Opinion
NOT TO BE PUBLISHED
APPEAL from a judgment of the Superior Court of San Diego County, Jay M. Bloom, Judge, Super. Ct. No. GIC832396
McINTYRE, J.
Anne Peik and Ralph Anders (the Plaintiffs) appeal a judgment entered after the superior court granted summary judgment in favor of Glenn Kawesch, M.D. and Southwest Eye Center, Inc. (collectively, Kawesch) on their claims for medical negligence and fraud. The Plaintiffs contend that the court erred in granting summary judgment on statute of limitations grounds because the evidence showed that their complaint was timely filed and that the court also erred in denying their prior motion for leave to amend their complaint to assert a claim for punitive damages against Kawesch. Because Kawesch died during the pendency of this action, the latter argument has become moot as to him individually. However, we agree with the Plaintiffs'statute of limitations arguments and their argument regarding the sufficiency of their showing in support of their punitive damage claim against the corporate defendant. Accordingly, we reverse the judgment in those respects.
FACTUAL AND PROCEDURAL BACKGROUND
Kawesch made extensive objections to the Plaintiffs' evidence submitted in connection with the motion for summary judgment, but the superior court overruled all of his objections. As Kawesch makes no appellate challenge to the superior court's evidentiary rulings, he has waived all such objections for the purposes of this appeal and thus the following factual recitation is based on all the evidence submitted by the parties in support of and opposition to the motion. (See Ann M. v. Pacific Plaza Shopping Center (1993) 6 Cal.4th 666, 670, fn. 1; Reyes v. Kosha (1998) 65 Cal.App.4th 451, 466, fn. 6.)
1. Peik
Peik consulted with Kawesch in December 1998 regarding farsightedness (hyperopia) in both of her eyes. After a series of tests, Kawesch recommended LASIK surgery to correct Peik's vision. The following month, Peik watched Kawesch's video regarding the proposed surgery and potential complications and risks thereof and signed consent forms representing that hyperopia was treatable with an excimer laser and that Kawesch's use of such a laser for such surgery was an "off label" use that was permitted by the federal Food and Drug Administration (the FDA). Kawesch performed hyperopic LASIK surgery on both of Peik's eyes using a VISX laser.
Peik thereafter had problems with blurry and fluctuating vision, eye discharge and loss of depth perception, all disclosed risks of a LASIK procedure. She consulted with Kawesch again on several occasions and was told that the visual problems were temporary and might continue for three months or longer; however, in June 1999, Kawesch told Peik that her vision had stabilized and recommended LASIK enhancement procedures to correct her continuing visual issues. Peik signed another set of consent forms and in July 1999 Kawesch performed the enhancement procedures with his VISX laser.
Peik continued to experience double images, halos and fluctuating and blurry vision that substantially impacted her ability to drive and carry out normal daily activities. Despite numerous visits in which Peik requested to see Kawesch personally, his staff repeatedly denied her such access, saying either that he was "unavailable" or that it was not his custom to see patients at followup appointments.
Peik became quite depressed as a result of the serious problems she experienced with her vision and Kawesch's staff's inability to help her. In September 2000, she consulted a cornea specialist for a second opinion and was told that the only way to solve her problems was to have corneal transplants. Peik declined to undergo further surgery and ultimately an optometrist prescribed contact lenses to help improve her vision.
2. Anders
Anders consulted Kawesch for the treatment of hyperopia in his left eye in December 1998. Kawesch recommended LASIK surgery to correct Anders' vision and represented to Anders that the surgery would involve the use of an approved excimer laser, although in an "off label" manner, and that Anders was an appropriate candidate for such surgery. Anders decided to go forward with the surgery and, on the day before the procedure, was shown a video that explained the nature of the procedure to be performed and potential complications and risks thereof. He also signed consent forms setting forth such complications and risks (including loss of vision, double vision, fluctuating vision, glare, halos and difficulty judging distances) and indicating that the surgery would involve an "off label" use of an approved medical device, which use was permitted by the FDA.
