Judge: Kimberly Knill, Case: 30-2020-01162412-CU-PO-CJC, Date: 2023-08-11 Tentative Ruling
Defendant Ethicon, Inc.’s Motion for Summary Judgment or, Alternatively, Summary Adjudication
Defendant Ethicon Inc.’s Motion for Summary Judgment is GRANTED.
Request for Continuance per Code of Civil Procedure section 437c, subdivision (h)
Plaintiff’s counsel submitted a declaration requesting a continuance. (See Code Civ. Proc., § 437c, subd. (h) [if it appears from affidavits facts essential to justify opposition may exist but cannot then be presented, court shall order a continuance].) Continuance of a motion for summary judgment is not mandatory when the declaration fails to make the necessary showing. (Johnson v. Alameda County Med. Ctr. (2012) 205 Cal.App.4th 521, 532 (Johnson).)
An opposing party's declaration in support of a motion to continue the summary judgment hearing should show the following: (1) facts establishing a likelihood that controverting evidence may exist and why the information sought is essential to opposing the motion; (2) the specific reasons why such evidence cannot be presented at the present time; (3) an estimate of the time necessary to obtain such evidence; and (4) the specific steps or procedures the opposing party intends to utilize to obtain such evidence. (Johnson, supra, 205 Cal.App.4th at p. 532.)
“The statute cannot be employed as a device to get an automatic continuance by every unprepared party who simply files a declaration stating that unspecified essential facts may exist.” (Johnson, supra, 205 Cal.App.4th at p. 532.) “There must be a justifiable reason why the essential facts cannot be presented. An inappropriate delay in seeking to obtain the facts may not be a valid reason why the facts cannot then be presented. The statute itself authorizes the imposition of sanctions for declarations presented in bad faith or solely for purposes of delay. (§ 437c, subd. (j)).” Cooksey v. Alexakis (2004) 123 Cal.App.4th 246, 257 (Cooksey).)
In this case, the declaration of Matthew Singer does not support a continuance, because:
• Mr. Singer states he has had access to the Global Document Production since September 2022 and has been meeting with experts for almost a year on this case.
• Mr. Singer does not state why facts regarding the Mission Hospital witnesses are necessary to opposing this motion. Although one of those depositions is not completed, Plaintiff provides no evidence the facts revealed in those depositions are material to the issues in this case.
• There is no justification why the discovery could not have been completed sooner, or more specifically, in time to oppose the instant motion. The deposition of Ethicon’s PMK commenced on 3/21/2023. If Ethicon was uncooperative in producing witnesses for deposition, Plaintiff should have moved this Court for an order compelling those depositions.
• Mr. Singer provides no reason why some of the information he seeks from Ethicon (See Singer Decl., ¶ 30) was not obtained through discovery requests and interrogatories.
• Mr. Singer indicates he has been diligent, but his declaration is devoid of any facts regarding what actions he has taken to obtain the necessary information from Ethicon, including any meaningful meet and confer efforts. There is no evidence counsel sent emails or even made a phone call to Ethicon to discuss the noticed depositions.
• Code of Civil Procedure section 437c, subdivision (h) states a party seeking a continuance can do so “by ex parte motion at any time on or before the date the opposition response to the motion is due.” Here, Plaintiff failed to move for ex parte relief or to notify the Court prior to filing its opposition that a continuance was necessary. Plaintiff did not ask for additional Ethicon discovery or a continuance of the summary judgment motion until July 28–the day her opposition to the motion was due. (Conour Decl. at ¶11.)
• Mr. Singer does not state what steps Plaintiff intends to take to obtain the discovery, and how long such actions would take. There is no pending motion to compel the deposition of Ethicon’s witness, and trial is set for two months away.
Moreover, trial has already been continued three times, the case has been pending since 2020, and Ethicon filed its original summary judgment motion (which was later withdrawn and replaced by the instant motion) on 11/2/2022. Plaintiff has had more than adequate opportunity to pursue discovery in opposition to Ethicon’s attempts to obtain summary judgment. While lack of diligence alone arguably should not make or break a continuance request (Bahl v. Bank of America (2001) 89 Cal.App.4th 389, 398), here there is much more. (See Braganza v. Albertson’s LLC (2021) 67 Cal.App.5th 144, 156 [inappropriate delay in seeking to obtain facts may not be valid reason why facts cannot then be presented; good faith showing further discovery is needed requires some justification for why discovery could not have been completed sooner]; see also Cooksey, supra, 123 Cal.App.4th at p. 257 [good faith showing further discovery is needed to oppose summary judgment requires some justification for why such discovery could not have been completed sooner].)
Accordingly, Plaintiff’s request for a continuance is DENIED.
