February 2, 2001
Re: United States v. Paul F. Fulk, Earnie S. Philpot, Para Tech
Industries, Inc., and Therasys, Inc., 3:00 CR 77 (S.D. Ohio) (Rice,
We are writing you because we have information suggesting that you may
have purchased, leased, or refurbished a CTD-Mark I device that was manufactured
by Para Tech Industries, Inc.
The Mandatory Victims Restitution Act of 1996 provides that all identified
victims directly and proximately harmed as a result of the commission of
the offense(s) in the above-entitled case receive notice of the following
On December 21, 2000, in Dayton, Ohio, Para Tech Industries, Inc. ("Para
Tech"), and Therasys, Inc. ("Therasys"), pled guilty to conspiring to defraud
the United States Food and Drug Administration ("FDA") of its authority
to regulate the distribution of medical devices. This charge relates to
the companies' distribution of an unapproved medical device known as the
CTD-Mark I, which the companies marketed as being a treatment device for
carpal tunnel syndrome. At the plea hearing, the companies admitted that
from at least December 1994, the owners and officers of Para Tech and Therasys
knew that the CTD-Mark I had not received clearance from the FDA, and was
not approved to be sold as a treatment device for carpal tunnel syndrome.
The companies further admitted that, from at least on or about February
16, 1995, through on or about August 28, 1999, the companies' owners and
officers agreed among themselves to deceive the FDA by making false statements
regarding Para Tech's continued manufacture, sale, and shipment in interstate
commerce of the CTD-Mark I devices.
On the same date, Paul F. Fulk, the Chief Executive Officer of both companies,
and Earnie S. Philpot, an officer and director of both companies, pled guilty
to a felony count charging them with conspiring to obstruct a pending FDA
inspection. At the guilty plea hearing, Paul Fulk and Earnie Philpot admitted
that, during an FDA inspection in December 1995, they attempted to conceal
from the FDA investigators the fact that both Para Tech and Therasys were
marketing and selling CTD-Mark I devices in interstate commerce without
The United States Probation Office has requested that the government obtain
information from individuals believed to be victims. The purpose of this
request is to aid the Court in identifying the victims entitled to restitution
and in determining what amount of restitution should be paid by the defendants
to those victims.
You may be entitled to restitution if you meet the following criteria:
1. You purchased, leased, or refurbished a CTD-Mark I device prior to August
12, 1999, for the purpose of treating patients with carpal tunnel syndrome;
2. You were not aware that the CTD-Mark I device was not approved or cleared
by the FDA for treatment of patients.
We cannot guarantee that restitution, or any particular amount of restitution,
will be awarded to you. That determination will be made by the Court. Moreover,
you should be aware that there may not be sufficient funds available to
pay victims full restitution.
If you believe that you are entitled to restitution and meet the criteria
set forth above, you need to let the United States Probation Office know.
With this letter, we are enclosing a complete explanation of the type(s)
of compensation you may be entitled to receive. (Explanation of Losses Subject
to Restitution). We are also enclosing a declaration (Economic Crime-Individual
Victim Impact Statement) that you should complete and forward to the United
States Probation Office as soon as possible. This declaration has the same
legal effect as an affidavit, but need not be notarized. This declaration
should be mailed to:
Ms. Margarette R. Foster
United States Probation Office
200 West 2nd Street
Dayton, OH 45402
(937) 225-2755 (facsimile)
You should also include all underlying documents you have to support your
claim of restitution.
In order for Ms. Foster to process all of the information, she must receive
the completed declaration by no later than February 16, 2001. Please
feel free to fax your response to Ms. Foster at 927-225-2755. Ms. Foster
will submit the declaration on your behalf to the sentencing Court.
At this time, no sentencing date has been set. Periodic updates with respect
to this and other information will be posted at a website sponsored by the
Department of Justice. You can access this website at:
If you are still in possession of a CTD-Mark I device, you should be aware
that the FDA has never approved the CTD-Mark I for treatment of carpal tunnel
syndrome. However, on August 12, 1999, the FDA approved the CTD-Mark I as
a device to perform traction and mobilization of the cervical muscles and
vertebrae. FDA's approval of the CTD Mark I as a cervical traction device
is for clinical use only by the prescription of a licensed physician. Should
you have any additional questions relating to the regulatory status of the
CTD-Mark I, please contact Harold P. Pellerite, Assistant to the Director,
Office of Compliance, Center for Devices and Radiological Health, FDA, at
We thank you for your assistance.
James E. Arnold
Consumer Protection Branch
U.S. Department of Justice
Washington, DC 20530