Roeder v. Am. Med. Sys.

CLEMENTINA ROEDER and RONALD ROEDER, JR., Plaintiffs, v. AMERICAN MEDICAL SYSTEMS, INC., Defendant.

No. 20-1051-JWB

United States District Court, D. Kansas

October 15, 2021

MEMORANDUM AND ORDER

JOHN W. BROOMES UNITED STATES DISTRICT JUDGE

This matter comes before the court on Defendant's motion to exclude the opinions of Dr. Rosenzweig. (Doc. 40). Defendant also seeks to exclude the opinions of Drs. Iakovlev, Blaivas Guelcher, and Mays. (Docs. 55-5, 55-10, 56-2, 56-6.) The motions have been fully briefed and the court is prepared to rule. (Docs. 41, 42, 46, 55-6, 55-7, 55-8, 55-11, 55-12 to 55-18, 56-1, 56-3 to 56-5, 56-7 to 56-10, 57-12, 57-13, 67 76.)^[1] For the reasons stated herein, Defendant's motions are GRANTED IN PART and DENIED IN PART and TAKEN UNDER ADVISEMENT IN PART.

I. Facts and Procedural History

This is a product liability action filed by Plaintiff Clementina Roeder (individually, “Plaintiff”) and her husband Ronald Roeder, Jr. (together with Plaintiff, hereinafter referred to as “Plaintiffs”) involving injuries allegedly sustained by Plaintiffs due to Defendant's products.

On January 6, 2011, Plaintiff complained to her physician Dr. Darrell Werth of stress incontinence and discomfort. Plaintiff had previously suffered from extensive stress urinary incontinence (“SUI”) and pelvic organ prolapse (“POP”). Plaintiff was diagnosed with a large cystocele (bladder prolapse) with associated uterine prolapse and urethral hypermobility. Dr. Werth recommended a hysterectomy with anterior mesh cystocele repair and sling suspension of the bladder neck. The proposed treatment involved implanting two vaginal mesh products (“the products”), the MiniArc Precise (“MiniArc”) for SUI and the Elevate Anterior Apical System with IntePro Lite (“Elevate”) for POP. Defendant American Medical Systems, Inc., manufactured and sold the products. (Docs. 66 at 2.)

On June 9, 2011, Plaintiff underwent the implant procedure in which the Elevate and MiniArc mesh products were implanted by Dr. Werth to treat Plaintiff's conditions. On July 1, 2015, Plaintiff saw Dr. Brian Flynn and complained of constant vaginal pain and burning, painful sexual intercourse, bleeding, infections, and frequent/urgent urination. (Doc. 91-6.) On October 6, 2016, Plaintiff underwent surgery by Dr. Flynn who removed the MiniArc and a portion of the Elevate. (Doc. 66 at 2.)

Plaintiffs filed this action on September 2, 2015, in the Pelvic Mesh Multidistrict Litigation in the United States District Court for the Southern District of West Virginia. See In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation, Case No. 12-MD-2325 (“MDL”). In that action and as raised in the pretrial order in this case, Plaintiff seeks damages on the basis that she suffered significant injuries due to the implantation of the products. Plaintiffs have identified several experts who will testify regarding the products. In 2018, while this action remained pending in the MDL, Defendant moved to exclude or limit the testimony of Plaintiffs' experts. (See Doc. 66 at 11-15) (listing outstanding Daubert motions filed in the MDL action). Prior to resolving those motions, Judge Goodwin transferred this case to this court. (Doc. 48.) After being transferred, a pretrial order was entered. The pretrial order directed the parties to supplement the briefing in the Daubert motions to identify any relevant Tenth Circuit authority. (Doc. 66 at 11.) The parties have now done so. (Docs. 67, 72, 76.) In ruling on these motions, the court has considered the briefing filed in the MDL action as identified in the pretrial order and the supplemental briefs.

II. Standard

Federal Rule of Evidence 702, which controls the admission of expert witness testimony, provides:

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 on sufficient facts or data;

(c) the testimony is the product of reliable principles and methods; and

(d) the expert has reliably applied the principles and methods to the facts of the case.

Fed. R. Evid. 702. Under this rule, the district court must satisfy itself that the testimony at issue is both reliable and relevant, in that it will assist the trier of fact, before permitting a jury to assess such testimony. Schulenberg v. BNSF Ry. Co., 911 F.3d 1276, 1282 (10th Cir. 2018) (citing United States v. Nacchio, 555 F.3d 1234, 1241 (10th Cir. 2009) (en banc)). The district court must first determine whether the witness is qualified by knowledge, skill, training, experience, or education to render an opinion. Id. If so, the district court must determine whether the witness's opinion is reliable by assessing the underlying reasoning and methodology. Id. at 1283. The court is not required to admit opinion evidence that is “connected to existing data only by the ipse dixit of the expert, ” and may exclude the opinion if “there is simply too great an analytical gap between the data and the opinion offered.” Id. (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)).

