Pharmaceutical Legal Glossary
Glossary of Pharmaceutical Law Terms
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Damages: The sum of money awarded to the
injured party in a personal injury lawsuit.
Default Judgment: A judgment issued when the defendant
offers no defense by not responding to the complaint. A
judge may issue a judgment without the necessity of a
trial.
Defendant: The person against whom a claim is brought.
Deponent: The person who testifies at a deposition.
Deposition: A pretrial discovery device in which one
party verbally answers questions from the other party.
DES: Diethylstilbestrol (DES) used to be prescribed to
pregnant women believed to need more estrogen to
maintain their pregnancies. Daughters of these women,
who were exposed in the womb to DES, developed a rare
form of vaginal cancer.
Discovery: A pre-trial phase in which both parties must
exchange all information relevant to the case - often in
the form of records, depositions, and other documents -
so that each side can fully prepare its case for trial.
Docket: A summary system kept by the clerk’s office
which contains a record of all pleadings, court orders
and other important activities in a case.
Drug: Any chemical compound that may be used on or
administered to humans as an aid in the diagnosis,
treatment, cure, mitigation, or prevention of disease or
other abnormal conditions.
Duract: In June 1998, Wyeth-Ayerst Laboratories, a
division of American Home Products Corporation announced
the recall of Duract because of post-marketing reports
of severe hepatic (liver) failure resulting in four
deaths and eight liver transplants. DURACT (bromfenac
sodium capsules), is a non-steroidal anti-inflammatory
analgesic indicated for the short-term (10 days or less)
management of acute pain. DURACT was introduced in July
1997, and approximately 2.5 million prescriptions have
been dispensed, the great majority of these for 10 days
or less. In February 1998, the company and the Food and
Drug Administration agreed on labeling changes to
further emphasize that DURACT should be used for 10 days
or less. These changes were initiated in response to
earlier reports of serious events associated with
longer-term use. "Although the revised labeling reduced
the number of prescriptions of longer duration and the
reports of severe liver events, it did not eliminate
them," says Dr. de Vane. "The company has now concluded
that further steps to limit use of a potent NSAID pain
reliever such as DURACT to just 10 days would not be
feasible or effective. In light of these circumstances,
as well as the availability of other therapies,
Wyeth-Ayerst has decided to withdraw the product."
Wyeth-Ayerst has sent letters of notification to more
than 600,000 health care professionals in the United
States. They are being advised to stop prescribing and
dispensing DURACT immediately. In addition, they have
been asked to consider contacting patients who may be
using the product longer than 10 days or who have a
history of liver disease, and advise these patients to
discontinue treatment. Patients are advised to discuss
concerns related to DURACT with their physician
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