Good Juice, Bad Juice

Did you hear the breaking news yesterday about dangerous levels of arsenic being found in our kids’ apple and grape juices? Well, it’s serious business.

Consumer advocates are saying the FDA is allowing too much inorganic arsenic into apple and grape juice and that the government is failing to enforce protective standards. The FDA allows 23 parts per billion as a benchmark to determine whether apple juice is contaminated. Consumers Union, publisher of Consumer Reports, is calling for this level to be reduced to as low as 3 parts per billion. The EPA’s level for drinking water, set at 10 parts per billion, is much safer than the juice our little ones are currently drinking!

Consumer Reports, a product-testing organization, analyzed 88 samples of juice and found that 9 of those samples had arsenic levels exceeding federal limits set for drinking water. Of those brands sampled were:

• Apple & Eve
• Great Value
• Mott’s
• Walgreens
• Welch’s

At least one of each of these brands had a sample that exceeded the 10 parts per billion threshold. Consumer Reports also reported that 25% of all juice samples had lead levels at or above the federal limit for bottled water. Grape juice samples were actually higher than apple juice.

What are the dangers of arsenic? Well, organic arsenic is not harmful to the body and will quickly pass through. It’s the inorganic arsenic that’s the problem. Inorganic arsenic is known to cause bladder, lung, and skin cancer as well as increase the risk of heart disease and type 2 diabetes. Some reports have even suggested that arsenic exposure can affect brain development in children!

So what should you do if you have a juice-drinking toddler? All of the experts, including the government and consumer advocates, agree that the concern is over drinking large amounts of juice over a long period of time. Drinking small amounts of apple juice is not harmful. However, options to consider are:

• Limit juice intake of children under 6 to 6 ounces a day.
• Limit juice intake of children over 6 to no more than 8-12 ounces a day
• Infants under 6 months should not consume juice at all
• Dilute your child’s juice with water first
• Diversify brands of juice purchased in case one brand tends to have higher arsenic levels

How "Hip" Are You?

Do you or a loved one have a Wright CONSERVE or a Wright PROFEMUR Total Hip System or know someone with a Wright PROFEMUR Z? Have you experienced any adverse reactions or symptoms since receiving your implant? Then you need some information that may help you save pain, time and money in the near future.

The Wright Conserve Total Acetabular System is a 3 component, metal-on-metal, device consisting of a femoral stem, a femoral head, and the acetabular cup. Implantation of this system began in 2004 and is very similar in design to the recalled DePuy ASR metal-on-metal hip implant device.

Due to the shallow nature of the Wright CONSERVE cup, constant heat and friction between the metal components may result in excess metal debris being released into the surrounding soft tissue and bloodstream. This metal toxicity is more specifically caused by increased levels of cobalt and chromium ions, which may lead to a multitude of health problems or permanent injury.

The three main problems associated with Wright implants are:

1. loosening of the device

2. the development of metalosis, and

3. the inhibition of bone grafting.

Common symptoms and difficulties associated with component loosening include:

1. difficulty standing or walking

2. difficulty rising from seated positions

3. unexplained hip, thigh, and groin pain

4. popping or crunching noises

5. tissue inflammation or infection, and

6. bone fractures.

Patients are also experiencing Aseptic Lymphocytic Vasculitis Associated Lesions (“ALVAL”) from elevated levels of chromium and cobalt in the bloodstream. Some of the symptoms of this metalosis include swelling in and around the implant site, dislocation, nerve palsy, cysts, necrosis, cardiac problems, intense pain at site of hip replacement, groin or thigh, and a noticeable mass or rash. Long-term injuries from metalosis can occur as well. Lastly, excess metal ions in the bloodstream may result in stunted bone growth.

What should you do if you or someone you know has received a defective joint replacement system? The first thing that you should do is to continue your treatment regimen and consult your doctor about your concerns immediately.

It is very important that you AVOID signing a release form of any kind from your physician, surgeon or Wright. This form would enable Wright to have complete access to all your medical records and give them possession of the defective implant upon removal. Also, it may be helpful to keep a journal detailing your symptoms. This may be helpful to both your physician as well as your legal representative if you believe you may have a claim against Wright. And remember not to release any of your confidential medical information to anyone representing Wright without first contacting an experienced team of hip replacement attorneys.

For more information or to discuss whether you have a potential case, please feel free to call the injury lawyers at the Studstill Firm, LLP at (478) 745-9002.

Even though the Wright Profemur Hip System has not yet been recalled, you may still be entitled to significant compensation if you have been experiencing hip replacement problems. The injury attorneys at the Studstill Firm, LLP have years of experience in defective product cases, including medical devices that claim to be safe. We will fight for your rights against the designer, manufacturer, and seller of defective hip implants such as the Wright Profemur Hip System.

