1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 SHARON DE EDWARDS, Case No. 21-cv-01828-JSC
8 Plaintiff, ORDER RE: DEFENDANT’S MOTION 9 v. FOR SUMMARY JUDGMENT
10 THERMIGEN LLC, Re: Dkt. No. 107 Defendant. 11
12 13 Plaintiff Sharon de Edwards, MD, sues Thermigen for fraudulently marketing and selling a 14 medical device as approved by the U.S. Food and Drug Administration as a treatment modality for 15 menopause symptoms. (Dkt. No. 63.)1 Before the Court is Defendant’s motion for summary 16 judgment. (Dkt. No. 107.) Having carefully considered the briefing, the Court concludes oral 17 argument is unnecessary, see Civ. L.R. 7-1(b), and DENIES Defendant’s motion for summary 18 judgment. A genuine dispute exists as to whether the alleged misrepresentation underlying each 19 of Plaintiff’s claims is actionable under California law. Additionally, the Court sua sponte 20 GRANTS summary judgment in favor of Plaintiff on Thermigen’s real-party-in-interest defense. 21 DISCUSSION 22 Plaintiff’s claims are all premised on her assertion Thermigen’s salesperson Mike Shepard 23 orally represented FDA approval of the medical device for treatment of menopause symptoms was 24 forthcoming. (See, e.g., Dkt. No. 95 at 1-2.) Mr. Shepard attests he never made such a 25 representation. (Dkt. No. 96-4 at ¶ 8.) Thermigen moves for summary judgment on the grounds 26 the alleged misrepresentation is nonactionable. 27 1 The purpose of summary judgment “is to isolate and dispose of factually unsupported 2 claims or defenses.” Celotex Corp. v. Catrett, 477 U.S. 317, 323-24 (1986). Under Federal Rule 3 of Civil Procedure 56, summary judgment is proper if Thermigen shows there is no genuine 4 dispute of material fact and Thermigen is entitled to judgment as a matter of law. Fed. R. Civ. P. 5 56. Thermigen bears the initial burden of demonstrating the lack of a genuine issue of material 6 fact. Celotex Corp., 477 U.S. at 323. To survive, Plaintiff must establish a genuine issue of 7 material fact for trial through probative evidence. Matsushita Elec. Indus. Co. v. Zenith Radio 8 Corp., 475 U.S. 574, 585-86 (1986); Intel Corp. v. Hartford Acc. & Indem. Co., 952 F.2d 1551, 9 1558 (9th Cir. 1991) (“If the moving party meets its initial burden of showing the absence of a 10 material and triable issue of fact, the burden then moves to the opposing party, who must present 11 significant probative evidence tending to support its claim or defense.” (cleaned up)). In ruling on 12 a motion for summary judgment, the Court must “view the evidence presented through the prism 13 of the substantive evidentiary burden.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 254 14 (1986). The evidence of the non-movant is to be believed, and all justifiable inferences are to be 15 drawn in the non-movant’s favor. Id. at 255. 16 I. Misrepresentation’s Actionability 17 Generally, “[p]redictions as to future events, or statements as to future action by some third 18 party, are deemed opinions” and thus do not constitute actionable misrepresentations. Borba v. 19 Thomas, 70 Cal. App. 3d 144, 152 (Ct. App. 1977).
