Opinion
Case No. EDCV 19-01904 JGB (SPx)
02-03-2023
Julian LOPEZ v. JOHNSON AND JOHNSON, et al.
Kristy M. Arevalo, McCune Law Group, McCune Wright Arevalo Vercoski Kusel Weck, Ontario, CA, Emily J. Kirk, McCune Law Group, McCune Wright Arevalo Vercoski Kusel Weck, Edwardsville, IL, for Julian Lopez. Michael Carl Zellers, Aggie B. Lee, Tucker Ellis LLP, Los Angeles, CA, Chad R. Hutchinson, Pro Hac Vice, Fred E. Bourn, III, Pro Hac Vice, Butler Snow LLP, Ridgeland, MS, David M. Cohen, Pro Hac Vice, Raquel Lucas Herraiz, Pro Hac Vice, Butler Snow LLP, New York, NY, G. Brian Jackson, Pro Hac Vice, Tara L. Blake, Travis B. Swearingen, Pro Hac Vice, Butler Snow LLP, Nashville, TN, Kasey M. Adams, Pro Hac Vice, Butler Snow LLP, Rodgeland, MS, for Johnson and Johnson, et al.
Kristy M. Arevalo, McCune Law Group, McCune Wright Arevalo Vercoski Kusel Weck, Ontario, CA, Emily J. Kirk, McCune Law Group, McCune Wright Arevalo Vercoski Kusel Weck, Edwardsville, IL, for Julian Lopez. Michael Carl Zellers, Aggie B. Lee, Tucker Ellis LLP, Los Angeles, CA, Chad R. Hutchinson, Pro Hac Vice, Fred E. Bourn, III, Pro Hac Vice, Butler Snow LLP, Ridgeland, MS, David M. Cohen, Pro Hac Vice, Raquel Lucas Herraiz, Pro Hac Vice, Butler Snow LLP, New York, NY, G. Brian Jackson, Pro Hac Vice, Tara L. Blake, Travis B. Swearingen, Pro Hac Vice, Butler Snow LLP, Nashville, TN, Kasey M. Adams, Pro Hac Vice, Butler Snow LLP, Rodgeland, MS, for Johnson and Johnson, et al.
Proceedings: Order (1) DENYING-IN-PART Defendants' Motion to Exclude Expert Testimony (Dkt. No. 70); and (2) GRANTING-IN-PART AND DENYING-IN-PART Defendants' Motion for Summary Judgment (Dkt. No. 54).
JESUS G. BERNAL, UNITED STATES DISTRICT JUDGE
Before the Court are two motions filed by Defendants Johnson and Johnson ("J & J") and Ethicon, Inc. (collectively, "Defendants"): (1) a motion to exclude certain opinions and testimony of Jin Yoo, M.D. ("MTE," Dkt. No. 70); and (2) a motion for summary judgment ("MSJ," Dkt. No. 54) (collectively, "Motions"). The Court determines the Motions are appropriate for resolution without a hearing. See Fed. R. Civ. P. 78; L.R. 7-15. After considering the papers filed in support of and in opposition to the Motions, the Court DENIES-IN-PART the MTE and GRANTS-IN-PART AND DENIES-IN-PART the MSJ.
I. BACKGROUND
This product liability case arises from Defendants' hernia mesh product, the Prolene Polypropylene Mesh ("Prolene Mesh"), and the injuries it allegedly caused Plaintiff Julian Lopez ("Lopez" or "Plaintiff"). Mr. Lopez commenced this action on October 4, 2019 against Defendants. ("Complaint," Dkt. No. 1.) The Complaint asserts the following seven causes of action: (1) strict liability - manufacturing defect ("Claim One"); (2) strict liability - failure to warn ("Claim Two"); (3) negligence ("Claim Three"); (4) negligent infliction of emotional distress ("Claim Four"); (5) breach of express warranty ("Claim Five"); (6) fraudulent concealment ("Claim Six"); and (7) negligent misrepresentation ("Claim Seven"). (Id.) On November 5, 2019, Defendants answered. ("J & J Answer," Dkt. No. 12; "Ethicon, Inc. Answer," Dkt. No. 13.)
On October 3, 2022, Defendants filed the MSJ and the following documents in support:
• Defendants' Statement of Undisputed Facts ("DSUF," Dkt. No. 54-1); and
• Declaration of Aggie B. Lee ("Lee MSJ Declaration," Dkt. No. 54-2) with attached exhibits.
On October 19, 2022, the Court granted the parties' stipulation to dismiss Claim One for strict liability manufacturing defect and Claim Three for negligent manufacturing defect. ("Stip Order," Dkt. No. 58.)
On October 24, 2022, Mr. Lopez filed an opposition to the MSJ ("MSJ Opposition," Dkt. No. 59) and the following documents in support:
• Plaintiff's Response to Defendants' DSUF ("DSUF Response," Dkt. No. 59-2);
• Plaintiff's Genuine Issues of Material Facts ("PGI," Dkt. No. 59-2 at 10); and
• Declaration of Kristy M. Arevalo ("Arevalo Declaration," Dkt. No. 60) with attached exhibits.
On October 31, 2022, Defendants replied to the MSJ ("MSJ Reply," Dkt. No. 61) and filed the following documents in support:
• Defendants' Reply to DSUF Response ("DSUF Reply," Dkt. No. 61-2);
• Defendants' Response to Plaintiff's PGI ("PGI Response," Dkt. No. 61-2 at 13);
• Defendants' Objections to Plaintiff's Evidence in Support of the MSJ Opposition ("Defendants' Evidentiary Objections," Dkt. No. 61-1); and
• Declaration of Aggie B. Lee ("Lee MSJ Reply Declaration," Dkt. No. 61-3) with attached exhibits.
Pursuant to the Court's standing order, the Court reminds Defendants that they should have added a fourth column to the PSUF to identify the facts that are in dispute, rather than inserting their response in the second column. (See "Standing Order," Dkt. No. 9.)
On December 5, 2022, Defendants filed the MTE to exclude certain opinions and testimony of Mr. Lopez's expert Dr. Jin Yoo ("Yoo") from trial and the MSJ. (See MTE.) In support of the MTE, Defendants filed the declaration of Aggie B. Lee ("Lee MTE Declaration," Dkt. No. 70-1) with attached exhibits. On December 30, 2022, Defendants filed a notice of errata to replace a reporter's certifications attached as exhibit 2 to the Lee MTE Declaration. ("Errata," Dkt. No. 71.)
On January 9, 2023, Mr. Lopez filed an opposition to the MTE ("MTE Opposition," Dkt. No. 72) and the declaration of Kristy M. Arevalo with attached exhibits. ("Arevalo MTE Declaration," Dkt. No. 72-2.)
II. FACTS
A. Evidentiary Objections
"A trial court can only consider admissible evidence in ruling on a motion for summary judgment." Orr v. Bank of America, NT & SA, 285 F.3d 764, 773 (9th Cir. 2002); see Fed. R. Civ. Proc. 56(e). At the summary judgment stage, district courts consider evidence with content that would be admissible at trial, even if the form of the evidence would not be admissible at trial. See, e.g., Fraser v. Goodale, 342 F.3d 1032, 1036 (9th Cir. 2003).
Defendants object to various paragraphs of the PGI by arguing that the evidence is not properly authenticated. (See Defs.' Evid. Obj. to PGI ¶¶ 13, 14, 15, 16.) Defendants object that Plaintiff has not submitted the reporter's certification for the deposition excerpts cited in those paragraphs. (Id.) As the court stated above, at the summary judgment stage, the court does not focus on the admissibility of the evidence's form, but instead focuses on the admissibility of its content. See, e.g., Fraser, 342 F.3d at 1036. The content of those depositions consist of the deponents' personal knowledge and could be admitted into evidence at trial in a variety of ways such as by having the deponents testify to all the relevant portions of the depositions from their personal knowledge. See Fed. R. Evid. 602. Because these deposition excerpts could be presented in an admissible form at trial, the court considers the content of the deposition excerpts.
B. Undisputed Facts
Except as noted, the following material facts are sufficiently supported by admissible evidence and are uncontroverted. They are "admitted to exist without controversy" for purposes of the Motion. See Fed. R. Civ. P. 56(e)(2); L.R. 56-3.
If the parties' objections are not specifically addressed in this order, they are OVERRULED as MOOT.
