United States v. Gilead Sciences, Inc.

• Court: District Court, N.D. California
• Decided: November 5, 2019
• Docket: 3:11-cv-00941
• Status: Unknown

Opinion

1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 UNITED STATES OF AMERICA, et al., Case No. 11-cv-00941-EMC

8 Plaintiffs, ORDER GRANTING UNITED 9 v. STATES’ MOTION TO DISMISS

10 GILEAD SCIENCES, INC., et al., Docket No. 183 11 Defendants.

12 13 Relators Jeff and Sherilyn Campie are former employees of Defendant Gilead Sciences, 14 Inc., a pharmaceutical drug manufacturer. They have filed a qui tam action against Gilead, 15 asserting, inter alia, a claim for violation of the federal False Claims Act (“FCA”). According to 16 the Campies, Gilead violated the FCA by submitting or causing to be submitted false claims for 17 payment under government payment programs such as Medicare and Medicaid. See 31 U.S.C. § 18 3729(a)(1)(A). 19 Previously, this Court granted Gilead’s motion to dismiss the Campies’ second amended 20 complaint (“SAC”). The Court dismissed not only the FCA claim but also related claims based on 21 state law, plus claims for retaliation under both the FCA and state law. On appeal, the Ninth 22 Circuit reversed and remanded to this Court. Currently pending before the Court is the United 23 States’ motion to dismiss. Although the government is not a party to this action (having declined 24 to intervene), it is a real party in interest and moves to dismiss pursuant to a provision in the FCA 25 that states as follows: “The Government may dismiss the action notwithstanding the objections of 26 the person initiating the action if the person has been notified by the Government of the filing of 27 the motion and the court has provided the person with an opportunity for a hearing on the motion.” 1 any related claims based on state law or any retaliation claims, whether based on the FCA or state 2 law. 3 Having considered the parties’ and the United States’ briefs and supporting documents, as 4 well as the oral argument of counsel, the Court hereby GRANTS the motion. 5 I. FACTUAL & PROCEDURAL BACKGROUND 6 A. Operative Second Amended Complaint 7 As reflected in the Ninth Circuit’s decision on appeal, the gist of the Campies’ SAC is as 8 follows. Gilead, a drug manufacturer, produces anti-HIV drug therapies, including the drugs 9 Atripla, Truvada, and Emtriva. See United States ex rel. Campie v. Gilead Scis., 862 F.3d 890, 10 895 (9th Cir. 2017). All three drugs contain the active ingredient embricitabine, commonly known 11 as FTC. See id. at 896. 12 To sell the three drugs, Gilead had to obtain approval from the FDA by filing new drug 13 applications (“NDAs”).

14 In its NDA applications, Gilead represented to the FDA that it would source the FTC from specific registered facilities in Canada, 15 Germany, the United States, and South Korea. But . . . as early as 2006, Gilead contracted with Synthetics China to manufacture 16 unapproved FTC at unregistered facilities. For a period of sixteen months beginning in December 2007, Gilead brought illicit FTC 17 from a Synthetics China facility into the United States to use in its commercial drugs, claiming that the FTC had come from its 18 approved South Korean manufacturer. . . .

