source: Caselaw Access Project

author: HARDIMAN, Circuit Judge.

license: Public Domain

text:
    UNITED STATES of America, EX REL. Gerasimos PETRATOS, Gerasimos Petratos, ex rel. United States of America; State of California; State of Colorado; State of Connecticut; State of Delaware; State of Florida; State of Georgia; State of Hawaii; State of Illinois; State of Indiana; State of Louisiana; State of Maryland; Commonwealth of Massachusetts; State of Michigan; State of Minnesota; State of Montana; State of Nevada; State of New Hampshire; State of New Jersey; State of New Mexico; State of New York; State of North Carolina; State of Oklahoma; State of Rhode Island; State of Tennessee; State of Texas; Commonwealth of Virginia; District of Columbia, Appellants v. GENENTECH INC; Roche Group; Hoffman La Roche, Inc.; Roche Holdings, Ltd.; F Hoffman—La Roche, Ltd
    No. 15-3805
    United States Court of Appeals, Third Circuit.
    Argued November 1, 2016
    (Filed: May 1, 2017)

      Michael J. DeBenedietis, Debenedictis & Debenedictis, LLC, 125 Kings Highway West, Haddonfield, NJ 08033, Adam Gu-tride, Seth Safier, Anthony Patek, Matthew T. McCrary, [Argued], Gutride Safier LLP, 100 Pine Street, Suite 1250, San Francisco, CA 94111, Counsel for Plaintiffs-Appellants

      Lawrence S. Lustberg, Gibbons P.C., One Gateway Center, Newark, NJ 07102, Matthew J. O’Connor, Mark W. Mosier [Argued], Matthew F. Dunn, David M. Zionts, Covington & Burling LLP, 850 10th Street, N.W., One City Center, Washington, DC 20001, Counsel for Defendants-Appellees
    Michael S. Raab, Weili J. Shaw [Argued], U.S. Department of Justice, 950 Pennsylvania Ave., N.W., Washington, D.C. 20530, Counsel for United States of America as Amicus Curiae in support of neither party
    Before: HARDIMAN and SCIRICA, Circuit Judges, and ROSENTHAL, District Judge.

       The Honorable Lee H. Rosenthal, United States District Judge for the Southern District of Texas, sitting by designation.

   OPINION OF THE COURT

HARDIMAN, Circuit Judge.

This appeal arising under the False Claims Act involves a multi-billion dollar cancer drug, Avastin, which was developed by Appellee Genentech. Relator Gerasimos Petratos, who was head of healthcare data analytics for Genentech, filed a qui tam action soon after leaving the company. He alleged that Genentech suppressed data that caused doctors to certify incorrectly that Avastin was “reasonable and necessary” for certain at-risk Medicare patients. The District Court dismissed Petratos’s suit for failure to state a claim. Although we disagree with the District Court’s grounds for dismissal, we will affirm because Petratos failed to satisfy the False Claims Act’s materiality requirement.

I

A

A widely prescribed cancer drug that has accounted for $1.13 billion a year in Medicare reimbursements, Avastin is approved by the FDA to treat several types of cancer. Petratos alleged that Genentech concealed information about Avastin’s health risks. Specifically, he claimed the company ignored and suppressed data that would have shown that Avastin’s side effects for certain patients were more common and severe than reported. According to Petratos, such analyses would have required the company to file adverse-event reports with the FDA, and could have resulted in changes to Avastin’s FDA label. Genentech also allegedly suppressed information regarding Avastin’s side effects for patients with renal failure despite a request to disclose that information by a “Key Opinion Leader,” a recognized industry expert who “influence[s] peers’ medical practice, including but not limited to prescribing behavior.” John Mack, A KOL by Any Other Name, 14-03 Pharm. Mktg. News 1, 1 (2015).

Petratos claimed Genentech’s data suppression was part of a formal campaign, dubbed “Optimizing Data Value,” during which the company avoided certain analy-ses and data sets that might yield negative results to mitigate its “business risk.” App. 324-26. Petratos asserted that he tried to bring the safety risks inherent in this strategy to the attention of upper management, but was told “to stop any further work in [the] area,” App. 318, and had his job “threatened,” App. 314.

As a consequence of Genentech’s data-suppression strategy, Petratos claimed the company caused physicians to submit Medicare claims that were not “reasonable and necessary.” In the opinion of one oncologist, if Genentech had properly disclosed Avastin’s side-effects for certain at-risk patients, “the standard of care would have been to prescribe a lower dose of Avastin, a lower frequency of doses, or no dose at all.” App. 341.

B

Initially filed in 2011, this case was heard by three judges of the United States District Court for the District of New Jersey. Soon before his retirement, Judge Cavanaugh dismissed Petratos’s initial complaint in part, but granted a stay of the order so Petratos could amend his complaint. The case was reassigned to Judge Wigenton, who rejected Genentech’s argument that an amendment would be futile and held that Petratos “sufficiently alleged causes of action” under the False Claims Act. App. 56. Finally, the case was transferred to Judge Arleo, who took a different tack than Judge Wigenton and reasoned that “medically ‘reasonable and necessary’ is a determination made by the relevant agency, not individual doctors.” App. 16-17. Because Petratos’s theory relied on the doctors as part of the “reasonable and necessary” determination, Judge Arleo deemed the complaint fatally deficient and dismissed all claims. App. 18-19. Petratos filed this timely appeal.

II

The. District Court had subject-matter jurisdiction over Petratos’s federal claim under 28 U.S.C. § 1881 and supplemental jurisdiction over his state-law claims under 28 U.S.C. § 1367. We have appellate jurisdiction under 28 U.S.C. § 1291. We “exercise plenary review of the District Court’s order granting appellees’ motion to dismiss for failure to state a claim.” United States ex rel. Wilkins v. United Health Grp., Inc., 659 F.3d 295, 302 (3d Cir. 2011). We review for abuse of discretion both the District Court’s decision to reconsider a predecessor judge’s ruling, Fagan v. City of Vineland, 22 F.3d 1283, 1290 (3d. Cir. 1994), and its denial of leave to amend the complaint, United States ex rel. Schumann v. Astrazeneca Pharms. L.P., 769 F.3d 837, 849 (3d Cir. 2014).

Ill

A

Petratos’s claims implicate three interlocking federal schemes: the False Claims Act, Medicare reimbursement, and FDA approval. We begin- by briefly outlining each scheme.

The False Claims Act is meant “to reach all types of fraud ... that might result in financial loss to the Government.” Cook Cty. v. United States ex rel. Chandler, 538 U.S. 119, 129, 123 S.Ct. 1239, 155 L.Ed.2d 247 (2003) (quoting United States v. Neifert-White Co., 390 U.S. 228, 232, 88 S.Ct. 959, 19 L.Ed.2d 1061 (1968)). A False Claims Act violation occurs when a person “knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval.” 31 U.S.C. § 3729(a)(1)(A). A claim is legally false when it does not comply “with a statute or regulation the compliance with which is a condition for Government payment.” Wilkins, 659 F.3d at 305.

The allegedly false claims in this case were submitted to the Medicare program, which reimburses the health care costs incurred by program beneficiaries. The Medicare statute provides that “no payment may be made” for items and services that “are not reasonable and necessary for the diagnosis and treatment of illness or injury.” 42 U.S.C. § 1395y(a)(l)(A). Because a claim can be false if it does not comply with statutory conditions for payment, the claims at issue here are false if Avastin was not “reasonable and necessary.” See id.

One important factor considered by the Centers for Medicare and Medicaid Services (CMS) to determine whether a prescribed drug is “reasonable and necessary” is whether it has received FDA approval. Indeed, CMS guidance explains that “with some exceptions, a drug must have final marketing approval from the FDA to be considered ‘reasonable and necessary.’ ” Medicare Benefit Policy Manual, CMS Pub. 100-2, ch. 1, § 30 (Part A). In most instances, the drug must also be used for a “medically accepted indication” — meaning that it has been deemed appropriate for the particular treated condition. 42 U.S.C. § 1395x(t)(2). An indication is “medically appropriate” if it has been approved by the FDA or supported by research in certain authoritative compendia. See id.; 42 C.F.R. § 414.930.

B

A False Claims Act violation includes four elements: falsity, causation, knowledge, and materiality. Universal Health Servs., Inc. v. United States ex rel. Escobar, — U.S. —, 136 S.Ct. 1989, 1996, 195 L.Ed.2d 348 (2016) (materiality); Wilkins, 659 F.3d at 304-05 (falsity, causation, knowledge). The District Court focused on the falsity element, concluding that the disputed claims were not false because they were “reasonable and necessary” as a matter of law.

