Caroline Ma v. Robert Lin, M.D. et al.

This is a medical malpractice and products liability action brought by plaintiff Caroline Ma (Plaintiff) against defendants Robert T. Lin, M.D. (Lin), Robert T. Lin, M.D. Inc. (Lin Inc.), Scott D. Barnes, M.D. (Barnes), IQ Laser Vision / Vision Institute of Norther California (IQ Laser Vision), Danny B. Luong, M.D. (Luong), Gregory Phan, M.D. (Phan), STAAR Surgical Company (STAAR), Vision Institute of Southern California, Inc. (Vision Institute), and Amber Li (Li).

Plaintiff filed the operative first amended complaint (FAC) in April 2023, alleging three causes of action: (1) medical malpractice (against Lin, Lin Inc., Barnes, IQ Laser Vision, Luong, Phan, and Vision Institute); (2) products liability / negligence (against STAAR and Barnes); and (3) intentional infliction of emotional distress (against Lin, Lin Inc., IQ Laser Vision, Phan, Vision Institute, and Li). Plaintiff later dismissed the third cause of action.

The FAC alleges that in May 2021, Plaintiff underwent a procedure performed by Phan to correct her vision at IQ Laser Vision’s facility. (FAC, ¶¶ 13, 18.) The procedure involved placing STAAR’s implantable collamer lenses (ICL) that would correct Plaintiff’s vision and eliminate her need for glasses. (Id. at ¶ 14.) During this procedure, Phan allegedly caused Plaintiff to suffer injury to both eyes. (Id. at ¶¶ 19, 21.) Lin and Barnes were present for the May 2021 procedure. (Id. at ¶ 18.)

At issue is defendants STAAR and Barnes’s motion for summary judgment, or in the alternative, summary adjudication. Plaintiff opposes. STAAR and Barnes filed both an initial summary judgment motion and an amended motion. Because statutory notice was proper as to the amended motion and Plaintiff responded to that motion, the court likewise focuses on the amended motion. Trial in this matter is set for February 16, 2027.

REQUEST FOR JUDICIAL NOTICE

STAAR and Barnes request judicial notice of three documents in support of its motion. “Judicial notice may not be taken of any matter unless authorized or required by law.” (Evid. Code, § 450.) A precondition to judicial notice in either its permissive or mandatory forms is that the matter to be noticed must be relevant to a material issue before the court. (Silverado Modjeska Recreation and Park Dist. v. County of Orange (2011) 197 Cal.App.4th 282, 307, fn. 18.)

Judicial notice of Exhibits A and B to the declaration of Eden Darrell under Evidence Code section 451, subdivision (b) is granted. Exhibits A and B are copies of the Federal Register approving STAAR’s Visian ICL and supplement for its Visian Toric ICL. Judicial notice of Exhibit C, the Food and Drug Administration’s (FDA) Summary of Safety and Effectiveness Data for the Visian Toric ICL is granted. (Evid. Code, § 452, subd. (c).)

Plaintiff’s request for judicial notice of the court’s (Hon. Chung) August 2025 order denying Lin, Lin Inc., IQ Laser Vision, Phan, Vision Institute, and Li’s motion for summary judgment is granted. (Evid. Code, § 452, subd. (d).)

Evidentiary Objections

STAAR and Barnes submitted evidentiary objections with their reply. The court declines to rule on these objections, which are preserved for appeal, because they are not material to the disposition of the motion. (Code Civ. Proc., § 437c, subd. (q).)

LEGAL STANDARDS FOR SUMMARY JUDGMENT OR ADJUDICATION

The pleadings limit the issues presented for summary judgment or summary adjudication and such a motion may not be granted or denied based on issues not raised by the pleadings. (Laabs v. City of Victorville (2008) 163 Cal.App.4th 1242, 1258.) The moving party bears the initial burden of production to make a prima facie showing that there are no triable issues of material fact. (Aguilar v. Atlantic Richfield Co. (2001) 25 Cal.4th 826, 850 (Aguilar).) A motion for summary judgment or adjudication shall be granted only if it completely disposes of an entire cause of action, an affirmative defense, a claim for damages, or an “issue of duty.” (See Code Civ. Proc., § 437c, subd. (f)(1).)

