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
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LEADING: Partner Traci Buschner to moderate Ethics panel at the FBA Qui Tam Conference.

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Another Reminder of Why Corporations Cannot Police Themselves

This article, written by Reuben Guttman and Traci Buschner who practice law with Guttman, Buschner & Brooks PLLC. Published in the McClatchy-Tribune News Service on August 13, 2014.

What kind of people would knowingly expose someone to the risk of infection just to make a buck?

Read carefully the allegations underlying the recent $97 million settlement between the U.S. Department of Justice and Community Health Systems and that question may be answered.

Responding to lawsuits brought under the False Claims Act by multiple whistleblowers, the government investigated and came to terms with the Nashville-based hospital giant resolving allegations that patients were admitted from emergency rooms to overnight stays not for medical necessity but for the purpose of racking up Medicare and Medicaid revenue and bilking private payers.

No harm, no foul. Right? Just skimming a few dollars off the government with no potential harm to patients? Right? Wrong on both counts!

While hospitals are places to get well, staying in a hospital is – these days – a place to acquire a hospital infection. According to allegations brought by three of the whistleblowers, including a physician at a CHS-owned Philadelphia hospital, overnight admission to a hospital absent medical necessity is not prudent medical practice. And, the rationale behind that conclusion is not just about saving dollars. It is a question of health and safety.

So, according to the allegations spanning multiple whistleblower law suits – as the publicly traded CHS was gobbling up community hospitals across the country, it was supporting its buying fling by admitting patients who allegedly did not need hospitalization.

And so the story goes; once again whistleblower lawsuits brought under the False Claims Act – a law allowing private citizens with knowledge of wrongdoing to bring suit in behalf of the government – was being used to recover taxpayer dollars and expose conduct placing citizens at risk. Technically these suits are about the submission of false claims for government payment or approval. In reality they are about much more.

In recent years, whistleblower litigation under the False Claims Act has uncovered conduct by giant pharmaceutical manufacturers including Abbott, GlaxoSmithKline, Amgen and Pfizer that has resulted in criminal convictions and billions of dollars in recovery for hard-pressed government payers. In each case the Government paid hundreds of millions of dollars in reimbursement for prescriptions that were the resulted of marketing tactics that violated the law. Patients were given medicine for reasons not solely grounded in medical necessity or rationale.

To be clear where companies including Abbott and Glaxo pleaded guilty to marketing schemes that placed patients at risk, they did so knowingly and in each case told the court they were pleading guilty because they were indeed guilty.

The tragedy is that the CHS settlement – a civil settlement – is yet another reminder that people captured by a corporate culture have willingly placed countless unwitting citizens at health risk all for the purpose of making additional profit. That is indeed the tragedy. The travesty is that even after the health care providers we once trusted have plead guilty to conduct that places people at risk, the U.S. Chamber of Commerce – or at least a few lawyers speaking on its behalf – still claim that these purportedly outstanding companies need to be cut some slack. Testifying before the U.S. House of Representatives’ Judiciary Committee Subcommittee on the Constitution and Civil Justice on July 30, lawyers for the Chamber attacked the False Claims Act, arguing that corporations should police themselves with whistleblowers being required to first report their concerns to corporate internal compliance personnel before alerting government officials.

Of course, these mouthpieces for the Chamber neglected to mention that every pharmacy giant that has pleaded guilty over the last five years had internal compliance programs that did not work so well. Actually, come to think of it, CHS also had an internal compliance program.

So what kind of people would knowingly expose someone to the risk of infection just to make a buck? One quick answer is definitely not the kind of people we want policing themselves for good behavior.

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Patients suffer from drug industry’s chronic greed

By Reuben Guttman and Traci Buschner who practice with Guttman, Buschner & Brooks PLLC in Washington DC.

Commentary: Give Big Pharma a dose of strong regulatory medicine

Pfizer is paying the U.S. government and a number of states more than $450 million to resolve allegations that its subsidiary, Wyeth Pharmaceuticals, unlawfully marketed the immunosuppressant drug, Rapamune.

