Jeffrey Newman Law Announces $36 Million Settlement in Whistleblower Case Involving British Medical Device Company BTG and U.S. Department of Justice
BOSTON, 2016-11-07 20:27 CET (GLOBE NEWSWIRE) --
British medical device maker BTG PLC and its subsidiary, Biocompatibles, Inc., have agreed to pay $36 million to the U.S. Government to resolve federal and state False Claims Act (FCA) allegations resulting from the off-label promotion of LC Bead, a medical device approved for use only for embolization of hypervascular tumors. $25 million of the settlement is to resolve the civil qui tam action, which alleged fraud, and $11 million of the settlement is a criminal fine against Biocompatibles.
The whistleblower, Ryan Bliss, is represented by Jeffrey A. Newman Esq., of Jeffrey Newman Law, and co-counsel Paul Lawrence II of Waters & Kraus of Dallas. In the complaint, Mr. Bliss, who oversaw marketing of Biocompatibles’ medical products in North America, revealed detailed information alleging that Biocompatibles lied to the Federal Drug Administration (FDA) about a drug delivery device called LC Bead and sold it for millions of dollars in the U.S. without clearance.
The suit alleged that Biocompatibles violated marketing regulations in its promotion activities to U.S. doctors, pushing LC Bead as a chemotherapy drug-delivery device that physicians could use for treatment of patients with various forms of cancer - a use the FDA had never approved. LC Bead was only cleared by the FDA for so-called “bland” embolization of blood vessels (i.e. blocking of blood supply) for the treatment of hypervascular tumors. The unapproved use of LC Bead as a drug-delivery device (wherein the beads are loaded with a chemotherapy drug) caused health care providers across the country to submit false claims for payment to Medicare, Medicaid and other federal health care programs, the Government alleged.
In 2009, Biocompatibles, which has its headquarters in Britain, filed with the FDA for Premarket Approval (PMA) of LC Bead to deliver chemotherapy drugs in humans. The FDA denied approval, stating there was not enough evidence demonstrating sufficient survival benefit to patients. Despite this, the company continued to sell the LC Bead in the United States for use as a drug delivery device and continues to do so. While Biocompatibles pleaded guilty to criminal charges that the company violated a law that prohibits the introduction of misbranded medical devices into interstate commerce, none of the management was prosecuted for any criminal wrongdoing.
“What’s remarkable about this case is that Biocompatibles had obtained clearance from the FDA for one use, when LC Bead was specifically designed and exclusively marketed to U.S. doctors for a completely different use that the FDA had refused to approve. The company went on to instruct providers to submit claims using the code established for approved procedures knowing that insurers would have denied coverage otherwise,” said attorney Newman.
LC Bead continues to be sold as drug eluting beads throughout the United States, and the same product is sold outside the United States but is marketed under the name DC Bead. The federal government and various states will receive a portion of the funds to settle allegations of fraudulent billing to Medicaid programs.
Mr. Bliss was awarded a portion of the funds collected by the Government in this case pursuant to The False Claims Act, which allows private citizens to file actions on behalf of the Government revealing fraudulent billing of Government agencies.
About Jeffrey Newman Law
Jeffrey Newman Law is a law firm dedicated to representing whistleblowers nationwide in False Claims Act (or “qui tam”) litigation involving fraud against the government. Founded by Jeffrey A. Newman Esq, the firm has a consistent track record of winning landmark, multi-million dollar settlements in cases involving Medicare, Medicaid, Pharmaceutical and healthcare fraud as well as other SEC and IRS whistleblower actions. In 2016 alone, the firm settled three cases amounting to over $165 million. For more information, please visit www.jeffreynewmanlaw.com or contact Jeffrey Newman Law at 1-800-682-7157.
Jeffrey A. Newman Esq.
