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OSHA Announces Interim Rule on Whistleblower Protections for Reporting Violations of Affordable Care Act

Last Friday, OSHA published an interim final rule, and invited public comment on whistleblower protections for reporting violations of Affordable Care Act's health insurance reforms.  The Affordable Care Act contains various provisions to make health insurance more affordable and accountable to consumers. Among the policies to achieve its goals, the Affordable Care Act's Section 1558 provides protection to employees against retaliation by an employer for reporting alleged violations of Title I of the act or for receiving a tax credit or cost-sharing reduction as a result of participating in a Health Insurance Exchange or Marketplace.

 

The interim final rule can be viewed at www.dol.gov/find/20130222/. Comments, which will be accepted for 60 days, may be submitted electronically via the federal e-rulemaking portal at http://www.regulations.gov, or by mail or fax. Faxed submissions, including attachments, must not exceed 10 pages and should be sent to the OSHA Docket Office at 202-693-1648. Comments submitted by mail should be addressed to the OSHA Docket Office, Docket No. OSHA-2011-0193, U.S. Department of Labor, Room N-2625, 200 Constitution Ave. NW, Washington, DC 20210.

A fact sheet about filing whistleblower complaints under the Affordable Care Act is available at http://www.osha.gov/Publications/whistleblower/OSHAFS-3641.pdf.

OSHA's press release on this issue can be found here.

 

Blood Medicine tells the story of Mark Duxbury's suffering to expose big pharma's abuse

Blood MedicineKathleen Sharp's book about pharmaceutical whistleblower Mark Duxbury will be released in paperback on September 1, 2012. It is Blood Medicine: Blowing the Whistle on One of the Deadliest Prescription Drugs Ever. I had the pleasure of interviewing journalist Kathleen Sharp on November 15, 2011.  You can listen to the archive of that interview here.

Mark Duxbury was a star salesman for a subsidiary of Johnson & Johnson. He was selling Procrit. Procrit is a type of erythropoietin, which is also called EPO. Following management direction, he convinced doctors that prescribing high doses would help cancer and dialysis patients. At the time, Johnson & Johnson was engaged in a bitter turf battle with competitor Amgen. Procrit became Johnson & Johnson's top selling drug. The U.S. government was paying more for EPO than it was for any other class of medications. Duxbury and a co-worker, Dean McClennan, became concerned about the reports of patients dying while taking Procrit. They insisted that their employer respond to this safety concern, and refrain from illegal marketing tactics. This issue cost him his job. By 2007, the dangers of Procrit became public, but not before too many Americans had died.

Duxbury and McClennan filed a whistleblower claim under the False Claims Act (FCA). Kathleen SharpDuxbury died before the litigation could be completed. Sharp (pictured) examines how a big pharmaceutical company can push its drugs through doctors and into patients' veins before any of them are aware of the true risks. Sharp explains how federal regulators facilitated the pharmaceutical companies and reacted slowly to the reports of adverse reactions. Even today, EPO is on the market, albeit with enhanced "black box" warnings.

Sharp also makes Duxbury's ordeal come to life. Much as attorney Steven Berk explained here, the recoveries of qui tam whistleblowers are rarely reported with the details of the suffering they endured for the public's benefit. In Blood Medicine, Sharp does report the details, in a flowing narrative that makes for an easy read of such a hard story.

Blood Medicine is an important story for whistleblowers, taxpayers and patients. We are indebted to Kathleen Sharp for her thorough research and insightful writing.

New York Times editorial supports FDA whistleblowers

In today's editorial, the New York Times expresses concerns about the targeted surveillance of whistleblowers at the Food and Drug Administration (FDA). The editorial recounts the claims made by six scientists and physicians who raised concerns about the safety and effectiveness of devices approved by higher FDA officials. FDA managers then began a campaign of targeted surveillance that included the installation of special software to capture every image that appeared on the computer screens of these whistleblowers. The editorial notes how the FDA managers sought criminal charges against the whistleblowers.  When that failed, the FDA began firing them. The editorial acknowledges how Sen. Charles Grassley warned FDA officials that interfering in a congressional investigation is against the law. The editorial then urges that if the whistleblowers' claims are true, the managers responsible are the ones who should be punished.

If you agree that targeting whistleblowers with invasive surveillance is wrong, you can TAKE ACTION. You can read more about the landmark case brought by these FDA whistleblowers here.

