January 23, 2022

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St. Jude Agrees to Pay $27 Million for Allegedly Selling Defective Heart Devices

9 min read
<div>St. Jude Medical Inc. (St. Jude) has agreed to pay $27 million to settle allegations under the False Claims Act that, between November 2014 and October 2016, it knowingly sold defective heart devices to health care facilities that, in turn, implanted the devices into patients insured by federal health care programs. St. Jude was acquired by Abbott Laboratories in January 2017.</div>
St. Jude Medical Inc. (St. Jude) has agreed to pay $27 million to settle allegations under the False Claims Act that, between November 2014 and October 2016, it knowingly sold defective heart devices to health care facilities that, in turn, implanted the devices into patients insured by federal health care programs. St. Jude was acquired by Abbott Laboratories in January 2017.

More from: July 8, 2021

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  • Defense Acquisitions: Restructured JTRS Program Reduces Risk, but Significant Challenges Remain
    In U.S GAO News
    In 1997, the Department of Defense (DOD) initiated the Joint Tactical Radio System (JTRS) program, a key element of its effort to transform military operations to be network centric. Using emerging software-defined radio technology, the JTRS program plans to develop and procure hundreds of thousands of radios that give warfighters the capability to access maps and other visual data, communicate via voice and video, and obtain information directly from battlefield sensors. The JTRS program has encountered a number of problems, resulting in significant delays and cost increases. The program is currently estimated to total about $37 billion. Given the criticality of JTRS to DOD's force transformation, Congress directed GAO to continue its ongoing review of the JTRS program. This report (1) assesses whether a recent restructuring puts the program in a better position to succeed and (2) identifies any risks that challenge the successful fielding of JTRS.The proposed JTRS restructuring--a plan DOD approved in March 2006--appears to address and reduce program risks that GAO and others have documented in recent years. While still meeting key requirements, including those related to DOD's network centric transformation effort, the revised approach is expected to develop and field capabilities in increments rather than attempting to develop and field the capabilities all at once. Costly and non-transformational requirements will be deferred to later increments. Deferring these requirements will allow more time to mature critical technologies, integrate components, and test the radio system before committing to production. JTRS program management has also been strengthened through the establishment of a Joint Program Executive Office (JPEO). The more centralized management structure should help the program improve oversight and coordination of standards, system engineering, and development of the radios. The real test will be in execution, and, for that, several management and technical challenges remain. First, JPEO must finalize the details of the restructuring, including formal acquisition strategies, independent cost estimates, and test and evaluation plans. DOD also needs to develop migration and fielding plans for how JTRS networking capabilities will be used. Completing and obtaining DOD's approval of these activities is needed to ensure the JTRS program is executable. There are also a number of longer-term technical challenges that the JTRS program must address. For example, the proposed interim solutions for enabling network interoperability among different JTRS variants have yet to be developed. In addition, integrating the radio's hardware onto diverse platforms and meeting respective size, weight, and power limitations has also been a longstanding challenge that must be overcome. Furthermore, operating in a networked environment open to a large number of potential users has generated an unprecedented need for information assurance. This need has resulted in a lengthy, technically challenging, and still evolving certification process from the National Security Agency. At the same time, the program must address the need to obtain and sustain commitments and support from the military services and other stakeholders--a challenge that has often hampered joint development efforts in the past. The extent to which DOD overcomes these challenges will determine the extent to which the program manages cost, schedule, and performance risks and supports JTRS-dependent military operations.
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  • 2019 Wiretap Report: Orders and Convictions Increase
    In U.S Courts
    Federal and state courts reported a combined 10 percent increase in authorized wiretaps in 2019, compared with 2018, according to the Judiciary’s 2019 Wiretap Report. Convictions in cases involving electronic surveillance also increased.
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  • Alternatives to Radioactive Materials: A National Strategy to Support Alternative Technologies May Reduce Risks of a Dirty Bomb
    In U.S GAO News
    What GAO Found GAO examined six common medical and industrial applications that use high-risk radioactive materials—identified through agency and expert reports—and found that three applications already have technically viable alternative technologies in many circumstances and for which there is market acceptance. For example, x-ray provides a technically viable alternative to replace cesium-137 blood irradiators, one of the common applications. Another of the applications has a technically viable alternative, though only in certain limited circumstances, and the two remaining applications do not yet have viable alternatives. For example, alternatives to replace americium-241 used in oil and gas well logging equipment, another common application, are still under development. Irradiator with Radioactive Material (left) and Alternative Technology (right) Users of applications that employ high-risk radioactive materials identified six factors they take into account when determining whether to adopt alternative technologies: technical viability of alternatives, device cost, costs to convert (such as facility renovations), disposal of radioactive materials, regulatory requirements, and liability and other potential costs associated with possessing high-risk radioactive materials. An accident at the University of Washington in May 2019 shows that liability and other potential costs would likely range from millions to billions of dollars if radioactive materials were accidentally released or used in a dirty bomb. These largely uninsured socioeconomic costs are an implicit fiscal exposure for the federal government, which could be expected to provide financial assistance. Several federal agencies and interagency entities support research and promote adoption of alternative technologies. For example, the National Nuclear Security Administration (NNSA) has removed 355 irradiators since 2004 and subsidized the replacement of some with x-ray technology. Congress also established the goal for the NNSA to eliminate the use of cesium-137 blood irradiators in the United States by 2027. At the same time, the Nuclear Regulatory Commission licenses radioactive materials for irradiators, consistent with its mission. Currently, no strategy exists to guide federal efforts to find alternatives and reduce risk. A strategy to support alternative technologies would ensure a cohesive federal approach and potentially reduce the implicit fiscal exposure associated with addressing socioeconomic damage from a dirty bomb. Why GAO Did This Study Radioactive material, which is dangerous if mishandled, is found in many medical and industrial applications. In the hands of terrorists, it could be used to construct a radiological dispersal device, or dirty bomb, that uses conventional explosives to disperse the material. Replacing technologies that use dangerous radioactive materials with safer alternatives may help protect people and reduce potential socioeconomic costs from remediation and evacuation of affected residents. Senate Report 116-102 included a provision for GAO to review alternative technologies to applications that use radioactive materials. This report examines (1) the potential for adopting alternative technologies in the United States for the six most commonly used medical and industrial applications; (2) factors affecting adoption of alternative technologies; and (3) federal activities relating to alternative technologies in the United States. GAO reviewed relevant documents to identify potential alternative technologies, conducted interviews with users of applications that employ radioactive material to identify factors affecting adoption of alternatives, and interviewed federal officials to discuss current federal activities relating to alternative technologies.
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  • Six Arrested on Federal Charge of Conspiracy to Kidnap the Governor of Michigan
    In Crime News
    The Department of Justice today announced that six men have been arrested and charged federally with conspiring to kidnap the Governor of Michigan, Gretchen Whitmer. According to a complaint filed Tuesday, October 6, 2020, Adam Fox, Barry Croft, Ty Garbin, Kaleb Franks, Daniel Harris and Brandon Caserta conspired to kidnap the Governor from her vacation home in the Western District of Michigan. Under federal law, each faces any term of years up to life in prison if convicted. Fox, Garbin, Franks, Harris, and Caserta are residents of Michigan. Croft is a resident of Delaware.
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  • Philadelphia Man and Woman Convicted of Tax Fraud
    In Crime News
    A federal judge convicted two Philadelphia residents at a bench trial of conspiring to defraud the United States and aiding and assisting in the preparation of false tax returns.
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  • Transportation Security Administration: Clear Policies and Oversight Needed for Designation of Sensitive Security Information
    In U.S GAO News
    Concerns have arisen about whether the Transportation Security Administration (TSA) is applying the Sensitive Security Information (SSI) designation consistently and appropriately. SSI is one category of "sensitive but unclassified" information--information generally restricted from public disclosure but that is not classified. GAO determined (1) TSA's SSI designation and removal procedures, (2) TSA's internal control procedures in place to ensure that it consistently complies with laws and regulations governing the SSI process and oversight thereof, and (3) TSA's training to its staff that designate SSI.TSA does not have guidance and procedures, beyond its SSI regulations, providing criteria for determining what constitutes SSI or who can make the designation. Such guidance is required under GAO's standards for internal controls. In addition, TSA has no policies on accounting for or tracking documents designated as SSI. As a result, TSA was unable to determine either the number of TSA employees actually designating information as SSI or the number of documents designated SSI. Further, apart from Freedom of Information Act (FOIA) requests or other requests for disclosure outside of TSA, there are no written policies and procedures or systematic reviews for determining if and when an SSI designation should be removed. TSA also lacks adequate internal controls to provide reasonable assurance that its SSI designation process is being consistently applied across TSA. Specifically, TSA has not established and documented policies and internal control procedures for monitoring compliance with the regulations, policies, and procedures governing its SSI designation process, including ongoing monitoring of the process. TSA officials told us that its new SSI Program Office will ultimately be responsible for ensuring that staff are consistently applying SSI designations. This office, which was established in February 2005, will also develop and implement all TSA policy concerning SSI handling, training, and protection. More detailed information on how this office's activities will be operationalized was not yet available. Specifically, TSA officials provided no written policies formalizing the office's role, responsibilities, and authority. TSA has not developed policies and procedures for providing specialized training for all of its employees making SSI designations on how information is identified and evaluated for protected status. Development of such training for SSI designations is needed to help ensure consistent implementation of the designation authority across TSA. While TSA has provided a training briefing on SSI regulations to certain staff, such as the FOIA staff, it does not have specialized training in place to instruct employees on how to consistently designate information as SSI. In addition, TSA has no written policies identifying who is responsible for ensuring that employees comply with SSI training requirements.
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  • Clinical Researchers Plead Guilty in Connection with Scheme to Falsify Drug Trial Data
    In Crime News
    A Florida nurse practitioner and a Florida woman pleaded guilty today to their participation in a conspiracy to falsify clinical trial data. 
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  • Judiciary Seeks $1.54 Billion for Infrastructure
    In U.S Courts
    Citing “crucial infrastructure needs for courthouse security, courthouse construction, and information technology,” the Judiciary is asking Congress for $1.54 billion as part of any infrastructure bill enacted by the legislative branch.
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  • [Protest of BOP Cancellation of Solicitation for Correctional Facility Construction]
    In U.S GAO News
    A firm protested the Bureau of Prisons' (BOP) cancellation of a solicitation for correctional facility construction, contending that BOP: (1) improperly cancelled the solicitation, since the specifications were not defective; and (2) should have made award to it, since it was the low bidder. GAO held that BOP properly cancelled the solicitation, since the conflicting specifications: (1) misled bidders and precluded them from competing on an equal basis; and (2) prejudiced the other bidders regarding the applicability of certain sales taxes. Accordingly, the protest was denied.
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  • Federal Court Finds Miami-Area Tax Preparer in Contempt for Violating Permanent Injunction
    In Crime News
    A federal court in the Southern District of Florida has held a Miami-area tax preparer in contempt for violating a permanent injunction that barred her from preparing, filing or assisting in the preparation or filing of federal tax returns for others.
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  • Supply Chain Security: CBP Works with International Entities to Promote Global Customs Security Standards and Initiatives, but Challenges Remain
    In U.S GAO News
    Oceangoing cargo containers play a vital role in global trade but can also pose a risk of terrorist exploitation. U.S. Customs and Border Protection (CBP), part of the Department of Homeland Security (DHS), oversees security of the supply chain--the flow of goods from manufacturer to retailer. CBP anticipates that adoption of uniform, international customs security standards could eventually lead to a system of mutual recognition whereby the customs security-related practices and programs taken by one customs administration are recognized and accepted by another administration. In response to congressional requesters, GAO determined (1) actions CBP has taken to develop and implement international supply chain security standards, (2) actions CBP has taken with international partners to achieve mutual recognition of customs security practices, and (3) issues CBP and foreign customs administrations anticipate in implementing 100 percent scanning of U.S.-bound container cargo. To conduct its work, GAO analyzed CBP documents on supply chain security programs and international cooperation initiatives and met with CBP officials and foreign customs officials from various trading partner nations. Also, GAO drew upon its related reports and testimony on supply chain security issued earlier this year--GAO-08-187 (Jan. 25), GAO-08-240 (Apr. 25), and GAO-08-533T (June 12). DHS provided technical comments on a draft of this report, which GAO incorporated where appropriate.To develop and implement international supply chain security standards, CBP has taken a lead role in working with foreign customs administrations and the World Customs Organization (WCO). Through the Container Security Initiative (CSI), CBP places staff at foreign seaports to work with host nation customs officials to identify high-risk container cargo bound for the United States, and through the Customs-Trade Partnership Against Terrorism (C-TPAT), CBP forms voluntary partnerships to enhance security measures with international businesses involved in oceangoing trade with the United States. In collaboration with 11 other members of the WCO, CBP developed the Framework of Standards to Secure and Facilitate Global Trade (SAFE Framework), which is based in part on the core concepts of the CSI and C-TPAT programs and provides standards for collaboration among customs administrations and entities participating in the supply chain. The SAFE Framework was adopted by the 173 WCO member customs administrations in June 2005; and as of July 2008 154 had signed letters of intent to implement the standards. CBP has actively engaged with international partners to define and achieve mutual recognition of customs security practices. Broadly, for example, CBP contributed to development of the SAFE Framework, which calls for a system of mutual recognition. More specifically, in June 2007, CBP signed a mutual recognition arrangement with New Zealand--the first such arrangement in the world--to recognize each other's customs-to-business partnership programs. Furthermore, in June of this year, CBP signed mutual recognition agreements with Jordan and Canada. By early 2009, CBP anticipates obtaining a mutual recognition agreement with the European Commission, which represents the 27 member nations of the European Union. CBP actively engages in the implementation of international customs security standards, however recent law, such as The Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11 Act) requiring that 100 percent of U.S.-bound container cargo be scanned at foreign seaports--using a nonintrusive inspection process involving equipment such as X-rays and radiation detection equipment--may affect worldwide adoption of international supply chain security standards. CBP and some foreign partners have stated that unless additional resources are made available, 100 percent scanning could not be met. Given limited resources, CBP and European custom administration officials said that 100 percent scanning may provide a lower level of security if customs officers are diverted from focusing on high-risk container cargo. Under the current risk-management system, for example, the scanned images of high-risk containers are to be reviewed in a very detailed manner. However, according to WCO and industry officials, if all containers are to be scanned, the reviews may not be as thorough. Further, a European customs administration reported that 100 percent scanning could have a negative impact on the flow of commerce and also would affect trade with developing countries disproportionately.
