Product News and Recalls

Across Country, Lawsuits Link Incurable Illness to MRI Dye – Gadolinium

By Evan George
Daily Journal Staff Writer
This article appears on Page 1

HEMET – Ramon Rodriguez was always good with his hands. The ex-Marine fixed cars, stitched leather and tinkered with home improvements, despite his diabetes and a failed kidney.
But that was before his skin began turning to stone.
It started as a stiffness in his legs and pain in his joints. Then, he began tripping. When his skin toughened, his doctors were puzzled.
Last year, Rodriguez, 65, was diagnosed with a rare, incurable disease called nephrogenic systemic fibrosis, in which a person’s skin hardens to such a rocklike texture that it can crack bones, burst vital organs and prevent surgeons from performing urgent medical procedures.
As cases of the rare malady piled up, researchers struggled to pinpoint its cause. All the victims shared one trait: kidney disease.
In 2006, researchers finally linked the mysterious disease to a type of contrast dye commonly used in medical imaging tests, like MRIs, that is toxic only to those with failed kidneys.
Now, nearly 100 patients around the country are separately suing the pharmaceutical companies behind such dyes, including Rodriguez, who will be filing a suit this week in San Bernardino County Superior Court,
“It is essentially a man-made disease resulting from this dye, and it has forever changed their lives at no fault of their own,” said Jason Ochs, an attorney with Lopez McHugh, based in Newport Beach, who represents Rodriguez and dozens of other plaintiffs.
Ochs’ clients are part of a growing number of patients in California and other states who have been diagnosed with the disease since it appeared in 1997. As many as 275 cases of nephrogenic systemic fibrosis have been reported to the Food and Drug Administration. Some say unreported cases could put that number closer to 1,000.
Though relatively rare, the horrific side effects have brought attention to the disease, which doctors say is a virtual death sentence.
Rodriguez now lives in a convalescent home, confined to leg braces and a wheelchair. The former handyman is unable to hold a spoon to feed himself because his right hand is frozen in a grotesque curl.
Rodriguez accuses General Electric, and its GE Healthcare subsidiary, of medical negligence for hiding the risk their medical dye posed to patients with kidney problems.
“Either they did studies and did not release them or they failed to do those studies,” Ochs said.
“Either way, it creates legal liability, and we will find out which it is the further we get into discovery,” Ochs said.
General Electric is just one of the major manufacturers facing lawsuits over medical dyes containing gadolinium, a toxic metal most commonly used to create dynamic and easy-to-read MRI and MRA scans.
Although that toxic metal is processed easily and quickly by patients with healthy kidneys, it can remain trapped for long periods in people with compromised kidneys, a 2006 study showed. The trapped toxin poisons patients, according to those reports.
It remains unclear how the companies will fight the growing number of lawsuits.
A General Electric representative has refused to comment on the specific lawsuits. He added that studies pointing to the dyes as the sole cause were inconclusive.
“The science is still evolving, but no definitive causal relationship has ever been found,” Ryan Fitzgerald, a GE Healthcare spokesman, said in a written statement.
Doctors and radiologists who reportedly consulted for GE did not return multiple phone calls requesting comment.
Mallinckrodt is another pharmaceutical company facing litigation over its gadolinium-based dye. The company also refused to comment on specific cases.
But a Mallinckrodt spokeswoman said the company was “fully cooperating with the Food and Drug Administration as they investigate the relationship between gadolinium-based contrast agents and nephrogenic systemic fibrosis.”
The FDA has issued three warnings to date regarding the use of gadolinium-based dyes.
The first came in June 2006, when the agency notified doctors and consumers it was evaluating a possible link between the new disease and the dyes, specifically General Electric’s product, called Omniscan.
That December, the FDA issued a warning that 69 cases had been reported, all of them in patients who had undergone imaging scans, which the agency called “more evidence of a causal relationship.”
Then, in May 2007, the FDA told the drug makers behind the four leading dyes to add a “black box” warning label about increased risks for the disease. It strongly recommended that patients be screened for kidney problems before being injected with any gadolinium-based dye.
Four months later, General Electric and Mallinckrodt, as well as Bayer and Bracco, sent a letter alerting doctors and hospitals of the new warning label on their products.
Ramon Rossi Lopez, managing senior partner at Lopez McHugh, who is helping Ochs on the cases, called that too little, too late. He said preliminary studies had shown for years that long periods of exposure to gadolinium was lethal and at-risk patients should have been warned.
