Archive for: October, 2010

ACTAVIS FENTANYL RECALL

U.S. Fentanyl Recall Information – Important Update for Consumers

On October 21, 2010, Actavis announced a recall of 18 Control/Lots of Fentanyl Transdermal System 25 mcg/h. Under this recall, all wholesalers and retailers are being asked to return the product they have on hand or in stock. Consumers are encouraged to return product in their possession. Fentanyl patches sold by Actavis in Europe are not impacted in this recall.

Actavis identified one lot of 25 mcg/hour Fentanyl patch (Control/Lot # 30349) shipped to market that contained one patch that released in vitro (test tube) its active ingredient faster than the approved specification. As a precautionary measure, in addition to the aforementioned lot, Actavis is recalling the Control/Lot Numbers listed below due to the possibility that additional patches may release active ingredient faster than the approved specification.

The 18 Control/Lots included in this recall are: Fentanyl Transdermal System 25mcg/hr CII NDC # 67767-120-18

Control/Lot # 30041 Expiration 12/2011
Control/Lot # 30049 Expiration 12/2011
Control/Lot # 30066 Expiration 12/2011
Control/Lot # 30096 Expiration 01/2012
Control/Lot # 30097 Expiration 02/2012
Control/Lot # 30123 Expiration 01/2012
Control/Lot # 30241 Expiration 02/2012
Control/Lot # 30256 Expiration 02/2012
Control/Lot # 30257 Expiration 03/2012
Control/Lot # 30258 Expiration 03/2012
Control/Lot # 30349 Expiration 03/2012
Control/Lot # 30350 Expiration 03/2012
Control/Lot # 30391 Expiration 03/2012
Control/Lot # 30392 Expiration 04/2012
Control/Lot # 30429 Expiration 04/2012
Control/Lot # 30430 Expiration 04/2012
Control/Lot # 30431 Expiration 04/2012
Control/Lot # 30517 Expiration 04/2012

Actavis distributed the subject lot numbers from 04/13/2010 to 09/09/2010. Lot/Control numbers can be found in the area indicated by the circled area on the product box pictured below. This number is also on the black and white side of the individual patch packaging in the lower left corner. We have notified the FDA of our action.

Actavis Fentanyl Pain Patch Overdose Lawsuit Attorney

If you or a loved one has been severely injured as a result of an Actavis fentanyl pain patch or other fentanyl pain patch, talk to an Actavis Fentanyl Pain Patch Lawsuit Attorney at the Willis Law Firm for legal advice about a potential Fentanyl Pain Patch lawsuit. You are not alone. Join other Actavis fentanyl pain patch victims and their families in fighting for their legal rights. It may be too late to recover from some of the devastating effects of the Actavis Fentanyl Pain Patch, but an experienced pharmaceutical products liability attorney at the Willis Law Firm can assist you in a legal action against the makers of the Actavis Fentanyl Pain Patch and in filing a Fentanyl Pain Patch Lawsuit.

Please fill out the Free Case Evaluation to the right or call us toll-free at 1-800-883-9858 for immediate help. Please keep in mind that certain states have a statute of limitations that limits the amount of time you have to file an Actavis Fentanyl Pain Patch lawsuit or to seek legal action. Contact our law firm immediately so we may explain the rights and options available to you and your family.

Actavis Issues Voluntary Recall – 18 Lots Fentanyl Transdermal System 25 mcg/h

PRESS RELEASES – 21 OCT 2010 / Product

Morristown, NJ – (October 21, 2010) – Actavis Inc. today announced a voluntary recall to the wholesale and retail levels only of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches manufactured for Actavis by Corium International in the United States.

Actavis identified one lot of 25 mcg/hour Fentanyl patch (Control/Lot # 30349) shipped to market that contained one patch that released its active ingredient faster than the approved specification in laboratory testing. An accelerated release of Fentanyl from a 25 mcg/hour patch can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing). The patches are packaged individually and boxed in quantities of five patches per box.

Actavis Fentanyl Pain PatchFentanyl Transdermal System is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.
As a precautionary measure, although unaware of any injuries associated with this issue, in addition to the aforementioned lot, Actavis is recalling the additional Control/Lot numbers noted below due to the possibility that additional patches may release active ingredient faster than the approved specification. The Control/Lot number appears on the bottom of the product box and on the black and white side of each individual patch packaging, in the lower left corner.

Recalled Control/Lot #s

30041, Exp 12/2011
30049, Exp 12/2011
30066, Exp 12/2011
30096, Exp 01/2012
30097, Exp 02/2012
30123, Exp 01/2012
30241, Exp 02/2012
30256, Exp 02/2012
30257, Exp 03/2012
30258, Exp 03/2012
30349, Exp 03/2012
30350, Exp 03/2012
30391, Exp 03/2012
30392, Exp 04/2012
30429, Exp 04/2012
30430, Exp 04/2012
30431, Exp 04/2012
30517, Exp 04/2012

Corium, a third party supplier for Actavis, manufactured the recalled patches at their Grand Rapids, Michigan facility. Under this recall, all wholesalers and retailers are being asked to return the product they have on hand or in stock. Fentanyl patches sold by Actavis in Europe are not impacted in this recall.  This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Actavis Fentanyl Pain Patch Overdose Lawsuit Attorney

Poorly designed and dangerous devices and medications such as the Actavis fentanyl pain patch, or any other defective fentanyl pain patch, may cause accidental overdose or other severe and devastating injuries or death.

