Virginia Security Contractor to Pay $44,000 Over Allegations of Illegally Exporting Firearms Accessories

Alexandria, VA — Pax Mondial LLC, doing business as Mondial Risk Management Company (MRMC), agreed to pay the United States $44,000 to settle civil fraud claims that it illegally exported firearms accessories from the United States to Afghanistan in 2012. At the time, MRMC was providing security services to support work on the Kandahar Helmand Power Project, a United States Government reconstruction project funded by the U.S. Agency for International Development (USAID).
The settlement, reached between MRMC and the U.S. Department of Justice in January 2016, resolves claims that MRMC violated the Arms Export Control Act (AECA) by shipping weapons accessories from the continental United States to a U.S. Army/Air Post Office (APO) in Afghanistan between April 2012 and June 2012.  Working under a subcontract for security services with USAID implementer Black and Veatch, MRMC obtained these accessories, which included rifle stocks, replacement pistol magazines, and other weapons parts, to supply its security teams in Kandahar, Afghanistan.  The government alleged that MRMC knowingly failed to adhere to its subcontract provisions and U.S. laws and regulations regarding the export of such materials in violation of the False Claims Act (31 U.S.C. § 3729 et seq.).
“I commend the work of our special agents and their federal partners,” said Ann Calvaresi Barr, USAID’s Inspector General. “It is vital that U.S. Government contractors comply with rules governing their work and conduct overseas, especially those concerning international shipments of weapons and related accessories.  Failure to adhere to those rules is not acceptable.”
During the investigation, federal authorities identified a number of export violations, including MRMC’s failure to consult with the U.S. Department of State’s Directorate of Defense Trade Controls (DDTC), a step that is required under both U.S. export laws and MRMC’s subcontract provisions.  Authorities also found that MRMC had failed to acquire the requisite permits, licenses, and registrations in order to ship these controlled items and had not registered as an exporter with DDTC.  MRMC did not disclose these violations to U.S. authorities until early 2013, long after the shipments had been made.
Under the settlement, Pax Mondial made no admission of liability.  The company registered with the Department of State’s DDTC while the investigation was underway.
The settlement is a result of joint investigative efforts by the USAID Office of Inspector General; U.S. Immigration and Customs Enforcement’s (ICE’s) Homeland Security Investigations (HSI); and the U.S. Attorney’s Office for the Eastern District of Virginia.

Former USAID contractor arrested on embezzlement charges

Afghan police working with American agents arrested an Afghan man on charges of stealing more than a half million dollars from an agricultural development fund supported by USAID.  The suspect in custody is Abdul Khalil Qadery, a former employee of Development Alternatives Inc. (DAI), a Bethesda, Maryland company.  The USAID press release can be found here.  There seems to have been no public participation or press release issued by the United States Department of Justice.  The likely explanations for this scenario, that often act in concert, are as follows: 1) the subject was an Afghan or a third party national, 2) there was insufficient evidence to charge the subject in United States courts and/or 3) there were extradition, removal or diplomacy considerations that applied.   USAID agents are pragmatic and routinely think creatively and “outside the box” to investigate and get their cases prosecuted. Afghanistan prisons are known for being particularly harsh and a maximum sentence of three years in an Afghanistan prison is considered extraordinarily “hard time”

Former USAID Senior Official Conflict of Interest

David Ostermeyer, who retired from the U.S. Agency for International Development (USAID) in 2012, will pay the government a $30,000 penalty to settle allegations that he participated in a matter in which he had a financial interest that conflicted with his duties when he was Chief Financial Officer of the agency, the Justice Department announced today.

We expect government officials to earn and maintain the trust of taxpayers by acting with the This requires, at a minimum, that they do their work free of prohibited conflicts of interest. The ” The government alleged that shortly before Ostermeyer retired from USAID, he helped the a position that Ostermeyer intended to apply for after he retired. In an effort to ensure he would be awarded the position, Ostermeyer allegedly tailored the solicitation to his specific skills and experiences.  Federal conflict of interest laws prohibit executive branch employees from participating personally and substantially in matters in which they have a financial interest. Since Ostermeyer had a financial interest in the contract solicitation, the government alleged that he could not participate in drafting it and, therefore, violated 18 U.S.C. § 208(a).
“To maintain public trust in our institutions, it is vital that those in government adhere to the highest standards of integrity,” said Michael Carroll, Acting Inspector General for USAID. “The exceptional work of the investigators and attorneys on this case reflects our resolve to uphold these standards.”  This settlement was the result of a coordinated effort by the Justice Department’s Civil Division and USAID’s Office of Inspector General. The claims resolved by this settlement are allegations only; there has been no determination of liability.

