Two lawsuits filed against Fresenius Medical Care over the chemicals it used in dialysis procedures have been transferred out-of-state.
Lawsuits filed by Linda Bryant, on behalf of the Estate of Dalta Dixie Pauley, and Larry DeBord have been transferred to a Multidistrict Litigation proceeding in a Massachusetts federal court. Fresenius has its headquarters in Waltham, Mass.
DeBord is a Kentucky man who says he suffered a stroke and heart attack as a result of using the company’s GranuFlo and/or NaturaLyte at a treatment center in the judicial district of U.S. District Court for the Southern District of West Virginia.
DeBord filed his complaint on June 7. Bryant filed hers May 8 in Kanawha County Circuit Court.
It was removed to federal court and transferred to the MDL on July 9. The lawsuit says Pauley had a heart attack two days after receiving treatment at Fresenius Medical Care in Dunbar.
“Dalta Dixie Pauley died as a result of receiving unreasonably dangerous dialysis chemicals that were unfit for the purpose they were designed and sold,” the complaint says.
“GranuFlo was in a dangerous and defective condition at the time of its sale and delivery to Dalta Dixie Pauley. Its defective condition presented a danger to its foreseeable users and consumers, including Dalta Dixie Pauley, during ordinary and foreseeable use of the product.”
The suit alleges six months after Pauley’s death, Fresenius sent an internal memorandum to certain medical directors and physicians warning them of risks associated with NaturaLyte and GranuFlo.
However, the suit says, Fresenius did not warn the federal Food and Drug Administration.
Actually I really think it is only tangential news on Fresenius (and this was really just a minor update on news that was already there). In general Fresenius has a pretty bad track record for such events and is particularly nasty about hiding such things from The FDA (and the public). Hence, why all the class actions against them. I do think it is probably helpful in some senses with the Takeda/Fresenius negotiations in the sense that F's track record isn't particularly sound...Conversely, another round of fatality issues (moving the Omontys problem to Fresenius, where it most likely belongs) is something they are very likely fighting hard (and using their market potential for Omontys as leverage to try to gain concessions on the fatality issues from Takeda). At some point (sooner than later I think), the Takeda negotiators will take a walk and just get on with Omontys without Fresenius IF Fresenius doesn't capitulate to their responsibilities (legal and with the public) concerning the 3 fatalities.
On March 29, 2012, the FDA reported the company’s voluntary Class 1 recall of both the chemicals. The recall warned users of the heightened risk for low blood pressure, low potassium levels, low blood oxygen, high carbon dioxide levels and cardiac arrhythmia, which could lead to sudden death.
“Had the severe health risks associated with Defendants’ NaturaLyte and/or GranuFlo been properly and/or adequately disclosed, the Decedent, Decedent’s treating physicians and/or healthcare facilities would not have purchase and/or used NaturaLyte and/or GranuFlo,” the complaint says.
Representing Bryant is Roger A. Decanio of The Sutter Law Firm in Charleston. Representing DeBord is James A. McKowen of James F. Humphreys & Associates in Charleston.
Bryant attempted to have her case remanded to Kanawha Circuit Court before it was transferred. Her memorandum says Fresenius operates approximately 20 dialysis clinics in the state.
The two lawsuits will join approximately 130 others in the MDL. Judge Douglas P. Woodcock is presiding over them.