If you or a loved one has been severely injured as a result of an Actavis fentanyl pain patch or other fentanyl pain patch, talk to an Actavis Fentanyl Pain Patch Lawsuit Attorney at the Willis Law Firm for legal advice about a potential Fentanyl Pain Patch lawsuit. You are not alone. Join other Actavis fentanyl pain patch victims and their families in fighting for their legal rights. It may be too late to recover from some of the devastating effects of the Actavis Fentanyl Pain Patch, but an experienced pharmaceutical products liability attorney at the Willis Law Firm can assist you in a legal action against the makers of the Actavis Fentanyl Pain Patch and in filing a Fentanyl Pain Patch Lawsuit.

Please fill out the Free Case Evaluation to the right or call us toll-free at 1-800-883-9858 for immediate help. Please keep in mind that certain states have a statute of limitations that limits the amount of time you have to file an Actavis Fentanyl Pain Patch lawsuit or to seek legal action. Contact our law firm immediately so we may explain the rights and options available to you and your family.

FDA Adverse Reaction Cold Therapy System 

FDA: Adverse Reaction Model Number 10B
Event Date 11/02/2005
Event Type Injury Patient Outcome Required Intervention;
Disability Event Description

“Ebice 10b cold therapy system was used following 2005 and 2006 podiatric surgical procedures performed for left foot problems and tarsal tunnel syndrome. The patient claims she has suffered cold thermal injury to the ankle, permanent nerve damage, chronic pain and rsd syndrome.”

Manufacturer Narrative

“Although the unit was not returned for evaluation, the instructions for use was reviewed. Exerts taken from the ifu: read all instructions before using ebice. A licensed health care practitioner must determine the appropriate treatment setting and the length of treatment for each patient. Individual sensitivity to a cryotherapy application varies. It is important to periodically check the color and sensitivity of the skin at the treatment site. The patient should be instructed that if the skin appears discolored or feels numb, immediately discontinue the cold therapy treatment and notify your health care practitioner. Cooling for one hour at a water temperature of 30 – 48 deg f may induce redness and edema that last for 24 hours after exposure. Some individuals are allergic to cold, reacting with hives, joint pain and swelling. When cryotherapy is selected as a treatment modality, close monitoring of the patient’s response to the cryotherapy treatment is critical. Water cycling adjustments or discontinuation of the treatment may be required if a patient demonstrates a localized hypothermia reaction. With a sudden sharp and persistent drop in temperature, vasoconstriction and increased viscosity of the blood in a local area may cause ischemic injury and degenerative changes in peripheral nerves. Localized reaction to cold may include childbain, frostbite or immersion syndrome. Prolonged tissues hypoxia and infarction necrosis of the affected tissue may develop. Vascular injury and edema become more evident as the temperature returns to normal.”

Cold Therapy Attorney

Poorly designed cold therapy machines can cause permanent nerve damage, frostbite, and numerious other serious side effect injuries. Seek immediate medical attention if you are suffering an emergency situation.

Cold therapy lawsuits are currently being filed by attorneys representing victims injured by these defective products. Cold therapy lawsuits claim that the cold therapy machines were defective in their design by not having adequate safety mechanisms to prevent injury. Cold machine lawsuits also claim these devices fail to adequately warn consumers of the risks involved with extended or prolonged use of their product.

If you or someone you know has been injured as a result of cold therapy, ice machines, recirculating ice coolers, cryotherapy or other forms of cold treatment, talk to a Cold Therapy Machine Attorney at the Willis Law Firm in Houston for legal advice about a potential cold therapy – cryotherapy lawsuit.  Please fill out the Free Case Evaluation at the right or call us toll-free at 1-800-883-9858.

Common peroneal nerve dysfunction is damage to the peroneal nerve leading to loss of movement or sensation in the foot and leg.    

Causes

The peroneal nerve is a branch of the sciatic nerve, which supplies movement and sensation to the lower leg, foot and toes. Common peroneal nerve dysfunction is a type of peripheral neuropathy (damage to nerves outside the brain or spinal cord). This condition can affect people of any age.

Dysfunction of a single nerve, such as the common peroneal nerve, is called a mononeuropathy. Mononeuropathy implies there is a local cause of the nerve damage, although certain bodywide conditions may also cause isolated nerve injuries.

Damage to the nerve destroys the covering of the nerve cells (the myelinmyelin sheath) or causes degeneration of the entire nerve cell. There is a loss of sensation, muscle control, muscle tone, and eventual loss of muscle mass because of lack of nervous stimulation to the muscles.

