Opinion
NOT TO BE PUBLISHED
APPEAL from a judgment of the Superior Court of Los Angeles County. No. BC385151 Ernest M. Hiroshige, Judge.
Engstrom, Lipscomb & Lack, Walter J. Lack and Mark E. Millard for Plaintiffs and Appellants.
Reed Smith, Michael K. Brown, Margaret M. Grignon, James C. Martin, Ginger F. Pigott and Lisa M. Baird for Defendants and Respondents.
DOI TODD, Acting P. J.
The trial court granted summary judgment in favor of defendants and respondents Medtronic, Inc., Medtronic Puerto Rico, Inc., and Medtronic Puerto Rico Operations Co. (collectively Medtronic) on the personal injury complaint filed by plaintiffs and appellants Bagram Bagumyan, Ovsanna Bagumyan, Raoul Benassaya, Jossette Benassaya, H. Aunalee Love, Ronald J. Paul, Nancy Paul, Charles Jackson, Betty Piscitello, Isaac Solorio, Samarit Solorio, John Paul Swanson, Analee Swanson and Rosemary Williams. Appellants alleged they were injured by a medical device that was defectively designed and manufactured by Medtronic. The trial court ruled that federal law preempted their claims. We affirm. On the basis of the undisputed evidence, the trial court properly determined that the Medical Device Amendments of 1976, 21 U.S.C. § 360c et seq. (MDA), preempted appellants’ state law claims.
FACTUAL AND PROCEDURAL BACKGROUND
Federal Regulation of Medical Devices.
Though “[t]he Federal Food, Drug and Cosmetic Act (FDCA), 52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq., has long required FDA [Food and Drug Administration] approval for the introduction of new drugs into the market, ” the introduction of new medical devices was originally governed by state law. (Riegel v. Medtronic, Inc. (2008) 552 U.S. 312, 315 (Riegel).) With the development of varying state measures, “Congress stepped in with passage of the Medical Device Amendments of 1976 (MDA), 21 U.S.C. § 360c et seq., which swept back some state obligations and imposed a regime of detailed federal oversight.” (Riegel, supra, at p. 315, fn. omitted.) The MDA includes an express preemption provision that prohibits states from imposing any requirement “which is different from, or in addition to” any federal requirement related to the safety or effectiveness of a medical device. (21 U.S.C. § 360k(a).)
“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... receives the most federal oversight, and requires premarket approval by the FDA. [Citation.]” (McGuan v. Endovascular Technologies, Inc. (2010) 182 Cal.App.4th 974, 977, fn. omitted (McGuan).) “In general, a device is assigned to Class III if it cannot be established that a less stringent classification would provide reasonable assurance of safety and effectiveness, and the device 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 ‘presents a potential unreasonable risk of illness or injury.’ [Citation.]” (Riegel, supra, 552 U.S. at p. 316.) Premarket approval of a class III device is a “‘rigorous’ process [that] requires an applicant to submit ‘full reports of all studies and investigations of the device’s safety and effectiveness that have been published or should reasonably be known to the applicant; a “full statement” of the device’s “components, ingredients, and properties and of the principle or principles of operation”; “a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device”; samples or device components required by the FDA; and a specimen of the proposed labeling. [Citation.]’ (Riegel, at p. 318.)” (McGuan, supra, at p. 977.)
As further explained by the McGuan court: “The FDA spends an ‘average of 1, 200 hours’ on each premarket approval application. [Citation.] In determining whether to grant premarket approval of a class III device, the FDA must, among other things, ‘weig[h] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.’ (21 U.S.C. § 360c(a)(2)(C).) The FDA will also ‘rely on the conditions of use included in the proposed labeling as the basis for determining whether or not there is a reasonable assurance’ of the device’s ‘safety and effectiveness.’ (21 U.S.C. § 360e(d)(1)(A).) In the event that the FDA grants premarket approval, it may condition its approval on adherence to various requirements. (21 U.S.C. §§ 360e(d), 360j(e)(1).) After approval, ‘the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.’ (Riegel, supra, 552 U.S. at p. 319.)” (McGuan, supra, 182 Cal.App.3d at pp. 977–978.)
FDA Approval of Medtronic’s Fidelis Leads.
In April 1992, Medtronic submitted a premarket approval (sometimes PMA) application for a pacemaker/defibrillator lead known as the “Transvene Lead System.” The FDA approved the PMA application in December 1993, assigning it PMA number P920015. On November 3, 2003, Medtronic sought approval from the FDA for the Sprint Fidelis 6949 lead (Fidelis lead) by submitting a PMA supplement application (PMA Supplement) to PMA number P920015. The device description contained in the PMA Supplement included a detailed feature comparison to the previously approved leads under PMA number P920015, a list of new features on the Fidelis lead and a description of the lead’s functional components. The PMA Supplement also provided a description of the testing performed on the Fidelis lead, including test methodology and results. Further, it described the manufacturing process, a set of proposed labeling and product literature, and a bibliography of relevant medical literature. The FDA acknowledged receipt of the PMA Supplement and assigned it PMA number P920015/S029.
