Eghnayem v. Boston Scientific Corp.

Citations: 57 F. Supp. 3d 658; 2014 U.S. Dist. LEXIS 152457; 2014 WL 5461991Docket: Civil Action No. 2:13-cv-07965

Court: District Court, S.D. West Virginia; October 27, 2014; Federal District Court

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The document outlines a series of motions related to the exclusion of expert testimony in a consolidated case involving Boston Scientific Corporation concerning the use of transvaginal surgical mesh for treating pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The defendant, Boston Scientific Corporation, filed multiple motions to exclude the testimonies of various experts, including Dr. Richard W. Trepeta, Dr. Michael Thomas Margolis, Dr. Thomas H. Barker, Dr. Jimmy W. Mays, Dr. Samuel P. Gido, Dr. Emery Salom, Dr. Peggy Pence, Dr. Mark Slack, Dr. Raybon, Dr. Linda Kiley, Dr. Vladimir Iakovlev, Dr. Konstantin Walmsley, and Dr. Jorge Pando. The court granted, denied, or partially granted these motions based on individual circumstances.

For plaintiffs, motions to exclude testimonies from Dr. Stephen H. Spiegelberg, Dr. Stephen Badylak, Dr. Matthew F. Davies, Dr. Christine L. Brauer, and Dr. Gary L. Winn were also addressed. The court ruled similarly on these motions, granting or reserving decisions on certain experts.

This case is part of a larger context involving over 60,000 cases across seven multidistrict litigations (MDLs), with more than 13,000 cases specifically associated with Boston Scientific Corporation.

The case involves four plaintiffs who underwent surgeries in Florida using the Pinnacle Pelvic Floor Repair Kit, a mesh product manufactured by BSC for treating pelvic organ prolapse (POP). The plaintiffs allege severe complications from the implantation, including erosion, infection, inflammation, organ perforation, and chronic pain, among others. They assert claims including negligence, design and manufacturing defects, failure to warn, and breach of warranty, seeking punitive damages.

Expert opinions are central to the case, with both parties having retained experts to support their positions. The motions in question pertain to the admissibility of these expert testimonies under the Daubert standard, which stipulates that expert testimony must be based on reliable principles and methods, be relevant, and assist the trier of fact. The court acts as a gatekeeper, ensuring that scientific testimony is reliable and relevant. While the proponent of expert testimony does not need to prove its correctness, they must provide sufficient evidence for admissibility. The reliability of the expert testimony is assessed based on factors such as testability, peer review, potential error rates, and general acceptance in the relevant scientific community. The inquiry is flexible, focusing on the expert's methodology rather than the conclusions drawn.

Factors from Daubert may be relevant for assessing the reliability of expert testimony, but their applicability can vary based on the specific issue, the expert’s expertise, and the subject matter. Expert testimony must relate to the case's issues to be considered relevant and helpful, with the "fit" between the testimony and the inquiry being crucial. Daubert emphasizes that scientific validity for one purpose does not guarantee validity for unrelated purposes. For admissibility under Rule 702, there must be a valid scientific connection to the inquiry.

The excerpt also discusses differential diagnosis, a scientific method used to identify the cause of a medical problem by systematically eliminating potential causes. A reliable differential diagnosis typically involves thorough physical examinations, medical histories, and clinical tests, leading to a probable cause that cannot be ruled out. However, an unreliable differential diagnosis may not provide a sound basis for causation opinions. Importantly, a medical expert's causation conclusion should not be excluded merely for failing to eliminate all alternative causes, as opposing parties' alternative causes should influence the weight of the testimony rather than its admissibility, unless the expert cannot explain why an alternative cause is not the sole cause.

The district court has significant discretion in deciding on the admissibility of expert testimony and determining its reliability. Additionally, experts cannot testify regarding a party's state of mind or the reasonableness of a party's actions, as such testimony would usurp the jury's role in fact-finding. Experts may review corporate documents to explain their opinions, provided those opinions are admissible, but they cannot address matters related to corporate conduct or ethics, as this would not assist the jury.

Opinion testimony that articulates legal standards or applies law to facts is typically inadmissible, as established in United States v. McIver. The author of the document emphasizes adherence to this principle while noting a trust in counsel to adjust expert testimony accordingly. Concerns regarding the litigation-driven nature of expert testimony do not automatically warrant exclusion, as financial compensation for expert testimony does not inherently undermine its reliability. However, the independence of an expert's research is relevant in evaluating the scientific validity of their opinions. 

BSC seeks to limit or exclude the testimony of several experts, specifically targeting Dr. Richard W. Trepeta, who is proposed as an expert on the pathology of vaginal mesh implantation. Dr. Trepeta is a board-certified pathologist with relevant fellowship credentials and experience in examining vulvar-vaginal pathology. BSC raises two objections to his testimony: he is not qualified to discuss polypropylene mesh properties or clinical responses to mesh implants, and his opinions are deemed unreliable and irrelevant. The author partially grants and partially denies BSC’s motion to exclude Dr. Trepeta, noting the need to assess his qualifications under Federal Rule of Evidence 702.

Dr. Trepeta's report addresses the properties of polypropylene mesh, specifically its degradation, contraction, and migration. He identifies degradation as either fragmentation or oxidation, which releases chemical components into surrounding tissues, and notes that contraction significantly reduces the mesh's physical size. BSC questions Dr. Trepeta's qualifications, asserting he lacks expertise as a material scientist, biochemist, or biomedical engineer, and has no training in polymer science or relevant mechanical/chemical testing. However, the court disagrees, highlighting Dr. Trepeta's extensive experience as a clinical pathologist, which includes knowledge of chemistry and pathology relevant to mesh materials. His examination of fifty pelvic mesh explants over the past five years has informed his understanding of chemical changes in the polypropylene. Consequently, the court finds him qualified to testify on these degradation aspects.

Additionally, Dr. Trepeta opines that the body's pathological response to polypropylene mesh causes permanent injuries, including pelvic distortion, sexual dysfunction, persistent pain, and altered bowel and bladder function. BSC argues that Dr. Trepeta is unqualified to make these claims because he does not treat patients for these conditions and lacks familiarity with stress urinary incontinence and pelvic organ prolapse. The court, referencing a previous ruling, maintains that Dr. Trepeta's extensive pathology experience equips him to correlate clinical data and reach diagnoses relevant to the clinical responses associated with polypropylene mesh. Therefore, the court affirms Dr. Trepeta's qualifications to provide expert testimony on both mesh degradation and the human clinical response to polypropylene mesh.

Dr. Trepeta examined fifty pathology samples from mesh removals and noted injuries consistent with tissue response or injury due to polypropylene. He compared his findings to existing medical literature, concluding they align with published reports on mesh erosion and exposure. His qualifications allow him to opine on the causal relationship between transvaginal mesh implantation and tissue response, leading to the denial of BSC's motion to exclude his testimony.

BSC challenged the reliability and relevance of Dr. Trepeta's opinions, particularly his methodology. Dr. Trepeta analyzed over fifty mesh explant samples from various physicians monthly for five years. He identified abnormalities through microscopic examination and reviewed twenty-four pathology reports from plaintiffs' counsel, finding them consistent with disease processes related to polypropylene. BSC argued that the selection of these reports was unreliable due to potential bias since they were chosen by plaintiffs' counsel and that Dr. Trepeta only relied on seventeen of the reports without reviewing the patients' medical records.

Plaintiffs countered that the pathology reports supplemented Dr. Trepeta's primary findings from the mesh explants and literature. They highlighted that even BSC’s expert acknowledged the practice of reviewing pathology reports from polypropylene explants as acceptable for assessing tissue response. While the acceptance of this method within the pathology community is noted, a significant concern remains regarding the lack of standards for selecting the pathology reports, which hinders the assessment of potential bias or error in Dr. Trepeta's review process.

In Lewis, et al. v. Ethicon, Inc., the expert opinion based on selectively chosen explant samples was excluded due to concerns over potential bias in sample selection. Similarly, in the current case, Dr. Trepeta’s opinions derived from a review of twenty-four pathology reports are excluded for the same reason. However, his other opinions are deemed reliable, as they are based on his professional experience with mesh pathology rather than solely on litigation-driven research. Dr. Trepeta provides specific causation opinions for plaintiffs Ms. Nunez and Ms. Betancourt, attributing their symptoms and complications directly to the implantation of polypropylene surgical mesh. He supports his conclusions with observations of inflammatory responses documented in their medical records, consistent with chronic mesh implantation. 

BSC challenges the reliability of Dr. Trepeta's specific causation opinions on the grounds that they are based on an unreliable general causation opinion and a faulty methodology due to his lack of direct review of the plaintiffs’ mesh specimens. The court finds Dr. Trepeta’s general causation opinion reliable, which undermines BSC's first argument. Regarding the methodology, while not reviewing pathology specimens may affect the credibility of his opinion, it does not preclude it. The court cites that an expert can provide reliable opinions without direct physical examination, as long as they apply the same intellectual rigor typical in their field. Dr. Trepeta has indicated that he often renders pathologic opinions without examining specimens.

