Granuflo powder/acid dialysate: Blame Doctors?
Despite several opportunities to right a wrong, Fresenius Medical Care (FMC) has conspicuously failed to define and clarify the potential issue and controversy surrounding its Granuflo dialysate powder acid concentrate. Judging by the content of its “Dear Doctor Letter” issued in March 2012, FMC is treating this deadly outcome as a matter of “fuzzy math” on the part of doctors. The letter implies that hundreds of doctors have simply neglected to read product labels correctly, and that those same doctors have failed to add simple figures to arrive at an accurate final product.
But how difficult would it be to add 24 units of bicarbonate with 8 units of acid from Granuflo, to get a yield of 32 units in the final solution? How did so many doctors arrive at 36 units instead of the mathematically expected 32? Did this suggestion of incompetency in math really cause the death of 941 patients from sudden cardiac arrest in FMC’s in-facility dialysis centers in 2010 alone? Or is this claim that doctors used fuzzy math just a shameless cover to hide a much greater problem? Is it a problem that Fresenius has had knowledge of since 2003 when a new formulation of Granuflo was approved for marketing?
Transvaginal Mesh Lawsuits Prompt Sixth Multidistrict Litigation
A sixth multidistrict litigation (MDL) for transvaginal mesh lawsuits was formed late last month to help handle the high number of cases involving the defective devices.
In August 2012, the Panel on Multidistrict Litigation ordered all federal cases regarding Coloplast transvaginal mesh transferred to one court in the Southern District of West Virginia. At least 24 federal lawsuits have been filed against Coloplast to date, according to the company. The panel noted in the transfer order that 13 cases had common questions of fact and that most claim Coloplast mesh and bladder sling products cause serious injury to their users.
The order states: “Centralization [moving cases into the MDL] is consistent with our recent decision creating separate pelvic repair product MDLs involving [other] defendants.”
HOUSTON — Matthews & Associates and Freese & Goss are scheduled to jointly try the first American Medical Systems transvaginal mesh case in the United States, in a Houston courtroom in February 2013.
A two-week trial is scheduled for Harris County District Court, where a judge granted preferential docket status to the case involving a 68-year-old Houston woman who developed problems after being implanted with transvaginal mesh. Such status puts the case at the head of the cue, meaning that this case is likely to go forward and be tried as scheduled, beginning Feb. 25.
The mesh caused the then 64-year-old woman severe pain and had to be surgically removed less than two years later. She continues to experience pain and emotional problems stemming from her injuries.
Between 30-50 percent of women will experience POP (Pelvic Organ Prolapse) in their lifetimes. More than 300,000 POP surgeries are performed each year, about one-third of them with mesh. Despite that large number, the FDA has announced it could find no benefit for women placing the mesh as compared to not placing it.
When the FDA released its own study that showed Actos can increase the risk of bladder cancer, it caused two foreign governments – France and Germany – to ban the drug outright, but it has never left the shelf in the U.S., where it is now being unleashed in generic form.
The Food and Drug Administration has approved the first generic version of the type 2 diabetes drug Actos, which will make the popular and controversial drug available at a lower price, hence likely to be taken by more and more diabetics. Mylan Pharmaceuticals will manufacture the first generic form of Actos in 15-, 30-, and 45-milligram doses.
NaturaLyte and GranuFlo, used in dialysis, appear to increase the risk of heart attack. On March 29, 2012, all Fresenius Medical Care (FMC) Naturalyte and Granuflo dialysates products were the subject of a class I FDA recall, which included all products manufactured since 2008. The FDA is also investigating whether the company’s failure to warn patients violated federal law. It appears now that Fresenius Medical Care (FMC) failed to alert the public to the GranuFlo heart attack risk for several months after first discovering the increased heart attack risk.
$5.5 Million Jury Award in Case against C.R. Bard
On July 23, 2012, a California jury awarded a 53-year-old Bakersfield woman $5.5 million for transvaginal mesh injuries. A former runner, Christine Scott first saw doctors in 2008 for stress urinary incontinence. She was implanted with transvaginal surgical mesh to treat it, but that “solution” morphed into a nightmare. The synthetic mesh eroded into her colon. In the product liability action, Ms. Scott said that the Avaulta Plus Biosynthetic Support System left her in chronic pain, incontinent and unable to have intercourse. She could urinate only with a catheter for five months. The jury returned the verdict in Kern County Superior Court before Judge William Palmer.
Ms. Scott also underwent eight additional removal surgeries, but the Avaulta still remains in her body. Many surgeons feel it cannot be removed safely. The jury awarded Ms. Scott $5 million, her husband $500,000 for the loss of their relationship.
Despite a 20-2 FDA advisory committee panel vote this week to approve the diet drug Qnexa, Director of Public Citizen’s Health Research Group, Dr. Sidney Wolfe, called the approval “reckless.” Evidence shows the drug poses significant risks and little evidence of long-lasting weight loss, wrote Dr. Wolfe. He compares Qnexa’s approval to the diet drug lorcaserin (Belviq), which the FDA approved last month despite concerns about heart valve damage. Research shows Qnexa increases heart rate, and four patients in the clinical trial suffered heart attacks compared to no heart attacks for the placebo group.
Dr. Wolfe also writes, “It is magical and delusional thinking for anyone to believe that a drug will turn off hunger without hitting other targets where it will do harm, usually to the cardiovascular system.” Therein seems to lie the entire problem of Western medicine, the belief that a single pill can magically cure any ill.
Do FDA administrators work for the public whom the agency is entrusted to protect, or pharmaceutical corporations who count on FDA approval? If they work for the public, why are they spying on their own scientists when those scientists raise questions about drug safety and the agency’s approval processes? The New York Times reported in July 2012 that the FDA conducted a vast surveillance operation against a group of its own scientists. Records that were accidentally released show the agency captured thousands of e-mails that concerned FDA scientists sent congressional members, lawyers, labor officials, journalists, and even President Barack Obama.
The European Medicines Agency said on June 21 that it was investigating Swiss group Roche Holding AG after a routine inspection found it had failed to properly assess 80,000 cases of possible adverse drug reactions dating from 1997 to the present. Among that alarming number of failed assessments were 15,161 deaths, which may have been due to the progression of natural diseases, but may have included deaths connected to Roche drugs.
Roche said that despite its failure to properly investigate the 80,000 adverse event reports, there is no evidence (regarding that failure) of a negative impact for patients. Neither, of course, is there any evidence that the company’s failure to investigate the 80,000 has NOT resulted in a negative impact for some patients.
A transvaginal mesh recall could be the opening gong of the death knell for the plastic mesh catastrophe unfolding across the nation. At the very least, transvaginal mesh (TVM) litigation took a step forward for plaintiffs this week when Johnson & Johnson’s Ethicon division informed the FDA that it intended to recall four of its Gynecare products: the Prolift Kit, Prolift +M Kit, Prosima Kit and TVT Secur.
The announcement is the latest in a series of troubling developments that began in July last year when the FDA reported a five-fold increase in deaths, injuries and/or malfunctions associated with transvaginal mesh (TVM) used in pelvic organ prolapse repair (POP) procedures. That report was followed in September 2011 by an advisory panel which urged the FDA to reclassify mesh products as “high-risk.” Then in January 2012, the FDA ordered several manufacturers to conduct further studies regarding the “side effects” and complications associated with their products.