Cycle Gear Motorcycle Helmets Recalled

 

Cycle Gear is recalling certain Street & Steel brand Big Bore model motorcycle helmets, sizes Extra Small and Small.  These helmets were manufactured in December of 2012.  The recall deals with the failure of the helmets to comply with dwell time requirements of Federal Motor Vehicle Safety Standard No. 2818 “Motorcycle Helmets”.  If you own one of these helmets, you should be aware that you may not be adequately protected in the event of a crash, increasing your risk of head and neck injuries.

The voluntary recall by Cycle Gear includes the ability to exchange your defective helmet with a replacement helmet, or alternatively, a refund on your investment.  If you own one of these helmets, please contact Cycle Gear by calling 1-800-292-5343 or by email to customerservice@cyclegear.com.

Is That School Bus Safe for My Child?

As parents, we want our children to be as safe as possible when we send them off to school.  Twenty years ago, we could assume our children were safe not only getting to school but in school.  Unfortunately, there are many aspects of school safety that we simply have no control over.  So we concentrate on the things we do have control over, such as how our children get to school.  If you are fortunate enough to be able to take your children to school every day, you have a great deal of control over their safety.  However, many of us have no choice but to trust the bus to transport our children safely from our homes to their school.  Do you know how safe your school bus company is?

The Federal Motor Carrier Safety Administration has developed an Online Safety Measurement System “Carrier Search” tool, which can be found at http://ai.fmcsa.dot.gov/sms/Data/Search.asp.  This search tool allows you to search for your school bus carrier, either by legal name or a trade name (“d/b/a” – doing business as).  Alternatively you can search by state.  Once you are able to locate your school bus company, you can get details on the company including unsafe driving, driver fitness, drugs/alcohol, crash indicator and other helpful details.  You may also access details regarding vehicle maintenance.

This tool makes it easier than ever to compare different transportation companies, if you have a choice, or to simply stay informed regarding the company you are entrusting with your child’s safety on their way to school.  You will note that most school buses do not have seat belts.  According to the American School Bus Council, school buses are designed to be safer than passenger vehicles in avoiding crashes and preventing injury.

Drivers are well trained and carefully screened, participating in pre-employment and random drug and alcohol testing, as well as frequent record checks.  The drivers receive specialized training in loading and unloading, as well as security and emergency medical procedures.  The buses themselves are equipped with stop arm signs, flashing red lights, cross-view mirrors and reinforced sides.  They are often painted a bright color to help keep them visible in inclement weather.  The National Highway Transportation Safety Administration has a website dedicated to school bus facts.  Ultimately, students are about fifty times more likely to arrive at school alive if they take the bus than if they drive themselves or ride with friends.  Statistics also show that students are actually safer riding the bus than even being drive by a parent.

For more information regarding school bus safety, please refer to the Federal Motor Carrier Safety Administration.

FDA Recalls Stryker Spine Oasys Midline Occiput Plate

The United States Food & Drug Administration (FDA) has issued a Class 1 Recall on the Stryker Spine OASYS Midline Occiput Plate, used as an implant in spinal surgeries.  The recall was issued as a result of reported fractures of the pin that connects the implant’s tulip head to the plate body.   On May 30, 2013, Stryker, the maker of the implant, had issued an Urgent Medical Device Recall requesting medical facilities to immediately stop using or distributing recalled lots.  In June of 2013, Stryker notified spinal implant surgeons to begin routine clinical and radiographic post-operative evaluation for patients with an implant.

The FDA recommends an urgent evaluation if a patient with an implant begins to experience pain, weakness or numbness.   After revision, Stryker recommends routine post-operative care and follow-up.

Stryker has learned that in cases where a post-operative fracture occurs in the pin that connects the tulip head to the plate body, serious side-effects can occur, including blood loss, nerve injury and the necessity of a revision surgery to attempt to replace a fractured implant.  Affected products were distributed between April 23, 2010 and February 12, 2013 and include an estimated 1,536 units in the United States and another 880 abroad.

If you or a loved one has experienced any of the above symptoms, contact an attorney experienced in evaluating these types of claims.  Compensation recovered can help pay for medical expenses, lifestyle changes due to disability, economic and emotional damages.

Granuflo/Naturalyte Litigation Demonstrate Potentially Devastating Effects for Patients of Dialysis

On March 29, 2012, the United States Food & Drug Administration (FDA) issued a Class 1 recall of a popular dialysis drug called GranuFlo, along with its sister drug Naturalyte.  According to the recall, these products can lead to “a high serum bicarbonate level in patients undergoing hemodialysis”.  This could contribute to additional side effects such as metabolic alkalosis, a significant risk factor which has been associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which could also result in heart attacks or cardiopulmonary arrest.

Evidence that Granuflo/Naturalyte could lead to such serious and devastating injuries, up to and including death, during dialysis led the FDA to take action in the form of a serious recall.  Unfortunately, these drugs still remain on the market, despite the fact that lawsuits have begun to emerge based on the terrible effects of the drugs.   Although not inherently dangerous products, NaturaLyte and GranuFlo can become lethal when mixed and administered incorrectly.  GranuFlo is the only acetic acid containing drug that also has sodium di-acetate.  The sodium acetate gets converted into bicarbonate by the patient’s liver, which results in increased bicarbonate levels beyond prescribed limits and causes an increased risk of metabolic alkalosis.

DaVita Healthcare, a national dialysis treatment provider that uses both GranuFlo and NaturaLyte during hemodialysis, is currently facing four class action lawsuits in the US District Court for the District of Colorado resulting from the adverse health effects associated with improper use of the drugs.  Both drugs are made by Fresenius Medical Care.   Lawsuits brought against Fresnius Medical Care are based on allegations that Fresnius knew about the possibility of adverse effects from its products but failed to warn doctors and facilities outside of the company.

If you or a loved one has suffered adverse effects during dialysis, please contact an attorney experienced in evaluating these types of claims.  Compensation recovered can help pay for medical expenses, lifestyle changes due to disability, economic and emotional damages, as well as funeral expenses for the worst cases.