20 There are, however, three recognized exceptions to the general rule: (1) where a party holds himself out to be specially qualified and the 21 other party is so situated that he may reasonably rely upon the former’s superior knowledge; (2) where the opinion is by a fiduciary 22 or other trusted person; (3) where a party states his opinion as an existing fact or as implying facts which justify a belief in the truth of 23 the opinion. 24 Id. 25 Thermigen makes no argument and adduces no evidence demonstrating the third exception 26 does not render Mr. Shepard’s alleged misrepresentation actionable; that is, Thermigen fails to 27 establish no reasonable trier of fact could find Mr. Shepard did not represent FDA approval was 1 forthcoming FDA approval. At the very least, a reasonable trier of fact could find Mr. Shepard’s 2 statement FDA approval was forthcoming implies Thermigen applied for FDA clearance of its 3 device for treatment of menopause symptoms. But the evidence supports a finding that in July 4 2018, a month after Plaintiff purchased the device, Thermigen had not yet sought “FDA clearance 5 or approval for the THERMIva for [vaginal rejuvenation].” (Dkt. No. 95-2 at 7.) Thermigen does 6 not address whether the false implication of a pending application for FDA approval of a device 7 for menopause treatment justifies a belief in such forthcoming approval, and thus fails to establish 8 Plaintiff’s belief in the forthcoming FDA approval was unjustifiable as a matter of law. So, 9 Thermigen fails to establish Mr. Shepard’s alleged misrepresentation is nonactionable. 10 Thermigen’s reliance on Borba v. Thomas is unpersuasive. 70 Cal. App. 3d 144 (Ct. App. 11 1977). Borba concerned a nonactionable representation from a private individual to another 12 equally knowledgeable private individual regarding the future conduct of public officials. The 13 state court ruled “where there is no relation of special trust or confidence between the buyer and 14 seller, and where the means of knowledge of the pertinent facts are equally available to both 15 parties, neither person can justifiably rely on the expressions of opinion by the other concerning 16 future events.” Id. at 155. But Thermigen fails to establish “the means of knowledge of the 17 pertinent facts” were equally available to Plaintiff and Mr. Shepard, Thermigen’s representative. 18 Id. Unlike in Borba, a reasonable trier of fact could find Thermigen had better access than 19 Plaintiff to facts pertinent to the status of Thermigen’s implied application for FDA approval. For 20 the same reason, Thermigen’s reliance on Brakke v. Economic Concepts, Inc., is unavailing. 213 21 Cal. App. 4th 761, 769-70 (2013). Unlike in Brakke, when a pension planning marketing 22 company’s statements regarding the Internal Revenue Service’s future treatment of a pension plan 23 were deemed nonactionable, Thermigen is better situated to determine and represent the status of 24 its own device’s implied application for FDA clearance. 25 Thermigen also argues the alleged misrepresentation is expressly disclaimed by the Sales 26 Agreement. But in California, “it is well-established” disclaimers disavowing all prior 27 representations “do not operate to insulate defrauding parties from liability or preclude [a plaintiff] 1 Cal. App. 5th 375, 393 (2019); see Cal. Civ. Code § 1668 (“All contracts which have for their 2 object, directly or indirectly, to exempt any one from responsibility for his own fraud, or willful 3 injury to the person or property of another, or violation of law, whether willful or negligent, are 4 against the policy of the law.”). So, Thermigen fails to establish the Sales Agreement’s disclaimer 5 shields Thermigen from liability for its fraudulent misrepresentations. 6 Accordingly, Thermigen’s motion for summary judgment on the grounds the alleged 7 misrepresentation is nonactionable is DENIED. 8 II.
