Personal injury lawyers at Messa & Associates, P.C. have recently come across news stating that Globus Medical Inc., a spinal implant manufacturer, will pay the U.S. Food and Drug Administration $1 million in penalties for selling its NuBone Osteoinductive Bone Graft product after the FDA rejected the device in 2009.
The FDA learned that Globus was distributing the NuBone Osteoinductive, despite being told that the medical device was not substantially equivalent (NSE) to legally-marketed products, during a September 2010 inspection. The company also ignored multiple warnings given by the FDA to stop selling the device, according to a commissioner for regulatory affairs.
The settlement requires Globus Medical to pay a $550,000 penalty fee and the company’s CEO, David Paul, to pay an additional $450,000 fine.
Personal Injury Lawyers: FDA Approval Process Required NuBone Osteoinductive Devices to Be Substantially Equivalent
The FDA currently uses two procedures to approve medical devices. Clinical trials are necessary to get approval for more critical devices. However, Globus Medical’s NuBone Osteoinductive is considered a medical device that poses a lower level of risk to patients. Therefore, Globus Medical was only required to show that the NuBone Osteoinductive was substantially equivalent to similar medical devices that are already on the market.
Personal Injury Lawyers in Philadelphia and New Jersey
The Philadelphia personal injury lawyers at Messa & Associates are experienced at handling cases involving pharmaceutical and medical device injuries. Our extremely skilled team of personal injury lawyers and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you have been injured by a defective medical device, a negligent medical provider, or have endured any other type of personal injury, contact the personal injury lawyers of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.
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A mass recall of defective birth control pills could result in unwanted pregnancies for the women taking the recalled Pfizer birth control pills. Pfizer recalled 14 lots of Lo/Ovral-28 tablets and 14 lots of generic Norgestrel and Ethinyl Estradiol tablets after discovering some of the blister packs may contain either too many or too few active pills and that the pills may be out of sequence. About one million packets of birth control pills are being recalled because of the error that could cause unintended pregnancies.
Behavioral differences include excessive fussiness, extended periods of crying, refusal to sleep lying down, or too much or too little sleep. Another common indicator of brain damage is developmental delays. There are typical milestones that are generally expected of young children at specific stages of their life. For instance, there is a general age when most infants begin crawling, rolling over, uttering their first word, and so forth. A child with brain damage may have difficulty reaching these milestones at the typical age. Other symptoms can include body temperature, skin color, breathing patterns, seizures, and other similar indicators.
Brain damage can be categorized in one of two ways – acquired and traumatic. Acquired brain injuries are those that do not result from external forces. For example, a stroke would cause an acquired brain injury because no outside forces are the cause. Depending on the site of the lesions ( a lesion is any area of tissue or organ that has suffered damage) and severity of the stroke, the brain damage can affect the victim in different ways. Traumatic brain injury is damage that is caused by external forces. A motor vehicle accident, known as MVA to medical professionals, is often the cause of traumatic brain injuries.
In 2007, the plaintiff was working as a plumber on a construction site under a general contractor and subcontractor. Day one on the job, he attempted to ascend a flight of stairs. As he climbed, the stairs collapsed beneath him. He suffered a burst fracture and had to undergo a two-level spinal fusion surgery to correct his injuries. 
