United States ex rel. Modglin v. DJO Global Inc. (114 F. Supp. 3d 993, 2015)

ORDER GRANTING DEFENDANTS’ MOTION TO DISMISS THE CORRECTED THIRD AMENDED COM- ■ PLAINT ■ '

MARGARET M. MORROW, District Judge.

Qui tam relators Doris Modglin and Russ Milko filed this action against defendants bjO Global Inc. (“DJO Global”), DJO, LLC (“DJO”), DJO Finance LLC (“DJO Finance”), Orthofix, Inc. (“Ortho-fix”), Biomet, Inc. (“Biomet”), and EBI, LP (“EBI”) under seal and in camera on August'20, 2012. Relators invoked the court’s federal question jurisdiction under 28 U.S.C. § 1331, and alleged a single claim for violation of the False Claims Act (“FCA”), 31 U.S.C. § 3729(a)(1)(A), (B). On December 26, 2012, they filed a first amended complaint, realleging the federal FCA claim and alleging state FCA claims under the equivalent statutes of twenty-nine states: California, Colorado, Connecticut, Delaware, the District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Louisiana, Maryland, Massachusetts, Michigan,, Minnesota, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Rhode Island,- Tennessee, Texas, Virginia, and Wisconsin. On May 17, 2013, the United States declined to intervene in the case. On July 19, 2013, each of the twenty-nine states declined to intervene. The court unsealed the amended complaint that day.

On October 3, 2013, pursuant to a request by relators; the court dismissed Or-thofix. On November 8, 2013, relators filed a second amended complaint, restating their federal and state FCA claims and adding EBI, LLC (with EBI, LP, “EBI”) as a defendant. On January 22, 2014, the parties stipulated- to dismiss DJO Global and DJO Finance as defendants; the court entered an order on the stipulation on January-28, 2014. On February 20, 2014, the court granted defendants’ motion to stay discovery until it decided their pending motion to dismiss the second amended complaint.) On May 5, 2014, the court held a hearing on. the motion to dismiss the second amended complaint. Following that hearing, the court took the motion under submission and directed the parties to file supplemental briefs addressing four questions. After the parties did so on July 7, 2014, the court issued an order dismissing the second amended complaint on September 2, 2014. The court dismissed the federal Medicare FCA cíaim based on submission of false claims and false certifications with prejudice except to the extent it was premised on the theory that defendants made implied false certifications by unlawfully promoting their devices for off-label uses. The court dismissed the federal FCA claim without prejudice to the extent based on.allegedly false claims submitted, to Medicaid, the Federal Employees Health Benefit Program, the Federal Workers Compensation Programs, the .Civilian Health and Medical Program of the Department of Veterans Affairs (“CHAMPVA”), and/or -Tricare. Finally, the court declined to exercise supplemental- jurisdiction over relators’ state law claims.

On September 22, 2014, relators filed a third amended complaint; subsequently, on September 29, 2014, they filed a corrected third amended complaint. On October 7, 2014, the court entered an order setting a briefing schedule and hearing date for defendants’ motions to dismiss the corrected third amended complaint. •That motion was filed jointly by defendants on October 22, 2014. Relators oppose the motion.

I. FACTUAL BACKGROUND

Relators assert that defendants — manufacturers and distributors of durable medical equipment (“DME”) — fraudulently caused the government to disburse money by filing claims with Medicare and other federal healthcare plans for reimbursement related to their provision of noninvasive, bone-growth stimulators (“stimu-lators”) that they knew had been prescribed by physicians for an off-label purpose, i.e., one not specifically approved by the Food and Drug Administration (“the FDA”). Defendants allegedly failed to reveal to Medicare and other federal healthcare plans that the stimulators were going to be used for off-label purposes. As the court explained in its order dismissing the second amended complaint, before one can understand the allegations in the complaint, it is necessary to provide an overview of the statutory and regulatory scheme that governs both FDA approval of medical devices and the coyerage of such devices by Medicare and other federal programs. The court begins by describing FDA approval of medical devices.

A. Background Regarding FDA Approval of Medical Devices

One of the “core objectives” of the Food, Drug, and Cosmetic Act (“the FDCA”), 21 U.S.C. § 301 et seq., is to ensure that “there is reasonable assurance of the safety and effectiveness of devices intended for human use.” Food and Drug Administration v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133-34, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000) (citing 21 U.S.C. § 393(b)(2)). To that end, the FDCA classifies medical devices in three categories: Classes I, II, and III. 21 U.S.C. § 360c(a). Class III devices include those that present a potentially unreasonable risk of illness or injury. Id., § 360c(a)(1)(C). Because of the risk associated with such devices, the FDA has determined that the manufacturers of such devices must submit premarket approval (“PMA”) applications to the FDA-and obtain premarket clearance before offering the devices for sale. 42 C.F.R. § 405.201(b). Class III devices that do not have PMA-approval cannot be marketed and are considered “adulterated.” 21 U.S.C. § 351(f)(1)(B) (“A ... device shall be deemed to be adulterated ...' if it is a class III device .. which ... is required to have in effect an approved application for premarket approval ... and ... which has an application which has been suspended or is otherwise not in effect”); 42 C.F.R. § 405.201(b).

The FDA gives a device PMA approval if it determines that the PMA application contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use. 21 C.F.R. § 814.2(a). It is “a ‘rigorous’ process in which the manufacturer submits extensive study reports, design specifications and descriptions, samples of the device, and proposed labeling to the FDA, and the FDA conducts a comprehensive review and evaluation of all the submitted documents and materials[.]” Kashani-Matts v. Medtronic, Inc., No. SACV 13-01161-CJC (RNBx), 2013 WL 6147032, *1 (C.D.Cal. Nov. 22, 2013).

If a medical device is used for a purpose other than that for which it has obtained PMA approval, the usage is “off-label.” Carson v. Depuy Spine, Inc., 365 Fed.Appx. 812, 815 (9th . Cir.2010) (Un-pub.Disp.) (“Drugs.and medical devices are approved or cleared by the FDA for marketing with labels describing the uses and the patient conditions which have been reviewed in the approval or clearance .process. Any use by a physician which differs from the use described in the label or from the patient conditions described in the label is called ‘off-label’ ”). The FDCA explicitly protects physicians’ ability to prescribe devices for off-label use. 21 U.S.C. § 396 (“Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally ■. marketed device to a patient for any condition dr disease within a legitimate health care practitioner-patient relationship”); see also Houston v. Medtronic, Inc., No. 2:13—cv-01679-SVW (SHx), 2014 WL 1364455, *1 n. 1 (C.D.Cal. April 2, .2014) (“Physicians, are permitted to use Class III devices in off-label manners”). Indeed, off-label use of medical devices is “generally accepted” within the medical community, and ,§ 396 of the FDCA “expressly disclaims any intent to directly regulate the practice of medicine.” Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 351 & n. 5, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (citing Beck & Azari, FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions, 53 Food & Drug L.J. 71, 72 (1998) (“Off-label use is widespread in the medical community and often is essential to giving patients optimal medical care, both of which medical ethics, FDA, and most courts recognize”)); see also Kashani-Matts, 2013 WL 6147032 at *1 n. 4 (“The FDA does not prohibit or regulate off-label use of medical devices by medical professionals, and the Supreme Court has emphasized that off-label use is not merely legitimate but important in the practice of medicine,” citing Buckman Co., 531 U.S. at 350, 121 S.Ct. 1012).

