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	<title>Schmidt &#38; Clark, LLP &#187; Gadolinium</title>
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		<title>MRI Contrast Agents Lawsuit</title>
		<link>http://www.schmidtandclark.com/mri-contrast-agents-lawsuit</link>
		<comments>http://www.schmidtandclark.com/mri-contrast-agents-lawsuit#comments</comments>
		<pubDate>Sun, 28 Jun 2009 08:20:41 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=1160</guid>
		<description><![CDATA[Gadolinium, Nephrogenic Systemic Fibrosis, Nephrogenic Fibrosing Dermopathy &#8211; Article Index
Below is a collection of Gadolinium, Nephrogenic Systemic Fibrosis (NSF) and Nephrogenic  Fibrosing Dermopathy (NFD) articles provided to you by Schmidt &#38; Clark, LLP. Please remember that if you or a loved one have developed NSF or NFD after having received an injection of a gadolinium-based contrast [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.schmidtandclark.com/wp-content/uploads/mri-contrast-agents-gadolinium-nsf.jpg"><img class="alignright size-thumbnail wp-image-1272" title="mri-contrast-agents-gadolinium-nsf" src="http://www.schmidtandclark.com/wp-content/uploads/mri-contrast-agents-gadolinium-nsf-200x200.jpg" alt="mri-contrast-agents-gadolinium-nsf" width="200" height="200" /></a>Gadolinium, Nephrogenic Systemic Fibrosis, Nephrogenic Fibrosing Dermopathy &#8211; Article Index</strong></p>
<p>Below is a collection of Gadolinium, Nephrogenic Systemic Fibrosis (NSF) and Nephrogenic  Fibrosing Dermopathy (NFD) articles provided to you by Schmidt &amp; Clark, LLP. Please remember that if you or a loved one have developed NSF or NFD after having received an injection of a gadolinium-based contrast agent, we can help. Please <a href="http://www.schmidtandclark.com/contact">contact us</a> for a Free Case Evaluation or call toll free 24 hrs/day (866) 588-0600.</p>
<h2>Main Gadolinium Content Sections</h2>
<ul>
<li><a href="http://www.schmidtandclark.com/gadolinium">Gadolinium</a></li>
<li><a href="http://www.schmidtandclark.com/nephrogenic-systemic-fibrosis-nsf">Nephrogenic Systemic Fibrosis</a> (NSF)</li>
<li><a href="http://www.schmidtandclark.com/nephrogenic-fibrosing-dermopathy-nfd">Nephrogenic Fibrosing Dermopathy (NFD)</a></li>
</ul>
<h2>Do I have a MRI Contrast Agent Lawsuit?</h2>
<p>The Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Gadolinium lawsuits. We are handling individual litigation nationwide and currently accepting new Gadolinium side effect cases in all 50 states.</p>
<p><em>If you or a loved one have developed NSF or NFD after having received an injection of a gadolinium-based contrast agent, we can help. Please </em><a href="http://www.schmidtandclark.com/contact"><em>contact us</em></a><em> for a Free Case Evaluation or call toll free 24 hrs/day (866) 588-0600.</em></p>
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		<title>Prohance MRI Scan &amp; Nephrogenic Systemic Fibrosis (NSF) Lawsuit</title>
		<link>http://www.schmidtandclark.com/prohance</link>
		<comments>http://www.schmidtandclark.com/prohance#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:54:02 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=452</guid>
		<description><![CDATA[Prohance (gadoteridol), a gadolinium-based contrast agent which is commonly used to improve the visibility of internal structures when patients undergo an MRI has been linked to a serious, life-threatening disease known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD).
If you or a loved one have had an MRI or MRA, and since developed [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.schmidtandclark.com/wp-content/uploads/mri-contrast-agents-gadolinium-nsf.jpg"><img class="alignright size-thumbnail wp-image-1272" title="mri-contrast-agents-gadolinium-nsf" src="http://www.schmidtandclark.com/wp-content/uploads/mri-contrast-agents-gadolinium-nsf-200x200.jpg" alt="mri-contrast-agents-gadolinium-nsf" width="200" height="200" /></a>Prohance (gadoteridol), a gadolinium-based contrast agent which is commonly used to improve the visibility of internal structures when patients undergo an MRI has been linked to a serious, life-threatening disease known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD).</strong></p>
<p><em>If you or a loved one have had an MRI or MRA, and since developed either NSF or NFD, you should <a href="http://www.schmidtandclark.com/contact">contact us</a> immediately. You may be entitled to compensation and we can help.</em></p>
<h2>What is the problem with Prohance?</h2>
<p>On May 23, 2007, the U.S. Food &amp; Drug Administration requested the manufacturers of Prohance (Bracco Diagnostics Inc.) of gadolinium-based contrast agents to add a new boxed warning on the product labeling because of reports linking the agents to the life-threatening skin disorders, Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy.</p>
<blockquote><p>“Patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as Nephrogenic Systemic Fibrosis (NSF). In addition, patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.”</p></blockquote>
<h2>What is Nephrogenic Systemic Fibrosis?</h2>
<p>NSF, also known as NFD is a skin condition that is often described as a swelling and tightening of the skin, usually limited to the extremities. The condition may develop over a short period of days or could take weeks to fully develop. NSF can also lead to death.</p>
<p>Severely affected patients may be unable to walk, or fully extend the joints of their arms, hands, legs, and feet. Complaints of muscle weakness are common.</p>
<h2>Signs of Nephrogenic Systemic Fibrosis</h2>
<ul>
<li>Burning</li>
<li>Itching</li>
<li>Swelling</li>
<li>Hardening and tightening of the skin</li>
<li>Red or dark patches on the skin</li>
<li>Yellow spots on the whites of the eyes</li>
<li>Stiffness in joints and trouble moving or straightening the arms, hands, legs, or feet</li>
<li>Pain deep in the hip bones or ribs</li>
<li>Muscle weakness</li>
</ul>
<h2>Do I have a Prohance MRI &amp; NSF Lawsuit?</h2>
<p>The Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Prohance MRI induced NSF lawsuits. We are handling individual litigation nationwide and currently accepting new Prohance MRI scan and Nephrogenic Systemic Fibrosis cases in all 50 states.</p>
<p><em>If you or a loved one have had an MRI or MRA, and since developed either NSF or NFD, you should <a href="http://www.schmidtandclark.com/contact">contact us</a> immediately. You may be entitled to compensation and we can help.</em></p>
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		<item>
		<title>OptiMARK MRI Scan &amp; Nephrogenic Systemic Fibrosis (NSF) Lawsuit</title>
		<link>http://www.schmidtandclark.com/optimark</link>
		<comments>http://www.schmidtandclark.com/optimark#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:52:05 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=450</guid>
		<description><![CDATA[OptiMARK (gadoversetamide), a gadolinium-based contrast agent which is commonly used to improve the visibility of internal structures when patients undergo an MRI has been linked to a serious, life-threatening disease known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD).
If you or a loved one have had an MRI or MRA, and since developed [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.schmidtandclark.com/wp-content/uploads/mri-contrast-agents-gadolinium-nsf.jpg"><img class="alignright size-thumbnail wp-image-1272" title="mri-contrast-agents-gadolinium-nsf" src="http://www.schmidtandclark.com/wp-content/uploads/mri-contrast-agents-gadolinium-nsf-200x200.jpg" alt="mri-contrast-agents-gadolinium-nsf" width="200" height="200" /></a>OptiMARK (gadoversetamide), a gadolinium-based contrast agent which is commonly used to improve the visibility of internal structures when patients undergo an MRI has been linked to a serious, life-threatening disease known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD).</strong></p>
<p><em>If you or a loved one have had an MRI or MRA, and since developed either NSF or NFD, you should <a href="http://www.schmidtandclark.com/contact">contact us</a> immediately. You may be entitled to compensation and we can help.</em></p>
<h2>What is the problem with OptiMARK?</h2>
<p>On May 23, 2007, the U.S. Food &amp; Drug Administration requested the manufacturers of OptiMARK (Mallinckrodt, Inc.) of gadolinium-based contrast agents to add a new boxed warning on the product labeling because of reports linking the agents to the life-threatening skin disorders, Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy.</p>
<blockquote><p>“Patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as Nephrogenic Systemic Fibrosis (NSF). In addition, patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.”</p></blockquote>
<h2>What is Nephrogenic Systemic Fibrosis?</h2>
<p>NSF, also known as NFD is a skin condition that is often described as a swelling and tightening of the skin, usually limited to the extremities. The condition may develop over a short period of days or could take weeks to fully develop. NSF can also lead to death.</p>
<p>Severely affected patients may be unable to walk, or fully extend the joints of their arms, hands, legs, and feet. Complaints of muscle weakness are common.</p>
<h2>Signs of Nephrogenic Systemic Fibrosis</h2>
<ul>
<li>Burning</li>
<li>Itching</li>
<li>Swelling</li>
<li>Hardening and tightening of the skin</li>
<li>Red or dark patches on the skin</li>
<li>Yellow spots on the whites of the eyes</li>
<li>Stiffness in joints and trouble moving or straightening the arms, hands, legs, or feet</li>
<li>Pain deep in the hip bones or ribs</li>
<li>Muscle weakness</li>
</ul>
<h2>Do I have a OptiMARK MRI &amp; NSF Lawsuit?</h2>
<p>The Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in OptiMARK MRI induced NSF lawsuits. We are handling individual litigation nationwide and currently accepting new OptiMARK MRI scan and Nephrogenic Systemic Fibrosis cases in all 50 states.</p>
<p><em>If you or a loved one have had an MRI or MRA, and since developed either NSF or NFD, you should <a href="http://www.schmidtandclark.com/contact">contact us</a> immediately. You may be entitled to compensation and we can help.</em></p>
]]></content:encoded>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Omniscan MRI Scan &amp; Nephrogenic Systemic Fibrosis (NSF) Lawsuit</title>
		<link>http://www.schmidtandclark.com/omniscan</link>
		<comments>http://www.schmidtandclark.com/omniscan#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:49:09 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=448</guid>
		<description><![CDATA[Omniscan (gadodiamide), a gadolinium-based contrast agent which is commonly used to improve the visibility of internal structures when patients undergo an MRI has been linked to a serious, life-threatening disease known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD).
