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	<title>Nuvaring Litigation</title>
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		<title>Nuvaring Litigation</title>
		<link>http://www.birthcontrolringlawsuitcenter.com/nuvaring-litigation-2/</link>
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		<pubDate>Wed, 01 Sep 2010 13:12:35 +0000</pubDate>
		<dc:creator>Steve Fields</dc:creator>
				<category><![CDATA[News]]></category>
		<category><![CDATA[Nuvaring Litigation]]></category>

		<guid isPermaLink="false">http://www.birthcontrolringlawsuitcenter.com/?p=1219</guid>
		<description><![CDATA[Nuvaring side effects involving deep vein thrombosis (DVT) is a blood clot, or thrombus, that forms within the deep veins of your body. It usually occurs within the femoral and popliteal veins of the legs. Two hormones (estrogen and desogestrel) are released into a woman&#8217;s body by the contraceptive ring; both encourage coagulation, and thus [...]]]></description>
			<content:encoded><![CDATA[<p>Nuvaring side effects involving deep vein thrombosis (DVT) is a blood clot, or thrombus, that forms within the deep veins of your body. It usually occurs within the femoral and popliteal veins of the legs. Two hormones (estrogen and desogestrel) are released into a woman&#8217;s body by the contraceptive ring; both encourage coagulation, and thus result in abnormal clotting. The dangers are serious. Please contact us for the latest <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawsuit/" target="_self">Nuvaring litigation</a></strong> news and how we can help if you have suffered from blood clots.</p>
<p><strong>Dangers Of A DVT</strong></p>
<p>There are three possible outcomes associated with a DVT; it is possible to experience all of them as the condition progresses. First, you will likely notice pain and swelling in the affected leg as the obstructing clot impedes your circulation.</p>
<p>Second, the one-way valves in your deep veins that are responsible for regulating the direction of blood flow become inflamed and suffer damage. Pain in the area will increase and may be accompanied by sores and skin discoloration. This is called post-thrombotic syndrome.</p>
<p>Third, a piece of the obstructing clot may break away and be carried along with your bloodstream. If the embolus (i.e. traveling clot) reaches your heart and lungs, it can cause a pulmonary embolism.</p>
<p>Anticoagulant drugs are the most common method used to treat a DVT. However, if a clot is large and in danger of breaking away from the vein&#8217;s wall, your doctor will recommend a more aggressive form of treatment.</p>
<p><strong>Catheter-Directed Thrombolytic Therapy</strong></p>
<p>Thrombolytic drugs are known as clot-busters because they dissolve thrombi. These medications initiate a chemical reaction in plasminogen and convert it into an enzyme called plasmin. Plasmin digests fibrin, the sticky strands that form a protective net over a clot. As the interlinked fibrin strands deteriorate, the clot dissipates.</p>
<p>These drugs can be administered intravenously or by catheter. The latter approach is preferred if a thrombus is large and in danger of becoming detached. The goal of thrombolytic therapy is to restore blood flow through the deep veins, and thereby minimize the risk of pulmonary embolism and valvular damage.</p>
<p><strong>Venous Thrombectomy: Removing Blood Clots</strong></p>
<p>A high-risk DVT, or one that has developed to an advanced stage (e.g. phlegmasia cerulea dolens) may require surgery. In such cases, thrombolytic therapy may be insufficient given the immediate risk of tissue damage and detachment of the clot. The procedure is called venous thrombectomy and involves extracting the clot from the deep veins.</p>
<p>It is a relatively simple operation and can be completed in less than three hours. First, your surgeon will introduce heparin into your bloodstream to slow coagulation. He or she will then insert a catheter into the femoral vein or popliteal vein, depending on the site of the blockage. Next, a venogram is done; your surgeon will introduce a contrast material through the catheter to better visualize the target vein.</p>
<p>There are two main approaches to removing the clot. The first approach involves drawing it through the catheter as a single mass. The second approach, called percutaneous mechanical thrombectomy, involves threading a thin wire past the clot. The catheter is advanced to the clot, and a device affixed to its tip is used to break it apart. Then, the individual fragments are drawn through the catheter. This latter approach is often necessary for large thrombi.</p>
<p><em>Is Surgical Extraction Of Blood Clots Necessary?</em></p>
<p>Surgery for <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-birth-control/" target="_self">Nuvaring problems </a></strong>involving a DVT are rare and usually considered a last resort. In most cases, the occluded vein can be resolved with anticoagulants and thrombolytic drugs. There are times, however, when use of these medications is deemed too dangerous due to the risk of internal bleeding. Venous thrombectomy offers an alternative.</p>
<p>If you or someone you know has suffered from abnormal clotting, DVT, or other Nuvaring side effects, you may have the right to file a claim against the manufacturer. Contact an experienced <strong><a href="http://www.birthcontrolringlawsuitcenter.com/how-we-can-help/" target="_self">Nuvaring lawyer</a></strong> to discuss your legal options.</p>
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		<title>Nuvaring Lawyers</title>
		<link>http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawyers-2/</link>
		<comments>http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawyers-2/#comments</comments>
		<pubDate>Fri, 20 Aug 2010 12:12:43 +0000</pubDate>
		<dc:creator>Steve Fields</dc:creator>
				<category><![CDATA[News]]></category>
		<category><![CDATA[Nuvaring Litigation]]></category>

		<guid isPermaLink="false">http://www.birthcontrolringlawsuitcenter.com/?p=1179</guid>
		<description><![CDATA[Most incidents of a stroke occur in the cerebrum. This portion of your brain is divided into distinct areas categorized as lobes. They include the parietal, frontal, temporal, and occipital lobes. Each section is responsible for different functions, and thus blockages within them produce different dysfunctions. If you have suffered from a stroke or blood [...]]]></description>
			<content:encoded><![CDATA[<p>Most incidents of a stroke occur in the cerebrum. This portion of your brain is divided into distinct areas categorized as lobes. They include the parietal, frontal, temporal, and occipital lobes. Each section is responsible for different functions, and thus blockages within them produce different dysfunctions. If you have suffered from a stroke or blood clots while using Nuvaring please contact us for a free consultation from one of our <strong><a href="http://www.birthcontrolringlawsuitcenter.com/how-we-can-help/" target="_self">Nuvaring lawyers</a></strong>. We are currently representing women throughout the United States.</p>
<p><strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-side-effects/" target="_self">Nuvaring side effects</a></strong> involving a stroke occurs when an embolus &#8211; in this case, a migrating blood clot &#8211; forms elsewhere in the body, and travels into a carotid artery. These arteries drain into a network of secondary artery branches, which ultimately deliver oxygen-rich blood to the various lobes of your brain. A traveling clot will migrate downstream until it forms a blockage. If this occurs, the flow of blood will become restricted, triggering side effects that reflect the associated lobe. We&#8217;ll cover these side effects in more detail below.</p>
<p><strong>Left And Right Parietal Lobes</strong></p>
<p>Together, the left and right sides of the parietal lobe contain the sensory cortex. This area of your brain controls many key functions, and thus a stroke that damages it can trigger several debilitating impairments. For example, you may experience a loss of sensation that presents as an inability to sense pressure, vibration, and changes in temperature.</p>
<p>If an embolus damages the back portion of the parietal lobe, you may have trouble distinguishing left from right, or performing calculations that were routine prior to the event. Damage to the right side might impair your ability to navigate through new places. Damage to the left side may result in an inability to understand language &#8211; in speech or written form.</p>
<p>There are many other dysfunctions related to this area of your brain. You may experience a loss of hand-eye coordination, reduced peripheral vision, and myriad other deficits.</p>
<p><strong>Frontal Lobe</strong></p>
<p>Like the parietal lobe, the frontal lobe can be divided into distinct sections based on the functions controlled by those sections. For example, injury to the front portion may result in a loss of ability to concentrate as well as persistent apathy, inattentiveness, and a loss of inhibition.</p>
<p>If a stroke injures the back portion of the frontal lobe, you may experience one-sided paralysis or weakness (called hemiparesis). A brain injury in the left hemisphere affects the right side of your body, and vice versa.</p>
<p>The middle portion of the frontal lobe is responsible for several functions, including those related to language and eye movement. Deficits in the former occasionally present as Broca&#8217;s aphasia, an impairment where the stroke survivor&#8217;s speech is labored and disjointed. The latter may present as an inability to move your eyes.</p>
<p><strong>Left And Right Temporal Lobes</strong></p>
<p>The left and right sides of the temporal lobe control functions associated with memory, language, hearing, emotion, and the manner in which we perceive various stimuli. If you suffer a Nuvaring stroke event that damages the left side of this lobe, you might experience a loss of memory for words and people&#8217;s names. An injury on the left side can also cause Wernicke&#8217;s aphasia, a language deficit where the survivor&#8217;s speech becomes incomprehensible. The survivor&#8217;s comprehension of others&#8217; speech also suffers.</p>
<p>Damage to the right side of the temporal lobe may cause a loss of memory for faces and images. Those whom you have known for years may suddenly become unfamiliar to you.</p>
<p>Hearing loss, hearing sounds that do not exist (auditory hallucinations), fits of rage, and even vertigo may also present.</p>
<p><strong>Occipital Lobe</strong></p>
<p>This lobe controls functions related to vision. There are many ways it can present, including central visual defect, cortical blindness, hallucinations, and visual agnosia (i.e. lack of recognition for familiar objects). In some cases, survivors may experience complete blindness.</p>
<p>Nuvaring problems involving a stroke are varied and dependent on the location of the clot. Their severity reflects the extent of brain damage caused by a carotid arterial blockage. If you have suffered from blood clots, stroke, or other side effects, you may be able to file a claim for compensation for your injuries. Contact an experienced <strong><a href="http://www.birthcontrolringlawsuitcenter.com/making-difference/" target="_self">Nuvaring lawsuit settlements</a></strong> lawyer to discuss your options.</p>
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		<title>Nuvaring Litigation News</title>
		<link>http://www.birthcontrolringlawsuitcenter.com/nuvaring-litigation-news/</link>
		<comments>http://www.birthcontrolringlawsuitcenter.com/nuvaring-litigation-news/#comments</comments>
		<pubDate>Wed, 11 Aug 2010 12:41:02 +0000</pubDate>
		<dc:creator>Steve Fields</dc:creator>
				<category><![CDATA[News]]></category>
		<category><![CDATA[Nuvaring Litigation]]></category>

