Corporate Compliance Programs: Pretext or Panacea?

Proponents of corporate compliance programs loudly sing their praises while detractors point to ceaseless prosecutions and a parade of civil suits—often resulting in multi-billion dollar verdicts or settlements—as evidence that they are ineffective. So, are corporate compliance programs a panacea or a pretext? The truth lies somewhere in between.

As a threshold issue, corporations are for-profit institutions. Indeed, most corporations have a mandate to maximize profit for shareholders. This can encourage senior management to operate in grey areas, and regulators may later deem their actions (and board oversight of such actions) to violate a wide array of laws. Second, formalistic compliance programs are not enough to ensure internal reporting of potential fraud and are not enough to inspire companies to take appropriate corrective actions. Instead, as set forth below, companies must take steps to ensure effective implementation of compliance programs and foster a culture of corporate compliance.

The countervailing factors that motivate officers and directors to engage in or acquiesce to fraudulent conduct or, alternatively, devise and implement an effective compliance program warrant in-depth treatment in a standalone piece. Here, I turn to answering the specific questions posed with these general principles in mind.

Question 1: Do corporate compliance programs actually suppress information from regulatory oversight?

Response: Yes, often appropriately. But meritorious—and sometimes non-meritorious—allegations of misconduct tend to get reported externally where internal responses are inadequate or the company has not created a culture of compliance and reporting.

Recent reports, compiled through surveys of hundreds of senior executives from a broad range of industries, indicate that roughly two-thirds of United States companies are affected by fraud. 1 Costs to companies, including reputational damage, can be substantial as can costs associated with remediation and investigation of fraudulent practices.

Internal reporting programs such as corporate compliance hotlines represent a company’s first line of defense against corporate fraud. Internal whistleblower hotlines are a key component of a company’s anti-fraud program: where such hotlines are implemented, tips are typically the most common method of detecting fraud. 2 Moreover, the Sarbanes-Oxley Act (“SOX”), international guidelines from the European Union, and the U.S. Federal Sentencing Guidelines have deemed hotline reporting programs a good and necessary business practice. At the same time, internal compliance hotlines serve to screen out frivolous and baseless claims.

In my experience counseling and defending large corporations on employment matters and corporate compliance, reports to company ombudsman, managers, or human resources and compliance personnel often lack merit or do not implicate fraud. Employees often file malicious or fictitious complaints against fellow employees or the organization to ward off pending termination or to seek revenge for perceived slights. But treating employees with respect, even in these situations, can dissuade employees from unwarranted external reports.

Unfortunately, despite strong incentives to self-report credible evidence of wrongdoing, companies may conceal such evidence. Like companies, whistleblowers have incentives under various statutory regimes to report internally. For example, under the SEC whistleblower program established by the Dodd–Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank”) in 2010, a whistleblower’s participation in internal compliance systems will generally increase an award and interference with or bypass of those systems can decrease an award. 3A whistleblower who reports conduct to the SEC within 120 days of reporting internally will also receive credit for any information the company later self-reports to the SEC. 4

In our experience, external reporting typically follows internal reporting when an employee felt the company response was not adequate. As of 2014, 80% of company insiders who reported potential misconduct to the SEC first raised their concerns internally to compliance personnel or their supervisors. 5 Likewise, Guttman, Buschner & Brooks attorneys have represented countless whistleblowers bringing cases under the False Claims Act and have helped recover billions of dollars on behalf of federal and state governments. In our experience, these whistleblowers typically reported internally first and only sought representation after the company responded inadequately or dismissed concerns as “this is the way we do business.” Thus, while corporate compliance hotlines and related reporting mechanisms serve as the first line of defense against fraud, the False Claims Act, Dodd-Frank and other whistleblower protection statutes effectively incentive employees to report fraud externally when a company’s response has been ineffective or where a company has not created a culture where employees feel comfortable reporting misconduct internally.