Sacramento Bee: “Patricia Davis, former Assistant Director, USDOJ Civil Division, joins GeyerGorey LLP”

Sacramento Bee: “Patricia Davis, former Assistant Director, USDOJ Civil Division, joins GeyerGorey LLP”

GeyerGorey LLP Issues Updated Representative Matters List; Experience is Wide and Deep

Representative Matters

Our attorneys have led and participated in some of the highest profile matters in the past decade, both while in the government and in private practice. We have been involved in the most significant criminal cartel cases, the most important mergers, the most notable civil antitrust investigations, the largest procurement fraud cases, and game-changing antitrust cases that reached the United States Supreme Court. Our collective experience stands as a testament to our work ethic, our drive for excellence, and the trust and responsibility we have been given by our clients and the government.

International Cartels:

  • Led investigation and prosecution of marine contractors engaged in conspiracy to suppress and eliminate competition to install deep sea oil platforms
  • Led investigation and prosecution of international freight forwarders engaged in conspiracy to fix prices on international air cargo shipments
  • Led investigation and prosecution of household-goods moving contractors engaged in conspiracy to fix prices for international moving services provided to Department of Defense
  • Investigation and prosecution of graphite electrodes manufacturers
  • Investigation and prosecution of ocean shipping companies
  • Investigation and prosecution of a FTSE 250 engineering company that resulted in the indictment, extradition and conviction of its former chief executive
  • Defended foreign construction company in investigation and prosecution of alleged billion-dollar bid rigging scheme, in related qui tam litigation, and in other related matters
  • Defended foreign vitamin manufacturers in investigations and prosecutions of alleged international price-fixing agreements
  • Defended foreign specialty chemical manufacturers in investigations and prosecutions of alleged international price-fixing agreements
  • Defended U.S.-based executive of foreign company in criminal and civil litigation related to his alleged role in an international cartel to fix prices in the marine supply industry
  • Defended foreign executive of foreign company in criminal and civil litigation related to his alleged role in the conspiracy to fix air cargo rates around the world
  • Defended international freight forwarder in criminal litigation related to its alleged role in an international conspiracy to rig bids on U.S. military shipping contracts
  • Investigation and subsequent prosecution of foreign vitamin manufacturers for price fixing conspiracy

Domestic Price Fixing and Bid Rigging:

  • Defended electrical products manufacturer in first felony prosecution under the Sherman Act and in civil treble damage litigation
  • Represented a class of nurses in litigation against a hospital association and a number of Arizona hospitals
  • Represented the State of Ohio against a number of dairies for allegedly rigging bids of school milk
  • Investigation and prosecution of highway paving contractors in multiple districts for bid rigging
  • Investigation and prosecution of military insignia providers supplying the Army Air Force Exchange System with over 4,000 items of insignia
  • Represented metal drum manufacturer in prosecution for price fixing
  • Investigation of polypropylene bag manufacturers and that resulted in the prosecution of a manufacturer for Buy American Act violations and conspiracy to defraud
  • Investigation and prosecution of nearly 40 cases against paving contractors for conspiring to rig bids in connection with federal and state highway and airport contracts
  • Investigation and prosecution of an auction rigging conspiracy involving auto parts to by the Department of Defense at Defense Reutilization Marketing Offices (DRMO)
  • Investigation and prosecution of multiple electrical construction contractors for conspiring to rig bids for major power wiring contracts associated with steel mills and waste water treatment plants
  • Investigation and prosecution of multiple wholesale grocery companies and bid managers for rigging bids to school districts, hospitals and jails in southern Texas
  • Investigation and prosecution of multiple dairies for rigging bids for school milk sold to districts in Louisiana
  • Investigation and prosecution of crawfish processors for fixing prices paid to crawfish farmers and fishermen
  • Investigation and prosecution of bribery conspiracy involving the reconstruction of the New Orleans levee system after Hurricane Katrina
  • Investigation and prosecution of fire protective services company and its president
  • Investigation and prosecution of an Iraq-based general construction bid rigging scheme
  • Investigation and prosecution of conspiracy to solicit kickback scheme involving security services on a US Agency for International Development contract
  • Investigation and prosecution of fuel theft from an overseas United States military facility
  • Investigation and prosecution of a Europe-based scheme to defraud the Iraqi government by facilitating the fraudulent claim for payment of armored vehicles that were never delivered
  • Represented individual accused of defrauding government defense agency out of hundreds of thousands of dollars of grant money
  • Represented company accused of defrauding government by failing to supply vitamin-enriched food products with the proper level of enrichment
  • Represented large computer software company in internal investigation of improper influence on government contracting process

General Criminal:

  • Defended CEO and three closely-held companies in a multi-state racketeering and tax fraud prosecution
  • Investigation and prosecution of multiple labor racketeering cases ranging from prosecutions of United Mine Worker Union officials for theft of union funds used to pay for the murder of a political opponent of the union president to the prosecution of two Boston-based racketeers for actions associated with their travel to California in connection with a union organizing effort at a San Rafael newspaper
  • Investigation and prosecution of the mayor of a New Jersey town for taking bribes in connection with the permitting of a tank farm at the terminus point of a major Gulf Coast to East Coast pipeline
  • Investigation and prosecution of the most prolific serial bank robber in United States history
  • Investigation and prosecution of the murder for hire of a government witness and one of the largest cocaine importation conspiracies East of the Mississippi River
  • Investigation and prosecution of numerous gun, drug and false identity cases
  • Investigation and prosecution of multiple obstructions of justice, contempt, false statement, witness tampering and perjury cases arising out of grand jury investigations
  • Investigation and prosecution of bank fraud cases
  • Represented individuals before the District of Columbia Court of Appeals in appeals from criminal convictions (more than a dozen cases)
  • Defended individual in intelligence community in investigation by DCIS for alleged violations of public corruption statutes (18 U.S.C §§ 207 & 208)
  • Defended individual in criminal investigation by Inspector General of NASA
  • Defended individual in federal bribery investigation
  • Defended government contractor in investigation by the Inspector General of the Department of Agriculture
  • Defended several regional hospitals in various unrelated federal investigations of allegedly fraudulent billing practices, Stark violations
  • Represented hospital CEO in investigation of alleged Stark violations
  • Represented pathology laboratory in healthcare fraud investigation
  • Represented national healthcare company in investigation of allegedly criminal off-label marketing
  • Represented various individuals in applications for presidential pardons

Mergers and Acquisitions:

  • Represented Warner Music in connection with the proposed acquisition of EMI by Universal Music
  • Represented DISH Network in opposition to the proposed acquisition of T-Mobile by AT&T
  • Represented Merck in connection with its acquisition of Schering Plough
  • Represented Simon Properties in connection with its acquisition of Prime Outlets
  • Obtained antitrust clearance in the acquisition of Liquid Container by Graham Packaging
  • Obtained consent decree against nuclear engineering firm which had acquired another firm with the same engineering specialty
  • Represented major home healthcare provider in acquisition valued in excess of $500 million
  • Represented pathology laboratory in merger valued in excess of $100 million
  • Represented foreign mining company in acquisition of US coal mines valued over $1 billion
  • Represented hospital management company in acquisition valued in excess of $500 million
  • Represented individual in several acquisitions of stock each valued in excess of $100 million
  • Represented major over-the-counter pharmaceutical company in four different acquisitions over several years whose values ranged from over $100 million to over $500 million
  • Represented national restaurant chain in acquisition valued at about $1 billion
  • Represented regional hospital chain in acquisition of a hospital valued above $50 million
  • Represented hospital valued in excess of $100 million in sale to state hospital system

Civil Antitrust Matters:.

  • Defended large telecommunications provider in three week trial for alleged exclusionary conduct directed towards telecom services resellers.
  • Represented large telecommunications provider as plaintiff in case alleging monopolization of market for telecom switch software.
  • Represented leading music copyright licensing organization in a decade-long investigation by the Department of Justice
  • Led the investigation of Ticketmaster at the Department of Justice
  • Led major, successful prosecution by United States Department of Justice of conspiracy among twenty-four leading market-makers in NASDAQ stocks, including Goldman, Sachs & Co. and J. P. Morgan Securities,  Inc. who had conspired to maintain spreads between buying and selling prices of NASDAQ stocks
  • Defended large telecommunications provider in multi-year litigation brought by competitive telecom carrier alleging monopolization of market for high speed data services
  • Led successful investigation and prosecution of Salomon Bros Inc. and two hedge funds, Caxton Corporation and Steinhardt Partners, LP, to limit the supply of two-year Treasury notes to the “repo,” or “repurchase agreement,” market
  • Successfully brought the Reagan Administrations ‘s first challenge to a merger (brewing industry)
  • Successfully represented the United States in a litigated matter challenging field of use restrictions in patent licensing agreement in specialty chemicals
  • Successfully represented the United States in challenge to professional rules of conduct limiting competition among accountants in Texas
  • Successfully represented the United States in challenge to acquisition by Texaco, Inc. of an independent oil refining company
  • Represented high-tech electronic service provider with respect to antitrust issues in a bet-the-company patent infringement case
  • Represented sporting goods manufacturer in vacating a consent decree
  • Represented leading music copyright pool in civil antitrust investigation leading to vacating of an earlier consent decree and modification of another consent decree
  • Represented hospital CEO in litigation arising from denial of physician staff privileges

Antitrust Compliance Counseling:

  • Advised large telecommunications provider on its price and product bundling
  • Advised large telecom provider in connection with a joint venture of three carriers to entire the mobile payments market with mobile phones
  • Advised major manufacturer of household appliances on antitrust compliance
  • Advised major manufacturer of high-end kitchen appliances on antitrust compliance
  • Advised major manufacturer of over-the-counter pharmaceutical on antitrust compliance
  • Advised regional airport on state action doctrine and compliance with antitrust laws
  • Advised national trade association on antitrust compliance and Noerr-Pennington doctrine
  • Advised international shipping company on compliance regarding competition, fraud, and foreign corrupt practices
  • Advised African government on contracting and anti-fraud and anti-corruption best practices