		<guid isPermaLink="false">http://www.birthcontrolringlawsuitcenter.com/?p=1148</guid>
		<description><![CDATA[Occasionally, there are warning signs that a stroke may lie on the horizon. One of these signs is a mini-stroke, also called a transient ischemic attack (TIA). In order to understand how a TIA might herald an impending stroke, it&#8217;s necessary to recognize the factors that cause it. Please contact us for the latest Nuvaring [...]]]></description>
			<content:encoded><![CDATA[<p>Occasionally, there are warning signs that a stroke may lie on the horizon. One of these signs is a mini-stroke, also called a transient ischemic attack (TIA). In order to understand how a TIA might herald an impending stroke, it&#8217;s necessary to recognize the factors that cause it. Please contact us for the latest <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawsuit/" target="_self">Nuvaring litigation</a></strong> news and information.</p>
<p><span style="text-decoration: underline;">Mini Stroke Explained</span></p>
<p>A full ischemic stroke is triggered by an interruption in the supply of blood, oxygen, and nutrients to your brain. In order to function properly, your brain cells need a continuous supply of these elements, which it receives through your carotid arteries. A stroke is normally caused by blood clots that form elsewhere in the body and travel to these arteries. When they arrive, they create a blockage and prevent blood from reaching the brain tissue. This causes the cells to begin to die within minutes.</p>
<p>A transient ischemic attack is caused by the same factors. For a short period, a portion your brain tissue becomes disconnected from its supply of blood, oxygen, and nutrients. This affects your brain&#8217;s function, and can trigger one or more impairments.</p>
<p><span style="text-decoration: underline;">Common Symptoms Of A Mini Stroke</span></p>
<p>Not all symptoms of a TIA are instantly noticeable. This might be the case when a mini-stroke cuts off the supply of blood to an area of your brain you rarely use, or use sporadically. On the other hand, if the flow of blood is restricted from a key area of your brain, you will likely notice immediate signs.</p>
<p>For example, if blood flow to the temporal lobe is obstructed, you might experience difficulty hearing or recalling memories from years past. An obstruction in the occipital lobe may produce vision problems. You might experience a sudden loss in eye-hand coordination if the parietal lobe is affected.</p>
<p>The most common area impacted during a mini stroke is the frontal lobe. This portion of your brain controls movement and sensation as well as functions related to speech, cognition, and behavior. Thus, weakness and numbness in the face and limbs are common. So, too, is an inability to speak or understand what others are saying. You may also experience vision problems and bouts of vertigo.</p>
<p><span style="text-decoration: underline;">Stroke Versus A Transient Ischemic Attack</span></p>
<p>Note that the symptoms associated with a TIA are very similar to those which present during a stroke. The difference between the two events is that the effects of a mini-stroke typically disappear within a day. By contrast, when you suffer a full stroke, the resulting impairments can potentially last for years. In some cases, even with long-term rehabilitation, they may last for the remainder of your life.</p>
<p>It is important to note that both conditions display similarly on an MRI. Without access to additional information, it is impossible to tell the two circumstances apart. This implies that while the effects of a TIA dissipate within twenty-four hours, the event may still result in permanent brain injury.</p>
<p><em>Is A Full Stroke Imminent?</em></p>
<p>Brain ischemia, regardless of its severity, suggests an underlying problem that must be addressed. Even if the effects of a mini-stroke disappear, the root cause of the event is likely to trigger a recurrence sometime in the future. It is estimated that nearly one in five people who experience a transient ischemic attack suffer a major stroke within a year. For this reason, urgent treatment is critical &#8211; not only to address your immediate symptoms, but to help prevent a future stroke.</p>
<p>In summary, even if Nuvaring side effects involving blood clots fail to cause a stroke, they can trigger a mini-stroke. Because a TIA may be a harbinger of a future stroke, the event should be treated with the same level of urgency.</p>
<p><strong>Nuvaring Litigation 2010</strong></p>
<p>If you or someone you know has suffered from blood clots, stroke, pulmonary embolism, or other Nuvaring problems, find out about your legal rights. Contact one of our <a href="http://www.birthcontrolringlawsuitcenter.com/how-we-can-help/" target="_self"><strong>Nuvaring lawyers</strong> </a>to discuss whether you should file a claim for compensation against the manufacturer.</p>
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		<title>Nuva ring Lawsuit News &#124; Nuvaring Class Action Lawyer</title>
		<link>http://www.birthcontrolringlawsuitcenter.com/nuva-ring-lawsuit-news-nuvaring-class-action-lawyer/</link>
		<comments>http://www.birthcontrolringlawsuitcenter.com/nuva-ring-lawsuit-news-nuvaring-class-action-lawyer/#comments</comments>
		<pubDate>Sat, 28 Mar 2009 15:18:42 +0000</pubDate>
		<dc:creator>Steve Fields</dc:creator>
				<category><![CDATA[NuvaRing Side Effects]]></category>
		<category><![CDATA[Nuvaring Lawsuit]]></category>
		<category><![CDATA[Nuvaring Litigation]]></category>

		<guid isPermaLink="false">http://www.nuvaringsideeffects.com/?p=556</guid>
		<description><![CDATA[Women throughout the United States who have suffered from a DVT or PE have looked at being part of a Nuvaring class action. Serious questions have been raised regarding whether the Nuvaring label had adequate warnings related to the risk of deep vein thrombosis (DVT), pulmonary embolism (PE) and other related conditions including strokes. The [...]]]></description>
			<content:encoded><![CDATA[<p>Women throughout the United States who have suffered from a DVT or PE have looked at being part of a <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawyer/" target="_self">Nuvaring class action</a></strong>. Serious questions have been raised regarding whether the Nuvaring label had adequate warnings related to the risk of <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawyer/" target="_self">deep vein thrombosis</a></strong> (DVT), <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-side-effects/" target="_self">pulmonary embolism</a></strong> (PE) and other related conditions including strokes. The following press release from the Office of Public Health and Science highlights the life-threatening risk of blood clots.</p>
<p><strong>Acting Surgeon General Issues ‘Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism&#8217;</strong></p>
<p>FOR IMMEDIATE RELEASE<br />
Monday September 15, 2008       Contact: Office of Public Health and Science<br />
                                                                   (202) 205-0143</p>
<p>Acting Surgeon General Steven K. Galson, M.D., M.P.H., today issued a Call to Action to reduce the number of cases of deep vein thrombosis and pulmonary embolism in the United States.</p>
<p>Galson urged all Americans to learn about and prevent these treatable conditions.</p>
<p>Deep vein thrombosis and pulmonary embolism affect an estimated 350,000 to 600,000 Americans each year, and the numbers are expected to increase as the U.S. population ages. Together, deep vein thrombosis and pulmonary embolism contribute to at least 100,000 deaths each year.</p>
<p>Deep vein thrombosis is a blood clot in a deep vein, most commonly in the lower leg or thigh. The clot can block blood flow and cause pain, swelling, and skin discoloration.<br />
In the most serious cases, deep vein thrombosis can lead to a pulmonary embolism &#8211; when part of the blood clot breaks loose and travels through the bloodstream to the lungs, where it can block a lung artery, causing damage to the lungs or other organs from lack of oxygen.</p>
<p>&#8220;Deep vein thrombosis and pulmonary embolisms are often &#8217;silent&#8217; conditions &#8211; they can occur suddenly and without symptoms,&#8221; Galson said. &#8220;But we have made a lot of progress in understanding how these disorders develop and how to prevent, diagnose, and treat them. It&#8217;s time to put this knowledge into action.&#8221;</p>
<p>Researchers have found that in most cases, deep vein thrombosis and pulmonary embolism develops in people who have an inherited blood clotting disorder or other risk factor, and who experience a triggering event.</p>
<p>&#8220;Being hospitalized or confined to bed rest, having major surgery, suffering a trauma, or traveling for several hours can increase a person&#8217;s risk of deep vein thrombosis and pulmonary embolism,&#8221; Galson said. &#8220;We want to increase the awareness and knowledge of these potentially deadly conditions and encourage patients and health care providers to take the steps to prevent them.&#8221;</p>
<p>The Call to Action urges a coordinated, multifaceted plan to reduce the numbers of cases of deep vein thrombosis and pulmonary embolism nationwide. The plan emphasizes the need for:</p>
<p>• Increased awareness about deep vein thrombosis and pulmonary embolism.<br />
• Evidence-based practices for deep vein thrombosis.<br />
• More research on the causes, prevention, and treatment of deep vein thrombosis.</p>
<p>The Call to Action resulted from a Surgeon General&#8217;s Workshop on Deep Vein Thrombosis which was convened in May 2006. The workshop was co-sponsored by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health.</p>
<p>&#8220;Deep vein thrombosis and pulmonary embolism are major public health problems, and NHLBI is committed to continuing to support important basic and clinical research to advance our understanding of these disabling and potentially fatal conditions,&#8221; NHLBI Director Elizabeth G. Nabel, M.D., noted. &#8220;Research is shedding light on genetic factors and the role of triggering events, behaviors, and conditions that increase the risk of developing dangerous blood clots. It is imperative that clinicians and public health experts work together to translate this scientific evidence to save lives.&#8221;</p>
<p>The Agency for Healthcare Research and Quality (AHRQ) contributed to the Call to Action with the release of two new guides &#8211; one for patients and another for health care providers &#8211; on how to prevent dangerous blood clots. &#8220;Fighting deep vein thrombosis and pulmonary embolism is a team effort that involves health care providers and patients,&#8221; said AHRQ Director Carolyn M. Clancy, M.D.</p>
<p>We represent all women suffering from <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-blood-clot-problems-nuva-ring-attorneys/" target="_self">Nuvaring side effects</a></strong> on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a <span style="text-decoration: underline;">free no-obligation consultation</span> please call toll free at 1-888-343-5375 or fill out our short online contact form and a <strong><a href="http://www.birthcontrolringlawsuitcenter.com/" target="_self">Nuvaring class action lawsuit</a></strong> attorney will contact you to answer any of your questions.</p>
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		<title>Nuvaring Lawsuit News &#124; Birth Control Ring Side Effects</title>
		<link>http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawsuit-news-birth-control-ring-side-effects/</link>
		<comments>http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawsuit-news-birth-control-ring-side-effects/#comments</comments>
		<pubDate>Sat, 21 Mar 2009 15:33:11 +0000</pubDate>
		<dc:creator>Steve Fields</dc:creator>
				<category><![CDATA[NuvaRing Side Effects]]></category>
		<category><![CDATA[Nuvaring Lawsuit]]></category>
		<category><![CDATA[Nuvaring Litigation]]></category>

		<guid isPermaLink="false">http://www.nuvaringsideeffects.com/?p=549</guid>
		<description><![CDATA[NuvaRing side effects including blood clots, stroke and heart attack have been reported by women throughout the United States using this third generation form of birth control. Many women who have suffered side effects of NuvaRing have filed a Nuvaring lawsuit based on the argument that this birth control ring increased the risk of developing [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawyer/" target="_self">NuvaRing side effects</a></strong> including blood clots, stroke and heart attack have <img class="alignright size-full wp-image-552" style="margin: 10px 5px;" title="Nuvaring Lawsuit News" src="http://www.birthcontrolringlawsuitcenter.com/wp-content/uploads/2009/03/csupreme-court-145x150.jpg" alt="Nuvaring Lawsuit News" width="145" height="150" />been reported by women throughout the United States using this third generation form of birth control. Many women who have suffered side effects of NuvaRing have filed a <strong><a href="http://www.birthcontrolringlawsuitcenter.com/" target="_self">Nuvaring lawsuit</a></strong> based on the argument that this birth control ring increased the risk of developing a life threatening blood clot. Some third generation contraceptives are associated with the hormone desogestrel which can cause changes in the blood clotting system allowing blood clots to form more easily. The birth control ring was approved by the Federal Drug Administration (FDA) on October 3, 2001 and first marketed in the United States in July 2002. NuvaRing is used by approximately 1.5 million women worldwide.</p>
<p>Following the recent Supreme Court decision in <strong><a href="http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf" target="_self">Wyeth v. Levine</a></strong>, lawyers for the manufacturer of Nuvaring withdrew their motion for summary judgment they had filed in November 2008. The motion had argued that the manufacturer should be protected from state product liability Nuvaring lawsuits because the FDA approved the Nuvaring warning label. Plaintiff&#8217;s who had brought a Nuvaring lawsuit had claimed that the birth control ring failed to adequately warn consumers about the greater risk of developing blood clots such as deep vein thrombosis (DVT) and pulmonary embolism.</p>
<p>We represent all women suffering from <strong>Nuvaring side effects</strong> on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a <span style="text-decoration: underline;">free no-obligation consultation</span> please call toll free at 1-888-343-5375 or fill out our short online contact form and a <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawyer/" target="_self">Nuvaring lawsuit</a></strong> attorney will contact you to answer any of your questions.</p>
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		<title>Nuvaring Class Action &#124; Nuva Ring Issues</title>
		<link>http://www.birthcontrolringlawsuitcenter.com/nuvaring-class-action-nuva-ring-issues/</link>
		<comments>http://www.birthcontrolringlawsuitcenter.com/nuvaring-class-action-nuva-ring-issues/#comments</comments>
		<pubDate>Sun, 25 Jan 2009 21:55:07 +0000</pubDate>
		<dc:creator>Steve Fields</dc:creator>
				<category><![CDATA[Nuvaring Litigation]]></category>

