District of South Carolina Settles Long Term Care Pharmacy Whistle Blower Case Completing Final Leg of Anemia Drug Litigation

Columbia, South Carolina —— A $2.5 million settlement with Pharmerica, a long term care pharmacy servicing hundreds of nursing homes across the nation, completes the final leg of litigation involving the illegal promotion of Aranesp, an anemia drug manufactured by Amgen, Inc.

In 2013, the US Attorney’s Office for the District of South Carolina, The Department of Justice Civil Frauds and a number of states executed a $24.9 million settlement with Amgen in this case. In 2014, Omnicare followed with a $4.19 million settlement. The recent settlement brings the government’s recovery in United States ex rel. Kurnik v. Amgen et al. to just over $31.5 million.

The Kurnik litigation was brought under federal and state false claims act statutes that allow private citizens to bring suit on behalf of the government to recover money expended as a result of fraud or other wrongful conduct. The government intervened in the Amgen and Omnicare portions of the case and the Relator pursued the case against Pharmerica on behalf of the government.

“Public health insurance programs shouldn’t foot the bill for drug company schemes that manipulate doctors and patients to maximize profits,” said South Carolina US Attorney Bill Nettles. “This case is an excellent example of how the government can work together with private whistleblowers to recover money for taxpayers.”

The United States was represented by Assistant US Attorneys Fran Trapp and James Leventis from the District of South Carolina Office.

Kurnik was represented by Dick Harpootlian and Chris Kenney of Richard A. Harpootlian, P.A. in Columbia, South Carolina and Reuben Guttman, Traci Buschner, Justin Brooks and Caroline M. Poplin, J.D., M.D. of Guttman, Buschner & Brooks PLLC in Washington, D.C.

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. 

Spotlight on privatisation of the courts

As debate in the US continues over mandatory arbitration clauses that have led to private adjudications, a new film focuses attention on the use of private forums and sealed proceedings to resolve matters of potential public importance.

Spotlight, starring Michael Keaton, focuses on the team of investigative journalists from The Boston Globe who exposed sexual abuse by Roman Catholic priests. The movie takes its name from The Globe’s ‘Spotlight Team’ of investigative reporters.

As stories about investigative journalism go, Spotlight is not All the President’s Men. It is not so much about a team of reporters finding the facts on their own as it is a story about reporters struggling to pry the facts – and story – loose from attorneys who have settled their cases in private forums or who are litigating with key documents sealed by confidentiality orders.  In Spotlight, it is the lawyers who have put the facts and story together; but it is a story that they must keep to themselves.

In a line that explains the rationale for transparency of the judicial and legislative process, Justice Brandeis notes that sunshine is the best disinfectant. Court proceedings that seemingly involve only private interests may very well have public import. For example, cases alleging sexual harassment and employment discrimination, even when brought by a single plaintiff, may involve conduct that is pervasive and thus relevant to others who might muster the courage to step forward and vindicate their own rights. Matters litigated in the sunshine may cause private entities and government oversight bodies to take action to protect against prospective injury. But for the work of the Spotlight Team, the pervasive nature of egregious conduct would not have seen the light of day.

Public litigation in the United States has brought to the surface facts that make cars safer, workplaces more tolerable for protected classes and the air we breathe less dangerous to human health. It does not even take a court ruling or jury verdict to make the point – information that comes to light during the litigation process may fuel legislative oversight and/or regulation. This is not merely a collateral benefit; it is the way the system is supposed to work. And – as Spotlight reminds us – there is a real benefit to a transparent system of justice.

Reuben Guttman is a prominent trial lawyer and founding partner at Washington, DC-based firm Guttman, Buschner & Brooks.

What it means to be a whistleblower

Individuals blowing the whistle can receive millions of dollars for their information but is this the motivation?

2012 can be looked upon as the year of the whistleblower as the US government was on a trajectory to collect more than US$5 billion from cases that were initiated by private citizens. “With the growth of multi-nationals, cross-border enforcement, complex financial products and the recent economic crisis, whistleblowing has become an integral part of compliance enforcement in the US,” said Jerry Martin, the US Attorney for the Middle District of Tennessee. As a federal prosecutor, Martin works closely with counsel for private citizens who can, in some cases, initiate litigation on behalf of the government.

A protected species in the US

In the US, a myriad of laws protect whistleblowers from retaliation and some laws even reward whistleblowers with bounties where their efforts result in monetary recovery. False Claims Acts at the Federal and State levels pay bounties as high as 30 per cent of the recovery, with an average payment of between 15 per cent and 20 per cent.

While the federal False Claims Act dates back to 1863, in 2010, the US Congress, through the Dodd-Frank Wall Street Reform and Consumer Protection Act, expanded the role of whistleblowers. Now, whistleblowers providing information to the Securities and Exchange Commission or the Commodity Futures Trading Commission may be awarded a bounty. The US Internal Revenue Service has its own whistleblower program and that agency recently paid out a bounty of US$104 million to a private citizen whose efforts led to the recovery of taxes from UBS.

What is the motivation for whistleblowing?

