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Full Opinion
(Daubert Motions)
Pending before the court are C.R. Bard, Inc. (âBardâ)âs Daubert motions:
As set forth below, Bardâs 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, Bardâs 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 plaintiffsâ motion [Docket 250] is GRANTED in part and DENIED in part.
1. 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.
II. Legal Standard
Under Federal Rule of Evidence 702, expert testimony is admissible if it will âhelp the trier of fact to understand the evidence or to determine a fact in issueâ and (1) is âbased upon sufficient facts or dataâ and (2) is âthe product of rehable principles and methodsâ which (3) has been reliably applied âto the facts of the case.â Fed.R.Evid. 702. A two-part test governs the admissibility of expert testimony. The evidence is admitted if it ârests on a rehable foundation and is relevant.â Daubert v. Merrell Dow Pharm., 509 U.S. 579, 597, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). The proponent of expert testimony does not have the burden to âproveâ anything. He must, however, âcome forward with evidence from which the court can determine that the proffered testimony is properly admissible.â 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: â[EJxpert witnesses have the potential to be both powerful and quite misleading[;Jâ the court must âensure that any and all scientific testimony ... is not only relevant, but reliable.â 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, 113 S.Ct. 2786). I âneed not determine that the proffered expert testimony is irrefutable or certainly correctâ â â[a]s with all other admissible evidence, expert testimony is subject to testing by â[vjigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof.â â United States v. Moreland, 437 F.3d 424, 431 (4th Cir.2006) (quoting Daubert, 509 U.S. at 596, 113 S.Ct. 2786 (alteration in original)); see also Maryland Cas. Co., 137 F.3d at 783 (noting that â[a]ll Daubert demands is that the trial judge make a âpreliminary assessmentâ of whether the proffered testimony is both reliable ... and helpfulâ).
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 âcan be (and has been) testedâ; (2) whether the theory âhas been subjected to peer review and publicationâ; (3) the âknown or potential rate of errorâ; (4) the âexistence and maintenance of standards controlling the techniqueâs operationâ; and (5) whether the technique has achieved âgeneral acceptanceâ 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, 113 S.Ct. 2786).
Despite these factors, â[t]he inquiry to be undertaken by the district court is âa flexible oneâ focusing on the âprinciples
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 âfit.â âFitâ is not always obvious, and scientific validity for one purpose is not necessarily scientific validity for other, unrelated purposes.... Rule 702âs âhelpfulnessâ standard requires a valid scientific connection to the pertinent inquiry as a precondition to admissibility.
Daubert, 509 U.S. at 591-92, 113 S.Ct. 2786 (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. âDifferential 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.â Westberry, 178 F.3d at 262. The Fourth Circuit has stated that:
A reliable differential diagnosis typically, though not invariably, is performed after âphysical examinations, the taking of medical histories, and the review of clinical tests, including laboratory tests,â and generally is accomplished by determining the possible causes for the patientâs 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, â[a] medical expertâs causation conclusion should not be excluded because he or she has failed to rule out every possible alternative cause of a plaintiffs illness.â The alternative causes suggested by a defendant âaffect the weight that the jury should give the expertâs testimony and not the admissibility of that testimony,â unless the expert can offer âno explanation for why she has concluded [an alternative cause offered by the opposing party] was not the sole cause.â
Id. at 265-66 (internal citations omitted).
III. Bardâs 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 Altenho-fen, 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. Bardâs motions as to each of these experts will be discussed below.
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. Zolnounâs opinions are classic ipse dixit opinions, unsupported by any testing or reliable methodology. As discussed below, Dr. Zolnounâs opinions should be excluded in their entirety and accordingly, Bardâs motion to exclude her opinions is GRANTED,
i. General Causation Opinions
Dr. Zolnoun sets forth two general causation opinions regarding âmechanisms by which transvaginal mesh procedures cause nerve injury and neuropathic pain.â (Zolnoun Report [Docket 91-2], at 3). The first is âa 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 is-chiorectal spaces.â (Id.). The second is âcaused by the well-established contraction and retraction of the mesh over time, resulting in entrapment of nerves in scar and fibrosis.â (Id).
