BOSTON, Apr 15, 2009 (BUSINESS WIRE) -- Orthofix International N.V. (NASDAQ: OFIX) (the Company) today announced
that a federal False Claims Act, or qui tam, complaint filed on March
23, 2005 against the primary manufacturers of bone growth stimulators in
the U.S., including the Company, has been unsealed by the United States
District Court for the District of Massachusetts. The civil complaint
against these manufacturers of bone growth stimulators appears to focus
on alleged reimbursement-related false claims associated with the sale
versus the rental of those devices.
The unsealing of the civil qui tam action is routine procedure and
allows the individual plaintiff involved to pursue civil claims in
federal court. The Company indicated that this week it also received
what it believes is a related subpoena from the Department of Justice
(DOJ) requesting documentation for a period from 1995 to 2009. The
Company believes the DOJ is requesting information primarily related to
claims for reimbursement for the sale of stimulation devices.
Orthofix announced earlier this month that its subsidiary, Orthofix
Inc., was approved for accreditation by the Accreditation Commission for
Health Care, Inc., (ACHC) for the provision of Durable Medical
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) services.
Obtaining accreditation is currently a voluntary activity where
healthcare organizations submit their internal policies, processes and
patient care delivery systems for peer review against national
standards. Meeting and maintaining such accreditation status indicates
the Company's compliance with ACHC's standards and its commitment to
quality in the provision of DMEPOS services.
About Orthofix
Orthofix International, N.V., a global medical device company, offers a
broad line of minimally invasive surgical, and non-surgical, products
for the spine, orthopedic, and sports medicine market sectors that
address the lifelong bone-and-joint health needs of patients of all
ages--helping them achieve a more active and mobile lifestyle.
Orthofix's products are widely distributed around the world to
orthopedic surgeons and patients via Orthofix's sales representatives
and its subsidiaries, including BREG, Inc. and Blackstone Medical, Inc.,
and via partnerships with other leading orthopedic product companies. In
addition, Orthofix is collaborating in R&D partnerships with leading
medical institutions such as the Orthopedic Research and Education
Foundation, Rutgers University, the Musculoskeletal Transplant
Foundation, Texas Scottish Rite Hospital for Children and National
Osteoporosis Institute. For more information about Orthofix, please
visit www.orthofix.com.
SOURCE: Orthofix International N.V.
Orthofix International N.V.
Dan Yarbrough, 617-912-2903
Vice President of Investor Relations
danyarbrough@orthofix.com
Copyright Business Wire 2009