The FDCA does, however, expressly prohibit Class III device manufacturers from marketing a PMA-approved device for an off-label use. 21' U.S.C. § 331 (proscribing, inter alia, “[t]he introduction ... into interstate commerce of any ... device ... that is adulterated or misbranded”); 21 C.F.R. § '814.80 (stating that once the-FDA has approved a PMA application, the manufacturer of the approved device may not manufacture, package, store, label, distribute, or advertise the device in a manner that is inconsistent with any conditions of approval specified in the PMA approval order for the device). Because off-label usage of medical devices “is an accepted and necessary corollary of the FDA’s mission to regulate in th[e] [medical field] without directly interfering with the practice of medicine,” however, Buckman Co., 531 U.S. at 349-50, 121 S.Ct. 1012, “a manufacturer is not liable [for having violated the FDCA] merely because it sells a device with knowledge that the prescribing doctor intends an off-label use,” Carson, 365 Fed-Appx. at 815. The manufacturer can only be liable for violating the FDCA if it markets or promotes the device for that purpose. If a device manufacturer wishes to market a device for an off-label purpose, it must submit a PMA supplement for review and approval by the FDA. 21 C.F.R. § 814.39.

B. Facts Alleged in the Corrected Third Amended Complaint Regarding FDA Approval of Defendants’ Stimulators

Relators allege that DJO, Biomet, and EBI — a wholly owned subsidiary of Biom-et — manufacture and market DME, including stimulators, throughout the United States. They assert that the FDA 'categorizes stimulators as Class III devices,' meaning that they must receive PMA approval before they can be marketed. More specifically, they allege that DJO manufactures and markets a stimulator called the SpinaLogic, and that the FDA has approved the SpinaLogic as an adjunct electrical treatment to primary lumbar spinal fusion surgery under PMA Number P910066. Biomet and EBI allegedly manufacture and market a stimulator called the SpinalPak. The FDA has approved the SpinalPak as an adjunct electrical treatment to primary lumbar spinal fusion surgery under PMA Number P850022.

C. Background Regarding Medicare Coverage of Medical Devices

1. Coverage Determinations by Medicare

The Medicare program is a federally funded health insurance program for the aged and disabled created by the Social Security Act (“the Medicare Act”), 42 U.S.C. § 1395 et seq. See International Rehabilitative Sciences Inc. v. Sebelius, 688 F.3d 994, 997 (9th Cir.2012) (“Medicare is the federal health insurance program for the elderly and disabled”). Part B of the Medicare Act provides medical insurance for medical and other health services needed by individual plan participants; this includes stimulators and other DME provided to Medicare patients by a DME provider. Id. (citing 42 U.S.C. §§ 1395j, 1395k(a)(2), 1395m). Under Part B, “Medicare beneficiaries receive medical treatment and the providers submit claims for government reimbursement.” Id. (citing § 1395n). Under the Medicare Act, only devices that are “reasonable and necessary for the diagnosis or treatment of illness’ or injury or to improve the functioning of a malformed body member” can be reimbursed. 42 - U.S.C. § 1395y(a)(1)(A). This limitation on coverage is intended to; control Medicare costs. International Rehabilitative Sciences, 688 F.3d at 997. The Act states that

“[a] device is not ‘reasonable and necessary5 — and thus is not eligible for Medicare coverage — if it is: [ (1) ] Not ‘safe5 and ‘effective5 — that is, if the device has not ‘been proven safe and effective based on authoritative evidence5 or is not ‘generally accepted in the medical community as safe and effective for the condition for which it is used5; [ (2) ] ‘[Experimental5 — that is, ‘investigational’; [ (3) ] Not ‘[appropriate5 for the individual beneficiary’s needs; or [ (4) ]'‘[Substantially more costly than a medically appropriate and realistically feasible alternative pattern of care.5 55 Id. (citing § 1395y(a)(1)(A) and 54 Fed.Reg. 4302, 4303-04 (Jan. 30, 1989); 60 Fed.Reg. 48417, 48418 (Sept. 19, 1995)).

Of. Medicare Program Integrity Manual § 13.7.T. (stating that “[i]n order of preference, [local coverage determinations] should be based on: [1] Published authoritative evidence derived from definitive randomized clinical trials or other definitive studies, and [2] General acceptance by the medical community (standard of practice), as supported by sound medical evidence”). “[The Centers for Medicare and Medicaid Services (‘CMS’) ] use[ ] the FDA categorization of a device as a factor in making Medicare coverage decisions.” 42 C.F.R. § 405.201(a)(1). Thus, “FDA clearance [] is necessary, but not sufficient, for Medicare coverage— To be ‘reasonable and necessary" for treatment, a device must be ‘safe and effective," but other considerations are also relevant— like whether there are less costly -but equally effective devices, available.” International Rehabilitative Sciences, 688 F.3d at 1002 (emphasis omitted).

In its Medicare Benefit Policy Manual (“the Medicare Manual”), the Department of Health and Human Services (“HHS”) considered the FDA categorization of devices and determined generally that “[devices that may be covered under Medicare include the following categories: [1] Devices appróved by the FDA through the Pre-Market Approval (PMA) process; [2] Devices cleared by the FDA through the 510(k) process; [3] FDA-approved IDE Category B devices; and [4] Hospital Institutional Review Board (IRB) approved IDE devices.”