On October 6, 2017, Dr. Kenneth T. Sim ("Dr. Sim") implanted Plaintiff Julian Lopez with Prolene Mesh, a prescription polypropylene mesh medical device manufactured by Ethicon, Inc. to repair an inguinal hernia. (DSUF ¶ 1.) Dr. Sim cut the mesh into two pieces and "keyhole[d] the mesh to allow the [spermatic] cord to go through the center of the mesh." (Id. ¶ 2.)
Within one month of his hernia surgery, Mr. Lopez experienced pain and pressure in the groin area and constipation. (DSUF Response ¶ 3.) Mr. Lopez experienced "an impact on his sexual function a couple weeks to a month after his" hernia surgery. (Id.) In 2018, Mr. Lopez experienced pain, numbness, and difficulty urinating. (DSUF ¶ 3.)
On March 19, 2019, Dr. David Chen ("Dr. Chen") surgically removed the Prolene Mesh, and stated in his observation report that he observed "a folded keyhole type mesh trapped around the mid inguinal portion of the cord with extension of mesh into the internal ring and a significant folding and constriction of the cord." (DSUF Response ¶ 4.) Dr. Chen testified that "ideally, that mesh should lay flat between the layers" but that the "folded keyhole mesh had strangled the cord," thus constricting Mr. Lopez's nerves. (DSUF ¶ 5.) After reviewing Dr. Chen's observation of the Prolene Mesh set forth in his operative report, Dr. Sim testified that Dr. Chen's observation is consistent with the way Dr. Sim intended the Prolene Mesh to be implanted. (DSUF ¶ 6.) Additionally, Dr. Sim testified that the Prolene Mesh is not held in place, it is anchored in place by closing tissue over it. (Arevalo Decl., Ex. L at 108: 8-25.) Dr. Sim testified that he does not use a suture to anchor the mesh because it carries the risk of damaging nerves, which he avoids doing. (Id.) He testified that the Prolene Mesh is so well placed that the mesh "has no chance to migrate." (Id.) Dr. Sim testified that he is aware of "reported instances from other folks" where Prolene Mesh has migrated. (Id. at 71:11-19.)
Mr. Lopez alleges that, "[e]ven after removal of the Prolene Mesh, [he] continues to suffer severe abdominal pain, numbness in the inguinal area, and erectile dysfunction associated with the failed Prolene Mesh." (Id. ¶ 7.) Mr. Lopez did not see or receive any documents or literature relating to the Prolene Mesh before his hernia surgery. (DSUF ¶ 9.)
At Dr. Sim's deposition, Plaintiff never asked him if different warnings would have prompted him to act differently. (DSUF ¶ 8.) Plaintiff did not ask Dr. Sim if he reviewed the Instructions for Use ("IFU") before the implant surgery. (Id.) At Dr. Sim's deposition, Plaintiff's counsel asked him whether he knew if his technique of implanting Prolene Mesh was consistent with the IFU and Dr. Sim replied "[t]hat's always been my way of handling the Prolene Mesh." (DSUF Response ¶ 8.)
Dr. Sim testified that he worked as a paid consultant for Ethicon, Inc. for about two to three years by training his colleagues on how to implant Prolene Mesh for hernia repair. (PGI ¶ 15.) Dr. Sim testified that he used Prolene Mesh "almost exclusively" in his own clinical practice. (Id.) When asked what his customary practice was in describing the risks of Prolene Mesh to a patient, Dr. Sim testified that his "usual and customary practice" was to "explain all the potential complications that could result from an inguinal hernia repair," such as "bleeding, infection, pain . . . a heart attack, any respiratory complications . . . [and] pain due to nerve irritation with a mesh implant." (PGI ¶ 16; Arevalo Decl., Ex. L at 52:19-53:17.) Dr. Sim did not testify that he explained to patients risks such as damage surrounding tissue, organs, or nerves due to mesh erosion, shrinkage or migration, numbness of the groin or genital area, urinary retention or painful urination, or constipation. (Id.) Dr. Sim testified that if a patient told him on the day of the surgery that he did not want to use Prolene Mesh, Dr. Sim would proceed without the mesh. (Arevalo Decl., Ex. L at 53:18-21.)
Dr. Chen testified that his "go-to mesh" for inguinal hernia surgeries is the UltraPro Advanced ("UltraPro"), which is an Ethicon product. (Arevalo Decl., Ex. Q at 23:14-24:25.) Dr. Chen testified that he uses the UltraPro because it was the first product designed to give patients less foreign body sensation, and it is much lighter than the Prolene Mesh, which means that patients feel it less. (Id.) Dr. Chen testified that he has been using the UltraPro for the past eleven years. (Id.)
III. LEGAL STANDARD
A. Motion to Exclude Expert Testimony
Federal Rule of Evidence 702 ("FRE 702") allows admission of "scientific, technical, or other specialized knowledge" by a qualified expert if four conditions are met: (a) the testimony will "assist 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." FRE 702(a)-(d).
The trial court is accorded wide discretion to act as gatekeepers for the admissibility of expert testimony. Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 151-52, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999). A court may consider several factors to determine the reliability of an expert's opinion, including whether a theory or technique has been tested, has been subjected to peer review and publication, has a high known or potential rate of error, and "enjoys 'general acceptance' within a 'relevant scientific community.' " Id. at 149-50, 119 S.Ct. 1167 (quoting Daubert v. Merrell Dow Pharm., 509 U.S. 579, 592-94, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993)). "The party offering the expert bears the burden of establishing that Rule 702 is satisfied." Sundance Image Tech., Inc. v. Cone Editions Press, Ltd., 2007 WL 935703, *4 (S.D. Cal. Mar. 7, 2007). FRE 702 should be applied consistent with the "liberal thrust" of the Federal Rules and their "general approach of relaxing the traditional barriers to 'opinion testimony.' " Daubert, 509 U.S. at 588, 113 S.Ct. 2786.
B. Motion for Summary Judgment
Summary judgment is appropriate when there is no genuine dispute as to any material fact. Fed. R. Civ. P. 56(a). The moving party has the initial burden of identifying the portions of the pleadings and record that it believes demonstrate the absence of an issue of material fact. See Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Where the non-moving party bears the burden of proof at trial, the moving party need not produce evidence negating or disproving every essential element of the non-moving party's case. Id. at 325, 106 S.Ct. 2548. Instead, the moving party need only prove there is an absence of evidence to support the nonmoving party's case. Id.; In re Oracle Corp. Sec. Litig., 627 F.3d 376, 387 (9th Cir. 2010). The moving party must show that "under the governing law, there can be but one reasonable conclusion as to the verdict." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).
If the moving party has sustained its burden, the non-moving party must then show that there is a genuine issue of material fact that must be resolved at trial. Celotex, 477 U.S. at 324, 106 S.Ct. 2548. The non-moving party must make an affirmative showing on all matters placed at issue by the motion as to which it has the burden of proof at trial. Celotex, 477 U.S. at 322, 106 S.Ct. 2548; Anderson, 477 U.S. at 252, 106 S.Ct. 2505. A genuine issue of material fact exists "if the evidence is such that a reasonable jury could return a verdict for the non-moving party." Anderson, 477 U.S. at 248, 106 S.Ct. 2505. "This burden is not a light one. The non-moving party must show more than the mere existence of a scintilla of evidence." In re Oracle, 627 F.3d at 387 (citing Anderson, 477 U.S. at 252, 106 S.Ct. 2505).
When deciding a motion for summary judgment, the court construes the evidence in the light most favorable to the non-moving party. Barlow v. Ground, 943 F.2d 1132, 1135 (9th Cir. 1991). Thus, summary judgment for the moving party is proper when a "rational trier of fact" would not be able to find for the non-moving party based on the record taken as a whole. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986).
IV. DISCUSSION
A. Defendants' Motion to Exclude Certain Opinions of Jin Yoo, M.D.
Defendants seek to exclude opinions by Plaintiff's expert Jin Yoo ("Dr. Yoo"), a general surgeon, regarding his claims that Plaintiff was injured as a result of alleged defects with Prolene Mesh's design and warnings. (MTE at 1.) Defendants argue that: (1) Dr. Yoo's specific causation opinions should be excluded because his differential diagnosis methodology is flawed; (2) Dr. Yoo's design defect opinions should be excluded because he does not rely on scientific data and his opinions are unreliable; (3) Dr. Yoo's opinion that other designs of Prolene Mesh would have been safer should be excluded because his opinion is unsupported and irrelevant; and (4) Dr. Yoo's warning opinions should be excluded because he is not qualified to opine on IFUs. (See MTE.) The Court addresses each contention below.
