Full opinion text
MEMORANDUM AND ORDER ON MOTION TO DISMISS F. Dennis Saylor IV, United States District Judge This is a qui tarn action alleging the submission of false claims to government health-care programs for a defective hip-replacement device. Relators Dr. Antoni Nargol and Dr. David Langton, who are expert witnesses in a related products-liability case involving the same device, have brought suit against defendants De-Puy Orthopaedics, Inc., DePuy, Inc., and Johnson & Johnson Services, Inc. DePuy manufactured and sold, among other hip-replacement devices, the Pinnacle metal-on-metal total hip-replacement device (“Pinnacle MoM”). The second amended complaint alleges that DePuy directly submitted and indirectly caused third parties to submit false claims for payments to government health-care programs for the Pinnacle MoM. According to the second amended complaint, the claims were false because DePuy made numerous misrepresentations to the FDA and surgeons concerning, among other things, the Pinnacle MoM’s failure rates. The relators filed the original complaint in this action under seal on May 18, 2012. On December 2, 2013, the relators filed a first amended complaint. The government declined to intervene on July 29, 2014. On June 5, 2015, the Court granted the rela-tors’ request to file a second amended complaint (“SAC”). Although the 168-page SAC alleges that DePuy made numerous misrepresentations about two of their devices — the ASR device and the Pinnacle MoM device — the specific counts in the SAC seek damages only as to the latter device. The SAC alleges claims of (1) causing false or fraudulent claims for payment to be presented to the United States in violation of 31 U.S.C. § 3729(a)(1)(A) (Count One); (2) knowingly making, using, or causing to be made or used false records or statements material to a false or fraudulent claim paid by the United States in violation of 31 U.S.C. § 3729(a)(1)(B) (Count Two); (3) conspiracy to violate the FCA in violation of 31 U.S.C. § 3729(a)(1)(C) (Count Three); and (4) violations of various state and municipal analogues to the Federal FCA (Counts Four through Thirty-Seven). DePuy has moved to dismiss the SAC under Fed. R. Civ. P. 12(b)(6) for failure to state a claim upon which relief can be granted and under Fed. R. Civ. P. 9(b) for failure to satisfy the heightened pleading requirements for fraud. The relators have since moved to unseal the SAC, and De-Puy has assented to that motion while requesting that documents concerning the motion to dismiss also be unsealed. Finally, while they have not formally filed a motion to amend the SAC, the relators contend in the conclusion of their opposition memorandum, sur-reply, and a post-hearing supplemental filing that they should be granted leave to amend and file a third amended complaint. The essence of a False Claims Act violation is making, or causing the making, of one or more false claims — that is, claims for payment — against the United States. The statute provides large awards to qui tarn relators as an incentive to bring such cases. The prospect of such an award may also, however, provide an incentive for individuals to try to convert virtually any set of allegations arising out of a defective product or faulty service into an FCA case. That is particularly true in the medical field, where the government purchases medical supplies and services on a large scale through Medicare, Medicaid, the VA, and other health-care programs. Normally, it requires no great leap of logic to conclude that if a medical device or a pharmaceutical is defective, the government must have purchased that product in great quantities, and therefore the manufacturer must have caused, directly or indirectly, the submission of false claims. In order to avoid so-called “parasitic” claims, and to try to guard against misuse of the FCA, the First Circuit has construed the statute fairly strictly. In doing so, the court has emphasized that the statute “attaches liability, not to the underlying fraudulent activity or to the governr ment’s wrongful payment, but to the claim for payment.” United States v. Rivera, 55 F.3d 703, 709 (1st Cir.1995). Among other things, FCA complaints must satisfy the particularity requirements of Fed. R. Civ. P. 9(b). The law requires relatively specific allegations of false claims, rather than generalized allegations based on supposition and logic; the relator must set forth with particularity the “who, what, when, where, and how” of actual claims that are alleged to be false. United States ex rel. Ge v. Takeda Phann. Co., 737 F.3d 116, 123 (1st Cir.2013). Here, the SAC includes hundreds of paragraphs of allegations, covering dozens of pages, of claimed fraudulent activity by DePuy. That satisfies one of the components of an FCA claim, but it does not satisfy them all. As set forth below, the allegations as to specific claims for payment for the specific device actually at issue in this case are sparse indeed. For that reason, and the other reasons set forth below, DePuy’s motion to dismiss will be granted. The relators’ request for leave to amend the SAC and file a third amended complaint will be denied. The present case is nearly four years old, has had three iterations of the complaint, and has seen the desks of three judges in this district. The relators have had ample opportunity to file a complaint that complies with the requirements of Rule 9(b), and have failed to do so. Finally, the parties’ motions to unseal the SAC and other filings related to the motion to dismiss will be granted. I. Background The facts summarized below are set forth in the SAC unless otherwise noted. A. Factual Background 1. The Parties Relator Dr. Antoni Nargol is an orthopedic surgeon residing in the United Kingdom. (SAC ¶ 68). In 2003 he became one of the earliest British adopters of the Pinnacle MoM device, and DePuy invited him to be on its “Pinnacle user group team.” (SAC ¶ 66). Dr. Nargol served as a testifying expert for the plaintiffs in Strum v. DePuy Orthopaedics, Inc. and Premier Orthopaedic Sales, Inc., No. 2011 L 009352 2404 (Cook Cty., Ill., Cir.Ct.) (“Strum litigation”). (SAC ¶ 68). Dr. Nargol also provided expert assistance to the plaintiffs’ executive committee in Kransky v. DePuy, Inc., No. BC 456086 (Cal.Sup.Ct.), in which the plaintiffs’ allegations focused on perceived design defects in the “ASR,” a device that is similar to the one at issue in this case, the Pinnacle MoM. (SAC ¶ 68). Dr. Nargol also served as a fact witness in Herlihy-Paoli v. DePuy Orthopaedics, Inc., No. 3:11-CV-04975-K (N.D.Tex.) (“Herlihy-Paoli litigation”). (SAC ¶ 68). Relator Dr. David Langton is an orthopedic surgeon residing in the United King- , dom. (SAC ¶ 69). Dr. Langton has performed research on failed hip-replacement surgeries and devices, including the Pinnacle MoM device. (SAC ¶ 70). The United States Food and Drug Administration (“FDA”) has retained Dr. Langton as a consultant regarding “failure rates and dimensions of MoM products sold in the United States, including the Pinnacle.” (SAC ¶ 72). Dr. Langton served as an expert witness in the Strum litigation and as a fact witness in the Herlihy-Paoli litigation. (SAC ¶ 72). According to the SAC, both the relators had personal experience in implanting the Pinnacle MoM device in their patients and began to alert defendants of the device’s defects in 2009. (SAC ¶ 24). Defendant DePuy Orthopaedics, Inc. is a designer, manufacturer, and distributor of orthopedic products that is based in Warsaw, Indiana. (SAC ¶ 73). DePuy Ortho-paedics manufactured the Pinnacle MoM device. (SAC ¶ 73). DePuy Orthopaedics is a wholly-owned subsidiary of Delaware-based DePuy, Inc., which in turn is a subsidiary of New Jersey-based Johnson & Johnson Services, Inc. (SAC ¶¶ 75-77). 