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The Wreck of the Andrea Doria and the Biotronik Anti-Kickback Enforcement Action

We have not had a This Day in History opening for the FCPA Compliance and Ethics Blog for some time. So not only is one long overdue but a shipwreck which occurred some 66 years ago makes a great opening for today’s start of a multi-part blog post series on a Federal Anti-Kickback  enforcement action which was announced last week, involving the Oregon based medical device manufacturer Biotronik Inc. (Biotronik).

The shipwreck of course was the catastrophe involving the Italian passenger liner the Andrea Doria and the Swedish passenger liner, the Stockholm off the coast of New York on this date in 1956. According to This Day in History, at approximately, 10:45 pm, the Stockholm showed up on the Andrea Doria’s radar screens, at a distance of about 17 nautical miles. Next Andrea Doria showed up on the Stockholm’s radar, at 12 miles away. The Andrea Doria Captain then “exacerbated a dangerous situation by making a turn to port for an unconventional starboard-to-starboard passing, which he wrongly thought the other ship was attempting.” Third Officer Johan-Ernst Bogislaus Carstens, commanding the bridge of the Stockholm, then made a conventional turn to starboard. Andrea Doria Captain Calami realized he was on a collision course with the Stockholm and turned hard to the left, hoping to race past the bow of the Swedish ship but it was too late. Five were killed on the Stockholm and 46 persons on the Andrea Doria died but over 1,600 were rescued. It was one of the final great nautical disasters involving the collision of passenger ships.

According to the Department of Justice (DOJ) Press Release, “the Federal Anti-Kickback Statute prohibits offering or paying anything of value to induce referrals of items or services covered by Medicare and other federally funded programs. The statute is intended to ensure that medical providers’ judgments are not compromised by improper financial incentives.” Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division, said, “Paying kickbacks to doctors to influence their selection of medical devices undermines the integrity of federal healthcare programs. When medical devices are used in surgical procedures, patients deserve to know that their device was selected based on quality of care considerations and not on improper payments from manufacturers.”

Biotronik is a company which manufactures and sells cardiac rhythm management (CRM) devices, including pacemakers, defibrillators, and cardiac resynchronization therapy (CRT) devices throughout the United States. The company engaged in bribery and corruption inside the US rather than outside of the US as we see in cases involving the Foreign Corrupt Practices Act (FCPA). The Press Release claims that the company engaged in a “kickback scheme to pay certain favored physicians to induce and reward their use of Biotronik’s pacemakers, defibrillators and other cardiac devices. In particular, Biotronik allegedly abused a new employee training program by paying physicians for an excessive number of trainings and, in some cases, for training events that either never occurred or were of little or no value to trainees.”

Biotronik was on actual knowledge that these payments were illegal as the corporate compliance function “warned that salespeople had too much influence in selecting physicians to conduct new employee training and that the training payments were being over-utilized.” The Press Release also noted, “the settlement also resolves allegations that Biotronik violated the Anti-Kickback Statute when it paid for physicians’ holiday parties, winery tours, lavish meals with no legitimate business purpose and international business class airfare and honoraria in exchange for making brief appearances at international conferences.”

Interestingly, this matter involved two whistleblowers. The civil settlement included the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act (FCA),  which, under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. The whistleblowers were Jeffrey Bell and Andrew Schmid, both of whom had been employed as independent sales representatives for Biotronik. They brought suit against the company, alleging, as stated in the Settlement Agreement, that Biotronik “knowingly caused the submission of false claims for payment to federal healthcare programs by providing remuneration to physicians to induce them to use Biotronik’s CRM devices in violation of the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b). The United States intervened in the Civil Action on June 21, 2021.” Bell and Schmid received approximately $2.1 million as their share of the recovery in this case.

Biotronik agreed to pay $12.95 million to resolve these allegations “by causing the submission of false claims to Medicare and Medicaid by paying kickbacks to physicians to induce their use of Biotronik’s implantable cardiac devices, such as pacemakers and defibrillators.” There were multiple US enforcement authorities involved in this case. The Press Release noted, “the resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section and the U.S. Attorney’s Office for the Central District of California. HHS-OIG assisted in the investigation.”

Join us tomorrow when we consider the bribery schemes allegedly used by Biotronik and the lessons learned for the compliance professional.

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Sunday Book Review

July 24, 2022 the Texas Women of Crime Fiction edition


In today’s edition of Sunday Book Review:

  • My Summer Darlings by May Cobb
  • Shadows of Pecan Hollow by Caroline Frost
  • Pay Dirt Road by Samantha Jayne Allen
  • More Than You’ll Ever Know by Katie Gutierrez

 Resource
In Texas, Women Crime Authors Have Finally Escaped the Shadow of ‘Gone Girl’ by Amy Gentry in Texas Monthly.

