Filed 1/27/14

CERTIFIED FOR PUBLICATION

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

SECOND APPELLATE DISTRICT

DIVISION FIVE

JOHN COLEMAN,

Plaintiff and Appellant,

v.

MEDTRONIC, INC., et al.,

Defendants and Respondents.

 B243609

 (Los Angeles County Super. Ct.

 No. SC112290)

APPEAL from a judgment of the Superior Court of Los Angeles County, Cesar C. 

Sarmiento, Judge. Affirmed in part, reversed in part, and remanded.

Law Offices of Martin N. Buchanan, Martin N. Buchanan; Girardi & Keese and 

James G. O‘Callahan for Plaintiff and Appellant.

Mayer Brown LLP, Andrew E. Tauber, Scott M. Noveck; Reed Smith LLP, 

Michael K. Brown, James C. Martin and Lisa M. Baird for Defendants and Respondents.

______________________________
2

Plaintiff and appellant John Coleman sued defendants and respondents Medtronic, 

Inc., and Medtronic Sofamor Danek USA, Inc. (collectively, Medtronic), alleging he 

suffered painful complications after a spinal surgery in which Infuse, Medtronic‘s

federally-approved bone fusion medical device, was used in an ―off-label‖ manner. 

Coleman‘s seven causes of action are generally based upon allegations that Medtronic 

defectively manufactured Infuse, promoted off-label uses of Infuse without adequately 

warning of the associated risks, and failed to take available steps to warn Coleman of the 

risks of such uses. The trial court sustained Medtronic‘s demurrer to Coleman‘s third 

amended complaint without leave to amend on the grounds that each cause of action was 

preempted by federal law. We conclude that Coleman may allege causes of action for 

negligence and strict liability in a manner that avoids federal preemption but has waived 

any claim of error with respect to the remaining causes of action. We therefore affirm in 

part, reverse in part, and remand to the trial court for further proceedings.

FACTUAL AND PROCEDURAL BACKGROUND

Medtronic manufactures and sells Infuse, a medical device used in surgery to 

strengthen the spines of individuals with degenerated vertebral discs. Infuse consists of 

an absorbable collagen sponge, rhBMP-2 (a manufactured version of a protein found in 

small quantities in the human body), and a titanium threaded fusion cage. During 

surgery, the doctor infuses the collagen sponge with liquid rhBMP-2 and inserts the 

sponge into the cage to both stabilize the spine and maintain spacing between the 

vertebrae during the fusion process. 

Under the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), as amended by 

the Medical Device Amendments of 1976 (MDA), the Federal Drug Administration 

(FDA) granted Infuse premarket approval for use in certain types of spinal fusion 

surgeries, including Anterior Lumbar Interbody Fusion (Anterior Fusion), where the 

surgical incision is on the patient‘s abdomen. Posterior Lumbar Interbody Fusion 

(Posterior Fusion) is an alternate form of spinal fusion surgery that approaches the spine 
3

through an incision in the patient‘s back. Posterior Fusion is considered an off-label use 

of Infuse because the FDA has only approved Infuse for use in Anterior Fusion.1

Coleman‘s third amended complaint alleges Medtronic promoted the off-label use 

of Infuse while downplaying the risk of complications, violating both state and federal 

laws. Medtronic sponsored a clinical trial in 1999 to explore the use of Infuse in 

Posterior Fusion but halted the trial because early results showed unwanted and 

uncontrolled bone growth in more than 70 percent of patients. Between 1998 and 2011, 

Medtronic entered into consulting and royalty agreements with ―Key Opinion Leaders‖ 

who were physicians touting Infuse through presentations and medical journal articles. 

Studies funded by Medtronic omitted discussion of bone growth in the spinal canal as an 

adverse event and instead reported no adverse events. Medtronic, however, was aware 

that adverse events or complications had been reported in between 20 and 70 percent of 

cases where Infuse was used in Posterior Fusion. Medtronic also provided information 

and instructions for off-label surgeries by placing sales personnel in hospital operating 

rooms. Medtronic‘s promotional activities increased the use of Infuse in Posterior 

Fusion. At the same time, various investigations by media, the Department of Justice, 

and the Congress raised questions about the safety of Infuse and about payments from 

Medtronic to physicians. 

In April 2009, Coleman underwent Posterior Fusion surgery of his L3–L5 

vertebrae. His surgeon used Infuse in an off-label manner. Coleman began suffering 

numbness and pain after the surgery. CT scans showed the collagen sponge had leaked 

rhBMP-2 and unwanted bone growth had encased the nerves in Coleman‘s spine. 

In April 2011, Coleman filed suit against Medtronic. The trial court sustained 

Medtronic‘s demurrers to Coleman‘s complaint and first amended complaint with leave 

 

1

 ― ̳[O]ff-label‘ usage of medical devices (use of a device for some other purpose 

than that for which it has been approved by the FDA) is an accepted and necessary 

corollary of the FDA‘s mission to regulate in this area without directly interfering with 

the practice of medicine. [Citation].‖ (Buckman Co. v. Plaintiffs’ Legal Comm. (2001) 

531 U.S. 341, 353.)
4

to amend. Medtronic filed a demurrer to Coleman‘s second amended complaint. 

Coleman‘s opposition to the demurrer attached a third amended complaint. On April 12, 

2012, the court sustained the demurrer to the second amended complaint but found the 

proposed third amended complaint sufficient, with the exception of Coleman‘s 

manufacturing defect claim. The court ordered Coleman to file a third amended 

complaint without the manufacturing defect claim and ordered Medtronic to file an 

answer. 

Four days later, a three-judge panel of the Ninth Circuit Court of Appeals held that 

a state law negligence cause of action based on a failure to report adverse information 

about an FDA-approved medical device as required by federal regulations was preempted 

by federal law. (Stengel v. Medtronic, Inc. (9th Cir. 2012) 676 F.3d 1159 (Stengel I).) 

Based on the decision in Stengel I, Medtronic demurred to Coleman‘s third amended 

complaint. The trial court sustained Medtronic‘s demurrer without leave to amend on 

June 13, 2012. 