2. Government Health-Care Programs Medicare is a health-insurance program administered by the United States Department of Health and Human Services (“HHS”). (SAC ¶ 85). Medicare provides payment for, among other things, medical services and equipment to persons over 65 years of age and those who are 18 years of age or older and are eligible for disability benefits. (SAC ¶82). For inpatient treatment, Medicare reimburses hospitals and other treating facilities through Medicare Part A. (SAC ¶ 83). For outpatient treatment, Medicare reimburses physicians and health-care providers through Medicare Part B. (SAC ¶ 83). Under the Medicare program, “no payment may be made under Part A or Part B for any expenses incurred for items or services which ... are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of the malformed body member.” (SAC ¶ 84) (citing 42 U.S.C. § 1395y(a)(l)(A)). To satisfy that standard, providers must provide, among other things, economical medical services, along with evidence that the service will be of a quality that meets professionally recognized standards of healthcare and will be supported by evidence of medical necessity and quality. (SAC ¶ 84) (citing 42 U.S.C. § 1320c-5(a)(l-3)). The SAC alleges that Medicare reimbursed qualified individuals for the purchase of the Pinnacle MoM device and the surgical procedures necessary to implant the device. (SAC ¶ 99). Medicaid is a health-insurance program administered by HHS jointly with agencies in each state. (SAC ¶ 100). It is designed to assist states in providing medical services, medical equipment, and prescription drugs for low-income persons who qualify for the program. (SAC ¶ 100). The SAC alleges that Medicaid, like Medicare, reimbursed qualified individuals for the purchases of the Pinnacle MoM device and the surgical procedures necessary to implant the device. (SAC ¶ 104). The United States Department of Veterans Affairs (“VA”) provides medical assistance, including comprehensive coverage for hip replacement, to military veterans. (SAC ¶ 105). The SAC alleges that DePuy “sold its Pinnacle hip implants directly to the VA.” (SAC ¶ 106). The National Contract Service (“NCS)” provides the VA with acquisition support for medical equipment and pharmaceuticals. (SAC ¶ 112). According to the SAC, “NCS is also responsible for national committed-use contracts and standardized blanket purchase agreements established against the Federal Supply Schedule Program.” (SAC ¶ 112). Medical equipment and supplies contracts are governed by the Federal Supply Schedule Group 65 Part II Section A. (SAC ¶ 115). That contract states that a “[contractor warrants and implies that the items delivered hereunder are merchantable and fit for use of the particular purpose described in this contract,” and that “[a]ll offerors must be in compliance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act for those medical device products intended to be delivered to the Government.” (SAC ¶¶ 116-17). The 65 II A contract also requires the contractor to notify the Assistant Director of the National Acquisition Center and various other officials if it sells a VA facility a product that “(1) requires modification, (2) is removed or recalled by the contractor or manufacturer due to defects in the product or potential dangers to patients, or (3) is subject to a suggested or mandatory modification, removal, or recall by a regulatory or official agency.” (SAC ¶ 120). The Civilian Health and Medical Program of the United States, now known as TRICARE, provides benefits for healthcare services furnished to members of the U.S. military and their family members. (SAC ¶ 124). TRICARE pays for medical devices and surgeries for its beneficiaries, including total hip-replacement devices like the Pinnacle MoM. (SAC ¶ 125). 3. FDA Regulations Governing Medical Devices The SAC contains significant detail concerning the FDA regulations governing medical devices that need not be fully detailed here. {See generally SAC ¶¶ 127-66). The FDA, which protects and promotes the public health through regulation of medical devices and pharmaceuticals, has three risk-based regulatory classifications for medical devices. (SAC ¶¶ 127-28). The Pinnacle MoM device was a Class III device and subject to the most stringent level of regulation imposed by the FDA. (SAC ¶¶ 129-30). There are only two ways by which a manufacturer can seek FDA approval for a new Class III medical device: the premarket approval (“PMA”) process and the “510(k)” clearance process. (SAC ¶ 131). The “more onerous” PMA process requires, among other things, a full report of all information known to the manufacturer concerning investigations into the device’s safety. (SAC ¶ 131). In contrast, under the 510(k) process, the manufacturer is required to demonstrate only that the device is “substantially equivalent in terms of safety and effectiveness to an existing FDA-approved device.” (SAC ¶ 131) (citing 21 C.F.R. § 807.92(a)(3)). A device is substantially equivalent if, when comparing it to the predicate, it has both the same intended use and the same technological characteristics as the predicate. (SAC ¶ 133). A device with different technological characteristics can be considered substantially equivalent only if the information submitted to the FDA does not raise new questions of safety and demonstrates that the device is at least as safe and effective as the predicate device. (SAC ¶ 133). 4. The Pinnacle MoM Device Before the alleged defects in DePuy’s Pinnacle MoM device came to light, another DePuy hip-replacement device, the ASR, suffered from alleged defects and was the subject of many products-liability lawsuits. (SAC ¶¶ 56-57). Those actions were ultimately the subject of an MDL proceeding in the Northern District of Ohio. (SAC ¶¶ 56-57). The SAC includes numerous references to ASR defects and allegedly fraudulent behavior by DePuy in connection with that device. (See, e.g., SAC ¶¶ 15, 24, 31-33, 35, 37-39, 42, 45, 47, 54-58, 64-66, 68, 71-72, 130, 184, 189, 190-91, 199, 238, 246, 262, 327). Those allegations, however, are not particularly relevant to the relators’ claims in this case, which is solely focused on the Pinnacle device — and more specifically, the Pinnacle MoM device comprised of a metal head and metal liner, as explained below. Hip-replacement devices replace the bone components of a hip joint, including the ball (femoral head) and socket (aceta-bulum). (SAC ¶¶ 167-69). A hip-replacement device generally includes four components: (1) a femoral stem; (2) a femoral head; (3) an acetabular cup; and (4) a liner that fits inside the cup and interacts with the head. (SAC ¶ 170). In metal-on-metal hip-replacement devices, the head, cup, and liner are all metal; MoM devices are expected to last longer than devices comprised of ceramic or polyethylene. (SAC ¶ 169). The space between the head and cup is referred to as “diametrical clearance.” (SAC ¶ 179). Bodily fluid fills in the diametrical clearance between the