Opinion
NOT TO BE PUBLISHED
Santa Clara County Super. Ct. No. CV010668
Mihara, J.
Plaintiff John Norks, who suffered severe injuries after he was implanted with the Ancure Endograft System (Ancure Device), brought a products liability and personal injury action against defendants Endovascular Technologies, Inc. (EVT), Guidant Corporation (Guidant), Advanced Cardiovascular Systems, Inc., and Origin Medsystems, Inc. The trial court granted defendants’ motion for summary judgment on the ground that plaintiff’s claims were preempted by federal law. Plaintiff has filed a timely appeal from the judgment of dismissal. We find no error and affirm the judgment.
EVT designed, manufactured, and distributed the Ancure Device. Guidant is the parent corporation of EVT. Both Advanced Cardiovascular Systems, Inc. and Origin Medsystems, Inc. had some involvement in the design and testing of the Ancure Device.
I. Federal Regulation of Medical Devices
“In enacting the Medical Device Amendments of 1976 (MDA) (21 U.S.C. § 360c et seq.) to the Federal Food, Drug, and Cosmetic Act (21 U.S.C., § 301 et seq.), Congress sought to ‘ “provide for the safety and effectiveness of medical devices intended for human use.” ’ (Medtronic, Inc. v. Lohr (1996) 518 U.S. 470, 474 (Lohr).) The MDA divides medical devices into three classifications: class I, class II, and class III. (21 U.S.C. § 360c(a)(1).) A class III device, such as the Ancure Device, receives the most federal oversight, and requires premarket approval by the FDA.” (McGuan v. Endovascular Technologies, Inc. (2010) 182 Cal.App.4th 974, 977 (McGuan).)
However, prior to obtaining premarket approval, a manufacturer of a class III device may apply for the Food and Drug Administration (FDA) authorization to use the device for clinical testing pursuant to an investigational device exemption (IDE). (See 21 U.S.C. § 360j(g).) A manufacturer is prohibited from conducting research of a device in the United States on human subjects without approval by the FDA and an institutional review board (IRB). (21 C.F.R. §§ 812.20; 812.42, 812.62.)
We refer to the Code of Federal Regulations in effect when defendants applied for IDE approval from the FDA.
In order to obtain an IDE, an applicant must submit: “a plan for any proposed clinical testing of the device and a report of prior investigations of the device” (21 U.S.C. § 360j(g)(3)(A)); information about “the methods, facilities and controls used for the manufacture, processing, packing, storage and... installation of the device” (21 C.F.R. §§ 812.20(b)(3)); an example of agreements to be executed by all investigators and the identities of all such investigators (21 C.F.R. § 812.20(b)(4)-(5)); details of each IRB that has been or will be asked to review the investigation and certification of the IRB’s decision (21 C.F.R. § 812.20(b)(6)); details about the institution where the testing will occur (21 C.F.R. § 812.20(b)(7)); proposed labeling for the device (21 C.F.R. § 812.20(b)(10)); and “[c]opies of all forms and informational materials to be provided [testing] subjects to obtain informed consent” (21 C.F.R. § 812.20(b)(11)). After reviewing this information, the FDA notifies the applicant that the proposed investigation has been approved, approved with modifications, or disapproved. (21 C.F.R. § 812.30.)
In addition to listing the relevant contraindications, hazards, adverse effects, warnings and precautions that must be included on the labeling, the FDA also requires that the labeling “shall not bear any statement that is false or misleading in any particular and shall not represent the device is safe or effective for the purposes for which it is being investigated.” (21 C.F.R. § 812.5(b).)
