured it again after it
had been explanted.

(Shull Dep. vol. I [Docket 98-3], at 172:6-173:5) (emphasis added). With respect to several other
opinions, such as the ability of mesh to saw into tissue, Dr. Shull testified:
Q.

Now . . . you say that you have observed in your practice banding of the
arms and bunching of the central mesh piece with these devices?

A.

That’s accurate.

Q.

Have you seen that specifically with regard to the Bard product?

A.

I cannot answer that. I’ve seen it in women who have had mesh placed for
the treatment of pelvic organ prolapse. In some circumstances I do not
know the name of the device and I cannot tell you specifically that I have
seen that with a Bard product.

...
Q.

Do you have any specific evidence that the arms or the mesh sawed into
the tissue of any of these individual Bellwether Plaintiffs?

A.

No.

...
Q.

Have you seen any evidence of mesh becoming hard and embrittled with
regard to vaginal mesh products?

A.

Yes.

Q.

Have you made that specific observation with regard to a Bard Avaulta
product?
24

A.

I do not know that for a fact.

(Shull Dep. vol. II [Docket 98-4], at 229:15-230:3; 232:24-233:3; 233:15-233:22). Without any
application to the facts of the case (Avaulta products), Dr. Shull’s opinions on these matters will
not assist the jury.5 Accordingly, I FIND that Dr. Shull’s opinions related to product design,
testing, and materials should be excluded.
iv.

Opinions Related to Product Marketing and Training

With respect to marketing, Dr. Shull admitted that he is not qualified to render opinions
on such matters. (Shull Dep. vol. I [Docket 98-3], at 116:5-116:10). A review of Dr. Shull’s
expert report also reveals that his opinion on Bard’s marketing is an effort to show that Bard
acted improperly in its marketing. (See Shull Report [Docket 98-2], at 29-31). As I have
previously ruled, such expert “opinions” regarding Bard’s motives, intent or state of mind should
be excluded because they are not properly the subject of expert testimony.
Finally, with respect to training, Dr. Shull’s opinion will not assist the jury because it is
not applied to the facts of the case. While Dr. Shull opines that Bard indiscriminately marketed
its Avaulta products to all physicians, including inexperienced and unqualified physicians, he
testified at his deposition:
5

To the extent that the plaintiffs cite Hershberger v. Ethicon Endo-Surgery, Inc., No. 2:10-cv00837, 2012 WL 524442, at *6 (S.D. W. Va. 2012), Bard is correct in pointing out that the opinion at
issue in Hershberger was derived from the doctor’s “personal observations during the course of treating
[the patient].” Even if Dr. Shull made a personal observation of “sawing” with respect to any Avaulta
products, because it was not in his role as treating physician of any of the bellwether plaintiffs, his
opinion is expert testimony subject to a Daubert challenge.
Additionally, the plaintiffs argue that “Dr. Shull’s testimony regarding mesh shrinkage, and the
sawing effect of its mesh arms . . . are not merely matters of opinion, but rather are verifiable facts.” (Pls.’
Resp. in Opp’n to Def. Bard’s Mot. to Limit the Expert Opinions & Testimony of Dr. Bob Shull [Docket
151], at 17). In support, the plaintiffs cite various Bard internal documents on this issue. (Id. at 17-19). As
previously held, Dr. Shull may not present expert opinion on Bard’s alleged knowledge. Further,
assuming arguendo that the plaintiffs are correct, there is no reason why the plaintiffs require an expert to
opine on these “verifiable facts.” Rather, such factual issues are properly presented as non-expert
evidence and testimony for the jury to consider.

25

Q.

Do you have an opinion as to whether the surgeons who performed the
implant surgery on the Bellwether Plaintiffs whether they were qualified
and capable of performing surgery in the pelvic floor area?

A.

By looking at the preoperative assessment, the operative notes, and the
follow-up, it appears that all of the surgeons are conscientious, described
things in ways that are understandable, and describe their operative
interventions and their subsequent evaluation of patients.

Q.

So it’s not the case in your view in any of these cases where Bard trained
or provided the product to a surgeon that was just not qualified?

A.

I don’t see that in the three patients for whom I’ve reviewed the records.

(Shull Dep. vol. II [Docket 98-4], at 358:2-358:19). He further testified that he had “no specific
information” as to whether he was aware of any instance where an unqualified and incapable
physician was brought to a Bard training program. (Id. at 358:20-359:3). Accordingly, I FIND
that Dr. Shull’s opinions related to product marketing and training should be excluded.
E.

The Plaintiffs’ Treating Physicians

As a preliminary matter, Bard argues that the plaintiffs never submitted a written Rule
26(a)(2)(B) report for the treating physicians and therefore, they may not present any expert
opinions. Bard’s substantive Daubert arguments attack the treating physicians’ qualifications to
opine on certain matters, and the relevancy and reliability of their opinions. In particular, Bard
seeks to exclude:
(1) testimony as to the existence of a product defect or inadequate design,
including the biomechanical properties of mesh; (2) testimony as to those alleged
defects causing injury; (3) testimony regarding other patients and complications
that the bellwether plaintiff they were treating did not experience; and (4)
testimony on topics that do not fall within the scope of their practice, such as
marketing practices, adverse event reporting, and corporate conduct, intent, and
duties.
(Def. Bard’s Mot. to Limit the Opinions & Testimony of Pls.’ Treating Physicians [Docket 103],
at 2; see also Def. Bard’s Mem. of Law in Supp. of Mot. to Limit the Expert Opinions &

26

Testimony of Pls.’ Treating Physicians [Docket 104], at 4). As discussed below, Bard’s motion is
GRANTED in part and DENIED in part.
i.

Federal Rule of Civil Procedure 26(a)(2)(B)

Pursuant to Federal Rule of Civil Procedure 26(a)(2)(B), an expert witness must provide
a written report if he or she “is one retained or specially employed to provide expert testimony in
the case or one whose duties as the party’s employee regularly involve giving expert testimony.”
Fed. R. Civ. P. 26(a)(2)(B). In Pretrial Order # 48, this court found that “[w]hile treating
physicians and surgeons are typically highly trained and educated, and offer opinions concerning
their care and treatment of their patients, they do not automatically qualify as ‘expert witnesses’
who must write a report and make Rule 26(a)(2)(B) disclosures.” (Pretrial Order # 48, Case No.
2:10-md-02187 [Docket 290], at 4). This court held that “[a]bsent evidence that a plaintiff’s
treating physician or surgeon is retained or specially employed to provide expert testimony, a
Rule 26(a)(2)(B) written report will not be required.” (Id. at 5).
The inquiry is whether the treating physician’s testimony addresses knowledge gained
and opinions formed during the course of treatment, or whether the treating physician seeks to
offer opinions which address information outside the scope of treatment. See Goodman v. Staples
the Office Superstore, LLC, 644 F.3d 817, 824-26 (9th Cir. 2011) (discussing and joining the
Sixth, Seventh, and Eighth Circuits in holding that “a treating physician is only exempt from
Rule 26(a)(2)(B)’s written report requirement to the extent that his opinions were formed during
the course of treatment.”); see also Hershberger v. Ethicon Endo-Surgery, Inc., No. 2:10-cv00837, 2012 WL 524442, at *6-7 (S.D. W. Va. Feb. 15, 2012) (analyzing whether an attending

27

surgeon’s testimony was that of a treating physician or an expert witness).6
The plaintiffs do not make clear whether they are offering any expert opinions through
the treating physicians. On one hand, the plaintiffs argue that the treating physicians “are not
retained experts, and their examination of these plaintiffs was for purposes of treatment, not for
purposes of providing testimony in these cases.” (Pls.’ Resp. in Opp’n to Def. Bard’s Mot. to
6

In footnote 3 of their response, the plaintiffs appear to argue that Rule 26(a)(2)(C), rather than
26(a)(2)(B), applies to the treating physicians in this case. In 2010, Rule 26 was amended to add
subsection (C), which states:
(C) Witnesses Who Do Not Provide a Written Report. Unless otherwise stipulated or
ordered by the court, if the witness is not required to provide a written report, this
disclosure must state:
(i) the subject matter on which the witness is expected to present evidence under
Federal Rule of Evidence 702, 703, or 705; and
(ii) a summary of the facts and opinions to which the witness is expected to
testify.

Fed. R. Civ. P. 26(a)(2)(C). According to the Advisory Committee Notes, this amendment seeks to
“resolve[] a tension that has sometimes prompted courts to require reports under Rule 26(a)(2)(B) even
from witnesses exempted from the report requirement.” Advisory Committee’s Notes on 2010
Amendments on Fed. R. Civ. P. 26. “Frequent examples include physicians or other health care
professionals and employees of a party who do not regularly provide expert testimony.” Id.
Case law since the 2010 Amendments continue to “adhere to traditional tests for determining
when a Treating Physician is considered to be a full-blown expert and when he is considered to be more
akin to a percipient witness with professional expertise.” Kondragunta v. Ace Doran Hauling & Rigging
Co., No. 1:11-cv-01094-JEC, 2013 WL 1189493, at *10 (N.D. Ga. Mar. 21, 2013). In Kondragunta,
Judge Carnes engaged in an exhaustive analysis of post-amendment case law and held, consistent with the
traditional test, that:
[I]f a physician’s opinion regarding causation or any other matter was formed and based
on observations made during the course of treatment, then no Subsection B report is
required, albeit the Subsection C report discussed above will be required. If, however, the
physician’s opinion was based on facts gathered outside the course of treatment, or if the
physician’s testimony will involve the use of hypotheticals, then a full subsection B
report will be required.
Id. at *12 (internal citations omitted); see also Hershberger, 2012 WL 524442, at *6-7 (analyzing
whether an attending surgeon’s testimony was that of a treating physician or an expert witness); but see
Kristensen ex rel. Kristensen v. Spotnitz, No. 3:09-CV-00084, 2011 WL 5320686, at *4 (W.D. Va. June
3, 2011) (questioning the continued viability of prior case law requiring Rule 26(a)(2)(B) reports from
treating physicians called upon to opine on information learned outside the course of treatment). This
court will apply the traditional test to determine whether a Rule 26(a)(2)(B) written report is required for
the plaintiffs’ treating physicians.

28

Limit the Expert Ops. & Testimony of Pls.’ Treating Physicians [Docket 146], at 3) [hereinafter
Pls.’ Resp. re: Treating Physicians]. On the other hand, the plaintiffs argue that the treating
physicians are qualified to testify as to the design of the Avaulta products. (See id. at 7-13). The
treating physicians are, of course, able to testify as to opinions formed during the course of
treatment.
To the extent that the treating physicians offer opinions formed outside the course of
treatment, I FIND that even if the plaintiffs violated Rule 26(a)(2)(B) by not submitting expert
reports, such violations were substantially justified or harmless under Fed. R. Civ. P. 37(c)(1).
See Hoyle v. Freightliner, LLC, 650 F.3d 321, 329 (4th Cir. 2011) (discussing the five-factor test
for determining whether nondisclosure is substantially justified or harmless). There was no
surprise to Bard because the treating physicians’ depositions were before the deadline for expert
reports and Bard had ample notice of any expert opinions that the treating physicians intended to
offer. Further, allowing the testimony would not disrupt the trial, and the plaintiffs properly
relied upon Pretrial Order # 48 in their decision not to submit expert reports for the treating
physicians. Thus, I will not exclude the testimony of the plaintiffs’ treating physicians simply
because they did not produce expert reports.
ii.

Bard’s Daubert Challenges to the Treating Physicians’ Testimony

I now turn to Bard’s Daubert challenges to the treating physicians’ testimony. Bard seeks
to preclude opinions regarding:
(1) physicians testifying as to the existence of a product defect or inadequate
design, including the biomechanical properties of mesh; (2) physicians testifying
as to those alleged defects causing injury; (3) physicians’ testimony regarding
other patients and complications that the bellwether plaintiff they were treating
did not experience; and (4) physicians’ testimony on topics that do not fall within
the scope of their practice, such as marketing practices, adverse event reporting,
and corporate conduct, intent, and duties.

29

(Def. Bard’s Mem. of Law in Supp. of Mot. to Limit the Expert Ops. & Testimony of Pls.’
Treating Physicians [Docket 104], at 4). The plaintiffs provide a lengthy summary of the treating
physicians’ qualifications. (See Pls.’ Resp. re: Treating Physicians [Docket 146], at 7-13). Even
assuming that the treating physicians are qualified to offer the expert opinions that they seek to
offer in this case, the plaintiffs have not shown any indicia of reliability underlying these
opinions. See Fed. R. Evid. 702 (requiring expert testimony to be “the product of reliable
principles and methods”).
In sum, I FIND that (1) causation opinions, if formed in the course of treatment of the
bellwether plaintiffs, and (2) fact testimony related to the learned intermediary issue,
specifically, whether the treating physicians would have used the Avaulta products if they were
given the warnings that the plaintiffs contend should have been given, should not be excluded.
These opinions fall within the realm of proper testimony from treating physicians. I further
FIND that (1) expert opinions, if any, on product design, (2) testimony regarding other patients
and complications unrelated to the bellwether plaintiffs treated by the physician, and (3) other
opinions formed outside of the treating physicians’ care and treatment of the bellwether plaintiffs
should be excluded. These latter opinions are fraught with reliability and relevancy issues.
F.

Bernd Klosterhalfen, M.D.

Dr. Klosterhalfen’s expert report states that his opinions concern “1) the products, 2) the
human body’s reaction to the products, and 3) the significant problems the products cause and
have caused women implanted with these products.” (Klosterhalfen Report [Docket 108-1], at 1).
Specifically, he offers opinions related to: (1) the qualifications that a surgeon should have to use
Avaulta products; (2) product design and materials; (3) polypropylene degradation; (4) curling

30

and folding of the mesh in addition to scarification and chronic inflammatory response; and (5)
other complications resulting from use of the mesh. (See generally id.).
Bard seeks to exclude Dr. Klosterhalfen’s opinions on the following issues:
(1) surgical technique and the requisite qualifications of surgeons to use Avaulta
products; (2) the marketing of Avaulta to doctors; (3) the design of the Avaulta
products, including an opinion on something called “effective pore size,” a term
that only one of his colleagues uses; (4) “surface degradation” in Avaulta
products; (5) Bard’s state of mind; and (6) medical causation related to the named
Plaintiffs.
(Def. Bard’s Mem. of Law in Supp. of Mot. to Limit the Ops. & Testimony of Dr. Bernd
Klosterhalfen, M.D. [Docket 116], at 1) [hereinafter Bard’s Mem. re: Klosterhalfen]. Bard also
seeks to preclude Dr. Klosterhalfen from relying on his database of explanted mesh products and
tissue samples in any of his opinions. As discussed below, Bard’s motion is GRANTED in part
and DENIED in part.
i.

