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	<title>Defending The Consumer</title>
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	<description>Consumer Lawyers &#38; Resource</description>
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		<title>Kidney Failure Treatment: Dialysis</title>
		<link>http://www.defendingtheconsumer.com/kidney-failure-treatment-dialysis/</link>
		<comments>http://www.defendingtheconsumer.com/kidney-failure-treatment-dialysis/#comments</comments>
		<pubDate>Fri, 04 Sep 2009 20:57:43 +0000</pubDate>
		<dc:creator>consumer injury lawyer</dc:creator>
				<category><![CDATA[OsmoPrep Injury Lawyer Kidney Failure]]></category>
		<category><![CDATA[OsmoPrep Visicol Kidney Failure Treatment]]></category>

		<guid isPermaLink="false">http://www.defendingtheconsumer.com/?p=2140</guid>
		<description><![CDATA[Healthy kidneys clean the blood by removing excess fluid, minerals, and wastes. They also make hormones that keep your body healthy.  When a person&#8217;s kidneys fail, harmful wastes build up in the body, blood pressure may rise, and the body may retain excess fluid and not make enough red blood cells.  Treatment for kidney failure [...]]]></description>
			<content:encoded><![CDATA[<h3 id="2140_when-your-kidneys-fa_1" style="text-align: justify;"><span class="Apple-style-span" style="font-size: 13px; font-weight: normal;">Healthy kidneys clean the blood by removing excess fluid, minerals, and wastes. They also make hormones that keep your body healthy.  When a person&#8217;s kidneys fail, harmful wastes build up in the body, blood pressure may rise, and the body may retain excess fluid and not make enough red blood cells.  Treatment for <a title="Kidney Failure" href="http://www.pharmawatchdog.com/?p=2016">kidney failure</a> can induce dialysis.  </span></h3>
<h3 id="2140_how-dialysis-works_1" style="text-align: justify;">How Dialysis Works</h3>
<p style="text-align: justify;">In dialysis, blood is allowed to flow, a few ounces at a time, through a special filter that removes wastes and extra fluids. The clean blood is then returned to the patients body. Removing the harmful wastes and extra salt and fluids helps control blood pressure and keep the proper balance of chemicals like potassium and sodium in the body.</p>
<p><strong>Dialysis Patients must undergo treatment 3 times a week for 3 to 5 hours at a time.</strong></p>
<h3 id="2140_conditions-related-t_1" style="text-align: justify;">Conditions Related to Kidney Failure</h3>
<p style="text-align: justify;">Kidneys not only clean the blood but they also make hormones and balance chemicals. When the kidneys stop working, patients may have problems with anemia and conditions that affect your bones, nerves, and skin. Some of the more common conditions caused by kidney failure are extreme tiredness, bone problems, joint problems, itching, and “restless legs.”</p>
<h4 id="2140_anemia-and-erythropo_1" style="text-align: justify;">Anemia and Erythropoietin (EPO)</h4>
<p style="text-align: justify;">Anemia is a condition in which the volume of red blood cells is low. Red blood cells carry oxygen to cells throughout the body. Without oxygen, cells can’t use the energy from food, so someone with anemia may tire easily and look pale. Anemia can also contribute to heart problems.</p>
<h4 id="2140_renal-osteodystrophy_1" style="text-align: justify;">Renal Osteodystrophy</h4>
<p style="text-align: justify;">Renal osteodystrophy, or bone disease of kidney failure, affects 90 percent of dialysis patients. It causes bones to become thin and weak or formed incorrectly and affects both children and adults. Symptoms can be seen in growing children with kidney disease even before they start dialysis. Older patients and women who have gone through menopause are at greater risk for this disease.</p>
<p style="text-align: justify;"><strong>Itching (Pruritus)</strong></p>
<p style="text-align: justify;">Many people treated with hemodialysis complain of itchy skin, which is often worse during or just after treatment. Itching is common even in people who don’t have kidney disease; in kidney failure, however, itching can be made worse by wastes in the bloodstream that current dialyzer membranes can’t remove from the blood.</p>
<h4 id="2140_sleep-disorders_1" style="text-align: justify;">Sleep Disorders</h4>
<p style="text-align: justify;">Patients on dialysis often have insomnia, and some people have a specific problem called the sleep apnea syndrome, which is often signaled by snoring and breaks in snoring.</p>
<p style="text-align: justify;">Many people on dialysis have trouble sleeping at night because of aching, uncomfortable, jittery, or “restless” legs. You may feel a strong impulse to kick or thrash your legs. Kicking may occur during sleep and disturb a bed partner throughout the night. The causes of restless legs may include nerve damage or chemical imbalances.</p>
<h4 id="2140_amyloidosis_1" style="text-align: justify;">Amyloidosis</h4>
<p style="text-align: justify;">Dialysis-related amyloidosis (DRA) is common in people who have been on dialysis for more than 5 years. DRA develops when proteins in the blood deposit on joints and tendons, causing pain, stiffness, and fluid in the joints, as is the case with arthritis.</p>
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		<title>FDA warns consumers of Hydroxycut dangers</title>
		<link>http://www.defendingtheconsumer.com/fda-warns-consumers-of-hydroxycut-dangers/</link>
		<comments>http://www.defendingtheconsumer.com/fda-warns-consumers-of-hydroxycut-dangers/#comments</comments>
		<pubDate>Wed, 02 Sep 2009 02:05:15 +0000</pubDate>
		<dc:creator>consumer injury lawyer</dc:creator>
				<category><![CDATA[Hydroxycut Recall Lawyer]]></category>
		<category><![CDATA[recall injury lawyer]]></category>
		<category><![CDATA[hydroxycut heart attacks]]></category>
		<category><![CDATA[hydroxycut injury lawyer]]></category>
		<category><![CDATA[hydroxycut muscle disorder]]></category>
		<category><![CDATA[hydroxycut strokes]]></category>

