Plaintiffs in thousands of GranuFlo and NaturaLyte lawsuits have asked a Massachusetts federal judge to compel Fresenius Medical Care North America to turn over all documents pertaining to a Corporate Integrity Agreement the company struck with the federal government in 2000. Court records indicate that Fresenius is fighting to limit discovery into that accord.
The agreement in question resolved allegations put forth by U.S. Department of Health and Human Services’ Office of Inspector General that Fresenius had filed false claims for reimbursement from federal healthcare programs. The agreement expired in 2008.
Plaintiffs assert that any violations of that agreement could be relevant to their punitive damage claims. But Fresenius disagrees, arguing in court papers that “plaintiffs’ request for an order compelling the production of essentially every document related to FMCNA’s performance under the corporate integrity agreement should be denied because those documents are wholly irrelevant to any issue in this case and will not lead to the discovery of admissible evidence.” Instead, Fresenius has asked the Court to limit discovery pertaining to the agreement to every document exchanged between the company and the Office of Inspector General related to GranuFlo and other dialysis concentrates.
The resolution of this dispute will impact more than 2,000 GranuFlo lawsuit filings that are currently pending in the U.S. District Court, District of Massachusetts. All of the claims allege that GranuFlo and NaturaLyte dialysis concentrates caused patients to suffer serious heart complications, including heart attacks, strokes and sudden cardiac death.
Both GranuFlo and NaturaLyte were recalled in March 2012, after the products were linked to the occurrence of life-threatening heart problems among patients treated at Fresenius-owned dialysis clinics. According to the recall notice, doctors were unaware that the medications had to be dosed differently than other dialysis concentrates. Failure to do so could result in a dangerous elevation of blood serum bicarbonate levels and related cardiovascular side effects.
Plaintiffs in these claims allege that GranuFlo and NaturaLyte were defectively designed, and that their instructions for use were inadequate. They also claim that Fresenius knew about their risks, but failed to warn doctors and patients in order to protect its sales of the products.
In addition to the GranufFlo recall claims pending in federal court, more than 3,000 additional lawsuits have been filed against Fresenius in Massachusetts Superior Court, Middlesex County.