If you or a loved one have had an MRI or MRA, and since developed [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.schmidtandclark.com/wp-content/uploads/mri-contrast-agents-gadolinium-nsf.jpg"><img class="alignright size-thumbnail wp-image-1272" title="mri-contrast-agents-gadolinium-nsf" src="http://www.schmidtandclark.com/wp-content/uploads/mri-contrast-agents-gadolinium-nsf-200x200.jpg" alt="mri-contrast-agents-gadolinium-nsf" width="200" height="200" /></a>Omniscan (gadodiamide), a gadolinium-based contrast agent which is commonly used to improve the visibility of internal structures when patients undergo an MRI has been linked to a serious, life-threatening disease known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD).</strong></p>
<p><em>If you or a loved one have had an MRI or MRA, and since developed either NSF or NFD, you should <a href="http://www.schmidtandclark.com/contact">contact us</a> immediately. You may be entitled to compensation and we can help.</em></p>
<h2>What is the problem with Omniscan?</h2>
<p>On May 23, 2007, the U.S. Food &amp; Drug Administration requested the manufacturers of Omniscan (GE Healthcare) of gadolinium-based contrast agents to add a new boxed warning on the product labeling because of reports linking the agents to the life-threatening skin disorders, Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy.</p>
<p>“Patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as Nephrogenic Systemic Fibrosis (NSF). In addition, patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.”</p>
<h2>What is Nephrogenic Systemic Fibrosis?</h2>
<p>NSF, also known as NFD is a skin condition that is often described as a swelling and tightening of the skin, usually limited to the extremities. The condition may develop over a short period of days or could take weeks to fully develop. NSF can also lead to death.</p>
<p>Severely affected patients may be unable to walk, or fully extend the joints of their arms, hands, legs, and feet. Complaints of muscle weakness are common.</p>
<h2>Signs of Nephrogenic Systemic Fibrosis</h2>
<ul>
<li>Burning</li>
<li>Itching</li>
<li>Swelling</li>
<li>Hardening and tightening of the skin</li>
<li>Red or dark patches on the skin</li>
<li>Yellow spots on the whites of the eyes</li>
<li>Stiffness in joints and trouble moving or straightening the arms, hands, legs, or feet</li>
<li>Pain deep in the hip bones or ribs</li>
<li>Muscle weakness</li>
</ul>
<h2>Do I have a Omniscan MRI &amp; NSF Lawsuit?</h2>
<p>The Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Omniscan MRI induced NSF lawsuits. We are handling individual litigation nationwide and currently accepting new Omniscan MRI scan and Nephrogenic Systemic Fibrosis cases in all 50 states.</p>
<p><em>If you or a loved one have had an MRI or MRA, and since developed either NSF or NFD, you should <a href="http://www.schmidtandclark.com/contact">contact us</a> immediately. You may be entitled to compensation and we can help.</em></p>
]]></content:encoded>
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		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Omniscan Lawsuit &#8211; Manufacturer Of Omniscan Sued By Former Nurse</title>
		<link>http://www.schmidtandclark.com/omniscan-lawsuit-manufacturer-of-omniscan-sued-by-former-nurse</link>
		<comments>http://www.schmidtandclark.com/omniscan-lawsuit-manufacturer-of-omniscan-sued-by-former-nurse#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:47:20 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=446</guid>
		<description><![CDATA[A lawsuit was recently filed in US District Court by a former nurse charging that Omniscan was responsible for causing her to develop a serious skin and joint condition called Nephrogenic Systemic Fibrosis. This may be the first lawsuit filed against GE Healthcare, the manufacturer of Omniscan, as a result of adverse events related to [...]]]></description>
			<content:encoded><![CDATA[<p>A lawsuit was recently filed in US District Court by a former nurse charging that Omniscan was responsible for causing her to develop a serious skin and joint condition called Nephrogenic Systemic Fibrosis. This may be the first lawsuit filed against GE Healthcare, the manufacturer of Omniscan, as a result of adverse events related to the contrast agent. Omniscan, also known as Gadodiamide, is a Gadolinium based contrast agent used to enhance MRI images. The agent is injected into the patient immediately prior to an MRI or MRA procedure to help physicians distinguish blood vessels from tissue.</p>
<p>The lawsuit alleges that days after receiving an injection of Omniscan, the individual developed the signature symptoms of Nephrogenic Systemic Fibrosis which, in turn, developed into extensive fibrosis of the arms, legs, and associated joints. The advancement of the condition has caused numerous effects that may be permanent and could ultimately lead to her death. The individual is now wheelchair bound and is unable to move her legs, several fingers, and her elbows beyond a slight bending and extension. Because of her condition, the individual is no longer able to work as a registered nurse.</p>
<p>The US Food and Drug Administration has received numerous reports of individuals developing Nephrogenic Systemic Fibrosis in recent years. In 2006, the number of reports received and confirmed prompted the US Food and Drug Administration to issue a Public Health Advisory Alert detailing the facts behind patients developing this serious, life-threatening condition after exposure to Gadolinium based contrast agents, such as Omniscan. Since then, much information has been released publicly detailing the link between Gadolinium based contrast agents and the development of Nephrogenic Systemic Fibrosis.</p>
<p>Nephrogenic Systemic Fibrosis has been found to only affect patients with moderate to end stage kidney disease and kidney failure who receive an injection of a Gadolinium based contrast agent prior to an MRI. The condition is considered a fibrosing disorder and can affect the skin, heart, lungs, diaphragm, liver, and skeletal muscles. The skin of the patient’s extremities begins to develop dark or reddened patches that start to tighten and harden, causing the patient extreme discomfort. The tightened skin restricts the movement of the joints and eventually causes the patient to lose their mobility.</p>
<p>Nephrogenic Systemic Fibrosis is considered a debilitating condition and may ultimately be fatal to the affected patient. The Centers For Disease Control concluded in its report that the use of Gadolinium based contrast agents should be avoided in patients with advanced renal failure. Other health agencies have also released reports saying that the use of Gadolinium based contrast agents for MRI imaging should be avoided if the patient has moderate to end-stage kidney disease.</p>
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		</item>
		<item>
		<title>Gadolinium Based Contrast Agent – ProHance</title>
		<link>http://www.schmidtandclark.com/gadolinium-based-contrast-agent-%e2%80%93-prohance</link>
		<comments>http://www.schmidtandclark.com/gadolinium-based-contrast-agent-%e2%80%93-prohance#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:46:46 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=444</guid>
		<description><![CDATA[ProHance is a MRI contrast agent manufactured by Bracco Diagnostics. It received approval from the US Food and Drug Administration in 1992 and was released to the retail market later that year. ProHance is used to enhance the images obtained by MRI procedures and is used to detail any abnormal tissue in the brain, spine, [...]]]></description>
			<content:encoded><![CDATA[<p>ProHance is a MRI contrast agent manufactured by Bracco Diagnostics. It received approval from the US Food and Drug Administration in 1992 and was released to the retail market later that year. ProHance is used to enhance the images obtained by MRI procedures and is used to detail any abnormal tissue in the brain, spine, and other associated tissues. It can also be used to detail lesions in the head or neck of adult patients.</p>
<p>Also known as Gadoteridol, ProHance is considered a paramagnetic contrast agent containing Gadolinium ions to increase its magnetic properties. When used in conjunction with MRI, it enhances and improves the images of the body and highlights any areas of abnormal growth. The solution is given by injection directly into the blood stream. The dosage is determined by the patient’s body weight and the MRI scan is taken within an hour of the initial injection. ProHance is eliminated from the body by the kidneys through the urine in about 24 hours. The solution can be used in the MRI procedures of both adults and children.</p>
<p>The most common side effects associated with the use of ProHance include nausea and an unusual taste in the mouth. In rare cases, the solution can cause facial edema, abdominal cramping, headache, fever, dry mouth, and vomiting. Some individuals who have taken ProHance experience an allergic reaction, characterized by pain or discomfort at the site of the injection, itching, watery eyes, shortness of breath, and a rash. ProHance can also affect the circulatory system, causing low blood pressure, palpitations, and angina pectoris.</p>
<p>ProHance, along with other Gadolinium based contrast agents, have been recently associated with the development of a very serious, debilitating condition called Nephrogenic Systemic Fibrosis. Nephrogenic Systemic Fibrosis is a progressive skin disorder characterized by the tightening and thickening of areas of the skin on the arms, legs, and occasionally the trunk of the body. This restricts the movement of the muscles and joints of the extremities, eventually causing a total loss of mobility. In some cases, individuals with Nephrogenic Systemic Fibrosis lose their mobility and become bedridden or wheelchair bound within weeks of the onset of the condition. There is no cure for Nephrogenic Systemic Fibrosis and an effective treatment is yet to be found.</p>
<p>In 2006, the US Food and Drug Administration released a Public Health Advisory warning the healthcare community about the link between the use of Gadolinium based contrast agents such as ProHance and the development of Nephrogenic Systemic Fibrosis in individuals with impaired renal function. The disorder seems to only occur in patients with moderate to end-stage kidney disease and kidney failure, causing some experts to speculate that the condition occurs because the Gadolinium based contrast agent is not cleared from the body by the kidneys effectively. Any individual with impaired renal function is advised to avoid the use of Gadolinium based contrast agents, as they are at a significantly increased risk of developing Nephrogenic Systemic Fibrosis.</p>
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		<title>Gadolinium Based Contrast Agent – OptiMARK</title>
		<link>http://www.schmidtandclark.com/gadolinium-based-contrast-agent-%e2%80%93-optimark</link>
		<comments>http://www.schmidtandclark.com/gadolinium-based-contrast-agent-%e2%80%93-optimark#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:46:12 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=442</guid>
		<description><![CDATA[OptiMARK is a Gadolinium based contrast agent used to enhance the images obtained by MRI procedures. Also known as Gadoversetamide, the agent is manufactured by Mallinckrodt, which is a division of Tyco Healthcare. OptiMARK is considered a paramagnetic MRI contrast agent and is used to increase the detail of MRI images of the brain, spine, [...]]]></description>