The initial surgery on Anders was aborted before the laser was used because of a complication in cutting a flap in his cornea, a prerequisite to the LASIK surgery. However, after a healing period, Anders signed another set of virtually identical consent forms and in April 1999 Kawesch performed hyperopic LASIK on his left eye, using a VISX laser.
Anders thereafter experienced reading problems, double vision, star bursts, night vision problems and loss of depth perception and developed an epithelial ingrowth in his left eye; all of these conditions were disclosed risks of having a LASIK procedure. Kawesch told Anders that his vision might continue to fluctuate for several months and that they would have to wait until his eye sight stabilized before determining whether further surgery was appropriate. In September 1999, Kawesch removed the epithelial ingrowth.
Anders continued to see Kawesch regarding these on-going problems with his vision and Kawesch again told him that the fluctuations in his vision were part of the normal healing process. Anders's vision did not stabilize until late April 2000, at which time Kawesch recommended that he undergo a LASIK enhancement procedure to correct his visual problems. Anders signed another set of consent forms, including one that noted the use of an excimer laser for the treatment of hyperopia was an appropriate, "off label" use of the equipment.
In May 2000, Kawesch performed the enhancement procedure on Anders's left eye, using a Nidek laser. Thereafter Anders experienced ghosting, reading problems and fluctuating vision and Kawesch prescribed a contact lens to correct some of those issues.
3. Thereafter
In 2002, the Medical Board of California (the Board) contacted Peik and Anders, seeking authorization to access the medical records relating to Kawesch's treatment of their eye problems, in connection with an administrative disciplinary proceeding against Kawesch. Both authorized the release of information to the Board and testified in the Board proceeding and Peik filed a written complaint recounting the visual problems she experienced after her surgeries and her numerous consultations with Kawesch's staff to address those problems. Her written complaint described several situations in which Kawesch's staff suggested either that she was doing well or that she was at fault for her continuing problems and another occasion when a staff member falsified her statements in her medical record. The complaint also expressed Peik's frustration that Kawesch refused to see her personally at appointments despite her repeated requests. In summarizing her dissatisfaction with Kawesch's treatment, Peik stated:
"I don't feel that I was ever a good candidate for Lasik at all and [Kawesch] knew that as soon as he saw my chart and examined me. . . .[Kawesch] seemed like he would do the surgery on almost anyone. It appears he had no concern for the safety of me as his patient or the outcome. . . . I am mad that [Kawesch] would refuse to see me so many times and just let less experienced Staff handle my difficult case. Once he did the surgery, it was like he was done with his part."
The Administrative Law Judge (the ALJ) recommended dismissal of the disciplinary charges relating to the quality of Kawesch's patient care and the Board accepted the ALJ's recommendation.
In June 2004, Peik and Anders were contacted by the attorney for another Kawesch patient who had sued Kawesch and was looking for witnesses to testify regarding Kawesch's treatment practices. The attorney (who later became the Plaintiffs' attorney in this action) informed them in part that Kawesch's Nidek laser was neither approved by the FDA, nor authorized by the laser's manufacturer, for use on patients who were farsighted.
4. This Action
The Plaintiffs filed this action against Kawesch in July 2004, asserting causes of action for medical negligence and fraud based on allegations that he used an illegal medical device to perform the LASIK procedures on them and that he "intentionally [withheld] such information from [them]." The Plaintiffs subsequently filed an amended complaint alleging that Kawesch used illegal software or hardware in both his Nidek and VISX lasers and that he misrepresented to them that they were good candidates for the procedure even though LASIK surgery was contraindicated for their specific visual conditions.
