FOR IMMEDIATE RELEASE
FEDERAL JUDGE IN KENTUCKY REJECTS INJUNCTION ON OXYCONTIN
Ruling protects patient access to appropriate pain
medications
London, Ky. - January 2, 2002 - Judge Jennifer B. Coffman
of the U. S. District Court for the Eastern District of Kentucky in an
order dated December 27, 2001 denied plaintiffs' motion in Foister, et al.
v. Purdue Pharma L.P., et al. that sought to impose a variety of
restrictions on access to OxyContin® (oxycodone HCL controlled-release)
Tablets, even by legitimate pain patients with valid physician
prescriptions. In denying plaintiffs' motion in its entirety, Judge
Coffman also rejected plaintiffs' efforts to restrict how the medication
is marketed in Kentucky.
The plaintiffs in Foister claim to represent a proposed class of persons
allegedly harmed by OxyContin after developing an addiction to it when it
was prescribed to them by a physician for pain relief.
Following an evidentiary hearing, during which Judge Coffman took
testimony under oath from plaintiffs' witnesses, the Court, in a 14-page
order and decision, denied both a preliminary injunction and a temporary
restraining order, finding that plaintiffs lacked standing and failed to
show a likelihood of irreparable harm. Judge Coffman said:
"The plaintiffs have failed to produce any evidence showing that the
defendants' marketing, promotional, or distribution practices have ever
caused even one tablet of OxyContin to be inappropriately prescribed or
diverted."
"We are extremely pleased with Judge Coffman's ruling rejecting an attempt
by plaintiffs' lawyers to hinder legitimate patients in pain in Kentucky
from receiving proper medication. OxyContin has helped thousands of
Kentuckians in pain to have a better quality of life," said Dr. Paul
Goldenheim, Executive Vice President, Worldwide R&D and senior physician
at Purdue Pharma L.P., the Stamford, Connecticut based manufacturer of
OxyContin.
Howard R. Udell, Executive Vice President and General Counsel at Purdue
Pharma noted that this was the first test in a series of so called class
actions brought by people who claim that they have been damaged as a
result of their use or misuse of OxyContin tablets.
"Purdue will challenge each of these baseless lawsuits and we are
confident that this will be the first of many similar decisions. We
believe that when judges consider the law and the facts, as contrasted
with the claims of plaintiffs' lawyers looking to profit from these
groundless lawsuits, they will conclude that the facts just don't support
the claims," said Udell.
Purdue Pharma L.P., headquartered in Stamford, Conn., is a privately-held
pharmaceutical company engaged in the research, development, production,
sales and marketing of both prescription and over-the-counter medicines
and hospital products.
The labeling for OxyContin tablets contain the following warnings:
OxyContin is an
opioid agonist and a Schedule II controlled substance with an abuse
liability similar to morphine.
Oxycodone can be abused in a manner similar to other opioid
agonists, legal or illicit. This should be considered when
prescribing or dispensing OxyContin in situations where the
physician or pharmacist is concerned about an increased risk of
misuse, abuse, or diversion.
OxyContin Tablets are a controlled-release oral formulation of
oxycodone hydrochloride indicated for the management of moderate to
severe pain when a continuous, around-the-clock analgesic is needed
for an extended period of time.
OxyContin Tablets are NOT intended for use as a prn analgesic.
OxyContin 80 mg and 160 mg Tablets are for use in opioid-tolerant
patients only. These tablet strengths may cause fatal respiratory
depression when administered to patients not previously exposed to
opioids.
OxyContin Tablets are to be swallowed whole and are not to be
broken, chewed, or crushed. Taking broken, chewed, or crushed
OxyContin Tablets leads to rapid release and absorption of a
potentially fatal dose of oxycodone. |
Full prescribing information for OxyContin
Tablets can be found online at the Purdue website at
http://www.purduepharma.com/PRESSROOM/PI/OXYCONTIN_PI.PDF.
This and other recent announcements are available on the Purdue Pharma web
site at www.purduepharma.com.
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