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 »
In prescription drug news, a jury recently decided that a doctor who prescribed Paxil over the phone must pay $1.5 million to the widow of a man who committed suicide. Joseph Mazella was a beloved high school basketball coach and assistant principal who had told his wife that he felt like his head was on fire. Janice Mazella had gotten out of the shower one morning when she found her 51-year-old husband dead. Mazella had been prescribed Paxil by Dr. William Beals for 10 years over the phone. In August 2009, Joseph Mazella called Dr. Beals when he began to feel anxious again. Despite not seeing his patient for a decade, Dr. Beals doubled Mazella’s Paxil dose and added the antipsychotic drug Zyprexa. A little more than a month later, Mazella committed suicide. Jurors are notoriously reluctant to blame a suicide on a drug or a doctor. Instead, like most people, are apt to blame suicides on individuals. This verdict is evidence that people are becoming increasingly aware of the effects of psychiatric drugs possibly doing more harm than good. Paxil came on the market in 1992. Since then, countless failure to warn lawsuits have been filed against GlaxoSmithKline alleging birth defects, suicide and addiction. According to ssristories.com, roughly 150 suicide cases were settled for ana average of about $2 million and about 300 [...] Read more »
For years the FDA has encouraged the use of generic drugs, insisting the generic brands were just as effective as brand name drugs. As it turns out, generic drugs may not be an equal alternative to its brand name counterparts. After receiving reports that patients taking the generic form of Wellbutrin, a popular antidepressant, suffered a relapse in their depression, the agency has decided to examine the ways in which generic drug manufacturers make extended release drugs. Although regulators claim that the problem seems to be limited to only one generic drug, a 300-milligram dose of bupropion, the FDA’s decision that generic is not the equivalent of the original brand name drug has raised concern and awareness amongst many consumers. According to Joe Graedon, a pharmacologist, the problem of less effective generic drugs may be more widespread than the FDA is aware. Critics of generic drugs say that even with the same active ingredients, generic companies are not always successful in replicating the extended-release effects of the originals. For some patients, cheaper alternatives may not be a suitable one, especially for consumers with prescriptions for extended-release drugs. Pharmaceutical companies also patent the way drugs are manufactured and designed to release the active ingredient. Therefore it is often the case that generic versions of such drugs are unable to have the same effects [...] 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 Wall Street Journal reported today that problems with the recalled heart defibrillator leads were known about for as much as five years before they were recalled. The recall of faulty St. Jude cardiac defibrillator leads was sparked by a warning letter issued to doctors in December 2010. Reportedly many physicians reported problems with the device years earlier, including the director of Johns Hopkins Medicine’s arrhythmia service, and the chief of electrophysiology at the University of Pittsburgh Medical Center. These doctors said they had encountered the so-called “inside-out” abrasion with their own patients between 2006 and 2009. These malfunctions were reported to St. Jude and company officials told them the incidents were isolated. St. Jude spokeswoman Amy Jo Meyer says the company as communicated “proactively” with doctors and the FDA. Following the 2010 warning, the FDA issued a second, November 2011 recall, citing insulation problems, including inside-out abrasion and externalized conductors. Individuals who have experienced electrical malfunction with a St. Jude heart device may be entitled to compensation for their medical care expenses, lost earnings, pain and suffering, and other damages. For more information, visit: http://www.dangerousproductslawyer.com/defective-st-jude-defibrillator-leads.
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 »