On July 25, 2012, the Ninth Circuit agreed to rehear Stengel I en banc. (Stengel v. 

Medtronic, Inc. (9th Cir. 2012) 686 F.3d 1121 (Stengel II).) On August 27, 2012, 

Coleman filed a timely notice of appeal. On January 10, 2013, the Ninth Circuit issued a 

unanimous 11-judge en banc decision holding that the plaintiff‘s state law negligence 

claims for failure to warn were not preempted by federal law. (Stengel v. Medtronic, Inc.

(9th Cir. 2013) 704 F.3d 1224 (Stengel III).)

Medtronic petitioned the United States Supreme Court for a writ of certiorari in 

Stengel III on May 10, 2013. On October 7, 2013, the Supreme Court issued an order 

stating: ―The Solicitor General is invited to file a brief in this case expressing the views 

of the United States.‖ (Medtronic, Inc. v. Stengel (Oct. 7, 2013, No. 12-1351) __ U.S. 

___ [134 S.Ct. 375].)
5

DISCUSSION

In his timely appeal, Coleman contends his failure to warn, negligence, and 

manufacturing defect claims are not preempted because they are based on state law duties 

that parallel requirements under federal law.2 Medtronic contends that Coleman‘s state 

law claims cannot survive preemption, and to the extent they do, they are inadequately 

pleaded.

A. Standard of Review

―We apply a de novo standard of review because this case was resolved on 

demurrer (McCall v. PacifiCare of Cal., Inc. (2001) 25 Cal.4th 412, 415) and because 

federal preemption presents a pure question of law (Spielholz v. Superior Court (2001) 86 

Cal.App.4th 1366, 1371).‖ (In re Farm Raised Salmon Cases (2008) 42 Cal.4th 1077, 

1089, fn. 10 (Farm Raised Salmon).) ―In ruling on a demurrer, the  ̳allegations [of the 

complaint] must be liberally construed, with a view to substantial justice between the 

parties.‘ (Code Civ. Proc., § 452; see Rickley v. Goodfriend (2013) 212 Cal.App.4th 

1136, 1141-1142 [court must liberally construe complaint, and draw all reasonable 

inferences in favor of its allegations].)‖ (Teva Pharmaceuticals USA, Inc. v. Superior 

Court (2013) 217 Cal.App.4th 96, 102.)

 

2

 Coleman‘s opening brief does not argue that his causes of action for fraud, 

intentional misrepresentation, unfair competition (Bus. & Prof. Code, §17200 et seq.), 

and concealment survive Medtronic‘s demurrer. Because no argument of error is 

presented, we conclude that Coleman has waived any such argument, and we do not 

address those causes of action.
6

B. Federal Regulation of Class III Medical Devices

The MDA ―imposed a regime of detailed federal oversight‖ including a ―rigorous 

regime of premarket approval‖ for Class III medical devices.3(Riegel v. Medtronic, Inc.

(2008) 552 U.S. 312, 316-317 (Riegel).) Before the FDA will grant premarket approval to 

a Class III medical device, it must be reasonably assured of the device‘s safety and 

effectiveness. (21 U.S.C. § 360e(d).)

4 The premarket approval process is very involved, 

and applicants, usually the device manufacturers, must meet many requirements both 

before and after the FDA grants premarket approval. (Riegel, supra, at pp. 318-319.) The 

agency must ―weigh[] any probable benefit to health from the use of the device against 

any probable risk of injury or illness from such use.‖ (§ 360c(a)(2)(C).) The FDA also 

reviews the device‘s proposed labeling as part of the premarket approval process, 

evaluating safety and effectiveness under the conditions of use set forth on the label (§ 

360c(a)(2)(B)), and determining that the proposed labeling is neither false nor misleading 

(§ 360e(d)(1)(A)). After this review process, the FDA decides whether to grant or deny 

premarket approval to a given device. (§ 360e(d).)

After premarket approval, applicants must report ―adverse events‖ to the FDA. 

These are incidents in which the device may have caused or contributed to death or 

serious injury, or malfunctioned in a manner that would likely cause or contribute to 

death or serious injury if it recurred. (21 C.F.R. § 803.50(a).) Applicants must also 

report new clinical investigations or scientific studies concerning the device of which the 

applicant knows or reasonably should have known. (Id., § 814.84(b)(2).) The FDA may

withdraw premarket approval based on newly reported data or existing information; it 

 

3

 Case law states that Infuse is a Class III medical device, but the complaint does 

not allege that fact. (See, e.g., Caplinger v. Medtronic, Inc. (W.D. Okla. 2013) 921 

F.Supp.2d 1206, 1210-1211.)

4

 All further statutory references are to title 21 of the United States Code, unless 

otherwise stated.
7

must withdraw approval if it determines that a device is unsafe or ineffective under the 

conditions in its labeling. (§ 360e(e)(1); see also Riegel, supra, 552 U.S. at pp. 319-320.)

The manufacturer cannot make any changes to the design, manufacturing, or

labeling of approved devices without first obtaining additional approval from the FDA. 

(§ 360e(d)(6); Riegel, supra, 552 U.S. at p. 319.) The FDA has an established procedure 

a manufacturer must follow if it wants to change the intended use for a device. (See 

§ 360e(d)(6); 21 C.F.R. § 814.39(a).)

Nothing in the MDA prevents a doctor from using a medical device in an off-label 

manner. (§ 396.) But the MDA and its implementing regulations place restrictions on 

manufacturers who know or have reason to know of uses other than those approved by 

the FDA. (See § 352(f); 21 C.F.R. §§ 801.4, 801.5, 801.109.) FDA regulations prohibit 

a device manufacturer from promoting the use of a device in a manner inconsistent with 

premarket approval. (§ 331(a); see also 21 C.F.R. § 814.80 [providing that a ―device may 

not be . . . advertised in a manner that is inconsistent with any conditions to approval 

specified in the [premarket approval] order for the device‖]; Riley v. Cordis (D. Minn. 