In November 2005, Kawesch filed a motion for summary judgment or, alternatively, summary adjudication of the Plaintiffs' claims against him, arguing that (1) the Plaintiffs were aware of their injuries (i.e., their visual problems) immediately after their surgeries and thus knew or were on inquiry notice regarding the possibility of wrong-doing, but did not timely file this action; (2) the hyperopic LASIK corrections he performed were lawful off label uses of the VISX and Nidek lasers; and (3) there was no evidence that he acted with an intent to defraud. In support of the motion, Kawesch submitted his own declaration, as well as a declaration by another ophthalmologist, that his uses of Nidek and VISX lasers to perform hyperopic LASIK on the Plaintiffs were legitimate "off label" uses of an approved medical device.
The Plaintiffs opposed Kawesch's motion and presented evidence of the following:
(1) The Nidek laser that had received FDA approval involved software (a 2.25e program) that could not be used to perform hyperopic corrective procedures, but Kawesch obtained unapproved software (a 2.25 dHC program) that could be used for such procedures, apparently by representing to the laser manufacturer that he was participating in an FDA-authorized clinical trial;
(2) Prior to 2000, the VISX laser that had received FDA approval involved key card software that could not be used to perform surgery to correct hyperopia with astigmatism, although Kawesch used unauthorized key cards in his VISX laser to perform hyperopic astigmatic correction procedures;
(3) Kawesch's use of the unauthorized software and key cards to perform the Plaintiffs'surgeries was illegal and could not properly be identified as an "off label" use of an approved medical device (see 21 U.S.C.A. § 351, subd. (c); 21 C.F.R. § 814.80 (1996));
(4) Kawesch knew his use of the lasers with the unauthorized software and key cards was illegal and not an appropriate "off label" use; and
(5) Kawesch violated applicable FDA regulations and breached the standard of care by performing hyperopic astigmatic LASIK and LASIK enhancement surgeries on the Plaintiffs.
Kawesch did not submit any additional evidence in reply, but reiterated his original arguments and asserted that the court should disregard the Plaintiffs' arguments and evidence regarding his correction of their astigmatism with the VISX laser because their complaint did not adequately allege any impropriety in that regard.
Based on the evidence before it and the arguments of counsel, the court granted Kawesch's motion for summary judgment on statute of limitations grounds. It thereafter awarded Kawesch costs of $9,489 and entered judgment in his favor. The Plaintiffs appeal.
DISCUSSION
1. The Timeliness of the Plaintiffs' Claims
A. The Medical Negligence Claim
Code of Civil Procedure, section 340.5 provides:
"In an action for injury or death against a health care provider based upon such person's alleged professional negligence, the time for the commencement of action shall be three years after the date of injury or one year after the plaintiff discovers, or through the use of reasonable diligence should have discovered, the injury, whichever occurs first. In no event shall the time for commencement of legal action exceed three years unless tolled for any of the following: (1) upon proof of fraud, (2) intentional concealment, or (3) the presence of a [nontherapeutic, nondiagnostic] foreign body [in the injured person]." (See also Jefferson v. County of Kern (2002) 98 Cal.App.4th 606, 610.)
Kawesch performed surgeries on the Plaintiffs in or prior to May of 2000, but the Plaintiffs did not file this action until July 2004, more than four years later. The Plaintiffs argue that the court erred in concluding that their claim was barred by the one-year statute of limitations because the statutory period did not begin to run until June 2004, when they first discovered the cause of their injuries. Kawesch disagrees and contends that, in any event, the Plaintiffs' malpractice claim is barred by the three-year statute of limitations.
i. The One-Year Statute of Limitations: Delayed Discovery
As previously noted, the one-year limitations period begins to run once the plaintiff discovers, or through the use of reasonable diligence should have discovered, the injury and its negligent cause. (Code Civ. Proc., § 340.5; see Jefferson v. County of Kern, supra, 98 Cal.App.4th at p. 610.) The rationale for this rule is that once a plaintiff is on notice, or is suspicious, of wrongdoing, he or she has an incentive to sue and "must decide whether to file suit or sit on [his or] her rights." (Jolly v. Eli Lilly & Co. (1988) 44 Cal.3d 1103, 1111.) Under such circumstances, the plaintiff must go find the facts, which may include the identity of the person at fault for her injury; she cannot simply wait for the facts to find her before filing suit. (Ibid.) During the continuance of the professional, fiduciary relationship between the physician and the patient, "the degree of diligence required of a patient in ferreting out and learning of the negligent causes of his condition is diminished," although the limitations period commences if the patient discovers the claim notwithstanding a physician's continuing efforts to conceal his wrongdoing. (Sanchez v. South Hoover Hospital (1976) 18 Cal.3d 93, 102.)
