Kaur v. Bos. Sci. Corp.

Decision Date11 May 2022
Docket NumberC. A. N19C-07-117 PEL
PartiesKULWINDER KAUR, Plaintiff, v. BOSTON SCIENTIFIC CORPORATION (d/b/a MANSFIELD SCIENTIFIC, INC. & MICROVASIVE, INC.), Defendant.
CourtDelaware Superior Court

Submitted: January 5, 2022

Robert J. Leoni, Esquire, Shelby & Leoni, 221 Main Street Wilmington, DE 19804, Attorney for Plaintiffs

Colleen D. Shields, Esquire, Eckert, Seamans, Cherin &amp Mellott LLC, 222 Delaware Avenue, 7th Floor, Wilmington, DE 19801, Attorney for Defendant

Francis J. Jones, Judge

Introduction

This opinion constitutes the Court's decision on Defendant's, Boston Scientific Corporation, d/b/a Mansfield Scientific, Inc. & Microvasive, Inc. ("BSC"), eight (8) Daubert motions. BSC asks this Court to determine whether the opinions and testimony of the Plaintiff's experts should be excluded under Delaware Rule of Evidence 702, Daubert v. Merrell Dow Pharmaceuticals, Inc. and M.G. Bancorporation, Inc. v. Le Beau.

This is a products liability claim that involves one of Boston Scientific's surgical mesh products - the Obtryx. Plaintiff has alleged that this polypropylene surgical mesh implant - midurethral slings ("MUS") - which was used by her surgeon to treat her for stress urinary incontinence ("SUI") and pelvic organ prolapse ("POP") has caused her to experience injuries.

This Court has reviewed both parties' materials and for the reasons set forth fully below, this Court GRANTS, in part, and DENIES, in part, BSC's motions.

Standard of Review

Delaware Rule of Evidence 702 governs the admissibility of expert testimony. Delaware has adopted the holdings in Daubert v. Merrell Dow Pharmaceuticals Inc.[1] and Kumho Tire Co., Ltd. v. Carmichael [2] to interpret the Delaware Rule. [3] In Daubert and Kumho, the United States Supreme Court interpreted and explained Federal Rule of Evidence 702, which is "substantially similar" to the Delaware Rule.[4] Delaware Rule 702 states:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise, if: (a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based upon sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the witness has applied the principles and methods reliably to the facts of the case.[5]

To be admissible, expert testimony must be "relevant and reliable." [6] To make this determination, the trial judge engages in a five-step analysis.[7] This analysis provides that the trial judge finds that:

(1) the witness is qualified as an expert by knowledge, skill, experience, training, or education;
(2) the evidence is relevant;
(3) the expert's opinion is based on information reasonably relied upon by experts in the particular field;
(4) the expert testimony will assist the trier of fact to understand the evidence or to determine a fact in issue; and
(5) the expert testimony will not create unfair prejudice or confuse or mislead the jury.[8]

The burden of establishing that the expert testimony is admissible lies with its proponent by a preponderance of the evidence.[9] "A strong preference exists" for admitting expert opinions "when they will assist the trier of fact in understanding the relevant facts or the evidence."[10]

Reliable expert testimony is premised on scientific or specialized knowledge which requires the testimony to be grounded in scientific methods and procedures and "supported by appropriate validation - i.e., 'good grounds,' based on what is known."[11]

Many scientific, technical, or specialized fields are not subject to peer review and publication which is why the test of reliability is "flexible." Rigid application of the Daubert factors cannot just be engaged to determine testimonial reliability in every field of expertise.[12] Even with all the advances of medical science, the practice of medicine remains an art, and a diagnosis in the practice of clinical medicine "is not an exact science."[13]

Again, a gatekeeping judge has "broad latitude" to determine whether an expert's proffered opinion is based upon the "proper factual foundation and sound methodology."[14] This "proper factual foundation" language has been distilled from Delaware Rule 702.[15] To meet the criterion for a "proper factual foundation," an expert's opinion must be based on "facts" and not "suppositions."[16] When applied to a medical expert, a causation opinion is admissible when it's "based on his analysis of the circumstances … not mere speculation over the cause."[17] And a proponent need only show by a preponderance of the evidence that her expert's opinions are reliable, not that they are correct.[18] So, this Court's Rule 702 reliability examination must focus on principles and methodology, not on the resultant conclusions.[19]