“A defendant seeking summary judgment must show that at least one element of the plaintiff’s cause of action cannot be established, or that there is a complete defense to the cause of action.” “The burden then shifts to the plaintiff to show there is a triable issue of material fact on that issue.” (Alex R. Thomas & Co. v. Mutual Service Casualty Ins. Co. (2002) 98 Cal.App.4th 66, 72; internal citations omitted.) “There is a triable issue of material fact if, and only if, the evidence would allow a reasonable finder of fact to find the underlying fact in favor of the party opposing the motion in accordance with the applicable standard of proof.” (Aguilar, supra, 25 Cal.4th at p. 850.)

While the same standards of admissibility govern both sides’ supporting evidence, the opposition evidence is liberally construed while the moving party’s evidence is strictly construed. (Saelzler v. Advanced Group 400 (2001) 25 Cal.4th 763, 768.) The evidence must be liberally construed in support of the opposing party, resolving any doubts in favor of that party. (Yanowitz v. L’Oreal USA, Inc. (2005) 36 Cal.4th 1028, 1037.)

DISCUSSION

STAAR and Barnes move for summary judgment or adjudication. Barnes asserts that he is entitled to summary adjudication of the first cause of action for medical malpractice because he owed no duty to Plaintiff. STAAR and Barnes assert that the second cause of action for products liability / negligence is preempted by the Medical Device Amendments of 1976 (MDA). (21 U.S.C. § 360c et seq.)

First Cause of Action – Medical Malpractice

The elements of a medical malpractice cause of action are: (1) a duty to use such skill, prudence, and diligence as other members of the profession commonly possess and exercise; (2) a breach of the duty; (3) a proximate causal connection between the negligent conduct and the injury; and (4) resulting loss or damage. (Lattimore v. Dickey (2015) 239 Cal.App.4th 959, 968.)

A physician-patient relationship is a predicate for a physician’s duty of care. Such a relationship arises from an express or implied contract that the doctor will treat the patient with proper professional skill. (McCurry v. Singh (2024) 104 Cal.App.5th 1170, 1176 (McCurry).) 7

“Generally, the agreement comes into existence ‘ “[w]hen the physician takes charge of a case and is employed to attend a patient.” ’ ” “The relationship does not arise when the physician ‘does not affirmatively treat or directly advise the patient.’ ” (Ibid.) “While it is the province of the jury, as trier of fact, to determine whether an unreasonable risk of harm was foreseeable under the particular facts of a given case, the trial court must still decide as a matter of law whether there was a duty in the first place, even if that determination includes a consideration of foreseeability.” (Clarke v. Hoek (1985) 174 Cal.App.3d 208, 214 (Clarke).)

Both parties discuss Clarke v. Hoek (1985) 174 Cal.App.3d 208. The Clarke court determined that a proctor observing a surgery to assess and report on a surgeon’s competence owed no duty of care to the patient to prevent the surgeon’s malpractice. (Id. at p. 211.) The Clarke court reasoned that the proctor did not take part in the patient’s care or surgery; was never requested, instructed, or authorized to provide care; observed outside the sterile field; never received, requested, or expected payment for proctoring; had not been requested to render care or to serve as the patient’s consultant; and had no authority to supervise or control the surgeon’s actions. (Id. at p. 217.) The court found no duty even though the proctor reviewed the patient’s x-rays and discussed the operative plan with the surgeon before the surgery. (Id. at p. 216.)

The evidence about this issue is undisputed; the parties instead dispute whether the evidentiary record (construed liberally in Plaintiff’s favor) supports the existence of a physician-patient relationship. Phan testified that he performed Plaintiff’s ICL procedure as part of STAAR’s Visian ICL Physician Certification Program, and that Barnes observed the procedure as a proctor. (Declaration of Eden M. Darrell, Ex. E [Phan Depo.], p. 117:3-20.) Barnes testified that he did not provide any medical treatment to Plaintiff, and did not recall meeting or communicating with Plaintiff. (Id., Ex.