		<guid isPermaLink="false">http://www.defendingtheconsumer.com/?p=2120</guid>
		<description><![CDATA[FDA Issues Hydroxycut Recall Warning The U.S. Food and Drug Administration (FDA) is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed [...]]]></description>
			<content:encoded><![CDATA[<h3 id="2120_fda-issues-hydroxycu_1" >FDA Issues Hydroxycut Recall Warning</h3>
<p style="text-align: justify;">The U.S. Food and Drug Administration (FDA) is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.</p>
<p style="text-align: justify;">Hydroxycut products are dietary supplements that are marketed for weight loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.</p>
<h3 id="2120_serious-health-risks_1" >Serious Health Risks</h3>
<p style="text-align: justify;">FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA.<br />
Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.<br />
Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.<br />
FDA urges consumers to stop using Hydroxycut products in order to avoid any undue risk, says Linda Katz, M.D., interim chief medical officer of FDA&#8217;s Center for Food Safety and Applied Nutrition. &#8220;Adverse events are rare, but exist,&#8221; Katz says. &#8220;Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products.</p>
<h3 id="2120_recalled-products_1" >Recalled Products</h3>
<p style="text-align: justify;">The list of products being recalled by Iovate currently includes:</p>
<p style="text-align: justify;">Hydroxycut Regular Rapid Release Caplets<br />
Hydroxycut Caffeine-Free Rapid Release Caplets<br />
Hydroxycut Hardcore Liquid Caplets<br />
Hydroxycut Max Liquid Caplets<br />
Hydroxycut Regular Drink Packets<br />
Hydroxycut Caffeine-Free Drink Packets<br />
Hydroxycut Hardcore Drink Packets (Ignition Stix)<br />
Hydroxycut Max Drink Packets<br />
Hydroxycut Liquid Shots<br />
Hydroxycut Hardcore RTDs (Ready-to-Drink)<br />
Hydroxycut Max Aqua Shed<br />
Hydroxycut 24<br />
Hydroxycut Carb Control<br />
Hydroxycut Natural</p>
<p style="text-align: justify;">Although FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall.</p>
<p style="text-align: justify;">Consumers who have these products are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.</p>
<p style="text-align: justify;">Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to FDA&#8217;s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.</p>
<p style="text-align: justify;">Online: Medwatch Reporting<br />
Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787<br />
Fax: 800-FDA-0178<br />
Phone: 800-FDA-1088<br />
FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects</p>
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		<title>JAMA questions Gardasil Safety</title>
		<link>http://www.defendingtheconsumer.com/jama-questions-gardasil-safety/</link>
		<comments>http://www.defendingtheconsumer.com/jama-questions-gardasil-safety/#comments</comments>
		<pubDate>Tue, 01 Sep 2009 03:39:30 +0000</pubDate>
		<dc:creator>consumer injury lawyer</dc:creator>
				<category><![CDATA[vaccine-injury-lawyer]]></category>
		<category><![CDATA[gardasil injury]]></category>
		<category><![CDATA[gardasil injury lawyer]]></category>
		<category><![CDATA[JAMA gardasil articles]]></category>
		<category><![CDATA[Vaccine Injury]]></category>

		<guid isPermaLink="false">http://www.defendingtheconsumer.com/?p=2075</guid>
		<description><![CDATA[In 2006, the FDA licensed Gardasil and approved its use for females ages 9 to 26. Unfortunately, it is not safe to base decisions regarding receipt of the Gardasil vaccine on FDA approval alone. The FDA has proven time and time again that it is simply incapable of fully protecting the public&#8217;s health. As a [...]]]></description>
			<content:encoded><![CDATA[<p style="text-align: justify;">In 2006, the FDA licensed Gardasil and approved its use for females ages 9 to 26. Unfortunately, it is not safe to base decisions regarding receipt of the Gardasil vaccine on FDA approval alone. The FDA has proven time and time again that it is simply incapable of fully protecting the public&#8217;s health. As a result, we must turn to independent studies of vaccine injury.  This information is vital in getting a view of the true picture of vaccine safety.</p>
<p style="text-align: justify;">The latest articles published in the Journal of American Medical Association (JAMA) are confirmation that there are more questions than answers available when it comes to the safety of Gardasil.</p>
<h3 id="2075_merck-relies-on-unre_1" style="text-align: justify;">Merck relies on unreliable VAERS as proof of Safety</h3>
<p style="text-align: justify;">VAERS is a voluntary reporting system operated by the FDA and the CDC that allows physicians, patients, manufacturers, and others to report various reactions resulting from the administration of the vaccines. According to Merck, the manufacturer of Gardasil, over 23 million doses of the Gardasil vaccine have been administered in the United States. Out of those 23 million doses, 12,424 adverse reactions have been reported. JAMA states that only about 6.2% of the 12,424 reports are considered serious.</p>
<p style="text-align: justify;">Unfortunately, the VAERS reporting system is rife with flaws and that information obtained from VAERS must be treated in a manner consistent with an imperfect system. Specifically, reports often lack information needed to make an accurate evaluation. There is also a notable concern of underreporting adverse reactions. <strong>Interestingly, it must be noted that 68% of the 12,424 reports were authored by Merck.</strong></p>
<h3 id="2075_mercks-focused-marke_1" style="text-align: justify;">Merck&#8217;s focused marketing on Doctors to Increase Recommendations</h3>
<p style="text-align: justify;">Merck’s “1 Less” campaign, directed at every adolescent-aged female instead of those populations at greatest risk, combined with the generous education grants for PMAs (professional medical associations), made with the primary goal of obtaining physician encouragement of Gardasil vaccinations, proved successful. According to JAMA, sales of Gardasil in 2008 were $1.4 billion worldwide.  The relationship between PMAs and Merck raises questions concerning Merck’s aggressive anticancer campaign’s influence on the responsibilities PMAs owe as impartial advocates for vaccinations.</p>