2009) 625 F.Supp.2d 769, 781-784 (Riley) [discussing federal regulations on promoting 

off-label uses].) ―The FDA forbids this practice because the FDA‘s review of a device‘s 

safety and effectiveness was not universal; it focused only on the intended use specified 

by a manufacturer. See 21 U.S.C. §§ 360c(a)(2), 360e(c)(1).‖ (Ramirez v. Medtronic, 

Inc. (D. Ariz., Aug. 21, 2013, CV-13-00512-PHX-GMS) __ F.Supp.2d __ [2013 U.S. 

Dist. LEXIS 118822] (Ramirez).)

C. Preemption of State Law Claims

1. Express Preemption

The MDA expressly preempts any state law that imposes ―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 
8

to the safety or effectiveness of the device or to any other matter included in a 

requirement applicable to the device under this chapter.‖ (§ 360k(a).)

In Riegel, the United States Supreme Court established a two-step framework for 

determining whether section 360k(a) expressly preempts a state law claim. First, the 

FDA must have established ―requirements‖ applicable to the particular medical device at 

issue. (Riegel, supra, 552 U.S. at p. 321.) The premarket approval requirements 

applicable to Class III medical devices satisfy this first prong. (Id. at pp. 322-323.) Next, 

state law claims are preempted if they impose requirements that relate to safety and 

effectiveness and are ―different from, or in addition to‖ the requirements under federal 

law. (Id. at pp. 321-322; see also Farm Raised Salmon, supra, 42 Cal.4th at p. 1094.) 

State law requirements can be established by either statute or common law. (Riegel, 

supra, 552 U.S. at pp. 324-325.) 

State law causes of action that provide ―a damages remedy for claims premised on 

a violation of FDA regulations‖ are not expressly preempted if they ― ̳parallel,‘ rather 

than add to, federal requirements.‖ (Riegel, supra, 552 U.S. at p. 330, quoting 

Medtronic, Inc. v. Lohr (1996) 518 U.S. 470, 495; see also Stengel III, supra, 704 F.3d at 

pp. 1228-1232 (en banc).) ―In order for a state requirement to be parallel to a federal 

requirement, and thus not expressly preempted under [section] 360k(a), the plaintiff must 

show that the requirements are  ̳genuinely equivalent.‘ State and federal requirements are 

not genuinely equivalent if a manufacturer could be held liable under the state law 

without having violated the federal law.‖ (Wolicki-Gables v. Arrow Int’l, Inc. (11th Cir. 

2011) 634 F.3d 1296, 1300 (Wolicki-Gables), quoting McMullen v. Medtronic, Inc. (7th 

Cir. 2005) 421 F.3d 482, 489.) The California Supreme Court applied the same approach 

in permitting the plaintiffs to proceed on claims based on state law food labeling 

requirements that were identical to federal requirements. (Farm Raised Salmon, supra, 

42 Cal.4th at p. 1094 [states are free to provide for private remedies under state law, so 

long as state law requirements are identical to federal law requirements].)

A state law claim that the FDA-approved warnings on a Class III medical device 

are inadequate, or that a device manufacturer failed to give additional warnings regarding 
9

use of the device, would be expressly preempted because the claim would impose a 

requirement under state law that is different than or in addition to what is required under 

federal law. (See Caplinger v. Medtronic, Inc. (W.D. Okla. 2013) 921 F.Supp.2d 1206, 

1219 (Caplinger) [plaintiff‘s fraudulent misrepresentation claim expressly preempted 

because it would ―establish labeling and warning requirements different from, or in 

addition to, federal requirements‖].) ― ̳To permit a jury to decide [a plaintiff‘s] claims 

that the information, warnings, and training material the FDA required and approved 

through [premarket approval] process were inadequate under state law would displace the 

FDA‘s exclusive role and expertise in this area and risk imposing inconsistent obligations 

on [the defendant].‘‖ (Hughes v. Boston Scientific Corp. (5th Cir. 2011) 631 F.3d 762, 

769 (Hughes), quoting Gomez v. St. Jude Medical Daig Div. Inc. (5th Cir. 2006) 442 F.3d 

919, 931.)

In contrast, if a plaintiff‘s state law claims are based on requirements that parallel

federal law, they are not expressly preempted. In Stengel III, supra, 704 F.3d 1224, the 

plaintiffs alleged a negligence failure to warn claim under Arizona law, claiming the 

device manufacturer breached its duty of reasonable care by failing to report to the FDA 

adverse events associated with a Class III medical device. The en banc opinion from the 

Ninth Circuit held that the plaintiff‘s state law claim was not expressly preempted 

because it relied on a state law requirement (duty to warn the FDA of adverse outcomes) 

that paralleled requirements under federal law. (Id. at p. 1233.) The concurring opinion, 

signed by seven of the eleven judges on the panel, explains: ―the [plaintiffs‘] negligence 

claim is not expressly preempted because it seeks to hold Medtronic accountable only for 

failing to do what federal law mandated—nothing more. The state law duty, as alleged 

by the [plaintiffs], is precisely parallel to the duties imposed by federal law.‖ (Id. at 

p. 1234 (conc. opn. of Watford, J.).) In Hughes, supra, 631 F.3d at pages 769-771, the 

Fifth Circuit reached a similar conclusion, holding that the plaintiff‘s state law claim is 

not expressly preempted when it ―does not impose additional or different requirements to 

the federal regulations, but is parallel to the federal requirements.‖
10

2. Implied Preemption

A state law cause of action for violation of the FDCA is barred under the doctrine 

of implied preemption if it is cognizable only by virtue of the provisions of the FDCA 

itself, rather than traditional state tort law. (Buckman Co. v. Plaintiffs’ Legal Comm. 

(2001) 531 U.S. 341, 353 (Buckman).) Subdivision (a) of section 337 states all actions to 

enforce FDCA requirements, including requirements under the MDA, ―shall be by and in 

the name of the United States.‖5 The Buckman court interpreted section 337(a) to mean

that ―the Federal Government rather than private litigants . . . are authorized to file suit 

for noncompliance with the medical device provisions.‖ (Buckman, supra, at p. 349, fn. 