I [Barnes Depo.], pp. 39:14-40:12.) Plaintiff confirmed that she never met Barnes before her May 2021 procedure. Nor did she communicate with Barnes on the day of her procedure or thereafter. (Id., Ex. D [Plaintiff’s Depo.], p. 173:12-17.) Barnes further testified that proctoring is limited to observing how a surgeon implements the steps of surgery and reminding them of the didactic training. (Barnes Depo., pp. 41:4-14, 46:9-12.) Proctors do not train, educate, teach, or tell the surgeon what to do. (Id. at p. 46:5-7.)

The surgeon is in control and responsible for the entire operation. (Id. at p. 80:15-22.)

Regarding the surgery itself, Phan stated during discovery that before and during the ICL procedure, Barnes discussed his tips and advice for the procedure. (Plaintiff’s Evidence, Ex. 16 [Phan’s Supp. Interrogatory Responses], No. 125.) Phan also stated that he consulted with Barnes because it was Phan’s first ICL procedure and that both STAAR and Barnes provided training for the procedure. (Phan’s SROG Response, Nos. 90-92, 135-136.) Barnes testified when he observed that the lens began to unfold incorrectly in Plaintiff’s right eye, he asked Phan what he wanted to do. (Barnes Depo., p. 108:3-13.)

Barnes recalled that Phan said he should take the lens out, and Barnes responded, “yeah, that is correct. So use an instrument to take that out.” (Id. at p. 108:12-15.) Barnes also testified that he looked through the oculars that Phan used to view Plaintiff’s left eye after Phan asked for his opinion. (Id. at p. 113:7-13.)

While it is a close question, the court finds that there was no physician-patient relationship between Barnes and Plaintiff (and therefore no duty of care). Barnes’s participation was greater than that of the proctor in Clarke, but was nonetheless insufficient to create a physician-patient relationship. Barnes did not consult directly with Plaintiff. Barnes’s 8

discussion with Phan before the surgery about which lens was appropriate is akin to the presurgery discussion that the Clarke court found was inadequate to create a physician-patient relationship. (Clarke, 174 Cal.App.3d at p. 216.) Barnes did not personally perform any medical procedure on Plaintiff. Barnes never affirmatively accepted any responsibility for Plaintiff’s care. (See McCurry v. Singh (2024) 104 Cal.App.5th 1170, 1178 [no physicianpatient relationship when an on-call specialist decided not to provide medical care to another doctor’s patient].)

Barnes’s limited discussion with Phan during the surgery is inadequate to create a physician-patient relationship. Plaintiff’s summary of the evidence on that point is telling, “After confirming the anterior capsule tear, Dr. Barnes agreed with Dr. Phan’s decision to abort the left-eye procedure.” (Plaintiff opposition MPA, 8:4-6, italics added.) Plaintiff’s physician-patient relationship was with Phan, not Barnes.

Second Cause of Action – Products Liability / Negligence

STAAR and Barnes contend that Plaintiff’s products liability / negligence cause of action is both expressly and impliedly preempted by the MDA because Plaintiff has not pleaded or proven that STAAR and Barnes violated the Federal Food, Drug, and Cosmetic Act (FDCA) in marketing and promoting the device or in training Phan.

Preemption Under the MDA

The MDA was enacted by Congress in 1976 to create a regime of detailed federal oversight over medical devices and sweep back state regulation of those devices. (Riegel v. Medtronic, Inc. (2008) 552 U.S. 312, 316 (Riegel).) The MDA has three classes of device, with class III devices being those “where the device is either useful in supporting or sustaining human life, substantially important in preventing the impairment of human health, or presents an unreasonable risk of illness or injury.” (Glennen v. Allergan, Inc. (2016) 247 Cal.App.4th 1, 8 (Glennen).)