Dr. Trepeta's lack of examination of pathology specimens does not inherently discredit his specific causation opinions, yet they are deemed unreliable due to his failure to conduct a differential diagnosis linking Ms. Nunez and Ms. Betancourt's pain to the Pinnacle device. Although plaintiffs reference Dr. Trepeta's deposition in another case involving Ms. Sanchez to support a differential diagnosis, the court finds this testimony unconvincing. Previously, Dr. Trepeta's specific causation testimony regarding Ms. Sanchez was excluded due to an inadequate differential diagnosis. A reliable differential diagnosis must be patient-specific, and excluding causes for Ms. Sanchez does not substantiate causation for the current plaintiffs. Thus, no reliable differential diagnosis exists for them either. 

In contrast, Dr. Iakovlev's opinions remain admissible because he conducted a thorough "morphological differential diagnosis," allowing him to rule out alternative causes. Consequently, Dr. Trepeta's specific causation opinions regarding Ms. Nunez and Ms. Betancourt are excluded, while his general causation opinions, except those based on selected pathologic reports, are accepted. BSC's motion to exclude Dr. Trepeta's opinions is granted in part and denied in part.

Separately, BSC seeks to exclude Dr. Michael Thomas Margolis's opinions related to polypropylene mesh slings, citing his failure to consider conflicting scientific literature and a lack of scientific basis for his assertions. BSC argues that Dr. Margolis's opinions either constitute legal opinions, exceed his expertise, or involve speculation about Boston Scientific's knowledge and intent.

The court has previously reviewed Dr. Margolis's expert testimony in the case of Sanchez v. Boston Scientific Corp., and has determined that the arguments regarding the admissibility of his opinions in the current case do not present materially different facts or exhibits. Consequently, the court adopts its prior ruling on Dr. Margolis. 

BSC argues that Dr. Margolis's opinions are unreliable due to his failure to consider contrary scientific studies. The court cites precedent indicating that an expert's opinion may be deemed unreliable if it disregards evidence contradicting their theory. Specifically, BSC challenges Dr. Margolis's assertions about high complication rates associated with polypropylene mesh, arguing that his reliance on underreported data and his approach of assuming worst-case scenarios lack scientific validity. The court agrees and excludes Dr. Margolis's opinions on this matter.

Additionally, BSC claims Dr. Margolis has not provided a scientific basis for his opinions, particularly regarding the lack of evidence supporting the clinical benefits of polypropylene mesh in treating pelvic organ prolapse (POP). The court notes that Dr. Margolis himself acknowledged the existence of studies supporting the use of polypropylene for this treatment, further undermining the reliability of his opinions.

Inconsistent witness statements can be scrutinized during cross-examination, as established in *Daubert* and *In re Paoli R.R. Yard PCB Litig.*. While traditional methods, such as vigorous cross-examination and the presentation of contrary evidence, can challenge admissible evidence, Dr. Margolis's inconsistencies raise questions about the reliability of his methods. Although he claims a lack of credible evidence for certain studies, he fails to clarify his reasoning, thereby rendering his opinions unreliable.

BSC contests Dr. Margolis's assertion that the infection rate of polypropylene mesh can be as high as 100%. Despite Dr. Margolis referencing scientific studies in support of his opinion, BSC highlights that the specific study he cites does not substantiate his claim of a 100% infection rate; it notes that while all mesh systems studied were contaminated with bacteria, it does not conclude that they were infected. The study indicates that bacterial contamination does not necessarily equate to infection and states that infection is a rare complication, contradicting Dr. Margolis's assertion. Consequently, his methodology in supporting the infection rate opinion is deemed unreliable.

BSC also challenges Dr. Margolis's claims regarding the percentage or quantity of their products he has removed, though this specific point is not elaborated in the summary. Overall, Dr. Margolis's opinions on these matters are excluded based on the identified inconsistencies and lack of supporting evidence.

Dr. Margolis testified regarding his experience with the removal of approximately 300 polypropylene mesh and sling products over the past 15 years, estimating that 10% to 15% of those were from Boston Scientific (BSC). He clarified that this estimate is based on his best recollection and that he does not keep precise records. Margolis admitted he cannot identify the brand of mesh post-explantation and often relies on operative records for product information, which he does not consistently receive. BSC contends that Margolis's opinions regarding the number or percentage of BSC products he has removed lack reliability and may be erroneous, referencing a precedent where expert analyses were excluded due to lack of control for error or bias.

The plaintiffs argued that a previous ruling in Lewis v. Ethicon, Inc. allowed for the admission of Margolis's testimony, but this was dismissed as Lewis involved different parties and circumstances. They also claimed that Margolis’s extensive experience should suffice as a basis for his opinions, citing Kumho Tire, which recognizes expertise as a valid foundation. However, it was emphasized that expert testimony must still be supported by solid validation, and Margolis has not consistently provided scientific backing for some of his opinions, as discussed in prior cases. Consequently, his opinions are excluded from consideration.

Dr. Margolis's opinions must adhere to reliable scientific methods to qualify as ‘scientific knowledge’ under Daubert. BSC seeks to exclude several of Dr. Margolis’s opinions regarding biomaterials and product design, but plaintiffs concede he will not present these at trial, rendering this part of BSC’s motion moot. Additionally, BSC argues that Dr. Margolis intends to testify about its state of mind during product development, which is impermissible expert testimony. The plaintiffs also concede he will not offer these opinions at trial, leading to this aspect of BSC’s motion being denied as moot. 

BSC moves to exclude Dr. Thomas H. Barker’s testimony, asserting that his opinions on polypropylene mesh behavior are unreliable and irrelevant due to alleged flaws in his testing methodology and claims of unqualified state of mind testimony. The court previously ruled on Dr. Barker's qualifications in Sanchez, finding him qualified to opine on polypropylene properties based on his Ph.D. in biomedical engineering and current academic position. The court adopts this prior ruling, granting BSC’s motion to exclude Dr. Barker’s testimony while noting that any differing facts or exhibits presented do not significantly impact the case.

Dr. Barker's expert report highlights his focus on mechanical forces and the mechanical properties of tissues and materials, specifically their influence on the host response. He possesses significant expertise in evaluating biomaterials, implant design, and the foreign body response, along with experience in human tissue repair and fibrosis, including cellular and molecular analyses. His postdoctoral research investigated the mechanisms behind biomaterial-associated fibrosis. Dr. Barker has published various book chapters and peer-reviewed articles in the fields of biomaterials and biomedical engineering.

However, BSC challenges the reliability and relevance of Dr. Barker's opinions based on his mechanical testing. They argue that his testing is flawed for several reasons: it does not adhere to the published protocols he claims to follow, lacks a sufficient sample size, fails to meet peer-reviewed publication standards, and does not accurately replicate the physiological conditions of the female pelvic floor.

Specifically, BSC points out that Dr. Barker did not use a saline bath, which is essential for mimicking human physiological conditions, as required by established protocols. This deviation, attributed to restrictions from Georgia Tech, undermines the reliability of his results, which showed significantly different outcomes compared to those of Drs. Shepherd and Moalli. Furthermore, BSC contends that Dr. Barker’s sample size was inadequate, testing only one piece of Obtryx mesh and two pieces of Pinnacle mesh, which he acknowledged prevented any meaningful statistical analysis. This limitation raises concerns about whether his findings were mere chance occurrences, leading to the conclusion that Dr. Barker's methodology is unreliable.

Dr. Barker expressed a desire for additional testing materials, stating he would have conducted more tests if they had been provided. His sample sizes for the Obtryx and Pinnacle devices were N=1 and N=2, respectively, which he acknowledged were too small to allow for statistical confidence testing, as a minimum sample size of three is required. This limitation rendered his testing unreliable. BSC criticized Dr. Barker’s methods for not adhering to peer-reviewed standards, to which he agreed during his deposition, conceding that his N=1 and N=2 results would not meet publication criteria.

Additionally, his testing methods did not replicate the physiological conditions of the female pelvic floor, further undermining the reliability of his conclusions. BSC referenced findings from the Sanchez case, which supported the argument that Dr. Barker's uniaxial testing could not accurately predict the behavior of the mesh in vivo due to the absence of multi-directional force considerations. Although plaintiffs argued that Dr. Barker's methods were generally accepted in the scientific community, citing his established testing protocols, the overall insufficiency of his sample sizes and failure to meet rigorous testing standards led to a conclusion that his methods were unreliable.

Plaintiffs assert that general acceptance of Dr. Barker’s methodology prevents a Daubert challenge, arguing it establishes a reliable foundation for his expert testimony. However, the trial judge emphasizes the necessity for reliability in expert opinions and acknowledges flexibility in assessment. Despite the general acceptance of cyclic tensile testing and stress deformation analyses in bioengineering, Dr. Barker's methodology is deemed unreliable due to his failure to simulate human body conditions in his evaluations of the mesh's in vivo behavior.

The court finds Dr. Barker's opinions regarding the mechanical mismatch between the mesh and the human body to be unreliable, as they are based on flawed testing methods that do not accurately reflect human physiological conditions. BSC challenges Dr. Barker’s opinions as being driven by litigation motives, but this argument is not addressed since the opinions are already deemed unreliable and inadmissible.

Dr. Barker’s testing included both the Pinnacle and Obtryx products, but since the Pinnacle is the focus of this case, the relevance of his findings on the Obtryx is not considered due to the unreliability of his overall methodology. Plaintiffs contend that Dr. Barker's insights are critical for demonstrating design flaws in BSC's meshes, drawing parallels to a previous case (Lewis v. Ethicon, Inc.). However, as Dr. Barker's methods are found unreliable, his opinions are excluded, negating the need to evaluate their relevance.

Plaintiffs reference specific causation from the Lewis trial transcript, but Dr. Barker does not provide specific causation opinions in this case. BSC argues that Dr. Barker is unqualified to give opinions on product design or testing, and the court previously found his state of mind testimony inadmissible. Dr. Barker claims that BSC designed the Pinnacle product inappropriately, which is excluded as it pertains to BSC's state of mind. Consequently, the court grants BSC’s motion to exclude Dr. Barker’s opinions.

BSC also seeks to exclude the testimony of Dr. Jimmy W. Mays and Dr. Samuel P. Gido, both experts in polymer materials who assessed the polypropylene mesh used in the Pinnacle. They concluded that the material is prone to oxidative degradation, rendering the product defective. Although their report claims reliance on training and testing data, BSC contends that the testing lacks reliability and relevance, echoing arguments made in the Sanchez case. The court finds no significant factual differences from Sanchez that would alter its conclusions regarding the admissibility of Drs. Mays and Gido’s testimony.

Mays and Gido's opinions are deemed unreliable due to their litigation-driven nature and inadequacy for jury assistance. The defendant contends that some of their opinions should be excluded as they pertain to BSC's state of mind and present inadmissible legal conclusions. Regarding the chemical and microscopic testing of Pinnacle explants, on September 24, 2013, Drs. Mays and Gido received product exemplars for control purposes and were later provided with explants from Steelgate, identified by plaintiffs’ counsel, Jennifer Black. After confirming fourteen explants were available, they were sent to Dr. Gido on October 1, 2013, of which only eleven contained suitable mesh for testing. Dr. Gido conducted three types of microscopic analyses on these samples.

Subsequently, Dr. Gido forwarded four explants to Dr. Mays on October 22, 2013, who performed three chemical analyses. The results were summarized in their expert report, but crucial details about the Thermogravimetric Analysis (TGA) and Transmission Electron Microscopy (TEM) were not included, with TGA data provided only through handwritten notes. BSC has raised specific reliability concerns about Mays and Gido’s testing, asserting they failed to control for error or bias and did not adhere to established testing protocols, leading to a prior determination of their opinions as unreliable under Daubert standards.

Plaintiffs' counsel selected the only available Pinnacle and Obtryx samples from the Steelgate repository, differing from the Lewis case where the sample size was unspecified. Some samples were excluded from testing due to insufficient mesh material, not bias. However, the limited and non-random selection of samples reduces the reliability of Drs. Mays and Gido's testing. They did not clarify whether their samples were representative, and there was no assessment of the error rate in their observations. Additionally, the doctors lacked knowledge about the explantation and preservation of the materials before testing. 

In their report, Dr. Gido utilized EDS testing to differentiate between polypropylene fibers and biological materials, emphasizing that the presence of nitrogen is a key indicator. However, he failed to analyze the statistical significance of minor nitrogen presence in samples. Both experts admitted that their bleach treatment techniques may not have effectively removed all biological material. They acknowledged not performing any statistical analyses or calculating error rates for their tests, which raises concerns about the reliability of their methods.

The Daubert standard evaluates whether expert analysis adheres to accepted scientific practices. The small sample size and the absence of statistical significance assessments challenge the credibility of Drs. Mays and Gido's conclusions. Furthermore, Dr. Mays admitted to not preparing a written methodology for SEM testing, and both experts referred to a subjective cracking standard established by Dr. Gido for their testing.

Dr. Mays and Dr. Gido acknowledge the absence of a published standard for their testing methodology. Dr. Gido has never established a cracking standard and admitted to inconsistencies in bleach cleaning applied to explants, using 6% bleach while Dr. Mays used 7.8%. They also failed to explain the omission of this testing from their original report and noted that Dr. Gido overlooked an Energy Dispersive X-ray Spectroscopy (EDS) test on one sample. Dr. Mays conducted Thermogravimetric Analysis (TGA) testing but did not include its results in their expert report. Despite employing tests supported by literature, the errors and inconsistent application of these methodologies cast doubt on their reliability, leading to the conclusion that their testing is unreliable and should be excluded, consistent with previous rulings in similar cases. 

While BSC argues for the exclusion of their unreliable testing, the plaintiffs contend that the tests merely confirmed Drs. Mays and Gido's pre-existing knowledge based on their training and literature. However, this argument relies on selective citation of Dr. Mays’s deposition, neglecting Dr. Gido’s opposing testimony that their conclusions were based on their own study rather than existing literature.

Dr. Mays characterizes his testing as "confirmatory," while Dr. Gido completed his testing prior to reviewing relevant literature and acknowledges that the data significantly influenced his report. Dr. Gido's opinions are based solely on his testing, which has been deemed unreliable, leading to the exclusion of his testimony. In contrast, Dr. Mays, who primarily relied on scientific literature and his experience, is permitted to testify about polypropylene degradation.

BSC challenges the reliability of Dr. Mays's opinions, claiming they are litigation-driven and selectively cite literature. However, the formulation of an expert's opinion for litigation does not inherently warrant exclusion. Dr. Mays has been found to cite multiple studies supporting his view on polypropylene's unsuitability as a permanent implant, many of which are recognized in the field of polymer science. His report includes a comprehensive list of scholarly articles considered in forming his opinions, indicating a robust basis for his conclusions.

BSC's argument that Dr. Mays's testimony lacks relevance because he cannot link degradation to specific clinical symptoms is countered by previous rulings that general causation testimony is admissible under Rule 702. Dr. Mays has also mentioned potential complications resulting from degradation, further supporting the relevance of his testimony.

Degradation is identified as a primary cause for the malfunction of certain medical devices, with Dr. Mays asserting its clinical significance. He is allowed to testify about the susceptibility of polypropylene to oxidation and degradation, based on his expertise and scientific literature, without referencing unreliable testing conducted with Dr. Gido. The ruling from Sanchez is adopted, permitting Dr. Mays's opinions to stand.

Regarding BSC’s state of mind, Dr. Mays presents two opinions indicating that BSC neglected the oxidation risks of polypropylene in the design of the Pinnacle and Obtryx meshes. If BSC was unaware of these risks, it reflects incompetence; if aware, it suggests a reckless disregard for safety for profit. However, expert opinions on BSC’s knowledge are deemed unhelpful to the jury and are excluded.

Dr. Mays also attempts to draw legal conclusions about BSC’s actions, which is inadmissible per Fourth Circuit standards. While he can express that the Pinnacle is unsuitable as a permanent implant, he cannot frame this as a legal conclusion. Thus, these statements are also excluded. 

BSC’s motion to exclude the opinions of Drs. Mays and Gido is partially granted and partially denied. Additionally, Dr. Salom, a urogynecologist, is presented to testify about his treatment of Plaintiff Dotres using the Pinnacle mesh implant and the subsequent complications. BSC challenges Dr. Salom’s testimony, arguing that the plaintiff did not submit a proper expert report, which would limit Dr. Salom’s opinions to those based solely on his treatment of Ms. Dotres.

BSC contends that Dr. Salom's testimony should be restricted under the Daubert standards of reliability and relevance, even if the court overlooks the improper expert report. The court denies BSC's motion. Under Federal Rule of Civil Procedure 26(a)(2)(B), parties must disclose the identity of trial witnesses and provide a comprehensive written report for any expert witness, detailing their opinions and the basis for them. Failure to comply can lead to exclusion of the witness, unless justified or harmless. Local Rule 26.1 exempts treating physicians from the full report requirement unless they were solely employed for expert testimony. Instead, a less rigorous disclosure is needed when treating physicians testify, as per Rule 26(a)(2)(C). Plaintiff Dotres submitted a report for Dr. Salom, which BSC argues is insufficient, claiming it qualifies as a Rule 26(a)(2)(C) disclosure rather than the required Rule 26(a)(2)(B) report, due to Dr. Salom addressing topics beyond his treatment of Dotres. BSC seeks to exclude specific testimony regarding the risks of mesh procedures and potential nerve damage from the Pinnacle Kit. In reply, Dotres agrees to omit these opinions and limit Dr. Salom's testimony to causation of injuries sustained by Dotres, consistent with prior case law. Hence, the court denies BSC's motion based on Rule 26.