The District Court reached its conclusion by conflating two separate standards from the Medicare statute. First, the Court noted that § 1395x provides that a drug is used for a “medically accepted indication” when it has been approved by the FDA or listed in authoritative compen-dia. 42 U.S.C. § 1395x(t)(2)(A). It then adopted the rule from another district court case that this “medically accepted” standard is coterminous with the “reasonable and necessary” standard in § 1395y(a)(1)(A). App. 14 (citing United States ex rel. Simpson v. Bayer Corp., 2013 WL 4710587, at *3 (D.N.J. Aug 30, 2013)). Consequently, the District Court held that because “Avastin is approved by the FDA and supported by compendia listings, ... [Petratos cannot] argue that prescriptions [for] Avastin were not ‘reasonable and necessary.’ ” App. 14 (citations omitted) (second alteration in original). The Court explained that its decision aligns with the principle that “ ‘reasonable and necessary’ is a determination made by the relevant agency, not individual doctors.” App. 17.

We disagree with the District Court’s reading of the statute. In our view, its analysis was premised on a false choice, namely, that “this dispute comes down to whether medically ‘reasonable and necessary’ is assessed by doctors individually or is defined by the regulatory scheme.” App. 16. But these two options do not account for all possibilities. As Petratos and the United States argue, a third possibility exists: that the “reasonable and necessary” determination is a process involving the FDA, CMS, and individual doctors. Indeed, CMS guidance, other Medicare provisions and regulations, and canons of statutory construction lead us to conclude that this is the best reading of the statute.

First, CMS guidance makes clear that the “reasonable and necessary” determination does not end with FDA approval. The claim at issue must also be “reasonable and necessary for [the] individual patient” based on “accepted standards of medical practice and the medical circumstances of the individual case.” Medicare Benefit Policy Manual, ch. 15, § 50.4.3 (emphases added). The Manual provides examples of when a drug treatment could be approved by the FDA and used for a medically accepted indication, but still not be “reasonable and necessary.” For example, a drug treatment is not “ ‘reasonable and necessary’ for Medicare Part B if standard medical practice indicates that oral administration (as opposed to injection) ‘is effective and is an accepted or preferred method of administration,’ or if the administration of injections ‘exceed[s] the frequency or duration of injections indicated by accepted standards of medical practice.’ ” United States Br. 21 (quoting Medicare Benefit Policy Manual, ch. 15, § 50.4.3).

Second, other Medicare provisions and regulations underscore the critical role of the physician in Medicare’s payment and reimbursement scheme. The regulations provide that “[t]he physician has a major role in determining utilization of health services furnished by providers. The physician decides upon admissions, orders tests, drugs, and treatments, and determines the length of stay.” 42 C.F.R. § 424.10(a). Under Medicare Parts A and B, it usually is “a condition for Medicare payment that a physician certify the necessity of the services and, in some instances, recertify the continued need for those services.” Id. Indeed, physicians prescribing Avastin often must submit CMS Form 1500 along with a claim for reimbursement, wherein the doctor certifies that the drug was “medically necessary and personally furnished by me or ... my employee under my direct supervision.” United States Br. 29-30 (quoting CMS Form 1500). In addition, the Medicare statute contains a separate section that outlines the obligations of physicians when providing services to plan beneficiaries, including the obligation to provide services “economically and only when, and to the extent, medically necessary.” 42 U.S.C. § 1320c-5(a).

Third, principles of statutory construction show that “medically accepted” and “reasonable and necessary” are not coterminous. “[T]he use of different words or terms within a statute demonstrates that Congress intended to convey a different meaning for those words.” Race Tires Am., Inc. v. Hoosier Racing Tire Corp., 674 F.3d 158, 165 (3d Cir. 2012) (citation omitted). And once this erroneous premise is removed from the District Court’s decision, its analysis falters. See App. 14 (reasoning that because “the ‘reasonable and necessary’ standard [is] coterminous with the ‘medically accepted’ requirement, ... [Petratos cannot concede that] Avastin is approved by the FDA and supported by compendia listings” and “still argue that prescriptions [for] Avastin were not reasonable and necessary”).

The cases cited by the District Court do not hold that the “reasonable and necessary” decision is decided exclusively by federal agencies. Rather, these cases show that federal agencies retain ultimate control over the decision and that Government approval is a necessary component of the determination. See, e.g., United States ex rel. Bodnar v. Secretary of Health & Human Servs., 903 F.2d 122, 125 (2d Cir. 1990). And none of the cited cases purports to eliminate the treating physician from the process. Indeed, other Courts of Appeals have recognized that “Congress intends the physician to be a key figure in determining what services are needed and consequently reimbursable.” Goodman v. Sullivan, 891 F.2d 449, 450 (2d Cir. 1989) (citing Rush v. Parham, 625 F.2d 1150, 1157 (5th Cir. 1980)).

From a practical perspective, this multi-step interpretation makes sense. CMS and the FDA are best positioned to make high-level policy decisions— such as issuing national coverage determinations and drug approvals. These general approvals demarcate what treatments can be considered “reasonable and necessary,” and are thus a necessary condition for reimbursement. Meanwhile, the doctors are best suited to evaluate each patient and determine whether a treatment is “reasonable and necessary for [that] individual patient.” See Medicare Benefit Policy Manual, ch. 15, § 50.4.3 (emphasis added). For example, Avastin is approved by the FDA to treat patients with metastatic colorectal cancer and such prescriptions are reimbursable by CMS. But if a doctor determined that a colorectal cancer patient had five hours to live and would best be treated with palliative care, then prescribing Avastin in that situation may not be “reasonable and necessary.”

C

Although we disagree with the District Court’s reasoning, we may affirm its judgment on any ground supported by the record. See, e.g., Guthrie v. Lady Jane Collieries, Inc., 722 F.2d 1141, 1145 n.1 (3d Cir. 1983). Our review of the record leads us to conclude that Petratos cannot establish materiality, which the False Claims Act defines as “having a natural tendency to influence, or be capable of influencing, the payment or receipt of money.” 31 U.S.C. § 3729(b)(4).

Just last year in Universal Health Services v. United States ex rel. Escobar, the Supreme Court confirmed that “[a] misrepresentation about compliance with a statutory, regulatory, or contractual requirement must be material to the Government’s payment decision in order to be actionable under the False Claims Act.” — U.S. —, 136 S.Ct. 1989, 1996, 195 L.Ed.2d 348 (2016). The Court described this standard as “demanding” and “rigorous,” id. at 2002-03, and explained that a material misrepresentation is one that goes “to the very essence of the bargain,” id at 2003 n.5 (citations omitted). This requirement helps ensure that the False Claims Act does not become “an all-purpose antifraud statute or a vehicle for punishing garden-variety breaches of contract.” Id. at 2003 (citation and internal quotation marks omitted).

The Supreme Court also provided guidance as to how the materiality requirement should be enforced. It explained that a misrepresentation is not material “merely because the Government designates compliance with a particular statutory, regulatory, or contractual requirement as a condition of payment ... [or because] the Government would have the option to decline to pay if it knew of the defendant’s noncompliance.” Id. Materiality may be found where “the Government consistently refuses to pay claims in the mine run of cases based on noncompliance with the particular statutory, regulatory, or contractual requirement.” Id. On the other hand, it is “very strong evidence” that a requirement is not material “if the Government pays a particular claim in full despite its actual knowledge that certain requirements were violated.” Id. Finally, materiality “cannot be found where noncompliance is minor or insubstantial.” Id.

Petratos’s allegations do not meet this high standard. As the District Court noted: “there are no factual allegations showing that CMS would not have reimbursed these claims had these [alleged reporting] deficiencies been cured.” App. 18. Petratos does not dispute this finding, which dooms his case. Simply put, a misrepresentation is not “material to the Government’s payment decision,” when the relator concedes that the Government would have paid the claims with full knowledge of the alleged noncompliance. See Universal Health Servs., 136 S.Ct. at 1996 (emphasis added). Similarly, we think that where a relator does not plead that knowledge of the violation could influence the Government’s decision to pay, the misrepresentation likely does not “have[ ] a natural tendency to influence ... payment,” as required by the statute. See 31 U.S.C. § 3729(b)(4). At a minimum, this would be “very strong evidence” that the misrepresentation was not material. Universal Health Servs., 136 S.Ct. at 2003.