“Because of the risks associated with them, new class III devices are required to go through a premarket approval (PMA) process ‘to provide reasonable assurance of [their] safety and effectiveness.’ ” (Glennen, supra, 247 Cal.App.4th at p. 8.) “Where PMA is required, the device’s proponent must file with the FDA an application providing a wide variety of information: reports of all investigations into the safety and effectiveness of the device, a statement of its components, a full description of the methods used to manufacture and produce the device, device samples, and specimens of proposed labeling.” “The FDA has broad authority to condition its approval in a number of ways, including requiring that the device meet formal performance standards (21 C.F.R. § 861.1(b)(3) (2016)), or any other postapproval requirement “necessary to provide reasonable assurance, or continued reasonable assurance, of the safety and effectiveness of the device.’ (21 C.F.R. § 814.82(a)(9) (2016).)” (Glennen, at p. 8.) “Moreover, the FDCA and its accompanying regulations impose continuing requirements on medical devices and their manufacturers after they receive PMA.” (Ibid.)

“The MDA contains an express preemption provision for medical devices, which provides that ‘no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement ... [¶] (1) which is different from, or in addition to, any requirement applicable under this [Act] to the device, and [¶] (2) which relates to the safety or effectiveness of the device or to any other matter included

in a requirement applicable to the device under this [Act].’ (§ 360k(a).) ” (Glennen, supra, 247 Cal.App.4th at p. 9.)

The United States Supreme Court set forth a two-part test to determine whether a state law claim is expressly preempted by the MDA. Preemption “under section 360k(a) applies if (1) the federal government established requirements applicable to the medical device in question, and (2) the state law claims concerning the device are based on requirements that are ‘ “different from, or in addition to” ’ the federal requirements, and relate to the safety and effectiveness of the device.” (Glennen, supra, 247 Cal.App.4th at p. 10, citing Riegel, supra, 552 U.S. at pp. 321-322.) “The first prong is automatically satisfied if the FDA authorizes commercial distribution of a class III medical device following the PMA process.” (Glennen, at p. 10.)

The MDA does not preempt a state law claim that is parallel to the federal requirements. To be parallel, the requirements must be genuinely equivalent. “ ‘ “State and federal requirements are not genuinely equivalent if a manufacturer could be held liable under the state law without having violated the federal law.” ’ ” (Id. at p. 10, quoting Wolicki-Gables v. Arrow Internat., Inc. (11th Cir. 2011) 634 F.3d 1296, 1300.) “If state law liability could be found notwithstanding compliance with the federal requirements, those state law duties are not parallel to the federal requirements and will be preempted.” (Glennen, at p. 10.)

“Even if a plaintiff’s claim is not expressly preempted, it will be deemed impliedly preempted if it conflicts with the FDCA’s enforcement scheme.” (Glennen, supra, 247 Cal.App.4th at p. 10.) “Implied preemption under the MDA bars claims seeking to enforce an exclusively federal requirement that is not grounded in traditional state tort law.” (Id. at p. 11.) “Claims not tied to state law tort duties are essentially private actions to enforce the FDCA and are barred by 21 United States Code section 337(a), a provision authorizing the federal government to enforce the MDA.” (Ibid.)

Together, express and implied preemption create a “ ‘ “ ‘narrow gap’ through which a state-law claim must fit to escape preemption.” ’ ” (Glennen, supra, 247 Cal.App.4th at p. 11.) The plaintiff must be suing for conduct that violates the FDCA to avoid preemption under 21 U.S.C. § 360k(a). But the plaintiff must not be suing because the conduct violates the FDCA because such a claim would be impliedly preempted under Buckman Co. v. Plaintiffs’ Legal Comm. (2001) 531 U.S. 341. (Glennen, at p. 12; see Buckman, at p. 347 [claims that a device manufacturer had made fraudulent representations to the FDA were “inherently federal in character” because the relationship between the manufacturer and the FDA “originates from, is governed by, and terminates according to federal law.”].) “Stated another way, ‘ “[i]n order to survive preemption, such claims ‘must be premised on conduct that both (1) violates the FDCA and (2) would give rise to a recovery under state law even in the absence of the FDCA.’ ” ’ ” (Glennen, at p. 12.)