19 Gilead ultimately sought approval from the FDA to use Synthetics China’s FTC in October 2008, but . . . had been including products 20 from Synthetics China in its finished drug products for at least two years before this approval was obtained in 2010. 21 22 Id. 23 According to the Campies, Gilead also engaged in misconduct because it used “falsified or 24 concealed data in support of its application to get Synthetics China approved by the FDA” – e.g., 25 Gilead claimed in its application that “it had received three full-commercial-scale batches of FTC 26 from Synthetics China that passed testing and were consistent with or equivalent to FTC batches 27 made from existing, approved manufacturers” but concealed the fact that two of the three batches 1 levels in excess of established limits’ and other impurities. A second batch had ‘microbial 2 contamination’ and showed the presence of arsenic, chromium and nickel contaminants.” Id. 3 Instead of reporting the failure to the FDA, Gilead “secured two new batches and amended its 4 [application] to include the substitute data.” Id. 5 The Campies allege that Gilead violated the FCA because it sought payment for its drugs 6 containing FTC either directly or indirectly from government programs, but payment for drugs 7 under these programs is contingent on FDA approval and, “because the drugs paid for by the 8 government contained FTC sourced at unregistered facilities, they were not FDA approved and 9 therefore not eligible for payment under the government programs.” Id. at 897. 10 B. Procedural History 11 In March 2015, Gilead moved to dismiss the Campies’ SAC. Although the government 12 had declined to intervene in this lawsuit, it filed a statement of interest (as the real party interest) 13 in response to Gilead’s motion, just as it did when Gilead moved to dismiss an earlier complaint 14 filed by the Campies. See Docket No. 129 (government’s statement). Although the government 15 did not take a position on the ultimate merits of the Campies’ lawsuit, it made some arguments 16 that were favorable to the Campies – e.g., that the FCA can be violated even if the defendant did 17 not make a “direct misrepresentation . . . to the payor agency” and that “a deviation from the drug 18 manufacturing process approved by the [FDA] could be . . . tantamount to producing a drug that is 19 not the same drug approved by the FDA, thereby potentially forming the basis of a FCA 20 violation.” Docket No. 19 (St. at 2-2). 21 In June 2015, this Court granted Gilead’s motion to dismiss – dismissing not only the FCA 22 claim but also all remaining claims, including those based on retaliation. See Docket No. 142 23 (order). The Campies appealed. On appeal, the United States filed an amicus brief. Again, the 24 government made arguments that were favorable to the Campies (without taking a position on the 25 ultimate merits of their case) – e.g., that “a claim can be ‘false or fraudulent’ when someone 26 represents that it has sold something different from what was actually provided – regardless of 27 whether or not the resulting product was ‘worthless’” and that “it is possible to state an FCA claim 1 are material to the submission of false or fraudulent claims to another government agency.” 2 United States ex rel. Campie v. Gilead Scis., Inc., No. 15-16380 (9th Cir.) (Docket No. 20) (Br. at 3 15, 22). Ultimately, the Ninth Circuit found in favor of the Campies. 4 Gilead thereafter petitioned the Supreme Court for review. Apparently, the Supreme Court 5 asked the United States for its views on petition, see Docket No. 200 (Friedman Decl. ¶ 7), and, in 6 response, the government filed an amicus brief in November 2018. See Docket No. 200 7 (Friedman Decl., Ex. B) (amicus brief). In the brief, the government argued, inter alia, that the 8 Ninth Circuit correctly held that “the government’s continued payment for a product, after 9 learning that the manufacturer has made misrepresentations to the government regarding that 10 product, can be strong evidence that the misrepresentations were not material to the government’s 11 payment decisions” but that, “under the circumstances of this case, . . . the fact of continued 12 government payments did not by itself require dismissal of respondents’ claims at the pleading 13 stage.” Docket No. 200 (Friedman Decl., Ex. B) (Amicus Br. at 7). 14 However, in the same brief, the government also asserted for the first time that, if the case 15 were remanded back to the district court, it would