After the IDE application has been approved, the FDA prohibits any deviation from the investigational plan, design, manufacturing techniques, clinical protocol, warnings or consent form which could potentially affect clinical subjects unless the FDA first approves the change. (See 21 C.F.R. § 812.35.) An applicant must maintain records and make reports “to the Secretary of data obtained as a result of the investigational use of the device during the exemption, as the Secretary determines will enable him to assure compliance with such conditions, review the progress of the investigation, and evaluate the safety and effectiveness of the device.” (21 U.S.C. § 360j(g)(2)(B)(ii).) The applicant must also comply with any “other requirements as the Secretary may determine to be necessary for the protection of the public health and safety.” (21 U.S.C. § 360j(g)(2)(B)(iii).) The FDA may withdraw its approval at any time in the event that an applicant does not comply with the approved clinical protocol. (21 C.F.R. § 812.30(b), (c).)
The statement of facts is based on undisputed facts and evidence presented by plaintiff in opposition to the motion for summary judgment. However, since the trial court sustained defendants’ objections to the declaration by plaintiff’s counsel on the grounds that the declaration was “replete argument and hearsay and not based on personal knowledge of the declarant, ” and plaintiff has not challenged this ruling on appeal, this evidence has not been included.
In March 1999, Guidant filed a premarket approval application for the Ancure Device. In September 1999, the FDA approved the application. However, many serious problems arose with the Ancure Device within the first year of premarket approval.
In October 2000, seven anonymous employees informed defendants of the following: there had been incomplete testing on the device; recommendations were made to physicians regarding the use of the device in a manner that had not been approved by the FDA; a component of the device had a failure rate of approximately 20 percent; defendants had failed to report product changes relating to safety and effectiveness; and defendants failed to submit medical device reports (MDR) as required by federal regulations.
Guidant temporarily recalled the Ancure Device between March 16 and August 17, 2001. During this period, Guidant submitted 10 premarket approval application supplements to the FDA to address the regulatory deficiencies.
On May 12, 2001, Guidant submitted an IDE application to the FDA. This application stated: “ ‘The purpose of this study is to confirm that the changes made to the ANCURE ENDOGRAFT System (“ANCURE System”) and deployment techniques included in the Instructions for Use (“IFU”) do not compromise the safety profile of the ANCURE System.’ ” The application also included tables of safety data indicating that of the 7, 364 devices sold prior to the recall there were 2, 725 complaints.
On June 12, 2001, the FDA granted conditional approval of the IDE application. The FDA letter of approval stated in part: “We would like to point out that FDA approval of your IDE application does not imply that this investigation will develop sufficient safety and effectiveness data to assure FDA approval of a premarket approval (PMA) application for this device.” The conditional approval also required Guidant to correct a number of stated deficiencies within 45 days. In July 2001, Guidant submitted responses to the FDA’s stated deficiencies. The FDA never informed defendants that it was taking any action to withdraw its approval of the IDE application. Nor did it take any action to suspend or halt the IDE clinical trial.
On July 24, 2001, plaintiff agreed to participate in the IDE clinical study for the Ancure Device. Plaintiff signed a consent form, which stated, in part, that “ ‘[t]he ANCURE System has been available for sale and the grafts have been placed in nearly 8, 000 patients in the U.S. since September 28, 1999.’ ” However, the form did not refer to the more than 2, 600 incidents involving the Ancure Device that were not reported to the FDA prior to March 2001. Plaintiff was then implanted with the Ancure Device in July 2001.
On August 17, 2001, the FDA reapproved the Ancure Device.
In June 2003, EVT entered into a plea agreement. EVT pleaded guilty to nine counts of shipping misbranded medical devices (21 U.S.C. §§ 331(a), 333(a)(2)) arising from the shipping of nine devices between November 3, 1999 and September 24, 2000, and one count of making false statements (18 U.S.C. § 1001), arising from the provision of incomplete information to the FDA inspector in July 2000. The plea agreement also stated: “From September 30, 1999 to March 16, 2001, defendant introduced approximately 7, 632 Devices into interstate commerce. [¶] Between September 30, 1999 and March 16, 2001, defendant filed 172 MDRs for the delivery system of the Ancure Device. [¶] On or about March 23, 2001, defendant disclosed to the FDA the existence of approximately 2, 628 additional MDRs concerning the delivery system of the Ancure Device that had not been previously reported to FDA, as required by law.” The plea agreement also required EVT to forfeit $10.9 million as well as pay a criminal fine of $32.5 million and a civil settlement of $49 million. The Ancure Device was withdrawn from the market in October 2003.