The first triggering event for the one-year limitations period involves a subjective test and will start the period running from the time that a plaintiff actually suspects his or her injury was caused by someone's wrongdoing. Although the Plaintiffs' evidence shows that they did not become suspicious of wrongdoing on Kawesch's part until June 2004, Kawesch argues that Peik's statements after her second surgery that "something was different this time" and in her July 2002 complaint in the Board proceedings against his license that she felt she had never been an appropriate candidate for LASIK surgery establish to the contrary. However, the question of whether a plaintiff was subjectively suspicious that her injury was caused by wrongdoing is "a factual determination presumptively in the domain of the jury" and summary judgment is proper only if "the uncontradicted facts established through discovery are susceptible of only one legitimate inference." (Bristol-Myers Squibb Co. v. Superior Court (1995) 32 Cal.App.4th 959, 964, disapproved on other grounds by Norgart v. Upjohn Co. (1999) 21 Cal.4th 383, 410, fn. 8.)
Here, we conclude that Peik's statements are not so unambiguous as to establish that she suspected her visual problems were the result of wrongdoing either in 1999 (the time of her second surgery) or in 2002 (when she authored her complaint in connection with the Board proceedings). Because there is a triable issue of fact in this regard, Kawesch has not established that Peik's medical malpractice claim was untimely under the first statutory triggering event. (See also Clark v. Baxter Healthcare Corp. (2000) 83 Cal.App.4th 1048, 1057-1060.)
The second triggering event for the one-year limitations period is based on an objective standard and will start the statutory period running once a reasonable person in the plaintiff's position would have suspected that his or her injury was caused by some type of wrongdoing. (Fox v. Ethicon Endo-Surgery, Inc. (2005) 35 Cal.4th 797, 805; Kitzig v. Nordquist (2000) 81 Cal.App.4th 1384, 1391.) Kawesch argues that the Plaintiffs knew all the essential facts, and thus should have reasonably suspected wrongdoing, as a result of their visual problems in their surgically treated eyes. However, the mere fact that an operation does not produce hoped-for results will not necessarily signify negligence so as to commence the running of the statutory period. (Kitzig v. Nordquist, supra, 81 Cal.App.4th at pp. 1391-1392, citation omitted; accord, Unjian v. Berman (1989) 208 Cal.App.3d 881, 885-886.)
In light of the undisputed evidence that the visual problems suffered by the Plaintiffs were all disclosed risks of a LASIK procedure, the mere fact that they were each aware of such problems immediately after their surgeries does not establish that a reasonable person in either of their positions would have suspected that his or her injury resulted from wrongdoing. "The best medical treatment sometimes fails, or requires long and difficult recuperation, or produces bad side effects [and] [t]hus even if a patient is unhappy with his condition, he may not suspect he has been wronged." (Gutierrez v. Mofid (1985) 39 Cal.3d 892, 899; see Fox v. Ethicon Endo-Surgery, Inc., supra, 35 Cal.4th at p. 805; Dolan v. Borelli (1993) 13 Cal.App.4th 816, 824.)
For these reasons, we conclude that the trial court erred in concluding as a matter of law that the Plaintiffs' malpractice claim was barred by the one-year limitations period specified in Code of Civil Procedure section 340.5.
ii. The Three-Year Statute of Limitations
(a) Accrual: Appreciable Harm
The three-year statutory limitations period begins to run on the date of "injury." For the purposes of applying the statute, "injury" refers to the damaging effect of the negligence rather than the act of negligence itself and is deemed to occur when "appreciable harm" first manifests. (Larcher v. Wanless (1976) 18 Cal.3d 646, 655-656 and fn. 11; Brown v. Bleiberg (1982) 32 Cal.3d 426, 437, fn. 8; Bispo v. Burton (1978) 82 Cal.App.3d 824, 831.) Appreciable harm "manifests" for purposes of commencing the three-year period when damage "become[s] evidenced in some significant fashion," regardless of whether the plaintiff is actually aware of the injury. (Marriage & Family Center v. Superior Court (1991) 228 Cal.App.3d 1647, 1654.)