<p style="text-align: justify;">According to JAMA, there are justifiable concerns surrounding the influence Merck’s marketing campaign has had on relationships with PMAs, in addition to the problems associated with reporting adverse effects by way of VAERS. The combination of  Merck&#8217;s marketing campaign and underreporting of adverse effects in VAERS (never mind that Merck authored a majority of the adverse event reports) is a receipe for a public health disaster.</p>
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		<title>FDA sends Zicam warning letter</title>
		<link>http://www.defendingtheconsumer.com/fda-sends-zicam-warning-letter/</link>
		<comments>http://www.defendingtheconsumer.com/fda-sends-zicam-warning-letter/#comments</comments>
		<pubDate>Tue, 04 Aug 2009 16:42:03 +0000</pubDate>
		<dc:creator>consumer injury lawyer</dc:creator>
				<category><![CDATA[Zicam injury loss of smell lawyer]]></category>

		<guid isPermaLink="false">http://www.defendingtheconsumer.com/?p=1461</guid>
		<description><![CDATA[June 16, 2009 Dear Mr. Hemelt: This letter concerns your firm’s marketing of the products Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs, and Zicam Cold Remedy Swabs, Kids Size. FDA has concluded that these products may pose a serious risk to consumers who use them. Specifically, FDA has received more than 130 [...]]]></description>
			<content:encoded><![CDATA[<p>June 16, 2009</p>
<p>Dear Mr. Hemelt:</p>
<p>This letter concerns your firm’s marketing of the products  Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs, and Zicam Cold Remedy Swabs, Kids Size.</p>
<p>FDA has concluded that these products may pose a serious risk to consumers who use them.  Specifically, FDA has received more than 130 reports of anosmia, (loss of sense of smell, which in some cases can be long-lasting or permanent), associated with use of these products. </p>
<p>To protect consumers, and in light of the violations described below, we ask that within fifteen working days of receipt of this letter, you notify this office in writing of the specific steps that you have taken to correct the violations.</p>
<p>These products are available without a prescription, and they contain zinc gluconate (identified as zincum gluconicum on their labels) as their active ingredient.  All are administered by direct application to the nasal cavity and, as described in the labeling, are intended for use in “adults and children 3 years of age and older (with adult supervision).”   These products are referred to hereafter as the “Zicam Cold Remedy intranasal products.”</p>
<p>According to the labeling accompanying the Zicam Cold Remedy intranasal products, each of these products “reduces” the “duration of the common cold” and the “severity of cold symptoms,” including specifically “sore throat • stuffy nose •sneezing • coughing • congestion.”   These claims make these products drugs, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body of man or other animals. </p>
<p>We are not aware of any data establishing that the Zicam Cold Remedy intranasal products are generally recognized as safe and effective for the uses identified in their labeling.[1]  On the contrary, as described below, there is evidence that these products pose a serious safety risk to consumers.  Because they are not generally recognized as safe and effective for their labeled uses, these products are new drugs, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p). </p>
<p>Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA‑approved application is in effect for it.  There are no approved new drug applications (NDAs) on file with FDA for any of the Zicam Cold Remedy intranasal products; you market them without FDA approval. </p>
<p>We recognize that the labeling for Zicam Cold Remedy intranasal products identifies them as homeopathic drug products with an active ingredient measured in homeopathic strength—Zincum Gluconicum 2X.  Nothing in the Act or the regulations issued under it exempts homeopathic drugs from the new drug approval requirements.  We acknowledge that many homeopathic drug products are manufactured and distributed without FDA approval under enforcement policies set out in the FDA’s Compliance Policy Guide entitled, “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)” (the CPG).  The enforcement discretion set forth in the CPG is not unlimited, however.  The CPG states that it “delineates those conditions under which homeopathic drugs may ordinarily be marketed in the U.S.” (emphasis added)  The qualifying word “ordinarily” indicates that the CPG specifically contemplates that there may be circumstances where a product that otherwise may meet the conditions set forth in the CPG may nevertheless be subject to enforcement action.</p>
<p>A significant and growing body of evidence substantiates that the Zicam Cold Remedy intranasal products may pose a serious risk to consumers who use them.  Specifically, FDA has received more than 130 reports of anosmia (loss of sense of smell, which in some cases can be long-lasting or permanent),associated with use of these products; some individuals also report loss of sense of taste.[2]  By comparison,  FDA has received few reports of anosmia associated with other widely-used intranasal products for treatment of the common cold that are marketed subject to approved NDAs or according to an OTC drug monograph.  Further, there is evidence in the published scientific literature that various salts of zinc can damage olfactory function in animals and humans. </p>
