On Monday of this past week, the United States Judicial Panel on Multidistrict Litigation issued the order for the transference to the US District Court for the Southern District of Florida, in Miami. US District Court Judge Donald M. Middlebrooks has been assigned the litigation, according to a report.
Miami affords a number of advantages, not the least of which is a low number of MDL dockets, and the accessibility of the metropolitan Miami area. Beyond that, consolidation made sense due to the degree of similarities emerging from the complaints.Indeed, many of the cases have a similar ring.
William 'Sonny' Morrill went in for heart bypass surgery, but the Sarasota man at 61 never made it out of hospital. Three days after the surgery, Morrill died from kidney failure and what the St. Petersburg Times describes as a 'triple whammy of heart attacks.'
His widow, Melissa, was so confident that he would be okay, she had bought him a new set of pajamas.
In 2005 Samuel Nakis underwent open-heart surgery at St. Luke's Hospital in Chesterfield, Missouri. During the procedure he was given Trasylol to help control bleeding. However, while the surgery went well, Nakis experienced post-operative kidney failure and required dialysis. He died a short while later.
And everyone by now is familiar with Joe Randone, a 52-year-old travel agent who went in for a routine heart valve replacement surgery. As seen on 60 Minutes, Randone went into the hospital healthy—but he never came out. His widow, Josephine, has filed an $80 million dollar product liability lawsuit against Bayer AG, stating that no amount of money could replace her husband.
One can well sympathize with her cause, given the dynamics of the case. The family did everything right. They reportedly checked out the surgeon and the anesthesiologist. They were assured the operation had a low complication rate. All seemed well.
During surgery, Randone was allegedly administered a Trasylol drip for four hours. Following surgery, his family was told there were complications. Randone's kidneys had failed, and he suffered blood clots and embolisms in his lower extremities. His legs required amputation below the knee, and his kidneys failed. He underwent dialysis. He retained so much fluid that his cornea fractured, and doctors had to sew his eyes shut. The 52-year-old required a tracheotomy and a feeding tube, and struggled like this for eight months before he gave up the fight and died of infection August 8, 2006.
A direct comparison of the suffering of such a once-healthy individual, and the events surrounding Trasylol at that time, point a grim and confusing picture. Evidence was mounting that Trasylol presented the kind of risk to health that Randone, and others like him, suffered first-hand. Noted researcher Dr. Dennis Mangano had warned an advisory panel of the US Food and Drug Administration (FDA) that Trasylol doubled the risk of kidney and heart failure and posed a 181 pre cent increased risk of stroke.
His exhaustive study, published in the New England Journal of Medicine in early 2006, concluded:
"The association between aprotinin (marketed as Trasylol) and serious end-organ damage indicates that continued use is not prudent. In contrast, the less expensive generic medications aminocaproic acid and tranexamic acid are safe alternatives."
Mangano's study came too late for Randone, who was in hospital when the study was initially published, in January of that year. It also came too late for Samuel Nakis, and Sonny Morrill. But it may not have proved too late for an estimated 22,000 individuals whose lives may have been saved had Trasylol been taken off the market in January 2006—rather than November 2007, when the Canadian BART study was halted after aprotinin (Trasylol) patients were dying.
What's equally maddening, say critics, is the well-documented dog-and-pony show that occurred during that time. Between January 2006, and September 2006 when the FDA convened an expert panel review to study the merits of Trasylol, Mangano claims to have made his data available to the FDA for independent corroborative analysis, but this was not done. At the same time, Trasylol manufacturer Bayer AG triggered an independent study of its own through the Harvard School of Medicine. The latter study reportedly mirrored Mangano's findings. While Bayer had the study in hand for the FDA review panel, it was not presented. In the face of the imbalance between Mangano's study data and Bayer's own, PRESENTED research which showed Trasylol was safe and effective—and without any further data, the panel re-affirmed Trasylol.
The panel did the same thing a year later—this time with Mangano's data, which was in sync with the Harvard study the FDA now had in its hands. Trasylol would stay. It wasn't until the BART study was halted that the players finally woke up and smelled the coffee. While they were napping, 22,000 lives were potentially lost.
An expensive loss to boot, given that Trasylol costs about $1000 per dose, as compared with about fifty bucks for older anti-bleeding drugs such as aminocaproic acid.
The hit to HMOs and overall health care costs would be astounding at that price, given the availability of far less-expensive, and far safer alternatives.
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That was the message in an editorial that accompanied two new studies profiling the risks of aprotinin, published this past February in the New England Journal of Medicine. Dr. Wayne A. Ray, a professor of preventative medicine at Vanderbilt University in Nashville, noted that when you have a new drug that behaves in similar fashion to an older medication, comparative studies need to be carried out BEFORE the new drug is allowed for widespread use."Had this been done ten years ago with Trasylol, many lives would have been saved."
That's cold comfort for Josephine Randone, Melissa Morrill and the widow of Samuel Nakis. They lost the life partners tragically, and needlessly. As Josephine laments,
"I was naive. I thought drug companies helped people and they make a profit too. After what I've learned and read, their bottom line is profit, not people. They made billions..."
As a result of the widespread publicity of this issue, and the lives affected, the number of lawsuits could reach new plateaus.
