Judge: Mark A. Young, Case: 19STCV11765, Date: 2022-09-08 Tentative Ruling

Case Number: 19STCV11765    Hearing Date: September 8, 2022    Dept: M

CASE NAME:           White, et al., v. Zimmer US, Inc., et al.

CASE NO.:                19STCV11765

MOTION:                  Motion for Summary Judgment/Adjudication

HEARING DATE:   9/8/2022

BACKGROUND

This action arises from an April 7, 2017, cervical disc replacement surgery performed by Dr. John Regan on decedent David White. During this surgery, Dr. Regan utilized the Mobi-C Cervical Disc system, developed and designed by the Zimmer Defendants. Plaintiffs claim that the Mobi-C system and the Trial Implant Holder is an unreasonably dangerous device in design.

Plaintiffs brought claims against Defendants Zimmer Biomet Holdings, Inc., Zimmer Biomet Spine, Inc., and LDR Spine USA, Inc. for 1) negligence, 2) negligent design, 3) strict products liability – failure to warn, 4) negligent product liability – failure to warn, 5) loss of consortium, 6) wrongful death, and 7) survival action.

Defendants move for summary judgment and/or adjudication of each claim, and as to the claim for punitive damages.

Legal Standard

            A party may move for summary judgment in any action or proceeding if it is contended the action has no merit or that there is no defense to the action or proceeding. (Code Civ. Proc., § 437c(a).) “The purpose of the law of summary judgment is to provide courts with a mechanism to cut through the parties' pleadings in order to determine whether, despite their allegations, trial is in fact necessary to resolve their dispute.” (Aguilar v. Atlantic Richfield Co. (2001) 25 Cal.4th 826, 843.)

“A party may move for summary adjudication as to one or more causes of action within an action, one or more affirmative defenses, one or more claims for damages, or one or more issues of duty, if the party contends that the cause of action has no merit, that there is no affirmative defense to the cause of action, that there is no merit to an affirmative defense as to any cause of action, that there is no merit to a claim for damages, as specified in Section 3294 of the Civil Code, or that one or more defendants either owed or did not owe a duty to the plaintiff or plaintiffs.” (Code Civ. Proc., § 437c(f)(1).) If a party seeks summary adjudication as an alternative to a request for summary judgment, the request must be clearly made in the notice of the motion. (Gonzales v. Superior Court (1987) 189 Cal.App.3d 1542, 1544.)  “[A] party may move for summary adjudication of a legal issue or a claim for damages other than punitive damages that does not completely dispose of a cause of action, affirmative defense, or issue of duty pursuant to” subdivision (t). (Code Civ. Proc., § 437c(t).) 

            To prevail, the evidence submitted must show there is no triable issue as to any material fact and that the moving party is entitled to judgment as a matter of law. (Code Civ. Proc., § 437c(c).) The motion cannot succeed unless the evidence leaves no room for conflicting inferences as to material facts; the court has no power to weigh one inference against another or against other evidence. (Murillo v. Rite Stuff Food Inc. (1998) 65 Cal.App.4th 833, 841.) In determining whether the facts give rise to a triable issue of material fact, “[a]ll doubts as to whether any material, triable, issues of fact exist are to be resolved in favor of the party opposing summary judgment…” (Gold v. Weissman (2004) 114 Cal.App.4th 1195, 1198-99.) “In other words, the facts alleged in the evidence of the party opposing summary judgment and the reasonable inferences there from must be accepted as true.” (Jackson v. County of Los Angeles (1997) 60 Cal.App.4th 171, 179.) However, if adjudication is otherwise proper the motion “may not be denied on grounds of credibility,” except when a material fact is the witness’s state of mind and “that fact is sought to be established solely by the [witness’s] affirmation thereof.” (Code Civ. Proc., § 437c(e).) 