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1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 SHARON DE EDWARDS, Case No. 21-cv-01828-JSC
8 Plaintiff, ORDER RE: DEFENDANT’S MOTION 9 v. FOR SUMMARY JUDGMENT
10 THERMIGEN LLC, Re: Dkt. No. 107 Defendant. 11
12 13 Plaintiff Sharon de Edwards, MD, sues Thermigen for fraudulently marketing and selling a 14 medical device as approved by the U.S. Food and Drug Administration as a treatment modality for 15 menopause symptoms. (Dkt. No. 63.)1 Before the Court is Defendant’s motion for summary 16 judgment. (Dkt. No. 107.) Having carefully considered the briefing, the Court concludes oral 17 argument is unnecessary, see Civ. L.R. 7-1(b), and DENIES Defendant’s motion for summary 18 judgment. A genuine dispute exists as to whether the alleged misrepresentation underlying each 19 of Plaintiff’s claims is actionable under California law. Additionally, the Court sua sponte 20 GRANTS summary judgment in favor of Plaintiff on Thermigen’s real-party-in-interest defense. 21 DISCUSSION 22 Plaintiff’s claims are all premised on her assertion Thermigen’s salesperson Mike Shepard 23 orally represented FDA approval of the medical device for treatment of menopause symptoms was 24 forthcoming. (See, e.g., Dkt. No. 95 at 1-2.) Mr. Shepard attests he never made such a 25 representation. (Dkt. No. 96-4 at ¶ 8.) Thermigen moves for summary judgment on the grounds 26 the alleged misrepresentation is nonactionable. 27 1 The purpose of summary judgment “is to isolate and dispose of factually unsupported 2 claims or defenses.” Celotex Corp. v. Catrett, 477 U.S. 317, 323-24 (1986). Under Federal Rule 3 of Civil Procedure 56, summary judgment is proper if Thermigen shows there is no genuine 4 dispute of material fact and Thermigen is entitled to judgment as a matter of law. Fed. R. Civ. P. 5 56. Thermigen bears the initial burden of demonstrating the lack of a genuine issue of material 6 fact. Celotex Corp., 477 U.S. at 323. To survive, Plaintiff must establish a genuine issue of 7 material fact for trial through probative evidence. Matsushita Elec. Indus. Co. v. Zenith Radio 8 Corp., 475 U.S. 574, 585-86 (1986); Intel Corp. v. Hartford Acc. & Indem. Co., 952 F.2d 1551, 9 1558 (9th Cir. 1991) (“If the moving party meets its initial burden of showing the absence of a 10 material and triable issue of fact, the burden then moves to the opposing party, who must present 11 significant probative evidence tending to support its claim or defense.” (cleaned up)). In ruling on 12 a motion for summary judgment, the Court must “view the evidence presented through the prism 13 of the substantive evidentiary burden.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 254 14 (1986). The evidence of the non-movant is to be believed, and all justifiable inferences are to be 15 drawn in the non-movant’s favor. Id. at 255. 16 I. Misrepresentation’s Actionability 17 Generally, “[p]redictions as to future events, or statements as to future action by some third 18 party, are deemed opinions” and thus do not constitute actionable misrepresentations. Borba v. 19 Thomas, 70 Cal. App. 3d 144, 152 (Ct. App. 1977).
20 There are, however, three recognized exceptions to the general rule: (1) where a party holds himself out to be specially qualified and the 21 other party is so situated that he may reasonably rely upon the former’s superior knowledge; (2) where the opinion is by a fiduciary 22 or other trusted person; (3) where a party states his opinion as an existing fact or as implying facts which justify a belief in the truth of 23 the opinion. 24 Id. 25 Thermigen makes no argument and adduces no evidence demonstrating the third exception 26 does not render Mr. Shepard’s alleged misrepresentation actionable; that is, Thermigen fails to 27 establish no reasonable trier of fact could find Mr. Shepard did not represent FDA approval was 1 forthcoming FDA approval. At the very least, a reasonable trier of fact could find Mr. Shepard’s 2 statement FDA approval was forthcoming implies Thermigen applied for FDA clearance of its 3 device for treatment of menopause symptoms. But the evidence supports a finding that in July 4 2018, a month after Plaintiff purchased the device, Thermigen had not yet sought “FDA clearance 5 or approval for the THERMIva for [vaginal rejuvenation].” (Dkt. No. 95-2 at 7.) Thermigen does 6 not address whether the false implication of a pending application for FDA approval of a device 7 for menopause treatment justifies a belief in such forthcoming approval, and thus fails to establish 8 Plaintiff’s belief in the forthcoming FDA approval was unjustifiable as a matter of law. So, 9 Thermigen fails to establish Mr. Shepard’s alleged misrepresentation is nonactionable. 