Eidson v. Medtronic, Inc. (40 F. Supp. 3d 1202, 2014)

ORDER GRANTING IN PART AND DENYING IN PART DEFENDANTS’ MOTIONS TO DISMISS RICHARD EIDSON’S COMPLAINT AND SCOTT AND APRIL BELL’S COMPLAINT

LUCY H. KOH, United States District Judge

Plaintiffs Scott and April Bell (“the Bells”) commenced this action on April 3, 2013, alleging that Scott Bell suffered harmful side effects following a spinal fusion operation in which his surgeon used a spinal fusion device produced by Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. (collectively, “Defendants”). ECF Bell No. 37, 13-CV-01502, Bell First Amended Complaint (hereinafter “Bell complaint”). Plaintiff Richard Eidson (“Eidson”) brought this action on May 6, 2013, also based on harmful effects he suffered after undergoing spinal surgery in which his surgeon used the same medical device produced by Defendants. ECF Eidson No. 38, 13-CV-02049, Eidson First Amended Complaint (hereinafter “Eidson complaint”). The two cases have been related because they involve the same product and similar questions of law. ECF Bell No. 23. On October 3, 2013, the Court granted Defendants’ motion to dismiss the Bells’ complaint and granted in part and denied in part Defendants’ motion to dismiss Eidson’s complaint. Eid-son v. Medtronic, Inc., 981 F.Supp.2d 868, 2013 WL 5533081 (N.D.Cal.2013) (“October 3, 2013 Order”). The Court held that all of the Bells’ claims were barred by the statute of limitations, and that all of Eid-son’s non-fraud claims were either preempted or failed to show a causal nexus between Eidson’s injuries and Defendants’ conduct. Id. at 890, 891-95, at *14, *16-18. The Court also held that Eidson’s fraud-based claims were not preempted and were pled with sufficient particularity under Federal Rule of Civil Procedure 9(b). Id. at 885-86, at *11. Both the Bells and Eidson were granted leave to amend.

Defendants now move to dismiss both amended complaints pursuant to Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim upon which relief may be granted. ECF Bell No. 42; ECF Eidson No. 39. This Order addresses both motions to dismiss.

The Court vacated the hearing on Defendants’ motion to dismiss the Eidson complaint. ECF No. 57. The Court-held a hearing on Defendants’ motion to dismiss the Bell complaint on May 8, 2014 concerning only the statute of limitations issue. Having considered the submissions and oral arguments of the parties, the relevant law, and the record in this case, the Court GRANTS IN PART with prejudice and DENIES IN PART Defendants’ motion to dismiss the Eidson complaint, and GRANTS IN PART with prejudice and DENIES IN PART Defendants’ motion to dismiss the Bell complaint.

I. BACKGROUND

A. Factual Allegations

1. Infuse Device and Premarket Approval

The Court reviewed the factual background of these cases in its October 3, 2013 Order. See Eidson, 981 F.Supp.2d at 872-76, 2013 WL 5533081, at *1-3. Here, the Court briefly notes the relevant facts.

Medtronic Sofamor Danek, USA, Inc. manufactures a medical device known as the Infuse Device (“Infuse”) which stimulates bone growth in spinal fusion surgeries. Bell Complaint ¶ 2; Eidson Complaint ¶2. Infuse consists of three components: (1) the active ingredient, a liquid form of the protein rhBMP-2 which stimulates bone growth, (2) a metallic spinal fusion cage (the “LT Cage”) to stabilize and hold in place the liquid protein, and (3) a spongy carrier for the protein. Id. ¶ 34; Id. ¶ 33. The FDA in July 2002 granted Infuse premarket approval (“PMA”) as a medical device under the Federal Food, Drug, and Cosmetic Act of 1938 (“FDCA”), as amended by the Medical Device Amendments of 1976 (“MDA”). Id. ¶¶58, 63; Id. ¶¶45, 60. Following this approval, Defendants were permitted to sell the Infuse Device. Id. ¶ 44; Id. ¶43.

The FDA’s approval letter stated that the Device may be implanted (1) from the anterior (front) abdomen, (2) for purposes of a single-level fusion, (3) within lumbar spine levels L4 through SI, and that Infuse must not be used without the LT Cage. Id. ¶¶ 65, 66; Id. ¶ 64. Any operation that uses the Device in a manner other than that approved by the FDA is called an “off-label” use. Id. ¶67; Id. ¶ 66. This includes operations in which the spine is approached from the back and operations without the LT Cage. Id. ¶¶ 4, 69; Id. ¶¶4, 68. During approval hearings, FDA officials expressed concern about potential side effects stemming from off-label use and advised Defendants to take steps to prevent such use. Id. ¶¶ 70, 73, 75-77; Id. ¶¶ 72-76.

Plaintiffs allege that beginning in 1999, Defendants were aware that medical studies had found evidence of severe side effects associated with the off-label use of Infuse, particularly excessive bone growth. Id. ¶¶ 103-105; Id. ¶¶ 104-105, 123. Despite this knowledge, Defendants embarked on a vigorous campaign to promote off-label uses of Infuse by establishing consulting/royalty agreements with physicians who advocated off-label uses. Id. ¶¶ 120-121, 179-184; Id. ¶¶ 119-120, 178-183. Defendants also funded studies and articles by opinion leaders that omitted mentions of the risks of off-label use or understated the incidence of adverse effects. Id. ¶¶ 105, 127; Id. ¶¶71, 104, 126. In addition, Defendants failed to report adverse events suffered by patients who used Infuse off-label to the FDA, and by April 2008 Defendants had reported only 262 of an estimated 50,000-250,000 adverse events. Id. ¶ 319; Id. ¶ 309. This failure to report led to the omission of these events from the FDA’s publicly accessible MAUDE database. Id. ¶¶ 113, 280; Id. ¶¶ 111-112, 279. These activities led to investigations by the Department of Justice resulting in a $40 million settlement and Corporate Integrity Agreement on July 18, 2006. Id. ¶¶ 146-150; Id. ¶¶ 145-149. Defendant’s promotion of off-label use also led to significant controversial media coverage in the Wall Street Journal and the New York Times. Id. ¶¶ 96, 185, 191; Id. ¶¶ 95,184,190-191.

2. Scott Bell’s surgery

In February 2005, Scott Bell underwent a spinal fusion operation in which his surgeon, Dr. Seago, used Infuse in an off-label manner by implanting it by posterior approach and by failing to use an LT Cage. Bell Complaint ¶ 286. The Bells allege that Defendants directly and indirectly encouraged his surgeon to use an off-label procedure. Id. ¶287. Dr. Seago did not inform the Bells that the operation would involve rhBMP-2, and the surgical consent form Mr. Bell signed inaccurately implied that the surgery would instead involve a natural iliac crest bone graft. Id. ¶ 290, 292. Only the hospital’s “sticker page” of equipment used in the procedure notes the use of an artificial protein graft. Id. ¶ 293. After his surgery, Scott Bell experienced increased pain and was told by Dr. Seago that this was due to a “biological phenomenon.” Id. ¶ 291. On March 2, 2007, Scott Bell was diagnosed with advanced bony overgrowth in the area of his spine targeted by the surgery. Id. ¶ 288. Scott Bell underwent corrective surgery for this overgrowth on May 3, 2007. Id. Neither Dr. Seago nor any of Scott Bell’s other physicians ever informed him that Infuse was used in his surgery and may have contributed to his side effects. Id. ¶¶ 294-296.