			<content:encoded><![CDATA[<p>OptiMARK is a Gadolinium based contrast agent used to enhance the images obtained by MRI procedures. Also known as Gadoversetamide, the agent is manufactured by Mallinckrodt, which is a division of Tyco Healthcare. OptiMARK is considered a paramagnetic MRI contrast agent and is used to increase the detail of MRI images of the brain, spine, and liver. The solution is generally administered by IV but can also be injected directly into the blood stream. OptiMARK is a solution containing a chelating agent called versetamide that binds to the paramagnetic Gadolinium ion, effectively reducing its toxicity. When injected into the body, the contrast agent increases the brightness of tissues when scanned by an MRI. The images are taken within an hour of the injection of OptiMARK.</p>
<p>The common side effects associated with OptiMARK include headache, dizziness, nausea, taste perversion, and vasodilatation. These side effects are typically mild when they occur. Less commonly occurring side effects include fever, increased sweating, neck pain, chest pain, hypertension, constipation, dry mouth, edema, and muscle cramps. In rare cases, an allergic reaction may occur, either localized to the site of the injection or spread throughout the body. In the event of an allergic reaction to OptiMARK, patients should seek medical treatment immediately to prevent the reaction from becoming life-threatening. Any patient with a known allergic or hypersensitivity to any of the ingredients contained in OptiMARK should avoid using the agent.</p>
<p>OptiMARK, along with other Gadolinium based contrast agents, have been linked to an increased risk of developing Nephrogenic Systemic Fibrosis in patients with advanced kidney disease or kidney failure. Nephrogenic Systemic Fibrosis is a serious, life-threatening condition that affects the skin and internal organs of the affected individual. The condition causes the skin of the extremities to swell and tighten, causing the patient great discomfort. The tightening of the skin begins to restrict the movement of the muscles and joints, causing them to stiffen as well. Nephrogenic Systemic Fibrosis causes many patients to lose their mobility and many are confined to a wheelchair or become bedridden. There is no cure for Nephrogenic Systemic Fibrosis and an effective treatment has yet to be found.</p>
<p>Patients that have advanced to end-stage kidney disease should avoid using a Gadolinium based contrast agent, such as OptiMARK, unless there is no other way to obtain the needed images. Patients already receiving dialysis may initiate dialysis promptly after exposure to a Gadolinium based contrast agent to clear the agent from the body. Factors that may increase the risk of developing Nephrogenic Systemic Fibrosis after exposure to OptiMARK include higher than normal or repeated doses of a Gadolinium based contrast agent in a patient with advanced kidney disease or kidney failure, although cases of Nephrogenic Systemic Fibrosis have occurred after a single dose of a Gadolinium based contrast agent.</p>
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		<title>Gadolinium Based Contrast Agent – Omniscan</title>
		<link>http://www.schmidtandclark.com/gadolinium-based-contrast-agent-%e2%80%93-omniscan</link>
		<comments>http://www.schmidtandclark.com/gadolinium-based-contrast-agent-%e2%80%93-omniscan#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:45:39 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=440</guid>
		<description><![CDATA[Omniscan was created as a contrast agent for use in Magnetic Resonance Imaging (MRI) procedures and was approved for use by the US Food and Drug Administration in 1993. Also known as Gadodiamide, the agent is considered a paramagnetic agent that tends to generate a localized magnetic field. When protons move through this field, the [...]]]></description>
			<content:encoded><![CDATA[<p>Omniscan was created as a contrast agent for use in Magnetic Resonance Imaging (MRI) procedures and was approved for use by the US Food and Drug Administration in 1993. Also known as Gadodiamide, the agent is considered a paramagnetic agent that tends to generate a localized magnetic field. When protons move through this field, the protons are reorganized in such a way as to provide highly detailed images of the body. The contrast agent can be used for both adults and children and comes in a variety of different sizes for use in the most commonly performed procedures. Packaging Omniscan in different sizes reduces the risk of a physician administering a wrong dosage through confusion of the dosing instructions.</p>
<p>Omniscan is commonly used for producing detailed images of the central nervous system, showing any lesions or tumors that are present. It is also used for the imaging of the chest, abdominal, and pelvic cavities as well as the musculoskeletal system. The contrast agent is administered by IV or injection directly into the blood stream. After allowing the contrast agent to circulate through the system for roughly 45 minutes, the MRI is performed and the images are taken. Omniscan is eliminated from the body by the kidneys through the urine within 24 hours of the administration of the dose, too quickly for the agent to decompose within the body causing a toxic reaction.</p>
<p>The most common side effects resulting from the use of Omniscan include headache, dizziness, and nausea, occurring in around 3% of patients during clinical trials. Some individuals have also experienced an allergic reaction occurring at the site of the injection, causing swelling, rash, and/or pain at the injection site. Other side effects experienced by patients who have taken Omniscan include fatigue, chest pain, fever, flushing, diarrhea, abdominal pain, and increased anxiety.</p>
<p>There is a possibility that a patient that has taken Omniscan may experience a serious adverse allergic reaction to the agent which will require emergency medical treatment to avoid numerous complications and/or death. Omniscan should not be administered to any patient suspected of being sensitive to its components. Any patient who has a history of drug reactions or known allergic reactions should be observed carefully to ensure that their health has not been compromised. Extreme caution should also be taken when administering Omniscan to patients with impaired renal function. Because the contrast agent is eliminated by the kidneys, any patient with impaired renal function may not be able to eliminate the agent from the body quickly enough to avoid serious complications.</p>
<p>Recent studies has linked Omniscan, along with other approved contrast agents containing Gadolinium, to a very serious, debilitating condition known as Nephrogenic Systemic Fibrosis. This condition only affects individuals with moderate to severe renal impairment or renal failure that have taken Omniscan or other FDA approved contrast agents containing Gadolinium prior to undergoing an MRI. The condition is characterized by the tightening and hardening of areas of the skin located on the extremities of the body. Eventually, the areas of affected skin begin to resemble an orange peel and restrict the movement of the joints and muscles beneath the areas of affected skin. There is no cure for the condition and an effective treatment has yet to be found.</p>
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		<title>Gadolinium Based Contrast Agent – MultiHance</title>
		<link>http://www.schmidtandclark.com/gadolinium-based-contrast-agent-%e2%80%93-multihance</link>
		<comments>http://www.schmidtandclark.com/gadolinium-based-contrast-agent-%e2%80%93-multihance#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:44:50 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=437</guid>
		<description><![CDATA[MultiHance is manufactured by Bracco Diagnostics based out of Princeton, New Jersey. Also known as Gadobenate dimeglumine, the contrast agent was approved by the US Food and Drug Administration for use in enhancing MRI images on November 23, 2004. MultiHance is considered a paramagnetic MRI contrast agent meaning that it tends to follow magnetic fields [...]]]></description>
			<content:encoded><![CDATA[<p>MultiHance is manufactured by Bracco Diagnostics based out of Princeton, New Jersey. Also known as Gadobenate dimeglumine, the contrast agent was approved by the US Food and Drug Administration for use in enhancing MRI images on November 23, 2004. MultiHance is considered a paramagnetic MRI contrast agent meaning that it tends to follow magnetic fields when used during an MRI procedure. Although it has only been available for a limited amount of time, MultiHance has proved its effectiveness time and time again in clinical trials.</p>
<p>MultiHance is created by taking Gadolinium ions and mixing them with a chelating agent called Gadobenate which forms a protective sphere around the ion making it more stable and reducing its toxicity. MultiHance costs about 20% more per dose when compared to other Gadolinium based contrast agents. Many medical professionals consider it well worth the price because the images obtained are so much clearer than images obtained using other contrast agents. The contrast agent is obtained as a clear solution that is injected into the veins prior to an MRI procedure.</p>
<p>Using MultiHance in conjunction with an MRI results in images that are highly detailed and significantly clearer than images obtained with the use of other contrast agents. The contrast agent is commonly used intravenously to enhance the images of the central nervous system in adults. It is used to pinpoint lesions and abnormal growths present in the brain, spine, and other associated tissues. It is also one of the few contrast agents that can be used for liver enhancement studies. Clinical studies have found that the use of MultiHance during MRI scans of the liver result greatly improves the chances of liver cancer detection and the detection of lesions in the liver.</p>
<p>Common side effects associated with the use of MultiHance include mild abdominal pain, sweating, minor skin rash, painful or burning sensation at the site of the injection, difficulty swallowing, and constipation. More serious side effects include dry mouth, gastrointestinal issues, tremors, increased salivation, dizziness, lightheadedness, and blurred vision. In rare cases, an allergic reaction may occur, resulting in a severe rash, hives, the swelling of the patient’s hands or face, and difficulty breathing. Anyone suspected of having an allergic reaction to MultiHance should obtain medical treatment immediately to avoid worsening the condition, which could cause death. Medical professionals should also be notified if the patient experiences tingling, numbness, or burning pain in your hands, arms, legs, or feet, as this can be a sign of a greater problem.</p>
<p>Recent studies have found a possible link between Gadolinium based contrast agents such as MultiHance and the development of a serious, debilitating condition named Nephrogenic Systemic Fibrosis. This condition is characterized by patches of rough, thickened skin appearing on the upper and lower extremities accompanied by a severe burning or itching sensation in the affected areas. This condition is very rare and is considered life threatening in severe cases. This condition only affects individuals who are suffering from advanced kidney disease or kidney failure at the time they undergo an MRI using a Gadolinium based contrast agent. There are close to 300 confirmed cases of Nephrogenic Systemic Fibrosis worldwide.</p>
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		<title>MultiHance MRI Scan &amp; Nephrogenic Systemic Fibrosis (NSF) Lawsuit</title>
		<link>http://www.schmidtandclark.com/multihance</link>
		<comments>http://www.schmidtandclark.com/multihance#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:43:48 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=435</guid>
		<description><![CDATA[MultiHance (gadobenate dimeglumine), a gadolinium-based contrast agent which is commonly used to improve the visibility of internal structures when patients undergo an MRI has been linked to a serious, life-threatening disease known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD).
