Synthes USA recalled Ti Synex II components on September 14, 2009, after six adverse event reports. On November 12, the Food and Drug Administration (FDA) announced that it had classified the recall of Synthes Ti Synex II central body components as Class I. This means that this product could pose an imminent hazard to health in patients.

Synthes Ti Synex II products are vertebral body replacement devices that are used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body due to a tumor or trauma (that is, a fracture).

For Synthes Ti Synex II lawsuit information, please call 1-888-377-8900 (toll free), email Attorney Fred Pritzker or submit our online form for a free consultation.

The six adverse event reports included moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) at six to fifteen months post implantation. Loss of device height may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for a reoperation or an operation to modify the implanted device.

Labels: Lawsuit, Lawyers

According to the FDA, some patients have died after the administration of Dexferrum, an iron dextran injection product. American Regent, manufacturer of Dexferrum sent a letter healthcare professionals stating that the boxed warning for Dexferrum had been changed to do the following:

1. Emphasize the warning about the risk of anaphylactic-type reactions from Dexferrum
2. Provide precautionary measures to mitigate the risk of anaphylactic-type reactions from Dexferrum
3. Add statements to clarify the differences in the chemical characteristics and clinical effects of iron dextran preparations to minimize potential confusion between products
   

A Dexferrum lawsuit would allege that American Regent failed to adequately warn the patient of the risks of anaphlylactic shock and failed to provide adequate instructions for administration. For a free consultation about a Dexferrum lawsuit, please call 1-888-377-8900 (toll free), email Attorney Fred Pritzker or submit our online free consultation form.
Clearly, American Regent should have provided enough information in the instructions for Dexferrum for medical professionals to administer the product safely.

The new boxed warning now provides the following information:

• Health professionals should administer a test dose of Dexferrum® prior to the first therapeutic dose; if no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic dose.
• Health professionals should observe the patient for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum.
• Fatal reactions have occurred following the test dose of Dexferrum and have also occurred when the test dose of Dexferrum was tolerated.
• Health professionals should note that patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions.
  

Below is the language on the new boxed warnings for Dexferrum:

Risk for Anaphylactic-type Reactions: Warnings regarding the risk for anaphylactic-type reactions have existed in the Warnings section prior to this change. The information that has been added provides guidance on patient observation following the administration of both the test dose and therapeutic administration and elevates the precaution about potential increased risks with concomitant use of angiotensin-converting enzyme inhibitor drugs. This new subsection also addresses the chemical differences and clinical effects of the available iron dextran products.

IMPORTANT SAFETY INFORMATION
Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection.

Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Dexferrum® (iron dextran injection, USP) administration.

Administer a test Dexferrum® dose prior to the first therapeutic dose.

During all Dexferrum® administrations, observe for signs or symptoms of anaphylactic-type reactions. Fatal reactions have followed the test dose of iron dextran injection and in situations where the test dose was tolerated.

Use Dexferrum® only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy.

Labels: Lawsuit, Lawyers, wrongful death

ADHD Medications that may be associated with sudden death in healthy children, according to the FDA: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics.

Research data published in the American Journal of Psychiatry suggests there may be an association between the use of stimulant medications prescribed to children with ADHD and sudden death in healthy children.

If your child has died or become seriously ill while using any of the ADHD medications above, the most common of which is Ritalin: 1) call our lawyers at 1-888-377-8900 (toll free) or 2) submit our free consultation form for review by our lawyers.

In the study, funded by the FDA and the National Institute of Mental Health (NIMH), the investigators compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly, most likely due to sudden cardiac disturbance, to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident. According to the study report, out of 564 healthy children who died suddenly, 10 were reported to be taking a stimulant medication at the time of death. Out of 564 healthy children who died in a motor vehicle accident, two were reported to be taking a stimulant medication at the time of death.

Labels: Lawsuit, Lawyers, wrongful death

On June 16, 2009 FDA altered consumers to the risk of anosmia (loss of smell) with the use of certain Zicam products marketed by Matrixx Initiatives. These Zicam products are zinc-containing, nasal cold remedies used to reduce the duration and severity of cold symptoms.

The Zicam products are:
--Zicam Cold Remedy Nasal Gel
--Zicam Cold Remedy Nasal Swabs
--Zicam Cold Remedy Swabs, Kids Size (a discontinued product).

The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products.

“Loss of sense of smell is a serious risk for people who use these products for relief from cold symptoms,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “We are concerned that consumers may unknowingly use a product that could cause serious harm, and therefore we are advising them not to use these products for any reason.”

People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment.