As a result, Plaintiffs Scott and April Bell bring five causes of action against Defendants in connection with Infuse: (1) fraudulent misrepresentation/fraud in the inducement (id. ¶¶ 299-311); (2) strict products liability—failure to warn (id. ¶¶ 312-327); (3) negligent misrepresentation (id. ¶¶ 328-338); (4) negligent failure to warn (id. ¶¶ 329-353); and (5) loss of consortium on behalf of April Bell (id. ¶¶ 354-356).

3. Richard Eidson’s surgery

On November 11, 2008, Plaintiff Richard Eidson underwent a spinal fusion operation that utilized Infuse in an off-label manner by implanting the device from the back, by using a multi-level fusion, and by failing to use an LT Cage. Eidson Complaint ¶285. Eidson alleges Defendants directly and indirectly encouraged his surgeon, Dr. Smith, to use an off-label procedure. Id. ¶ 285-286. After the surgery, Eidson began experiencing pain, weakness, decreased sensation, and decreased reflexes in his legs and back pain. Id. ¶287. On May 14, 2012, he was diagnosed with fluid-filled cysts within the vertebral bodies where the surgery had taken place, and now has severe pain, reduced sensation, strength, and reflexes in his lower extremities. Id. ¶288. He has also suffered bone resorption and bone overgrowth. Id. ¶ 12.

As a result, Eidson brings four causes of action against Defendants in connection with Infuse: (1) fraudulent misrepresentation/fraud in the inducement (id. ¶¶ 290-302); (2) strict products liability—failure to warn (id. ¶¶ 303-317); (3) negligent misrepresentation (id. ¶¶ 318-328); and (4) negligent failure to warn (id. ¶¶ 329-342).

B. Procedural History

Plaintiffs Scott and April Bell filed their original complaint on April 3, 2013. ECF Bell No. 1. Defendants filed a Motion to Dismiss the Complaint on May 14, 2013. ECF Bell No. 10. Plaintiffs filed an opposition to the Motion to Dismiss on July 1, 2013. ECF Bell No. 20. Defendants filed a reply on July 22, 2013. ECF Bell No. 24.

Plaintiff Richard Eidson filed his complaint on May 6, 2013. ECF Eidson No. 1. Defendants filed a Motion to Dismiss the Complaint on May 28, 2013. ECF Eidson No. 9. Plaintiff filed an opposition to the Motion to Dismiss on July 1, 2013. ECF Edison No. 18. Defendants filed a reply on July 22, 2013. ECF Eidson No. 21.

On October 3, 2013, the Court granted Defendants’ motion to dismiss as to the Bells’ claims and granted in part and denied in part Defendants’ motion to dismiss as to Eidson, giving both plaintiffs leave to amend.

Plaintiffs Scott and April Bell filed a First Amended Complaint on November 15, 2013. ECF Bell No. 37. Defendants filed a Motion to Dismiss the First Amended Complaint on January 8, 2014. ECF Bell No. 42 (“Bell MTD”). Plaintiffs filed an opposition on February 7, 2014. ECF Bell No. 46 (“Bell MTD Opp’n”). Defendants filed a reply on February 21, 2014. ECF Bell No. 47.

Plaintiff Richard Eidson filed a First Amended Complaint on November 15, 2013. ECF Eidson No. 38. Defendants filed a Motion to Dismiss the First Amended Complaint on January 8, 2014. ECF Eidson No. 39 (“Eidson MTD”). Plaintiff filed an opposition on February 7, 2014. ECF Edison No. 46 (“Eidson Opp’n”). Defendants filed a reply on February 21, 2014. ECF Eidson No. 47 (“Eidson Reply”).

II. LEGAL STANDARDS

A. Motion to Dismiss Under Rule 12(b)(6)

Federal Rule of Civil Procedure 12(b)(6) permits a party to move to dismiss a complaint for failure to state a claim upon which relief can be granted. To survive a motion to dismiss, a complaint must plead “enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). A claim is plausible when the plaintiff pleads “factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). For purposes of ruling on a Rule 12(b)(6) motion, a court “accept[s] factual allegations in the complaint as true and construefs] the pleadings in the light most favorable to the nonmoving party.” Manzarek v. St. Paul Fire & Marine Ins. Co., 519 F.3d 1025, 1031 (9th Cir.2008). Moreover, the court “presumefs] that general' allegations- embrace those specific facts that are necessary to support the claim.” Nat'l Org. for Women v. Scheidler, 510 U.S. 249, 256, 114 S.Ct. 798, 127 L.Ed.2d 99 (1994), quoting Lujan v. Defenders of Wildlife, 504 U.S. 555, 561, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). A complaint’s non-conclusory factual allegations and reasonable inferences drawn from them, “must be plausibly suggestive of a claim entitling the plaintiff to relief.” Moss v. United States Secret Serv., 572 F.3d 962, 970 (9th Cir.2009), citing Iqbal, 129 S.Ct. at 1949.

A court is not required, however, to “ ‘assume the truth of legal conclusions merely because they are cast in the form of factual allegations.’ ” Fayer v. Vaughn, 649 F.3d 1061, 1064 (9th Cir.2011) (per curiam) (quoting W. Mining Council v. Watt, 643 F.2d 618, 624 (9th Cir.1981)). A court also need not accept as true allegations contradicted by judicially noticeable facts, Shwarz v. United States, 234 F.3d 428, 435 (9th Cir.2000). Mere “conclusory allegations of law and unwarranted inferences are insufficient to defeat a motion to dismiss.” Adams v. Johnson, 355 F.3d 1179, 1183 (9th Cir.2004); accord Iqbal, 556 U.S. at 678, 129 S.Ct. 1937.

B. Federal Rule of Civil Procedure 9(b)

When sitting in diversity, a court applies Federal Rule of Civil Procedure 9(b)’s heightened pleading standard to any state law causes of action sounding in fraud or deceit. See Vess v. Ciba-Geigy Corp. USA, 317 F.3d 1097, 1103 (9th Cir.2003). Rule 9(b) provides that “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” A complaint must “be ‘specific enough to give defendants notice of the particular misconduct ... so that they can defend against the charge and not just deny that they have done anything wrong.’ ” Kearns v. Ford Motor Co., 567 F.3d 1120, 1124 (9th Cir.2009) (citation omitted). The complaint must include facts regarding the “time, place, and specific content of the false representations as well as the identities of the parties to the misrepresentations.” Edwards v. Marin Park, Inc., 356 F.3d 1058, 1066 (9th Cir.2004) (citation omitted). In addition, “[t]he plaintiff must set forth what is false or misleading about a statement, and why it is false.” In re GlenFed, Inc. Sec. Litig., 42 F.3d 1541, 1548 (9th Cir.1994) (en banc), superseded by statute on other grounds.

