Medical Information on Georgia Drivers Licenses

Georgia drivers with certain medical conditions can now choose to have their conditions listed on the back of their Georgia driver's license or state identification card. The Georgia Department of Driver Services now has 16 conditions which may be included on the license, including pacemaker, autism, hearing loss, seizures, brain injury, and diabetes. Other conditions could be added in the future according to Susan Sports, a spokeswoman with the state agency.


Having the information on a driver's license could aid emergency responders in knowing how to best treat people who may be unconscious, advocates say. The information could help law officers determine whether a medical condition, such as a brain injury, may be affecting treatment or behavior.


The information may also be especially helpful for people with hearing loss who are unable to hear instructions or communicate well with law enforcement.


The decision to give motorists the option of having the information was prompted by a state Senate bill signed into law last year that allows people with post-traumatic stress disorder to put a notation on their licenses. "It could make the difference in saving a life," said state Sen. Ronald Ramsey, D-Decatur.


Participation in the new program is voluntary. Forms are available online that need to be filled out by the applicant and submitted at the time of obtaining a license or ID card. For some (non-obvious) conditions, verification from a doctor will also be required.

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.

Hip Implant Not Giving You Problems?

If you have a hip implant or if you know someone who has had a hip replacement, the following information may be helpful to you regardless of whether the hip implant is causing you problems or injuries today.

Hip Implant Recall

One year ago, Johnson & Johnson recalled a hip implant it manufactures under the DePuy Orthopaedics label. It turns out the DePuy ASR hip implant system is faulty. It is a metal-on-metal (“MOM”) product that began being implanted in 2003. At first, DePuy marketed the hip as new technology that was the “Rolls Royce” of hip implants – it was designed to be implanted in a younger, more active population for long-term use.

Timeline of the Recall 

After only a couple years of use, problems with the device began to surface. The first reports of problems appeared in 2005. In 2007, DePuy began pulling some of its systems off the market in Australia due to widely-publicized problems, but it stayed on the market in the United States. In 2009, DePuy began a “silent recall” which involved decreasing sales and pulling some of its inventory from the market. On July 17, 2010, DePuy finally issued an official recall of the ASR Acetabular implants, more than 5 years after the problems began.

Problems with Design 

As it turns out, the device was very poorly designed. The shallow nature of the cup is different than other MOM devices in two primary ways that have caused problems:

1. It causes excessive heat and friction between the metal cup and the metal ball; and
2. The size, design and location of the resurfacing cup are three important factors that relate to the release of metal ions in the body. The design at issue here increases friction at multiple contact points between the femoral head and the acetabular cup. 

Injuries to Patients

The problems with the implant have required revision surgeries where the patient has to have the DePuy system removed and a new system put in. Some of the common symptoms and difficulties associated with the DePuy recalled product include:

• Difficulty standing or walking
• Crunching or popping noises
• Hip fractures or dislocation
• Inflammation and swelling
• Tissue and muscle infection and necrosis (which is tissue death)
• Cobalt and Chromium Toxicity also known as Metalosis
• Severe Pain
• Dislocation
• Loss of muscle mass

Metalosis

Metalosis is a common problem caused by metallic particles being released into surrounding tissue and into the bloodstream. The excessive heat and friction between the metal cup and the metal ball creates these metallic particles. The friction results in ions of chromium and cobalt being released into the body. As a result, patients are experiencing Aseptic Lymphocytic Vasculitis Associated Lesions (“ALVAL”) from heavy metal toxicity. Symptoms of metalosis include:

• Swelling in and around the implant site
• Spontaneous dislocation of the hip
• Nerve palsy
• Noticeable mass or rash
• Groin or thigh pain
• Fatigue
• Intense pain in the hip

The long-term injuries from metalosis include:

• Damage to the tissue and muscle surrounding the prosthesis, including necrosis
• Bone deterioration (may be progressive)
• Infection
• Possibly cancerous

No Problems Yet?