Within these general categories of devices eligible for coverage, HHS “may make [Medicare] coverage determinations [for certain types of devices] via up-front rules.” The agency, however, has “discretion ... whether to make [broad] determinations [as to whether a particular device is reimbursable] ... or [whether to have Medicare contractors make that decision based on a] case-by-case adjudication.” Id. at 1001. When HHS engages in rule-making regarding the scope of coverage for certain devices, it issues National Coverage Decisions (“NCDs”). “An NCD is a determination-... of whether a particular item or service is covered nationally under Medicare.” 42 C.F.R. § 405.1060(a)(1). NCDs are compiled in the Medicare Manual. “Once published .,an NCD is binding on all Medicare carriers.” Almy v. Sebelius, 679 F.3d 297, 299 (4th Cir.2012) (“[T]he Secretary [of HHS] can make. a ‘national coverage determination’ (NCD) binding throughout the Medicare system and not subject to review by administrative law judges”); see also 42 C.F.R. § 405.1060(a)(4) (“An NCD is-binding on fiscal intermediaries, carriers, ... [administrative law judges], and the [Medicare Appeals Council],” among others). Additionally, individual carriers — the - private insurance carriérs with whom HHS contracts to administer claims — can issue Local Coverage Determinations (“LCDs”). LCDs address local coverage issues; Almy, 679 F.3d at 299-300. If no NCD or LCD addresses a particular device, contractors determine coverage on a case-by-case basis. Id., at 300 (“Filially, if no NCD or LCD is in place, ‘contractors may make individual claim determinations,’ including whether a particular DME meets the statutory requirement of being ‘reasonable and necessary”’ (citing 68 Fed.Reg. 63,-693)). ,

(The reimbursement of stimulators is covered by. NCD 150.2. NCD 150.2 states- that stimulators are covered by Medicare for six uses, one of which is “as an adjunct to spinal fusion surgery” for certain patients. Thére are also four LCDs that address the coverage 'of stimu-lators. Each mirrors the criteria set forth in NCD 150.2, in that it provides that stimulators are covered, inter alia, “as an adjunct to spinal fusion surgery.” Neither NCD 150.2 nor the four LCDs covering stimulators distinguish between stimu-lators used on one part of the spine, e.g., the cervical spine, versus another, e.g., the lumbar spine. Nor do they distinguish between stimulators based on on-label versus off-label usé.

NCD 280.1, the “Durable Medical Equipment Reference List” is a “quick reference tool” that applies “(where appropriate) to all DME national coverage determinations (NCDs).” It provides a list of

“generic categories of equipment on which NCDs have been made by ... CMS— In the case of-equipment categories that have been determined by CMS. to be covered under the DME benefit, the list outlines the conditions of coverage that must be met if payment is to be allowed for the rental or purchase of the DME by a particular patient, or cross-refers to another section of the manual where the applicable coverage criteria are described in more detail. With respect to equipment categories that cannot be covered as.DME, the list includes a brief explanation of why the equipment is not covered____When the contractor receives a claim for an.item of equipment which does not appear to fall logically into any of the generic categories listed, the contractor has the authority and responsibility for deciding whether those items are covered under the DME benefit. These decisions must be made by each contractor based on the advice of its. medical consultants, taking into account: [1] The Medicare Claims Processing Manual, Chapter 20, T>urable Medical .Equipment, Prosthet-ics and Orthotics, and Supplies (DME-POS)- [;]' [2] Whether the item has been approved for marketing by the Food and Drug Administration (FDA) and is otherwise generally considered to be safe and effective for the purpose intended; and [3] Whether the item is reasonable and necessary for the individual patient.” . .

NCD 280.1 thus serves as a first point of reference for contractors attempting to determine whether a certain device or a certain use of a device is covered. Specifically, it provides an index of some of the national coverage determinations Medicare has made. It-lists some devices that are covered and refers the reader to the NCD controlling that device. It also lists some devices that are not covered and articulates why HHS has determined that that device cannot be covered. For devices that HHS has not explicitly declared covered or uncovered, NCD 280.1 sets forth the factors a contractor must consider in making a case-by-case coverage determination. NCD 280.1 is not comprehensive, however. Certain devices that are covered by a particular NCD are not referenced in NCD 280.1. This is because NCD 280.1 was meant only to-aid in determining coverage for “certain pieces of DME and especially for those items commonly referred to by both brand and generic names.” As the NCDs are -binding on Medicare contractors, the contractors must follow an NCD dictating coverage for a certain device, even if that device is not listed in NCD 280.1.

2. The Reimbursement Process

To submit a claim for reimbursement, DME providers fill out and submit to Medicare CMS Form 15Q0. Section 23 of -the form includes, a space for the provider to list any PMA approval number covering the device for which it seeks reimbursement. Providers seeking reimbursement for stimulators must also include a “KF” modifier on CMS Form 1500, which indicates that the provider is billing Medicare for a Class III device.

Together with CMS Form 1500, the provider must .submit- a Certificate of Medical Necessity. The Certificate of Medical. Necessity used for Class III stim-ulators is CMS 847.- CMS 847' has four sections.. Section - A seeks general information concerning the.patient, physician; and supplier. Section B requests information regarding the medical necessity for the device, and states: “Information in this Section May Not Be Completed by the Supplier of the Items/Stipplies.” Section C provides space for a “Narrative Description of Equipment and Cost.” Section C instructs the person completing the form to provide a “(1) Narrative description of all items, accessories and options ordered; (2) [the] Supplier’s charge; and (3) [the] Medicare Fee Schedule Allowance for each item, accessory, and option.” Section D is the physician’s attestation and signature.

The DME provider must also include a Healthcare Common Procedure Coding System (“HCPCS”) number for the device for which it is requesting reimbursement on both CMS Form 1500 and CMS 847. There is a generic HCPCS code number for all stimulators: E0748.

By regulation, DME providers seeking reimbursement must furnish sufficient information to Medicare’s claim processing contractors that they can determine whether payment is due. 42 C.F.R. § 424.5(a)(6) (“As a basis for Medicare payment, the following conditions must be met: ... The provider, supplier, or beneficiary, as appropriate, must furnish to the intermediary or carrier sufficient information to determine whether payment is due and the amount of payment”).

D. Facts Alleged in the Second Amended Complaint Regarding Defendants’ Submission of Claims to the Medicare Program

Relators allege that defendants are approved Medicare DME providers. They assert that when a physician prescribes a stimulator manufactured by one of the defendants, a loeal distributor under contract to the defendant collects relevant medical records and prescriptions and forwards them to an insurance administrator at the defendant’s home office. The insurance administrator and claims processor then prepare and submit claims to Medicare and other insurance earners. Relators assert that since approximately September 18, 2001, defendants have routinely submitted false or fraudulent claims for stimulators to Medicare. Specifically, they allege that defendants have requested reimbursement for stimulators approved for lumbar spine use when they knew, and did-not reveal, that the stimu-lators had been distributed for off-label cervical spinal use. Relators contend that the stimulators are not reimbursable if they are not distributed for the use for which they have PMA approval. They allege that, by indicating on CMS Form 1500 a PMA approval number for a stimulator approved only for lumbar, and not for cervical, spine use, defendants expressly or implicitly misrepresent the device’s intended use. Stated differently, they contend that by reporting their stimulator’s PMA approval number on CMS Form 1500, defendants affirmatively represent that the stimulator will be used on the lumbar spine when they know it will be used on the cervical spine instead. Relators assert that, because there is only one HCPCS code covering stimulators used on all parts of the spine, and because defendants’ stimulators are only approved for use on the lumbar spine, unless defendants specifically indicate in the narrative description portion of CMS 847 that the device has been distributed for an off-label use, they violate the requirement that they furnish sufficient information to permit Medicare’s claim processing, contractors to determine whether payment is due. Relators also contend that by failing to indicate in the narrative description portion of CMS 847 that the stimulator is being distributed for an off-label use, defendants expressly and/or impliedly misrepresent that the stimulator is being distributed and used for the use that is PMA-approved and use of the device is therefore reimbursable.

