Hundreds of deaths linked to medical malpractice with fentanyl pain patch

Posted
by Jim Orr

Fentanyl is a potent opioid that is 80 to 100 times stronger than morphine. It is in the class of drugs called opioids. Fentanyl can be prescribed outside the hospital in pill, lollypop and patch form. All 3 are being inappropriately prescribed and it is killing hundreds of people. Heygood, Orr & Pearson is the leading law firm in the country bringing claims against doctors who negligently prescribe these fentanyl products.

Fentanyl Patches

The ignorance of doctors when it comes to this drug product is shocking. Fentanyl patches are a drug patch that consist of a backing, fentanyl laced adhesive and a release liner. The release liner is removed and the patch is placed on the body, usually on the arm, shoulder or back. They come in sizes 12, 25, 50, 75 and 100 mcg/hr. The main brands of fentanyl patches are Duragesic, Sandoz, Mylan, Actavis and Watson. The patch is designed to release fentanyl for 3 days and then to be replaced with another patch. Fentanyl patches are approved only for chronic (i.e., long lasting) moderate to severe pain that has not responded to other less potent pain medications. The common mistakes that our firm is seeing doctors commit in prescribing fentanyl patches that cause deaths are:

1) Prescribing them for acute or post operative pain. The full prescribing information that comes with fentanyl patches that is authored by the patch manufacturer and approved by the FDA (the “Package Insert”) clearly states that fentanyl patches should not be used for acute (i.e., short term) pain or post operative pain and that violating this rule can cause death. Doctors routinely violate this rule and cause patient deaths. Our firm has represented the families of patients killed by this common area from patches prescribed after surgery for reflux to patches prescribed after a broken arm to patches prescribed after a hysterectomy. The fact that fentanyl patches should not be prescribed for post operative pain is so important that a warning is about this contraindication is printed on the box in which the patches come.

2) Prescribing fentanyl patches to opioid naïve patients. The package insert for fentanyl patches clearly warns that they should not be prescribed to patients unless they are already opioid tolerant. In fact, they must be taking the equivalent of 60 mg of morphine a day for a week or longer to be a candidate for fentanyl patches. The package insert warns that the consequence of violating this dictate can be death. Despite this clear warning (that is also printed on the box in large type), doctors routinely violate it and cause patients death. Our firm has recently settled numerous wrongful death cases where patients who had never taken any opioids or had only used mild amounts of opioids were prescribed fentanyl patches and died on the first patch.

3) Overestimating the initial dose of fentanyl patches. The package insert states that fentanyl patches are only to be used if less potent pain medications have failed to control the pain at issue. As a result, patients who start fentanyl patch therapy are usually being converted from another opioid pain medication to fentanyl patches. The package insert warns that when this is done, the correct dose has to be carefully selected and that overestimating the initial dose can cause death on the first patch. Despite this clear warning, our firm has routinely seen doctors prescribing fentanyl patches at the larger sizes when only the smaller sizes are justified based on the opioid tolerance of the patient. Our firm has settled numerous wrongful death lawsuits involving this error that cause the patient to die on the first patch.

4) Prescribing fentanyl patches at the same time as other CNS depressant medications. The package insert for fentanyl patches warns that the concomitant use of fentanyl patches with other CNS depressants can cause death. The package insert says that prescribing these medications together has to be done with extreme caution and if it is done, then the dose of one or both agents should be cut in half. Despite this clear warning, our firm has also seen this this warning violated by doctors frequently. In fact, it seems that the majority of doctors seem to ignore this warning, scoffing at the package insert like it as some cya document that warns of nonexistent risks. This could not be further from the truth. The FDA strictly enforces the requirement that all warnings in package inserts be backed up by data that the risk actually occurs. Thus, if a warning about death is in the package insert, that means that people have died from doctors violating that warning.

5) Prescribing fentanyl patches to patients with significant pulmonary problems. The mechanism of death from fentanyl is respiratory depression. The fentanyl blocks the brain’s stimulation of the body to breathe and the patient simply stops breathing and dies. Because of the way fentanyl kills patients, the package inserts warnings that extreme caution should be utilized in prescribing fentanyl patches to patients predisposed to respiratory depression because of pulmonary conditions such as COPD, Asthma or pulmonary fibrosis. Despite this warning, our firm has also seen this warning ignored by many doctors. Our firm has settled numerous wrongful death lawsuits involving doctors that have ignored this warning and killed their patient.

6) Prescribing fentanyl patches at the same time with P450 3A4 inhibitors. The body uses the cytochrome called P450 3A4 to metabolize fentanyl. The problem is that the body uses this same cytochrome to metabolize other medications in addition to fentanyl. If two medications that are metabolized by the same cytochrome are taken together, this can interfere with the body’s ability to metabolize one or both drugs and cause a build up of one or both drugs in the body. As a result, the package insert identifies other drugs that are metabolized by the cytochrome P450 3A4 and warns that they should not be prescribed at the same time as fentanyl. These other drugs are: ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil. Despite these clear instructions, our firm has seen numerous doctors prescribe fentanyl patches with one and sometimes two of these medications resulting in patient deaths.

Fentanyl Pills and Lollipops

Fentanyl is also available in pill (Fentora) and lollypop (Actiq) form. Similar to fentanyl patches, these medications are approved only to treat patients who are opioid tolerant. They cannot be used to treat acute or post operative pain. They should not be used with P450 3A4 inhibitors. The package inserts for these products also warn about using them with other CNS depressant and sedating medications. Similarly, the package inserts warn about using them with patients who suffer from pulmonary conditions or other conditions that my predispose them to respiratory depression. As with fentanyl patches, all these warnings are routinely violated by doctors and patients are dying as a result.

There is another important limitation related to fentanyl pills (Fentora) and lollypops (Actiq). They are only approved only to treat breakthrough pain in cancer patients. Despite this limited approval, doctors prescribe these products for back pain to headaches. These drug products have only been approved for use in cancer patients because that is the only patient population where the benefit of the drug is not outweighed by the risk of death. Fentora and Actiq are commonly prescribed to patients who don’t have cancer and needless patient deaths are the consequence.

Heygood, Orr & Pearson

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. In addition to our experience and expertise specific to fentanyl, our firm employs only the best and brightest attorneys. We are as comfortable in the courtroom as we are writing complicated legal briefs. We enjoy only the highest reputation with opposing counsel and the court.

If you have lost a loved one due to a fentanyl product, contact our firm for a free consultation. You can reach us by calling toll-free at 1-877-446-9001, or by filling out our free online contact form.