As summarized in In re Medtronic, Inc. Sprint Fidelis Leads Prods. (D.Minn. 2009) 592 F.Supp.2d 1147, 1153 (In re Medtronic): Medtronic “is one of the world’s largest manufacturers of medical devices, including implantable cardiac defibrillators (‘ICDs’). [Citation.] ICDs are small devices implanted in patients’ chests to monitor heart rates and correct heart-rhythm abnormalities. [Citation.] They do so through small wires called ‘leads’ that on one end are attached to the ICD and on the other end are attached directly to the patient’s heart muscle through a coronary vein. [Citation.] If electrodes on the leads detect that the patient’s heart is out of rhythm, the ICD sends an electric shock to the heart muscle through the leads in order to correct the problem. [Citation.] ICDs and the leads attached to them are categorized as ‘Class III’ devices under the FDCA.”
On June 8, 2004, the FDA granted premarket approval of the Fidelis lead as sought in PMA number P920015/S029. The approval permitted Medtronic to commercially distribute the Fidelis lead subject to enumerated conditions of approval.
Appellants’ Lawsuit.
Each of the appellants was implanted with a Fidelis lead sometime in 2006 or 2007. Manufacturing traceability cards for those leads indicated that they were manufactured in compliance with all FDA-approved specifications and processes. At various points during 2007 and 2008, each of the appellants experienced inappropriate and unnecessary shocking which they each attributed to the Fidelis lead. In October 2007, Medtronic announced a voluntary recall of several lead models, including the Fidelis lead. According to the recall notice, the leads were being recalled because a small number of fractures had been detected, which could result in inappropriate shocking or a loss of therapy including pacing or shocking.
In July 2008, appellants filed a first amended complaint, alleging multiple claims on the grounds that the Fidelis leads were defectively designed and manufactured, leading to malfunction and causing serious physical trauma. After the trial court sustained in part and overruled in part Medtronic’s demurrer, appellants filed the operative second amended complaint in January 2009, alleging causes of action for strict liability, negligence, breach of warranty and loss of consortium. Appellants alleged that “Medtronic researched, designed, developed, assembled, manufactured, marketed, promoted, sold, and distributed four models of defective leads, including the Sprint Fidelis 6949 LFJ extendable/retractable screw fixation (S) model” as well as other models. They alleged that each model contained the same defect, which manifested as conductor fracture, resulting most commonly in inappropriate shocks.
Medtronic answered, generally denying the allegations and asserting multiple affirmative defenses.
Summary Judgment.
Medtronic moved for summary judgment in March 2009 on the ground that the MDA preempted all of appellants’ claims. In support of the motion, Medtronic submitted the declaration of Tim Samsel, vice-president, quality and regulatory, cardiac rhythm disease management. His responsibilities included the preparation, oversight, management and the establishment of policy regarding FDA submissions for clinical testing and marketing of Medtronic products. In his declaration, he described the PMA application process for the Fidelis leads; he attached to his declaration a letter from the FDA approving the PMA Supplement. Medtronic also submitted the declaration of Michael Mierkiewicz, a Medtronic engineering manager for cardiac rhythm disease management products. He reviewed and attached to his declaration each of the traceability cards for the Fidelis leads implanted in appellants, and declared that each card confirmed the leads at issue were manufactured in accordance with the specifications and procedures approved by the FDA through the PMA process.
The trial court granted Medtronic’s motion to file under seal copies of the traceability cards attached to Mierkiewicz’s declaration, and they remain under seal in this Court as part of the Joint Appendix.
Appellants opposed the motion on the ground that Medtronic failed to meet its burden to show that approval of the PMA Supplement was the type of action warranting preemption pursuant to the MDA. In support of their opposition they offered their own declarations, discovery responses and reports available on the FDA’s Web site. They also sought judicial notice of several documents generated by the FDA, as well as numerous medical journal articles. In addition, they submitted evidentiary objections to the Samsel and Mierkiewicz declarations.
In reply, Medtronic objected to the evidence offered by appellants and their judicial notice request. It responded to appellants’ evidentiary objections. Medtronic also submitted copies of documents it had recently produced to appellants in discovery, including the original 1993 approval of the PMA application for the Transvene Lead System as well as the PMA Supplement application.
Following a May 29, 2009 hearing, the trial court granted summary judgment on the ground of federal preemption. It ruled that Medtronic met its burden to show that the Fidelis leads were approved through the PMA process and, for that reason, appellants were precluded from bringing state law claims challenging the design, manufacturing process or labeling of the leads. The trial court expressly relied on the Samsel and Mierkiewicz declarations to conclude that the undisputed evidence established the leads underwent the full rigors of the PMA process. Though it overruled both parties’ initial evidentiary objections—with the exception of sustaining an objection to one sentence in appellants’ counsel’s declaration—it sustained appellants’ objections to the PMA documents Medtronic submitted in connection with its reply to the motion. It granted in part and denied in part appellants’ judicial notice request and granted Medtronic’s request to take judicial notice of underlying documents filed in Riegel.
Judgment was entered in August 2009 and this appeal followed.
DISCUSSION
Appellants contend the trial court erred in granting summary judgment. They argue that Medtronic failed to meet its burden to show that the PMA process here was entitled to preemptive effect. Alternatively, they contend that even if Medtronic established a threshold showing, they raised a triable issue of fact as to whether the PMA Supplement warranted preemption and whether they alleged “parallel” claims not subject to preemption. As part of their challenge, they also argue that the trial court abused its discretion in overruling their objections to the declarations submitted by Medtronic. We find no merit to any of appellants’ contentions.
I. Standard of Review.
“Following a grant of summary judgment, we review the record de novo for the existence of triable issues, and consider the evidence submitted in connection with the motion, with the exception of evidence to which objections were made and sustained. (Guz v. Bechtel National, Inc. (2000) 24 Cal.4th 317, 334.)” (Wall Street Network, Ltd. v. New York Times Co. (2008) 164 Cal.App.4th 1171, 1176.)