BSC's Daubert challenges regarding Dr. Salom's testimony are addressed as follows: BSC seeks to exclude Dr. Salom's opinion on the risks of implanting the Pinnacle device without proper cutting, arguing it lacks relevance to Ms. Dotres’s case. However, since Plaintiff Dotres has agreed not to present this opinion, BSC's challenge is denied. BSC also aims to exclude Dr. Salom’s testimony about Ms. Dotres’s current condition, claiming it is speculative, but again, Dotres has agreed not to elicit such opinions since Dr. Salom last treated her in March 2012, leading to a denial of BSC's motion on this point as well.

The plaintiff argues that if they are precluded from eliciting certain testimony, BSC should also be limited. The court affirms that BSC's cross-examination of Dr. Salom will be confined to the scope of the plaintiff's direct examination, as per Federal Rules of Evidence. BSC must establish Dr. Salom's personal knowledge if calling him as a witness, and any objection regarding this can be raised during trial. Additionally, BSC cannot present Dr. Salom as an expert witness due to a failure to file a Rule 26 disclosure. The court emphasizes that the details of cross-examination are at its discretion, and concerns about deposition questions do not indicate trial proceedings. Consequently, BSC’s Motion to Exclude the Opinions and Testimony of Dr. Salom is denied.

Regarding Dr. Peggy Pence, she serves as a clinical and regulatory consultant, advising on product development and compliance with FDA standards, among other responsibilities.

Dr. Pence presents four main opinions regarding BSC's Pinnacle product: 1) BSC did not adequately test the product before market release; 2) the product was inadequately labeled; 3) patients could not give informed consent for its surgical implantation due to misbranding; and 4) BSC failed to meet post-market vigilance standards, contributing to additional misbranding. BSC seeks to exclude Dr. Pence's testimony entirely. The court has previously evaluated Dr. Pence's qualifications under the Daubert standard in the case of Sanchez v. Boston Scientific Corp., concluding that despite lacking a medical degree, her extensive experience—over 40 years in medical device research and development—qualifies her to provide opinions on the safety and efficacy of mesh products. The court affirms that her knowledge regarding clinical trials and product labeling is relevant to this case.

In evaluating the reliability and relevance of Dr. Pence's opinions, she asserts that BSC should have conducted thorough preclinical and clinical testing of the Obtryx Sling and Pinnacle PFR Kits before marketing, as failing to do so constitutes a breach of the standard of care expected from a medical device manufacturer. Dr. Pence based her assessment on risks associated with polypropylene mesh and evidence from Material Safety Data Sheets from 2004 indicating its unsuitability for permanent implantation. Previously, in a related case (Lewis v. Ethicon), Dr. Pence's opinion was excluded for lack of a reliable foundation, as she failed to provide authority requiring specific tests. BSC contends that Dr. Pence's current expert report similarly lacks reliability due to an absence of cited authority compelling BSC to conduct the disputed tests, while plaintiffs argue that Dr. Pence has addressed prior deficiencies in her revised report.

Plaintiffs assert that Dr. Pence's methodology and opinions are supported by extensive evidence, including peer-reviewed articles, regulations, and internal documents, rather than solely her professional opinion. This is a departure from previous concerns regarding the reliability of her expert report, which now includes references to studies emphasizing the necessity of clinical trials before using mesh materials in surgery. Notably, Dr. Pence cites a 2006 study by the French National Authority for Health, which advised that the use of vaginal mesh for treating genital prolapse should remain under clinical research and called for further studies on various outcomes and potential adverse effects. Additionally, she references recommendations from the National Institute for Health and Care Excellence that stress the need for stringent clinical governance in mesh repairs.

Dr. Pence's critique of BSC’s pre-market testing for polypropylene mesh is bolstered by authoritative studies, leading to the conclusion that her methodology is reliable under the Daubert standard, resulting in the denial of BSC's motion to exclude her opinion.

Furthermore, Dr. Pence presents two key opinions regarding BSC’s product labeling. She claims that BSC marketed their products without adequate usage instructions and failed to provide sufficient warnings about potential risks, which impeded patients' ability to give informed consent. Although BSC argues that these opinions should be excluded due to their connection to FDCA branding requirements—deemed irrelevant to the case—plaintiffs maintain the relevance of Dr. Pence’s testimony to their failure to warn claim. They emphasize that her insights about the necessary information missing from BSC’s instructions for use and patient brochures are critical for the jury's understanding of the case.

Testimony regarding product labeling is deemed relevant for guiding the jury in state law claims concerning the appropriateness of such labeling. The focus in failure to warn cases is on the safety associated with inadequate labeling rather than physical product flaws. BSC contends that Dr. Pence’s opinions on its labeling practices lack a reliable basis, as she fails to support her claims that BSC's labeling did not meet the standard of care, merely asserting that BSC “should have gone further.” The plaintiffs argue that Dr. Pence's reliance on medical publications and the FDA’s database provides sufficient authority for her opinions. However, while Dr. Pence cites various sources, the information does not substantiate her assertion that BSC failed to meet the required standard of care regarding labeling, as it does not address whether the complications cited should have been included as warnings. Consequently, her reliance on vague concepts like “the standard of care” and “a matter of ethics” fails to meet the reliability standards established by Daubert. Additionally, Dr. Pence uses FDCA provisions and FDA regulations to define labeling criteria, which may be relevant to the failure to warn claim. Nonetheless, it is crucial to consider the potential for confusion and misleading information when evaluating expert testimony, particularly since the FDCA requirements are not directly at issue in this case. This could mislead the jury into believing that FDA regulations dictate warning standards in West Virginia.

Dr. Pence's testimony regarding the adequacy of Boston Scientific Corporation's (BSC) product labeling, based on FDA regulations, has been excluded due to the risk of jury confusion outweighing its probative value. The court cited the case Lewis v. Johnson, stating that alleged shortcomings in FDA procedures do not support state law products liability claims. Dr. Pence's opinions hinge solely on violations of the FDCA and FDA regulations, which do not pertain to the claims at hand and represent legal conclusions rather than expert opinions. Furthermore, her assertions about BSC's failure to report adverse events to the FDA were deemed irrelevant to whether BSC provided adequate warnings or if the products were defective. Compliance with FDA regulations was found to have minimal relevance to the plaintiffs' claims, and discussing these complexities risks confusing the jury. Consequently, Dr. Pence's opinions on product labeling and post-market vigilance are excluded.

In relation to Dr. Mark Slack, BSC filed motions to exclude his testimony, including a typical Daubert motion and a request for leave to submit a supplemental brief following his deposition. Since the court granted BSC's Daubert motion regarding Dr. Slack, the request for further briefing has been denied. Dr. Slack is identified as a consultant gynecologist and practicing urogynecologist in the United Kingdom.

Eighty-five percent of Dr. Slack's daily practice focuses on managing prolapse and incontinence. He provides opinions on four topics related to Boston Scientific Corporation's (BSC) mesh products: pelvic floor anatomy and dysfunction, necessary research and testing for marketing, directions for use, and physician training. While BSC does not contest his views on pelvic floor anatomy and dysfunction, it seeks to exclude his opinions on the other three topics, arguing that he is unqualified and lacks a reliable basis for his conclusions. BSC also claims that Dr. Slack's report includes improper expert testimony, such as narrative testimony, conclusory statements regarding BSC's state of mind, and legal conclusions.

The court agrees to exclude Dr. Slack's opinions related to BSC's marketing and physician training, granting BSC's motion to limit his testimony. Dr. Slack’s report is characterized as a narrative review of corporate documents, filled with improper testimony about BSC's mindset and legal interpretations. It is noted that BSC had a duty to evaluate potential complications of their mesh products and failed to adequately warn physicians and patients about risks associated with the devices. Evidence suggests that BSC was aware of potential severe complications, including the need for invasive surgery, as early as 2003. BSC also recognized the importance of physician training on patient safety and aimed to establish a standardized surgical technique. However, much of Dr. Slack's testimony merely recounts BSC's actions without providing substantial expert analysis, which is not permissible for expert testimony. Consequently, his opinions regarding BSC's knowledge and legal implications are excluded.

BSC's motion to exclude Dr. Slack's testimony is granted. Regarding Dr. R. Brian Raybon, a board-certified obstetrician and gynecologist specializing in pelvic and reconstructive surgery since 1998, BSC challenges his testimony on two grounds: (1) his general causation opinions about mesh lack reliable support, and (2) he did not perform a proper differential diagnosis for Ms. Dotres. Consequently, BSC seeks to exclude both general and specific causation testimony.