The two Pfizer (NYSE:PFE) whistleblowers who initiated the case, Marlene Sandler and Scott Paris, were pharmaceutical sales representatives who raised concerns through a lawsuit filed under the Federal False Claims Act that their company actively marketed Rapamune for purposes not approved by the FDA and paid kickbacks to doctors in order to increase sales.

The resolution of the Rapamune case is one more settlement in a long procession of cases brought against the pharmaceutical industry for unlawfully marketing drugs. Last year, GlaxoSmithKline (NYSE:GSK) paid (LSS:UK:GSK) more than $3 billion to resolve allegations of misbranding and kickbacks with regard to a number of drugs including the blockbuster asthma and COPD drug, Advair.

Meanwhile, Abbott Labs (NYSE:ABT) paid a total of $1.6 billion to resolve civil and criminal allegations with regard to marketing derelictions of its drug Depakote. And, as recently as April, Amgen (NASDAQ:AMGN) paid almost $25 million to settle claims that it had paid kickbacks to induce sales of its anemia drug, Aranesp.

These are only some examples; over the last decade, almost every major pharmaceutical manufacturer has been sanctioned either civilly, criminally, or both for unlawfully marketing their drugs.

More than money

Unfortunately, these cases are remembered for the money. The press thrives on resolutions that break new monetary barriers of recovery. The lawyers bask in this success of high-profile settlements. The regulators make claims at least hinting that compliance enforcement works.

Somewhere lost in the discussion is the patients.

Today, there are countless people whose drug regimens have been dictated at least in part by marketing agendas and not medical necessity. There are the elderly in nursing homes who are easy prey for the industry because they too often lack the ability to ask questions about their treatment, let alone provide the truly informed consent to allow it to occur. Too often they are placed on drugs because of protocols implemented by intermediary long-term care pharmacies, which are incentivized with payoffs by the pharmaceutical industry.

Then there are the children whose doctors are either on the payroll of the industry or have been influenced by paid industry opinion leaders. With doses of anti-psychotics and anti-epileptics touted as mood stabilizers, too many children are dosed with drugs to change behaviors that in yesteryear would have been dealt with through less-invasive means.

Finally, there are patients, like those on Rapamune, who have life-threatening illnesses and must make decisions based on truthful information. They are in no position to distrust their physicians or the pharmaceutical industry that makes their drugs. On the edges of life itself, to do so would be to question those who provide any hope of recovery. This is what the industry marketers know.

Checkup and testing

Unlawfully marketing drugs is not just about the government or third-party payers paying for unnecessary products. It is about disseminating misinformation to those who have a window of time and opportunity to make critical medical decisions.

If our physician had committed the same derelictions, and paid fines to resolve civil and criminal penalties, it is a safe bet that we would be looking for another doctor. Yet we do not have the same choice, given the relatively limited number of companies that manufacturer drugs, which when used for proper purposes and in a proper manner can be life-changing, if not life-saving.

Pfizer has paid its fine to the Department of Justice and to the states. It is now time for Congress to take a hard look at the conduct of the pharmaceutical industry. Oversight by the FDA is not sufficient. A systemic marketing violation impacting thousands of patients is an exponential train wreck.

In this country, a train wreck warrants an investigation by the National Transportation Safety Board. There needs to be a similar board, perhaps a Pharmaceutical Safety and Investigation Board, which looks at derelictions like the one that occurred with regard to Rapamune and makes a full disclosure to the medical community.

The tragedy of the Rapamune case, and cases like it, is not the lost dollars to the government but the dissemination of misinformation through unlawful marketing that skews medical decision-making. For this injury, money alone does not set the record straight.

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Guttman & Buschner Represent Whistleblowers in Justice Dept. $257 Million Civil Settlement with Wyeth over Unlawful Marketing of Rapamune

Pfizer subsidiary pleads guilty to off-label marketing of powerful immunosuppressent Rapamune; settlement latest in series of major off-label whistleblower cases against Abbott, GlaxoSmithKline and Amgen

WASHINGTON, DC (July 30, 2013) – Leading whistleblower attorneys Reuben Guttman and Traci Buschner of Guttman, Buschner & Brooks PLLC represented two key whistleblowers behind a $257.4 million settlement announced today between drugmaker Wyeth Pharmaceuticals, a subsidiary of Pfizer, and the U.S. Department of Justice stemming from alleged marketing abuses of Wyeth’s powerful immunosuppressant drug Rapamune. The case was originally brought by  Marlene Sandler and Scott Paris, both of whom were sales representatives for the company.