MSPB Approves Stay for FDA Whistleblower

The Merit Systems Protection Board (MSPB) recently allowed a stay in the termination of a Food and Drug Administration (FDA) whistleblower, Paul T. Hardy. The Office of Special Counsel (OSC) requested the stay on his behalf due to reasonable belief that Mr. Hardy’s recent termination from the FDA constituted a violation of the Whistleblowers Protection Act (WPA).

According to the OSC, there is substantial evidence that Mr. Hardy’s termination was a direct retaliation for disclosures he made about serious safety issues with a screening device designed to detect breast cancer. The OSC explained that Mr. Hardy’s whistleblowing “raised issues related to exposing the general population to unwarranted radiation exposure and ineffective cancer screening devices.”

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Special Counsel moves to protect two whistleblowers

Carolyn LernerSpecial Counsel Carolyn Lerner (pictured) announced today that she filed requests yesterday on behalf of two federal whistleblowers to protect them from adverse personnel actions. She filed the requests with the Merit System Protection Board (MSPB) in support of Paul T. Hardy, a Regulatory Review Officer for the U.S. Public Health Service (USPHS), and Franz Gayl, a high-level civilian science and technology adviser to the U.S. Marines Corps.

These actions by the Office of Special Counsel (OSC) were unprecedented in the prior administration. Today marks the beginning of new assertiveness by the OSC, and new grounds for optimism by federal employees at every level. Bravo!

Hardy and Gayl have endured hostility from management for years. It is long overdue that someone in government finally took a stand on their behalf. Thankfully, the newly installed Special Counsel is in just the right position to take that stand. Here in this corner, we are so pleased. Follow the continuation of this blog post to read more about Hardy and Gayl's cases.

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Dr. Duane Bonds files petition with Supreme Court to expand protections for federal employees

Dr. Duane Bonds

Dr. Duane Bonds has filed a petition with the U.S. Supreme Court this week. Dr. Bonds was our nation's top researcher on sickle cell disease until she blew the whistle on the unauthorized cloning of participants' cells. In January, the U.S. Court of Appeals for the Fourth Circuit ruled that she had a right to a jury trial on her claims under the Whistleblower Protection Act (WPA). Bonds v. Leavitt, 629 F.3d 369, 384 (4th Cir. 2011). However, it let stand the dismissal of her claims of retaliation against her in violation of Title VII. Title VII is part of the Civil Rights Act. The Fourth Circuit said that Title VII protects federal employees only to the extent that it protects employees in the private sector, and that protection applies only to concerns about discrimination in employment. The Fourth Circuit held that Title VII does not protect federal employees when they raise concerns about discrimination against minority members of the public.

My colleague Michael D. Kohn and I filed Dr. Bonds' petition for a writ of certiorari this week asking the Supreme Court to accept this case so it can say that federal employees are protected when they protest discrimination against the minorities the government is supposed to serve. The key provision of Title VII, 42 U.S.C. §2000e-16 provides that all personnel actions taken against a federal employee “shall be made free from any discrimination based on
race, color, religion, sex, or national origin,” Recently, the federal appeals court in the District of Columbia said that this provision requires the federal government to set a higher standard than it imposes on the private sector.  Ford v. Mabus, 629 F.3d 198 (D.C. Cir. 2010). Dr. Bonds' petition provides the Supreme Court a chance to make this holding apply throughout the country.  More information about Dr. Bonds' case is available in this prior blog post.

Sylvester wins at ARB in a victory for all whistleblowers

Steve Kohn, Kathy Sylvester, Pat McDermott

On May 25, 2011, the Department of Labor's Administrative Review Board (ARB) issued a major decision in favor of whistleblowers. In Sylvester v. Parexel International, ARB Case No. 07-123 (ARB May 25, 2011), the ARB held that a whistleblower only needs a "reasonable belief" of a violation to engage in protected activity under the 2002 Sarbanes-Oxley Act (SOX). The ARB makes clear that a whistleblower does not have to wait for a violation to actually happen, and need not inform management of the basis of that reasonable belief. Indeed, since SOX prohibits companies from violating rules of the Securities and Exchange Commission (SEC), a whistleblower can have a reasonable belief about a violation that has nothing to do with any fraud against shareholders. The ARB also rejects the idea that a SOX violation has to be "material" to form the basis of a whistleblower's "reasonable belief." The ARB has also freed whistleblowers of the unnecessary hurdle of "pleading" their claims under the high "Iqbal" standard.