A defendant seeking summary judgment need not “conclusively negate an element of the plaintiff’s cause of action.” (Aguilar v. Atlantic Richfield Co. (2001) 25 Cal.4th 826, 853 (Aguilar).) Rather, the moving defendant bears the burden of persuasion that “[o]ne or more of the elements of the cause of action” in question “cannot be separately established, ” or that “defendant establishes an affirmative defense” thereto. (Code Civ. Proc., § 437c, subds. (o)(1) & (2).) The moving party bears an initial burden of production to make a prima facie showing of the nonexistence of any triable issue of material fact; satisfaction of that burden causes a shift, and the opposing party is then subjected to a burden of production to “make a prima facie showing of the existence of a triable issue of material fact.” (Aguilar, supra, at p. 850.) 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.” (Ibid.) We affirm summary judgment where it is shown that no triable issue of material fact exists and the moving party is entitled to judgment as a matter of law.
Though we independently review the trial court’s grant of summary judgment, “[w]e review the trial court’s evidentiary rulings on summary judgment for abuse of discretion. [Citations.] As the parties challenging the court’s decision, it is [appellants’] burden to establish such an abuse, which we will find only if the trial court’s order exceeds the bounds of reason. [Citation.] ‘Where a trial court has discretionary power to decide an issue, an appellate court is not authorized to substitute its judgment of the correct result for the decision of the trial court.’ [Citation.] We will only interfere with the lower court’s judgment if appellant can show that under the evidence offered, ‘“no judge could reasonably have made the order that he did.”’ [Citation.] [Appellants’] showing will be ‘insufficient if it presents a state of facts which simply affords an opportunity for a difference of opinion.’ [Citation.]” (DiCola v. White Brothers Performance Products, Inc. (2008) 158 Cal.App.4th 666, 679–680.)
II. Federal Preemption Principles.
As explained in McGuan, supra, 182 Cal.App.4th at page 981, “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.”’ [Citations.]” The MDA contains an express preemption provision which 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 Act to the device, and [¶] (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this Act.” (21 U.S.C. § 360k(a).)
In Riegel, supra, 552 U.S. 312, the United States Supreme Court considered whether the MDA’s preemption provision barred common law claims that challenged the safety and effectiveness of class III medical devices which received approval through the PMA process. At issue there was a catheter marketed by Medtronic—a class III device that had received premarket approval from the FDA and supplemental approvals for label changes thereafter. (Riegel, supra, at p. 320.) The plaintiffs alleged the catheter was “designed, labeled, and manufactured in a manner that violated” state common law, and that these defects caused severe injuries. (Ibid.) They brought claims for “strict liability; breach of implied warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter.” (Ibid.)
The Riegel court concluded that resolving the preemption issue involved a two-part inquiry. First, the court “must determine whether the Federal Government has established requirements applicable to” the medical device at issue. (Riegel, supra, 552 U.S. at p. 321.) If there are applicable federal requirements, the court must then determine 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. [Citation.]” (Id. at p. 322; McGuan, supra, 182 Cal.App.4th at p. 982.)
Turning to the first part of the inquiry, Riegel held 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.)” (McGuan, supra, 182 Cal.App.4th at p. 982.) In reaching this conclusion, the Riegel court expressly distinguished its prior holding in Medtronic, Inc. v. Lohr (1996) 518 U.S. 470 (Lohr), where the court had held that substantial-equivalence review pursuant to title 21 United States Code section 510(k) did not impose a device-specific federal “requirement.” (Riegel, supra, 552 U.S. at p. 322.) Given that substantial-equivalence review enables medical devices to be “marketed only so long as they remain substantial equivalents of the relevant pre-1976 devices, ” the court regarded the process as an exemption rather than a requirement. (Ibid.; Lohr, supra, at pp. 493–494.)
The Riegel court continued: “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.... [T]he FDA may grant premarket approval only after it determines that a device offers a reasonable assurance of safety and effectiveness, § 360e(d). 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, supra, 552 U.S. at pp. 322–323.)
Riegel was consistent with existing California authority construing the PMA process to impose a federal requirement for the purpose of preemption. (Jessen v. Mentor Corp. (2008) 158 Cal.App.4th 1480, 1488 [recognizing approval through the PMA process as a specific federal requirement giving rise to preemption]; Blanco v. Baxter Healthcare Corp. (2008) 158 Cal.App.4th 1039, 1052 [“the FDA’s approval of a PMA application is a federal requirement specific to a particular device”]; Steele v. Collagen Corp. (1997) 54 Cal.App.4th 1474, 1489 [“The design, manufacture, and labeling of the device, as approved by the FDA as safe and effective after the device has undergone the PMA process, are the specific federal requirements giving rise to preemption”].)
Addressing the second part of the preemption inquiry, Riegel concluded that common law tort duties impose “‘requirement[s]’ and would be pre-empted by federal requirements specific to a medical device.” (Riegel, supra, 552 U.S. at pp. 323–324.) Rejecting the notion that a state-law “requirement” was limited to a state statute or regulation, the Riegel court reasoned that “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, supra, at p. 325; McGuan, supra, 182 Cal.App.4th at pp. 982–983.)