<p>A homeopathic drug product marketed without an approved NDA is not subject to the enforcement discretion set forth in the CPG when there is evidence of a safety risk associated with the product, as is the case for the Zicam Cold Remedy intranasal products.  Under these circumstances, the Agency enforces the Act’s new drug approval requirement, a provision that is essential to protect the public health by holding firms responsible for demonstrating, based on adequate and well-controlled clinical investigations, that a product is safe and effective for each of its intended uses before marketing it.  Therefore, an approved NDA is required for the Zicam Cold Remedy intranasal products, regardless of their homeopathic status.  Your introduction of the Zicam Cold Remedy intranasal products into interstate commerce, without an approved application, violates sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a).</p>
<p>Additionally, Zicam Cold Remedy intranasal products are misbranded under section 502(f)(2) of the Act, 21 U.S.C. § 352(f)(2), because their labeling does not bear adequate warnings regarding the risk of anosmia associated with the product.  In light of this failure to bear adequate warnings, these products are also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), taking into account the considerations set forth in section 201(n) of the Act, 21 U.S.C. § 321(n).</p>
<p>The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products.  You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.  A description of the new drug approval process can be found on FDA’s internet website at http://www.fda.gov/cder/regulatory/applications/default.htm.  Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD‑240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.</p>
<p>You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.  Other federal agencies may take this Warning Letter into account when considering the award of contracts.</p>
<p>Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations.  Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.    If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the corrections.  Furthermore, please advise this office what actions you will take to address product that you have already distributed.</p>
<p>In addition to the reports FDA has received directly from consumers, the agency is aware that Matrixx appears to have more than 800 reports related to loss of sense of smell associatedwith Zicam Cold Remedy intranasal products.  Please contact Elisabeth Walther at the contact information below to arrange submission of all reports you have related to loss of sense of smell associated with Zicam Cold Remedy intranasal products.  Please indicate which of these reports have been previously submitted to FDA. </p>
<p>Additionally, if another firm or firms manufacture the products identified above, your reply should include the name and address of all such firms.  If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer.  Address your reply to the U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, Attention: Elisabeth Walther, Pharmacist.</p>
<p>Sincerely,</p>
<p>Deborah M. Autor, Esq.<br />
Director<br />
Office of Compliance<br />
Center for Drug Evaluation and Research<br />
U.S. Food and Drug Administration</p>
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		<title>FDA warns about Zicam Injury</title>
		<link>http://www.defendingtheconsumer.com/warnings-on-three-zicam-intranasal-zinc-products/</link>
		<comments>http://www.defendingtheconsumer.com/warnings-on-three-zicam-intranasal-zinc-products/#comments</comments>
		<pubDate>Tue, 04 Aug 2009 15:46:35 +0000</pubDate>
		<dc:creator>consumer injury lawyer</dc:creator>
				<category><![CDATA[Zicam injury loss of smell lawyer]]></category>

		<guid isPermaLink="false">http://www.defendingtheconsumer.com/?p=1453</guid>
		<description><![CDATA[On June 16, 2009, the Food and Drug Administration (FDA) warned consumers to stop using and discard three zinc-containing Zicam intranasal products due to Zicam related injuries. The products may cause a loss of sense of smell. Intranasal products are administered through the nose. What products are affected by this warning? FDA&#8217;s action affects Zicam’s [...]]]></description>
			<content:encoded><![CDATA[<p style="text-align: justify;">On June 16, 2009, the Food and Drug Administration (FDA) warned consumers to stop using and discard three zinc-containing Zicam intranasal products due to Zicam related injuries. The products may cause a loss of sense of smell.</p>
<p style="text-align: justify;">Intranasal products are administered through the nose.</p>
<p style="text-align: justify;"><strong>What products are affected by this warning?</strong></p>
<p style="text-align: justify;">FDA&#8217;s action affects Zicam’s three intranasal products that contain zinc. The three Zicam products claim to reduce the duration of the common cold and the severity of cold symptoms.</p>
<p style="text-align: justify;">The products (listed with their size and product numbers) are</p>
<p style="text-align: justify;">• Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)<br />
• Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)<br />
• Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)</p>
<p style="text-align: justify;">The Zicam intranasal zinc products are widely sold in pharmacies, other retail stores, and on the Internet. Zicam Cold Remedy Swabs, Kids Size, has already been discontinued, but FDA is concerned that consumers may have the product in their home. FDA has special concerns regarding use of intranasal zinc in children. Children may experience a loss of sense of smell but may be less likely to communicate the condition.</p>
<p style="text-align: justify;"><strong>Are oral zinc products affected by this warning?</strong></p>
<p style="text-align: justify;">No. This warning does not involve oral zinc tablets and lozenges taken by mouth.<br />
Dietary zinc is also not subject to this warning.  Zinc is an important trace mineral that is an essential part of the human diet.  Among other things, Zinc is needed for a healthy immune system (the body&#8217;s defense), and is critical for normal growth. Zinc primarily comes from food.  The best way to get the daily requirement of essential vitamins and minerals is to eat a balanced diet that contains a variety of foods.<br />