            Once the moving party has met their burden, the burden shifts to the opposing party “to show that a triable issue of one or more material facts exists as to that cause of action or a defense thereto.” (Code Civ. Proc., § 437c(p)(1).) “[T]here is no obligation on the opposing party... to establish anything by affidavit unless and until the moving party has by affidavit stated facts establishing every element... necessary to sustain a judgment in his favor.” (Consumer Cause, Inc. v. SmileCare (2001) 91 Cal.App.4th 454, 468.) 

“The pleadings play a key role in a summary judgment motion. The function of the pleadings in a motion for summary judgment is to delimit the scope of the issues and to frame the outer measure of materiality in a summary judgment proceeding.” (Hutton v. Fidelity National Title Co. (2013) 213 Cal.App.4th 486, 493, quotations and citations omitted.) “Accordingly, the burden of a defendant moving for summary judgment only requires that he or she negate plaintiff's theories of liability as alleged in the complaint; that is, a moving party need not refute liability on some theoretical possibility not included in the pleadings.” (Ibid.) 

EVIDENTIARY ISSUES

Plaintiffs’ objections are OVERRULED, including Plaintiff’s objections to new evidence submitted in reply by Defendants.

Defendants’ objections are also OVERRULED. 

In the future, the parties are ordered to comply with California Rules of Court, rule 3.1354(b) and (c) as to the formatting of these objections and the inclusion of a proposed order.    (See Hodjat v. State Farm Mutual Automobile Ins. Co. (2012) 211 Cal.App.4th 1, 9 [trial court not required to give a second chance at filing properly formatted papers].)  

Analysis

Plaintiff concedes that the third and fourth causes of action regarding the failure to warn claims should be dismissed. Thus, the motion is granted as to these causes of action and they are dismissed.

On June 21, 2022, the Parties filed a stipulation to dismiss defendant Zimmer and claims based on allegations of a manufacturing defect.  That order was signed on June 27, 2022.

Summary Judgment Motion

In their moving papers, Defendants present two general theories that there is no genuine issue of material fact as to Plaintiffs’ negligence, negligent design, strict products liability – failure to warn, negligent product liability – failure to warn, loss of consortium, wrongful death, or survival action claims. They assert that Plaintiffs have failed to produce any evidence—expert or otherwise— demonstrating 1) the existence of a product defect; or 2) that such a defect or Defendants’ alleged negligent conduct caused Plaintiffs’ damages. They reason that since each cause of action in this case requires proof of a defect and/or causation, the entire suit is subject to summary judgment.

Products Liability

A plaintiff’s first task in a strict liability action is to establish that the injury-producing object or instrumentality was legally defective. For this purpose, a product may be “defective” because of a manufacturing defect, a design defect, or a warning defect. (Carlin v. Superior Court (1996) 13 Cal.4th 1104, 1110.) To recover in negligence, a plaintiff must prove the same two elements plus an additional element, namely, that the defect in the product was due to negligence of the defendant. (Jiminez v. Sears, Roebuck & Co. (1971) 4 Cal.3d 379, 383.) 

This action focuses on design defects. “Design defects appear in products that, although properly manufactures, are dangerous because they lack a critical feature needed to ensure safe use.” (Webb v. Special Electric Co., Inc. (2016) 63 Cal.4th 167, 180.) “A product design may be found defective if: (1) ‘the product failed to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner’ (consumer expectations test) [citation]; or (2) the risk of danger inherent in the product’s design outweighs the design’s benefits (risk benefit test).” (Id.)

The well-known elements for negligence are: (1) a legal duty owed to the plaintiff to use due care; (2) breach of duty; (3) causation; and (4) damage to the plaintiff. (County of Santa Clara v. Atlantic Richfield Co. (2006) 137 Cal.App.4th 292, 318.) A defendant’s negligence is the actual cause of the plaintiff’s injury if it is a substantial factor in bringing about the harm. (Mitchell v. Gonzales (1991) 54 Cal.3d 1041, 1052-53.)

