GranuFlo® Goes To Court
(or "It’s a Scary Time To Be a Dialysis Patient in the U.S.  -  Part II")

by Gary Peterson, 9/27/2013

(Last edited: (10/1/13, 6:55 AM EDT)




Here is some of my favorite dialogue from the 1999 movie “A Civil Action.”  Two opposing lawyers talk as they wait for the jury to decide:

Corporation’s attorney: What's your take?

Personal injury attorney: They'll see the truth.

Corporation’s attorney: The truth? I thought we were talking about a court of law. Come on, you've been around long enough to know that a courtroom isn't a place to look for the truth. The truth is at the bottom of a bottomless pit.

In a Boston courtroom on Sept. 27th, another chapter in the multidistrict litigation (MDL2428) began regarding alleged harm caused by the use of GranuFlo and Naturalyte, dialysis concentrate products produced by Fresenius Medical Care (FMC) named in an FDA Class I Recall in March 2012. (See RenalWEB's background information page.)

For the last year, television commercials and internet ads from personal injury law firms about potential dangers in dialysis treatments have bombarded the public.

If the case is not quickly dismissed or settled, it has the potential to become extremely messy for the entire dialysis industry.  The personal injury lawyers will, of course, focus heavily on Fresenius Medical Care’s role.  Complicating the matter, however, is the fact that many of these lawyers have also begun pursuing cases against other dialysis providers that use Granuflo.  In turn, these dialysis providers will naturally blame the product’s manufacturer, FMC.  In turn, FMC is likely to claim that its products have FDA approval, have been used for more than a decade, and are safe. Accordingly, FMC will likely use its enormous legal resources to redirect blame for any harm on individual physicians.   In the end, the personal injury lawyers are likely to pursue cases against any and all involved parties that have significant assets or malpractice insurance.

With so much at stake, dialysis professionals in this tight knit industry have gone silent.  Since the FDA Class I recall, the Granuflo and Naturalyte products have been quietly relabeled, not reformulated.  Despite the Class I recall and ten years of internal FMC memos noting intractable clinician errors with GranuFlo and machine settings, there has not been a massive industry effort to reduce these errors and/or the potential harm to patients.  This still-needed effort should include Fresenius Medical Care, the other dialysis providers, AAMI (the medical device regulating body), equipment manufacturers, dialysis concentrate manufacturers, physician and nursing groups, CMS, and state inspectors.

Why hasn’t this happened? Where is the truth?

The truth has already been a casualty of this litigation.

Are dialysis patients safe today?  Even though the products were recalled, they were never pulled from the marketplace.

Understandably, patients want to feel safe. Patients and their families want and need to know if they should worry about continued errors and unnecessary risks.It is my opinion that there is still much confusion and that patients are still in danger.

To start, I believe that Naturalyte should never have been included in a Class I recall, which warns of serious adverse health consequences or death.  It would have greatly helped everyone understand the situation if Naturalyte had been explained separately. Naturalyte has the same chemical composition that is used by virtually all dialysis concentrate manufacturers and includes some risk factors for errors.  GranuFlo, however, has a unique chemical composition that includes the use of sodium diacetate, which can double those errors, as well as increase the risk of potential harm to patients. The use of GranuFlo and other concentrates in the same clinic also greatly increases the risk of errors by clinical, technical, medical, and information technology staff. Another source of confusion, in my opinion, is that the likelihood of errors is increased by design flaws in the Fresenius dialysis machine user interfaces when any manufacturer’s dialysis concentrate is used.

The FDA could have prevented much of this confusion if it had instead:
  1. only included GranuFlo in the Class I dialysis concentrate recall, and
  2. created an additional Class I or II recall for problems/errors caused by the bicarbonate settings and readings of Fresenius dialysis machine interfaces. These errors often result in the misdelivery of the prescribed therapy, especially when a combination of Granuflo and other acid concentrates are used in the same clinic.

As a vertically integrated company, FMC manufactures the products, owns the dialysis facilities, employs leading and influential physicians, has employees placed high within regulating bodies, and sells products to other dialysis providers utilizing contracts that depend on the bundled use of several products.  The normal system of checks and balances between manufacturers, clinics, and physicians in medical device safety has been destroyed.

Had FMC acted quickly and massively to reduce problems and errors related to GranuFlo use, it would have made the personal injury lawyers’ cases against FMC much easier to prove. By acting as minimally as possible, FMC can maintain that their products are safe and that any actual harm that has occurred was due to individual physician errors. This has set a terrible precedent for potential future abuses and for potentially creating other safety problems that will be insufficiently addressed.

For now, the dialysis industry organizations have circled the wagons. If all parties act are willing to act as if no significant problems remain and quietly tolerate the continued errors, the lawsuits are unlikely be successful. That leaves only patients and individual physicians to speak out.  Unfortunately, virtually all patient advocates -- nearly all of which are financially intertwined with FMC – have failed to speak out about this patient safety issue.  Individual physicians who speak out face professional ostracism and potentially enormous legal expenses.

