FENTANYL PATCH UPDATE: AUGUST 27, 2009 - Following years of litigation and FDA scrutiny, a subsidiary of Johnson & Johnson, Ortho-McNeil, has removed the reservoir Duragesic fentanyl patch from the market. Duragesic is one of J&J's top-selling drugs with more than $2 billion in sales in 2005 alone. However, the reservoir design can cause leaks which has led to numerous recalls. Fentanyl is 100 times more potent than morphine and therefore a leaking patch can be fatal. Our Fentanyl Patch Litigation Team has successfully prosecuted wrongful death cases throughout the entire United States representing the families whose loved ones have died as a result of leaking Duragesic reservoir patches. The FDA has investigated more than 120 deaths that may have been caused by the dangerous patch. After nineteen years of marketing and selling the reservoir design to the general public, J&J has replaced the reservoir patch design with a "new" design that they allege does not leak. However, Johnson & Johnson's "new design" is not new. Johnson & Johnson has been using the matrix technology in Europe for years. Additionally, generic manufacturers of the fentanyl patch have been using the matrix technology in the United States for years. If you suspect that a loved one may have died due to a leaking fentanyl patch, recalled or otherwise, contact our firm immediately to speak with a member of our Fentanyl Patch Litigation Team.

History of Recalls August 7, 2009 - Watson Pharmaceuticals has recalled one lot of 100 mcg/hr Fentanyl Transdermal System patches with the lot number 145287A. A number of patches leaking Fentanyl have been found in this lot that was shipped to consumers between April 2, 2009 and May 20, 2009. Direct contact with Fentanyl gel from a leaking patch can cause serious injury or death. The recalled patches have expiration dates of February 2011 and were manufactured by Watson Laboratories, Inc. and distributed by Watson Pharma, Inc.

December 31, 2008 - Pricara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has recalled one lot of 50mcg/hr DURAGESIC® fentanyl patches with the lot number 0817239 and one lot of fentanyl patches sold by Sandoz Inc. with the lot number 0816851. Due to a manufacturing defect these lots may have a "cut" along one side of the patch. The result is a possible release of fentanyl gel from the patch, exposing patients or caregivers directly to the fentanyl gel causing serious injury or death.

On February 17, 2004, Janssen Pharmaceutica Products LP ("Janssen") issued, with the approval of the U.S. Food & Drug Administration (FDA) a Class I Recall of all units of its 75mcg/hr Duragesic™ product bearing a specific lot number. Later on April 5, 2004, Janssen issued another urgent recall to include additional lot numbers that also may have contained defective Duragesic™ patches. That product is manufactured for Janssen by Alza Corporation ("alza"). Both Janssen and Alza are wholly owned subsidiary companies of Johnson & Johnson.

Duragesic™, known as a "pain patch," is an adhesive patch applied to the to the skin which is intended to deliver a steady dose of a powerful opioid pain medication (fentanyl) through the skin over an extended time to persons suffering from chronic and/or debilitating pain. The recall itself applies only to specific manufacturing lots of the 75mcg strength product, which (according to recall notices) were designed with a faulty seal which permits full strength fentanyl to leak from the patch delivery system.

If the leakage occurs while the patch is on the skin, patients are potentially caused to suffer an overdose of fentanyl which can result in fatal respiratory and/or cardiac arrest or other, serious physical reactions. The Duragesic™ Patch litigation in which Eisenberg, Rothweiler, Winkler, Eisenberg & Jeck PC has taken a leading role, involves recalled patches and other Duragesic patches that are suspected of leaking fentanyl leading to the death of our clients due to "fentanyl toxicity."

About Duragesic

The Duragesic pain patch contains as its active ingredient the potent narcotic fentanyl, which, like other narcotics, is highly addictive. The fentanyl is delivered through the transdermal Duragesic patch in a continuous dose over a three-day period to help manage moderate to severe chronic pain that is unresponsive to other painkillers or that requires round the clock treatment.

Duragesic is one of Johnson & Johnson’s top-selling drugs with more than 80 million patches sold each year. In 2005 alone, it brought in nearly $2 billion in sales. It was in 2004 that the FDA began to question the safety of the popular pain patch.

Janssen, a subsidiary of Johnson & Johnson, began marketing the Duragesic pain patch more than 15 years ago. Over the years, the company has made numerous claims about the safety of the patch, including the relatively low risk of abuse and harmful side effects. Such claims were patently overstated, according the FDA.

Duragesic and the FDA

In addition to the 2004 recall of millions of Duragesic patches mentioned above, in June 2005, doctors began receiving warning letters from the Johnson & Johnson subsidiary that manufactures the Duragesic patch. The letters warned that a number of individuals accidentally exposed to Duragesic—either by touching or sitting on the patches—suffered serious medical problems including death.