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
GSV Asset Management Announces Strategic Investment from HMC Capital-Led Group14.12.2017 21:03 | Pressemelding
WOODSIDE, Calif. and NEW YORK, Dec. 14, 2017 (GLOBE NEWSWIRE) -- GSV Asset Management, LLC ("GSV"), a modern merchant bank that identifies, advises, and invests in the fastest growing, most dynamic companies in the world - the Stars of Tomorrow - today announced a strategic investment from a group led by HMC Capital ("HMC"), a leading Latin American advisory and investment firm. While terms of the deal were not disclosed, the investment will result in a minority ownership interest for the HMC-led group in GSV Asset Management. Proceeds will be used to enhance GSV's ongoing investment activities, as well as to accelerate its strategic expansion into new business areas and geographies. "We are very excited to partner with HMC Capital, a multi-billion dollar asset manager that brings a range of complimentary capabilities to GSV Asset Management," said Michael Moe, founder of GSV. "GSV stands for Global Silicon Valley and our alliance with HMC reflects our shared commitment t
TrueCommerce Datalliance Releases Third 2017 Update for Vendor Managed Inventory Platform14.12.2017 19:28 | Pressemelding
Latest Software Update Enhances Browser, Productivity Experience CINCINNATI, Dec. 14, 2017 (GLOBE NEWSWIRE) -- TrueCommerce Datalliance, a leading vendor managed inventory service solutions provider, announced today that it released the third scheduled 2017 update to its VMI platform. The free update is part of TrueCommerce Datalliance's commitment to improving the functionality of its cloud-based supply chain software. Highlights of the release include several improvements to its system architecture and capabilities: Google Chrome is now officially supported Order Worksheets are now easier to view in Internet Explorer One-click access to recently changed or added items Mass Launch Order Preview lists all items suggested or added via allocation "We promise our customers three major updates every year," said Connie Shafer, TrueCommerce Datalliance Producti
ATTO announces support for Apple® Release of the new iMac Pro14.12.2017 18:37 | Pressemelding
ATTO's line of ThunderboltTM technology enabled products continue to revolutionize connectivity to storage AMHERST, N.Y., Dec. 14, 2017 (GLOBE NEWSWIRE) -- ATTO Technology, Inc., a global leader of storage and network connectivity and infrastructure solutions for data-intensive computing environments, today confirmed their continued commitment to the newly released line of product updates and innovations from Apple. With the powerful and new iMac Pro® now shipping, ATTO continues to support the new offerings from this industry leading manufacturer. "Our deep relationship with Apple over the last 30 years continues to drive our position as a leading force within the Apple community," said Timothy J. Klein, president and CEO at ATTO Technology. The iMac Pro sets a new standard for Apple design and performance and complements why users select ATTO products. As Apple pushes the boundaries of desktop computing, ATTO continues to provide industry leading products that op
Seaborn Networks' CEO Larry Schwartz is Named in List of 100 Most Powerful People in Telecoms Worldwide14.12.2017 16:12 | Pressemelding
BOSTON, Dec. 14, 2017 (GLOBE NEWSWIRE) -- Seaborn Networks ("Seaborn"), a leading developer-owner-operator of submarine fiber optic cable systems, is pleased to announce that Larry Schwartz, Seaborn's Chairman & CEO, has been named one of the 100 most powerful people in the telecoms industry by Global Telecoms Business ("GTB"). The Power 100 List annually identifies the most influential people in telecoms, content and Internet companies, selecting nominations from readers of the publication. Larry is one of only six people included on the list from the global subsea and data center industries. GTB notes that these top 100 were "those the industry felt were the real power, the real influencers, behind the telecoms sector" and were chosen by the editorial team with input from GTB's readers. In only a few years, Larry has led Seaborn from being a start-up to now being a leading player in the global telecommunications industry, setting precedents with its business model, fina
Mayo Clinic to begin Prospective Clinical Study with Medibio Technology for Expanded Market Opportunities14.12.2017 15:10 | Pressemelding
Study designed to determine differential diagnosis in depression patients Study designed to monitor patient data following pharmacological treatment SYDNEY, Australia and MINNEAPOLIS, Dec. 14, 2017 (GLOBE NEWSWIRE) -- Medibio Limited (MEB or the Company) (ASX:MEB) (OTCQB:MDBIF), a mental health technology company that has pioneered the use of objective biometrics to assist in the screening, diagnosing, monitoring and management of depression and other mental health conditions, is pleased to announce the first prospective clinical trial with Mayo Clinic under a 5-year Master Clinical Trial Agreement that was signed in October of this year. This initial study, undertakes the prospective diagnosis and longitudinal monitoring of both unipolar and bipolar depression, along with the depressive subtypes (melancholic and atypical). The primary goal is to characterize longitudinal autonomic, circadian, and
The 1st free cross-border ecommerce library available to online merchants14.12.2017 10:00 | Pressemelding
A competitive edge instrumental in succeeding in today's dynamic retail world AMSTERDAM, The Netherlands, Dec. 14, 2017 (GLOBE NEWSWIRE) -- Acapture, a global, data-driven omnichannel PSP, has released a complete library of free infographics for merchants, outlining the latest exclusive data for 31 of the world's most exciting ecommerce markets. Online retailers, marketplaces, and other ecommerce merchants are given a competitive edge, instrumental in succeeding in today's dynamic retail world. With each infographic providing actionable stats, facts and figures from a major ecommerce region, illustrated with clear, reader-friendly graphics, the collection is essential reading for all merchants looking to seize current cross-border opportunities. By understanding the preferred local payment methods, the most popular B2B and B2C product categories, top import and export regions, most popular ecommerce sites and much more, merchants can make
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom