A fentanyl pain patch is a drug patch similar to the patch that most people are familiar with, Nicoderm. However, instead of delivering a smoking cessation drug, a fentanyl patch delivers a powerful opioid pain medication called fentanyl.
Fentanyl is an extremely powerful narcotic that is 80 to 100 times stronger than morphine. Fentanyl patches are intended for persistent, moderate to severe chronic pain. Fentanyl patches were first approved by the Food and Drug Administration (FDA) in 1990 and are only approved to treat persistent, chronic pain that has not responded to less potent pain medications. Furthermore, a patient must be tolerant to opioids in order to be a candidate for fentanyl patch therapy.
Each fentanyl patch is to be worn for three days, during which time the patch is intended to release the drug in a constant and even amount. When a patch is applied, the skin under the system absorbs the fentanyl, and a depot of fentanyl is created in the upper skin layers.
The fentanyl in these skin layers then becomes available for absorption into the blood. Peak blood levels of fentanyl typically occur 24 to 72 hours after initial patch application and are intended to reach a steady state with continuous use. The size of the patch determines the dose it delivers.
Patients at Risk of a Fentanyl Overdose
Unfortunately, fentanyl patches have killed thousands of patients by causing fatal respiratory depression. One way that fentanyl patches kill people is by malfunctioning and dispensing too much fentanyl. Our firm has represented hundreds of families who have had a loved one die while using a defective fentanyl patch.
But defective patches are not the only danger associated with fentanyl. Doctor negligence is also a factor in many fentanyl deaths. Fentanyl deaths caused by doctor negligence have become such a significant problem that the FDA has issued public health advisories to alert doctors about the dangers of deaths and life-threatening side effects caused by inappropriately prescribed fentanyl patches.
Here are some of the most common examples of doctor negligence in prescribing the patch:
Prescribing a fentanyl patch for acute pain or post-surgical pain
Fentanyl patches should never be used for acute pain or post-operative pain. The danger of using fentanyl patches in this way is so significant that that the prescribing information for the patch contains a “black-box” warning to physicians that prescribing fentanyl patches to patients for acute or post-surgical pain can cause life-threatening respiratory depression. To put it more simply, prescribing fentanyl patches for acute or post-surgical pain can kill patients.
This contraindication is based on the fact that acute pain is inherently unstable, with the severity changing frequently throughout the day. A long-acting opioid does not match the fluctuations of acute pain, and can cause respiratory depression during the less-painful periods. This mismatching of pain severity with opioid dose is most significant with the fentanyl patch due to its slow rise in blood concentration (it reaches its peak concentration 33.5 hours after initial application, according to the prescribing information).
Prescribing fentanyl patches to patients for acute or post-surgical pain is also dangerous because many patients with acute or post-surgical pain do not have sufficient tolerance to opioids for fentanyl patches to be a safe medication. That issue is discussed in more detail below.
Prescribing fentanyl to opioid naïve or opioid intolerant patients
Fentanyl patches should not be prescribed to patients who are opioid naïve (who are not already using narcotic pain medicine) or to patients who have insufficient tolerance to opioids (whose dose of narcotic pain medicine is too low for the fentanyl dose prescribed). Prescribing fentanyl patches to patients who are opioid naïve or who have insufficient tolerance to opioids can and does kill patients by causing fatal respiratory depression.
The prescribing information for the patch contains multiple “black box” warnings to physicians about this danger:
Because serious or life-threatening hypoventilation could occur, DURAGESIC® (fentanyl transdermal system) is contraindicated: in patients who are not opioid-tolerant.
DURAGESIC® is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid tolerant patients may lead to fatal respiratory depression. Overestimating the DURAGESIC® dose when converting patients from another opioid medication can result in fatal overdose with the first dose.
The prescribing information includes a dose conversion guideline for doctors to use to assess a patient’s tolerance to opioids (based on the narcotic pain medicine they are already taking) and select the appropriate fentanyl dose.
Sadly, far too many doctors ignore these warnings and dosage guidelines and prescribe fentanyl for patients with insufficient opioid tolerance, often with tragic results. We hear the same sad story time and time again: a patient’s doctor prescribes fentanyl for a patient who is not already on narcotic pain medicine or prescribes too high a fentanyl dose for them and the patient dies shortly thereafter.
Prescribing fentanyl patches with other drugs that cause respiratory depression
Another common mistake that doctors make is failing to take appropriate precautions when prescribing fentanyl to patients who are taking other drugs that can cause respiratory depression. Fentanyl belongs to a class of drugs call central nervous system depressants (commonly called CNS depressants). Patients who are prescribed fentanyl patches are often taking other medications (such as other narcotic pain medications, antidepressants, and tranquilizers) that can depress the central nervous system. The prescribing information warns doctors of the need to significantly reduce the dose of at least one of the CNS depressants:
The concomitant use of DURAGESIC® (fentanyl transdermal system) with other central nervous system depressants, including but not limited to other opioids, sedatives, hypnotics, tranquilizers (e.g., benzodiazepines), general anesthetics, phenothiazines, skeletal muscle relaxants, and alcohol, may cause respiratory depression, hypotension, and profound sedation or potentially result in coma.
When such combined therapy is contemplated, the dose of one or both agents should be significantly reduced. Doctors often fail to follow this advice, leading to many patient deaths from combined drug toxicity.
Fentanyl Pain Patch Lawsuits Filed by Heygood, Orr & Pearson
In the very first jury trial by the lawyers of Heygood, Orr & Pearson against makers of a fentanyl transdermal pain patch, a Florida jury awarded a $5.5 million verdict to the family of Adam Hendleson, a man who died while wearing a Duragesic fentanyl pain patch. Jim Orr, partner at Heygood, Orr & Pearson and lead trial attorney in the Hendelson case told the New York Times, “Tests showed that Adam had three times the lethal dose of fentanyl in his system at the time of his death.”
More recently, Heygood, Orr & Pearson obtained a $16,560,000 judgment for the family of a Cicero, Illinois woman who died while wearing a Duragesic fentanyl transdermal pain patch. After a three-week trial, a Chicago jury found two Johnson & Johnson subsidiaries liable for the death of 38-year-old Janice DiCosolo, a mother of three. Mrs. DiCosolo died as a result of using a defective Duragesic patch that her doctor had prescribed to alleviate the intense pain she experienced from a neurological condition called reflex sympathetic dystrophy.
Michael Heygood, a partner at Heygood, Orr & Pearson and trial attorney in the Dicosolo case, stated after the trial, “Janice Dicosolo is dead because the companies that made her fentanyl patch refused to put the health, safety and welfare of their customers ahead of their corporate greed. It is gratifying when a jury listens and makes a decision based upon the evidence and not upon unsupported arguments by a company refusing to take responsibility for their action.”
Loved One Hurt by Fentanyl? Our Law Firm Can Help.
If your family member or loved one suffered an overdose caused by the fentanyl, you may qualify to file a lawsuit against a manufacturer of fentanyl products, doctors who prescribed the drug, or pharmacies or distributors who filled the prescription. The first step in taking legal action is to contact an attorney to learn more about whether you may qualify to file a case.
The lawyers at Heygood, Orr & Pearson have filed lawsuits on behalf of victims of opioid overdoses, including fentanyl. In fact, our firm has handled more lawsuits involving fentanyl than all other law firms in the country combined.
For more information about filing a fentanyl lawsuit and to find out if you qualify to file a case, contact the lawyers at Heygood, Orr & Pearson for a free legal consultation. You can reach us by calling toll-free at 1-877-446-9001, or by following the link to our free fentanyl case evaluation form.