		<guid isPermaLink="false">http://www.nuvaringsideeffects.com/?p=506</guid>
		<description><![CDATA[UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
(St. Louis)

IN RE NUVARING PRODUCTS LIABILITY : 4:08 MDL 1964 RWS
LITIGATION

ALL CASES
Honorable Rodney W. Sippel

MEMORANDUM OF LAW IN SUPPORT OF
\ DEFENDANTS' MOTION FORSUMMARY JUDGMENT
OR, IN THE ALTERNATIVE, MOTION FORPARTIAL SUMMARY JUDGMENT,
BASED ON THE DEFENSE OF FEDERAL PREEMPTION;
STATEMENT OF UNCONTROVERTED MATERIAL FACTS

Fed. R. Civ. Proc. 56
TABLE OF CONTENTS
Page
I INTRODUCTION 1
II [...]]]></description>
			<content:encoded><![CDATA[<pre>UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
(St. Louis)

IN RE NUVARING PRODUCTS LIABILITY : 4:08 MDL 1964 RWS
LITIGATION

ALL CASES
Honorable Rodney W. Sippel

MEMORANDUM OF LAW IN SUPPORT OF
\ DEFENDANTS' MOTION FORSUMMARY JUDGMENT
OR, IN THE ALTERNATIVE, MOTION FORPARTIAL SUMMARY JUDGMENT,
BASED ON THE DEFENSE OF FEDERAL PREEMPTION;
STATEMENT OF UNCONTROVERTED MATERIAL FACTS

