It is common practice to use a warming device, such as 3M’s Bair Hugger, during hip and knee replacement surgeries. This is to guard against the risk of hypothermia and to ensure normal blood flow during the operation. The Bair Hugger has been in common use for over 25 years, and 3M claims that almost 180 million operations have been carried out … [Read more...]
The Growing Scope of the FDA Warnings about Power Morcellators
The FDA first issued a warning about the use of power morcellators in hysterectomy and myomectomy procedures in April 2014 and then expanded and clarified it in Sept 2014. Since that time there have been growing voices of disquiet against the devices, with the first lawsuits being filed in Pennsylvania in March 2014, and up to two dozen cases … [Read more...]
The Three Hurdles of Proving Damages in a Power Morcellation Case
The number of hysterectomy operations in the United States each year exceeds 500,000. Of that number, approximately 55,000 involved the use of power morcellation devices between 1995 (when they were licensed for use in gynecological surgery) and 2014 (when the FDA started to issue warnings against their use in certain circumstances). Based on … [Read more...]
Three Legal Avenues in a Power Morcellation Device Case
The FDA has issued two warnings against the use of power morcellators in certain gynecological surgeries. The first in April 2014 to highlight that 1 in 350 women will have an undetected sarcoma that can potentially have lethal consequences if the devices are used. With a second in November 2014 to further make clear when the devices should not be … [Read more...]
Three Legal Paths for IVC Filter Litigants to Explore
There have been significant developments in the potential for IVC Filter litigation. The safety of IVC Filters was first highlighted by the FDA in August 2010, with over 900 problem cases being reported. Since then, the FDA has carried out further investigations into the issues of IVC Filters moving, failing entirely or having parts come away. In … [Read more...]
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