16 move to dismiss [the Campies’] suit under Section 3730(c)(2)(A). That determination is based in part on the government’s thorough 17 investigation of respondents’ allegations and the merits thereof. In addition, if this suit proceeded past the pleading stage, both parties 18 might file burdensome discovery and Touhy requests for FDA documents and FDA employee discovery (and potentially trial 19 testimony), in order to establish “exactly what the government knew and when,” which would distract from the agency’s public-health 20 responsibilities.” Based on all those considerations, the government has concluded that allowing this suit to proceed to discovery (and 21 potentially a trial) would impinge on agency decisionmaking and discretion and would disserve the interests of the United States. 22 23 Docket No. 200 (Friedman Decl., Ex. B) (Amicus Br. at 15). 24 II. DISCUSSION 25 A. Legal Standard 26 The purpose of the FCA is "to discourage fraud against the 27 government." The FCA imposes civil liability on any person who person who "conspires to defraud the Government by getting a false 1 or fraudulent claim allowed or paid." To encourage the disclosure of potential fraud, under the qui tam provisions of the FCA, relators 2 may "bring a civil action for a violation of [§] 3729 for the person and for the United States Government." 3 4 Cell Therapeutics, Inc. v. Lash Grp., Inc., 586 F.3d 1204, 1205 (9th Cir. 2010) 5 Although the FCA allows a private individual to bring a qui tam action, as noted above, the 6 act also contains a provision that allows the government to dismiss the action. Section 7 3730(c)(2)(A) states as follows: “The Government may dismiss the action notwithstanding the 8 objections of the person initiating the action if the person has been notified by the Government of 9 the filing of the motion and the court has provided the person with an opportunity for a hearing on 10 the motion.” 31 U.S.C. § 3730(c)(2)(A). 11 Section 3730(c)(2)(A), in and of itself, does not provide any standard by which to evaluate 12 a motion to dismiss by the government. However, the Ninth Circuit addressed the standard in 13 United States ex rel. Sequoia Orange Co. v. Baird-Neece Packing Corp., 151 F.3d 1139 (9th Cir. 14 1998), as both parties acknowledge. 15 In Sequoia, the Ninth Circuit recognized that the FCA “is silent regarding the 16 circumstances under which the government may dismiss a qui tam action,” but “the decision to 17 dismiss has been likened to a matter within the government’s prosecutorial discretion in enforcing 18 federal laws.” Id. at 1143; see also id. at 1144 (noting that amendments to the FCA “actually 19 increased, rather than decreased, executive control over qui tam lawsuits”). Accordingly, the court 20 rejected the proposition that “lack of merit” is the only ground upon which the government may 21 seek dismissal. Id. Even “a meritorious suit may be dismissed upon a proper showing.” Id. 22 As to what constitutes a proper showing, the Ninth Circuit endorsed the district court’s 23 two-step analysis to test the justification for dismissal

24 “(1) identification of a valid government purpose; and (2) a rational relation between dismissal and accomplishment of the purpose.” If 25 the government satisfies the two-step test, the burden switches to the relator “to demonstrate that dismissal is fraudulent, arbitrary and 26 capricious, or illegal.” 27 1 Id. at 11451; see also United States ex. rel. Sequoia Orange Co. v. Sunland Packing House Co., 2 912 F. Supp. 1325, 1341 (E.D. Ca. 1995) (district court stating that the first step is “whether the 3 challenged action has a legitimate purpose” and that the second step is whether there is “a 4 reasonable fit between the governmental purpose and the agency action”). The Ninth Circuit also 5 indicated that a hearing on a motion to dismiss would be appropriate where “‘the relator presents a 6 colorable claim that the settlement or dismissal is unreasonable in light of existing evidence, that 7 the Government has not fully investigated the allegations, or that the Government’s decision was 8 based on arbitrary or improper considerations.’” Sequoia, 151 F.3d at 1145 (quoting the Senate 9 Report). Finally, the Ninth Circuit commented that the two-step analysis above was essentially 10 “[t]he same analysis [that] is applied to determine whether executive action violates substantive 11 due process.” Id. 12 In Sequoia, the district court had similarly commented that "there need not be a tight fitting 13 relationship between [the governmental purpose and the agency action]; it is enough that there are 14 plausible, or arguable, reasons supporting the agency decision." Id. Citing Heckler v. Chaney, 15 470 U.S. 821 (1985), the district court had also underscored that “[a]n agency’s decision not to 16 prosecute or enforce, by criminal or civil means, is a decision generally committed to an agency’s 17 absolute discretion.” Sequoia, 912 F. Supp. at 1351. In Heckler, the Supreme Court explained 18 that

19 an agency decision not to enforce often involves a complicated balancing of a number of factors which are peculiarly within its 20 expertise. Thus, the agency must not only assess whether a violation has occurred, but whether agency resources are best spent on this 21 violation or another, whether the agency is likely to succeed if it acts, whether the particular enforcement action requested best fits 22 the agency’s overall policies, and, indeed, whether the agency has enough resources to undertake the action at all. An agency 23 generally cannot act against each technical violation of the statute it is charged with enforcing. The agency is far better equipped than 24 the courts to deal with the many variables involved in the proper ordering of its priorities. 25 26