Here, Defendants raise affirmative evidence that demonstrates that there was no design defect.  On April 7, 2017, Mr. White underwent anterior cervical discectomy and disc replacement at C4-C5 and C5-C6. (Id., ¶ 21.) The surgery was performed by Dr. John Regan, who on or about March 6, 2017, had diagnosed Mr. White with “cervical spondylosis effecting (sic.) C4-5, 5-6 with central and lateral stenosis.” (Id., ¶ 22.) Dr. Regan ultimately recommended a two-level artificial disc replacement for Mr. White, which would be covered by Medicare. (Id., ¶ 25.) Dr. Regan chose this treatment plan and chose to use the Mobi-C system based on his medical judgment concerning Mr. White’s condition and because the Mobi-C was approved for two-level use by the Food and Drug Administration (“FDA”). (Id., ¶ 26.) In their complaint, Plaintiffs specifically take issue with the Mobi-C’s Trial Implant Holder instrument and its lack of a mechanical stop mechanism to prevent a trial implant from contacting the spinal cord.

The Trial Implant Holder is a surgical instrument included in the Mobi-C instrument set. (UMF ¶ 3.) During surgery, the Trial Implant Holder attaches to a “trial implant” to assist the surgeon when inserting the trial implant into the disc space. (Id., ¶ 4.) The trial implant is used to measure or confirm the size of Mobi-C cervical disc to be used in the space. (Id., ¶ 5.)

The Mobi-C system received premarket approval from the FDA in August 2013. (UMF ¶¶ 6-7.) Surgeons, like Mr. White’s surgeon Dr. John Regan, must complete training on Mobi-C’s surgical technique before LDR Spine or Zimmer Biomet Spine will permit the surgeon to implant the device. (Id., ¶ 12.) The Surgical Technique, which is provided to the surgeon during training, is also available online. (Id., ¶¶ 13.) Dr. Regan completed surgeon training in September 2013. (Id., ¶ 14.) Further, the consulting design surgeons considered a similar feature originally included on the Trial Implant Holder to adjust the depth—an adjustable stop feature. (Id., ¶ 16.) Following months of consideration, in March 2005, the design surgeons decided to remove it for clinical reasons. (Id., ¶ 17.)

They further posit that a review of the available competitive alternative designs reveals that the majority of trial implant holders in other similar systems on the market do not include a stop mechanism. (UMF ¶¶ 20 & 69.) The design team asked the original creators to remove the adjustable stop feature from the Trial Implant Holder because they did not find the feature useful, as the depth of the disc was already measured and the process of inserting the trial implant was monitored with x-rays, the inclusion of the feature impeded vision of the disc space, and it was not a standard feature of trial implant holders that they used from other manufacturers of like instruments and devices. (Id.) The removal of the adjustable stop feature from the Trial Implant Holder was a change validated by all of the design surgeons. (Id., ¶ 18.)  Further, Dr. Regan offers no criticism of the Trial Implant Holder, either in general or specific to Mr. White’s April 7, 2017 surgery. (See id., ¶¶ 14, 29, 40, 50, 51, 53, 54.)  As such, Defendants have met their initial burden as to this issue.

In response, Plaintiffs present evidence that creates a dispute of material fact as to the existence of a design defect. While performing a cervical disc replacement (or a multiple level replacement) with the Mobi-C device, surgeons must utilize what is called the Trial Implant Holder to insert a spacer (or pseudo) implant to make sure the final implant is the correct size. (PUMF 2.) The Trial Implant Holder, in this case was designed, manufactured, and distributed to surgeons without a critical safety device known as a mechanical stop, which is designed to keep surgeons from going too far and damaging the spinal cord of patients undergoing surgery. (PUMF 1, 240.)  Plaintiffs produce evidence that Defendants negligently provided Trial Implant Holders for use with no mechanical stopping mechanism to protect the spinal cord of those undergoing serious spinal surgery. (Truman Decl., ¶ 21, Lycette Decl., ¶¶ 8(k)(l); Pressman Decl., ¶ 6.)  Plaintiff submits evidence that the removal of the stop feature increased the risk of harm to the patient. (See Dispute as to UMF ¶¶ 19-20.) Plaintiffs produce evidence that a reasonably careful manufacturer, designer, or supplier would not sell a Trial Implant Holder without a stop for use in a spinal surgery as a result of the foreseeable harm of a catastrophic spinal injury. (PUMF ¶¶ 250, 251.) Other suppliers on the market provided Trial Implant Holders with a stop mechanism at the time of Plaintiffs injuries. (Id., ¶ 67.) As noted above, the original Trial Implant Holder distributed to those utilizing the Mobi-C device had a stop on the Trial Implant Holder. Furthermore, the Implant Holder that is utilized to implant the final Mobi-C device has a stop on the holder. (Id., ¶ 49.) Plaintiff shows that the design is feasible, but Defendants chose the more dangerous option. (PUMF ¶¶ 77-85, 202.) Further, Defendants knew of the risks of injury if the Trial Implant Holder was sold without a stop. (Id. ¶¶ 64, 138, 206, 207, 208, 233.)