The court grants in part and denies in part BSC’s motion. Dr. Raybon asserts several general causation opinions regarding the Pinnacle mesh, claiming it causes ongoing nerve irritation, chronic inflammation, and a toxic environment leading to nerve function loss. BSC argues these opinions lack scientific basis, likening them to previously excluded testimony by Dr. Zolnoun in a related case, which was deemed personal and unscientific. Plaintiffs counter this by comparing Dr. Raybon’s qualifications to Dr. Steege's, whose opinions were accepted despite not having direct experience with mesh procedures, citing his extensive knowledge of related issues.

Despite recognizing Dr. Raybon's qualifications, the court finds his general causation opinions do not meet the standards set forth in Daubert, implying they are insufficiently grounded in scientific methodology.

Federal Rule of Evidence 702 permits expert opinion testimony only when it is grounded in the expert’s relevant knowledge and expertise. Dr. Steege, who has a proven background in pelvic pain, was deemed qualified to testify about nerve trauma from mesh implantation. In contrast, Dr. Raybon's qualifications are insufficient for such testimony; he lacks specialization in pelvic and vaginal pain etiology, and his knowledge of nerve trauma related to mesh is limited to his experiences with a small number of post-implantation patients. A significant analytical gap exists between the data and his opinions, which do not meet the reliability standards outlined in Daubert. Dr. Raybon's assertion that Pinnacle mesh causes nerve irritation and chronic inflammation is based solely on his personal experience without supporting studies or peer-reviewed work, failing to pass Daubert scrutiny. Additionally, his claim that at least 30% of his patients experienced complications related to Pinnacle mesh is unsupported by objective data, relying instead on memory and estimations without reviewing medical records. Previous cases have excluded similar testimony that lacks a clear methodology for determining complication rates. As a result, Dr. Raybon's general causation testimony regarding the etiology of Pinnacle mesh is excluded.

Expert testimony must be substantiated beyond mere assertions, as established in Holesapple v. Barrett. Consequently, Dr. Raybon's testimony regarding the complication rate of his patients is excluded. In his expert report, Dr. Raybon evaluates Ms. Dotres and concludes that her voiding dysfunction, pain, and defecatory issues are likely due to nerve irritation from the Pinnacle mesh. BSC contests this opinion, arguing that Dr. Raybon's lack of a proper differential diagnosis undermines his conclusions, pointing out that he neither examined nor interviewed Ms. Dotres, relying solely on her medical history and deposition.

While physical examination is typically indicative of a reliable differential diagnosis, it is not a strict requirement if there are sufficient medical records available. Dr. Raybon reviewed records from four doctors who examined Ms. Dotres, which supports his analysis. The essence of a differential diagnosis involves evaluating alternative causes of a medical condition. Dr. Raybon considered two potential alternative causes for Ms. Dotres’s issues: preexisting constipation and back pain. He argues that the absence of defecatory problems prior to the mesh implantation indicates the mesh is the cause. However, BSC counters this by highlighting Ms. Dotres's admission of having constipation before the surgery and Dr. Raybon's inability to completely rule out the exacerbation of her preexisting condition as a factor. Additionally, Dr. Raybon dismissed spinal stenosis as a cause of her urinary and pelvic pain, further detailing his reasoning in his deposition.

Dr. Raybon concluded from an examination of Ms. Dotres's medical records that there was no objective evidence for her symptoms, particularly motor or sensory deficits in her legs typically associated with spinal injuries. BSC challenges this opinion, noting that Dr. Raybon acknowledged he could not completely rule out back pain as a contributor to her nerve impingement and incontinence. However, the court emphasized that these challenges pertain to the credibility of Dr. Raybon's opinion rather than its admissibility. 

In assessing the Daubert objection, the court's role is to evaluate whether the expert's methodology is scientifically valid. Dr. Raybon's approach involved a thorough review of Ms. Dotres's records and the consideration of potential causes for her symptoms, leading him to conclude that the Pinnacle mesh was the most likely cause. The court previously accepted similar methodology as reliable. 

An expert's inability to entirely exclude alternative causes does not inherently warrant exclusion under Daubert, provided the expert can explain why those alternatives are not the primary cause. Dr. Raybon indicated that the timing of Ms. Dotres's increased constipation and other symptoms post-surgery suggested a compelling causal link to the mesh. He also ruled out spinal stenosis based on the absence of leg motor or sensory deficits. 

Dr. Raybon's report and testimony reflect that he considered alternative causes and determined that while he could not exclude them entirely, they were less likely responsible for her condition. This methodology aligns with Daubert standards. BSC's criticisms of Dr. Raybon's differential diagnosis pertain to the weight of his testimony rather than its admissibility. The court finds Dr. Raybon's methodology to be reliable for Daubert purposes, allowing for further exploration of his conclusions at trial.

704BSC’s motion regarding specific causation is denied, while BSC's Motion to Exclude Dr. Raybon's opinions is granted in part (general causation) and denied in part (specific causation). BSC seeks to exclude Dr. Linda Kiley’s testimony, claiming she is unqualified to provide general causation opinions on transvaginal mesh properties and that her opinions lack scientific grounding. Dr. Kiley, a board-certified OB/GYN with expertise in Female Pelvic Medicine and Reconstructive Surgery, is the treating physician for Ms. Eghnayem, having performed her Pinnacle mesh removal surgery in 2012. 

Dr. Kiley's general causation findings suggest that transvaginal mesh does not effectively address pelvic organ prolapse, may lead to biofilm development and inflammation due to polypropylene contamination, and that biofilm is implicated in related symptoms and complications. She further attributes Ms. Eghnayem's pelvic pain and other complications to infections, inflammation, and mesh-related issues. 

BSC contends that Dr. Kiley’s failure to conduct a proper differential diagnosis undermines her specific causation opinions. Despite this, Dr. Kiley’s extensive experience (over 20 years, 10,000 surgeries, and significant exposure to mesh-related complications) supports her qualifications in commenting on surgical meshes and their complications, although she has never used polypropylene transvaginal mesh kits in her procedures.

Dr. Kiley has removed an average of one polypropylene mesh sling or POP device monthly from patients over the past six years, indicating her experience with these devices. Although she may be qualified to discuss the properties and complications of polypropylene transvaginal mesh, her general causation opinions are deemed unreliable. Boston Scientific Corporation's (BSC) challenge to Dr. Kiley’s general causation opinions regarding biomaterials is considered moot, as the plaintiff concedes that Dr. Kiley will not opine on those matters.

BSC also contests the reliability of Dr. Kiley’s general causation opinions, arguing they lack a scientific foundation. Dr. Kiley claims to have observed numerous surgical procedures and studied various medical texts and reports to form her opinions. However, the review of her expert report reveals no citation of scientific studies, and her list of relied-upon materials does not include any scientific references. While she mentions some scientific sources during her deposition, her report fails to comply with Federal Rule of Civil Procedure 26, which requires a complete statement of opinions and the basis for them. The absence of specific studies referenced in her report prevents a determination of whether her opinions are based on a reliable method.

Consequently, Dr. Kiley’s general causation opinions are excluded. Additionally, she intends to offer specific causation opinions regarding Ms. Eghnayem, asserting that the injuries sustained by Ms. Eghnayem are caused by the Boston Scientific Pinnacle system, but her general causation opinions' exclusion casts doubt on her specific causation claims.

Pelvic pain, dyspareunia, bleeding during intercourse, urinary incontinence, vaginal tenderness, and mesh erosion were linked to infection, inflammation, nerve entrapment, shrinkage, and scarring of the mesh. BSC contests the reliability of Dr. Kiley’s causation opinions, arguing she did not conduct a proper differential diagnosis, which is essential for expert testimony. Such a diagnosis typically involves physical examinations, medical history review, and clinical tests to identify and eliminate potential causes of symptoms. BSC claims Dr. Kiley failed to account for Ms. Eghnayem’s pre-existing pelvic pain, the treatments by other physicians, and individual factors like genetics or co-morbidities. Dr. Kiley asserts she reviewed Ms. Eghnayem's medical history, examined her, and treated her. She emphasized that performing a differential diagnosis is standard procedure for her, initiated by the patient's history and refined through examination. Dr. Kiley acknowledged considering Ms. Eghnayem’s pre-existing pain in her treatment, highlighting her unique perspective as both the treating physician and the one who performed revision surgery, which allowed her to understand the progression of symptoms and their relationship to the mesh product.

Ms. Eghnayem experienced pain associated with her implantation of the Boston Scientific Pinnacle mesh, which improved after its removal. Dr. Kiley noted mesh erosion during surgery and linked it to the pain experienced by both Ms. Eghnayem and her husband. He identified significant scarring and vaginal varicosities related to the mesh during the 2012 removal procedure. Following the removal, Dr. Kiley placed a biologic graft, which he stated did not adversely affect Ms. Eghnayem's recovery as her symptoms improved post-surgery. Dr. Kiley's opinion on the causation of her symptoms is grounded in his evaluations before, during, and after her surgery, as well as his clinical experience treating similar cases. His diagnosis is deemed reliable and withstands Daubert scrutiny, leading to a partial grant and denial of BSC's motion concerning his testimony. 