Many people who have had problems with their hips have had a hip replacement or revision surgery. However, many people who have the faulty product may not be currently experiencing problems with the device and they may not be aware that they need to act now to preserve their potential claims for a future revision surgery. Here’s why:

In these types of cases involving massive produce recalls affecting thousands of people, the manufacturer will enter into an agreement that stops the clock from running out on people who have been affected. What this does is allow people who don’t realize they are affected to be able to proceed at a later time when they realize they need to do something. Unfortunately DePuy and Johnson & Johnson have not done this and it looks like they are not going to. That means that people in Georgia (and other states that have only a 2 year statute of limitations) who have these faulty hip implants but have not yet experienced symptoms of pain or needed a hip revision surgery or who do not yet have high levels of cobalt and chromium toxicity will still be required to act no later than August of 2012 or lose their ability to pursue a claim against the manufacturer.

What You Need To Do

Because the deadline will most likely be August of 2012, anyone who has a hip implant (even if you have not had any adverse effects) needs to do the following:

1. Contact their surgeon to determine what type of implant they have
2. Get an appointment to have diagnostic testing performed to determine if your implant is injuring you
3. Do NOT sign a release from the surgeon or DePuy or Johnson & Johnson
4. Consider keeping a journal of the problems and treatment related to the hip implant
5. Contact an attorney that handles the DePuy cases for a free consultation as soon as possible

Please feel free to contact one of our hip implant recall attorneys for more information. Danny Studstill is located in South Georgia near Tifton and Valdosta. Haynes Studstill is located in Middle Georgia in Macon. We would be happy to speak with you and help you determine if you need to take action.

New Car Seat Safety Laws Aim to Protect 6 to 8 year olds in Car Accidents

A new law that goes into effect in Georgia this Friday will be a crucial step in closing the gap between Georgia law and federal guidelines when it comes to child seat safety laws and protecting children in car accidents.

Beginning July 1, the minimum age for a child to stop using a booster seat will change from 6 to 8. However, children under the age of 8 who weigh more than 40 pounds and are more than 4 feet 9 inches tall will be exempted from the law. Children who are less than 40 pounds and shorter than 57 inches tall are just too small to properly be restrained by a vehicle's seatbelt alone. They will be required to use a booster seat or 5-point harness.

Statistics show that only about 12% of children between the ages of 6 and 8 are currently using booster seats so there will be a lot of children going back into booster seats that had previously been using only the vehicle's lap and shoulder belt. But the bright side is this: statistics also show that children who are properly restrained have a much greater chance of surviving a motor vehicle collision with minor injuries or no injuries at all.

While children may reach the age where all they are required to use is a booster seat, experts agree that car seats with a 5-point harness are the best protection for children less than 100 pounds. The reason is this simple: the 5-point harness system is designed to distribute the forces of a car crash across the strongest bones of a child's body--the shoulders, chestbone and thigh bones--and minimize the strain placed on the child's neck and spine. The fact that a child has reached the minimum requirement to begin using a booster seat does not mean that it is the safest choice.

For more information on children's safety in cars, please see our September 30, 2010 post about car seats. We posted great videos that demonstrate what a difference a 5-point harness can make in a car crash.

Understanding Sunscreen Labels: FDA Helps Reduce Confusion and Permanent Injury

The U.S. Food and Drug Administration (FDA) announced Tuesday that sunscreen products meeting modern standards for effectiveness may be labeled with new information to help consumers find products that, when used with other sun protection measures, reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn.

The final regulation allows sunscreen products that pass the FDA’s test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays to be labeled as “Broad Spectrum.” Both UVB and UVA radiation contribute to sunburn, skin cancer, and premature skin aging. Sunburn is primarily caused by UVB radiation.

Under the new labeling, sunscreens labeled as both Broad Spectrum and SPF 15 (or higher), if used regularly, as directed, and in combination with other sun protection measures will help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.

Here's the key: Products that have SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test, but only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed.

Any product that is not Broad Spectrum, or that is Broad Spectrum but has an SPF between 2 to 14, will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.

In addition to the final rule for sunscreen labeling, the FDA also released a Proposed Rule that would limit the maximum SPF value on sunscreen labels to “50 +”, because there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50.

The new regulations will become effective for most manufacturers in one year.

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.