Bard argues that Dr. Zolnounâs 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: âasbestos, which causes asbestosis and mesothelioma; silica, which causes silicosis; and cigarette smoke, which causes cancer.â Id.; see also n. 5 (âThere 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.â). The court based this idea on Kumho Tire, noting that a âtrial court does not need to waste time with a Daubert hearing where the reliability of an expertâs methods is properly taken for granted.... â Id. at 1239 n. 5 (internal quotation marks omitted).
Bard contends that Dr. Zolnounâs 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. Zolnounâs 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.
The plaintiffs then argue that Dr. Zol-nounâs general causation opinions are based upon a reliable basis and methodology because she âproperly relies on her clinical experience and relevant, peer-reviewed literature to establishâ these opinions. (Pis.â Resp. in Oppân to Def.âs Mot. to Exclude Certain Testimony from Pis.â Proposed Expert Witness Dr. Denniz Zolnoun, M.D., M.P.H. [Docket 157], at 7). I disagree. A review of Dr. Zolnounâs lengthy deposition transcript shows that her opinions are simply ipse dixit opinions.
For example, with respect to Dr. Zol-nounâs first general causation opinionâ that the trocars and the arms of the mesh
Q. But you agree in any patient itâs 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, itâs obvious. I mean, Iâve seen the propylene mesh. Avaulta mesh is not something Iâve 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 theyâre 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 tro-cars that we havenât talked about?
A. Other than the fact that Iâve 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 the biomechanics of how they rotate the vagina. Empirical evidence based on my experience, thatâs 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, itâs obvious. Those propylene meshes are very rigid and that my finger on a glove catches, Iâm really sorry, but I donât understand how to prove this.... Iâm not sure what scientific proof youâre 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 youâve never touched an Avaulta mesh, Avaulta Solo, Avaulta Plus when it was just coming out of the package?
A. ... [N]o, I havenât. 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, par-arectal space.
Q. But youâve never touched one before it was inserted into someoneâs body?
A. No.
Q. This mesh eroding that youâre 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. Zolnounâs first general causation opinion is therefore based on nothing more than her personal, unscientific observation and opinion that âitâs obviousâ that mesh arms are sharp and can serrate or tear nerves.
Dr. Zolnounâs second general causation opinion â that mesh causes nerve injury by the contraction and retraction of the mesh over time, resulting in entrapment of nerves in scar and fibrosis â is similarly lacking in any reliable basis and methodology and is simply an ipse dixit opinion. For example, she testified:
As you stated, Iâm not an expert in mesh and traction and contraction. So I cannot possibly be an expert in amount of scarring because of mesh because thatâs not what I do. But if you ask me as a pain person, then this contraction happens, itâs 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. Zolnounâs general causation opinions should be excluded.
ii. Specific Causation Opinions
Dr. Zolnounâs 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. Zolnounâs general causation opinions are not based on reliable methodology and principles, her specific causation opinions â based on her general causation opinions â 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) (â[E]stablishing general causation is an essential prerequisite to proving specific causationâ).
B. Dean Altenhofen, M.D.
According to the plaintiffs, Dr. Altenho-fen will opine on:
*606 (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.
(Pis.â Resp. in Oppân to Def. Bardâs Mot. to Exclude the Testimony & Ops. of Dean Altenhofen, M.D. [Docket 149], at 3). Bard argues that Dr. Altenhofenâs opinions regarding complication rates and injuries are not based on reliable methodology, and that his opinions regarding Bardâs IFUs, Avaulta training, and statements by Bard sales representatives are irrelevant to the facts of the bellwether plaintiffs. As discussed below, Dr. Altenhofenâs opinions should be excluded in their entirety and accordingly, Bardâs 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. Alten-hofen opines were caused by the mesh products. Using simple division â the number of patients implanted with Avaulta mesh products divided by the number of patients that suffered complications â Dr. Altenhofen arrives at his complication rate. According to the plaintiffs, âDr. Altenho-fenâs 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.â (Id. at 7).
The fundamental problem with Dr. Al-tenhofenâs complication rate opinion is that it has no basis in any reliable methodology. Importantly, Dr. Altenhofenâs 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 â a complication rate of 23.53%. (Altenhofen Report [Docket 94-2], at 2). Interestingly, despite a mathematical complication rate of 23.53%, Dr. Altenhofenâs initial expert report also noted that â[m]ore than 30% of my patients developed injuries and complications that required repair and revision.â (Id. at 3).
During his deposition, Dr. Altenhofen corrected his initial expert report, testifying that he had 18 patients, not 16, who suffered complications â 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 patientsâ records are in Exhibit 7?
A. Thereâs 17 individual patients in this booklet.
Q. I guess what Iâm trying to get at is what is the correct number, 16, 17, or 18?
A. All right. So thereâs one, two, three, four, five, six, seven eightâ*607 thereâs 18. Iâm sorry, thereâs 18 in this booklet here.
Q. Why does your report only refer to 16?
A. Maybe a miscalculation or a count here. Thereâs one â 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. Altenhofenâs deposition, which further alters Dr. Altenhofenâs complication rate. (See Errata Sheet [Docket 149-1], at 6-7). 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 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. Altenhofenâs methodology of producing his complication rate is unreliable, resulting in multiple changes to his expert report on this issue. Accordingly, I FIND that Dr. Altenhofenâs complication rate opinion should be excluded.
ii. Opinions Regarding IFXJs, Training, and Marketing
Dr. Altenhofenâs 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 Bardâs IFUs and training, as well as Bardâs sales representativeâs 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 âknowledge, skill, experience, training, or educationâ in this particular area. Fed. R.Evid. 702. To the extent that Dr. Altenhofen might opine on Bardâs 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. Altenhofenâs 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 âRelationship Expertsâ) to opine on the plaintiffsâ damages. According to the plaintiffs, âDr. Janell L. Carroll will offer opinions about the impact of the bellwether plaintiffsâ loss in terms of body image, self-esteem, confidence, sexual drive and the ability to maintain an affectionate sexual relationship,â and âDr. Timothy J. Loving will offer opinions about the impact of the bellwether plaintiffsâ 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.â (Pls.â Resp. in Oppân to Def.âs Mot. to Exclude the Ops. & Testimony from Pis.â Proposed Expert Witnesses Dr. Loving & Dr. Carroll [Docket 150], at 1-3).
(1) Plaintiffs can themselves describe how their lives have changed without the need for expert testimony, (2) the subject matter of the Relationship Expertsâ 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 Plaintiffsâ stories.
(Def. Bardâs 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 Expertsâ opinions should be excluded in their entirety and accordingly, Bardâs motion to exclude their opinions is GRANTED.
i. Opinions that Would not Assist the Jury â Unnecessary for Subject Matter
Expert testimony which âmerely regurgitates factual information that is better presented directly to the jury rather than through the testimony of an expert witnessâ 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 Expertsâ 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 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 âscriptsâ 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 peopleâs expectations of sexual behavior.... Importantly, once we have a script for specific social situations, it is very difficult to deviate from those scripts. Thus, itâs no surprise that Wanda and Greg Queen see no point in even beginning the process of their (and most peoplesâ) sexual intimacy scripts: itâs 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 201:19-202:2). However, this discussion of âscriptsâ follows from what the Queens told Dr. Loving: âThey both commented that thereâs âno pointâ in touching, or kissing, or rubbing somebodyâs shoulders when you know it canât go anywhere else.â (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 âno pointâ 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 Expertsâ depositions and reports are replete with these kinds of opinions. Accordingly, I FIND that the Relationship Expertsâ opinions related to the impact of the plaintiffsâ loss in terms of their intimate relationships should be excluded.