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Daily Compliance News

July 23, 2022 the Child Labor in Alabama edition


In today’s edition of Daily Compliance News:
· The US blacklists former Paraguayan President.   (Al-Jazeera)
· An Arab Spring for South Africa? (Bloomberg)
· SEC says crypto is unregulated securities. (WaPo)
· Hyundai used child labor in Alabama. (Reuters)

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Creativity and Compliance

Do We Really Have to do E&C Training?

Where does creativity fit into compliance? In more places than you think. Problem-solving, accountability, communication, and connection – all take creativity. Join Tom Fox and Ronnie Feldman on Creativity and Compliance, part of the award-winning Compliance Podcast Network. In this episode, Tom and Ronnie continue their short series of provocative statements on compliance training and communications, followed by a discussion. In this episode, Ronnie pitches today’s question to Tom on is ethics and compliance training is required? Highlights include:

·      Is E&C training required by law?

·      Why doesn’t E&C training work?

·      Why not spend your time doing things that help?

·      How E&C training can promote speak-up culture.

·      Why E&C training provides tools and resources.

·      How E&C training gets leadership involved.

Resources:

Ronnie Feldman (LinkedIn)
Learnings & Entertainments (LinkedIn)
Ronnie Feldman (Twitter)

Learnings & Entertainments (Website)

60-Second Communication & Awareness Shorts – A variety of short, customizable, quick-hitter “commercials” including songs & jingles, video shorts, newsletter graphics & Gifs, and more. Promote integrity, compliance, the Code, the helpline and the E&C team as helpful advisors and coaches.

Workplace Tonight Show! Micro-learning – a library of 1-10-minute training and communications wrapped in the style of a late-night variety show that explains corporate risk topics and why employees should care.

Custom Live & Digital Programing – We’ll develop programming that fits your culture and balances the seriousness of the subject matter with more engaging delivery.

Tales from the Hotline – check out some samples.

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Presidential Leadership Lessons for the Business Executive

Presidential Leadership Lessons from John Tyler


In this episode, we consider the presidency of the 10thPresident, John Tyler. Tyler was the first president to ascend to the position after the death of President in office, William Henry Harrison. This ascendency, as his presidency was fraught with difficulties and conflict. We consider the following:

  1. Tyler was not viewed as a legitimate president as he ascended due to the death of a President in office, William Henry Harrison.
  2. Tyler was the first President against whom impeachment proceedings were brought.
  3. Tyler had no real political base while President, as he had been in the Democratic Party until he became a Whig to run in 1840.
  4. Tyler was the first President to veto legislation based upon policy, not constitutional considerations.
  5. Tyler was the first President to have a mass Cabinet resignation.
  6. Tyler was the first President to have his Cabinet nominees defeated in the Senate.
  7. Tyler was the only President to face an open, armed rebellion from a State, the Dorr Rebellion in Rhode Island, up until Lincoln.

In addition to the foregoing, Richard Lummis and I consider the leadership lessons from Tyler in the following areas:

  1. His ascension to the Presidency and establishment of the Tyler Principle for succession.
  2. Economic issues, including the tariff and veto of the Bank bills.
  3. His handling of the Dorr Rebellion
  4. Texas Annexation
  5. The Princeton Incident
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Daily Compliance News

Daily Compliance News: July 22, 2022 the Serious Farce edition


In today’s edition of Daily Compliance News:

  • SFO skewered in UK report. (The Law Society Gazette)
  • Chinese government begins a takeover of HSBC. (WSJ)
  • Twitter spy trial begins. (NYT)
  • Credit Suisse agrees to pay to defraud bondholders from the Tuna Bond case. (Reuters)
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Blog

Fostering Ethical Conduct Through Psychological Safety: Part 3 – Fixing an Unsafe Workplace