Today’s blockbuster settlement of the whistleblower case was originally panned by the Justice Department, but raised the ire of a Congressional oversight committee in 2010.

The case, filed under seal in 2005 in U.S. District Court for the Eastern District of Pennsylvania, led to an investigation by the Justice Department and multiple states into abusive marketing practices related to Rapamune, which is primarily approved by the FDA for individuals following kidney transplants to help the body prevent organ rejection. On Dec.3, 2006, the DOJ filed a formal notice with the Eastern District declining to intervene in the case.

Guttman and Buschner continued to move forward with the case, and filed an amended complaint on behalf of the whistleblowers on May 24, 2010 ─ which spurred a formal inquiry by the U.S. House of Representatives Committee on Oversight and Government Reform, then chaired by U.S. Representative Edolphus Towns.

On Sept. 21, 2010, the Justice Department intervened in the case and transferred it to the U.S. the District Court for the Western District of Oklahoma in Oklahoma City, where an investigation was initiated with regard to claims brought by a third whistleblower.

The settlement agreement notes the broad scope of Wyeth’s alleged unlawful marketing of Rapamune for well over a decade, spanning from September 1999 to December 2011:

Wyeth (a) knowingly promoted the sale and use of Rapamune for uses for which it had not been approved by the United States Food and Drug Administration (FDA), including for use in connection with solid organ transplant patients other than kidney transplant patients, which were not medically-accepted indications (as defined in 42 U.S.C. § 1396r-8(k)(6)), and were not covered by Medicare, Medicaid and other Federal health care programs; and (b) knowingly promoted the sale and use of Rapamune in treatment regimens that had not been approved by the FDA including the use of Rapamune with transplant patients who used another immunosuppressant drug before using Rapamune and the use of Rapamune in combination with certain types of products other than cyclosporine and corticosteroids.

Ms. Sandler and Mr. Paris were represented by Reuben Guttman and Traci Buschner. Mr. Guttman is one of the country’s preeminent whistleblower lawyers, having representing individuals in some of the largest pharmaceutical and financial services cases on record.

“Pfizer subsidiary Wyeth joins a parade of other pharma giants to plead guilty and pay significant penalties for unlawfully marketing their drugs,” said Mr. Guttman. “The abuses related to illicit marketing of Rapamune paint a disturbing portrait. Wyeth leadership placed a highly vulnerable patient population at serious health risk. Exposing those whom drug makers have pledged to heal to increased risk merits immediate congressional oversight. Hopefully, the settlement will prompt Congress to take action.”

Mr. Guttman continued: “Over the past five years, at least half a dozen pharma giants have paid fines for conduct that places patients in harm’s way, yet not a single individual has been held accountable. Our nation can no longer afford the expenditure for drugs that don’t work, cause additional harm and saddle the country with the long-term of obligation of paying for the medical care of victims. These cases are reported in terms of dollars but they are more about conduct that impacts patients and taxpayer.”

In the last three years, Guttman and Buschner have had unprecedented success representing lead whistleblowers in the government’s $1.6 billion settlement with Abbott (2012); its $1.04 billion settlement with GlaxoSmithKline (2012); and its $24.9 million dollar settlement with Amgen (2013). The firm also represented whistleblower Lynn Szymoniak, who first reported claims of robo-signing to 60 Minutes and whose allegations led to a $95 million settlement as part of the government’s historic $25 billion settlement with the country’s four largest banks (2012).

Mr. Guttman and Ms. Buschner currently represent several relators in an ongoing case, in which the government has intervened, against defense contractor LockheedMartin regarding alleged environmental noncompliance and mishandling of hazardous waste at the Paducah Kentucky Gaseous Diffusion Plant.

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