Parks v. Ethicon, Inc.
| Decision Date | 16 October 2020 |
| Docket Number | Case No.: 20-CV-989 TWR (RBB) |
| Court | U.S. District Court — Southern District of California |
| Parties | DONNA PARKS; DELBERT PARKS, Plaintiffs, v. ETHICON, INC.; JOHNSON & JOHNSON, Defendants. |
ORDER (1) DENYING DEFENDANTS' MOTION TO EXCLUDE EXPERT TESTIMONY, AND (2) GRANTING IN PART AND DENYING IN PART DEFENDANTS' MOTION FOR SUMMARY JUDGMENT
Presently before the Court are Defendants Ethicon, Inc. and Johnson & Johnson's Motions for Summary Judgment ("MSJ," ECF No. 34) and to Exclude Certain Case-Specific Opinions of Daniel Elliott, M.D. ("Daubert Mot.," ECF No. 36). The Court held a hearing on October 15, 2020, at which the Parties agreed to submit the motions on the briefing. (See ECF No. 108.) Having carefully considered the Parties' arguments, evidence, and the law, the Court DENIES Defendants' Daubert Motion and GRANTS IN PART AND DENIES IN PART Defendants' Motion for Summary Judgment as follows.
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The Parties agree to the following undisputed facts:
Plaintiff Donna Parks, a resident of California, visited Dr. Shawn Menefee in 2010 with complaints of pelvic organ prolapse. (ECF No. 35 ("MSJ Mem.") at 2 (citing ECF No. 1 ¶ 4; ECF No. 34-1 at 6).) On January 8, 2010, Dr. Menefee implanted Gynemesh PS at Kaiser Hospital in San Diego, California. (Id. (citing ECF No. 34-2; ECF No. 34-3 at 77:6-17).)
In January 2010, Dr. Menefee was familiar with the risk of complications from pelvic mesh products generally, including exposure or erosion, infection, acute and/or chronic pain, urinary problems, recurrence or failure, bowel/bladder/blood vessel perforation during insertion, bleeding, wound complications, inflammation, fistula formation, vaginal scarring, organ or nerve damage, neuromuscular problems, need for additional surgeries, foreign body response, contraction or shrinkage of tissue, dyspareunia (pain with intercourse), and a decrease in patient quality of life. (Id. at 3 (citing ECF No. 34-4 at 97:9-99:4, 101:12-103:7).) However, Dr. Menefee was not aware of all the risks associated with the transvaginal use of Gynemesh PS at the time of Plaintiff's surgery. (MSJ Opp'n at 2 (citing ECF No. 44-1 at 56:8-59:22, 60:1-21, 61:22-62:22).)
Through the years, Dr. Menefee has read most Instructions for Use ("IFUs") accompanying mesh products because they come as a package insert; nonetheless, it is not his practice to read them before every surgery. (MSJ Mem. at 3 (citing ECF No. 34-4 at 141:13-17).) He also could not recall whether he had read the Gynemesh PS IFUs before Plaintiff's surgery in January 2010, (id. at 4), although he believed that he had. (MSJ Opp'n at 2 (citing ECF No. 44-1 at 141:18-23).)
Dr. Menefee testified that he does not rely on IFUs, including the Gynemesh PS IFUs, in making his surgical decisions, (MSJ Mem. at 3 (citing ECF No. 34-4 at 140:4-7)), and that he did not rely on the Gynemesh PS IFUs in performing Plaintiff's surgery. (Id. at 4 (citing ECF No. 34-4 at 148:20-149:1).) Instead, Dr. Menefee believes that surgical decision-making should be based on the best clinical evidence available, aphysician's clinical experience, and the experience of a physician's peers. (Id. at 3 (citing ECF No. 34-4 at 140:9-16).) Dr. Menefee therefore based his decision to use Gynemesh PS for Plaintiff on his clinical experience, discussions with peers, and the then-available medical research. (Id. (citing ECF No. 34-4 at 140:17-20).)
Based on that information and in his medical judgment, Dr. Menefee determined that the benefits of using a sling to treat Plaintiff's stress urinary incontinence outweighed the risk at that time. (Id. at 2 (citing ECF No. 34-4 at 71:25-72:9).) Dr. Menefee also believed that his decision to use Gynemesh PS for Plaintiff was an appropriate alternative for the surgical management of her prolapse in 2010. (Id. at 3 (citing ECF No. 34-4 at 139:23-140:3).)
Dr. Menefee does not recall giving Plaintiff an industry brochure, (id. at 4 (citing ECF No. 34-4 at 148:20-149:1)), and Plaintiff does not recall receiving any documents from Dr. Menefee. (Id. at 2 (citing ECF No. 34-3 at 15:11-19, 21:17-20).) Plaintiff testified that Dr. Menefee did not advise her to look at the U.S. Food and Drug Administration's consumer website. (Id. at 2 (citing ECF No. 34-3 at 15:11-19, 21:17-20).) Plaintiff's decision to proceed with the surgery was based solely on Dr. Menefee's recommendation, (id. (citing ECF No. 34-3 at 25:12-15)), and she did not perform any independent research either before or after the surgery. (Id. (citing ECF No. 34-3 at 25:12-15).)