The Supreme Court’s guidance in Universal Health Services also militates against a finding of materiality. The mere fact that § 1395y is a condition of payment, without more, does not establish materiality. See id. In addition, Petratos not only fails to plead that CMS “consistently refuses to pay” claims like those alleged, see id., but essentially concedes that CMS would consistently reimburse these claims with full knowledge of the purported noncompliance. Nor has he cited to a single successful claim under § 1395y involving drugs prescribed for their on-label uses or a court decision upholding such a theory.

Petratos’s allegations are much like the sort of “minor or insubstantial” noncompliance that the Supreme Court explained should not be litigated under the False Claims Act. See id. Petratos does not claim that Genentech’s safety-related reporting violated any statute or regulation. He acknowledges that the FDA would not “have acted differently had Genentech told the truth.” App. 64. And as we have explained, he does not dispute that CMS would reimburse these claims even with full knowledge of the alleged reporting deficiencies.

In fact, Petratos admits that he disclosed “material, non-public evidence of Genentech’s campaign of misinformation” to the FDA and Department of Justice in 2010 and 2011. App. 337. Since that time, the FDA has not merely continued its approval of Avastin for the at-risk populations that Petratos claims are adversely affected by the undisclosed data, but has added three more approved indications for the drug. Nor did the FDA initiate proceedings to enforce its adverse-event reporting rules or require Genentech to change Avastin’s FDA label, as Petratos claims may occur. And in those six years, the Department of Justice has taken no action against Genentech and declined to intervene in this suit.

Since Petratos concedes that the expert agencies and government regulators have deemed these violations insubstantial (or at least would do so if made aware), we do not think it appropriate for a private citizen to enforce these regulations through the False Claims Act. See United States v. Sanford-Brown, Ltd., 840 F.3d 445, 447 (7th Cir. 2016) (dismissing False Claims Act complaint on materiality grounds because “federal agencies in this case have already examined [the claims] multiple times over and concluded that neither administrative penalties nor termination was warranted” (citations and internal quotation marks omitted)). After all, the False Claims Act is not “a blunt instrument to enforce compliance with all ... regulations.” Wilkins, 659 F.3d at 307 (citation omitted).

Petratos’s arguments to the contrary are unpersuasive. First, he claims that materiality is established because “if physicians would have prescribed no or less Avastin, the Government would have paid less claims.” Reply Br. 4. In other words, Petratos argues that materiality can be established by proving that the alleged fraud was the “but for” cause of the submitted claim. Petratos’s argument conflates materiality with causation, a separate element of a False Claims Act cause of action. See Wilkins, 659 F.3d at 304-05. Collapsing the materiality analysis into a causation inquiry would render the materiality element “surplusage” and fail to “give effect ... to every clause and word of [the] statute,” which we are loath to do. Tavarez v. Klingensmith, 372 F.3d 188, 190 (3d Cir. 2004) (citations and internal quotation marks omitted). And even the causation element cannot be met merely by showing “but for” causation. See United States ex rel. Hendow v. Univ. of Phoenix, 461 F.3d 1166, 1174 (9th Cir. 2006) (explaining that the false claim must be “integral to a causal chain leading to payment” (citations omitted)); United States Br. 27 (“The United States does not contend that a claim is necessarily false or fraudulent because an antecedent fraud was a ‘but for’ cause of the claim being submitted.”); cf. Paroline v. United States, — U.S. —, 134 S.Ct. 1710, 1720, 188 L.Ed.2d 714 (2014) (“Proximate cause is a standard aspect of causation in ... the law of torts”). If a “but for” causation theory is insufficient to meet the causation element — where that type of proof is more properly directed — it follows that it should be insufficient to demonstrate materiality.

Petratos next argues that it is incorrect to focus our materiality inquiry on the Government’s payment decision. Rather, he claims that “the relevant question is whether Genentech’s fraudulent misrepresentations were material to the physicians’ determinations.” Reply Br. at 13. Petratos points to Universal Health Services, where the Supreme Court quoted a treatise to explain that “materiality ‘look[s] to the effect on the likely or actual behavior of the recipient of the alleged misrepresentation.’” Universal Health Servs., 136 S.Ct. at 2002 (quoting 26 R. Lord, Williston on Contracts § 69:12, p. 549 (4th ed. 2003)). Petratos reads this language to mean that in indirect-causation cases — where the fraud is first directed at an intermediary who then unwittingly forwards it to the Government for payment — we look solely to the initial recipient of the misrepresentation and not to the Government.

We disagree; The full context of the quotation shows that when the Court wrote “the recipient of the alleged misrepresentation,” it was referring to the Government, not the initial recipient. See id. This makes sense because the Government will always be the recipient of the misrepresentation in the False Claims Act context. See Wilkins, 659 F.3d at 304-05 (explaining that a plaintiff must prove that “the defendant presented or caused to be presented to an agent of the United States a claim for payment” (emphasis added) (citation omitted)). Indeed, when the Court turned to materiality in the False Claims Act — specific context, it exclusively referred to the Government as the ultimate recipient of the misrepresentation. Universal Health Servs., 136 S.Ct. at 1996 (“A misrepresentation about compliance with a statutory, regulatory, or contractual requirement must be material to the Government’s payment decision in order to be actionable under the False Claims Act.” (emphasis added)).

Our sister courts have interpreted Universal Health Services the same way. See, e.g., United States ex rel. Garzione v. PAE Gov’t Servs., Inc., 670 Fed.Appx. 126, 127 (4th Cir. 2016) (“The relevant question is whether the defendant knowingly violated a requirement that the defendant knows is material to the government’s decision to pay a claim.”); United States ex rel. Escobar v. Universal Health Servs., Inc., 842 F.3d 103, 109 (1st Cir. 2016) (“In order for False Claims Liability to attach, these misleading omissions must be material to the government’s decision to pay the claim.”); United States v. Sanford-Brown, Ltd., 840 F.3d 445, 447 (7th Cir. 2016) (dismissing claim where there was “no evidence that the government’s decision to pay [the claim] would likely or actually have been different had it known of [the violation]”). Besides, it would make little practical sense to give the doctors’ materiality determinations dispositive weight. Because the False Claims Act was passed to protect the federal treasury, United States v. McNinch, 356 U.S. 595, 599, 78 S.Ct. 950, 2 L.Ed.2d 1001 (1958), and since the Government decides on payment, Universal Health Servs., 136 S.Ct. at 1996, it is the Government’s materiality decision that ultimately matters.

By attempting to focus our inquiry solely on the physician’s materiality determination, Petratos again tries to pass off restyled causation arguments as proof of materiality. The alleged fraud’s effect on physicians is relevant to the extent that it caused claims eventually to reach CMS. That is, evidence of how the claim makes its way to the government should be considered under the causation analysis, while the materiality analysis begins after a claim has been submitted. The materiality inquiry, in asking whether the government’s payment decision is affected, assumes that the claim has in fact reached the government. See Universal Health Servs., 136 S.Ct. at 1996.

The Supreme Court’s treatment of indirect-causation cases confirms this result. In United States ex rel. Marcus v. Hess, the defendant contractors submitted fraudulent bids to local governments for various projects funded by the federal government. 317 U.S. 537, 542-43, 63 S.Ct. 379, 87 L.Ed. 443 (1943). Even though the fraud was not directed at the federal government in the first instance, the Court held the defendants liable because their “fraud did not spend itself with the execution of the contract,” but rather “taint[ed]” the claims paid by the United States. Id. at 543-44, 63 S.Ct. 379. In other words, if the fraud had deceived only the initial recipients (and not the government), then the defendants would not have been liable under the False Claims Act. Therefore, the alleged fraud must affect the United States’ payment decision to be actionable. Following this logic, our focus here should not be whether the alleged fraud deceived the prescribing physicians, but rather whether it affected CMS’s payment decision. Because it did not, Petratos’s claim fails.

In holding that Petratos did not sufficiently plead materiality, we now join the many other federal courts that have recognized the heightened materiality standard after Universal Health Services. See, e.g., United States ex rel. Kelly v. Serco, Inc., 846 F.3d 325, 333-35 (9th Cir. 2017); San ford-Brown, 840 F.3d at 447; City of Chicago v. Purdue Pharma L.P., 211 F.Supp.3d 1058, 1078-79 (N.D. Ill. 2016); United States ex rel. Scharff v. Camelot Counseling, 2016 WL 5416494, at *8 (S.D.N.Y. Sept. 28, 2016); United States v. N. Adult Daily Health Care Ctr., 205 F.Supp.3d 276, 295-96 (E.D.N.Y. 2016); Knudsen v. Sprint Commc’ns Co., 2016 WL 4548924, at *12-13 (N.D. Cal. Sept. 1, 2016); cf. Escobar, 842 F.3d at 111 (finding FCA violations material where those violations were “as central to the bargain as the United States ordering and paying for a shipment of guns, only to later discover that the guns were incapable of firing”).