4.) The plaintiffs in Buckman sought to pursue a state law fraud claim based on 

purported misrepresentations the defendants made to the FDA during the premarket 

approval process. Because the plaintiffs‘ fraud-on-the-FDA claim ―existed solely by 

virtue‖ of federal requirements, it was impliedly preempted under section 337. (Id. at p. 

353.) The court recognized that plaintiffs pursuing state law claims relying on 

―traditional state tort law which had predated the federal enactments in question[]‖ would

not be subject to implied preemption, but the claims before them did not meet that 

criteria. (Id. at pp. 352-353.) To survive implied preemption, the conduct on which the 

plaintiffs‘ claim is based ―must be the type of conduct that would traditionally give rise to 

liability under state law -- and that would give rise to liability under state law even if the 

FDCA had never been enacted.‖ (Riley, supra, 625 F.Supp.2d at p. 777.) 

The California Supreme Court briefly mentioned Buckman when discussing the 

preemptive effect of section 337 on the plaintiff‘s efforts to privately enforce a California 

 

5

 The full text reads: ―Except as provided in subsection (b) of this section, all 

such proceedings for the enforcement, or to restrain violations, of this chapter shall be by 

and in the name of the United States. Subpoenas for witnesses who are required to attend 

a court of the United States, in any district, may run into any other district in any 

proceeding under this section.‖ (§ 337(a).)
11

statute regulating food labeling that was identical to FDCA regulations. (Farm Raised 

Salmon, supra, 42 Cal.4th at p. 1087.) The court rejected the argument that section 337 

bars such a suit, reasoning that the ―[p]laintiffs do not seek to enforce the FDCA; rather,

their . . . claims are predicated on violations of obligations imposed by [state law.]‖ (Id. 

at p. 1095.) ―Section 337 does not apply to the state law claims presented here. The 

statute, by its very terms, only implicates efforts to enforce federal law. What section 

337 does not do is limit, prohibit, or affect private claims predicated on state laws.‖ (Id. 

at pp. 1095-1096.) Also, in McGuan v. Endovascular Technologies, Inc. (2010) 182 

Cal.App.4th 974, 984-985, the court found the plaintiff‘s state law fraud claims to be 

impliedly preempted under Buckman, where the plaintiff alleged the defendant made 

fraudulent statements to the FDA.

Several federal courts, including the Ninth Circuit, have interpreted Buckman

narrowly, concluding that state law causes of action that refer to federal statutes and 

regulations as providing the basis for state law liability are not impliedly preempted 

because they remain based in traditional state tort law. (See, e.g., Stengel III, supra, 704 

F.3d at pp. 1228-1232 [no preemption of a state law claim based on a state law duty that 

parallels a federal requirement]; Hughes, supra, 631 F.3d at p. 775 [negligence claim not 

impliedly preempted based on Buckman’s distinction between ―fraud-on-the-FDA‖ 

claims and claims relying on traditional state tort law]; Bausch v. Stryker Corp. (7th Cir. 

2010) 630 F.3d 546, 556-557 (Bausch) [the plaintiff‘s manufacturing defect claims are 

not impliedly preempted because they are tort law claims, not fraud on a federal agency].)

Other courts have taken a broader approach, focusing on Buckman‘s reasoning that 

a state law claim could survive implied preemption only if it relied ―on traditional state 

tort law which had predated the federal enactment in question.‖ (See, e.g., In re 

Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation (8th Cir. 2010) 623 

F.3d 1200, 1205-1206 (Sprint Fidelis) [claims based on failure to file adverse event 

reports ―are simply an attempt by private parties to enforce the MDA‖ foreclosed by 

implied preemption]; Houston v. Medtronic, Inc. (C.D. Cal., July 30, 2013, No. 22:13-cv1679SVW-SH) ___ F.Supp.2d ___ [2013 U.S. Dist. LEXIS 108996 *27] (Houston) [―any 
12

negligence claim based solely on illegal off-label promotion is impliedly preempted 

under Buckman and § 337(a)‖]; Caplinger, supra, 921 F.Supp.2d at p. 1219 [negligence 

claim based on off-label promotion impliedly preempted because it ―is not based on 

conduct that would give rise to a recovery under state law even in the absence of the 

FDCA‖].) 

The panel opinion in Stengel I that preceded the en banc opinion in Stengel III

interpreted Buckman broadly, reasoning that there was ―no meaningful distinction 

between the [plaintiffs‘] failure-to-warn claims and the  ̳fraud-on-the-FDA‘ claims held 

to be preempted in Buckman.‖ (Stengel I, supra, 676 F.3d at p. 1164.) The en banc panel 

in Stengel III came to a different conclusion, finding neither express nor implied 

preemption where the plaintiffs‘ proposed complaint alleged (1) a ― ̳continuing duty to 

monitor the product after premarket approval and to discover and report to the FDA any 

complaints about the product‘s performance and any adverse health consequences of 

which it became aware and that are or may be attributable to the product,‘‖ (2) that 

―Medtronic failed to perform its duty under federal law to warn the FDA[,]‖ and (3) 

―because Medtronic failed to comply with its duty under federal law, it breached its  ̳duty 

to use reasonable care‘ under Arizona negligence law.‖ (Stengel III, supra, 704 F.3d at p. 

1232.) 

3. Permissible State Law Claims are not Subject to Express or Implied 

 Preemption

In order to state a claim that avoids both express and implied preemption, a 

plaintiff ― ̳must be suing for conduct that violates the FDCA (or else his claim is 

expressly preempted by § 360k(a)), but the plaintiff must not be suing because the 

conduct violates the FDCA (such a claim would be impliedly preempted under 

Buckman).‘‖ (Sprint Fidelis, supra, 623 F.3d at p. 1204, quoting Riley, supra, 625 

F.Supp.2d at p. 777.) Stated differently, to survive both express and implied preemption, 

a state law cause of action ―must be premised on conduct that both (1) violates the 
13

FDCA and (2) would give rise to a recovery under state law even in the absence of the 

FDCA.‖ (Riley, supra, 625 F.Supp.2d at p. 777.)