Other Civil Litigation:

  • Represented Haiti in multinational investigation and litigation leading to the recovery of money stolen by its former president Jean-Claude Duvalier
  • Represented developers in multiple appeals involving alleged illegal cooperative conversion terms
  • Defended law firm in $10 million professional malpractice action
  • Defended various healthcare providers in numerous different federal investigations of alleged fraud, related qui tam cases, and related whistleblower termination actions
  • Defended CMS contractor in qui tam case
  • Represented regional Medicare Advantage organization in suit against the U.S. Government
  • Defended book distributor and publisher in defamation case
  • Defended author in defamation case
  • Represented gaming company in civil rights action relating to state gaming regulations
  • Defended copyright and trademark owner in intellectual property litigation
  • Defended local retailer of gray market goods in trademark infringement litigation
  • Represented major multinational corporation in suit seeking refund of local corporate franchise tax
  • Represented government contractor in appeal of denial of security clearance
  • Defended employers in cases alleging violation of wage-and-hour statute
  • Represented developers in multiple appeals involving alleged illegal cooperative conversion terms
  • Defended employer in case alleging employment discrimination
  • Defended employer in case alleging sexual harassment
  • Defended employers in cases alleging unlawful discharge

Experience by Industry:

  • Air Cargo
  • Aircraft Parts (Domestic)
  • Airlines
  • Airport Contracts
  • Automobile Dealers (Domestic)
  • Airlines
  • Asset Forfeiture
  • Auction Rigging (Multiple Industries)
  • Banking (International)
  • Baked Goods (Domestic)
  • Baking Soda
  • Book Publishing
  • Bridge Construction
  • Carbon Products
  • Caustic Soda
  • Cell Towers (Domestic)
  • Chemicals (Multiple Products, Domestic and International)
  • Clothing and Textiles (Multiple Products, Domestic and International)
  • Computer Software
  • Construction (Domestic and International)
  • Copyright and Trademark
  • Dairy Products
  • Deep sea Oil Platforms
  • Democratization Programs
  • Electrical Products
  • Embassy Construction
  • Engineering
  • Export-Import Bank Clients (Multiple Industries, International)
  • Food Service Contracts (Multiple Industries, Domestic and International)
  • Financial Institutions (Domestic and International)
  • Fire Protection Services
  • Freight Forwarding (Domestic and International)
  • Fuel Supply (Domestic and International)
  • General Construction (Multiple Industries, Domestic and International)
  • Government Contracts (Multiple Industries, Domestic and International)
  • Graphite Electrodes
  • Highway Construction
  • Hospitals
  • Housing Foreclosure Auctions (Domestic)
  • Information Technology (Multiple Industries, Domestic and International)
  • Industrial Gases (Domestic and Multiple Products)
  • LIBOR
  • Marine Contractors
  • Medical Products (Multiple Products, Domestic and International)
  • Metal Drums
  • Military Insignia (International)
  • Military Moving and Storage
  • Mining and Related Products (Multiple Industries, Domestic)
  • Motor Vehicles (Domestic)
  • Municipal Bonds (Multiple Industries, Domestic and International)
  • Nursing
  • Ocean Shipping (International)
  • Oilfield Supplies
  • Pharmaceuticals (Multiple Products, Domestic and International)
  • Polypropylene bags
  • Rock Salt
  • Seafood
  • Security Contracts
  • School District Contracts (Multiple Industries)
  • Soda Ash
  • Shipping (Multiple Industries, Domestic and International)
  • Slag Removal
  • Telecommunications
  • Tobacco
  • Translation Services
  • Trucking
  • US Agency for International Development Contractors and Grant Recipients
  • Vitamins
  • Warzone
  • Waste Hauling
  • Wholesale Groceries
  • Wireless
  • World Bank Contractors and Grant Recipients (International)
  • Vitamins

 

Experience by Subject Matter:

  • Antitrust (Civil and Criminal)
  • Auction Rigging
  • Bank Robberies (Domestic)
  • Bank Fraud
  • Bid-Rigging
  • Bribery
  • Buy American Act Violations
  • Capital Crimes
  • Cartels (Multiple Products, Domestic and International)
  • Cash Smuggling (International, multiple procurements by multiple governments)
  • Civil Merger and Non-Merger Cases (Multiple Products, Multiple Industries Domestic and International)
  • Civil Rights Actions
  • Competition Advocacy
  • Contempt
  • Contracting Fraud
  • Corporate Defense (Multiple Industries, Domestic and International)
  • Criminal Conspiracies
  • Defamation
  • Disaster Fraud
  • Drug Cartels and Trafficking
  • Embezzlement
  • Employment Law
  • False Claims
  • False Statements
  • Federal Trade Commission Matters
  • Firearms and Weapons Offenses (Domestic and International)
  • Foreign Corrupt Practices Act (FCPA) (Multiple Industries)
  • Forgery
  • Fuel Theft
  • Grant Fraud (Multiple Industries, Multiple Agencies, Domestic and International)
  • Hart-Scott-Rodino Pre-Merger Notification
  • Health Care Fraud (Compliance, Organizational Defense, Whistleblowers)
  • Kickbacks
  • Identity Theft
  • Intellectual Property
  • Mail Fraud
  • Market Allocation
  • Mergers and Acquisitions
  • Money Laundering (Multiple Industries, Domestic and International)
  • Monopolies (Multiple Industries, Domestic and International)
  • Murder for Hire
  • Non-governmental Organizations (International)
  • Obstruction of Justice
  • Overseas Contingency Operations
  • Perjury
  • Presidential Pardons
  • Price Fixing
  • Procurement Fraud (Multiple Industries, Domestic and International)
  • Professional Malpractice Defense
  • Public Corruption
  • Qui Tam Matters
  • Racketeering
  • Securities Fraud
  • Stark Violations
  • Tax Fraud (International, Domestic and State)
  • Territorial Allocation
  • Webb-Pomerene Organizations (International)
  • Weapons Offenses (Domestic and International)
  • Whistleblowers (Multiple Industries, Domestic and International)
  • Wire Fraud
  • Witness Tampering

Noted Antitrust and Disaster Fraud Prosecutor Joan E. Marshall Joins GeyerGorey LLP

Joan Marshall who prosecuted the worldwide vitamins cartel and brought a series of fraud cases in the aftermath of Hurricane Katrina, has joined the firm as a partner. Previously, Ms. Marshall was with the US DOJ Antitrust Division in the Dallas Field Office. She is the tenth former DOJ prosecutor to join the new boutique law firm in less than a year.Joan Marshall_4small

FOR IMMEDIATE RELEASE

 

PRLog (Press Release) – Aug. 6, 2013 – WASHINGTON, D.C. — GeyerGorey LLP is pleased to announce that Joan E. Marshall, a former Department of Justice prosecutor, has joined the firm as partner. Ms. Marshall will open a new office for the firm, in Dallas, where she will be resident.

Ms. Marshall comes to GeyerGorey from the Antitrust Division of the Department of Justice, where she also served as a prosecutor on the Department’s Disaster Fraud Task Force and its predecessor, the Hurricane Katrina Fraud Task Force. While with the Department of Justice, Ms. Marshall supervised numerous multi-agency investigations of bid rigging, price fixing, mail fraud, wire fraud, bank fraud, bribery, perjury and obstruction of justice.

Ms. Marshall had the distinction of breaking the Dallas Field Office’s acclaimed vitamins cartel case and helped to devise, structure and carry out what became one of the most comprehensive international investigations and prosecutions of all time, resulting in more than $1 billion in collected criminal fines. She led the Antitrust Division’s bribery prosecutions involving construction of the levees surrounding New Orleans after the devastation of Hurricane Katrina. Her experience spans investigations and prosecutions involving numerous industries including wholesale groceries, milk, seafood, medical equipment, oilfield supplies, military moving and storage, road and building construction, and municipal finance.

“We are thrilled that Joan has decided to join us,” said Hays Gorey. “She adds deep experience with numerous enforcement agencies and compliments our experience in key industries like oil and gas exploration, not to mention the fraud piece. Our corporate compliance and competition expertise is a perfect fit in the Dallas-Ft. Worth market, which has the largest concentration of corporate headquarters in the United States.”

Ms. Marshall is a frequent speaker on antitrust enforcement and fraud prevention and detection and has developed numerous training programs. She is a recipient of the United States Department of Justice, Assistant Attorney General’s Award and certificates of appreciation from the United States Department of Homeland Security, Office of Inspector General, and the United States Army Criminal Investigation Command, Major Procurement Fraud Unit.

Robert Zastrow, who was Verizon’s Assistant General Counsel for 15 years before co-founding the firm in October 2012, added, “Joan’s extensive background and expertise nicely complements our firm’s unique philosophy and enriches our solid bench in the White Collar world.” Co-founder, Brad Geyer added: “We are very involved in servicing the government contractor and the non-profit and non-governmental organization community and we are excited to roll in Joan’s disaster fraud experience into our overall product offerings. It is also unusual to have career prosecutors in one firm that worked on the highest profile matters on both the criminal and civil worlds. Joan will give us a strategic presence in the Dallas market, which is home to companies in the airline, technology, energy, banking, medical and defense contracting sectors.”

Headquartered in Washington, D.C., GeyerGorey LLP specializes in white collar criminal defense, particularly investigations and cases involving allegations of economic crimes, such as violations of the federal antitrust laws (price fixing, bid rigging, territorial and customer allocation agreements), procurement fraud, securities fraud, foreign bribery (Foreign Corrupt Practices Act) and qui tam (False Claims Act) and other whistleblower actions. The firm also conducts internal investigations of possible criminal conduct and provides advice regarding compliance with U.S. antitrust, anti-bribery and other laws.