Motion for Summary Judgment
“The party moving for summary judgment bears the burden of persuasion that there is no triable issue of material fact and that he is entitled to judgment as a matter of law. That is because of the general principle that a party who seeks a court’s action in his favor bears the burden of persuasion thereon. (See Evid. Code, § 500.) There is a triable issue of material fact if, and only if, the evidence would allow a reasonable trier of fact to find the underlying fact in favor of the party opposing the motion in accordance with the applicable standard of proof.” (Aguilar v. Atlantic Richfield Co. (2001) 25 Cal.4th 826, 850 (fn omitted).)
Code of Civil Procedure section 437c(p)(2) states, “A defendant or cross-defendant has met his or her burden of showing that a cause of action has no merit if the party has shown that one or more elements of the cause of action, even if not separately pleaded, cannot be established, or that there is a complete defense to the cause of action. Once the defendant or cross-defendant has met that burden, the burden shifts to the plaintiff or cross-complainant to show that a triable issue of one or more material facts exists as to the cause of action or a defense thereto. The plaintiff or cross-complainant shall not rely upon the allegations or denials of its pleadings to show that a triable issue of material fact exists but, instead, shall set forth the specific facts showing that a triable issue of material fact exists as to the cause of action or a defense thereto.”
Once the defendant has met this burden, the burden shifts to the plaintiff to show a triable issue of one or more material facts exists as to the cause of action or a defense thereto. (Code Civ. Proc., § 437c, subd. (p)(1).)
Plaintiff did not file a substantive opposition to the motion and has submitted no evidence to dispute Ethicon’s undisputed material facts. As will be seen, Ethicon has met its burden to show every cause of action has no merit, and Plaintiff has not met her burden to show a triable issue of one or more material facts exists as to any cause of action.
Strict Liability
A manufacturer is not strictly liable for injuries caused by an implanted prescription medical product which has been (1) properly made and (2) distributed with information regarding risks and dangers of which the manufacturer knew or should have known at the time. (Hufft v. Horowitz (1992) 4 Cal.App.4th 8, 11, citing Brown v. Superior Court (1988), 44 Cal.3d 1049, 1058).)
The TVT Exact is an FDA-cleared implantable prescription medical device. (Ramm Decl., ¶ 13.) There is no evidence the product was not properly made. Dr. Granese testified she could not be certain the TVT Exact malfunctioned and testified only that she expected to be able to remove the sheath during the course of the procedure and was not able to remove a portion. (Granese Depo., p. 119:8-120:16.) Further, the TVT Exact was also distributed with Instructions for Use providing directions and warnings. (Ramm Decl., ¶¶ 7, 15.)
Negligence – Design Defect
Plaintiff also brings a general negligence design claim. To prevail on this claim, she must prove Ethicon failed to use the amount of care in designing the device that a reasonably careful designer would use in similar circumstances to avoid exposing others to a foreseeable risk of harm. (Howard v. Omni Hotels Management Corp. (2012) 203 Cal.App.4th 403, 430.)
Plaintiff has not shown a product design defect caused her injuries. (Merrill v. Navegar, Inc. (2001) 26 Cal.4th 465, 479.) Plaintiff must prove causation—that “the product did not perform safely as it should” and “the failure resulted from the product’s design”; thus, a causal connection between the alleged defective design and its failure is necessary. (Soule v. Gen. Motors Corp. (1994) 8 Cal. 4th 548, 566.)
There is no evidence the TVT Exact or Implant Sheath caused Plaintiff’s injuries. It is not enough to show Plaintiff suffered a bladder perforation and experienced pain after surgery. She must connect the injury with a design defect in the product. (See Barrett v. Atlas Powder Co. (1978) 86 Cal.App.3d 560, 564 [“to establish liability, it is not enough that the action happened, nor may liability inferences favorable to plaintiff be drawn from that fact. The plaintiff must prove by competent evidence that the product was either defective in design or manufacture or both, thus causing the injury.”]; see also, e.g., Klinker v. Johnson & Johnson (E.D. Cal. Jan. 23, 2023) 2023 WL 358923, at *8 [granting summary judgment on design defect, under California law, because “[the expert’s] report does not identify any design defects in the TVT and instead offers the conclusory opinion that Ms. Klinker’s injuries were caused by ‘the implanted mesh’ and ‘mesh placement’”].)
Ethicon’s expert, Dr. Olga Ramm, a Board Certified Female Pelvic Medicine and Reconstructive Surgery subspecialist with a background in Obstetrics and Gynecology, opines the bladder perforation was not caused by the plastic in the Implant Sheath or migration of the Implant Sheath. (Ramm Decl., ¶¶ 44, 45.) The Implant Sheath ended up in the bladder due to an unrecognized bladder perforation during the passage of the needle during surgery. (Ramm Decl., ¶ 45.) Moreover, the TVT Exact mesh and Implant Sheath did not cause or contribute to Plaintiff’s femoral neuropathy. (Ramm Decl., ¶ 47.)
