|
 |
 |
| 5 entries found. Viewing page 1 of 1. |
| |
| June 21, 2010 |
| Federal Judge in NSF Litigation Stands By Previous Order on Expert Testimony |
| Posted By DeCarli Law |
 |
Another favorable ruling was issued in the federal multi-district litigation (MDL), where the claims of some people suffering from nephrogenic systemic fibrosis (NSF) are being adjudicated. On Friday, June 18, 2010, Judge Aaron Polster declined to change his earlier ruling on the admission of expert testimony, with one small exception. We reported the earlier ruling in a previous blog entry.
Defendant GE Healthcare filed a motion asking the Court to reconsider its ruling on expert testimony issued on May 4, 2010. GE Healthcare is the manufacturer of Omniscan, one of the most popular and dangerous brands of gadolinium-based contrast agents. As Judge Polster explained in his order, GE Healthcare's motion for reconsideration challenged "every ruling by this Court that resulted in the partial or wholesale exclusion of the testimony or opinions of [GE Healthcare]'s expert witnesses."
Judge Polster declined to change his earlier ruling, with one narrow exception. The previous order excluded in its entirety the testimony of Dr. Waymack, GE Healthcare's lone regulatory expert. However, the plaintiffs had only sought to exclude a portion of his testimony. The Court therefore modified its order to permit Dr. Waymack to testify on matters other than those that the plaintiffs asked to exclude.
Significantly, the Court observed that "the association between gadolinium-based contrast agents, severe renal impairment and NSF is virtually inescapable." NSF, also known as Nephrogenic Fibrosing Dermopathy (NFD), is an incurable disease characterized by hardening of the skin and other body tissues. Gadolinium-based contrast agents are used in various medical procedures, including MRI, MRA, and CT scans (CAT scans). As the Court's order observed, diabetics and others with severe kidney impairment are most at risk of developing NSF.
The attorneys at DeCarli Law are familiar with NSF, and represent people who suffer from NSF in state and federal court. If you believe you or a loved has NSF, you may contact the gadolinium lawyers at DeCarli Law for a free, no-obligation telephone consultation. You may also contact them online using the contact form on the lower left portion of this screen.
|
|
| Continue reading "Federal Judge in NSF Litigation Stands By Previous Order on Expert Testimony" » |
|
Permalink  |
| |
| May 10, 2010 |
| Federal Judge Rejects GE Healthcare Arguments to Exclude Expert Testimony on Cause of NSF |
| Posted By DeCarli Law |
|
A recent court ruling has strengthened the legal position in federal court of those suffering from Nephrogenic Systemic Fibrosis (NSF). A federal judge rejected the arguments of defendant GE Healthcare that plaintiffs should not be allowed to present expert testimony on how GE Healthcare’s brand of gadolinium-based contrast agent, Omniscan, causes NSF.
Some NSF victims have filed their claims in federal court, and their claims have been consolidated using a procedure known as multi-district litigation (MDL). The NSF MDL is pending in the United States District Court for the Northern District of Ohio. In federal court, scientific evidence must be sufficiently reliable in order for it to be presented to a jury. General Electric Healthcare claimed that the evidence presented by NSF victims on how Omniscan causes NSF was not sufficiently reliable for the jury to hear the evidence.
The federal court rejected GE Healthcare’s argument, and ruled that evidence supporting the “free gadolinium” theory could be presented to the jury. In rejecting GE Healthcare’s request, the Court noted that GE’s own experts acknowledge that it is “the prevailing theory in the scientific community.” To read the entire order, go HERE
. To learn more about how Omniscan and other gadolinium-based contrast agents cause NSF, go HERE
.
Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD), is an incurable disease characterized by hardening of the skin and other body tissues. The only known cause of NSF/NFD are the gadolinium-based contrast agents used in a medical procedure such as an MRI, MRA, angiogram/angioplasty, and CT scan (CAT scan), among others. Diabetics and others with severe kidney impairment are most at risk of developing NSF. The attorneys at DeCarli Law are familiar with NSF, and help people who suffer from NSF assert their legal rights. If you believe you or a loved has NSF, feel free to contact the gadolinium lawyers at DeCarli Law for a free, no-obligation telephone consultation.
|
|
| Continue reading "Federal Judge Rejects GE Healthcare Arguments to Exclude Expert Testimony on Cause of NSF" » |
|
| Permalink |
| |
| January 06, 2010 |
| Gadolinium-Based Contrast Agents Speed Multiple Myeloma Cell Growth |
| Posted By DeCarli Law |
|
A paper presented at the recent annual convention of the American Society of Hematology reported that exposure to the gadolinium-based contrast agent Omniscan, manufactured by GE Healthcare, speeds the growth of multiple myeloma cells.
Multiple myeloma is a cancer of the white blood cells. MRIs enhanced with gadolinium-based contrast agents are frequently used to image bone marrow, where white blood cells are produced. The researchers found that multiple myeloma cell growth rates were 8-20 times greater after exposure to Ominiscan, depending on the size and frequency of Omniscan exposure.
Significantly, autopsies of eight multiple myeloma patients who had repeated exposures to Omniscan revealed “massive quantities of gadolinium accumulation in tissues” regardless of renal function. This is particularly troubling. The current understanding is that people with impaired renal function are at the greatest risk of the gadolinium ion breaking free from the contrast agent and depositing in their bodies because their kidneys are unable to remove the agent from their bodies before it begins breaking down. These findings indicate that large amounts of gadolinium can be deposited in the body even if a person’s kidneys are functioning normally.