The Riegel court concluded that both elements of its own two part test were satisfied. Evidence the catheter was approved through the PMA process—including through a supplemental application—established the federal requirement. (Riegel, supra, 552 U.S. at pp. 321–323.) Reasoning that “reference to a State’s ‘requirements’ includes its common-law duties, ” the court further ruled that the plaintiff’s state law claims were preempted. (Id. at p. 324.) The court in McGuan reached the same result with respect to state law claims alleged by a plaintiff who suffered injuries from an “Ancure Endograft System” used to treat abdominal aortic aneurysms. (McGuan, supra, 182 Cal.App.4th at p. 976.) There, after the FDA granted premarket approval of the device, serious problems arose and the manufacturer recalled and stopped marketing the device. (Id. at pp. 978–979.) As a result of what was later shown to be false information, the FDA subsequently reapproved the device. (Id. at p. 979.) The McGuan court determined that because “the FDA gave its approval of the device’s design, testing, intended use, manufacturing methods, performance standards, and labeling” through the PMA process, the plaintiffs’ allegations that the device “was unsafe and its warnings were inadequate” sought to “impose requirements that are ‘“different from, or in addition to”’ the MDA.” (McGuan, supra, at p. 983.) For that reason, it determined the plaintiffs’ claims were preempted. (Ibid.)
As noted in In re Medtronic, supra, 592 F.Supp.2d at page 1152, “following Riegel, courts across the country have applied Section 360k(a) broadly, preempting all manner of claims from strict products liability and negligence [citations].” (See also Lewkut v. Stryker Corp. (S.D. Tex. 2010) __ F.Supp.2d __, 2010 WL 1544275 at *7 [citing cases].) In sum, the law is unambiguous that the MDA preempts common law claims challenging the safety and effectiveness of a medical device given premarket approval by the FDA.
III. The Trial Court Properly Determined That Appellants’ Claims are Preempted.
In granting summary judgment, the trial court ruled that Medtronic met its burden to show that the Fidelis leads received premarket approval from the FDA and, accordingly, “under Riegel, [appellants] are precluded from bringing state law claims challenging the design, manufacturing process, or labeling of a medical device that has been approved by the FDA via the PMA process.” We find no basis to disturb this conclusion.
A. The FDA’s Approval of the Fidelis Leads Through the PMA Process Constituted the Establishment of a Federal Requirement Under the MDA.
“California Courts of Appeal and numerous federal Courts of Appeal have held the FDA’s approval of a PMA application is a federal requirement specific to a particular device.” (Blanco v. Baxter Healthcare Corp., supra, 158 Cal.App.4th at p. 1052.) Here, Medtronic offered Samsel’s declaration in support of its summary judgment motion to establish that Medtronic received premarket approval for the Fidelis leads as a supplement to the original PMA application for the Transvene Lead System. He confirmed that the Fidelis leads are class III medical devices requiring FDA approval through the PMA process. Samsel attached to his declaration the FDA’s letter approving the PMA Supplement with conditions. Samsel averred that the FDA had never suspended, withdrawn or revoked its approval of the Fidelis leads. On the basis of his review of traceability cards, Mierkiewicz declared that Fidelis leads implanted in appellants were the same model approved through the PMA Supplement, and were manufactured in accordance with the procedures and specifications approved by the FDA through the PMA process. Moreover, the trial court took judicial notice of the FDA Web site pages showing approval of the PMA Supplement, and we, too, have granted Medtronic’s request to take judicial notice of the same materials.
On appeal, Medtronic requests judicial notice of the entire FDA database related to the PMA Supplement, including the application itself. Together with its reply brief below, Medtronic sought to offer a copy of the application in support of its motion and the trial court sustained appellants’ objections to that evidence. Guided by the principle that in reviewing summary judgment we may consider only the evidence that was properly before the trial court at the time of its ruling (L&B Real Estate v. Superior Court (1998) 67 Cal.App.4th 1342, 1346), we decline to take judicial notice of the database. In light of the trial court’s ruling, we have also disregarded the parties’ references to the PMA Supplement application that improperly appear in their briefs on appeal.
Medtronic’s evidentiary showing is similar to that found adequate in other cases to demonstrate that approval through the PMA process establishes the federal requirement for purposes of the MDA’s preemption provision. (See, e.g., Jessen v. Mentor Corp., supra, 158 Cal.App.4th at p. 1491 [no triable issue of fact where declaration established the device at issue was a class III device, described the PMA process, and confirmed the FDA’s premarket approval of the device]; Blanco v. Baxter Healthcare Corp., supra, 158 Cal.App.4th at p. 1052 [no triable issue of fact where declarations established that the defendant filed a PMA application for the device, the device went through the PMA process and the FDA issued premarket approval for the device]; Rankin v. Boston Scientific Corp. (E.D.Ky. Feb. 19, 2010) No. 09-177, 2010 WL 672135 at *2 [no triable issue of fact where declaration showed device was a class III medical device and stated that all versions of the device underwent the PMA process; no triable issue created by uncertainty as to which model of the device the plaintiff received]; Scott v. Pfizer, Inc. (E.D.Tex. 2008) 249 F.R.D. 248, 254 [no triable issue of fact where declaration described the FDA’s approval of the device through the PMA process]; Hughes v. Cook (W.D. Tenn. 2006) 452 F.Supp.2d 832, 840–841 [no triable issue of fact where declaration established that the medical device was subject to FDA review through the PMA process, described the materials submitted to the FDA for that process and averred that the FDA approved the device after reviewing those materials]; Grant v. Memry Corp. (N.D. Ohio 2006) No. 1:04 CV 2338, 2006 WL 1330324 at *2–3 [no triable issue of fact where declarations described PMA application and subsequent FDA approval].)