10 Thermigen’s reliance on Borba v. Thomas is unpersuasive. 70 Cal. App. 3d 144 (Ct. App. 11 1977). Borba concerned a nonactionable representation from a private individual to another 12 equally knowledgeable private individual regarding the future conduct of public officials. The 13 state court ruled “where there is no relation of special trust or confidence between the buyer and 14 seller, and where the means of knowledge of the pertinent facts are equally available to both 15 parties, neither person can justifiably rely on the expressions of opinion by the other concerning 16 future events.” Id. at 155. But Thermigen fails to establish “the means of knowledge of the 17 pertinent facts” were equally available to Plaintiff and Mr. Shepard, Thermigen’s representative. 18 Id. Unlike in Borba, a reasonable trier of fact could find Thermigen had better access than 19 Plaintiff to facts pertinent to the status of Thermigen’s implied application for FDA approval. For 20 the same reason, Thermigen’s reliance on Brakke v. Economic Concepts, Inc., is unavailing. 213 21 Cal. App. 4th 761, 769-70 (2013). Unlike in Brakke, when a pension planning marketing 22 company’s statements regarding the Internal Revenue Service’s future treatment of a pension plan 23 were deemed nonactionable, Thermigen is better situated to determine and represent the status of 24 its own device’s implied application for FDA clearance. 25 Thermigen also argues the alleged misrepresentation is expressly disclaimed by the Sales 26 Agreement. But in California, “it is well-established” disclaimers disavowing all prior 27 representations “do not operate to insulate defrauding parties from liability or preclude [a plaintiff] 1 Cal. App. 5th 375, 393 (2019); see Cal. Civ. Code § 1668 (“All contracts which have for their 2 object, directly or indirectly, to exempt any one from responsibility for his own fraud, or willful 3 injury to the person or property of another, or violation of law, whether willful or negligent, are 4 against the policy of the law.”). So, Thermigen fails to establish the Sales Agreement’s disclaimer 5 shields Thermigen from liability for its fraudulent misrepresentations. 6 Accordingly, Thermigen’s motion for summary judgment on the grounds the alleged 7 misrepresentation is nonactionable is DENIED. 8 II. Real Party in Interest 9 As an affirmative defense, Thermigen asserts Plaintiff is not the real party in interest under 10 Federal Rules of Civil Procedure 17(a)(1). (See, e.g., Dkt. No. 96 at 7-8.) Though neither party 11 has moved for summary judgment on Thermigen’s real-party-in-interest affirmative defense, the 12 Court may sua sponte grant summary judgment. Fed. R. Civ. P. 56(f). In the Court’s prior order 13 denying Plaintiff’s motion for summary judgment, the Court noted “[t]here appears no genuine 14 dispute Plaintiff is the real party in interest” because the Sales Agreement unambiguously 15 demonstrates Plaintiff purchased the device. (Dkt. No. 109 at 2.) Nonetheless, the Court provided 16 Thermigen the opportunity to show cause in writing by June 27, 2024, why a genuine dispute 17 exists as to whether Plaintiff purchased the device. (Id. at 3.) The Court cautioned, “[i]f 18 Defendant fails to show cause, the Court will grant summary judgment in Plaintiff’s favor on 19 Defendant’s real-party-in-interest affirmative defense.” (Id.) Thermigen failed to submit a written 20 submission responding to the Court’s order to show cause. Accordingly, the Court GRANTS 21 summary judgment in favor of Plaintiff on Thermigen’s real-party-in-interest defense. 22 // 23 // 24 // 25 // 26 // 27 // 1 CONCLUSION 2 For the stated reasons, Thermigen’s motion for partial summary judgment is DENIED and 3 Thermigen’s real-party-in-interest defense is DISMISSED with prejudice. 4 This Order disposes of Docket No. 107. 5 IT IS SO ORDERED. 6 || Dated: July 30, 2024 7 8 ne AACQWELINE SCOTT CORLEY 9 United States District Judge 10 11 a 12
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