<strong></strong></p>
<p style="text-align: justify;"><strong>Why did FDA take action?</strong></p>
<p style="text-align: justify;">The agency has received more than 130 reports of anosmia—the loss of sense of smell—associated with use of these three Zicam products.<br />
Many people who experienced a loss of sense of smell say that the condition occurred with the first dose, although some people have reported loss of sense of smell after later doses. FDA is concerned that the loss of sense of smell may be permanent.</p>
<p style="text-align: justify;"><strong>What steps did FDA take?</strong></p>
<p style="text-align: justify;">• FDA issued a public health advisory warning consumers to stop using and discard or return the Zicam zinc-containing intranasal products.<br />
• The agency sent a warning letter to Matrixx Initiatives advising the firm that these products cannot be marketed without FDA approval. The warning letter also states that the products do not include adequate warnings about the risk of loss of sense of smell.</p>
<p style="text-align: justify;"><strong>What should consumers do if they experience harm related to these products?</strong></p>
<p style="text-align: justify;">FDA recommends they contact their health care professional if they experience loss of sense of smell or other problems after using any zinc-containing products that are administered into the nose.</p>
<p style="text-align: justify;">The agency asks health care professionals and consumers to report possible cases of loss of sense of smell or other problems after use of these products to FDA through the MedWatch program, either online or by phone at 1-800-FDA-1088.</p>
<p style="text-align: justify;">Date Posted: June 16, 2009</p>
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		<item>
		<title>Zonegran (Zonisamide) linked to Metabolic Acidosis</title>
		<link>http://www.defendingtheconsumer.com/zonegran-zonisamide-linked-to-metabolic-acidosis/</link>
		<comments>http://www.defendingtheconsumer.com/zonegran-zonisamide-linked-to-metabolic-acidosis/#comments</comments>
		<pubDate>Sat, 06 Jun 2009 14:23:39 +0000</pubDate>
		<dc:creator>consumer injury lawyer</dc:creator>
				<category><![CDATA[zonegran-zoisamide-metabolic-acidosis]]></category>

		<guid isPermaLink="false">http://www.defendingtheconsumer.com/?p=1402</guid>
		<description><![CDATA[FDA notified healthcare professionals that updated clinical data has determined that treatment with zonisamide, indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy, can cause metabolic acidosis in some patients. Patients with predisposing conditions or therapies may be at greater risk for developing metabolic acidosis and the risk of zonisamide-induced [...]]]></description>
			<content:encoded><![CDATA[<p style="text-align: justify;">FDA notified healthcare professionals that updated clinical data has determined that treatment with zonisamide, indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy, can cause metabolic acidosis in some patients. Patients with predisposing conditions or therapies may be at greater risk for developing metabolic acidosis and the risk of zonisamide-induced metabolic acidosis appears to be more frequent and severe in younger patients. FDA recommends that healthcare professionals measure serum bicarbonate before starting treatment and periodically during treatment with zonisamide, even in the absence of symptoms and is working with the makers of zonisamide to revise the product labeling to reflect this new safety information. The notification includes recommendations for healthcare providers, information for patients, and a data summary.</p>
<p style="text-align: justify;">keywords:  FDA warning, Zonegran, Zonisamide, epilepsy, metabolic acidosis</p>
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		<title>FDA Warning On Vaginal Slings</title>
		<link>http://www.defendingtheconsumer.com/fda-warning-on-vaginal-slings/</link>
		<comments>http://www.defendingtheconsumer.com/fda-warning-on-vaginal-slings/#comments</comments>
		<pubDate>Sat, 30 May 2009 02:28:18 +0000</pubDate>
		<dc:creator>consumer injury lawyer</dc:creator>
				<category><![CDATA[vaginal-mesh-injury-lawyer]]></category>

		<guid isPermaLink="false">http://www.defendingtheconsumer.com/?p=1361</guid>
		<description><![CDATA[FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence Issued: October 20, 2008 Dear Healthcare Practitioner: This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). [...]]]></description>
			<content:encoded><![CDATA[<p style="text-align: justify;">FDA Public Health Notification:</p>
<p style="text-align: justify;"><strong>Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence</strong></p>
<p style="text-align: justify;">Issued: October 20, 2008</p>
<p style="text-align: justify;">Dear Healthcare Practitioner:</p>
<p style="text-align: justify;">This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.</p>
<p style="text-align: justify;">Nature of the Problem</p>
<p style="text-align: justify;">Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.</p>
<p style="text-align: justify;">The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.</p>
<p style="text-align: justify;">Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.</p>
<p style="text-align: justify;">Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.</p>
<p style="text-align: justify;">Recommendations</p>
<p style="text-align: justify;">Physicians should:</p>
<p>Obtain specialized training for each mesh placement technique, and be aware of its risks.</p>
<p>Be vigilant for potential adverse events from the mesh, especially erosion and infection.</p>
<p>Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.</p>
<p style="text-align: justify;">Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.</p>
<p style="text-align: justify;">Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall (in POP repair).</p>
<p style="text-align: justify;">Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.</p>