Accordingly, the motion for summary judgment is DENIED as to this issue.

Medical malpractice

The elements of medical malpractice are: “(1) the duty of the professional to use such skill, prudence, and diligence as other members of his profession commonly possess and exercise; (2) a breach of that duty; (3) a proximate causal connection between the negligent conduct and the resulting injury; and (4) actual loss or damage resulting from the professional's negligence.” (Simmons v. West Covina Medical Clinic (1989) 212 Cal.App.3d 696, 701-02 citations omitted.)  “Both the standard of care and defendants’ breach must normally be established by expert testimony in a medical malpractice case.”  (Avivi v. Centro Medico Urgente Medical Center (2008) 159 Cal. App. 4th 463, 467.) Notably, causation is ordinarily a question of fact for a jury. (Ortega v. Kmart Corp. (2001) 26 Cal. 4th 1200, 1214.)

A defendant moving for summary judgment in a medical malpractice action must “present evidence that would preclude a reasonable trier of fact from finding it was more likely than not that their treatment fell below the standard of care.”¿ (Johnson v. Superior Court (2006) 143 Cal.App.4th 297, 305.) “Both the standard of care and defendants’ breach must normally be established by expert testimony in a medical malpractice case.”¿(Avivi v. Centro Medico Urgente Medical Center (2008) 159 Cal. App. 4th 463, 467.) “When a defendant moves for summary judgment and supports his motion with expert declarations that his conduct fell within the community standard of care, he is entitled to summary judgment unless the plaintiff comes forward with conflicting expert evidence.”¿(Munro v. Regents of University of California (1989) 215 Cal. App. 3d 977, 984-985.)¿ An expert declaration, if uncontradicted, is conclusive proof as to the prevailing standard of care and the propriety of the particular conduct of the health care provider.¿(Starr v. Mooslin (1971) 14 Cal. App. 3d 988, 999.) 

Defendants meet their initial burden to show that the negligent conduct did not cause Plaintiffs’ damages since Dr. Regan’s conduct did not fall below the standard of care. Specifically, Dr. Regan’s testimony, Mr. White’s medical records, and his loss of neuromonitoring signals do not in any way set forth that the Trial Implant Holder caused or contributed to Mr. White’s injury. (UMF ¶¶ 49, 63.)

Defendants establish that Dr. Regan was very familiar with the Mobi-C and its instruments, including the Trial Implant Holder, having performed over thirty disc replacement surgeries with the Mobi-C prior to April 7, 2017. (UMF ¶ 29.) During the surgery on April 7, 2017, after Dr. Regan had successfully implanted the first disc into the C5-C6 vertebral space, Mr. White lost evoked potentials, i.e., sensory and motor signals, and suffered a spinal cord injury while Dr. Regan was working on the C4-C5 space. (Id., ¶ 30.) In the minutes before Mr. White’s neuromonitoring signals were lost, Dr. Regan had distracted, i.e., spread, the C4-C5 space and had inserted the trial implant, which necessarily required the use of the Trial Implant Holder. (Id., ¶ 31.) Upon loss of motor and sensory signals, Dr. Regan called for spinal cord trauma protocol, removed the trial implant, implanted a second Mobi-C device of the same size as he used in C5-C6, and closed up the patient so he could be taken to get an MRI. (Id., ¶ 33.) Mr. White’s subsequent MRI revealed “focal spinal cord edema and central canal stenosis in the cervical spine at C4-C5.” (Id., ¶ 34.) Mr. White was returned to the operating room, and Dr. Regan performed a posterior laminectomy decompression from C4-C6, removed the Mobi-C artificial discs he had implanted, and stabilized Mr. White’s spine with fusion from C4-C6. (Id., ¶ 35.) Mr. White was rendered a C4 quadriplegic. (Id., ¶ 36.)