 

 

 

 

 

   

Contrack International Inc. Agrees to Pay $3.5 Million to Resolve False Claims Act Allegations

Contrack International Inc., a global design and construction company headquartered in McLean, Va., has agreed to pay $3.5 million to settle allegations that it submitted false claims in connection with U. S. Agency for International Development (USAID) contracts, the Justice Department announced today.

“Misrepresentations during contract negotiations undermine the integrity of the government procurement process,” said Stuart F. Delery, Acting Assistant Attorney General for the Civil Division.  “The Justice Department will take action where contractors misrepresent their qualifications for government contracts and programs.”

The settlement concerns USAID-funded contracts for the construction of water and wastewater infrastructure projects in the Arab Republic of Egypt in the 1990s.  The bidders for these contracts were required to receive prequalification and, in some cases, establish that they were U. S. companies.  However, the contracts were ultimately performed by a joint venture partnership among Contrack; Washington Group International, Inc., a subsidiary of URS Corporation; and Misr Sons Development S.A.E. (Hassan Allam Sons), an Egyptian company.  The government filed suit under the False Claims Act and the Foreign Assistance Act alleging that the joint venture partners evaded the prequalification requirement by concealing the identity of the joint venture partners, which prevented USAID from accurately evaluating their qualifications.  As a result, the government alleged that Contrack and its partners received USAID-funded contracts for which they were ineligible. “Proper public contracting, government efficiency and government accountability rely on complete information from contractors,” said Wendy J. Olson, U.S. Attorney for the District of Idaho.  “Along with our partners at USAID and the Department of Justice’s Commercial Litigation Branch, we will aggressively seek to recover improperly awarded taxpayer dollars.”

This settlement – which resolves only Contrack’s liability – was the result of a coordinated effort by the Department of Justice, Civil Division, Commercial Litigation Branch; the U.S. Attorney’s Office for the District of Idaho; and the USAID Office of Inspector General.  The government is continuing to pursue its claims against the other two defendants in the suit.

The case is United States v. Washington Group International Inc. f/k/a/ Morrison Knudsen, Corporation; Contrack International, Inc.; and Misr Sons Development S.A.E. a/k/a Hassan Allam Sons, No. 04-555 (N.D. Idaho).  The claims resolved by this settlement are allegations only, and there has been no determination of liability.

Generic Drug Manufacturer Ranbaxy Pleads Guilty & Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA

In the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA Inc. , a subsidiary of Indian generic pharmaceutical manufacturer Ranbaxy Laboratories Limited, pleaded guilty today to felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of Ranbaxy’s manufacturing facilities in India, the Justice Department announced today.   Ranbaxy also agreed to pay a criminal fine and forfeiture totaling $150 million and to settle civil claims under the False Claims Act and related State laws for $350 million.

 

The federal Food, Drug and Cosmetic Act (FDCA) prohibits the introduction or delivery for introduction into interstate commerce of any drug that is adulterated.   Under the FDCA, a drug is adulterated if the methods used in, or the facilities or controls used for, its manufacturing, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, current Good Manufacturing Practice (cGMP) regulations.   This assures that a drug meets the requirements as to safety and has the identity and strength, and meets the quality and purity characteristics, which the drug purports or is represented to possess.

 

Ranbaxy USA pleaded guilty to three felony FDCA counts, and four felony counts of  knowingly making material false statements to the FDA.   The generic drugs at issue were manufactured at Ranbaxy’s facilities in Paonta Sahib and Dewas, India. Under the plea agreement, the company will pay a criminal fine of $130 million, and forfeit an additional $20 million.

 

“When companies sell adulterated drugs, they undermine the integrity of the FDA’s approval process and may cause patients to take drugs that are substandard, ineffective, or unsafe,” said Stuart F. Delery, Acting Assistant Attorney General for the Civil Division of the Department of Justice.  “We will continue to work with our law enforcement partners to ensure that all manufacturers of drugs approved by the FDA for sale in the United States, both domestic and foreign, follow the FDA guidelines that protect all of us.”

 

“This is the largest false claims case ever prosecuted in the District of Maryland, and the nation’s largest financial penalty paid by a generic pharmaceutical company for FDCA violations,” said U.S. Attorney for the District of Maryland Rod J. Rosenstein.  “The joint criminal and civil settlement, which reflects many years of work by FDA agents and federal prosecutors, holds Ranbaxy accountable for a pattern of violations and should improve the reliability of generic drugs manufactured in India by Ranbaxy.”