If you or a loved one have had an MRI or MRA, and since [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.schmidtandclark.com/wp-content/uploads/mri-contrast-agents-gadolinium-nsf.jpg"><img class="alignright size-thumbnail wp-image-1272" title="mri-contrast-agents-gadolinium-nsf" src="http://www.schmidtandclark.com/wp-content/uploads/mri-contrast-agents-gadolinium-nsf-200x200.jpg" alt="mri-contrast-agents-gadolinium-nsf" width="200" height="200" /></a>MultiHance (gadobenate dimeglumine), a gadolinium-based contrast agent which is commonly used to improve the visibility of internal structures when patients undergo an MRI has been linked to a serious, life-threatening disease known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD).</strong></p>
<p><em>If you or a loved one have had an MRI or MRA, and since developed either NSF or NFD, you should <a href="http://www.schmidtandclark.com/contact">contact us</a> immediately. You may be entitled to compensation and we can help.</em></p>
<h2>What is the problem with MultiHance?</h2>
<p>On May 23, 2007, the U.S. Food &amp; Drug Administration requested the manufacturers of MultiHance (Bracco Diagnostics Inc.) of gadolinium-based contrast agents to add a new boxed warning on the product labeling because of reports linking the agents to the life-threatening skin disorders, Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy.</p>
<blockquote><p>“Patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as Nephrogenic Systemic Fibrosis (NSF). In addition, patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.”</p></blockquote>
<h2>What is Nephrogenic Systemic Fibrosis?</h2>
<p>NSF, also known as NFD is a skin condition that is often described as a swelling and tightening of the skin, usually limited to the extremities. The condition may develop over a short period of days or could take weeks to fully develop. NSF can also lead to death.</p>
<p>Severely affected patients may be unable to walk, or fully extend the joints of their arms, hands, legs, and feet. Complaints of muscle weakness are common.</p>
<h2>Signs of Nephrogenic Systemic Fibrosis</h2>
<ul>
<li>Burning</li>
<li>Itching</li>
<li>Swelling</li>
<li>Hardening and tightening of the skin</li>
<li>Red or dark patches on the skin</li>
<li>Yellow spots on the whites of the eyes</li>
<li>Stiffness in joints and trouble moving or straightening the arms, hands, legs, or feet</li>
<li>Pain deep in the hip bones or ribs</li>
<li>Muscle weakness</li>
</ul>
<h2>Do I have a MultiHance MRI &amp; NSF Lawsuit?</h2>
<p>The Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in MultiHance MRI induced NSF lawsuits. We are handling individual litigation nationwide and currently accepting new MultiHance MRI scan and Nephrogenic Systemic Fibrosis cases in all 50 states.</p>
<p><em>If you or a loved one have had an MRI or MRA, and since developed either NSF or NFD, you should <a href="http://www.schmidtandclark.com/contact">contact us</a> immediately. You may be entitled to compensation and we can help.</em></p>
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		<title>Magnevist and Nephrogenic Systemic Fibrosis</title>
		<link>http://www.schmidtandclark.com/magnevist-and-nephrogenic-systemic-fibrosis</link>
		<comments>http://www.schmidtandclark.com/magnevist-and-nephrogenic-systemic-fibrosis#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:41:36 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=433</guid>
		<description><![CDATA[The first cases of Nephrogenic Systemic Fibrosis were discovered in 1997 with the first medical references detailing the condition written in 2000. The condition only affects individuals with impaired renal function or renal failure and causes the skin and connective tissues in the body to thicken and harden. The typical symptoms of Nephrogenic Systemic Fibrosis [...]]]></description>
			<content:encoded><![CDATA[<p>The first cases of Nephrogenic Systemic Fibrosis were discovered in 1997 with the first medical references detailing the condition written in 2000. The condition only affects individuals with impaired renal function or renal failure and causes the skin and connective tissues in the body to thicken and harden. The typical symptoms of Nephrogenic Systemic Fibrosis include darkened patches appearing on the skin, a severe itching or burning sensation beneath the skin, skin becoming so tight that it begins to restrict movement. The condition affects males and females equally and can be found in individuals of every age, from children to seniors. Nephrogenic Systemic Fibrosis is a progressive condition and can ultimately prove to be fatal.</p>
<p>There is no known cure available for Nephrogenic Systemic Fibrosis and current treatments are often ineffective. The only option that has a consistent effect on the progression of the condition seems to be the improvement of renal function, which has been shown to halt the progression of the condition and in rare cases, began to reverse the damage done by the disorder. The exact reason for the development of Nephrogenic Systemic Fibrosis in some individuals remains unknown, the agents suspected of causing the development of the condition include surgery, vascular injury, and exposure to Gadolinium based contrast agents.</p>
<p>In 2006, the FDA issued two public health advisories warning healthcare professionals and patients with impaired renal function about the increased risk of developing Nephrogenic Systemic Fibrosis when exposed to a Gadolinium based contrast agent such as Magnevist. In all of the cases of Nephrogenic Systemic Fibrosis that the FDA had investigated, every individual had received an injection of a Gadolinium based contrast agent prior to an MRI procedure in the 2 days to 18 months before the onset of the condition. Although only three of the five approved Gadolinium based contrast agents were conclusively linked to these patients developing Nephrogenic Systemic Fibrosis, the FDA believes that the increased risk applies to all of the approved Gadolinium based contrast agents.</p>
<p>The manufacturer of Magnevist, Bayer Healthcare Pharmaceuticals, reports that they are cooperating fully with the US Food and Drug Administration and health authorities investigating the issue. Reports have been received linking the development of Nephrogenic Systemic Fibrosis to an injection of Magnevist, but those cases are still under review. Out of the 78 reports received by the manufacturer claiming an association between Magnevist and the development of Nephrogenic Systemic Fibrosis, 27 of the cases have been deemed plausible, 5 of the cases have been deemed unlikely, and 46 of the cases need more information to draw a conclusion. To date, Magnevist has been used in more than 80 million applications throughout the world and is available for use in more than 100 countries.</p>
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		<item>
		<title>Gadolinium Based Contrast Agent &#8211; Magnevist</title>
		<link>http://www.schmidtandclark.com/gadolinium-based-contrast-agent-magnevist</link>
		<comments>http://www.schmidtandclark.com/gadolinium-based-contrast-agent-magnevist#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:40:42 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=431</guid>
		<description><![CDATA[Magnevist was the first Gadolinium based contrast agent approved for use in the United States by the US Food and Drug Administration. Introduced in 1988, the contrast agent has been used in more than 80 million applications worldwide. As the first contrast agent approved for use in enhancing MRI images, Magnevist is still considered an [...]]]></description>
			<content:encoded><![CDATA[<p>Magnevist was the first Gadolinium based contrast agent approved for use in the United States by the US Food and Drug Administration. Introduced in 1988, the contrast agent has been used in more than 80 million applications worldwide. As the first contrast agent approved for use in enhancing MRI images, Magnevist is still considered an industry leader in its field. Magnevist is used in a wide variety of clinical applications including the imaging of the head, neck, body, and the central nervous system and is approved for use in both adults and children. The contrast agent is available in over 100 countries and is the most studied MRI contrast agent with over 14,000 medical references and citations in scientific literature.</p>
<p>Magnevist is manufactured by Berlex Inc. based in Wayne, New Jersey. Also known as Gadopentetate dimeglumine, it is produced as an injectable solution that is used to assist in the diagnosis of a variety of medical conditions. Magnevist enhances images taken with an MRI and highlights problem areas such as abnormal growths or tumors. The solution is injected directly into the vein prior to undergoing an MRI and the contrast agent is removed from the body by the kidneys.</p>
<p>Common side effects associated with the use of Magnevist includes headache, nausea, vomiting, and an altered taste in the mouth. These side effects are generally mild and occur in a small number of patients. More serious side effects include chest pain, dizziness, flushing, localized discomfort at the site of the injection, and excessive sweating. Rarely, a severe allergic reaction can occur characterized by difficulty breathing, the appearance of a skin rash or hives, and intense itching sensations. An allergic reaction to the solution requires urgent medical treatment avoid serious, life-threatening complications. Serious adverse event associated with Magnevist are considered rare.</p>
<p>Clinical studies conducted recently have discovered a link between Gadolinium based contrast agents such as Magnevist and the development of a severe, occasionally fatal condition called Nephrogenic Systemic Fibrosis. This condition is characterized by the appearance of darkened or reddened patches on the skin that start to thicken and tighten, causing severe discomfort and debilitating pain. As the skin tightens, it begins to impair movement and causes muscles to weaken and atrophy. In severe cases, the movements become so restricted that attempting movement can break bones. Many patient suffering from Nephrogenic Systemic Fibrosis become confined to a wheelchair or become bedridden.</p>
<p>There is no cure available for Nephrogenic Systemic Fibrosis. Many of the treatment options recommended for the relief of the symptoms are ineffective. The disorder only occurs in patients with moderate to advanced kidney disease and those with kidney failure that have received an injection of a Gadolinium based contrast agent prior to undergoing an MRI. Nephrogenic Systemic Fibrosis is considered a rare condition with less than 300 cases confirmed worldwide. Although it is not confirmed that Gadolinium based contrast agents are responsible for the development of Nephrogenic Systemic Fibrosis, the association is strong enough to warrant a public health advisory issued by the US Food and Drug Administration warning of the increased risk. </p>
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		<item>
		<title>Magnevist MRI Scan &amp; Nephrogenic Systemic Fibrosis (NSF) Lawsuit</title>
		<link>http://www.schmidtandclark.com/magnevist</link>
		<comments>http://www.schmidtandclark.com/magnevist#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:39:59 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=429</guid>
		<description><![CDATA[Magnevist (gadopentetate dimeglumine), a gadolinium-based contrast agent which is commonly used to improve the visibility of internal structures when patients undergo an MRI has been linked to a serious, life-threatening disease known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD).