<p style="text-align: justify;">Additional patient information can be found on the following FDA Consumer website.</p>
<p style="text-align: justify;">Reporting Adverse Events to FDA</p>
<p style="text-align: justify;">FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of surgical mesh, you should follow the reporting procedure established by your facility.</p>
<p style="text-align: justify;">We also encourage you to report adverse events related to surgical mesh that do not meet the requirements for mandatory reporting. You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online, by phone at 1-800-FDA-1088, or obtain the fillable form online, print it out and fax to 1-800-FDA-0178 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.</p>
<p style="text-align: justify;">Getting More Information</p>
<p style="text-align: justify;">If you have questions about this notification, please contact the Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 240-276-3356, or by e-mail at phann@cdrh.fda.gov. You may also leave a voice mail message at 240-276-3357 and we will return your call as soon as possible.</p>
<p style="text-align: justify;">FDA medical device Public Health Notifications are available on the Internet. You can also be notified through e-mail each time a new Public Health Notification is added to our web page. To subscribe to this service, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39 .</p>
<p style="text-align: justify;">Sincerely,</p>
<p>Daniel G. Schultz, MD</p>
<p>Director</p>
<p>Center for Devices and Radiological Health</p>
<p>Food and Drug Administration</p>
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		<item>
		<title>Environmental Contamination</title>
		<link>http://www.defendingtheconsumer.com/environmental-contamination-lawyer/</link>
		<comments>http://www.defendingtheconsumer.com/environmental-contamination-lawyer/#comments</comments>
		<pubDate>Mon, 18 May 2009 00:24:14 +0000</pubDate>
		<dc:creator>consumer injury lawyer</dc:creator>
				<category><![CDATA[environmental-contamination-lawyer]]></category>

		<guid isPermaLink="false">http://www.defendingtheconsumer.com/?p=1136</guid>
		<description><![CDATA[<p style="text-align: justify;">Every day, countless individuals are exposed to high levels of dangerous toxins that linger unseen in their environment. Some of these toxins are natural, others man-made, yet both can cause serious injury—especially to the young or infirm. Such injury from toxins is known as toxic tort, and millions of Americans suffer from it every year.  Our toxic tort attorneys have extensive experience handling environmental contamination litigation, including Attorney Mark Sadaka, whose background in environmental toxicology gives him the leading edge in environmental contamination cases.</p>]]></description>
			<content:encoded><![CDATA[<p style="text-align: justify;">Every day, countless individuals are exposed to high levels of dangerous toxins that linger unseen in their environment. Some of these toxins are natural, others man-made, yet both can cause serious injury—especially to the young or infirm. Such injury from toxins is known as toxic tort, and millions of Americans suffer from it every year.</p>
<p style="text-align: justify;">The Potts Law Firm cares about your health. We are fierce and tenacious litigators who will not stop until we’ve reached the justice you deserve. Our toxic tort attorneys have extensive experience handling environmental contamination litigation, including Attorney Mark Sadaka, whose background in environmental toxicology gives him the leading edge in environmental contamination cases.</p>
<p style="text-align: justify;">Groundwater pollution is one of the most common causes of environmental contamination. Although it’s well-known that groundwater pollution develops near landfills and hazardous waste sites, many people don’t realize that it can occur right in their own backyard—from faulty septic systems or fertilizers and other chemicals, including hexavalent chromium (chromium VI), mercury, trichloroethylene (TCE), benzene, polychlorinated biphenyls (PCBs), perchlorate, and pesticides. Once ingested, such toxins can cause severe illness.</p>
<p style="text-align: justify;">The most prevalent source of toxic tort, however, comes directly from large corporations. Employees, consumers, and the general public alike have experienced painful injury and long-term illness due to corporate negligence. Contaminated pharmaceuticals, chemical pollutants in the workplace, asbestos, and many other toxins cause a span of injuries, including brain damage, lung failure, cancer, and birth defects. Many tort cases involve class action suits against the corporation responsible for these illnesses, helping individuals pull together as a group to find justice.</p>
<p style="text-align: justify;">If you or a loved one has suffered serious injury as the result of environmental contamination, your legal rights must be protected. Call us today, toll-free, at 1-888-99-POTTS (1-888-997-6887), or fill out our “Free Case Review” form, and a qualified attorney will evaluate your case for free. Together, we can work to protect your rights.</p>
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		<title>Food Poisoning</title>
		<link>http://www.defendingtheconsumer.com/food-poisoning-injury-lawyer/</link>
		<comments>http://www.defendingtheconsumer.com/food-poisoning-injury-lawyer/#comments</comments>
		<pubDate>Mon, 18 May 2009 00:16:31 +0000</pubDate>
		<dc:creator>consumer injury lawyer</dc:creator>
				<category><![CDATA[food-poisoning-injury-lawyer]]></category>

		<guid isPermaLink="false">http://www.defendingtheconsumer.com/?p=1133</guid>
		<description><![CDATA[Foodborne illness is a serious public health problem. The Centers for Disease Control and Prevention (CDC) estimates that each year 76 million people get sick, more than 300,000 are hospitalized, and 5,000 die as a result of foodborne illnesses. Our food poisoning lawyers have seen countless incidents where a manufacturer&#8217;s or retailer&#8217;s negligence has been [...]]]></description>
