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Recent Blog Posts in November 2009 |
| 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 |
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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.
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| November 17, 2009 |
| FDA Staff: Omniscan, Magnevist and OptiMARK Gadolinium-Based Contrast Agents Most Likely to Cause NSF |
| Posted By DeCarli Law |
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In a recently-prepared FDA document, staff members conclude that Omniscan, Magnevist, and OptiMARK are the gadolinium-based contrast agents with the highest risk of causing Nephrogenic Systemic Fibrosis (NSF). A much lower NSF risk is associated with Prohance and Multihance. These conclusions are contained in a briefing document prepared for an upcoming FDA committee meeting that will consider changing the warning labels to reflect these differing risks.
The briefing document was prepared for an Advisory Committee meeting to be held on December 8, 2009, which will re-evaluate the current warnings required for gadolinium-based contrast agents. Currently, all gadolinium-based contrast agents must have the same warning, regardless of brand. This decision was made in 2007, based on the information available at that time about NSF. However, the warning labels may change if the recommendations of FDA staff members are adopted.
Various FDA staff reports contained in the briefing document recommend heightened warning labels for the three more dangerous contrast agents: Omniscan, Magnevist, and OptiMARK. A lesser warning would be required for Prohance and Multihance, which are associated with fewer cases of NSF. In fact, the makers of Optimark have already changed their warning label on their own, as reported in a previous blog post, contraindicating use of their product for patients with severe renal disease and those awaiting a liver transplant.
The FDA documents provide further support for what has already become apparent in NSF lawsuits: most people develop NSF after exposure to Omniscan, Magnevist, and OptiMARK.
If you or someone you know has developed Nephrogenic Systemic Fibrosis (NSF) after exposure to gadolinium-based contrast agents during an MRI or other medical procedure, consider contacting the MRI lawyers at DeCarli Law for a free, no obligation consultation.
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| Continue reading "FDA Staff: Omniscan, Magnevist and OptiMARK Gadolinium-Based Contrast Agents Most Likely to Cause NSF" » |
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| November 12, 2009 |
| Insurance Coverage for Fleet Phospho-Soda Injuries |
| Posted By DeCarli Law |
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A recent settlement likely means more money to pay claims made by people whose kidneys failed after using Fleet Phospho-Soda and Fleet Phospho soda EZ Prep Bowel Cleansing System.
Hundreds of people had sued C.B. Fleet Inc., the manufacturer of Fleet Phospho-Soda and Fleet Phospho soda EZ Prep Bowel Cleansing System, after use of these products caused their kidneys to fail. C.B. Fleet submitted the claims to its insurance carriers, but an excess carrier, Axis Surplus Insurance Co., refused to pay the claims. C.B. Fleet has a $10 million excess insurance policy from Axis.
C.B. Fleet and Axis were litigating their coverage dispute in the United States District Court for the Western District of Virginia. Following a settlement, the federal court dismissed the lawsuit on Tuesday, November 10, 2009.
With the insurance coverage dispute resolved, C.B. Fleet now likely has more financial resources to compensate people injured by its products. Fleet Phospho-Soda and Fleet Phospho soda EZ Prep Bowel Cleansing System were over-the counter oral sodium phosphate (OSP) products that people used before undergoing a colonoscopy. Both products were recalled from the market when it was revealed they caused kidney failure. Other OSP products used before a colonoscopy are Visicol and OsmoPrep, available only by prescription.
If you or a loved one suffered kidney failure (renal failure) within 30 days after using either of these Fleet products, you may have a legal claim for this injury. Importantly, a Fleet lawsuit or OSP lawsuit should be filed sooner rather than later, since C.B. Fleet may have limited financial resources to pay for people’s injuries. Contact a Fleet Phospho attorney or OSP lawyer at DeCarli Law for a free telephone consultation.
UPDATE: As of August 1, 2010, DeCarli Law is no longer accepting new cases for people injured by Fleet Phospho-Soda or Fleet Phospho soda EZ Prep Bowel Cleansing System.
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| November 10, 2009 |
| Movement Toward Consolidation of New Jersey YAZ, Yasmin and Ocella Side Effect Lawsuits |
| Posted By DeCarli Law |
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The New Jersey Law Journal has reported that New Jersey YAZ, Yasmin and Ocella lawsuits may be consolidated before a single judge. The New Jersey judiciary is considering a request from Judge Donald Volkert Jr. of Prossaic County, New Jersey, that YAZ, Yasmin and Ocella lawsuits be given mass tort status.