If you or a loved one have had an MRI or MRA, and since [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.schmidtandclark.com/wp-content/uploads/mri-contrast-agents-gadolinium-nsf.jpg"><img class="alignright size-thumbnail wp-image-1272" title="mri-contrast-agents-gadolinium-nsf" src="http://www.schmidtandclark.com/wp-content/uploads/mri-contrast-agents-gadolinium-nsf-200x200.jpg" alt="mri-contrast-agents-gadolinium-nsf" width="200" height="200" /></a>Magnevist (gadopentetate dimeglumine), a gadolinium-based contrast agent which is commonly used to improve the visibility of internal structures when patients undergo an MRI has been linked to a serious, life-threatening disease known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD).</strong></p>
<p><em>If you or a loved one have had an MRI or MRA, and since developed either NSF or NFD, you should <a href="http://www.schmidtandclark.com/contact">contact us</a> immediately. You may be entitled to compensation and we can help.</em></p>
<h2>What is the problem with Magnevist?</h2>
<p>On May 23, 2007, the U.S. Food &amp; Drug Administration requested the manufacturers of Magnevist (Bayer Schering Pharma) of gadolinium-based contrast agents to add a new boxed warning on the product labeling because of reports linking the agents to the life-threatening skin disorders, Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy.</p>
<blockquote><p>“Patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as Nephrogenic Systemic Fibrosis (NSF). In addition, patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.”</p></blockquote>
<h2>What is Nephrogenic Systemic Fibrosis?</h2>
<p>NSF, also known as NFD is a skin condition that is often described as a swelling and tightening of the skin, usually limited to the extremities. The condition may develop over a short period of days or could take weeks to fully develop. NSF can also lead to death.</p>
<p>Severely affected patients may be unable to walk, or fully extend the joints of their arms, hands, legs, and feet. Complaints of muscle weakness are common.</p>
<h2>Signs of Nephrogenic Systemic Fibrosis</h2>
<ul>
<li>Burning</li>
<li>Itching</li>
<li>Swelling</li>
<li>Hardening and tightening of the skin</li>
<li>Red or dark patches on the skin</li>
<li>Yellow spots on the whites of the eyes</li>
<li>Stiffness in joints and trouble moving or straightening the arms, hands, legs, or feet</li>
<li>Pain deep in the hip bones or ribs</li>
<li>Muscle weakness</li>
</ul>
<h2>Do I have a Magnevist MRI &amp; NSF Lawsuit?</h2>
<p>The Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Magnevist MRI induced NSF lawsuits. We are handling individual litigation nationwide and currently accepting new Magnevist MRI scan and Nephrogenic Systemic Fibrosis cases in all 50 states.</p>
<p><em>If you or a loved one have had an MRI or MRA, and since developed either NSF or NFD, you should <a href="http://www.schmidtandclark.com/contact">contact us</a> immediately. You may be entitled to compensation and we can help.</em></p>
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		<title>Risk for Nephrogenic Systemic Fibrosis in Patients with Advanced Kidney Disease</title>
		<link>http://www.schmidtandclark.com/risk-for-nephrogenic-systemic-fibrosis-in-patients-with-advanced-kidney-disease</link>
		<comments>http://www.schmidtandclark.com/risk-for-nephrogenic-systemic-fibrosis-in-patients-with-advanced-kidney-disease#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:16:03 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Diseases]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=427</guid>
		<description><![CDATA[A study was recently conducted to determine the risk of developing Nephrogenic Systemic Fibrosis (NSF) in patients with advanced kidney disease who had undergone an MRI using a Gadolinium based contrast agent. The study determined that for each MRI procedure using a Gadolinium based contrast agent that the patient undergoes, the risk of developing a [...]]]></description>
			<content:encoded><![CDATA[<p>A study was recently conducted to determine the risk of developing Nephrogenic Systemic Fibrosis (NSF) in patients with advanced kidney disease who had undergone an MRI using a Gadolinium based contrast agent. The study determined that for each MRI procedure using a Gadolinium based contrast agent that the patient undergoes, the risk of developing a case of Nephrogenic Systemic Fibrosis increases by 2.4%. NSF is a potentially fatal disease with no known cure or effective treatment. Based on this study, researchers have determined that patients with advance kidney disease should avoid exposure to agents containing Gadolinium. If the Gadolinium containing agents cannot be avoided, the risks and benefits should be carefully assessed before treatment begins.</p>
<p>Nephrogenic Systemic Fibrosis is considered a systemic disorder characterized by the tightening and thickening of the skin on the extremities. Over time, the surface of the skin begins to resemble the peel of an orange and the soft tissue begins to harden and calcify. The condition can result in extreme discomfort and many patients experience a severe burning sensation in the areas of the skin that are affected. The condition is progressive and the more advanced stages of NSF can affect the internal organs, causing them to scar and thicken as well. The first cases of Nephrogenic Systemic Fibrosis were discovered in 1997 and the first medical references were written in 2000.</p>
<p>Because Nephrogenic Systemic Fibrosis was discovered so recently, not much is known about the condition. There seems to be a positive correlation between NSF and Gadolinium exposure in patients with advanced kidney disease. In 2006, the US Food and Drug Administration issued a public health alert warning of the increased risk of developing NSF when patients with advanced kidney disease use a Gadolinium based contrast agent before undergoing an MRI. Nephrogenic Systemic Fibrosis tends to occur only in patients with advanced kidney disease or kidney failure and then only if the patient has received an injection of a Gadolinium based contrast agent within recent months. Not all patients with advanced kidney disease develop the condition, regardless of whether or not they have received an injection of a Gadolinium based contrast agent.</p>
<p>After compiling the information gained by the studies researching the correlation between kidney disease, Gadolinium based contrast agents, and the development of Nephrogenic Systemic Fibrosis, researchers have come to the conclusion that only individuals with advanced kidney disease or kidney failure are at risk to develop NSF. All of the recorded cases of NSF seemed to have appeared within several weeks to several months after patients had received an injection of a Gadolinium based contrast agent. Because Gadolinium is removed from the body by the kidneys, experts believe that NSF may be caused by Gadolinium remaining in the body for an extended period of time because the kidneys cannot effectively remove it from the body. More research will be needed to determine the exact cause of the development of Nephrogenic Systemic Fibrosis, but in the meantime all patients with advanced kidney disease are advised to avoid exposure to Gadolinium and Gadolinium based contrast agents.</p>
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		<title>Dialysis May Prevent Nephrogenic Systemic Fibrosis</title>
		<link>http://www.schmidtandclark.com/dialysis-may-prevent-nephrogenic-systemic-fibrosis</link>
		<comments>http://www.schmidtandclark.com/dialysis-may-prevent-nephrogenic-systemic-fibrosis#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:15:29 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Diseases]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=425</guid>
		<description><![CDATA[The US Food and Drug Administration recently issued an alert to the healthcare community warning of an increased risk of the development of Nephrogenic Systemic Fibrosis in patients with impaired renal function or renal failure who have received a Gadolinium based contrast agent prior to an MRI procedure. The alert, which was issued in December [...]]]></description>
			<content:encoded><![CDATA[<p>The US Food and Drug Administration recently issued an alert to the healthcare community warning of an increased risk of the development of Nephrogenic Systemic Fibrosis in patients with impaired renal function or renal failure who have received a Gadolinium based contrast agent prior to an MRI procedure. The alert, which was issued in December of 2006, details 90 cases of Nephrogenic Systemic Fibrosis that developed in patients with impaired renal function within two days to eighteen months after receiving an injection of a Gadolinium based contrast agent.</p>
<p>A research team from Yale University, which contains the world’s leading authority on cases of Nephrogenic Systemic Fibrosis, recommends that the aggressive use of dialysis should be used as soon as possible after the MRI procedure to remove the Gadolinium based contrast agent from the body of the patient. They believe that two dialysis sessions within 24 hours of the completion of the MRI procedure using a Gadolinium based contrast agent will prevent the development of Nephrogenic Systemic Fibrosis by removing the Gadolinium from the body. In patients with normal renal function, Gadolinium is removed from the body by the kidneys but in patients with impaired renal function, the kidneys may not be strong enough to remove the Gadolinium from the body allowing it to build up and become toxic.</p>
<p>There is no effective treatment available for Nephrogenic Systemic Fibrosis and the only thing that seems to reverse the condition is an improvement in renal function. The experts at Yale believe that by placing the patient on dialysis immediately following the MRI procedure, the contrast agent is cleared from the patient’s body, minimizing the risk of developing Nephrogenic Systemic Fibrosis. The best course of action to manage Nephrogenic Systemic Fibrosis is to avoid the occurrence of the condition in the first place. The first round of dialysis will remove up to 80% of the Gadolinium from the body and the second round will make the body 95% clear.</p>
<p>There are five FDA approved Gadolinium based contrast agents that could potentially cause the development of Nephrogenic Systemic Fibrosis in patients with impaired renal function, although only three have been positively linked to the disorder. The three associated with the development of the condition are gadoversetamide (OptiMark, Mallinckrodt, St. Louis, Missouri), gadopentetate dimeglumine (Magnevist, Berlex Imaging, Montville, New Jersey), and gadodiamide (Omniscan, GE Healthcare, Princeton, New Jersey). All are approved for use in MRI procedures and are commonly used “off-label” for MRA procedures.</p>
<p>Although the US Food and Drug Administration doesn’t actually recommend dialysis to avoid the development of Nephrogenic Systemic Fibrosis, they do say that it may be necessary for patients with impaired renal function to undergo dialysis if they received a Gadolinium based contrast agent for the enhancement of MRA images, as the MRA procedure requires much higher doses of a Gadolinium based contrast agent to be effective. To date, there is no treatment regiment utilizing dialysis to remove a Gadolinium based contrast agent from the body approved for use in patients with impaired renal function or renal failure. As research continues, using dialysis to prevent an occurrence of Nephrogenic Systemic Fibrosis will be one of many treatment options explored.</p>
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		<title>Treatment Options for Nephrogenic Systemic Fibrosis / Nephrogenic Fibrosing Dermopathy</title>
		<link>http://www.schmidtandclark.com/treatment-options-for-nephrogenic-systemic-fibrosis-nephrogenic-fibrosing-dermopathy</link>
		<comments>http://www.schmidtandclark.com/treatment-options-for-nephrogenic-systemic-fibrosis-nephrogenic-fibrosing-dermopathy#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:14:55 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Diseases]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=423</guid>
		<description><![CDATA[Nephrogenic systemic fibrosis (NSF) is an extremely rare condition that occurs in some individuals enduring an advanced stage of kidney disease. Also known as nephrogenic fibrosing dermopathy (NFD), the first cases of the condition were documented in 1997. Since then, less that 300 cases have been confirmed worldwide. Researchers are unsure what causes the condition, [...]]]></description>
			<content:encoded><![CDATA[<p>Nephrogenic systemic fibrosis (NSF) is an extremely rare condition that occurs in some individuals enduring an advanced stage of kidney disease. Also known as nephrogenic fibrosing dermopathy (NFD), the first cases of the condition were documented in 1997. Since then, less that 300 cases have been confirmed worldwide. Researchers are unsure what causes the condition, but recent studies have indicated that a connection exists between NSF/NFD and solutions commonly used in MRI procedures called Gadolinium based contrast agents. To date, the US Food and Drug Administration has received over 90 reports of NSF/NFD cases linked to the injection of a Gadolinium based contrast agent.</p>