As proof that defendants have submitted such claims for reimbursement, rela-tors plead facts concerning their interactions with defendants over the years. They allege that in 1997, relator Milko was hired as a direct sales representative-for Orthofix to promote and sell stimulators. Orthofix is a major manufacturer and distributor of stimulators and defendants’ primary competitor. Orthofix manufactures and distributes the only stimulator with PMA approval for cervical usé: the Cervical-Stim. Orthofix developed the Cervical-Stim after the FDA issued a public warning in 1997 stating that Orthofix had been unláwfully marketing its Physio-Stim stimulator for cervical usé because’it did not have PMA approval to use the device in that manner. Orthofix’s PMA approval for the Physio-Stim covers only use for “the treatment of nonunion of long bone fractures acquired secondary to trauma and for the treatment of flat bones, excluding vertebra.” ■ The warning letter stated that use of the Physio-Stim for treatment of cervical spine fusion was “a change in indication that required a PMA [supplement” if Orthpfix intended to continue marketing the device for that purpose.

Relators allege that on July 1, 2005, Milko became an Orthofix distributor and that he has continued in that capacity since, marketing and selling the Cervical-Stim and Orthofix’s other, non-cervical stimulators. .They assert that because of his position with Orthofix, Milko learned that defendants were distributing their stimulators for off-label, cervical use. Specifically, they allege that Milko heard that DJO sales personnel verbally instructed patients to use the SpinaLogie by folding it up, placing a pillow over it, and lying their head on the pillow for 30 minutes and that they reassured doubtful patients that the device worked better on the cervical spine than on the lumbar spine, although not approved for that use, because the cervical spine was a smaller area to heal.

■ In April 2011, a sales associate working for Milko left his employ and went to work for DJO; the associate sold the SpinaLogie in the same geographic area in which Mil-ko sold Orthofix products. Milko allegedly lost “some of his best physician referral sources, including physicians who regularly referred Medicare patients for cervical bone growth stimulators, even though [as noted,] Orthofix sold the only approved cervical device.” As a result, Milko concluded that DJO must have filled cervical stimulator prescriptions for Ms former physician clients with the SpinaLogie and charged Medicare and other federally sponsored health care programs for it.

Relators assert that Milko sued Ms former associate for violating a non-competition agreement. During the lawsuit, Mil-ko deposed two referrmg physicians, both of whom are Medicare providers who perform lumbar and cervical spine fusion surgeries. Both doctors testified that they had ordered stimulators from Milko’s former associate.

Relators allege that on June 21, August 30, and September 1, 2011, the Spine and Brain Institute m Las Vegas, Nevada, faxed prescriptions on behalf of Dr. John Anson, the ordering' physician, to the local DJO sales representative for SpinaLogie; the institute indicated that the patients were Medicare beneficiaries and were diabetic. On February 2, 2012, DJO submitted a claim to the Minnesota Health Care Programs for a stimulator to be used following cervical .fusion surgery. The Minnesota program paid DJO $835.82.

In August 2012, DJO’s Regional Sales Director and a DJO sales representative told relator Modglin, a private investigator licensed by the state, of California, that DJO routinely billed federally sponsored health care programs like Medicare and Medicaid for off-label distribution of Spina-Logic for use on the cervical spine. In March 2013, Milko attended the national convention of the American Academy of Orthopedic Surgeons in Chicago. There, he spoke with DJO -representatives, who told him that in some areas of the country, at least 75% of DJO’s business came from selling the SpinaLogie for cervical use. Relators assert that at some point, two patients told Milko when he fitted them with lumbar stimulators that they had previously been fitted with the SpinaLogie following prior, cervical spinal surgeiies.

In May 2013,. an Orthofix sales representative in Temecula, California, switched companies and began to sell the SpinaLogic. After two weeks, the representative returned to Orthofix. Relators contend that while working for DJO, DJO upper management told the sales representative that 40% of the company’s SpinaLogie business involved off-label, cervical spine applications.

As respects the SpinalPak manufactured by Biomet and EBI, relators allege that Milko has provided replacement Cervical-Stims to Medicare patients who complained that their use of the SpinalPak on the cervical spine caused skin irritation on their necks. Relators assert that Milko confirmed these complaints by observing large, red skin irritations on the patients. The patients, purportedly said that Biomet and EBI representatives told them to use the SpinalPak only for a couple of hours per day, as tolerated.

On February 16 and March 10, 2010, and again on March 18, 2011, Biomet and EBI submitted claims to the Minnesota Health Care Programs for off-label stimu-lators under Code E0748, for use following cervical spinal fusion surgery. They were paid $817.05, $3,901.41, and $3,897.50 on the claims, respectively.

Relators allege that on September 5, 2012, Dr. David Ketroser, a neurologist, contacted the office of a neurosurgeon in Minnesota. An employee confirmed that the office routinely prescribed the Spinal-Pak for cervical and lumbar fusions, for both Medicare and non-Medicare patients,- and that it had done so for a particular patient Ketroser had referred.

On May 20, 20Í3, Milko asked a former Biomet distributor who now sells Orthofix devices how Biomet succeeded in securing Medicare payment for a lumbar-only device when the physician’s order indicated cervical application. The individual purportedly told him that neither the CMS, 847 Form nor the.E0748 billing code reveal the level of the spine for which the device was ordered. On May 29, 2013, a former Biomet sales representative told Modglin that she had sold Biomet’s devices off-label to Medicare patients for use on the cervical spine. On May 31, 2013, a former Biomet sales representative told Modglin that he had sold the SpinalPak to Medicare and Medicaid patients in -Texas between 2009 and 2011 for use on the cervical spine.