As a further example, the district court in Riegel relied on a similar declaration to conclude that the MDA preempted the plaintiff’s claims. (Riegel, supra, 552 U.S. at pp. 320–321.) Pursuant to Medtronic’s request, the trial court here took judicial notice of the Riegel declaration, finding it similar to Samsel’s declaration and concluding that “Samsel is competent to testify to the matters stated in his declaration and that he sufficiently establishes that the leads in question received the initial premarket approval and were [in] compliance with FDA specifications with respect to the supplemental process.”
We find no merit to appellants’ challenges to the admission and legal effect of Medtronic’s evidence. Appellants contend that the trial court abused its discretion in admitting the Samsel declaration because it was neither based on personal knowledge nor permitted under Evidence Code section 1523 as oral testimony proving the content of a writing. With respect to appellants’ first objection, “[d]eclarations in support of or opposition to a motion for summary judgment or adjudication ‘shall be made by any person on personal knowledge, shall set forth admissible evidence, and shall showaffirmatively that the affiant is competent to testify to the matters stated in the affidavitsor declarations’ (Code Civ. Proc., § 437c, subd. (d), italics added.)” (Lopez v. University Partners (1997) 54 Cal.App.4th 1117, 1124.) Appellants contend that Samsel’s declaration did not satisfy this requirement because Samsel declared that Medtronic—not he, personally—submitted the application for the PMA Supplement.
While, as discussed below, we conclude that appellants’ evidentiary challenges lack merit, it would have been helpful to our analysis for Medtronic to have provided some meaningful response to appellants’ arguments instead of summarily dismissing them as a “quibble over various technicalities....”
The trial court rejected appellants’ argument on the ground that Samsel sufficiently established his personal knowledge to testify about the PMA process for the Transvene Lead System and the PMA Supplement process for the Fidelis leads. It reasoned that Samsel demonstrated his personal knowledge of the matters set forth in his declaration by describing his role and responsibilities at Medtronic, outlining the PMA process for the Fidelis leads and authenticating the FDA letter approving the PMA Supplement. As the “Vice-President, Quality and Regulatory, Cardiac Rhythm Disease Management, ” Samsel declared that he was “responsible for the preparation, oversight, and management of, and the establishment of policy regarding, submission to the FDA for clinical testing and marketing clearance of Medtronic products.” He further described his familiarity with the FDA’s PMA process and provided specific facts detailing the steps Medtronic took to secure the FDA’s approval of the PMA Supplement. Samsel further averred that he “could and would competently testify” to all matters set forth in his declaration. Accordingly, Samsel affirmatively demonstrated that he was competent to testify to the matters set forth in his declaration on the basis of his personal knowledge. (See Jones v. P.S. Development Co., Inc. (2008) 166 Cal.App.4th 707, 720 [objection based on lack of personal knowledge properly overruled where declarant stated he had personal knowledge and declarant’s status as project supervisor rendered him competent to testify about specific facts concerning the project] disapproved on another point in Reid v. Google, Inc. (2010) 50 Cal.4th 512, 532, fn.7; cf. John Siebel Associates v. Keele (1986) 188 Cal.App.3d 560, 567 [declarant’s statement he could competently testify to the facts set forth in his declaration constituted a sufficient showing of personal knowledge].)
We likewise reject the second aspect of appellants’ evidentiary challenge that Samsel’s declaration violates Evidence Code section 1523, subdivision (a), which provides in relevant part that “[e]xcept as otherwise provided by statute, oral testimony is not admissible to prove the content of a writing.” Appellants assert that this provision precluded Samsel from testifying as to the contents of the PMA Supplement application. But implicit in appellants’ challenge is the notion that proof of the contents of the PMA Supplement application was necessary to the trial court’s ruling on summary judgment. To the contrary, as indicated above, courts do not require parties to submit all documents generated during the PMA process in order to conclude that a medical device has received approval via that process. (E.g., Jessen v. Mentor Corp., supra, 158 Cal.App.4th at pp. 1491–1492 [declarations describing the PMA process and the device’s FDA approval established a device-specific federal requirement under the MDA].) Rather, evidence that a medical device has received premarket approval is the critical component of the federal requirement. (See Funk v. Stryker Corp. (S.D. Tex. 2009) 673 F.Supp.2d 522, 526 [“The Supreme Court found that all PMA-approved devices met the first prong of preemption under § 360k because the FDA imposed device-specific requirements on them”].) Here, Samsel declared that the Fidelis leads received premarket approval in June 2004 and attached a true and correct copy of the FDA letter granting that approval. (See also In re Medtronic, supra, 592 F.Supp.2d at p. 1153 & fn. 8 [“The FDA granted Medtronic’s applications for supplemental PMA of the Sprint Fidelis leads in June 2004, ” including for model 6949].)