head and cup to prevent friction and wear caused by the two pieces rubbing together. (SAC ¶ 180). Under the brand of “DePuy Or-thopaedics Pinnacle Hip Solutions,” DePuy marketed three head-on-liner categories of Pinnacle devices: “metal-on-metal, ceramic-on-polyethylene, and metal-on-polyethylene.” (SAC ¶ 176; Def. Mem. Ex. C at 5). DePuy offered three types of Pinnacle heads: (1) aSphere M-Spec and M-Spec (both metal); (2) Standard Metal (metal); and (3) BIOLOX delta (ceramic). (Def. Mem. Ex. C at 3). DePuy offered three types of Pinnacle liners: (1) Ultamet and Ultamet XL (both metal); (2) Marathon (polyethylene); and (3) AltrX (polyethylene). (Def. Mem. Ex. C at 3). The Standard Metal head was not compatible with Pinnacle metal liners; it could be used only with polyethylene liners. (Compare Def. Mem. Ex. C at 8, with Def. Mem. Ex. C at 10,16). Thus, there was one combination of Pinnacle components that combined to create a Pinnacle MoM device: an aSphere M-Spec or M-Spec metal head with an Ultam-et or Ultamet XL metal liner. (SAC ¶ 176; Def. Mem. Ex. C at 3). The Pinnacle device — consisting of a head, cup, and liner— could be used with a variety of separate DePuy femoral stems, including the CO-RAIL stem, the SUMMIT stem, the AML stem, the TRI-LOCK stem, and the S-ROM stem. (See Def. Mem. Ex. D at 29). But those stems were not part of the Pinnacle MoM device, as they could be used with other DePuy hip-replacement devices, such as the ASR. (Id.). As alleged in Counts One through Thirty-Seven of the SAC, the relators seek recovery under 31 U.S.C. § 3729(a)(1)(A)-(C) for claims involving only DePuy’s Pinnacle MoM device (which must use an M-Spec head and an Ultamet liner). On December 13, 2000, the FDA approved the Pinnacle Ultamet 36mm metal liner as part of the 510(k) approval process, based on “substantial equivalence with the DePuy Ultima Unipolar Adapter Sleeves (“Ultima”), cited as the Ultamet’s predicate device.” (SAC ¶ 177). The diametrical clearance set forth in the Ultam-et’s 510(k) application was in the “40-80 micron tolerance band.” (SAC ¶ 181). According to the SAC, DePuy purposely manufactured the Pinnacle MoM device with a lower diametrical clearance than other devices. (SAC ¶ 183). It marketed the Pinnacle MoM’s lower diametrical clearance under the theory that as diametrical clearance decreases, the volume of fluid lubricating the joint increases. (SAC ¶ 183). The SAC alleges that when diametrical clearance is small, “the consequences of any deformation of the cup, even if slight, are dire for the patient.” (SAC ¶ 183). When DePuy added the 36mm Ul-tamet liner to its Pinnacle product line in 2005, DePuy advised the FDA that the diametrical clearance dimension was not 40-80 microns, but was in fact 80-120 microns. (SAC ¶ 186). The SAC alleges that the FDA, upon learning of the inaccuracy, “specifically advised DePuy that, had it known that the 36mm liner’s dimensions were not as DePuy had represented, the device would not have been granted a ‘substantial equivalence’ waiver .... Instead, DePuy would have had to make a full application for PMA.” (SAC ¶ 187). 5. DePuy’s Allegedly Fraudulent Acts Involving the Pinnacle Device The relators allegedly learned of the defects in the ASR and Pinnacle MoM devices through their own work with the hip implants. (SAC ¶¶ 24, 47). They began reporting those defects to DePuy in 2007, and continued to do so through 2011. (SAC ¶¶ 24, 47). Those defects included (1) surface wear resulting in metal ion exposure causing patient necrosis (tissue death), me-tallosis (metallic staining of tissues), and osteolysis (degradation of the bone) (SAC ¶ 29); (2) “diametrical clearance” and “taper trunnion” defects causing high device-failure rates (SAC ¶ 42); and (3) femoral neck fractures at high rates. (SAC ¶ 45). The SAC includes nearly fifty pages detailing DePuy’s allegedly fraudulent actions in concealing those defects while pursuing FDA approval for the Pinnacle MoM device, marketing the device to surgeons, and selling the device to government health-care programs. {See generally SAC' ¶¶ 201-412). The Court will not detail every allegation of DePuy’s claimed improper conduct, many of which are irrelevant to the Pinnacle MoM device and the present FCA claims. The Court will, however, attempt to summarize the allegations, which fall into two broad categories. First, the SAC alleges that DePuy knowingly made material false statements and omissions to the FDA and to medical providers about the “specifications, manufacturing process, safety, and failure rates” of its Pinnacle MoM device. (SAC ¶ 201). Those false statements, according to the SAC, “armed and induced surgeons to make similar certifications when seeking reimbursement from the [g]overnment” and “had a natural tendency to influence the [government's payment for the Pinnacle devices.” (SAC ¶ 203). The SAC identifies nine subcategories of materially false statements that DePuy made to the FDA and surgeons. The SAC alleges that but for those false statements, the FDA would not have approved the device and “surgeons would not have utilized Pinnacle hip replacements or certified them to government health programs as reasonable and medically necessary.” (SAC ¶ 256). 1. The SAC alleges that “in official communications with the FDA, DePuy falsely represented that Pinnacle implants had a 96 percent to 96.5 percent success rate.” (SAC ¶ 204). Specifically, it alleges that on June 27, 2012, a DePuy director gave a presentation to the FDA’s Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. (SAC ¶ 205). The purpose of that meeting was to “seek expert scientific and clinical opinion on the risks and benefits of these types of devices ■ based on available scientific data.” (SAC ¶ 205). At the meeting, the De-Puy director told the panel that “Ul-tamet metal-on-metal articulation is performing consistent with or better than other metal-on-metal products: 4 to 4.5 percent cumulative revision rate at five years, regardless of head size.” (SAC ¶ 206). According to the SAC, as of February 29, 2012, DePuy’s own internal database showed that “metal Pinnacle hips” had a cumulative revision rate of 15 percent after five years of use. (SAC ¶ 207). The SAC alleges that “had DePuy truthfully stated its internal results indicating a 15 percent revision rate at five years, the FDA would likely not have continued to clear the product for the market ... [and] the government would likely have discontinued use of the Pinnacle device for government health-care recipients.” (SAC ¶ 210). When the FDA approved the Pinnacle for implantation in patients, the FDA stated “[i]t is, however, [DePuy’s] responsibility to determine if the change [or] modification to the device or its labeling could significantly affect the device’s safety or effectiveness and thus require submission of a new 510(k).” (SAC ¶ 211). 2. The SAC alleges that “DePuy made false statements to surgeons claiming that Pinnacle boasted a 99.9 percent success rate” and that those statements caused surgeons to submit false claims to the government. (SAC ¶ 212). Specifically, it alleges that DePuy began circulating marketing materials in 2007 that touted a 99.9 percent success rate for “Pinnacle products” based on data and research that was - “conducted and written up by DePuy itself and funneled to a third-party author to create the appearance of impartiality.” (SAC ¶¶ 212-13). It alleges that De-Puy continued to advertise this false figure until 2013, even though its internal data showed a 15 percent cumulative revision rate as early as February 29, 2012. (SAC ¶¶ 228-29). 