1. Dr. Yoo's Specific Causation Opinions
Defendants argue that Dr. Yoo did not use a reliable differential diagnosis because he did not rule out Dr. Sim's surgical technique or Plaintiff's mental state. (MTE at 5-10.) The Court disagrees.
"A differential diagnosis [or etiology] is 'a patient-specific process of elimination that medical practitioners use to identify the most likely cause of a set of signs and symptoms from a list of possible causes.' " Stanley v. Novartis Pharms. Corp., 11 F. Supp. 3d 987, 1000 (C.D. Cal. 2014) (quoting Ruggiero v. Warner-Lambert Co., 424 F.3d 249, 254 (2d Cir. 2005)). Differential diagnosis has "long been recognized in this circuit as a reliable methodology, so long as it is 'properly conducted.' " Northrup v. Covidien, LP, 2021 WL 5507217, at *3 (C.D. Cal. Nov. 24, 2021) (quoting Clausen v. M/V NEW CARISSA, 339 F.3d 1049, 1057, 1058 (9th Cir. 2003)). The Ninth Circuit laid out the differential diagnosis process in Clausen. First, an expert should "compile a comprehensive list of hypotheses that might explain the set of salient clinical findings under consideration. The issue at this point in the process is which of the competing causes are generally capable of causing the patient's symptoms or mortality. Expert testimony that rules in a potential cause that is not so capable is unreliable." Clausen, 339 F.3d at 1057-58 (internal citations omitted). The second step is for the expert to engage in a process of eliminating or ruling out the identified potential causes. The "expert must provide reasons for rejecting alternative hypotheses using scientific methods and procedures and the elimination of those hypotheses must be founded on more than subjective beliefs or unsupported speculation." Clausen, 339 F.3d at 1058 ("A district court is justified in excluding evidence if an expert 'utterly fails . . . to offer an explanation for why the proffered alternative cause' was ruled out.") (quoting Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 202 (4th Cir. 2001)).
Defendants argue that Dr. Yoo has provided no reasoned basis for his opinion that the Prolene Mesh, and not Dr. Sim's surgical technique, contributed to the folding of the mesh. (MTE at 7.) Not so. Dr. Yoo states in his report that, in reaching his opinions, he reviewed Plaintiff's medical records and surgical history, Dr. Sim's surgical technique, the depositions of Drs. Sims and Chen, Plaintiff's deposition, and the medical literature relevant to the case. ("Yoo Report," Dkt. No. 70-2 at 3, 7-8.) Dr. Yoo explains that as to Dr. Sim he did not see any "evidence of surgeon error or deviation from the procedural steps." (Yoo Report at 5.) In his deposition, Dr. Yoo testified that there are different ways to fix inguinal hernias, that he believes Dr. Sim performed an adequate repair, and does not believe that Dr. Sim's technique violated any principles even though Dr. Sim did not use a Lichtenstein repair, a recognized technique. ("Yoo Deposition," Dkt. No. 72-3 at 249:2-21.) When asked how he ruled out Dr. Sim's surgical technique as contributing to injuries that Plaintiff sustained, Dr. Yoo testified that a primary reason was the type of tissue-based repair method that Dr. Sim used and the way that Dr. Sim used the Prolene Mesh. (Id. at 263:4-25.)
Thus, to the extent that Defendants argue that Dr. Yoo did not "adequately rule out" Dr. Sim's surgical technique, this is a credibility determination that goes to the weight of his opinions, not their admissibility. Stanley, 11 F. Supp. 3d at 1001. Defendants can cross-examine Dr. Yoo regarding his opinion on Dr. Sim's surgical technique. See id. ("[T]o the extent [d]efendant argues that Dr. Sung did not adequately rule out additional factors, this is a credibility determination that goes to the weight and the admissibility of his opinions. Defendants can cross-examine Dr. Sung regarding additional factors that he did not rule out during trial.); cf. Northrup, 2021 WL 5507217, at *4 (excluding expert's testimony because expert presented no evidence of any reasoned basis for the elimination of any potential cause).
As to Plaintiff's mental state, Dr. Yoo testified that Plaintiff's anxiety contributes to his pain and numbness, and thus, because Dr. Yoo has not ruled out Plaintiff's anxiety, Defendants argue that he has not reliably pinpointed the Prolene Mesh as the cause for Plaintiff's injuries. (MTE at 9-10.) However, as Plaintiff correctly highlights, Dr. Yoo does not opine that Plaintiff's anxiety caused his symptoms, he opines it exacerbated his experience of his groin pain after Plaintiff's hernia surgery. (MTE Opp'n at 13 (emphasis added).) As support for his opinion, Dr. Yoo points to the absence of any indication for anxiety in Plaintiff's medical and psychiatric records prior to the implant surgery. (Id.) Moreover, this circuit does "not require that an expert be able to identify the sole cause of a medical condition in order for his or her testimony to be reliable. It is enough that a medical condition be a substantial causative factor." Messick v. Novartis Pharms. Corp., 747 F.3d 1193, 1199 (9th Cir. 2014) (holding that the district court abused its discretion in excluding expert's causation testimony simply because the expert could not determine in a patient who has multiple risk factors at one time which of those particular factors was causing the medical condition).
Accordingly, the Court is satisfied that Dr. Yoo's specific causation testimony is the product of reliable methods. The Court DENIES Defendants' MTE as to Dr. Yoon's specific causation testimony.
2. Dr. Yoo's Design Defect Opinions
Defendants argue that Dr. Yoo's design defect opinions should be excluded because he does not rely on scientific data for the following opinions: (1) Prolene Mesh is defective because it is a heavyweight mesh that causes a higher inflammatory response; and (2) the form of Prolene Mesh leads to a propensity of it contracting and balling up. (MTE at 10.) As to Dr. Yoo's design defect opinion on the weight of the Prolene Mesh, Defendants argue that it is unreliable because he cited one review paper that does not address Prolene Mesh or why the weight of mesh correlates with inflammatory response, he did not conduct an exhaustive literature search specific to Prolene Mesh, and he relies on the prevailing consensus in the surgical community that heavyweight meshes increase the risk of post-operative complications. (Id.)
Plaintiff counters that Dr. Yoo did in fact review medical literature that supports his conclusions. For example, in his expert report, Dr. Yoo offers multiple human and animal studies that demonstrate an increased risk of groin pain and numbness as a result of using a heavyweight mesh. (MTE Opp'n at 16.) Dr. Yoo also cites to a peer-reviewed human analysis comparing the performance of lightweight meshes with heavyweight meshes in inguinal hernia repair which found lower levels of pain with lightweight meshes. (Id.) Furthermore, Dr. Yoo testified that his opinions on design defect are based on his knowledge of the field, including the consensus among practicing surgeons in his specialty, which indicates reliability. Wendell, 858 F.3d at 1232 (judges can consider whether the theory or technique employed by the expert is generally accepted in the scientific community.) To the extent that Defendants disagree with Dr. Yoo's conclusions, this Court does not have license to "determine the veracity of [Dr. Yoo's] conclusions at the admissibility stage." Elosu v. Middlefork Ranch Inc., 26 F.4th 1017, 1026 (9th Cir. 2022). The "Daubert inquiry does not require (or even allow) the district court to exclude an expert's opinion merely because the court is not persuaded that the expert's read of the evidence is the best one." In re Roundup Prods. Liability Litig., 390 F. Supp. 3d 1102, 1134 (N.D. Cal. 2018). Based on the record, the Court finds that Dr. Yoo's opinions are not the "junk science" that Rule 702 was meant to exclude. Wendell, 858 F.3d at 1237. Accordingly, the Court DENIES Defendants' MTE as to Dr. Yoo's heavyweight opinion.