E. Defendants’ Request for Judicial Notice.

Defendants request that the court take judicial notice of certain documents‘they contend are relevant to this motion. All of the applications are unopposed. In deciding a Rule 12(b)(6) motion, the court generally looks only to the face of the complaint and documents attached thereto. Van Buskirk v. Cable News Network, Inc., 284 F.3d 977, 980 (9th Cir.2002); Hal Roach Studios, Inc. v. Richard Feiner & Co., Inc., 896 F.2d 1542, 1555 n. 19 (9th Cir.1990). A court normally must convert a Rule 12(b)(6) motion into a Rule 56 motion- for summary judgment if it “considers evidence outside the pleadings — A court- may, however, consider certain materials — documents attached to the complaint, documents incorporated by reference in the complaint, -or matters of judicial notice — without converting the mo-tion____” United States v. Ritchie, 342 F.3d 903, 907-08 (9th Cir.2003). See Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308, 322, 127 S.Ct. 2499, 168 L.Ed.2d 179 (2007) (a court may consider “other sources courts ordinarily examine when ruling on Rule 12(b)(6) motions to dismiss, in particular, documents incorporated into the complaint by reference, and matters of which a court may take judicial notice”); Branch v. Tunnell 14 F.3d 449, 453 (9th Cir.1994) (noting that a court may consider a document whose contents are alleged in a complaint, so long as no party disputes its authenticity), overruled oh other grounds in Galbraith v. County of Santa Clara, 307 F.3d 1119 (9th Cir.2002). Under Rule 201, the court may-judicially notice a 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 reasonably be questioned.” Fed.R.Evid. 201(b).

Defendants ask the court to take judicial notice of three exhibits. The first contains excerpts of the October 1, .2011 Michigan Medicaid Provider Manual. The second contains excerpts of the October 1, 2005 Michigan Medicaid Provider Manual, while the third contains excerpts _ of . the Nevada Medicaid Services Manual. Each of the exhibits is found on the state’s medicare websites. Under Rule 201, the. court can take judicial notice- of “[pjublic records and government documents available from reliable sources on the Internet,” such as websites run by governmental agencies. See Hansen Beverage Co. v. Innovation Ventures, LLC, No. 08-CV-1166-IEG, 2009 WL 6597891, *1 (S.D.CaL Dec. 23, 2009) (citing Jackson v. City of Columbus, 194 F.3d 737, 745 (6th Cir.1999)). See also Daniels-Hall v. National Education Association, 629 F.3d 992, 999 (9th Cir.2010) (taking judicial notice of information on the websites of two school districts because they were government entities); Paralyzed Veterans of Am. v. McPherson, No. C 06-4670, 2008 WL 4183981, *5 (N.D.Cal. Sept. 8, 2008) (“Information on government agency websites has often been treated as properly subject to judicial notice”). The court therefore’ grants defendants’ request for judicial notice.

IL DISCUSSION

A. Legal Standard Governing Motions to Dismiss

A Rule 12(b)(6) motion tests the legal sufficiency of the claims asserted in the complaint. A Rule 12(b)(6) dismissal is proper only where there is either a “lack of a cognizable legal theory,” .or “the absence of sufficient facts alleged under a cognizable legal theory.” Balistreri v. Pacifica Police Dept., 901 F.2d 696, 699 (9th Cir.1988). The court must accept all factual' allegations pleaded in the complaint a:s true, and- construe them and 'draw all rea-’ sonable inferences from them in favor -of the nonmoving party. Cahill v. Liberty Mut. Ins. Co., 80 F.3d 336, 337-38 (9th Cir.1996); Mier v. Owens, 57 F.3d 747, 750 (9th Cir.1995).

The court need not, however, accept as true unreasonable inferences or conclusory legal allegations cast in the form of factual allegations. See Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 553-56, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (“While a complaint attacked by a Rule.'12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiffs obligation to provide the ‘grounds’ of his ‘entitle[ment] to relief requires more than labels and conclusions, and a formulaic recitation of the elements 'of a cause of action will not do”).’ Thus, a plaintiffs complaint must “contain sufficient factual matter, accepted as true, to ‘state a claim'to relief that is plausible on its face.’ ... A claim1 has facial plausibility 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); see also Twombly, 550 U.S. at 555, 127 S.Ct. 1955 (“Factual allegations must be enough to raise a right to relief above the speculative level, on the assumption that all the allegations in the complaint- are true (even if doubtful in fact)” (citations omitted)); Moss v. United States Secret Service, 572 F.3d 962, 969 (9th Cir.2009) (“[F]or a complaint to survive a motion to dismiss, the non-conclusory ‘factual content,’ and reasonable inferences from that content, must be plausibly suggestive of a claim entitling the plaintiff to relief,” citing Iqbal and Twombly).

B. Relators’ Federal FCA Claim

Because relators’ FCA claim provides the only basis for subject matter jurisdiction, the court addresses it first.

1. Legal Standard Governing Federal FCA Claims

The FCA, 31 U.S.C. §§ 3729 et seq., provides for “the recovery of civil penalties from those who' knowingly present a false or fraudulent claim to the federal government for payment, or knowingly use a false record to avoid or decrease an obligation to pay the federal government.” Hagood v. Sonoma County Water Agency, 81 F.3d 1465, 1467 n. 1 (9th Cir.), cert. denied, 519 U.S. 865, 117 S.Ct. 175, 136 L.Ed.2d 116 (1996). Originally enacted to punish and prevent massive frauds perpetrated by large contractors during the Civil War, the FCA’s chief goal was to provide for restitution to the government of money taken from'it by fraud. See United States v. Bomstein, 423 U.S. 303, 309, 96 S.Ct. 523, 46 L.Ed.2d 514 (1976). The Supreme Court has refused to 'adopt a restrictive reading of the statute, however, holding that the FCA is a “remedial statute [that] reaches beyond ‘claims’ which might be legally enforcéd, to all fraudulent attempts to cause the Government to pay out sums of money.” United States v. Neifert-White Co., 390 U.S. 228, 233, 88 S.Ct. 959, 19 L.Ed.2d 1061 (1968); United States v. McLeod, 721 F.2d 282, 284-85 (9th Cir.1983).