Common causes of damage to the peroneal nerve include the following:

•Trauma or injury to the knee
•Persistent use of Cold Therapy Machines or other forms of Cold Therapy on the knee area
•Fracture of the fibula (a bone of the lower leg)
•Use of a tight plaster cast (or other long-term constriction) of the lower leg
•Pressure to the knee from positions during deep sleep or coma
•Injury during knee surgery.

People who are extremely thin or emaciated (for example, from anorexia nervosa) have a higher-than-normal risk of common peroneal nerve injury. Conditions such as diabetic neuropathy or polyarteritis nodosa, as well as exposure to certain toxins, can also cause damage to the common peroneal nerve.

Symptoms

•Decreased sensation, numbness or tingling in the top of the foot or the outer part of the upper or lower leg
 
•Weakness of the ankles or feet

•Walking abnormalities

•”Slapping” gait (walking pattern in which each step taken makes a slapping noise)

•Foot drop (unable to hold foot horizontal)

•Toes drag while walking

Exams and Tests

Examination of the legs may show a loss of muscle control over the legs (usually the lower legs) and feet. The foot or leg muscles may atrophy (lose mass). There is difficulty with dorsiflexion (lifting up the foot and toes) and with eversion (toe-out movements).

Muscle biopsy or a nerve biopsy may confirm the disorder, but they are rarely necessary.

Tests of nerve activity include:

•EMG (electromyography, a test of electrical activity in muscles)

•Nerve conduction tests

•MRI to look for compressive lesion along nerve

Other tests are determined by the suspected cause of the nerve dysfunction, based on the person’s history, symptoms, and pattern of symptom development. They may include various blood tests, x-rays, scans, or other tests and procedures.

Treatment

Treatment is aimed at maximizing mobility and independence. Any illness or other source of inflammation that is causing the neuropathy should be treated.

If there is no history of trauma to the area, the condition developed suddenly with minimal sensation changes and no difficulty in movement, and there is no test evidence of nerve axon degeneration, then a conservative treatment plan will probably be recommended.

Corticosteroids injected into the area may reduce swelling and pressure on the nerve in some cases.

Surgery may be required if the disorder is persistent or symptoms are worsening, if there is difficulty with movement, or if there is evidence on testing that the nerve axon is degenerating. Surgical decompression of the area may reduce symptoms if the disorder is caused by pressure on the nerve. Surgical removal of tumors or other conditions that press on the nerve may be of benefit.

Over-the-counter or prescription analgesics may be needed to control pain. Other medications may be used to reduce the stabbing pains that some people experience, including gabapentin, carbamazepine, or tricyclic antidepressants such as amitriptyline. Whenever possible, medication use should be avoided or minimized to reduce the risk of side effects.

If pain is severe, a pain specialist should be consulted so that all options for pain treatment are explored.

Physical therapy exercises may be appropriate for some people to maintain muscle strength.

Orthopedic assistance may maximize the ability to walk and prevents contractures. This may include use of braces, splints, orthopedic shoes, or other equipment.

Vocational counseling, occupational therapy, or similar intervention may be recommended to help maximize mobility and independence.

Outlook (Prognosis)

The outcome depends on the underlying cause. Successful treatment of the underlying cause may resolve the dysfunction, although it may take several months for the nerve to grow back.  If nerve damage is severe, disability may be permanent. The nerve pain may be quite uncomfortable.

Possible Complications

•Decreased ability to walk
•Permanent decrease in sensation in the legs or feet
•Permanent weakness or paralysis in the legs or feet
•Side effects of medication

When to Contact a Medical Professional

Call your health care provider if you have symptoms that indicate common peroneal nerve dysfunction.

Prevention

Avoid prolonged use of Cold Therapy machines or devices which cool the knee area. Use of Cold Therapy devices should be limited to periods of less than 30 minutes at a time.  Avoid prolonged pressure to the back or side of the knee. Injuries to the leg or knee should be treated promptly.

If a cast, splint, dressing, or other possible constriction of the lower leg causes a tight feeling or numbness, notify your health care provider.

Alternative Names

Neuropathy – common peroneal nerve; Peroneal nerve injury; Peroneal nerve palsy

Cold Therapy Attorney

Cold therapy lawsuits are being filed by lawyers representing victims injured by these defective products. Cold therapy lawsuits claim that the cold therapy machines were defective in their design by not having adequate safety mechanisms to prevent injury. Cold machine lawsuits also claim these devices fail to adequately warn consumers of the risks involved with extended or prolonged use of their product.

Poorly designed cold therapy machines can cause permanent nerve damage, skin & tissue damage (frost bite) and numerious other serious side effects. Seek immediate medical attention if you are suffering an emergency situation.

If you or someone you know has been severely injured as a result of cold therapy, ice machines, recirculating ice coolers, crynotherapy or other forms of cold treatment, talk to a Cold Therapy Attorney at the Willis Law Firm in Houston for legal advice about a potential cold therapy – cryotherapy lawsuit.  Please fill out the Free Case Evaluation at the right or call us toll-free at 1-800-883-9858.