D. Failure to Warn 

Coleman‘s state law claim for failure to warn is expressly preempted to the extent 

it is based on the theory that Medtronic should have given warnings different than those 

approved by the FDA. Allowing Coleman to proceed on such a claim would impose 

requirements ―different from, or in addition to‖ federal requirements. (§ 360k(a); see 

also Riegel, supra, 552 U.S. at pp. 321-322.) However, Coleman focuses on two other 

theories of liability for failure to warn. He contends Medtronic violated state common 

law and parallel federal requirements by (1) failing to report adverse information about 

Infuse to the FDA after FDA approval and (2) promoting the off-label use of Infuse in 

Posterior Fusion. We address the two theories separately.

1. Failure to Warn the FDA

Medtronic initially contends that Coleman forfeited the argument that his failure to 

warn claims should survive preemption based on Medtronic‘s failure to file adverse event 

reports by conceding that issue before the trial court. We disagree. Coleman opposed 

Medtronic‘s demurrer, arguing he adequately alleged a cause of action for failure to 

warn. At the hearing on the demurrer, Coleman did not concede he failed to state a cause 

of action. Coleman did acknowledge the existence of the original Stengel I opinion, but 

never stated it had been correctly decided. Given the de novo standard of review, and the 

state of the record on appeal, we find that Coleman did not forfeit the issue. Even if he 

did, we have discretion to permit parties to propose new theories in appellate briefing 

― ̳―when the issue posed is purely a question of law based on undisputed facts, and 

involves important questions of public policy.‖‘ [Citation.]‖ (Farm Raised Salmon, 
14

supra, 42 Cal.4th at p. 1089, fn. 11, quoting Cedars-Sinai Medical Center v. Superior 

Court (1998) 18 Cal.4th 1, 6.)

Coleman‘s failure to warn claim based on Medtronic‘s failure to file adverse event 

reports with the FDA is not subject to express or implied preemption. (Stengel III, supra, 

704 F.3d at p. 1233; Hughes, supra, 631 F.3d at p. 771.) Federal law requires 

manufacturers of Class III devices to file adverse event reports whenever the device may 

have caused or contributed to death or serious injury, or malfunctioned in a manner that 

would likely cause or contribute to death or serious injury if it recurred. (§ 360i; 21 

C.F.R. § 803.50(a).) California law imposes a parallel requirement under the common 

law strict liability tort of failure to warn. The device manufacturer can be found liable if 

it ―did not adequately warn of a particular risk that was known or knowable in light of the 

generally recognized and prevailing best scientific and medical knowledge available at 

the time of manufacture and distribution.‖ (Anderson v. Owens-Corning Fiberglas Corp.

(1991) 53 Cal.3d 987, 1002; see also, Rest.3d Torts, Products Liability (1998) § 6, subds. 

(b) & (d).)

We conclude Stengel III provides the correct framework for analysis, and we are 

not persuaded by Medtronic‘s argument that Stengel III is wrongly decided. We 

recognize, of course, that Stengel III is not binding on this court, but it is persuasive 

authority that we elect to follow. (James v. State (2013) 219 Cal.App.4th 1265, fn. 7.) 

The Fifth and Ninth Circuits have now determined that state law claims based on failure 

to file adverse event reports with the FDA are not subject to preemption. (Stengel III, 

supra, 704 F.3d at p. 1233; Hughes, supra, 631 F.3d at p. 771.) We see no distinction 

between the present case and the allegations at issue in Stengel III, other than the fact that 

Coleman‘s claim is a strict liability failure to warn claim under California law, while the 

plaintiff in Stengel III alleged a negligence claim under Arizona law. 

The Eighth Circuit has taken a different approach to similar allegations, holding 

that to the extent a state law claim is premised upon a manufacturer‘s failure to follow an 

FDA regulation, such a claim is impliedly preempted under Buckman. The ―[p]laintiffs 

alleged that Medtronic failed to provide the FDA with sufficient information and did not 
15

timely file adverse event reports, as required by federal regulations. As the district court 

concluded, [citation], these claims are simply an attempt by private parties to enforce the 

MDA, claims foreclosed by [section] 337(a) as construed in Buckman, 531 U.S. at [page]

353. [Citation.]‖ (Sprint Fidelis, supra, 623 F.3d at pp. 1205-1206.) We believe such a 

broad interpretation of Buckman is unwarranted, as it would preempt almost any state law 

claim that references a federal requirement, even though the plaintiff is relying on state 

law, not federal law, to state a cause of action. (See, e.g., Farm Raised Salmon, supra, 42 

Cal.4th at p. 1093 [§ 337 bars private enforcement of the FDCA, but it does not bar 

private enforcement of state law requirements that are identical to FDCA provisions].)

Medtronic contends failure to warn the FDA is not a cognizable claim under 

California law because a device manufacturer only has a duty to warn doctors, who then 

convey the warnings as appropriate to their patients. (Carlin v. Superior Court (1996) 13 

Cal.4th 1104, 1116 (Carlin).) Coleman responds by pointing out that Medtronic does not 

explain why the duty to warn the medical profession would not include the duty to warn 

the FDA, if that is the sole permissible mechanism for publicizing the additional risks 

associated with a medical device. Such a duty to convey warnings to a third party who 

can reasonably be expected to warn the consumer is recognized in other contexts. (See, 

e.g., Persons v. Salomon North America, Inc. (1990) 217 Cal.App.3d 168, 178.) We 

agree with Coleman that the duty to warn should not be so narrowly defined as to exclude 

a requirement to file adverse event reports with the FDA if that is the only available 

method to warn doctors and consumers. As the concurrence pointed out in Stengel III, 

construing this duty in that way creates a causation hurdle that plaintiffs would not 

otherwise face. ―To prevail, they will ultimately have to prove that if Medtronic had 

properly reported the adverse events to the FDA as required under federal law, that 

information would have reached [the plaintiff‘s] doctors in time to prevent his injuries.‖ 

(Stengel III, supra, 704 F.3d at p. 1234 (conc. opn. of Watford, J.).) However, at this 

state of the proceedings, taking the allegations of the complaint as true, Coleman has 

alleged facts sufficient to state causes of action in strict liability and negligence based on 

Medtronic‘s failure to warn. 
16

2. Off-Label Promotion

A separate theory for Coleman‘s failure to warn claim is grounded in Medtronic‘s 

alleged practice of promoting off-label uses for Infuse, specifically its use in Posterior 

Fusion. Here, the preemption analysis is slightly different and leads us to the conclusion 

that, to the extent Coleman‘s failure to warn claim is based on Medtronic‘s promotion of 

off-label use, it is expressly preempted. 