IV

We turn next to what is essentially a procedural challenge. Petratos claims that Judge Arleo erred by granting Genen-tech’s motion to dismiss in light of Judge Wigenton’s earlier finding that Petratos had “sufficiently alleged causes of action.” App. 56. He alleges that Judge Arleo did not satisfy our rule that absent “ ‘exceptional circumstances,’ ‘judges of co-ordinate jurisdiction sitting in the same court and in the same case should not overrule the decisions of each other.’ ” Petratos Br. 22 (quoting Hayman Cash Register Co. v. Sarokin, 669 F.2d 162, 168 (3d Cir. 1982) (citation omitted)).

Though Petratos does not cite it by name in his opening brief, he invokes the “law of the case” doctrine: a judicial rule of practice meant to “maintain consistency and avoid reconsideration of matters once decided during the course of a single continuing lawsuit.” 18 Charles A. Wright & Arthur R. Miller, Federal Practice and Procedure § 4478 (2d ed.). The law of the case doctrine is unhelpful to Petratos because it “does not limit the power of trial judges to reconsider their [own] prior decisions.” Williams v. Runyon, 130 F.3d 568, 573 (3d Cir. 1997). Therefore, “[ijnterlocu-tory orders ... remain open to trial court reconsideration, and do not constitute the law of the case.” Perez-Ruiz v. Crespo-Guillen, 25 F.3d 40, 42 (1st Cir. 1994). And the grant of a leave to amend is an interlocutory order. Powers v. Southland Corp., 4 F.3d 223, 229 (3d Cir. 1993). Therefore, Judge Wigenton’s order granting leave to amend was not the law of the case — and Judge Arleo was within her discretion to disagree with it.

That this case was transferred between judges does not change the result. Although the doctrine provides that “a successor judge should not lightly overturn decisions of [her] predecessors in a given case,” “it does not limit the power of trial judges from reconsidering issues previously decided by a predecessor judge from the same court.” Fagan, 22 F.3d at 1290; see also Rimbert v. Eli Lilly & Co., 647 F.3d 1247, 1252 (10th Cir. 2011) (explaining that the “law of the case doctrine has no bearing on the revisiting of interlocutory orders, even when a case has been reassigned from one judge to another”).

V

Finally, Petratos argues that the District Court abused its discretion because it denied his request for leave to amend without explanation. But there was nothing to explain. Petratos offered no reason why leave to amend was appropriate or what his amendment would have looked like. His cursory request for leave was contained in the final clause of his brief opposing Genentech’s motion to dismiss. See App. 99 (“Relator respectfully requests that this Court deny Genentech’s motion in its entirety or, alternatively, that Relator be granted leave to amend.”). This threadbare recital was insufficient. “While Federal Rule 15(a) provides that leave to amend shall be freely given when justice so requires, a mere request in [a brief in] opposition to a motion to dismiss — without any indication of the particular grounds on which amendment is sought — does riot constitute a motion within the contemplation of Rule 15(a).” U.S. ex rel. Williams v. Martin-Baker Aircraft Co., 389 F.3d 1251, 1259 (D.C. Cir. 2004) (citation omitted). Because Petratos did not properly seek leave to amend in the District Court, we will not consider this argument on appeal.

Petratos’s allegations may be true and his concerns may be well founded — but a False Claims Act suit is not the appropriate way to address them. He concedes that Genentech followed all pertinent statutes and regulations. If those laws and regulations are inadequate to protect patients, it falls to the other branches of government to reform them. We will affirm the judgment of the District Court.

      . A claim may be factually or legally false. Wilkins, 659 F.3d at 305. "A claim is factually false when the claimant misrepresents what goods or services that it provided to the Government.” Id. Although Petratos halfheartedly argues that the claims at issue are factually false, he is incorrect. There is no dispute that the physicians actually provided the claimed good (Avastin) in the claimed doses.

      . The Court also rejected the argument that materiality is "too fact intensive” to allow dismissal at the pleading stage, explaining that plaintiffs must “plead[] facts to support allegations of materiality.” Id. at 2004 n.6.

      . Having reached this conclusion, it follows that Petratos's two related claims also fail. Petratos’s state law claims are, as he notes, dependent on the viability of his FCA claim. See Petratos Br. 54 (arguing that because “dismissal of the FCA claims was in error, the dismissal of the other claims should be reversed.”). The same is true for his "reverse” FCA claims. A reverse false claim occurs when a defendant acts improperly to avoid paying an “obligation” owed to the government. 31 U.S.C. § 3729(a)(1)(G). But Genen-tech did not violate the FCA and, as the District Court noted, Petratos "provides no other basis for reverse false claims liability.” App. 21.


author: RESTREPO, Circuit Judge.

text:
    Yusef STEELE, Appellant v. Warden CICCHI; Deputy Warden F. Masone; Internal Affairs Sgt. De Amicis; Captain C. Barth
    No. 14-3127
    United States Court of Appeals, Third Circuit.
    Argued: June 16, 2016
    (Filed: May 3, 2017)

      MICHAEL S. DOLUISIO, CATHERINE V. WIGGLESWORTH, Dechert, 2929 Arch Street, 18th Floor, Cira Centre, Philadelphia, PA 19104, WILLIAM STEWART [ARGUED], University of Pennsylvania, School of Law, 3400 Chestnut Street Philadelphia, PA 19104, Counsel for Appellant.
    LORI A. DVORAK [ARGUED], Dvorak & Associates, 390 George Street, 8th Floor, New Brunswick, NJ 08901, Counsel for Appellee Edmond Cicchi.
    CLARK W. CONVERY, Convery Con-very & Shihar, 32 South Main Street, Edison, NJ 08837, Counsel for Appellee Deputy Warden F. Masone.
    PATRICK J. BRADSHAW, Kelso & Bradshaw, 132 Hamilton Street, P.O. Box 1208, New Brunswick, NJ 08903, Counsel for Appellee Internal Affairs Sgt. De Arm-éis.
    SUSAN K. O’CONNOR, Hoagland Lon-go Moran Dunst & Doukas, 40 Paterson Street, P.O. Box 480, Room 301, New Brunswick, NJ 08903, Counsel for Appel-lee Captain C. Barth.
    Before: AMBRO, RESTREPO, and NYGAARD, Circuit Judges

       Mr. Stewart, a law student, was permitted to enter his appearance and participate in oral argument pursuant to Third Circuit L.A.R. 46.3. We note that Mr. Stewart and his supervising attorneys represented Appellant pro bono. We thank them for taking this case on a pro bono basis and for their excellent advocacy on Appellant’s behalf.

   OPINION OF THE COURT

RESTREPO, Circuit Judge.

Plaintiff/Appellant Yusef Steele was a pretrial detainee housed at the Middlesex County Adult Correction Center (“MCACC”) in New Jersey in late 2008 and early 2009. During the course of his detention at MCACC, officials at the facility received credible information that Steele was involved in a scheme with an outside bail bonds service, Speedy Bail Bonds. Officials believed that Steele was threatening other detainees in order to coerce them into using Speedy and that Steele was receiving some form of compensation from Speedy for his efforts. After interviewing Steele and advising him of the allegations against him, officials placed him in administrative segregation while they continued to investigate his conduct. During his time in segregation, Steele’s telephone privileges were restricted to legal calls only.

Steele claims in this Section 1983 suit that the DefendanVAppellee MCACC officials violated his due process rights when they transferred him to administrative segregation in the facility and restricted his phone privileges, which interfered with his ability to attempt to find a co-signer for his own bail. The District Court granted summary judgment for all Defendants. For the reasons that follow, we will affirm.

I. FACTUAL BACKGROUND

On December 22, 2008, Steele was arrested for violating a narcotics restraining order. He was then placed into pretrial detention at MCACC. The next day, Steele’s bail was set at $50,000, which he was unable to pay.

On February 23, 2009, while Steele remained in detention at MCACC, Robert Gluck, a private attorney, contacted MCACC Deputy Warden Masone about safety concerns Gluck had for his client, another MCACC detainee. According to Gluck, Steele approached Gluck’s client and threatened to disclose his client’s sex offense charges to MCACC’s general population if Gluck’s client did not use a specific bail bonds service, Speedy Bail Bonds. Gluck reported that Steele handed his client a document that listed his client’s charges and bail amount. Gluck also faxed to Masone a copy of the document.