The cases on which appellants rely are inapposite. (See Beane v. Paulsen (1993) 21 Cal.App.4th 89, 92–93 & fn. 4 [objection that declaration failed to authenticate attached exhibits deemed waived when it was first raised in reply brief on appeal] disapproved on another point in Beal Bank, SSB v. Arter & Hadden, LLP (2007) 42 Cal.4th 503, 514; Hoover Community Hotel Development Corp. v. Thomson (1985) 167 Cal.App.3d 1130, 1136–1137 [declaration setting forth someone else’s intent is a conclusion of law that must be disregarded on summary judgment]; Family Service Agency of Santa Barbara v. Ames (1958) 166 Cal.App.2d 344, 350–352 [summary judgment reversed where facts set forth in declarations conflicted, and the moving party failed to attach the public records corroborating its version of the events]; Low v. Woodward Oil Co., Ltd. (1955) 133 Cal.App.2d 116, 121 [declaration found incompetent for summary judgment purposes where it purported to opine as to the legal effect of several recorded deeds, none of which was attached to the declaration].) Accordingly, we find no basis to disturb the trial court’s exercise of discretion in overruling objections to the Samsel declaration.
Appellants also purport to challenge the trial court’s admission of the Mierkiewicz declaration, characterizing the declaration as “highly suspect, ” and contend that the trial court should have judicially noticed several medical journal articles. In order to demonstrate an abuse of discretion, an appellant must affirmatively challenge the trial court’s evidentiary rulings on appeal by providing some analysis and citation to authority. (Roe v. McDonald’s Corp. (2005) 129 Cal.App.4th 1107, 1114.) Appellants’ cursory assignments of error are inadequate and we deem any issues concerning the correctness of the trial court’s rulings with respect to the Mierkiewicz declaration and the judicial notice request to have been waived. (See Lopez v. Baca (2002) 98 Cal.App.4th 1008, 1014–1015.)
Appellants further argue that even if the Samsel and Mierkiewicz declarations are considered, Medtronic’s evidence of FDA approval of the Fidelis leads fell short of satisfying the device-specific federal requirement under the MDA. First, they attempt to distinguish supplemental premarket approval of the Fidelis leads from the “‘rigorous’ process” otherwise involved in FDA premarket approval. (Riegel, supra, 552 U.S. at p. 317.) As Riegel explained: “Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness. § 360e(d)(6)(A)(i). If the applicant wishes to make such a change, it must submit, and the FDA must approve, an application for supplemental premarket approval, to be evaluated under largely the same criteria as an initial application. § 360e(d)(6); 21 CFR § 814.39(c).” (Riegel, supra, at p. 319.)
Case law uniformly confirms that both the PMA process and the PMA supplement process establish a federal requirement under the MDA. In concluding there was no triable issue of fact as to whether a PMA supplement established a federal requirement with respect to an approved medical device, the court in Franklin v. Medtronic, Inc. (D. Colo. May 12, 2010) 2010 WL 2543579 at *1, footnote 1, stated: “To be clear, a PMA Supplement is not any less extensive than an Original PMA Application. [Citation.] Rather, it is supplemental only insofar as it alleviates a manufacturer from resubmitting materials that are redundant of materials already submitted to the FDA pursuant to the PMA process for a previous or related device. [Citation.] All existing material, as well as any new material, is subject to the same ‘rigorous’ scrutiny that the Original PMA Application received. [Citation.]” (Accord, Rattay v. Medtronic, Inc. (N.D.W.Va. 2007) 482 F.Supp.2d 746, 758 [concluding “that the FDA’s approval of the PMA supplement for Medtronic’s Indura catheter created federal requirements governing the catheter under the § 360k(a) preemption provision”]; Enlow v. St. Jude Medical, Inc. (W.D. KY 2001) 210 F.Supp.2d 853, 858 [“where, as here, the FDA has approved a medical device under a PMA Supplement and imposed conditions of approval, a specific federal requirement for purposes of preemption under the MDA is established”]; In re Medtronic Polyurethane Insulated Pacing Lead (E.D.Tex. 1999) 96 F.Supp.2d 568, 570 [“for purposes of a preemption analysis... there is no difference between the PMA process and the PMA Supplement process”].) Indeed, the medical device at issue in Riegel was approved through the PMA Supplement process, which the court concluded established a federal requirement. (Riegel, supra, 552 U.S. at pp. 320, 322–323.)
Next, appellants contend that the PMA Supplement was inadequate because the FDA’s approval letter indicated that approval was for the addition of a polyurethane overlay. The trial court summarized appellants’ argument: “[They] argue that this is significant because, given that the FDA only looks to those modifications and evaluates and conducts an analysis on the changes that were requested, the approval was not given for the thinner version of the leads in question and therefore did not receive the full PMA process.” Appellants’ position finds no support in the law. There is no authority for the proposition that a court may reexamine the PMA process to evaluate whether the FDA expressly considered the particular feature of the device that is claimed to be defective. (See Riley v. Cordis Corp. (D.Minn. 2009) 625 F.Supp.2d 769, 779 [“nothing in Riegel even hints that whether a state-law claim is expressly preempted by § 360k(a) turns on the nature or extent of the information made available to the FDA at the time it approved a device”].) Rather, as explained in Riegel, the statutory and regulatory requirements associated with the PMA process insure that the FDA receives sufficient information to thoroughly evaluate the device’s safety and effectiveness. In order to receive premarket approval, a device manufacturer must submit a multivolume application which “includes, among other things, full reports of all studies and investigations of the device’s safety and effectiveness that have been published or should reasonably be known to the applicant; a ‘full statement’ of the device’s ‘components, ingredients, and properties and of the principle or principles of operation’; ‘a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device’; samples or device components required by the FDA; and a specimen of the proposed labeling. § 360e(c)(1).” (Riegel, supra, 552 U.S. at p. 318.)
