Author Archives: Reuben Guttman

by Reuben A. Guttman. Guttman practices law with Guttman, Buschner & Brooks PLLC 

There are more than 3,000 drug trials being conducted in China. Indeed, data from these trials is almost certain to find its way into applications filed back in the United States with the Food and Drug Administration.

Do large drug companies – which trade on U.S. domestic securities exchanges – accurately report complete information about drug trials conducted in China? Or do language barriers and cultural differences make it difficult – if not impossible – to secure unbiased results from these trials? Understanding that concepts imbedded in the western rule of law, including “conflict of interest,” “kick back,” and “independence,” may have different meanings elsewhere is crucial to understanding the magnitude of the problem, and we have no way of answering these questions with complete certainty.

The scary part is that our regulators – including the SEC, the FDA and the EPA – are so woefully understaffed that they lack the resources to fully enforce compliance in the United States, let alone on a global scale.

In a global economy, understanding and investigating conduct abroad is essential to domestic compliance enforcement. But triple the staff of domestic compliance enforcement agencies, and there still would not be enough government officials to enforce compliance in a global economy.

The truth is that since the founding of our republic, we have recognized that compliance enforcement cannot be left solely in the hands of government regulators. Compliance with our most fundamental constitutional protections, including the landmark decisions in Brown v Board of Education and New York Times v. Sullivan, have been accomplished through private party litigation — not government enforcement actions.
Our environmental, antitrust, and civil rights laws have specific provisions allowing private citizens to bring enforcement actions. Our laws are constructed this way because we as a nation understand that substantive law absent an ability to enforce compliance is meaningless. To have an enumerated right or privilege that cannot be protected or secured is the same as having no right or privilege at all. To ensure compliance enforcement, we have created mechanisms that leverage our abilities so that culprits understand that being caught and sanctioned is more than a mere theoretical possibility.  Indeed, Congress has passed laws, including the False Claims Act and the Dodd-Frank Act, that reward whistleblowers who bring to the government information about conduct that causes the wrongful payment of government monies and that lead to a recovery.
These laws tap the technical, cultural, and even language expertise of whistleblowers on both a domestic and global scale. In 2001, a German citizen named Kurt Bunk brought suit under the False Claims Act in a federal court in Virginia against freight companies engaging in a conspiracy – conceived in Europe – to elevate the cost of shipping services sold to the U.S. military.  The case resulted in the recovery of millions of dollars to the U.S. Treasury.  While not a U.S. citizen, Bunk’s expertise in the shipping industry, his knowledge of the German language, his ability to review thousands of documents written in German, and his account of facts necessary to prove the wrongful conduct were essential to a domestic compliance effort.

It would seem obvious that individuals who participate in compliance enforcement that benefits U.S. citizens or U.S. regulatory agencies should minimally receive protection in our courts. At a time when our State Department spends millions of dollars abroad extolling the virtues of U.S. “rule of law,” it would be ironic that a foreign citizen who aids in the enforcement of our laws would not be extended protection by our courts against retaliation. Yet, that is exactly what happened recently to Liu Meng-Lin, a citizen of Taiwan and a compliance officer for the healthcare division of Siemens China, Ltd.
According to a lawsuit Liu filed in a New York federal court, he discovered that Siemens employees were indirectly making improper payments to officials in North Korea and China in connection with the sale of medical equipment to those countries. Liu complained internally, and was terminated, whereupon he reported to the SEC that Siemens had violated the Foreign Corrupt Practices Act – an Act that prohibits companies that trade stock on U.S. exchanges from making payments to foreign officials to secure business. Liu also alleged that Siemens had violated Dodd Frank’s anti-retaliation provisions.
The federal court dismissed Liu’s case, and the U.S. Court of Appeals for the Second Circuit recently sustained that decision, refusing “extraterritorial” enforcement of the Dodd Frank anti-retaliation proscriptions. The Second Circuit found it of no consequence that Siemens trades its stock on U.S. exchanges – and presumably to U.S. purchasers – or that Liu may be entitled to a bounty from the SEC if the agency successfully pursues Siemens for FCPA violations.  The Court justified its holding by maintaining that there is a presumption against extraterritorial application of a law where there is no clear congressional intent to do so.
Really? In a global economy where the court conceded that Liu might actually be entitled to a monetary award from the SEC?
There’s another irony: At a time when large corporations through the U.S. Chamber of Commerce are maintaining that whistleblowers should report their grievances to internal compliance personnel before going to regulatory bodies, a big publicly traded company has established – at least in one court – that foreigners have no rights of redress in U.S. courts if their internal disclosure results in retaliation.

Regardless of whether the Second Circuit is correct in its analysis, its decision is a blow to whistleblower programs essential to enforcement of laws that, at the very least, protect those who reside within our domestic boundaries.  If the Second Circuit is correct that Congress was not clear in its intent to protect foreigners who help in the enforcement of domestic laws, it is time for Congress to speak up.

by Reuben A. Guttman. Guttman practices law with Guttman, Buschner & Brooks PLLC.

Can a corporation really investigate its own behavior? Do internal compliance programs really work, or does their mere existence give well-compensated employees plausible rationale not to question conduct that would otherwise be questionable?

