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| August 12, 2010 |
| After Years of Delay, Bayer Asks the FDA for Approval of Gadovist, its Safer Gadolinium-Based Contrast Long Available in Europe |
| Posted By DeCarli Law |
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The FDA has just accepted Bayer Schering Pharma's New Drug Application for Gadovist, a gadolinium-based contrast agent currently sold in Europe and other parts of the world, but not in the United States. A New Drug Application is the procedure a drug company uses to formally request the FDA to allow it to sell a drug in the United States.
Although Bayer's application for Gadovist is new, Gadovist itself is not. Gadovist has been approved for sale in the European Union since 1998. However, until recently, Bayer has not sought approval for selling it in the United States. This decision -- whatever its basis -- has put Americans at risk.
Gadovist has a macrocyclic molecular structure, which means the gadolinium ion is surrounded by an organic chelate. In contrast, Magnevist, the Bayer contrast agent sold in the United States, has a linear ionic molecular structure. Magnevist's molecular structure is less stable than Gadovist's macrocyclic structure. As a result, European regulatory agencies recognize than Magnevist is less safe than Gadovist. The EU equivalent of the FDA requires the Magnevist label to state that it is contraindicated (not recommended) for use on people with severe renal impairment. Gadovist does not have this restriction.
A gadolinium-based contrast agent's molecular stability has dire health consequences, especially for people with impaired renal function, like those on dialysis. If a gadolinium-based contrast agent breaks down within the human body, the person is at risk of developing nephrogenic systemic fibrosis (NSF). 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 is the use of gadolinium-based contrast agents in medical procedures such as MRI, MRA and CT scans (CAT scans).
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| Continue reading "After Years of Delay, Bayer Asks the FDA for Approval of Gadovist, its Safer Gadolinium-Based Contrast Long Available in Europe" » |
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| June 08, 2010 |
| The Cleveland Plain Dealer Reports Fleet Settlement Coming Soon |
| Posted By DeCarli Law |
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The Cleveland Plain Dealer has reported that C.B. Fleet Co. is "close to reaching a final settlement" with people across the country who say their kidneys were harmed by Fleet's over-the-counter laxatives. See Diana Suchetka, "Settlement Coming in Suit Concerning Oral Laxatives," The Plain Dealer, May 19, 2010. C.B. Fleet Co. was the manufacturer of Fleet Phospho-Soda and Fleet Phospho soda EZ Prep Bowel Cleansing system.
The article attributed the following statements to C.B. Fleet: "While we are encouraged by the progress made to date on the global settlement, there are several matters remaining to be resolved." "Fleet hopes that a conclusion can be reached soon that serves as a positive outcome for all concerned."
Fleet Phospho-Soda and Fleet Phospho soda EZ Prep Bowel Cleansing System were over-the-counter products used for bowel cleansing to prepare for a colonoscopy. These products were recalled from the market after the FDA issued a safety alert on December 11, 2008, warning that they can cause kidney failure (renal failure). Side effects include dialysis and the need for a kidney transplant.
You may have a strong legal claim if you or a loved one used one of these products before a colonoscopy, suffered kidney damage or a kidney injury shortly after the colonoscopy, including later requiring dialysis or a kidney transplant. Contact the Fleet injury attorneys at DeCarli Law for a free, no obligation consultation. As is often the case with legal claims, a short deadline may apply to your claim, so please contact us as soon as possible if you believe you suffered a Fleet kidney injury or Fleet kidney damage.
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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| Continue reading "The Cleveland Plain Dealer Reports Fleet Settlement Coming Soon" » |
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| January 08, 2010 |
| Dialysis or Kidney Transplant After Colonoscopy |
| Posted By DeCarli Law |
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If you began having serious kidney problems just weeks after a colonoscopy, the cause may have been the Fleet Phospho-Soda or Fleet Phospho soda EZ Prep Bowel Cleansing System you used before your colonoscopy.
Fleet Phospho-Soda and Fleet Phospho soda EZ Prep Bowel Cleansing System were over-the-counter products recommended to cleanse the bowels before a colonoscopy. They are a type of oral sodium phosphate or “OSP.” The FDA issued a safety alert on December 11, 2008, warning that OSPs can cause kidney failure (renal failure), and the Fleet products were recalled from the market. Side effects include dialysis and the need for a kidney transplant.
If you or a loved one used one of these products before a colonoscopy, and are now on dialysis or were forced to have a kidney transplant, you may have a strong legal claim. Contact the attorneys at DeCarli Law for a free, no obligation consultation. As is often the case with legal claims, a short deadline may apply to your claim, so please contact us as soon as possible if you believe you were injured by Fleet Phospho-Soda or Fleet Phospho soda EZ Prep Bowel Cleansing System.
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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| Continue reading "Dialysis or Kidney Transplant After Colonoscopy" » |
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| 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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| Continue reading "European Health Agency to Label Gadolinium-Based Contrast Agents as High-, Medium-, or Low-Risk for Causing 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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| Continue reading "Insurance Coverage for Fleet Phospho-Soda Injuries" » |
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