As to Dr. Yoo's opinions about the deficiencies in the Prolene Mesh's form, Defendants argue that Dr. Yoo is not a material scientist, has no expertise in designing a medical device, he conducted no testing to compare the form of Prolene Mesh with other mesh products, and his report does not rely on any testing or studies conducted by others. (MTE at 14-15.) The Court partially agrees. In his report, Dr. Yoo states that he has worked on biologic/mesh designs for hernia repair use and he has expertise and knowledge regarding the inguinal structure and its reactions to materials and devices. (Yoo Report at 2.) Because Dr. Yoo states that he has worked on mesh designs, the Court does not agree with Defendants that he has no expertise in designing a medical device. Furthermore, although Defendants are correct that Dr. Yoo conducted no testing, the absence of independent research does not mean his methods are unreliable. Wendell, 858 F.3d at 1235 (Where " 'the proffered expert testimony is not based on independent research,' the experts can instead present 'other objective, verifiable evidence that the testimony is based on 'scientifically valid principles.' " Id. (quoting Daubert v. Merrell Dow Pharms., Inc., 43 F.3d 1311, 1317 (9th Cir. 1995))). Here, Plaintiff argues that Dr. Yoo reviewed multiple human and animal studies that demonstrate an increased risk of groin pain and numbness as a result of using a mesh "lacking form." (MTE Opp'n at 16.) However, after looking at the citations that Plaintiff provides, the Court is unable to confirm that those studies address a mesh's form. Thus, based on the record, the only support Plaintiff provides for Dr. Yoo's form design opinion is his vague experience. Although Dr. Yoo's form design opinion may be shaky, "[s]hakiness [ ] does not require exclusion." Gold v. Lumber Liquidators, Inc., 323 F.R.D. 280, 294 (N.D. Cal. 2017) (citing Primiano v. Cook, 598 F.3d 558, 564 (9th Cir. 2010), as amended (Apr. 27, 2010) ("Shaky but admissible evidence is to be attacked by cross examination, contrary evidence, and attention to the burden of proof, not exclusion.")). Because Dr. Yoo has some expertise in designing medical devices, the Court DENIES Defendants' MTE as to Dr. Yoo's opinions about Prolene Mesh's form.
3. Dr. Yoo's Alternative Design Opinions
Defendants argue that Dr. Yoo's safer alternative design opinions should be excluded because he does not rely on scientific data for the following opinion that Prolene Mesh could have been made safer by: (1) "making it an intermediate weight mesh, (2) giving it more form so that it is less likely for it to contract or ball up, and (3) coat it with extracellular matrix to mitigate the foreign body reaction from the body to minimize scarring an inflammation." (MTE at 15; Yoo Report at 7.) Defendants argue that during his deposition, Dr. Yoo was unable to identify a study comparing Prolene Mesh to an intermediate weight mesh, and thus his opinion is unreliable. (MTE at 15.) However, in his report, Dr. Yoo cited several studies comparing lightweight and heavyweight mesh products and one of those studies showed that a lightweight mesh causes less pain than a heavyweight mesh. (MTE Opp'n at 16.) Thus, although Defendants may disagree with Dr. Yoo's opinions about his conclusions on an intermediate mesh based on those studies, that goes to the weight of his opinions, not admissibility. See Elosu, 26 F.4th at 1026. Next, Defendants argue that because Dr. Yoo could not identify a clinical study comparing Prolene Mesh with a mesh that has "more form" that suggests any difference in complications, his opinion is unreliable. (MTE at 16.) But as explained above, because Dr. Yoo has some experience in designing mesh devices and because an expert can rely on his own experiences, the Court does not find this as sufficient basis to exclude his opinion. Northrup, 2021 WL 5507217, at *4 ("[T]he text of Rule 702 expressly contemplates that an expert may be qualified on the basis of experience.").
Defendants also argue that even if the Court finds Dr. Yoo's opinion on alternative mesh designs reliable, his testimony should be excluded because he does not opine that Plaintiff's injuries would have been avoided or lessened if Dr. Sim had implanted him with one of the alternative designs. (MTE at 17.) This critique goes to the weight of Dr. Yoo's opinions, not their admissibility.
Lastly, Defendants argue that Dr. Yoo's opinions about an extracellular matrix coating is unreliable because his opinion is based on a rat study finding that a mesh that is coated mitigates a body's response and he made no effort to extrapolate the results of that rat study to humans. (MTE at 16.) "The Ninth Circuit has rejected a per se rule that animal studies are inadmissible due to the uncertainties in extrapolating from effects on mice and rats to humans." Sugar Ass'n, Inc. v. McNeil-PPC, Inc., 2008 WL 11338092, at *3 (C.D. Cal. July 21, 2008) (citing Metabolife Int'l, Inc. v. Wornick, 264 F.3d 832 at 842-43 (9th Cir. 2001)). Animal studies "can be used to support theories on human health, but the district court retains its gatekeeper function in requiring analytical support for the extrapolation from animals to human[s]." Domingo ex rel. Domingo v. T.K., 289 F.3d 600, 606 (9th Cir. 2002). The Court agrees with Defendants that Dr. Yoo has provided no support for the extrapolation from the rat study to humans. However, Dr. Yoo also cited another article that explains that meshes with coatings are the "gold standard" and that they have shown to minimize the risk of mesh contraction, provide mechanical integrity, and contain anti-inflammatory properties for humans. (MTE Opp'n at 17.) Thus, while Dr. Yoo's opinions on extracellular matrix coating appear shaky, the Court finds his opinions admissible. See Primiano, 598 F.3d at 564 ("Shaky but admissible evidence is to be attacked by cross examination, contrary evidence, and attention to the burden of proof, not exclusion."). Accordingly, the Court DENIES Defendants' MTE as to Dr. Yoo's opinions on alternative designs.
4. Dr. Yoo's Warning Opinions
Defendants' last argument is that the Court should exclude Dr. Yoo's warning opinions because he is not qualified to testify that the IFU should have been worded differently. (MTE at 17-18.) As explained below, the Court grants Defendants summary judgment as to Plaintiff's failure to warn claims and thus, Defendants' exclusion argument regarding Dr. Yoo's warning opinions is MOOT.
B. Defendants' Motion for Summary Judgment
Defendants move for summary judgment on all of Mr. Lopez's remaining six causes of action: strict liability - failure to warn (Claim Two); negligence as to failure to warn and design defect (Claim Three); negligent infliction of emotional distress (Claim Four); breach of express warranty (Claim Five); fraudulent concealment (Claim Six); and negligent misrepresentation (Claim Seven). (See MSJ.)
As stated above, on October 19, 2022, the Court granted the parties' stipulation to dismiss Plaintiff's causes of action for strict liability manufacturing defect and negligent manufacturing defect. (See Stip. Order.)
1. Claim Two and Three: Strict Liability and Negligence - Failure to Warn
Defendants argue that Plaintiff's strict liability and negligence claims based on a failure to warn theory fail because Plaintiff cannot show causation. (MSJ at 3.) Specifically, Defendants argue that Plaintiff has no evidence that Dr. Sim would have acted differently if Prolene Mesh's IFU contained different or additional warnings, and in the absence of that evidence, Plaintiff cannot prove causation. (Id.)
The Court notes that Plaintiff's negligence claim (Claim Three) encompasses both negligent warnings and negligent design. (See Compl. ¶¶82, 84, 86, 90, 98.) In this section, the Court considers Plaintiff's claim for negligent warning.
A failure-to-warn claim may be brought under either a theory of negligence or a theory of strict liability." Hannan v. Bos. Sci. Corp., 2020 WL 2128841, at *6 (N.D. Cal. May 5, 2020). "The learned intermediary rule is part and parcel of a failure-to-warn analysis in California." Sanchez v. Bos. Sci. Corp., 38 F. Supp. 3d 727, 732 (S.D.W. Va. 2014) (applying California law). "Under the learned intermediary rule, manufacturers of prescription drugs and medical devices satisfy their duty to warn if they provide adequate warnings to prescribing physicians, rather than patients." Id. (citing Carlin, 13 Cal. 4th at 1116, 56 Cal.Rptr.2d 162, 920 P.2d 1347); see also Brown v. Superior Ct., 44 Cal. 3d 1049, 1062 n.9, 245 Cal.Rptr. 412, 751 P.2d 470 (1988) ("It is well established that a manufacturer fulfills its duty to warn if it provides adequate warning to the physician."); Hannan v. Bos. Sci. Corp., 2020 WL 2128841, at *7 (N.D. Cal. May 5, 2020) (applying learned intermediary rule to a defendant's pelvic mesh products).