C. Leave to Amend

If the Court determines that the complaint should be dismissed, it must then decide whether to grant leave to amend. Under Rule 15(a) of the Federal Rules of Civil Procedure, leave to amend “should be freely granted when justice so requires,” bearing in mind that “the underlying purpose of Rule 15 ... [is] to facilitate decision on the merits, rather than on the pleadings or technicalities.” Lopez v. Smith, 203 F.3d 1122, 1127 (9th Cir.2000) (en banc) (internal quotation marks omitted). Nonetheless, a court “may exercise its discretion to deny leave to amend due to ‘undue delay, bad faith or dilatory motive on part of the movant, repeated failure to cure deficiencies by amendments previously allowed, undue prejudice to the opposing party ..., [and] futility of amendment.’ ” Carvalho v. Equifax Info. Servs., LLC, 629 F.3d 876, 892-93 (9th Cir.2010) (alterations in original) (quoting Foman v. Davis, 371 U.S. 178, 182, 83 S.Ct. 227, 9 L.Ed.2d 222 (1962)).

D. Requests for Judicial Notice

While a court generally may not consider evidence or documents beyond the complaint in the context of a Rule 12(b)(6) motion to dismiss, Federal Rule of Evidence 201(d) provides that “[a] court shall take judicial notice [of an adjudicative fact] if requested by a party and supplied with the necessary information.” A court may take judicial notice of any fact that is “not subject to reasonable dispute in that it is either (1). generally known within the territorial jurisdiction of the trial court or (2) capable of accurate and ready determination by resort to sources whose accuracy cannot be reasonably questioned.” Id.

A court may consider documents “whose contents are alleged in a complaint and whose authenticity no party questions,” despite such documents not being physically attached to the pleadings. Knievel v. ESPN, 393 F.3d 1068, 1076 (9th Cir.2005). A court may also take judicial notice of “matters of public record outside the pleadings.” Mack v. S. Bay Beer Distribs., Inc., 798 F.2d 1279, 1282 (9th Cir.1986), overruled on other grounds by Astoria Fed. Sav. & Loan Ass’n v. Solimino, 501 U.S. 104, 111 S.Ct. 2166, 115 L.Ed.2d 96 (1991). While matters of public record are proper subjects of judicial notice, a court may take notice only of the authenticity and existence of the documents, not the veracity or validity of their contents. See Lee v. City of Los Angeles, 250 F.3d 668 (9th Cir.2001).

Defendants have filed Requests for Judicial Notice in support of their motions to dismiss both Plaintiffs’ complaints. ECF Bell No. 44; ECF Eidson No. 41. With regard to Defendants’ motion to dismiss the Bell complaint, the documents as to which Defendants request notice are precisely the same as those contained in the Request for Judicial Notice accompanying their motion to dismiss the original complaint. See ECF Bell No. 11; ECF Bell No. 44. Because Plaintiffs have not filed an opposition to these requests and for the reasons set forth in this Court’s October 3, 2103 Order, the Court grants all of Defendants’ requests.

With regard to Defendant’s motion to dismiss the Eidson complaint, Exhibits AH, for which Defendants request notice, are the same as those contained in the Request for Judicial Notice accompanying Defendants’ motion to dismiss the original complaint. See ECF Eidson No. 10; ECF Eidson No. 41. Plaintiffs have not filed an opposition to these requests, and for the reasons set forth in this Court’s October 3, 2103 Order, the Court grants Defendants’ request for judicial notice with regard to those exhibits.

However, Defendants also request judicial notice of one document not contained in the Request for Judicial Notice accompanying their motion to dismiss the original complaint. The newly included document, Exhibit' I, consists of a Medtronic “Important Medical Information” label regarding the use of Infuse. ECF Eidson No. 41, at 2. Defendants assert that Exhibit I is the warning label in effect at the time of Eidson’s surgery. Id. at 3^4. The Court based its grant of all Defendants’ previous requests on the fact that “all of the documents at issue appear on the FDA’s public website,” and were matters of the public record. Eidson, 981 F.Supp.2d at 878-80, 2013 WL 5533081, at *5-6. With regard tó Exhibit I, however, Defendants provide no citation to any FDA website or publication, and the label itself is a creation of Medtronic rather than the FDA. Exhibit I thus does not qualify as a matter of public record. Nonetheless, the Court grants the request for judicial notice. Defendants invoke the doctrine of incorporation by reference, claiming that the Eidson complaint challenges the sufficiency of the Infuse warning label and thus incorporates that label by reference. ECF Eidson No. 41, at 3-4. The Court agrees. Eidson’s complaint asserts that any warnings issued by Defendants regarding the dangers of off-label use were “insufficient in light of’ Defendant’s promotional activities. Eidson Complaint ¶ 309(iii). Accordingly, Eidson directly challenges the sufficiency of the FDA-approved warnings and the contents of those warnings are thus incorporated in his complaint. Moreover, Eidson has not opposed Defendants’ Request for Judicial Notice of Exhibit I nor questioned its authenticity. Thus, because a court may consider documents “whose contents are alleged in a complaint and whose authenticity no party questions,” Knievel, 393 F.3d at 1076, the Court takes judicial notice of Exhibit I.

III. REGULATORY BACKGROUND AND PREEMPTION LAW

Before addressing Defendants’ arguments, the Court sets forth the regulatory background and legal framework for preemption.

A. Federal Regulation of Medical Devices

In 1976, Congress enacted the MDA, which “imposed a regime of detailed federal oversight” over the entry of medical devices. Riegel v. Medtronic, 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). Notably, a process of premarket approval was established for new Class III devices. Id. at 316-17, 128 S.Ct. 999. Premarket approval is a “rigorous” process in which the manufacturer submits to the FDA extensive reports, design specifications and descriptions, samples of the device, and proposed labeling, and the FDA spends an average of 1,200 hours per application reviewing and evaluating these materials. Id. at 317-18, 128 S.Ct. 999. The FDA then “weigh[s] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use,” and “grants premark-et approval only if it finds there is a ‘reasonable assurance’ of the device’s ‘safety and effectiveness.’” Id. (internal quotation marks omitted).

B. Federal Preemption

1. Express Preemption

Defendants move to dismiss Eidson’s complaint on the ground that all of his state law claims are expressly preempted by the MDA. The MDA contains an express preemption provision:

[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a). The Supreme Court established a two-step framework for analyzing express preemption under the MDA in Riegel, 552 U.S. at 322, 128 S.Ct. 999. The court must first determine whether the FDA has established requirements applicable to the device at issue. If so, the court must then determine whether the plaintiffs claims are based on state requirements regarding the device that are “different from, or in addition to” the federal requirements, and that relate to the safety or effectiveness of the device-. Id. at 321-22, 128 S.Ct. 999. If so, the plaintiffs claims are expressly preempted by the MDA. Id. at 316, 128 S.Ct. 999.