Answering these questions must begin with the age-old concern about conflicts of interest. The Book of Matthew counsels that “no man can serve two masters.” Our democracy itself is founded out of concern for the evils of self-interest, a form of conflict of interest. We abandoned a monarchy in favor of elected officials and then, fearing their self-interest, we created a system of checks and balances.

As our democracy emerged, scrutiny of conflicts of interest that might taint decision making – or at least the decision itself – has become ingrained in our processes. Corporations that are engaged in litigation must file disclosure statements identifying their affiliated entities so that judges can disqualify themselves – or be subject to disqualification – where they perhaps maintain a stock ownership interest associated with a litigant. Attorneys are schooled early on about the pitfalls of bringing a client into a business deal where the attorney has an interest. When our labor laws were promulgated in 1935, there were proscriptions against company dominated unions. Why? Because an employer has an inherent conflict of interest between steering a course toward maximizing shareholder returns and maximizing employee pay and benefits.

Given that the concern about conflicts of interest is so ingrained in our way of thinking, rejection of proposals to allow corporations to investigate themselves as a predicate to government regulatory agency involvement should be logical. Can we count on a corporation to investigate itself, to fully and accurately disclose its conduct so that victims may take recourse, and at the same time take action to prevent recurring wrongdoing – all of which may cause the business to lose money? And if a corporation were able to fulfill these tasks, would the reported result have sufficient integrity to withstand public scrutiny? Do we really trust the reports of corporations that investigate their own improprieties?

Representatives of the U.S. Chamber of Commerce – actually not just mere representatives, but lawyers supposedly versed in the doctrine of conflicts of interest – recently testified before a U.S. House of Representatives Oversight Committee that whistleblowers ready to pursue relief under the False Claims Act should be incentivized or required to allow a corporation to investigate its own alleged wrongful conduct before any concern is raised to an independent government authority.

The False Claims Act – dating back to 1864 – allows private citizens to bring suit on behalf of the United States Government where they have knowledge that wrongful or fraudulent conduct has caused the expenditure of government monies. Civil penalties under the statute may also be assessed when a “false claim” for payment “is submitted or caused to be submitted.” All cases filed under the False Claims Act are filed under seal allowing the government to investigate the case before public litigation actually proceeds. Sometimes civil litigation initiated by whistleblowers under the False Claims Act has resulted in parallel criminal proceedings. Examples include cases against Pfizer, GlaxoSmithKline, and Abbott Laboratories. Civil and criminal sanctions exceeding $6 billion in total were imposed against these companies for unlawfully marketing drugs that caused the expenditure of Medicare/Medicaid dollars. And in each of these cases the defendants or their subsidiaries pleaded guilty to a criminal infraction because – as the plea agreements made clear – they were guilty.

Each of these companies had internal compliance programs, and yet in each case the wrongful conduct was pervasive, brought billions of dollars of revenue to the Defendant, and persisted for years. These are not isolated examples. Enron, Tyco, and WorldCom all had internal compliance programs that proved incapable of addressing pervasive and, at least initially, profitable wrongdoing.

Where wrongful conduct actually results in increased revenue that rewards corporate officers and employees, is it plausible that a corporation’s internal compliance mechanism can freely and fully investigate and right wrongful behavior? Do corporations, and those individuals that guide them, really have an incentive to fully address wrongful conduct that generates significant revenue? These are important questions particularly at a time when civil and criminal penalties are merely part of the cost of doing business; they are as much “a part of the game” as is a calculated tripping penalty in an ice hockey contest where a goal is imminent. The truth is that even after Pfizer, GSK, and Abbott collectively paid billions of dollars to settle charges of unlawful marketing, these pharmaceutical giants still walked away with billions of dollars in profits from their unlawful conduct. Even the public announcement of settlements and guilty pleas had little or no impact on their market capitalization!

The point is that companies and corporate officials that make money off of wrongful conduct have a conflict of interest when it comes to self-investigation of profitable impropriety. There is a real danger – and not just an economic one – in requiring whistleblowers to utilize internal compliance reporting mechanisms before voicing concerns to independent government regulators. In the False Claims cases against Pfizer, GSK and Abbott, the underlying allegations involved marketing derelictions that potentially placed patients in harm’s way or perhaps even caused personal injury or death. Do we really want to encourage matters of health and safety to be kept from independent government regulators and perhaps injured victims? Do we really a trust a company that placed revenue over patient safety to investigate its own impropriety and come clean?

If internal compliance programs are not effective in addressing pervasive wrong doing, the question remains as to whether they are – at worst – merely benign. Should we be legitimately concerned that the existence of these programs may cause employees not to question corporate behavior? In the cases involving Pfizer, GSK, and Abbott, the alleged wrongful conduct was not any secret to the hundreds of sales representatives who dallied from doctor to doctor hawking drugs. Yet only a few insiders stepped forward to blow the whistle. Did there exist corporate cultures leading employees to believe that giant corporations with internal rules and compliance programs could do no wrong? Why, for example, in the case General Motors’ faulty ignition switches, did the revelation of the wrongdoing not come from a GM employee but from an outside expert working for a plaintiff’s lawyer?

While these are all important questions, their answer is perhaps age-old and embedded in biblical wisdom. Unfortunately creating the illusion that a corporation can investigate its own alleged impropriety may very well lull the diligence of those who would otherwise raise concern.