Opinions Related to Surgeon Qualifications

Bard argues that Dr. Klosterhalfen seeks to opine that: (1) “the surgeon must be very
experienced and well trained to even attempt” the usage of Avaulta products and that (2) “[d]ue
to the complexity of the mesh design . . . even the very experienced pelvic floor surgeons
experience complications with Avaulta products.” (Id. at 3). Bard argues that Dr. Klosterhalfen,
as a pathologist, is not qualified to opine on these issues. Dr. Klosterhalfen testified, for example:
Q.

. . . Can you tell us what your experience is with respect to mesh used in
pelvic floor reconstruction other than being a co-author to the DePrest
article?

A.

So no, I’m – you want to say I’m – basically, it’s not a field I should talk
about. That’s not true. You see, I have – if we talk about clinical studies, I
agree I’m not the expert. If we talk about operation procedures, I agree I
am not the expert. But – but I am the only one who has 500 explants. And
you must know, and now we will come with evidence levels of studies, do
you know what a pathologist is doing? And this is our basic work. . . .
What we do is we collect samples, we observe, we investigate. We have
31

subgroups. And, of course, in prolapse repair, I’m the expert if you talk
about the histology and the pathology of these meshes because there’s
nobody else who has this data pool.
(Klosterhalfen Dep. vol. I [Docket 108-2], at 74:10-75:7). He further testified:
Q.

. . . So with respect to pelvic organ prolapse repair surgery, I think we’ve
already agreed you are not a surgeon, correct?

A.

Yeah.

Q.

You have never performed this procedure, correct?

A.

Yeah. But I have –

Q.

Is that right?

A.

Yes, that’s true.

...
Q.

So you have never attempted to perform pelvic organ prolapse repair with
any of the Avaulta products, correct?

A.

No.

(Id. at 76:21-77:4; 79:13-79:16). Bard argues that because Dr. Klosterhalfen admitted he was not
an expert on surgical procedures or clinical studies, is not a surgeon, and has never performed or
attempted to perform a pelvic organ prolapse repair with an Avaulta (or any other) product, he is
not qualified to offer an expert opinion on surgical techniques.
The plaintiffs respond by arguing that Dr. Klosterhalfen is qualified “based on his
experiences, discussions and observations of the procedures being performed, and his extensive
research in this specific subject area.” (Pls.’ Resp. in Opp’n to Def. Bard’s Mot. to Limit the
Ops. & Testimony of Dr. Bernd Klosterhalfen, M.D. [Docket 156], at 3) [hereinafter Pls.’ Resp.
re: Klosterhalfen]. For example, Dr. Klosterhalfen testified that:
Q.

Okay. Going to your report, you mention that with pelvic utilization of
polypropylene mesh constructed with arms and implanted transvaginally,
32

such as Avaulta biosynthetic (Classic), Avaulta Solo, and Avaulta Plus,
the surgeon must be very experienced and well trained to even attempt its
usage. That’s in your report, correct?
...
A.

Yeah, that’s true. You see, basically, as an opinion leader in that field, I
have seen a lot of these operations, and I have made wet labs, and I’ve
discussed, of course, to representatives and to professionals in this field.
And I know that this operation is highly complicated. And so I know a
little bit more than the pathology.

...
Q.

Maybe we can shortcut some of this. Are you going to be offering an
opinion about the procedure itself of doing pelvic floor reconstruction?

A.

I’m offering my opinion – well, the statement that I’ve heard and have
spoken to surgeons saying that this is a complicated operation. And that I
have seen operations during congresses and during wet labs, and you can
see that it’s – for a normal surgeon who never have done it, it’s highly
complicated because you’re working blind.

(Klosterhalfen Dep. vol. I [Docket 108-2], at 75:16-76:10; 78:13-78:24). After review of Dr.
Klosterhalfen’s qualifications and deposition testimony, I FIND that Dr. Klosterhalfen is
qualified to offer his expert opinions on surgeon qualifications. A witness may be qualified as an
expert by “knowledge, skill, experience, training, or education,” and Dr. Klosterhalfen has
shown that he is qualified by his knowledge. Fed. R. Evid. 702.
ii.

Opinions Related to Product Design

Dr. Klosterhalfen offers design opinions relating to (1) the complexity of the mesh design
and (2) the necessary pore size of the meshes. Bard argues that Dr. Klosterhalfen is not qualified
to offer opinions related to product design and that his opinions have no factual foundation. Bard
takes particular issue with Dr. Klosterhalfen’s “effective pore size” opinion, arguing that it has
no scientific basis, that “it is also questionable how strongly it is received among the few who
study the concept,” and that it is irrelevant (Bard’s Mem. re: Klosterhalfen [Docket 116], at 6).
33

The plaintiffs spend the bulk of their response arguing that (1) Dr. Klosterhalfen is
qualified to testify on these issues and that (2) Dr. Klosterhalfen provides a sufficient and reliable
basis for his opinion on effective pore size. (See Pls.’ Resp. re: Klosterhalfen [Docket 156], at 311). The record shows that Dr. Klosterhalfen is qualified to offer such opinions. Again, a witness
may be qualified as an expert by “knowledge, skill, experience, training, or education.” Fed. R.
Evid. 702. Dr. Klosterhalfen has significant experience analyzing mesh explants, and more
importantly, in the consulting and designing of mesh products. Bard’s attempts to limit Dr.
Klosterhalfen’s consulting and design experience are unconvincing.
An expert’s opinions must be based on reliable principles and methods applied to the
facts of the case. Fed. R. Evid. 702. Dr. Klosterhalfen’s opinions related to pore size are properly
applied to the facts of this case. He saw Bard’s calculations of the pore size for the Avaulta
products and opined that they were inadequate. (See Klosterhalfen Report [Docket 108-1], at 3).7
Turning to the sufficiency and reliability of Dr. Klosterhalfen’s basis for his pore size opinions, it
is important to note the difference between his opinions on pore size and effective pore size. Dr.
Klosterhalfen opines that Avaulta mesh products should have a pore size of 3 millimeters or
greater (before implantation) and an “effective pore size” of at least 1 millimeter (after
implantation). (Klosterhalfen Report [Docket 108-1], at 3). These appear to be two separate, but
related opinions.8 Bard does not appear to contest Dr. Klosterhalfen’s opinion regarding pore
size, and this opinion is amply supported by scientific literature. With respect to effective pore

7

Bard also seeks to exclude Dr. Klosterhalfen’s opinion regarding “the complexity of the mesh
design.” (Klosterhalfen Report [Docket 108-1], at 2). It is unclear what opinions Dr. Klosterhalfen seeks
to render in this regard, but in any case, he has not provided any basis for rendering any opinions
regarding the “complexities” of the Avaulta mesh design beyond pore size.
8
In essence, a mesh product with a pore size of 3 millimeters or greater prior to implantation
would have an effective pore size of 1 millimeter or greater after implantation.

34

size, the analysis is more difficult. For example, Dr. Klosterhalfen testified regarding a 2011
article provided by the plaintiffs:
Q.

. . . Now, what does macroporosity mean?

A.

I think, basically, he – in that case, he describes the pore size, basically. So
he’s talking about large pore concept.

Q.

Okay. And the millimeter range is constituted of all relative large pores
existing between the columns of stitches. The knitting pattern controls the
size, shape, and density of such large pores. The macroporosity has an
even more important impact on the mesh integration because insufficient
pore size will generate the mesh fibrotic encapsulation, which will bridge
between the mesh yarns and then be responsible for the mesh shrinkage
and potential pain or discomfort during tissue contraction. Then he refers
to figures 25.2 and 25.3 illustrate the encapsulation mechanism according
different mesh pore sizes. From this study and others, it sounds that the
cutoff in pore size to limit the risk of fibrous capsule formation and
subsequent shrinkage is around 1.5 – 1 to 1.5 millimeters. Several teams
showed that macroporosity was the key factor to control fibrosis. In that –
is that confirmatory or not confirmatory of your opinions that you have
rendered in regard to effective pore size and the importance of effective
pore size?

MR. BROWN: Objection, there’s no reference in there to effective pore size.
A.

Yeah, it’s a little bit – little bit tricky, but all together I think it confirms
our concept, but the problem here is whether he’s talking about effective
pore size or just the pore size. But what is clearly coming out, that they
recognize the importance of the pore – of the pore for the tissue
integration, especially here with what is very nice in that group because, as
I say, they are pretty good. He’s talking about the knitting pattern which
controls the size and the shape and density of that large pore, so he is little
bit talking about effective pore size.

(Klosterhalfen Dep. vol. II [Docket 108-4], at 634:6-635:24) (emphasis added). Dr. Klosterhalfen
further noted that the author “describes what we mean with effective pore size. So what he’s
talking about, that the pore must be stable even if you have mechanical stress on the mesh, and
that’s pretty nice true.” (Id. at 636:17-636:21). Additionally, the parties agree that Dr. Muhl
published a study on effective pore size. Bard’s attempts to discredit the article ignore the

35

plaintiffs’ argument that Dr. Muhl’s study was peer-reviewed and published in a peer-reviewed
publication.9 Accordingly, I FIND that Dr. Klosterhalfen’s expert opinions related to product
design should not be excluded.
iii.

Opinions Related to Bard’s Marketing Practices and State of Mind

As discussed more fully supra related to Dr. Shull’s expert opinions and consistent with
those findings, I FIND that Dr. Klosterhalfen’s opinions related to Bard’s marketing practices
and state of mind should be excluded.10
iv.

Opinions Related to Surface Degradation

Dr. Klosterhalfen offers his expert opinion relating to surface degradation of meshes,
which plays a role in a “chronic inflammatory process that is long term and induces scarification,
contraction of tissues, pain, and infection, both clinical and subclinical.” (Klosterhalfen Report
[Docket 108-1], at 4-5). Bard argues that this opinion should be excluded because (1) Dr.
Klosterhalfen based this opinion on a series of scanning electron micrographs (SEMs) that “lack
the necessary foundation to support an admissible opinion,” (2) this opinion is based on “shaky
science at best, making it inherently unreliable,” and (3) he made several admissions, including
that “he did not see any evidence of surface degradation on the explants of any of the bellwether
Plaintiffs.” (Bard’s Mem. re: Klosterhalfen [Docket 116], at 8-9).

9

Bard places too much reliance on its argument that the concept of effective pore size is not
generally accepted in the scientific community. Although general acceptance is one factor to consider
under Daubert, it does not end the inquiry. See Crisp, 324 F.3d at 266 (considering general acceptance in
the relevant scientific or expert community as one of five factors).
10
The plaintiffs argue that this is not a Daubert issue, but rather an issue to be presented in a motion
in limine. I disagree. Under Federal Rule of Evidence 702, an expert may testify in the form of an opinion
only if it will assist the jury. See Fed. R. Evid. 702. For example, Dr. Klosterhalfen offers the opinion that
“[i]t was inappropriate to sell the Avaulta meshes for utilization by every surgeon who practices as an
urologist or gynecologist.” (Klosterhalfen Report [Docket 108-1], at 2). These types of opinions are not
properly the subject of expert testimony and therefore, I will exclude them via a Daubert ruling.

36

Again, an expert’s opinions must be based on reliable principles and methods applied “to
the facts of the case.” Fed. R. Evid. 702. Dr. Klosterhalfen testified:
Q.

With respect to the women we’re calling bellwether plaintiffs, you
reviewed pathology for four because one did not have any, right?

A.

That’s true, yes.

Q.

And did you see any evidence of surface degradation on the explants of
any of the bellwether plaintiffs?

A.

No, you can’t with this methodology what I’m doing. In most cases the
fiber is gone after processing the tissue for that staining.

(Klosterhalfen Dep. vol. II [Docket 108-4], at 600:12-600:21). Accordingly, Dr. Klosterhalfen’s
opinion on this issue is not applied “to the facts of the case” as required by Rule 702.
Accordingly, I FIND that Dr. Klosterhalfen’s expert opinions related to surface degradation
should be excluded.
v.

Opinions Related to Medical Causation

Dr. Klosterhalfen opines that the Avaulta meshes are a proximate cause of the pain,
contraction, and other problems that the bellwether plaintiffs experience. Bard argues that Dr.
Klosterhalfen is not qualified to opine on causation, and that the basis for his opinions is
unreliable. Dr. Klosterhalfen’s very job as a pathologist qualifies him to opine on this issue.
Additionally, Dr. Klosterhalfen’s basis is effectively that because he reviews a large number of
explants and has seen patterns that can observed in nearly all of them, that the patterns are a
general result of the procedure or of the mesh. For example, he testified:
Q.

And so you disagreed with the – so you believe the mesh in each instance
was responsible for the complication listed?

A.

The mesh as its own pathology. I cannot say – I cannot – I cannot say in
each instance, of course. But here, you find general rules, how these
meshes behave in the body. I’m absolutely agree it’s possible that you
have a special patient with a special situation, why he got an infection in
37

this mesh, okay. But what you see here, that you have always patterns
which you can observe in nearly all of these implants, and there must be a
general behavior of these meshes in this special location. For instance,
look, the erosion mostly you’ll find at one place in the vagina. Why is
that? If you find 90 percent or 80 percent or the majority of the erosion at
one place, there must be something very particular, huh?
(Klosterhalfen Dep. vol. I [Docket 108-2], at 138:8-139:1). Furthermore, Dr. Klosterhalfen
effectively rules out other potential causes by discussing the randomization in his data:
Q.

And your data pool does not take into account the other medical
conditions that may have led to infection, for example, correct?

A.

Oh, yeah, but you – but, basically, you sell these products not for healthy
people, yeah? You know that these people have diabetes, that they have
obesity, that they have hypertension, which all promotes infection. That
you have to know. So – but basically, if you got a special level, and if you
have 500 tissue samples, these data are randomized. You cannot say that
this lady – this special lady has this infection because she has diabetes,
especially if all of the 500 implants or explants show all the same.

(Id. at 136:5-136:18). Finally, Dr. Klosterhalfen testified regarding his review of the pathology
slides of the bellwether plaintiffs Ms. Jones, Ms. Queen, and Ms. Cisson:
A.

Basically, the meshes show all what here was addressed and before. They
show the scar tissue formation, they show this wrinkling, they show
entrapped nerves. And, basically, I think in that location the meshes play a
major role for the complaints of these women, yeah.

(Klosterhalfen Dep. vol. II [Docket 108-4], at 641:17-641:22). In short, Dr. Klosterhalfen has
demonstrated a sufficient and reliable basis for his causation opinions. Accordingly, I FIND that
Dr. Klosterhalfen’s expert opinions related to causation should not be excluded.
vi.

Dr. Klosterhalfen’s Reliance on his Personal Database

Dr. Klosterhalfen relied on a personal database of explanted devices and tissue samples in
forming his opinions. Bard argues that any opinion based on this database should be excluded
because Dr. Klosterhalfen has not disclosed this data, the data is unreliable, and the data is
irrelevant. I disagree. At his deposition in January and February of 2013 in Europe, Dr.
38

Klosterhalfen declined to produce his personal explant database because of German privacy
laws. He explained that the explants were the property of the patient and each patient’s consent
was required for disclosure. (Klosterhalfen Dep. vol. I [Docket 108-2], at 23:17-23:25). Instead,
he produced a chart in German and English about the patient, the explant and certain findings
including the patient’s date of birth, characteristics of the mesh such as pore and weight, and
brand of the product if known, date of implant, the primary indication, the patient’s subjective
complaints, objective complaints, the explant date and other findings. Despite its apparent
dissatisfaction with Dr. Klosterhalfen’s chart, Bard did not timely move to compel the
production of the explant database.
Dr. Klosterhalfen’s reliance on this personal database, created over years for purposes
unrelated to this litigation, is part of his knowledge and experience that he may base his opinions
on under Federal Rule of Evidence 703. Accordingly, I FIND that Dr. Klosterhalfen’s reliance
on his personal database does not render his opinions unreliable.
G.

Lennox Hoyte, M.D.

Dr. Hoyte offers opinions related to: (1) Bard’s marketing of the products to inadequately
trained surgeons; (2) product design and biomechanics of Avaulta mesh,11 and; (3) causation.

11

As stated by the plaintiffs:
Dr. Hoyte holds the opinion that the transvaginal implantation of Bard’s Avaulta Solo,
Plus and Biosynthetic Prolapse Organ repair systems is problematic for a variety [of]
reasons: the blind placement of the mesh arms cut muscle tissue and may damage nerves;
the side to side fixation of the mesh arms in combination with the known tendency of
polypropylene mesh to shrink creates non-anatomic mechanical stresses on the pelvic
muscles causing pain; the static nature of the mesh restricts the functional mobility of the
pelvic floor organs and restricts the natural movements of the vagina during defecation,
urination and intercourse causing pain during these activities; and the transvaginal
placement of the mesh exposes the mesh to the “clean-contaminated” vaginal microbian
environment presenting an opportunity for the mesh to be contaminated.

(Pls.’ Resp. in Opp’n to Def. Bard’s Mot. to Limit the Expert Ops. & Testimony of Dr. Lennox Hoyte
[Docket 147], at 2).

39

Bard takes issues with all of these opinions. As discussed below, Bard’s motion is GRANTED
in part and DENIED in part.
i.

Opinions Related to Biomechanics, Biomechanical Analysis, and
Product Design

Bard argues that (1) Dr. Hoyte is not qualified to render opinions in these areas; (2) Dr.
Hoyte’s opinions are unreliable; and (3) Dr. Hoyte’s opinions will not assist the jury.
a.

Qualifications – Biomechanics and Biomechanical Analysis

Bard argues that Dr. Hoyte is not qualified to opine on biomechanics because he is “not a
biomedical engineer, biomaterial engineer, or biomaterials expert. He has never designed any
products containing mesh. He is not an expert in biomaterials or biomechanics. He is not a
physicist. He is not a radiologist or neuroradiologist and is not qualified to render opinions based
on radiologic images.” (Def. Bard’s Mem. of Law in Supp. of its Mot. to Limit the Ops. &
Testimony of Lennox Hoyte, M.D. [Docket 117], at 5) [hereinafter Bard’s Mem. re: Hoyte]. In
short, Bard focuses on what Dr. Hoyte is not. Dr. Hoyte, however, has two engineering degrees –
a Bachelor of Science in electrical engineering from Worcester Polytechnic and a Master of
Science in electrical engineering and computer science from Massachusetts Institute of
Technology. (Hoyte Curriculum Vitae [Docket 110-3], at 2; see also Hoyte Dep. vol. I [Docket
110-1], at 194:24-195:6). He practiced as an engineer for twelve years. (Hoyte Dep. vol. I
[Docket 110-1], at 195:7-195:13). A review of his deposition testimony also reveals that he is
amply qualified; for example, he testified:
Q.

And then since you became a physician and after medical school – and, of
course, we will go through your C.V., you went through your residency
and your Fellowship, you stopped practicing as an engineer on a day to
day basis?

A.

Not correct.

40

Q.

Explain.

A.

Actually part of my research activity as a resident, a Fellow, and ongoing
has been biomechanical analysis of tissues in the pelvic floor. I have been
studying the pelvic floor from an engineering perspective since 1993.

...
Q.

And then I will pull out your resume and look at it while we’re talking.
But since becoming a doctor you spend your professional time as a
physician, correct?

A.

I’m a physician researcher, and my research area involves biomechanical
analysis of pelvic floor structures.

Q.

Okay.

A.

One of the earliest works that I did was actually this 3D reconstruction
based on MR-based data. And this was published as – reported on as early
as 1999. And I have been doing biomechanical analysis as a researcher in
an ongoing way. So no, I haven’t stopped. You can’t stop being an
engineer.

(Id. at 195:17-197:2). The plaintiffs also argue that “[a]t least a quarter of his publications
involve three dimensional mapping of women with prolapse issues.” (Pls.’ Resp. in Opp’n to
Def. Bard’s Mot. to Limit the Expert Ops. & Testimony of Dr. Lennox Hoyte [Docket 147], at 5)
[hereinafter Pls.’ Resp. re: Hoyte]. With respect to his qualifications to render opinions based on
radiologic images, Bard itself addressed Dr. Hoyte’s qualifications to serve as a preceptor when
it stated that he “is one of the leaders in pelvic MRI data in the world.” (Preceptor Qualification
Form [Docket 147-1], at 1). Dr. Hoyte also has extensive experience in the interpretation of
MRIs; for example, he testified:
Q.

So there is an official interpretation that is conducted by the radiologists,
by the Board certified radiologists or neuroradiologists, and then you say
you utilize those images and reports and do your own, from your
standpoint, is that what you are saying?

A.

As a surgeon and an anatomist required to correct pelvic floor disorders, I
have to personally interpret the images myself because my surgery, my
41

surgical intervention, my clinical intervention depends on my impressions
that I see from interpreting the images.
Q.

Okay.

A.

So while I’m not a radiologist in the sense of a radiologist looking for
tumors, for cancer, for abnormal radiologic – traditional radiologic
structures, I’m looking very specifically the structural information
contained in that MRI, and in that area I’m very much an expert.

(Hoyte Dep. vol. I [Docket 110-1], at 52:16-53:9).
While Dr. Hoyte is not a radiologist, he has significant experience interpreting MRIs.
Furthermore, his research experience in the field of biomechanics involving the pelvic floor
makes him amply qualified. In sum, Dr. Hoyte is qualified “by knowledge, skill, experience,
training, or education” to opine as to biomechanics and biomechnical analysis. Fed. R. Evid. 702.
Accordingly, I FIND that Dr. Hoyte is qualified to offer his expert opinions on biomechanics
and biomechanical analysis.
b.

Qualifications – Product Design

Bard argues that Dr. Hoyte is not qualified to opine on the design of Avaulta mesh
because he has no training or experience using Avaulta products. Bard heavily emphasizes that
Dr. Hoyte “never implanted an Avaulta device transvaginally in a live patient.” (Bard’s Mem. re:
Hoyte [Docket 117], at 5) (emphasis omitted). An expert witness may be qualified by
“knowledge, skill, experience, training, or education.” Fed. R. Evid. 702 (emphasis added). From
a review of Dr. Hoyte’s testimony, he clearly has knowledge of Avaulta products and the design
of Avaulta products. While he may not have experience implanting an Avaulta device, he has
explanted Avaulta devices, and personally observed other physicians implanting an Avaulta
device. Bard itself sought out Dr. Hoyte’s services as a preceptor:

42

A.

Well, let’s see. I think in the Boston time I think they were referring to me
as a potential surgeon that they could recruit as somebody that would be a
Bard implanter who –

...
A.

. . . They were complimentary about myself and my skills as a surgeon and
my abilities and my reputation and things like that and is going to be great,
when he comes to Tampa you guys can recruit him –

Q.

Okay.

A.

--and make him be a Bard preceptor, he’s good for us, you know, those
kinds of things is what I –

(Hoyte Dep. vol. II [Docket 110-2], at 520:9-520:12; 521:18-522:1). In sum, it is clear that Dr.
Hoyte is qualified “by knowledge, skill, experience, training, or education” to opine as to the
design of Avaulta mesh products.12 Fed. R. Evid. 702. Accordingly, I FIND that Dr. Hoyte is
qualified to offer his expert opinions on the design of the Avaulta mesh products.
c.

Reliability – Biomechanical Analysis and Opinion

Bard takes issue with Dr. Hoyte’s biomechanical analysis “using a mesh-free method and
creat[ing] a variety of graphics, purported computer simulation videos and 3-D models of a
pelvis.” (Bard’s Mem. re: Hoyte [Docket 117], at 6). Bard argues that (1) Dr. Hoyte selected the
MRI of a non-bellwether plaintiff as a model for his graphics, videos, and 3-D models, without

12

Bard’s cited authorities are unpersuasive. See, e.g., Khoury v. Philips Med. Sys., 614 F.3d 888,
893 (8th Cir. 2010). In Khoury, the Eighth Circuit found that a doctor was unqualified to opine on the
design of laboratories or of monitor banks and radiation shields because the doctor was an ergonomist and
otherwise had “no training, education, or experience” in the design of medical laboratories or of monitor
banks and radiation shields. Id. Khoury did not deal with a lack of first-hand experience with a particular
product; rather, it dealt with a lack of training, education, or experience in the design of the entire class of
products. Khoury’s holding would not preclude in and of itself, for example, the testimony of a doctor
who had some training, education, or experience in the design of laboratories or of monitor banks and
radiation shields to opine on the specific laboratories or monitor banks and radiation shields that were at
issue in that case. In other words, it was not the doctor’s lack of first-hand experience with the Cath Lab 5
or the BH5000 product, but his lack of experience with any laboratories or monitor banks or radiation
shields, that caused him to be unqualified.

43

ensuring that it was representative of the four bellwether plaintiffs and (2) Dr. Hoyte made no
allowance for any variation amongst pelvic floors in women.
It is worth keeping in mind, at the outset, the opinion that Dr. Hoyte seeks to offer based
on his biomechanical analysis: “where the anterior Avaulta mesh kit would be placed in a female
pelvis and what happens to the mesh and the surrounding structures during the normal dynamic
operation of the pelvis from various activities.” (Pls.’ Resp. re: Hoyte [Docket 147], at 10). Dr.
Hoyte’s methodology in his biomechanical analysis appears to be reliable and grounded in
scientific basis. For example, he testified:
A.

I have used an insert here to attach to the pelvic sidewall to show how the
vagina is actually attached. This is based on a peer-reviewed, anatomically
agreed upon understanding in living women of how the pelvis and the
vagina relate to each other. . . . Based on our understanding of the past ten
years, some work by Dr. Delancey, myself, and others, demonstrated the
living anatomy in the female pelvis, and it is now agreed upon from peerreviewed data that this is actually the shape of the vagina in the pelvis.

(Hoyte Dep. vol. I [Docket 110-1], at 84:16-85:10). Dr. Hoyte relied upon peer-reviewed
literature to determine that his model is a representative pelvic floor, and his reconstruction of it
is also based upon peer-reviewed literature. (See id. at 63:24-64:4). Bard argues that Dr. Hoyte’s
model is not representative of the pelvises of any of the bellwether plaintiffs, or even the
individual whose MRI he used to base his model. However, Dr. Hoyte’s model is designed to be
generally representative of the female pelvis. It is Dr. Hoyte’s opinion that in “a woman’s pelvic
floor, invariably the structures that you will find there and the relationships between the
structures are pretty uniform.” (See Hoyte Dep. [Docket 110-1], at 64:10-64:16). I FIND that Dr.
Hoyte’s biomechanical analysis and opinions are sufficiently reliable to withstand a Daubert
challenge.

44

d.

Reliability – Product Design

The plaintiffs failed to respond to Bard’s arguments regarding the reliability of Dr.
Hoyte’s opinions on this issue. While Dr. Hoyte may be qualified to opine on the design of the
Avaulta products, such qualifications, without more, do not form a reliable basis for the expert’s
opinions. Dr. Hoyte’s expert report, however, suggests that he relied not only on his knowledge
and experience, but also on scientific literature. (See, e.g., Hoyte Report [Docket 110-3], at 4-5)
(“The same is recognized in the scientific literature.”). Accordingly, I FIND that Dr. Hoyte’s
product design opinions are sufficiently reliable.
e.