State law claims can escape preemption only if they are based on state duties “parallel” to federal duties stemming from the FDA regulations. See Stengel v. Medtronic Inc., 704 F.3d 1224, 1228 (9th Cir.2013) (en banc). If state law liability could be found notwithstanding compliance with the federal requirements, those state law duties are not parallel to the federal requirements and will be preempted. See Riegel, 552 U.S. at 328, 128 S.Ct. 999. “To properly plead parallel claims that survive preemption, a plaintiff must allege facts (1) showing an alleged violation of FDA regulations or requirements related to [the device], and (2) establishing a causal nexus between the alleged injury and the violation.” Erickson v. Boston Scientific Corp., 846 F.Supp.2d 1085, 1092 (C.D.Cal.2011) (internal quotation marks omitted).

2. Implied Preemption

The MDA also prohibits suits by private litigants to enforce the provisions of the Act, requiring that all such actions “shall be by and in the name of the United States.” 21 U.S.C. § 337(a). The Supreme Court, in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), interpreted this provision as impliedly preempting claims seeking to enforce an exclusively federal requirement not grounded in traditional state tort law. See id. at 352-53, 121 S.Ct. 1012.

The Supreme Court in Buck-man impliedly preempted a plaintiffs claims alleging that a device manufacturer made misrepresentations to the FDA during the PMA process. Id. at 348, 121 S.Ct. 1012 (“[T]he plaintiffs’ state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, federal law”). However, courts have made clear that Buckman should not be read to foreclose claims based on any conduct that violates the FDCA. Rather, state law claims may avoid preemption if they rely on traditional state tort law duties which predate the FDCA requirements. See, e.g., Riley v. Cordis Corp., 625 F.Supp.2d 769, 776-77 (D.Minn.2009) (to escape preemption, conduct forming the basis of claims “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.”). In sum, a claim is impliedly preempted under Buck-man if it is cognizable only by virtue of the provisions of the FDCA itself, and would not be independently viable under state law; conversely, a state law cause of action escapes implied preemption if it would state a claim under state law even in the absence of the FDCA. See Buckman, 531 U.S. at 348, 121 S.Ct. 1012.

Together, express preemption and implied preemption provide only a “narrow gap” through which a plaintiffs claims must fit in order to survive. Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1120 (9th Cir.2013) (“The 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).”) (emphasis in original) (citation omitted).

IV. ANALYSIS

A. Analysis of Defendant’s Argument that the Bells’ Claims are Time-Barred

The Court first addresses Defendants’ argument that all of the Bells’ claims are time-barred. Bell MTD at 4-8. In its October 3, 2013 Order, this Court dismissed the Bells’ claims with leave to amend, finding that the claims were barred by the statute of limitations because the Bells’ complaint did not allege sufficient facts regarding the discovery rule. Eidson, 981 F.Supp.2d at 891-95, 2013 WL 5533081, at *16-18. The Court finds that the Bells have now alleged sufficient facts to plead the discovery rule, and thus rejects Defendants’ argument that all of the Bells’ claims are time-barred.

In their amended complaint, the Bells have included the following assertions regarding their delay in discovering Defendants’ wrongdoing and filing their suit:

(1) “At the time of his surgery on February 24, 2005, Dr. Randall Seago did not inform plaintiff Scott Bell that he was using rhBMP-2 by any name (INFUSE®, BMP), and did not obtain his consent to use rhBMP-2.” Bell Complaint ¶ 290.

(2) “Mr. Bell’s consent form does not mentioned [sic] rhBMP, BMP, or INFUSE®. Instead, ... the consent implies that bone was to be taken from Mr. Bell’s iliac crest, not that INFUSE® would be used.” Id. at ¶ 292.

(3) “The operative report itself does not mentioned [sic] the use of rhBMP-2. Only the separate ‘sticker page,’ which is the hospital’s record of devices and equipment used during the procedure, mentions the use of rhBMP-2.” Id. at ¶ 293.

(4) “When plaintiff Scott Bell experienced increased pain after his surgery, Dr. Randall Seago told him that his pain was due to a ‘biological phenomenon’ in terms of the way Mr. Bell’s body uniquely reacted to surgery. Dr. Seago did not state, or imply in any way, that Mr. Bell’s pain and other symptoms were- potentially the result of any product used during the surgery.” Id. at ¶ 291.

(5) “At no time did any of Scott Bell’s treating physicians inform him that rhBMP-2 had been used in his surgery.” Id. at ¶ 294.

(6) “At no time did any of Scott Bell’s treating physicians inform him that any product defect of failure might have caused or contributed to his new symptoms.” Id. at ¶ 295.

(7) “Until April 2012, Scott Bell had no reason to suspect, and did not suspect, that any product defect or failure might have caused his symptoms.” Id. at ¶ 296.

(8) “In April 2012, Scott Bell’s mother saw a lawyer commercial regarding lawsuits involving MEDTRONIC’S INFUSE® device. She mentioned this to Scott Bell, asking whether that device might have been used in his surgery. Within two weeks, in April 2012, Scott Bell contacted a lawyer in order to find out whether this device had been used in his surgery and might have contributed to his injuries.” Id. at ¶ 297.

(9) “Despite diligent investigation by Plaintiff into the cause of his injuries, including numerous consultations with Mr. Bell’s medical providers, the nature of Plaintiffs injuries and damages, and their relationship to INFUSE® was not discovered, and through reasonable care and diligence could not have been discovered, until a date within the applicable statute of limitations for filing Plaintiffs claims.” Id. at ¶ 298.

Defendants argue that the Bells have failed to plausibly allege facts regarding why their failure to file a timely claim should be excused. Bell MTD at 4-8. The Court disagrees.

