Zetz v. Bos. Sci. Corp.

• Decision Date: 05 December 2022
• Docket Number: 1:19-cv-00451-AWI-SAB
• Parties: AUTUMN ZETZ and ERIC ZETZ, Plaintiffs, v. BOSTON SCIENTIFIC CORPORATION, Defendant.
• Court: U.S. District Court — Eastern District of California

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AUTUMN ZETZ and ERIC ZETZ, Plaintiffs, v. BOSTON SCIENTIFIC CORPORATION, Defendant.

No. 1:19-cv-00451-AWI-SAB

United States District Court, E.D. California

December 5, 2022

ORDER ON DEFENDANT'S MOTIONS TO EXCLUDE EXPERT OPINIONS AND MOTION FOR SUMMARY JUDGMENT (DOC. NOS. 98, 99 100, 101, 102, 103, 104)

This product liability case stems from injuries that allegedly occurred after a pelvic mesh device was surgically implanted into Plaintiff Autumn Zetz. Ms. Zetz and Plaintiff Eric Zetz filed suit against Defendant Boston Scientific Corporation for damages in Fresno County Superior Court alleging strict liability, negligence, breach of warranty, fraud misrepresentation, and loss of consortium. Doc. No. 1-1. The matter was removed to this Court pursuant to 28 U.S.C §§ 1332, 1441, 1446. Doc. No. 1. Pending before the Court are Defendant's Motions to Exclude Expert Opinions and Motion for Summary Judgment. Doc. Nos. 98, 99, 100, 101 102, 103, 104. For the reasons discussed below, the Court will grant in part and deny in part Defendant's Motions to Exclude Expert Opinions and grant in part and deny in part Defendant's Motion for Summary Judgment.

FACTUAL BACKGROUND^[1]

Defendant manufactures and markets the Obtryx™ Transobturator Mid-Urethral Sling System (“Obtryx”), a prescription medical device that the Food and Drug Administration (“FDA”) cleared for marketing in 2004. JSUMF ¶¶ 1-2. The Obtryx is a mid-urethral polypropylene mesh sling surgically implanted by a physician for treatment of stress urinary incontinence (“SUI”). JSUMF ¶ 4. The Obtryx is accompanied by Directions for Use (“DFU”), which outline the product's indications for use, contraindications, and directions for use. JSUMF ¶¶ 5-6.

The polypropylene resin that Defendant used to manufacture the Obtryx was a material manufactured by Phillips Sumika Polypropylene Company (“PSPC”). PUMF ¶ 1. The Material Safety Data Sheet (“MSDS”) for the polypropylene instructed “[d]o not use this [] material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.” PUMF ¶ 2; Doc. No. 115-4 at 2. In Defendant's contract with PSPC signed October 1, 2004, the indemnification provision “advised and cautioned [Defendant] to make its own determination and assessment of the safety and suitability of the PSPC polypropylene product for use by, for, and on behalf of [Defendant],” and stated it was the “responsibility” of Defendant “to ensure that the PSPC propylene product is suited to [Defendant's] specific application. PUMF ¶ 4.

On November 12, 2008, Ms. Zetz underwent a surgical implant of the Obtryx pelvic mesh from Dr. Gilbert Dale in California. DUMF ¶ 11. At the time Ms. Zetz received the implant, the Obtryx DFU contained the following precautions:

PRECAUTIONS

• Standard surgical practices should be followed for the suburethral sling procedure as well as for the management of contaminated or infected wounds.

• The procedure should be performed with very careful attention to avoid laceration of any vessels, nerves, bladder and bowel.

• Do not remove the protective plastic sleeve covering mesh implant until proper position has been confirmed.

• Ensure the mesh is placed without tension under the mid-urethra.

• Use of this device should be done with the understanding that subsequent infection may require removal of the mesh.

• Patients should be counselled to refrain from heavy lifting, exercise and intercourse for a minimum of four (4) weeks after the procedure. Physician should determine when it is suitable for each patient to return to normal activities.

• Should dysuria, bleeding or other problems occur, the patient should be instructed to contact the physician immediately.

• Do not use any mechanical means of contact with the mesh (such as clips, staples etc.) within the urethral support region of the mesh as mechanical damage to the mesh may occur.

• Avoid excessive tension on the mesh during handling.

JSUMF ¶ 7.

The Obtryx DFU also listed the following potential complications from use of the Obtryx:

POTENTIAL COMPLICATIONS

The following complications have been reported due to suburethral sling placement, but are not limited to:

• As with all implants, local irritation at the wound site and/or a foreign body may occur.

