RE:Legal Storms ChurningThis makes the FDA's upcoming decision to extend claims all the more important. And, this is part of the reason the FDA is being extremely cautious and calculated on the one hand, yet have obvious pressure on them in our patients' best interest to get extended claims done on the other hand. The FDA will approach extending claims to TSO3's revolutionary technology on a case by case, scope by scope, basis so that the standard of care changes gradually and the industry is given time to implement change. But, one can ask, why go so slow in the US leaving hundreds of thousands of patients per year at risk, when a solution is apparent, and approved in Canada (and apparently in Europe)?
And, you can bet the lawyers, the health care providers, and the industry are all aware of this. If you developed an infection, such as those recently reported in the LATimes that resulted in two deaths, and you know and your health care provider knows or should have known that there is a solution available that effectively eliminates this risk for the scope used, (in these recent cases the notorious but useful Olympus Q180V duodenoscope), the liability lawyers will be and are all over this. The more the lawyers make noise and initiate legal action, on behalf of the injured and potentially injured, and on behalf of health care providers looking to protect themselves from liabilities, the more pressure grows to get these improvements to health care implemented. These improvements cannot be implemented too soon, IMHO. WKH
(P.S., I thought I might add, should those recent comments about pumpers and dumpers be in some way aimed in my direction, I am a surgeon concerned for patients' welfare, not a pumper, and, rather than dumping, I recently added substantially to my position following the cc. All is good, and getting better.)