The FCA authorizes individuals, known as “relators,” to file civil suits, known as “qui tam actions,” against persons who present false claims to the government. 31 U.S.C. § 3730. It makes liable any person who has (1) knowingly presented or caused to be presented a false or' fraudulent claim; (2) knowingly made, used or caused to be made or used a false record or statement to get a false or fraudulent claim paid;' or (3) conspired to defraud the government by getting a false or fraudulent claim paid. 31 U.S.C. § 3729(a)(l)-(3). The FCA defines “knowing”- as having actual knowledge of information, or acting in either deliberate ignorance or reckless disregard of the information’s truth or falsity. 31 U.S.C. § 3729(b). Congress amended the FCA to include this definition to make “‘firm ... its intention that the act not punish honest mistakes or incorrect claims submitted through mere negligence.’ ” United States ex rel. Hochman v. Nackman, 145 F.3d 1069, 1073 (9th Cir.1998) (quoting S.Rep. No. 99-345 at 7 (1986), 1986 U.S.C.C.A.N. 5266, 5272); see also United States ex rel. Hagood v. Sonoma County Water Agency, 929 F.2d 1416, 1421 (9th Cir.1991) (“[T]he statutory definition of ‘knowingly5 requires at least ‘deliberate ignorance’ or ‘reckless disregard’ ”). Thus, “[t]he phrase ‘known to be false’ ... means [known to be] ‘a lie.’ ” Wang v. FMC Corp., 975 F.2d 1412, 1421 (9th Cir.1992); see United States ex rel. Anderson v. Northern Telecom, Inc., 52 F.3d 810, 815-16 (9th Cir.1995). . “The FCA does not define false. Rather, courts decide whether a claim is false or fraudulent by determining whether a defendant’s representations are accurate in light of applicable law.” United States v. Bourseau, 531 F.3d 1159, 1170-71 (9th Cir.2008).

“A civil action for False Claims Act liability requires four essential elements: ‘(1) a false statement or fraudulent course of conduct, (2) made with, scienter, (3) that was material, causing (4) the government, to pay out money or forfeit moneys due.’ ” United States ex rel. Ruhe v. Masimo Corp., 977 F.Supp.2d 981, 991 (C.D.Cal.2013) (citing United States ex rel. Hendow v. University of Phoenix, 461 F.3d 1166, 1174 (9th Cir.2006)); see also Ebeid ex rel. United States v. Lungwitz, 616 F.3d 993, 997 (9th Cir.2010) (same). A plaintiff “must show an actual false claim for payment being made to the Government”; “[e]vidence of an actual false claim is the sine qua non of a False Claims Act violation.” United States ex rel. Aflatooni v. Kitsap Physicians Serv., 314 F.3d 995, 1002 (9th Cir.2002); see also Cafasso, United States ex rel. v. General Dynamics C4 Systems, Inc., 637 F.3d 1047, 1055 (9th Cir.2011) (“ ‘It seems to be a fairly obvious notion that False Claims Act suit ought to require a false claim.’ ‘[T]he [FCA] attaches liability, not to' the underlying fraudulent activity or to the government’s wrongful payment, but to the “claim for payment,” ’ ” citing Aflatooni, 314 F.3d at 997, and United States v. Rivera, 55 F.3d 703, 709 (1st Cir.1995) (internal alterations original)); United Stales ex rel. Hopper v. Anton, 91 F.3d 1261, 1266-67 (9th Cir.1996) (“Violations of laws, rules, or regulations alone do not create a cause of action under the FCA. It is the false certification of compliance which creates liability when certification is a prerequisite to obtaining a government benefit.... [Thus there is no FCA liability] where regulatory compliance was not a sine qua non of receipt of state funding”).

Relators who assert that a defendant has made a false claim can allege that defendant, has submitted a factually false claim, or that defendant has given- a false certification. The prototypical false claims action alleges a factually false claim, i.e., an explicit lie in a claim for payment, such as an overstatement of the amount due. See Maa v. Ostroff, No. 12-cv-00200-JCS, 2013 WL 1703377, *15 n. 3 (N.D.Cal. Apr. 19, 2013) (“The ‘factually false’ theory refers to the ‘archetypal qui tarn False Claims Action’ in which ‘a private company overcharges under a government contract, [and] the claim for payment itself is literally false or fraudulent,’” citing Hendow, 461 F.3d at 1170 (alteration original)). Re-lators relying on a false certification theory allege that defendant’s claim is false because defendant certified to a government agency that it had complied with laws, rules, or regulations governing the reimbursement of claims or other provision of benefits when it had not. See Hopper, 91 F.3d at 1266 (“Violations of laws, rules, or regulations alone do not create a cause of action under the FCA, It is the false certification of compliance [with those rules] which creates liability when certification is a prerequisite to ob: taining a government benefit”). There are two types of false certification claims— expressly false certification and impliedly false certification.

“Express certification simply means that the entity seeking payment certifies compliance with a law, rule or regulation as part of the process through which the claim for payment is submitted. Implied false certification occurs when an ' entity has previously- undertaken to expressly comply with a law,- rule, or regulation, and that obligation is implicated by submitting a claim for payment even though a certification of compliance is not required in the process of submitting the claim.” Ebeid, 616 F.3d at 998.

To show that claims were false un-dena false certification theory, a complaint “must plead with particularity allegations that provide a reasonable basis to infer that (1) the defendant explicitly undertook to comply with a law, rule-or regulations that is implicated in submitting a claim for payment and that (2) claims were submitted (3) even though the defendant was not in compliance with that law, rule or regulation.” Id. '

Like other allegations of fraud in federal court, claims “brought under the FCA must fulfill the requirements of Rule 9(b)” of the Federal Rules of Civil Procedure. United States ex rel. Lee v. Smith-Kline Beecham, Inc., 245 F.3d 1048, 1051 (9th Cir.2001); see also Cafasso, 637 F.3d at 1054 (“The heightened pleading standard of Rule 9(b) governs FCA claims”). Under Rule 9(b),' “[i]n all averments of fraud or mistake, the circumstances constituting fraud or mistake shall be stated with particularity.” Fed.R.Civ.Proc. 9(b). Conclusory allegations are insufficient, and the facts constituting the fraud must be alleged with specificity. Moore v. Kayport Package Exp., Inc., 885 F.2d 531, 540 (9th Cir.1989). “A pleading is sufficient under Rule 9(b) if it-identifies the circumstances constituting fr'aud so that a defendant can prepare an adequate answer to the allegations. While statements of the time, place and nature of the alleged fraudulent activities are-sufficient, mere -conclusory allegations of fraud are insufficient.” Id. at 540 (citation omitted). See also Cooper v. Pickett, 137 F.3d 616, 627 (9th Cir.1997) (to satisfy Rule 9(b), “the complaint [must] identify] the circumstances of the alleged fraud so that defendants can prepare an adequate answer” (internal quotations omitted)); DiLeo v. Ernst & Young, 901 F.2d 624, 627 (7th Cir.1990) (“Although states of mind may be pleaded generally, the ‘circumstances’ must be pleaded in detail. This- means the who, what, when, where,.and how”);- Walling v. Beverly Enters., 476 F.2d 393, 397 (9th Cir.1973) (concluding that allegations stating the time, place, and nature of allegedly fraudulent activities met Rule 9(b)’s particularity requirement).

