Jeffrey Newman Law Announces $36 Million Settlement in Whistleblower Case Involving British Medical Device Company BTG and U.S. Department of Justice
(Thomson Reuters ONE) -
False Claims Act lawsuit revealed BTG subsidiary, Biocompatibles, fraudulently
marketed its LC Bead device for uses that had been denied approval by the FDA
BOSTON, Nov. 07, 2016 (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.
Contact:
Jeffrey A. Newman Esq.
www.JeffreyNewmanLaw.com
Email: jeffrey(at)jeffreynewmanlaw.com
Phone: 617-823-3217
Media Contact:
Andrea LePain
eMedia Junction
andrea(at)emediajunction.com
Phone: 617-275-8112
Cell: 617-894-1153
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Jeffrey Newman Law via GlobeNewswire
Datum: 07.11.2016 - 20:35 Uhr
Sprache: Deutsch
News-ID 505472
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Kategorie:
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