Several of the Relationship Expertsâ 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:
Without professional testimony the jury might look at a plaintiff and tie âsexuality with attractive body typesâ. 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 plaintiffsâ appearances had never been described to her, and that she only had knowledge of a plaintiffs physical experience if that plaintiff offered such information. (Carroll Dep. [Docket 100-5], at 33:2-35:12). Regardless of whether Dr. Carrollâs opinion is true as a general matter, and regardless of whether the bellwether plaintiffs do or do not have the âattractive body typesâ described by her, Dr. Carroll has simply not applied this stated principle âto the facts of the case.â Fed.R.Evid. 702.
Dr. Lovingâs testimony regarding how personal relationships affect morbidity and mortality â the âlife expectancyâ testimony that Bard takes issue with â also suffers from a similar defect. For example, Dr. Loving testified:
Q. Okay. Well, in term â your point here â and now that Iâm 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 atâ 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 thoseâ those deficits, if you will, would lead to a reduction in life expectancy, but Iâm not â Iâm not proposing a specific amount for a specific individual.
(Loving Dep. [Docket 100-3], at 102:8-102:20). Dr. Lovingâs âlife expectancyâ opinion is effectively that because the plaintiffs engage in less physical intimacy subsequent to the mesh-related complications than they engaged in prior to the complications, there will be some reduction of life expectancy for the plaintiffs. Regardless of whether Dr. Lovingâs opinion is true as a general matter, however, this general opinion has not been applied âto the facts of the caseâ 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 Expertsâ reports allude to discussions of causation. (See, e.g., Carroll Report [Docket 100-1], at 2) (âBased on my expertise, the implantation of the vaginal mesh product significantly contributed to all of these losses.â). 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 â much less a reliable one â for these opinions. Accordingly, I FIND that any causation opinions by Dr. Loving or Dr. Carroll should be excluded.
According to the plaintiffs, âDr. Shull holds the opinion that the transvaginal implantation of Bardâs Avaulta Solo and Plus products are inappropriate for use in women for a variety [of] reasons-â (Pis.â Resp. in Oppân to Def. Bardâs Mot. to Limit the Expert Opinions & Testimony of Dr. Bob Shull [Docket 151], at 2-3). Dr. Shullâs 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 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. Shullâs expert report: (1) opinions related to Bardâs 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. Shullâs opinions as to these issues should be excluded and accordingly, Bardâs motion to exclude his opinions is GRANTED,
i. Opinions Related to Bardâs 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. Shullâs expert report discusses Bardâs knowledge, state of mind, alleged bad acts, failures to act, and corporate conduct and ethics. Dr. Shull opines, for example, that âBard, in fact, recognized the problems created by not having clinical data supporting the use of the Avaulta products.â (Shull Report [Docket 98-2], at 4). He then opines that â[p]atient safety ... should have been the highest priority for Bard, not the âfirst to be cut.â It is also unethical for a company to withhold relevant clinical information from physicians .... â (Id. at 5; see also, e.g., id. at 10) (âBard also knew that the amount of mesh â the âmesh loadâ â and the material characteristics ... would be an issue with their products.â); (id. at 10-11) (âBard 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.â); (id. at 14) (âBard documents show that the company recognized the need to have large pores (3-5mm) to avoid contraction and what is described as âscar plate formation.â â); (id.) (âI see no evidence that Bard ... addressed the question of synthetic material surface area used as a function of risks and benefits.â); (id. at 14-15) (âBard ... documents demonstrate [that it was] aware of shrinkage and contraction when tissue comes in contact with the polypropylene and xenograft materials.â).
Similar statements are pervasive throughout the first forty pages of Dr. Shullâs expert report. For example, Section II is titled âBard did not inform doctors of safety concerns,â Section III is titled âBard acted irresponsibly in the recruitment, training, and monitoring of surgeons,â Section IV is titled âBard sales representatives appear to be giving medical advice, both in the operating room and in the management of complications,â and Section V is titled âBard seems to lack concern for the individual womanâs health and safety, focusing instead simply on sales.â (See id. at 24-40).
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. Shullâs 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 life-altering and can be permanent. Bard ... s