By
Amanda C. Fields
General
Counsel
Recently, it came to
our attention that many pharmacists, particularly
those with a compounding practice in the Dallas
area, received a subpoena duces tecum ("SDT")
pertaining to an ongoing lawsuit, State of Texas
vs. Apothecure, Inc., Spectra Pharm, Inc., and
Gary D. Osborn, Individually.
If you are not familiar with
this matter, please allow us to provide you some
background. In December 2007, the Texas
Attorney General joined an enforcement action with
the State of Oregon against a Dallas-based drug
manufacturer and pharmacist. The State of
Texas ("Texas") charged Apothecure, Inc., and its
owner, Mr. Gary D. Osborn, with formulating a
highly potent injectable painkiller mixture
alleged to be associated with three deaths.
Texas also took action against Spectra Pharm,
Inc., an Apothecure-owned retail store that
advertises and sells over-the-counter drugs and
dietary supplements. Texas and Oregon are
jointly prosecuting this enforcement effort.
The defendants are charged with violating state
and federal laws that protect patients from
unlawful or dangerous pharmaceutical
products. The drug linked to the deaths,
Colchicine, is recognized by the U.S. Food and
Drug Administration ("FDA") for the treatment of
gout. Texas alleges that the defendants
formulated Colchicine to treat neck and back pain,
and that they did not safeguard patients by
testing the mixture for potency strength.
Texas alleges that Apothecure and Mr. Gary D.
Osborn unlawfully manufactured drugs not approved
by the FDA, and did so under the guise of
"compounding" prescription drugs. Texas
pharmacies can legally compound drugs by
combining, mixing or altering ingredients to
create a customized medication for an individual
patient based on a physician's prescription.
However, Texas law requires that customized
compounded drugs be approved by the FDA. The
defendants claim that Apothecure is authorized to
"compound" drugs. However, Texas alleges
that Apothecure's actual activities exceed the
pharmacy's authorized scope of practice, crossing
the line into prescription drug
manufacturing. Texas charged Apothecure
with: violating state law by manufacturing
drugs that are not approved by the FDA as required
by federal law, selling prescription drugs to
persons in several states and countries in which
the defendant is not authorized to operate as a
pharmacy and/or drug manufacturer, substandard
manufacturing practices that result in adulterated
or misbranded drugs, and selling prescription
drugs to persons who cannot lawfully prescribe
drugs in Texas. In addition, the lawsuit
alleges the defendants failed to use proper
manufacturing practices, employed incorrect labels
and made exaggerated claims about the benefits of
its dietary supplements. The defendants are
charged with violating the Texas Deceptive Trade
Practices Act ("DTPA"), which can result in
penalties of $20,000.00 per violation, and with
violating the Texas Food, Drug and Cosmetic Act,
which can carry penalties of up to $25,000.00 per
day, per violation.
A SDT is a type
of subpoena that requires a witness to answer
questions and/or produce documents pertaining to a
proceeding. The term is from the Latin duces
tecum, meaning "you shall bring with you."
This particular SDT is compelling witnesses,
particularly pharmacists with a compounding
practice in the Dallas area, to answer certain
written questions enumerated in the SDT, instead
of (at least at this time) testifying live.
You are required by Texas law to respond to the
SDT, within a certain time frame (defined at the
beginning of the SDT) and to have your response
properly notarized by a notary public.
Please note that failure to obey a SDT may be
deemed contempt of court, punishable by a fine or
confinement, or both. While an attorney is
not necessary to represent you in your response to
the SDT, you may wish to consider contacting your
attorney to assist you in preparing your response
to the SDT. If you do not have an attorney,
we can provide you with contact information of an
appropriate attorney to assist you. An
attorney can work with you in preparing your
response and answering any questions you may have
regarding the form or substance of your response,
advise you about your involvement in the
proceedings at issue, and work with you to ensure
that your cooperation is not somehow used against
you in a negative manner. For example,
one of the questions on the SDT is, "Have you ever
misfilled a prescription?" Another is, "Do
you now or have you ever offered for sale
compounded drugs with non-FDA approved
ingredients?" These are questions that might
appear to you to be somewhat of a "fishing
expedition," and an attorney can assist you with
fully complying with the SDT and at the same time,
protecting you and your pharmacy.
Questions? Please contact our
General Counsel Amanda C. Fields at
afields@aprx.org.