III. Statement of the Case
In December 2003, plaintiff filed a complaint in which he alleged that he had suffered severe injuries after he was implanted with the Ancure Device in July 2001. His complaint alleged seven causes of action: strict product liability (failure to warn); strict product liability (Restatement Second of Torts § 402A); negligence; breach of express warranty; breach of implied warranty; fraudulent concealment; and punitive damages. Plaintiff’s complaint focused on defects in the design, testing, and manufacture of the Ancure Device, the failure to warn of all possible adverse side effects, and the fraudulent concealment of the dangers and defects of the product. The complaint did not refer to violations of federal law.
On May 13, 2008, plaintiff filed a motion to amend his complaint. The proposed amended complaint added a cause of action for fraud on the FDA, plaintiff’s physician, and plaintiff. In June 2008, the trial court denied the motion.
In August 2008, defendants filed a motion for summary judgment on the ground that plaintiff’s claims were preempted by 21 United States Code section 360k(a) of the MDA. Plaintiff filed opposition to the summary judgment motion. After granting the motion for summary judgment, the trial court entered judgment in favor of defendants.
IV. Discussion
A. Motion for Summary Judgment
1. Standard of Review
“In bringing a motion for summary judgment, a party bears the ‘burden of persuasion’ that there are no triable issues of material fact and that the moving party is entitled to judgment as a matter of law. (Aguilar v. Atlantic Richfield Co. (2001) 25 Cal.4th 826, 850 (Aguilar).) A defendant may be entitled to judgment as a matter of law where there is ‘an affirmative defense to that cause of action.’ (Code Civ. Proc., § 437c, subd. (o)(2).) After the defendant meets the burden of establishing all elements of the affirmative defense, the burden shifts to the plaintiff to show that a genuine issue of material fact exists as to that defense. (Code Civ. Proc., § 437c, subd. (p)(2).) ‘There is a triable issue of material fact if, and only if, the evidence would allow a reasonable trier of fact to find the underlying fact in favor of the party opposing the motion in accordance with the applicable standard of proof.’ (Aguilar, at p. 850, fn. omitted.) Our review of a ruling on a summary judgment motion is de novo. (County of Santa Clara v. Atlantic Richfield Co. (2006) 137 Cal.App.4th 292, 316.)” (McGuan, supra, 182 Cal.App.4th at p. 981.)
2. Federal Preemption
In McGuan, supra, 182 Cal.App.4th 974, this court summarized preemption principles regarding the MDA and class III devices as follows:
“Congress has the power under the supremacy clause of article VI of the federal Constitution to preempt state law. ‘[S]tate law that conflicts with federal law is “without effect.” ’ (Cipollone v. Ligget Group, Inc. (1992) 505 U.S. 504, 516, quoting Maryland v. Louisiana (1981) 451 U.S. 725, 746.) As the United State Supreme Court has explained, federal law preempts state law in three circumstances. ‘First, Congress can define explicitly the extent to which its enactments pre-empt state law. [Citation.] Pre-emption fundamentally is a question of congressional intent, [citation] and when Congress has made its intent known through explicit statutory language, the courts’ task is an easy one. [¶] Second, in the absence of explicit statutory language, state law is pre-empted where it regulates conduct in a field that Congress intended the Federal Government to occupy exclusively.... [¶] Finally, state law is pre-empted to the extent that it actually conflicts with federal law.’ (English v. General Electric Co. (1990) 496 U.S. 72, 78-79.)
“The preemption provision of the MDA states in relevant part: ‘[N]o 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.’ (21 U.S.C. § 360k(a).)