The undisputed evidence established that Medtronic provided the requisite information in connection with the PMA Supplement. The evidence offered by Medtronic showed that the PMA Supplement application “contained a thorough device description, including a detailed feature comparison to previously approved leads under PMA 920015; a list of new features on the model; and a description of the functional components of the lead. The application also provided a description of testing performed on the Fidelis leads, including the results of those tests, and in particular discussed both in-vitro bench testing and animal studies that were performed to assess the electrical and physiological performance of the 6949 lead. The manufacturing process for the 6949 leads was also discussed in the submission, which included a section identifying two new processes in the manufacturing of the Fidelis leads—resistance welding of certain components and laser ablation of insulation.” Medtronic’s evidence further established that in granting premarket approval of the Fidelis leads, “the FDA approved for sale all aspects of the Fidelis 6949 lead and all of its components.” Appellants offered no evidence to suggest that the PMA Supplement application omitted any required information, including testing results, a statement of all the Fidelis lead components or a description of the manufacturing processes. Under these circumstances, the trial court properly concluded that because Medtronic’s evidence “establishes that the leads in question received premarket approval and that the process for receiving supplemental approval of the leads included descriptions, discussions, and identification of all aspects of the leads, ” appellants failed to demonstrate the existence of a triable issue of material fact as to whether the Fidelis leads received FDA approval sufficient to establish a federal requirement.
Finally, appellants persist on relying on Lohr, supra, 518 U.S. 470, in asserting that Medtronic failed to meet its burden to establish the existence of a federal requirement. There, the court declined to find that the FDA’s substantial-equivalence review conducted pursuant to title 21 United States Code section 510(k) imposed device-specific requirements (Lohr, supra, at pp. 493–494.) The court explained that substantial-equivalence review is an exemption to PMA review that allows a device manufacturer to market a device found to be substantially equivalent to one marketed before 1976 without going through the rigors of the PMA process. (Ibid.) “As a result, ‘substantial equivalence determinations provide little protection to the public. These determinations simply compare 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.]” (Id. at p. 493.)
The court in Riegel expanded on the distinction between premarket approval and substantial equivalence offered in Lohr, explaining: “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.” (Riegel, supra, 552 U.S. at pp. 322–323; see also Funk v. Stryker Corp., supra, 673 F.Supp.2d at p. 526 [observing that “[t]he differences between the PMA and § 510(k) are significant, ” one example being that “a § 510(k) review takes twenty hours to complete, whereas the PMA entails 1, 200 hours of work”].) Unlike devices reviewed for substantial equivalence, “[t]he Supreme Court found that all PMA-approved devices met the first prong of preemption under § 360k because the FDA imposed device-specific requirements on them.” (Funk v. Stryker Corp., supra, at p. 526.) Because the undisputed evidence established that the FDA approved the Fidelis leads through the PMA process, Medtronic met its burden to show the existence of a federal requirement under the MDA.
B. Appellants’ State Law Claims are Preempted Because They Would Impose Different or Additional Requirements on the Fidelis Leads.
The second aspect of the preemption inquiry involves a determination of whether appellants’ state law claims rely on any requirement of California law applicable to the Fidelis leads “that is ‘different from, or in addition to’ federal requirements and that ‘relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device.’ [Citation.]” (Riegel, supra, 552 U.S. at p. 323.) The MDA expressly preempts any state law claim that would impose different or additional duties relating to any requirement imposed through the PMA process. (Id. at pp. 327–328; McGuan, supra, 182 Cal.App.4th at p. 983.)
In the operative complaint, appellants alleged causes of action for strict liability, negligence, breach of warranty and loss of consortium. More specifically, appellants alleged as the factual basis for their claims that “Medtronic knew and had reason to know that the Sprint Fidelis Leads were not safe for the patients for whom they were prescribed and implanted, because the leads fractured and otherwise malfunctioned, and therefore failed to operate in a safe and continuous manner, causing serious medical problems....” They further alleged that “[a]s a result of their defective design and manufacture, Medtronic’s Sprint Fidelis Leads suffer fracture, leading to malfunction in the transmission of the electrical signal from the ICD to the patient’s heart.”
In support of their first strict liability cause of action, appellants alleged that “Medtronic’s Sprint Fidelis Leads were expected to and did reach [appellants] without substantial change in their condition as manufactured and sold by Medtronic.... At the time the Sprint Fidelis Leads reached [appellants], they were in the aforementioned defective condition, ” one which was not contemplated by expected users and which was unreasonably dangerous to expected users. They further alleged that the Fidelis leads were “unreasonably dangerous by reason of defective research, development, manufacture, assembly, inspection, testing, warning, advertisement, marketing, sale and distribution of the part of” Medtronic. They premised their second cause of action for strict liability on Medtronic’s failure to provide proper warnings to physicians and patients regarding possible complications from the Fidelis leads and the failure to conduct adequate postmarketing warning and instruction. In connection with their negligence cause of action, appellants alleged that Medtronic breached its duty of care by incorporating a defect into the design of the Fidelis leads and by “designing, developing, manufacturing and assembling the Sprint Fidelis Leads in such a manner” that they were prone to malfunction and failure. And in support of their breach of warranty cause of action, appellants alleged that the Fidelis leads were “defective, unmerchantable, and unfit for ordinary use when sold, and unfit for the particular purpose for which they were sold, and subjected [appellants] to severe and permanent injuries.”
Appellants’ loss of consortium cause of action incorporated the factual allegations supporting their other causes of action.