While harm or damage that remains undetected might not be deemed to constitute appreciable harm until it is identified by diagnosis (see Steingart v. White (1988) 198 Cal.App.3d 406, 415 [where plaintiff was repeatedly told that her breast lump was nonthreatening, she did not suffer appreciable harm until years later, when the lump was diagnosed as cancerous]), harm or damage that has clearly surfaced and is noticeable will constitute "injury" for purposes of the three-year statute even if the plaintiff does not recognize it as such. (Marriage & Family Center v. Superior Court, supra, 228 Cal.App.3d at p. 1654; see also Arrendondo v. Regents of University of California (2005) 131 Cal.App.4th 614, 619 [whether the plaintiff suspects the negligent cause of her harm is irrelevant in determining whether appreciable harm has manifested].) Kawesch contends that the Plaintiffs suffered appreciable harm and discovered all of the facts essential to their malpractice claim immediately after their surgeries, when they began to experience visual problems. The Plaintiffs responded that their vision problems did not constitute appreciable harm because those problems were disclosed risks of the surgery (i.e., acould occur without any negligence), to which they had consented.
We agree with the Plaintiffs' argument. The fact that they experienced visual problems, all of which were disclosed risks of LASIK surgery when performed on an appropriate candidate, did not constitute appreciable harm sufficient to trigger the running of the three-year limitations period as to their claim that, in obtaining their consent to the procedures, Kawesch concealed relevant information regarding the nature of those procedures, including the facts that the equipment he used was illegal and/or that the procedures were contraindicated to treat hyperopia or hyperopia with astigmatism. (See Warren v. Schecter (1997) 57 Cal.App.4th 1189 [in an action for lack of informed consent, the plaintiff's experiencing of disclosed side effects of a surgical procedure does not constitute manifestation of appreciable harm]; compare McNall v. Summers (1994) 25 Cal.App.4th 1300, 1310-1311 [plaintiff's serious and continuous memory loss after undergoing electroconvulsive therapy constituted appreciable harm triggering the accrual of the three-year limitations period]; Hills v. Aronsohn (1984) 152 Cal.App.3d 753, 762 [plaintiff's discovery of lumps and experience of soreness in her breasts constituted appreciable harm resulting from intrabreast silicone injections 8 years earlier].)
(Kawesch now objects that the Plaintiffs' complaint does not include sufficient allegations relating to either his use of the VISX laser or the fact that they had astigmatism (which rendered the use of the VISX laser on them improper). However, Kawesch specifically argued and presented evidence regarding his use of the VISX laser in his moving papers. Further, although the first amended complaint is not a model of pleading, it does allege that Kawesch was investigated for using illegal key cards in his VISX laser and suggest that he negligently used an "illegal laser" on them. Finally, in connection with the summary judgment motion, the Plaintiffs made repeated requests to amend their complaint in this regard, although the court never addressed those requests, but simply granted the motion for summary judgment.)
We reject Kawesch's argument that the Plaintiffs' malpractice claim is barred by the three-year statute of limitations.
(b) Tolling: Fraud or Intentional Concealment
The three-year limitations period is tolled where a defendant's false representation or intentional concealment prevents the plaintiff from bringing the action before the period of limitations has run. (Brown v. Bleiberg, supra, 32 Cal.3d at p. 438; Bowman v. McPheeters (1947) 77 Cal.App.2d 795, 804.) This rule is based on principles of estoppel, that is, that a culpable defendant should not be permitted to profit from his own wrong, to the extent that it hinders an otherwise diligent plaintiff from discovering the basis for a claim. (Sanchez v. South Hoover Hospital, supra, 18 Cal.3d at p. 99.)