“The United States Supreme Court considered the scope of this preemption provision in Riegel [v. Medtronic, Inc. (2008)] 552 U.S. 312 [(Riegel)]. In Riegel, the plaintiffs alleged that the defendant’s catheter, a class III device, was ‘designed, labeled, and manufactured in a manner that violated’ state law common law, and that these defects caused severe injuries. (Riegel, at p. 320.) The plaintiffs’ complaint stated claims for ‘strict liability; breach of implied warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter.’ (Riegel, at p. 320.) At issue was whether the preemption provision in the MDA barred common law claims that challenged the safety and effectiveness of class III devices which had received premarket approval by the FDA. (Riegel, at p. 315.) In resolving this issue, the court articulated a two-part test: (1) ‘whether the Federal Government has established requirements applicable to’ the defendant’s catheter, and (2) if so, whether the ‘common-law claims are based upon [state] requirements with respect to the device that are “different from, or in addition to” the federal ones, and that relate to safety and effectiveness.’ (Riegel, at pp. 321-322.)
“The court first found that premarket approval imposes federal requirements because it is granted ‘only after [the FDA] determines that a device offers a reasonable assurance of safety and effectiveness’ and because ‘the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application.’ (Riegel, supra, 552 U.S. at p. 323.) Turning to the second question, the court, relying on Lohr, supra, 518 U.S. at page 512, concluded that tort duties under common law impose ‘ “requirement[s]” and would be pre-empted by federal requirements specific to a medical device.’ (Riegel, at pp. 323-324.) As the court explained, ‘excluding common-law duties from the scope of pre-emption would make little sense. State tort law that requires a manufacturer’s catheters to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect. Indeed, one would think that tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation. A state statute, or a regulation adopted by a state agency, could at least be expected to apply cost-benefit analysis similar to that applied by the experts at the FDA: How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court.’ (Riegel, at p. 325.) Accordingly, the court held that the plaintiffs’ common law claims were preempted by federal law. (Riegel, at pp. 323-324.)” (McGuan, supra, 182 Cal.App.4th at pp. 981-982.) Applying the test set forth in Riegel, this court held in McGuan that state law claims for strict product liability, negligence, breach of express warranty, and breach of implied warranty in connection with the Ancure Device were preempted by the MDA. (McGuan, at p. 983.)
In Riegel, the issue of whether the breach of express warranty and negligence in manufacturing causes of action were preempted was not before the court. (Riegel, supra, 552 U.S. 312, 321, fn. 2.)
Here, plaintiff’s complaint alleged: defendants failed to provide adequate warnings with the Ancure Device; there were defects in the design, testing, and manufacture of the Ancure Device; defendants were negligent in designing, manufacturing, testing, advertising, warning, marketing, and selling the Ancure Device; defendants breached an express warranty that the Ancure Device was “safe and well tolerated”; defendants breached an implied warranty that the Ancure Device was “of merchantable quality and safe for the use for which it was intended”; and defendants intentionally failed to disclose that the Ancure Device was “dangerous, defective, and likely to cause serious consequences to users.”
In contrast to McGuan and Riegel, the present case does not involve premarket approval of the Ancure Device. Plaintiff argues that under Riegel state claims are preempted only after an FDA finding of safety and effectiveness. He takes the position that an IDE approval is analogous to the § 510(k) approval in Lohr, supra, 518 U.S. 470 in which the Supreme Court held that the plaintiff’s state law claims involving a medical device that had received § 510(k) approval were not preempted.
