A leading manufacturer of glucose monitoring devices has issued a Class I recall of two of its devices. Dexcom is recalling its G4 Platinum and G5 Mobile Continuous Monitoring Systems (CGM) due to a potentially deadly defect with their alarms. The devices are supposed to sound an audible alarm if the user’s blood glucose has…
Medical devices and tools must be sterile, or else expose patients to serious infection. Hospitals and medical clinics are often full of germs, because those facilities are where sick people go. If doctors, nurses and device manufacturers are not sufficiently careful, disease can spread from patient to patient. Two people who died at a California…
Consumer product safety is important regardless of the type of product; any item can be dangerous if it enters the stream of commerce with hazardous defects. But when it comes to products that are going to be implanted directly into or onto the human body, it is blatantly obvious that safety standards need to clear…
Sometimes an inherently dangerous product is perfectly safe if used as directed. There could be a variety of sources of information about using a product safely, but one of the most common is product packaging and labeling. For example, picture a sleep aid medication. Take too much, and it could be harmful. But labels on…
In many cases, when you are harmed, in order to collect compensation, you must prove that those who harmed you were negligent; in other words, that they owed you a duty, they breached that duty and in doing so caused you harm, and this resulted in damages (i.e., harm for which a fair dollar value…
As we have previously noted for readers, whether the latest product is a drug or device, approval by the Food and Drug Administration to market and sell a pharmaceutical or medical device hardly ensures the safety OR performance of that product going forward. There has been a steady parade over the last 30 years of…
The defective hip design team at Walkup Melodia in San Francisco is representing clients with defective Stryker hips in claims against the manufacturer. Stryker Corporation recalled its ABG II and Rejuvenate hip implant systems last year after patients began to suffer injuries from corrosion. The company recently told reporters that it will spend between $700…
An increase in adverse event reports for Intuitive Surgical’s da Vinci robots has prompted the FDA to urge doctors to engage in additional training before using these devices. In 2013, there were 3,697 adverse event reports associated with the da Vinic surgical robot. These reports involved patient death, injury, and machine malfunction. The number of…
Intuitive surgical has issued a voluntary recall for instruments associated with its da Vinci robotic surgical system. Intuitive Surgical issued a field notice to physicians that announced a recall related to its da Vinci surgical system. Walkup Melodia’s defective medical device team has been monitoring a number of post-surgical da Vinci patients and evaluating their…
A court-mandated mediation of possible Stryker Rejuvenate hip settlements is about to get underway in New Jersey state court. Currently, there are more than 430 cases pending in coordinated litigation in the court. Ten of these cases were chosen for mediation. Six of these 10 cases were selected by the Court, while plaintiffs and defense…
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