Dr. Regan twice testified under oath that the trial implant was in the disc space, that the trial implant did not enter the spinal canal, that the trial implant was not tapped beyond the posterior margin, and that the trial implant did not impact Mr. White’s spinal canal or spinal cord. (Id., ¶¶ 39, 40, 50, 51.) Dr. Regan explains that the trial implant was not placed too deep and did not come into contact with the spinal canal or spinal cord based on x-rays taken during the surgery. (Id., ¶ 51.) He testified that an x-ray taken contemporaneously during the surgery showed that the trial implant was within the disc space and not in the spinal canal. (Id., ¶¶ 52, 53.) Dr. Regan further testified that, based on his decades of experience, the loss of neuromonitoring signals around the same time as the trial implant being placed into C4-C5 with the Trial Implant Holder is not indicative that the trial or holder caused Mr. White’s injury. (Id., ¶ 54.)

            Plaintiffs properly dispute this evidence with declarations from medical experts. (See Disputes to UMF ¶ 31.) Plaintiffs note that the entire time Dr. Regan was working on the space between C5 and C6, performing the distraction, there was no indication that there was any problem with motor potentials. (PUMF ¶ 24.) In fact, until Dr. Regan tapped the trial implant holder into place, there was zero loss of motor signal. (Id., ¶ 26.) Ms. Read, who was present at the surgery, confirmed trial was tapped into place when the signals were lost. (Read Depo.26:20 – 25.) The MRI showed that there was a focal, concentrated area of edema on the spinal cord where Dr. Regan was doing the tapping on the trial implant holder at C4-C5. (PUMF ¶ 28.) Even Dr. Regan admitted the focal spinal cord edema can be caused by a mechanical compression of the spinal cord, which can be caused by Dr. Regan or another surgeon using a device that has no stop on it and that goes too far into the spinal cord. (Id.) Further, Dr. Regan ordered steroids, which is a treatment when there has been a blunt force trauma to the spine not an ischemic injury. (Id., ¶ 218.)

The declarations further conclude that the failure to put a mechanical stop on the Trial Implant Holder contributed to Mr. White’s injuries. (Id., ¶¶ 195, 207, 208, 215-220.) “In my opinion based on the timing of the injury, the fact that there was no stopping mechanism on the trial implant holder and the appearance of the spinal cord injury on the MRI images taken postoperatively this injury was caused by the lack of a mechanical stop on the trial implant holder and that had there been a mechanical stop the injury to Mr. White’s spinal cord would not have occurred as the mechanical stop would have prevented contact with the spinal cord.” (Lycette Decl., ¶ 8(k); see also Pressman Decl., ¶ 6.)

For these reasons, Defendants’ motion as to medical malpractice is denied.  Defendants’ motion for summary judgment is dependent on the above causes of action. Thus, the motion would fail as to those causes for the same reasons discussed above.

Zimmer Biomet

Defendant Zimmer Biomet Holdings, Inc. (ZGHI) separately seeks summary judgment because it did not design, manufacture, or sell the device at issue in this matter.  The complaint alleges that ZGHI engaged in the business of manufacturing, designing, assembling, compounding, testing, inspecting, packaging, labeling, fabricating, constructing, analyzing, distributing, servicing, merchandising, recommending, advertising, promoting, marketing and selling a product known as the Mobi-C Cervical Disc Prosthesis and its component parts, instruments, and constituents, for use by members of the general public. (FAC ¶10.)

In the motion, ZBHI puts forth evidence that it never designed, manufactured, or sold the Mobi-C or its instruments, which includes the Trial Implant Holder. (UMF, ¶ 56.) In April 2017, at the time of the surgery at issue, LDR Spine USA, Inc. and Zimmer Biomet Spine, Inc. were both indirect subsidiaries of ZBHI. (Id ¶ 59.) In April 2017, ZBHI did not operate or manage the operations of either Zimmer Biomet Spine, Inc. or LDR Spine USA, Inc. (SOF, ¶ 60.) In October 2018, LDR Spine USA, Inc. was dissolved, and the LDR product lines, which include the Mobi-C and its instruments, were then offered exclusively under the Zimmer Biomet Spine portfolio of products. (Id., ¶ 61.)

In opposition, Plaintiff demonstrates that ZBHI would be a successor to the LDR entities it acquired. (See Dispute to UMF ¶¶ 58-60.) Plaintiff notes that Zimmer Biomet Spine, Inc. was a manufacturer of the subject device at the time of the surgery upon Mr. White in 2017. (PUMF 127.) ZBHI owned 100 percent of the stock of Zimmer Biomet Spine, Inc. as of April of 2017. (Id., ¶ 103.) ZBHI acquired LDR Spine USA, Inc., the LDR Holding Corporation, and all the associated trade names on July 13, 2016. (St. Louis Dec. ¶ 6; PUMF ¶¶96, 102.) On October 18, 2018, LDR Spine USA, Inc. was dissolved. [PUMF 99]

 Generally, where one corporation sells or transfers all of its assets to another corporation, the latter is not liable for the debts and liabilities of the former. (See Franklin v. USX Corp., (2001) 87 Cal.App.4th 615, 621.) Many exceptions exist: (1) where the purchaser expressly or impliedly agrees to such assumption; (2) where the transaction amounts to a consolidation or merger of the two corporations; (3) where the purchasing corporation is merely a continuation of the selling corporation; or (4) where the transaction is entered into fraudulently to escape liability for debts. (See id.) Notably, on summary judgment, the successor has the burden to show that “the exceptions that create successor liability do not apply[.]” (Fisher v. Allis-Chalmers Corp. Product Liability Trust (2002) 95 Cal.App.4th 1182, 1188.)

Since LDR entities were dissolved following a complete purchase by ZBHI, ZBHI fails to show that the transaction did not amount to an effective consolidation or merger of the two corporations. At a minimum, there would be a dispute of fact as to whether the transaction amounted a consolidation of merger, or if ZBHI continued to operate as a joint venture

Plaintiff also offers that ZBHI operated as a joint venture with LDR/ZBS at the time of the surgery.  “A joint venture has been defined in various ways but most frequently perhaps as an association of two or more persons who combine their property, skill or knowledge to carry out a single business enterprise for profit. (Holtz v. United Plumbing & Heating Co. (1957) 49 Cal.2d 501, 506.) Although case specific, the existence of a joint venture should establish (1) the existence of a joint interest in a common business or enterprise; (2) mutual exercise of control over the common enterprise; and (3) mutual contributions by the parties in the form of capital, services, or both. (Id. at 506-07.) “Where the existence of a contract is at issue and the evidence is conflicting or admits of more than one inference, it is for the trier of fact to determine whether the contract actually existed.”  (Bustamante v. Intuit, Inc. (2006) 141 Cal.App.4th 199, 208.)  The above evidence demonstratse that at the time of the procedure, Defendants Zimmer Biomet Spine, Inc., ZBHI and LDR Spine USA, Inc. were joint venturers as suppliers/manufacturers/designers in the stream of commerce for the product at issue in this case.

Thus, Plaintiffs properly put ZGHI’s liability at issue.