A plaintiff asserting causes of action based on a failure to warn must prove that (1) defendants' "warnings were inadequate, and (2) the inadequate warnings were a substantial factor in causing plaintiff's harm." Shahbaz v. Johnson & Johnson, 2020 WL 5894590, at *17 (C.D. Cal. July 31, 2020). Only the second prong is at issue here. Thus, Plaintiff must prove that Dr. Sim, "the implanting physician, would have acted differently had he received adequate warnings." Id.; see Motus v. Pfizer Inc., 196 F. Supp. 2d 984, 995 (C.D. Cal. 2001), aff'd sub nom. Motus v. Pfizer Inc. (Roerig Div.), 358 F.3d 659 (9th Cir. 2004). To satisfy this burden, Plaintiff must demonstrate that the non-disclosed risk associated with Prolene Mesh "was sufficiently high that it would have changed the treating physician's decision to prescribe the product for the plaintiff." Motus, 196 F. Supp. 2d at 995. A "product defect claim based on insufficient warnings cannot survive summary judgment if stronger warnings would not have altered the conduct of the prescribing physician." Pfizer Inc. (Roerig Div.), 358 F.3d at 661 (affirming district court's decision to grant defendant's motion for summary judgment because plaintiff "failed to establish proof that stronger warnings would have changed her husband's medical treatment").
Defendants point to the following evidence to demonstrate that Plaintiff cannot prove causation: (1) at Dr. Sim's deposition, Plaintiff never asked him if different warnings would have prompted him to act differently; (2) at Dr. Sim's deposition, Plaintiff's counsel did not ask Dr. Sim if he reviewed the IFU for the Prolene Mesh before the implant surgery for Plaintiff; and (3) after reviewing Dr. Chen's observation of the Prolene Mesh set forth in his operative report, Dr. Sim testified that Dr. Chen's observation is consistent with the way that Dr. Sim intended the Prolene Mesh to be implanted. (DSUF ¶¶ 6, 8.) Plaintiff maintains that there is a genuine dispute as to whether a different warning would have changed Dr. Sim's prescribing decision. (MSJ Opp'n at 4-10.) Plaintiff argues that even without direct testimony on the topic, a reasonable jury could still conclude that: (1) Dr. Sim's decision to prescribe the product would have changed if he had different warnings; and (2) Dr. Sim would have counseled Plaintiff differently and Plaintiff would have refused consent. (Id.) After reviewing the record, the Court finds that Plaintiff has not provided any evidence showing that Dr. Sim would have taken a difference course of action if he had been given an adequate warning.
The Court notes that the Ninth Circuit has recently certified a question to the California Supreme Court of whether there are potentially two ways of establishing causation in the failure-to-warn context: (1) "[c]an a plaintiff meet the causation requirement by showing that the physician (if informed of the potential dangers in using the product) would have relayed stronger warnings to the patient such that a prudent person would have declined using the medical product?; or (2) "does the plaintiff have to prove that a manufacturer's stronger risk warning would have altered the physician's decision to prescribe the product?" Himes v. Somatics, LLC, 29 F.4th 1125 (9th Cir. 2022). This question remains pending before the California Supreme Court. See Himes v. Somatics (Mecta Corp.), No. S273887 (Cal. Sup. Ct. June 15, 2022) (request for certification granted).
Courts have analyzed causation under both of those inquiries. Compare Motus v. Pfizer Inc., 196 F. Supp. 2d at 997 (finding that plaintiff failed to create a question of fact for the jury because although the treating doctor testified that if he had been aware of a different warning he would have passed that information along to his patient, the court stated that his testimony did not establish that if that warning had been provided, he would not have prescribed Zoloft) with Stanley, 11 F. Supp. 3d at 1003 (finding that there is a genuine issue of material fact as to causation and the failure to warn because both of plaintiff's oncologists testified that they would have had a different conversation with their patients regarding the risks and benefits of the drugs at issue). The Court analyzes Plaintiff's arguments under both inquiries.
a. Dr. Sim's Prescription Decision
First, Plaintiff points to evidence that, in his view, shows that Dr. Sim relies on Defendants' representations of Prolene Mesh. (MSJ Opp'n at 5.) Plaintiff highlights Dr. Sim's testimony where he testified that his technique of implanting the Prolene Mesh is consistent with the product's instructions for use ("IFU") as proof that he relied on the IFU. (See id. at 5; DSUF Response ¶ 8.) This testimony shows that Dr. Sim read the Prolene Mesh IFU, but it is not evidence that a different warning on the Prolene Mesh would have changed Dr. Sim's prescribing practice or his decision to implant the product in Plaintiff. See Brennan v. Johnson & Johnson, 2022 WL 17219513, at *13 (C.D. Cal. Nov. 18, 2022) (finding that plaintiff did not meet her shifted burden of setting forth evidence showing a genuine issue of material fact because although plaintiff showed that her physician testified that she read the IFU, relied on the warnings provided by defendants, and believed she had an informed consent process, this evidence did not establish a genuine issue of material fact that her physician would have altered her prescribing decision.) Next, Plaintiff points to evidence that shows that Defendants sent Dr. Sim Prolene Mesh sales material, that it was Defendants' practice to have their sales representatives review instructions for use or labeling with surgeons they worked with, that some surgeons may have relied on sales representatives' information to purchase products, and that Dr. Sim was once an Ethicon, Inc. paid consultant and trained his colleagues on how to implant Prolene Mesh for hernia repair. (PGI ¶ 15; MSJ Opp'n at 6-7.) Again, this evidence establishes Dr. Sim's familiarity with the product, but does not demonstrate that Dr. Sim would have acted differently had he received different warnings. Cf. Wendell v. GlaxoSmithKline LLC, 858 F.3d 1227, 1238 (9th Cir. 2017) (finding genuine dispute of material fact as to whether warnings would have changed the doctor's prescribing practices because the doctor testified that reading drug labels is part of his decision making process and there was evidence that he changed his prescribing practices after he learned of incidents of cancer in patients taking certain drugs that were similar to the drug at issue).
Plaintiff also argues that Dr. Sim's recitation of his customary practices in describing the risks of Prolene Mesh for inguinal hernia repair to a patient does not include risks of damage to surrounding tissue, numbness of groin area, painful urination, or constipation. (MSJ Opp'n at 7.) Plaintiff argues that this proves that Dr. Sim was not aware of all the risks associated with use of the Prolene Mesh. (Id.) Even if Dr. Sim was unaware of the specific risks that Plaintiff encountered, Plaintiff has not provided evidence demonstrating that had Dr. Sim known about those risks, Dr. Sim would have acted differently. See McBroom v. Ethicon, Inc., 2021 WL 824411, at *4 (D. Ariz. Mar. 4, 2021) ("The mere theoretical possibility that a warning about increased risks may have influenced the doctor's informed consent process or his decision to use the Prolift and TVT Secur devices is not sufficient to create a triable issue on causation.").
Additionally, Plaintiff argues that he need not show that Dr. Sim would have refrained from implanting the Prolene Mesh because there is evidence that Plaintiff's explanting surgeon, Dr. Chen, switched from using Prolene Mesh to a different mesh for inguinal hernia repair. (MSJ Opp'n at 7-8.) Plaintiff argues that he needs to only provide evidence that one of Plaintiff's treating physicians would have altered their prescribing or treatment behavior had they been provided adequate warnings. (Id.) Plaintiff cites two cases to support his argument. (See id. at 8 (citing Georges v. Novartis Pharms. Corp., 2012 WL 9083365 (C.D. Cal. Nov. 2, 2012)) ("Georges"); In re Aredia & Zometa Prods. Liab. Litig., 2009 WL 2497692 (M.D. Tenn. Aug. 13, 2009) ("Aredia").) In Georges, the plaintiff was on an ongoing prescription drug regimen with multiple doctors prescribing drugs for his related health issues. Georges, 2012 WL 9083365 at *1-2. There, the court stated that even if the record had shown that plaintiff's oncologist, the prescribing physician, had received different instructions and had still chosen to prescribe the drugs at issue (Aredia and Zometa), that finding would not have been fatal to plaintiff's causation argument. Id. at *6. The court explained that because the record suggested that another one of plaintiff's doctors, his oral surgeon, changed his treatment procedures as he became aware of risks with the drugs, plaintiff had demonstrated that one of his " 'treating physicians, not simply the prescriber, would have behaved differently,' " and thus plaintiff could avoid summary judgment. Id. at *6 (quoting In re Aredia, 2009 WL 2497692 at *2). Similarly, in In re Aredia, the court found that although Plaintiff's oncologist might still have prescribed the drug even if he had different warning instructions, Plaintiff's dentist or oral surgeon might have behaved differently, and thus the court found that there was a genuine issue of material fact as to whether one of plaintiff's physicians would have behaved differently. See In re Aredia.