			<content:encoded><![CDATA[<p style="text-align: justify;">Foodborne illness is a serious public health problem. The Centers for Disease Control and Prevention (CDC) estimates that each year 76 million people get sick, more than 300,000 are hospitalized, and 5,000 die as a result of foodborne illnesses.</p>
<p style="text-align: justify;">Our food poisoning lawyers have seen countless incidents where a manufacturer&#8217;s or retailer&#8217;s negligence has been directly responsible for outbreaks of food poisoning. The Food and Drug Administration estimates that two to three percent of all foodborne illnesses lead to secondary long-term illnesses. For example, certain strains of E.coli can cause kidney failure in young children and infants; Salmonella can lead to reactive arthritis and serious infections; Listeria can cause meningitis and stillbirths; and Campylobacter may be the most common precipitating factor for Guillain-Barre syndrome.  A serious bout of food poisoning can leave a victim with significant medical expenses, lost wages and other problems.  The food poisoning lawyers at our firm are committed to helping victims of food borne illnesses receive the compensation they deserve.</p>
<h3 id="1133_food-poisoning-can-b_1" style="text-align: center;">Food Poisoning can be Caused by Bacteria and Viruses</h3>
<p style="text-align: center;"><span style="text-decoration: underline;"><strong>Some</strong></span> of the conditions associated with bacteria and viruses found in food:</p>
<table border="0">
<tbody>
<tr>
<th>Condition</th>
<th>Source</th>
<th>Symptoms</th>
</tr>
<tr>
<td>Botulism (Bacteria)</td>
<td>Found in canned goods, sausages, meat products, and seafood products.</td>
<td>Neurotoxic symptoms, including double vision, inability to swallow, speech difficulty, and progressive paralysis of the respiratory system.</td>
</tr>
<tr>
<td>Campylobacteriosis (Bacteria)</td>
<td>Found in raw poultry, meat, and unpasteurized milk.</td>
<td>Diarrhea, abdominal cramping, fever, and sometimes bloody stools. Lasts 7-10 days.</td>
</tr>
<tr>
<td>E.Coli (Bateria)</td>
<td>Found in beef that has not been cooked sufficiently. sprouts, lettuce, salami, unpasteurized milk and juice, and swimming in or drinking sewage-contaminated water. E.Coli bacteria in diarrheal stools of infected persons can be passed from one person to another if hygiene or handwashing habits are inadequate.</td>
<td>Severe bloody diarrhea and abdominal cramps; sometimes the infection causes nonbloody diarrhea or no symptoms. Usually little or no fever is present, and the illness resolves in 5 to 10 days.</td>
</tr>
<tr>
<td>Listeriosis (Bacteria)</td>
<td>Found in soft cheese, unpasteurized milk, hot dogs and deli meats, imported seafood products, frozen cooked crab meat, cooked shrimp, and cooked surimi (imitation shellfish).</td>
<td>Fever, headache, nausea, and vomiting. Primarily affects pregnant women and their fetuses, newborns, the elderly, people with cancer, and those with impaired immune systems. Can cause fetal and infant death.</td>
</tr>
<tr>
<td>Perfringens (Bacteria)</td>
<td>In most instances, caused by failure to keep food hot.</td>
<td>Abdominal pain and diarrhea, and sometimes nausea and vomiting.</td>
</tr>
<tr>
<td>Salmonellosis (Bacteria)</td>
<td>Raw meats, poultry, eggs, milk and other dairy products, shrimp, frog legs, yeast, coconut, pasta and chocolate.</td>
<td>Abdominal pain and diarrhea, and sometimes nausea and vomiting.</td>
</tr>
<tr>
<td>Shigellosis (Bacteria)</td>
<td>Found in milk and dairy products, poultry, and potato salad. Food becomes contaminated when a human carrier does not wash hands and then handles liquid or food that is not thoroughly cooked afterwards.</td>
<td>Abdominal cramps, diarrhea, fever, sometimes vomiting, and blood, pus, or mucus in stool.</td>
</tr>
<tr>
<td>Hepatitis A (Virus)</td>
<td>Mollusks (oysters, clams, mussels, scallops, and cockles) become carriers when their beds are polluted by untreated sewage.</td>
<td>Begins with malaise, appetite loss, nausea, vomiting, and fever.  After 3-10 days patient develops jaundice with darkened urine. Severe cases can cause liver damage and death.</td>
</tr>
</tbody>
</table>
<h3 id="1133_signs-and-symptoms-o_1" style="text-align: center;">Signs and Symptoms of Food Poisoning</h3>
<p style="text-align: justify;">If you experience any of the following signs and symptoms, either alone or in combination, you may be suffering from food poisoning:</p>
<ul>
<li>Bloody diarrhea Weight loss</li>
<li>Diarrhea leading to dehydration</li>
<li>Fever Prolonged diarrhea</li>
<li>Neurologic involvement, such as paresthesias, motor weakness, cranial nerve palsies</li>
<li>Sudden onset of nausea, vomiting, diarrhea,</li>
<li>Severe abdominal pain</li>
</ul>
<h3 id="1133_long-term-effects-of_1" style="text-align: center;">Long Term Effects of Food Poisoning</h3>
<p style="text-align: justify;">As discussed briefly above, food poisoning can cause serious long-term health problems, and our food poisoning lawyers have seen many victims who were still dealing with the consequences of food borne illnesses months and even years later after an initial illness.  E. coli victims sometimes require kidney transplants. They may also have scarred intestines that cause lasting digestive difficulty. Even E. coli  patients who supposedly recovered can experience long-term health problems later on, as it is estimated that  10 percent of E. coli sufferers develop a life-threatening complication called hemolytic uremic syndrome, or HUS, where their kidneys and other organs fail.</p>
<p style="text-align: justify;">Salmonella also has potential long-term health consequences.  Some victims of Salmonella will develop a disease called Reiter’s Syndrome, a difficult- to- treat form of reactive arthritis that causes severe joint pain, irritation of the eyes, and painful urination. Reiter’s Syndrome can plague its victims for months or years, and can lead to chronic arthritis.  Certain strains of shigella and yersinia bacteria, far more common abroad than in the U.S., can also trigger Reiter’s Syndrome.</p>