With nearly everyone threatened financially in some way, the industry can no longer act quickly or effectively to correct known safety problems with GranuFlo. Unless some action is taken, patients can only hope to dodge potential errors related to its use for years to come.  Due to complex financial structures within the industry, the threats created by this litigation have made dialysis patients less safe.  Any settlement is likely to include nondisclosure agreements, with the truth and its lessons remaining unknown.

Whatever the outcome of this case, win or lose, it is no longer possible for this industry to claim that it promotes a culture dedicated to patient safety.  Perhaps that’s the one knowable truth near the bottom of this bottomless pit.


Neither Gary Peterson, the RenalWEB Corporation, any related business entity, or any associate have any financial interests dependent on the outcome of this litigation. There is no intention by any of these parties to pursue any kind of whistleblower or legal action to gain financially from any issue related to this litigation. To remain impartial, Gary Peterson has not participated in discussions or communications with any actual/potential plaintiff/defendant or their legal representatives. RenalWEB has not gained additional advertising revenues from its coverage of this issue over the last two years.


As editor of RenalWEB and in the role of a journalist, I feel I need to identify what I believe to be the most significant source of misinformation for patients on the GranuFlo issue.  Despite contacting this individual and hoping to resolve this privately for the last two weeks, the lack of any urgency displayed by her in correcting this misinformation -- and then creating even more misinformation -- impels me to share this information with the public.

Dori Schatell, the Executive Director of the Medical Education Institute, has posted more than one message over the last nine months on a dialysis patient discussion Facebook page that states that GranuFlo has been reformulated and also implies that there are no longer any significant safety concerns.

Her postings appeared on the “Dialysis Discussion Uncensored” public Facebook page in January and September of this year and have been read by thousands of patients and their family members.

On Jan. 2, 2013 at 11:15 am, Dori Schatell posted this message:

“Granuflo has been reformulated, Ellen, so there is nothing to worry about now. Apparently, checking bicarb levels was NOT standard practice, which is one reason why the docs didn't know what was going on.”

As of Sept. 26th, that posting still appears on this public Facebook page: http://www.facebook.com/groups/DialysisUncensored/permalink/326024730839494/.

The owner of the Dialysis Discussion Uncensored Facebook page then repeated that misinformation in this May 2013 thread:
http://www.facebook.com/groups/DialysisUncensored/permalink/394288787346421/

On Sept. 12, 2013, Dori Schatell posted this message in regard to another inquiry about GranuFlo or Naturalyte:

“It's been re formulated & is fine now.”

It appeared on this page: http://www.facebook.com/groups/DialysisUncensored/permalink/442609805847652/
This appeared after John Kim’s posting about GranuFlo and Naturaltye at 12:55 am.  After I saw this, I confronted Ms. Schatell multiple times about her misstatement. After several e-mails, this September posting was deleted.

In my contacts with her since that time, she has been unwilling to publically express regret or concern for being the source of this misinformation for so many people. Instead, she added this comment to the thread on Sept. 25th:

"Hi y'all. Gary Peterson, who must have either seen this thread on the larger FB or is lurking in this group (though his name did not show up) took issue with a post I've already deleted about Granuflo. My point was that John does NOT need to worry about this now, because the situation has been handled. I thought that it had been handled by reformulating it after the recall. Actually, it doesn't look like the product itself is different--but the product was not exactly the problem. The problem was that it was reformulated in 2002, without telling nephs. Docs were then prescribing it wrong, and not checking the serum bicarb lab test values that would have alerted them to the higher risk of heart problems or even death. The recall got enough attention that nephs have now changed the way they prescribe so this is no longer a risk--but the attorneys will keep advertising on TV for probably years while they try to sort out who was actually harmed by the product (vs. who had heart problems due to diabetes, high blood pressure, poorly done fluid removal, etc...). Here's a link to some FDA info about the recall. http://www.fda.gov/.../safety/listofrecalls/ucm309990.htm"

I would suggest that patients who want a clarification should print the above paragraph and take it to their physician for discussion.

The Medical Education Institute has received large revenue streams from FMC in the recent past.


On Wednesday, Sept. 25th, continuing bicarbonate dosing errors received significant discussion at the medical director symposium at the NRAA conference in Seattle. Due to anti-trust agreements, names of products were not used. However, specific descriptions of acid concentrates that require dial-down adjustment of 8 mEq/L and the confusion created for staff by default machine settings and the use of different combinations of acid concentrates in a clinic were discussed.

Finally, here are some example letters that may be useful to physicians and patients who want to change this situation in their clinics. Eliminating GranuFlo from clinics will greatly reduce the potential for errors.


   


 

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