In Riegel, supra, 552 U.S. 312, the court distinguished medical devices that have received § 510(k) approval with those that have received premarket approval. “A new device need not undergo premarket approval if the FDA finds it is ‘substantially equivalent’ to another device exempt from premarket approval. [Citation.] The agency’s review of devices for substantial equivalence is known as the § 510(k) process.” (Riegel, at p. 317.) “Premarket approval, in contrast, imposes ‘requirements’ under the MDA as we interpreted it in Lohr. Unlike general labeling duties, premarket approval is specific to individual devices. And it is in no sense an exemption from federal safety review -- it is federal safety review. Thus, the attributes that Lohr found lacking in § 510(k) review are present here. While § 510(k) is ‘ “focused on equivalence, not safety, ” ’ [citation], premarket approval is focused on safety, not equivalence. While devices that enter the market through § 510(k) have ‘never been formally reviewed under the MDA for safety or efficacy, ’ [citation], the FDA may grant premarket approval only after it determines that a device offers a reasonable assurance of safety and effectiveness, [citation]. And while the FDA does not ‘ “require” ’ that a device allowed to enter the market as a substantial equivalent ‘take any particular form for any particular reason, ’ [citation], the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness.” (Riegel, at pp. 322-323.)
In our view, IDE approval of a medical device is more similar to premarket approval than § 510(k) approval. “[A]lthough the IDE process and the PMA process are not identical, a comparison of the governing regulations reveals no material differences.” (Kemp v. Medtronics, Inc. (6th Cir. 2000) 231 F.3d 216, 227.) In granting IDE approval, the FDA imposes detailed requirements on the design, manufacture, and warnings for class III devices as well as the conduct of the clinical investigation. Prior to granting IDE approval, the FDA must determine whether “the risks to the subjects are not outweighed by the anticipated benefits to the subjects and the importance of the knowledge to be gained, or informed consent is inadequate, or the investigation is scientifically unsound, or there is reason to believe that the device as used is ineffective.” (21 C.F.R. § 812.30(b)(4).) Thus, these requirements allow the FDA to “evaluate the safety and effectiveness of the device.” (21 U.S.C. § 360j(g)(2)(B)(ii).) Safety and effectiveness of the device, however, are not paramount concerns in § 510(k) approval. Pursuant to the § 510(k) process, the FDA compares “ ‘ a post-1976 device to a pre-1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device. If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.’ [Citation.]” (Lohr, supra, 518 U.S. at p. 493.) Moreover, the purpose of an IDE, which is “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 and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose” (21 U.S.C. § 360j(g)(1)) is more consistent with that of the premarket approval of a medical device. In contrast, the purpose of § 510(k) approval is to promote competition among manufacturers of medical devices. (Lohr, at p. 494 [“In providing for this exemption to PMA review, Congress intended merely to give manufacturers the freedom to compete, to a limited degree, with and on the same terms as manufacturers of medical devices that existed prior to 1976”].) In addition, unlike a device marketed under § 501(k) that is not required to “ ‘take any particular form for any particular reason, ’ ” (Riegel, supra, 552 U.S. at p. 323), a device that has received IDE approval is subject to ongoing review for safety and effectiveness. (21 U.S.C. § 360j(g)(2)(B)(ii).)
In any event, any distinction between IDE approval and premarket approval in the present case is a distinction without a difference. Here, the FDA granted defendants’ premarket approval application supplements approximately three weeks after plaintiff was implanted with the Ancure Device. In order to grant the premarket approval application, the FDA necessarily conducted a safety review and concluded that the Ancure Device was reasonably safe and effective. Since there is no indication that the device implanted in plaintiff was in any way different from the one that was ultimately approved by the FDA, plaintiff’s argument distinguishing IDE approval from premarket approval has no merit.
Nor are we persuaded that an FDA finding that a medical device is safe and effective is necessary for IDE preemption. We agree with the reasoning of Slater v. Optical Radiation Corp. (7th Cir. 1992) 961 F.2d 1330: “The FDA can hardly be expected to specify the safe and effective design of a device when it is still experimental. If there were a known safe and effective design, the device would no longer be experimental. The point of the experiment is to find out whether it is safe and effective. [Citation.] In the experimental phase the appropriate regulations of safety and effectiveness are procedural rather than substantive ones. They do not specify the safe and effective design; they specify the procedures for determining whether the experimental design is safe and effective. These are requirements relating to safety and effectiveness and they can therefore have preemptive effect. [¶] Of course the FDA will not grant an investigational-device exemption unless it believes that the device has sufficient promise of being proved safe and effective to justify the risk of its being used on human beings. Although that belief is different from a certification that the design of the device is safe and effective, it is a certification that the design is sufficiently safe and effective to allow experimental use on human beings.” (Id. at p. 1333, italics added.) Accordingly, we conclude that Riegel is controlling in cases involving medical devices that have received IDE approval.