Delaware courts generally recognize that challenges to the "factual basis of an expert opinion go[] to the credibility of the testimony, not the admissibility, and it is for the opposing party to challenge … the expert opinion on cross-examination."[20] "The different depth with which [an expert] pursued particular lines of investigation and the different assumptions they made are readily subject to cross-examination and to evaluation by the fact finder for credibility and weight."[21] An expert's testimony will only be excluded in the narrow circumstance where he is shown to have completely neglected the core facts of the case.[22] And, under Delaware Rule 702, a medical doctor's opinion "based on his own knowledge" and informed by his review of a patient's records may certainly be sufficient to clear the Daubert/Bowen reliability threshold.[23]

Analysis
General Objections

BSC raises various general objections as to the challenged experts. BSC asserts that the experts should be precluded from offering narrations of BSC's company documents opinions on BSC's corporate conduct, and opinions in the form of legal conclusions.

As has been consistently held by the MDL Court, [24] the foregoing topics exceed the scope of expert witness's testimony and will not assist the trier of fact.[25]Thus, in accord with various courts that have ruled on these issues, this Court will not permit the experts to offer their opinions about BSC's state of mind.[26] Nor will the experts be permitted to offer opinions about the reasonableness of BSC's actions.[27] As to narratives of BSC's corporate documents, assuming these opinions are otherwise admissible, the experts are permitted to offer testimony regarding BSC's corporate documents to the limited extent that they relied upon the documentation to form the basis of their opinions.[28]

The experts will also be precluded from offering any opinions phrased as legal conclusions. "[O]pinion testimony that states a legal standard or draws a legal conclusion by applying law to the facts is generally inadmissible."[29] By allowing such testimony would be to allow the trier of fact's fact-finding function to be usurped and this Court will not allow that.

Bruce Rosenzweig, M.D.

Dr. Rosenzweig is a urogynecologist and a professor of obstetrics and gynecology in Chicago, Illinois. Plaintiffs offer Dr. Rosenzweig as a general causation expert on the properties of polypropylene mesh used in the Obtryx, its reaction when implanted in the body, and the possible complications associated with their use to treat SUI.

A. Properties of Polypropylene Opinions BSC argues that Dr. Rosenzweig is neither qualified nor are his opinions reliable on this topic, especially as to his opinions relating to degradation of mesh. Plaintiff responds that this Court, in a previous ruling, permitted Dr. Rosenzweig to offer his opinions on this point and that the Court should do the same here.

In Harris v. Bos. Sci. Corp., [30] this Court found Dr. Rosenzweig both qualified to offer his opinions about polypropylene properties and that his opinions were reliable under Daubert. As to Dr. Rosenzweig's qualifications, this Court relied on the rationale of the Court in Wilkerson v. Bos. Sci. Corp., [31] where the Court explained:

Dr. Rosenzweig's established background and skills in pelvic surgery, polypropylene, and the complications associated with degradation qualify him to opine on the degradation process, even though his knowledge about the precise biochemical interactions involved might not be as extensive as that of others… Any gaps in Dr. Rosenzweig's knowledge go to his credibility, not his admissibility as an expert.[32]

Also, BSC argues that Dr. Rosenzweig's opinions on this point are unreliable. This Court did not agree with BSC when it raised this argument in Harris and still does not.[33] Dr. Rosenzweig has more than twenty years of experience in examining patients. In addition to his experience, Dr. Rosenzweig has reviewed an abundance of medical literature regarding the degradation of polypropylene. In lieu of his experience and review, Dr. Rosenzweig's opinions about polypropylene properties, including his opinion that mesh degrades, is sufficiently reliable under Daubert.

Based on the foregoing, this Court concludes that Dr. Rosenzweig is qualified to offer his opinions about the properties of polypropylene, including degradation, and that these opinions are sufficiently reliable under Daubert.

B. BSC's Product Testing Opinions

BSC argues that Dr. Rosenzweig is not qualified to offer opinions about BSC's product testing. Plaintiff concedes that Dr. Rosenzweig will not be offering these opinions. Therefore, BSC's motion on this point is GRANTED.

C. Link Between Cancer and Polypropylene Mesh Opinions

BSC argues that Dr....

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