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Fentanyl Patch-Recalls, Deaths, Overdoses Connected with Powerful Pain Patches By James C. Lewis, Attorney Shapiro, Cooper, Lewis & Appleton, P. C. (Virginia Beach, VA)

Our personal injury lawyers at Shapiro, Cooper, Lewis & Appleton, have accepted fentanyl patch cases involving overdose or death under highly unusual circumstances–such as a sudden wrongful death where the fentanyl drug is linked to overdose or death.
Fentanyl is one of the most powerful opioid analgesics with a potency approximately 81 times that of morphine.
A number of fatal fentanyl overdoses have been directly tied to the drug over the past several years. In particular, several drug manufacturers of time-release fentanyl patches have already been sued over allegations of defective product claims as well as other claims. One of several claims is that a malfunction of the patches caused an overdose of fentanyl to leak and to be absorbed by patients, resulting in life-threatening side effects and even death.
Manufacturers of fentanyl transdermal pain patches have voluntarily recalled numerous lots of their patches and the FDA has issued Public Health Advisories related to the fentanyl patch dangers. Manufacturers affected include Janssen Pharmaceutica Products, L.P.; Alza Corporation; Actavis South Atlantic, LLC; Sandoz; Cephalon, Inc. and Mylan.
On June 19, 2007, a $5.5 million jury verdict was awarded in a case against Johnson & Johnson subsidiaries, Alza Corporation and Janssen Pharmaceutica Products, the manufacturers of the Duragesic fentanyl transdermal pain patch. The case was tried in the Federal District Court for the Southern District of Florida, West Palm Beach Division. The jury reached a verdict for the family of a 28-year-old Florida man (Adam Hendelson) who died while wearing a fentanyl transdermal pain patch, and one allegation was that a defective “fold over” in the patch allowed a lethal amount of the drug to be absorbed.
Fentanyl is one of the most potent narcotics available. It is a Schedule II controlled substance. Janssen Pharmaceutical Products, LP, has recalled several lots of pain control patches because of the Duragesic leak and the number of deaths and injuries that resulted. News reports claim that more than 30 Duragesic wrongful death claims and fentanyl patch lawsuits have been filed nationwide already.

Fentanyl is a dangerous drug and medical providers and care-takers are prescribing this drug in situations that it is not required, due to inadequate instructions from the manufacturer we contend. Further, we believe that the dangers of fentanyl extend beyond the recalled defective Duragesic pain patches, and providers do not appreciate the high dangers associated with the fentanyl patch.
Leaking Duragesic pain control patches can release enough fentanyl to cause an overdose. Symptoms and signs of a fentanyl overdose can include slowed breathing and heartbeat, pinpoint pupils, cold clammy skin, loss of or change in consciousness, and seizures.
Johnson & Johnson announced a voluntary recall of a popular version of their Duragesic pain patch. About 32 million patches sold by PriCara, a unit of J & J, are being recalled due to concerns that a defect could expose patients to excess doses of the powerful opioid, fentanyl. The recall involves the widely used 25-microgram per hour patch used to treat lower-weight and newer patients suffering from chronic pain, although numerous other dosages are available as well.
In 2004 the company issued a recall of some batches of the less popular 75-microgram per hour patch. Johnson & Johnson has been sued by at least 75 people alleging injury from the Duragesic patch.

Some personal injury attorneys have assserted that these fentanyl patches should be recalled from the US market, citing the safer and more effective alternative pain medications.
The Food and Drug Administration also issued a Public Health Advisory regarding the safe use of fentanyl pain patches, such as Duragesic, citing reports of deaths in patients using the patch. Problems with leaky patches lead Janssen Pharmaceutical Products to recall several shipments of the Duragesic pain patch.

For example, the FDA issued this news release in early 2008:

Actavis Recalls Remaining Fentanyl Patches in the US as Precaution
FOR IMMEDIATE RELEASE — Morristown, NJ, March 1, 2008 — Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, today announced that its subsidiary Actavis South Atlantic LLC is proceeding with the voluntarily recall from wholesalers and pharmacies of all lots of Fentanyl transdermal system CII patches sold in the United States.
This recall is an expansion of the Company’s initial recall of fourteen lots of Fentanyl transdermal patches announced on February 17, 2008. That recall was due to the identification of a possible fold-over defect present in the product that potentially could cause leakage of the fentanyl gel. The remaining lots of Fentanyl transdermal system patches are being recalled as a precautionary measure because Actavis lacks assurance that all patches are free from defects.
All of the recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States.
Fentanyl patches sold by Actavis in Europe are not affected by this recall.
As per the approved product labelling for Fentanyl transdermal system, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are leaking or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.
Please note: Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches may be labelled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names:
Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-18.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-18.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-18.
[partly omitted]

Fentanyl transdermal system is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.

