If a family member is a patient at a treatment center and the staff administers a medication that causes severe injury or death, who is liable? The facility that purchased the medication? The staff member who administered it? Or perhaps, the company that manufactured it in the first place?
This is the question that is coming up in the litigation surrounding the dialysis product, GranuFlo, manufactured by the German pharmaceutical firm Fresenius. GranuFlo is a dry acid powder used to help cleanse a dialysis patient’s blood, and it was approved for use in 2003 under the FDA’s controversial medical device certification process known as “510(k)”. GranuFlo has been used at dialysis around the country, including centers owned and operated by DaVita Healthcare, a Colorado-based company specializing in kidney issues. GranuFlo, used during the blood-cleansing process to increase a dialysis patient's blood pH levels, has now been implicated in thousands of deaths from spontaneous cardiac arrest.
Not surprisingly, hundreds of lawsuits have now been filed. The targets of these lawsuits range from Fresenius (the manufacturer) to DaVita (the clinic who administered the product), and in some very rare instances, the doctors and nurses who prescribed or used GranuFlo.
It's not the first time DaVita has been sued in connection with Granuflo. Ironically, DaVita was involved in a lawsuit filed by Granuflo's manufacturer, Frenesius, which operates its own competing clinics. DaVita was not the defendant in that case, but the fact that their clinics were allowed by the state of Illinois to operate in competition with Fresenius' own dialysis clinics was an issue.
Although these fierce corporate competitors have not been shy to seek legal action against each other in the past, the GranuFlo lawsuits raise a question about the responsibility of multiple parties in the supply chain of medical and pharmaceutical products. Lawyers for DaVita are petitioning a federal judge to dismiss a case against the company on grounds that they had no way of knowing about the harmful effects of the drug. And, in fact, there is evidence that Fresenius did know about the risks of GranuFlo, but did not divulge that information to clinics outside the company's own networks, citing excuses that the findings were too preliminary, and that to publish the information in a major medical journal would have been premature and have taken too long (this in the age of Twitter). In fact, the Food and Drug Administration itself was not aware of the problem until an internal memo was anonymously leaked to that agency.
Taking all of this into consideration, it is possible that DaVita may have justification for having the case against it thrown out – unless it can be proven that the company continued to use the medication after the FDA made the public aware of its dangerous side effects. How the federal judge in the case will rule remains to be seen, however.
Donaghy, Neil. “Clinic Files Motion to Dismiss DaVita Dialysis Lawsuits.” Injury Lawyer News, 28 August 2013.
Sundar, Sindhu. “Fresenius Hid 'Serious' Health Risks Of GranuFlo, Suit Says.” Law360.com, 27 August 2013.
Learn more about GranuFlo lawsuits