The FDA has issued Matrixx Initiatives, maker of these Zicam products, a warning letter telling it that these products cannot be marketed without FDA approval.

“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of CDER’s Office of Compliance.

For information about a Zicam lawsuit, please contact Pritzker Olsen Attorneys:

• 1-888-377-8900 (toll free)
• Submit our free consultation form
  

Labels: Lawsuit, Lawyers, product liability, zinc poisoning

Denture users throughout the nation are suing denture cream manufacturers Proctor & Gamble Co. and GlaxoSmithKline PLC, alleging that Fixodent and PoliGrip denture creams cause zinc poisoning (hyperzincemia) and dangerously low copper levels (hypocupemia), which leads to loss of balance, paralysis, tingling, numbness, pain and other neurological problems.

Cases from California, Colorado, Florida, New York, Ohio, Oklahoma, Pennsylvania and Tennessee have been filed and may be consulidated in multidistrict litigation (MDL) (In re Denture Cream Products Liability Litigation, M.D.L. No. 2051). If this happens all denture cream zinc poisoning cases filed in federal court will be part of the MDL.

Our law firm supports MDL for denture cream lawsuits because the pre-trial procedures will be streamlined, which should result in quicker recoveries for clients. When an elderly client's quality of life is diminished because a manufacturer failed to warn him or her of the risk of zinc poisoning and the resulting neuropathy, justice requires swift action that fully compensates that injured person.

Please contact us for denture cream lawsuit information. Our lawyers have a national reputation and have appeared on CBS News and Fox News discussing product safety litigation.

Our lawyers can help you:

• 1-888-377-8900 (toll free) or
• Complete our free consultation form.

For more information, please see the following:

• Fixodent Lawsuit
• PoliGrip Lawsuit
  

Labels: denture cream lawsuit, Lawyers

Pritzker Olsen Attorneys is representing people who suffered a ruptured tendon after taking Levaquin. To contact our attorneys about our Levaquin lawsuit cases, please call 1-888-377-8900 (toll free) or submit our Levaquin lawsuit consultation form.

We handle Levaquin cases nationwide. For each case, we are investigating both product liability and medical malpractice issues.

The Levaquin lawsuits involving product liability claims may be consolidated in multi-district litigation (MDL), which would streamline pre-trial preparations, which includes requests for documents, interrogatories (requests for answers to specific questions), and depositions (interviews of witnesses and others taken in the presence of a court reporter).

Levaquin, a fluoroquinolones antibiotic, has been associated with an increased risk of tendon rupture. According to research, this risk is increased in patients over 60, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.

Companies associated with the manufacture of Levaquin include the following:

• PriCara, a division of Ortho-McNeil-Janssen Pharmaseuticals, Inc.
• Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaseuticals, Inc.
• Ortho-McNeil-Janssen Pharmaseuticals, Inc.
  

Although Levaquin has other side effects, our law firm is only taking Levaquin tendon rupture cases.

Labels: Lawsuit, Lawyers, product liability

Certain Medtronic Kappa® and Sigma® pacemakers may fail at a higher than expected rate due to separation of wires that connect the electronic circuit to other pacemaker components (e.g., battery, connector). This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.

Medtronic has observed 285 Kappa devices and 131 Sigma devices with this failure mechanism.

Wire separation on a Medtronic Kappa or Sigma pacemaker may cause serious injury or death:

Some patients, whose devices experience a wire separation resulting in a loss of pacing output, will experience a return of bradycardia symptoms (e.g. fainting or lightheadedness). In rare cases involving pacemaker dependent patients, loss of pacing output may result in death or serious injury. Medtronic has received two reports of patient death where it is possible but unclear whether this issue may have been a factor.

If you would like information about a Medtronic lawsuit, please contact Attorney Elliot Olsen, managing attorney for our Medtronic lawsuits.

You may look up specific model and serial numbers to see if your pacemaker is affected.

Labels: Lawyers, Medtronic lawsuit

The FDA has received reports of liver injury associated with the use of certain Hydroxycut products manufactured by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, New York. Liver injuries have included jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA.

Compensation for Hydroxycut liver failure and other liver damage may include the following:

• Medical expenses
• Cost of care
• Lost wages
• Pain and suffering
• Disability
  

When applicable, there may be recovery for past and future expenses, losses and pain and suffering. In addition to physical pain, “pain and suffering” can include emotional distress, suffering and embarrassment. Our attorneys will fight to get you the compensation you deserve. We also feel strongly that large recoveries from manufacturers send a message that companies need to put consumer safety first. To contact a lawyer at Pritzker Olsen about a Hydroxycut lawsuit, please call 1-888-377-8900 (toll free) or submit our free consultation form.

