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Matthews & Associates is a law firm of trial lawyers, investigators, consul- tants and medical personnel. We help people harmed by negligence, greed or incompetence. With more than 100 years of combined legal experience, our lawyers have practiced in nearly all 50 states and P.R.. We have the resources to handle any personal injury case.

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Matthews Legal News

FDA Recalls GranuFlo & NaturaLyte

Recall initiated March 29, 2012

 

Blame Doctors' Math for Granuflo?

Fresenius Medical Care does

 

FMC & Sodium Diacetate

Hemodialysis Patients Need Perfect Balance

 

"Dear Doctor" Letter too little too late

Fresenius (FMC) too slow to respond

 

  


Matthews Legal News

"Dear Doctor" Letter too little too late

Posted by Administrator (admin) on Nov 21 2012 at 11:18 AM
Matthews Legal News >>

In a “Dear Doctor letter” issued the same day as the recall March 29, 2012, Fresenius Medical Care (FMC) advised care providers that dialysates do contain acid units, with emphasis on prescribing accurate units of acids in preparing final buffer solutions. And yet FMC failed to inform the prescribing physicians of the real problem, which is the very chemical nature of Sodium diacetate. The use of Sodium diacetate is not problematic; but failing to expressly inform prescribers that it yields two acid units is.

A full six months before the recall, FMC had warned its own dialysis centers and doctors about the use of incorrect units of acids, but they failed to warn other centers and physicians who use Naturalyte and GranuFlo products. FMC only warned the others when forced to warn them six months later by the FDA's class I recall of the FMC products.  It is not yet clear whether FMC had a legal obligation to notify other customers; but that apparent obligation is currently being evaluated by FDA. We  think it is very clear that FMC  had a moral and fiduciary duty to do so. It appears the company placed profits ahead of patient safety.

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