Enborg v. Ethicon, Inc. ( 2022 )

1 2 UNITED STATES DISTRICT COURT 3 EASTERN DISTRICT OF CALIFORNIA 4 5 CASE NO. 2:20-cv-02477-AWI-BAK 6 TERRI ENBORG, et al. ORDER DENYING PLAINTIFF’S 7 Plaintiff, MOTION TO RECONSIDER ORDER EXCLUDING EXPERT OPINIONS ON 8 v. TVT BRANDING AND WARNINGS 9 ETHICON, INC., et al., (Doc. No. 171) 10 Defendants. 11 12 13 Plaintiff Terri Eborg brings a motion, Doc. No. 171, seeking reconsideration of an order 14 excluding expert testimony regarding branding and warnings for the TVT device at issue in this 15 case. See Doc. No. 153. The motion has been fully briefed and was taken under submission 16 following oral argument on April 25, 2022. Doc. No. 184. For the reasons set forth below, the 17 motion will be denied. 18 BACKGROUND 19 On March 16, 2022, the Court issued an order granting summary judgment in Ethicon’s1 20 favor on Enborg’s “failure to warn” claims on a finding, under California’s “learned intermediary 21 doctrine,” that a reasonable jury could not conclude that additional information regarding risks 22 associated with the TVT device would have affected the course of treatment prescribed and 23 implemented by Enborg’s doctor. See Doc. No. 153 at 34:16-26.2 Further, the Court excluded, 24 inter alia, opinions offered by three of Enborg’s experts with respect to product branding and 25 warnings on the grounds that such opinions are not relevant to Enborg’s claim for negligent design 26 27 1 Unless otherwise specified, “Ethicon,” as used herein, refers to both remaining Defendants in this action—Johnson & Johnson and its subsidiary Ethicon, Inc. 2 Page number citations are to the page number in the CM/ECF stamp at the top of each page of documents on the 1 defect (the only claim remaining in this case). Specifically, the Court excluded: 2 • Dr. Peggy Pence’s opinions that (i) the TVT device was misbranded due to failure 3 to warn; (ii) the TVT device was misbranded as a result of false or misleading 4 labeling; and (iii) the TVT device was misbranded under federal law because of 5 failure to meet the post-marketing vigilance standard of care, see Doc. No. 153 at 6 4-6 (excluding opinions in Doc. No. 103-3 at 91, 96 & 115); 7 • Dr. Bruce Rosenzweig’s opinion that TVT disclosures were inadequate because 8 they did not include certain information contained in Material Safety Data Sheets 9 (“MSDS”) for polypropylene resin (a material used in the TVT), see Doc. No. 153 10 at 3 (excluding opinions in Doc. No. 106-3 at 62-64); and 11 • Dr. Donald Ostergard’s opinions that Ms. Enborg could not have provided 12 informed consent to her doctor because product materials omitted information 13 regarding adverse events and polypropylene resin, and Ms. Enborg’s doctor did not 14 have “all the knowledge known” to Ethicon about the TVT. See Doc. No. 153 at 15 19:27-20:3 (excluding opinions in Doc. No. 111-3 at 8-9).3 16 Enborg contends that these opinions are “necessary and relevant to [her] pending negligent 17 design defect claim,” Doc. No. 171 at 8:4-18, and seeks reconsideration of the rulings excluding 18 them pursuant to Rule 54(b) of the Federal Rules of Civil Procedure, Local Rule 230(j) and the 19 Court’s inherent authority. Id. at 5:14-16 and 8:4-18. 20 LEGAL FRAMEWORK 21 An order that resolves fewer than all the claims among the parties “is subject to revision at 22 any time before the entry of judgment adjudicating all the claims and the rights and liabilities of 23 all the parties.” Fed.R.Civ.P. 54(b); see also E.D. Cal. L.R. 230(j). Where reconsideration of a 24 25 3 Enborg states at one point that she is also seeking reconsideration as to warning opinions offered by Dr. Vladimir 26 Iakovlev. Doc. No. 171 at 9:3. The Court’s order excluding Dr. Iakovlev’s warning opinions, however, is based on a finding that Dr. Iakovlev is not qualified to offer warnings opinions and Enborg’s statement that she does not intend to 27 offer Dr. Iakovlev’s warnings opinions at trial, in addition to the finding, at issue here, that warnings opinions are irrelevant to Enborg’s design defect claim. Doc. No. 153 at 10:20-25. The analysis in this order applies to Dr. Iakovlev’s warning opinions, but they are also properly excluded for the other reasons set forth in the Court’s order on 1 non-final order is sought, the court has “inherent jurisdiction to modify, alter or revoke it.” United 2 States v. Martin, 226 F.3d 1042, 1048–49 (9th Cir. 2000). Generally stated, reconsideration is 3 appropriate where there has been an intervening change in controlling law, new evidence has 4 become available, or it is necessary to correct clear error or prevent manifest injustice. See Sch. 5 Dist. No. 1J Multnomah County, Oregon v. ACandS, Inc., 5 F.3d 1255, 1263 (9th Cir.1993); 6 Cachil Dehe Band of Wintun Indians of Colusa Indian Cmty. v. California, 649 F. Supp. 2d 1063, 7 1069 (E.D. Cal. 2009). “Clear error occurs when the reviewing court on the entire record is left 8 with the definite and firm conviction that a mistake has been committed.” Smith v. Clark Cty. Sch. 9 Dist., 727 F.3d 950, 955 (9th Cir. 2013). 