Analysis

It is undisputed that the lenses at issue are class III medical devices approved by the FDA under the PMA process. (Statement of Undisputed Fact No. 4.)

It is important to start with the FAC’s allegations, as the pleadings limit the issues presented for summary judgment. (Laabs, supra, 163 Cal.App.4th at p. 1258.) Plaintiff’s second cause of action does not directly allege that STAAR or Barnes negligently trained Phan. The FAC instead alleges, “Defendants STAAR SURGICAL COMPANY, SCOTT D. 10

BARNES, M.D. ... breached its duty and failed to exercise ordinary care and was negligent in promoting and marketing of the device to purchasers including Plaintiff CAROLINE MA through inadequately and improperly trained health care providers.” (FAC, ¶ 45, italics added.) A cause of action based on STAAR and Barnes’s marketing and promotion of the medical device is expressly preempted. (Riegel, supra, 552 U.S. at pp. 323-324 [“common-law causes of action for negligence and strict liability do impose ‘requirement[s]’ and would be pre-empted by federal requirements specific to a medical device.”].)

Plaintiff contends the second cause of action should be construed as alleging that STAAR and Barnes were negligent by allowing Phan to perform the surgery even though Phan had not completed the “certification requirements contained in STAAR’s FDA-approved labeling.” (MPA opposition, 15:14-20.) Even if the FAC is construed to allege that theory of liability, the claim is nonetheless impliedly preempted under the reasoning of Glennen.

In Glennen, the plaintiff’s claim was based on the manufacturer’s alleged failure to train physicians how to use its medical device as required by the FDA. (Glennen, supra, 247 Cal.App.4th at p. 20.) The court held the inadequate training allegation was impliedly preempted because no state law duty required a medical device manufacturer to offer a physician training program. (Ibid.) The court further noted that while the record did not reflect whether the FDA evaluated the adequacy of the training program, the inadequate training allegation would go “beyond whatever the FDA did do, or chose not to do, in approving the product.” (Id. at p. 21.) Thus, the plaintiff’s claim would “ ‘displace the FDA’s exclusive role and expertise in the area.’ ” (Ibid.)

Here, as in Glennen, there is no state law duty requiring a manufacturer to offer a physician training program. STAAR received a PMA letter from the FDA requiring that the lenses’ labeling must “specify the requirements that apply to the training of practitioners who may use the device as approved in this order.” (Darrell Decl., Exs. A-B.) STAAR and Barnes submitted a Direction for Use (DFU) that generally referred to STAAR’s training and certification program. (Declaration of Deana Boushell, Exs.

C-F.) The operative DFUs each state, “All physicians must complete the STAAR Surgical Visian [ICL] TICL Physician Certification Program to use.” (Id., Exs. E-F.) STAAR did not submit materials for its Physician Certification Program, and the FDA did not require or request the materials for the approval process. (Id. at ¶ 10.) Plaintiff’s negligent training cause of action is impliedly preempted.

Scott v. C.R. Bard, Inc. (2014) 231 Cal.App.4th 763 (Scott), relied on by Plaintiff, is distinguishable. The manufacturer in Scott voluntarily provided training for a medical device as part of its marketing strategy. The Scott court determined that although a medical device manufacturer has no duty to train a physician in using the device, where the manufacturer undertakes the training it may be held liable for the negligent undertaking of that responsibility. (Id. at p. 774.) By contrast, STAAR’s training and certification were part of the FDA’s requirements. (Accord, Glennen, supra, 247 Cal.App.4th at p. 20 [“the training program at issue arose solely out of requirements imposed by the FDA. Under this set of facts, plaintiff cannot allege a state law claim for negligent undertaking.”].)

STAAR and Barnes’s motion for summary adjudication of the second cause of action for negligent training is granted.

CONCLUSION

The motion for summary judgment is granted.

The court will prepare the order.

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