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  • Ohio Resident Pleads Guilty to Operating Darknet-Based Bitcoin ‘Mixer’ That Laundered Over $300 Million
    In Crime News
    An Ohio man pleaded guilty today to a money laundering conspiracy arising from his operation of Helix, a Darknet-based cryptocurrency laundering service.
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    In Justice News
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  • Antitrust Division Economics Director of Enforcement Jeffrey Wilder at the IAM and GCR Connect SEP Summit
    In Crime News
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  • Missile Defense: Recent Acquisition Policy Changes Balance Risk and Flexibility, but Actions Needed to Refine Requirements Process
    In U.S GAO News
    What GAO Found In 2002, the Department of Defense (DOD) provided the Missile Defense Agency (MDA) with flexibilities to diverge from traditional requirements-setting and acquisition processes and instead implement a unique approach to managing its acquisitions. After completing studies in 2019, DOD revised those flexibilities in 2020 by making significant changes to MDA's requirements-setting and acquisition processes (see figure). Most notably, the Under Secretary of Defense for Acquisition and Sustainment, rather than the MDA Director, now determines whether major MDA programs may progress through the development phases. 2020 Department of Defense Changes to Missile Defense Acquisition Process Most of the changes are consistent with GAO's identified acquisition best practices and align with changes GAO previously recommended. For example, MDA must now obtain independent cost estimates and Under Secretary of Defense approval of its acquisition strategies. The warfighter (military planners and weapon system operators) also now has greater requirements-setting responsibility. GAO previously recommended these actions to improve the likelihood of MDA delivering effective capabilities to the warfighter as promised. However, DOD did not establish processes and products that would fully align missile defense capabilities in early development with operational-level warfighter requirements. Instead, DOD continues to rely on MDA to identify its own operational-level requirements, which could result in MDA later having to make costly, time-consuming design changes to meet warfighter needs. GAO also found that DOD generally met the statutory requirements Congress established for changing missile defense non-standard acquisition processes and responsibilities by: (a) consulting with required DOD officials; (b) certifying this consultation occurred; (c) reporting the changes to Congress; and (d) generally waiting the required 120 days before implementing the changes. U.S. Strategic Command determined that it did not need to take these same actions on changes it made to requirements-setting processes. GAO also found that DOD generally met a statutory requirement to obtain an independent study on MDA's acquisition process and organizational placement within DOD. As required, DOD updated congressional defense committees on the scope of the study report and provided the report to congressional committees. However, DOD exceeded the statutorily mandated reporting deadline by 13 days. Why GAO Did This Study Since MDA was established in 2002, DOD has invested over $174 billion developing and fielding missile defense capabilities. MDA has used its acquisition flexibilities to quickly develop and field capabilities, but has also had setbacks. In 2020, DOD determined that modifications to MDA's acquisition flexibilities were needed to better balance risk. Congress recently prohibited DOD from changing certain missile defense acquisition processes and responsibilities unless certain requirements were met. Congress also required DOD to enter into a contract for an independent study of MDA's acquisition process and organizational placement within DOD. The National Defense Authorization Act for Fiscal Year 2021 included a provision for GAO to assess whether DOD complied with these requirements. This report assesses the effects of recent changes DOD made to missile defense non-standard acquisition processes and responsibilities and whether, in doing so, it met the statutory requirements. GAO reviewed DOD documents and policies issued in 2020 and interviewed DOD officials.
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  • United States – Iceland Memorandum for Economic Cooperation
    In Crime Control and Security News
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  • Justice Department Settles with Iowa-Based Nursing Home and Management Company to Resolve Immigration-Related Discrimination Claim
    In Crime News
    The Department of Justice announced today that it reached a settlement with JP Senior Healthcare LLC and JP Senior Management LLC, resolving the department’s claims that these companies violated the Immigration and Nationality Act (INA) by discriminating against a Latino employee based on assumptions that the worker was not a U.S. citizen.
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