Companies are most likely to dissuade external reporting by creating and implementing effective compliance programs as well as self-reporting credible allegations of misconduct. Such self-reporting may also result in cooperation credit. Indeed, on September 9, 2015, Deputy Attorney General Sally Yates issued a memo instructing the DOJ to seek individual accountability from individuals perpetrating wrongdoing in the course of fighting corporate fraud and misconduct. 6 The memo was sent to every United States Attorney, the Assistant Attorney General heading up each DOJ division, the Director of the Executive Office for United States Trustees, and the Director of the FBI.

Consistent with the Yates directives, we have seen renewed focus on individual accountability in the False Claims Act cases we have litigated alongside the government over the past year. This has manifested in the government’s decision to name individual executives as defendants in complaints in intervention, the structure of settlements, and a myriad of other ways.

In keeping with its renewed focus on individual liability, the Yates memo articulated several changes to DOJ policy regarding the definition of “cooperation credit” for corporations. These changes are applicable to criminal as well as civil enforcement matters. Corporations historically have received and continue to receive more favorable settlement terms when the government concludes they provided material cooperation with respect to a government investigation. But companies have struggled to understand what it means to “cooperate” in a post-Yates world.

In a September 27, 2016 speech, Principal Deputy Associate Attorney General Bill Baer provided some insight as to what such cooperation now entails, highlighting the importance of prompt and material assistance. 7 Merely responding to a subpoena or civil investigative demand (“CID”) will not qualify as cooperation. Rather, a company hoping to obtain cooperation credit is expected to provide specific information about any and all employees involved in wrongdoing that is unknown to DOJ and that materially assists in its investigations. Thus, while meritless claims not implicating fraud are properly vetted and disposed of through company screening without ever coming to the attention of government regulators and investigators, an effective compliance program will also develop mechanisms to affirmatively identify and provide material information to regulatory agencies investigating the company.

Question 2: Do corporate compliance programs create an environment where employees are led to believe that wrongdoing in the corporate environment is implausible because a compliance program exists?

Response: No. But implicit or explicit directives from management can lead to false beliefs that particular actions comport with the law.

A corporate compliance program should and generally does sensitize employees to the fact that wrongdoing isplausible. A strong compliance program often identifies the relevant laws applicable to an employees’ day-to-day activities and may include fact patterns the company has identified as violative of relevant laws. For example, compliance training for pharmaceutical sales representatives is likely to and should inform employees that promoting off-label uses of company drugs can be deemed to be a violation of the Federal Food, Drug, and Cosmetic Act and likewise expose the company to liability under the False Claims Act. 8

Having said that, we have represented relators in False Claims Act cases in which company management has been warned by its own third-party regulatory consultants that certain conduct and types of interactions with physicians is proscribed. These companies have nonetheless directed such conduct in business plans, training documents, and other written directives to sales representatives. Similarly, employee performance reviews may—in writing—encourage conduct that is deemed by the government to be unlawful. Managers may also encourage such conduct when accompanying employees on sales detailing visits.

Thus, the existence of written policies and a compliance program does not itself create an environment where employees believe wrongdoing is implausible. But written directives, communications, and training by management can cause employees to believe that particular conduct is appropriate and in conformity with stated company policies and cause them to ignore other signs or evidence that such conduct is—in fact—unlawful.

Question 3: From a practical viewpoint, what kind of corporate compliance programs work better than others?

Response: Corporate compliance programs that incorporate the principles of communication, responsiveness, and transparency

Above all, compliance programs should be transparent and comprehensible to employees (and management), and the goals of enforcement mechanisms should be clearly communicated. Measures also must be implemented to ensure prompt and efficient responses to allegations of corporate wrongdoing. How this manifests will vary from industry to industry and company to company. It largely depends on the service or product a company offers, specific rules and regulations that govern the company, the size and geographic breadth of a company, and a myriad of other factors.

In addition to general principles of communication, responsiveness, and transparency, certain key factors tend to underlie effective compliance programs:

1. Guidelines: companies should have explicit guidelines that instruct employees how to perform their jobs in a legal and ethical manner, including training programs, codes of conduct, and written performance standards.

2. Surveillance: companies should have official policies and procedures that detail the manner in which they will monitor employees and how (and to whom) employees can report wrongdoing.