<p>NSF/NFD is a skin disorder characterized by the skin located on the extremities becoming tight and stiff to the point of extreme discomfort. The surface of the skin begins to resemble orange peel and the soft tissue beneath the affected areas begins to harden. Patients afflicted with NSF/NFD report that they feel an itching, burning sensation in the skin and sometimes experience sharp, shooting pains within the tissue underneath the affected areas. The condition typically develops over a period of months, but in some cases, the condition can go from non-existent to severe within a matter of days.</p>
<p>There is no one recommended treatment option for NSF/NFD that is consistently effective, although there are quite a few treatment options that are commonly used to alleviate the symptoms of the condition. One commonly used treatment method is the prescription of oral steroids, namely prednisone. This oral steroid is used in the treatment of a large number of different conditions and has been shown to be effective in a number of inflammatory diseases. The medication has also been shown to improve renal function in patients with kidney disease so NSF/NFD is being battled on both fronts.</p>
<p>Another treatment option used to relieve the symptoms of NSF/NFD is Dovonex. Dovonex is a topical medication that can improve the skin sensations experienced by individuals suffering from NSF/NFD. This medication is derived from naturally occurring vitamin D and is not considered a steroid like many other topical medications. Dovonex can significantly decrease the irritation, redness, and scaling signature to NSF/NFD but it cannot cure the condition. The medication can cause irritation if placed on the face, so patients are warned to avoid accidental transfer to the facial area.</p>
<p>Some individuals with NSF/NFD have found that regular physical therapy has been effective at slowing the stiffening of the joints. Activities such as swimming can help keep the joints mobile while avoiding the jerky movements that can cause joint damage. Deep massage has also been shown to be effective in relieving some of the pain associated with NSF/NFD. Many physicians recommend that regardless of which other treatments are pursued, physical therapy and deep massage should be included in the treatment regiment.</p>
<p>There are quite a few other treatments available for the relief of symptoms of NSF/NFD. Each works with varying degrees of success, but none are effective all the time with every patient. Researchers continue to try to find an effective treatment and a cure for NSF/NFD, but any breakthroughs in those areas are still years away.</p>
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		<title>The Symptoms and Signs Of Nephrogenic Systemic Fibrosis / Nephrogenic Fibrosing Dermopathy</title>
		<link>http://www.schmidtandclark.com/the-symptoms-and-signs-of-nephrogenic-systemic-fibrosis-nephrogenic-fibrosing-dermopathy</link>
		<comments>http://www.schmidtandclark.com/the-symptoms-and-signs-of-nephrogenic-systemic-fibrosis-nephrogenic-fibrosing-dermopathy#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:14:07 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Diseases]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=421</guid>
		<description><![CDATA[Nephrogenic systemic fibrosis (NSF), also known as nephrogenic fibrosing dermopathy (NFD), is a rare condition characterized by the tightening and stiffening of the skin on the extremities. The condition is exclusive to patients in moderate to late stage kidney disease and affects men and women of every age and nationality. There are no confirmed cases [...]]]></description>
			<content:encoded><![CDATA[<p>Nephrogenic systemic fibrosis (NSF), also known as nephrogenic fibrosing dermopathy (NFD), is a rare condition characterized by the tightening and stiffening of the skin on the extremities. The condition is exclusive to patients in moderate to late stage kidney disease and affects men and women of every age and nationality. There are no confirmed cases of the condition noted prior to 1997, with only 300 confirmed cases occurring worldwide. The majority of the cases of NSF/NFD are found in Europe, Asia, and North America.</p>
<p>The origin of the condition is a mystery, with no credible links to ingested medications, kidney dialysis, or any microorganism. In recent years, a connection between cases of NSF/NFD and the injection of a Gadolinium based contrast agent prior to a magnetic resonance imaging (MRI) procedure has been found. In December of 2006, the US Food and Drug Administration (FDA) had received 90 reports of NSF/NFD occurring in the months after the patient had received an injection of a Gadolinium based contrast agent in order to clarify the images produced by an MRI. This prompted the FDA to open an investigation which found that out of the 75 cases that they meticulously reviewed, all of the patients had received a Gadolinium based contrast agent injection, all had undergone an MRI, and all had moderate to late stage kidney disease.</p>
<p>The onset of NSF/NFD is characterized by dark or reddened areas appearing on the skin. Individuals experiencing the condition report an itching or burning feeling underneath the skin that can range in intensity from mild to severe. The skin of the body starts to thicken and swell, most commonly on the extremities but also affecting the trunk of the body in some cases. The surface of the skin begins to look like the peel of an orange and skin lesions that resemble blisters may appear on the areas between the wrist and shoulders or the areas between the ankles and thighs. Patients have also reported significant joint pain and bone pain occurring deep within the ribs and hips.</p>
<p>As NSF/NFD progresses, the individual will start to experience muscle weakness and severe, sharp pains beneath the affected areas of the skin. Medical testing will show that the soft tissue beneath the affected areas has begun calcification, which is a build up of calcium deposits in the soft tissue causing the tissue to harden. The affected areas of the skin will continue to tighten and thicken, causing severe discomfort and limiting the amount of movement that can be performed by the affected limb. Individuals experiencing a severe case of NSF/NFD may lose the ability to stretch or flex their arms, legs, hands, or feet and, in some cases, are unable to walk or perform normal activities. The movement restriction can become so great that attempting movement may cause bone breakage.</p>
<p>NSF/NFD can develop over a period of days or months, with about 5% of cases classified as rapidly progressive. There is no consistently effective treatment method for the condition, although symptoms may be alleviated by a number of medications. The progression of the condition can be arrested by an improvement in renal function, and in some cases, renal function improvement can slowly reverse the effects of NSF/NFD. Research is ongoing as medical professionals attempt to understand and cure this devastating condition.</p>
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		<title>Nephrogenic Systemic Fibrosis and MRI Contrast Agents</title>
		<link>http://www.schmidtandclark.com/nephrogenic-systemic-fibrosis-and-mri-contrast-agents</link>
		<comments>http://www.schmidtandclark.com/nephrogenic-systemic-fibrosis-and-mri-contrast-agents#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:13:23 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=419</guid>
		<description><![CDATA[Until recently, it was believed that MRI contrast agents were some of the safest solutions used on humans. Very few side effects and adverse reactions were reported and many of those issues were very mild. Then, in 2006 researchers discovered a plausible link between the use of Gadolinium based MRI contrast agents and the development [...]]]></description>
			<content:encoded><![CDATA[<p>Until recently, it was believed that MRI contrast agents were some of the safest solutions used on humans. Very few side effects and adverse reactions were reported and many of those issues were very mild. Then, in 2006 researchers discovered a plausible link between the use of Gadolinium based MRI contrast agents and the development of a debilitating condition called Nephrogenic Systemic Fibrosis. The condition reportedly developed when patients with impaired renal function received an injection of a Gadolinium based MRI contrast agent prior to an MRI procedure. Out of the cases reviewed by the US Food and Drug Administration, all patients had impaired renal function or renal failure and all received a Gadolinium based MRI contrast agent injection prior an MRI. The cases all developed within two days to eighteen months of receiving the initial injection.</p>
<p>The first cases of Nephrogenic Systemic Fibrosis were discovered in 1997 and the first medical references about the condition were written in 2000. Nephrogenic Systemic Fibrosis is a condition that causes a progressive fibrosis of the skin, soft tissue, and internal organs of an individual. When involving the skin, the condition causes thickening patches located on the hands, feet, arms, and legs which creates a painful itching or burning sensation in the skin. As the skin tightens, it restricts the movement of the joints causing the patient to slowly lose their mobility. Over time, the skin can become so tight and stiff that attempting movement can break a bone.</p>
<p>As Nephrogenic Systemic Fibrosis progresses, the soft tissue beneath the affected areas of skin will begin to calcify. This causes the tissue to stiffen and harden, further restricting the movement of the patient. If Nephrogenic Systemic Fibrosis spreads to the internal organs, it causes the same damage resulting in the thickening and scarring of the affected organs. 5% of all cases of Nephrogenic Systemic Fibrosis are fatal because of progressive organ failure. The condition was first noted in patients undergoing dialysis who had received large doses of Gadolinium based MRI contrast agents prior to MRI or MRA procedures. Patients undergoing dialysis for renal failure have the highest risk of developing the condition.</p>
<p>Most patients that receive a Gadolinium based MRI contrast agent prior to an MRI procedure are not at risk for developing Nephrogenic Systemic Fibrosis because their renal function is normal. Only patients with impaired renal function or renal failure have been found to develop the condition. Although the development of Nephrogenic Systemic Fibrosis has been definitively linked to only three of the approved Gadolinium based MRI contrast agents, the US Food and Drug Administration believes that any of the five approved agents could cause the development of the condition. The cause of cases of Nephrogenic Systemic Fibrosis occurring following the injection of a Gadolinium based MRI contrast agent remains unknown, as not all patients with impaired renal function develop the disorder. Research continues to understand Nephrogenic Systemic Fibrosis and to find an effective treatment or cure for the disorder.</p>
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		<title>The Theory Behind How Gadolinium Based Contrast Agents Cause Nephrogenic Systemic Fibrosis</title>
		<link>http://www.schmidtandclark.com/the-theory-behind-how-gadolinium-based-contrast-agents-cause-nephrogenic-systemic-fibrosis</link>
		<comments>http://www.schmidtandclark.com/the-theory-behind-how-gadolinium-based-contrast-agents-cause-nephrogenic-systemic-fibrosis#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:12:40 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=417</guid>
		<description><![CDATA[In 2006, reports began to emerging linking the usage of Gadolinium based contrast agents to the development of a rare condition called Nephrogenic Systemic Fibrosis. The condition was first noted in patients undergoing dialysis who had recently received an injection of a contrast agent containing Gadolinium prior to an MRI or MRA procedure. While the [...]]]></description>
			<content:encoded><![CDATA[<p>In 2006, reports began to emerging linking the usage of Gadolinium based contrast agents to the development of a rare condition called Nephrogenic Systemic Fibrosis. The condition was first noted in patients undergoing dialysis who had recently received an injection of a contrast agent containing Gadolinium prior to an MRI or MRA procedure. While the cause of this association is not yet understood, researchers believe that in some way, the injection of a Gadolinium based contrast agent into a patient with impaired renal function or renal failure can cause the development of Nephrogenic Systemic Fibrosis.</p>
<p>One theory behind the reason for the development of Nephrogenic Systemic Fibrosis following an injection with a Gadolinium based contrast agent is that the Gadolinium ion may become separated from the contrast agent, allowing it to move freely throughout the body. This freed Gadolinium is a toxic agent that causes Nephrogenic Systemic Fibrosis as it travels throughout the body. Biopsies of the tissue affected by the condition have resulted in the discovery of Gadolinium ions in the cells of the affected tissue. This is the most direct evidence available that Gadolinium based contrast agents can cause Nephrogenic Systemic Fibrosis.</p>