After obtaining this information from Gluck, Masone and Sergeant Paul De Ami-cis began an investigation of Steele and Speedy’s activities within MCACC. They interviewed Gluck’s client, who confirmed that Steele threatened him and provided him with a specific phone number to use to arrange his bail. Masone and De Amicis confirmed that the phone number belonged to a Speedy office.

De Amicis continued the investigation by reviewing recorded phone calls from the unit in which Steele was housed. He found numerous calls between Steele and Speedy, during which Steele referenced detainees’ names, identification numbers, and the specific amounts of their bails. According to De Amicis, Steele bragged in some of those phone conversations about “his ability to get other inmates to post bail using Speedy” and Steele “referred to credit he expected to receive for bails he recruited for Speedy.” App. 1312. Based on the results of the preliminary investigation, MCACC officials believed that Steele “was acting as an illegal agent for Speedy” and that he was receiving some type of compensation from Speedy in exchange for his efforts to arrange detainees’ bails. App. 1312.

MCACC officials met with Steele on February 25, 2009, just two days after Gluck’s call, to discuss the allegations. During the meeting, MCACC officials apprised Steele of a complaint they received that he had been “making money for the bail bondsmen,” “threatening inmates,” and “trying to get money out of [them].” App. 1303. Officials asked Steele to explain his actions with Speedy and permitted him to respond to their questions. Steele admitted to helping other detainees arrange bails, but denied that he was receiving any compensation from Speedy. Steele stated that he was arranging detainees’ bails with Speedy “out of the goodness of [his] heart.” App. 1305. As officials were meeting with Steele on February 25th, MCACC corrections officers searched Steele’s cell and found materials that corroborated the allegations against him. These materials included lists of detainees’ names, bail-amounts, and phone numbers of detainees’ friends and relatives.

That same day, Steele was transferred to administrative segregation. De Amicis averred that Steele was placed in administrative segregation in order “to prevent him from posing additional security risks in the [MCACC] and to allow further investigation into Speedy’s activities without [Steele’s] interference.” App. 1313. Later in the day on February 25th, Masone and De Amicis met with employees of Speedy, who confirmed that Steele was an “associate” who was recruiting other detainees to use Speedy for their bail bonds. App. 1313. After further investigation, MCACC officials contacted the county prosecutor’s office and the New Jersey Department of Banking and Insurance.

The MCACC “Inmate Guidelines” manual (“the Manual”), which served as a guide for inmate conduct and jail procedures, contained a number of provisions addressing telephone access at the facility. It provided that individuals housed in the general population had open access to collect call telephones for personal calls and were allowed an unlimited number of legal calls. It also provided that individuals placed in “disciplinary lockup” were not permitted telephone access, with the exception of legal telephone calls. App. 1345. The Manual did not address telephone access for detainees housed in administrative segregation. While he remained in administrative segregation, Steele was permitted only to make legal calls, through the MCACC social work office.

On March 5, 2009, Steele’s bail was reduced from $50,000 to $2,500. Thereafter, Steele made three attempts to contact his attorney to help him obtain a co-signer for his bail. Steele reached the attorney’s secretary twice, and made contact with his lawyer on his third attempt. On March 20, 2009, Steele’s bail was posted and he was released.

II. PROCEDURAL HISTORY

Steele originally filed this action pro se in July 2009 in the United States District Court for the District of New Jersey. The operative Amended Complaint was filed pro se in May 2012. In his Amended Complaint, Steele asserted several claims under 42 U.S.C. § 1983: violations of his First, Eighth, and Fourteenth Amendment rights.

In December 2013, after five rounds of summary judgment motions, the District Court granted summary judgment to Defendants as to Steele’s First and Eighth Amendment claims. The Court denied summary judgment as to Steele’s claims under the Due Process Clause of the Fourteenth Amendment, but permitted Defendants to move for summary judgment again on those claims in January 2014. In May 2014, the District Court granted summary judgment to all Defendants on Steele’s Fourteenth Amendment claims, holding that they did not violate Steele’s rights under the substantive and procedural components of the Due Process Clause. Steele filed this timely appeal.

III. JURISDICTION & STANDARD OF REVIEW

The District Court had jurisdiction over this Section 1983 action pursuant to 28 U.S.C. § 1331. We have jurisdiction over this appeal pursuant to 28 U.S.C. § 1291.

Summary judgment is appropriate where the moving party carries its burden to establish that “there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). “We review an award of summary judgment de novo, applying the same test on review that the District Court should have applied.” MBIA Ins. Corp. v. Royal Indem. Co., 426 F.3d 204, 209 (3d Cir. 2005). That is, we review “the facts in the light most favorable to the nonmoving party and draw all inferences in that party’s favor.” Burns v. PA Dep’t of Corr., 642 F.3d 163, 170 (3d Cir. 2011) (quoting Armbruster v. Unisys Corp., 32 F.3d 768, 777 (3d Cir. 1994)).

IV. DISCUSSION

The Due Process Clause of the Fourteenth Amendment prohibits states from “depriv[ing] any person of life, liberty, or property, without due process of law,” U.S. Const, amend. XIV, and contains both substantive and procedural components, Cty. of Sacramento v. Lewis, 523 U.S. 833, 845-46, 118 S.Ct. 1708, 140 L.Ed.2d 1043 (1998). Steele claims that Defendants violated both components, which we address in turn below.

A. Substantive Due Process

“The substantive component of the Due Process Clause limits what government may do regardless of the fairness of procedures that it employs,” Boyanowski v. Capital Area Intermediate Unit, 215 F.3d 396, 399 (3d Cir. 2000), in order to “guarantee protection] against government power arbitrarily and oppressively exercised,” Lewis, 523 U.S. at 846, 118 S.Ct. 1708 (citing Daniels v. Williams, 474 U.S. 327, 331, 106 S.Ct. 662, 88 L.Ed.2d 662 (1986)). To maintain a substantive due process claim, Steele must have been deprived of a particular interest that “is protected by the substantive due process clause.” Chainey v. Street, 523 F.3d 200, 219 (3d Cir. 2008).

Steele claims that Defendants’ actions infringed on four separate liberty interests. First, he asserts that Defendants interfered with his “constitutionally-protected liberty interest” in “posting bail once his bail was set.” Br. of Appellant 16 (capitalization omitted). Second, Steele argues that by placing him in administrative segregation, Defendants interfered with his constitutional liberty interest in avoiding punishment prior to an adjudication of guilt. Third, Steele contends that Defendants interfered with his “state-created liberty interest ]” in accessing the telephones at MCACC, an interest that Steele argues was created by the MCACC Manual. Br. of Appellant 24. Fourth, Steele argues that his administrative segregation violated his “state-created liberty interest in remaining part of the general prison population.” Suppl. Br. of Appellant 1-2.

As an initial matter, Steele cannot proceed on his third and fourth claimed liberty interests, because substantive due process claims do not arise out of state-created liberty interests. In contrast to procedural due process rights, which may be derived from state law, “[s]ubstan-tive due process rights are founded not upon state law but upon deeply rooted notions of fundamental personal interests derived from the Constitution.” Nunez v. Pachman, 578 F.3d 228, 233 (3d Cir. 2009) (quoting Nilson v. Layton City, 45 F.3d 369, 372 (10th Cir. 1995)); see also Regents of Univ. of Mich. v. Ewing, 474 U.S. 214, 229, 106 S.Ct. 507, 88 L.Ed.2d 523 (1985) (Powell, J., concurring) (explaining that procedural due process protects certain interests even though those interests are “derived from state law rather than the Constitution,” but “substantive due process rights are created only by the Constitution”). Therefore, as we examine Steele’s substantive due process claims here, we consider only Steele’s two claimed constitutionally protected liberty interests, which are themselves interrelated. These are: (1) exercising his bail option once his bail was set, and (2) remaining free from punishment before an adjudication of guilt.