Defendants argue that Georges and In re Aredia are distinguishable and the Court agrees. Unlike in those cases, Plaintiff was not experiencing an ongoing treatment with various drug prescriptions from multiple doctors at the same time for related health issues. One doctor, Dr. Sim, surgically implanted Plaintiff with one medical device. (DSUF ¶ 1.) More than a year later, Dr. Chen surgically removed the Prolene Mesh from Plaintiff. (DSUF Response ¶ 4.) Dr. Chen's testimony that he switched from using Prolene Mesh to using the UltraPro Advanced Ethicon ("UltraPro") mesh for hernia repair after learning that patients feel the UltraPro mesh less, that the UltraPro is designed to give patients less foreign body sensation, and that it is "much lighter," has no bearing on how Dr. Sim would have reacted to different warnings at the time that he implanted the medical device in 2017. (MSJ Opp'n at 9; MSJ Reply at 4.) Furthermore, Plaintiff has filed to cite any case where a plaintiff met his burden of proving causation in a medical device failure to warn claim through the testimony of someone else other than the learned intermediary who implanted the device. And the Court finds no such case. Indeed, courts' analyses focus on the implanting physician. See, e.g., Shahbaz, 2020 WL 5894590, at *17 (finding that the plaintiff could not prove that that "the implanting physician would have acted differently had he received adequate warnings" in the absence of the implanter's own testimony); Contreras v. Bos. Sci. Corp., 2016 WL 1436682, at *3 (S.D.W. Va. Apr. 11, 2016) (applying California law) (finding that "plaintiffs have not provided any citations to the record showing that Dr. Baker, the implanting physician, would have taken a different course of action even if she had been given an adequate warning").
Notably, the Court notes that Georges only cites In re Aredia to support its conclusion that a plaintiff can avoid summary judgment by demonstrating that any of plaintiff's treating physicians, not simply the prescriber, would have behaved differently. Georges, 2012 WL 9083365, at *6. In re Aredia cites two cases to support that conclusion. See In re Aredia, 2009 WL 2497692, at *2 (citing Motus v. Pfizer, Inc., 196 F.Supp.2d 984, 990-91 (C.D. Cal. 2001) ("Motus") and Nix v. SmithKline Beecham Corp., 2007 WL 2526402, at * 2 (D. Az. Sept. 5, 2007) ("Nix") (applying California law)). In neither Motus nor Nix, do the courts state that the learned intermediary analysis applies to any of plaintiff's treating physicians. Indeed, in Nix, the court states that "evidence as to how physicians other than Dr. Hoehne, [the prescribing physician], would have reacted to additional warnings is irrelevant to the learned intermediary analysis." Nix, 2007 WL 2526402, at * 2 (internal quotes omitted).
Plaintiff also argues that evidence in the record suggests that Dr. Sim did not expect or anticipate that the Prolene Mesh would migrate and damage nerves. (MSJ Opp'n at 11.) Plaintiff argues that because Dr. Sim had those "expectations," Dr. Sim would have altered his prescribing or treatment behavior had he been warned of mesh migration, nerve damage, and other post-operative complications associated with Prolene Mesh. (Id.) However, even if Dr. Sim had those expectations, Plaintiff has not provided any evidence that if a different warning had been provided, Dr. Sim would have changed his conduct. Cf. Stanley, 11 F. Supp. 3d at 1003 (finding a triable issue of fact where treating doctor testified that after learning about stronger warnings, he will now prescribe the drug at issue in a more conservative manner such as by "dental monitoring" his patients). Thus, the Court finds no evidence in the record that Dr. Sim would have changed his treatment decision had he been given different warnings.
Plaintiff's citations show that Dr. Sim testified that he does not use a suture to anchor the Prolene Mesh because it carries the risk of damaging nerves, which he avoids doing. (Arevalo Decl., Ex. L at 108: 8-25.) He testified that the Prolene Mesh "has no chance to migrate," because of how well he places it. (Arevalo Decl., Ex. L at 108: 8-25.) This implies that perhaps Dr. Sim had the expectation that the Prolene Mesh would not damage nerves and would not migrate. However, Dr. Sim also testified that he is aware of "reported instances from other folks" where Prolene Mesh has migrated. (Id. at 71:11-19.) Thus, the Court finds that Dr. Sim's expectations are disputed.
b. Dr. Sim's Informed Consent Process
Plaintiff's final argument is that even if Dr. Sim had learned about the additional risks and still chosen to prescribe the Prolene Mesh, testimonial evidence shows that his informed consent process would have been altered to include additional or different warnings. (MSJ Opp'n at 9.) For example, when asked what his customary practice was when meeting with a patient prior to surgery to obtain informed consent, Dr. Sim testified that he would "revisit with them all the potential risks, complications, outcomes, options," the type and physical property of the mesh implant, and "offer the patient a choice of using the mesh or not to use the mesh at all." (Id.; PGI ¶ 16.) Plaintiff argues that this testimony shows that had Dr. Sim known of the additional risks, he would have informed Plaintiff of those risks and Plaintiff would not have consented to the use of Prolene Mesh. (Id.) To support his argument that he would not have consented, Plaintiff points to evidence demonstrating that in other instances, Plaintiff has rejected prescriptions, such as by not taking opioids prescribed for pain, and that he has discontinued use of psychiatric medication after concluding that the benefits of that medication did not outweigh the consequences. (MSJ Opp'n at 10.)
Defendants counter that the key question is whether Dr. Sim would have changed his prescription decision, not whether he would have changed information passed along to the patient. (MSJ Reply at 4.) As the Court noted above, the Ninth Circuit has recently certified this question to the California Supreme Court asking whether a plaintiff can establish causation by showing that the physician (if informed of the potential dangers in using the product) would have relayed stronger warnings to the patient such that a prudent person would have declined using the medical product. Himes v. Somatics, LLC, 29 F.4th 1125 (9th Cir. 2022). This question remains pending before the California Supreme Court. See Himes v. Somatics (Mecta Corp.), No. S273887 (Cal. Sup. Ct. June 15, 2022) (request for certification granted). Under this "prudent person" inquiry, Plaintiff's argument fails as well.
Here, Plaintiff argues that he would have refused treatment by giving examples of other times that he has declined different treatments. (See MSJ Opp'n at 10.) The Ninth Circuit has previously rejected a similar argument, holding that a patient-plaintiff cannot establish causation through a post-hoc declaration. See Himes v. Somatics, LLC, 2022 WL 989469, at *3 (9th Cir. 2022) ("We disagree with the appellants' contention that in establishing causation through warnings, the effect of a stronger warning on a patient could be determined through the patient's subjective post-hoc declaration."). "I[f] it were possible to establish causation through warnings communicated to the patient by the physician, the effect on the patient must be determined based on what a prudent person in the patient's position would have done with the benefit of stronger warnings." Id. Because Plaintiff does not argue that a prudent person would have declined the treatment, his argument fails. See Brennan, 2022 WL 17219513, at *13 (declining to consider how an adequate warning would have impacted plaintiff's decision to consent to surgery because plaintiff did not assert that a prudent person would have declined the treatment).
Accordingly, the Court finds that Plaintiff has not put forth evidence that Dr. Sim would have altered his prescribing practices. Thus, because Defendants have met their initial burden of showing that there is an absence of evidence regarding causation and the Court finds that Plaintiff has failed to meet his shifted burden on causation, the Court GRANTS summary judgment as to Plaintiff's Claim Two (strict liability - failure to warn) and Claim Three (negligence - failure to warn).
2. Claim Three: Negligence - Design Defect
Defendants argue that Plaintiff cannot meet his burden of proving a negligent design defect claim as a matter of law because: (1) Plaintiff's expert's, Dr. Yoo, causation opinions are not reliable; and (2) his opinions that the defects in Prolene Mesh's design caused Plaintiff's injuries cannot be reconciled with Dr. Sim's testimony that the mesh performed the way that he intended for it to perform. (MSJ at 5.)
A product is not negligently designed so long as " 'the manufacturer took reasonable precautions in an attempt to design a safe product or otherwise acted as a reasonably prudent manufacturer would have under the circumstances.' " Torres v. Taser Int'l, Inc., 277 F. App'x 684, 686 (9th Cir. 2008) (quoting Barker v. Lull Engineering, Co., 20 Cal. 3d 413, 434, 143 Cal.Rptr. 225, 573 P.2d 443 (1978)). Where "the complexity of the causation issue is beyond common experience, expert testimony is required to establish causation." Stephen, Stephen v. Ford Motor Co., 134 Cal. App. 4th 1363, 1373 (2005). Plaintiff has designated Dr. Yoo to opine that alleged defects in Prolene Mesh's design caused it to contract and ball up, thus constricting Plaintiff's nerves. (MSJ at 5.)
As stated above, the Court finds Dr. Yoo's design defect opinions reliable. Furthermore, the Court finds that it is disputed whether the Prolene Mesh performed the way that Dr. Sim intended it to perform. The only support in the record that Defendants cite for this contention is Dr. Sim's testimony where he testified that it was his intention for the Prolene Mesh to be folded and key-holed, but that does not mean that the Prolene Mesh performed the way that he expected it to. (MSJ at 5.) Indeed, Plaintiff points to other excerpts of Dr. Sim's testimony where he testified that his intention when doing surgeries is to avoid damaging his patients' nerves and for the Prolene Mesh to be anchored in place and not migrate, which is the opposite of how the explanting surgeon, Dr. Chen, found the mesh. (MSJ Opp'n at 12.) In his operative report, Dr. Chen states that he found that the Prolene Mesh had possibly migrated and that Plaintiff's genital nerve and cord were compromised. (See Arevalo Decl., Ex. B at 3-5.) Thus, it is disputed whether the Prolene Mesh performed the way Dr. Sim intended it to perform. Accordingly, the Court DENIES Defendants' summary judgment as to Plaintiff's negligent design defect claim.
3. Claim Four: Negligent Infliction of Emotional Distress
Defendants move to dismiss Plaintiff's negligent infliction of emotional distress claim, arguing that it is not a separate tort or cause of action, but a component of his damages for his negligence claim. (MSJ at 6.) The Court agrees. In California, "there is no independent tort of negligent infliction of emotional distress . . . [t]he tort is negligence." Potter v. Firestone Tire & Rubber Co., 6 Cal. 4th 965, 984, 25 Cal.Rptr.2d 550, 863 P.2d 795 (1993); see Wong v. Jing, 189 Cal. App. 4th 1354, 1377, 117 Cal.Rptr.3d 747 (2010) ("A claim of negligent infliction of emotional distress is not an independent tort but the tort of negligence to which the traditional elements of duty, breach of duty, causation, and damages apply."). As Plaintiff "brings a separate claim for negligence, it would be redundant to allow him to also bring a claim for negligent infliction of emotional distress." Mendia v. Garcia, 165 F. Supp. 3d 861, 879 (N.D. Cal. 2016) (denying leave to amend to add a separate claim of negligent infliction of emotional distress because it would be futile); see also Los Angeles Cellular Telephone Co. v. Superior Court, 65 Cal. App. 4th 1013, 1016 n. 1, 76 Cal.Rptr.2d 894 (1998) (when plaintiff pleads both negligence and negligent infliction of emotional distress claims, the court may treat them as a single cause of action). Accordingly, the Court DISMISSES Plaintiff's negligent infliction of emotional distress claim.
4. Claim Five: Breach of Express Warranty
Defendants ague that Plaintiff's breach of express warranty claim fails because he: (1) lacks evidence that he gave pre-suit notice; (2) does not identify the terms of the warranty; (3) does not show that he was in privity with Defendants; (4) even if he was not required to be in privity, there is no evidence that either he or Dr. Sim relied on the express warranties; and (5) cannot show that he was injured by any breach of warranty. (MSJ at 6-8.) Defendants' first argument fails. "[W]here, as here, a breach of express warranty claim is brought by injured consumers against manufacturers with whom they have not dealt, then notice is not required." McVicar v. Goodman Glob., Inc., 1 F. Supp. 3d 1044, 1057 (C.D. Cal. 2014) (internal quotations omitted). Accordingly, Plaintiff was not required to provide pre-suit notice because he did not directly deal with Defendants. See Freeman v. Ethicon, Inc., 2021 WL 9216640, at *3 (C.D. Cal. Nov. 1, 2021) (plaintiff did not need to give notice to manufacturer); see Greenman v. Yuba Power Prod., Inc., 59 Cal. 2d 57, 61, 27 Cal.Rptr. 697, 377 P.2d 897 (1963) (stating that the "injured consumer is seldom steeped in the business practice which justifies the [notice requirement]" "and at least until he has had legal advice, it will not occur to him to give notice to one with whom he has had no dealings.") (internal citations omitted).
As to Defendants' second argument that Plaintiff does not identify the terms of the warranty, Plaintiff asserts that the statements in Prolene Mesh's IFU which accompanied each set of the Prolene Mesh provide a description of the product and that Defendants created express warranties through Prolene Mesh's marketing materials. (MSJ Opp'n at 18.) "[T]o prevail on a breach of express warranty claim, the plaintiff must prove (1) the seller's statements constitute an affirmation of fact or promise or a description of the goods; (2) the statement was part of the basis of the bargain; and (3) the warranty was breached." Weinstat v. Dentsply Internat., Inc., 180 Cal. App. 4th 1213, 1227, 103 Cal. Rptr.3d 614 (2010) (internal quotes omitted). Plaintiff does not identify which marketing materials he refers to, but does cite to the Prolene Mesh's IFU which at the very least contain a description of the product. (See MSJ Opp'n at 18-19, 20.) Plaintiff points to the following language in the IFU: (1)"[t]his material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use" and (2) "potential adverse reactions . . . are those typically associated with surgically implantable materials, including inflammation, seroma foundation, adhesion formation, fistula formation, extrusion and potentiation of infection." (Id. at 21.) Thus, through the IFU, Plaintiff has identified Defendants' statements that constitute a description of the goods.
Next, Defendants argue that Plaintiff's breach of express warranty claim fails because Plaintiff has no privity with Defendants. (MSJ at 7.) Plaintiff argues that privity is not required here. (MSJ Opp'n at 19-20.) Plaintiff is correct. The "general rule is that privity of contract is required in an action for breach of either express or implied warranty and that there is no privity between the original seller and a subsequent purchaser who is in no way a party to the original sale." Burr v. Sherwin Williams Co., 42 Cal. 2d 682, 695, 268 P.2d 1041 (1954). However, "privity is not an absolute requirement in express warranty claims." Tapia v. Davol, Inc., 116 F. Supp. 3d 1149, 1160 (S.D. Cal. 2015) (finding that plaintiff's express warranty claim against manufacturer of hernia repair device does not require privity of contract because plaintiff's claim is based on the manufacturer's written representations in labels and written advertising materials.) In Burr, the California Supreme Court noted an exception to the showing of privity based on a plaintiff's reliance on a manufacturer's representations in "labels or advertising materials" to provide the basis for an express warranty. Burr, 42 Cal. 2d at 696, 268 P.2d 1041; see Dagher v. Ford Motor Co., 238 Cal. App. 4th 905, 927, 190 Cal.Rptr.3d 261 (2015) (California courts have not adhered to a strict application of privity for express warranty claims in products liability cases.); see Evraets v. Intermedics Intraocular, Inc., 29 Cal. App. 4th 779, 789-94, 34 Cal.Rptr.2d 852 (1994) (in action by plaintiff against manufacturer that made the lens that was later implanted in plaintiff's eye, the court stated that privity between the plaintiff and manufacturer is a necessary element for plaintiff's breach of implied warranty claim, but that "privity is not a requirement for actions based upon an express warranty"), abrogated on other grounds by Mize v. Mentor Worldwide LLC, 51 Cal. App. 5th 850, 860, 265 Cal.Rptr.3d 468 (2020); Coleman v. Bos. Sci. Corp., 2011 WL 3813173, at *4 (E.D. Cal. Aug. 29, 2011) ("[P]rivity is not an absolute requirement for express warranty claims under California law, because reliance on a seller's representations may provide the basis for an express warranty claim even absent privity."). Accordingly, because Plaintiff's breach of express warranty claim is based on Defendants' representation in its IFU label, Plaintiff's breach of express warranty claim does not require privity.
