The Medtronic INFUSE Bone Graft uses a genetically engineered protein to help fuse damaged vertebrae and was deemed “revolutionary” when launched in 2002. The bone graft offered doctors an alternative to more traditional forms of treatment for patients suffering from degenerative disc disease, but the medical device was (and is) only approved for use in the lower back region. Allegedly, this did not stop Medtronic from marketing the INFUSE Bone Graft as a form of treatment for injuries of the cervical spine (neck region). It is important to note that it is illegal for a medical device manufacturer to market a product for purposes other than approved by the U.S. Food and Drug Administration (FDA). Complications Associated with Off-label Use of the Medtronic INFUSE Bone Graft In 2008, the FDA warned physicians of the dangers associated with the “off-label” use of the INFUSE Bone Graft. (The term “off-label” is commonly used to describe the use of a drug or medical device for purposes other than approved by the FDA.) The FDA warned physicians that use of the bone graft in the cervical spine could cause life threatening complications, including compression of the airway and neurological structures of the neck, severe dysphagia (difficult swallowing), and swelling of the neck, throat, mouth, and shoulders. If not treated promptly, these complications could result in the death of [...] Read more »
Medical and fitness experts have heavily scrutinized Skechers Shape-ups toning shoes unstable, thick sole. These experts agree that the shoes rocker bottom sole can cause serious injuries one of two ways: either from falling or from extended wear. Despite the rampant reports of injuries related to the use of Shape-ups, Skechers has recently marketed the toning shoes to young children. Children are very susceptible to serious injuries while wearing Shape-ups for a number of reasons. Most children are exploring the world around them and may not be as careful as an adult when walking or stepping up or down in Shape-ups. Children are also still developing motor skills, such as balance and coordination – two skills needed when walking in unbalanced Shape-ups. Finally, children’s bones are still developing and extended use of a Skechers Shape-ups could interfere with a child’s growth process. Types of Skechers Shape-ups Children’s Injuries Children can suffer from the same types of Shape-ups related injuries as adults. Bone fractures, or broken bones as they are also referred to, are one of the most common types of Skechers Shape-ups related injuries. Head injuries, muscle strains/tears, lacerations, spinal cord injuries, Achilles tendon injuries, back injuries, bruises, and neck injuries are also common. Children can also suffer emotional injuries after experiencing a traumatic accident and injury. Getting Legal Help As a parent, you [...] Read more »
Extended use of the popular toning shoe, Skechers Shape-ups, can cause serious, debilitating injuries. Skechers alleges that Shape-ups kinetic wedge sole, which is intentionally designed to be unstable, will help wearers get in shape while on the job, walking or running errands. Several independent studies have shown, however, that the kinetic wedge sole shoe can put excessive strain on muscles, ligaments, tendons, and feet. Nurses and Skechers Shape-ups Injuries Shape-ups were heavily marketed to nurses, many of who spend the majority of their shifts standing and walking. Many nurses purchased the shoes with the hopes of improving muscle tone and improving posture, just as Skechers claimed the shoes would do. Sadly, many nurses discovered that after long periods of use, the shoes instead caused them to suffer serious injuries, such as stress fractures, muscle tears, plantar fasciitis, bursitis, hammer toe, broken bone injuries, and contusions. Nurses are not the only workers who are suffering from Skechers Shape-ups injuries, however. Any worker whose job requires them to stand or walk a lot could be at risk for an injury caused by the extended use of Shape-ups. A 38-year-old Ohio woman who wore her Shape-ups to work as a waitress developed stress fractures in both hips even though she had the bone density of a young woman. Learning What Your Legal Rights Are After suffering a [...] Read more »