27 1 Given the reference to substantive due process, the Court rejects the Campies’ suggestion that the 1 Heckler, 470 U.S. at 831. 2 Consistent with the above, the Ninth Circuit noted in Sequoia that “a rational relation test 3 avoids any separation of powers concerns,” id.; that is, there was no indication that the judicial 4 review would pose a significant barrier to the executive branch’s exercise of its prosecutorial 5 authority. See Sequoia, 151 F.3d at 1145-46. The executive branch’s prosecutorial authority was 6 respected because no more was required to justify “the dismissal motion than [what] is mandated 7 by the Constitution itself” – i.e., due process prohibits arbitrary or irrational prosecutorial 8 decisions. Id. at 1146. 9 Not all courts have agreed with the Ninth Circuit’s approach. In fact, even though the 10 Ninth Circuit’s review is limited in nature, several circuit courts have endorsed an even less 11 rigorous review. For example, the D.C. Circuit has indicated that the government has an 12 “unfettered right to dismiss an action” under § 3730(c)(2)(A) and that “[t]he relator’s right to a 13 hearing” is “simply to give the relator a formal opportunity to convince the government not to end 14 the case.” Swift v. United States, 318 F.3d 250, 252-53 (D.C. Cir. 2003); see also United States v. 15 UCB, Inc., No. 17-CV-765-SMY-MAB, 2019 U.S. Dist. LEXIS 64267, at *5-6 (S.D. Ill. Apr. 15, 16 2019) (noting split of authority, with the Tenth Circuit following the Ninth Circuit, but with the 17 Fifth and Eighth Circuits following the D.C. Circuit). 18 B. Valid Government Purpose 19 In its papers, the United States has identified two government purposes that would be 20 served by dismissal of the FCA claim: (1) “to prevent [the Campies] from undermining the 21 considered decisions of FDA and CMS about how to address the conduct at issue here,” and (2) 22 “to avoid the additional expenditure of government resources on a case that it fully investigated 23 and decided not to pursue,” especially as the FDA has “taken into account [the Campies’] claims 24 in its regulatory oversight of Gilead[] and taken actions it deemed appropriate.” Mot. at 8-9. In 25 response, the Campies do not claim that the identified purposes are invalid or illegitimate. Indeed, 26 they acknowledge that such purposes have been identified as relevant considerations by the U.S. 27 Department of Justice (“DOJ”). See Docket No. 200 (Friedman Decl., Ex. C) (in DOJ memo, 1 including preventing interference with agency policies and programs and preserving government 2 resources); Docket No. 230 (Friedman Decl., Ex. C) (DOJ Manual § 4-4.111) (identifying same 3 factors); see also Docket No. 241 (3d Crooke Decl. ¶ 4) (noting that the DOJ manual incorporated 4 the substance of the DOJ memo from January 2018). 5 The Campies, however, do argue that there is an insufficient factual basis to support the 6 asserted government purposes. Cf. United States v. Acad. Mortg. Corp., No. 16-cv-02120-EMC, 7 2018 U.S. Dist. LEXIS 70096, at *10 (N.D. Cal. Apr. 25, 2018) (noting that “a more searching 8 form of rational basis analysis applies where the factual record, not any conceivable justification, 9 matters”). For example, the Campies contend that, to the extent that the government seeks 10 dismissal based on cost, the government has not provided any evidence to show that it 11 “meaningful considered what the cost of the suit might be” and “failed to make even a cursory 12 showing that it had considered the potential proceeds from the litigation, a central factor in the 13 cost analysis.” United States v. Academy Mortgage Corp., No. 16-cv-02120-EMC, 2018 U.S. 14 Dist. LEXIS 171251, at *7, 9 (N.D. Cal. Oct. 3, 2018). 15 The Court does not agree. Although the Campies have tried to analogize the instant case to 16 Academy Mortgage – another case over which the Court presided – Academy Mortgage was a 17 markedly different case from the case at bar. In Academy Mortgage, there was no indication that 18 the government had conducted any real investigation of the FCA claim, see United States v. Acad. 19 Mortg. Corp., No. 16-cv-02120-EMC, 2018 U.S. Dist. LEXIS 109489, at *2, 4 (N.D. Cal. June 20 29, 2018) (stating that “[t]he Relator’s evidence showed that the Government performed only a 21 limited investigation of the original complaint” – i.e., interviewing the Relator and examining 22 documents produced by her and also turning down an “offer[] to provide additional information” – 23 and “appears not to have investigated the amended complaint at all”). 