3. Sticks and Carrots: companies should identify and implement sanctions for wrongdoing as well as rewards in the form of promotions and positive reviews for demonstrated competence and compliance with company guidelines. A program can be well-drafted on paper but useless in practice if a company does not punish misconduct or reward behavior it wishes to incentivize.

4. Leadership: it is not enough to have formal procedures in place to foster compliance. The “water cooler” conversation and conduct of top-level management are equally important. The “tone at the top” and informal communications as set by leadership behavior is critical, but it is equally critical for top management to monitor and instill the same behavioral norms in middle management.

5. Independence of compliance personnel. Local management are rarely trained as investigators, and may be part of the problem. Likewise, local human resources personnel may appear to employees to be aligned with management and unlikely to take employee concerns seriously, disincentivizing employees from raising concerns about potential misconduct. Accordingly, effective compliance programs often provide mechanisms for employees to report concerns to independent third parties (such as ombudsmen) specifically trained in addressing employee concerns. Depending on the nature of the complaint, legal personnel, compliance officers, or human resources personnel may need to become involved after the initial investigation has begun.

Corporate compliance programs play an important role in modern corporate governance. But they are only as good as management’s commitment to effective resolution of employee concerns and implementation of corrective action when credible misconduct has been identified. Companies have strong incentives to get it right.

Footnotes

Justin S. Brooks is a founding partner of Guttman, Buschner & Brooks PLLC. Mr. Brooks represents relators in qui tam litigation under the False Claims Act and other federal and state statutes and corporate clients in a wide variety of complex commercial and employment litigation. He also provides employment and compliance counseling to companies, represents institutional investors in shareholder derivative and corporate governance litigation, and represents employees in employment litigation of all types. He has represented clients in claims brought under the Federal False Claims Act, securities laws, the Worker Adjustment and Retraining Notification Act (WARN), Racketeer Influenced and Corrupt Organizations Act (RICO), and various employment discrimination, labor and environmental statutes.Prior to founding the firm, Mr. Brooks worked at Kirkland & Ellis LLP, Morgan, Lewis & Bockius LLP, and Grant & Eisenhofer P.A. He also served as law clerk for a federal judge. He has authored numerous articles on class action litigation and other topics.

1. Kroll, 2013/2014 Global Fraud Report, Who’s Got Something to Hide? 12 (2013), http://www.kroll.com/en-us/global-fraud-report.

2. See, e.g., Ass’n of Certified Fraud Exam’rs, Report to the Nations on Occupational Fraud and Abuse, 2014 Global Fraud Study 19 (2014), https://www.acfe.com/rttn/docs/2014-report-to-nations.pdf.

3. 17 C.F.R. § 240.21F-6(a)(4); 17 C.F.R. § 240.21F-6(b)(3).

4. 17 C.F.R. § 240.21F-4(b)(7).

5. U.S. Sec. & Exch. Comm’n, 2014 Annual Report to Congress on the Dodd-Frank Whistleblower Program 16 (2014), http://www.sec.gov/about/offices/owb/annual-report-2014.pdf.

6 .See Memorandum from the Office of the Deputy Attorney Gen. to the Assistant Attorney Gen., Antitrust Div., the Assistant Attorney Gen., Civil Div., the Assistant Attorney Gen., Criminal Div., the Assistant Attorney Gen., Envtl. and Nat. Res. Div., the Assistant Attorney Gen., Nat’l Sec. Div., the Assistant Attorney Gen., Tax Div., the Dir., Fed. Bureau of Investigation, the Dir., Exec. Office for U.S. Trs., & all U.S. Attorneys (Sept. 9, 2015) https://www.justice.gov/dag/file/769036/download.

7 .See Bill Baer, Principal Deputy Assoc. Attorney Gen., Remarks at Society of Corporate Compliance and Ethics Conference (Sept. 27, 2016) https://www.justice.gov/opa/speech/principal-deputy-associate-attorney-general-bill-baer-delivers-remarks-society-corporate.

8 .The type of conduct that qualifies as “promotion” and the degree to which certain activity may be protected by the First Amendment involve a nuanced assessment, is largely unsettled, and varies from jurisdiction to jurisdiction. Detailed discussion is beyond the scope of this article.

GBB files amicus on behalf of law professors in FCA case before Supreme Court

Congress intended the False Claims Act to apply broadly and reach all fraudulent attempts to cause the United States Government to pay out money. In Universal Health Services, Inc. v. United States ex rel. Escobar, a key case pending before the United States Supreme Court, the Petitioner has urged a counter-textual interpretation that would vitiate the False Claims Act and compromise Congress’ intent.  On behalf of a distinguished group of law professors, Guttman, Buschner & Brooks PLLC has filed an amicus brief in the matter.

The amicus brief proposes a comprehensive model, the application of which will ensure the Act continues to effectuate Congress’ intent.  As the brief explains, the starting point for determining whether conduct is fraudulent and should be captured by the Act begins by looking to principles of common law fraud. However, Congress expanded upon the liability available under the False Claims Act, specifically by eliminating traditional reliance and scienter requirements of common law. Application of the Act’s statutory provisions expanding liability, coupled with use of limiting principles of materiality – routinely applied to other fraud statutes to ensure minor violations are not cognizable – balances concerns of the Act’s over-expansion with its stated purpose to broadly reach all fraudulent or deceitful acts that cause the Government to pay out money.

The full amicus brief is available here: Universal Health Services Inc v US and Massachusetts, ex rel Escobar and Correa – Brief of Law Professors as Amici.

Doctors promoting treatments on social media routinely fail to disclose ties to drug makers

by Sheila Kaplan (Statnews.com)

Washington – Physicians across the United States routinely offer medical advice on social media — but often fail to mention that they have accepted tens and sometimes hundreds of thousands of dollars from the companies that make the prescription drugs they tout.

A STAT examination of hundreds of social media accounts shows that health care professionals virtually never note their conflicts of interest, some of them significant, when promoting drugs or medical devices on sites such as Facebook, Instagram, and Twitter. The practice cuts across all specialties.

. . .

But Reuben Guttman, an attorney in Washington who specializes in food and drug law, said the system leaves patients vulnerable to misinformation.

“Doctors who accept these dollars and then turn around and promote on social media corrupt the market for honest medical information,” Guttman said. “And drug companies that pay these doctors are similarly poisoning the market for honest information.”

Read the full article at statnews.com.

Whistleblower program will be one of the most significant national gatherings of 2016

Feb. 18 and 19, the Center for Advocacy and Dispute Resolution and the Emory Corporate Governance and Accountability Review will partner to present “Fraud Against the Government & SEC Whistleblower Actions Training.” This event will feature more than 20 authorities on fraud, including U.S. attorneys, experts from the U.S. Securities and Exchange Commission and judges.

The training will be held from 8:30 a.m. to 4 p.m. each day in Tull Auditorium, Gambrell Hall at Emory Law.

Reuben Guttman, partner with Guttman Buschner & Brooks, PLLC and senior fellow with the Center for Advocacy and Dispute Resolution, said, “We think that for would-be whistleblowers and their counsel, the Emory program will be one of the most significant national gatherings in 2016. The program will offer them an opportunity to hear directly from regulators about how they can work to maximize their contributions to federal whistleblower programs.”

Attendees can earn up to 12 CLE credits along with the Certificate of Completion of Emory University School of Law’s Advocacy and Dispute Resolution Training in Case Investigation. Registration is now open.

Featured panelists and instructors include:

  • John A. Horn, U.S. Attorney for the Northern District of Georgia
  • William M. Nettles, U.S. Attorney for the District of South Carolina
  • David Rivera, U.S. Attorney, Middle District of Tennessee
  • Sean McKessey, Director, Office of Whistleblower, U.S. Securities and Exchange Commission
  • Benjamin Singer, Chief, Securities & Financial Fraud Unit, Fraud Section, Criminal Division, U.S. Department of Justice
  • Walter Jospin, Regional Director, Atlanta Regional Office, U.S. Securities and Exchange Commission
  • William P. Hicks, Associate Regional Director, Atlanta Regional Office, U.S. Securities and Exchange Commission
  • Stephen E. Donahue, Assistant Regional Director, Atlanta Regional Office, U.S. Securities and Exchange Commission
  • Randy Chartash, Chief, Economic Crime Section at United States Attorney’s Office
  • Reuben Guttman, Partner, Guttman Buschner & Brooks, PLLC and Senior Fellow, Center for Advocacy and Dispute Resolution, Emory University School of Law
  • John Floyd, Partner, Bondurant Mixson & Elmore LLP
  • Michael A. Sullivan, Partner, Finch McCranie LLP
  • Sam Sheldon, Partner, Quinn, Emmanuel Urquhart & Sullivan, LLP
  • Bob Magnanini, Partner, Stone and Magnanini, LLP
  • David Bocian, Partner, Kessler, Topaz, Meltzer, Check, LLP
  • Traci Buschner, Partner, Guttman, Buschner & Brooks, PLLC
  • Christopher Haney, CPA, CFE, CHC, Forensus Group, LLC
  • Richard Harpootlian, Harpootlian Law
  • Jerry Martinj, Partner, Barrett Johnston Martin & Garrison, LLC
  • Amy Berne, Chief, Civil Division, United States Attorney’s Office, Northern District of Georgia
  • Sally Molloy, Assistant U.S. Attorney at U.S. Attorney’s Office, Northern District of Georgia
  • Paul Zwier, Professor; Director Center for Advocacy and Dispute Resolution, Emory University School of Law
  • Hon. Matt McCoyd, Magistrate Court Judge, DeKalb County; Associate Director Center for Advocacy and Dispute Resolution, Emory University School of Law

Reuben Guttman: The lawyer pharma loves to hate

Reuben Guttman wants us all to be concerned about what’s in our medicine cabinets. A Washington lawyer who specializes in prosecuting pharmaceutical fraud, Guttman has gone after Pfizer, Abbott, GlaxoSmithKline, and several other top drug makers — and he usually wins big, recouping billions of dollars for federal and state governments.

STAT talked with Guttman about bad behavior in the drug industry, and whom he trusts for his own medical care.

The lawsuits you’ve won often center on unlawful marketing and kickback schemes. How widespread are these practices? 

The problem is pervasive and exists throughout the entire health care system. It starts when the captains of publicly traded health care companies make promises to Wall Street with regard to revenue projections. Those promises result in compromises to pure medical decision-making. Drugs are marketed to patients — that is to say, put in patients’ bodies — not for reasons of medical necessity but because the pharmaceutical company needs to make its revenue mark.

How does your work as a lawyer impact the health care system?

I think that we bring litigation which surfaces information demonstrating how medical decision-making has been tainted by economic drivers, including bonuses and promises to Wall Street.

And the consequence for patients?

The collateral damage is a huge amount of health care dollars wasted and patients put at risk through drugs that are marketed without regard to their safety and efficacy.

Is there anything patients can do to protect themselves?

We’re in an era where people have to ask questions — really hard questions — especially if you’re a parent and a kid’s getting a drug or a procedure.

Knowing what you know, do you avoid doctors and hospitals?

I don’t think anybody has the luxury of avoiding doctors and hospitals.

What’s the next big pharma scam? 

The market for medical information has been poisoned. The evidence with Risperdal [an antipsychotic medication] indicated that Janssen used aghostwriter to help generate journal articles signed by doctors, then placed [those articles] in the hands of sales representatives or into the stream of medical information so they would influence prescription-writing behavior.

What do you do in your spare time?

I follow the Washington Capitols.

Are you an athlete yourself? 

I play in an ice hockey league in suburban Maryland, just outside of D.C. Some of the guys I play [against] show up defending some of the pharma companies.

As a litigator, you have to see the negative in everyone. Is it hard to go through life that way, always taking the cynical view?

There’s going to be greed and discrimination. If you’re going to be on the public interest side, you’re always figuring out how to monitor and how to challenge.

When you were a kid, did you fantasize about being a whistleblower attorney?

What I really wanted to do was be an investigative journalist, but when I got out of college those jobs were hard to find.

Reuben Guttman is a founding partner at Guttman, Buschner & Brooks. This interview has been edited and condensed. 

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