Stengel III only involved a failure to warn claim based on a manufacturer‘s failure 

to provide adverse event reports to the FDA; the court did not consider any allegations of 

off-label promotion. (Stengel III, supra, 704 F.3d 1224.) In our view, Coleman‘s failure 

to warn claim cannot include a theory of off-label promotion because he would inherently 

be claiming that by promoting the off-label use of Infuse, Medtronic incurred a duty to 

warn plaintiff and his doctors about the risks of such use. Because Medtronic has already 

complied with federal requirements for warnings and labeling, any state law requirement 

to provide additional warnings would be different from, and in addition to, federal 

requirements. (Riegel, supra, 552 U.S. at p. 319; see also Caplinger, supra, 921 

F.Supp.2d at p. 1218, fn. 4 [―the federal requirement that manufacturers not promote 

devices for off-label uses is not genuinely equivalent to the state law requirements that a 

manufacturer provide adequate warnings to physicians about the risks of its medical 

device . . . .‖].) 

Coleman contends that his state law claim parallels the federal prohibition against 

manufacturers promoting off-label use because federal regulations prohibit ―adulteration‖ 

and ―misbranding.‖ However, we do not consider the state and federal requirements to 

be ―genuinely equivalent.‖ Federal regulations prevent device manufacturers from 

promoting off-label use of FDA-approved devices. (See, Ramirez, supra, __ F.Supp.2d 

at p. ___ [2013 U.S. Dist. LEXIS 118822 at *4.) Those requirements are substantively 

different than the requirements imposed by California common law in the failure to warn 

context. Strict liability failure to warn under California law imposes a requirement to 

―warn of a particular risk that was known or knowable in light of the generally 
17

recognized and prevailing best scientific and medical knowledge available at the time of 

manufacture and distribution.‖ (Carlin, supra, 13 Cal.4th at p. 1112.) We are unaware 

of any case law recognizing a state law claim for failure to warn based upon allegations 

that the manufacturer had a duty to refrain from marketing altogether, rather than 

marketing with adequate warnings. Because the federal and state requirements are not 

genuinely equivalent, Coleman‘s failure to warn claim is expressly preempted under 

section 360k.

At least one recent case involving Infuse used in Posterior Fusion takes a different 

approach, concluding that state law claims based on off-label promotion are not subject to 

a preemption analysis because off-label promotion takes manufacturers outside the 

protection of the statutory scheme, including the protection afforded by preemption. 

(Ramirez, supra, __ F.Supp.2d at p. ___ [2013 U.S. Dist. LEXIS 118822.) The starting 

premise in Ramirez is that ―the FDA reviewed Infuse‘s safety and effectiveness only for 

the uses Medtronic specified in its [premarket approval] application, and the regulations 

are premised on that review. [Citations.]‖ (Id. at p. *20.) Examining whether plaintiff‘s 

claims based on Medtronic‘s off-label promotion were expressly preempted, the court 

noted that the fundamental purpose of express preemption ―is to avoid having another 

entity (jury, state regulators, or state legislatures) arrive at a determination regarding a 

device‘s safety that conflicts with the conclusion the FDA made after the rigorous 

[premarket approval] process.‖ (Id. at *30.) When a plaintiff brings a claim against a 

manufacturer ―that arises out of a use that has not been reviewed by the FDA but has 

been promoted by the manufacturer‖ the purpose of express preemption is not served by 

preempting the claim. (Ibid.) ―It would make little sense to allow Medtronic to receive 

the protection of preemption when it is actively promoting off-label uses that have not 

been reviewed by the FDA.‖ (Id. at *34.) The Ramirez court concluded that the shield 

provided by express preemption drops when the manufacturer violates the prohibitions 

against off-label promotion. The court also found the plaintiff‘s claims were not subject 

to implied preemption because they are not ―wholly derivative‖ of federal law, like the 

claims at issue in Buckman. It held that the plaintiff could bring a state law claim ―for 
18

knowingly concealing information in off-label promotion even if off-label promotion was 

legal under federal law. The core of her claim under state law does not turn on the 

existence of a federal infraction, and is therefore permissible under Buckman.‖ (Id. at 

*42.)

We find the approach taken in Ramirez unpersuasive. To avoid preemption, a 

plaintiff must state a cause of action based on state law that parallels a federal 

requirement. (Riegel, supra, 552 U.S. at p. 330.) Here, because the requirements 

imposed by state law do not parallel the federal requirements, Coleman‘s off-label 

promotion failure to warn claim is expressly preempted by section 360k(a).

E. Negligence 

Coleman‘s negligence claim is based on the same two theories as his failure to 

warn claim: failure to submit adverse event reports to the FDA and off-label promotion. 

We address each theory separately. 

1. Failure to Warn The FDA.

For the same reasons discussed with respect to Coleman‘s failure to warn claim, 

the negligence cause of action based on Medtronic‘s failure to report adverse events to 

the FDA is not preempted, and is adequately pleaded to survive demurrer. 

Medtronic contends that Coleman‘s allegation of ―negligence per se‖ is 

insufficient to save the claim from preemption because section 337(a) constrains ―[a] 

state‘s ability to use a federal statute violation as a basis for state tort liability[.]‖ (Kemp 

v. Medtronic, Inc. (6th Cir. 2000) 231 F.3d 216, 236 (Kemp).) But Kemp predates both 

Buckman and Riegel, and the cases are divided on whether a claim based on negligence 

per se is subject to preemption. ―There is no unanimity in the courts which have 

addressed the issue of whether negligence per se claims should be allowed to proceed 

under the FDCA. . . . While a substantial number of jurisdictions allow claims based on 
19

the violation of federal requirements denoted as  ̳parallel claims,‘ others determine that 

even those claims are preempted.‖ (Howard v. Zimmer, Inc. (Okla. 2013) 299 P.3d 463, 

471-472 & fns. 35 & 36 [listing cases permitting parallel state law claims and cases 

finding preemption of state law claims].) We agree with the cases finding no preemption 

of state law claims based on negligence per se. (See, e.g., Howard v. Zimmer, Inc. (10th 

Cir. 2013) 718 F.3d 1209, 1210 [negligence per se claim for violation of federal 

regulation is recognized under Oklahoma law and is not preempted]; Hughes, supra, 631 

F.3d 762 [invoking negligence per se to support state negligence claim parallel to federal 

requirements is not expressly or impliedly preempted]; Ellis v. C.R. Bard, Inc. (11th Cir.

