U.S. District Judge Rules that Whistleblower Protections Don’t Extend Overseas

Whistleblower News

U.S. Disctrict Judge Nancy Atlas ruled last week in Houston that whistleblower protections do not apply overseas.  Khaled Asadi filed suit claiming that General Electric retaliated against him after he voiced concern that the company had violated the Foreign Corrupt Practices Act.

Click here for the full article from the Wall Street Journal Corruption & Currents Blog.  http://blogs.wsj.com/corruption-currents/2012/07/03/judge-says-anti-retaliation-provisions-dont-cover-foreign-whistleblowers/

Guttman and Buschner Represent Key Whistleblower in Justice Dept.’s $1.04 Billion Civil Settlement with GlaxoSmithKline

Reuben Guttman Articles, Traci Buschner Articles, Whistleblower News

Reuben Guttman led team on behalf of a former GlaxoSmithKline Therapeutic Sales Manager who alleged misrepresentation in promotion of company’s asthma/COPD drug Advair; firm’s third major whistleblower recovery in 2012, following Abbott Labs’ $1.6 billion settlement and banks’ $25 billion payment over ‘robo-signing’ mortgage fraud. 

BOSTON and WASHINGTON (July 2, 2012) — Reuben Guttman of Guttman, Buschner and Brooks PLLC has represented one of several key whistleblowers behind a $1.04 billion settlement announced today between drug maker GlaxoSmithKline and the U.S. Department of Justice stemming from alleged marketing abuses of various GSK medications. Lois Graydon, is a nursing professional and former GSK Therapeutic Sales Manager.

The U.S. Attorney’s office in Boston led the investigation into promotional tactics behind a total of nine GSK drugs. An accompanying criminal component of the case is expected to substantially increase the sum of the recovery.

Reuben Guttman and Traci Buschner are counsel to Lois Graydon, a registered nurse. She is one of the “relators” who alleged that GSK made false and misleading statements about Advair’s safety and efficacy, thus enabling false or fraudulent claims to Medicare, Medicaid, and other reimbursement programs.

Advair’s share of the recovery – more than $700 million – amounts to over half of the total civil settlement of $1.04 billion.

“The False Claims Act plays an important role in health industry compliance enforcement; health care is an issue that touches everyone and oversight, diligence and transparency are critical,” said Mr. Guttman, one of the country’s leading whistleblower attorneys.

“It is important that the medical community pays attention to this settlement and others and asks critical questions about the scientific support for the use of prescription drugs,” he added.

“In this election year, the safety of pharmaceuticals and their cost to the health care system should be front and center,” Mr. Guttman said.

He added, “Whistleblowers play an important role in compliance enforcement of our laws. We were proud to have represented one of the whistleblowers on this important case under the False Claims Act.”

 

AEI Presents Study on the Effects of Anti-Industry Bias

Whistleblower Articles

Last Thursday, June 21, 2012, the American Enterprise Institute held a panel, entitled “Muzzle pharma, harm patients: The dangers of anti-industry bias.”  Sitting on the panel were George Chressanthis, a professor at Temple University, Nitin Jain, a principal at ZS Associates headquarters, Thomas Stossel, a hematologist and oncologist, and J.D. Kleinke, a health care business expert.  The panel presented a new study which aimed at determining the relationship between physicians’ choices of drugs and their access to sales representatives from pharmaceutical companies.  The study looked at between 58,000 to 72,000 cases for three different drugs, Januvia, Vytorin, and Avandia, in an attempt to cover a broad range of cases which would inspire a change in drug choices.  Januvia was their sample for a first-in-class drug, Vytorin, for a negative clinical trial, and Avandia, for an FDA imposed black-box warning.  All the physician and prescription information for the cases were provided by the pharmaceutical companies and no patient outcomes were evaluated.  The study found that, generally, doctors take longer to change to first-in-class drugs but also take longer to switch away from drugs that had a negative clinical trial or for which the FDA had issued a black box warning.  Ultimately, it concluded that access limits are a part of an institutional framework whose anti-industry bias, manifested in access limits, have harmful consequences for patients.  Doctors need to operate from the largest body of information, they argued, and that to restrict them from information in any way adversely affects patient health.

Though the study presented clearly and incontestably that access to representatives caused a change in how physicians made decisions regarding drugs, without a further study of patient outcomes, there’s no basis from which to decide whether or not these changes were productive or effective.  The panel wanted to say that doctors should not rely solely on sales reps for their information but at the same time wanted to say that these same sales reps made a significant impact on physicians’ decision-making procedure.  The intimated bias was that these changes were positive changes, but without more concrete data on the practical results of these prescription changes, it is impossible from this study alone to judge decisively whether access limits have unintended and adverse consequences for patient health.

“The SEC, SEC, SEC, what are they going to do with all the whistleblowers, whistleblowers, whistleblowers …”

Whistleblowers Blog

If you recall, the Dodd Frank whistleblower provisions were promulgated partially in response to the SEC‘s failure to heed the warnings of whistleblower Harry Markopolis who warned the agency early on about Bernie Madoff.

What flowed from the Madoff debacle was an expanded whistleblower rewards program. And this is a good thing. Yet what was not addressed was the problem that was at the root of the SEC’s failure to address Markopolis’ warnings — staffing!

The SEC has one (yes “1”) examiner for every $12 billion in assets that it has to oversee.  And the agency is so overworked that there is no guarantee that a whistleblower will ever make personal contact with an SEC investigator.  The Dodd Frank Whistleblower rules actually anticipate this predicament.  Once the whistleblower files with the agency, the rules encourage the whistleblower to check out the SEC’s website to determine if the agency settled a case like the one the whistleblower reported.  It is than up to the whistleblower to file papers explaining to the agency how he or she provided help in securing a resolution.  Shouldn’t the agency already know this?

Making whistleblowers part of the SEC’s compliance program is important.  But the only way the system will really work is if whistleblowers are able to pursue their cases in the absence of SEC action. This is how the False Claims Act works and this year recoveries will be in the billions.  Having recently represented the lead whistleblower in the government’s $1.6 billion recovery against Abbott labs for marketing derelictions with regard to the drug depakote, we have personal knowledge that whistleblowers who hire an experienced attorney to represent them as they navigate the SEC process works.

Romney’s Education Plan

Whistleblowers Blog

Privatize education and open up the floodgates to education fraud.  That is what Mitt Romney wants to do.  It is bad enough that Education Secretary Arne Duncan has allowed billions to be spent on charter schools and loans for dubious online degrees; now the Republican presidential candidate has made this a cornerstone of his education plan.

The truth is that government lacks the oversight ability to ensure that basic education — let alone academic excellence — is being provided by charter schools and online providers.  At least in the case of online providers, accreditation has been privatized and there are no regulations which regulate the accreditors who provide the green light for the flow of government backed student loans that allow customers to pay their bills.

Before any candidate lays down plans to send taxpayer dollars to the private sector, one thing is clear; there needs to be a clear regulatory and compliance enforcement system to provide standards and sanctions against those that violate them.  These days federal dollars are too scarce to waste and the nation’s future depends on a substantive education system.

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