POWERS v. OPTICAL RADIATION CORPORATION

Reset A A Font size: Print

Court of Appeal, Second District, Division 5, California.

Nadia D. POWERS, Plaintiff and Appellant, v. OPTICAL RADIATION CORPORATION, Defendant and Respondent.

No. B081789.

Decided: July 27, 1995

Nossaman, Guthner, Knox & Elliott, Alvin S. Kaufer and Jean Spitzer, Los Angeles, for plaintiff and appellant. Morris, Polich & Purdy, Steven M. Crane and Douglas J. Collodel, Los Angeles and Kathlene Landgraf Kolts, Pasadena, for defendant and respondent.

Appellant Nadia D. Powers appeals a judgment dismissing her complaint for personal injuries allegedly caused by an intraocular lens manufactured by respondent Optical Radiation Corporation.   The trial court granted summary judgment in respondent's favor on the ground appellant's claim is preempted by the Medical Device Amendments of 1976 to the Food, Drug and Cosmetic Act of 1938.  (21 U.S.C. § 301 et seq.)   We affirm in part and reverse in part, and remand with directions.

FACTS

In December 1991, appellant filed a Judicial Council form complaint seeking damages for personal injuries allegedly caused by an intraocular lens (“IOL”) manufactured by respondent and sold under the name of Stableflex.   The IOL was surgically implanted to replace her own lens, which had been removed after it became clouded by a cataract.   The complaint's only cause of action was for product liability.

In September 1993, respondent moved for summary judgment on the ground that appellant's product liability claim was preempted by federal law and must be dismissed.   A few days before the motion was scheduled to be heard in October 1993, appellant's current counsel substituted back into the case and filed an ex parte application for leave to file a supplemental memorandum of points and authorities in opposition to respondent's motion for summary judgment.   In addition to reworking appellant's arguments against preemption, the supplemental memorandum of points and authorities asked 1 for leave to file an amended complaint alleging causes of action for:  (1) fraudulent concealment, (2) product liability for failure to perform safely, (3) product liability for defective design, (4) product liability for failure to warn, (5) product liability for improper manufacture, (6) negligence per se, (7) negligent design, manufacture, distribution, and sale, (8) negligent failure to recall, (9) distribution of adulterated device, (10) breach of implied warranty of fitness, and (11) violation of the investigative device exemption under 21 United States Code section 360j, subdivision (g)(1).

The court denied appellant's ex parte application.   A few days later, the court granted summary judgment on the ground the product liability claim was preempted.   During the hearing on the motion, the court stated that even if it were to grant leave to file an amended complaint, appellant's additional proposed causes of action would also be preempted.   Appellant filed a motion for reconsideration, which was denied, and the court thereafter entered judgment in respondent's favor and the case was dismissed.

Appellant appeals denial of her motion to amend and the judgment of dismissal.

DISCUSSION

1. Procedural Posture & Standard of Review

 This case comes to us in a procedural posture which we cannot ignore, for it affects our standard of review, and ultimately our disposition.   The proceedings below ended after appellant's complaint, stating a single cause of action for product liability, was dismissed.   Subsumed within that dismissal was denial of appellant's motion to file an amended complaint alleging other causes of action.   Respondent suggests we confine our review to dismissal of the product liability claim alone, because, as the record stands, it was the only operative cause of action.2  We reject respondent's suggestion, however, and shall review the causes of action in the proposed amended complaint under the authority granted us under Civil Procedure Code section 906 [“[R]eviewing court may review ․ any intermediate ruling, proceeding, order or decision which involves the merits or necessarily affects the judgment or order appealed from․”  (Ibid.) ]

 On appeal, we independently review the granting of summary judgment (Saldana v. Globe–Weis Systems Co. (1991) 233 Cal.App.3d 1505, 1510–1511, 285 Cal.Rptr. 385), and review denial of appellant's motion to amend for abuse of discretion.  (Mesler v. Bragg Management Co. (1985) 39 Cal.3d 290, 296, 216 Cal.Rptr. 443, 702 P.2d 601.)

2. The Regulatory Framework

 The Medical Device Amendments (the Amendments) to the Food, Drug and Cosmetic Act (the FDCA) give the Food and Drug Administration (the FDA) comprehensive regulatory authority over medical devices.   The Amendments establish a statutory scheme for all devices intended for human use, with the least dangerous items subject only to “general controls” (Class I, 21 U.S.C. § 360c, subd. (a)(1)(A)) and the most dangerous items subject to the most stringent regulations (Class III, 21 U.S.C. § 360c, subd. (a)(1)(C)).   A medical device is within the most dangerous category, or Class III, if “insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, and ․ [¶] [the device] presents a potential unreasonable risk of illness or injury․”  (21 U.S.C. § 360c, subd. (a)(1)(C)(i)-(ii).   Stableflex is a Class III medical device.

Although most Class III medical devices must receive premarket approval from the FDA (21 U.S.C. § 360e), certain devices may be granted an “investigational device exemption” (IDE) from the normally required approvals “to encourage, to the extent consistent with the protection of the public health and safety and with ethical standards, the discovery and development of useful devices intended for human use.”  (21 U.S.C. § 360j, subd. (g)(1).)   These Amendments contemplated significant latitude would be given developers of IDEs in order “to encourage innovation by exempting promising experimental devices from the usual requirement of establishing the safety and efficacy of a medical device before it can be sold․”  (Slater v. Optical Radiation Corp. (7th Cir.1992) 961 F.2d 1330, 1331–1332.)   Stableflex was provided to appellant under the investigational device exemption.

By an express preemption clause, the Amendments prohibit states from imposing any requirement relating to a device's safety or efficacy different from, or in addition, to federal requirements.  (21 U.S.C. § 360k [“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 [the FDCA], 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 [the FDCA]”].)   The federal regulations recognize this is not a blanket preemption.  “State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements․”  (21 C.F.R. § 808.1(d) (1994);  Evraets v. Intermedics Intraocular, Inc. (1994) 29 Cal.App.4th 779, 785–787, 34 Cal.Rptr.2d 852.)