Fed. R. Civ. Proc. 56
TABLE OF CONTENTS
Page
I INTRODUCTION 1
II STATUTORY AND REGULATORY FRAMEWORK .4
A. The FDA's Statutory Authority For Regulating Prescription Drugs 4
B. The FDA's Regulation OfDrug Labeling 5
III FACTUAL BACKGROlJND 8
A. The FDA Has Carefully And Deliberately Regulated Combined Hormonal
Contraceptives For Decades 8
1. The FDA Has Long Evaluated The Risk ofVTE for All Combined
Hormonal Contraceptives 8
2. The FDA Carefully Reviewed And Approved The NDA for
NuvaRing®, and Mandated the VTE Warnings for Its Label .lO
3. Following Approval ofthe NuvaRing® NDA, the FDA Has
Continued Careful Monitoring ofThromboembolic Risks
Associated With Combination Hormonal Contraceptives 12
IV ARGUMENT 13
A. Organon is Entitled to Summary Judgment Because Plaintiffs' State Law
Claims Are Preempted By Federal Law 13
1. Plaintiffs' Claims Are Preempted Because It Is Impossible for
NuvaRing® to Comply With Both The Federal Mandates and the
Standards that Plaintiffs Seek To Impose Through Their State Law
Based Tort Claims 15
2. Plaintiffs' Claims Are Preempted Because They Obstruct the
Objectives and Purposes ofthe FDCA and Its Implementation by
the FDA 20
B. Plaintiffs Cannot Avoid Preemption By Arguing Defendants Misled The
FDA, Because Such Claims Also Are Preempted .22
V CONCLUSION 24
STATEMENT OF UNCONTROVERTED MATERIAL FACTS PER LOCAL RULE 7-
4.01(E) 1
I INTRODUCTION
Defendants Organon USA, Inc., Organon Pharmaceuticals USA, Inc. LLC (flkla Organon
Pharmaceuticals USA, Inc.), Organon International, Inc. and Schering-Plough Corporation
(collectively, "defendants" or "Organon") move for summary judgment on the ground that the
MOL plaintiffs' lawsuits are preempted by federal law.
The MDL plaintiffs assert product liability claims relating to NuvaRing®, a prescription
pharmaceutical consisting ofa flexible, transparent vaginal ring containing a combined
honnonal contraceptive, estrogen (ethinyl estradiol) with a "third generation" progestin
(etonogestrel). More specifically, plaintiffs assert causes of action for negligent failure to warn;
strict liability design defect; fraud and misrepresentation; breach ofexpress and implied
warranty; manufacturing defect; and "[v]iolation ofconsumer protection laws in various states."
See Affidavit ofMelissa A. Geist ("Geist Aff."), Exhibit A (Oct. 22, 2008 Letter from Blau
Brown &#038; Leonard LLC identifying the "causes of action and facts common to" all the MDL
plaintiffs' claims) at 3-4.
In support ofthese causes ofactio~ plaintiffs assert that: (1) NuvaRing® "is defective in
that it contains too much progestin" and "an unduly dangerous form ofthird generation
progestin"; and (2) NuvaRing®'s labeling fails to adequately warn ofa potential association
between hormonal contraceptives and blood clots, venous thromboembolism ("VIE"), stroke,
and/or other conditions. See id. I
1See also lenn First Amended Complaint, ~ 14 ("Defendants Organon failed to warn ofthe
extent of the risk ofvenous thromboembolism, including Deep Vein 1brombosis (OVT) and
Pulmonary Embolism (PE) and death associated With the use ofthe novel combined
contraceptive vaginal route ofadministration, the NuvaRing®."); Mecca (Blau Brown)
Complaint, ~ 23 ("Defendants failed to warn prescribing physicians and the public that the
Continued on following page
1
These allegations, however, fail to account for the regulatory role ofthe Food and Drug
Administration which has the sole authority, by statute and by regulation, to determine whether a
drug is safe and efficacious and what can be contained in a drug's labeling. Here, moreover, the
record is uncontradicted that, after exhaustive review and analysis, the FDA approved
NuvaRing® as safe and effective and, after a similar exhaustive and ongoing review, approved
NuvaRing's® labeling.
Indeed, the regulatory history ofNuvaRing® demonstrates that the FDA engaged in a
considered and deliberate risk-benefit analysis concerning the very aspects ofthe NuvaRing®
design and labeling challenged in this litigation: the alleged propensity ofcombined hormonal
contraceptives to increase VTE and similar risks. This regulatory history demonstrates that the
FDA has been aware of issues pertaining to thromboembolic risks allegedly associated with
combined hormonal contraceptive products, has stayed abreast ofthe relevant scientific data
concerning products in the class, and has mandated labeling revisions when deemed appropriate.
Under these circumstances, plaintiffs' product liability claims are preempted because
those claims directly conflict with the FDA's regulatory actions, decisions and objectives. The
only circuit to directly address the effect ofpreemption on tort claims involving prescription
drugs has so held on a record analogous to the one before this Court. See Colacicco v. Apotex,
Inc., 521 F.3d 253, 269 (3d Cir. 2008) (implied preemption defense barred state law product
Continued from previous page
NuvaRing was associated with increased risk ofcardiovascular thromboembolic complications
than the pill.").
-2-
liability lawsuit where plaintiff faulted suicide warning on prescription drug but FDA had
carefully mandated the suicide warning based on its evaluation of scientific data.).2
There is every reason to conclude that the Eighth Circuit would recognize the preemptive
effect ofthe FDA's regulatory decision-making as applied to this record. In Brooks v.
Howmedica, Inc., 273 F.3d 785, 796-98 (8th Cir. 2001) (en bane), the Eighth Circuit found a
failure to warn claim preempted where, as here, FDA had the exclusive responsibility for the
substance ofthe product's labeling and where, as here, it exercised its judgment concerning the
contents ofthe label with knowledge ofthe alleged safety issue. Although Brooks involved
express preemption and a prescription medical device, instead ofimplied preemption and a
prescription pharmaceutical, its reasoning and rationale safeguarding the primacy ofFDAdecision-
making apply with equal force here as well. See Ehlis v. Shire Richwood, Inc., 233 F.
Supp. 2d 1189,1198 (D.N.D. 2002) (holding preemption barred product liability claim over
2 Many other courts have applied principles ofimplied preemption to foreclose claims made
against drug manufacturers. See also Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341,
348 (2001) (implied preemption barred claims that defendant misled the FDA into approving its
prescription device); Pennsylvania Employees Benefit Trust Fund v. Zeneca, Inc., 499 F.3d 239,
253 (3d Cir. 2007) (consumer fraud and false advertising claims preempted by FDA regulation
ofdrug label and advertising); O'Neal v. Smithkline Beecham Corp., 551 F. Supp. 2d 993,100203
(B.D. Cal. 2008) (implied conflict preemption barred injury tort claim over prescription
antidepressant warnings); Longs v. Wyeth, 536 F. Supp. 2d 843, 847 (N.D. Ohio 2008) (implied
preemption barred plaintiff's product liability claim that FDA never should have approved
prescription diet drug); Dobbs v. Wyeth Pharm., 530 F.Supp.2d 1275, 1280-81 (W.D. Okla.
2008) (implied preemption barred product liability claim over prescription antidepressant
warnings); Masterson v. Apotex Corp., 2008 WL 3262690 (S.D. Fla. Aug. 7, 2008) (implied
preemption barred product liability failure to warn claim over prescription generic drug's birth
defect warning); Mensing v. Wyeth, 2008 WL 2444689 (D. Minn. June 17,2008) (implied
preemption barred product liability failure to warn claim involving prescription generic drug);
Mason v. Smithkline Beecham Corp., 2008 WL 1835350 (C.D. Ill. Apr. 23,2008) (implied
conflict preemption barred injury tort claim over prescription antidepressant warnings); Horne v.
Novartis Pharmaceuticals Corp., 2008 WL 818819 (W.D.N.C. March 25,2008) (implied
preemption barred failure to warn and other claims involving prescription drug). In addition, the
United States Supreme Court will hear oral argument in a case raising these issues, Wyeth v.
Levine, No. 06-1249, on November 3, 2008.
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prescription ADHD drug; "plaintiffs' claims in this case mirror those brought by Brooks, and
although plaintiffs in oral argument attempted to distinguish the FDA from the MDA, the court is
not convinced that preemption would not apply in this case").
In the end, plaintiffs are attempting to use their various tort claims to second-guess the
FDA's regulatory judgments and to penalize defendants for their compliance with the FDA's
regulatory mandates. Principles ofimplied preemption are intended to foreclose both results.
The FDA made its evaluations and decisions with awareness ofthe alleged risks plaintiffs
identify, and that is dispositive of plaintiffs' lawsuit. Summary judgment is warranted and
respectfully urged.
II STATUTORY AND REGULATORY FRAMEWORK
A. The FDA's Statutory Authority For Regulating Prescription Drugs
The FDA is the federal health agency charged by Congress with ensuring that drugs are
safe and effective and that drug labeling adequately infonns users ofthe risks and benefits ofthe
product. See generally 21 U.S.C. § 201 et seq. The Food, Drug and Cosmetic Act ("FDCA")
prohibits the marketing ofa new prescription drug until the FDA detennines the drug is safe and
effective for its intended use, and mandates the language that must be contained in the product
label. See 21 U.S.C. §§ 355(d), 505.
When evaluating a New Drug Application ("NDA"), the FDA must weigh the potential
safety risks associated with the new drug against the therapeutic benefits to patients. The FDA
strikes a balance between those often competing considerations by regulating "the conditions
prescribed, recommended, or suggested in the proposed labeling." See 21 U.S.C. § 355(d); see
also 21 C.F.R. § 314.50(d)(5)(viii) (requiring NDAs to include a "summary ofthe benefits and
-4-
risks ofthe drug, including a discussion ofwhy the benefits exceed the risks under the conditions
stated in the labeling"); FDA, Guidance for Industry, Development and Use ofRisk
Minimization Action Plans 4 (Mar. 2005) (describing the FDA's risk-benefit assessment as
measuring whether, under labeled conditions of use, "the clinical significance and probability of
[a drug's] beneficial effects outweigh the likelihood and medical importance of its harmful or
undesirable effects"»)
In this way, the FDA fulfills its dual mission to "protect the public health" by barring
access to unsafe or ineffective drugs, and to "promote the public health" by ensuring prompt
access to effective and beneficial medicines. 21 U.S.C. § 393(b).
B. The FDA's Regulation OfDrug Labeling
Because prescription drugs carry unavoidable, and often serious, risks for some patients,
"drug labeling serves as the standard under which FDA determines whether a product is safe and
effective" [50 Fed. Reg. 7452, 7470 (Feb. 22, 1985)], and it is "[t]he centerpiece ofrisk
management" [71 Fed. Reg. 3922,3934 (Jan. 24,2006)]. FDA-approved drug labeling
"communicates to health care practitioners the agency's fonnal, authoritative conclusions
regarding the conditions under which the product can be used safely and effectively." 71 Fed.
Reg. at 3934.
A drug's labeling must include "a summary ofthe essential scientific information needed
for the safe and effective use ofthe drug." 21 C.F.R. § 201.56(a)(1). To achieve this result, the
FDA reviews the labeling proposed with each NDA and may approve an NDA only if it finds:
(1) that the drug is "safe for use under the conditions prescribed, recommended, or suggested in
3 Available at http://www.fda.gov/cder/guidance/6358fnl.pdf.
-5-
the proposed labeling thereof'; (2) that there is "substantial evidence that the drug will have the
effect it purports or is represented to have under the conditions ofuse prescribed, recommended,
or suggested in the proposed labeling thereof'; and (3) that the proposed labeling is not "false or
misleading in any particular." 21 U.S.C. § 355(d). Further, the FDA can withhold NDA
approval until the manufacturer makes changes to the labeling that the Agency deems necessary.
21 C.F.R. § 314.105(b); see also id. § 314.110(a).
Once the FDA approves an NDA, a manufacturer can distribute the drug only with FDAapproved
labeling. See id. § 314.105(b) ("[A]pproval will be conditioned upon the applicant
incorporating the specified labeling changes exactly as directed, and upon the applicant
submitting to FDA a copy ofthe final printed labeling prior to marketing."); see also Colacicco,
521 F.3d at 257-60. A manufacturer may not change a drug's FDA-approved labeling without
obtaining the FDA's prior approval ofa supplemental NDA. See 21 U.S.C. § 355(a), (b)(I)(F),
(c)(I)(A), (d); see also 21 C.F.R. § 314.70(b)(2)(v)(A), (b)(3).4
A narrow regulatory exception to this rule pennits a manufacturer, who has filed a
supplemental NDA, to implement a labeling change before FDA has acted on the application if
the change is intended "[t]o add or strengthen a contraindication, warning, precaution, or adverse
4 Similar features of the FDA's premarket approval of Class III medical devices recently led the
Supreme Court to find preemption ofstate-law tort claims in that analogous context. Riegel v.
Medtronic, Inc., 552 U.S.-' 128 S. Ct. 999, 1008 (2008). In Riegel, the Court held that once a
Class III medical device receives premarket approval, the FDCA (as amended by the Medical
Device Amendments of 1976 (MDA» forbids the manufacturer to make any change without
FDA permission, including a change to the approved labeling, that would "affect safety or
effectiveness." ld. at 1005. Any change must be submitted by supplemental application for FDA
approval before implementation. ld. The Supreme Court thus held that the FDA's detailed,
individualized review ofthe safety and effectiveness of each Class III medical device imposed a
federal-law "requirement" that an approved device be made "with almost no deviations from the
specifications in its approval application," and pr.eempted conflicting state-law requirements
applicable to the device. ld. at 1006-1007. The same holds true for prescription drugs, which
are subject to an approval process that is very similar to the MDA's premarket approval process.
-6-
reaction," or "[t]o add or strengthen an instruction about dosage and administration that is
intended to increase the safe use of the drug product" ifpremised on new information not already
known to the Agency. 21 C.F.R. § 314.70(c)(6)(iii)(A), (C); see also Brief for the United States
as Amicus Curiae in Wyeth v. Levine, No. 06-1249, at 23-24 (S. Ct. June 2007)5 (CBE regulation
does not allow manufacturers to reassess the same risks and benefits already accounted for by the