10 PLAINTIFF’S MOTION 11 Enborg contends that exclusion of the opinions at issue here was “clear error” because she 12 has a design defect claim and the California Court of Appeal held in Hansen v. Sunnyside 13 Products., Inc., 55 Cal. App. 4th 1497 (1997), as modified (July 18, 1997), that “package 14 warnings” are relevant to determining whether a product has a design defect under the 15 “risk/benefit test.” Doc. No. 171 at 11:27-13:12. 16 Ethicon argues that the Court’s order could not constitute “clear error” because Hansen 17 involves a defendant’s burden under the burden shifting framework applicable to strict product 18 liability claims, and no California court has applied Hansen to negligent design defect claims. 19 Doc. No. 179 at 5:15-6:25. Further, Ethicon argues that the reasoning in Hansen is inapplicable 20 because the opinions at issue here involve warnings as to inherent product risks, not instructions 21 for safer use. Id. at 7:3-11. Finally, Ethicon argues that reconsideration is not warranted because 22 the Court has already held, in granting summary judgment on Enborg’s “failure to warn” claims, 23 that Enborg “cannot prove causation based on any inadequacy in TVT’s warnings.” Id. at 9:8- 24 10:20. 25 DISCUSSION 26 The Court agrees with Ethicon that Hansen does not apply here. 27 In Hansen, a user of stain remover containing hydrofluoric acid brought a strict product 1 “risk/benefit test.” 55 Cal. App. 4th at 1502. As to the claim under the “risk/benefit test”—which 2 looks at “whether the risk of harm outweigh[s] the benefits of [a] product”—plaintiff showed “she 3 suffered an injury proximately caused by the product’s design” and thus, the burden shifted to the 4 defendant manufacturer to prove that its product was not defective. Id. at 1504, 1513. 5 In closing argument at trial, defense counsel took the position that jurors could consider 6 warning labels on the bottle to determine whether the product had a design defect under the 7 “risk/benefit test.” Id. at 1504. Specifically, defense counsel argued that “the warnings on [a] 8 product … are an integral part of the design of the product” and that the question to be asked 9 under the “risk/benefit test” is, “If used pursuant to the instructions, ... do the advantages of the 10 product ... outweigh the risks?” Hansen, 55 Cal. App. 4th at 1504–05 (internal quotation marks 11 omitted). 12 The front of the stain remover bottle apparently stated as follows: “Danger. May Be Fatal 13 or Cause Permanent Damage, Vapor Harmful, Causes Severe Burns Which May Not Be 14 Immediately Painful or Visible. Read Carefully All Cautions on Back Panel. Keep Out of Reach 15 of Children.” Hansen, 55 Cal. App. 4th at 1502. The back panel, for its part, stated: “Danger. 16 Contains hydrofluoric acid. Use only with rubber gloves, avoid contact with skin. Do not taste, 17 swallow or breathe. Rinse empty container thoroughly with water before discarding.” Id. It also 18 contained a “first aid” section addressing various scenarios, including contact with skin, contact 19 with eyes and swallowing. Id. In the event of skin contact, for example, it stated: “Immediately 20 remove contaminated clothing. Flush skin with water for 15 minutes. Be very careful to clean 21 under fingernails.” Id. As to contact with eyes, it stated: “Rinse immediately with water. Remove 22 contact lenses, if any, then flush eyes with water for another 10 to 15 minutes.” Id. And for 23 swallowing it stated, “Rinse mouth. Drink a glass of water or milk. Do not cause vomiting,” in 24 addition to stating, “Get immediate medical care. Call your Poison Center, emergency department 25 or a physician. Specific antidotal treatment may be needed.” Id. 26 The jury found in favor of defendant, Hansen, 55 Cal. App. 4th at 1508, but the trial court 27 granted judgment notwithstanding the verdict (“JNOV”) in plaintiff’s favor on liability, finding 1 the risk/benefit test.” Hansen, 55 Cal. App. 4th at 1508. 