Bill J. Allen died last week. Not familiar with the name? Then check out his New York Times (NYT) obituary. Perhaps outside of Illinois or Ohio, he ran one of the most brazen state legislature corruption schemes around, in the state of Alaska. His power and influence were so great that he was the cooperating witness who brought down a sitting Senator, Ted Stevens, although the Indictment was withdrawn after conviction but before sentencing due to prosecutorial misconduct.
Allen held court at a suite at the Westmark Baranof, a luxury Art Deco hotel four blocks from the State Capitol in Juneau, where he and his cronies “dished out money and told their visitors what they wanted in return. Mr. Allen and his circle seemed to revel in their shamelessness. He and Mr. Smith always booked Suite 604, and Mr. Allen always sat in the same chair. He bragged that he kept $100 bills in his front pocket, the easier to dole them out to friendly politicians. The girlfriend of one politician even had hats embroidered with the letters CBC, for “Corrupt Bastards Club.””
Allen and his brazen corruption schemes seem like a good way to introduce the concluding Part 3 of my series on fostering an ethical culture through psychological safety. This series is based on a recent article in the MIT Sloan Management Review, Summer edition, entitled “Fostering Ethical Conduct Through Psychological Safety” by Antoine Ferrère, Chris Rider, Baiba Renerte, and Amy Edmondson. In Part 1 we introduced the concept of psychological safety and why it is so important to creating an ethical culture in a business. In Part 2, we considered how to determine the state of psychological safety in your organization. Today in Part 3 we consider what happens in an organization where psychological safety is lacking and steps an organization can take to remedy this deficiency.
The authors believe that “when psychological safety is lacking, it may be a consequence of the employee having witnessed unethical behavior.” Moreover, the inversion of psychological safety “correlated to the quantity of unethical behavior noticed. Put simply, the more unethical behavior a person saw, the more likely they were to feel psychologically unsafe. This suggests that the experience of seeing more unethical behavior may diminish the psychological safety experienced by an employee.” Simply put if your bosses engage not only in corrupt behavior but simply unethical behavior, it will send a message throughout the organization that reporting unethical behavior will not be favored. One only need think of Jes Staley, former Chief Executive Officer (CEO) of Barclay’s who engaged in illegal behavior in attempting to unmask an internal whistleblower. In November 2021, Staley resigned amid a regulatory probe into whether he mischaracterized his relationship with the financier and sex offender Jeffrey Epstein. In many ways Barclays has never recovered.
The authors basically state the obvious when they write, “it makes intuitive sense that being in a work environment where unethical behavior is prevalent might diminish psychological safety.” Put another way “people are most reluctant to speak up in ethically troubled environments, where we most need them to do so.” This is an important issue for every Chief Compliance Officer (CCO) and business leader. To overcome such a deficiency, they found that “several other factors correlated with strong speak-up behavior, keeping everything else constant: moral engagement, moral attentiveness, and organizational justice combined with clarity of expectations.”
Moral engagement. As a CCO you should endeavor to create an atmosphere where ethical conduct matters, “so that when employees recognize a potentially unethical situation, they will be motivated to do what’s right.” At Novartis International AG, the authors noted the company “created a decision-making framework called the Decision Explorer to support associates in making ethical decisions. Rooted in the company’s code of ethics, the tool helps employees work through a situation to surface ethical considerations.”
Moral attentiveness. You can educate employees to recognize the ethical dimensions of situations. They point to the example at Novartis who “runs practical ethics training sessions that immerse employees in hypothetical scenarios where they must practice ethical decision-making. Another approach is to have managers highlight examples of ethical and unethical behavior with their teams and encourage dialogue on workplace ethics. Such grassroots employee contributions build trust and commitment by giving employees a role in strengthening the code of behavior by which they are expected to live.”
Organizational justice. Obviously talk is cheap and it is actions, not deeds, that matter. The Department of Justice (DOJ) has made clear in the Update to the Evaluation of Corporate Compliance Programs that the keeper and responsibility of institutional justice sits with the CCO and the authors find that this same concept “is vital to building a reputation of organizational justice.”
Clarity of expectations. CCOs must communicate a clear message to employees so that employees will have “an understanding of organizational standards and are clear about expectations.” Second, CCOs must act decisively in response to employee reports of misconduct to show that there are consequences for unethical behavior. To foster greater psychological safety, coach and empower line managers to create safe spaces for discussing ethical concerns, and help them react appropriately when such issues are raised.
The siloed nature of this issue must also be addressed. As previously noted, this issue touches multiple corporate disciplines including HR, ethics and integrity, risk management, legal and compliance. There must be a cross-functional approach in building a culture of ethics and performance. For example, Novartis created a cross-functional working group focused on the notion of ethical leadership.
The authors concluded, “Building a psychologically safe environment to facilitate speaking up about ethical conduct is relevant to both company reputation and long-term business performance. Unethical conduct can remain hidden for a time but is likely to be discovered eventually, causing far more harm than if it were caught and corrected early. Psychological safety thus can help organizations respond and improve quickly instead of allowing misconduct and unethical behavior to fester and further degrade workplace psychological safety, thus triggering a vicious cycle.” Every compliance professional should use the research from the authors study to craft a program to create or improve the psychological safety at your organization. The authors frankly state that organizations which have relied on speak-up channels or ombudspersons as mechanisms for reporting unethical behavior is no longer sufficient. “They need to be complemented by efforts to actively shape and promote an ethical climate in which managers are equipped to support employees’ ability to say what they think and react appropriately to what they hear.”

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Life With GDPR

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