The Public Citizen, a nonprofit consumer advocacy organization, has petitioned the U.S. Food and Drug Administration (FDA) to put a black box warning on the labels of three classes of drugs indicating the risk of combining the drugs. These three drugs: angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor blockers (ARBs), and aliskiren are widely used for the treatment of high blood pressure and are among the top selling drugs in the nation. In 2011, more than 249 million ACE inhibitor and ARB prescriptions were dispensed. Studies show that combining the drugs does not provide the patient with any added benefits over using the drugs individually and in fact, show that combining them can cause serious side effects, such as low blood pressure, high potassium levels, and kidney failure. The Public Citizen is also asking the FDA to distribute an approved Medication Guide to patients alerting them of the risks of combining ACE inhibitors, ARBs, and aliskiren. Finally, the Public Citizen wants the FDA to distribute a “Dear Doctor” letter, warning doctors and other healthcare providers of the risks of combination treatment. Taking Legal Action Against Pharmaceutical Companies If you or a loved one suffered a serious side effect after using a combination of ACE inhibitors, ARBs, and aliskiren, you would be well advised to seek the counsel of a competent dangerous drug attorney [...] Read more »
On October 6, 2012, the New England Compounding Pharmacy issued a recall for all of its products that were compounded and distributed from its Massachusetts facility after a fungal meningitis outbreak connected to one of their products has sickened 84 people and tragically killed seven. The U.S. Food and Drug Administration (FDA) has linked the illness to contaminated steroids sold by the New England Compounding Pharmacy, also known as the New England Compounding Center (NECC). The contaminated steroid, methylprednisolone acetate, was distributed to facilities in 23 states from July 2012 through September 2012. All 91 cases of fungal meningitis have surfaced in nine states: Tennessee, Virginia, Florida, North Carolina, Maryland, Ohio, Indiana, Michigan and Minnesota. At this time, no other NECC products have been linked to the outbreak, however, the company said the “recall is being taken as a precautionary measure.” A complete list of affected products can be found on the FDA website. Healthcare providers who have a NECC product should stop using the product immediately. NECC is notifying its customers of the recall via fax. Symptoms of Fungal Meningitis Meningitis is inflammation of the meninges, the protective membranes covering the brain and spinal cord. Because the inflammation is located so closely to the brain and spinal cord, meningitis is classified as a medical emergency and can be fatal. Fungal meningitis is a [...] Read more »
On September 19, 2012, Zimmer Holdings Inc. received a warning letter from the U.S. Food and Drug Administration (FDA) after inspection of its Puerto Rico plant raised concerns over the manufacturing of certain hip implants. In the letter sent to Zimmer, the FDA noted testing and manufacturing issues specifically related to the company’s manufacturing of Trilogy Acetabular Hip System, which has been sold in the United States since 2003. The FDA’s letter states that Zimmer has not implemented a testing mechanism to show that its products have met design specifications. The letter also states that the company has not validated the effect of manufacturing operations on Trilogy Acetabular Hip System products that utilize metallic spikes. Metallic spikes are used to connect the hip replacement device to the patient’s bone when cement and screws cannot be used. The medical device maker said it is notifying consumers of the manufacturing issue and has suspended release of the spiked hip device products until the effect of manufacturing operations can be validated. The FDA requires all drug and medical device manufacturers to take certain steps to ensure a product’s design and manufacturing quality. Estey Bomberger – More than 70 Years Experience Helping the Injured If you or someone you know has experienced complications as a result of receiving a Trilogy Acetabular Hip System, you would be well advised [...] Read more »
Q. I heard Skechers reached a settlement with the Federal Trade Commission. What were the allegations against Skechers? A. In May 2012, Skechers agreed to pay $40 million to settle a Federal Trade Commission (FTC) lawsuit that claimed the shoe company exaggerated the effectiveness of Shape-ups toning shoes. After conducting investigations in several states, the FTC found no evidence to support Skecher’s claims that Shape-ups improve muscle activation and tone. As a result of the settlement, consumers who purchased a pair of Shape-ups may be able to receive a refund. Q. I filed a refund claim online. How much money can I expect to receive? A. Individuals who filed a claim online may receive a full or partial refund of the price of the shoes. However, if you suffered a serious injury while wearing a Skechers Shape-ups, the FTC settlement refund does not reimburse you for injury-related damages. If you suffered a serious head injury, bone fracture injury, ankle injury, muscle injury, back injury or any other type of serious injury while wearing Shape-ups, you may be able to file a personal injury claim to collect financial compensation from Skechers. Q. If I decide to file a personal injury claim, how much financial compensation can I collect? A. Many factors, such as the severity of your injury, determine the amount of compensation awarded to [...] Read more »