3. Appellant's Causes of Action

 Our analysis in this matter is aided by the recent decision of Evraets v. Intermedics Intraocular, Inc., supra, 29 Cal.App.4th 779, 34 Cal.Rptr.2d 852.  Evraets involved a plaintiff claiming personal injuries from implantation of an IOL who sued the manufacturer for fraud, product liability, negligence, negligence per se, and breach of express and implied warranties.   The Evraets trial court sustained a demurrer to the complaint without leave to amend on the ground the claims were preempted.   The court of appeal reversed, finding the Amendments do not create a blanket preemption.   Relying on the leading case of Cipollone v. Liggett Group, Inc. (1992) 505 U.S. 504, 112 S.Ct. 2608, 120 L.Ed.2d 407, the court stated each cause of action must be analyzed on a case-by-case basis to determine which are preempted and which are not.  (Evraets v. Intermedics Intraocular, Inc., supra, 29 Cal.App.4th at pp. 785–787, 34 Cal.Rptr.2d 852.)   The court concluded causes of action imposing requirements “different from, or in addition to” federal requirements were preempted.  (Id. at p. 785, 34 Cal.Rptr.2d 852.)   Causes of action based, however, on a legal duty independent of federal requirements directly related to a medical device's safety or efficacy—such as the duty not to lie—were not preempted.  (Id. at pp. 785–787, 34 Cal.Rptr.2d 852.)   Because we find Evraets correctly applies controlling authority, we adopt it here.

 a.   Fraudulent Concealment:  Appellant alleges that respondent knew Stableflex posed risks to her eyesight beyond those inherent to any experimental device and concealed those risks from her.   Federal law does not preempt this cause of action.   As Evraets notes, “[w]hile Congress intended to encourage the development of new medical devices, there is no evidence of a congressional intent to exonerate from liability manufacturers who engage in deceit to obtain approval to market their product.”  (Evraets v. Intermedics Intraocular, Inc., supra, 29 Cal.App.4th at p. 789, 34 Cal.Rptr.2d 852.)  “The federal scheme [of preemption] is designed to provide some measure of consistency to the manufacturing and marketing of medical devices.   It is not designed to cover a more general obligation—the duty not to deceive.”   (Evraets v. Intermedics Intraocular, Inc., supra, 29 Cal.App.4th at p. 791, 34 Cal.Rptr.2d 852.)   While respondent complains that Evraets' holding is a “rote” application of Cipollone, it is a correct application nevertheless.

 b.   Product Liability for Failure to Perform Safely:  Appellant alleges Stableflex failed to perform safely as an ordinary patient would expect.   Under Evraets this claim is preempted because “[s]tate claims for negligence and strict liability undermine the congressional purpose of allowing lens manufacturers leeway in developing and perfecting their product.   These theories are predicated on the notion that a manufacturer has a duty to market a safe product.   By definition, experimental medical devices are not known to be safe products, yet society has an interest in encouraging their use, despite the risks involved․  [¶] ․ There is an apparent unanimity of opinion that the manufacturers of intraocular lenses cannot be sued under state law theories of negligence or strict liability.  [Citations.]”  (Id. at pp. 787–788, 34 Cal.Rptr.2d 852.)

c. Product Liability for Defective Design:  Appellant alleges Stableflex was defectively designed.   Like her claim for failure to perform safely, this cause of action is preempted.  (Id. at pp. 787–788, 34 Cal.Rptr.2d 852.)

 d.   Product Liability for Failure to Warn:  Appellant alleges Stableflex “was distributed without adequate information regarding the risks and dangers of which [respondent] knew or should have known at the time.”   To the extent this cause of action asserts the defect was caused because it was sold without proper warnings, it is preempted under Evraets.  (Id. at pp. 787–788, 34 Cal.Rptr.2d 852.)   To the extent, however, this cause of action alleges respondent's failure to warn was due to respondent's deliberate concealment of known facts, the cause of action constitutes a claim for fraudulent concealment which is not preempted.  (Id. at pp. 790–791, 34 Cal.Rptr.2d 852.)

e. Product Liability for Improper Manufacture:  Appellant alleges Stableflex was not properly manufactured.   Under Evraets, this claim is preempted.   (Id. at pp. 787–788, 34 Cal.Rptr.2d 852.)

f. Negligence per se:  Appellant alleges respondent failed to comply with applicable federal regulations governing investigation and distribution of Stableflex.   While Evraets holds that negligence claims are preempted, it simultaneously holds that negligence per se claims are not, because “[i]n applying a negligence per se theory, the state's requirements are equal to the federal requirements;  in fact, they simply adopt the federal standard of conduct.  [Citation.]”  (Id. at p. 792, 34 Cal.Rptr.2d 852.)

 We are unpersuaded by this distinction and decline to apply it.  “Negligence per se” is, strictly speaking, not a cause of action distinct from negligence, but rather an evidentiary doctrine used to establish the standard of care when negligence is claimed.  (Cade v. Mid–City Hosp. Corp. (1975) 45 Cal.App.3d 589, 596–597, 119 Cal.Rptr. 571.)   Moreover, accepting this distinction is tantamount to creating a private right of action to enforce FDA regulations concerning medical devices where no such right exists.  (Rodriguez v. SK & F Co. (1st Cir.1987) 833 F.2d 8, 9 [“Food, Drug and Cosmetic Act does not afford a private cause of action” (citations) ];  Pacific Trading Co. v. Wilson & Co., Inc. (7th Cir.1976) 547 F.2d 367, 370.) 3  Furthermore, we hesitate to find such a right because doing so would place with non-expert triers of fact the determination whether a medical device complies with applicable federal regulations, a necessarily complicated technical question better left to the FDA's expertise.   Such a transfer is particularly ill-advised because it creates the risk of conflicting jury verdicts from across the country as to whether an IOL was defective, a result which would undermine the national uniformity preemption is designed to produce.   Thus, this claim is preempted.

g. Negligence:  Appellant contends respondent negligently designed, manufactured, distributed, and sold Stableflex.   Under Evraets, these claims are preempted.  (Evraets v. Intermedics Intraocular, Inc., supra, 29 Cal.App.4th at pp. 787–788, 34 Cal.Rptr.2d 852.)

h. Negligent Failure to Recall:  Appellant contends respondent failed to inform her about Stableflex's dangers after adverse reactions by other IOL patients caused respondent to withdraw Stableflex from the market.   According to appellant, if she had been notified, she could have had her Stableflex removed earlier than she did, avoiding further injury.   To the extent appellant contends the failure to inform her was due to negligence, her claim is preempted under Evraets.  (Id. at pp. 787–788, 34 Cal.Rptr.2d 852.)

 i.   Distribution of Adulterated Devices:  Appellant contends Stableflex was adulterated in that it was sold under an investigational device exemption but failed to comply with the exemption's requirements.  (21 U.S.C. § 351, subd. (a), (i) [a device is adulterated “[i]f it is a device for which an exemption has been granted [as an investigational device] and the person who was granted such exemption or any investigator who uses such device under such exemption fails to comply with a requirement prescribed by or under [the investigational device exemption”].)   Appellant argues adulterated products lose the protection of preemption.