Additionally, Dr. Iakovlev, an anatomical pathologist, presented findings from a study correlating explanted mesh pathology with clinical symptoms, concluding that women with pelvic mesh devices face a heightened risk of chronic pelvic pain due to increased innervation in that area. BSC contends that Dr. Iakovlev's general causation opinions and specific deformation findings lack reliability under Daubert standards.

Dr. Iakovlev is deemed unqualified to provide opinions on mesh design, polypropylene degradation, and specific causation related to Ms. Egh-nayem, with his opinions considered unreliable. Boston Scientific Corporation (BSC) challenges the reliability of Dr. Iakovlev’s mechanical testing, specifically a "stretch test" he conducted on BSC mesh to assess deformation under simulated body forces. His method involved stretching the mesh to 120% of its original length but lacked adherence to standardized testing protocols, as he did not document a written procedure or measure the force applied accurately. Additionally, he did not provide measurements related to the clamp settings, could not explain how he achieved the 120% stretch, and did not account for potential confirmation bias. Dr. Iakovlev also could not confirm that his lab tests accurately replicate the behavior of mesh in the human body, as he only measured one-directional forces. BSC's objections focus on the lack of testing standards and the differences between in vitro and in vivo conditions. The court references previous rulings in Tyree v. Boston Scientific, finding the arguments against Dr. Iakovlev's methodology consistent and insufficiently material to alter the conclusions regarding the reliability of his stretch test. Furthermore, Dr. Iakovlev acknowledged not using gloves or sterilizing the mesh during testing, further undermining the credibility of his results.

Dr. Iakovlev asserts that the stretch test he conducted was based on length rather than force, rendering force regulation irrelevant. However, he acknowledges that he did not standardize his testing methods or results and lacks knowledge on the general acceptance of his methodology within the medical community. When questioned about the reliability of his results, he only stated that the stretch test was a simulation, which was deemed insufficient.

BSC challenges Dr. Iakovlev's methodology, arguing that he failed to replicate an in vivo environment, as his tests involved uniaxial forces rather than the multidi-rectional forces experienced in the female pelvic floor. While the uniaxial nature does not solely undermine the reliability of his methodology, the lack of consideration for multidi-rectional forces significantly impacts its admissibility. Dr. Iakovlev's assumption that similar forces yield similar behavior is viewed as inadequate for meeting the standards of Daubert scrutiny. Consequently, his opinions based on the stretch test are ruled unreliable and excluded.

Regarding general causation opinions, BSC contends that Dr. Iakovlev's methodology lacks reliability in his review of over 130 mesh explants from various sources, including BSC. BSC argues that the lack of criteria for selecting the explants renders the results irrelevant. In contrast, the plaintiff claims that Dr. Iakovlev followed standard procedures and observed nerve issues in all BSC explants. However, Dr. Iakovlev did not clarify how the explants were selected, and his testimony indicated that he had no knowledge of the selection methodology used by the plaintiffs' lawyers. This raises further questions about the reliability of his findings.

Dr. Iakovlev's expert opinions on general causation related to pelvic mesh explants are excluded due to a lack of scientific methodology in his sample selection and failure to demonstrate a potential rate of error in his observations. While the plaintiffs assert that Dr. Iakovlev's independent analysis validates his conclusions, this does not meet the scientific standards required for his general causation opinions, particularly concerning the Bendavid study. However, Dr. Iakovlev is permitted to testify about specific causation related to Ms. Edwards' mesh, as the reliability concerns are not present in that context.

BSC seeks to exclude Dr. Iakovlev’s opinions on mesh design, deformation, and polypropylene degradation based on the same Bendavid study, which has been deemed unreliable. In contrast, Dr. Iakovlev provides specific causation opinions regarding Ms. Eghnayem’s mesh, attributing her symptoms to various reactions caused by the mesh, including chronic inflammation and nerve entrapment.

BSC challenges Dr. Iakovlev’s qualifications to render clinical opinions based on his status as a pathologist rather than a urogynecologist. However, the court acknowledges Dr. Iakovlev's extensive experience in diagnostic examination and his role as an academic physician. The court has previously allowed pathologists to testify about polypropylene mesh properties, indicating that Dr. Iakovlev’s qualifications are sufficient for the specific opinions he presents.

Dr. Richard W. Trepeta and Dr. Bernd Klosterhalfen are referenced in the context of evaluating Dr. Iakovlev's qualifications to provide specific causation opinions related to the mesh used in a plaintiff's case. The court found Dr. Iakovlev qualified based on his experience as a pathologist and his examination of Ms. Eghnayem's mesh explants. Despite BSC's contention that Dr. Iakovlev’s opinions were unreliable due to his inability to conduct a clinical differential diagnosis, the court clarified that pathologists typically perform morphological differential diagnoses, which do not require physical examinations. Dr. Iakovlev based his conclusions on a thorough review of clinical records and specimen examinations, supported by input from clinical colleagues to address alternative causes. The court determined that challenges to the accuracy of his conclusions were appropriate for cross-examination rather than exclusion. Consequently, BSC's motion to exclude Dr. Iakovlev's specific causation opinions was partially denied.

Regarding Dr. Konstantin Walmsley, a urologist specializing in pelvic organ prolapse and urinary incontinence, BSC sought to exclude his opinions on the suitability of the Pinnacle device for treating pelvic organ prolapse (POP). BSC argued that Dr. Walmsley lacked qualifications to comment on polypropylene design and properties, and claimed that his opinions on complications and safer alternatives were unreliable. Furthermore, BSC aimed to exclude Dr. Walmsley’s legal conclusions and speculative statements about BSC’s intentions.

BSC argues for the exclusion of Dr. Walmsley’s specific causation opinions, claiming they lack reliability. The plaintiffs clarify that Dr. Walmsley will not address opinions on polypropylene design, testing, warnings, properties, legal conclusions, or state of mind, leading to BSC’s motion on these points being denied as moot. BSC’s challenge to Dr. Walmsley’s opinions on mesh complications is also denied. BSC contends these opinions rely solely on Dr. Walmsley’s limited personal experience rather than empirical data, particularly criticizing his references to serious complications based on treating only five patients and anecdotal experiences with colleagues. However, Dr. Walmsley has significant experience with polypropylene repair kits and attempts to clarify his limited patient interactions. He supports his opinions with scientific literature, specifically addressing complications associated with vaginal mesh and graft materials in his report. The court finds that Dr. Walmsley’s knowledge, experience, and literature review meet the standards for reliability under Daubert.

Regarding safer alternatives, BSC claims Dr. Walmsley’s opinions are unreliable due to a lack of peer-reviewed studies and his own disavowals during deposition. The court finds these claims unfounded, noting that Dr. Walmsley cites the Nygaard article in his expert report to substantiate his assertion of existing safe and effective alternatives to mesh surgery. In deposition, he provides comparative data on complication rates between mesh and non-mesh repairs, further supporting his claims.

Dr. Walker, in preparing his report, frequently reviews peer-reviewed literature on mid-urethral slings but did not rely on specific studies for this case. Peer-reviewed literature is one of many tools available to expert witnesses. Dr. Walmsley, with extensive experience in pelvic organ prolapse (POP) procedures, has noted a significant difference in complications between polypropylene and non-polypropylene treatments, leading him to rarely use synthetic mesh in his practice. He indicates that while synthetic mesh can be viable in limited cases, such as for elderly patients who prefer to avoid invasive surgery, it is often a last-resort option. Dr. Walmsley critiqued the standard of care from 2008 to 2010, asserting that physicians lacked sufficient information about mesh products to provide adequate warnings and obtain informed consent.

Despite BSC's claim that Dr. Walmsley disavows his opinions on synthetic mesh, his testimony suggests he acknowledges its functionality while also recognizing safer alternatives. Specifically, he asserts that Ms. Betancourt and Ms. Nunez do not meet the narrow criteria for synthetic mesh use, making his opinions on safer alternatives relevant to their cases. 

BSC contests the reliability of Dr. Walmsley’s specific causation opinions regarding Ms. Nunez, arguing they are based solely on personal observations and not supported by her medical records. Conversely, the plaintiff argues that Dr. Walmsley conducted a reliable differential diagnosis that identified mesh erosion as the source of her ongoing pain, despite the absence of current symptoms in her records. Dr. Walmsley reviewed her medical records, pathology report, and deposition, dismissing alternative pain sources during his testimony. His approach aligns with the precedent that a reliable differential diagnosis does not necessitate a physical examination.