Plaintiff filed her lawsuit directly in the In re Ethicon, Inc. Pelvic Repair System Products Liability Litigation, MDL No. 2327 (S.D. W.Va.), on February 13, 2014. (MSJ Mem. at 4 (citing ECF No. 1).) She has designated one case-specific expert, Dr. Daniel S. Elliott. (Id. (citing ECF No. 34-5).) Dr. Elliott opines that the Gynemesh product caused Plaintiff's alleged vaginal scarring and narrowing, resulting in a "severe compromise in Ms. Parks' quality of life." (Id. (quoting ECF No. 34-6 at 62).) He further opines that she has pelvic pain, pelvic floor myalgia, and dyspareunia and that it is highly unlikely that these conditions will resolve completely. (Id. (citing ECF No. 34-6 at 62).) Dr. Elliott also
/ / /believes that this "long-term negative impact" could lead to "feelings of isolation, loneliness, depression and suicide." (Id. (quoting ECF No. 34-6 at 62).)
Federal Rule of Evidence 702 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.
Rule 702 "contemplates a broad conception of expert qualifications." Hangarter v. Provident Life & Accident Ins. Co., 373 F.3d 998, 1015 (9th Cir. 2004) (quoting Thomas v. Newton Int'l Enters., 42 F.3d 1266, 1269 (9th Cir. 1994)). "Shaky but admissible evidence is to be attacked by cross examination, contrary evidence, and attention to the burden of proof, not exclusion." Primiano v. Cook, 598 F.3d 558, 564 (9th Cir. 2010).
Additionally, under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), "the district court judge must ensure that all admitted expert testimony is both relevant and reliable." Wendell v. GlaxoSmithKline LLC, 858 F.3d 1227, 1232 (9th Cir. 2017); see also Grodzitsky v. Am. Honda Motor Co., 957 F.3d 979, 984-85 (9th Cir. 2020). "The focus of the district court's analysis 'must be solely on principles and methodology, not on the conclusions that they generate,'" and "the court's 'task . . . is to analyze not what the experts say, but what basis they have for saying it.'" Wendell, 858 F.3d at 1232 (alteration in original) (quoting Daubert, 509 U.S. at 595; Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311, 1316 (9th Cir. 1995) ("Daubert II")). Courts also consider "whether experts are testifying 'about matters growing naturally' out of their own independent
/ / /research, or if 'they have developed their opinions expressly for purposes of testifying.'" Id. (quoting Daubert II, 43 F.3d at 1316).
"These factors are illustrative, and they are not all applicable in each case." Id. "The inquiry is flexible, . . . and Rule 702 should be applied with a liberal thrust favoring admission." Id. (citation and quotation marks omitted). Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999); see also Abarca v. Franklin Cnty. Water Dist., 761 F. Supp. 2d 1007, 1021 (E.D. Cal. 2011) (citations omitted).
"[T]he proponent [of the proposed expert] has the burden of establishing that the pertinent admissibility requirements are met by a preponderance of the evidence." Fed. R. Evid. 702 advisory committee's note (2000).
Defendants request that the Court preclude Dr. Elliott's case-specific opinions relating to two issues: (1) Plaintiff's future mental health, and (2) Plaintiff's informed consent process. (See Daubert Mot. at 1; see also ECF No. 37 ("Daubert Mem.") at 1.)
In his expert report, Dr. Elliott indicates that "[t]he long-term impact [of Plaintiff's lack of quality, pain-free physical intimacy] on [Plaintiff's] quality of life is difficult to accurately ascertain[;] however, many studies have shown the long-term negative impact leading to feelings of isolation, loneliness, depression and suicide." (ECF No. 36-1 at 62.) Defendants urge the Court to preclude Dr. Elliott from offering such opinions at trial because "he is not qualified to opine about mental health and because he has not opined that Plaintiff has suffered from or will suffer from such mental health issues." (See Daubert Mem. at 1-2.)
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Defendants argue that Dr. Elliott is not qualified to offer an opinion on Plaintiff's mental health because he "is a urologist and pelvic surgeon, not a psychiatrist" and he "does not treat patients for mental health conditions." (Daubert Mem. at 2.) Plaintiff counters that "[q]uality of life assessments are central to the treatment of pelvic organ prolapse, including mesh surgery, and Dr. Elliott . . . is well-qualified to offer testimony on Ms. Parks['] quality of life." (ECF No. 43 ("Daubert Opp'n") at 2 (citing Fed. R. Evid. 702).)
The Court agrees with Plaintiff. Dr....
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