3. The SAC alleges that DePuy made false statements to surgeons “claiming] that the Pinnacle device’s low diametrical clearances created a benefit to patients that distinguished the devices from competing products.” (SAC ¶ 233). Beginning in early 2010, the relators conducted research on a “large volume of failed Pinnacle ... implants” and concluded that the device suffered from a “diametrical clearance defect” such that “the diametrical clearance of the [] device was considerably lower than the specification required by the FDA.” (SAC ¶ 238). After the research, the rela-tors repeatedly alerted DePuy executives about the improper clearances. (SAC ¶¶ 245-48). DePuy; in apparently undated marketing materials to surgeons, touted that the Pinnacle’s “eup-to-head bearing clearance, enhances the potential for fluid lubrication and minimizes wear to maximize survivorship.” (SAC ¶ 250). According to the SAC, “DePuy knew that pa-r tients were not obtaining the purported benefits of Pinnacle’s low diametrical clearances” and “was fully aware that many patients and surgeons— most notably Dr. Nargol — were complaining of high ion rates and high failure rates.” (SAC ¶ 255). 4.The SAC alleges that even though “DePuy knew that its devices were responsible for dangerous concentrations of metal ions in the bloodstreams of patients,” it told the FDA that “metal ions were not a source of concern for metal-on-metal patients.” (SAC ¶ 257). In the June 2012 presentation to the FDA, the DePuy director said that the Pinnacle generated “metal wear debris” in patients’ bloodstreams in “low amounts.” (SAC ¶258). The SAC alleges that surgeons began notifying DePuy “as early as 2001 that metal ions generated by metal-on-metal implants were a cause for concern.” (SAC ¶ 260). 5. The SAC alleges that DePuy made false statements to surgeons about the causes of the Pinnacle MoM’s high failure rates. Specifically, “beginning in 2009, Dr. Nargol repeatedly contacted DePuy to warn it of explosive growth in the number of Pinnacle hip revision surgeries he was performing.” (SAC ¶ 269). According to the SAC, DePuy told Dr. Nargol that the “problems resulted from his implantation technique.” (SAC ¶ 270). At the time, “DePuy knew ... that the problems in Dr. Nargol’s patients stemmed from device defects, not from [his] surgical methods” because, in part, other surgeons were “experiencing and notifying DePuy of widespread failures with the Pinnacle implant.” (SAC ¶¶ 271-72). 6. The SAC alleges that DePuy made false statements to surgeons about the Pinnacle MoM’s angle of inclination in its use instructions. (SAC ¶ 276). It cites an internal DePuy email written by an engineer expressing confusion about the proper angle of inclination for the Pinnacle’s cup positioning. (SAC ¶ 277). Accordingly, the SAC alleges, “DePuy did not know the proper angle of implantation for Pinnacle hips, and [] any recommendation it made in its manuals disseminated to hospitals and surgeons was therefore false.” (SAC ¶ 278). 7.The SAC alleges that DePuy “intentionally withheld disclosure of the Pinnacle’s diametrical clearance manufacturing defects to [the] FDA, contrary to its FDA-mandated obligation to report them in an updated 510(k) application.” (SAC ¶280). In 2000, DePuy submitted its 510(k) application along with various certifications that it “conducted a reasonable search of all information known or otherwise available about the types and causes of safety and effectiveness problems that have been reported for metal-on-metal hip systems.” (SAC ¶ 282). On July 26, 2005, a DePuy regulatory-affairs associate wrote to the FDA attaching a chart “replacing] the chart originally included as Exhibit 4 of the submission, which contained a miscalculation.” (SAC ¶286). The SAC alleges “[o]n information and belief, the ‘corrected’ 2005 table contained measurements or analysis of measurements of DePuy’s devices that DePuy learned were not accurate.” (SAC ¶ 287). On August 5, 2005, a member of the FDA cautioned DePuy that it would be the company’s “responsibility to determine if the change or modification to the device or its labeling could significantly affect the device’s safety or effectiveness and thus require submission of a new 510(k).” (SAC ¶ 291). According to the SAC, that notification “imposed an affirmative obligation on DePuy to provide the FDA with updated information,” and even when the relators notified DePuy of the Pinnacle diametrical clearance issues beginning in 2008, “[o]n information and belief, De-Puy never corrected its July 26, 2005 submissions to reflect Relator Lang-ton’s measurements.” (SAC ¶¶ 292-96). 8. The SAC alleges that DePuy “intentionally withheld disclosures of the Pinnacle device’s taper trunnion and surface roughness defects in presentations to the FDA.” (SAC ¶ 300). The alleged “taper trunnion” defect concerns the area where the end of the femoral stem (the trunnion) is inserted into the area of the head (the taper); that taper trunnion “is not meant to move and thus should not generate any wear.” (SAC ¶¶ 188-89). However, the SAC alleges that the relators discovered a defect in the Pinnacle device where, due in part to the large head size of the Pinnacle, the “taper toggles against the trunnion, causing the release of metal debris.” (SAC ¶ 190). The alleged “surface roughness” defect also concerns the taper trunnion area of the device, but involves friction between the trunnion, which is designed to be rough, and the taper, which is designed to be smooth. (SAC ¶ 195). The SAC alleges that the relators discovered a defect in many Pinnacle devices where the surface of the taper was rough and created friction with the trunnion, which in turn caused friction and release of metal debris. (SAC ¶ 197). The relators allege that they notified DePuy of the two defects beginning in 2011 and continued to do so into 2012. (SAC ¶¶ 305-06). The SAC alleges that DePuy willfully omitted any discussion of the reported taper trunnion and surface roughness defects during the June 2012 meeting with the FDA. (SAC ¶¶ 307-10). 9. The SAC alleges that “DePuy intentionally failed to disclose adverse events to the FDA.” (SAC ¶ 312). On June 7, 2011, following an Establishment Inspection of DePuy’s Indiana facility, the FDA issued a report concluding that DePuy had “delayed reporting adverse [Pinnacle] MoM events by five months to three-and-a-half years, well beyond the acceptable timeframe under FDA regulations.” (SAC ¶ 314). The report also noted that DePuy failed to investigate complaints involving the possible failure of its device to meet production specifications; a DePuy employee stated that the company received approximately 450 complaints per month about hip-replacement devices but that DePuy assigned only one employee to investigate them. (SAC ¶ 315). Second, the SAC alleges that DePuy knowingly caused the submission of direct claims for “medical devices with dimensions materially different than those the government bargained for.” (SAC ¶ 201). The SAC identifies three sub-categories of DePuy’s allegedly materially false statements or omissions that caused the government to pay for “nonconforming, non-functioning, and unsafe devices that would not have been purchased but for DePuy’s fraudulent conduct.” (SAC ¶ 325). 