One month later in July, the FDA announced that it was looking into reports of serious Duragesic side effects, including 120 deaths. The agency specifically warned of the risk of fentanyl overdose with the Duragesic patch, stating that alcohol, heat, and certain medications all increase the risk of overdose.

The FDA also warned of other dangers associated with the pain patch, including depressed respiratory functioning, low blood pressure, coma, addiction and withdrawal.

Duragesic Trials

In one of the most recent lawsuits to go to trial, Johnson & Johnson was ordered to pay $5.5 million in damages. The jury deemed Duragesic responsible for the death of a man who died after a defective patch released a lethal dose of fentanyl into his system. At least 100 other Duragesic lawsuits are currently awaiting trial.

If you or a loved one has suffered serious injury because of the Duragesic pain patch, it is important to ensure that your legal rights are protected. You may be eligible to seek compensation for your losses, including medical expenses, pain and suffering, and more. Please contact us today for a FREE consultation with one of our caring and competent personal injury lawyers who can help you seek the justice you deserve.

Duragesic Side Effects

Overdose

The most dangerous Duragesic Patch side effect is fentanyl overdose, which occurs upon the rapid release of the drug into the body. Factors that can cause the rapid release of fentanyl and lead to a potential overdose include heat, inappropriate use, and patch defects.

The U.S. Food and Drug Administration is currently investigating 120 deaths attributed to Duragesic overdoses. Juries across the country have found the maker of the patch, Johnson & Johnson, liable for the death of those that suffered a fentanyl overdose because of a defective Duragesic patch.

Withdrawal & Other Duragesic Patch Side Effects

Since the Duragesic patch contains a very powerful narcotic (80 times more potent than morphine), its use can cause both physical and psychological dependency in a short period of time. When a patient becomes dependent on the drug, they may suffer severe withdrawals when they stop taking it. Some of the symptoms of Duragesic withdrawal include:

• Anxiety
• Severe depression
• Tremors
• Abdominal cramps
• Mood swings

Other serious, potentially life threatening Duragesic patch side effects include heart arrhythmia, impaired breathing, low blood pressure, and coma. The risk of experiencing these dangerous Duragesic patch side effects increases when the patch is used in combination with other drugs that affect the nervous system, such as muscle relaxants, sleep aids, antipsychotics, and other narcotic painkillers.

Duragesic Alternatives

The Duragesic pain patch has raised concerns among Food and Drug Administration officials and experts in the medical community since studies linked the drug to at least 120 deaths. With the potent narcotic fentanyl as its active ingredient, the Duragesic patch is widely prescribed to treat chronic pain. Despite its benefits, the patch carries significant risks, which include fentanyl overdose and even death.

If you or a loved one is using the fentanyl patch to manage chronic pain, you should know that there are Duragesic alternatives that can help you manage your pain safely and effectively without the risks.

• Local anesthetic injections can be injected into muscles and joints as well as the area around nerve roots to alleviate certain factors that cause pain, such as muscle spasms, swelling, and abnormal nerve activity.
• Physical and aquatic therapy can be individually tailored to help enhance daily functioning and also mitigate pain with whirlpool treatments and various types of massage.
• Electrical Stimulation is a Duragesic alternative that uses transcutaneous electrical nerve stimulation (TENS) to manage pain. TENS is a non-painful treatment that decreases pain by targeting nerve fibers with a small, battery-powered device.
• Acupuncture is an ancient Chinese practice involving the insertion of very fine needles into precise points on the body. Many acupuncturists have specialized training in the area of pain management.
• Surgery is often a last resort option for treating pain, since it carries its own risks. However, when pain is severe and unresponsive to other procedures and treatments, surgery may be performed on certain nerves to provide the patient with some relief. Psychological support from a trained professional is sometimes essential for dealing with the emotional and physical effects of chronic pain. Oftentimes, severe and persistent pain can leave a person feeling sad and hopeless, which in turn can interfere with work and personal relationships. A psychologist or psychiatrist can provide information on self-help therapies, including relaxation techniques, biofeedback, and more.
• To learn more about the Duragesic alternatives best for you, it is important to contact a physician skilled in pain management.

If you or a loved one has suffered serious injury because of the Duragesic pain patch, it is important to ensure that your legal rights are protected. You may be eligible to seek compensation for your losses, including medical expenses, pain and suffering, and more. Please contact us today for a FREE consultation with one of our caring and competent personal injury lawyers who can help you seek the justice you deserve.