Applying the test set forth in Riegel, we have concluded that the FDA has established requirements applicable to the Ancure Device under the IDE, thereby satisfying the first prong of the Riegel test. The second prong has also been satisfied. Plaintiff’s complaint was based on alleged defects in the design, testing, and manufacture of the Ancure Device and the failure to warn of all possible adverse side effects. However, plaintiff has not alleged that defendants violated FDA regulations. Since the FDA authorized the use of the Ancure Device for clinical testing pursuant to an IDE prior to plaintiff’s surgery, the FDA approved the device’s design, testing, intended use, manufacturing methods, and labeling. Thus, to the extent that plaintiff’s complaint alleged that the Ancure Device was unsafe and its warnings were inadequate, he was seeking to impose state law requirements that were “ ‘different from, or in addition to’ ” the MDA. Consequently, the state law claims for strict product liability, negligence, breach of express warranty, and breach of implied warranty were preempted under the MDA.
We will consider whether plaintiff’s claims that defendants misled the FDA and fraudulently concealed facts from plaintiff and plaintiff’s physician were preempted in our discussion regarding plaintiff’s proposed amended complaint.
Relying on Prudhel v. Endologix, Inc. (E.D. Cal. 2009)__ F.3d __ [2009 WL 2045559] (Prudhel), plaintiff argues that he has alleged a parallel claim under Riegel. Riegel stated that the preemption provision of the MDA “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel, ’ rather than add to, federal requirements.” (Riegel, supra, 552 U.S. at p. 330.) In Prudhel, the plaintiffs alleged that the defendant violated numerous federal regulations in the design, manufacture and testing of a medical device that had received premarket approval by the FDA. (Prudhel, at p. __ [2009 WL 2045559, at p. *2.) Prudhel concluded that “a state law claim that requires more than mere noncompliance with federal requirements-for example, that the violation of federal requirements have been reckless or unreasonable-is not precluded, notwithstanding the fact that such a claim uses a standard that is literally ‘different from’ the federal requirements. [Citation.] Such a state law claim does not impose conflicting requirements on manufacturers and thereby disrupt the federal regulatory scheme.” (Prudhel, at p. __ [2009 WL 2045559, at p. *8.) The present case is factually distinguishable from Prudhel. Here, plaintiff has failed to specify any violations of FDA regulations that were linked to his alleged injuries.
Riegel declined to consider the plaintiffs’ argument that they had stated parallel claims because the issue was not raised before the Second Circuit or in their petition for review. (Riegel, supra, 552 U.S. at p. 330.)
B. Motion to Amend Complaint
Plaintiff also argues that the trial court’s denial of his motion to amend was error.
Plaintiff sought to amend his complaint by adding a cause of action for fraud on the FDA as well as fraud on plaintiff and his physician based on defendants’ failure to comply with federal regulations by providing accurate information to the FDA. The proposed amended complaint alleged, in part, that “Guidant failed to report to the FDA the true facts known to Guidant concerning the safety and effectiveness of the commercial use of the Ancure delivery system, ... that Guidant starting in at least early 2000 was in serious violation of FDA regulations concerning most facets of quality control, that Guidant had inadequate data to show the Ancure delivery system was safely used during commercial implants, and that Guidant’[s] failures to obtain FDA approval for changes to the delivery system and procedures, and failure to submit thousands of required Medical Device Reports to the FDA, were intentional by Guidant senior management.” It further alleged that Guidant made these misrepresentations with the intent that the FDA, physicians, and patients, including plaintiff, would rely on them in 2001.