Relevance

The plaintiffs also failed to respond to Bard’s arguments regarding the relevance of Dr.
Hoyte’s opinions on the issues of biomechanics and product design. However, Dr. Hoyte’s
opinions on the biomechanics and product design of the Avaulta mesh are relevant to the issues
of product defect, notwithstanding the lack of a specific application to the bellwether plaintiffs.
For example, the question of whether a product is defectively designed does not have to relate to
whether it was defectively designed as implemented in a particular patient. Accordingly, I FIND
that Dr. Hoyte’s opinions related to biomechanics and product design of the Avaulta mesh are
relevant and would assist the jury.
ii.

Opinions Related to Specific Causation

Bard’s reply to the plaintiffs’ response argues that on March 28, 2013, the plaintiffs filed
a supplemental report for Dr. Hoyte’s opinions, which include “brand-new, never previouslydisclosed specific causation opinions.” (Def. Bard’s Reply in Supp. of its Mot. to Limit the Ops.
& Testimony of Lennox Hoyte, M.D. [Docket 171], at 12). Bard argues that I should not

45

consider the supplemental report. The plaintiffs argue that Dr. Hoyte did, in fact, offer a specific
causation opinion in his first report.
Federal Rule of Civil Procedure 26(e) governs the supplementing of disclosures. A
disclosure must be supplemented or corrected “in a timely manner if the party learns that in some
material respect the disclosure or response is incomplete or incorrect, and if the additional or
corrective information has not otherwise been made known to the other parties during the
discovery process or in writing.” Fed. R. Civ. P. 26(e)(1)(A). Dr. Hoyte’s original expert report
was submitted pursuant to the October 15, 2012 deadline. Six months later, and a week after
Bard filed its Daubert challenges to Dr. Hoyte’s opinions, the plaintiffs submitted the
supplemental report.
Dr. Hoyte’s original expert report offers two opinions related to causation. First, he
states:
To a reasonable degree of medical and scientific certainty, it is my professional
medical opinion that the design defects and/or actions caused by the design
defects cause and contribute to the pain experienced by women with transvaginal
Avaulta mesh implants.
(Hoyte Report [Docket 110-3], at 6). Next, he states:
I can state with reasonable medical certainty that what is being shown in the
graphics is representative of what is experienced by the women who have
difficulties with the Avaulta products. After reviewing the medical records,
including operative reports and follow-up evaluations of Ms. Queen, Ms. Cisson,
Ms. Jones, Ms. Rizzo, Ms. Smith, I can say with reasonable medical certainty that
the symptoms experienced by these 5 women are consistent with the findings
demonstrated by these MRI derived simulation graphics, and also consistent with
my clinical experience with the many women whom I have treated for
transvaginal mesh related complications.
(Id. at 9). I FIND that Dr. Hoyte offers specific causation opinions in his original expert report,
and that his supplemental report clarifies the basis for the specific causation opinions that he

46

originally offered. Accordingly, I will consider the supplemental report and Bard’s substantive
Daubert challenges to Dr. Hoyte’s opinions.13
Bard argues that Dr. Hoyte is not qualified to offer opinions on specific causation and
that his specific causation opinions are unreliable. As an urogynecologist with significant
experience with pelvic repair and Avaulta products, Dr. Hoyte has personally examined hundreds
of patients with mesh complications. As a result, Dr. Hoyte is qualified to offer specific
causation opinions. In addition, Dr. Hoyte has reviewed the bellwether plaintiffs’ medical
records and has performed a sufficiently reliable differential diagnosis to support his specific
causation opinions.14 Accordingly, I FIND that Dr. Hoyte’s specific causation opinions should
not be excluded under Daubert.
iii.

Opinions Related to Bard’s Marketing Practices

As discussed more fully supra related to Dr. Shull’s expert opinions and consistent with
those findings, I FIND that Dr. Hoyte’s opinions regarding Bard’s marketing of the Avaulta
products are not an appropriate subject of expert testimony and will not assist the jury.
H.

David A. Kessler, M.D.

Dr. Kessler’s lengthy report of almost 200 pages seeks to offer a total of ten expert
opinions:
a.
b.

Bard . . . had responsibility for the safety of their Avaulta products.
FDA regulations and state tort liability operate independently.

13

This ruling is limited very narrowly to the circumstances surrounding and the contents of Dr.
Hoyte’s expert reports. The parties are specifically admonished that this ruling does not invite the parties
to indiscriminately file supplemental expert reports under the guise of clarifying the basis for an earlier
opinion.
14
Dr. Hoyte rules out any fault by the surgeon in his supplemental report. Moreover, Dr. Hoyte
effectively rules out other possibilities by suggesting that, to a reasonable degree of medical certainty, the
complications experienced by the bellwether plaintiffs are so consistent with those that Dr. Hoyte has
observed and experienced that nothing other than the mesh could be the cause.

47

c.

d.
e.

f.
g.
h.
i.
j.

A device company has a responsibility, independent of what the FDA
directs it to do, to alert physicians and patients to risks that are known to
the company.
Bard knew there were safety issues with their Avaulta Products and should
have investigated these risks in humans before marketing.
Bard stated their Avaulta Products were new and revolutionary. These
products had different technological characteristics and raised safety
questions, yet Bard claimed to FDA these products were substantially
equivalent. Substantially equivalent devices cannot pose new safety or
technological characteristics.
Bard failed to adequately disclose adverse risks associated with their
products to physicians.
Bard withheld material information from FDA, physicians, and patients.
Bard inappropriately promoted its products.
Bard failed to objectively evaluate and take action concerning potential
problems.
Bard’s Avaulta Products were not “reasonably safe” and should not have
been marketed.

(Kessler Report [Docket 113-2], at 8-9). Bard argues that Dr. Kessler’s report “contains
innumerable opinions that go far beyond the regulation of medical devices and the permissible
scope for regulatory expert testimony.” (Def. Bard’s Mem. of Law in Supp. of its Mot. to Limit
the Ops. & Testimony of David A. Kessler, M.D. [Docket 114], at 1) [hereinafter Bard’s Mem.
re: Kessler]. Bard moves to exclude the following opinions of Dr. Kessler:
(1) legal opinions and legal standards regarding, inter alia, the state law duties
applicable to Bard and the interplay between state law product liability law and
federal regulations; (2) opinions regarding Bard’s knowledge, motivation, state of
mind, corporate conduct, or intent; (3) opinions regarding the safety of Bard’s
Avaulta devices and whether the devices were reasonably safe; (4) opinions
regarding the design, manufacturing, and testing of Bard’s Avaulta devices; (5)
opinions regarding the adequacy of the warnings and labeling that Bard provided
for its Avaulta devices; (6) opinions regarding the risks demonstrated for pelvic
mesh in scientific and medical literature; (7) medical opinions, including those
relating to causation, injuries, or other issues relating to specific plaintiffs; (8)
opinions regarding “safety signals” for Bard’s Avaulta devices; and (9) opinions
regarding whether Bard allegedly violated FDA regulations or otherwise acted
inappropriately in its 510(k) submissions, its disclosures to the FDA, its
promotion of its products, and its post-marketing activities.

48

(Id. at 3-4). I will consider each of these arguments in turn. As discussed below, Bard’s motion is
GRANTED in part and DENIED in part.
i.

Opinions Related to Bard and Others’ Knowledge, Intent, or Motives

Bard argues that “Dr. Kessler spends the majority of his voluminous Report summarizing
and selectively quoting from internal corporate emails, literature in Bard’s possession, deposition
testimony of corporate employees, and internal company documents” without presenting any
expert analysis of these facts. (Id. at 5) (internal citations omitted). Bard also argues that Dr.
Kessler “also intertwines his own speculative views about the supposed knowledge and intent of
Bard.” (Id. at 6).
Dr. Kessler’s expert report is replete with such types of expert opinions. For example, it
appears that the entirety of Section VI of his report opines on what Bard knew and when Bard
knew it. The plaintiffs argue that “[t]his is classic use of expert testimony to establish what was
known and knowable to a defendant, and when it was known or knowable.” (Pls.’ Resp. in
Opp’n to Def. Bard’s Mot. to Limit the Expert Ops. & Testimony of David A. Kessler, M.D.
[Docket 152], at 8) [hereinafter Pls.’ Resp. re: Kessler]. As discussed previously, however, while
an expert may rely on these materials as part of the basis for their opinions, Bard’s knowledge,
intent, or motives are simply not appropriate subjects for expert testimony. The documents and
testimony should be presented directly to the jury, not through an expert. To the extent that Dr.
Kessler opines on Bard’s knowledge, intent, or motives, such conclusions are factual inferences
for the jury to determine, not for an expert to opine. Accordingly, I FIND that Dr. Kessler may
not offer expert testimony on Bard’s knowledge, intent, or motives.

49

ii.

Opinions that are Impermissible Legal Conclusions

In the Fourth Circuit, “opinion testimony that states a legal standard or draws a legal
conclusion by applying law to the facts is generally inadmissible.” United States v. McIver, 470
F.3d 550, 562 (4th Cir. 2006). Dr. Kessler’s expert report seeks to draw various legal
conclusions, which is properly the jury’s role. For example, Section IX is entitled “Bard failed to
adequately disclose adverse risks associated with their products,” and subsection D states that
“Bard failed to warn on its label . . . .” (Kessler Report [Docket 113-2], at 108, 120) (emphasis
added). Section XVI is entitled “Bard’s Avaulta products were ‘not reasonably safe.’” (Id. at
170) (emphasis added). Such statements draw legal conclusions from facts. The questions of
whether Bard’s Avaulta products were not reasonably safe, for example, or whether Bard failed
to warn, are questions for the jury, not for Dr. Kessler.
That is not to say that Dr. Kessler is precluded from offering expert testimony related to
the FDA 510(k) framework and process, Bard’s actions taken with respect to this framework and
process, and form an expert opinion that embraces an ultimate issue, to the extent that it may be
relevant and assist the jury. Under Federal Rule of Evidence 704, “[a]n opinion is not
objectionable just because it embraces an ultimate issue.” Fed. R. Evid. 704(a). The Fourth
Circuit has explained that the “role of the district court . . . is to distinguish opinion testimony
that embraces an ultimate issue of fact from opinion testimony that states a legal conclusion.”
United States v. Barile, 286 F.3d 749, 760 (4th Cir. 2002). “The best way to determine whether
opinion testimony contains legal conclusions, ‘is to determine whether the terms used by the
witness have a separate, distinct and specialized meaning in the law different from that present in
the vernacular.’” Id. (quoting Torres v. Cnty. of Oakland, 758 F.2d 147, 151 (6th Cir. 1985)).
Thus, Dr. Kessler may not offer an expert opinion that, for example, Bard’s Avaulta products

50

were “not reasonably safe” or that Bard “failed to warn.” Dr. Kessler may, however, offer a more
general expert opinion, using terms that do not have a separate, distinct, and specialized meaning
in the law.
Dr. Kessler’s expert report also seeks to state legal standards, which is properly the
court’s role. The court will instruct the jury on Bard’s duties and obligations under state law.
Similarly, to the extent that the court finds it relevant, the interplay between FDA regulations and
state tort liability is also the type of instruction that the jury will receive from the court.
Accordingly, I FIND that Dr. Kessler may not offer expert opinions that state legal standards.
iii.

Opinions Relating to Bard’s Disclosures to the FDA

Bard argues that Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 343 (2001)
precludes the admission of Dr. Kessler’s opinions regarding certain information that he believes
Bard should have provided to the FDA. In short, Buckman held that “the plaintiffs’ state-law
fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, federal law.”
Id. at 348. The plaintiffs argue that there are no such claims here, and therefore Buckman is
inapplicable. I agree.
Nevertheless, the question remains as to the relevancy of Dr. Kessler’s opinions to the
instant case. As noted above, Dr. Kessler may not testify that Bard violated FDA regulations—
such testimony would be drawing legal conclusions. However, Dr. Kessler may testify, for
example, that Bard did not disclose certain information to the FDA that Dr. Kessler, as a former
Commissioner of the FDA, would have found pertinent. These opinions are relevant to the
instant matter because evidence of Bard’s “efforts to manipulate the regulatory process” may be
relevant to the state law claims at issue. In re Medtronic, Inc., Implantable Defibrillators Litig.,
465 F. Supp. 2d 886, 900 (D. Minn. 2006). Accordingly, I FIND that Dr. Kessler may offer

51

expert opinions related to Bard’s disclosures to the FDA, as long as his opinions do not
impermissibly draw legal conclusions.
iv.

Opinions Relating to Product Design, Testing, and Labeling

Bard argues that while Dr. Kessler “may be qualified to testify about federal regulation of
medical devices,” he is not qualified to offer any medical opinions or opinions on the design,
testing or labeling of the Avaulta products. (Bard’s Mem. re: Kessler [Docket 114], at 11-16).
Bard argues that Dr. Kessler is not an expert in any of these areas because: (1) he has no
expertise implanting or using pelvic mesh products; (2) he is not an engineer, biomedical
engineer, biomaterial engineer, or pathologist, and; (3) he is not an expert on the products, has no
expertise as to what risk information or instructions would be appropriate for a urogynecologist
performing a mesh implantation procedure, and has no experience drafting medical device
warnings.
Federal Rule of Evidence 702 notes that a witness may be qualified “by knowledge, skill,
experience, training, or education.” Fed. R. Evid. 702. Rule 703 further notes that experts may
base their opinions on facts or data that they have “been made aware of or personally observed.”
Fed. R. Evid. 703. Through his experience as Commissioner of the FDA, Dr. Kessler has
obtained expertise regarding these matters. For example, he testified:
Q.

You’re not a biomaterials expert, are you?

A.

I am certainly have – with regard to these issues as they interact with the
regulatory process, I have expertise. And have dealt with some of the most
complex biomaterials issues, as I’m sure you’re well aware, I mean, over
the – you know, while at FDA. And so I – you know, I – I do – but in the
context of the regulatory environment.

...
Q.

Outside of regulatory, do you have any expertise in biomaterial analysis?

52

A.

As – as – as you would have in – in training, both medical and scientific
training. And I’ve – again, so I certainly have expertise that exceeds, I
mean, through medical and scientific training, but I’ve – you know, again,
people – there should be – there should be biomaterials experts. My – my
usefulness is how biomaterials can interact with the regulatory process –

(Kessler Dep. [Docket 113-1], at 176:22-177:4; 178:11-178:20). In sum, as long as Dr. Kessler’s
expert opinions on product design, testing, and labeling are given in the context of the FDA
regulatory process, I FIND that he is qualified to offer such opinions The reliability of such
opinions is another issue, however, as discussed below.
v.