<p>According to this theory, the impaired renal function of patients on dialysis increases risk of the patient developing the disorder because the Gadolinium is not removed from the body by the kidneys as it is in patient with normal renal function. Because of the patient’s impaired renal function, the Gadolinium remains in the body for an extended period of time which increases the risk that some of the Gadolinium ions will break free of the contrast agent solution. Although there is no hard evidence to support this theory, many researchers find it plausible.</p>
<p>The individuals most susceptible to developing Nephrogenic Systemic Fibrosis are patients undergoing dialysis for renal failure. As the renal function gets worse, the risk for developing the condition increases. The FDA has issued a public health alert warning medical professionals to exercise caution with using Gadolinium based contrast agents with patients with moderately to severely impaired renal function and renal failure. The risk of developing the disease should be carefully weighed and alternative treatments discussed before making a final decision.</p>
<p>Based on current information, approximately 3% to 5% of patients with impaired renal function or renal failure will develop Nephrogenic Systemic Fibrosis after receiving a Gadolinium based contrast agent injection prior to an MRI procedure. In some cases, the benefit of obtaining detailed images from the MRI will outweigh the small risk of developing Nephrogenic Systemic Fibrosis, but in other cases, other treatment options may be the better choice. Each decision should be made on a case by case basis and should be based on the current stage of the patient’s renal function.</p>
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		<title>Devastating Condition Called Nephrogenic Systemic Fibrosis Subject Of Alert By The FDA</title>
		<link>http://www.schmidtandclark.com/devastating-condition-called-nephrogenic-systemic-fibrosis-subject-of-alert-by-the-fda</link>
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		<pubDate>Thu, 25 Jun 2009 20:12:02 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Diseases]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=415</guid>
		<description><![CDATA[The US Food and Drug Administration has recently become aware of a number of cases of Nephrogenic Systemic Fibrosis occurring in some individuals with advanced kidney disease and kidney failure. These individuals had recently undergone an MRI or MRA procedure using a Gadolinium based MRI contrast agent to enhance the images obtained the procedure. There [...]]]></description>
			<content:encoded><![CDATA[<p>The US Food and Drug Administration has recently become aware of a number of cases of Nephrogenic Systemic Fibrosis occurring in some individuals with advanced kidney disease and kidney failure. These individuals had recently undergone an MRI or MRA procedure using a Gadolinium based MRI contrast agent to enhance the images obtained the procedure. There are five Gadolinium based MRI contrast agents approved for use in MRI image enhancement by the FDA, but there are no approved contrast agents for MRA procedures. Due to this association, the FDA is recommending that physicians carefully weigh the risk of using a Gadolinium based MRI contrast agent to improve the images of the MRI against the risk of the patient developing this potentially fatal condition.</p>
<p>Patients with advanced kidney disease or kidney failure are warned that they stand the greatest risk of developing Nephrogenic Systemic Fibrosis after exposure to a Nephrogenic Systemic Fibrosis. All of the confirmed cases of the condition have occurring in patients with moderate to severe kidney disease and those undergoing dialysis. Research continues into the association between Gadolinium based MRI contrast agents and the development of Nephrogenic Systemic Fibrosis, with investigators learning more about the condition with every passing day.</p>
<p>The first cases of Nephrogenic Systemic Fibrosis were identified in 1997 and were found to affect patients with acidosis and renal failure exclusively. The condition causes the fibrosis of the skin in patchy areas on the upper and lower extremities. The onset of the condition appears as reddened or darkened patches on the skin that begin to harden and become thick. This causes the patient severe discomfort and limits their ability to move. As Nephrogenic Systemic Fibrosis moves throughout the body, it also causes fibrosis of the soft connective tissue and internal organs of the patients. In some cases, the patient dies of organ failure.</p>
<p>Although the appearance of the condition is quite distinctive, a skin biopsy is needed for a definitive diagnosis. The presence of Gadolinium ions can be found contained in the cells of the inspected tissue, furthering the belief that Gadolinium based MRI contrast agents are the cause of the condition. The signature symptoms of Nephrogenic Systemic Fibrosis are darkened areas appearing on the skin, difficulty extending the joints of the upper and lower extremities, skin swelling and tightening, deep bone pain, and a persistent burning or itching sensation in the affected areas of the skin. Over time, the patient will experience a hardening of the tissue beneath the affected area due to the calcification of the soft tissue. Nephrogenic Systemic Fibrosis is a progressive condition with no known cure and no consistently effective treatment. This makes the avoidance of developing the condition in the first place the best course of action to take.</p>
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		<title>Nephrogenic Systemic Fibrosis Associated with Agents Containing Gadolinium</title>
		<link>http://www.schmidtandclark.com/nephrogenic-systemic-fibrosis-associated-with-agents-containing-gadolinium</link>
		<comments>http://www.schmidtandclark.com/nephrogenic-systemic-fibrosis-associated-with-agents-containing-gadolinium#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:11:24 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=413</guid>
		<description><![CDATA[Nephrogenic Systemic Fibrosis is a condition that causes the skin on the extremities to become thick and harden, causing debilitation, severe pain, and disfiguring the person that it affects. The condition only occurs in patients with advanced kidney disease or kidney failure and then, only after they have been exposed to a Gadolinium based contrast [...]]]></description>
			<content:encoded><![CDATA[<p>Nephrogenic Systemic Fibrosis is a condition that causes the skin on the extremities to become thick and harden, causing debilitation, severe pain, and disfiguring the person that it affects. The condition only occurs in patients with advanced kidney disease or kidney failure and then, only after they have been exposed to a Gadolinium based contrast agent during an MRI or MRA procedure. The condition is considered a rare one, with less that 300 confirmed cases occurring worldwide.</p>
<p>In 2006, a hospital in St. Louis, Missouri informed the CDC that they had found that a number of patients in their dialysis unit had developed cases of Nephrogenic Systemic Fibrosis. In all, 33 patients were confirmed as having the condition. All of the patients had received an injection of a Gadolinium based contrast agent prior to an MRI in the months before the onset of the condition. An investigation was conducted and it concluded that the Gadolinium based contrast agent received prior to the MRI was the most likely cause for the development of Nephrogenic Systemic Fibrosis.</p>
<p>The cases were confirmed by the use of a skin biopsy of the affected areas of the body along with visual confirmation of the condition. The investigation was quickly widened to include all of the St. Louis area, with researchers contacting many hospitals and radiology clinics to see if they had experienced any thing similar. Information was collected from the patient’s medical histories and complied into a general report. No connection was found between the ages of the patients, the sex of the patients, amount of time since dialysis treatment begun, type of dialysis received, or inpatient status at the hospital. The most common thread between all of the affected patients was exposure to a Gadolinium based contrast agent in the months preceding the onset of the condition.</p>
<p>Nephrogenic Systemic Fibrosis was identified as a skin disorder occurring in patients with impaired renal function in 1997. Also known as Nephrogenic Fibrosing Dermopathy, there is very little information available about the progression of the condition or its causes. The cases discovered in St. Louis represent the largest geographic cluster of cases of Nephrogenic Systemic Fibrosis in the world and give researcher some definitive evidence that Gadolinium based contrast agents may be responsible for the development of the condition. While the association cannot be completely confirmed, the evidence is enough to warrant caution in the use of Gadolinium based contrast agents in patients with advanced kidney disease or kidney failure.</p>
<p>Nephrogenic Systemic Fibrosis is a rare condition, occurring in less than 5% of patients with impaired renal function who use a Gadolinium based contrast agent to enhance their MRI images. Experts recommend that patients with impaired renal function should avoid exposure to Gadolinium based contrast agents until more is understood about Nephrogenic Systemic Fibrosis and the role that Gadolinium based contrast agents play in the development of the condition. In this case, it is better to be safe than sorry.</p>
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		<title>Do Gadolinium Based Contrast Agents Cause Nephrogenic Systemic Fibrosis?</title>
		<link>http://www.schmidtandclark.com/do-gadolinium-based-contrast-agents-cause-nephrogenic-systemic-fibrosis</link>
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		<pubDate>Thu, 25 Jun 2009 20:10:48 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=411</guid>
		<description><![CDATA[In 2006, a report was released detailing a rare condition affecting a small number of individuals suffering from kidney damage and kidney failure. The condition was called Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) and was considered potentially life threatening. All of the patients detailed in the report had received a Gadolinium based [...]]]></description>
			<content:encoded><![CDATA[<p>In 2006, a report was released detailing a rare condition affecting a small number of individuals suffering from kidney damage and kidney failure. The condition was called Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) and was considered potentially life threatening. All of the patients detailed in the report had received a Gadolinium based contrast agent during an MRI procedure in the weeks and months before the onset of the condition. The condition affects patients with significant renal failure and is considered extremely rare, with less than 300 cases confirmed worldwide.</p>
<p>The first reports of NSF/NFD found in medical literature were written in 2000. The relative newness of the condition means that very little is known about the condition. NSF/NFD is characterized areas of skin that thicken and tighten while the connective tissue underneath begins to calcify. The condition can be extremely painful and results in very limited movement and joint pain. Some patients suffering from NSF/NFD lose the ability to walk. The thickening of the skin restricts joint movement and can eventually become so tight that the attempt to move portions of the body affected by the condition can result in broken bones. The condition can also cause the thickening and scarring of the internal organs of the patient.</p>
<p>NSF/NFD is considered a progressive disease and could be fatal for the patient afflicted. There is no known cure for NSF/NFD. There are many treatment options available to alleviate the symptoms of the condition, but their success is limited. The best treatment for NSF/NFD is to arrest or improve the renal function of the patient, which has been shown to slowly reverse the effects of the condition. Topical medications can reduce the redness and inflammation of the condition and oral steroids may be prescribed as an anti-inflammatory agent.</p>
<p>Whether the Gadolinium based contrast agent administered during the MRI was the cause of the cases of NSF/NFD is unknown, but the information available was enough for the US Food and Drug Administration (FDA) to issue a warning to the healthcare community advising of a possible link. Typically, the patients who develop a case of NSF/NFD have complicated medical histories and it is difficult for researchers to determine conclusively that a Gadolinium based contrast agent was responsible for the development of NSF/NFD. The FDA’s investigation continues as more information is discovered.</p>
