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

The head of the U.S. Consumer Product Safety Commission says her agency is continuing to investigate Yamaha Rhino rollover accidents and deaths and may intervene to protect the public from what she describes as a "very high risk.''

The remarks from Inez Tenenbaum were part of a CBS Evening News investigative report on the accident history of the high-powered ATV, which has sold 150,000 units since being introduced in the U.S. in 2003.

CBS news reporter Armen Keteyian said Rhino rollovers have killed 59 people and are related to nearly 400 injuries. The machine has a high center of gravity and other design flaws that can lead to rollovers on flat, paved ground at speeds as low as 15 mph, CBS reported.

Eric Hageman, an attorney at Pritzker Olsen law firm, is on the plaintiff's steering committee for Yamaha Rhino lawsuits pending in U.S. District Court in Kentucky. Hageman, who has filed Rhino rollover lawsuits against Yamaha Motor Corp. USA, says the CBS probe reinforces his belief that the Rhino has an unsafe design and should be removed from the market.

Not surprisingly, Yamaha told CBS that it believes the Rhino to be safe and reliable.

Said Hageman, the Yamaha Rhino lawyer: "The Rhino is incredibly dangerous, even at low speeds and on flat terrain, because of inherent flaws in its design, including having a narrow track width, high platform, high center of gravity, wheels too small to maintain stability, and top-heavy design. No repairs can fix all of those problems''

To contact our lawyers about a Yamaha Rhino lawsuit, please call 1-888-377-8900 (toll free) or submit our Rhino Rollover free consultation form. WE ARE NOT PAID UNLESS YOU WIN.

Labels: attorney, Lawsuit, Rhino rollover, Yamaha Rhino

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

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

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