Reliability of Dr. Kessler’s Opinions Relating to Product Safety, Design,
Testing and Labeling, and Bard’s Promotion of its Products, Safety
Signals, and Post-Marketing Activities

Bard attacks the reliability of Dr. Kessler’s opinions, arguing that “his Report is entirely
devoid of an independent, objective, and scientifically valid method in reaching his opinions.”
(Bard’s Mem. re: Kessler [Docket 114], at 17). A review of Dr. Kessler’s lengthy report reveals
that some of his expert opinions are sufficiently reliable, while others are not. Taking, for
example, Section VII, Dr. Kessler first states that “[t]o be substantially equivalent, a device
cannot raise new questions about safety and effectiveness.” (Kessler Report [Docket 113-2], at
80). Dr. Kessler then discussed the differences between the Avaulta products and their predicate
products, and relied upon Bard documents, testimony, and scientific literature in Bard’s
possession in forming his opinions that the Avaulta devices do, in fact, raise new questions about
safety and effectiveness.15 Dr. Kessler’s opinions regarding the adequacy of product labeling and
warnings and safety signals similarly appear to be reliable with references to medical
publications and documentation of risks and adverse events. Accordingly, I FIND that Dr.

15

Dr. Kessler’s report refers several times to “scientific literature in Bard’s possession.” (See, e.g.,
Kessler Report [Docket 113-2], at 90).

53

Kessler’s opinions related to product safety, design and labeling and warnings are sufficiently
reliable to be admissible.
In contrast, Dr. Kessler’s opinion that Bard needed to conduct human clinical trials is an
example of an opinion that is not reliable. In essence, Dr. Kessler summarized the reasons for
conducting human clinical trials, identified risks of the mesh products, and concluded on these
bases that Bard should have conducted clinical trials. This opinion is based on his personal
opinion, rather than any reliable basis.16 Dr. Kessler’s opinions related to Bard’s promotion of its
products and post-marketing activities should similarly be excluded. Accordingly, I FIND that
Dr. Kessler’s opinions related to human clinical trials and Bard’s promotion of its products and
post-marketing activities should be excluded.
vi.

Opinions Related to Specific Causation

Both parties agree that Dr. Kessler will not provide any opinions related to specific
causation. Additionally, to the extent that Dr. Kessler opines on issues of general causation, I
FIND that such opinions should be excluded. Dr. Kessler, as a regulatory expert, is not qualified
to render opinions “on the risks of injury and damage caused by Bard’s Avaulta products.” (Pls.’
Resp. re: Kessler [Docket 152], at 13).
I.

Ahmed El-Ghannam, Ph.D.

Dr. El-Ghannam is a biomaterials and bioengineering expert retained by the plaintiffs
primarily to offer opinions on the design of the Avaulta mesh products, particularly on the issue
of polypropylene degradation. Bard identifies four sets of Dr. El-Ghannam’s opinions that it
challenges: (1) specific causation; (2) design defects; (3) manufacturing processes; and (4) the
adequacy of Bard’s FDA qualifying tests. Bard argues that Dr. El-Ghannam is not qualified to
16

At times, it appears that the plaintiffs conflate qualification with reliability. Certainly, Dr. Kessler
is qualified as former Commissioner of the FDA to offer expert opinions on testing; however, his
opinions must still be grounded in reliable methodology and principles. Fed. R. Evid. 702.

54

render any of the opinions that he seeks to offer and that his foundations are unreliable. As
discussed below, Bard’s motion is GRANTED in part and DENIED in part.
i.

Opinions Related to Specific Causation

Bard argues that Dr. El-Ghannam may not testify as to specific causation. I agree. It
appears that Dr. El-Ghannam is qualified by virtue of his education, experience and training as a
biomedical engineer to testify as to causation—how the Avaulta mesh “affects the biological
system.” (El-Ghannam Dep. vol. II [Docket 130-3], at 323:21). Nothing in his expert report,
however, suggests that he is offering an opinion that any of the particular bellwether plaintiffs
was injured by the Avaulta mesh that was implanted in them. (See generally El-Ghannam Report
[Docket 130-1]). Rather, it seems that Dr. El-Ghannam opines that the degradation of
polypropylene is one of the causes for the product’s failure inside the body generally. Moreover,
while the plaintiffs argue that Dr. El-Ghannam is “qualified to testify regarding specific injury
causation,” that section of their response argues that Dr. El-Ghannam is qualified to testify as to
causation and makes no argument regarding specific causation.17 (Pls.’ Resp. in Opp’n to Def.
Bard’s Mot. to Exclude the Ops. & Testimony of Ahmed El-Ghannam, Ph.D. [Docket 166], at 4)
[hereinafter Pls.’ Resp. re: El-Ghannam]. Accordingly, I FIND that Dr. El-Ghannam may not
offer any expert opinions as to specific causation.

17

The plaintiffs cite and quote Thorpe v. Davol, Inc., MDL No. 07-1842ML, 2011 WL 470613, at
*25 (D.R.I. Feb. 4, 2011) to support this argument. The basis for Dr. El-Ghannam’s conclusion here and
Dr. Ducheyne’s conclusion in Thorpe appear to differ. For example, in Thorpe, Dr. Ducheyne personally
observed the plaintiff’s explanted product and explained in detail how he arrived at the conclusion that it
broke. Here, at most, Dr. El-Ghannam has only tested and analyzed explanted mesh from “certain of these
bellwether Plaintiffs.” (Pls.’ Resp. re: El-Ghannam [Docket 166], at 5). Perhaps in part because Dr. ElGhannam did not intend to offer specific causation opinions in this case, he does not seem to have a
sufficiently reliable basis for doing so.

55

ii.

Opinions Related to Design Defects

Dr. El-Ghannam seeks to render opinions regarding the degradation of polypropylene
pelvic mesh. Bard first argues that Dr. El-Ghannam is not qualified to opine on the degradation
of the specific material at issue, polypropylene. Dr. El-Ghannam is certainly qualified in the field
of biomaterials and biomedical engineering – he is educated and his professional experience has
focused in this field. For example, he testified that:
Q.

You’re not an expert in the design of surgical mesh, are you?

A.

I’m an expert in biomaterials, and a surgical mesh an implant material. So
I am – I know how to analyze the composition and structure, I know what
is required for a material to be biocompatible, I know what is the effect of
persisting conditions on the structure of the material, I know what
parameters would affect the properties of the material, whether these
parameters are related to the persisting conditions or the environment
during service inside the patient. So I know biomaterials and whatever
related to the behavior of the material or the response to this material
when it is implanted into the body.

(El-Ghannam Dep. vol. II [Docket 130-3], at 343:23-344:13). Moreover, he testified:
A.

. . . I wanted to emphasize again here one important point. The surgical
mesh is used as an implant inside the patient, and as I said earlier whether
it’s a surgical mesh or it is a titanium implant or it is a ceramic material, as
long as this material is going to be inserted into the body, it has to be
biocompatible. So the biocompatibility is a preliminary test that’s not
related what kind of materials or what is the physical shape of this
material should be.

(Id. at 345:1-345:11). Finally, he testified:
Q.

What do you consider your subspecialty to be?

A.

I’m a biomaterialist.

Q.

And have you had additional training in biomaterials beyond your medical
degree, biomedical engineering degree?

A.

That’s – that’s what I am.

Q.

Okay.
56

A.

I’m a biomaterialist. I do evaluation of biomaterials, I do development of
new biomaterials or modify biomaterials, study them.

Q.

Other than your work on this litigation, what other implantable medical
devices have you worked on?

A.

That’s all my career. That’s what I do for living.

(El-Ghannam Dep. vol. I [Docket 130-3], at 232:7-232:22). Bard points out that Dr. ElGhannam’s history in biomaterials has concentrated in the bioceramic area. (Id. at 232:23233:12). However, testimony also revealed that he has some experience with polymeric material:
Q.

You have not conducted, outside of litigation, biomaterials testing on
medical devices made of polymeric material; is that correct?

A.

As I indicated early on, I included polymethylmethacrylate as a carrier for
antibiotics in my study to compare it with the ceramic.

Q.

As a control?

A.

As a control, yes.

Q.

Right. But other than that, nothing else?

A.

There was a student who got her Master thesis in working with polylactic
acid, polyglycolic acid, and bioceramic composites. So we mixed the
polymer with the ceramic and then studied the response to this composite.

Q.

And that was your student?

A.

One of my students, yes.

(Id. at 233:13-234:3). I have some concerns about Dr. El-Ghannam’s qualifications to testify
specifically as to the properties of polypropylene. However, in sum, Dr. El-Ghannam has
extensive education and experience in biomaterials generally—which include polymers—and
particularly as it relates to materials implanted in the human body. Accordingly, I FIND that Dr.
El-Ghannam has demonstrated sufficient knowledge of the area of polypropylene to qualify him
to offer opinions on design defects.
57

Next, Bard argues that Dr. El-Ghannam’s design defect opinions are unreliable because
his scanning electron microscopy (“SEM”), Fourier transform infrared spectroscopy (“FTIR”)
and Gel Permeation Chromatography (“GPC”) testing lacked methodology and was unreliable.
Bard makes arguments regarding Dr. El-Ghannam’s “[u]nreliable record keeping” and note
taking, his “lack of testing protocols,” his “[u]nreliable handling of mesh samples,” his
“[u]nreliable tissue culture immersion and bleach testing,” and his “[u]nreliable removal of
biologics and contaminants on explant samples.” (Def. Bard’s Mem. of Law in Supp. of its Mot.
to Exclude the Ops. & Testimony of Ahmed El-Ghannam, Ph.D. [Docket 131], at 8-12)
[hereinafter Bard’s Mem. re: El-Ghannam]. Essentially, Bard contends that while the tests
themselves are ordinarily reliable, Dr. El-Ghannam conducted the tests in an unreliable manner
and therefore, his opinions derived from the tests should be excluded. The plaintiffs respond by
merely citing to Dr. El-Ghannam’s Supplemental Rule 26 Report, which purports to address “in
detail each of the critiques of his testing by Bard’s experts, including his alleged improper
cleaning and handling of the mesh samples.” (Pls’ Resp. re: El-Ghannam [Docket 166], at 9
n.10).
Dr. El-Ghannam’s supplemental report does not address all of the methodology issues
Bard presented. Upon review of his deposition testimony, I have some concerns about the
reliability of the methodology that he used. First, for example, Dr. El-Ghannam did not appear to
follow any written protocols in conducting his tests:
Q.

When you did the tissue culture medium testing, were you following any
kind of a written protocol?

A.

No.

Q.

Did you write out the protocol that you were following as you did it?

A.

I did. I didn’t bring that with me. I will send that to you.
58

(El-Ghannam Dep. vol. I [Docket 130-3], at 142:2-142:9). However, he had previously testified:
Q.

What is the literature you’re relying on to establish that it’s appropriate to
use a tissue culture medium to evaluate the potential degradation of a
polymer?

A.

This is the common test that all research groups who work on developing
new materials or studying modifications of materials or biomaterials will
do. And this is also in – so it’s very common in the literature. It’s very
common also in the books.

...
A.

. . . If you go to the literature, it’s – that’s what every bioengineer is doing,
to evaluate the response or the interaction between the material and tissue
fluids. In my – in my own research, that’s what I do. And for my Ph.D.,
that’s what I did. For – for people who work with wide variety of material,
this is A, B, C biomaterials evaluation.

(Id. at 122:15-123:16). Additionally, his supplemental report notes that he has been using SEM
and FTIR testing since 1984. (El-Ghannam Supplemental Report [Docket 130-2], at 1).
Second, Dr. El-Ghannam’s handling of the pristine mesh samples is of some concern. For
example, his supplemental report states: “[t]he pristine implant is taken from the box so it does
not have any biological contaminants.” (Id. at 28). More specifically, “[t]he pristine Avaulta
polypropylene samples were taken from the original Bard packages to the FTIR machine for
analysis without any treatment.” (Id.). During deposition, however, he testified:
Q.

First of all, how do you cut the sample?

A.

With a scissor.

Q.

Just the scissors on your desk?

A.

Just a scissor on the lab, yes. Scissor that I get from the lab.

...
Q.

. . . So you go into your office. Do you take the scissors back with you?

59

A.

Well, the scissors are everywhere.

(El-Ghannam Dep. vol. I [Docket 130-3], at 24:9-24:13; 27:17-27:19). While this in and of itself
may not necessarily indicate that the mesh samples were contaminated, it is certainly possible
that Dr. El-Ghannam’s use of nothing more than “a good pair of scissors”—with no indication
that the scissors were cleaned or sterilized prior to use—could have contaminated the pristine
mesh samples on their way to being tested. (Id. at 24:19).
Third, Dr. El-Ghannam used bleach to clean tissue from the explants, and immersed the
pristine implants to test any effect that bleach may have had on the polypropylene:
A.

The goal for immersing the pristine implant in the bleach is to mimic the
same immersion treatment that I do for the explants that has tissues. So
when I immersed the samples that has tissues in the bleach to remove the
tissues, I also wanted to see what would happen to the pristine if it were to
be immersed in the same solution.

(Id. at 150:20-151:7). Dr. El-Ghannam was unable to point to any part of his report where he
compared the pristine implants without bleach to the pristine implants with bleach, however:
Q.

Can you show me in the report where there’s a comparison from the
pristine implants to the pristine implants treated with bleach?

A.

The only part that I found is that on page 2 where I see in the second
paragraph under the title, Scanning Electron Microscope, on line number
3, I just reported here, other pristine samples were also immersed in the
bleach, NaOCI, and analyzed by SEM. See Exhibit 14, photomicrographs.
The details of my analyses are described below. And I really did not see
part of the discussion after that about the comparison.

Q.

You did not?

A.

I did not.

(Id. at 176:12-176:25).
When Dr. El-Ghannam used bleach to clean tissue from the explants, the method he used
to evaluate whether material was left behind was simply by “eyeballing” it:

60

Q.