Negligence – Manufacture
Plaintiff’s strict liability or negligent manufacturing claim fails as a matter of law. (See Complaint, ¶ 52.) “[A] manufacturing or production defect is readily identifiable because a defective product is one that differs from the manufacturer’s intended result or from other ostensibly identical units of the same product line.” (Barker v. Lull Engineering Co. (1978) 20 Cal.3d 413, 429.) (See also Garrett v. Howmedica Osteonics Corp. (2013) 214 Cal.App.4th 173, 190 [citing In re Coordinated Latex Glove Litigation (2002) 99 Cal.App.4th 594, 607].)
Plaintiff has no evidence the TVT Exact Dr. Granese used did not conform to the manufacturer’s design. (SUF No. 75.) Because neither the explanted mesh device nor any of the Implant Sheath removed during either procedure were retained, there is no way to identify any defect specific to this device or its component parts, including the sheath. (SUF No. 54.) Therefore, she cannot state a claim for negligent manufacture.
Failure to Warn
In this case, the “learned intermediary doctrine” applies, because Ethicon’s TVT Exact is a prescription medical device. Under the “learned intermediary doctrine,” the physician stands in the shoes of the product’s ordinary user, and the manufacturer must warn doctors about product risks. “This duty does not extend to patients, with whom manufacturers have no cost-effective channel of communication and for whom the data would be duplicative even if the patient could interpret it.” (See Gall v. Smith & Nephew, Inc. (2021) 71 Cal.App.5th 117, 122.)
Here, the evidence shows when Plaintiff saw Dr. Granese for a preop visit, the doctor discussed the risks of the TVT Exact, including: nonresolution of disease; bleeding; infection; organ injury (surrounding but not limited to the ureters, bowel, intestines bladder), cardio-pulmonary arrest, stroke, seizure, wound healing impairment, cosmetic defect, vaginal vault prolapse, urinary incontinence and urinary retention, as well as mesh complications. Plaintiff signed an informed consent for the procedure that included the risks. (SUF No. 33).
Moreover, Plaintiff cannot meet her burden of proving a different warning would have avoided the complications she experienced. Dr. Granese and Dr. Markus testified they never read or relied on TVT Exact’s warnings prior to Plaintiff’s surgery. (SUF Nos. 26, 27, 28.) This alone precludes Plaintiff from maintaining a claim against Ethicon for failure to warn.
Negligent Recall
Negligence for “recall/retrofit” applies where the defendant “became aware of [a] defect after the product was sold”; defendant failed to recall, retrofit, or warn of the product’s dangers; and the defendant’s failure to recall or retrofit the product “was a substantial factor in causing [plaintiff’s] harm.” (CACI No. 1223 (Oct. 2004 rev.); see also Lunghi v. Clark Equipment Co. (1984) 153 Cal.App.3d 485, 494).)
Plaintiff alleges Ethicon failed to conduct an adequate recall campaign, but there is no evidence to support Plaintiff’s claim.
Negligence Based on Phone Call to Ethicon
Plaintiff also alleges negligence based on the interoperative call Dr. Granese directed to Ethicon during the surgery. But the facts show that Dr. Granese made a phone call to Ethicon after she had placed the TVT Exact in Plaintiff. (SUF No. 46.) Dr. Granese removed the mesh after speaking with Ethicon in an attempt to find and remove the Implant Sheath. (SUF No. 50.)
Moreover, Dr. Granese’s decision to stop looking for the sheath was based on her independent medical judgment, including considerations of the length of time under anesthesia, her being in stirrups, infection, blood loss, and anesthesia complications. (SUF No. 48.) There is no evidence any specific statements by Ethicon caused Dr. Granese to act differently.
Breach of Warranty
Plaintiff’s claims for breach of express and implied warranty fail on the merits. “[S]ince a breach of express warranty claim is a strict liability claim, California does not recognize such claims against a medical device manufacturer.” (Fischer v. Boston Sci. Corp. (C.D. Cal. Mar. 25, 2020) 2020 WL 2300138, at *3.) The California Supreme Court—in rejecting strict liability for design defects of prescription drugs—likewise held a cause of action for breach of warranty does not lie against a prescription drug manufacturer so long as an adequate warning of risks is given. (Brown, supra, 44 Cal.3d at 1072 n.14.) Accordingly, this claim fails.
Plaintiff also failed to give pre-suit notice of the alleged breach as required by California law. (See Com. Code, § 2607(3)(A); Mance v. Mercedes-Benz USA (N.D. Cal. 2012) 901 F.Supp.2d 1147, 1153 n.4 [“A plaintiff must also plead that he or she provided the defendant with pre-suit notice of the breach.”]). Plaintiff bears the burden of proving reasonable notice. (Cardinal Health 301, Inc. v. Tyco Electronics Corp. (2008) 169 Cal.App.4th 116, 135.) The issue can be determined as a matter of law where the relevant facts are undisputed and support one inference. (Id. at p. 136.)
Ethicon to give notice and to submit a proposed judgment for the court’s review and signature within 10 days.