<p>There are five Gadolinium based contrast agents that are approved by the FDA for use in MRI procedures. The most common severe side effect associated with the solutions is allergic reaction, which can become life-threatening very quickly. Although over 3000 individuals participated in the clinical studies prior to the release of the Gadolinium based contrast agents, very few of these patients had renal failure or advanced kidney disease. Because the solution is removed from the body by the kidneys, it is reasonable to believe that if the kidneys are not working properly, then the Gadolinium based contrast agent is not being removed from the body efficiently and that can cause serious problems.</p>
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		<title>What Is Nephrogenic Systemic Fibrosis / Nephrogenic Fibrosing Dermopathy?</title>
		<link>http://www.schmidtandclark.com/what-is-nephrogenic-systemic-fibrosis-nephrogenic-fibrosing-dermopathy</link>
		<comments>http://www.schmidtandclark.com/what-is-nephrogenic-systemic-fibrosis-nephrogenic-fibrosing-dermopathy#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:10:00 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Diseases]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=409</guid>
		<description><![CDATA[Nephrogenic systemic fibrosis, also known as nephrogenic fibrosing dermopathy, is a debilitating disorder affecting the skin. The condition affects both men and women of every age, from infants to the elderly, but typically occurs in individuals that are middle aged. The condition can affect individuals of every ethnicity and has been found mainly in Europe, [...]]]></description>
			<content:encoded><![CDATA[<p>Nephrogenic systemic fibrosis, also known as nephrogenic fibrosing dermopathy, is a debilitating disorder affecting the skin. The condition affects both men and women of every age, from infants to the elderly, but typically occurs in individuals that are middle aged. The condition can affect individuals of every ethnicity and has been found mainly in Europe, Asia, and North America. The condition is considered rare, with less than 300 confirmed cases worldwide.</p>
<p>Currently, all cases of NSF/NFD occur in patients in an advanced stage of kidney disease. None of the cases has occurred prior to 1997 and no evidence exists to link the condition to a microorganism, to an ingested medication, or to dialysis. The length of time that the individual has been suffering from kidney disease also appears to not be a factor in the development of NSF/NFD as it can occur in the earlier stages of kidney disease as well as in individuals that have been suffering from kidney disease for years.</p>
<p>Recent reports have found a strong correlation between the development of NSF/NFD and drugs containing gadolinium which are used as contrast agents during an MRI. By December of 2006, the US Food and Drug Administration had received 90 reports of cases of NSF/NFD occurring in patients that had recently received an injection of a gadolinium based contrast agent prior to undergoing an MRI. Of the cases studied in depth by the US Food and Drug Administration, all of the patients were in moderate to late stage kidney disease, all had received an injection of a gadolinium based contrast agent, and all had undergone an MRI.</p>
<p>Individuals experiencing NSF/NFD have reported the skin of their extremities swell and tighten, limiting movement and causing great discomfort. In rare cases, the condition affects the trunk of the body as well. Patients with severe cases of the condition may be unable to stretch and flex their arms, hands, legs, or feet and may even lose the ability to walk. The individual may experience significant muscle weakness and moderate to severe joint pain. Bone pain occurring in the hips and ribs are also commonly reported symptoms of NSF/NFD.</p>
<p>Around 5% of cases of NSF/NFD progress rapidly, quickly changing the skin from supple to thick and stiff within a period of months. The condition starts with reddened or dark patches appearing on the skin, accompanied by an itching, burning sensation. As the condition progresses, the texture of the skin starts to resemble the peel of an orange and radiography will reveal that the soft tissue of the skin has undergone calcification. Areas affected by NSF/NFD become hard and stiff and severe sharp pains may occur in the tissue beneath the affected skin.</p>
<p>There is no effective treatment option available for NSF/NFD, but the symptoms of the condition can be relieved with numerous treatments. Improvement of the renal function of the patient has the ability to slow, halt, or even reverse the progression of NSF/NFD. Because the condition is rare and was discovered relatively recently, there are a lot of things about the condition that are not understood. Research continues to help medical professionals understand and conquer this debilitating disease.</p>
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		<title>Gadolinium and NSF/NFD</title>
		<link>http://www.schmidtandclark.com/gadolinium-and-nsfnfd</link>
		<comments>http://www.schmidtandclark.com/gadolinium-and-nsfnfd#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:09:07 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=407</guid>
		<description><![CDATA[A public health advisory was recently issued by the US Food and Drug Administration warning about a severe disorder associated with advanced kidney disease and the use of gadolinium based contrast agents used during magnetic resonance imaging (MRI). As of December 2006, the agency had received over 90 reports of patients suffering from advance kidney [...]]]></description>
			<content:encoded><![CDATA[<p>A public health advisory was recently issued by the US Food and Drug Administration warning about a severe disorder associated with advanced kidney disease and the use of gadolinium based contrast agents used during magnetic resonance imaging (MRI). As of December 2006, the agency had received over 90 reports of patients suffering from advance kidney disease developing a debilitating disease called nephrogenic systemic fibrosis, also known as nephrogenic fibrosing dermopathy, after using a gadolinium based contrast agent and undergoing an MRI. When the FDA performed an in depth analysis of 75 of the cases, they found that all had moderate to late stage kidney disease, all had received an injection of a gadolinium based contrast agent, and all had undergone an MRI. Because of this connection, the FDA has recommended that all patients with moderate to late stage kidney disease requiring an imaging procedure be given alternative treatments.</p>
<p>Nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy (NSF/NFD) is a disorder in which the skin of the patient becomes thick and hard. The condition can also affect the internal organs of the patients, causing them to thicken and scar as well. Patients experiencing NSF/NFD report a sensation of burning or itching in their skin while it visibly swells, hardens, and tightens. In some cases, patients have reported the appearance of dark or red patches on the skin. NSF/NFD causes joints to become stiff and patients suffering from the condition may have difficulty moving their arms, hands, legs, and feet. Yellow spots may appear in the white portion of the eye, accompanied by bone pain deep in the hips and ribs and significant muscle weakness. Symptoms of NSF/NFD can appear as soon as two days and as long as eighteen months after the exposure to the gadolinium based contrast agent. Many of the patients affected received a high or multiple doses of the contrast agent, but the condition has also occurred in patients that only received a single dose.</p>
<p>It is not yet clear why individuals with advanced kidney disease who have been exposed to gadolinium based contrast agents have an increased risk of developing NSF/NFD. There are five of these agents approved by the FDA for use during MRI procedures. These include Magnevist (manufactured by Bayer Healthcare Pharmaceuticals), MultiHance (manufactured by Bracco Diagnostics, Inc.), Omniscan (manufactured by GE Healthcare), OptiMARK (manufactured by Mallinckrodt Inc.), and ProHance (also manufactured by Bracco Diagnostics, Inc.). Although NSF/NFD has only been linked to three of the gadolinium based contrast agents, the FDA believes that the condition can occur with the use of any of them.</p>
<p>NSF/NFD is a rare condition, with less than 300 confirmed cases worldwide. Of the cases that have been reviewed, all of them developed the condition after receiving an injection of a gadolinium based contrast agent. The agents have also been found in the skin biopsies of patients suffering with NSF/NFD. The FDA is now advising against the usage of gadolinium based contrast agents in patients with advanced kidney disease and if the agents must be used, the patient should undergo prompt dialysis after the MRI procedure has been completed. There is no effective treatment available for NSF/NFD, but the condition can be slowed, and sometimes reversed, by improving the renal function of the patient. </p>
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		<title>Gadolinium and Magnetic Resonance Imaging (MRI)</title>
		<link>http://www.schmidtandclark.com/gadolinium-and-magnetic-resonance-imaging-mri-2</link>
		<comments>http://www.schmidtandclark.com/gadolinium-and-magnetic-resonance-imaging-mri-2#comments</comments>
		<pubDate>Thu, 25 Jun 2009 20:08:31 +0000</pubDate>
		<dc:creator>Schmidt &#38; Clark, LLP &#124; A National Law Firm</dc:creator>
				<category><![CDATA[Product Liability]]></category>
		<category><![CDATA[Gadolinium]]></category>

		<guid isPermaLink="false">http://www.schmidtandclark.com/?p=405</guid>
		<description><![CDATA[Gadolinium is considered a paramagnetic metal ion, a substance that is known to move into magnetic fields. It is this property that makes Gadolinium so useful in Magnetic Resonance Imaging (MRI) and was approved for this use by the US Food and Drug Administration (FDA) in 1988. The substance is used as a contrast agent, [...]]]></description>
			<content:encoded><![CDATA[<p>Gadolinium is considered a paramagnetic metal ion, a substance that is known to move into magnetic fields. It is this property that makes Gadolinium so useful in Magnetic Resonance Imaging (MRI) and was approved for this use by the US Food and Drug Administration (FDA) in 1988. The substance is used as a contrast agent, meaning that the substance creates a clearer picture when used in conjunction with an MRI. In some cases, Gadolinium is used with Magnetic Resonance Angiography, another imaging procedure, even though it has not been approved by the FDA for this use. An MRA is an upgraded type of MRI used to study images of blood vessels. This procedure can detect heart defects, heart disease, and strokes using highly specialized imaging techniques.</p>
<p>An MRI or MRA can be performed without the use of a contrast agent containing Gadolinium, but many believe that MRI images that are taken using Gadolinium based contrast agent are highly superior to images taken without them. Measures are taken to ensure that the toxicity of the Gadolinium is greatly reduced and the contrast agent is eliminated from the body by the kidneys in a short period of time. Although it has been reported that the use of a Gadolinium based contrast agent can enhance the images collected from a MRA, the FDA has not yet approved any Gadolinium based contrast agent for this use. The MRA does have the ability to obtain detailed images without the use of any contrast agent.</p>
<p>There are no MRI contrast agents approved by the FDA that are free of Gadolinium. Any other contrast agent requires the use of an X-ray to provide detailed images of the body. These contrast agents are commonly used in CT scans, X-rays, and X-ray angiography, but are of no use when used with an MRI. There are five Gadolinium based contrast agents that are approved for use during MRI by the FDA. These approved contrast agents include Magnevist (manufactured by Bayer Healthcare Pharmaceuticals), Omniscan (manufactured by GE Healthcare), OptiMARK (manufactured by Mallinckrodt Inc.), MultiHance (manufactured by Bracco Diagnostics), and ProHance (also manufactured by Bracco Diagnostics).</p>
<p>Contrast agents containing Gadolinium have been linked to a rare, potentially life threatening illness that occurs in patients with kidney disease or kidney failure. The condition is called Nephrogenic Systemic Fibrosis (NSF) also known as Nephrogenic Fibrosing Dermopathy (NFD). NSF/NFD causes thickening and tightening of the skin on the body resulting in limited physical abilities and causing a great amount of pain and discomfort. The condition will also affect the connective tissues of the body, causing them to calcify and stiffen, and may spread to the individual’s internal organs, causing the failure of these organs. There is no cure available for NSF/NFD and many treatments are not effective every time with every patient. NSF/NFD is a progressive condition which can ultimately result in the death of the patient. NSF/NFD is considered a rare condition, with less than 300 confirmed cases occurring worldwide.</p>
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