Do you do anything further at that point to ensure that all the tissue is
removed from the mesh other than the eyeball evaluation that you’ve done
after it comes out of the incubator?

A.

I do scanning electron microscope analysis.

Q.

Before that, is there any other test or step you take to ensure that there’s no
tissue remaining?

A.

No, I don’t.

(Id. at 206:20-207:4). In short, while Dr. El-Ghannam adamantly believes that questions about
possible artifacts in his analysis have no basis, the above examples make clear that there is some
basis for questioning his methodology in conducting the SEM and FTIR testing. Dr. ElGhannam’s methodology is certainly not flawless. However, I FIND that it is minimally
satisfactory to pass a Daubert challenge, and is more properly tested at trial during crossexamination and the testimony of counter experts.
Finally, although Bard spends another several pages arguing that “Dr. El-Ghannam’s
degradation opinions are flawed and unreliable,” its remaining arguments are based on his
ultimate conclusions. (Bard’s Mem. re: El-Ghannam [Docket 131], at 12). For example, Bard
argues that Dr. El-Ghannam’s “images are instead evidence of foreign materials,” (Id. at 13), and
that certain conclusions are “simply and demonstrably inaccurate.” (Id.). In short, experts can
disagree on their opinions and conclusions, as long as they are based on reliable principles and
methods. Fed. R. Evid. 702. I FIND that Dr. El-Ghannam’s testing methodology is sufficiently
reliable for his design defect opinion to pass a Daubert challenge.
iii.

Opinions Related to Manufacturing Process

Bard argues that Dr. El-Ghannam is not qualified to opine on the manufacturing process,
and that his opinions are unreliable and nothing more than ipse dixit opinions. After review of
Dr. El-Ghannam’s deposition testimony and his supplemental report, it appears that he is
61

qualified—and his opinions are reliable—to an extent. With respect to the heating process, Dr.
El-Ghannam has explained adequately and with sufficiently reliable basis in his deposition
testimony and supplemental report, the effects of subjecting the polypropylene material in the
Avaulta mesh to the heat during the manufacturing process. (See generally El-Ghannam
Supplemental Report [Docket 130-2]). However, with respect to the knitting process, Dr. ElGhannam testified, in part:
Q.

How are these – can you – do you understand how the knitting process
works for these implants?

A.

I have an idea, but really I’m not a textile engineer.

Q.

Okay. So you’re not – textile engineering is not an area of your expertise?

A.

No, it’s not.

Q.

And you’ve not carefully reviewed the manufacturing documents to see
and understand how the knitting process is conducted, correct?

A.

Correct.

(El-Ghannam Dep. vol. I [Docket 130-3], at 272:16-273:2). Accordingly, I FIND that Dr. ElGhannam may opine on the manufacturing process as it relates to temperature, but not as it
relates to the knitting process of the mesh.
iv.

Opinions Related to the Adequacy of Bard’s FDA Qualifying Tests

Because the plaintiffs do not intend for Dr. El-Ghannam to testify regarding the
sufficiency of Bard’s 510(k) testing, such opinions are excluded. With respect to the “stiffness”
measurements set forth in Dr. El-Ghannam’s Rule 26 report at pages 26-27, Dr. El-Ghannam
does not appear to provide any reliable basis supporting this opinion. Dr. El-Ghannam states that
“[t]his is a further defect with this mesh as the variation of the degree of stiffness would result in
improper transduction of the mechanical signal between the components of the same mesh.” (El-

62

Ghannam Report [Docket 130-1], at 26). The plaintiffs do not point to any basis from scientific
literature or otherwise for Dr. El-Ghannam’s opinion on this issue. Accordingly, I FIND that Dr.
El-Ghannam may not opine on the “stiffness” measurements regarding Avaulta mesh.
J.

Anthony B. Brennan, Ph.D.

Dr. Brennan is a biomaterials and biomedical engineering expert retained by the plaintiffs
primarily to offer opinions on the design of the Avaulta mesh products. Bard notes three
particular areas that Dr. Brennan criticizes: “(1) the biocompatibility and stability of the Avaulta
mesh products; (2) the pore size of the Avaulta products; and (3) Bard’s measurements of the
pore size and failure to test the ‘effective pore size’ dimensions under load.” (Def. Bard’s Mem.
of Law in Supp. of its Mot. to Exclude the Ops. & Testimony of Anthony B. Brennan, Ph.D.
[Docket 128], at 1) [hereinafter Bard’s Mem. re: Brennan]. Bard argues that Dr. Brennan is not
qualified to render any of his opinions and that his opinions are neither reliable nor relevant. At
the outset, I note that Bard’s arguments as to the admissibility of Dr. Brennan’s opinions are
substantially similar to, and based in part, on its arguments as to the admissibility of Dr. ElGhannam’s opinions.
i.

Qualifications

Bard argues that Dr. Brennan lacks the qualifications to testify as to polypropylene
surgical mesh. Bard’s arguments here are nearly identical to its arguments against Dr. ElGhannam’s qualifications. See supra, Section I. Here, Dr. Brennan also clearly has extensive
education and experience in biomaterials generally. His expert report notes that he is
“knowledgeable about a number of chemical fields including polymeric biomaterials, polymeric
materials . . . [and] physical and chemical aging of polymers and nanocomposites.” (Brennan
Report [Docket 127-1], at 2). In sum, he appears even more qualified than Dr. El-Ghannam in

63

this particular subject. Accordingly, I FIND that Dr. Brennan is qualified to offer opinions on the
design of the Avaulta mesh.18
ii.

Reliability of Opinions Related to Degradation and Molecular Weight

Next, Bard argues that Dr. Brennan’s opinions are unreliable because he did not review
sufficient data and his opinions were “predicated upon Dr. El-Ghannam’s scientifically
unreliable and inadmissible images and findings.” (Bard’s Mem. re: Brennan [Docket 128], at 6).
As previously discussed, I ruled that Dr. El-Ghannam’s opinions are based on sufficiently
reliable methodology to pass a Daubert challenge. Moreover, after reviewing Dr. Brennan’s
expert report, cited literature and deposition testimony, I FIND that Dr. Brennan relies on
sufficient and reliable scientific literature.19 For example, while Bard takes issue with Dr.
Brennan’s reliance on literature produced by plaintiffs’ counsel, Dr. Brennan testified that he
requested additional literature:
Q.

So the medical literature that you reviewed in order to prepare your expert
report was literature that is provided to you by the plaintiffs’ lawyers,
right?

18

Bard argues that Dr. Brennan admitted he was not an expert on the design of pelvic mesh, citing
his deposition testimony:
Q.

You are not an expert in the design of pelvic mesh, is that correct?

A.

Correct.

(Brennan Dep. vol. I [Docket 127-2], at 67:20-67:22). Dr. Brennan’s expert report discusses his opinion
that “[f]rom a biomechanical viewpoint, the Avaulta mesh products and female pelvic tissue are not
compatible. The Avaulta mesh fibers degrade after implantation into women. . . .” (Brennan Report
[Docket 127-1], at 2-3). While it may be obvious to one trained in the legal profession that Dr. Brennan is
opining on issues related to the design of the Avaulta mesh products because he is opining on the
materials from which the Avaulta mesh products are designed, it is also somewhat obvious that Dr.
Brennan believes there is a difference between being an expert in “the design of pelvic mesh” and being
an expert that is qualified to testify regarding the material properties and characteristics and the
biocompatibility of the mesh.
19
Disagreements in the literature or conclusion do not preclude an expert from testifying, as long as
the expert’s testimony “will help the trier of fact” and is “based on sufficient facts or data” and the
“product of reliable principles and methods” that are applied “to the facts of the case.” Fed. R. Evid. 702.

64

A.

Not exactly.

Q.

Okay. What is the “not exactly” part of that statement?

A.

Because a lot of the literature, I – I pull and ask them to get for me.

Q.

Okay.

A.

So they provide it, but it’s because I have asked for it directly, you know,
by reviewing the literature.

...
A.

And so I asked them to bring me literature, and then I asked them for
literature on subjects that I wanted to look at.

(Brennan Dep. vol. I [Docket 127-2], at 98:4-99:10). It is also clear that, in forming his opinions,
Dr. Brennan relied on more than just Dr. El-Ghannam’s data and opinions. Dr. Brennan did, of
course, review the data from Dr. El-Ghannam’s testing and consider the data; however, he did so
in the process of reaching his own independent conclusions and opinions.20 Accordingly, I FIND

20

Dr. Brennan testified:
Q.

Did you see evidence of artifacts or contamination in the SEM images that you
reviewed?

A.

There were some indications of material build-up on the polypropylene fibers for
some of the explants. I think I – I included that in my expert report that there
was.

Q.

And what – you said there were indications of material build-up on the
polypropylene fibers in some explants. Were you able to determine what those
materials were?

A.

No. I did not go in and look at them in detail. I think it’s important that – it’s – I
don’t know how to say this in this setting. But I try to teach my students to be
careful they don’t get caught up in the wrong information that’s facing them. And
on those fibers that I included that had some extra material on the surface they
had such substantial cracking and degradation in the surface that it becomes
almost a nonissue what the additional material might be on that surface.

(Brennan Dep. vol. II [Docket 127-2], at 268:16-269:11).

65

that Dr. Brennan’s opinions regarding degradation and molecular weight are based on sufficient
and reliable facts and data.
iii.

Reliability of Opinion Related to Oxidation

Bard argues that Dr. Brennan’s assertion that polypropylene fibers degrade in the human
body through the oxidative process is unreliable and flawed because (1) it is derived from Dr. ElGhannam’s data and (2) it ignores a fundamental scientific principle that “[o]xidative
degradation of polypropylene materials leads to discoloration or browning.” (Bard’s Mem. re:
Brennan [Docket 128], at 11-12). I have already addressed above Bard’s arguments regarding
Dr. Brennan’s use of Dr. El-Ghannam’s data. With respect to the fundamental scientific principle
that Bard argues, I note that the Exponent Report states: “Oxidative degradation of
polypropylene materials can lead to discoloration (e.g., browning).” (Exponent Report [Docket
127-4], at 148) (emphasis added). The fact that oxidation can lead to discoloration does not mean
that it necessarily will. Accordingly, I FIND that Dr. Brennan’s opinion regarding oxidation is
not unreliable.
iv.

Reliability and Relevance of Opinions Derived from Tensile Testing and
Pore Size Measuring

Bard argues that Dr. Brennan’s tensile testing is irrelevant to the instant matters because
it is not applied “to the facts of the case.” Fed. R. Evid. 702. Dr. Brennan did his tensile testing in
an attempt to replicate Bard’s testing: “I tried to discern what Bard had done, and that is what
this test in Figure 6 was about was trying to replicate that.” (Brennan Dep. vol. I [Docket 127-2],
at 185:13-185:16). Bard also argues that Dr. Brennan’s opinions concerning inadequate pore size
should be excluded. According to his report, Dr. Brennan seeks to offer three different opinions
regarding pore size, which appear to rely, in part, on his tensile testing:

66

[1] Bard incorrectly measured and misrepresented the size of Avaulta mesh pores
at rest and did not consider smaller pores when making measurements. [2] Bard
did not test the most important aspect of the pores, which is the effective
dimension under load. Deformation of the mesh product during and after
implantation decreases the size of the pores. [3] The pore sizes did not allow for
adequate tissue ingrowth and caused excessive scarring and encapsulation of the
Avaulta mesh product.
(Brennan Report [Docket 127-1], at 3). After review of Dr. Brennan’s report and deposition
testimony, and the parties’ arguments, I FIND that to the extent Dr. Brennan relies on his tensile
testing to render opinions related to how mesh performs inside the female pelvis, such opinions
should be excluded; these opinions would not assist the jury because the tensile testing is not
intended to represent how mesh performs inside the female pelvis. However, opinions derived
from tensile testing regarding the effect of stress on the mesh are admissible. I further FIND that
Dr. Brennan is qualified to testify as to pore size, and that his opinions are based on reliable
principles and methodology and properly applied to the facts of the case.
K.

Arnold L. Lentnek, M.D., FACP21

Dr. Lentnek’s expert report sets forth several opinions. First, he opines that “Carolyn
Jones developed repetitive vaginal erosions with exposure and ultimately partial extrusion of the
prosthesis” approximately fifteen months after implantation of Bard Avaulta products. (Lentnek
Report [Docket 105-2], at 4). Next, he offers the opinion that the “pattern of local irritation
associated with formation of granulation tissue and ultimately with partial extrusion” was not the
result of infection, but is “typical of a submucosally implanted foreign body that fails to become
incorporated within the submucosal stoma.” (Id. at 4-5). Bard does not take issue with Dr.
Lentnek’s opinion that Ms. Jones’s inflammation was not the result of infection, but rather the
presence of a foreign body. (See Def. Bard’s Mem. of Law in Supp. of its Mot. to Limit the Ops.
21

Dr. Lentnek’s opinions are offered only for one bellwether plaintiff, Carolyn Jones. Accordingly,
all citations to the docket in this section are to the Jones case.

67

& Testimony of Arnold Lentnek, M.D. [Docket 106], at 1) [hereinafter Bard’s Mem. re:
Lentnek]. Bard does, however, take issue with Dr. Lentnek’s remaining opinions. First, Bard
takes issue with opinions related to the material used in the Avaulta mesh products:
Such objects, due either to fiber pattern, fiber pore size or chemical composition,
do not permit the in-growth of fibrous tissue through the material and instead
become surrounded by a fibrous capsule around the material. They thus fail to
become firmly anchored within the submucosal tissues. This failure of fibrous ingrowth and consequent incorporation into the soft tissue permits the object to shift
slightly with normal body movement. Over time this constant shifting results in
local tissue inflammation and ultimately in erosion through the adjacent mucosa.
(Lentnek Report [Docket 105-2], at 5) (emphasis in original). Bard also takes issue with Dr.
Lentnek’s opinions related to causation: “To a reasonable degree of medical probability, this
failure of fibrous in-growth and soft tissue incorporation resulted in local irritation and ultimately
in extrusion of both the Align sling as well as the anterior and posterior vaginal mesh.” (Id.).
Finally, Bard argues that Dr. Lentnek has no basis for offering any opinion on the risk of future
erosions or need for additional surgeries. (See id.) (“Ms. Jones remains at increased risk of
developing future instances of vaginal erosion with . . . the need for additional surgical
procedures.”). As discussed below, Bard’s motion is GRANTED in part and DENIED in part.
i.