 

Ranbaxy USA admitted to introducing into interstate commerce certain batches of adulterated drugs that were produced at Paonta Sahib in 2005 and 2006, including Sotret, gabapentin, and ciprofloxacin.   Sotret is Ranbaxy’s branded generic form of isotretinoin, a drug used to treat severe recalcitrant nodular acne; gabapentin is a drug used to treat epilepsy and nerve pain; ciprofloxacin is a broad-spectrum antibiotic.   In a Statement of Facts filed along with the Information, Ranbaxy USA acknowledged that FDA’s inspection of the Paonta Sahib facility in 2006 found incomplete testing records and an inadequate program to assess the stability characteristics of drugs.   “Stability” refers to how the quality of a drug varies with time under the influence of a variety of factors, such as temperature, humidity, and light.  Such testing is used to determine appropriate storage conditions and expiration dates for the drug, as well as to detect any impurities in the drug.

Ranbaxy also acknowledged that the FDA’s 2006 and 2008 inspections of the Dewas facility found the same issues with incomplete testing records and an inadequate stability program, as well as significant cGMP deviations in the manufacture of certain active pharmaceutical ingredients and finished products.   Ranbaxy USA also acknowledged that in 2003 and 2005 the company was informed of cGMP violations by consultants it hired to conduct audits at the Paonta Sahib and Dewas facilities.   Those cGMP violations resulted in the introduction into interstate commerce of some adulterated drugs.

Ranbaxy USA further admitted to failing to timely file required reports known to FDA as “field alerts” for batches of Sotret and gabapentin that had failed certain tests.   With respect to Sotret, Ranbaxy USA was aware in January 2003 that a batch of Sotret failed an accelerated dissolution stability test but continued to distribute the batch into the United States for another 13 months.   With respect to gabapentin, Ranbaxy USA was aware at various times between June and August 2007 that certain batches of gabapentin were testing out-of-specification, had unknown impurities, and would not maintain their expected shelf life.   Nevertheless, Ranbaxy USA did not notify FDA and institute a voluntary recall until October 2007.

Ranbaxy USA also admitted to making false, fictitious, and fraudulent statements to the FDA in Annual Reports filed in 2006 and 2007 regarding the dates of stability tests conducted on certain batches of Cefaclor, Cefadroxil, Amoxicillin, and Amoxicillin and Clavulanate Potassium, which were manufactured at the Dewas facility.   Ranbaxy USA was found to have conducted stability testing of certain batches of these drugs weeks or months after the dates reported to FDA.   In addition, instead of conducting some of the stability tests at prescribed intervals months apart, the tests were conducted on the same day or within a few days of each other.   This practice resulted in unreliable test results regarding the shelf life of the drugs.   Ranbaxy USA also acknowledged that drug samples waiting to be tested were stored for unknown periods of time in a refrigerator, which did not meet specified temperature and humidity ranges for an approved stability chamber, and that this was not disclosed to the FDA.

The criminal case is U.S. v. Ranbaxy USA, Inc., JFM-13-CR-0238 (D. Md.).

Under the civil settlement, Ranbaxy has agreed to pay an additional $350 million to resolve allegations that it caused false claims to be submitted to government health care programs between April 1, 2003, and September 16, 2010, for certain drugs manufactured at the Paonta Sahib and Dewas facilities.   The United States contends that Ranbaxy manufactured, distributed, and sold drugs whose strength, purity, or quality differed from the drug’s specifications or that were not manufactured according to the FDA-approved formulation.   The United States further contends that, as a result, Ranbaxy knowingly caused false claims for those drugs to be submitted to Medicaid, Medicare, TRICARE, the Federal Employees Health Benefits Program, the Department of Veterans Affairs, and the U.S. Agency for International Development (USAID), which administers the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR).

The federal government’s share of the civil settlement amount is approximately $231.8 million, and the remaining $118.2 million will go to the states participating in the agreement.

The civil settlement resolves a lawsuit filed in U.S. District Court for the District of Maryland under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery.   As part of today’s resolution, the whistleblower, Dinesh Thakur, a former Ranbaxy executive, will receive approximately $48.6 million from the federal share of the settlement amount.   The case is U.S. ex rel. Thakur v. Ranbaxy Laboratories Limited, Case No. JFM-07-962 (D. Md.).

With the exception of the allegations to which Ranbaxy pleaded guilty in the Criminal Information, there has been no determination of liability as to the claims settled by the civil agreement.

Last year, FDA and Ranbaxy agreed to an injunction that prevents drugs produced at the Paonta Sahib and Dewas facilities from entering the U.S. market until the facilities have been brought into full compliance with the FDCA and its implementing regulations.

Since September 16, 2008, when the FDA placed drugs from those facilities on an Import Alert, Ranbaxy has not imported drugs from those facilities into the U.S.   In addition, the injunction requires Ranbaxy to review and verify data contained in Ranbaxy’s past drug applications to the FDA.   United States v. Ranbaxy Laboratories, Ltd., et al. , Case No. JFM-12-250 (D. Md).

“The FDA expects that companies will comply with the cGMP requirements mandated by law so that consumers can be assured that their medical products are safe and pure,” said John Roth, director of the FDA’s Office of Criminal Investigations. “The investigation that led to this settlement uncovered evidence showing that certain lots of specific drugs produced at the Paonta Sahib facility were defective, in that their strength differed from, or their purity or quality fell below, that which they purported to possess. The FDA and its law enforcement partners will continue to aggressively pursue companies and their executives who erode public confidence in the quality and safety of medical products by distributing products that do not comply with the law.”

