Fentanyl Pain Patch Lawyers
Robinson Calcagnie Robinson Shapiro Davis, Inc. (RCRSD) has handled numerous lawsuits against manufacturers of time-release fentanyl patches for making defective products and failing to adequately warn patients of the dangers their products possess. Several cases involve patch malfunctions which cause patients to absorb an excessive amount of fentanyl, resulting in life-threatening side effects including death.
Do You Have a Potential Fentanyl Patch Lawsuit?
The defective medical devices litigation lawyers at RCRSD are experienced trial lawyers who focus on representing plaintiffs in fentanyl-related litigation. If you or a family member has suffered serious injury, coma or death stemming from the use of a fentanyl patch, contact the personal injury attorneys at RCRSD today to schedule an appointment.
Pain patch manufacturers include Janssen Pharmaceutica Products, L.P., Alza Corporation, Actavis South Atlantic, LLC., Sandoz, and Cephalon, Inc. Although many manufacturers of fentanyl transdermal pain patches have voluntarily recalled various lots of their patches, and the Food and Drug Administration (FDA) has issued Public Health Advisories related to the fentanyl patch dangers, defective patches are still on the market today.
Fentanyl patch manufacturers are finally being brought to justice for the damage their defective products have inflicted on consumers. 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 lawsuit was brought by the family of Adam Hendleson, a 28-year-old Florida man who died while wearing a fentanyl transdermal pain patch. This case – the first federal trial involving a fentanyl patch – was tried in the Federal District Court for the Southern District of Florida, West Palm Beach Division, by Jim Orr, RCRSD’s Fentanyl litigation co-counsel. On November 17, 2008, Orr successfully handled another case against the same manufacturers in a Cook County Circuit Court, winning a $16.5 million jury verdict for the family of 38-year-old Janice DiCosolo, a mother of three who died while wearing the patch in 2004.
Autopsy reports of Fentanyl patch users will often note the cause of death as “Fentanyl Toxicity.” Fentanyl toxicity is an overdose of Fentanyl in the body whether by accident, intentional abuse or misuse, or from exposure to a defective transdermal Fentanyl patch releasing excessive amounts of Fentanyl and resulting in toxic levels that induce fentanyl death.
Possible signs and symptoms of Fentanyl toxicity vary from patient to patient depending on the dosage, size of the patient, other drugs or medicines being prescribed, and other medical issues. An overdose of Fentanyl can be fatal or result in serious life threatening-symptoms including hypoventilation (the slowing or stopping of breathing), cold or discolored skin, low blood pressure, pinpoint pupils of the eyes, or a slow or weakened heartbeat. The likelihood of a Fentanyl overdose increases when it is combined with narcotics such as oxicodone or other medicines.
Pain Patch Advisory Information
Duragesic’s black box warning advises that the drug should not be used to manage acute postoperative pain, including pain after outpatient surgery, or for mild or intermittent chronic pain that can be managed with less powerful drugs, at a dose higher than 25 micrograms per hour, by children under age 12, or by patients under age 18 who weigh less than 110 lbs. Fentanyl patches should not be used in concert with other opioid analgesics such as oxycodone (OxyContin) or oxymorphone (Roxicet, Numorphan).
The FDA is conducting an investigation into several deaths associated with Fentanyl transdermal patches. The agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use.
Side effects of the Duragesic patch include nausea, vomiting, constipation, drowsiness, weakness, dry mouth, hypotension, and loss of appetite. Users are warned to avoid exposure to external heat sources such as heating pads and electric blankets, hot tubs, heated water beds, heat lamps, etc., because of a potential for temperature-dependent increases in Fentanyl release that may lead to an overdose.
Handling a Fentanyl Patch Lawsuit
Fentanyl patch lawsuits are lengthy and difficult endeavors that require a tremendous amount of investigation and work. A law firm must navigate several strict filing rules, including state or federal deadlines, in addition to determining which pharmaceutical companies, patch manufacturers, healthcare providers or companies in the distribution chain should bear responsibility for contributing to the death or injury. RCRSD evaluates every lawsuit on an individual basis before determining whether the firm will represent a plaintiff. This evaluation may include reviewing medical records from prescribing doctors, hospitals, pharmacies and the Offices of the City or County Medical Examiner, and speaking with key witnesses near the victim at or near the time of their death or injury. Upon a favorable review of this information by our team of medical experts and attorneys, clients will be retained and a product liability lawsuit will be filed against all defendants responsible for the client’s damages.