24 In the instant case, the Court has been presented with substantial evidence that, after the 25 Campies filed their lawsuit in 2010,2 the United States investigated their allegations “for over two 26 years.” Docket No. 184 (Russo Decl. ¶ 2). The investigation included review of the Campies’ 27 1 pleadings and disclosure statement (including accompanying materials), interviews of the 2 Campies, consultations with experts from the Department of Health and Human Services 3 (“DHHS”) (including the Food and Drug Administration (“FDA”), meetings with Gilead, 4 collection of documents (over 600,000 pages), interviews of witnesses, and review of the history 5 of multiple manufacturing lots identified by the Campies as having serious problems (including 6 supporting documentation). See Docket No. 184 (Russo Decl. ¶¶ 2-3). 7 Moreover, the instant case is somewhat unique in that the above was not the only 8 government investigation of the alleged misconduct identified by the Campies. Even before the 9 Campies filed suit – as well as thereafter – the FDA was involved with oversight of Gilead, 10 including specifically with respect to its use of Synthetics China. This is detailed in the Scavdis 11 Declaration submitted by the United States. See Docket No. 185 (Scavdis Decl. ¶ 1) (testifying 12 that he is an Assistant Special Agent in Charge at the FDA, Office of Criminal Investigations). 13 For example: 14 • In 2008, Gilead applied (through a Prior Approval Supplement or “PAS”) for 15 permission to use FTC from a new manufacturer, i.e., Synthetics China. See 16 Docket No. 185 (Scavdis Decl. ¶ 2); see also Docket No. 198-6 (Wiener Decl. ¶ 23 17 & Ex. 6) (initial PAS). “In March 2009, FDA conducted an on-site inspection of 18 Synthetics China” and, “[a]s part of the inspection, Gilead disclosed that two 19 validation batches of API [active pharmaceutical ingredient] did not meet the 20 specifications for the drug[], but that changes were made to the process design and 21 the validation was repeated and acceptable results were obtained. FDA did not 22 issue a Form 483,[3] having recorded no deficiencies with the manufacturing or 23 testing operations at Synthetics China that warranted further action.” Docket No. 24 185 (Scavdis Decl. ¶ 2). In May 2009, FDA approved the PAS. See Docket No. 25 185 (Scavis Decl. ¶ 2). 26 3 A FDA Form 483 is also known as a Notice of Inspectional Observations. See Docket No. 201 27 (Wiener Decl. ¶ 34). “An FDA form 483 is issued at the end of an on-site inspection if the FDA 1 • In early 2010, “FDA inspected Gilead’s San Dimas facility and identified certain 2 violations of the Current Good Manufacturing Practice (cGMP) regulations. . . . 3 FDA issued a Warning Letter on September 21, 2010.”4 Docket No. 185 (Scavdis 4 Decl. ¶ 3). Thereafter, “FDA evaluated the corrective actions that Gilead took in 5 response to the Warning Letter,” and, in August 2011, “FDA issued a letter to 6 Gilead stating that those corrective actions appeared to address the violations 7 identified in the Warning Letter.” Docket No. 185 (Scavdis Decl. ¶ 3). 8 • In April 2011, FDA did a second on-site inspection of the Synthetics China facility 9 but did not issue a Form 483 based on that inspection. See Docket No. 185 10 (Scavdis Decl. ¶ 4). 11 • “Between November 2011 and January 2012, Gilead submitted Field Alert Reports 12 to FDA related to particulates in finished product at Gilead’s Foster City facility.” 13 Docket No. 185 (Scavdis Decl. ¶ 5); see also Docket No. 201 (Wiener Decl. ¶ 41) 14 (referring to Gilead’s FAR in January 2012). FDA inspected the Foster City 15 facility in June 2012 and issued a Form 483 relating to cGMP deficiencies. See 16 Docket No. 185 (Scavdis Decl. ¶ 5). Gilead responded to the Form 483 in July 17 2012. In its response, Gilead addressed, inter alia, contamination of FTC sourced 18 from Synthetics China. See Docket No. 198-6 (Wiener Decl. ¶¶ 34, 42 & Ex. 13) 19 (Gilead’s response to Form 483). After receiving the response, FDA took no 20 further action, neither a recall nor a physician or consumer alert. 21 • “In March 2012, FDA requested additional information about validation and 22 reprocessing of batches at Synthetics China, and received additional information 23 from Gilead in April 2012.” Docket No. 185 (Scavis Decl. ¶ 6). Thereafter, “[i]n 24 March 2013, FDA conducted a third on-site inspection of the Synthetics China 25 facility” but “did not issue a Form 483 based” on that inspection. Docket No. 185 26 (Scavis Decl. ¶ 6). 27 1 Given the above investigations spanning from 2009 to 2013, the Court finds that there is a 2 concrete factual basis for the United States to argue that allowing the Campies to proceed with the 3 FCA claim would “undermin[e] the considered decisions of FDA and CMS about how to address 4 the conduct at issue here.” Mot. at 10. Unlike Academy Mortgage, here, there was no cursory 5 decision to move for dismissal without an adequate record of an investigation by the government. 6 The Campies protest still that the factual basis for the other identified government purpose 7 supporting dismissal – i.e., cost of continued litigation on the FCA claim – lacks a sufficient 8 factual basis. The Campies note, in particular, that they offered to narrow the scope of their FCA 9 claim which would therefore lessen any burden to the United States if litigation were to continue. 10 The record reflects that the United States considered the Campies’ proposal to limit the scope of 11 their FCA claim but still concluded that dismissal was appropriate. See Docket No. 241 (3d 12 Crooke Decl. ¶¶ 2-3). Although the specificity of the government’s cost analysis in the Third 13 Crooke Declaration could have been more robust (the declaration did not provide specific details), 14 which would have been made this an easier case, the Campies’ argument ultimately is not 15 persuasive. As an initial matter, the Court does not accept the Campies’ suggestion that a cost- 16 benefit analysis must be quantitative in nature – i.e., that the United States is required to do some 17 kind of mathematical calculation. See United States ex rel. Balko v. Sr. Home Care, Inc., No. 18 8:13-cv-3072-T-17TBM, 2017 U.S. Dist. LEXIS 121575, at *18-19 (M.D. Fla. May 2, 2017) 19 (rejecting relator’s argument that “the settlement amount is by definition ‘arbitrary’ because it is 20 not based on any mathematical valuation of the false claims and was simply an agreed-upon 21 number to which the Relator originally agreed to with no tether to the number or scope of the false 22 claims presented in the case”; stating that there is no requirement that the amount of a settlement 23 be “based on a mathematical formula of the alleged false claims”). The critical question is 24 whether the United States engaged in a meaningful consideration of cost and benefit such that its 25 decision to seek dismissal is supported by a rational basis. 26 The Campies assert that, even under a qualitative approach, there was not a meaningful 27 consideration of either benefit or cost. The Campies focus in particular on the benefit side of the 1 obtained if the Campies were to prevail (even if the Campies were to narrow their FCA claim). 2 See, e.g., Docket No. 228-3 (Friedman Decl., Ex. B) (claiming that the narrowed FCA claim could 3 still be worth more than $100 million). But the United States has certified that it considered the 4 merits of the FCA claim and potential for monetary recovery, including after the Campies 5 proposed to narrow their FCA claim. See Docket No. 225 (2d Crooke Decl. ¶ 3); Docket No. 241 6 (3d Crooke Decl. ¶¶ 2-3). Although the Campies fairly argue that the certification is conclusory, 7 the Court cannot ignore the particular backdrop for the certification in this case – in particular, the 8 investigations done by the FDA between 2009 and 2013 which led to the issuance of only one 9 warning letter and one Form 483, each of which ultimately resulted in no further action by the 10 FDA after Gilead responded, including but not limited to a recall or even a consumer or physician 11 alert. As the government noted in its brief to the U.S. Supreme Court, the fact that it continued 12 payment notwithstanding its knowledge of Gilead’s misrepresentations casts some doubt on the 13 element of materiality. 14 As for the cost side of the equation, the Campies argue that there will be at most only a 15 limited discovery burden on the government if the FCA claim were to be litigated,5 but that 16 position is not convincing. A critical issue in this case will be whether Gilead’s alleged 17 misrepresentations were material, as Gilead is taking the position that materiality is lacking since 18 the FDA continued to approve the drugs at issue “even after the agency became aware of 19 [Gilead’s] noncompliance.” Gilead, 862 F.3d at 906. Thus, discovery into “exactly what the 20 government knew and when” cannot be avoided. Id. Under the facts of this case, this will likely 21 entail extensive discovery into government witnesses and documents by either or both the 22 Campies and Gilead. 23 Accordingly, the Court concludes that there is a factual basis in this case to support both 24 government purposes asserted by the United States and a rational relationship between dismissal 25 26 5 See Docket No. 200 (Friedman Decl., Ex. C) (DOJ memo) (noting that “[e]xamples of potential 27 costs may include, among other things, the need to monitor or participate in ongoing litigation, 1 and accomplishment of those purposes.6 Because the United States has satisfied Sequoia’s two- 2 step test, the burden now switches to the Campies “‘to demonstrate that dismissal is fraudulent, 3 arbitrary and capricious, or illegal.’” Sequoia, 151 F.3d at 1145. 4 C. Arbitrary and Capricious 5 The Court holds that the Campies have failed to establish that dismissal would fall under 6 any of the above categories. The Campies primarily argue that the government’s request to 7 dismiss is arbitrary and capricious but, as indicated by the discussion above, that position is not 8 well supported under the particular facts and circumstances of this case. There was a multi-year 9 investigation into the Campies’ allegations and Gilead’s practices related to Synthetics China, and 10 the government made deliberate enforcement decisions in regard thereto. The government 11 considered the burdens of this litigation evident in the nature of, e.g., the materiality issues likely 12 to be central to this case. 13 Other facts additionally point to a non-arbitrary approach by the United States with respect 14 to the instant case. For example: 15 • The United States has never been dismissive of the Campies’ FCA claim, even 16 participating in the Ninth Circuit appeal and making arguments favorable to the 17 Campies. 18 • The United States has been involved in this case from 2010 to the present, spanning 19 two different administrations. 20 • There is nothing to suggest that the United States has a pattern of not taking qui 21 tam complaints seriously or a pattern of moving to dismiss. Between October 2017 22 and September 2019, more than 1,200 qui tam complaints have been filed and the 23 United States has intervened or partially intervened in approximately 218.7 24 6 This is not to say that, in different circumstances, a more specific showing needs to be made by 25 the government.

26 7 The United States’ involvement in the 218 cases may also have impacted the United States’ decision as to how to proceed with the instant case – i.e., given its limited resources, at a certain 27 point, the United States may have had to prioritize which litigations to pursue. See Docket No. 1 Furthermore, since the DOJ memo of January 2018 (discussing factors to consider 2 in whether to move to dismiss), the United States has moved to dismiss in only 36 3 cases. See Docket No. 241 (3d Crooke Decl. ¥ 4). 4 The Court thus concludes that the Campies have failed to satisfy their burden of showing 5 that dismissal is arbitrary, capricious, fraudulent, or illegal. 6 Il. CONCLUSION 7 The United States’ motion to dismiss is thereby granted. Although the main FCA claim 8 || has now been dismissed, the Campies may still proceed with their remaining claims (including but 9 not limited to the retaliation claims) absent further order of the Court. 10 This order disposes of Docket No. 183. 11 12 IT IS SO ORDERED.

14 Dated: November 5, 2019

16 — if 5 ED M. CHEN nited States District Judge 18 19 20 21 22 23 24 25 26 27 28 prerogatives”). However, the Court expresses no opinion on such.