But the rejection of expert testimony is the exception rather than the rule, and “[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.” Daubert v. Merrell Dow Pharm., Inc. 509 U.S. 579, 596 (1993).

“The court has discretion to determine how to perform its gatekeeping function under Daubert.” In re EpiPen (Epinephrine Injection, USP) Mktg., Sales Practices & Antitrust Litig., No. 17-MD-2785-DDC-TJJ, 2020 WL 1164869, at *3 (D. Kan. Mar. 10, 2020) (citing Bill Barrett Corp. v. YMC Royalty Co., LP, 918 F.3d 760, 770 (10th Cir. 2019)). The most common method of fulfilling that role is by conducting a Daubert hearing, “although such a process is not specifically mandated.” Goebel v. Denver & Rio Grande W. R.R. Co., 215 F.3d 1083, 1087 (10th Cir. 2000). In this instance, neither party has requested a Daubert hearing. With the exception of Dr. Iakovlev, the court finds that a Daubert hearing is not necessary here because of the nature of the opinions expressed, the relative completeness of the expert's reports, and the materials cited in support of and against the challenged opinions, including numerous decisions regarding these experts in other courts. Ho v. Michelin N. Am., Inc., 520 Fed.Appx. 658, 664 (10th Cir. 2013) (district court permissibly exercised its discretion in ruling without a formal Daubert hearing). Should additional Daubert issues arise at trial that require further inquiry, the court will determine at that time how to handle them. Cf. Bill Barrett Corp. v. YMC Royalty Co., LP, 918 F.3d 760, 772 (10th Cir. 2019) (“a judge does not abuse his discretion by conducting a Daubert hearing in the presence of the jury through direct examination and voir dire.”) (citing Goebel, 215 F.3d at 1087)

III. Analysis

A. Dr. Guelcher and Dr. Mays

Defendant seeks to exclude the opinions of both Dr. Guelcher and Dr. Mays. Dr. Scott Guelcher has a Ph.D. in chemical engineering and completed post-doctoral training in biomedical engineering. He is currently a professor of chemical and biomolecular engineering at Vanderbilt University. (Doc. 56-8, Exh. A.) Dr. Jimmy Mays has a Ph.D. in polymer science. He is currently a professor of chemistry at the University of Tennessee. (Id., Exh. C.) Both of these experts have extensive experience in their field of study and have published numerous peer-reviewed papers. Both experts opine that polypropylene mesh, which is used by Defendant in the products at issue, degrades when inside the body due to oxidation which results in chain scission and diminished mechanical properties. (Id., Exh. A at 4; C. at 5.) Dr. Guelcher further opines that the oxidative degradation can lead to adverse events including inflammation and pain, Defendant knew about the effects of oxidation on polypropylene stability but did not consider the risks to the detriment of the patients, and alternative procedures and materials were available when the mesh was first commercialized. (Id., Exh. A at 4.) Defendants seek to exclude these opinions for the reasons discussed herein.

1. Medical Literature

Defendant argues that Dr. Guelcher and Dr. Mays' general causation opinions are unreliable because they are based on unreliable articles that do not confirm in vivo degradation of AMS pelvic mesh and because the experts have not independently tested AMS's mesh. First, Defendant points to a 2017 peer-reviewed article published in a scientific journal and co-authored by Dr. Guelcher. See A.D. Talley, et al., Oxidation and Degradation of Polypropylene Transvaginal Mesh, J. of Biomaterials Sci., Polymer Ed. (2017) (“the Talley study”); Doc. 56-9, Exh. E. The abstract of the Talley study states that the study tested the hypothesis that polypropylene transvaginal mesh oxidizes under in vitro conditions simulating the foreign body reaction, resulting in degradation of the polypropylene mesh. Id. at 2. Three slings were evaluated and the specimens were incubated in an oxidative medium for up to five weeks. According to the study, oxidation and degradation of the mesh were evidenced by chemical and physical changes under the simulated in vivo conditions. Id.

Defendant argues the Talley study is unreliable because the intentional oxidative testing reported does not form a reliable basis for the degradation opinions, Dr. Iakovlev did not follow a protocol when scraping...