 Evraets raises, but does not answer, the question whether a claim for adulteration is preempted.  (Id. at pp. 793–794, 34 Cal.Rptr.2d 852.)   Nevertheless, we hold that however this claim is cast, it is preempted.   To the extent appellant alleges adulteration as an independent theory of recovery, it is preempted because there is no private right of action to enforce compliance with FDA regulations.  (Rodriguez v. SK & F Co., supra, 833 F.2d at p. 9;  Pacific Trading Co. v. Wilson & Co. Inc., supra, 547 F.2d at p. 370.)   To the extent appellant alleges adulteration is a fact which denies Stableflex the protection of preemption, her contention runs counter to the principle that the FDA, not judges or juries, is the proper entity to determine compliance with FDA regulations.

 j.   Breach of Implied Warranty of Fitness:  Appellant contends Stableflex was unfit for its intended use.4  Evraets did not address this cause of action in terms of preemption, holding instead that it was barred because of lack of privity between the patient and the IOL's manufacturer.   (Evraets v. Intermedics Intraocular, Inc., supra, 29 Cal.App.4th at p. 788, 34 Cal.Rptr.2d 852.)   Appellant properly concedes, however, that under Evraets' analysis such a claim, by alleging inherent defects in Stableflex, is preempted.

 k.   Violation of Investigational Device Exemption (21 U.S.C. § 360j(g)(1)):  Appellant contends respondent knowingly violated the requirements of the investigational device exemption in order to improperly mass market Stableflex.   We find that this claim is preempted.   To the extent appellant alleges this as an independent theory of recovery, it is preempted because there is no private right of action to enforce compliance with FDA regulations.  (Rodriguez v. SK & F Co., supra, 833 F.2d at p. 9;  Pacific Trading Co. v. Wilson & Co., Inc., supra, 547 F.2d at p. 370.)   Any assertion of failure to comply with FDA regulations brings it within the protection of the federal preemption.

DISPOSITION

Appellant's original form complaint was fatally defective because its sole cause of action for product liability was preempted.   Summary judgment as to that complaint was thus proper.   On the other hand, appellant's proposed amended complaint contains two causes of action that, to the extent they rest on an allegation of deliberate concealment of facts known to respondent, are not preempted:  fraudulent concealment (first amended cause of action), and product liability for failure to warn (fourth amended cause of action).   Yet, the amended complaint was not accepted for filing on the ground that all of its claims were preempted.   Such denial of leave to amend was an abuse of discretion and the judgment must be reversed as to those causes of action.   (Honig v. Financial Corp. of America (1992) 6 Cal.App.4th 960, 965–967, 7 Cal.Rptr.2d 922;  cf. Hebert v. Los Angeles Raiders, Ltd. (1991) 23 Cal.App.4th 414, 425–426, 29 Cal.Rptr.2d 540 [proper to deny leave to amend complaint to include claims which are barred].)   In all other respects, the judgment is affirmed.

Accordingly, we remand this matter to the trial court with instructions to hear appellant's motion for leave to amend in accordance with this opinion.   By remanding, we do not mean to interfere with the proper exercise of the court's discretion by implying leave must be granted, but rather simply that preemption is not a proper ground for denying appellant leave to amend to add causes of action for fraudulent concealment, and product liability for failure to warn.   We leave to the trial court the determination whether, after a hearing, there are other valid reasons not on the record for denying appellant leave to amend to add those claims.   Each side to bear its costs on appeal.

I. INTRODUCTION

I concur in my colleagues' analysis concerning the preemptive effect of 21 United States Code section 360(k) except in one respect.   I disagree with my colleagues insofar as they adopt the analysis appearing in Evraets v. Intermedics Intraocular, Inc. (1994) 29 Cal.App.4th 779, 794, 34 Cal.Rptr.2d 852 and thereby permit plaintiff to pursue her constructive fraud claim.   Like virtually every other court that has considered the issue, I believe the scope of the preemptive language in 21 United States Code section 360k(a) preempts a constructive fraud claim.

II. THE STATUTORY SCHEME

A. Standard of statutory review

Because the present case involves a question of federal statutory interpretation, the following is the proper standard of review described by the United States Supreme Court.   In Kaiser Aluminum & Chemical Corp. v. Bonjorno (1990) 494 U.S. 827, 835, 110 S.Ct. 1570, 1575, 108 L.Ed.2d 842, quoting from Consumer Product Safety Comm'n v. GTE Sylvania (1980) 447 U.S. 102, 108, 100 S.Ct. 2051, 2056, 64 L.Ed.2d 766, the United States Supreme Court held:  “The starting point for interpretation of a statute ‘is the language of the statute itself.   Absent a clearly expressed legislative intention to the contrary, that language must ordinarily be regarded as conclusive.’ ”   The United States Supreme Court has noted that “the statutory language controls its construction” (Ford Motor Credit Co. v. Cenance (1981) 452 U.S. 155, 158, fn. 3, 101 S.Ct. 2239, 2241, fn. 3) and that “ ‘[t]here is, of course, no more persuasive evidence of the purpose of a statute than the words by which the [L]egislature undertook to give expression to its wishes.’   [Citations.]”  (Griffin v. Oceanic Contractors, Inc. (1982) 458 U.S. 564, 571, 102 S.Ct. 3245, 3250, 73 L.Ed.2d 973.)   In interpreting a statute, the United States Supreme Court has noted:  “ ‘In expounding a statute, we must not be guided by a single sentence or member of a sentence, but look to the provisions of the whole law, and to its object and policy.’  [Citations.]  Our objective in a case such as this is to ascertain the congressional intent and give effect to the legislative will.”  (Philbrook v. Glodgett (1975) 421 U.S. 707, 713, 95 S.Ct. 1893, 1898, 44 L.Ed.2d 525.)   On another occasion, the court stated, “We do not, however, construe statutory phrases in isolation;  we read statutes as a whole.”  (United States v. Morton (1984) 467 U.S. 822, 828, 104 S.Ct. 2769, 2773, 81 L.Ed.2d 680, fn. omitted.)   Further, in interpreting a statute, the Supreme Court has emphasized the importance:  of avoiding “absurd results” (United States v. Turkette (1981) 452 U.S. 576, 580, 101 S.Ct. 2524, 2527, 69 L.Ed.2d 246);  “ ‘an odd result’ ” (Public Citizen v. Department of Justice (1989) 491 U.S. 440, 454, 109 S.Ct. 2558, 2567, 105 L.Ed.2d 377) or “unreasonable results whenever possible.”   (American Tobacco Co. v. Patterson (1982) 456 U.S. 63, 71, 102 S.Ct. 1534, 1538, 71 L.Ed.2d 748.)   Moreover, the Supreme Court has noted, “Judicial perception that a particular result would be unreasonable may enter into the construction of ambiguous provisions, but cannot justify disregard of what Congress has plainly and intentionally provided.”  (Commissioner v. Asphalt Products Co., Inc. (1987) 482 U.S. 117, 121, 107 S.Ct. 2275, 2278, 96 L.Ed.2d 97.)   In Griffin v. Oceanic Contractors, Inc., supra, 458 U.S. at p. 571, 102 S.Ct. at p. 3250, the court stated:  “Nevertheless, in rare cases the literal application of a statute will produce a result demonstrably at odds with the intentions of its drafters, and those intentions must be controlling․  [Citations.]”   When a statute is unambiguous, its language cannot “be expanded or contracted by the statements of individual legislators or committees during the course of the enactment process.  [Citation.]”  (West Virginia Univ. Hospitals, Inc. v. Casey (1991) 499 U.S. 83, 98–99, 111 S.Ct. 1138, 1147, 113 L.Ed.2d 68.)1