<p style="text-align: justify;">About 1 in 1,000 sufferers of campylobacter, a diarrhea-causing infection spread by raw poultry, develop far more serious Guillain-Barre syndrome a month or so later. Their body attacks their nerves, causing paralysis that usually requires intensive care and a ventilator to breathe. It is estimated about a third of the nation’s Guillain-Barre cases have been linked to previous campylobacter, even if the diarrhea was very mild, and they typically suffer a more severe case than patients who never had food poisoning.  Our food poisoning lawyers have represented many people who have experienced such health problems years after they thought they were recovered from food poisoning, and we know how devastating these disorders can be.  For that reason, our food poisoning lawyers will do everything they can to insure that victims of these illnesses are compensated for their suffering.</p>
<h3 id="1133_legal-help-for-food-_1" style="text-align: center;">Legal Help for Food Poisoning Victims</h3>
<p style="text-align: justify;">If you or someone you love suffered from food poisoning, you have valuable legal rights. Please fill out our online form or call 1 800 99 POTTS (1-800-997-6887) as soon as possible to discuss your case with one of our food poisoning injury lawyers.</p>
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		<item>
		<title>Personal Injury</title>
		<link>http://www.defendingtheconsumer.com/personal-injury/</link>
		<comments>http://www.defendingtheconsumer.com/personal-injury/#comments</comments>
		<pubDate>Sun, 17 May 2009 23:52:19 +0000</pubDate>
		<dc:creator>consumer injury lawyer</dc:creator>
				<category><![CDATA[Practice Areas]]></category>

		<guid isPermaLink="false">http://www.defendingtheconsumer.com/?p=1118</guid>
		<description><![CDATA[<p style="text-align: justify;">Accidents happen. Unfortunately, when accidents happen, injuries, damages, and expenses also happen. Insurance companies, manufacturers, and other companies are unwavering and intimidating, but you can rest assured that you don’t have to fight for your rights alone.  Our firm has extensive experience in personal injury cases, including automobile, bus, and trucking accidents.</p>]]></description>
			<content:encoded><![CDATA[<p style="text-align: justify;">Accidents happen. Unfortunately, when accidents happen, injuries, damages, and expenses also happen. Insurance companies, manufacturers, and other companies are unwavering and intimidating, but you can rest assured that you don’t have to fight for your rights alone.</p>
<p style="text-align: justify;">The Potts Law Firm has extensive experience in personal injury cases, including automobile, bus, and trucking accidents. Our team will dedicate itself to your case, because we believe that responsible parties should be just that—responsible. We are uncompromising advocates for our clients.  Our team will work to ensure that your voice is heard and your rights are protected.</p>
<p style="text-align: justify;">Some areas you may wish to seek compensation for include:</p>
<p style="padding-left: 30px; text-align: justify;">•	Lost property<br />
•	Medical expenses—past, current, and future<br />
•	Pain and suffering<br />
•	Loss of income<br />
•	Change in lifestyle or enjoyment of life<br />
•	Other distress—psychological, emotional, etc.</p>
<p style="text-align: justify;">If another party is responsible for your injury, you have the right to seek damages for your suffering.</p>
<p style="text-align: justify;">Personal injury cases involve injury that has resulted from another party’s negligence, intentional action, or liability.</p>
<p style="text-align: justify;">Negligence is the most common basis for a personal injury claim. Negligence results from another party causing an accident or otherwise failing their duty to prevent an accident, thereby leading to injury. For example, if another driver fails to adhere to a speed limit or traffic sign, that driver is negligent. To prove a negligence case, you must prove three facts:</p>
<p style="padding-left: 30px; text-align: justify;">1.	The other party was negligent.<br />
2.	Their negligence was the cause of the accident.<br />
3.	Their negligence resulted in your injury and damages.</p>
<p style="text-align: justify;">Intentional actions involve another party purposely causing injury. Examples of intentional actions causing personal injury are assault and battery. When another party willfully causes harm, more than physical injury and damages are at stake. In such cases, there are emotional and psychological stresses involved, and, sometimes, both criminal and civil lawsuits.</p>
<p style="text-align: justify;">Liability involves a faulty or defective product that causes injury. Product liability laws exist to protect the consumer from any injury or other adverse consequences to using a manufacturer’s product. In such cases, you must prove that the product was dangerous when used in the way the manufacturer intended. Liability cases can involve manufacturers, wholesalers, and retailers. See our Product Liability page for more information on liability.</p>
<p style="text-align: justify;">There are many factors to prove in a personal injury case, and the dedicated attorneys at the Potts Law Firm will work to prove all related damages for your case, so that we can reach the best settlement for you.</p>
<p style="text-align: justify;">At The Potts Law Firm, we can assure you that, though accidents do happen, if they happen to you, we will fight to get you the compensation you deserve. Most states have a statute of limitations for seeking personal injury damages, so contact our offices today, toll-free, at 1-888-99-POTTS (1-888-997-6887) for a free case evaluation, so that we can start working with you to protect your legal rights. The sooner we can build your case, the sooner you can find some relief.</p>
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