Regular Ring of Fire Radio listeners and visitors to the show's website may have seen a recent article by the show's producer, Farron Cousins, regarding pending cases against German-based pharmaceutical firm Fresenius and its flagship product, Granuflo . In the article, Mr. Cousins reports that Fresenius is claiming plaintiffs injured by their dialysis drug have no case. Not only are allegations of “failure to warn” groundless, company attorneys say, there were no dangers in the first place!
The latter, of course, flies in the face of readily-available evidence – namely, an internal memo circulated among the company's own doctors working at Fresenius' own private facilities. The information in this memo was not shared with doctors and facilities outside of the Fresenius network until the FDA intervened and forced them to declare a recall of their products.
Why Did Fresenius Delay?
According to Franklin Maddux, Chief Medical Officer of the company's North American division, there was no effective or efficient way of sharing the information with outside facilities, other than to publish the information in a professional journal such as the Journal of the American Medical Association or the New England Journal of Medicine – a process that would have taken weeks, perhaps months.
Indeed? In this age of Twitter, Instant Messaging, YouTube and a thousand-and-one other methods of virtually instant mass communication?
That's a question a prominent Web journalist has been asking recently. He writes, “...it appears extraordinary that in the midst of the present information age that allows for news and data to be transmitted globally in mere nanoseconds, a company cannot (or allegedly chose not) to communicate a problem.”
To this, Dr. Maddux responds that the findings were “too preliminary to warrant publication.”
Yet, when there are lives at stake, is it not best to err on the side of caution?
Is Fresenius liable for “failure to warn” its clients and customers about possible adverse events due to its flagship product?
That is what judges and juries will be determining in the coming months.
Fresenius Medical Care Internal Memo Re: Dialysate Bicarbonate, Alkalosis and Patient Safety. Available at http://graphics8.nytimes.com/packages/pdf/business/fresenius-memo.pdf.
Gibb, Gordon. “No Trouble Communicating GranuFlo Lawsuit Claims, but Alkali Dosing Errors?” Lawyers and Settlements, 17 February 2013. Available at http://www.lawyersandsettlements.com/articles/granuflo-recall/granuflo-lawsuit-dialysate-concentrates-hemodialysis-5-18481.html?utm_expid=3607522-0&utm_referrer=https%3A%2F%2Fwww.google.com%2F#.USz4cjAmrk0.
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