Opinions Related to Materials

Bard argues that Dr. Lentnek is not qualified to testify about the specific material used in
the Avaulta products, that his opinions are not reliable, and that he abandoned this opinion
during deposition. With respect to qualifications, Bard argues that Dr. Lentnek is not qualified to
render the opinion that the Avaulta products “due either to fiber pattern, fiber pore size, or
chemical composition, do not permit the in-growth of fibrous tissue through the material . . .”
and that the lack of such in-growth “permits the [mesh product] to shift slightly with normal
body movement,” which ultimately “results in local tissue inflammation and ultimately in

68

erosion through the adjacent mucosa.” (Bard’s Mem. re: Lentnek [Docket 106], at 6) (emphasis
in original). Bard argues that Dr. Lentnek is not an expert in biomaterials and biomechanics and
has no specialized training, knowledge or experience in “any of the relevant medical specialties”
such as urogynecology. (Id.). I agree in part.
Dr. Lentnek testified, for example:
Q.

And the assignment you were hired, retained as an expert for your
expertise in infectious disease; is that correct?

A.

Yes. Well, infectious disease and my knowledge of the potential
inflammatory properties of implanted prosthetic devices, yes.

Q.

Let’s talk about that for a little bit. What type of experience do you have in
that area, sir?

A.

Well, in my practice we routinely see individuals who have had various
materials implanted in their body, be it prosthetic joints, prosthetic cardiac
valves, or prosthetic mesh as in the case here, and that forms a
considerable portion of the practice.

...
Q.

What are the reasons why [the prosthesis] may not take?

A.

They can be mal-positioned and therefore can be in a position where they
cause local irritation and ultimately rejection. There can be mechanical
and/or chemical properties to which the body will react and therefore
reject material; they can become infected, and therefore, again the body
will react to not only the bacteria but to the material as well and reject
them. . . .

(Lentnek Dep. [Docket 105-1], at 12:12-12:25; 13:5-13:14). I FIND that Dr. Lentnek is
qualified, based on his role as an infectious disease specialist, regarding the causes of infection
and inflammation. His role includes the determination of why inflammation exists, and his
knowledge and experience include pelvic repair mesh devices. (See, e.g., Lentnek Dep. [Docket
105-1], at 53:16-54:6). However, I also FIND that Dr. Lentnek is not qualified to testify
specifically that the failure of fibrous in-growth was the result of “fiber pattern, fiber pore size or
69

chemical composition” because this opinion exceeds the scope of his qualifications. (Lentnek
Report [Docket 105-2], at 5).22
ii.

Opinion on Future Erosions and Need for Additional Surgeries

Bard argues that Dr. Lentnek’s opinion that the plaintiff “remains at an increased risk of
developing future instances of vaginal erosion with . . . the need for additional surgical
procedures” should be excluded. (Bard’s Mem. re: Lentnek [Docket 106], at 12). Bard, again,
argues that Dr. Lentnek is not qualified to render this opinion and that this opinion is not based
on sufficient facts or data. I disagree. Dr. Lentnek testified:
A.

I have had individuals routinely who have had perivaginal and pelvic
inflammatory conditions, including infection. I have treated those
individuals. And I have read about and see both short and long-term
complications of that condition. So I think I can offer an informed
judgment about what condition she is prone to develop. I don’t know that
she absolutely will develop those conditions but I do know what kind of
conditions she is susceptible to.

(Lentnek Dep. [Docket 105-1], at 108:20-109:4). As a result of Dr. Lentnek’s experience in his
area of expertise, he has gained the knowledge and experience to qualify him to testify as to the
risk of future erosions and the need for additional surgical procedures due to the residual tape
and mesh left in place inside the plaintiff. Additionally, based on his review of the plaintiff’s
medical history and his own experience and knowledge, Dr. Lentnek appears to have relied upon
sufficient facts or data to reach this opinion. Accordingly, I FIND that Dr. Lentnek may offer the
opinion that the plaintiff “remains at increased risk of developing future instances of vaginal

22

I therefore do not reach Bard’s argument regarding the reliability or abandonment of this opinion.
Without the specific testimony regarding fiber pattern, pore size, or chemical composition, Dr. Lentnek’s
opinion on this issue is limited to the opinion that the plaintiff’s inflammation was caused by the Avaulta
mesh and his understanding, without referring to the design or materials of the mesh, of how and why the
plaintiff’s inflammation was caused by the mesh. A review of Dr. Lentnek’s curriculum vitae and
deposition testimony reveals that he is qualified to render opinions on these matters and that he has relied
upon sufficient bases.

70

erosion with . . . the need for additional surgical procedures.” (Lentnek Report [Docket 105-2], at
5).
L.

Julia E. Babensee, Ph.D.

Dr. Babensee’s expert report sets forth her primary opinion that “the most concerning
aspect of the Avaulta devices is their lack of biocompatibility.” (Babensee Report [Docket 1554], at 4). Dr. Babensee’s opinion regarding lack of biocompatibility is broken up into several
different factors, including an incompatibility between the polypropylene mesh and the pelvic
tissue and polypropylene degradation in vivo through oxidation. (See generally id. at 6-9). Dr.
Babensee also opines on causation. (See, e.g., id. at 9) (“Cumulatively, it is my opinion that the
host responses to the Avaulta devices demonstrated by Queen, Cisson, Jones, and Smith are
similar and consistent with that observed in the majority of other similarly implanted women.”).
Bard argues for the exclusion of Dr. Babensee’s opinions related to polypropylene, including its
degradation, and for the exclusion of her opinions related to causation. Finally, Bard argues that
Dr. Babensee testified to an opinion regarding porosity during her first deposition which she did
not disclose in her Rule 26 expert report, and therefore the opinion should be excluded. Bard
attacks both Dr. Babensee’s qualifications and her methodology. As discussed below, Bard’s
motion is GRANTED in part and DENIED in part.
i.

Qualifications – Polypropylene

Bard argues that Dr. Babensee is not qualified to render opinions related to polypropylene
or the theory of its degradation. Bard’s arguments here are similar to its arguments regarding Dr.
El-Ghannam and Dr. Brennan’s qualifications. See supra, Sections I & J. In short, Bard argues
that Dr. Babensee’s education was in chemical engineering and applied chemistry, she has no
background or experience with polypropylene outside of litigation, and she has no experience

71

with medical devices outside of litigation. (See Def. Bard’s Mem. of Law in Supp. of its Mot. to
Limit the Ops. & Testimony of Julia E. Babensee, Ph.D. [Docket 155], at 3-6) [hereinafter
Bard’s Mem. re: Babensee].
A review of Dr. Babensee’s curriculum vitae and deposition testimony reveals that while
her education was in chemical engineering and applied chemistry, her postdoctoral work and
research have focused in the area of biomaterials and biomedical engineering. (See, e.g.,
Babensee Curriculum Vitae [Docket 155-3]). One of her areas of research is host responses to
implantable biomaterials, and she has previously studied implantable materials generally. (See
Babensee Dep. vol. I [Docket 155-1], at 105:20-107:12). In short, while Dr. Babensee may not
have background or experience in the specific area of polypropylene or with medical devices
specifically, she is qualified to testify as to the host response to the Avaulta mesh products
because of her general background and experience in the area of studying implantable materials
in the human body and studying the effects thereof. Moreover, because she studies the
interaction between implanted materials and human tissue, she necessarily has experience
studying what happens to the implanted materials and human tissue. Accordingly, she is
qualified to testify as to the theory of degradation in polypropylene. In sum, I FIND that Dr.
Babensee is qualified to render opinions related to polypropylene.
ii.

Opinions Related to Degradation

Bard argues that Dr. Babensee’s opinions rely on (1) her histological observations and (2)
Dr. El-Ghannam’s testing, and that both are unreliable. Bard contends that Dr. Babensee’s
histology observations are unreliable because (a) in some instances, there was a delay between
her observation of a slide and the creation of a photomicrograph of the slide and (b) her
methodology for analyzing and documenting her slide observations exhibit “grave

72

inconsistencies.” (Bard’s Mem. re: Babensee [Docket 155], at 14). Bard then contends that “all
of [Dr. Babensee’s] purported opinions rely upon the unscientific and unreliable testing of Dr.
Ahmed El-Ghannam, Ph.D.” and that she was unaware of the methodology Dr. El-Ghannam
employed to create the SEMs. (Id. at 15). The plaintiffs have responded to each of these points.
In sum, it appears that Dr. Babensee’s histology analysis is based on sufficiently reliable
methodology. She explained the methodology of how she received or prepared the slides, what
she did when she went through each slide and the notes that she took. (See generally Babensee
Dep. vol. I [Docket 155-1], at 226-243). The notes and charts are imperfect, but Dr. Babensee
testified:
Q.

So Exhibit 11, just so when we all leave here we understand this, has
representative histological observations, but you did not intend to nor did
you provide observations on every slide?

A.

Only because they were the same as what was already written here.

(Id. at 246:25-247:6). She also testified that even though she did not specifically write about
every slide, she looked at them all. (Id. at 246:17-246:24). With respect to her degradation
opinions, although she did review Dr. El-Ghannam’s SEMs, she did so in combination with her
review of peer-reviewed literature to reach her own independent conclusions and opinions. She
also testified that the SEMs were not a problem to her because “the end product is representative
of what I would expect SEMs to look like of – of this kind of mesh material.” (Id. at 219:16219:18). Accordingly, I FIND that Dr. Babensee’s testimony related to polypropylene and
specifically, degradation of polypropylene, is admissible.

73

iii.

Opinions Related to Specific Causation

Bard first argues that Dr. Babensee is not qualified to render causation opinions. A
review of Dr. Babensee’s expert report, curriculum vitae and deposition testimony reveals that
she is qualified to render causation opinions in this matter based on her experience in pathology.
Bard then argues that Dr. Babensee’s causation opinion is not relevant and will not assist
the jury. Dr. Babensee’s expert report offers the opinion that “the host responses to the Avaulta
devices demonstrated by Queen, Cisson, Jones, and Smith are similar and consistent with that
observed in the majority of other similarly implanted women.” (Babensee Report [Docket 1554], at 9) (emphasis added). She further opines that:
It is my opinion that if an Avaulta device has been implanted in a woman, and the
woman develops complaints such as pain, dyspareunia, infection, vaginal
shortening, scarification and urinary and defecatory dysfunction, that more likely
than not, to a reasonable degree of scientific probability, the Avaulta device(s) is a
contributing factor of the problems.
(Id.). Her deposition testimony is very similar:
Q.

Now, whether you can specifically identify in the Plaintiffs whether they
have these specific conditions, you just don’t know, do you?

A.

But as a group the common – these complaints are common amongst any,
you know, combination of these are common amongst the Plaintiffs.

Q.

Okay.

A.

And what’s common is the implantation of the mesh.

(Babensee Dep. vol. I [Docket 155-1], at 186:15-186:25; see also id. at 201:1-201:7). Dr.
Babensee’s conclusion, based on her expertise in pathology, is that the bellwether plaintiffs
demonstrate the same type of responses that are seen in women implanted with these products
generally. I FIND that this opinion is relevant and will be helpful to the jury. However, Dr.
Babensee’s causation opinion will be limited to that which she set forth in her expert report.

74

iv.

Opinions Related to Porosity

Bard argues that Dr. Babensee did not provide her opinion on the pore size of the Avaulta
products in her expert report, but did so for the first time at her deposition. The plaintiffs respond
that Dr. Babensee’s expert report discussed encapsulation of the mesh, which is the result of
small pore size. However, Dr. Babensee testified:
Q.

So what you’re saying is this binder that has the handwritten note Porosity
on it and the addition materials that came to us, I think, earlier this week
with an amended Exhibit 5, which we’ll mark in a little while, references
or relates to an additional opinion?

A.

Yes.

Q.

And tell me what that opinion is.

A.

That the porosity of the mesh is – is smaller than what is recommended to
provide a more appropriate host response for the implants.

...
Q.

Yeah, we’ll talk more about that when we get to – into the, you know, the
actual opinions. But I think what you’re saying is Exhibit 3, although, you
signed off on it on October 12th, 2012, does not contain this additional
opinion about porosity, correct?

A.

Correct.

Q.

And that’s something that you – and you haven’t done an amended
complaint? I mean, an amended report?

A.

No, no.

Q.

You haven’t written anything about that, correct?

A.

No.

(Id. at 30:9-31:13) (emphasis added). The plaintiffs’ arguments therefore directly contradict Dr.
Babensee’s testimony. Accordingly, I find that Dr. Babensee’s porosity opinion is a new opinion,

75

not discussed in her Rule 26 expert report. Because this is a new opinion, and no supplemental
report has been filed, I FIND that Dr. Babensee’s porosity opinion should be excluded.
IV.

The Plaintiffs’ Daubert Motion
The plaintiffs filed a single Daubert motion seeking to exclude certain opinions and

testimony of Maureen Reitman, Sc.D. and Marta Villarraga, Ph.D. (the “Exponent Experts”).
The Exponent Experts filed a 202-page joint expert report (the “Exponent Report”) seeking to
opine on a variety of matters. (See Exponent Report [Docket 127-4], at 191-92). The plaintiffs
argue that certain opinions should be excluded because the Exponent Experts (1) offer lawyer
arguments that are not expert opinions; (2) are not qualified to opine on or criticize Dr. Hoyte’s
biomechanical analysis based on 3-D models; (4) offer general factual narratives that are not
expert opinions; (5) selectively removed data from the results of their FTIR testing; and (6) never
presented or discussed SEM opinions.23
A.