Even if the Plaintiffs had suffered appreciable harm immediately as a result of their surgeries, the three-year statutory period would not bar their medical malpractice claim if their evidence was sufficient to create a triable issue of fact as to whether Kawesch committed fraud or concealment that precluded them from discovering that they had a basis for a claim against him. In this regard, the time for filing an action has been tolled where the physician's affirmative conduct, occurring sometime within three years after the manifestation of appreciable harm, prevents the plaintiff from timely bringing suit. (Trantafello v. Medical Center of Tarzana (1986) 182 Cal.App.3d 315, 321; Bowman v. McPheeters, supra, 77 Cal.App.2d at p. 804; see Pashley v. Pacific Elec. Ry. Co. (1944) 25 Cal.2d 226.) Such affirmative conduct includes a physician's lies to his patient about the reason for the medical treatment or the nature of the treatment performed. (See Hundley v. St. Francis Hospital (1958) 161 Cal.App.2d 800, 806-807 [period tolled where doctor misrepresented that he had performed a more extensive surgery than that to which the plaintiff had consented because it was justified by "the pathology that he found"]; Bowman v. McPheeters, supra, 77 Cal.App.2d at pp. 797, 804 [tolling where doctor made misrepresentations as to the cause and nature of the plaintiff's injury (cancer) and misrepresented that the injury would resolve on its own]; compare Trantafello v. Medical Center of Tarzana, supra, 182 Cal.App.3d at p. 321 [surgeon's failure to disclose that he used an experimental acrylic implant, rather than bone, in surgically repairing the plaintiff's neck did not constitute intentional concealment for purposes of tolling the three-year limitations period].)
In this case, the evidence submitted by the Plaintiffs is sufficient to create a triable issue of fact as to whether Kawesch's repeated representations, before and after their surgeries, regarding the propriety of his use of the Nidek and VISX lasers to treat their visual problems constituted fraud or concealment that would toll the three-year statutory period. (See Brown v. Bleiberg, supra, 32 Cal.3d at pp. 437-438 [evidence of a podiatrist's representations that he had surgically removed a number of small tumors from the plaintiff's feet was sufficient to create a triable issue of fact regarding the tolling of the three-year statute of limitations in the plaintiff's action brought 13 years later, after she discovered that the podiatrist had actually removed portions of her foot bones during the surgery].) Thus, we cannot uphold the trial court's grant of summary judgment based on the running of the three-year statute of limitations.
B. The Fraud Claim
A three-year statute of limitations in Code of Civil Procedure section 338, subdivision (d) applies to a cause of action for fraud. Pursuant to the statute, a fraud claim does not accrue, and thus the statute of limitations does not begin to run, "until the discovery, by the aggrieved party, of the facts constituting the fraud . . . ." (Code Civ. Proc., § 338, subd. (d).) The purpose of this provision is to promote the resolution of claims on the merits and to prevent the limitations period from running even before the fraud victim is aware of the wrong perpetrated against him. (Deveny v. Entropin, Inc. (2006) 139 Cal.App.4th 408,421.) The limitations period begins to run at the time the aggrieved party discovers either the fraud or facts that would lead a reasonably prudent person to suspect fraud. (Ibid.)
The foregoing standards are similar to those applied in construing whether the three-year limitations period under Code of Civil Procedure section 340.5 is subject to tolling for fraud or intentional concealment. (Bowman v. McPheeters, supra, 77 Cal.App.2d at p. 798, citing Sears v. Rule (1945) 27 Cal.2d 131, 147.) Using the same analysis applied under section 1(A)(ii)(b) above, we conclude that the Plaintiffs' evidence is sufficient to create a triable issue of fact as to whether they were delayed in discovering the facts underlying their fraud cause of action and thus that the trial court erred in summarily adjudicating that cause of action in Kawesch's favor.