2002) 311 F.3d 1272 [Georgia law permits a claim for negligence per se for violation of 

the FDCA].) The only convincing reason to dismiss a cause of action based on 

―negligence per se‖ is if such a claim is not cognizable under state law. (See, e.g., 

McClelland v. Medtronic, Inc. (M.D. Fla. 2012) 944 F.Supp.2d 1193 [dismissing a 

plaintiff‘s claim because Florida does not recognize violation of federal laws or 

regulations as a basis for a state law cause of action].)6

California recognizes the applicability of negligence per se in a broad range of 

scenarios, including violation of federal law. ―There is no doubt in [California] that a 

federal statute or regulation may be adopted as a standard of care. [Citation.] More to 

the point, a federal standard in the [FDCA] has been adopted as a standard of care in a 

negligence action. [Citation.]‖ (DiRosa v. Showa Denko K.K. (1996) 44 Cal.App.4th 

799, 808; see also Evraets v. Intermedics Intraocular, Inc. (1995) 29 Cal.App.4th 779, 

791-792 (Evraets) [a claim resting on the doctrine of negligence per se is not preempted 

by the FDCA].) The primary limitation on the applicability of negligence per se is that

injury must result from ―an occurrence of the nature which the . . . regulation was 

designed to prevent‖ and the person suffering the injury ―was one of the class of persons 

for whose protection the . . . regulation was adopted.‖ (Evid. Code, § 669, subds. (a)(3) 

 

6

 California Rules of Court, rule 8.1115, prohibiting citation of unpublished 

opinions, does not prevent the citation of unpublished federal opinions. (Farm Raised 

Salmon, supra, 42 Cal.4th at p. 1096, fn. 18.)
20

& (4).) Here, the FDA‘s regulations are designed to limit risk inherent in Class III 

medical devices, and as a recipient of one of those devices, Coleman is in the class of 

persons the regulations are meant to protect. Medtronic does not present a persuasive 

argument as to why a negligence claim resting on a theory of negligence per se would be 

subject to preemption. Because Coleman‘s negligence claim based on Medtronic‘s 

failure to file adverse event reports is cognizable under California law and is parallel to 

federal requirements, he may proceed on this theory.

2. Off-Label Promotion

Our analysis of Coleman‘s negligence cause of action based on the theory of offlabel promotion is again slightly different. ―A complaint in an action for negligence must 

allege (1) the defendant‘s legal duty of care towards the plaintiff, (2) the defendant‘s 

breach of that duty, (3) injury to the plaintiff as a proximate result of the breach, and (4) 

damage to the plaintiff.‖ (Jones v. Grewe (1987) 189 Cal.App.3d 950, 954.) In 

establishing a duty of care, Coleman alleges Medtronic violated federal regulations by 

promoting off-label uses of Infuse. Many of the citations to federal law appear as part of 

Coleman‘s failure to warn cause of action, rather than his negligence cause of action, but 

we review the complaint as a whole. (Quelimane Co. v. Stewart Title Guaranty Co.

(1998) 19 Cal.4th 26, 38.) Medtronic argues that the facts alleged in Coleman‘s 

complaint do not establish a causal connection between Medtronic‘s off-label promotion 

and Coleman‘s injuries, because the FDA-approved warnings already warn of potential 

bone growth and nerve damage. However, we find that the factual allegations are 

sufficient at the pleading stage, because the complaint alleges that Medtronic‘s 

promotional activities misrepresented the risks associated with off-label use. 

Assuming the truth of Coleman‘s factual allegations, his negligence claim based 

on the theory of off-label promotion is neither expressly nor impliedly preempted, 

because it ―parallels‖ the federal requirements prohibiting misbranding and adulteration. 

(See, e.g., § 331(a), 21 C.F.R. § 814.80.) The complaint includes citations to a number of 
21

federal regulations Medtronic allegedly violated, including those that prohibit 

adulteration or misbranding of devices. Unlike his failure to warn claim, Coleman‘s 

negligence claim is premised on a state requirement that is parallel to the federal 

requirement to refrain from off-label marketing. In pursuit of a state negligence claim, 

Coleman is arguing that Medtronic violated its duty of reasonable care, which would 

parallel the federal duty to comply with the regulations prohibiting misbranding and 

adulteration.

In concluding that Coleman‘s negligence claim based on off-label promotion is 

not preempted, we recognize that the district courts have recently been divided on the 

issue. In a recent decision from the Central District of California, the court explained its 

finding of implied preemption as follows: ―Any negligence claim based solely on illegal 

off-label promotion is impliedly preempted under Buckman and [section] 337(a). Like 

the  ̳fraud on the FDA‘ claim in Buckman, the instant claim that Defendants engaged in 

illegal off-label marketing of the Infuse Device  ̳exist[s] solely by virtue‘ of federal 

regulations, and is not rooted in any traditional state tort law. Permitting this claim to 

proceed would essentially allow a private litigant to attempt to enforce the FDCA.‖ 

(Houston, supra, ___ F.Supp.2d at p. __ [2013 U.S. Dist. LEXIS 108996 at *27]; see also 

Caplinger, supra, 921 F.Supp.2d at p. 1223; but see Alton v. Medtronic, Inc. (D. Or. Sept. 

6, 2013, No. 3:13-CV-409-PK) ___ F.Supp.2d ___, 2013 U.S. Dist. LEXIS 127190 *53

[concluding negligence claim involving off-label promotion is not preempted].)