FDA, but rather "must be based on new information"); cf Riegel v. Medtronic, Inc., 552 U.S.
-' 128 S. Ct. 999, 1005 (2008) (discussing analogous CBE regulation for medical devices).6
Even where the CBE exception might be applicable, however, the FDA retains the
ultimate authority to decide whether the additional warning language can be utilized. As the
FDA has expressly acknowledged, the over inclusion ofrisk information in product labeling is
not necessarily protective of patients as such information can distort the risk versus benefit
analysis that is critical to a prescriber's ability to make appropriate judgments about product use.
71 Fed. Reg. 3934,3935 ("Exaggeration of risk could discourage appropriate use ofa beneficial
drug."). Thus, "the determination ofwhether labeling revisions are necessary is, in the end,
squarely and solely FDA's under the act." Id. at 3934.
5 Available at http://www.abanetorglpubliced/preview/briefs/pdfs/07-08/061249
PetitionerAmCuUSA.pdf.
6 FDA also recently published a proposed change to the CBE provision "to codify" this
longstanding view and to "reaffirm that a CBE supplement is appropriate to amend the labeling
for an approved product only to reflect newly acquired information and to clarify that a CBE
supplement may be used to add or strengthen a contraindication, warning, precaution or adverse
reaction only if there is sufficient evidence ofa causal association with the drug, biologic or
medical device." 73 Fed. Reg. 2848,2849 (Jan. 16,2008).
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OJ FACTUAL BACKGROUND
A. The FDA Has Carefully And Deliberately Regulated Combined Hormonal
Contraceptives For Decades
1. The FDA Has Long Evaluated The Risk of VTE for All Combined Hormonal
Contraceptives.
The FDA has regulated - and mandated - warnings regarding the potential risk ofVTE
associated with the use ofhormonal contraceptives for decades. Beginning in 1970, the FDA
published a Final Rule requiring "uniform labeling" for hormonal contraceptives ("class
labeling''), stressing that the "most important complication" to be communicated to the patient
"is abnormal blood clotting which can have a fatal outcome." See Geist Aff., Exhibit D at 9002.
This regulation further required manufacturers to include inserts to be dispensed to patients with
the same warning. Id. at 9002-03.7
In 1976, the FDA issued revised physician and patient labeling for all combined
hormonal contraceptives based on "[s]ignificant new information" regarding thromboembolic
disorders and other risks associated with such product use. Geist MI., Exhibit E at 53633. The
FDA mandated that all manufacturer labels contain contraindications for any woman with
"[t]hrombophlebitis or thromboembolic disorderst' or a "past history ofdeep vein
7 With respect to prescription drugs, "labeling" or "professional labeling" is "a compilation of
information about the product, approved by FDA, based on the agency's thorough analysis ofthe
new drug application (NDA) .... This labeling contains information necessary for safe and
effective use. It is written for the health care practitioner audience." 71 Fed. Reg. at 3922. The
term "patient insertst' or "patient labeling't means special labeling distributed directly to patients
and "refers to any labeling that has been reviewed and approved by the agency that provides
information for patients and is for distribution to patients who are prescribed a drug. This term
includes approved printed patient information specifically required by regulation (e.g., for oral
contraceptives (21 CFR 310.501) and estrogens (21 CFR 310.515»." 71 Fed. Reg. at 3954.
-8-
thrombophlebitis or thromboembolic disorders," and it required that all labeling contain several
new thromboembolism warnings, including the following language: "use oforal contraceptives
is associated with increased risk of several serious conditions including thromboembolism,
stroke ...." Id. at 53634. The FDA specified at that time that "[a]bnormal blood clotting" be
described first under "The Dangers of Oral Contraceptives" in a patient insert as well as the
physician labeling. Id. at 53640.
Similarly, the FDA has closely regulated hormonal contraceptive products containing
third-generation progestins for thromboembolic risks, long before NuvaRing® was approved.
See Declaration ofTitia M.T. Mulders ("Mulders Decl."), Exhibit Bat 10. In August 1994, the
FDA issued its "Guidance for Industry on Combined Oral Contraceptives - Labeling for
Healthcare Providers and Patients" (the "COC Guidance"), as well as several draft amendments
thereto (issued June 2000 and March 2004), in order to impose uniform labeling among
combined oral contraceptive products. The 2004 draft version ofthe COC Guidance,
specifically directed the inclusion ofwarnings for thromboembolic risks like VTE in the
Contraindications and Warnings sections, including the following warning:
For desogestrel containing products: Several epidemiologic studies
indicate that OCs containing desogestrel are associated with a higher
risk of venous thromboembolism than OCs containing other
progestins. In general, these studies indicate an approximate 2-fold
increased risk, which corresponds to an additional 1 to 2 cases of
venous thromboembolism per 10,000 women-years of use. However,
data from other studies have not shown this 2-fold increase in risk.
Geist Aff., Exhibit B at 5.
In 1995, the FDA issued a statement entitled "Oral Contraceptives and Risk ofBlood
Clots" in response to inquiries about oral contraceptives containing third generation progestins.
Geist Aff., Exhibit F. Although the FDA stated that some studies suggested an approximate twofold
increase in the risk ofVTE for third generation contraceptives as compared to products
-9-
containing older progestins, it also stated that the risk did not require women to stop using the
product and was "not great enough to justify switching to other products." See id At the same
time, the FDA indicated that it would work with manufacturers to further update the labeling. Id
2. The FDA Carefully Reviewed And Approved The NDA for NuvaRing®, and
Mandated the VTE Warnings for Its Label
NuvaRing® is the first and only contraceptive vaginal ring approved for delivering
combined hormones. See Mulders Decl., Exhibit D at NDA-0127486, NDA-0127490. When
placed in the vagina, the ring releases continuous levels ofetonogestrel and an estrogen over a
three-week period. Id at NDA-0127490.
Organon submitted the NuvaRing® NDA (No. 21-187) on December 28, 1999. Mulders
Decl., Exhibit A. Organon's submission included the results of"two large Phase 3 studies"
(Study 068003 and Study 034219) regarding the "contraceptive efficacy, vaginal bleeding
patterns, and safety ofthe NuvaRing regimen," as well as other studies including those
comparing NuvaRing® with second-generation oral contraceptives and thromboembolic events
reported during the studies. Mulders Decl., Exhibit B. These studies provided information on
contraceptive efficacy and cycle control, risk ofserious adverse events including VTE, lipid and
carbohydrate metabolism, coagulation and fibrinolysis (the body's clotting and clot dissolving
mechanism), and pharmacokinetic effects ofNuvaRing®. Id
After reviewing the data and information submitted, the FDA Medical Officer's Review8
stated "there is a solid database of safety information" concerning NuvaRing®, and that there
were "no major changes ofconcern in the hemostasis [blood clotting] parameters." Mulders
8 The role ofan FDA Medical Officer is to review all ofthe information about a new drug to
ensure that it is safe and effective and contains accurate product labeling. Mulders Decl. '10.
- 10-
Decl., Exhibit Bat 4,6. The FDA's Medical Officer's Review further stated that the FDA's
"primary concern [was] the increased risk ofVTE associated with combination hormonal
contraceptives containing a third-generation progestin, such as the etonogestrel in NuvaRing®."
Id. at 2.
Almost two years later, on October 3, 200 I, the FDA approved the NuvaRing® NDA.
Mulders Decl., Exhibit D. Again, the FDA addressed safety issues potentially associated with
the alleged increased risk ofVTEs in desogestreVetonogestrel containing combined hormonal
contraceptives by requiring that "[t]he final printed label ... reflect the increased risk ofvenous
thromboembolism (VTE) associated with combination hormonal contraceptives containing a socalled
third generation progestin such as desogestrel." Mulders Decl., Exhibit B at 2.
The FDA provided substantive comments and instructions to Organon concerning the
NuvaRing® labeling, including the following:
• October 6, 2000 - the FDA stated it would require a warning about the increased risk of
VTE associated with combined hormonal contraceptives containing third generation
progestins. See Mulders Decl., Exhibit B at 2.
• November 2000 - the FDA considered label language regarding epidemiology studies of
third generation oral contraceptives and VTE risks as follows: "There is evidence of an
association between the following conditions and the use ofcombination hormonal
contraceptives, although additional confirmatory studies are needed"; "[m]esenteric
thrombosis"; and "[r]etinal thrombosis"; "[c]ombination hormonal contraceptives may
increase the tendency to develop strokes (blockage or rupture ofblood vessels in the
brain) and angina pectoris (chest pain)"; and risks of side effects like blood clots "may be
greater with etonogestrel-containing combination hormonal contraceptives, such as
NuvaRing®, than with certain other low-dose pills." See Mulders Decl., Exhibit Cat
NDA-0125666, NDA-0125672.
• December 2000 - the FDA directed that the NuvaRing® label "include the text that is
required for all desogestrel-containing OCs regarding an approximate 2-fold increased
risk ofVTE with third generation OCs compared with certain second generation OCs."
The FDA noted that "[t]he potential increased incidence ofvenous thromboembolism
(VTEs) associated with third generation OCs, including those containing desogestrel ...
remains the major safety concern." Mulders Decl., Exhibit Eat 5,2, respectively.
- 11 -
• December 2000 - the FDA directed that the NuvaRing® label should include a statement
that "it is unknown whether NuvaRing® is distinct from combination oral
contraceptives" when comparing the risk ofNuvaRing® to other combined honnonal
contraceptives. ld. at 7.
When the FDA approved the NuvaRing® NDA in October, 2001, Organon incorporated
the FDA's ultimate directives regarding label language into the final version ofthe printed label.
See Mulders Decl., Exhibit D.
3. Following Approval of the NuvaRing® NDA, the FDA Has Continued
Careful Monitoring of Thromboembolic Risks Associated With Combination
Hormonal Contraceptives
After product approval, the FDA remained engaged in monitoring the safety and efficacy
ofNuvaRing® and regulating the product labeling. Such regulatory oversight resulted in revised
labeling, including:
• July 20,2005 - Changes to the Contraindications section ofthe NuvaRing® label
regarding thromboembolism, along with changes to the Patient Information section
regarding the risk of cigarette smoking and stroke. Mulders Decl., Exhibit F at NDA0129785,
NDA-0129823;
• March 2007 - Changes to the NuvaRing® label, including changes to the "Warnings"
section ofthe physician labeling regarding arterial thromboembolic events, hypertension
and risk of stroke. See Affidavit ofJune Bray ("Bray Aff."), , 13 &#038; Exhibit A.
• March 2007 - Changes to the patient labeling regarding use ofNuvaRing® prior to
surgery because ofthe risk of blood clots. Bray Aff., Exhibit A at 14.
In addition, the FDA has received VTE adverse events reported to Organon [see 21
C.F.R. section 314.80(a), (c)(2)] and requested additional information when necessary in the
Agency'sjudgment. See, e.g., Bray Mf.,,~ 15-16 &#038; Exhibit B.
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IV ARGUMENT
A. Organon is Entitled to Summary Judgment Because Plaintiffs' State Law Claims
Are Preempted By Federal Law
The uncontradicted record demonstrates that the FDA carefully exercised its expert
regulatory judgment regarding NuvaRing®, based on more than 30 years of expertise with all
known data regarding hormonal contraceptives and thrombogenicity. Plaintiffs' tort causes of
action, and the allegations that underlie them, directly conflict with the FDA's explicit
judgments. Congress has made the decision, however, that paramount FDA authority over drug
safety and labeling is the best way to protect patient health. The FDA's federal requirements
trump conflicting state requirements like plaintiffs seek to impose. Principles of federal
preemption accordingly bar this lawsuit.
Rule 56(c) ofthe Federal Rules of Civil Procedure requires that summary judgment be
granted when, as in this case, "there is no genuine issue as to any material fact and the moving
party is entitled to ajudgment as a matter oflaw.n Anderson v. Liberty Lobby, Inc., 477 U.S.
242,247 (1986); see also Cameo Homes v. Kraus-Anderson Const. Co., 394 F.3d 1084, 1087
(8th Cir. 2005). Through Rule 56, courts may summarily resolve all or part ofa claim. Fed. R.
Civ. Proc. 56(b).
The party opposing summary judgment bears the burden ofcoming forward with specific
facts to show there is a genuine issue for trial. See Forrest v. Kraft Foods, Inc., 285 F.3d 688,
691 (8th Cir. 2002). A fact issue is considered "genuinen only if there is sufficient evidence on
which a reasonable jury could base a fmding in favor ofthe non-moving party. Anderson, 477
U.S. at 249. Conclusory statements, speculation, unsubstantiated allegations, or merely
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colorable evidence will not suffice. See, e.g.• Banovetz v. King, 66 F. Supp. 2d 1076, 1079 (D.
Minn. 1999).
Federal preemption of state law arises from the Supremacy Clause of the U.S.
Constitution, which states:
This Constitution, and the Laws of the United States which shall be made in
pursuance thereof . . . shall be the supreme Law of the Land; and the Judges in
every State shall be bound thereby, any Thing in the Constitution or Laws of any
State to the Contrary notwithstanding.
U.S. Const. art. VI, cl. 2. 9
Even when Congress has not expressly declared its intent to have federal law preempt
state law, "implied conflict preemption" may result. l0 Congress is understood to imply a
preemptive effect for federal law when state laws either (a) "make it 'impossible' for private
parties to comply with both state and federal law" or (b) "prevent or frustrate the
accomplishment ofa federal objective." Geier v. Am. Honda Motor Co., 529 U.S 861, 873