The Court notes that other district courts including this Court have found that privity of contract is required under a breach of express warranty claim. See Jager v. Davol Inc., 2016 WL 6157942, at *4 (C.D. Cal. Oct. 20, 2016) ("in the context of implantable medical devices, courts have generally concluded that [ ] exceptions [to privity] do not apply, since the transaction is between the manufacturer and the physician, not the patient.") (internal quotes omitted). In Jager, in support of its conclusion, the Court cited other district court cases where courts dismissed claims for breach of express warranty for lack of privity. Id. However, after further analysis of those district court cases and the California case law that those cases cite, the Court concludes that privity is an element of a breach of implied warranty claim, but not of an express warranty claim where a purchaser relied on representations made by a manufacturer in labels or advertising material. Compare Blanco v. Baxter Healthcare Corp., 158 Cal. App. 4th 1039, 1059, 70 Cal.Rptr.3d 566, (2008) (finding that because plaintiff relied on her physician's skill and judgment to select the product, as evidenced by the fact that it was prescribed by a licensed physician, plaintiff cannot sue manufacturer for breach of implied warranties) (emphasis added) with Evraets v. Intermedics Intraocular, Inc., 29 Cal. App. 4th 779, 787, n. 4, 34 Cal.Rptr.2d 852 (1994) (in action by plaintiff against manufacturer that made the lens that was later implanted in plaintiff's eye, the court stated that privity between plaintiff and manufacturer is a necessary element for plaintiff's breach of implied warranty claim, but that "privity is not a requirement for actions based upon an express warranty") (citing Rodrigues v. Campbell Indus., 87 Cal. App. 3d 494, 500, 151 Cal.Rptr. 90 (1978) (in action by crew members of a fishing vessel against manufacturers of the vessel, court stated that privity between the parties remains a requirement for actions based upon an implied warranty, but not an express warranty)).
Defendants also argue that Plaintiff cannot prevail on his breach of express warranty claim because there is no evidence that he or Dr. Sim relied on any express warranty. (MSJ at 7.) Plaintiff argues that he does not need to show reliance. (MSJ Opp'n at 20.) As other courts have noted, California law is "unsettled" with respect to whether in the absence of privity, a plaintiff needs to show reliance. See, e.g., Watkins v. MGA Ent., Inc., 574 F. Supp. 3d 747, 757 (N.D. Cal. 2021). Plaintiff cites to Weinstat, in support of his argument that Plaintiff does not need to show reliance. (MSJ Opp'n at 20 (citing Weinstat, 180 Cal. App. 4th at 1213, 103 Cal.Rptr.3d 614).) "In Weinstat, the court concluded that California Commercial Code section 2313 abandoned the 'Pre-Uniform Commercial Code law governing express warranties requir[ing] the purchaser to prove reliance on specific promises made by the seller.' " Watkins, 574 F. Supp. 3d at 758 (quoting Weinstat, 180 Cal. App. 4th at 1227, 103 Cal.Rptr.3d 614). Instead, the court found, "[a]ny affirmation, once made, is part of the agreement unless there is 'clear affirmative proof' that the affirmation has been taken out of the agreement." Weinstat, 180 Cal. App. 4th at 1229, 103 Cal.Rptr.3d 614. "Thus, in Weinstat, where a group of dentists brought a claim for breach of express warranties against the manufacturer of the allegedly defective medical device, from which they had purchased the product, the court concluded that statements made in the directions for use that were delivered with the product after it was purchased became part of the basis of the bargain between the plaintiffs and the seller." Watkins, 574 F. Supp. 3d at 758. This Court, like others, concludes that the discussion of reliance in Weinstat is limited to the facts of that case, namely, that the parties were in privity, and that the pre-U.C.C. requirement that there must be actual reliance where the parties are not in privity continues to apply. See, e.g. Watkins v. MGA Ent., Inc., 574 F. Supp. 3d at 758.
Here, there is no dispute that Plaintiff was not in privity with Defendants, in contrast to the parties in Weinstat. Thus, Plaintiff needs to present evidence that his physician relied on Defendants' IFU label. Plaintiff meets that burden. At his deposition, Plaintiff's counsel asked Dr. Sim whether he knew if his technique of implanting Prolene Mesh was consistent with the IFU and Dr. Sim replied "[t]hat's always been my way of handling the Prolene Mesh." (DSUF Response ¶ 8.) Furthermore, Dr. Sim testified that he was once an Ethicon, Inc. paid consultant and trained his colleagues on how to implant Prolene Mesh for hernia repair. (PGI ¶ 15.) Based on those facts, a reasonable juror could conclude that Dr. Sim relied on the Prolene Mesh IFU.
Defendants' last argument is that Plaintiff cannot show that he was injured by any breach of warranty. (MSJ at 8.) The Court finds that a genuine dispute of material fact exists as to whether the express warranty was breached. Plaintiff asserts that the Prolene Mesh did not perform as warranted because Dr. Chen found that the Prolene Mesh had migrated, strangled Plaintiff's spermatic cord, and constricted Plaintiff's nerves. (DSUF ¶ 5.) Based on the record, a reasonable juror could conclude that the express warranty was breached. Accordingly, the Court DENIES summary judgment as to Plaintiff's breach of express warranty claim.
5. Claim Six and Seven: Fraudulent Concealment and Negligent Misrepresentation
Defendants argue that Plaintiff's fraud and misrepresentation claims fail for lack of reliance. (MSJ at 8-9.) Specifically, they argue that Plaintiff testified that he did not rely on any representations by Defendants and there is no testimonial evidence that Dr. Sim relied on any representations. (Id.)
In California, the elements of fraudulent concealment are "(1) the defendant must have concealed or suppressed a material fact, (2) the defendant must have been under a duty to disclose the fact to the plaintiff, (3) the defendant must have intentionally concealed or suppressed the fact with the intent to defraud the plaintiff, (4) the plaintiff must have been unaware of the fact and would not have acted as he did if he had known of the concealed or suppressed fact, and (5) as a result of the concealment or suppression of the fact, the plaintiff must have sustained damage." Nissan Motor Acceptance Cases, 63 Cal. App. 5th 793, 826, 277 Cal.Rptr.3d 914 (2021) (quotation marks omitted). "The elements of negligent misrepresentation are similar to intentional fraud except for the requirement of scienter; in a claim for negligent misrepresentation, the plaintiff need not allege the defendant made an intentionally false statement, but simply one as to which he or she lacked any reasonable ground for believing the statement to be true." LockandLocate, LLC v. Hiscox Ins. Co., 549 F. Supp. 3d 1093, 1100-01 (C.D. Cal. 2021) (quoting Charnay v. Cobert, 145 Cal. App. 4th 170, 184, 51 Cal.Rptr.3d 471 (2006)). In California, reliance in a fraudulent concealment or negligent misrepresentation case may be proved by establishing that "had the omitted information been disclosed, [the plaintiff] would have been aware of it and behaved differently." Mirkin v. Wasserman, 5 Cal. 4th 1082, 1093, 23 Cal.Rptr.2d 101, 858 P.2d 568 (1993).
Similar to the failure to warn claim, the Court finds that although Plaintiff presents evidence that Dr. Sim may have relied on Defendants' representations regarding Prolene Mesh, Plaintiff has not presented any evidence that had any other information been disclosed, Dr. Sim would have behaved differently. See Enborg v. Ethicon, Inc., 2022 WL 800879, at *21 (E.D. Cal. Mar. 16, 2022) (granting manufacturer summary judgment as to plaintiff's negligent misrepresentation claim because even if physician was not aware of the omitted risks, there is no evidence that knowledge of those risks would have altered the physician's prescription decision). Accordingly, the Court GRANTS Defendants summary judgment as to Plaintiff's fraudulent concealment and negligent misrepresentation claims.
V. CONCLUSION
For the foregoing reasons, the Court ORDERS as follows:
1. Defendants' MTE is DENIED-IN-PART. The Court DENIES Defendants' MTE as to Dr. Yoo's specific causation and design opinions. Defendants' exclusion argument regarding Dr. Yoo's warning opinion is MOOT.
2. Defendants' MSJ is GRANTED-IN-PART. The Court GRANTS summary judgment as to Plaintiff's strict liability and negligent failure to warn claims, and Plaintiff's fraudulent concealment and negligent misrepresentation claims. The Court DENIES summary judgment as to Plaintiff's negligent design defect claim and Plaintiff's breach of express warranty claim.
3. The Court DISMISSES Plaintiff's negligent infliction of emotional distress claim.
4. The hearing on the MSJ and MTE scheduled for February 6, 2023 is VACATED.