History of the Fentanyl Pain Patches
Fentanyl (Duragesic, Durogesic, Actiq, Fentora, Sublimaze (fentanyl citrate) is a synthetic primary μ agonist opioid commonly used to treat post-operative and chronic breakthrough pain. Fentanyl’s potency is approximately 81 times that of morphine, and has an LD50 of 3.1 milligrams per kilogram in rats, 0.03 milligrams per kilogram in monkeys, and an as of yet undetermined LD50 among humans. It was first synthesized by Dr. Paul Janssen in 1959 following the medical inception of meperidine several years earlier, and based initially on the chemical starting point of piperidine and applicable opioid activity. Fentanyl first saw widespread clinical use with the production of fentanyl citrate, which entered the clinical practice as a general anesthetic under the trade name Sublimaze in the 1960s. Following this, many other Fentanyl analogs have been developed and introduced into the medical practice, including alfentanil and remifentanil.
In the mid 1990s, Fentanyl saw its first widespread palliative use with the clinical introduction of the DURAGESIC® patch. In the next decade, the first quick-acting prescription formations of Fentanyl for personal use were introduced with the Actiq lollipop and Fentora buccal tablets. Through the delivery method of transdermal patches, Fentanyl is currently the most widely, clinically-used synthetic opioid, with several new delivery methods currently in development. Additionally, Fentanyl is classified as a Schedule II drug under Title II of the U.S. Comprehensive Drug Abuse Prevention and Control Act of 1970.
In February 2004, Janssen and the FDA notified healthcare professionals of a Class I recall of DURAGESIC® 75 mcg/h. Only Control Number 0327192 (expiration October 2005) was subject to this recall. A potential seal breach on one edge may allow the drug to leak from the patch and could result in an increased absorption of the opioid component, Fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness and potentially life threatening complications. Over 400,000 patches were included in the initial recall.
In July 2005, the FDA issued a Public Health Advisory regarding the safe use of transdermal Fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management. In addition, a patient information sheet and an alert to healthcare professionals were issued identifying several important safety precautions for the use of Fentanyl transdermal patches. These safety precautions include but are not limited to patient education regarding signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage, and disposal.
In 2007, the Institute for Safe Medication Practices and the Division of Public Health Sciences at the Wake Forest University School of Medicine, conducted a longitudinal Adverse Events Reporting System Review of the U.S. FDA’s most dangerous drugs. The study revealed Fentanyl to be the second most dangerous drug available on the market with the second highest number of suspect drug deaths. Over the eight years of the study, fentanyl was involved in no fewer than 3,500 suspect drug deaths during the 8-year period.
In February 2008, Johnson & Johnson recalled lots of DURAGESIC® patches manufactured by its subsidiaries. First, the FDA announced on February 12, 2008, that PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., would recall all lots of 25 mcg DURAGESIC® (fentanyl transdermal system) patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. The patches may have a cut edge that could lead to the Fentanyl gel leaking out, and a potential for overdose. The recalled fentanyl patches were sold by Sandoz and Pricara in the U.S. and Canada. Then, on February 17, 2008, Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, announced that 14 lots of its Fentanyl transdermal system CII patches sold in the United States by Actavis’ subsidiary Actavis South Atlantic LLC, would be voluntarily recalled from wholesalers and pharmacies.
On August 8, 2008, Watson Pharmaceuticals, Inc. announced that its 75 mcg/hr fentanyl transdermal patches would be recalled from wholesalers and pharmacies. [The recalled patches are from Lot Number 92461850, have expiration dates of August 31, 2009, and were manufactured by Watson Laboratories, Inc. The affected lot of Fentanyl Transdermal System patches was shipped to customers between January 30, 2008, and March 19, 2008.]
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Note: If you believe you have a potential Fentanyl patch lawsuit, keep any and all patches that are still in your possession. Do not return or destroy any patches.