2. Preemption
Kawesch argues that, even if the Plaintiffs' claims are not time-barred, they depend on whether his use of the Nidek and VISX lasers was illegal under the federal Food, Drug and Cosmetic Act (the Act) and as such are impliedly preempted by section 337, subdivision (a) thereof (hereafter section 337(a)), which requires that an action to enforce the Act be prosecuted by and in the name of the United States. (21 U.S.C. § 337; see also 21 U.S.C. § 360k [the Act's express preemption provision, which precludes a state from imposing as to a device intended for human use any requirement that (1) is different from, or in addition to, any requirement under the Act or (2) relates to the safety or effectiveness of the device].) However, the law does not support his argument. (See Armstrong v. Optical Radiation Corp. (1996) 50 Cal.App.4th 580, 594 [holding that a plaintiff's claims for negligence, strict liability and breach of warranty against the manufacturer of a surgical fluid used during her eye surgery were not preempted by the Act]; Evraets v. Intermedics Intraocular, Inc. (1994) 29 Cal.App.4th 779, 785-787 [plaintiff alleging design defects in intraocular lens implanted in his eye was not preempted under the Act from pursuing state law claims for fraud, negligent violations of the Act or product adulteration].)
Kawesch's reliance on Buckman Co. v. Plaintiffs' Legal Committee (2001) 531 U.S. 341 for a contrary conclusion is misplaced. There, the United States Supreme Court held that the Act impliedly preempted state law "fraud-on-the-agency" claims that were based on allegations the medical device manufacturer's consultant made false statements to the FDA in obtaining its approval to market the device. (Id. at pp. 343, 348.) The high court concluded that the recognition of state law claims would inevitably conflict with the FDA's responsibility to police fraud consistently with its judgment and objectives and cause applicants to fear that disclosures deemed appropriate by FDA would be subsequently deemed insufficient by a state court and thus such claims were impliedly preempted by the Act. (Id. at pp. 348-351.)
Here, the Plaintiffs' claims are not based on allegations that Kawesch fraudulently obtained FDA approval to use the Nidek and VISX lasers for hyperopic astigmatic surgeries and thus the analysis of Buckman simply does not assist Kawesch in establishing that those claims are impliedly preempted by section 337(a) of the Act. In fact, the Buckman court specifically acknowledged that existing precedent excepted out state law causes of actions for violations of federal safety requirements from the Act's express preemption provision, which cuts against Kawesch's position in this case. (Buckman Co. v. Plaintiffs' Legal Committee, supra, 531 U.S. at pp. 352-353, citing Medtronic, Inc. v. Lohr (1996) 518 U.S. 470; see generally Cipollone v. Liggett Group, Inc. (1992) 505 U.S. 504, 517 [recognizing that where Congress has enacted legislation that includes an express preemption provision, matters outside the scope of the express provision are not preempted].)
For the foregoing reasons, we conclude that the Plaintiffs' medical malpractice and fraud claims are not preempted by section 337(a) of the Act.
3. Punitive Damages
Code of Civil Procedure section 425.13 provides in relevant part that:
"(a) In any action for damages arising out of the professional negligence of a health care provider, no claim for punitive damages shall be included in a complaint or other pleading unless the court enters an order allowing an amended pleading that includes a claim for punitive damages to be filed. The court may allow the filing of an amended pleading claiming punitive damages on a motion by the party seeking the amended pleading and on the basis of the supporting and opposing affidavits presented that the plaintiff has established . . . there is a substantial probability . . . the plaintiff will prevail on the claim pursuant to Section 3294 of the Civil Code[, which authorizes an award of punitive damages where the defendant is guilty of oppression, fraud or malice]."
For the purposes of applying Civil Code section 3294, "oppression" refers to despicable conduct that subjects a person to "cruel and unjust hardship" in conscious disregard of that person's "rights" and "malice" includes "despicable conduct" committed by the defendant "with a willful and conscious disregard of the rights or safety of others." (Civ. Code, § 3294, subds. (c)(1), (2)).
