Too many corporations think they have too much to gain by not telling the truth. That’s been a common theme from Day One of this blog — whether the culprit has been oil giants like BP, lying about the extent of the Deepwater Horizon oil spill, or the natural gas companies who don’t want you to know what they’re doing with fracking wastes, or dishonesty by some of the planet’s largest medical and pharmaceutical firms. Not long ago, I told you about a major problem involving faulty metal hip replacements, and the government’s failure to properly regulate them.
In my work as a trial lawyer, I come across this all the time. Money-making companies that think if they cover up a problem — a faulty product, say, or illegal dumping — it will simply go away. But it usually doesn’t. A government agency may — or may not — step in to make sure that folks don’t get hurt in the future. And lawyers like me are the last means of resort for citizens who’ve been harmed in the past.
Lately, I’ve been following a case that is particularly egregious. It involves an industry leader in the field of kidney dialysis that had received considerable evidence that its treatment method was linked to a rise in fatal heart failures, and yet its executives made a conscious decision not to inform other health clinics. Here’s how the story was reported recently in the New York Times:
The Food and Drug Administration is investigating whether the nation’s largest operator of dialysis centers violated federal regulations by failing to inform customers of a potentially lethal risk connected to one of its products, an F.D.A. official said.
The company, Fresenius Medical Care, treats more than a third of the estimated 400,000 Americans receiving dialysis. It also is the leading supplier of dialysis machines and disposable products, which are used by many clinics in addition to its own.
Last November, Fresenius’s medical office sent an internal memo to doctors practicing in the company’s dialysis centers, warning them that failure to properly use one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest. “In light of these troubling findings,” the memo said, doctors should take corrective action. “This issue needs to be addressed urgently,” the memo added later.
But Fresenius, which is based in Germany, did not immediately warn other centers that use the product, which is known as GranuFlo. It did so only in late March after the F.D.A. received, anonymously, a copy of the internal memo and questioned the company about it.
Here is some additional reporting from RenalWEB, the speciality news organization that first broke the news.
Fresenius Medical Care North America is the largest division of Fresenius Medical Care AG, headquartered in Germany, and is the largest dialysis services and products company in both the U.S. and the world. FMC is uniquely vertically integrated in its business environment in that FMC both owns thousands of dialysis clinics and it also manufactures the dialysis machines and nearly all the medical products used in dialysis care including dialyzers, blood lines, needles, dialysis concentrate, etc. FMC has separate business divisions for clinic operations and for product manufacturing and sales. The FMC products division “sells” products not only to its own clinics’ division, but also to many of its leading competitors, including DaVita, DCI, Renal Ventures, and many others.
When the possible correlation between Granuflo use, alkalosis, and cardiopulmonary arrest was finally made by the Fresenius Medical Services division around 2010, FMC made this information and urgent medical recommendations solely available to its own physicians and clinics. Sudden cardiac death is the leading cause of death for dialysis patients. The internal FMC memo specifically recommended action for patients with pre-dialysis bicarbonate levels of >28mEq/L and especially for those who also had pre-dialysis serum potassium levels of <4 mEq/L. This 6-page internal FMC memo shows that for at least 15 months, FMC did not share this information with the thousands of non-FMC physicians and clinics that were using the Granuflo product. It then appears that FMC received an inquiry on March 27, 2012 from the FDA specifically about Granuflo-related products and alkalosis. Only then did FMC provide a scientifically-ambiguous, 2-page memo with far less actionable information to its non-FMC customers on March 29, 2012. The March 29 memo did not mention any patient blood levels. The most at-risk population of all, “acute” dialysis patients, are not mentioned in either memo.
According to the New York Times report, federal regulators are troubled by the failure of Fresenius to go to its many unaffiliated customers and inform them of the findings regarding Granuflo — and understandably so. The company’s official explanation that it had no good way to get in touch with these health centers simply does not hold water. And the discovery that patients with elevated levels of bicarbonate in their blood had as much as a six times higher risk of suffering cardiac arrest is alarming.
In this case, unlike other recent cases of medical or environmental malfeasance, it does seem like the proper U.S. authorities are moving aggressively and quickly — and that’s good. But that’s still too late for hundreds of families who may have lost loved ones, or for other patients who may have endured pain, all because of this apparent lapse in judgment by Fresenius. For them, justice and closure will have to come through other means.
For my Jan. 21 blog post about problems with hip replacements, go to: https://www.stuarthsmith.com/thousands-of-failures-later-feds-to-finally-regulate-hip-replacements/
To read coverage of the problems with the Fresenius dialysis product from the New York Times, please check out: http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_r=1&&pagewanted=print
For more reporting on the story from RenalWEB, please read: http://www.renalweb.com/writings/alkalosis/BetterFMCOutcomes.htm
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