Allegedly Non-Expert Lawyer Arguments

The plaintiffs argue that much of “the Exponent Report is largely nothing more than what
Bard’s lawyers can argue at the trial of this case.” (Pls.’ Mot. to Exclude Ops. & Testimony of
Marta Villarraga, Ph.D. & Maureen Reitman, Sc.D. & Brief in Supp. [Docket 250], at 5)
[hereinafter Pls.’ Mot. re: Exponent Experts]. The plaintiffs point to: (1) arguments regarding the
plaintiffs’ experts’ degradation testimony; (2) testimony pointing out alleged inconsistencies in
the plaintiffs’ experts’ reports; (3) statements that the plaintiffs’ experts have no scientific basis
for their opinions; (4) criticisms of the plaintiffs’ experts’ failure to take into account certain
aspects of Bard’s testing and clinical experience; and (5) criticisms of the plaintiffs’ experts’
causation opinions.
23

The plaintiffs lead by arguing that the Exponent Experts are “professional expert
witnesses/consultants” that should be subject to a more rigorous Daubert analysis. (Pls.’ Mot. re:
Exponent Experts [Docket 250], at 4).

76

To the extent that the Exponent Experts purport to simply make arguments that Bard’s
lawyers may make, such testimony is not expert opinion and should be excluded. Simply
pointing out inconsistencies does not require any “scientific, technical, or other specialized
knowledge.” Fed. R. Evid. 702. For example, the Exponent Experts’ contention that “if we . . .
assume that the alleged degradation is as pervasive as the plaintiffs’ experts suggest, then one
would expect clinical observations to reveal the patient population to consistently exhibit
degraded meshes and encounter the same types of complications as the plaintiffs” is a fancy way
of stating a simple logical inference: if the problem is as bad as the plaintiffs contend, then more
(or all) patients should be experiencing the problem. (Exponent Report [Docket 127-4], at 152).
Additionally, the Exponent Experts’ attack the plaintiffs’ experts’ causation opinions by
noting that (1) “successful clinical outcomes have been reported for patients following the use of
Avaulta products” and (2) the post-operative pain experienced by the bellwether plaintiffs “are
not unique to patients undergoing vaginal repair with polypropylene meshes.” (Id. at 166). To the
extent that the Exponent Experts simply rely on these bases for their opinions—such as Section
5.3.3 of the Exponent Report—such opinions should be excluded as they are more appropriately
lawyer arguments that the jury can understand without the assistance of the experts. (See id. at
166).24
However, the Exponent Experts’ attacks on the plaintiffs’ experts’ scientific basis for
their opinions and their alleged failure to take into account certain testing and clinical experience
are admissible. As the Third Circuit explained in United States v. Mitchell:
On the one hand, the court must exclude some evidence as a gatekeeper, by
preventing opinion testimony that does not meet the requirements of qualification,
24

In contrast, in Section 5.3.4 the Exponent Experts discuss and apply scientific literature to support
their opinion that infections suffered by the bellwether plaintiffs may not be related to the Avaulta
products. The experts would assist the jury in understanding the application and discussion of this
scientific literature.

77

reliability and fit from reaching the jury. But on the other hand, the court is only a
gatekeeper, and a gatekeeper alone does not protect the castle; as we have
explained, a party confronted with an adverse expert witness who has sufficient,
though perhaps not overwhelming, facts and assumptions as the basis for his
opinion can highlight those weaknesses through effective cross-examination.
365 F.3d 215, 245 (3d Cir. 2004) (internal citations and quotation marks omitted); see also
Maryland Cas. Co. v. Therm-O-Disc, Inc., 137 F.3d 780, 783 (4th Cir. 1998) (noting that “[a]ll
Daubert demands is that the trial judge make a ‘preliminary assessment’ of whether the proffered
testimony is both reliable . . . and helpful”). Thus, in addition to attacking the substance of an
expert’s opinions, a counter-expert may also opine on the unreliability of the data on which an
expert’s opinions is based. These types of opinions also necessarily require some “scientific,
technical, or other specialized knowledge.” Fed. R. Evid. 702. Accordingly, the plaintiffs’
motion to exclude the Exponent Experts’ “non-expert opinions” is GRANTED in part and
DENIED in part as discussed above.
B.

Criticisms of Dr. Hoyte’s 3-D Modeling

The plaintiffs argue that neither of the Exponent Experts is qualified to render any
opinions regarding Dr. Hoyte’s MRI modeling. (See Exponent Report [Docket 127-4], at 17984). A review of Dr. Hoyte’s MRI modeling reveals that a “finite element analysis” was
conducted on his 3-D models, and a review of Dr. Villarraga’s curriculum vitae and the
Exponent Report reveals that Dr. Villarraga is qualified to opine on the subject of finite element
analyses. For example, Dr. Villarraga has published papers in which she conducted a finite
element analysis. (See Vilarraga Curriculum Vitae [Docket 258-4], at 3). She has also taught
graduate and undergraduate courses on the subject of finite element analysis. (See Exponent
Report [Docket 127-4], at 17). Finally, Dr. Villarraga’s experience “includes analysis of devices
used in . . . urogynecological . . . surgery). (Id. at 16). In sum, Dr. Villarraga is qualified to

78

render opinions regarding Dr. Hoyte’s MRI modeling. Accordingly, the plaintiffs’ motion to
exclude the Exponent Experts’ opinions regarding Dr. Hoyte’s 3-D modeling is DENIED with
respect to Dr. Villarraga. However, because Bard has not made any attempt to argue that Dr.
Reitman is qualified to render opinions regarding Dr. Hoyte’s 3-D modeling, the plaintiffs’
motion to exclude on this issue is GRANTED with respect to Dr. Reitman.
C.

Factual Narratives

The plaintiffs argue that the Exponent Experts may not offer “general factual narratives
based on information about which they have no first hand knowledge, and about which the jury
is capable of understanding and drawing their own conclusions.” (Pls.’ Mot. re: Exponent
Experts [Docket 250], at 11). First, experts may form opinions by relying on facts that they have
“been made aware of,” as long as “experts in the particular field would reasonably rely on those
kinds of facts or data in forming an opinion on the subject.” Fed. R. Evid. 703. Accordingly, they
do not need first-hand knowledge but may be supplied this information. Additionally, the
plaintiffs do not contend that experts in the field do not reasonably rely on these kinds of facts or
data.
I FIND that Liberty Media Corp. v. Vivendi Universal, S.A. provides the appropriate
solution to the situation at hand. 874 F. Supp. 2d 169, 174 (S.D.N.Y. 2012). The Southern
District of New York in Liberty Media held:
[The expert] will not be permitted to exhaustively recount all of the facts of the
case. . . . [The expert] will not be permitted to recount the entire history of
Vivendi through the class period. Rather, [the expert] must draw on the facts only
as necessary—and in as concise a manner as possible—to support his opinion . . .
which is based on his experience in corporate valuations. I decline to parse [the
expert]’s report paragraph-by-paragraph to determine where the report turns from
expert analysis to factual narrative. Rather, I trust plaintiffs’ counsel will exercise
discretion in allocating trial time and will only present the facts necessary to
support [the expert]’s opinion. In the event plaintiffs’ counsel fails to exercise
appropriate discretion, I will cut off any lengthy factual narrative.
79

Id. Accordingly, the plaintiffs’ motion to exclude factual narratives by the Exponent Experts is
GRANTED in part to the extent that they may not seek to offer factual narratives, but DENIED
in part to the extent that they may present the bases for their expert opinions in this case.
D.

Opinions Based on FTIR Test Data

The plaintiffs argue that Dr. Reitman conducted FTIR testing on explanted mesh
material, but removed a portion of the test results. Dr. Reitman was asked at her deposition:
Q.

Why is there a gap?

A.

We blanked out the background signals. So there is—in that region, that’s
where you’ll pick up moisture and carbon dioxide from the air. So it’s a
noise element. And so we will – we will look at the full spectra, and
there’s very few materials that have an actual signal in there, and we know
it’s noise, so we simply just blank it as opposed to artificially making it
straight.

(Reitman Dep. [Docket 250-2], at 264:22-265:5). Bard argues that Dr. Reitman employed a
“conventional approach and standard analysis” when she blanked out the supposed noise. (Def.
Bard’s Mem. of Law in Opp’n to Pls.’ Mot. to Exclude the Ops. & Testimony of Dr. Marta L.
Villarraga, Ph.D. & Dr. Maureen T. F. Reitman, Sc.D. [Docket 258], at 18). Bard also argues
that “Dr. Reitman used her vast education, training, and experience to determine what
information was simply irrelevant ‘noise’ that could be ‘blanked out.’” (Id.).
This “blanking out” is problematic. On one hand, if it was simply irrelevant noise, then
there should have been no problem in submitting the full results of the testing; the plaintiffs’
experts could analyze the test results and agree that it was irrelevant noise. On the other hand, if
it was something more than irrelevant noise, then Dr. Reitman has blanked out relevant
information that may have called her opinions into doubt and supported the plaintiffs’ theories.
In short, the problem is that regardless of whether the “blanked out” portion of the test results

80

was noise or not, and regardless of Dr. Reitman’s explanation of why it was blanked out, Dr.
Reitman’s selective presentation of the test results raises substantial doubt about the reliability of
her methodology. Accordingly, the plaintiffs’ motion to exclude Dr. Reitman and Dr.
Villarraga’s opinions based on the FTIR testing is GRANTED.
E.

Opinions Based on SEM Images

The plaintiffs argue that the Exponent Experts offered only a “bare conclusion” and “no
opinion or expert analysis regarding any SEM images of unimplanted Avaulta mesh.” (Pls.’ Mot.
re: Exponent Experts [Docket 250], at 17). The plaintiffs thus argue that the Exponent Experts
should be precluded from “offering any SEM imaging of unimplanted mesh, or from offering
any opinion regarding any SEM imaging of unimplanted mesh beyond that stated on page 152 of
the Exponent Report.” (Id. at 18).
A review of the Exponent Report and the supplemental report reveals that the Exponent
Experts analyzed Dr. El-Ghannam’s SEM images and conducted their own SEM testing. Their
analysis of Dr. El-Ghannam’s SEM imaging is admissible, and I have also ruled that the
supplemental report is admissible. Accordingly, the plaintiffs’ motion to exclude the Exponent
Experts’ opinions based on SEM images is DENIED.
V.

Effect of Daubert Rulings
I emphasize that my rulings excluding expert opinions under Rule 702 and Daubert are

dispositive of their admissibility in these cases, but that my rulings not to exclude expert opinions
are not dispositive of their admissibility. In other words, to the extent that certain expert opinions
might be cumulative or might confuse or mislead the jury, they may still be excluded under Rule
403 or some other evidentiary rule. I will take up these issues as they arise.

81

VI.

Conclusion
A.

Cisson, 2:11-cv-00195

For the reasons discussed above, it is ORDERED that in Cisson (2:11-cv-00195), Bard’s
motions with respect to Dr. Zolnoun [Docket 91], Dr. Altenhofen [Docket 94], Dr. Loving and
Dr. Carroll [Docket 100] and Dr. Shull [Docket 98] are GRANTED, and Bard’s motions with
respect to the treating physicians [Docket 103], Dr. Klosterhalfen [Docket 108], Dr. Hoyte
[Docket 110], Dr. Kessler [Docket 113], Dr. El-Ghannam [Docket 130], Dr. Brennan [Docket
127], and Dr. Babensee [Docket 154] are GRANTED in part and DENIED in part. It is further
ORDERED that the plaintiffs’ motion [Docket 250] is GRANTED in part and DENIED in
part. The Clerk is instructed to file a copy of this Memorandum Opinion and Order in Cisson.
B.

Queen, 2:11-cv-00012

For the reasons discussed above, it is ORDERED that in Queen (2:11-cv-00012), Bard’s
motions with respect to Dr. Zolnoun [Docket 95], Dr. Altenhofen [Docket 98], Dr. Loving and
Dr. Carroll [Docket 104] and Dr. Shull [Docket 101] are GRANTED, and Bard’s motions with
respect to the treating physicians [Docket 107], Dr. Klosterhalfen [Docket 110], Dr. Hoyte
[Docket 114], Dr. Kessler [Docket 117], Dr. El-Ghannam [Docket 132], Dr. Brennan [Docket
129], and Dr. Babensee [Docket 154] are GRANTED in part and DENIED in part. It is further
ORDERED that the plaintiffs’ motion [Docket 254] is GRANTED in part and DENIED in
part. The Clerk is instructed to file a copy of this Memorandum Opinion and Order in Queen.
C.

Rizzo, 2:10-cv-01224

For the reasons discussed above, it is ORDERED that in Rizzo (2:10-cv-01224), Bard’s
motions with respect to Dr. Zolnoun [Docket 122], Dr. Altenhofen [Docket 125], Dr. Loving and
Dr. Carroll [Docket 130] and Dr. Shull [Docket 129] are GRANTED, and Bard’s motions with

82

respect to the treating physicians [Docket 134], Dr. Klosterhalfen [Docket 137], Dr. Hoyte
[Docket 141], Dr. Kessler [Docket 144], Dr. El-Ghannam [Docket 159], Dr. Brennan [Docket
156], and Dr. Babensee [Docket 181] are GRANTED in part and DENIED in part. It is further
ORDERED that the plaintiffs’ motion [Docket 276] is GRANTED in part and DENIED in
part. The Clerk is instructed to file a copy of this Memorandum Opinion and Order in Rizzo.
D.

Jones, 2:11-cv-00114

For the reasons discussed above, it is ORDERED that in Jones (2:11-cv-00114), Bard’s
motions with respect to Dr. Zolnoun [Docket 102], Dr. Altenhofen [Docket 108], Dr. Loving and
Dr. Carroll [Docket 114] and Dr. Shull [Docket 111] are GRANTED, and Bard’s motions with
respect to the treating physicians [Docket 117], Dr. Klosterhalfen [Docket 121], Dr. Hoyte
[Docket 124], Dr. Kessler [Docket 127], Dr. El-Ghannam [Docket 142], Dr. Brennan [Docket
139], Dr. Lentnek [Docket 105], and Dr. Babensee [Docket 165] are GRANTED in part and
DENIED in part. It is further ORDERED that the plaintiffs’ motion [Docket 261] is
GRANTED in part and DENIED in part. The Clerk is instructed to file a copy of this
Memorandum Opinion and Order in Jones.
The Court DIRECTS the Clerk to send a copy of this Order to counsel of record and any
unrepresented party.
ENTER:

83

June 4, 2013