Riegel held that state law tort claims, including causes of action for strict liability and negligence, impose requirements that are different from or in addition to the device-specific federal requirements, and are hence preempted. (Riegel, supra, 552 U.S. at p. 324.) Applying this holding, the court in McGuan, supra, 182 Cal.App.4th at page 983, stated: “Since the FDA reapproved the Ancure Device prior to plaintiffs’ surgeries, the FDA gave its approval of the device’s design, testing, intended use, manufacturing methods, performance standards, and labeling. Thus, to the extent that plaintiffs’ complaints allege that the Ancure Device was unsafe and its warnings were inadequate, they are seeking to impose requirements that are ‘“different from, or in addition to”’ the MDA. Consequently, the state law claims for strict product liability, negligence, breach of express warranty, breach of implied warranty, and violations of the Consumer Legal Remedies Act are preempted under the MDA.” The same reasoning applies here. To the extent that appellants contend the Fidelis leads were defectively designed and manufactured, they are seeking to impose requirements that are different from or in addition what the FDA approved. As a result, their claims are preempted.
We reject appellants’ effort to recharacterize their defective manufacturing allegations as “parallel” claims not subject to preemption. Riegel explained that because state law claims are preempted only to the extent they are different from or in addition to federal law requirements, 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. [Citations.]” (Riegel, supra, 552 U.S. at p. 330.) But in order to allege a parallel claim, a plaintiff “cannot simply incant the magic words ‘Medtronic violated FDA regulations’ in order to avoid preemption.” (In re Medtronic, supra, 592 F.Supp.2d at p. 1158.) Rather, “[t]o properly allege parallel claims, the complaint must set forth facts showing ‘action or inaction in [defendants’] efforts to take part in the PMA process or implement its results[.] [Citation.]” (Parker v. Stryker Corp. (D. Colo. 2008) 584 F.Supp.2d 1298, 1301; accord, Franklin v. Medtronic, Inc., supra, 2010 WL 2543579 at *8 [“Merely alleging that Defendant generally failed to comply with federal requirements is insufficient to overcome the preemptive reach of Section 360k(a) without some factual detail as to why Defendant violated federal regulations”]; Williams v. Cyberonics, Inc. (E.D. Pa. 2009) 654 F.Supp.2d 301, 306 [“No state common-law claim can survive if it allows a claimant to proceed without showing a departure from federal standards”].)
Appellants’ allegations that Medtronic defectively and negligently designed and manufactured the Fidelis leads set forth no facts showing or even suggesting noncompliance with federal regulations. For this reason, appellants’ reliance on Hofts v. Howmedica Osteonics Corp. (S.D.Ind. 2009) 597 F.Supp.2d 830 (Hofts) is misplaced. There, the plaintiff sued a medical device manufacturer alleging several state law tort theories. Importantly, however, the plaintiff specifically alleged that the device was unreasonably dangerous and defective because the manufacturing process “did not satisfy the FDA’s PMA standards” for the device and the defect was a deviation from the manufacturing standards approved by the FDA. (Id. at p. 836.) The court reasoned that the plaintiff’s claims were not preempted because “it is clear that Hofts bases his tort claims on his allegations that Howmedica failed to meet the FDA’s requirements, not on allegations that Howmedica failed to depart from or exceed those requirements. A jury could find that Howmedica breached the duty of care it owed to Hofts by failing to adhere to the FDA’s manufacturing requirements without imposing different or additional requirements.” (Ibid.) The Hofts court distinguished the plaintiff’s allegations from the tort claims alleged in Riegel, explaining the latter “were not based on the defendant’s alleged failure to follow federal requirements, but instead were based on the plaintiffs’ allegations that Medtronic had breached state tort duties even though it had complied with federal requirements.” (Hofts, supra, at p. 836.)
Even setting aside that Hofts stands alone in its conclusion that a plaintiff need not allege specific facts showing the failure to comply with federal regulations in order to avoid preemption, appellants here did not even make the minimal showing required by Hofts. Appellants nowhere alleged that any defect in the Fidelis leads resulted from a failure to comply with standards imposed through the PMA process. Appellants’ allegations are akin to those held preempted in Funk v. Stryker Corp., supra, 673 F.Supp.2d at page 532, where the court observed that “Funk does not cite a single FDA requirement violated by [defendant] HOC or any fact indicating the presence of impurities on the device. Instead he essentially relies on a circular argument that because he was injured and because the device (allegedly) contained impurities, HOC therefore violated FDA regulations. Such reasoning is contrary to the holding in Riegel.” (See also Williams v. Cyberonics, Inc., supra, 654 F.Supp.2d at p. 307 [existence of a parallel claim must be shown by evidence that the medical device at issue deviated from the FDA-approved standards; a plaintiff is not entitled to a legal inference that a device is defective because it malfunctioned during normal operation].)
See generally Lewkut v. Stryker Corp., supra, 2010 WL 1544275 at *7, fn. 3 (noting that several courts have discredited the reasoning in Hofts).
Accordingly, we find no basis to disturb the trial court’s conclusion that appellants’ “allegations do not reflect that the alleged defects in the Fidelis leads were the result of noncompliance from specific requirements imposed by the PMA, but that the standard manufacturing processes for the leads resulted in the unsafe devices.” Appellants failed to state parallel claims for relief sufficient to overcome the preemptive effect of the MDA.
DISPOSITION
The judgment is affirmed. Medtronic is entitled to its costs on appeal.
We concur: ASHMANN-GERST J., CHAVEZ J.