Thus, to satisfy Rule 9(b), a plaintiff must specify the content of the fraudulent representation, the person who made it, when and where the representation was made, and the manner in which it was untrue and misleading, or the circumstances indicating that it was false. See In re GlenFed Securities Litigation, 42 F.3d 1541, 1548 (9th Cir.1994) (en banc). See also Vess v. Ciba-Geigy Corp., 317 F.3d 1097, 1107 (9th Cir.2003) (plaintiff “alleges that the APA misrepresented its connection -to Novartis, but*, he does not identify any specific' misrepresentations or specify when and where they occurred. These allegations are not particular enough to satisfy Rule 9(b)”).

“The knowledge or scienter element of a fraud claim need not be pleaded with particularity, but may be [ ] alleged generally pursuant to Rule 9(b). However, knowledge must still be pleaded- sufficiently to make entitlement to relief plausible.” Owens v. Bank of America, N.A, No. 11-cv-4580-YGR, 2013 WL 1820769, *4 (N.D.Cal. Apr. 30, 2013); see also Odom v. Microsoft Corp., 486 F.3d 541, 554 (9th Cir.2007) (“While the factual circumstances of the fraud itself must be - alleged .with particularity, the state of mind — or scien-ter — of the defendants may be alleged more generally”); In re GlenFed Inc. Securities Litigation, 42 F.3d at 1547.(“We conclude that plaintiffs may aver scienter generally, just as the rule states — that.is, simply by-saying that, scienter existed”).

2, FCA Liability Premised on Implied False Certifications

The second amended complaint alleged that Medicare covers defendants’ stimu-lators only when prescribed for. on-label use, and that defendants’ failure affirmatively to disclose the fact that the stimu-lators had been prescribed for off-label use constituted the submission of a false claim. Relators also alleged that defendants made an implied false certification because they had an affirmative obligation — under 21 C.F.R. §§ 801.4 and § 814.39 — to seek a PMA supplement given knowledge that the devices were prescribed from time to time for off-label -uses. The court disagreed that these allegations were sufficient to plead the submission of a false claim or making of a false certification.

With regard to relators’ argument that failure to disclose that the stimulators had been prescribed for off-label use, the court explained that because “the Medicare regulations- and the Medicare Manual do not bar reimbursement of devices supplied for off-label use, the fact that defendants have allegedly not filed a PMA supplement or obtained PMA approval for cervical use of their stimulators does not bar them from obtaining reimbursement for the devices if HHS has otherwise determined that they are ‘reasonable and necessary.’” See United States ex rel. Nowak v. Medtronic, Inc., 806 F.Supp.2d 310, 348 (D.Mass.2011) (“Nowak relies almost entirely upon the flawed rationale that because the biliary stents are unapproved for use in the biliary tree, they are ‘categorically’ or ‘statutorily’ nonreimbursable under the various federal health care programs”); United States ex rel. Ruhe v. Masimo Corp., 977 F.Supp.2d 981, 993 (C.D.Cal.2013) (“In the context of False Claims Act cases involving promotion of medical devices, courts have recognized that ‘off-label use of a medical device is not the same as a medically unnecessary use of that drug or device’”).

The court also found defendants’ false certification argument unavailing. It noted that although § 801.4 appears; at first blush, to-.support relators’ theory, courts in the Ninth Circuit and elsewhere have not construed § 801.4 as imposing an affirmative duty on manufacturers to file a PMA supplement under § 814.39 whenever time they know or should know that a patient intends to use, or that a physician has prescribed or will prescribe, a device for off-label use. The court observed that the Ninth Circuit had unequivocally concluded in Carson v. Depuy Spine, Inc., 365 Fed.Appx. 812, 815 (9th Cir.2010) (Unpub.Disp.), that “a manufacturer is not liable [under the FCA] merely because it sells a device with knowledge that the prescribing doctor .intends an off-label use.” Although not binding, the court found this explicit Ninth Circuit holding highly persuasive, and thus declined to accept relators’ theory. The court also discussed Riley v. Cordis Corp., 625 F.Supp.2d 769, 781 (D.Minn.2009), in which a Minnesota district' court directly addressed whether § 801.4 imposed an affirmative duty on manufacturers1 to file a PMA supplement whenever they know that their products are being used for off-label purposes, and concluded that it did not. The court noted that even without Carson, it would find Riley persuasive and would adopt its reasoning. As a result, the court found that relators’ false certification claim failed. The court therefore dismissed relators’ Medicare FCA claim with prejudice to the extent it was premised on these theories.

The court nonetheless conchided that re-lators might be able to allege an FCA claim under an implied' false certification theory based on off-label promotion of the stimulators by defendants. Stated differently, the court noted it was possible that relators could allege that defendants engaged in off-label promotion of the type that would trigger a duty to file PMA supplement, and' hence permit them to plead submission of false claims based on an implied false certification theory. Accordingly, the court granted “narrow” leave to amend “limited to this one theory.” The initial question, therefore, is whether relators have adequately alleged that defendants engaged in off-label promotion of the stimulators,

a. Whether the Corrected Third Amended Complaint Sufficiently Alleges that Defendants Engaged in Off-Label Promotion

Defendants contend that as alleged in the corrected third amended complaint, re-lators’ assertion that they were required to file a PMA supplement is flawed for two reasons. First, defendants maintain that to the extent relators rely on the false claim and false certification theories they pled in the second amended complaint— allegations the court dismissed with prejudice — the claim once again fails. The court agrees. Relators devote a significant portion of their opposition to discussion of § 814.39, but appear to misunderstand the order dismissing the second amended complaint and granting limited leave to amend the Medicare FCA claim. Relators contend that “nowhere does the [court’s prior order] state that the only way that" an affirmative obligation to comply with" PMA [supplement requirements can arise is through off-label ‘marketing.’ ” While this may be true, what rela-tors fail to appreciate is that the court granted leave to amend only to the extent they could plead implied false certification due to defendants’ off-label promotion of the stimulators and failure to submit a PMA. To the extent relators attempt to replead an FCA Medicare claim based on the fact that defendants submitted claims without affirmatively disclosing that their stimulators would be used for off-label purposes and/or based on the fact that defendants purportedly certified compliance with all applicable rules and regulations falsely because they had not submitted a PMA supplement to cover known off-label prescription or use, therefore, they exceeded the scope of the leave to amend granted. The court therefore dismisses these allegations again with prejudice. See Raiser v. City of Los Angeles, No. CV 13-2925 RGK (RZ), 2014 WL 794786, *4 (C.D.Cal. Feb. 26, 2014) (“When a district court grants leave to amend for a specified purpose,.it does not thereafter abuse its discretion by dismissing any portions of the amended complaint that were not permitted”); Haines v. Brand, No. CV 11-01335 YGR, 2012 WL 2237366, *7 (N.D.Cal. June 14, 2012) (“Judge Chen previously dismissed Plaintiffs claim for intentional infliction of emotional distress with prejudice on the basis that the Brand is immune from this state tort law claim.... Therefore, Plaintiffs claim for intentional infliction of emotional distress, which already was dismissed with prejudice, is Dismissed With Prejudice, again.”); Kennedy v. Full Tilt Poker, No. CV 09-07964 MMM (AGRx), 2010 WL 3984749, *1 (C.D.Cal. Oct. 12, 2010) (noting that the court had stricken a third amended complaint because plaintiffs’ new claims and the addition of new defendants “exceeded the authorization to amend the court granted,” and plaintiffs had not sought leave to add new claims or defendants as required by Rule 15); PB Farradyne, Inc. v. Peterson, No. C 05-3447 SI, 2006 WL 2578273, *3 (N.D.Cal. Sept. 6, 2006) (striking, without leave to amend, a new theory of liability alleged in third amended complaint because the new claim was “outside the scope of the leave to amend granted” when court dismissed second amended complaint); Serpa v. SBC Telecommunications, Inc., No. C 03-4223 MHP, 2004 WL 2002444, *3 (N.D.Cal. Sept. 7, 2004) (striking a claim asserted for the first time in an amended complaint, since the new claim exceeded the scope of the .court’s order granting limited, leave to amend); cf. Siskiyou Regional Education Project v. United States Forest Service, 565 F.3d 545, 559-60 (9th Cir.2009) (affirming a district court’s decision to strike intervenor’s answer/counterclaims because allegations “exceeded the bounds” of the limited intervention granted).