(2000).
9 The implied conflict preemption issue in this case is a defense to liability and a matter of
"ordinary preemption," because it is concerned only with whether plaintiffs' state law tort claims
impermissibly conflict with federal law. This motion does not involve the jurisdictional issues
of"complete preemption," which relate to whether Congress intended to convert all nominally
state law claims into federal claims sufficient to create federal question jurisdiction. It thus is
unlike the complete preemption issues discussed in St. John~ Mercy Health System v.
Healthlink, Inc., 2008 WL 4204721 (B.D.Mo. Sept. 9,2008) (Sippel, J.) (on motion for remand,
issue was whether ERISA created "complete preemption" converting a state claim into a federal
question) and in Gillenwater v. Burlington Northern &#038; Santa Fe Ry. Co., 481 F. Supp. 2d 998
(B.D. Mo. 2007) (Sippel, J.) (on reconsideration ofmotion for remand, issue was "complete
preemption" and whether Congress intended the Federal Railroad Safety Act to convert a state
claim into a federal question).
10 Implied conflict preemption is one oftwo types of"ordinary preemption," the other being
express. Express preemption requires a court to look to the text and structure ofa federal statute
to discern Congress' intent with respect to the scope ofpreemption. See Brooks v. Howmedica.
Inc., 273 F.3d 785, 792 (8th Cir. 2001) (en bane). Implied preemption differs from express
preemption "in that it turns on the identification of 'actual conflict'" rather than interpretation of
statutory language. Geier v. American Honda Motor Co., 529 U.S. 861,884 (2000).
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Because the FDA is vested with the exclusive authority to make the determination that a
particular prescription drug is "safe and effective" when used in accordance with the approved
labeling, product liability suits based upon a contrary assessment of the adequacy ofa drug's
label pose an obstacle to the FDA's ability to carry out its congressionally-mandated
responsibilities. In addition, because manufacturers must comply with FDA mandates, it is
impossible for them to, at the same time, comply with contrary directions imposed by juries
applying their understanding of state law tort duties. Tort claims such as those at issue in this
lawsuit thus are preempted.
1. Plaintiffs' Claims Are Preempted Because It Is Impossible for NuvaRing® to
Comply With Both The Federal Mandates and the Standards that Plaintiffs
Seek To Impose Through Their State Law Based Tort Claims
The FDA's review ofNDAs is a rigorous process that focuses on whether the drug is safe
and effective under the labeled conditions of use and whether its labeling complies with
extensive and detailed regulations. FDA approval ofa drug's labeling is thus part and parcel of
its approval of the drug itself. If the FDA finds anything it judges to be deficient in the proposed
labeling during its review ofan NDA, the FDA will specify exactly how those deficiencies
should he corrected and final approval ofthe NDA is "conditioned upon the applicant
incorporating the specified labeling changes exactly as directed." 21 C.F.R. § 314.105(b).
The FDCA required that Organon incorporate the FDA-mandated language regarding
thromboembolic events. No deviation was permitted without FDA approval. By contrast,
plaintiffs seek to impose state law obligations which would require Organon to deviate from
those established by the expert agency charged with responsibility for making determinations
- 15 -
concerning the safety, efficacy and labeling of combined honnonal contraceptives. 11 Because
these two directives are in direct conflict, plaintiffs' claims are preempted as a matter oflaw.
In Colacicco, the Third Circuit recognized the fundamental problem with state court
actions that challenge FDA approval and labeling decisions when Congress sought to assign
exclusive authority over prescription drugs to the FDA:
State standards of care undoubtedly differ from state to state. Absent a
determination that the FDA-approved labeling and the FDA's refusal to require
the warnings suggested by plaintiffs in this case preempt state tort actions, the
manufacturers may be subjected to considerable liability based on varying
standards, with no benclunark that they should follow.
521 F.3d at 267-68; see also Pennsylvania Employees Benefits Trust Fund, 499 F.3d at 251 ("the
purpose of protecting prescription drug users in the FDCA would be frustrated if states were
allowed to interpose consumer fraud laws that pennitted plaintiffs to question the veracity of
statements approved by the FDA.").
Comparing the FDA's regulation ofNuvaRing® with its regulation of the anti-depressant
in Colacicco is instructive regarding the effect ofthose actions on preemption. The facts in this
MDL parallel those in Colacicco, and implied conflict preemption is the result in each. In
Colacicco, the FDA was acutely aware that anti-depressants known as SSRIs potentially posed a
risk of increased suicidality in some patients. Colacicco, 521 F.3d at 269-270. The Agency
reviewed the scientific studies and carefully deliberated on the issue time and again, each time
concluding that stronger suicide warnings were not scientifically justified and did not pennit
label changes on the issue. ld at 269. Because the FDA's actions established federal law that
controlled how the drug had to be labeled, the Third Circuit concluded that those FDA drug-
11 See Riegel, 129 S. Ct. at 1007-1008 ("[C]ommon-law liability is premised on the existence of
a legal duty, and a tort judgment therefore establishes that the defendant has violated a state-law
obligation." (internal quotation marks omitted)).
- 16-
labeling requirements preempted tort claims that sought to impose liability on the manufacturer
despite its compliance with federal law. Id at 267, 269.. 12 Just as the FDAwas aware ofthe
potential suicide risk with SSRI, so too was the FDA aware ofthe potential VTE risk with
combined hormonal contraceptives, including NuvaRing®. Just as the FDA carefully (and
repeatedly) weighed the scientific data regarding SSRIs and instructed the manufacturer about
the language it had to include on the drug label, so too did the FDA carefully (and repeatedly)
weigh the scientific data regarding VTEs and instructed defendants about the language to be
included on the NuvaRing® label.
Notably, the Third Circuit based its decision in Colacieco, in part, on the FDA's
awareness and detailed scrutiny of safety risks and its control over whether and how the
prescription product label would warn about those potential risks. Id at 269. In Brooks, an en
bane panel of the Eighth Circuit employed this same rationale in upholding express preemption
involving a prescription medical device. Brooks, 273 F.3d at 796-98 (failure to warn claim
preempted where FDA had authority and responsibility to mandate prescription device warnings,
the FDA knew of alleged safety issue and mandated warning language).
In Brooks, the FDA "heavily regulated" a bone cement known as Simplex, through the
NDA process for prescription drugs, evaluating all scientific data and reviewing the label "word
for word." Id at 788. After an amendment to the FDCA granted the FDA regulatory authority
over medical devices, Simplex was reclassified from a drug to a device although the Agency's
12 The Third Circuit has rejected the contention that the FDA must "formally" deny a drug
manufacturer's request to add the specific contested warning in order for preemption to result.
Colacicco, 521 F.3d at 272 (rejecting the "notion that, in order to rise to the level ofa conflict in
this situation, the FDA's rejection ofa warning must be imbued with the formality proposed by
plaintiffs."). Federal law results when an agency acts with '''fairness and deliberation' which
would suggest that Congress intended the agency's action to be a binding and exclusive
application of federal law." See Fellner v. TriUnion, 539 F.3d 237, 245 (3rd Cir. 2008).
- 17 -
regulatory activity remained constant. Id at 789. Upon learning of information suggesting a risk
posed from vapors from Simplex, the FDA mandated warnings about that risk, and mandated
additional changes to the label language as the data warranted. Id. at 789-90. The Eighth Circuit
thus concluded that tort claims that depended on a duty to give warnings different from what the
FDA required were preempted:
The failure to warn claim asserted by [plaintifl] would interfere or
conflict with the specific federal requirements imposed during the
regulation of Simplex. A jury finding of negligent failure to warn
would be premised on the fact that the label for Simplex was not
written in a particular way or did not contain certain information.
This would be equivalent to a state regulation imposing specific
label requirements.
****
The effect of a jury finding of negligent failure to warn would be
that state law would require Howmedica to change the label and
package insert for Simplex, but Howmedica may not unilaterally
make such changes under federal law.
Id at 796.
The Brooks decision makes clear that in the Eighth Circuit, as in the Third, a conflict
between what the FDA requires and what a plaintiff's tort claims necessarily demand results in
preemption - regardless of whether a drug or device is at issue. See Ehlis, 233 F. Supp. 2d at
1198 (in holding that preemption barred product liability claim over prescription ADHD drug,
the district court stated "plaintiffs' claims in this case mirror those brought by Brooks, and
although plaintiffs in oral argument attempted to distinguish the FDA from the MDA, the court is
not convinced that preemption would not apply in this case").
- 18 -
This conclusion is buttressed by the FDA's own position on the preemptive effect ofits
labeling mandates - one deserving ofdeference from the courts. 13 In the January 2006 new drug
labeling rules, the FDA reiterated its longstanding view that lawsuits seeking to impose duties in
conflict with FDA requirements, as these cases do, obstruct the Agency's ability to ensure that
prescribing physicians receive accurate and helpful information about the proper use of
prescription drugs:
FDA believes that under existing preemption principles, FDA approval of
labeling under the act, whether it be in the old or new format, preempts
conflicting or contrary state law. The discussion that follows, therefore,
represents the government's long standing views on preemption, with a particular
emphasis on how that doctrine applies to State laws that would require labeling
that conflicts with or is contrary to FDA-approved labeling.
71 Fed. Reg. 3934 (Jan. 24, 2006) (codified at 21 C.F.R. §§ 201.56-201.58, 201.80, 201.100,
314.70,601.12).
Here, in particular, the FDA's safety and efficacy determination for NuvaRing® and its
substantive input into the NuvaRing® labeling was informed by decades ofexperience with
hormonal contraceptives. Both before and after approval ofNuvaRing®, the FDA took
deliberate positions concerning the VTE risks associated with NuvaRing®, and other combined
hormonal contraceptives, that had the force of federal law and dictated what the label had to say
13 It is well-settled that an agency's interpretation ofits own regulations is entitled to substantial
deference and that a court can reject the agency's stated position only if it is "plainly erroneous
or inconsistent with the regulation." Auer v. Robbins, 519 U.S. 452,461 (1997) (quoting
Robertson v. Methow Valley Citizens Council, 490 U.S. 332, 359 (1989»; see also Geier, 529
U.S. at 883 (deference to agency determination of preemptive effect of its regulations). Such
deference is appropriate here because the FDA "is uniquely qualified to determine whether a
particular form of state law stands as an obstacle to the accomplishment and execution ofthe full
purposes and objectives of Congress and, therefore ... should be preempted." Medtronic v.
Lohr, 518 U.S. 470, 496 (1996) (citations and internal quotation marks omitted) (preemption
under the Medical Device Amendments).
-19 -
with no discretion left to the manufacturer. The FDA's oversight and regulation thus extended to
the very risks now at issue in this litigation and that places this case squarely within the ambit of
Colacicco, Brooks, and Ehlis. The manifest conflict between the FDA's federal requirements for
NuvaRing® and the standards plaintiffs demand in this litigation leads to the same result:
application ofpreemption and dismissal ofthe lawsuits.
2. Plaintiffs' Claims Are Preempted Because They Obstruct the Objectives and
Purposes ofthe.FDCA and Its Implementation by the FDA
Plaintiffs' lawsuits are subject to implied preemption for an additional reason as well: "it
is now established that lawsuits based on state tort law, as well as on state statutes, may be
viewed as presenting obstacles to federal objectives and hence barred as preempted." Colacicco,
521 F.3d at 267; see also id at 276 (commenting that "[w]e are not scientists and we do not
purport to have any expertise on [the alleged drug risk]. That is within the FDA's authority.").
For prescription drugs like NuvaRing®, Congress's objective in passing the FDCA was
to assign "comprehensive scientific evaluation ofthe product's risks and benefits" exclusively to
the FDA. 71 Fed. Reg. 3934; see also Brief for the United States as Amicus Curiae, Wyeth v.
Levine, No. 06-1249, at 7 (Dec. 2007) (contrary tort claims are "implied[ly] preempted by the
FDCA because they challenge labeling that FDA approved after being informed ofthe relevant
health risk, based on its expert weighing ofthe risks and benefits ofrequiring additional or
different warnings."). As Colacicco concluded, tort litigation poses a distinct obstacle to that
federal objective, and implied conflict preemption again is the result.
For example, plaintiffs' design defect claims essentially allege that NuvaRing® should
not have been marketed at all despite the FDA's determination that NuvaRing® was safe and
effective for marketing. Plaintiffs' label-based claims allege that the label language the FDA
mandated was inadequate. But through the FDCA, Congress established a drug approval regime
- 20-
in which an expert scientific agency makes uniform, national judgments about the safety and
effectiveness of prescription drugs by balancing therapeutic benefits against safety risks ex ante,
taking into account the interests ofall potential patients. FDA struck precisely that type of
balance in approving NuvaRing® after reviewing data regarding potential thromboembolic