“Courts are liberal in allowing the amendment of pleadings at any stage of the proceedings where the amendment does not cause prejudice to the rights of other parties. (Hayutin v. Weintraub (1962) 207 Cal.App.2d 497, 505.) We review the trial court’s determination on this issue under the abuse of discretion standard. (Id. at pp. 505-506.) However, a trial court does not abuse its discretion in denying leave to amend ‘if it appears from the complaint that under applicable substantive law there is no reasonable possibility that an amendment could cure the complaint’s defect.’ (Heckendorn v. City of San Marino (1986) 42 Cal.3d 481, 486.)” (McGuan, supra, 182 Cal.App.4th at p. 987.)
Here, plaintiff’s proposed amended complaint was identical to the proposed amended complaints in McGuan, supra, 182 Cal.App.4th 974. In McGuan, relying on Buckman Co. v. Plaintiffs’ Legal Comm. (2001) 531 U.S. 341 (Buckman), this court held that a cause of action for fraud on the FDA as well as fraud on plaintiffs and their physicians was preempted by federal law and thus the trial court did not err in denying their motions to amend the complaints. (McGuan, at pp. 984-987.)
McGuan reasoned: “In Buckman, the plaintiffs suffered injuries after orthopedic bone screws were implanted in their spines. [Citation.] The plaintiffs then brought state tort law claims in which they alleged that the defendant made fraudulent representations to the FDA in obtaining approval to market these class III devices, and they would not have been injured if these representations had not been made. [Citation.] The Buckman court began its discussion by observing that ‘[p]olicing fraud against federal agencies is hardly “a field which the States have traditionally occupied, ” [citation]’ and thus the nature of the plaintiffs’ claims was insufficient to warrant a presumption against preemption. [Citation.] The court based this conclusion on the principle that ‘the relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.’ [Citation.]
“Based on this ‘analytical framework, ’ the court held that state law fraud-on-the-FDA claims conflicted with, and thus, were impliedly preempted by federal law. [Citation.] As the court explained, ‘[t]he conflict stems from the fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Administration, and that this authority is used by the Administration to achieve a somewhat delicate balance of statutory objectives. The balance sought by the Administration can be skewed by allowing fraud-on-the-FDA claims under state tort law.’ [Citation.] After reviewing the extensive disclosure requirements of the MDA and the provisions governing the detection, deterrence and punishment of false statements made during the approval process, the court concluded that state tort law fraud-on-the-FDA claims would ‘inevitably conflict with the FDA’s responsibility to police fraud consistently with the Administration’s judgment and objectives.’ [Citation.] Since the court held that the claims were impliedly preempted, it did not consider whether the claims were expressly preempted under 21 United States Code section 360k. [Citation.]” (McGuan, supra, 182 Cal.App.4th at pp. 984-985.) Similarly, here, under Buckman, plaintiff’s state law tort claims for fraud are preempted by federal law.
As did the plaintiffs in McGuan, plaintiff argues that the proposed amended complaint stated a “parallel” claim under Riegel. McGuan rejected this argument, stating: “[T]hough plaintiffs’ fraud claims are premised on violations of FDA regulations, that does not resolve the issue. In contrast to Riegel, Buckman was not interpreting the MDA preemption provision. Instead, Buckman relied on implied preemption principles. [Citation.] Those same principles apply with equal force to claims involving defendants’ misrepresentations to plaintiffs and their physicians after March 2001. It is undisputed that the FDA found no violations of federal regulations after March 2001. Thus, if plaintiffs were allowed to proceed with their state law fraud claims, a finding of liability would also ‘conflict with the FDA’s responsibility to police fraud consistently with the Administration’s judgment and objectives.’ [Citation.]” (McGuan, supra, 182 Cal.App.4th at p. 986.) Accordingly, since the claims in plaintiff’s proposed amended complaint were preempted by federal law, the trial court did not abuse its discretion in denying leave to amend.
V. Disposition
The judgment is affirmed.
WE CONCUR: Bamattre-Manoukian, Acting P. J.; Duffy, J.