We conclude that Coleman‘s negligence claim is not preempted. The claim is

rooted in traditional state tort law and exists regardless of the FDCA and its regulations 

because the manufacturer of a medical device owes a duty of reasonable care to the 

consumer of such a device even in the absence of FDA regulations. In Buckman, the 

plaintiff‘s fraud claims were impliedly preempted because they existed ―solely by virtue 

of the FDCA disclosure requirements.‖ (Buckman, supra, 531 U.S. at p. 353.) The 

doctrine of negligence per se simply directs the trier of fact to the federal requirements to 

establish the applicable standard of care. (Elsner v. Uveges (2004) 34 Cal.4th 915, 927 & 

fn. 8 [negligence per se borrows statutes to establish a duty or standard of care].) 
22

Coleman uses the negligence per se doctrine, well recognized in California tort law, to 

ensure that the state law duty he alleges directly parallels federal law; however, he is 

pursuing a remedy under state law, not federal law. (See Farm Raised Salmon, supra, 42 

Cal.4th at p. 1093.)

G. Manufacturing Defect

―[I]f a plaintiff pleads that a manufacturer of a Class III medical device failed to 

comply with either the specific processes and procedures that were approved by the FDA 

or the [Current Good Manufacturing Practices] themselves and that this failure caused the 

injury, the plaintiff will have pleaded a parallel claim.‖ (Bass v. Stryker Corp. (5th Cir. 

2012) 669 F.3d 501, 512.) Coleman‘s second amended complaint alleged that the Infuse 

device implanted in him was defective because it failed to ―comply with the 

manufacturing specifications required by Infuse‘s Premarket Approval and Current Good 

Manufacturing Practices under the FDCA as they related to the leakage of rhBMP-2 into 

the surgical site.‖ In ruling on Medtronic‘s demurrer to the second amended complaint, 

the trial court directed this claim dismissed without leave to amend because the complaint 

did not identify a specific requirement of the premarket approval process which Coleman 

alleges Medtronic violated. 

Coleman contends that at the pleading stage he is not required to identify the 

specific manner in which Medtronic violated the federal requirements. He argues his 

general allegation that Medtronic failed to comply with those requirements is sufficient to 

determine that his manufacturing defect claim is not subject to preemption. 

Medtronic responds by citing several cases, including one from the Eleventh 

Circuit, for the proposition that the ― ̳[p]laintiffs cannot simply incant the magic words 

―[the defendants] violated FDA regulations‖ in order to avoid preemption.‘ [Citation.]‖ 

(Wolicki-Gables, supra, 634 F.3d at pp. 1301-1302.) The court in Wolicki-Gables

concluded that the plaintiffs did not allege a manufacturing defect cause of action with 

enough specificity to preclude a finding that the claim was expressly preempted, because 
23

the state law claim was potentially ―different than, or in addition to‖ the federal 

requirements. In Evraets, supra, 29 Cal.App.4th 779, a different division of this court 

considered a negligence cause of action in which plaintiffs used the doctrine of 

negligence per se to allege liability based on a lens manufacturer‘s failure to comply with 

extensive protocols for such lenses, as specified in the Code of Federal Regulations. The 

court sustained the demurrer with leave to amend, because the ―complaint fails to 

illuminate which of the innumerable regulatory requirements respondents failed to 

satisfy. In this regard, his pleading is inadequate. Evraets must specify which of the 

protocols respondents violated. He cannot make respondents and the court guess at 

which law was violated.‖ (Id. at p. 794.)

However, the Eighth Circuit has expressed concern with the concept of dismissing 

a claim on preemption grounds without at least providing a plaintiff with some 

opportunity for discovery. (Sprint Fidelis, supra, 623 F.3d at pp. 1206-1207.) In that 

case, the plaintiffs argued that without discovery, it would be impossible to meet a 

pleading standard requiring them to identify a specific federal requirement of the 

premarket approval process, because the information is only available to the 

manufacturer and the FDA. The court stated the plaintiffs‘ ―argument -- which focuses 

on the timing of the preemption ruling -- would have considerable force in a case where a 

specific defective Class III device injured a consumer, and the plaintiff did not have 

access to the specific federal requirements in [premarket approval] prior to commencing 

the lawsuit.‖ (Id. at p. 1206.) In that case, plaintiffs made a deliberate decision to not

seek discovery, and so the court affirmed dismissal of the claim ―as pleaded and argued.‖ 

(Ibid.) The Seventh Circuit has also concluded that claims of negligence and strict 

liability for a defective product can survive preemption based on general allegations that 

the company violated federal law. (Bausch, supra, 630 F.3d at p. 554 [agreeing with 

dissent in Sprint Fidelis that the ―plaintiffs could not be expected to plead their claims 

with greater specificity without discovery to obtain access to confidential government 

and company documents‖].) 
24

In light of the reasoning in Sprint Fidelis and Bausch, we conclude that it is 

premature to determine whether Coleman has alleged a state law requirement that is 

parallel to federal requirements to survive preemption. At the pleading stage, we can 

only conclude that the complaint alleges sufficient facts to state a cause of action for 

manufacturing defect, the issue of preemption will necessarily be addressed after 

Coleman has some opportunity to conduct discovery.

DISPOSITION

The judgment is affirmed to the extent the trial court sustained the demurrer to the 

third amended complaint without leave to amend as to the causes of action for fraud, 

intentional misrepresentation, violation of Business and Professions Code section 17200, 

concealment, and strict liability failure to warn on a theory of off-label promotion. The 

judgment is reversed to the extent the trial court sustained the demurrer to the third 

amended complaint without leave to amend as to the causes of action for (1) strict 

liability failure to warn based on a failure to warn the FDA theory, (2) negligence, and 

(3) design defect. We remand the case for further proceedings. Costs on appeal are 

awarded to Coleman. 

KRIEGLER, J.

We concur:

TURNER, P. J.

FERNS, J.*

 

*

Judge of the Los Angeles County Superior Court assigned by the Chief Justice 

pursuant to article VI, section 6 of the California Constitution.