Punitive Damages

Punitive damages are appropriate when there is “clear and convincing evidence that the defendant has been guilty of oppression, fraud, or malice.” (Civ. Code § 3294(a).) “ ‘Malice’ means conduct which is intended by the defendant to cause injury to the plaintiff or despicable conduct which is carried on by the defendant with a willful and conscious disregard of the rights or safety of others.” (Civ. Code, § 3294(c)(1).) “‘Oppression’ means despicable conduct that subjects a person to cruel and unjust hardship in conscious disregard of that person’s rights.” (Civ. Code, § 3294(c)(2).) As used in defining oppression and malice, despicable is a powerful term used to describe circumstances that are “base,” “vile,” or “contemptible.” (Coll. Hosp., Inc. v. Superior Court (1994) 8 Cal.4th 704, 721, 726.) The statute “plainly indicates that absent an intent to injure the plaintiff, “malice” requires more than a “willful and conscious” disregard of the plaintiffs' interests. The additional component of “despicable conduct” must be found.” (Ibid.) Punitive damages require more than the mere commission of a tort. (Taylor v. Superior Court (1979) 24 Cal.3d 890, 894-95.) A plaintiff must establish the defendant was aware of the probable dangerous consequences of his conduct and that he willfully and deliberately failed to avoid those consequences to support an award of punitive damages based on conscious disregard of the safety of others. (Penner v. Falk (1984) 153 Cal.App.3d 858, 867.)

“While the clear and convincing evidentiary standard is a stringent one, it does not impose on a plaintiff the obligation to ‘prove’ a case for punitive damages at summary judgment. [Citation.] However, where the plaintiff's ultimate burden of proof will be by clear and convincing evidence, the higher standard of proof must be taken into account in ruling on a motion for summary judgment or summary adjudication, since if a plaintiff is to prevail on a claim for punitive damages, it will be necessary that the evidence presented meet the higher evidentiary standard. [Citations.] But as with a judgment of nonsuit, summary judgment on the issue of punitive damages is proper only when no reasonable jury could find the plaintiff's evidence to be clear and convincing proof of malice, fraud or oppression.” (Spinks v. Equity Residential Briarwood Apartments (2009) 171 Cacl.App.4th 1004, 1053 [internal quotations omitted].) 

The Court agrees that the record shows that no juror could find clear and convincing evidence of malice, oppression, or fraud in the design of the Trial Implant Holder. The lack of malice, oppression, and fraud is evidenced by the fact that trial implant holders in the majority of competitor cervical disc replacement and similar spinal systems do not employ a stop mechanism on their trial implant holders. (UMF ¶¶ 20 & 69.) As discussed, the original consulting design surgeons retained by LDR Medical during the development of the Mobi-C system and its instruments specifically considered and used a Trial Implant Holder with an adjustable stop feature, and asked LDR Medical to remove the stop mechanism for clinical reasons, not to intentionally harm people. (Id., ¶¶ 16–18.) The design surgeons found that the adjustable stop mechanism on the Trial Implant Holder was not useful, as the depth of the disc was already measured and the process of inserting the trial was monitored with x-rays, and the adjustable stop feature impeded the surgeon’s vision of the disc space. (Id., ¶ 17.) Biomedical mechanical engineering expert Jorge Ochoa opines that the design of and warnings accompanying the Trial Implant Holder met established industry procedures and practices, and was not unreasonably dangerous. (Id., ¶¶ 64–68, 71, 72.)

In response, Plaintiffs do not present any evidence of malice, fraud or oppression. Instead, Plaintiffs focuses on how the damage could have been prevented if they chose an alternative design with a stop. While Plaintiffs present certain Risk Management documents which demonstrates that Defendants considered the risks involved regarding a stop, and that the lack of a stop could cause consumers to incur serious injuries. (PUMF 64, 206, 261.) However, this is different from evidence which clearly and convincingly demonstrates that Defendants knew of the probable dangerous consequences of this conduct, or that Defendants “willfully” or “deliberately” failed to include these design features. Instead, the record shows that Defendants, at worst, were negligent and did not consciously disregard the safety of others.

Accordingly, the motion for summary adjudication as to punitive damages is GRANTED.

The motion is otherwise DENIED.