B. The three types of medical devices

In 1976, Congress enacted the Medical Device Amendments (21 U.S.C. § 301 et seq.), hereafter referred to as the M.D.A., to the Food, Drug, and Cosmetic Act of 1938.   The M.D.A. required annual registration of companies that made “devices.”   The M.D.A. also defined the types of medical devices that were subject to the registration by the Food and Drug Administration (F.D.A.).  (21 U.S.C. § 360(b).)   Further, the M.D.A. identified three classification of medical devices intended for human use in 21 United States Code section 360c.   The first of the three classifications, Class I, was identified as follows:  “(A) Class I, General Controls [¶] (i) A device for which the controls authorized by or under section 351, 352, 360, 360f, 360h, 360i, or 360j of this title or any combination of such sections are sufficient to provide reasonable assurance of the safety and effectiveness of the device.  [¶] (ii) A device for which insufficient information exists to determine that the controls referred to in clause (i) are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but because it—[¶] (I) is not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and [¶] (II) does not present a potential unreasonable risk of illness or injury, [¶] is to be regulated by the controls referred to in clause (i).”

The second of the three classifications was referred to as follows:  “(B) Class II, Special Controls [¶] A device which cannot be classified as a class I device because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with section 360(k) of this title), recommendations, and other appropriate actions as the Secretary deems necessary to provide such assurance.   For a device that is purported or represented to be for a use in supporting or sustaining human life, the Secretary shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assurance.”

The third type of device identified involved more new and experimental types of medical apparatus or appliances.   It is this third type of medical device that is at issue in this case.   The statutory definition was as follows:  “(C) Class III, Premarket Approval [¶] A device which because—[¶] (i) it (I) cannot be classified as a class I device because insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, and (II) cannot be classified as a class II device because insufficient information exists to determine that the special controls described in subparagraph (B) would provide reasonable assurance of its safety and effectiveness, and (ii)(I) is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or [¶] (II) presents a potential unreasonable risk of illness or injury, [¶] is to be subject, in accordance with section 360e of this title, to premarket approval to provide reasonable assurance of its safety and effectiveness.  [¶] If there is not sufficient information to establish a performance standard for a device to provide reasonable assurance of its safety and effectiveness, the Secretary may conduct such activities as may be necessary to develop or obtain such information.  [¶] (2) For purposes of this section and sections 360d and 360e of this title, the safety and effectiveness of a device are to be determined—[¶] (A) with respect to the persons for whose use the device is represented or intended, [¶] (B) with respect to the conditions of use prescribed, recommended, or suggested in the labeling of the device, and [¶] (C) weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.  [¶] (3)(A) Except as authorized by subparagraph (B), the effectiveness of a device is, for purposes of this section and sections 360d and 360e of this title, to be determined, in accordance with regulations promulgated by the Secretary, on the basis of well-controlled investigations, including clinical investigations where appropriate, by experts qualified by training and experience to evaluate the effectiveness of the device, from which investigations it can fairly and responsibly be concluded by qualified experts that the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device.  [¶] (B) If the Secretary determines that there exists valid scientific evidence (other than evidence derived from investigations described in subparagraph (A))—[¶] (i) which is sufficient to determine the effectiveness of a device, and [¶] (ii) from which it can fairly and responsibly be concluded by qualified experts that the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device, [¶] then, for purposes of this section and sections 360d and 360e of this title, the Secretary may authorize the effectiveness of the device to be determined on the basis of such evidence.”

This third type of medical device was subject to approval by the Secretary of Health and Human Services (the secretary).  (21 U.S.C. § 360e(b).)   The M.D.A. referred to the permission granted by the secretary as “premarket approval.”   The M.D.A. provided that the secretary was to promulgate regulations concerning the premarket approval of class III devices.   Further, Congress specified certain practices, standards, and time frames to be utilized in the administrative procedure leading to the acceptance or disapproval of an application for premarket approval of a class III device.   (21 U.S.C. § 360e(c), (d), (f), (g), (h), & (i).)   Further, the Congress specified specific rules to be followed in the event the secretary decided to withdraw the premarket approval of a class III device.  (21 U.S.C. §§ 360e(e), (g), & (i), 360g(f).)

In the event of the disapproval of an application for premarket approval or the withdrawal by the secretary of a previously approved class III device, the manufacturer or distributor could file a petition in the United States Court of Appeals.  (21 U.S.C. § 360g(a).)   Congress set forth:  a 30 day time limit for filing the petition;  venue requirements;  service of process rules;  a requirement that the secretary lodge the administrative record with the circuit court (21 U.S.C. § 360g(a);  a procedure for enlarging the administrative record (21 U.S.C. § 360g(b));  and a substantial evidence standard of review by the Court of Appeals.  (21 U.S.C. § 360j(c).

As part of the M.D.A., the secretary was authorized to provide notification of dangerous devices and order their removal from interstate commerce.  (21 U.S.C. § 360h.)   The secretary was granted regulatory authority to require record keeping by manufacturers and distributors of class III devices as well as the filing of reports concerning such medical devices.  (21 U.S.C. § 360i.)   Extensive requirements were imposed for the rule-making process by Congress as part of the M.D.A. (21 U.S.C. § 360j.)

C. The preemptive language

After setting forth extensive statutory language concerning class III devices and their regulation by the secretary, Congress addressed the effect of state requirements of on medical appliances as follows:  “(a) General rule [¶] Except as provided in subsection (b) of this section, 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 chapter 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 chapter.  [¶] (b) Exempt requirements [¶] Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a) of this section, under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if—[¶] (1) the requirement is more stringent than a requirement under this chapter which would be applicable to the device if an exemption were not in effect under this subsection;  or [¶] (2) the requirement—[¶] (A) is required by compelling local conditions, and [¶] (B) compliance with the requirement would not cause the device to be in violation of any applicable requirement under this chapter.”  (21 U.S.C. § 360k(a) & (b).)   It is this language which is at the heart of the present appeal.