1. Exercising bail option

There is no dispute between the parties that Steele had a constitutionally protected liberty interest in exercising his bail option, once bail had been set, sufficient to trigger substantive due process protection. We agree. Such a right emanates from the liberties “at the heart” of the Due Process Clause: the freedom “from government custody, detention, or other forms of physical restraint” prior to any determination of guilt. Zadvydas v. Davis, 533 U.S. 678, 690, 121 S.Ct. 2491, 150 L.Ed.2d 653 (2001); see also Foucha v. Louisiana, 504 U.S. 71, 80, 112 S.Ct. 1780, 118 L.Ed.2d 437 (1992) (“Freedom from bodily restraint has always been at the core of the liberty protected by the Due Process Clause from arbitrary governmental action”). The Supreme Court has ex-, plained that an arrestee’s right to freedom from pretrial detention is subordinated to other interests only in specific circumstances — particularly where there has been an adjudication that detention is necessary because an “arrestee presents an identified and articulable threat to an individual or the community,” United States v. Salerno, 481 U.S. 739, 750-51, 107 S.Ct. 2095, 95 L.Ed.2d 697 (1987), or to “ensure [an arrestee’s] presence at trial,” Bell v. Wolfish, 441 U.S. 520, 523, 99 S.Ct. 1861, 60 L.Ed.2d 447 (1979). But those circumstances do not exist in a case like this one, where there has already been a judicial determination that an arrestee is eligible for release on bail and bail has been set for that arrestee.

Other Circuits acknowledge that substantive due process protection of this liberty interest attaches once arrestees are deemed eligible for release on bail. For instance, in Dodds v. Richardson, the Tenth Circuit explained that “an arrestee obtains a liberty interest in being freed of detention once his bail is set because the setting of bail accepts the security of the bond for the arrestee’s appearance at trial.” 614 F.3d 1185, 1192 (10th Cir. 2010). Likewise, the Eleventh Circuit held in Campbell v. Johnson that “[t]he Fourteenth Amendment Due Process Clause includes the right to be free from continued detention after it was or should have been known that the detainee was entitled to release.” 586 F.3d 835, 840 (11th Cir. 2009) (internal quotation marks omitted). Accordingly, we conclude that Steele had a protected liberty interest in exercising his bail option once his bail was set.

Having established that his asserted liberty interest is protected by substantive due process, Steele must also show that “the government’s deprivation of that protected interest shocks the conscience.” Chainey, 523 F.3d at 219. The Supreme Court has instructed that we must apply the “shocks the conscience” standard where, as here, the challenged government action is executive in nature rather than legislative. See Lewis, 523 U.S. at 845-47, 118 S.Ct. 1708. “[T]he exact degree of wrongfulness necessary to reach the ‘conscience-shocking’ level” will “de-pende ] upon the circumstances of a particular case,” and may range from “deliberate indifference” to “actual intent to cause harm.” Vargas v. City of Phila., 783 F.3d 962, 973 (3d Cir. 2015) (internal quotation marks omitted). We cannot say that Defendants’ actions here amount to even deliberate indifference.

MCACC officials permitted Steele, during his time in administrative segregation, to make calls to his attorney to arrange for bail. Indeed, Steele made three such phone calls to his attorney’s office, through the MCACC social work office, beginning the day after Steele’s bail was reduced from $50,000 to $2,500. Steele offered no evidence that MCACC staff prevented or inhibited him from attempting to contact his attorney via phone. Steele also offered nothing to suggest that his attorney was ill-equipped to assist Steele with arranging bail. In addition, Steele’s access to mail was not restricted during his time in segregation. In short, though MCACC officials curtailed Steele’s unlimited, non-legal phone privileges during his administrative segregation, officials preserved two key channels of communication through which Steele could attempt to secure his bail while in segregation.

Steele’s circumstances are distinguishable from the arrestees’ circumstances in Dodds and Campbell. In Dodds, after a judge set the plaintiff-arrestee’s bond, two individuals asked employees at the jail where the plaintiff was housed about posting bond on the plaintiffs behalf. Dodds, 614 F.3d at 1189-90. Those individuals were told in response by jail employees that bond would not be accepted before the plaintiff was arraigned by a judge, consistent with local policies. Id. The Tenth Circuit concluded that evidence showing the defendants’ policies “prevented felony arrestees whose bail had been set from posting bail after hours and before arraignment” was sufficient to overcome summary judgment on plaintiffs due process claim. Id. at 1206 (emphasis added).

In Campbell, jail administrators refused to accept court-approved real estate documents as security for the plaintiff-arres-tee’s bail for months after his bail was set. Campbell, 586 F.3d at 838-39. The Eleventh Circuit found this evidence sufficient to overcome summary judgment on the plaintiffs due process claim. Id. at 840-42; see also Gaylor v. Does, 105 F.3d 572 (10th Cir. 1997) (reversing grant of summary judgment for defendants on plaintiff-arres-tee’s due process claim, where bail was set but was never communicated to the plaintiff or other individuals inquiring about it). Officials’ actions in Dodds and Campbell unreasonably inhibited, and essentially prevented, the plaintiffs from exercising their bail options after bail was set. On the record before us, we cannot say that MCACC officials put Steele in the same predicament.

At bottom, we cannot agree with Steele’s argument that in the specific circumstances of this case substantive due process required Defendants to provide Steele with unlimited, non-legal telephone privileges during his time in administrative segregation so that he could attempt to find a co-signer for his bail and exercise his bail option. Defendants’ limitation of Steele’s phone privileges did not “shock the conscience,” and therefore, Steele’s claim that Defendants violated his due process right to exercise his bail option fails.

2. Freedom from punishment

Steele also claims that his placement in administrative segregation violated his substantive due process right to be free from punishment. Under the analytical framework established in Bell, detention officials’ restrictions on pretrial detainees will constitute punishment prohibited by the Due Process Clause when: (1) “there is a showing of express intent to punish on the part of [those] [] officials”; (2) “the restriction or condition is not rationally related to a legitimate non-punitive government purpose,” i.e., “if it is arbitrary or purposeless”; or (3) “the restriction is excessive in light of that purpose.” Stevenson, 495 F.3d at 67-68 (quoting Rapier, 172 F.3d at 1005). Of these three possible means to establish punishment, Steele asserts only the second and third; he has not argued in his briefing that such an intent to punish was express in nature.

The term “punishment” in this context warrants further explanation. “Punishment,” as used in Bell, refers to the punishment of a pretrial detainee for his alleged criminal conduct, committed prior to his detention, for which he has not yet been convicted. Bell, 441 U.S. at 535-36, 99 S.Ct. 1861. The Supreme Court explained that this type of “punishment” is prohibited by the Due Process Clause because the detainee “ha[d] not been adjudged guilty of any crime” and “had only a ‘judicial determination of probable cause as a prerequisite to [the] extended restraint of [his] liberty following arrest.’ ” Id. at 536-37, 99 S.Ct. 1861 (quoting Ger- stein v. Pugh, 420 U.S. 103, 114, 95 S.Ct. 854, 43 L.Ed.2d 54 (1975)). Bell did not concern the type of “punishment” or discipline alleged in this case: punishment of a detainee for his in-facility conduct that might violate the facility’s rules and policies. Despite the apparent distinctions between Bell and cases where a detainee claims that he was “punished” for his in-facility conduct, we agree with the First Circuit’s determination in Collazo-Leon v. U.S. Bureau of Prisons that the “theoretical constitutional premises of Bell’s analysis provides some rational guidance” for evaluating claims involving in-facility conduct that could warrant disciplinary action. 51 F.3d 315, 317-18 (1st Cir. 1995),

With that understanding, we turn to the question of whether Defendants had a “legitimate governmental objective” in transferring Steele to administrative segregation in this case. Steele argues that his segregation did not serve any rational purpose other than punishment. Viewing the evidence in the light most favorable to Steele, as we must, we cannot agree that Steele has presented evidence sufficient to create a genuine dispute of material fact on this issue. The record shows that Steele was placed into administrative segregation for internal security reasons.

The Supreme Court repeatedly has emphasized that maintaining internal security and order in jails and prisons are “legitimate governmental objectives” and that courts must give prison officials considerable discretion to manage internal security in their institutions. See, e.g., Sandin v. Conner, 515 U.S. 472, 482-83, 115 S.Ct. 2293, 132 L.Ed.2d 418 (1995) (“[FJederal courts ought to afford appropriate deference and flexibility to state officials trying to manage a volatile environment.”); Hewitt v. Helms, 459 U.S. 460, 472, 103 S.Ct. 864, 74 L.Ed.2d 675 (1983) (“Prison administrators ... should be accorded wide-ranging deference in the adoption and execution of policies and practices that in their judgment are needed to preserve internal order and discipline and to maintain institutional security.” (quoting Bell, 441 U.S. at 547, 99 S.Ct. 1861)), receded from on other grounds by Sandin, 515 U.S. at 482-83, 115 S.Ct. 2293; Bell, 441 U.S. at 561, 99 S.Ct. 1861 (“Ensuring security and order at the institution is a permissible non-punitive objective, whether the facility houses pretrial detainees, convicted inmates, or both.”). Courts must afford such deference because “assessing the seriousness of a threat” requires officials to do more than simply take stock of the “specific facts surrounding a particular incident; instead, they must consider the character of the inmates confined in the institution, recent and longstanding relations between prisoners and guards, prisoners inter se, and the like.” Hewitt, 459 U.S. at 474, 103 S.Ct. 864.