The Sylvester decision is a significant departure from the decision of the prior administration. All those decisions that required protected activity to "definitively and specifically" implicate a violation of law are now out-of-date. Indeed, in separate concurring opinions, three of the four ARB judges specifically rejected the "definitively and specifically" standard since it is not in the statute.

When considered together with Brown v. Lockheed Martin Corp, ARB No. 10-050, ALJ No. 2008-SOX-49 (ARB Feb. 28, 2011) (no fraud against shareholders need be shown), and Johnson v. Siemens Building Technologies, Inc., ARB Case No. 08-032 (ARB Mar. 31, 2011) (SOX covers the employees of subsidiaries), the Sylvester decision marks a decided turn in favor of recognizing whistleblowers as servants of the public purpose and deserving of strong protection. The ARB is clearing away the hurdles that made SOX so difficult for whistleblowers during its first eight years.

Pictured above are Stephen M. Kohn, Kathy Sylvester and her attorney E. Patrick McDermott. Stephen Kohn co-wrote amicus briefs with me on behalf of the National Whistleblowers Center and Douglas Evans. Congratulations to Kathy Sylvester, her co-complainant Theresa Neuschafer, and their attorney, Patrick McDermott of Annopolis, Maryland. They have helped breath new life into SOX on behalf of future generations of whistleblowers.

Oregon Lawmakers Seek to Stregthen Whistleblower Protections for Healthcare Workers

The Oregon legislature is debating a bill which would protect from retaliation any hospital employee who reports misconduct that he/she believes is a violation of law, policy, or professional standards. Under current Oregon law, nurses already enjoy these protections. Senate Bill 237 would extend these protections to all hospital staff. 

Although it is unfortunate that the law contains an internal-reporting requirement for particular types of disclosures, it is particularly heartening to see states taking steps to fill the gaps in protection for healthcare workers. Employees in the medical field have long been without protection, and they were provided with very limited protections under the Patient Protection and Affordable Care Act of 2009. The whistleblower-protection portions of that law mainly protected employees who report to their employer misconduct with regard to insurance, such as the refusal of coverage based on improper reasons, like pre-existing conditions (it is notable that the 2009 national healthcare law also provided crucial amendments to the False Claims Act). Until Congress passes a national law protecting healthcare employees who blow the whistle, it is vital that states like Oregon step up to the plate for medical professionals in their state.


 

Ninth Circuit protects social worker's court testimony

Last week, the U.S. Court of Appeals for the Ninth Circuit issued an opinion holding that a social worker is protected from retaliation for his courtroom testimony about  a former client. The case is Clairmont v. Sound Mental Health and Wilson, No. 09-35856 (9th Cir. 2011).

From 2005 to 2007, Sound Mental Health (SMH) of Seattle, Washington, employed Richard Clairmont as a domestic violence  program manager. He supervised a treatment program for offenders and members of the public.  SMH had a contract with the Seattle Municipal Court. In exchange for providing the services and making regular reports to the Court, the Court gave SMH office space and equipment. Joni Wilson was the Manager of Probation Services for the Court.

In 2007, a criminal defense attorney subpoenaed Clairmont to provide expert testimony in her client's case.  The client spoke Spanish, and had been terminated by a competing treatment program. Clairmont agreed to provide the testimony about the possibility that the client was treated differently because of the language issue. The Court's probation office was seeking a court determination that the client had violated the terms of probation such that the court should revoke probation and impose a jail sentence. When Wilson learned about Clairmont's testimony, Wilson called Clairmont's supervisor at SMH. Two weeks later, SMH fired Clairmont because of "critical feedback from the City of Seattle Domestic Violence Probation Officers Unit about your performance." The letter noted that "The program is in jeopardy. They have proposed a stop-referral beginning immediately. This leaves SMH with no option but to terminate your employment effective today.

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ARB holds first oral argument in a SOX case

Today the Department of Labor's Administrative Review Board (ARB)ARB held its first oral argument in a case under the Sarbanes-Oxley Act (SOX). Last November, the ARB gave notice of today's oral argument, and invited interested groups to submit friend-of-the-court (or "amicus") briefs. The ARB asked the parties to address issues of how specific OSHA complaints have to be, whether Administrative Law Judges (ALJs) can grant motions to dismiss on the pleadings, and the nature of protected activity under SOX. A prior blog post covered the amicus briefs, including the briefs of the National Whistleblowers Center and Doug Evans. Pictured here are ARB Board Members Luis Corchado, Paul Igasaki (Chair), E. Cooper Brown (Vice-Chair) and Joanne Royce.

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