Call our office today at (478) 745-9002 to discuss your situation. Your initial consultation is free of charge – and confidential – and you pay nothing unless we win your case.

Are Bad Boy Buggies Living Up To Their "Bad" Name?

The manufacturer of Bad Boy Buggies, an off-road utility vehicle, has recently recalled 3,200 Bad Boy Buggies due to a defective steering arm assembly. Essentially, the recall was issued because the vehicles contain a defective steering arm assembly which could break during normal operation and leave the vehicle uncontrollable and result in crashes with injuries.

According to the manufacturer, there have been 15 reported incidents of the steering arm breaking in these vehicles causing the driver to lose control. The following Bad Boy Buggy Models (pictured below) are involved in the recall: (1) Bad Boy LT; (2) Classic; (3) XT; (4) XTO, and (5) XT Safari. 

These models were manufactured at BB Buggies in Augusta, Georgia and Bad Boy Enterprises, LLC in Natchez, Mississippi and were sold nationwide.

This recall follows on the heels of an earlier recall of 9,300 Bad Boy Classic Buggies which contained defective accelerator petals that caused sudden and unintended acceleration. That recall involved Bad Boy Classic Buggies which were manufactured by Bad Boy Enterprises, LLC between 2003 and May 2010.

Owners of these vehicles should stop using them immediately and contact Bad Boy Buggies at (855) -738 3711 or visit its website at http://www.badboybuggies.com/.

Diabetes Drug Linked to Bladder Cancer

Actos is a drug that is manufactured by Takeda, a Japanese pharmaceutical company, and prescribed to treat type-2 diabetes. In September 2010, the FDA announced that Actos may be linked to urinary bladder cancer. This announcement was made by the FDA after a ten year epidemiological study revealed an increase in bladder cancer in patients taking Actos. After this study was published, Actos was removed from the market in Germany and France, but not in the U.S.

The FDA has since required Actos’ warning label to be revised to include the risk of urinary bladder cancer as a possible side effect.

Actos is currently marketed as a stand-alone drug or in combination form as Actoplus Met, Acoplus Met XR, and Duetact. Actos was designed to increase the cell’s sensitivity to insulin. It was widely prescribed in the United States as the “preferred medicine” for treating type-2 diabetes.

Unbelievably, there is strong evidence that suggests that Takeda, the Japanese manufacturer of Actos, knew of the increased risks of bladder cancer posed by Actos as early as the pre-clinical carcinogenicity studies, which showed an increase in drug-induced tumors in the bladders of rats. Despite these studies, which showed an increased risk of tumors, Takeda marketed and sold Actos without any warning whatsoever of an increased risk of bladder cancer.

In fact, it was only after the FDA required the revision to Actos’ warning label that doctors and patients were made aware of the risk of bladder cancer. Unfortunately, millions of Americans took Actos and were exposed to an increased risk of bladder cancer.

If you or a family member took Actos and have been diagnosed with bladder cancer, our Georgia injury lawyers would like to talk with you about your potential claims against Takeda.

Building Bones or Breaking Bones?

Dangers of Osteoporosis Medications
An advisory panel for the FDA is set to meet this Friday to determine the future for osteoporosis medications. Osteoporosis is a condition in which the bones become thin and weak and break easily. The FDA panel is expected to make recommendations on whether use of osteoporosis frugs should be limited to a few years or whether some women should temporarily stop treatment, a concept known as a drug holiday. It was originally thought that osteoporosis medications could be used indefinitely. However, problems began surfacing in the late 1990's that changed the outlook.

Fosamax (an oral bisphosphonate) is probably the most common medication that has been prescribed to both men and women as a treatment and preventative for osteoporosis. It has also been prescribed to women and men who are taking corticosteroid medications. Most commonly, women take Fosamax during and after menopause.

Fosamax is not the only drug in this class of oral bisphosphonates. The other more common names are Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid.  However, in the 16 years since the FDA approved the first oral bisphosphonate, which was Fosamax made by Merck & Co., they have all had numerous problems.

Jaw Bone Danger
The Journal of Oral and Maxillofacial Surgeons reported a link between bisphosphonates and a serious bone disease called Osteonecrosis of the Jaw (ONJ). ONJ is a disfiguring and disabling condition of the jaw bone that causes infection and rotting of the jaw bone. Typical presentation of Osteonecrosis is pain, soft-tissue swelling and infection, loosening of teeth, drainage, and exposed bone. Symptoms may occur spontaneously, or at the site of previous tooth extraction. Some cases require the complete removal of the affected jaw bone.
The FDA and the manufacturer of Fosamax issued a warning to health care professionals on September 24, 2004 of the danger of ONJ associated with the use of this drug.