Gadolinium is a rare earth element long known to be toxic to human tissue. Gadolinium-based contrast agents, used for medical scans such as MRI and MRA, cause Nephrogenic Systemic Fibrosis (“NSF”). NSF is a progressive, incurable disease characterized by hardening of the skin and other body tissues. Dialysis patients are most at risk of developing NSF. If you or someone you know has NSF, you may have a legal claim against the manufacturer of the gadolinium-based contrast agent that caused the disease. Contract the NSF lawyers/MRI attorneys at DeCarli Law for a free consultation. |
|
| Continue reading "Gadolinium-Based Contrast Agents Speed Multiple Myeloma Cell Growth" » |
|
| Permalink |
| |
| November 20, 2009 |
| European Health Agency to Label Gadolinium-Based Contrast Agents as High-, Medium-, or Low-Risk for Causing NSF |
| Posted By DeCarli Law |
|
The European Medicines Agency (EMEA) issued a press release today, stating that it would begin classifying gadolinium-based contrast agents into three risk categories based on their likelihood of causing Nephrogenic Systemic Fibrosis (NSF). Of the brands labeled as high risk for NSF, three are sold in the United States. These are Omniscan, Magnevist and OptiMARK.
The EMEA is the European agency responsible for evaluating medicinal products. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) reviewed all gadolinium-based contrast agents because of their association with NSF, the serious and sometimes life-threatening condition characterized by the hardening of skin, joint, muscle and organ tissues. Because of the risk for people with kidney problems, the CHMP concluded that all gadolinium-based contrast agents should be classified as either high risk, medium risk, or low risk of causing NSF.
For high-risk contrast agents such as Omniscan, Magnevist and OptiMARK, the CHMP recommends contraindications in patients with severe kidney problems, in patients who are scheduled for or have recently received a liver transplant, and in newborn babies up to four weeks of age. For medium- and low-risk contrast agents, the CHMP recommends adding new warnings for use in patients with kidney problems and those awaiting a liver transplant. Vasovist and MultiHance are the contrast agents labeled by the EMEA as having a medium-risk of causing NSF that are sold in the United States. The only low-risk contrast agent sold in the United States is ProHance.
The EMEA’s categorization of gadolinium contrast agents is similar to the recent conclusions by FDA staff members that Omniscan, Magnevist and OptiMARK are the contrast agents with the greatest risk of causing NSF, which was reported in our previous blog post. However, the European health agency has gone further than the FDA will likely go. The CHMP recommends that laboratory tests be conducted before administration of any gadolinium-based contrast agents in order to screen people for kidney problems. Further, the CHMP recommends the following information for all gadolinium-based contrast agents:
- A warning that the elderly may be at particular risk of NSF due to impaired ability of their kidneys to clear gadolinium from the body.
- A statement that there is no evidence to support the initiation of hemodialysis to prevent or treat NSF in patients not already undergoing hemodialysis.
- A statement that the type and dose of contrast agent used should be recorded.
Hopefully, when the FDA holds its own committee meeting on December 8, 2009 to discuss warning labels for gadolinium-based contrast agents, it will follow the lead of the European health agency. A complete copy of today’s EMEA press release can be found HERE.
Before late 2007, although the manufacturers knew of the NSF risk, they did not inform doctors and patients in the United States that gadolinium-based contrast agents could cause Nephrogenic Systemic Fibrosis (NSF) when used on people with kidney problems, especially those undergoing dialysis. If you or a loved one had kidney problems and underwent a medical scan with a gadolinium-based contrast agent, you were at risk of developing NSF. Contact the MRI lawyers/NSF attorneys at DeCarli Law for a free consultation to learn more about your legal options if you think you may have NSF.
|
|
| Continue reading "European Health Agency to Label Gadolinium-Based Contrast Agents as High-, Medium-, or Low-Risk for Causing NSF" » |
|
| Permalink |
| |
| November 04, 2009 |
| UV-A1 Therapy Promising for Nephrogenic Systemic Fibrosis (NSF) |
| Posted By DeCarli Law |
|
A recent study indicates that UV-A1 phototherapy has promise for reducing symptoms of Nephrogenic Systemic Fibrosis (NSF). Four patients with NSF were treated with UV-A1. The skin on all four softened, and for two, their hand and leg mobility improved.
The study was conducted by the Dermatology Department of the University of Texas Southwestern Medical Center, in Dallas. All four patients had NSF and were undergoing hemodialysis. They were treated with a UV-A1 bed with varying levels of radiation depending on their complexion. UVA radiation has a long wavelength that enables it to reach the subcutis (the connective tissue beneath the skin).
After treatment, the effected areas of the skin on all four of the patients became less hard, and had decreased pain and itching. Two had increased joint mobility, resulting in an enhanced quality of life. Significantly, their improvements appeared to last. The patients were tracked for varying lengths of time after treatment (six months to one year), and their improved skin condition and mobility lasted during those periods. This is very promising, since the improvements from other experimental treatments appear far more temporary.
You may obtain a complete copy of this study HERE. Tran, et al., “UV-A1 Therapy for Nephrogenic Systemic Fibrosis,” Archives of Dermatology, Vol. 145, No. 10, Oct. 2009, pp. 1170-1182.
Nephrogenic systemic fibrosis (NSF) is a disease characterized by hardening of the skin and other tissue caused by exposure to a gadolinium-based contrast agent. Dialysis patients and others with renal failure (kidney failure) are at greatest risk for this MRI side effect. If you have been diagnosed with NSF or are experiencing symptoms of NSF (hardening of the skin, joint pain), you may have a legal claim against the manufacturer of the contrast agent used in your treatment. Contact the MRI lawyers/NSF attorneys at DeCarli Law for a free consultation.
|
|
| Continue reading "UV-A1 Therapy Promising for Nephrogenic Systemic Fibrosis (NSF)" » |
|
| Permalink |
| |
| 5 entries found. Viewing page 1 of 1. |
| | |
|
 |