issues, and in mandating the specific label language it did.
As the FDA has explained, claims demanding the withdrawal ofan FDA-approved
medication (on pain oftort liability), or advocating warnings that conflict with FDA standards,
interfere with the agency's intricate and intensive regulation ofprescription drug labeling, and
interfere with purposes behind the federal regulatory scheme in several ways:
• "State law requirements can undermine safe and effective use." 71 Fed. Reg.
3922,3935.
• "State law attempts to impose additional warnings can lead to labeling that does
not accurately portray a product's risks, thereby potentially discouraging safe and
effective use of approved products or encouraging inappropriate use and
undermining the objections ofthe [FDCA]." Id
• "State law actions ... threaten FDA's statutorily prescribed role as the expert
Federal agency responsible for evaluating and regulating drugs." Id
• "State actions are not characterized by centralized expert evaluation ofdrug
regulatory issues. Instead, they encourage, and in fact require, lay juries to
second-guess the assessment ofbenefits versus risks ofa specific drug to the
general public... That individualized reevaluation ofthe benefits and risks ofa
product can result in relief- including the threat ofsignificant damages awards or
penalties - that creates pressure on manufacturers to attempt to add warnings that
the FDA has neither approved nor found to be scientifically required." Id
This sort ofinterference too triggers implied preemption principles. In Longs v. Wyeth,
536 F. Supp. 2d 843, 847 (N.D. Ohio 2008), for example, the court concluded that implied
preemption barred plaintiff's product liability contention that the FDA should not have approved
prescription diet drug, because the drug was defectively designed. The court concluded that such
a claim "directly conflicts with the FDA's authority to determine which drugs are sufficiently
- 21 -
safe and effective to be marketed." ld The court noted "although plaintiff asserts that she
alleges only that [Wyeth] should not have marketed Redux, and that she does not argue that the
FDA did anything wrong, the court finds that her claim that Redux should never have been
placed on the market interferes with the FDA's objectives." ld
As in Longs, plaintiffs here likewise contend that the FDA never should have approved
NuvaRing®, and that it should not be sold to patients because third generation oral
contraceptives are unsafe. But a jury cannot reach this conclusion without fundamentally
interfering with the regulatory scheme established by Congress, and its delegation ofexclusive
authority to the FDA to decide which drugs are sufficiently safe and effective to be sold. This
unquestionable interference with federal objectives requires dismissal on preemption grounds.
B. Plaintiffs Cannot Avoid Preemption By Arguing Defendants Misled The FDA,
Because Such Claims Also Are Preempted
Apparently anticipating this preemption motion, some plaintiffs have sought to avoid it
by alleging that defendants misled the FDA in securing and maintaining approval for the
NuvaRing® NDA.14 Confronting similar allegations (brought directly as claims for "fraud on
the FDA"), the Supreme Court concluded such claims are preempted. In Buckman Co. v.
Plaintiffs'Legal Committee, 531 U.S. 341,343 (2001), the plaintiffs contended that the
defendant company ""made fraudulent representations to the [FDA] in the course ofobtaining
approval to market [bone] screws." The plaintiffs further claimed that "[h]ad the representations
14 See Jenn First Amended Complaint, ~ 47 ("Defendants failed to provide proper and full
information as to the safety ofthe NuvaRing to the U.S. Food and Drug Administration, which
regulates the sale ofthe NuvaRing."); Mecca (Blau Brown) Complaint, ~ 25 ("Defendants failed
to provide proper and full information as to the safety ofthe NuvaRing to the U.S. Food and
Drug Administration, which regulates the sale ofthe NuvaRing.").
- 22-
not been made, the FDA would not have approved the devices, and plaintiffs would not have
been injured." Id. The court held "such claims are pre-empted by the Federal Food Drug and
Cosmetic Act." Id (citations omitted).
The Buckman Court noted that the FDCA creates a comprehensive regulatory scheme and
confers upon the FDA power to police the behavior ofregulated entities, including fraud
committed on the agency. Id at 348. The Court thus reasoned that permitting state courts to
adjudicate whether the FDA was defrauded or its rules complied with would "inevitably conflict
with the FDA's responsibility to police fraud consistently with the [FDA's] judgment and
objectives." Id. at 350. Therefore, allowing ajury to determine, under state law, whether a
company withheld material information from FDA would "cause applicants to fear that their
disclosures to the FDA, although deemed appropriate by the Administration, will later be judged
insufficient in state court. Applicants would then have an incentive to submit a deluge of
information that the Agency neither wants nor needs." Id at 351.
Consistent with Buclanan's reasoning, the Third Circuit held that claims alleging that a
manufacturer withheld or manipulated data presented to the FDA "border on" claims for fraud on
the FDA and "should be brought before the FDA." Colacicco, 521 F.3d at 272; see also Garcia
v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004) (holding that federal law preempts any effort
to assess fraud on the FDA except where the FDA itselfhas found such fraud); O'Neal, 551 F.
Supp. 2d at 996 (same); In Re Aredia and Zometa Products Liability Litigation, 2008 WL
913087 (M.D. Tenn. April 2, 2008) (implied preemption barred plaintiffs effort to prove up
"fraud on the FDA" exception to Michigan's FDA regulatory compliance defense). Further, the
FDA's continued monitoring of a particular risk and approval of a drug after all ofthe allegedly
"withheld" or "manipulated" information is before the agency, lays to rest any claim that an
- 23 -
earlier or more prominent presentation ofthe information would have made any difference in
FDA rejection ofthe need for a warning. Colacicco, 521 F.3d at 273-274.15
V CONCLUSION
NuvaRing® received regulatory approval after the FDA's expert evaluation, conducted
with an acknowledged awareness ofthe alleged risks plaintiffs raise as the basis for their tort
claims. It is difficult to imagine a more direct conflict with the FDA's regulatory authority than
tort claims that would contravene the very efficacy and labeling decisions FDA has made
principle ofimplied preemption are intended to foreclose that result. Defendants therefore
respectfully request that the Court dismiss, with prejudice, each and every claim for failure to
warn; strict liability design defect; fraud and misrepresentation; breach of express and implied
warranty; manufacturing defect; and violation ofstate consumer protection laws because they are
preempted by federal law.
IS The Supreme Court's decision in Warner-Lambert Co., LLC v. Kent, 128 S. Ct. 1168 (2008)
has no precedential value and thus does not affect the validity of Colacicco or Garcia.
- 24-
DATED: November 4, 2008
Respectfully submitted,
REED SMITH LLP
/s/ Melissa A. Geist
Melissa A. Geist
REED SMITH LLP
Princeton Forrestal Village
136 Main Street
Suite 250
Princeton, NJ 08540
(609) 987 0050
Barbara R. Binis
REED SMITH LLP
2500 One Liberty Place
1650 Market Street
Philadelphia, PA 19103-7301
(215) 851-8100
Sonja S. Weissman
REED SMITH LLP
1999 Harrison Street
Suite 2400
Oakland, CA 94612-3572
(510) 763 2000
Lisa M. Baird
REED SMITH LLP
355 South Grand Avenue
Suite 2900
Los Angeles, CA 90071
(213) 457-8000
Counsellor Defendants Organon USA, Inc.,
Organon Pharmaceuticals USA, Inc. LLC (f/k/a
Organon Pharmaceuticals USA, Inc.), Organon
International, Inc. andSchering-Plough
Corporation
- 25-
CERTIFICATE OF SERVICE
I hereby certify that on this 4th day ofNovember, 2008, I caused the foregoing to be
presented to the Clerk ofCourt for filing and uploading to the CMlECF system, which will send
notification ofsuch filing to all counsel who registered with the CMlECF system consistent with
the Court's order.
lsi Melissa A. Geist
Melissa A. Geist
- 26-
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
(St. Louis)
IN RE NUVARING PRODUCTS LIABILITY : 4:08 MDL 1964 RWS
LITIGATION
ALL CASES
Honorable Rodney W. Sippel
ATTACHMENT
SEPARATE STATEMENT OF UNCONTROVERTED MATERIAL FACTS IN
SUPPORT OF MEMORANDUM OF LAW IN SUPPORT OF DEFENDANTS'
MOTION FOR SUMMARY JUDGMENT BASED ON THE DEFENSE OF FEDERAL
PREEMPTION
STATEMENT OF UNCONTROVERTED MATERIAL FACTS
PER LOCAL RULE 7-4.01(E)
1. Organon submitted the NuvaRing® NDA (No. 21-187) on December 28, 1999.
• Declaration ofTitia M. T. Mulders ("Mulders DecL '" ExhibitA (transmittal letter
dated Dec. 28, 1999 submitting NuvaRing® NDA, application No. 21-187, to the
FDA).
2. In it, Organon provided the results of"two large Phase 3 studies" (Study 068003 and
Study 034219) regarding the "contraceptive efficacy, vaginal bleeding patters, and safety ofthe
NuvaRing regimen", as well as other studies including those comparing NuvaRing® with
second-generation oral contraceptives and thromboembolic events reported during the studies.
These studies provided information on contraceptive efficacy and cycle control, risk ofserious
adverse events including VTE, lipid and carbohydrate metabolism, coagulation and fibrinolysis
(the body's clotting and clot dissolving mechanism), and pharmacokinetic effects with
NuvaRing®.
• Mulders DecL, Exhibit B (description ofstudies in FDA Medical Officer's Review,
NDA 21-187, October 6,2000);
• Mulders DecL, ~ 9.
4. The October 6, 2000 FDA Medical Officer's Review stated: "there is a solid database of
safety information" on NuvaRing®, "[t]he agency goal ofa total ofat least 10,000 evaluable
cycles was easily achieved" (the two large clinical studies alone provided over 23,000 cycles of
safety data), and "there were no major changes ofconcern in the hemostasis [blood clotting]
parameters."
• Mulders DecL, Exhibit Bat 3-4,6 (FDA Medical Officer's Review, NDA 21-187,
October 6, 2000).
5. This FDA Medical Officees Review further stated that the FDA's "primary concern
[was] the increased risk ofVTE associated with combination hormonal contraceptives containing
a third-generation progestin, such as the etonogestrel in NuvaRing®."
• Id. at 2.
6. This FDA's Medical Officer's Review stated the Agency would require a warning about
the increased risk ofVTE associated with combined hormonal contraceptives containing third
generation progestins.
• It!. at 2,6,60.
1.A
7. In November 2000, correspondence from the FDA regarding label language about
epidemiology studies ofthird generation oral contraceptives and VTE risks stated: "There is
evidence ofan association between the following conditions and the use of combination
hormonal contraceptives, although additional confrrmatory studies are needed"; "[m]esenteric
thrombosis"; and "[r]etinal thrombosis" and "[c]ombination hormonal contraceptives may
increase the tendency to develop strokes (blockage or rupture ofblood vessels in the brain) and
angina pectoris (chest pain)."
• Mulders Decl., Exhibit C at NDA-0125666, NDA-0125672 (Organon's Point-byPoint
Responses to FDA Labeling Comments ofNovember 22, 2000 and
NuvaRing® Package Insert with FDA Comments).
8. In December 2000, the FDA directed that the NuvaRing® label "include the text that is
required for all desogestrel-containing DCs regarding an approximate 2-fold increased risk of
VTE with third generation OCs compared with certain second generation Des." The FDA noted
that "[t]he potential increased incidence ofvenous thromboembolism (VTE) associated with
third generation OCs, including those containing desogestrel ... remains [the] major safety
concern. No safety data exists on long-term use (>13) cycles ofNuvaRing®)."
• Mulders Decl., Ex/dbit Eat 5, 2, respectively (December 18, 2000Addendum to
Original Medical Officer's Review).
9. In December 2000, the FDA directed that the NuvaRing® label should include a
statement that "it is unknown whether NuvaRing® is distinct from combination oral
contraceptives" when comparing the risk ofNuvaRing to other combined hormonal
contraceptives.
• Mulders DecL, Exhibit E at 7.
10. The FDA specified that "[t]he Final Printed Label (FPL) should reflect the increased risk
ofvenous thromboembolism (VTE) associated with combination hormonal contraceptives
containing a 'third-generation progestin' such as desogestrel."
• Mulders DecL, Exhibit Eat 7.
11. On October 3,2001, the FDA approved the NuvaRing® NDA.
• Mulders DecL, ExhibitD (FDA's October 3, 2001 Approval Letter andFinal
Printed Labeling);
• Affidavit ofMelissa A. Geist ("Geist Aff.'" Exhibit A at 1 (October 22, 2008 letter
from Blau Bown &#038; Leonard LLC).
2.A
12. Organon incorporated the FDA's ultimate directives regarding label language into the
fmal version ofthe printed label, including the FDA-specified language about studies showing a
two-fold risk, contraindications for women at higher risk for thromboembolism; warnings about
thromboembolism and stroke; and adverse reactions including thromboembolism, stroke, VTE,
and arterial thromboembolism.
• Mulders DecL, Exhibit D.
13. By email dated July 20, 2005, the FDA approved changes to the Contraindications
section of the NuvaRing® label regarding thromboembolism, along with changes to the Patient
Information section regarding the risk ofcigarette smoking and stroke.
• Mulders DecL, Exhibit Fat NDA-0129785, NDA-0129823.
14. The FDA approved changes to the NuvaRing® label, proposed by Organon in March
2007, including changes to the "Warnings" section ofthe physician labeling regarding arterial
thromboembolic events, hypertension and risk of stroke.
• Affidavit ofJune Bray (1lBray Aff. '" ~ 13 &#038; ExhibitA (March 30, 2007 letterfrom
Organon to FDA).
15. The FDA also approved changes to the NuvaRing® patient labeling, including regarding
use ofNuvaRing® prior to surgery because ofthe potential risk of blood clots.
• Id.
16. At no time has the FDA ever found or declared the NuvaRing® label to be out of
conformance with the FDA labeling requirements, and at no time has the FDA ever withdrawn
approval for NuvaRing®.
• Mulders Decl., ~ 25.
3.A</pre>]]></content:encoded>
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		<title>Nuva ring problems &#124; Nuvaring lawyer</title>
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		<pubDate>Sat, 24 Jan 2009 21:06:55 +0000</pubDate>
		<dc:creator>Steve Fields</dc:creator>
				<category><![CDATA[Nuvaring Litigation]]></category>