A federal court sitting in diversity on a state law claim must apply the state statute of limitations. Bancorp Leasing & Fin. Corp. v. Agusta Aviation Corp., 813 F.2d 272, 274 (9th Cir.1987). Because the statute of limitations is an affirmative defense, the “defendant has the burden of proving the action is time-barred.” Grisham v. Philip Morris, Inc., 670 F.Supp.2d 1014, 1020 (C.D.Cal.2009) (citation omitted). Under California Civil Procedure Code § 335.1, personal injury claims based on defective products are subject to a two-year limitations period. Soliman v. Philip Morris Inc., 311 F.3d 966, 971 (9th Cir.2002). “In ordinary ... actions, the statute of limitations ... begins to run upon the occurrence of the last element essential to .the cause of action.” Gutierrez v. Mofid, 39 Cal.3d 892, 899, 218 Cal.Rptr. 313, 705 P.2d 886 (1985) (citation omitted). Therefore, for personal injury claims, the date of accrual of the cause of action is generally the date of physical injury. See Jolly v. Eli Lilly & Co., 44 Cal.3d 1103, 1109, 245 Cal.Rptr. 658, 751 P.2d 923 (1988). Although the general rule provides that the statute of limitations begins to run “when the cause of action is complete with all of its elements,” Norgart v. Upjohn Co., 21 Cal.4th 383, 389, 87 Cal.Rptr.2d 453, 981 P.2d 79 (1999), the discovery rule delays the commencement of the running of the statute until the plaintiff “is aware of her injury and its negligent cause.” Jolly, 44 Cal.3d at 1109, 245 Cal.Rptr. 658, 751 P.2d 923. More specifically, under the discovery^ rule, the statute of limitations begins to run not when the plaintiff sustains her injury, but rather “when the plaintiff suspects or should suspect that her injury was caused by wrongdoing, that someone has done something wrong to her.” Id. at 1110, 245 Cal.Rptr. 658, 751 P.2d 923. Thus, the discovery rule “delays accrual until the plaintiff has, or should have, inquiry notice of the cause of action.” Fox v. Ethicon Endo-Surgery, Inc., 35 Cal.4th 797, 807, 27 Cal.Rptr.3d 661, 110 P.3d 914 (2005). However, a “plaintiff whose complaint shows on its face that [her] claim would be barred without the benefit of the discovery rule must specifically plead facts to show (1) the time and manner of discovery and (2) the inability to have made earlier discovery despite reasonable diligence.” Id. at 808, 27 Cal.Rptr.3d 661, 110 P.3d 914 (citation omitted). Here, the Bells did not file their lawsuit until six years after Scott Bell sustained his injuries and underwent corrective surgery in May 2007. Eidson, 981 F.Supp.2d at 894-95, 2013 WL 5533081, at *18. Nonetheless, the Bells argue that their claims are not barred by the statute of limitations because the discovery rule delayed the accrual of their claims. Below, the Court explains why the Bells have now pled sufficient facts to allege the delayed discovery rule. First, the Court explains why it is plausible that, as the Bells argue, the Bells were not on inquiry notice concerning the role Infuse played in causing Scott Bell’s injuries until April 2012 when Scott Bell’s mother saw a commercial about lawsuits concerning Infuse. Second, the Court explains why the Bells have pled sufficient facts showing (1) the time and manner of discovery and (2) the inability to have made earlier discovery despite reasonable diligence.

First, the Court concludes that it is plausible that the Bells were not on inquiry notice until April 2012. The discovery rule “delays accrual until the plaintiff has, or should have, inquiry notice of the cause of action.” Fox, 35 Cal.4th at 807, 27 Cal.Rptr.3d 661, 110 P.3d 914. Inquiry notice occurs “when the plaintiff suspects or should suspect that her injury was caused by wrongdoing, that someone has done something wrong to her.” Jolly, 44 Cal.3d at 1110, 245 Cal.Rptr. 658, 751 P.2d 923. “The question when a plaintiff actually discovered or reasonably should have discovered the facts for purposes of the delayed discovery rule is a question of fact unless the evidence can support only one reasonable conclusion.” Ovando v. County of Los Angeles, 159 Cal.App.4th 42, 61, 71 Cal.Rptr.3d 415 (2008) (citing Jolly, 44 Cal.3d at 1112, 245 Cal.Rptr. 658, 751 P.2d 923); see also Ward v. Westinghouse Canada, Inc., 32 F.3d 1405, 1408 (9th Cir.1994) (“Under California law, the question of when [the plaintiff] was on inquiry notice of potential wrongdoing is a factual question.”). See also E-Fab, Inc. v. Accountants, Inc. Services, 153 Cal.App.4th 1308, 64 Cal.Rptr.3d 9, 17 (2007) (“Resolution of the statute of limitations issue is normally a question of fact. More specifically, as to accrual, once properly pleaded, belated discovery is a question of fact. As our state’s high court has observed: ‘There are no hard and fast rules for determining what facts or circumstances will compel inquiry by the injured party and render him chargeable with knowledge. It is a question for the trier of fact.’ However, whenever reasonable minds can draw only one conclusion from the evidence, the question becomes one of law.”) (internal citations and quotation marks omitted).

Here, in light of the Bells’ allegations, the Court finds that the question of when the Bells were on inquiry notice of Defendants’ alleged wrongdoing is a question of fact, and cannot be decided as a matter of law at this stage of the proceedings, because the Bells’ allegations do not support only one reasonable conclusion. While Defendants argue that the only reasonable conclusion is that the Bells were on inquiry notice by May 2007 when Scott Bell underwent corrective surgery for his bony overgrowth or at the latest by 2008, Bell MTD at 8, it is plausible that the Bells were not on inquiry notice that Scott Bell’s injury was caused by Infuse until April 2012. This is because the Bells allege that Scott Bell’s surgeon never told him that Infuse was to be used in the 2005 surgery nor obtained Scott Bell’s consent to use it. Id. at ¶ 290. Nor did any physician ever tell Scott Bell that Infuse had been used in his surgery. Id. at ¶ 294. Further, Scott Bell’s surgery consent form, which did not mention Infuse, implied that the bone to be used in the surgery was to be taken from Scott Bell’s iliac crest. Id. at ¶ 292. The Bells further allege that no physician told Scott Bell that a product defect might have contributed to his new pain or symptoms. Id. at ¶ 295. To the contrary, when he began experiencing pain, his surgeon told him his pain was due to a “ ‘biological phenomenon’ in terms of the way [his] body uniquely reacted to surgery.” Id. at ¶ 291. Accepting these facts as true and construing them in Plaintiffs’ favor as the Court must at this stage, the Court finds it is plausible that the Bells did not have reason to know or suspect that wrongdoing caused Scott Bell’s injuries until April 2012 when Scott Bell’s mother saw a commercial regarding Infuse. Id. at ¶ 296. This is because given Scott Bell’s doctors’ failure to disclose the use of Infuse in Scott Bell’s surgery and representations about the cause of his pain, Scott Bell may reasonably have relied on his doctor’s representations rather than trying to figure out on his own that Infuse was used during his surgery and that Infuse caused his injuries.

