Defective Fentanyl Pain Relief Patches have caused countless preventable deaths.
What is Fentanyl?
Fentanyl is a synthetic opioid that is the strongest pain medication on the prescription market today – 100 times more potent than morphine. Fentanyl is classified by the Drug Enforcement Agency as a Schedule II drug which means that any prescription for the drug must be written in triplicate form, with one copy retained by the physician, one by the pharmacy and one copy is sent to the health department of the state in which the prescription was written. Because of its powerful pain killing abilities, Fentanyl is commonly included in the array of drugs used to induce anesthesia for surgery. Fentanyl was first synthesized by Dr. Paul Janssen in 1960 and, since that time, has been delivered to patients through injection, IV, tablets, lollipop and a drug patch.
What is a Fentanyl Patch?
A Fentanyl 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 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.
Risks Associated with the Fentanyl Patch
When a Fentanyl patch is not manufactured to exact standards it can leak onto a patient’s skin. When a Fentanyl pain patch leaks, it can exponentially increase the amount of Fentanyl that is introduced into a patient’s bloodstream. This increased Fentanyl level often results in the death of the patient wearing the leaking Fentanyl patch.
Several manufacturers of the Fentanyl pain patch fail to utilize state-of-the-art multi-laminate designs for their Fentanyl patches which make them more susceptible to malfunctioning, in turn allowing the person wearing such patch to receive a lethal dose of Fentanyl.
According to the package insert that accompanies every Fentanyl patch, the patch is intended to produce a certain level of Fentanyl in the patient’s blood. In this package insert appears the following table:
The second column labeled as “Mean (SD) Maximal Concentration Cmax” sets forth the maximum blood concentration each size patch is intended to produce. If the patch fails and produces a higher concentration, then it has not performed as designed and is defective.
The FDA has received hundreds of reports of fatalities linked to the use of Fentanyl patches. These fatalities can and have been attributed to a myriad of problems with the patches, including
- seal breaches in patches that allow Fentanyl gel to leak from an unsealed channel in the patch (often referred to as a “stringer leaker”),
- seal breaches where an entire side of the patch was not sealed during the manufacturing process,
- seal breaches that were caused by improper manufacturing processes (often called the “fold-over defect”) and
- a variety of other manufacturing and design defects.
Leaking Fentanyl can result in fatal overdoses not only for patients but also for medical care providers working with and administering Fentanyl.
Fentanyl Injuries
An overdose of Fentanyl can be lethal. When a Fentanyl patch leaks or is defective in some way and delivers an uncontrolled and unintended amount of Fentanyl to a patient, death is almost certain to occur. When Fentanyl comes into direct contact with a person’s skin, often as a result of a leaky patch, it is likely to cause a fatal overdose of Fentanyl.
Once an overdose of Fentanyl occurs, a person will begin to experience impaired breathing and respiratory depression, which, if not treated immediately, leads to death. Signs of an overdose from a defective Fentanyl patch often include:
- Difficulty in breathing
- Shallow breathing
- Extreme sleepiness/sedation
- Inability to walk or talk normally
- Faint, dizzy or confused feelings
Brands of Fentanyl Pain Patches
Fentanyl pain patches are sold under many brand names including:
- Duragesic (brand name)
- Avtavis (generic)
- Abreka (generic)
- Mylan (generic)
- Sandoz (generic)
- Watson (generic)
Warnings and Recalls of Fentanyl
Over the past 10 years, Fentanyl patch manufacturers under the FDA’s supervision have recalled millions of defective Fentanyl pain patches. Each time, the FDA ensured that public warnings were issued to warn health care providers and the public at large that using a defective Fentanyl pain patch could cause life-threatening consequences.
In February 2004, Janssen Pharmaceutica Products, LP issued a Class I Recall for one lot of the Duragesic Fentanyl transdermal pain patch. This recall was initiated because a potential seal breach on one edge of the patch (known as a “fold-over defect”) could allow a leak of Fentanyl gel. Janssen estimated that up to 19,000 of the Fentanyl patches in this recall might leak Fentanyl gel.
During the investigation into these recalled patches, the FDA found extensive manufacturing defects in addition to the “fold-over defects,” including the “stringer leaker” defect, “cut corners” in the patches, “bubbles in the seal” and holes in Fentanyl patches. Based upon this investigation, it is clear that millions of additional patches were manufactured in other batches that were not recalled but nonetheless contained Fentanyl patches that suffered from leak defects.
According to Janssen (a Johnson & Johnson subsidiary) during the February 2004 recall, exposure to the gel from a Duragesic Fentanyl patch “could result in an increased absorption of the opioid component, Fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, or potentially life threatening complications.”
On April 2004, Janssen expanded the February 2004 recall of defective Fentanyl patches to include more than one million additional Duragesic patches.
In 2005, the FDA issued an additional warning to the public regarding the dangers and risks associated with the Fentanyl patches. The advisory contained information about recognizing the signs of an overdose, proper patch application, drug interactions, safeguards for children, and correct storage and disposal of the patch.
In December 2007, another FDA safety warning was issued, this time directed at incorrect prescribing of Fentanyl by doctors. It stated, “Reports indicate that doctors have inappropriately prescribed the Fentanyl patch to patients for acute pain following surgery, for headaches, occasional or mild pain, and other indications for which a Fentanyl patch should not be prescribed.”
In February 2008, Johnson & Johnson was again forced to recall additional defective Duragesic Fentanyl patches. This time they recalled approximately 32 million patches due to possible leak defects. Included in this recall were millions of Fentanyl patches sold by Sandoz, Inc. (a generic brand of Fentanyl patches) because of the possibility of a cut along one side of the drug reservoir within the patch. In their press release related to this latest recall, the sellers of the Duragesic and Sandoz patches again warned that these defective patches could cause “respiratory depression and possible overdose, which may be fatal.”
In February 2008, the international generic pharmaceutical company Actavis Group HF announced that millions of Actavis Fentanyl patches were being recalled from wholesalers and pharmacies because of concerns in the manufacturing process.
In March 2008, Actavis broadened its February 2008 recall to include all remaining lots of its transdermal Fentanyl patches.
In March 2008, the first recall of Watson Fentanyl patches occurred. According to the FDA, Watson Fentanyl patch Lot Number 92461681 was recalled because it was “super potent.”
In August 2008, a second Watson Fentanyl patch recall was announced in a press release by Watson Pharmaceuticals, Inc. In connection with this Fentanyl patch recall, Watson notified the U.S. Food and Drug Administration (FDA) that Fentanyl patches from Lot Number 92461850 were leaking Fentanyl gel, which could lead to potentially fatal respiratory depression and overdose for the patients using those patches.
In December 2008, additional Duragesic Sandoz Fentanyl patches were recalled. Once again, a problem in the manufacturing process led to patches that may have a cut in the pouch exposing the patients directly to the dangerous Fentanyl gel. The companies cautioned that, if used, the defective patches could cause a fatal overdose.
In August 2009, Watson Pharmaceuticals, Inc. announced another recall of Watson Fentanyl patches — this time of all Fentanyl patches from Lot Number 145287A that were manufactured by Watson Laboratories, Inc. and distributed by Watson Pharma, Inc. According to Watson’s press release, patches that leaked Fentanyl gel “have been detected in this lot, potentially exposing patients or caregivers directly to Fentanyl gel.” Watson Pharmaceuticals, Inc. further explained that “exposure to Fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.”
In October 2010, an additional recall of millions of Actavis Fentanyl patches was announced by Actavis.
In November 2010, an additional recall of Watson Fentanyl patches was announced for Lot Number 264085A. These Fentanyl patches were recalled by Watson because they suffered from a miscalibrated and/or defective delivery system.
Fentanyl Litigation at Heygood, Orr & Pearson
Heygood, Orr & Pearson is the leading law firm in the United States representing family members in lawsuits against the makers and distributors of defective Fentanyl pain patches. Heygood, Orr & Pearson represents more families who have lost a loved one from a defective Fentanyl patch and tried more lawsuits against the manufacturers of defective pain patches than all other lawyers in the country combined. The lawyers at Heygood, Orr & Pearson have also settled more cases against the manufacturers of defective patches throughout the United States than all other lawyers across the country combined.
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, 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.”
In connection with the hundreds of Fentanyl pain patch cases filed by Heygood, Orr & Pearson on behalf of their clients, the attorneys at the firm have examined under oath hundreds of drug company executives, scientists, engineers, physicians and manufacturing workers – sometimes repeatedly. Heygood, Orr & Pearson has also retained the best expert witnesses in the country in the areas of toxicology, pathology, pharmaceutical manufacturing and patch technology. In addition, Heygood, Orr & Pearson has obtained millions of pages of documents from the drug companies related to Fentanyl patches, which have been reviewed, analyzed and catalogued. In doing so, Heygood, Orr & Pearson has amassed by far the most extensive library and collection of documents and depositions related to Fentanyl patches in existence. In many ways, the documents and depositions in the Heygood, Orr & Pearson Fentanyl library is more extensive than any in the possession of the pharmaceutical companies.
The lawyers at Heygood, Orr & Pearson achieve the highest compensation possible for families who lost a loved one due to a defective Fentanyl patch. On behalf of families across the United States, Heygood, Orr & Pearson is actively pursuing cases and lawsuits against the manufacturers of all Fentanyl patches such as Duragesic, Actavis, Mylan, Sandoz and Watson.
What You Can Do
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, and if the loss was as a result of a defective Fentanyl patch, to demand that the drug company be held responsible. Contact us for a free consultation so we can help you determine the best way to protect your legal rights and interests and hold the drug companies responsible for your preventable and unnecessary loss.