Of course, officials’ discretion is not unbridled. They cannot insulate themselves from liability under the Due Process Clause by mechanically citing to broad internal security interests, regardless of how insignificant or unlikely to .occur a particular threat might be. But the record before us suggests that the threat posed to internal security by Steele’s conduct was legitimate and ongoing. MCACC officials had evidence that Steele was conducting an illegal bail bonds scheme with Speedy over the phone. They also believed that Steele’s actions endangered other detainees in the facility because Steele was threatening to disclose detainees’ charges to the general MCACC population if those detainees did not use Speedy’s service. So Steele “was placed in administrative segregation ... to prevent him from posing any additional security risks in the facility,” and to allow for continued investigation, without Steele’s interference. App. 1313.

Steele appears to argue further that even if mitigating against security risks was the legitimate, non-punitive purpose behind Defendants’ actions, placement in administrative segregation was “excessive” in light of this purpose. Stevenson, 495 F.3d at 67-68. Steele posits that, instead of transferring him to administrative segregation, MCACC officials “could simply have monitored [him] more closely, or further limited his movements and communication opportunities with other prisoners.” Suppl. Br. of Appellant 3. But the Due Process Clause does not mandate that MCACC officials use the least restrictive means available to accomplish their non-punitive objective. See Bell, 441 U.S. at 542 n.25, 561, 99 S.Ct. 1861; see also Block v. Rutherford, 468 U.S. 576, 590 n.10, 591 n.11, 104 S.Ct. 3227, 82 L.Ed.2d 438 (1984) (noting that “administrative officials are not obliged to adopt the least restrictive means to meet their legitimate objectives”). Indeed, the Supreme Court was careful to explain in Bell that “[gjovern-mental action does not have to be the only alternative or even the best alternative for it to be reasonable, to say nothing of constitutional.” Bell, 441 U.S. at 542 n.25, 99 S.Ct. 1861; see also Proctor v. LeClaire, 846 F.3d 597, 609 (2d Cir. 2017) (stating that the Supreme Court made clear in Hewitt that administrative segregation “is appropriate when necessary to incapacitate an inmate who ‘represents a security threat’ or to ‘complet[e] ... an investigation into misconduct charges’ ” (quoting Hewitt, 459 U.S. at 476, 103 S.Ct. 864)).

Steele’s transfer to administrative segregation was not an excessive response by MCACC officials to legitimate internal security concerns. As discussed, MCACC officials believed that Steele’s alleged bail bonds scheme posed a risk to other detainees because they had received information that Steele threatened to disclose a detainee’s sex offense charges to the general population as part of the scheme. In light of these security concerns, it was a non-excessive response for MCACC officials to temporarily remove Steele from the general population, where he would be in a position to make such threats to other detainees, while they investigated his conduct.

In sum, Steele has not met his “heavy burden of showing that [Defendants] have exaggerated their response to the genuine security considerations that actuated” his move to more restrictive conditions. Bell, 441 U.S. at 561-62, 99 S.Ct. 1861. Therefore, we conclude that Steele’s transfer to administrative segregation did not violate his substantive due process rights under Bell.

B. Procedural Due Process

In addition to his substantive due process claims, Steele asserts that Defendants denied his procedural due process rights when they transferred him to administrative segregation. To maintain a procedural due process claim, Steele must show that: (1) Defendants deprived him of an individual liberty interest that is encompassed within the Fourteenth Amendment’s protection, and (2) the procedures Defendants made available to him did not provide due process of law. Hill v. Borough of Kutztown, 455 F.3d 225, 233-34 (3d Cir. 2006). The liberty rights protected by procedural due process are broader than those protected by substantive due process; they “may arise from the Constitution itself, by reason of guarantees implicit in the word ‘liberty,’ ” or they “may arise from an expectation or interest created by state laws or policies.” Wilkinson v. Austin, 545 U.S. 209, 221, 125 S.Ct. 2384, 162 L.Ed.2d 174 (2005); see also Layton v. Beyer, 953 F.2d 839, 845 (3d Cir. 1992). Interests in the latter category are often referred to as “state-created” liberty interests.

Assuming without deciding that Steele’s claimed liberty interests are protected, we agree with the District Court that Steele has not shown a genuine issue of material fact as to whether Defendants provided due process of law. The Supreme Court has explained that when an individual is transferred to administrative segregation because he is “feared to be a threat to institutional security,” detention officials must provide only

an informal, nonadversary evidentiary review ... for the decision that an inmate represents a security threat and the decision to confine an inmate to administrative segregation pending completion of an investigation into misconduct charges against him. An inmate must merely receive some notice of the charges against him and an opportunity to present his views to the prison official charged with deciding whether to transfer him to administrative segregation .... So long as this occurs, and the decisionmaker reviews the charges and then-available evidence against the prisoner, the Due Process Clause is satisfied.

Hewitt, 459 U.S. at 474, 476, 103 S.Ct. 864; see also Stevenson, 495 F.3d at 70 (citing Hewitt). This informal review must take place “within a reasonable time following an inmate’s transfer.” Hewitt, 459 U.S. at 476 n.8, 103 S.Ct. 864.

Steele does not argue that he received insufficient process under Hewitt. Indeed, he appears to acknowledge that he received notice of the allegations against him in an interview with prison officials that took place prior to his transfer. Steele himself testified that he was informed during the February 25, 2009, meeting that MCACC officials had received a complaint about him “making money for the bail bondsmen” and “threatening, inmates” to “try[] to get money out of them.” App. 1303. Steele was clear in his deposition that he understood the nature of the allegations against him, explaining that in “[t]he first meeting I’m getting the information. Now I know what’s going on. Now I know that they are saying that, okay, we think that you’re getting paid for every bail that you bring to them.... We think that you’re doing this wrong. We think you’re doing this illegal.” App. 1305. Steele admitted during the February 25th meeting that he had arranged bail bonds with Speedy for other inmates, but claimed he was arranging the bonds “out of the goodness of [his] heart.” App. 1305. There is no evidence in the record to suggest that Steele sought and was denied the opportunity to present any additional facts or evidence in support of his position. And while MCACC officials may not have believed Steele’s explanation for his conduct, there is no evidence in the record to suggest that they failed to consider his explanation.

The focus of Steele’s procedural due process challenge circles back to Defendants’ asserted reasons for transferring Steele to administrative segregation. He argues that he was transferred for disciplinary reasons, and, therefore, due process protections required MCACC officials to provide him with a written statement of the evidence and charges against him, which he did not receive. See Stevenson, 495 F.3d at 70-71. For the reasons already noted, however, we agree with the District Court that the summary judgment record in this case shows that Steele’s transfer was for institutional security reasons rather than for discipline or punishment. Steele was administratively separated from the general MCACC population pending further investigation into his conduct and Speedy’s activities within the MCACC. Therefore, he was due the level of process outlined in Hewitt,

Steele also contends throughout his briefing that Defendants violated the Due Process Clause by failing to follow the procedures outlined in the Manual. Even if we were to find that the parties’ actions implicated certain procedures set forth in the Manual, there is no standalone protected liberty interest in those procedures. See Rodriguez v. McLoughlin, 214 F.3d 328, 339 (2d Cir. 2000) (explaining that a state statute “that merely establishes procedural requirements does not thereby create a liberty interest, because an expectation of receiving process is not, without more, a liberty interest protected by the Due Process Clause” (internal quotation marks omitted)). The Supreme Court has explained that

[p]rocess is not an end in itself. Its constitutional purpose is to protect a substantive interest to which the individual has a legitimate claim of entitlement. ... The State may choose to require procedures for reasons other than protection against deprivation of substantive rights, of course, but in making that choice the State does not create an independent substantive right.

Olim v. Wakinekona, 461 U.S. 238, 250-51, 103 S.Ct. 1741, 75 L.Ed.2d 813 (1983). In other words, a valid due process claim will not automatically follow from Defendants’ failure to abide by the Manual’s procedural requirements.

