Suits target Waltham maker of dialysis solutions
(Waltham, MA, 07/16/14) Fresenius Medical Care at 920 Winter Street in Waltham. Wednesday, July 16, 2014. (Staff photo by Stuart Cahill
LEGAL BATTLE: Fresenius Medical Care is facing thousands of lawsuits over its dialysis solutions.
By Bob McGovern and Jordan Graham | jordan.graham@bostonherald.com |
PUBLISHED: July 17, 2014 at 12:00 a.m. | UPDATED: November 18, 2018 at 12:00 a.m.
Hordes of alleged victims and their families from across the country are descending on two Bay State courts, claiming a Waltham company did not explain the risks of its dialysis solutions, which are now the subject of nearly 5,500 lawsuits.
Fresenius Medical Care, which manufactures dialysis solutions GranuFlo and NaturaLyte, is fending off a tidal wave of lawsuits that allege the two products caused heart attacks, strokes and, in some cases, death. More than 1,800 cases have been filed in U.S. District Court in Boston, according to plaintiffs' attorneys, and another 3,694 have been filed in Middlesex Superior Court, according to state officials.
"We stand by the detailed allegations in the complaint that for years Fresenius knew about the dangers associated with GranuFlo and NaturaLyte, but turned a blind eye to the injuries the products could and would cause," said Lauren Barnes, a lead attorney in the case. "By doing so, the company allowed thousands of individuals and their families to suffer significantly and needlessly."
A Fresenius spokesman defended the company's products, which are still publicly available, and said they continue to save lives across the country.
"GranuFlo and NaturaLyte are safe and effective when used in accordance with their labels and instructions for use," said spokesman Kent Jarrell. "Both products are essential to dialysis."
Since there are so many different lawsuits, the two courts consolidated the cases. As it currently stands, U.S. District Court Judge Douglas P. Woodlock and Superior Court Judge ?Maynard Kirpalani will hear the cases. Since there is no class action, the judges will hear a bellwether case — a lawsuit that generally represents all plaintiffs — to determine whether Fresenius is at fault, according to a plaintiffs' attorney.
Fresenius allegedly knew an improper mixture of its products could cause serious health problems or death in people receiving dialysis, according to a lead complaint. Plaintiffs allege that a 2011 internal memo explaining certain risks showed that the company "knowingly failed to notify" patients or the FDA.
In 2012, the FDA issued a Class 1 recall for NaturaLyte and GranuFlo requiring the company to change the products' labeling. A Class 1 recall, the most pressing drug recall, is used when there "is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death," according to the FDA.
The FDA, however, has never removed the products from the market.
"GranuFlo and NaturaLyte received appropriate FDA clearance before they were initially marketed, and that clearance remains in effect," Jarrell said. "The FDA has not suggested any change in the production formulation or asked that the products be removed from the market or returned by clinics to Fresenius Medical Care."
Earlier this year, the company recalled a batch of NaturaLyte because the fluid developed higher than acceptable bacteria levels. Fresenius said that recall is not related to the one in 2012 or the litigation.
Fresenius operates 11 dialysis clinics in Massachusetts. The Department of Public Health was not able to say if it had received any complaints. Fresenius also has a drug store license and a wholesale distributor license in Massachusetts.
With the wave of litigation, dozens of lawyers have filed suit, but the entire case is being handled by a smaller team of attorneys who work together on guiding the process, according to Jeff Grand, a lawyer whose firm "currently represents hundreds of clients" in the suit.
Bob McGovern