On September 25, 2012, Specialized Bicycle Components Inc. issued a recall for approximately 12,000 of its Globe model bikes because the front fork can break, posing a fall and injury hazard to riders. Specialized has received four reports of the front fork breaking and causing a fall. The falls resulted in riders sustaining head injuries, facial fractures, shoulder injuries, and cuts. The recall includes some 2008 and 2009 men and women’s Globe model bikes, including Globe Elite, Globe Sport Disc, and Globe Comp. The bicycles with defective forks manufactured by Kinesis, were sold at Specialized retailers nationwide from July 2007 to July 2012 for $500 to $1,100. The Consumer Product Safety Commission (CPSC) and Specialized are advising consumers to stop using the bikes immediately until a replacement fork is installed. For a complete list of affected Globe bike models, please visit the CPSC website. Do not wait to Contact a Product Liability Attorney If you or someone you know was injured while riding a Specialized Globe bicycle, please do not wait to get legal help. Your legal rights may entitle you to financial compensation and you do not want to risk your one chance to recover funds for medical bills, lost earnings and wages, and pain and suffering. Waiting to seek the counsel of competent product liability (area of law defective products fall under) attorney [...] Read more »
A recall that was issued last Saturday by Sunland Inc. for salmonella contaminated Trader Joe’s Valencia peanut butter now applies to 76 peanut and almond butters sold under various brand names at retailers across the nation. At this time, only the Trader Joe’s brand Valencia peanut butter has been linked to salmonella, however, the New Mexico based company decided to recall all of the possibly contaminated product because the named nut butters were made on the same line of the company’s factory. At least 29 people in 18 states have been sickened by the contaminated peanut butter. A Sunland spokeswoman said that none of its food safety testing procedures detected salmonella and none of the peanut butter that was shipped has tested positive. According to the Centers for Disease Control and Prevention (CDC), the salmonella strain found in the Trader Joe’s peanut butter is hard to detect. The CDC described the salmonella strain as “particularly cunning” and Sunland has not been able to identify the source of the contamination. The company is working closely with the CDC and U.S. Food and Drug Administration to determine how the product became tainted. Customers who have a nut butter affected by the recall should discard the product immediately. For more information on the September 22, 2012 recall and for a complete list of affected products, please click [...] Read more »
Skechers Shape-ups, which is a type of athletic shoe designed to create an unbalanced surface, has caused hundreds of consumers to suffer serious bone fracture injuries. Despite the public’s perception, a severe bone fracture, or broken bone as they are also called, can have serious long-term physical, emotional, and financial consequences. Skechers Shape-ups Bone Fracture Injuries The following is a list of the different types of bone fracture injuries caused by the use of Skechers Shape-ups toning shoes: Ankle fracture Hip fracture Skull fracture Tibia fracture Femur fracture Pelvic fracture Clavicle fracture Wrist fracture Stress fracture Humerus fracture Other types of bone fractures. A serious bone fracture can limit an individual’s mobility – walking or driving may not be possible. Daily tasks like cooking and cleaning may be difficult to execute without help, and the ability to work may not be possible for a bone fracture victim. Victims who cannot work may find it difficult to pay basic living expenses, let alone costly medical bills. Do consumers injured while wearing a pair of Skechers Shape-ups have any legal recourse? Filing a Lawsuit to Obtain Compensation If a Skechers Shape-ups toning shoe caused your bone fracture injury, you may be able to file a lawsuit against Skechers. It must be noted, however, that lawsuits against Skechers must be filed two years from when [...] Read more »