The decision to blow the whistle is fraught with emotion and complex legal and factual analysis. Who are these whistleblowers and why do they do it?
Meredith McCoyd was an Atlanta, Georgia sales representative for Abbott Laboratories before she filed her False Claims Act lawsuit against Abbott in 2007. Her recovery led to a 2012 settlement between the government and Abbott totaling US$1.6 billion to resolve allegations that the company illegally marketed its antiepileptic drug Depakote. For her part, Ms. McCoyd will receive a bounty which will pay her well into the millions of dollars. Ms. McCoyd says she was “concerned about the widespread use of the drug to treat patients with Alzheimer’s and other psychological disorders that were not studied or approved by the FDA.” She also realized that “the training we received from the company convinced many sales representatives, including me for a time, that marketing to these patients and paying doctors to prescribe was legal when it was not.”

Whistleblowers don’t have to work for the company

Not all whistleblowers are employees. Lynn Szymoniak, a Florida attorney, whose original research and persistence led to exposure of the US mortgage robo-signing scandal, provided information to the government in 2010 and filed a suit under the False Claims Act. Information generated from her case was a catalyst for portions of the government’s $25 billion bank settlement with five banks, including Bank of America and JPMorgan Chase. Ms. Szymoniak, who herself had been a defendant in a foreclosure case, will reap a multi-million dollar bounty.

Whistleblowers often face the question of whether their concerns can be addressed by a company’s internal compliance programme. Glenn Demott was one of the six whistleblowers whose litigation culminated in the government’s 2009 US$2.3 billion settlement with Pfizer. And, as Mr. Demott will attest, not all whistleblowers have a smooth ride. Mr. Demott initially resorted to internal compliance channels to raise concerns about the company’s marketing practices. Only after he was met with a deaf ear, did he seek redress in court under the False Claims Act. He alleged that the company’s unlawful marketing practices caused the government to spend precious healthcare dollars to pay for unnecessary prescriptions. “I would blow the whistle again for a good cause if needed,” said Demott.

A global model?

“The citizens of the United States are well served by an efficient government, and whistleblowers play an important role in eliminating fraud, abuse, and conduct that causes harm to the government and the public,” said William Nettles, the US Attorney for the District of South Carolina who was the chief lawyer for the government in Lynn Szymoniak’s case. Demott, Szymoniak and McCoyd, in varying degrees, illustrate the role that whistleblowers play in the US legal system as the economy and the products that are produced become more complex. While they are US citizens, US laws, including the False Claims Act, allow for non-citizens, even those living outside US borders, to blow the whistle and benefit from bounties. Now, it will be interesting to see whether the US whistleblower model will be a recipe for compliance enforcement all over the world.

Guardians of the People

As a UK gas costs fall under the spotlight for alleged price-fixing, Reuben Guttman makes the case for whistleblowers.

NEW YORK – A revival of Ibsen’s 1882 play, An Enemy of the People, is currently running on Broadway.  The drama tells the story of a doctor who blows the whistle on a Norwegian town’s bathhouse because it draws contaminated water from a local tannery.

Ibsen does not use the modern expression ‘whistleblower’, but that term accurately describes the play’s protagonist, Dr. Stockman, the bathhouse medical director, who publicists the health hazard despite skepticism from townspeople, who, urged by the mayor and his allies, are led to believe all is well.

Dr. Stockman initially has the support of the local newspaper, which is prepared to publish his findings.  But the paper changes course after the mayor informs the publisher and the editor about the high cost of re-routing the bathhouse pipes and the revenue loss caused by the renovations.

Monopoly of truth

With economics placed over health, the paper declines to publish Dr. Stockman’s findings.  Rationalizing the decision, the publisher convinces himself that Dr. Stockman’s concerns are without merit.  He tells the mayor that the editor ‘is not such a fool as to go and ruin his paper and himself for such an imaginary grievance’.

At a town meeting, Dr. Stockman voices what he sees as a greater issue: ‘I propose to raise a revolution against the lie that the majority has the monopoly of truth,’ he proclaims.  But in the end, the townspeople declare Dr. Stockman ‘an enemy of the people’; he loses his job and his social status in the community.

Though written a century ago, Ibsen’s play provides insight into the mindset and plight of what could have been a 21st-century whistleblower.  The playwright reminds us that, almost by definition, whistleblowers challenge accepted views or ways of doing business.  Deciding to raise a voice involves the balancing of moral obligations against the dangers of retaliation.  And, even where whistleblowers are correct in their views — or at least have bona fide reasons for airing them — they still may face retribution as their good names may be sullied by pre-textual attacks.

Bounties

In the US, there is some recognition of the value of whistleblowers in enforcing compliance with the rule of law.  To varying degrees, whistleblowers have played roles in exposing frauds from Enron to Madoff.

There is even a trend in the US towards legislating to allocate bounties to those whistleblowers that follow carefully regulated steps and provide information to government enforcement agencies.  The Federal False Claims Act pays bounties to those who bring suit in the name of the government against people or corporations that cause the misappropriation of federal government monies or property.  The Dodd Frank Act pays bounties to whistleblowers for reporting securities fraud to the Securities and Exchange Commission.  Even the Internal Revenue Service, which collects tax monies, doles out bounties to those who report tax cheats.  Under these laws, bounties are paid without regard to a whistleblower’s place of residence or even citizenship.

Snitches

I have often been asked when traveling abroad why Americans reward ‘snitches’.  Of course, I say that in the US we call them whistleblowers, a word that arose in the 1970s when consumer activist Ralph Nader demonstrated that individual citizens that speak up on matters, including safety in the automobile industry, serve an important social role.

Now, I can point them to a Norwegian playwright who recognized more than a century ago that challenging accepted ways — especially those that cause physical harm — is worthy practice, albeit one fraught with personal risk. Compensation for taking this risk seems just.

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