Thigh Bone Danger
Unfortunately, Fosamax and other bisphosphonates (which include Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid) did not only cause problems with jaw bones. In October of 2010, all manufacturers of bisphosphonates were required by the FDA to include in the warning section of their label a description of low-energy femoral shaft and subtrochanteric fractures that are associated with the use of drugs in this class.

The FDA reviewed data from an ongoing safety review of oral bisphosphonates and determined that use of the drug was related to an increased risk of thigh fractures. More specifically, it was determined that low-energy femoral shaft and subtrochanteric fractures were occurring in patients who were taking bisphosphonates like Fosamax. This means that people were suffering broken thigh bones without trauma to the leg – literally just walking down the street and all of a sudden the thigh bone would snap and break.


Other Dangers
Bisphosphonate users are also at increased risk of developing stomach ulcers if they are taking this medication with anti-inflammatory drugs. The FDA has also examined a link between these bone building drugs and irregular heartbeats. Physicians have also indicated that these drugs cause musculoskeletal pain including back pain, joint pain, intense muscle spasms and also headaches, numbness in the hands, chest pain & tightness, and persistent dizziness.


Other Bisphosphonates
Among the group of bisphosphonates approved for use in the US are Fosamax, Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid.


What You Can Do
Because these bone density building drugs and medications can do more harm than good, doctors encourage patients to follow a good diet and do weight-bearing exercise in lieu of taking medications to remedy ailments such as low bone density. Talk with your doctor to determine if there are alternative ways you can build and support your bones without taking these medications.

If you know someone who has had a broken thigh bone (or subtrochanteric fracture), ask them if they are taking Fosamax or any other oral bisphosphonate (like Reclast, Boniva, Actonel, Zometa, Aredia, Didronel and Skelid). If so, tell them to contact a pharmaceutical injury lawyer immediately to determine if they have a case.

Cholesterol-Lowering Drug Warning

The Food and Drug Administration warned Wednesday that a popular cholesterol-lowering drug should no longer be prescribed at its highest dosage to new patients because of concerns that it can cause muscle damage.

The drug is simvastatin and the unsafe dosage level is 80 milligrams. This dosage level can increase the risk for myopathy, which is a form of muscle damage.

Simvastatin is sold under the brand name Zocor, in addition to being sold as a generic product. It is also sold in combination with other drugs under the brand names Vytorin and Simcor.

The FDA recommendation is that doctors only continue prescribing the 80 mg dose to patients who have been taking it for at least a year without experiencing problems.

Additionally, simvastatin should not be taken with some other drugs, including some antibiotics, HIV drugs and anti-fungal medications, according to the FDA and Merck, which makes the drug.

In 2010, about 2.1 million patients in the United States were prescribed a product containing simvastatin at that dose, the agency said. About 12 percent of simvastatin users take that dose, according to Merck.

Teething Baby? Think Twice About Oral Medications

The FDA recently issued a warning concerning the use of Benzocaine, a local anesthetic used to relieve pain in the mouth and gums. The product is commonly used for pain associated with teething, canker sores, and irritation of the mouth and gums.

The FDA became concerned about products containing benzocaine because they may cause a rare but serious and possibly fatal condition where oxygen in the blood stream is greatly reduced. This condition is called methemoglobinemia. In the most serious cases, this condition can result in death.

Benzocaine products do not currently carry any warnings regarding methemoglobinemia, therefore, the FDA is concerned that consumers might not be aware of the danger or know what to look for when using these products. Signs and symptoms of methemoglobinemia include pale, gray or blue colored skin, lips and nail beds, shortness of breath, fatigue, confusion, headache, lightheadedness, and rapid heart rate.

The FDA is particularly concerned about the use of benzocaine products in children under two years of age. There have been 21 reported cases of methemoglobinemia after using benzocaine gels and liquids. Eleven of the 21 cases occurred in children under age two.

If while using benzocaine products any of the symptoms of methemoglobinemia appear, persons should stop using the product immediately and call 911. If left untreated, serious cases may lead to permanent injury to the brain and body tissues, and even death. Parents are cautioned not to use this product on children less than two years of age unless it is given under the advice and supervision of a healthcare professional. These products should always be kept out of reach of children.

The American Academy of Pediatrics recommends that for teething problems in children, safer alternatives such as chilled teething rings or gentle massage to the gums using a cloth or your finger are preferred over benzocaine products. For a list of products containing benzocaine, visit the FDA’s website.

Recalled Hip Implants

After complaints from several hundred patients and a warning letter from the FDA, Johnson & Johnson is recalling its popular metal-on-metal hip replacement mechanism known as the ASR XL Acetabular System. This product is made by DePuy Orthopaedics which is a division of Johnson & Johnson.

This product is being recalled due to its high failure rate which results in additional hip replacement surgeries to many patients. One such type of failure is that the implant does not properly adhere to the bone and becomes unattached. Another such failure is that over time metal particles slough off and the debris causes inflammation, tissue damage and extreme pain to an individual. There is also some research that indicates that the cobalt and chromium materials used in these implants can be toxic and may lead to certain cancers, including leukemia.