Research found no medical literature linking the specific finding to an increased risk of erosion. In evaluating Dr. Walmsley’s differential diagnosis regarding Ms. Nunez’s symptoms, it was noted that any potential errors would impact the testimony's weight rather than its admissibility. Dr. Walmsley’s differential diagnosis was deemed reliable as he adequately considered and eliminated alternate causes.

BSC raised objections concerning Dr. Walmsley’s reports for Ms. Betancourt, pointing out typographical errors where “Martinez” was not replaced with “Betancourt” in several instances, suggesting a lack of independent analysis. Dr. Walmsley defended this by stating that many mesh-related complications, such as pelvic pain and mesh erosion, overlap, leading to similar reports. He clarified that he meticulously vetted the medical records and considered potential deviations in the standard of care.

Dr. Walmsley confirmed that he conducted an independent analysis of Ms. Betancourt’s medical records and pathology report, dismissing alternative causes of her pain. He also noted that there was no indication in the medical records linking her dyspareunia to her hysterectomy, as the complications arose two years post-surgery, and he deemed estrogen deficiency to be less relevant in the early stages of her condition.

Errors in Dr. Walmsley’s differential diagnosis impact the weight of his testimony, not its admissibility, as established in Westberry, 178 F.3d at 265. The court finds Dr. Walmsley's differential diagnosis reliable, having adequately considered and ruled out alternative causes for Ms. Betancourt's symptoms. Consequently, BSC's motion to exclude Dr. Walmsley's testimony is denied.

Dr. Jorge Pando, a treating physician for Ms. Betancourt post-mesh implant surgery, diagnosed her with vaginal mesh erosion and performed surgery to remove part of the mesh. The plaintiffs intend to present Dr. Pando as a non-retained expert to testify about his treatment of Ms. Betancourt and his opinion linking her pelvic pain and dyspareunia to the Pinnacle mesh and its implantation by Boston Scientific Corporation. BSC seeks to exclude Dr. Pando's testimony, arguing that he was not timely designated as an expert per court orders and that his testimony should be restricted to his treatment of Ms. Betancourt.

The court notes that while expert reports are not required for treating physicians, they must still provide a summary of their opinions under Rule 26(a)(2)(C). The plaintiffs' report for Dr. Pando meets these requirements but failed to disclose him as an expert within the timeline set by the court's pretrial orders. The relevant deadlines included: June 9, 2014, for expert reports; June 20, 2014, when the plaintiffs first met Dr. Pando; and other deadlines for expert discovery and Daubert motions, culminating in July 25, 2014, for Daubert briefings. The plaintiffs did not comply with the established timeline for Dr. Pando's disclosure.

On July 30, 2014, plaintiffs designated Dr. Jorge Pando as a nonretained expert, but provided his expert report fifty-one days past the June 9 deadline, rendering the disclosure untimely under Pretrial Order #95. Consequently, the plaintiffs cannot use Dr. Pando as a trial witness unless they demonstrate that the delay was substantially justified or harmless, as outlined in Fed. R. Civ. P. 37(c)(1). The Fourth Circuit's criteria for this assessment include: (1) the surprise to the opposing party, (2) the ability to remedy that surprise, (3) the potential disruption to the trial, (4) the explanation for the delay, and (5) the significance of the testimony.

In this case, BSC was unfairly surprised by the late disclosure, having prepared to depose Dr. Pando as a fact witness instead of as an expert. This change in approach allowed the plaintiffs to lead the questioning during the deposition, which would not have occurred if they had disclosed Dr. Pando's expert status on time. The plaintiffs' late submission of the report, just eight days after the deposition, did not adequately remedy the surprise, especially compared to a previous case, Goldman v. Phillips Son Drilling, where the report was submitted only one day late. Furthermore, the delay hindered BSC's ability to file a Daubert objection to Dr. Pando’s testimony, which was required by July 18, 2014, and the plaintiffs did not address this issue in their arguments. Overall, the factors indicate that the plaintiffs’ failure to disclose Dr. Pando in a timely manner was neither substantially justified nor harmless.

The fourth factor supports BSC’s motion, as the plaintiffs claim Dr. Pando was unavailable for deposition until July 22, 2014. Despite this, the plaintiffs could have taken steps to prepare BSC for his testimony, such as strategizing during their initial meeting with him a month prior or filing a motion for an extension to submit his expert report. Instead, they notified BSC 51 days post-deadline regarding Dr. Pando’s intent to testify on specific causation. The significance of his testimony is diminished, as another expert can also provide similar opinions for Ms. Betancourt. As such, the plaintiffs' late disclosure of Dr. Pando's testimony is deemed untimely and lacking substantial justification, leading to the granting of BSC’s Motion to Exclude his testimony.

Regarding the plaintiffs' attempt to exclude the testimony of Dr. Stephen H. Spiegelberg, a chemical engineer, the plaintiffs challenge his opinions on the safety and material properties of polypropylene used in BSC’s pelvic mesh devices. They argue that certain of his opinions, particularly those regarding medical organization statements and his intent related to the Material Safety Data Sheet (MSDS), should be excluded. The court has previously evaluated Dr. Spiegelberg's testimony in a related case and finds that the reasoning and conclusions from that case remain applicable.

Differences in fact and exhibits are not deemed materially significant by the court. The plaintiffs aim to exclude Dr. Spiegelberg’s references to position statements from medical organizations, such as the American Urogynecological Society (AUGS) and the Society for Female Urology and Urodynamics (SUFU), which endorse the safety of polypropylene for treating female pelvic floor disorders. They argue that Dr. Spiegelberg is unqualified and lacks reliable methodology, emphasizing that position statements do not constitute expert opinions and that he is not employing specialized knowledge as required by Federal Rule of Evidence 702. Therefore, the court reserves the ruling on the admissibility of this testimony for trial.

The plaintiffs also seek to exclude Dr. Spiegelberg’s opinions regarding the Material Safety Data Sheet (MSDS) created by Chevron Phillips, arguing that these opinions inappropriately address the company's state of mind or intent. While Dr. Spiegelberg’s report generally reviews relevant records and scientific literature, certain sections improperly delve into Chevron Phillips's motivations. The court previously ruled that Dr. Spiegelberg's assertion regarding the absence of a scientific reason for a specific warning was based on liability concerns rather than evidence. His opinion, stating that Chevron Phillips did not add the caution based on scientific or medical issues, relies on an unclear deposition from Mr. Zakrzewski, who admitted a lack of knowledge regarding the MSDS's authorship and rationale. Dr. Spiegelberg's conclusions are thus deemed unreliable, as they rest on ambiguous testimony that does not provide clear support for his claims.

Mr. Zakrzewski’s statements do not provide sufficient evidence for Dr. Spiegelberg to conclude that Chevron Phillips lacked a scientific basis for its cautionary measures. Expert testimony may only address internal corporate documents to support admissible opinions; issues concerning Chevron Phillips’s knowledge, intentions, or ethical conduct are inappropriate for expert testimony as they do not aid the jury. The intent of parties is a question for the jury, not for experts, as reinforced by case law. Consequently, Dr. Spiegelberg’s opinions regarding Chevron Phillips’s state of mind related to the Material Safety Data Sheet (MSDS) are excluded, affirming previous rulings. The plaintiffs’ motion to exclude Dr. Spiegelberg’s testimony is partially granted.

Regarding Dr. Stephen Badylak, a biomaterials expert, the plaintiffs seek to exclude his opinions as well. Dr. Badylak asserts several points about polypropylene mesh, including its appropriateness as an implantable material, the absence of device failure evidence, and compliance with industry standards. He also filed a supplemental report citing Mr. Zakrzewski’s deposition to support his view that the Medical Application Caution in the MSDS for the polypropylene used in surgical mesh was not based on safety concerns or scientific data. The plaintiffs challenge Dr. Badylak’s opinions on medical organizations' statements and his interpretations of state of mind concerning the MSDS. His testimony has been previously reviewed under Daubert standards, and the case reference is noted.

The court's reasoning and conclusions from the Tyree case apply here, despite differing arguments from the parties. The plaintiffs aim to exclude Dr. Badylak's references to medical organization statements on the safety and efficacy of polypropylene material, asserting that these statements do not constitute expert opinions and therefore are not subject to admissibility concerns. The court reserves the decision on evidentiary rulings for trial.

Additionally, the plaintiffs seek to exclude Dr. Badylak's opinions regarding Chevron Phillips's knowledge and conduct related to the Material Safety Data Sheets (MSDS) for polypropylene used in Boston Scientific products. They argue that this constitutes a covert examination of Chevron Phillips's intent. The court finds no evidence supporting that Dr. Badylak's MSDS-related claims were rooted in safety concerns or scientific data, leading to the exclusion of his opinions on Chevron Phillips's state of mind. Consequently, the plaintiffs' Motion to Exclude Dr. Badylak's Testimony is partially granted and partially reserved.