As respects the only portion of the federal Medicare FCA claim in the corrected third amended complaint that relators were granted leave to plead — i.e., an implied false certification claim premised on off-label promotion and failure to submit a PMA supplement — defendants contend that relators have failed to allege with-the requisite specificity under Rule 9(b) that defendants in fact marketed their devices for off-label use. Defendants assert that the corrected third amended complaint does not describe with specificity, any instance in which a DJO or EBI sales representative marketed the SpinaLogic or Spi-naPak for cervical spine use. Nor, they note, does it identify any sales representatives who engaged in off-label promotion, or any manager or executive who directed or sanctioned off-label promotion. Finally, defendants contend that no allegations suggest when the purported marketing occurred, where it occurred, or under what circumstances it occurred. As noted, to satisfy Rule 9(b), relators must specify the content of the fraudulent representation or omission, the person who made it, when and where the representation or omission was made, and the .manner in which it was untrue and misleading, or circumstances indicating that it was false. See GlenFed Securities Litigation, 42 F.3d at 1548; Ebeid, 616 F.3d at 999 (holding that FCA claims cannot be pled under a “relaxed” Rule 9(b) standard).

Given the theory, on which a claim of implied false certification due to off-label promotion and failure to submit a PMA supplement is. based, pleading specific facts concerning any off-label promotion by defendants is necessary to provide the “particular details of [the] scheme to submit false claims.” Ebeid, 616 F.3d at 998-99; see United States ex rel. Bennett v. Medtronic, Inc., 747 F.Supp.2d 745, 779 (S.D.Tex.2010) (“In addition, the relators have failed to plead with sufficient particularity the alleged false claims. The rela-tors have not identified any Medtronic employees who engaged in off-label promotion nor specific physicians or hospitals who received the promotions. They have not alleged the ‘who’ or ‘where’ of the alleged fraud”); cf. Hawkins v. Medtronic, Inc., No. CV 13-00499 AWI SK, 2014 WL 346622, *13 (E.D.Cal. Jan. 30, 2014) (“Plaintiff fails to allege not only the content of the off-label promotion directed at his spine surgeon and on which the surgeon relied, but he also fails to allege who made those representations to his surgeon and when the representations were made. Rule 9(b) requires more than the generalized allegations made here.”).

In their, opposition, relators argued that the corrected third amended complaint satisfied Rule 9(b). At the hearing, however, they ■ disclaimed any intention of pleading an implied false certification claim based on off-label promotion. The court nonetheless addresses the off-label promotion arguments made in their opposition, as this is the only theory on which the court granted leave to amend upon dismissal of thé second amended complaint. In their opposition, relators contend they adequately alleged that it was defendants’ corporate-wide policy and practice to train their representatives to tell physicians, that all stimulators are the same and therefore that their lumbar devices could be safely used on the cervical spine, In particular, they cite paragraphs 131 and 143. Paragraph 131 alleges that Milko “learned from DJQ personnel that its sales representatives are instructed to tell physicians that [it is] permissible to use their lumbar device on the cervical spine.” Paragraph 143 states that Milko “was also informed by EBI personnel at trade conventions that its sales representatives routinely tell physicians that it is permissible to use their lumbar device on the cervical spine.” Neither allegation satisfies Rule 9(b).

Although both paragraphs sufficiently allege the “content” of the purported promotional statements, neither identifies who made the statements. Where fraud has allegedly been perpetrated by a- corporation, a plaintiff must allege the names of the employees or agents who purportedly made the statements or omissions that give rise to the claim, or at a mininium identify them by title and/or job responsibility. See, e.g., United States ex rel. Lee v. SmithKline Beecham, Inc., 245 F.3d 1048, 1051 (9th Cir.2001) (holding that Rule 9(b) was not satisfied, inter alia, because plaintiff did not “identify the [defendant’s] employees who performed the tests, or provide any dates, times, or places the tests were conducted”); Arch Ins. Co. v. Allegiant Prof'l Bus. Servs., Inc., No. CV 11-1675 CAS (PJWx), 2012 WL 1400302, *3 (C.D.Cal. Apr. 23, 2012) (“The requirement of specificity in a fraud action against a corporation requires the plaintiff to allege the names of the persons who made the allegedly fraudulent fepre-sentations, their authority to speak, to whom they spoke, what they said or wrote, and when it was said or written”); Dooms v. Fed. Home Loan Mortgage Corp., No. CV F 11-0352 LJO DLB, 2011 WL 1232989, *14 (E.D.Cal. Mar. 31, 2011) (“In a fraud action against a corporation, a plaintiff must ‘allege the names of the persons who made the allegedly fraudulent representations, their authority to speak, to whom they spoke, what they said or wrote, and when it was said or written’ ”); Flowers v. Wells Fargo Bank, N.A., No. C 11-1315 PJH, 2011 WL 2748650, *6 (N.D.Cal. July 13, 2011) (same). The corrected third amended complaint does not do this. It simply states that unidentified “DJO personnel” and “EBI personnel” informed Milko of defendants’ purported policy and practice. At a minimum, re-lators must identify the speakers by their job titles and/or responsibilities. See Bennett, 747 F.Supp.2d at 779 (“The relators have not identified any Medtronic employees who engaged in off-label promotion nor specific phys