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2016-11-07

Jeffrey Newman Law: Jeffrey Newman Law Announces $36 Million Settlement in Whistleblower Case Involving British Medical Device Company BTG and U.S. Department o

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@jeffreynewmanlaw.com
Phone: 617-823-3217

Media Contact:

Andrea LePain
eMedia Junction
andrea@emediajunction.com
Phone: 617-275-8112
Cell: 617-894-1153

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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

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