III. PERTINENT DECISIONS CONCERNING PREEMPTION

The language relevant to the present case in 21 United States Code section 360k(a) is:  “[N]o 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 chapter to the device, and [¶] (2) which relates to the safety or effectiveness of the device․” 2  Hence, the preemptive statute prohibits a state from imposing “any requirement—[¶] ․ which is different from, or in addition to, any requirement [imposed by the Medical Device Act] ․ which relates to the safety ․ of the device․”  (21 U.S.C. § 360k(a)(1) & (2).)   The term “any” which appears twice in the preemptive statute.   The scope of 21 United States Code section 360k(a) was described by the Third Circuit Court of Appeals as follows:  “This section pre-empts only state imposed requirements.   Further, it pre-empts those requirements only when they differ from or add to a previously established FDA requirement and relate to the safety or efficacy of the regulated device.   When a state law differs from or adds to a FDA requirement and when a state law relates to the safety or effectiveness of a device approved by the FDA, the state law is pre-empted.   Conversely, when a state law neither imposes requirements nor differs from or adds to a FDA requirement nor relates to the safety or effectiveness of the device or to any other matter included in a FDA requirement, the state law is not pre-empted by § 360k.”  (Michael v. Shiley, Inc. (3rd Cir.1995) 46 F.3d 1316, 1323.)   The Eighth Circuit described the preemptive impact of 21 United States Code section 360k(a) in this fashion:  “Thus, a state tort claim is preempted only if (1) the FDA has established regulations specific to the medical device in issue, (2) the state claim imposes a requirement different from, or in addition to, any FDA requirement for the device, and (3) the claim relates to the safety or effectiveness of the device, or to any other matter included in an MDA requirement for the device.”  (Martello v. CIBA Vision Corp. (8th Cir.1994) 42 F.3d 1167, 1168.)

At the outset, it bears emphasis that there is a presumption against preemption when historic state police powers are the subject of a federal statute.   The United States Supreme Court has held, “When considering pre-emption, ‘we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.’ ”  (Wisconsin Public Intervenor v. Mortier (1991) 501 U.S. 597, 605, 111 S.Ct. 2476, 2482, 115 L.Ed.2d 532;  accord, Rice v. Santa Fe Elevator Corp. (1947) 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447.)   The Supreme Court has described the presumption against preemption in the following manner, “ ‘Consideration under the Supremacy Clause starts with the basic assumption that Congress did not intend to displace state law.’ ”  (Building & Trades Council v. Associated Builders (1993) 507 U.S. 218, 224, 113 S.Ct. 1190, 1194, 122 L.Ed.2d 565;  Maryland v. Louisiana (1981) 451 U.S. 725, 746, 101 S.Ct. 2114, 2129, 68 L.Ed.2d 576.)   Finally, the Supreme Court has noted:  “In the interest of avoiding unintended encroachment on the authority of the States, however, a court interpreting a federal statute pertaining to a subject traditionally governed by state law will be reluctant to find pre-emption.   Thus, pre-emption will not lie unless it is ‘the clear and manifest purpose of Congress.’  [Citation.]”  (CSX Transp., Inc. v. Easterwood (1993) 507 U.S. 1732, ––––, 113 S.Ct. 1732, 1737, 123 L.Ed.2d 387.)

There are two types of preemption—express or implied.   The United States Supreme Court has described the differing types of preemption as follows:  “In determining whether federal law pre-empts a state statute, we look to congressional intent.  ‘ “Pre-emption may be either express or implied, and ‘is compelled whether Congress' command is explicitly stated in the statute's language or implicitly contained in its structure and purpose.’ ” '   [Citations.]  (‘If the intent of Congress is clear, that is the end of the matter;  for the court ․ must give effect to the unambiguously expressed intent of Congress'[ ] ).  We ‘begin with the language employed by Congress and the assumption that the ordinary meaning of that language accurately expresses the legislative purpose.’  [Citation.]”  (FMC Corp. v. Holliday (1990) 498 U.S. 52, 56–57, 111 S.Ct. 403, 407, 112 L.Ed.2d 356;  accord, Fidelity Federal Sav. & Loan Assn. v. de la Cuesta (1982) 458 U.S. 141, 152–153, 102 S.Ct. 3014, 3022, 73 L.Ed.2d 664.)

The United States Supreme Court has repeatedly held that when a federal statute uses “relates to” language such as appears in 21 United States Code section 360k(a), a preemptive effect is intended by Congress.   In Morales v. Trans World Airlines, Inc. (1992) 504 U.S. 374, 383–384, 112 S.Ct. 2031, 2036–2037, 119 L.Ed.2d 157, the Supreme court set forth its established rule as follows:  “Section 1305(a)(1) expressly pre-empts the States from ‘enact[ing] or enforc[ing] any law, rule, regulation, standard, or other provision having the force and effect of law relating to rates, routes, or services of any air carrier․’  For purposes of the present case, the key phrase, obviously, is ‘relating to.’   The ordinary meaning of these words is a broad one—‘to stand in some relation;  to have bearing or concern;  to pertain;  refer;  to bring into association with or connection with,’ Black's Law Dictionary 1158 (5th ed. 1979)—and the words thus express a broad pre-emptive purpose.   We have repeatedly recognized that in addressing the similarly worded pre-emption provision of the Employee Retirement Income Security Act of 1974 (ERISA), 29 U.S.C. § 1144(a), which pre-empts all state laws ‘insofar as they ․ relate to any employee benefit plan.’   We have said, for example, that the ‘breadth of [that provision's] pre-emptive reach is apparent from [its] language,’ Shaw [v. Delta Air Lines, 463 U.S. 85, 95, 103 S.Ct. 2890, 2899–2900, 77 L.Ed.2d 490 (1983) ];  that it has a ‘broad scope,’ Metropolitan Life Ins. Co. v. Massachusetts, 471 U.S. 724, 739 [105 S.Ct. 2380, 2388, 85 L.Ed.2d 728] (1985), and an ‘expansive sweep,’ Pilot Life Ins. Co. v. Dedeaux, 481 U.S. 41, 47 [107 S.Ct. 1549, 1552, 95 L.Ed.2d 39] (1987);  and that it is ‘broadly worded,’ Ingersoll–Rand Co. v. McClendon, 498 U.S. 133, 138 [111 S.Ct. 478, 482, 112 L.Ed.2d 474] (1990), ‘deliberately expansive,’ Pilot Life, supra, [481 U.S.,] at 46, [107 S.Ct., at 1552,] and ‘conspicuous for its breadth,’ Holliday, supra, [498 U.S.,] at [58, 111 S.Ct. at 407].   True to our word, we have held that a state law ‘relates to’ an employee benefit plan, and is pre-empted by ERISA, ‘if it has a connection with or reference to such a plan.’  Shaw, supra, [463 U.S.,] at 97 [103 S.Ct. at 2900].   Since the relevant language of the ADA is identical, we think it appropriate to adopt the same standard here:  State enforcement actions having a connection with, or reference to, airline ‘rates, routes, or services' are pre-empted under 49 U.S.C.App. § 1305(a)(1).”

This general statement of law has specific application to 21 United States Code section 360k(a) with its prohibition against “any requirement” which is different from that imposed by the M.D.A. which “relates to the safety or effectiveness of the” lens in the present case.   Federal courts are largely in accord that this language preempts state court tort actions in connection with safety issues concerning class III medical devices.  (Martello v. CIBA Vision Corp., supra, 42 F.3d at p. 1168 [state tort claims for strict liability, breach of express and implied warranties, and negligence preempted by M.D.A. for injuries sustained as a result of use of soft contact lens disinfectant system, a class III device];  Gile v. Optical Radiation Corp. (3rd Cir.1994) 22 F.3d 540, 541–546 [products liability and negligence remedies arising from plaintiff's blindness resulting from implanting intraocular lens constitute a “requirement” within the meaning of 21 U.S.C. § 360k(a) and are preempted];  Duncan v. Iolab Corporation (11th Cir.1994) 12 F.3d 194, 195 [negligence, strict liability, and breach of implied warranty claims arising from defective intraocular lenses preempted by M.D.A.];  Slater v. Optical Radiation Corp. (7th Cir.1992) 961 F.2d 1330, 1332–1334 [state tort claims for negligence, strict liability, and breach of implied warranty arising from injuries sustained by anterior-chamber intraocular lens preempted by 21 U.S.C. § 360k(a) ].)   Further, federal courts are in agreement that the preemptive effect of 21 United States Code section 360k(a) includes state tort theories.  (Michael v. Shiley, Inc., supra, 46 F.3d at p. 1323;  Gile v. Optical Radiation Corp., supra, 22 F.3d at pp. 541–542.)   Finally, Congress fully expected the M.D.A. to apply to intraocular lenses.   The M.D.A. makes specific reference to intraocular lens.  (21 U.S.C. § 360j(1)(3)(D)(iii);  Slater v. Optical Radiation Corp., supra, 961 F.2d at p. 1332;  American Soc. of Cataract & R. Surgery v. Sullivan (D.D.C.1991) 772 F.Supp. 666, 673.)

IV. THE EFFECT OF THE M.D.A. ON FRAUD BASED STATE TORT CLAIMS

My colleagues have accepted the analysis appearing in Evraets v. Intermedics Intraocular, Inc., supra, 29 Cal.App.4th at p. 789, 34 Cal.Rptr.2d 852, which holds that a state fraud claim is not preempted by the M.D.A.   I respectfully disagree with the moral, logical, and highly principled analysis set forth by my colleague, Presiding Justice Roger Boren, in Evraets to the effect that a state fraud theory does not fall within the scope of “any requirement” which is different from that imposed by the M.D.A. which “relates to the safety or effectiveness of the” lens in the present case.  (21 U.S.C. § 360k(a).)   First, decisional authority construing the M.D.A. holds that a fraud claim is in fact preempted by 21 United States Code section 360k(a).   (King v. Collagen Corp. (1st Cir.1993) 983 F.2d 1130, 1132, 1136 [fraud claims preempted by M.D.A.];  Mitchell v. Collagen Corp. (N.D.Ind.1994) 870 F.Supp. 885, 897 (21 U.S.C. § 360k(a)) preempts Indiana common law fraud claim in connection with Collagen compounds];  Talbott v. C.R. Bard, Inc. (D.Mass.1994) 865 F.Supp. 37, 52 [fraud claims premised on failure to warn of dangers of heart catheter, a class III medical device, preempted by 21 U.S.C. § 360k(a) ];  Burnett v. Pfizer, Inc. (E.D.Ky.1994) 864 F.Supp. 25, 26 [M.D.A. preempts fraud claim arising from defective artificial heart valve];  Griffin v. Medtronic, Inc. (D.Md.1994) 840 F.Supp. 396, 397;  [fraud claim concerning pacemaker preempted by M.D.A.];  Kemp v. Pfizer, Inc. (E.D.Mich.1993) 835 F.Supp. 1015, 1018, 1022 [fraud claims concerning a prosthetic heart valve, a class III device, preempted by M.D.A.];  Covey v. Surgidev Corp. (N.D.Ohio 1993) 815 F.Supp. 1089, 1090, 1093–1095 [fraud theory in connection with intraocular lens preempted by 21 U.S.C. § 360k(a) ];  Green v. Dolsky (1994) 433 Pa.Super. 556, 641 A.2d 600, 606–607 [fraud claim arising from Collagen implant preempted];  cf. Michael v. Shiley, Inc., supra, 46 F.3d at p. 1329 [fraud is a state law requirement which is preempted if the M.D.A. regulations apply to the device];  Hunsaker v. Surgidev Corp. (M.D.Pa.1992) 818 F.Supp. 744, 754, affd. (3rd Cir.1993) 5 F.3d 1489 [tort claim premised upon a knowing failure to warn of defects with intraocular lens preempted by M.D.A.].)

Second, apart from the fact a majority of courts which have considered the issue have concluded fraud based claims can be preempted under the M.D.A., the statutory language as well as the pertinent regulation compel the conclusion plaintiff's constructive fraud claim is barred under established federal preemption principles.   The specific constructive fraud allegations appearing in the amended complaint are as follows:  before the lens was implanted in plaintiff's eye, defendant had actual knowledge they would cause injuries;  defendant had been warned the lens would cause “uveitis, glaucoma, hyphema, corneal decompensation, corneal transplantation, frequent loss of vision, and quite often loss of the eye itself”;  defendant knew a similar lens had been withdrawn from the market because of the injuries it had caused;  defendant concealed this information from plaintiff and her physician;  and plaintiff, who was unaware of these dangers, would not have used the lens had defendant warned her.

Fraudulent concealment is a specific requirement imposed by California law.   The basis of this state's constructive fraud law was described by the California Supreme Court as follows:  “However, like much of our law, the law of deceit in California is not purely statutory;  it is a mixture of statutory and common law.   Provisions of the Civil Code that are substantially the same as the common law, such as the provisions that codify common law torts, ‘must be construed as continuations thereof, and not as new enactments.’   (Civ.Code, § 5.)  Civil Code sections 1709 and 1710 have been recognized as continuations of the common law.  [Citation.]”  (Mirkin v. Wasserman (1993) 5 Cal.4th 1082, 1091–1092, 23 Cal.Rptr.2d 101, 858 P.2d 568.)   California recognizes a cause of action for fraudulent concealment in the absence of a fiduciary relationship under the following circumstances:  “In transactions which do not involve fiduciary or confidential relations, a cause of action for non-disclosure of material facts may arise in at least three instances:  (1) the defendant makes representations but does not disclose facts which materially qualify the facts disclosed, or which render his disclosure likely to mislead;  (2) the facts are known or accessible only to defendant, and defendant knows they are not known to or reasonably discoverable by the plaintiff;  (3) the defendant actively conceals discovery from the plaintiff.”  (Warner Constr. Corp. v. City of Los Angeles (1970) 2 Cal.3d 285, 294, 85 Cal.Rptr. 444, 466 P.2d 996, fns. omitted;  accord, Goodman v. Kennedy (1976) 18 Cal.3d 335, 346–347, 134 Cal.Rptr. 375, 556 P.2d 737.)   Each of these three forms of fraudulent concealment finds its basis in Civil Code sections 1572 and 1710 3 .  (Warner Constr. Corp. v. City of Los Angeles, supra, 2 Cal.3d at p. 294, fn. 5, 85 Cal.Rptr. 444, 466 P.2d 996 [failure to disclose all material facts thereby rendering representation misleading];  Lingsch v. Savage (1963) 213 Cal.App.2d 729, 735, 29 Cal.Rptr. 201 [failure to disclose facts only known by defendant];  Herzog v. Capital Co. (1945) 27 Cal.2d 349, 353, 164 P.2d 8 [active concealment].)

The regulations propounded under the authority of the M.D.A. (21 U.S.C. § 360j(g)) for intraocular lens of the kind used by plaintiff are found at 21 Code of Federal Regulations sections 813.1–813.170.   Those regulations do not impose a fraudulent concealment requirement on disclosure of information concerning intraocular lens.   The specific regulation concerning promotion and sale of intraocular lens provides:  “(a) Neither the sponsor nor any person acting for or on behalf of the sponsor shall disseminate any promotional material representing that the lens being investigated is safe and effective for the purposes for which it is under investigation.   This requirement does not restrict the full exchange of scientific information concerning the device, including dissemination of scientific findings.   However, this requirement prohibits promotional claims by the sponsor that the lens is safe and effective while the device is being investigated to establish its safety and effectiveness.  [¶] (b) The sponsor of the study of an intraocular lens may distribute the lens only if the sponsor has an effective exemption under this part for all lenses sold, and all patients who receive a lens are included in an investigational study under an exemption.”  (21 C.F.R. § 813.50 (1994).)   Nothing in this explicit regulation concerning dissemination of information by a sponsor of an investigation, which in this case was defendant, refers to fraudulent concealment and in fact permits full disclosure of scientific information but prohibits promotional claims.   California's fraudulent concealment statutes and decisionally based authority identifying three forms of tort liability in the absence of a confidential relationship created a “requirement [¶] ․ which is different from, or in addition to, any requirement” imposed by the M.D.A. (21 U.S.C. § 360k(a).)

To further complicate matters from plaintiff's perspective, her concealment claims directly relate to the safety of the intraocular lens.   As noted previously, 21 United States Code section 360k(a) preempts any state tort requirement “which relates to the safety” of a class III device.   Plaintiff's concealment claims all relate to the safety of the intraocular lens.   Her amended complaint alleges;  defendant had knowledge of “the dangers [in] using the ․ lens”;  defendant had knowledge the lenses “had caused serious injuries to others”;  defendants had been warned by an authority in the field that the lens were “dangerous”;  another lens manufactured by a competitor had been removed from the market “because of injuries which that lens had caused”;  defendant had “concealed ․ information ․ about the dangers”;  and the “defects in and dangers of the ․ lens were not apparent [nor] known to plaintiff or to her physician”;  and had the dangers concealed by defendants been known, plaintiff would not have purchased or used the lens.   All of plaintiff's claims relate to the “safety” of the lens which falls completely within the express preemptive language in 21 United States Code section 360k(a).   Accordingly, because her claims all relate to the safety of a class III medical devices which is regulated pursuant to the M.D.A., the trial court correctly refused to permit the filing of the amended complaint.

V. THE PROBLEMS RESULTING FROM Evraets

Evraets holds that the M.D.A. did not preempt that plaintiff's express warranty, negligence per se (Evid.Code, § 669), and fraud theories.  (Evraets v. Intermedics Intraocular, Inc., supra, 29 Cal.App.4th at pp. 789–792, 34 Cal.Rptr.2d 852.)   This holding, as my colleagues recognize in part, is at odds with national judicial interpretation of the M.D.A. in the context of intraocular lens and 21 United Code section 360k.   First, the express warranty claim was in fact preempted.   As noted previously, 21 Code of Federal Regulation section 813.50 prohibits distribution of promotional material concerning the safety of intraocular lens but specifically permits “full exchange of scientific information concerning the device, including dissemination of scientific findings.”   Under California law, an express warranty is defined as follows by the Commercial Code section 2313, subdivision (1):  “(a) Any affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain creates an express warranty that the goods shall conform to the affirmation or promise.  [¶] (b) Any description of the goods which is made part of the basis of the bargain creates an express warranty that the goods shall conform to the description.  [¶] (c) Any sample or model which is made the part of the basis of the bargain creates an express warranty that the whole of the goods shall conform to the sample or model.  [¶] (2) It is not necessary to the creation of an express warranty that the seller use formal words such as ‘warrant’ or ‘guarantee’ or that [she or] he have a specific intention to make a warranty, but an affirmation merely of the value of the goods or a statement purporting to be merely the seller's opinion or commendation of the goods does not create a warranty.”  Commercial Code section 2313 has been interpreted to create a presumption as to the materiality of statement made concerning a product and to place the burden on the seller to prove a warranty was not part of the bargain.  (Keith v. Buchanan (1985) 173 Cal.App.3d 13, 23, 220 Cal.Rptr. 392.)  Commercial Code section 2313 and California's judicial interpretation and application of its express warranty law constitutes a “requirement” (21 U.S.C. § 360k(a)) different from that set forth in title 21 of the Code of Federal Regulations, section 813.50 which permits the disclosure of scientific information to physicians concerning intraocular lens.   Finally, apart from the clear statutory language, the federal circuits are in accord that express warranties are preempted when a class III device is regulated by the M.D.A. (Martello v. CIBA Vision Corp., supra, 42 F.3d at p. 1169.)

Second, as my colleagues correctly recognize, Evraets incorrectly held that a Evidence Code section 669 negligence per se theory was not preempted by the M.D.A.  California Evidence Code section 669 constitutes a requirement different from that imposed by the M.D.A. and is hence preempted.  (21 U.S.C. § 360k(a).)   California is the only jurisdiction where negligence, per se or otherwise, and a state statute can serve as the basis for a suit involving a class III medical device which is subject to regulation.   Evraets holds that a negligence claim is preempted.  (Evraets v. Intermedics Intraocular, Inc., supra, 29 Cal.App.4th at pp. 787–788, 34 Cal.Rptr.2d 852.)   However, Evraets also holds that a negligence per se claim is not preempted.  (Id. at p. 791–792, 34 Cal.Rptr.2d 852.)   Evidence Code section 669 is merely a codification of a presumption.   (Peterson v. City of Long Beach (1979) 24 Cal.3d 238, 244, 155 Cal.Rptr. 360, 594 P.2d 477;  1 Witkin, Cal.Evidence (3d ed. 1986) § 213, p. 170.)   If negligence is a preempted theory;  it follows that the fact a presumption is available to a plaintiff should not logically create state court jurisdiction.   The tort is preempted or it is not.   Finally, the negligence per se theory available only in California permits a plaintiff to sue for a violation of the federal regulations—something other jurisdictions recognize is strictly prohibited.  (Michael v. Shiley, Inc., supra, 46 F.3d at p. 1329;  National Bank of Commerce v. Kimberly–Clark Corp. (8th Cir.1994) 38 F.3d 988, 992;  Gile v. Optical Radiation Corp., supra, 22 F.3d at p. 544.)   Hence, I am in agreement with my colleagues insofar as they part company with Evraets as to the preemptive effect of the M.D.A. on negligence per se claims.4  Finally, for the reasons previously expressed, plaintiff's constructive fraud claim was preempted.

VI. CONCLUSION

I conclude all of plaintiff's claims are preempted by the M.D.A.   Accordingly, I concur in all of my colleagues' analysis except that part that holds there has been no preemption of plaintiff's fraudulent concealment claims.   I would affirm the judgment.

FOOTNOTES

1.   Appellant's initial request for leave to file an amended complaint was not made by formal motion, but rather consisted of a passage in her memorandum of points and authorities that if summary judgment were granted on the product liability claim, she wished to have the opportunity to assert additional causes of action not subject to preemption.   It was only when appellant moved for reconsideration that she formally moved for leave to file an amended complaint.

2.   Respondent argues we should not entertain arguments concerning the causes of action in the proposed amended complaint because the first time appellant requested in writing leave to amend her complaint was in conjunction with her motion for reconsideration, which was filed after respondent's motion for summary judgment had already been granted (but before judgment was entered).   This overlooks the fact that appellant implicitly sought leave to amend when she filed her ex parte application before the motion for summary judgment was heard.

3.   Appellant contends a private right of action is not barred, relying on Toole v. Richardson–Merrell Inc. (1967) 251 Cal.App.2d 689, 703–704, 60 Cal.Rptr. 398.   However, we deem the unambiguous pronouncements of Rodriguez v. SK & F Co., supra, 833 F.2d 8, and Pacific Trading Co. v. Wilson & Co., Inc., supra, 547 F.2d 367, to be a correct statement of the law since there are more recent interpretations of federal law by federal courts.

4.   Appellant's reply brief asks that if the case is remanded to the trial court, she be given leave to add a cause of action for breach of express warranty.   Beyond noting that under Evraets such a claim is not preempted (Evraets at pp. 788–789, 34 Cal.Rptr.2d 852) and that respondent's cases purporting to be to the contrary (Brown v. Superior Court (1988) 44 Cal.3d 1049, 245 Cal.Rptr. 412, 751 P.2d 470, Artiglio v. Superior Court (1994) 22 Cal.App.4th 1388, 27 Cal.Rptr.2d 589, and Hufft v. Horowitz (1992) 4 Cal.App.4th 8, 5 Cal.Rptr.2d 377) are inapposite because they do not address the question of preemption, we leave to the trial court's discretion whether to grant such leave.

1.   The California Supreme Court has adopted similar rules pertaining to the construction of statutes enacted by our Legislature.   (Lakin v. Watkins Associated Industries (1993) 6 Cal.4th 644, 659, 25 Cal.Rptr.2d 109, 863 P.2d 179;  People v. Jones (1993) 5 Cal.4th 1142, 1164, 22 Cal.Rptr.2d 753, 857 P.2d 1163.)

2.   21 United States Code section 360k(a), which contains the preemptive language begins, “Except as provided in subsection (b)․”  21 United States Code section 360k(b) permits a state or local public entity to secure an exemption from the preemptive effect of the M.D.A. by proving there are “compelling local conditions.”  (21 U.S.C. § 360k(b)(2)(A).   Further, the proposed local requirement must not violate the M.D.A.  (21 U.S.C. § 360k(b)(2)(B).)   Plaintiff does not contend that the Secretary of Health and Human Services has promulgated any regulations which permit California to impose its tort laws in connection with the intraocular lens which are at issue in the present case.

3.   Civil Code section 1572 states:  “Actual fraud, what.   Actual fraud, within the meaning of this Chapter, consists in any of the following acts, committed by a party to the contract, or with his connivance, with intent to deceive another party thereto, or to induce him to enter into the contract:  [¶] 1.   The suggestion, as a fact, of that which is not true, by one who does not believe it to be true;  [¶] 2.   The positive assertion, in a manner not warranted by the information of the person making it, of that which is not true, though he believes it to be true;  [¶] 3.   The suppression of that which is true, by one having knowledge or belief of the fact;  [¶] 4.   A promise made without any intention of performing it;  or, [¶] 5.   Any other act fitted to deceive.”Civil Code section 1710 provides:  “Deceit, what.   A deceit, within the meaning of the last section, is either:  [¶] 1.   The suggestion, as a fact, of that which is not true, by one who does not believe it to be true;  [¶] 2.   The assertion, as a fact, of that which is not true, by one who has no reasonable ground for believing it to be true;  [¶] 3.   The suppression of a fact, by one who is bound to disclose it, or who gives information of other facts which are likely to mislead for want of communication of that fact;  or, [¶] 4.   A promise, made without any intention of performing it.”

4.   The Evraets court cites Slater v. Optical Radiation Corp., supra, 961 F.2d at p. 1334 for the proposition that a negligence per se claim may be pursued under state law.  (Evraets v. Intermedics Intraocular, Inc., supra, 29 Cal.App.4th at p. 791, 34 Cal.Rptr.2d 852.)   Slater does not address that issue.   Further, Evraets cites the decision of Reiter v. Zimmer, Inc. (S.D.N.Y.1993) 830 F.Supp. 199, 203–204 for the proposition a state law negligence per se claim may be pursued.  (Evraets v. Intermedics Intraocular, Inc., supra, 29 Cal.App.4th at p. 791, 34 Cal.Rptr.2d 852.)  Reiter does not address a state law negligence per se claim.

GODOY PEREZ, Associate Justice.

ARMSTRONG, J., concurs.