An 18-year-old college -bound woman was given a prescription for a fentanyl patch and died less than 24 hours after a tonsillectomy. A 15-year-old died after being given the patch for pain associated with dental surgery.
“The sad thing is that these cases are just a few of hundreds of similar tragedies with this drug,” noted Michael Cohen of the Institute for Safe Medication Practices in his piece Doctors risk patient safety by prescribing fentanyl painkiller for short-term pain.*
Fentanyl is an opioid analgesic, a pain medication similar to Morphine but approximately 100 times stronger. It is a controlled substance and requires a prescription from your doctor.
Fentanyl is frequently used after surgery. However, Fentanyl is available in a variety of forms, and the different forms of Fentanyl are for different patients at different times under different circumstances.
In the hospital, Fentanyl is most commonly given as an IV injection or an IV drip. The drug can also be given with a PCA (Patient Controlled Analgesia) pump, where the patient presses a button to have a small dose of pain medication delivered through their IV.
For patients taking Fentanyl at home, the most common form of Fentanyl is the transdermal patch. The Fentanyl transdermal system patch contains a high concentration of Fentanyl, a very potent Schedule II opioid.
A transdermal patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the bloodstream. Fentanyl patches work by releasing fentanyl into body fats, which then slowly release the drug into the bloodstream over 48 to 72 hours. Dosage is based on the size of the patch, since the transdermal absorption rate is generally constant at a constant skin temperature.
The brand name Fentanyl Transdermal System patch is called Duragesic. In generic form, Fentanyl Extended Release Transdermal System patches are made by Actavis, Lavipharm, Mylan, Teva Pharmaceuticals and Watson.
The patches are only to be used for chronic pain (and, even then, only in certain patients who meet specific requirements). The Fentanyl patch is for patients who need continuous, around-the-clock narcotic (opioid) pain relief and whose pain cannot be managed by other pain medicines. Fentanyl patches should only be used by patients who have already been taking other narcotic pain medicine on a regular schedule and are tolerant to its effects. Thus, for example, the patch can be appropriate for the kind of pain that cancer patients may experience.
The Fentanyl patch is not for acute pain management requiring short-term opioids. Similarly, the patch is not for mild pain management and intermittent or “as needed” pain management. Furthermore, the Fentanyl patch is also not for post-operative pain management, including outpatient or day surgeries.
According to the ISMP’s Cohen, “Unfortunately, even though there is a boxed warning and clear label instructions not to use the drug in patients with acute postoperative pain, we frequently learn about cases where the warnings were ignored by doctors when prescribing the drug.”*
What can go wrong when the wrong patient is given the Fentanyl patch? Death. A “black box warning” set out in the prescribing information insert that accompanies the fentanyl patch includes the following warning to health care professionals:
Respiratory Depression and Death
Respiratory depression and death may occur with use of DURAGESIC, even when DURAGESIC has been used as recommended and not misused or abused.
DURAGESIC is contraindicated for […] acute pain, and postoperative pain.
A “black box warning” means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. It is the strongest alert the FDA can require.
Elsewhere, the prescribing information insert repeats such warnings:
DURAGESIC is contraindicated in the following patients and situations due to the risk of fatal respiratory depression: […]
• in the management of acute or intermittent pain, or in patients who require opioid analgesia for a short period of time.
Respiratory Depression and Death
Respiratory depression is the chief hazard of DURAGESIC. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death.
DURAGESIC has a narrow indication and should be prescribed only by healthcare professionals who are knowledgeable in the administration of potent opioids and management of chronic pain […].
DURAGESIC is contraindicated for […] acute pain, and postoperative pain
Despite all of these warnings, the ignorance of doctors when it comes to fentanyl is shocking. One of the mistakes that our law firm continues to see doctors commit in prescribing fentanyl patches that cause deaths is prescribing the patch for acute or postoperative pain. Other doctors have prescribed the patch for patients who are opioid naïve, have prescribed higher dosages than appropriate and have prescribed the patch in conjunction with other sedating medications. In each instance, their patient died.
Heygood, Orr & Pearson has successfully prosecuted more cases involving deaths due to fentanyl products than all the other firms in the country combined. We have spent years studying fentanyl, its uses and its misuses. We have deposed hundreds of doctors, scientists and experts on the subject of fentanyl products.
If you or a loved one has experienced the tragedy of losing a family member as a result of Fentanyl pain patch usage, you and your family deserve answers to your questions. If the loss was as a result of a prescribing error, you have the right to demand that the responsible healthcare provider be held accountable. Contact us for a free consultation so we can help you determine the best way to protect your legal rights and interests.
To receive a free legal consultation and find out if you are eligible to file a case, please call our toll-free number at 1-877-446-9001, or by filling out our free case evaluation form located on this page.