Another FDA warning and discussion of Fentanyl issued by the FDA Consumer Magazine:
(Feb. 17, 2008)
Proper Use of Fentanyl Pain Patches
By Michelle Meadows
Fentanyl skin patches provide convenient and effective relief for many people who experience chronic pain, and who have been taking pain medications for long periods of time. But health care providers and patients should be aware that deaths and other serious problems have resulted from accidental overdoses related to inappropriate use of the fentanyl patch, the Food and Drug Administration says.
The patch is applied to the skin and delivers fentanyl, a potent, strong opiate analgesic. The drug is slowly absorbed through the skin into the bloodstream and can relieve pain for up to three days from a single patch application.
********* [partly omitted]
The most frequent use of the fentanyl patch has been to treat pain in people with cancer, and it is only appropriate for patients who have developed a degree of tolerance to the opiate analgesic effects because they have been previously using this type of drug, says Robert J. Meyer, M.D., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.
The FDA is investigating deaths and overdoses that have occurred with both brand-name and generic fentanyl patches. The brand Duragesic (fentanyl transdermal system), manufactured by Janssen L.P. of Titusville, N.J., was approved by the FDA in 1990. A generic version, manufactured by Mylan Laboratories Inc. of Canonsburg, Pa., was approved in 2005.
In July 2005, the FDA issued a public health advisory on the fentanyl patch. Meyer says the advisory focuses on improving education about the signs of an overdose, proper patch application, drug interactions, proper storage and disposal of the patch, and safeguards for children.
The powerful pain-relieving properties of all opiates are countered by significant risks of depressed breathing that can cause unexpected death. Signs of an overdose include trouble breathing or shallow breathing, extreme sleepiness or sedation, an inability to walk or talk normally, and feeling faint, dizzy, and confused. People who experience these symptoms should seek emergency medical attention. Removing the patch won’t reverse the problem; the drug is still absorbed into the body for more than 17 hours after the patch is removed.
The fentanyl patch should not be used for short-term, acute pain, pain that is not constant, or pain after an operation. “The patch is not for pain that occurs after surgery such as tonsillectomies or dental procedures,” Meyer says.
The patch is only for people who experience moderate-to-severe chronic pain that is expected to last for weeks or longer and that cannot be managed by acetaminophen-opioid combinations, nonsteroidal analgesics, or as-needed dosing with short-acting opioids.
The patch also shouldn’t be the first narcotic pain medicine that is prescribed. It should be used only in people who have been taking opiate analgesics for a period of time. It could be used if people have been taking at least 60 milligrams (mg) of oral morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equally strong dose of another opioid for a week or longer. Stanski says, “This prior opiate dosing results in a degree of tolerance, or resistance to the opiate that is relevant when the patch is subsequently used.” Children who are younger than 2 years should not use the fentanyl patch. It also shouldn’t be used in children 2 years of age or older who are not already using other opioid narcotic pain medicines. Patches should always be prescribed at the lowest dose needed for pain relief.
Some deaths have occurred because more than one patch was applied at the same time. Other problems associated with the patch include not removing one patch before applying another, and the failure of multiple caregivers to notice that someone else has applied a patch. The patches are clear, relatively transparent, and easily blend into the skin background.
The Institute for Safe Medication Practices (ISMP) received a report of a 77-year-old woman who died in March 2005 after using the fentanyl patch. Her primary care physician called in a prescription for the patch without examining her or educating her about the drug. She did not receive education from the pharmacy either, according to the ISMP’s report.
The woman’s friend helped her place the patch on her buttock, and the woman later used a heating pad in that area. Heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated water beds should not be used with the patch. “The heat will speed up the movement of fentanyl from the patch into the body much more rapidly than normal,” Stanski says. “This creates a risk for an overdose situation.”
Two days later, friends discovered that the woman had died. She had apparently used two of the five patches prescribed. According to the ISMP, in addition to using a heating pad with the patch, it is suspected that a second patch was applied without removing the first one.
Too much medication from a fentanyl patch also could be absorbed if a patch is damaged or broken. The effects may also be exaggerated if a person wearing a patch drinks alcohol, or takes other medicines that depress brain function. “As part of its pain-relieving effect, fentanyl also causes brain depression as seen by some sleepiness and sedation,” Stanski says. “This can add to the effects of other drugs like sedatives and tranquilizers.”
Death and other serious problems have occurred because people were accidentally exposed to the fentanyl patch. According to Janssen, a patch was transferred from an adult to a child while hugging. In another case of unintended exposure, someone accidentally sat on a patch.
The ISMP says that a mother reported that her 4-year-old son died after applying the patch to his body. He either used a discarded fentanyl patch or a new one. She found him on the floor near an overturned trash can that contained discarded patches and wrappers.

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