1. As detailed above, the SAC alleges that DePuy knowingly or recklessly disregarded evidence, allegedly first provided to it by the relators, that the Pinnacle MoM’s nonconforming diametrical clearances were causing device failures. (SAC ¶¶ 327-32). It alleges that DePuy was on notice of the Pinnacle MoM’s improper measurement testing procedures as early as 2009, when it acquired a competitor and began to use its own “state-of-the-art measuring equipment.” (SAC ¶ 335). In June 2010, after the relators notified DePuy of the Pinnacle’s improper clearance measurements, a DePuy employee e-mailed Dr. Langton, stating that if DePuy concluded from the relators’ research that its MoM parts “were out of specification,” the company would “need to notify patients if [DePiiy] had made a serious manufacturing error.” (SAC ¶ 338). In its 2011 report, the FDA found that “33 Pinnacle metal liners were out of conformance” because they “fell below thé lower specification limit” for diametrical clearance. (SAC ¶ 342). The FDA report notified DePuy that “[t]he production capabilities for the Pinnacle MoM liners and MoM femoral heads at the Leeds facility should be reviewed.” (SAC ¶ 343). According to the SAC, “DePuy continued to manufacture Pinnacle components with full knowledge that the manufacturing process was producing yet more parts with the same conformance issues.” (SAC ¶ 343). The SAC also' alleges “on information and belief’ that DePuy provided the FDA with statistical analyses about the failure rates of its Pinnacle device that excluded “critical analyses [that] relators provided to DePuy.” (SAC ¶ 345). After the FDA expanded the scope of its request to include data back to January 2007, the SAC alleges that DePuy “responded by producing very little data.” (SAC ¶ 348). According to the SAC, “DePuy’s failure to conduct and report such statistical analyses violated 21 C.F.R. § 820.250, which requires statistical analysis to assess trending.” (SAC ¶ 350). It also alleges that because DePuy employed only one person to “review and analyze the approximately 450 complaints received per month,” it “willfully ignored and mischaracterized the causes of the[ ] complaints in order to avoid its obligation to adequately verify and validate its manufacturing processes.” (SAC ¶¶ 355-56). It alleges that DePuy’s “failure to respond to relators’ complaints regarding the clearance deformities” violated 21 C.F.R. § 820.198(a), which establishes a duty to “maintain adequate procedures for receiving, reviewing, and evaluating complaints.” (SAC ¶ 357). 2. The SAC alleges that beginning in 2005, DePuy “knowingly or recklessly failed to adopt adequate process validation methods” that were “necessary to consistently manufacture [ ] Pinnacle devices within specification.” (SAC ¶ 358). It alleges that the “relators, with additional expert assistance, have determined that De-Puy’s inspection and testing procedures were unable to verify whether DePuy’s Pinnacle devices [were] manufactured within their required specifications,” both for diametrical clearance and surface roughness. (SAC ¶¶ 359-60). It alleges that De-Puy, by failing to ensure that its manufacturing process was capable of producing devices within required specifications, “produced, marketed, and sold ... a device that [was] different than the subject of the 510(k)” and caused the government to purchase devices that it would not have otherwise purchased without 510(k) approval. (SAC ¶¶ 363-65). 3. The SAC alleges that “DePuy’s failure to implement validation procedures necessary to ensure consistent manufacture of products confirming to their specifications was material to the government’s purchase of DePuy’s Pinnacle devices.” (SAC ¶ 397). Specifically, it alleges that the “FDA premised its post-market approval of the Pinnacle’s diametrical clearance dimensions upon DePuy’s representation that the Pinnacle’s failure rates were comparable to those of its competitors,” and without that approval, the government would not have approved the device for reimbursement. (SAC ¶ 397). When the FDA learned in 2005 that DePuy’s 510(k) application in 2000 for the Ultamet 36mm liner contained incorrect diametrical clearance dimensions, it stated that “given this new information, the Pinnacle 36mm system would not have been cleared in 2000.” (SAC ¶¶ 399-400). According to the SAC, the FDA “nevertheless did not require DePuy to file a supplemental 510(k), much less obtain PMA, expressly because DePuy represented that the device’s failure rates were within industry standards.” (SAC ¶ 401). But the SAC alleges that De-Puy “was aware [at that time] that the Pinnacle substantially deviated from specifications and had disproportionately high failure rates,” and “[i]n order to maintain FDA approval and continue to sell the Pinnacle, DePuy obscured this information from the FDA, medical providers, and the public for several years.” (SAC ¶403). In May 2013, DePuy announced that it would stop selling the Pinnacle MoM device as of August 2013. (SAC ¶ 55). More than 5,000 personal injury lawsuits involving the Pinnacle MoM device were eventually transferred to an MDL proceeding in the Northern District of Texas. (SAC ¶ 58). The SAC alleges that “all claims made to the government for costs associated with the Pinnacle device at any time from DePuy’s 510(k) application to the date the Pinnacle was withdrawn from the market constitute false claims under the FDA.” (SAC ¶ 412). Finally, the SAC twice refers to 42 U.S.C. § 1395y(a)(l)(A), which prohibits Medicare payments for treatments that are not “reasonable and necessary.” The SAC alleges: Hospital certifications involving claims for Pinnacle hip implants were false because claim reimbursements for these products constituted payment for services which were “not reasonable and necessary for the diagnosis and treatment of illness or injury,” in violation of 42 U.S.C. § 1395y(a)(l)(A). By marketing these products as safe, effective, and medically appropriate, and concealing overwhelming evidence to the contrary, DePuy willfully caused hospitals to file such false certifications when seeking Medicare reimbursement. DePuy caused physicians, hospitals and other providers to submit false certifications on all these forms concerning claims for Pinnacle hip surgery procedures. Surgeries to implant these irredeemably faulty devices were not “reasonable and necessary for the diagnosis and treatment of illness or injury,” within the meaning of 42 U.S.C. § 1395y(a)(l)(A). (SAC ¶¶ 88, 99). 6. Alleged False Claims The SAC alleges that “the government directly purchased or reimbursed hundreds of thousands of Pinnacle products.” (SAC ¶ 7). It alleges that DePuy made false statements that caused health-care providers to submit indirect false claims for the Pinnacle MoM to Medicare and Medicaid, and that DePuy itself also submitted direct false claims to the VA. a. Alleged Indirect False Claims The SAC alleges one representative indirect false claim and then supports that claim with statistical evidence of the Pinnacle sales to Medicare and Medicaid patients. (See SAC ¶¶ 413-72). As to the indirect claim, the SAC alleges: One such device was implanted into patient “F.I”. On or about November 12, 2007, patient F.I. was implanted with a DePuy Pinnacle hip implant by a surgeon at Stony Brook University Medical Center, 10 I Nicolls Road, Stony Brook, New York 11794. The surgeon was, upon information and belief, Dr. “J.N.”. In November 2007, Mr. F.I. received Medicaid insurance through HealthFirst, a managed care organization that provides government-sponsored health insurance plans in New York. On information and belief, DePuy’s surgical instructions and materials provided to Dr. J.N. regarding implantation of F.I. with the Pinnacle device represented that the device was a safe and effective hip implant device when implanted in accordance with such instructions. DePuy’s product label accompanying the Pinnacle device stated that the product was indicated for use as the acetabular component in total hip-replacement procedures. On information and belief, under the heading “Information for Use,” the product label stated that an “instrumentation system, as well as a system of trial components, is available to assure proper fit and alignment of the prosthesis” and that physicians should refer to the surgical technique manual on their use. Within the Pinnacle’s packaging, DePuy provided surgeons with Instructions for Use (“IFU”) of the product. The IFU contained numerous false statements regarding the safety and efficacy of the Pinnacle MoM. The IFU stated, “An instrument system, as well as system of trial components, is available to assure proper fit and alignment of the prosthesis.” The IFU also instructed the surgeon to “refer to the appropriate surgical technique manual on the use of the instrument system.” In reality, surgeons could not achieve a proper fit and alignment of the prosthesis by using DePuy’s tools and instructions. Around the time of Mr. F. I.’s surgery, DePuy widely distributed the Ultamet Technical Monograph, a Pinnacle marketing material, throughout the United States. This pamphlet falsely stated that the Pinnacle MoM implants experienced reduced wear as compared to competing devices because of the purported benefit of their low diametrical clearances. At the time of Mr. F.I.’s surgery, other safe and effective alternatives were widely available on the market. As alleged above, DePuy’s marketing materials and device operating instructions claimed that the ASR and Pinnacle’s lower failure rates and diametrical clearance specifications were superior to those competing produets[.] On information and belief, but for De-Puy’s false statements, Dr. J.N. would have chosen a different available device for the hip-replacement surgery he performed on Mr. F.I. As with Mr. F.I.’s ASR XL hip prosthesis, Mr. F.I’s Pinnacle device quickly failed, ás a result of manufacturing defects in the device, including nonconforming diametrical clearance dimensions. The failures resulted in great pain and suffering to F.I. and posed the possibility of additional revision surgery. Mr. F.I’s implantation with a Pinnacle device was neither medically reasonable nor medically necessary, because of the unreasonably high possibility that the device would fail and release metal ions into Mr. F.I.’s blood stream. No reasonable physician would implant a hip-replacement device with a failure rate of 15 percent at five years. In order to obtain Government reimbursement in connection with the procedure, Stony Brook University Medical Center and Dr. J.N. certified that Mr. F.I.’s Pinnacle device was reasonable and medically necessary for his treatment under 42 U.S.C. § 1395y(a)(l)(A). This certification was false as the implantation of a defective device is not a medically reasonable treatment. Upon information and belief, on or about November 2007, Stony Brook University Medical Center submitted a claim to Medicaid for Mr. F.I.’s Pinnacle hip device and implant surgery. Medicaid paid for Stony Brook’s hip device and implant surgery. New York Medicaid reimbursed approximately $34,000 in costs for the implantation of Mr. F.I.’s Pinnacle device. Without DePuy’s false representations and warranties, Mr. F.I. would not have received a DePuy implant and the Government would not have expended funds on the device. If Dr. J.N. had been provided appropriate information showing the truth about the Pinnacle, Dr. J.N. would not have selected the Pinnacle implant for F.I’s procedure. Similarly, had DePuy divulged what it knew about the Pinnacle, the Government would not have approved any claim for reimbursement for the costs of the system. (SAC ¶¶ 414-20, 423-24, 426-28, 432). According to the SAC, “over one million MoM hips were sold worldwide” during the times relevant to the complaint. (SAC ¶ 434). “Amongst the models manufactured at DePuy plants, the Pinnacle MoM Hip was one of the most widely used hip-replacement systems that remained in the international market place.” (SAC ¶434). The SAC alleges that the United States “constitutes almost two-thirds of the world’s orthopedic device market.” (SAC ¶ 435). Over 300,000 hip-replacement surgeries were performed in the United States in 2010. (SAC ¶436). The SAC alleges that, “[a]ecordingly, it follows that hundreds of thousands of Pinnacle products were implanted in government healthcare recipients and reimbursed by the government during the lifespan of the product.” (SAC ¶ 437). The SAC alleges that between 2005 and 2010, New York Medicaid paid for an average of approximately 1,280 claims each year for total hip-replacement devices. (SAC ¶ 438). New York State Medicaid paid approximately $52 million to cover its total cost for inpatient visits for those 1,280 claims, or $40,625 per claim. (SAC ¶ 439). In 2010, New York State’s Federal Medical Assistance Percentage (“FMAP”) was approximately 50 percent. (SAC ¶ 440). The SAC alleges that “[tjherefore, the United States paid an additional $52 million to cover its total cost for each inpatient visit for those 1,280 claims, or $40,625 per claim.” (SAC ¶441). New York State Medicaid covers approximately 8 percent of all Medicaid beneficiaries in the United States; therefore, according to the SAC, “thousands more Medicaid patients received total hip-replacement devices in 2010, at a cost of hundreds of millions of dollars to the Plaintiff States and the United States.” (SAC ¶ 442). The SAC alleges that “[a]lthough the proportion of MoM hip-replacement devices on the United States market had begun to decline by 2010, according to the FDA, in 2010, a full 27 percent of all total hip-replacement surgeries were MoM device surgeries.” (SAC ¶ 443). “During relevant periods, DePuy’s two MoM hip implant products (the Pinnacle and the ASR XL) had captured 75 percent of the Metal on Metal hip-replacements market. Prior to 2010, the Pinnacle constituted roughly 50 percent of DePuy’s MoM hip-replacement sales.” (SAC ¶ 444). The SAC alleges that “[g]iven the August 2010 recall of the ASR, the Pinnacle would have constituted at least 70 percent of DePuy’s Metal on Metal hip-replacement sales.” (SAC ¶ 445). Therefore, according to the SAC, “between 2005 and 2010, nearly 850 Pinnacle devices were purchased by New York State Medicaid.” (SAC ¶ 446). The relators estimate that the diametrical clearance defect affected 14.93 percent of “explant head[s]” and 50.41 percent of “explant liner[s].” (SAC ¶ 447). Thus, “relators estimate that nearly 425 Pinnacle devices bearing the diametrical clearance manufacturing defect would have been paid for by New York State Medicaid between 2005 and 2010.” (SAC ¶ 448). Based on the alleged 14 percent