• Tissue responses to the implant could include vaginal extrusion, erosion through the urethra or other surrounding tissue, migration of the device from the desired location, fistula formation and inflammation. The occurrence of these responses may require removal of the entire mesh.

• Like all foreign bodies, the mesh may potentiate an existing infection.

• Excess tension may cause temporary or permanent lower urinary tract obstruction and retention.

• Known risks of surgical procedures for the treatment of incontinence include pain, infection, erosion, device migration, complete failure of the procedure resulting in incontinence and mild to moderate incontinence due to incomplete support or overactive bladder.

• In addition to the above listed potential complications, allergic reaction, abscess, detrusor instability, pelvic and vaginal pain, dysparenia, vaginal bleeding, vaginal discharge, dehiscence of vaginal incision, edema and erythema at the wound site have been reported due to suburethral sling procedure.

• It has also been reported that groin pain, orthostatic symptoms, fatigue and shortness of breath may occur due to the potential development of hematoma in the obturator foramen.

JSUMF ¶ 8.

Approximately nine years after receiving the Obtryx implant, Ms. Zetz began experiencing internal pelvic pain on her right side. DUMF ¶ 13. On May 3, 2018, Ms. Zetz had a neurogram performed at UCSF Health which indicated “abnormal hyperintense T2 hyperintensity involving the left greater than right pudendal nerves.” DUMF ¶ 14; Doc. No. 115-44 at 5. Ms. Zetz thereafter consulted with Dr. Greg Vigna, who was both a lawyer and a physician, and hired him as her lawyer. DUMF ¶ 18. On November 28, 2018, Ms. Zetz underwent surgery with Dr. Lisa Rogo-Gupta to remove the Obtryx sling, and on July 24, 2019, Ms. Zetz underwent another surgery with Dr. Michael Hibner to remove groin mesh. DUMF ¶¶ 21, 28. Despite these surgical operations, Ms. Zetz still allegedly experiences pain.

On January 30, 2019, Plaintiffs filed a Complaint against Defendant in Fresno County Superior Court alleging strict liability, negligence, breach of warranty, fraud, misrepresentation, and loss of consortium. Doc. No. 1-1. Defendant is a Delaware corporation with its principal place of business and corporate head office located in Massachusetts. JSUMF ¶ 3. On April 12, 2019, Defendant removed the case to this Court pursuant to 28 U.S.C. §§ 1332, 1441, 1446. Doc. No. 1. On April 19, 2019, Defendant filed a motion to dismiss Plaintiffs' Complaint, which the Court granted in part and denied in part. Doc. Nos. 6, 15. On August 9, 2019, Plaintiffs filed the operative First Amended Complaint (“FAC”) for damages, including punitive damages, alleging the following four causes of action: (1) failure to warn, (2) negligence, (3) breach of express warranty, and (4) loss of consortium. Doc. No. 16. Defendant thereafter filed its Motion to Exclude Expert Opinions and Motion for Summary Judgment. Doc. Nos. 98, 99, 100, 101, 102, 103, 104.

I. DEFENDANT'S MOTIONS TO EXCLUDE EXPERT OPINIONS

Defendant's motions look to exclude the opinions of the following experts: (1) Michael Thomas Margolis, (2) Peggy Pence, (3) Ie-Ming Shih, (4) Jimmy Mays, (5) Robert Tremp, and (6) Darryl Zengler. The Court will review the alleged basis for exclusion for each individual expert below.

LEGAL FRAMEWORK

The Court has a duty to act as a “gatekeeper” for expert testimony by assessing its admissibility. See Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 145 147 (1999); Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 592 (1993); Fed.R.Evid. 104(a) (“The court must decide any preliminary question about whether a witness is qualified, a privilege exists, or evidence is admissible.”). This inquiry is governed in part by Rule 702 of the Federal Rules of Evidence, which pertains to “Testimony by Expert Witnesses” and 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.

The Supreme Court set forth the following, non-exhaustive factors for reviewing the reliability of an expert opinion: (1) whether the particular scientific theory has been or can be tested; (2) whether the theory has been subjected to peer review and publication; (3) the known or potential rate of error; (4) whether there are standards controlling the method; and (5) whether the technique has gained general acceptance in the relevant scientific community. Daubert, 509 U.S. at 593-94. “[N]othing in either Daubert or the Federal Rules of Evidence requires a district court to admit opinion evidence that is connected to existing data only by the ipse dixit of the expert,” and “a trial court may exclude evidence when it finds that there is simply too great an analytical gap between the data and the opinion proffered.” Domingo v. T.K., 289 F.3d 600, 607 (9th Cir. 2002) (quoting GE v. Joiner, 522 U.S. 136 146 (1997)). “However, expert testimony may still be reliable and...