Full opinion text
MEMORANDUM OPINION AND ORDER (Daubert Motions) JOSEPH R. GOODWIN, District Judge. Pending before the court are C.R. Bard, Inc. (“Bard”)’s Daubert motions: Defendant C.R. Bard, Inc.’s Motion to Limit the Opinions and Testimony of Denniz Zol-noun, M.D., M.P.H. [Docket 91]; Defendant C.R. Bard, Inc.’s Motion to Exclude the Testimony and Opinions of Dean Al-tenhofen, 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 108]; 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, 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. Kes-sler, M.D. [Docket 113]; Defendant C.R. Bard, Inc.’s Motion to Exclude the Opinions and Testimony of Ahmed El-Ghan-nam, 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]; and Defendant C.R. Bard, Ine.’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, Se.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. 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. These MDLs involve use of transvaginal surgical mesh to treat pelvic organ prolapse or stress urinary 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 rehable 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 rehable foundation and is relevant.” 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 “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: “[EJxpert witnesses have the potential to be both powerful and quite misleading[;J” the court must “ensure that any and all 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, 113 S.Ct. 2786). 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 ‘[vjigorous 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, 113 S.Ct. 2786 (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, 113 S.Ct. 2786). 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, 113 S.Ct. 2786); see also Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999) (“We agree with the Solicitor General that ‘[t]he factors identified in Dau-bert may or may not be pertinent in assessing reliability, depending on the nature of the issue, the expert’s particular expertise, and the subject 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, 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. “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 plaintiffs 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 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 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. 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 is-chiorectal 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). 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. The plaintiffs then argue that Dr. Zol-noun’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. (Pis.’ Resp. in Opp’n to Def.’s Mot. to Exclude Certain Testimony from Pis.’ 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. Zol-noun’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 tro-cars 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 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, par-arectal 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. 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 an essential prerequisite to proving specific causation”). Thus, I FIND that Dr. Zolnoun’s specific causation opinions also should be excluded. B. Dean Altenhofen, M.D. According to the plaintiffs, Dr. Altenho-fen 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. (Pis.’ 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. Alten-hofen 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. Altenho-fen’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. Al-tenhofen’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%, 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 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. 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 IFXJs, 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 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 Pis.’ 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 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 201:19-202:2). 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: 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 plaintiffs 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 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. Loving’s opinion is true 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-” (Pis.’ 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 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 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. 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 life-altering 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. 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 biom-aterials. 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. (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 Dau-bert standard.” In re Bausch & Lomb, Inc. Contact Lens Solution Prods. Liab. Litig., MDL 1785, 2009 WL 2750462, at *10 (D.S.C. Aug. 26, 2009) (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 rehable. 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. 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 Avaul-ta product? 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. 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: 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 Phgsi-cians 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 Dauberb 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 Pis.’ Treating Physicians [Docket 103], at 2; see also Def. Bard’s Mem. of Law in Supp. of Mot. to Limit the Expert Opinions & 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.” FecLR.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 “[ajbsent evidence that a plaintiffs 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-ev-00837, 2012 WL 524442, at *6-7 (S.D.W.Va. Feb. 15, 2012) (analyzing whether an attending surgeon’s testimony was that of a treating physician or an expert witness). 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 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. (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.” (Kloster-halfen 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 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. Klosterhal-fen’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: Kloster-halfen], 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 De-Prest 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 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.” (Pis.’ 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 Pis.’ Resp. re: Klosterhal-fen]. 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 transvagi-nally, 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. Klos-terhalfen’s “effective po