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 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

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

People who use dentures should be aware that lawsuits have been filed alleging that use of PoliGrip and other denture creams caused zinc poisoning, which can cause paralysis, loss of balance, tingling in the arms and legs, unexplained pain and other neurological problems.

A simple test will determine if you have zinc poisoning.

If you do, please contact our law firm about a PoliGrip lawsuit. Our law firm is investigating the connection between PoliGrip and zinc poisoning. We are representing several people injured by medical products, and have gained a national reputation in the area of complex product liability litigation. Our lawyers have appeared on CBS News, Fox News and numerous local television stations.

Contact our law firm for a free consultation about a possible Super PoliGrip lawsuit: 1-888-377-8900 (toll free) or complete our free consultation form.

Labels: denture cream lawsuit, zinc poisoning

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