“It was almost like they were playing Russian roulette, because they knew it was a very dangerous chemical to have in the body for any long period of time,” said Lopez, who specializes in suing pharmaceutical companies.
“It is the same old story, if it affects their sales adversely, they do the minimal – sometimes nothing,” Lopez said.
Lopez McHugh has cases in every U.S. time zone, including two in Texas, one in Montana and five in Louisiana. The firm is handling 10 percent of the cases nationwide.
Plaintiffs’ lawyers across the country have begun seeking cases online. Internet searches for “nephrogenic systemic fibrosis” or “gadolinium” turn up nearly a dozen pages devoted to suing over the disease.
At least 27 cases related to gadolinium-based dyes are wending through state courts, three of them in California, Ochs said.
Many more have been moved from state courts into federal courts by motions filed by the drug makers. More than 50 such cases await a hearing before U.S. District Court Judge Dan Aaron Polster of the Northern District of Ohio in Cleveland.
That could lead to a skirmish over jurisdiction, observers say, with plaintiffs’ lawyers hoping to litigate in state courts in order to expedite the cases of deathly ill patients.
Meanwhile, Ochs and Lopez said they see new cases weekly.
Even as late as May 2007, Lopez said, after the FDA released its warning, some patients with weak kidneys still were being injected with gadolinium dyes. He said those people have the best chance of prevailing in a lawsuit.
“Those people could have been saved, so the [companies] have no excuse,” Lopez said.
One of those plaintiffs is Michael Gleaton, 60.
Like many who have fallen ill with Nephrogenic Systemic Fibrosis, Gleaton’s medical problems started with kidney failure related to diabetes about five years ago.
Not long after, Gleaton, a chauffeur to the stars, also was diagnosed with cancer.
Though the news was a blow to the athletic, 6-foot-7-inch father, Gleaton continued working for his A-list clients, which included actor Denzel Washington, model Naomi Campbell and Prince Phillip. He kept up his driving schedule during his treatment.
Between 2002 and May 2007, Gleaton underwent multiple MRI and MRA scans at Cedar-Sinai Medical Center in Los Angeles, where radiologists injected Gleaton with both Omniscan and OptiMARK dyes, according to the complaint.
In early 2007, Gleaton began noticing a new and excruciatingly painful symptom that made it impossible to keep driving.
“I can’t even explain it, but in the base of every finger I had a pain that would never go away, that would keep me up at night,” Gleaton said.
One of those late nights, Gleaton caught a television infomercial about the disease that said patients with his symptoms should contact an attorney. When he called, he was referred to Lopez McHugh.
Gleaton said he already requires nursing assistance, and it only will get worse. He said he hopes a lawsuit will teach the drug companies a lesson about warning consumers even if the at-risk population is small. He also wants compensation to help care for his family.
“Cancer I beat, and I just came through a kidney and liver transplant, but I had no reason for getting this [disease],” Gleaton said.
“It is something I got because someone didn’t tell me something I should have been aware of,” he said.
His lawsuit, and another on behalf of a Santa Monica woman named Priscilla Geffen, have named Cedars-Sinai’s radiology department and hospital staff, as well as General Electric and Mallinckrodt. Their suits seek general, special and punitive damages as well as costs for future medical care.
A spokesman for Cedars-Sinai was unavailable for comment.
Although both lawsuits were filed in state court, they could be moved to federal court, a transfer the plaintiffs are fighting in hope of expediting trials. Both plaintiffs allege the pharmaceutical companies, as well as their physicians, never should have injected them with gadolinium-based dyes. Gleaton v. General Electric, BC383624, (L.A. Super. Ct., filed Jan. 11, 2008), Geffen v. General Electric, BC383625, (L.A. Super. Ct., filed Jan. 11, 2008).
Lopez said General Electric deserves much of the blame because the company holds the largest share of the market for gadolinium-based dye, and their product, Omniscan, contains a higher concentration of gadolinium, making it more lethal.
The first published study linking the dyes to disease, released in 2006, found that patients given Omniscan developed symptoms of the disease within just 2 weeks.
Rodriguez, the ex-Marine who will sue this week, said he noticed his painful, puzzling symptoms a month after receiving a round of MRIs.
“My walking started to go,” Rodriguez said, “I would stumble and I couldn’t understand why, and each day I got worse and worse.”
Finally, he checked himself into a convalescent home because it became too difficult for his wife to care for him.
Unable to move, he has gained 60 pounds. When nurses help lift him out of bed, he spends much of his days at a window staring at cars passing by. He said his lawsuit is validating, but not comforting, because he knows he is dying.
“What can I do? I’m helpless now,” Rodriguez said. “I’m not quite a vegetable, but I can’t do anything at all,” he said.

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