2 The California Court of Appeal reversed the JNOV. The “risk/benefit test,” the Court of 3 Appeal reasoned, involves weighing “the risk of danger inherent in [a] challenged design” against 4 the “benefits of such design” to determine whether a design poses “excessive preventable danger.” 5 Hansen, 55 Cal. App. at 1512. The “risk of danger,” in turn, involves both the “gravity” and 6 “likelihood” of harm. Id. at 1513 (citing Barker v. Lull Engineering Co., 20 Cal.3d 413, 430 7 (1978)). “[P]ackage warnings” can prevent—or reduce the likelihood of—harm if followed, and 8 thus “are relevant in determining whether [a] product has a design defect under the risk/benefit 9 test.” Id. at 1513, 1515 and 1519. 10 Courts have found that the “risk/benefit test” can be applied to prove design defect for 11 negligent design defect claims like Enborg’s claim in this case, in addition to strict product 12 liability claims like the claim in Hansen. See e.g., Chavez v. Glock, Inc., 207 Cal. App. 4th 1283, 13 1304–05 (2012). Unlike Hansen, however, this case does not involve use instructions. See In re 14 Ethicon, Inc., 2014 WL 457544, at *5 (S.D.W. Va. Feb. 3, 2014) (Goodwin, J.) (distinguishing 15 between warnings as to inherent danger, on the one hand, and instructions for safer use, on the 16 other, in connection with the TVT). Dr. Pence, for example, opines that Ethicon falsely claimed in 17 a marketing piece that the TVT had “5 Years of Proven Performance,” Doc. No. 103-3 at 92, 18 while failing to report “a number of adverse events and malfunctions …, rendering the TVT 19 devices misbranded.” Id. at 116. Dr. Rosenzweig opines that Ethicon failed to disclose that 20 polypropylene resin used in TVT mesh is susceptible to breaking down after implantation. Doc. 21 No. 106-3 at 64 (“The fact that the mesh in the TVT is susceptible to breaking down when in 22 contact with peroxides makes it an unsuitable material to be placed in the vagina for the reasons 23 discussed above. At the very least, Ethicon should have disclosed this information to physicians 24 and patients considering use of their pelvic mesh.”). And Dr. Ostergard opines that TVT materials 25 failed to disclose “that the product could degrade in the body or cause cancer in the future,” that 26 “the mesh would be contaminated by bacteria during insertion,” and that “the MSDS by the 27 manufacturer of the resin [used in the TVT] stated that [the resin] should not be placed into a 1 In deciding a similar motion to reconsider, the MDL Court found that the TVT warning in 2 | question was not relevant to the “‘risk/benefit test” because it did not “address a safe method or 3 |manner of using the TVT.” See In re Ethicon, Inc., 2014 WL 457544 at *5 (emphasis original). 4 |“The warning serve[d] only to inform physicians of the risks of implanting the device,” the court 5 |found, and “[t]here [wa]s no way that the TVT’s design c[ould] be used in a safer manner by 6 | following the warning.” Id. (emphasis original). 7 The same is true here. The warnings opinions offered by Drs. Pence, Rosenzweig and 8 | Ostergard may inform whether “[a] physician [] implants the device or chooses an alternative 9 | treatment,” In re Ethicon, Inc., 2014 WL 457544 at *5, but unlike the instructions in Hansen, they 10 | do nothing to reduce the “likelihood” (or gravity) of harm from using the TVT. The holding in 11 | Hansen that “warnings on a product label are relevant in determining whether the product has a 12 | design defect under the risk/benefit test” 1s, therefore, inapplicable here. See Hansen, 55 Cal. App. 13 at 1519. 14 Enborg provides no basis other than Hansen for her contention that her experts’ warnings 15 | opinions are relevant to her negligent design defect claim. Thus, Enborg has failed to show “clear 16 | error’—or even that a mistake may have been made—and her motion will be denied.* See Smith, 17 |727 F.3d at 955. 18 ORDER 19 Accordingly, IT IS HEREBY ORDERED that Plaintiff Terri Enborg’s motion to reconsider 20 No. 171) is DENIED. 21 IT IS SO ORDERED. 53 |Dated: _ April 29, 2022 _. 7 LZ : 7 Cb Lod — SENIOR DISTRICT JUDGE 24 25 26 27 28 light of this finding, it is unnecessary for the Court to address Ethicon’s other arguments for denying Enborg’s