• While financial recoveries under the federal False Claims Act (FCA) continued at a fast pace last year, the U.S. Department of Justice (DOJ) started 2018 with a proverbial "bang" by issuing new internal guidance directing government lawyers to consider filing motions to dismiss FCA qui tam actions where the government declines to intervene.
  • These new DOJ policies, together with other ongoing developments, have the potential to significantly change the landscape of FCA enforcement in the year ahead.
  • Companies operating in heavily regulated industries such as healthcare, telecommunications, energy and defense should be mindful of these emerging trends in FCA enforcement.

While financial recoveries under the federal False Claims Act (FCA) continued at a fast pace last year, the U.S. Department of Justice (DOJ) started 2018 with a proverbial "bang" by issuing new internal guidance directing government lawyers to consider filing motions to dismiss FCA qui tam actions where the government declines to intervene. The DOJ also issued guidance prohibiting government lawyers from relying on a defendant's failure to comply with other agencies' guidance documents as a basis for proving violations of applicable law in affirmative civil enforcement actions. These new DOJ policies, together with ongoing developments concerning the elements of scienter and materiality stemming from the landmark U.S. Supreme Court decision in United Health Services v. United States ex rel. Escobar, have the potential to significantly change the landscape of FCA enforcement in the year ahead. Companies operating in heavily regulated industries such as healthcare, telecommunications, energy and defense should be mindful of these emerging trends in FCA enforcement.

Year in Review: Record FCA Recoveries

The FCA prohibits 1) knowingly submitting a false claim to the government for payment, 2) causing another to submit a false claim to the government for payment, 3) knowingly making a false record or statement to get a false claim paid by the government, and 4) reverse-false claims, where one acts improperly to avoid paying the government. The FCA was substantially revised and strengthened in 1986 by increasing damages to treble damages, increasing penalties from $2,000 to a range of $5,000 to $10,000, establishing retaliation protections for whistleblowers, lowering the burden of proof to a preponderance of the evidence standard and establishing liability for reckless disregard of the truth.1 Since its inception, the FCA has "serve[d] as the government's primary civil remedy to redress false claims . . . relating to . . . defense and national security, food safety and inspection, federally insured loans and mortgages, highway funds, small business contracts, agricultural subsidies, disaster assistance, and import tariffs."2 Since 1986, DOJ has recovered $56 billion in civil cases involving false or fraudulent claims.3 The DOJ recovered $3 billion in fiscal year (FY) 2010;4 $5.69 billion in FY 2014;5 $3.5 billion in FY 2015;6 and $4.7 billion in FY 20167. FY is measured from Oct. 1 through Sept. 30.

The volume of financial recoveries under the FCA continued at a record pace last year. The DOJ recovered $3.7 billion in FCA cases in FY 2017.8 A total of $2.4 billion of those settlements came from healthcare fraud cases, including a $465 million settlement with Mylan Inc. for allegedly classifying the EpiPen as a generic drug – though it has no generic competition – in order to avoid paying higher rebates to Medicaid.9 The DOJ also recovered $350 million from Shire Pharmaceutical LLC for allegedly inducing physicians to overuse its products, providing kickbacks and unlawful marketing of a product for a use not approved by the FDA.10 Recoveries also include a $296 million jury verdict in the government's favor against Allied Home and Mortgage Capital Corp. for alleged housing and mortgage fraud; a $125 million settlement with Bechtel National Inc. for allegedly fraudulent billing related to nuclear quality standards; and an $89 million settlement with Financial Freedom for allegedly fraudulent servicing of reverse mortgages, among others.11

Notably, $3.4 billion of the $3.7 billion recovered in FY 2017 related to "qui tam" lawsuits filed under the FCA.12 Qui tam lawsuits allow private parties to litigate on behalf of the federal government. The FCA incentivizes whistleblowers (called "relators") to report illegal conduct to the government by sharing a portion of the recovery with them, generally between 15 percent and 25 percent of the action's proceeds.13 31 U.S.C. §3730(d)(1). The DOJ paid out $392 million to whistleblowers in FY 2017 for exposing fraud by filing qui tam complaints. However, recent changes in guidance at DOJ – the Granston Memorandum and the Brand Memorandum – and the continuing evolution of the FCA's materiality standard post United Health Services v. United States ex rel. Escobar, 579 U.S. ___ , 136 S.Ct. 1989 (2016) (Escobar) may have an impact on future FCA and qui tam recoveries.