five-year failure rate in Pinnacle’s internal system, the relators allege that between 2005 and 2010, “nearly 130 Pinnacle devices paid for by New York State Medicaid would have failed in patients at [five] years.” (SAC ¶ 451). b. Alleged Direct False Claims The SAC alleges that the VA entered into two contracts with DePuy “that include the sale of the Pinnacle hip implants.” (SAC ¶ 474). The SAC alleges: On February 21, 2006, DePuy was awarded an Orthopaedics Implant contract worth $8,042,500 by the VA National Acquisition Center with the Procurement Instrument Identifier V797P-9 1 88. The VA Point of Contact for the contract was Deborah Koval. On April 29, 2011 DePuy entered' into another Indefinite Delivery contract with the VA National Acquisition Center with the Procurement Instrument Identifier VA-797P-0263. The VA NAC Point of Contact was Timothy Richards and the DePuy Contract Point of Contact was Michelle Roberts. Since 2011, this contract has involved payment for dozens of Pinnacle components. (SAC ¶¶ 476-77). The SAC then alleges that the following twelve “purchases” by the VA are “representative claims” for purposes of the False Claims Act. (SAC ¶¶ 479-90). 479. [0]n January 18, 2011, VA employee Aryeh Lax from Los Angeles, California ordered a “SUMMIT FEMORAL STEM” and “ARTICUL/EZE METAL ON MET AL FEMORAL HEAD” from DePuy. This order obligated the VA to pay $3,358.38. 480. On January 30, 2011, Lax ordered a “SUMMIT FEMORAL STEM” and “ARTICUL/EZE METAL ON METAL FEMORAL HEAD” from DePuy. This order obligated the VA to pay $3,358.38. 481. On February 27, 2011, Lax ordered a Pinnacle product from DePuy. This order obligated the VA to pay $4,779.50. 482. On June 1, 2012, VA employee Scott Delancey from Grand Junction ordered a Pinnacle product from DePuy. This order obligated the VA to pay $3,967.00. 483. On September 29, 2011, VA employee Loretta Henry McLain from Los An-geles ordered a Pinnacle product from DePuy. This order obligated the VA to pay $8,712.14. 484. On September 27, 2012, VA employee Kami Wiggins from Martinsburg ordered a Pinnacle product from DePuy. This order obligated the VA to pay $15,228.50. 485. On September 28, 2007, Naval Medical Center employee Jojie Urrete from San Diego, California ordered a “Pinnacle metal on metal” device from DePuy. This order obligated the Navy to pay $8,000.00. 486. On February 22, 2008, Urrete ordered a “Summitt (sic) Pinnacle metal on metal” device from DePuy. This order obligated the Navy to pay $13,000.00. 487. On June 18, 2007, Department of the Army employee Ann Slagle from Tacoma, Washington ordered a “SUMMIT METAL ON METAL” device from DePuy. The Summit stem is one of the parts of the Pinnacle Hip replacement system. This order obligated the Army to pay $9,000.00. 488. On February 7, 2008, Naval Medical Center employee C. Johnson from San Diego, California ordered a “Srom Metal on Metal” device form DePuy. The S-Rom is a metal head used as a part of the Pinnacle Hip replacement system. This order obligated the Navy to pay $9,000.00. 489. On July 5, 2007, Department of the Army employee Amparo Hall from Tacoma, Washington ordered “SUMMIT METAL ON METAL SYS.” The Summit stem is one of the parts of the Pinnacle Hip replacement system. This order obligated the Army to pay $10,000.00. 490. On July 12, 2007, Department of the Army employee Amparo Hall from Tacoma, Washington ordered “SUMMIT METAL ON METAL SYSTEM.” The Summit stem is one of the parts of the Pinnacle Hip replacement system. This order obligated the Army to pay $10,000.00. B. Procedural Background On May 18, 2012, the relators filed the original complaint in this case under seal. The complaint alleged, among other things, violations of the False Claims Act. The FCA claims were pursued by the rela-tors on behalf of the United States as a qui tarn action. The Court granted the relators’ motion to file an amended complaint on December 2, 2013. On July 29, 2014, the government filed a notice declining to intervene in this case. On August 13, 2014, the case was partially unsealed. On May 4, 2015, the relators filed under seal a motion to file a second amended complaint. DePuy opposed that motion on May 26, 2015. On June 5, 2015, the Court granted the relators’ motion to amend the complaint and deemed the SAC, effectively the relators’ third complaint, as the operative complaint. The SAC, which remains sealed, alleges claims of (1) causing false or fraudulent claims for payment to be presented to the United States in violation of 31 U.S.C. § 3729(a)(1)(A) (Count One); (2) knowingly making, using, or causing to be made or used false records or statements material to a false of fraudulent claim paid by the United States in violation of 31 U.S.C. § 3729(a)(1)(B) (Count Two); (3) conspiracy to violate the FCA in violation of 31 U.S.C. § 3729(a)(1)(C) (Count Three); and (4) violations of various state analogues to the FCA (Counts Four through Thirty-Seven). On June 29, 2015, DePuy filed a motion to dismiss. DePuy contends that the rela-tors’ FCA claims fail to state a claim for which relief can be granted under Fed. R. Civ. P. 12(b)(6), and that they also fail to satisfy the pleading requirements of Fed. R. Civ. P. 9(b). DePuy also contends that the conspiracy and state-law FCA claims should be dismissed for the same reasons. On August 24, 2015, the relators moved to unseal the SAC. DePuy assented to that motion on September 2, 2015, but requested that other documents also be unsealed, including (1) the relators’ motion to unseal the SAC, their accompanying memorandum of law and exhibits, and DePuy’s response and accompanying exhibits; and (2) all documents and filings related to De-Puy’s motion to dismiss. II. Legal Standard On a motion to dismiss, the Court “must assume the truth of all well-plead[ed] facts and give ... plaintiff the benefit of all reasonable inferences therefrom.” Ruiz v. Bally Total Fitness Holding Corp., 496 F.3d 1, 5 (1st Cir.2007) (citing Rogan v. Menino, 175 F.3d 75, 77 (1st Cir.1999)). To survive a motion to dismiss, the complaint must state a claim 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). That is, “[flactual 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).” Id. at 555, 127 S.Ct. 1955 (citations omitted). “The plausibility standard is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Twombly, 550 U.S. at 556, 127 S.Ct. 1955). Dismissal is appropriate if the facts as alleged do not “possess enough heft to show that plaintiff is entitled to relief.” Ruiz Rivera v. Pfizer Pharm., LLC, 521 F.3d 76, 84 (1st Cir.2008) (alterations omitted) (internal quotation marks omitted). III. Analysis A. Counts One and Two: Federal FCA Claims Counts One and Two of the SAC allege violations of the FCA. Under the FCA, it is unlawful for a person or entity to (1) knowingly present, or cause to be presented, a false or fraudulent claim for payment or approval to the United States, (2) knowingly make, use, or cause to be made or used, a false record or statement material to a false or fraudulent claim; or (3) conspire to commit a violation of the statute. 31 U.S.C. §§ 3729(a)(l)(A)-(C). To be actionable under the FCA, a false statement must be material to a false claim — that is, the false statement must “hav[e] a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property.” United States ex rel. Loughren v. Unum Grp., 613 F.3d 300, 307 (1st Cir.2010) (quoting 31 U.S.C. § 3729(b)(4)). Private persons, known as relators, can file civil qui tam actions on behalf of the United States against persons or entities who violate the act. 31 U.S.C. § 3730(b). The government can intervene in a qui tam action and assume primary responsibility over it. Id. §§ 3730(b)(2), (b)(4), (c)(1). The relator is eligible to collect a portion of any damages awarded in a qui tam action, whether or not the government intervenes. Id. § 3730(d). 1. Rule 9(b) DePuy contends that - the FCA claims should be dismissed because the SAC does not satisfy the pleading requirements of Fed. R. Civ. P. 9(b). That rule requires that “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” Fed. R. Civ. P. 9(b). The heightened pleading requirements of Rule 9(b) apply to claims brought under all three subsections of the FCA. United States ex rel. Ge v. Takeda Pharm. Co., 737 F.3d 116, 123-24 (1st Cir.2013). The First Circuit explained the reasoning for applying those requirements to FCA claims in United States ex rel. Duxbury v. Ortho Biotech Products, L.P. (“Duxbury II ”): “Although [the FCA’s] financial incentive encourages would-be relators to expose fraud, it also attracts parasitic relators who bring FCA damages claims based on information within the public domain or that the relator did not otherwise discover.” 719 F.3d 31, 33 (1st Cir.2013) (citations and internal quotation marks omitted). “For those reasons, there are a number of limitations on qui tam actions, including the particularity requirements of Rule 9(b).” Ge, 737 F.3d at 123 (citing Duxbury II, 719 F.3d at 33). a. Direct Claims For allegations of direct false claims under 31 U.S.C. § 3729(a)(1)(A), “[r]elators are required to set forth with particularity the ‘who, what, when, where, and how’ of the alleged fraud.” Ge, 737 F.3d at 123 (quoting United States ex rel. Walsh v. Eastman Kodak Co., 98 F.Supp.2d 141, 147 (D.Mass.2000)). “Because FCA liability attaches only to false claims, merely alleging facts related to a defendant’s alleged misconduct is not enough. Rather, a complaint based on § 3729(a)(1)(A) must ‘sufficiently establish that false claims were submitted for government payment’ as a result of the defendant’s alleged misconduct.” Id. at 124 (emphasis in original) (quoting United States ex rel. Rost v. Pfizer, Inc., 507 F.3d 720, 733 (1st Cir.2007)). Indeed, “[e]vidence of an actual false claim is the sine qua non of a False Claims Act violation.” United States ex rel. Karvelas v. Melrose-Wakefield Hosp., 360 F.3d 220, 225 (1st Cir.2004) (internal citations omitted), abrogated on other grounds by Claudio-De Leon v. Sistema Universitario Ana G. Mendez, 775 F.3d 41 (1st Cir.2014); see also United States v. Rivera, 55 F.3d 703, 709 (1st Cir.1995) (“[T]he [FCA] statute attaches liability, not to the underlying fraudulent activity or to the government’s wrongful payment, but to the claim for payment.”). As the First Circuit explained in Ge concerning the particularity requirement for pleading false claims: A relator must provide details that identify particular false claims for payment that were submitted to the government. In a case such as this, details concerning the dates of the claims, the content of the forms or bills submitted, their identification numbers, the amount of money charged to the government, the particular goods or services for which the government was billed, the individuals involved in the billing, and the length of time between the alleged fraudulent practices and the submission of claims based on those practices are the types of information that may help a relator to state his or her claims with particularity. These details do not constitute a checklist of mandatory requirements that must be satisfied by each allegations included in a complaint. However, we believe that some of this information for at least some of the claims must be pleaded in order to satisfy Rule 9(b). 737 F.3d at 124 (internal quotation marks and alterations omitted) (quoting Karvelas, 360 F.3d at 232-33); see also United States ex rel. Escobar v. Universal Health Servs., 780 F.3d 504, 515 (1st Cir.2015) (noting that while there was no “mandatory checklist” to satisfy the particularity requirement, relators “succeeded in linking their allegations of fraud to specific claims for payment” because the complaint “allege[d] twenty-seven separate dates on which claims were submitted in connection with Yarushka’s care, each time including the relevant billing codes, amount invoiced, and the name of the [ ] staff member who provided the treatment for which reimbursement was sought”), cert. granted, — U.S. -, 136 S.Ct. 582, 193 L.Ed.2d 465 (2015). Here, the SAC alleges that the VA purchased twelve hip devices directly from DePuy pursuant to two procurement contracts. (SAC ¶¶ 473-90). Those alleged false claims, however, do not satisfy Rule 9(b)’s heightened pleading requirements. First, ten of the twelve alleged claims do not allege with sufficient particularity that the VA purchased the specific DePuy product that is the sole focus of this action: the Pinnacle MoM hip-implant device. (See SAC ¶¶ 494, 500). As described above, De-Puy manufactured Pinnacle devices that had various combinations of head, liner, and cup materials, including “metal-on-metal, ceramic-on-polyethylene, or metal-on-polyethylene.” (SAC ¶¶ 176-77; Def. Mem. Ex. C at 5). The alleged defects concern the interaction of a metal head with a metal liner in a Pinnacle device. There was only one head and liner combination of Pinnacle parts that produced a Pinnacle metal-on-metal, or MoM, device: a M-Spec or aSphere M-Spec head with an Ultamet or Ultamet XL liner. (SAC ¶¶ 176-77; Def. Mem. Ex. C at 3). Before turning to the specific alleged false claims, the Court notes that the SAC uses the terms “Pinnacle” and “MoM” inconsistently. In paragraph 6, the SAC states that “Relators Antoni Nargol and David Langton — world-renowned experts on hip-implant products — allege that De-Puy submitted false claims for payment for one of DePuy’s MoM devices: the Pinnacle Acetabular Hip System (‘Pinnacle’).” (SAC ¶ 6). It is unclear whether the relators intended to define “Pinnacle” to mean “the Pinnacle Acetabular Hip System” (which comprises metal, ceramic, and polyethylene products) or to mean the metal-on-metal subset of Pinnacle devices. Seven paragraphs later, relators use the specific term “MoM.” (See SAC ¶ 13) (“In one June 2010 email, a top DePuy executive admitted to Dr. Langton that, were DePuy to conclude from Relators’ research that its MoM parts ‘were out of specification,’ the Company would ‘need to notify patients if we have made a serious manufacturing error.’ ”). And in the 200-paragraph section detailing the alleged DePuy misrepresentations, relators use the term “MoM” consistently. (See, e.g., SAC ¶¶201, 248, 259, 273, 277, 279, 307, 310-11, 314, 316, 319-20, 334, 338, 340, 343-44, 348-49, 351-52, 361, 379, 395-96). The complaint thus seems to make clear that the only relevant fraudulent- activity involved Pinnacle metal-on-metal devices. But in the section that alleges the proposed false claims, the relators use vague terms such as “Pinnacle products” or refer to products that are not a part of the Pinnacle system at all. i. Paragraphs 479-480 179. [0]n January 18, 2011, VA employee Ary eh Lax from Los Angeles, California ordered a “SUMMIT FEMORAL STEM”