Further, where a plaintiff establishes a state-created liberty interest, a court must determine the level of process due by drawing from federal constitutional law, not from state laws, regulations, or policies. Layton, 953 F.2d at 851-52 (holding that while consideration of state regulations “may be relevant in determining” what process is due, “they clearly do not, in and of themselves, define or control the requirements of the Constitution”); see also Cleveland Bd. of Edu. v. Loudermill, 470 U.S. 532, 541, 105 S.Ct. 1487, 84 L.Ed.2d 494 (1985) (explaining that “once it is determined that the Due Process Clause applies, ... [t]he answer to th[e] question [of what process is due] is not to be found in the [state] statute”). So here, the MCACC Manual does not dictate what level of process will pass constitutional muster. Accordingly, this argument fails.

V. CONCLUSION

For the foregoing reasons, the District Court’s grant of summary judgment to all Defendants on Steele’s substantive and procedural due process claims will be affirmed.

      . The parties have not disputed the facts outlined herein, unless otherwise noted.

      . Sergeant De Amicis stated that the officials who attended the meeting were Warden Cic-chi, Deputy Warden Masone, and De Amicis. According to Steele’s complaint, Masone, Defendant Captain Barth, and probably De Ami-cis attended the meeting. During his deposition, Steele stated that Barth and Masone were the MCACC officials who attended the February 25th meeting.

      . On February 26, 2009, MCACC provided Steele with a letter confirming his transfer to administrative segregation, which noted that the Classification Committee would review Steele’s status on a monthly basis.

      . The New Jersey Department of Corrections' 1999 "Handbook for Discipline for Inmates” was appended to the Manual. The Handbook addressed telephone access for inmates placed in Administrative Segregation. However, the Handbook stated that it applied only to state-sentenced inmates. Steele has not argued on appeal that the Handbook applied to him; his arguments center on the MCACC’s own internal Manual.

      . This Court granted Steele appointment of counsel for his appeal. He does not challenge the District Court's disposition of his First and Eighth Amendment claims.

      . To be clear, Steele claims a liberty interest in exercising his bail option using funds already available to him. His claim does not touch on issues relating to the amount of his bail or his ability to pay.

      . The District Court addressed Steele's allegations regarding bail access only insofar as they related to the question of whether his transfer to administrative segregation amounted to unconstitutional punishment. Because we understand Steele to advance these as two factually intertwined but legally independent substantive due process claims, we will address each separately.

      . Where the government infringes on a plaintiff's right through legislative activity, by contrast, the Supreme Court has explained that we must determine whether the legislation at issue is “narrowly tailored to serve a compelling state interest." Washington v. Glucksberg, 521 U.S. 702, 721, 117 S.Ct. 2258, 138 L.Ed.2d 772 (1997).

      . Precedent addressing various constitutional protections of telephone access in detention settings informs and is consistent with our decision here. See, e.g., Valdez v. Rosenbaum, 302 F.3d 1039, 1042-43, 1047 (9th Cir. 2002) (restricting telephone access of detainee placed in administrative segregation to one legal telephone call per day did not violate plaintiffs substantive due process rights); Washington v. Reno, 35 F.3d 1093, 1100 (6th Cir. 1994) (explaining that inmates do not have a constitutional right to unlimited telephone use); Benzel v. Grammer, 869 F.2d 1105, 1108 (8th Cir. 1989) (noting that inmates do not have a right to unlimited telephone use, and telephone communication with relatives and friends may be restricted "in a reasonable manner”); Martin v. Tyson, 845 F.2d 1451, 1458 (7th Cir. 1988) (holding that it did not violate the Due Process Clause to limit pretrial detainees' non-legal calls); Strandberg v. City of Helena, 791 F.2d 744, 747 (9th Cir. 1986) (stating that detainees' and inmates' constitutional right to telephone access is "subject to rational limitations in the face of legitimate security interests of the penal institution” (internal quotation marks omitted)).

      . In their briefing, the parties apply the Bell v. Wolfish "punishment” framework, discussed in greater detail in Section IV(A)(2), infra, to Steele's bail claim. The District Court also applied the Bell framework to Steele’s claims in its summary judgment opinion. But we do not find Bell to be squarely applicable to Steele's claim.
      The Supreme Court in Bell explained that it was not addressing "the curtailment of liberty” resulting from the "decision to detain an accused.” 441 U.S. at 533-34, 541, 99 S.Ct. 1861. Rather, the Court was addressing specific conditions of pretrial confinement, such as double-bunking of detainees, which were "aspect[s] of pretrial detention” that did not violate other constitutional guarantees. Id. In this Circuit, we have applied Bell to address a range of conditions of pretrial detention, such as strip searches, Florence v. Bd. of Chosen Freeholders of Cty. of Burlington, 621 F.3d 296 (3d Cir. 2010); triple-celling, Hubbard v. Taylor, 538 F.3d 229 (3d Cir. 2008); and placement in isolation, Stevenson v. Carroll, 495 F.3d 62 (3d Cir. 2007). Other Circuits similarly have applied Bell to address conditions such as strip searches, Byrd v. Maricopa Cty. Sheriff's Dept., 629 F.3d 1135 (9th Cir. 2011); and solitary confinement, Rapier v. Harris, 172 F.3d 999 (7th Cir. 1999).
      Steele's bail claim, however, challenges more than conditions of his pretrial detention. He challenges the curtailment of a separate and independent liberty interest that arose from his pretrial detention: his right to be freed from that detention, by exercising his bail option, once his bail was set. This claim fits awkwardly into the Bell framework, and more comfortably into the general "shocks the conscience” substantive due process framework applicable to executive actions. Nevertheless, for many of the same reasons provided in Section IV(A)(2), infra, Steele’s bail claim would fare no better under Bell.

      . The First Circuit explained in Collazo-Leon,

      [o]n the authority of Bell, it may be divined that even if a restriction or condition may be viewed as having a punitive effect on the pretrial detainee, it is nonetheless constitutional if it also furthers some legitimate governmental objective such as addressing a specific institutional violation and is not excessive in light of the seriousness of the violation.... If there is a reasonable relation between the sanctions and legitimate institutional policies, an intent to punish the detainee for prior unproven criminal conduct cannot be inferred.
      51 F.3d at 318.

      . According to the complaint submitted about Steele’s conduct, Steele had specifically threatened to disclose one detainee's child sex offense charges. As Sergeant De Amicis pointed out in his affidavit, “[c]hild sex offenders are among the most hated members of the inmate population,” so concerns for that detainee’s safety were ‘'justifiably].” App. 1311.

      . To the extent Steele argues separately that the restriction of his phone privileges constituted prohibited "punishment” under Bell, we disagree, given that Steele admitted to contact with Speedy over the phone.

      . Steele also argues that the District Court failed to consider his pro se "letter brief” as an affidavit in opposition to Defendants’ summary judgment motion. Having considered the letter brief for purposes of this appeal, we conclude that, without more, Steele’s conclu-sory statement that "defendants used the Administrative Segregation as a punishment because [Steele] did not want to agree with the defendants to lie on Speedy bail bonds” is not sufficient evidence to create a genuine issue of material fact as to the purpose for Steele’s transfer and to overcome summary judgment as to Steele’s substantive due process claims. Suppl. Br. of Appellant 5.

      . Steele also argues, in a single paragraph, that the absence of a specific notice informing him that his telephone privileges would be restricted in administrative segregation violates the Due Process Clause. We cannot agree that MCACC officials were required to explain in their interview with Steele all of the attendant restrictions of his administrative segregation. The key inquiry was whether he received notice of the charges against him and had an opportunity to respond. Hewitt, 459 U.S. at 476, 103 S.Ct. 864; see also Artway v. Att’y Gen. of State of N.J., 81 F.3d 1235, 1252 (3d Cir. 1996) ("Due Process requires 'notice reasonably calculated ... to apprise interested parties of pendency of the action and afford them an opportunity to present their objections.’ ” (quoting Mullane v. Central Hanover Bank & Trust, 339 U.S. 306, 314, 70 S.Ct. 652, 94 L.Ed. 865 (1950))); Taylor v. Rodriguez, 238 F.3d 188, 192-93 (2d Cir. 2001) (holding that "the effect of the notice should be to compel the charging officer to be [sufficiently] specific as to the misconduct with which the inmate is charged to inform the inmate of what he is accused of doing so that he can prepare a defense to those charges and not be made to explain away vague charges.” (internal quotation marks omitted)). As discussed, there is no dispute that Steele received such notice here.