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Novartis and U.S. Attorney’s Office Settle FCA and Criminal Allegations Regarding Trileptal® for $422.5 Million


Novartis Pharmaceuticals reached a settlement agreement totaling $422.5 million with the U.S. Attorney’s Office for the Eastern District of Pennsylvania regarding civil allegations under the False Claims Act and criminal allegations under the Food, Drug, and Cosmetic Act relating to its misbranding of Trileptal®.

U.S. OSC Affirms Whistleblower’s Warning that FAA Ignored Violations

The U.S. Office of Special Counsel stated in a press release that a Federal Aviation Administration (FAA) safety inspector was correct when blowing the whistle on the FAA’s overlooking of safety violations at Erie Aviation, a repair station operator that services commercial airlines.  The Wendell H. Ford Aviation Investment and Reform Act for the 21st Century, also known as AIR21, protects employees who expose air carrier safety violations.  To learn more about The Employment Law Group® law firm’s Airline Whistleblower Practice, click here.

Senate Unanimously Approves Bill to Repeal Dodd-Frank Provision Granting Confidentially for SEC Investigations

The Senate unanimously approved Bill S.3717, which would repeal provisions in section 929I of the Dodd-Frank Act that grant confidentiality to SEC investigations of fraud committed by publicly-traded companies.  Under Section 929I, the SEC cannot be compelled to disclose information provided to the SEC by whistleblowers; however, the SEC must still comply with the information requests made by Congress, Federal agencies, or a court order in an action brought by the United States or SEC.  The new Senate Bill would replace this confidentiality provision with one clarifying that Exemption 8 of the Freedom of Information Act applies to SEC investigations.   Exemption 8 protects matters that are “contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions.”

For information about The Employment Law Group® law firm’s SEC Whistleblower Practice.

New York Expands False Claims Act and Strengthens Whistleblower Protections

New York recently amended its False Claims Act (FCA) by expanding the Act’s coverage and strengthening the Act’s whistleblower protections.  The New York FCA now applies to violations of New York tax law when the violator’s income from sales exceeds one million for the year in which the violation took place.  Furthermore, whistleblower protections are now afforded to contractors and agents in addition to employees, and whistleblowers are now protected when they are “harmed or penalized by an employer, or prospective employer” because of “lawful acts done by the employee, contractor, agent, or associated others.”   The amendments explicitly confirm that the keeping of documents evidencing fraud or transmitting those documents to the government or the whistleblower’s attorney is a “lawful act” even when the activity violates a contract or a duty of the employee so long as that activity furthers efforts to stop one or more FCA violations.

For information about The Employment Law Group® and its False Claims Act Whistleblower Practice.

GAO Reports Weaknesses in DOL OSHA Whistleblower Program and Provides Recommendations

The Government Accountability Office (GAO) reported to Congress its findings on the OSHA whistleblower program in its report titled “Whistleblower Protection: Sustained Management Attention Needed to Address Long-standing Program Weaknesses.”  The GAO concludes that OSHA has neglected its whistleblower program and has failed to implement GAO’s prior recommendations.  Sens. Tom Harkin (D-IA) and Patty Murray (D-WA), and Reps. George Miller (D-CA) and Lynn Woolsey (D-CA) responded to the GAO report with a press release stating:

The GAO found that for the last two decades, the Labor Department has not provided adequate management attention to the whistleblower program. The independent watchdog agency said the program’s training for investigators and their supervisors is inconsistent from region to region, that internal controls are lacking to monitor compliance with policies and procedures, and that few of the GAO’s previous recommendations from 2009 have been implemented.

The GAO also noted that despite an increased workload over the years, the number of inspectors has remained relatively flat, and urged the program establish a separate budget for the whistleblower program. In fiscal year 2009 more than 2,100 whistleblower complaints were filed with OSHA.  Congress provided the Labor Department with funds for 25 additional whistleblower investigators in fiscal year 2010 to deal with a growing caseload.

In the report, the GAO provides the Secretary of Labor with the following recommendations for strengthening its whistleblower program:

To improve program performance and oversight, we are recommending that the Secretary of Labor require OSHA to take several actions:

  • Ensure that all investigators complete mandatory training. 
  • Require staff who supervise investigators to complete the mandatory investigator training. 
  • Track whistleblower program expenses, including FTEs, separately from other OSHA programs, and annually report these expenses to Congress. 
  • Develop an action plan, with specific milestones, for addressing identified internal control weaknesses. This plan should include mechanisms for strengthening the whistleblower national office’s control over the program. 
  • Incorporate strategic goals specifically for the whistleblower program into Labor’s strategic plan, and develop performance measures to track progress in achieving these goals.

For more information about The Employment Law Group® and its Whistleblower Law Practice, click here.