13 lawsuits for injuries from YAZ, Yasmin and Ocella birth control pills are pending in Prossaic County, and 26 lawsuits are pending in other New Jersey counties. Judge Volkert wrote the Acting Administrative Director of the Courts in New Jersey on October 22, 2009, requesting mass tort status. The Administrative Office of the Courts has since issued a notice that it will accept public comments on Judge Volkert’s proposal through the end of this year.
If mass tort status is granted, the cases will be consolidated in one of three New Jersey counties where mass torts are heard: Atlantic County, Bergen County, or Middlesex County. Selection of a specific county and judge can have a significant impact on claims made by women injured by YAZ, Yasmin or Ocella. Injured women may have other options, such as filing their claims in federal court, or in the courts of other states such as California.
YAZ, Yasmin and Ocella birth control pills can cause pulmonary embolism (PE), deep vein thrombosis (DVT), stroke, heart attacks, hyperkalemia, gallbladder disease, and even death. The risk of blood clots (thrombosis) is twice as great with YAZ/Yasmin/Ocella as it is with older birth control pills. Likewise, unlike YAZ/Yasmin/Ocella, older forms of birth control pills have virtually no risk of gallbladder disease or hyperkalemia. You can learn more about the side effects of YAZ/Yasmin/Ocella, and about YAZ lawsuits, HERE.
If you or a loved one has died, suffered a stroke, blood clot, heart attack, arrhythmia or had their gallbladder removed after using YAZ, Yasmin or Ocella oral contraceptives, contact the YAZ lawyers of DeCarli Law for a free consultation.
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| Continue reading "Movement Toward Consolidation of New Jersey YAZ, Yasmin and Ocella Side Effect Lawsuits" » |
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| November 10, 2009 |
| New OptiMARK Label Warns Against Any Use on Patients with Severe Renal Failure |
| Posted By DeCarli Law |
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Mallinkrodt Inc., the manufacturer of gadolinium-based contrast agent OptiMARK, announced yesterday that it has submitted a label change that warns against any use of OptiMARK on patients with severe renal impairment due to the risk of Nephrogenic Systemic Fibrosis (NSF). OptiMARK’s revised label contraindicates the product’s use in patients with acute or chronic severe renal insufficiency (kidney failure), as well as patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplant period.
This is a major change from OptiMARK’s prior warning, which was significantly weaker. The prior warning, which all other gadolinium-based contrast agents sold in the United States also have, only cautions against use of OptiMARK on patients with severe renal failure. It says that OptiMARK and the other gadolinium-based contrast agents can properly be used if “the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI).” The new label will warn against any use of OptiMARK on patients with kidney failure.
Although OptiMARK’s maufacturer describes this label change as voluntary, there is likely more going on behind the scenes. On December 8, 2009, the Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee will meet to review the current warnings required for gadolinium-based contrast agents. It may be that Mallinckrodt was worried the FDA would order a warning change, so it decided to make the change itself in order to claim the move was voluntary.
This label change is important for the ongoing MRI side effect lawsuits brought by people suffering from Nephrogenic Systemic Fibrosis (NSF), especially for people who contracted NSF after using the GE product Omniscan. OptiMARK’s chemical structure is similar to the structure of Omniscan. Both have a linear structure, which may contribute to why OptiMARK and Omniscan have an approximately 30% lower thermodynamic stability than their competitors Magnevist, Multihance, and Prohance. Also, a disproportionately greater number of people have developed NSF after use of Omniscan and OptiMARK relative to the market share of these products. It will be interesting if GE makes a similar label change for Omniscan -- or if the FDA orders GE to do so.
Nephrogenic Systemic Fibrosis (NSF) is a debilitating and sometimes fatal disease characterized by the hardening of the skin, muscle and internal organs. If you or a loved one developed NSF after treatment with a gadolinium-based contrast agent during an MRI or other medical scan, contact the MRI side effect lawyers/NSF attorneys at DeCarli Law for a free consultation to learn about your legal options.
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| November 04, 2009 |
| UV-A1 Therapy Promising for Nephrogenic Systemic Fibrosis (NSF) |
| Posted By DeCarli Law |
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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.
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