Defendants’ arguments to the contrary are unavailing. Defendants argue that the Bells should have been on inquiry notice by May 2007 because the reasonable person would have requested his surgical records from his initial surgery after having to go through corrective surgery in May 2007. Bell MTD at 6. Defendants claim those records would have revealed the alleged wrongdoing because the Bells’ own complaint concedes that the separate sticker page to the operative report, which is the hospital’s “record of devices and equipment used during the procedure,” mentioned the use of rhBMP-2, the protein used in Infuse. Id. (citing Bell Complaint at ¶293). The Bells have also conceded that the operative report indicated the use of “Infuse,” see ECF No. 60 (Letter from Plaintiffs’ Counsel to the Court). Defendants further note how Scott Bell’s pre-surgery consent form indicated that an “intervertebral fusion device” was to be used in the surgery, Bell MTD at 6 (citing Bell Complaint at ¶ 292). However, Defendants’ argument is unpersuasive because it is plausible that the reasonable person would not see a need to request or inspect his surgical records if his physician failed to disclose the use of Infuse during surgery and led him to believe that a “biological phenomenon” caused his injuries. See, e.g., Unjian v. Berman, 208 Cal.App.3d 881, 885, 256 Cal.Rptr. 478 (1989) (finding triable issue of fact as to delayed discovery because an operation’s failure to produce expected result would not necessarily suggest to the ordinary person that operation had been performed negligently and a jury could reasonably conclude plaintiff was justified in accepting doctor’s explanations); Lamb v. Scripps Clinic, 2006 WL 172070, *5 (Cal.App.4th Dist.2006) (reversing grant of summary judgment to defendant on statute of limitations grounds where plaintiffs doctor “responded in a manner that could lead a reasonable person to believe there was no negligence” by himself and the other doctors who participated in plaintiffs surgery); Lucas v. Somberg, 2006 WL 2270928, *1 (Cal.App.2d Dist.2006) (finding triable issue of fact as to delayed discovery, reasoning that because plaintiff “was given an explanation [by doctor] that there would be no resulting scars [from his burns], the question of his reasonable diligence in discovering his permanent scarring is one of fact”). On this point, the California court of appeal’s decision in Unjian is illustrative. There, a plaintiff sued his plastic surgeon after unsuccessful facelift surgery. Id. at 883-884, 256 Cal.Rptr. 478. Although the plaintiff noticed shortly after the operation that his face looked “ ‘worse’ ” after the operatioh, he remained in the surgeon’s care for ten more months and the defendant surgeon told him the problem could have been caused by a preexisting condition. Id. at 883, 256 Cal.Rptr. 478. Reversing a summary judgment in favor of the plastic surgeon, the court of appeal found triable issues of fact existed as to whether California Code of Civil Procedure ¶ 340.5 was tolled by the plaintiffs delayed discovery. Id. at 888, 256 Cal.Rptr. 478. The court of appeal reasoned that the fact that the operation did not produce the expected result did not necessarily connect the injury to the defendant’s negligence. Id. at 885, 256 Cal.Rptr. 478. The court of appeal found the plaintiff could have reasonably accepted the doctor’s alternative explanation of the injury and therefore there was a triable issue as to when the plaintiff knew or should have known of the injury and its negligent cause. Id. at 884-888, 256 Cal.Rptr. 478. Like in Unjian, it is plausible that Scott Bell reasonably accepted his doctor’s explanation that a “biological phenomenon” caused his injuries and thus found no reason to inquire further.

Second, Defendants argue that even assuming the Bells were not placed on inquiry notice by May 2007, they should have been placed on notice by 2008 because their complaint alleges that the off-label use of Infuse was the subject of widespread media attention as early as July 1, 2008, including articles that stated that off-label use could lead to bony overgrowth of the type whiéh Scott Bell was experiencing. See Bell MTD at 6-7; Bell Complaint ¶ 96 (discussing September 4, 2008 Wall Street Journal article linking off-label use of Infuse to “unwanted bone growth near nerves” and stating that 75 percent of adverse events reported to the FDA involved off-label use); id. ¶ 201 (noting a May 19, 2009 New York Times article regarding Defendants coming under investigation by the Department of Justice for off-label promotion of Infuse); id. ¶ 94 (citing how FDA issued on July 1, 2008 a “Public Health Notification” warning about the “serious complications” that may arise from off-label use). Defendants’ argument fails because it has been rejected by California courts. In Unruh-Haxton v. Regents of University of California, 162 Cal.App.4th 343, 364, 76 Cal.Rptr.3d 146 (Cal.App.4th Dist.2008), the California court of appeal held that “public awareness of a problem through media coverage alone [cannot] create [] constructive suspicion for purposes of [the delayed] discovery [rule].” This is because “[t]he statute of limitations does not begin to run when some members of the public have a suspicion of wrongdoing, but only ‘once the plaintiff has a suspicion of wrongdoing.’ ” Id. at 361, 76 Cal.Rptr.3d 146 (citing Nelson v. Indevus Pharmaceuticals, Inc., 142 Cal.App.4th 1202, 1206, 48 Cal.Rptr.3d 668 (Cal.App.2d Dist.2006) (emphasis in original)).

Similarly, in Nelson, the plaintiffs cause of action arose from her use of a diet drug sold as Redux. Id. at 1204, 48 Cal.Rptr.3d 668. The defendant argued that the plaintiffs action was barred by the statute of limitations, because the limitations period began to run when the dangers of a similar drug, known as “Fen-phen,” were widely publicized. Id. The court of appeal disagreed, finding that the plaintiff had no obligation to read newspapers and watch television news or otherwise seek out information not disclosed by her prescribing doctor. Id. at 1208, 48 Cal.Rptr.3d 668. The court of appeal’s conclusion was bolstered by Code of Civil Procedure section 340.8, the statute of limitations for claims involving toxic torts or hazardous materials, which specifically provides that “[m]e-dia reports regarding the hazardous material or toxic substance contamination do not, in and of themselves, constitute sufficient facts to put a reasonable person on inquiry notice that the injury or death was caused or contributed to by the wrongful act of another.” Id. (citing Cal. Code. Civ. P. ¶ 340.8). In sum, the court of appeal held there is no rule of “constructive suspicion” that triggers the statute of limitations simply when the dangers of a product are publicized.

Federal courts applying California law have come to similar conclusions. See, e.g., Yumul v. Smart Balance, Inc., 733 F.Supp.2d 1134, 1143 n. 17 (C.D.Cal.2010) (rejecting defendant’s argument that media reports would suffice to show that plaintiff was on inquiry notice as a matter of law); Migliori v. Boeing N. Am., Inc., 97 F.Supp.2d 1001, 1011 (C.D.Cal.2000) (holding at motion to dismiss stage that “[t]he mere fact of publicity ... does not conclusively show that a plaintiff must be imputed with knowledge” and does not establish that plaintiffs’ claims are time-barred as a matter of law). Here, the Bells’ complaint nowhere alleges that the Bells were aware of these articles, saw them, or read them, and thus it is plausible that they were not in fact aware of such articles or information. See Unruh-Haxton, 162 Cal.App.4th at 363-364, 76 Cal.Rptr.3d 146 (rejecting defendant’s claim that publicity gave rise to plaintiffs’ constructive knowledge of the media coverage); McGill v. M.J. Brock & Sons, Inc., 76 Cal.App.4th 1396, 91 Cal.Rptr.2d 135, 142-143 (1999) (denying summary judgment to defendants on statute of limitations grounds and rejecting argument that media reports sufficed to put plaintiffs on notice because “there is no evidence that any of the plaintiffs read any of those articles or even received any of those newspapers.”).