Of course, this recall comes in the wake of several other recalls by Johnson & Johnson – most notably Tylenol Children's liquid. The president of DePuy Orthopaedics said, “We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the costs of doctor visits, tests and procedures associated with the recall.”

If you or anyone you know has been injured by a product such as the DePuy hip implant or any other defective product contact our Valdosta Attorneys for a free consultation about your potential case.

Product Recall - Shrek Promotional Glasses

Just weeks after Wal-Mart and other stores recalled jewelry sold at their stores due to the presence of cadmium, McDonalds is also recalling its promotional Shrek themed glasses for the same reason. These glasses are 16 ounces and come in four different designs (Shrek, Fiona, Puss n’ Boots, and Donkey).

Please see the May 20, 2010 post for details on the dangers of ingesting cadmium. You can also visit www.cdc.gov or www.epa.gov.

The CSPC spokesperson, Scott Wolfson, has stated that the amount of cadmium found in these glasses is “slightly above the protective level currently being developed by the agency.” He also said the glasses contain “far less cadmium than the children's metal jewelry that CPSC has previously recalled."

So far, no injuries have been reported as a result of the toxic chemical found in the paint on the glasses. However, out of an abundance of precaution, McDonalds has recommended that their customers stop using the glasses and is offering $3 refunds on those glasses. (They were originally sold for $2 each.)

If you or anyone you know has been injured by a product such as this or any other defective product, contact us for a free consultation about your potential case.

Paxil & Birth Defects

Paxil is a popular antidepressant which has been on the market since 1992 and is manufactured by GlaxoSmithKline. It is used to treat people with depression, OCD, anxiety, PTSD, and PMDD as well as other similar conditions.

As with almost any anti-depressant, there is a long list of possible side effects associated with taking Paxil. One such potential side effect is birth defects if the drug is taken by a woman during pregnancy. Studies have shown that if Paxil is taken during the first trimester a baby is 1 ½ - 2 times more likely to be born with a heart defect (usually holes in the interior walls of the heart). Other studies have shown that if Paxil is taken any time after the first 20 weeks of pregnancy, a baby may be born with persistent pulmonary hypertension (abnormal blood flow through the heart and lungs and thus insufficient oxygen to their bodies). This condition can lead to multiple organ failure, brain damage, developmental delays, neurological deficits and ultimately death.

For more information on how Paxil can affect a baby if taken during pregnancy, please visit this website or the FDA’s website. Also, please view the GlaxoSmithKline’s September 2005 letter to healthcare professionals on this matter.

If you, your baby or anyone you know has been injured by this or any other pharmaceutical product, contact us for a free consultation about your potential case.

Baby Stroller Safety Risk

I was reading the June 2010 issue of the Consumer Reports magazine and came across something that parents with small children might like to know. Consumer Reports has rated three models of baby strollers as “Don’t Buy: Safety Risk” – those strollers are:

- Valco Baby Tri-Mode
- Tike Tech City X3 all-terrain stroller
- Tike Tech X3 Port jogging stroller

These strollers received this rating due to the hazard of an unrestrained child slipping beneath the grab bar and getting stuck resulting in potential injury or death. (This is referred to as “submarining.”) Although the Consumer Products Safety Commission does not specify the particular strollers involved, they do report that there have been at least 10 infant deaths associated with submarining between 1995 and 2008.

Safety regulations require that if the space beneath the bar is large enough for a child’s body to pass through, it must also be large enough for the child’s head to pass through. Of course, a child should always be properly strapped into his or her stroller.

If your child or the child of anyone you know has been injured by a faulty product such as these or any other defective products, contact us for a free consultation about your potential case.

Product recall: Miley Cyrus jewelry

Just yesterday, Wal-Mart announced that it was recalling its entire line of the popular Miley Cyrus brand of jewelry following reports that the jewelry contains a high level of cadmium – a toxic metal.

Long-term exposure to this metal is dangerous because it can cause bone softening and kidney failure and because it can hinder brain development. There is no danger in wearing the jewelry; however, it can be very dangerous if the metal is ingested. For example, many children place their jewelry/pendants in their mouth and suck and chew on them. This particular jewelry line, when exposed to a chemical similar to stomach acid, very easily released the toxic metal.

Exposure to this chemical is especially hazardous to girls ages 6-11. This may be because girls in this age range tend to have iron deficiencies and their bodies substitute cadmium instead.

Wal-Mart has also recalled some of its Disney pendants.

Claire’s and Dollar N More stores have also recalled some of the charm bracelets sold at their stores.

If you or anyone you know has been injured by a product such as this or any other defective product, contact us for a free consultation about your potential case.