Prior to trial, the Plaintiffs moved to amend their complaint to add a request for punitive damages against Kawesch. The superior court denied the motion without prejudice, concluding that the Plaintiffs had not submitted evidence showing a substantial probability that they would prevail on the proposed claim. The Plaintiffs appeal from this ruling, arguing that the court erred in denying their motion because their evidence was sufficient to show fraud, oppression or malice. During the pendency of this appeal, however, Kawesch died unexpectedly, a situation that renders the Plaintiffs' appellate challenge to this ruling moot as to him. (See Code Civ. Proc., § 377.42 ["In an action or proceeding against a decedent's personal representative or, to the extent provided by statute, against the decedent's successor in interest, on a cause of action against the decedent, all damages are recoverable that might have been recovered against the decedent had the decedent lived except damages recoverable under Section 3294 of the Civil Code or other punitive or exemplary damages"]; compare Whelan v. Rallo (1997) 52 Cal.App.4th 989, 991-996 and authorities cited therein [holding that a punitive damage award that is entered as part of a judgment prior to the defendant's death survives the death].) Because the issue is not moot as to the corporate defendant, however, we will address the Plaintiffs' argument on the merits.
In ruling on a motion for leave to assert a punitive damage claim against a health care provider, the trial court does not "weigh the merits of the claim or consider its likely outcome at trial," but must instead simply determine whether the plaintiffs' evidence, if believed by the trier of fact, is sufficient to establish that the defendant acted with oppression, fraud or malice; if it is, the court must grant the motion. (College Hospital, Inc. v. Superior Court (1994) 8 Cal.4th 704, 719, fn. 6; Looney v. Superior Court (1993) 16 Cal.App.4th 521, 539.) Here, the Plaintiffs contend that the superior court erred in denying their motion for leave to amend their complaint to assert a request for punitive damages because the evidence submitted in connection with the motion was sufficient to make the requisite showing. We agree.
In support of their motion, the Plaintiffs submitted evidence that (1) the Nidek and VISX lasers Kawesch used in their surgeries were only approved by the FDA for performing PRK on patients with myopia, with or without astigmatism; (2) the lasers, in their approved state, could not be used to perform hyperopic astigmatic LASIK procedures, so Kawesch had to use unauthorized software and/or hardware on his lasers to do the surgeries; (3) Kawesch's use of the unapproved software and/or hardware constituted an adulteration of the lasers and precluded him from properly describing hyperopic astigmatic surgeries to prospective patients as involving an "off-label" use of the lasers; (4) in response to the 2001 inquiry from the manufacturer of the Nidek laser, Kawesch falsely represented that his Nidek laser did not "include any alterations or adjustments that permit the performance of [off-label procedures]" and that he was not "performing or intending to perform" such procedures; (5) Kawesch had a custom and practice of performing refractive surgery on patients for whom such procedures were contraindicated; (6) no reasonable ophthalmologist practicing in the community would have used a Nidek or VISX similar to the ones Kawesch had to perform corrective surgery on Anders or Peik in January of 1999; and (7) Anders and Peik sustained damages to their vision as a result of Kawesch's improper use of the lasers to treat their visual problems.
This evidence, if believed, would support a finding by the trier of fact that Kawesch (and thus the corporate defendant of which he was a principal) knew that the use of the adulterated lasers on the Plaintiffs was improper and created a significant risk of injury to their eyesight and that he made false statements to them regarding the safety and efficacy of the procedures to induce them to undergo the procedures, for his own financial gain. Because this evidence is sufficient to support a finding of oppression, malice or fraud, we conclude the superior court erred in denying the Plaintiffs' motion under Code of Civil Procedure section 425.13 as to the corporate defendant.
DISPOSITION
The judgment is reversed and the matter is remanded for further proceedings consistent with this opinion. The Plaintiffs are to recover their costs on appeal.
WE CONCUR: BENKE, Acting P.J., HUFFMAN, J.