Duragesic/Fentanyl Patch
In 1990, the FDA approved for use a trans-dermal Durgesic patch
which releases the powerful opiate fentany into the human body
in a time-released manner. The Duragesic patch is indicated for
the management of serve, chronic pain (such as cancer pain) that
cannot be managed with less powerful drugs such as
acetaminophen-opioid combinations and nonsteroidal anaglesics.
The Duragesic patch was orginally manufactured and designed by
Johnson & Johnson subsidiaries Janssen Pharmaceuticals and Alza.
The Duragesic patch is one of the highes selling chronic pain
relief products in the world. In 2005 and 2006, Johnson &
Johnson had $1.5 billion and $1.29 billion in worldwide sales
for the Duragesic patch, respectively. In February 2004, Janssen
and the FDA recalled over 400,000 Duragesic patches. The recall
was prompted by a potential seal breach, which may allow the
drup to leak for the patch, resulting in an increased absorption
of fentanyl into the system. In April 2004, the recall was
expanded to include a total of 2.2 million patches. Health
officals believe that over 20 percent of the recalled patches
are still in use.
In July 2005, the FDA issued a Public Health Advisory regarding
the safe use of these transdermal fentanyl patches in reponse to
reports of deaths in patients using this potent narcotic
medication for pain management. The FDA also issued a patient
information sheet and an alert to healthcare professionals
identifying several precautions for the use of fentanyl
transdermal patches. These safety precautions included patient
education regarding signs for overdose, proper patch
application, use of other medications while using the patch,
safeguards for children, and proper storage and disposal.
The FDA is currently investigating 120 deaths linked to the
Duragesic fentanyl patch. The Agency has been examining the
circumstances of the product use to determine if the reported
adverse events, including deaths resulting from a fentanyl
overdose, may be related to inappropriate use of the patch of
factors related to the quality of the product. If is possible
that some patients and their healthcare providers may not be
completely aware of the dangers of these potent narcotic drug
products and the important recommendations regarding their safe
use.
The numerous deaths associated with these patches have prompted
at least 100 lawsuits across the United States. To date, two of
these cases have gone to trial, both resulting in verdicts for
the Plaintiffs. A Texas jury awarded $772,500 to the family of a
woman who died in 2004 from a leak in the Duragesic patch she
was using to alleviate pain from a car accident. According to
the lawsuit, the 45 year-old woman had 10 times the amount of
therapeutic fentanyl in her system at the time of her death. In
June 2007, a Flordia jury awarded the family of a Flordia man
who died from a fentanyl patch overdose, $5.5 million. The 28
year-old man, prescribed the fentanyl patch for pain after a car
accident,had over 3 times the lethal amount of fentanyl in his
system at the time of his death.
If you or someone you love was injured as a result if using the
Duragesic patch, please call our firm at (888) 933-1514 or email
us at info@beltlawfirm.com.