Symptoms of Hydroxycut Liver Failure and Liver Damage

Symptoms of liver damage including the following:

• Jaundice, a yellow discoloration of the skin and eye whites due to abnormally high levels of bilirubin in the bloodstream
• Excessive fatigue
• Weakness
• Stomach or abdominal pain
• Itching
• Loss of appetite
• Dark urine
• Pale stool
• Bone loss
• Easy bleeding and bruising
  
• Small, spider-like blood vessels visible in the skin
• Enlarged spleen
• Fluid in the abdominal cavity
• Chills
• Pain from the biliary tract or pancrea
• Enlarged gallbladder
• Impaired consciousness
• Changes in logical thinking, personality, and behavior
• Mood changes
• Impaired judgement
• Drowsiness
• Confusion
• Sluggish speech and movement
• Disorientation
• Loss of consciousness
• Coma
  

Liver Disease Related Health Problems

Common health problems associated with liver disease:

• Jaundice, a yellow discoloration of the skin and eye whites due to abnormally high levels of bilirubin (bile pigment) in the bloodstream
• Cholestasis, reduced or stopped bile flow
• Liver enlargement (hepatomegaly)
• Portal hypertension, abnormally high blood pressure in the portal vein, which supplies the liver with blood from the intestine
• Ascites, fluid build-up in the abdominal cavity, caused by fluid leaks from the surface of the liver and intestine
• Liver encephalopathy, the deterioration of brain function due to toxic substances
  

Hydroxycut Liver Damage Prompts Recall

In response to reports of liver failure and other liver damage associated with certain Hydroxycut products, Iovate has issued a recall of the following products:

Hydroxycut Hardcore 8 fl. oz. Grape Explosion
Hydroxycut Hardcore 8 fl. oz. Triple Wildberry
Hydroxycut 280ct-3 Pak Kit *Discontinued*
Hydroxycut 280ct-6 Pak Kit *Discontinued*
Hydroxycut 100ct-6 month supply (7 bottles+ 4 free) Kit
Hydroxycut 2x60ct Club Pack US Kit
Hydroxycut 100ct-1 month supply (1 bottle+1 free) Kit
Hydroxycut 58 cap 12-pack Target US Kit *Discontinued*
Hydroxycut 100ct-3 month supply (4 bottles+2 free) Kit
Hydroxycut Sachet Twin Pack US Kit
Hydroxycut Instant Weight Loss Shot 12 x 2oz - Wild berry US Kit
Hydroxycut Hardcore Shredded Stack Kit120ct
Hydroxycut 60 Rapid Release Caplets
Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Read more about the Hydroxycut recall.

Keywords: Hydroxycut lawsuit, Iovate class action lawsuit, liver damage, liver failure, Hydroxycut liver failure, lawyer, attorney, law firm, suit for damages, compensation for liver failure, Hydroxy Cut, Hydroxicut, hydroxcut, hydroxycut.com, hydroxy-cut, hydrox-cut, liver failure from Iovate Hydroxycut.

ALABAMA AL, ALASKA AK, ARIZONA AZ, ARKANSAS AR, CALIFORNIA CA, COLORADO CO,CONNECTICUT CT, DELAWARE DE, DISTRICT OF COLUMBIA DC, FLORIDA, GEORGIA GA, HAWAII HI, IDAHO ID, ILLINOIS IL, INDIANA IN, IOWA IA, KANSAS KS, KENTUCKY KY, LOUISIANA LA, MAINE ME, MARYLAND MD, MASSACHUSETTS MA, MICHIGAN MI, MINNESOTA MN, MISSISSIPPI MS, MISSOURI MO, MONTANA MT, NEBRASKA NE, NEVADA NV, NEW HAMPSHIRE NH, NEW JERSEY NJ, NEW MEXICO NM, NEW YORK NY, NORTH CAROLINA NC, NORTH DAKOTA ND, OHIO OH, OKLAHOMA OK, OREGON OR, PENNSYLVANIA PA, RHODE ISLAND RI, SOUTH CAROLINA SC, SOUTH DAKOTA SD, TENNESSEE TN, TEXAS TX, UTAH UT, VERMONT VT, VIRGINIA VA, WASHINGTON WA, WEST VIRGINIA WV, WISCONSIN WI, WYOMING WY

Labels: Hydroxycut, Iovate, Lawsuit, Lawyers

The FDA has received 23 reports of serious health problems associated with certain Hydroxycut products. Most of the 23 reports involved liver injuries, including liver damage and liver failure, some requiring a liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

In response, Iovate Health Sciences has agreed to a Hydroxycut recall of the following products:

Hydroxycut Hardcore 8 fl. oz. Grape Explosion
Hydroxycut Hardcore 8 fl. oz. Triple Wildberry
Hydroxycut 280ct-3 Pak Kit *Discontinued*
Hydroxycut 280ct-6 Pak Kit *Discontinued*
Hydroxycut 100ct-6 month supply (7 bottles+ 4 free) Kit
Hydroxycut 2x60ct Club Pack US Kit
Hydroxycut 100ct-1 month supply (1 bottle+1 free) Kit
Hydroxycut 58 cap 12-pack Target US Kit *Discontinued*
Hydroxycut 100ct-3 month supply (4 bottles+2 free) Kit
Hydroxycut Sachet Twin Pack US Kit
Hydroxycut Instant Weight Loss Shot 12 x 2oz - Wild berry US Kit
Hydroxycut Hardcore Shredded Stack Kit120ct
Hydroxycut 60 Rapid Release Caplets
Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Hydroxycut Recall: Liver Damage
and Liver Failure Compensation

If you have suffered liver damage or liver failure after using Hydroxycut, contact our law firm regarding a Hydroxycut lawsuit seeking the following:

• Medical expenses (past and present)
• Lost wages (past and future)
• Pain and suffering (past and future)

Pain and suffering can include compensation for physical pain associated with liver damage and liver failure, suffering, emotional distress, and disability.

Partner Elliot Olsen is managing attorney for these cases. To contact Elliot, please call 1-888-377-8900 (toll free) or submit our free consultation form.

Posted May 2009

Labels: FDA recall, Hydroxycut, Iovate, Lawsuit, Lawyers

Medtronic and the FDA have announced a recall of the following ventricular catheter models:

• Innervision Snap Shunt Ventricular Catheter, BioGlide®, Catalog Number 27782
• Snap Shunt Ventricular Catheter, BioGlide®, Catalog Number 27802
• Snap Shunt Ventricular Catheter, BioGlide®, Catalog Number 27708
  

According to Medtronic, it has been determined from nine reports of disconnected catheters requiring revision surgery, that the listed ventricular catheters may become detached from the snap base assembly after implantation and that this condition may increase the need for emergency revision surgery.

Consequences for a patient with failure of a Medtronic ventricular catheter may include: nausea, vomiting, headache, lethargy, change in mental status, seizures, visual disturbance, and other more serious conditions.

If you or a loved one has had to have emergency surgery due to a defective Medtronic catheter, you may have grounds for a Medtronic lawsuit.

Our law firm is representing a number of patients in Medtronic lawsuits. Our managing attorney for these Medtronic lawsuit cases is Elliot Olsen. If you would like to discuss your Medtronic catheter case with Elliot or another attorney at our law firm, please call 1-888-377-8900 (toll free) or submit our free consultation form.

You should also ask us about federal preemption and Riegel v. Medtronic, which may affect your ability to obtain compensation from Medtronic.

Labels: Lawyers, Medtronic lawsuit

Actavis Inc. has announced that its subsidiary Actavis South Atlantic LLC is proceeding with the voluntarily recall from wholesalers and pharmacies of all lots of Fentanyl transdermal system CII patches sold in the United States.

This Fentanyl patch recall is an expansion of an initial Fentanyl recall of fourteen lots of Fentanyl transdermal patches announced on February 17, 2008 (Fentanyl recall - Fentanyl death - Fentanyl overdose). That recall was due to the identification of a possible fold-over defect present in the product that potentially could cause leakage of the Fentanyl gel. The remaining lots of Fentanyl transdermal system patches are being recalled as a precautionary measure because Actavis lacks assurance that all patches are free from defects.

Fentanyl patches are dangerous, and anyone coming in contact with the Fentanyl gel within the patch is at risk for serious adverse events, including respiratory depression and possible overdose, which may cause death.

If you are using a Fentanyl patch and have not experienced any adverse events, you need to contact your medical provider immediately.

If you believe you have been injured by Fentanyl, contact one of our lawyers regarding this Fentanyl patch recall and other Fentanyl recalls. You may be entitled to compensation for your injuries. If a family member died after using a Fentanyl patch, contact us for information on wrongful death litigation. To contact us, please call toll-free at 1-888-377-8900 or submit our free case consultation form.

Again, this Fentanyl patch recall is extremely serious and all caution should be used regarding the Fentanyl patches. We urge you to contact your medical provider immediately if you are using a Fentanyl patch. We also urge you to send this information to anyone you know who may be using a Fentanyl patch.

Posted March 2008.

Labels: Fentanyl Patch Recall, Free Consultation, Lawyers