“I would like to express my appreciation for the exceptional work of our investigators and that of their FDA and Department of Justice partners,” said Michael G. Carroll, USAID Deputy Inspector General.   “This settlement represents the culmination of years of investigative effort and signals our continuing commitment to the integrity of U.S. government systems and our determination to hold those who seek to defraud or mislead to account.”

The criminal case was prosecuted by the U.S. Attorney’s Office for the District of Maryland and the Civil Division’s Consumer Protection Branch.   The civil settlement was negotiated by the U.S. Attorney’s Office for the District of Maryland and the Civil Division’s Commercial Litigation Branch.   The case was investigated by agents from the FDA’s Office of Criminal Investigations and USAID’s Office of Inspector General.   The FDA’s Office of Chief Counsel, HHS Office of Counsel to the Inspector General, Office of the General Counsel-CMS Division, and the National Association of Medicaid Fraud Control Units also provided assistance.

This criminal and civil resolution is part of the government’s emphasis on combating health care fraud and another step for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced by Attorney General Eric Holder and Kathleen Sebelius, Secretary of the Department of Health and Human Services in May 2009. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover more than $10.3 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department’s total recoveries in False Claims Act cases since January 2009 are over $14.3 billion.

One Former Development Worker Sentenced for Embezzlement and Fraud, Another Acquitted

A former contractor for a recently completed U.S. Agency for International Development (USAID) project in Afghanistan has been sentenced to two-and-a-half years in prison and a $9,500 fine.

Corruption Tribunal on April 8, 2013. The Tribunal found Mr. Anwarzai guilty of violating Afghan Penal Code Article 268, regarding embezzlement of funds and Article 310 regarding the forgery of official documents.

Abdul Khabir Kakar, another former contractor accused in the case, was acquitted and
subsequently released. He was not found to have been involved in the fraud.
The sentencing came as part of what U.S. Government officials described as an ongoing campaign against fraud and waste in reconstruction and development activities in Afghanistan. The investigation was conducted jointly by the Afghanistan Attorney General’s Office Anti-Corruption Unit and USAID’s Office of Inspector General.
Commenting on the Anti-Corruption Tribunal’s ruling, USAID’s Deputy Inspector General Michael G. Carroll expressed his appreciation for the strong partnership between USAID’s OIG investigators and Afghan law enforcement officials that led to the recent ruling. “Partnerships with law enforcement agencies overseas are critical to our efforts to combat waste, fraud, and abuse in development activities worldwide. This sentencing demonstrates how effective these partnerships can be,” he said.
Noor Anwarzai and Abdul Khabir Kakar are former employees of the recently concluded
Afghanistan Farm Service Alliance project implemented by Citizen’s Network for Foreign Affairs (CNFA). The two were arrested by the Afghan National Police in November 2012 on charges of conspiring to embezzle approximately $10,000 of USAID funds. They were accused of falsifying official documentation from the Afghan Ministry of Finance, indicating that CNFA had paid the appropriate local property taxes for the office building when they had not.

Two Former Development Workers Arrested for Fraud

KABUL, AFGHANISTAN | DECEMBER 2, 2012 – Two former contractors on a recently completed U.S. Agency for International Development (USAID) project in Afghanistan have been arrested on fraud charges. The action came as part of what U.S. Government officials described as an on-going campaign against fraud and waste in U.S. development efforts in Afghanistan.
Abdul Khabir Kakar and Noor Anwarzai were arrested by the Afghan Attorney General’s Anti Corruption Unit on charges of conspiring to steal approximately $10,000 of USAID’s funds in 2011. The two former employees are accused of falsifying official documentation from the Afghan Ministry of Finance (MOF), indicating that USAID’s implementing partner had paid the appropriate local property taxes for the office building used on the project.
Abdul Khabir Kakar was the Chief of Party, and Noor Anwarzai was the Finance Manager for USAID’s Afghanistan Farm Service Alliance (AFSA) project, implemented by Citizen’s Network for Foreign Affairs (CNFA). The arrested individuals were not U.S. government employees, but employees of the implementing partner.
The arrests were made by the Afghan National Police and investigators from the Afghan Attorney General’s Anti Corruption Unit, with the assistance of the USAID Office of Inspector General (OIG).
Commending the work of those involved, USAID OIG’s Assistant Inspector General for Investigations, Lisa Risley, cited the strong partnership between USAID OIG and Afghan authorities in preventing fraud, waste and abuse within USAID programs and operations in Afghanistan, adding that this level of cooperation has helped protect U.S. taxpayer dollars in Afghanistan.
As Afghan nationals, both Kakar and Anwarzai will be facing prosecution in an Afghan court on possible criminal charges carrying a maximum sentence of 3 years in prison and possible financial penalties.