The Court further notes that even assuming the Bells saw these media articles, it is plausible that the articles would not have put the Bells on notice because the Bells allege they had no idea that Infuse was used in Scott Bell’s surgery. This point distinguishes this case from Soliman v. Philip Morris Inc., 311 F.3d 966 (9th Cir.2002). There,’ a California plaintiff brought suit against a tobacco company claiming that smoking had injured him. Id. at 969. The company moved for dismissal on statute of limitations grounds because the plaintiff had smoked for thirty-some years before filing his claim and did not qualify for the delayed discovery rule because he should have been on notice of the health hazards of smoking long before filing his claim. Id. at 970. The district court granted the motion to dismiss, and the Ninth Circuit affirmed, holding that a “smoker who is injured by a product he believed to be safe has reason at least to suspect that its manufacturer or seller has done something wrong.” Id. at 972. The court held the limitations period began when the plaintiff should have known he was addicted. Id. at 973. Despite the fact that the plaintiff claimed he didn’t realize he was addicted until the year 2000, “a reasonable person would have discovered it sooner” given that “the dangers of nicotine addiction have been in the public spotlight for many years.” Id. at 973, 975. Soliman is inapposite here because Soliman obviously knew he was smoking. In contrast, Scott Bell had no idea that Infuse had been used in his surgery because his doctors never told him it was and actually indicated to him in 2007, before the media coverage-of Infuse in 2008, that his injuries were caused by a biological phenomenon. Thus, it is plausible that Scott Bell would not have known that media reports on Infuse, to the extent he saw them, applied to him.

In sum, the Court cannot conclude that the only reasonable inference to be drawn from the Bells’ allegations is that a reasonable person in Scott Bell’s position would have been on inquiry notice at the latest by 2Ó08. Thus, Defendants have not met their burden of showing that the Bells suspected or should have suspected the wrongful cause of Scott Bell’s injuries by 2008.

Second, the Court explains why the Bells have pled sufficient facts showing (1) the time and manner of discovery and (2) the inability to have made earlier discovery despite reasonable diligence. “Once the plaintiff has a suspicion of wrongdoing, and therefore an incentive to sue, she must decide whether to filé'suit or sit on her rights. So long as a suspicion exists, it is clear that the plaintiff must go find the facts; she cannot wait for the facts to find her.” Jolly, 44 Cal.3d at 1111, 245 Cal.Rptr. 658, 751 P.2d 923. Thus, in California, a “plaintiff whose complaint shows on its face that [her] claim would be barred without the benefit of the discovery rule must specifically plead facts to show (1) the time and manner of discovery and (2) the inability to have made earlier discovery despite reasonable diligence.” Fox, 35 Cal.4th at 808, 27 Cal.Rptr.3d 661, 110 P.3d 914 (citation omitted). The burden is “on the plaintiff to show diligence; eonclu-sory allegations will not withstand demurrer.” Id. (internal quotations omitted).

The Bells have met their burden with respect to the first prong of the Fox test by alleging the time and manner of discovery, i.e., when they were on inquiry notice of Defendants’ alleged wrongdoing. Their complaint makes clear how and when Scott Bell discovered facts sufficient to put the Bells on notice. The complaint alleges Scott Bell was alerted in April 2012 by his mother based on a television commercial she saw, after which time Scott Bell contacted a lawyer to investigate. Bell Complaint ¶ 297. The Bells have also pled sufficient facts with respect to the second prong of the Fox test by alleging that they acted with reasonable diligence to discover the cause of his injuries and were unable to have made earlier discovery despite such diligence. Bell Complaint ¶ 298. Standing alone, such allegations would be deemed conclusory and would fail to withstand dismissal. However, the Bells allege additional facts that support their allegations, as elaborated above. For example, they allege that they made “numerous consultations with Mr. Bell’s medical providers,” id. that his doctor never informed him Infuse was to be used in the surgery, that Scott Bell’s consent form never mentioned Infuse but implied that the bone was to be taken from his iliac crest instead, that his doctor told him his pain was due to a “biological phenomenon” and did not mention it could be caused by any product used during his surgery. Id. at ¶¶ 290-296. These allegations could support the inference that a reasonably diligent person would not have made an earlier discovery by investigating further, given that Scott Bell may have reasonably relied on his doctor’s statement that the cause of his injuries was just a “biological phenomenon.” Accordingly, the Court finds that the Bells have pled sufficient facts showing their inability to have made earlier discovery despite reasonable diligence.

Finally, the Court notes that four of the cases cited by Defendants, namely Jolly, Norgart, Fox, and Gutierrez, are readily distinguishable from the instant .case. “In both Jolly and Norgart, the court emphasized that the plaintiffs had ample reason to suspect the basis of their claims.” Fox, 35 Cal.4th at 814, 27 Cal.Rptr.3d 661, 110 P.3d 914. In fact, in those cases, as well as in Gutierrez, the plaintiffs actually admitted that they suspected the defendant’s wrongful conduct at a time that rendered their claims time-barred. See Jolly, 44 Cal.3d at 1112, 245 Cal.Rptr. 658, 751 P.2d 923; Norgart, 21 Cal.4th at 405-6, 87 Cal.Rptr.2d 453, 981 P.2d 79; Gutierrez, 39 Cal.3d at 895-97, 218 Cal.Rptr. 313, 705 . P.2d 886 (noting that plaintiff conceded in her deposition that “she felt [as early as 1978] that the surgeons had ‘done something wrong’ to her.”). In this case, on the other hand, Scott Bell’s medical providers did not inform him that Infuse was used in his surgery and instead implied the bone was to be taken from his iliac crest, and also told him that his post-surgery pain was the result of a “biological phenomenon” and his unique reaction to the surgery. Additionally, Jolly and Norgart were decided at the summary judgment stage, meaning the court was “presented with a more fully developed factual basis for determining when and how the plaintiff discovered an injury, whether the plaintiff conducted a reasonable investigation, when such an investigation would have brought to light the factual basis for the cause of action ... and whether the plaintiff could have discovered the factual basis for a cause of action earlier by exercising reasonable diligence.” Fox, 35 Cal.4th at 810, 27 Cal.Rptr.3d 661, 110 P.3d 914. On the other hand, this motion has been brought at the pleading stage, so the Court must take all of the Bells’ factual allegations as true. Finally, unlike the plaintiff in Fox, the Bells did not fail to “allege facts explaining why [they] did not have reason to discover earlier the factual basis of’ their claims. Id. at 806, 27 Cal.Rptr.3d 661, 110 P.3d 914.

Because the Court finds that the Bell complaint alleges sufficient facts to satisfy the pleading requirements of the discovery rule, the Court rejects Defendants’ argument that the Bell complaint must be dismissed as time-barred.

B. Analysis of both Richard Eidson and the Bells’ Fraudulent Misrepresentation/Fraud in the Inducement Claims, Negligent Misrepresentation Claims, Strict Liability Failure to Warn Claims, and Negligent Failure to. Warn Claims

Both Eidson and the Bells bring the same four causes of action: (1) fraudulent misrepresentation/fraud in the inducement; (2) negligent misrepresentation; (3) strict products liability failure to warn; and (4) negligent failure to warn. The Bells also bring a fifth cause of action: loss of consortium on behalf of April Bell. The Court addresses April Bell’s consortium claim in Part IV.C below. In this section, the Court addresses both Eidson and the Bells’ fraudulent misrepresentation/fraud in the inducement claims, negligent misrepresentation claims, strict liability failure to warn claims, and negligent failure to warn claims. Defendants raise the exact same arguments against each of these four claims in their motion to dismiss the Eid-son complaint and their motion to dismiss the Bell complaint. Thus, the Court addresses Defendants’ arguments together with respect to both Eidson and the Bells’ claims below. The Court refers collectively to Eidson and the Bells as “Plaintiffs” below.

