-- Attorney General Anne Milgram announced
today that the state has issued subpoenas
to Synthes Spine, Inc. , a Pennsylvania-based
company that manufactures and markets a
synthetic spinal disk known as ProDisc.
The state also subpoenaed Viscogliosi Brothers,
LLC, a New York-based investment firm that
generated the start-up capital for the company
that originally owned the device.
Brothers formed Spinal Solutions, Inc.,
which originally owned the ProDisc device,
and operated several investment funds whose
main asset was Spine Solutions. Synthes,
Inc., a global medical device company based
in Switzerland, acquired Spine Solutions
in 2003, and markets ProDisc under the corporate
banner Synthes Spine.
ProDisc is an artificial spinal disk approved
by the federal Food and Drug Administration
for use in patients in August 2006. The
synthetic replacement disk has been surgically
implanted in thousands of patients as an
alternative to conventional spinal surgery,
in which the vertebrae are fused to alleviate
disk-related back pain.
to Attorney General Milgram, the state subpoenas
were issued today in New York and Pennsylvania
and seek information spanning a time period
from January 1, 1999 through the present.
other things, the subpoenas seek information
concerning the investment backing that funded
ProDisc’s development. The subpoenas
also seek information concerning physician
participation in, and the results of, clinical
studies of ProDisc. It was largely on the
basis of clinical study results presented
in 2005 that FDA approved ProDisc for commercial
sale and distribution in the United States.
principal focus of the state’s inquiry
is whether required disclosures were made
regarding surgeons – including some
licensed to practice in New Jersey -- who
endorsed ProDisc as researchers and also
had an investment interest in the device.
The state’s investigation is being
conducted by the Affirmative Litigation
Unit within the Division of Law.