The Granston Memorandum's Factors for Dismissal

Qui tam complaints reflect an outsized and growing portion of the DOJ's civil enforcement work. Approximately 12 new qui tam complaints are filed every week, totaling 669 in FY 2017. The government is required to investigate and decide whether to intervene in qui tam litigation. The government is typically very successful when it does decide to intervene; 87 percent of qui tam recovery in FY 2017, approximately $3.01 billion, stemmed from cases where the government intervened. Despite the government's rate of success when it intervenes, DOJ only intervenes in 25 percent of cases – leaving whistleblowers to litigate the remaining 75 percent of qui tam cases.

The DOJ recently issued internal guidance directing its attorneys to consider filing motions to dismiss FCA qui tam actions where the government declines to intervene. As Michael Granston, the director of the DOJ's Civil Fraud Section noted in his Jan. 10, 2018, memorandum to the Civil Fraud Section (the "Granston Memorandum"), "[e]ven in non-intervened cases, the government expends significant resources in monitoring these cases. . . . If the cases lack substantial merit, they can generate adverse decisions that affect the government's ability to enforce the FCA." Accordingly, the DOJ must act as a "gatekeeper" to ensure the effectiveness of FCA actions, which the Granston Memorandum suggests DOJ attorneys do by judiciously seeking dismissal of FCA actions under 31 U.S.C. section 3730(c)(2)(A). Though "the Department has utilized section 3730(c)(2)(A) sparingly . . . it remains an important tool to advance the government's interest, preserve limited resources, and avoid adverse precedent." As such, the Granston Memorandum highlights seven factors the DOJ should consider in deciding whether to move for dismissal.

The first factor is "[c]urbing meritless qui tam claims." The Granston Memorandum suggests dismissing a relator's qui tam claim where: 1) the claim is "facially lacking in merit" due to a baseless legal theory, 2) is grounded on frivolous factual allegations, or 3) where, after intervention, the government's investigation determines the case is meritless.

The second factor is "[p]reventing parasitic or opportunistic qui tam actions." These are actions where the relator's action "duplicates a pre-existing government investigation and adds no useful information to the investigation." This second factor can be viewed as an extension of the "government action rule", 31 U.S.C. §3730(e)(3), which bars qui tam suits that "are the subject of a civil suit or an administrative civil money penalty proceeding in which the government is already a party."

The third factor is "[p]reventing interference with agency policies and programs." This factor may apply where the qui tam action "threatens to interfere with an agency's policies or the administration of its programs and [the agency] has recommended dismissal to avoid these effects." The Granston Memorandum cites numerous cases to illustrate, including where a qui tam complaint was dismissed because the litigation would "delay the clean-up and closure of" a nuclear weapons manufacturing facility. SeeUnited States ex rel. Ridenour v. Kaiser-Hill Co., LLC, 397 F.3d 925, 937 (10th Cir. 2005).

The fourth factor is "[c]ontrolling litigation brought on behalf of the United States." This factor weighs in favor of dismissal when the qui tam action could interfere with existing or ongoing litigation, such as in In Re Natural Gas Royalties Qui Tam Litigation, MDL Docket No. 1293 (D. Wyo. Oct. 9, 2002) (In Re Natural Gas Royalties). In In Re Natural Gas Royalties, the relator filed multiple separate qui tam actions in multiple districts against more than 300 defendants. After the government agreed to intervene in some cases, it moved to dismiss others on the grounds that the nonintervened claims would interfere with DOJ's prosecution of the intervened claims.

The fifth factor is "[s]afeguarding classified information and national security interests." The Granston Memorandum specifies that this factor particularly applies to cases "involving intelligence agencies or military procurement contracts."

The sixth factor is "[p]reserving government resources." The Granston Memorandum identifies that the DOJ should consider dismissal "when the government's expected costs are likely to exceed any expected gain." Costs include "the opportunity cost of expending resources on other matters with a higher and/or more certain recovery." One example of dismissal to preserve resources occurred in United States ex rel. Nicholson v. Spigelman, et al., No. 1:10-cv-03361, 2011 WL 2683161 (N.D. Ill. July 8, 2011), where "estimated government losses, even with statutory penalties and damages multiplier, were less than the costs of monitoring the litigation and responding to discovery requests."

The final factor is "[a]ddressing egregious procedural errors." The Granston Memorandum explains that the basis for dismissal under this factor is "problems with the relator's action that frustrate the government's efforts to conduct a proper investigation." An example would be when the relator "ignored repeated requests from the Office of the U.S. Attorney to serve the qui tam complaint and disclose material facts."

Escobar's Evolution and the Granston Memorandum

The Supreme Court's decision in Escobar continues to be one of the most significant FCA decisions in recent memory. Escobar dealt with the implied certification theory of FCA liability, wherein liability attaches when "the claim does not merely request payment, but also makes specific representations about the goods or services provided," and "[defendant's] failure to disclose noncompliance with material statutory, regulatory, or contractual requirements makes those representations misleading half-truths."14

The relator in Escobar alleged that defendant held itself out as a provider of mental health services, including by licensed physicians and professionals, when in reality defendant's employees did not have proper licenses or accreditations. However, the court noted that the FCA is not "an all-purpose fraud statute," and thus, the misrepresentation must be material for liability to attach on an implied certification theory. The Supreme Court vacated and remanded, as the First Circuit did not use the Supreme Court's new, more stringent materiality standard.

Federal appellate courts have begun to interpret the Escobar materiality standard in varying ways. In United States ex rel. Petratos v. Genentech Inc., 855 F.3d 481 (3d Cir. 2017), the Third Circuit affirmed a dismissal of an FCA suit alleging that Genentech suppressed data about one of its cancer drugs. The complaint alleged that because Genentech suppressed data about the cancer drug, the drug was not appropriate for use in some patients and therefore, physicians submitted Medicare claims for payment that were not "reasonable and necessary," as required by statute. The Third Circuit affirmed the district court's dismissal of the case, noting that there were no factual allegations that the government would not have reimbursed the claims had Genentech reported the data.15 Moreover, the U.S. Food and Drug Administration (FDA) continued to approve the drug even after the relator disclosed his evidence to the FDA and the DOJ. Thus, the Third Circuit held, Genentech's suppression of the drug data was not material.

The D.C. Circuit reached a similar procedural result when it affirmed summary judgment for defendants in McBride v. Halliburton Co., 848 F.3d 1027 (D.C. Cir. 2017) (McBride). In McBride, the relator alleged that a government contractor double-counted the number of U.S. armed forces members using its contractually-provided facilities, causing the government to overpay based on inaccurate "headcounts." The court affirmed summary judgment because the relator failed to "offer evidence that any misrepresentation regarding headcount data (if one existed) was material." Plaintiffs' failure to provide any evidence as to materiality was fatal to the action.

The Fifth Circuit notably used the Escobar decision to reverse a $660 million jury award due to lack of materiality in United States ex. Rel. Harman v. Trinity Industries Inc., 872 F.3d 645 (5th Cir. 2017). Relator alleged here that the defendant knowingly and falsely certified that its highway guardrails met federal guidelines and therefore, states that purchased the guardrails were eligible for reimbursement from the federal government. There, the Fifth Circuit reversed the jury award because the federal agency was fully aware of the relator's allegations about a product's design specifications but still maintained the "unwavering position" that the product was eligible for federal reimbursement. The agency's decision to continue reimbursing for the product indicated that the relator's allegations were not material to repayment.

Notably, these three cases all overlap (to varying degrees) with the factors discussed in the Granston Memorandum. Genentech and McBride both could be characterized as "meritless" claims given that there was no evidence of materiality offered in either case. Likewise, Trinity Industries could be classified as "meritless," given the agency's decision to keep reimbursing for the product in question, and as interfering with agency policies and programs. The Fifth Circuit noted that the Federal Highway Administration (FHWA) issued an official memorandum stating that "[a]n unbroken chain of eligibility for Federal-aid reimbursement [for the product in question] has existed since September 2, 2005." Thus, the DOJ may have had grounds to dismiss under the Granston Memorandum's factors because the FHWA maintained a consistent policy toward the product and allowing the case to proceed to trial may have impacted the FHWA's administration of its policies and programs.

Although the Granston Memorandum had not been issued at the time of the Ninth Circuit's decision in United States ex. rel Max Bennett v. Biotronik, Inc., 876 F.3d 1011 (9th Cir. 2017)(Biotronik), this decision strongly illustrates application of the materiality, parasitic action and government resource factors. In Biotronik, the Ninth Circuit held that qui tam relators may not bring FCA cases that are duplicative of past or present cases in which the government is a party, including prior qui tam cases in which the government intervenes. On its face, this holding incorporates the second Granston factor, the parasitic qui tam action. The court also notes in dicta that "[t]he United States investigated [a previous relator]'s charges for nearly four years," possibly supporting a dismissal on grounds that relitigating a parasitic claim would waste government resources. Though the court did not dismiss on materiality grounds, a strong argument could be made that the relator's claims were not material because the government intervened in an identical claim before Bennett filed, declined to intervene in Bennett's identical action, and finally settled or dismissed the claims it intervened in. (See Holland & Knight's alert, "The Government Never Dies: Ninth Circuit Upholds Government Action Rule Dismissal," Dec. 8, 2017.)

The DOJ also recently issued guidance prohibiting its attorneys from relying on a defendant's failure to comply with other agencies' guidance documents as a basis for proving violations of applicable law in affirmative civil enforcement actions. The Jan. 25, 2018, memorandum from Associate Attorney General Rachel Brand (Brand Memorandum) specifically prohibits DOJ civil litigators from treating guidance documents from federal agencies as binding authority. Oftentimes, executive agencies promulgate and issue "guidance documents" for the industries the agency handles. In the past, DOJ prosecutors have used a company's noncompliance with these guidance documents as affirmative proof of noncompliance with the underlying law. Likewise, companies have argued that compliance with guidance documents necessarily means compliance with the underlying law. However, the Brand Memorandum particularly notes that guidance documents cannot create additional legal obligations. Absent independent evidence of noncompliance with regulations or statute, noncompliance with guidance documents is not sufficient to support an enforcement action.

Thus, while agency guidance documents could previously have provided a ground for proving a qui tam relator's complaint, noncompliance with guidance documents alone cannot support a FCA action in light of the Brand Memorandum. Moreover, preventing DOJ prosecutors from using guidance documents to "prove up" a FCA claim could result in a decrease in meritorious claims.

Impact on Future Cases

In 2018 and beyond, the interplay between the Granston and Brand Memoranda and the continued evolution of the FCA's materiality standard post-Escobar will play an important role in the types and number of FCA and qui tam claims filed, dismissed and settled. The long-term impact of these new policies will become more clear over time as the DOJ applies the polices to FCA cases. Regardless, these new policies provide substantial arguments for companies seeking to dismiss FCA claims. Now more than ever, government contractors and companies operating in heavily regulated industries should consider updating their compliance and ethics programs to account for these emerging trends in FCA enforcement.