The plaintiffs also aim to limit or exclude Dr. Matthew F. Davies's testimony, arguing that his methodology regarding preexisting infectious causes for mesh complications lacks sufficient factual basis and reliable scientific principles. Dr. Davies is a qualified physician specializing in Obstetrics and Gynecology and is affiliated with Penn State Milton S. Hershey Medical Center.

Dr. Davies specializes in treating women with pelvic floor disorders and has performed over 600 mesh-based prolapse repairs. In his expert report, he asserts that the mesh extrusion experienced by the plaintiff does not stem from a defect in the Pinnacle device but rather from a healing issue influenced by several risk factors. Although the plaintiff objects to Human Papillomavirus (HPV) as a contributing factor, Dr. Davies identifies multiple risk factors for mesh extrusion, including concomitant hysterectomy and mid-line incisions. He highlights that the plaintiff, Ms. Nunez, was suffering from atrophic vaginitis and hypoestrogenism during her third extrusion, conditions that can weaken vaginal tissue and increase extrusion risk.

The plaintiff challenges Dr. Davies’s assertion that pre-existing tissue infection related to HPV caused her complications, claiming his testimony relies on an unproven premise regarding the link between HPV and mesh complications. The plaintiff’s motion against Dr. Davies was found to lack organization and specificity regarding the objections raised. The court provides background on Ms. Nunez’s medical history, including her diagnoses and surgeries, and notes that she was diagnosed with HPV in 2010, two years after her initial surgery. The court has carefully reviewed Dr. Davies’s expert report and deposition regarding the HPV issue and ultimately denies the plaintiff’s motion.

Dr. Davies does not assert that the plaintiff had HPV prior to her diagnosis on August 10, 2010. His references to HPV are factual and accurately reflect the medical record. The plaintiff misinterprets Dr. Davies's conclusions regarding her medical history, particularly his mention of chronic cystic cervicitis, which is distinct from HPV. Dr. Davies acknowledges that chronic cystic cervicitis may have various causes, including HPV, but he cannot definitively state HPV as the cause without a diagnosis. The plaintiff also contests Dr. Davies’s assessment of factors contributing to her mesh extrusion and excision, which he attributes to multiple causes such as improper healing post-hysterectomy, incorrect sling placement, and a vaginal infection, not a defect in the Pinnacle mesh. Dr. Davies clarifies that the infection referenced is vaginal cuff cellulitis, not HPV.

Regarding her second surgery on October 27, 2010, the plaintiff challenges Dr. Davies’s statements linking HPV to mesh complications, arguing they lack reliable support. However, the court notes that district courts have significant discretion in applying Daubert's reliability standards. Dr. Davies's conclusions are backed by his extensive clinical experience, relevant medical training, and a thorough review of the literature. He posits that HPV can weaken vaginal tissue, potentially increasing the risk of mesh extrusions, drawing from over twenty years of experience and more than 600 mesh-based prolapse repairs. His expert opinion is deemed sound and admissible in court.

Dr. Davies is allowed to testify about the general relationship between HPV infections and mesh complications, leading to the denial of Plaintiff Nunez’s Motion to Exclude his testimony. In contrast, the plaintiffs' motion to exclude expert testimony from Dr. Christine Brauer, a former FDA employee and regulatory consultant, is addressed. The plaintiffs seek to exclude Dr. Brauer’s opinions on various topics, including the FDA regulatory process, the clearance of BSC devices, and related documentation. The court has previously evaluated Dr. Brauer's testimony under the Daubert standard in a related case, Sanchez v. Boston Scientific Corp., and finds that the arguments presented are not materially different from those already considered. 

The court reiterates its consistent position that the FDA’s 510(k) process does not pertain to the safety or efficacy of medical devices and does not impose requirements relevant to state tort law. Consequently, evidence regarding the 510(k) process and related FDA actions is deemed irrelevant under Federal Rule of Evidence 402 and potentially misleading under Rule 403. Therefore, Dr. Brauer’s expert opinions are excluded in their entirety.

Dr. Brauer’s opinions are entirely excluded based on a prior ruling in Sanchez. The plaintiffs seek to exclude the testimony of Dr. Gary L. Winn, a safety expert with 30 years of experience and a professor at West Virginia University. They argue that Dr. Winn is unqualified, his methodology is unreliable, and his opinions consist of impermissible legal conclusions regarding Chevron Phillips's knowledge about Material Safety Data Sheets (MSDS). BSC opposes the motion, asserting that the MSDS's relevance is supported by the plaintiffs' arguments. 

The court has previously evaluated Dr. Winn's testimony in Tyree v. Boston Scientific Corp., where it ruled on similar grounds. Although the current case presents different arguments, the court finds the reasoning from Tyree applicable. Dr. Winn’s expert report discusses the development and standardization of MSDSs and concludes that raw polypropylene is not hazardous, deeming the 2004 Chevron Phillips MSDS irrelevant. The court disagrees, emphasizing that the presence of a warning in the MSDS is significant, but concludes that Dr. Winn's narrative review of MSDSs is not beneficial for the jury. Consequently, Dr. Winn's opinions regarding MSDSs are excluded entirely, adopting the prior ruling from Tyree. 

Finally, the court clarifies that while its Daubert rulings determine the admissibility of expert opinions, non-exclusion does not guarantee admissibility if the opinions are deemed cumulative or misleading under Rule 403 or other evidentiary rules, with such concerns to be addressed as they arise.

The court's conclusion details the outcomes of various motions related to expert witnesses in the case. The defendant's motions regarding Dr. Trepeta, Dr. Margolis, Dr. Barker, Drs. Mays and Gido, Dr. Pence, Dr. Slack, Dr. Raybon, Dr. Ki-ley, and Dr. Iakovlev are granted in part and denied in part, except for Dr. Barker's motion, which is fully granted, and Dr. Salom's, which is fully denied. The motions concerning Dr. Walmsley are denied in part and deemed moot, while the motion regarding Dr. Pando is fully granted. 

For the plaintiffs, motions concerning Dr. Spiegelberg and Dr. Badylak are granted in part and reserved in part, Dr. Davies' motion is denied, and the motions regarding Dr. Brauer and Dr. Winn are fully granted. The court acknowledges the significance of its rulings given the context of over 60,000 related cases and emphasizes its reliance on the record and the arguments presented, alongside referencing prior rulings in the Sanchez case, which involved similar expert testimonies. The court also notes a previous joint expert report and clarifies that the practice is permissible under Rule 26.

Co-authored expert reports are permissible when experts collaborate on the same materials and reach identical conclusions. However, if the report lacks a reliable foundation and is unclear or contradictory, it risks being ruled inadmissible. This concern arises if it is uncertain whether both experts endorse all opinions or if their individual contributions are not specified. A plaintiff's argument regarding the reliability of Drs. Mays and Gido's testing has already been evaluated and dismissed. The plaintiff contends that since BSC did not file a Rule 26 report to disclose Dr. Salom as an expert, they should be barred from presenting his testimony. Rule 26 only mandates disclosure by the party offering the witness, placing the responsibility on the plaintiff to disclose Dr. Salom. BSC can cross-examine Dr. Salom without a Rule 26 report but must file one if they decide to call him as a defense expert. Previous rulings indicated that certain opinions could mislead the jury, but since the failure to warn claim is still active, those conclusions do not apply here. The court notes that Dr. Slack's opinions, which are impermissible, undermine the entirety of his report, negating the need to address BSC's reliability objections further. The parties have agreed that Dr. Kiley will not provide general or specific causation opinions on biofilm, thus those aspects will not be evaluated. BSC's references to Dr. Kiley's report pertain to her specific causation opinions, while the plaintiff does not dispute that Dr. Kiley aims to opine on general causation. Dr. Kiley asserts her qualifications to address issues related to surgical meshes and slings, and the court assumes she intends to offer general causation opinions.

Dr. Iakovlev conducted testing on BSC slings, which are not relevant to the current case. While he reported examining twenty-three samples, discrepancies in his deposition indicate he only examined twenty-one. BSC's attempt to exclude all of Dr. Iakovlev's testimony due to the unreliability of his samples lacks merit; his general conclusions about mesh may be inadmissible, but his specific findings regarding Ms. Eghnayem's mesh, based on her explant review, are permissible. Consequently, BSC's motion to exclude Dr. Iakovlev's opinions on mesh design, deformation, and polypropylene degradation specific to Ms. Eghnayem is denied. The plaintiffs submitted two expert reports by Dr. Walmsley for Ms. Betancourt and Ms. Nunez, which are identical except for each plaintiff's medical history. The focus will primarily be on Ms. Betancourt's report unless discussing Ms. Nunez's specifics. The plaintiffs' objections to certain statements by Dr. Davies, particularly regarding HPV's impact on the second surgery, are noted. Additionally, there is evidence of an agreement indicating BSC's responsibility for determining the suitability of polypropylene use.