Defendants argue that all of. Plaintiffs’ claims are expressly and impliedly preempted, Eidson MTD at 4-18, and that their fraud claims are not pled with the requisite particularity and fail to state a claim under California law. Eidson MTD at 19-21. Plaintiffs respond that their claims are not preempted, are pled with the requisite particularity, and state valid claims under state law. See generally Eid-son Opp’n. The Court discusses each of Defendants’ three arguments in turn below.

1. Preemption of Plaintiffs’ Claims

The Court first addresses whether each of Plaintiffs’ claims are expressly or impliedly preempted under federal law.

а. Fraud-based claims: fraudulent misrepresentation/fraud in the inducement claim and negligent misrepresentation

The Court will consider Plaintiffs’ two fraud-based claims together: Plaintiffs’ fraudulent misrepresentation/fraud in the inducement claim and negligent misrepresentation claim. The Court concludes that neither claim is expressly or impliedly preempted.

In its October 3, 2013 Order, the Court noted that Eidson’s original complaint was unclear as to precisely what conduct by Defendants formed the basis of Eidson’s fraud-based claims. The two fraud-based claims evaluated in the October 3, 2013 Order were the fraudulent misrepresentation/fraud in the inducement claim and strict products liability misrepresentation claim. The Court held that to the extent Eidson’s fraud-based claims alleged misrepresentations or omissions in the FDA-approved warning labels accompanying Infuse, such claims were expressly preempted because “requiring Defendants to alter the Infuse Device’s warnings and label in order to provide extra warnings beyond those already approved during the PMA process would impose labeling and warning requirements ‘different from, or in addition to’ federal requirements.” Eidson, 981 F.Supp.2d at 884, 2013 WL 5533081, at *9. The Court held that if, on the other hand, Eidson’s fraud-based claims alleged Defendants made misrepresentations or omissions in the course of promoting Infuse for off-label use, such claims were not expressly or impliedly preempted. See id. at 884-86, at *10-11. As a result, the Court denied Defendants’ motion to dismiss Eidson’s fraud-based claims.

After the October 3, 2013 Order, Eidson amended his complaint to allege two fraud-based claims: fraudulent misrepresentation/fraud in the inducement, and negligent misrepresentation. The first, his fraudulent misrepresentation/fraud in the inducement claim, is the same as in his original complaint because he left it unaltered. The second, negligent misrepresentation, is a new claim because Eidson changed his original strict products liability misrepresentation claim to a negligent misrepresentation claim. The Bells also have amended their complaint to allege two fraud-based claims: fraudulent misrepresentation/fraud in the inducement, and negligent misrepresentation. The Bells’ fraudulent misrepresentation/fraud in the inducement claim is substantively identical to the fraudulent misrepresentation/fraud in the inducement claim in Eidson’s amended complaint, and the Bells’ negligent misrepresentation claim is substantively identical to the negligent misrepresentation claim in Eidson’s amended complaint.

As to the Plaintiffs’ first fraud claim, fraudulent misrepresentation/fraud in the inducement, Defendants urge dismissal on the grounds that this claim “still appears to challenge the sufficiency of the Infuse Device FDA-approved labeling.” Eidson MTD at 7. Plaintiffs’ oppositions suggest rather that this claim is based on fraudulent conduct in the course of off-label promotion. Eidson MTD at 4. As to the second fraud claim, negligent misrepresentation, that claim alleges that Defendants negligently made misrepresentations or omissions in the course of promoting Infuse for off-label use. Eidson Complaint ¶¶ 318-328. Defendants urge dismissal of this claim on the grounds that any cause of action based on off-label promotion is expressly and impliedly preempted. Eid-son MTD at 15,17.

The Court analyzes Defendants’ challenge to the Plaintiffs’ two fraud-based claims together below and concludes that Defendants have not provided any persuasive reason for the Court to change its original conclusion in its October 3, 2013 Order that the fraud-based claims are not expressly or impliedly preempted to the extent they are based on fraudulent conduct in the course of off-label promotion,

i. Express preemption

Plaintiffs’ fraudulent misrepresentation/fraudulent inducement and negligent misrepresentation claims are not expressly preempted because they impose state tort law duties that parallel federal requirements. Defendants argue that because off-label promotion is not necessarily a violation of federal law, state claims based on such promotion cannot be parallel to federal requirements. Eidson MTD at 13-14. However, as the Court noted in its October 3, 2013 Order, courts in the Ninth Circuit have generally held that device manufacturers are prohibited by federal law from promoting or advertising off-label use because such promotion is deemed to be false or misleading. See Eidson, 981 F.Supp.2d at 884-85, 2013 WL 5533081, at *10; Carson v. Depuy Spine, Inc., 365 Fed.Appx. 812, 815 (9th Cir.2010) (“[W]hile doctors may use a drug or device off-label, the marketing and promotion of a Class III device for an unapproved use violates Section 331 of the FDCA.”); In re Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, 590 F.Supp.2d 1282, 1287 (C.D.Cal.2008) (“Under FDA regulations, drug manufacturers are prohibited from promoting off-label uses of prescription drugs.”). Thus, as this Court previously explained, the duties underlying these two fraud claims are not “different from, or in addition to” the federal requirement banning off-label promotion because there is “no likelihood that Defendants could be held liable under [the] state law without having violated [ ] federal law.” Eidson, 981 F.Supp.2d at 884, 2013 WL 5533081, at *10 (citation omitted).

Even assuming off-label promotion per se does not constitute a violation of federal law as Defendants argue, see Eidson MTD at 13-14, Defendants have advanced no authority suggesting that federal law permits false and misleading off-label marketing, and there is in fact law to the contrary. In holding that fraud claims based on Medtronic’s promotion of Infuse escaped express preemption, the court in Houston v. Medtronic, Inc., 957 F.Supp.2d 1166 (C.D.Cal.2013), held that federal law requires that advertising beyond the subject device’s label not be false or misleading. Id. at 1179-80. Thus, here, even assuming truthful off-label promotion does not violate federal law, Plaintiffs’ claims still escape express preemption because they allege that specific aspects of Defendants’ promotion activities were false or misleading. For example, Plaintiffs allege Defendants knowingly marketed Infuse in misleading ways, such as by paying kickbacks to “opinion leaders” to directly advocate off-label use of Infuse to other spine surgeons without disclosing their financial relationship with Defendants and bankrolling falsified medical studies and articles. Eidson Complaint ¶¶ 104, 119-122. Accordingly, the Court concludes that the state tort law duties underlying Plaintiffs’ claims are not “different from, or in addition to” feder