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			<content:encoded><![CDATA[We represent all women suffering from <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawyer/" target="_self">Nuva ring problems</a></strong> on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at <strong>1-888-343-5375</strong> or fill out our short online contact form and a <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawyer/" target="_self">Nuvaring lawyer</a></strong> will contact you to answer any of your questions.

The plaintiffs involved with Nuvaring litigation have claimed causes of action including failure to warn; strict liability design defect; fraud and misrepresentation; breach of warranty; manufacturing defect and violation of consumer protection laws.

The Nuvaring manufacturer, Organon Pharmaceuticals USA, has argued that claims of women who have suffered from serious side effects like blood clots are preempted because Nuvaring birth control was approved by the FDA.

Click here for the .pdf of the original document: <strong><a href="http://www.birthcontrolringlawsuitcenter.com/wp-content/uploads/2008/12/defendant-motion-76-081107-111m.pdf" target="_blank"><span style="color: #0000ff;">Defendant&#8217;s Summary Judgment Motion</span></a></strong>.

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		<pubDate>Sat, 17 Jan 2009 18:46:48 +0000</pubDate>
		<dc:creator>Steve Fields</dc:creator>
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			<content:encoded><![CDATA[We represent all <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawyer/" target="_self">Nuvaring litigation</a></strong> clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at <strong>1-888-343-5375</strong> or fill out our short online contact form and a <strong><a href="http://www.birthcontrolringlawsuitcenter.com/" target="_self">Nuva ring side effects</a></strong> lawyer will contact you to answer any of your questions.

Click here for the .pdf of the original document: <strong><a href="http://www.birthcontrolringlawsuitcenter.com/wp-content/uploads/2008/12/doc-54-case-management-order-1-filed-11-01-08.pdf" target="_blank"><span style="color: #0000ff;">Case Management Order</span></a></strong>.

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<p style="text-align: center;"><span style="color: #ff0000;">Case 4:08-md-01964-RWS Document 54 Filed 11/07/2008 Page 1 of 2</span></p>

<p style="text-align: center;">UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
EASTERN DIVISION

 

IN RE NUVARING PRODUCTS                           ) 4:08MD1964 RWS
LIABILITY LITIGATION                                           )
                                                                                   ) ALL CASES
<p style="text-align: center;"><strong><span style="text-decoration: underline;">CASE MANAGEMENT ORDER No. 1</span></strong></p>

IT IS HEREBY ORDERED that Defendant&#8217;s motion for an order requiring Plaintiffs to file a master consolidated complaint [#37] is GRANTED by consent. Plaintiffs shall file a master consolidated brief no later than February 6, 2009.

IT IS FURTHER ORDERED that Plaintiffs shall provide Defendants with a completed and notarized Plaintiff&#8217;s Fact Sheet no later than January 6, 2009 for each case that has been transferred to this MDL Court on or before today&#8217;s date. For all future cases transferred to this Court, Plaintiffs shall provide Defendants with a completed and notarized Plaintiff&#8217;s Fact Sheet for each case within 75 days after Defendants have filed an answer in that case.

IT IS FURTHER ORDERED that Defendants shall provide to Plaintiffs June Bray&#8217;s documents no later than December 8, 2008. Defendants shall produce the documents of Rob Kaper, Phil Deming, and Ed Baker on a rolling basis no later than February 4, 2009.

IT IS FURTHER ORDERED that Plaintiffs shall file a response to Defendants&#8217; Lone Pine motion no later than January 23, 2009. Defendants&#8217; reply brief shall be filed no later than February 6, 2009. Plaintiffs shall file a response to Defendants&#8217; motion for a qualified protection order and motion requiring the submission of document preservation notices no later than December 5, 2008. Defendants&#8217; reply brief shall be filed no later than December 17, 2008.

IT IS FURTHER ORDERED that Defendants&#8217; motion to stay discovery [#44] is DENIED.
Case 4:08-md-01964-RWS Document 54 Filed 11/07/2008 Page 2 of 2

IT IS FURTHER ORDERED that a teleconference is set on November 19, 2008 at
10:00 a.m. Plaintiffs&#8217; counsel shall initiate the call and have all parties on the line before contacting the my chambers at 314-244-7430.

IT IS FURTHER ORDERED that a hearing of all fully briefed motions shall be heard on February 19, 2009 at 10:00 a.m. in Courtroom 10 South. Counsel who wish to monitor the hearing, and any future courtroom proceedings, may do so on a teleconference call to be initiated by the Court (an order will follow providing the teleconference number). Counsel who participate by teleconference may only monitor the hearing. If any counsel wants to actively participate in a courtroom proceeding they must appear in person at the court.

Dated this 7th day of November, 2008.
-2­

If you or a loved one has experienced <strong>Nuva ring side effects</strong> including <strong>DVT</strong>, <strong>pulmonary embolism</strong> or <strong>stroke</strong> please call or e-mail us to find out your legal options. We offer a free no-obligation consultation from Nuvaring attorneys who can give you the latest updates on Nuvaring litigation and claims filing deadlines.

We are currently representing women affected by <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-report-problem/" target="_self">Nuva ring issues</a></strong> nationwide.]]></content:encoded>
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		<title>Nuvaring Lawsuits &#124; Nuva Ring Dangers</title>
		<link>http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawsuits-nuva-ring-dangers/</link>
		<comments>http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawsuits-nuva-ring-dangers/#comments</comments>
		<pubDate>Sat, 10 Jan 2009 18:46:21 +0000</pubDate>
		<dc:creator>Steve Fields</dc:creator>
				<category><![CDATA[Nuvaring Litigation]]></category>

		<guid isPermaLink="false">http://www.nuvaringsideeffects.com/?p=461</guid>
		<description><![CDATA[We represent all Nuvaring lawsuits clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Nuvaring lawyer will contact you to answer any [...]]]></description>
			<content:encoded><![CDATA[We represent all <strong><a href="http://www.birthcontrolringlawsuitcenter.com/" target="_self">Nuvaring lawsuits</a></strong> clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at <strong>1-888-343-5375</strong> or fill out our short online contact form and a <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawyer/" target="_blank">Nuvaring lawyer</a></strong> will contact you to answer any of your questions.

Click here for the .pdf of the original document: <strong><a href="http://www.birthcontrolringlawsuitcenter.com/wp-content/uploads/2008/12/doc-21-rule-16-order-filed-100308.pdf" target="_blank"><span style="color: #0000ff;">Rule 16 Order</span></a></strong>.

If you do not have Adobe Acrobat Reader you can get a free copy <strong><a href="http://get.adobe.com/reader/" target="_blank"><span style="color: #0000ff;">here</span></a></strong>.
<p style="text-align: center;">UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
EASTERN DIVISION

IN RE NUVARING PRODUCTS                   ) 4:08MD1964 RWS
LIABILITY LITIGATION                                   )
                                                                           ) ALL CASES
<p style="text-align: center;"><strong><span style="text-decoration: underline;">ORDER SETTING RULE 16 CONFERENCE</span></strong></p>

IT IS HEREBY ORDERED that:

1. Scheduling Conference: A Scheduling Conference pursuant to Fed.R.Civ.P. 16 is set for Thursday, November 6, 2008, at 10:00 a.m. in Courtroom 10 South. At the scheduling conference counsel will be expected to discuss in detail all matters covered by Fed.R.Civ.P. 16, as well as all matters set forth in their joint proposed scheduling plan described in paragraph 3.

2. Meeting of Counsel: Prior to the date for submission of the joint proposed scheduling plan set forth in paragraph 3 below, counsel for the parties shall meet to discuss the following: a) identifying generally the common facts and issues, arising out of both claims and defenses,
to be addressed in discovery in this MDL, b) any issues relating to preservation of discoverable information, c) any issues relating to disclosure or discovery of electronically stored information, including-
(i)
the form or forms in which it should be produced,

(ii)
the topics for such discovery and the time period for which such discovery will be sought,
(iii) the various sources of such information within a party&#8217;s control that should be searched for electronically stored information, and
(iv) whether the information is reasonably accessible to the party that has it, in terms
of the burden and cost of retrieving and reviewing the information,
d) any issues relating to claims of privilege or of protection as trial-preparation material,
including &#8211; if the parties agree on a procedure to assert such claims after production &#8211; whether
to ask the Court to include their agreement in an order,
e) an agreed upon proposed protective order to be filed with the Court by October 14, 2008 (if
an agreement cannot be reached the parties shall each submit a proposed protective order and
the Court will select one),
f) the time frame for document production and completion,
g) the resolution of issues relating to Plaintiffs&#8217; fact sheets and the timing of responses,
h) whether Defendants should utilize a fact sheet,
i) whether Plaintiffs should be permitted to propound more that 75 interrogatories,
j) the best way to identify the claims common to all Plaintiffs (master/uniform pleadings?),
k) general schedule for depositions of fact and expert witnesses,
l) Plaintiffs&#8217; duty to preserve medical raw data and test data for each Plaintiff,
m) ex parte contacts, in the ordinary course of business and otherwise, by Defendants with
Plaintiffs&#8217; prescribing physicians,
n) opportunity and timing of referral to alternative dispute resolution,
o) whether an overview to the Court of the science behind the claims and defenses is
appropriate,
p) other topics listed below or in Fed.R.Civ.P. 16 and 26(f).

Counsel will be asked to report orally on the matters discussed at this meeting when they appear before the undersigned for the scheduling conference, and will specifically be asked to report on the potential for settlement; whether settlement demands or offers have been exchanged, without
revealing the content of any offers or demands; and, suitability for Alternative Dispute Resolution. This meeting is expected to result in the parties reaching agreement on the form and content of a joint proposed scheduling plan as described in paragraph 3 below.
Only one proposed scheduling plan may be submitted in any case, and it must be signed by counsel for all parties. It will be the responsibility of counsel for the plaintiff to actually submit the joint proposed scheduling plan to the Court. If the parties cannot agree as to any matter required to be contained in the joint plan, the disagreement must be set out clearly in the joint proposal, and the Court will resolve the dispute at or shortly after the scheduling conference.

3. Joint Proposed Scheduling Plan: No later than October 30, 2008, counsel shall file with the Clerk of the Court a joint proposed scheduling plan. All dates required to be set forth in the plan shall be within the ranges set forth below for the applicable track:
Track 1: Expedited Track 2: Standard Track 3: Complex *Disposition w/i 12 mos of filing *Disposition w/i 18 mos of filing *Disposition w/i 24 mos of filing *120 days for discovery *180-240 days from R16 Conf. for *240-360 days from R16 Conf
discovery/dispositive motions for discovery/dispositive motions
The parties&#8217; joint proposed scheduling plan shall include:
(a)
whether the Track Assignment is appropriate; NOTE: This case has been assigned to Track 2: ( Standard ).

(b)
dates for joinder of additional parties or amendment of pleadings;

(c)
a discovery plan including:

 

(i)
any agreed-upon provisions for disclosure or discovery of electronically stored information,
(ii) any agreements the parties reach for asserting claims of privilege or of protection
as trial-preparation material after production,
(iii) a date or dates by which the parties will disclose information and exchange documents pursuant to Fed.R.Civ.P. 26(a)(1),
(iv) whether discovery should be conducted in phases or limited to certain issues,
(v)
dates by which each party shall disclose its expert witnesses&#8217; identities and reports, and dates by which each party shall make its expert witnesses available for deposition, giving consideration to whether serial or simultaneous disclosure is appropriate in the case,

(vi)
whether the presumptive limits of ten (10) depositions per side as set forth in Fed.R.Civ.P. 30(a)(2)(A), and twenty-five (25) interrogatories per party as set forth in Fed.R.Civ.P. 33(a), should apply in this case, and if not, the reasons for the variance from the rules,
(vii) whether any physical or mental examinations of parties will be requested pursuant to Fed.R.Civ.P. 35, and if so, by what date that request will be made and the date the examination will be completed,
(viii) a date by which all discovery will be completed (see applicable track range, Section 3. above);
(ix) any other matters pertinent to the completion of discovery in this case,
(d)
the parties&#8217; positions concerning the referral of the action to mediation or early neutral evaluation, and when such a referral would be most productive;

(e)
dates for filing any motions to dismiss or motions for summary judgment (see applicable track range, Section 3. above);
(F) any other matters counsel deem appropriate for inclusion in the Joint Scheduling Plan.

4. Disclosure of Corporate Interests: All non-governmental corporate parties are reminded to comply with Disclosure of Corporate Interests by filing a Certificate of Interest with the Court pursuant to E.D.Mo. L.R. 2.09.

Dated this 3rd day of October, 2008.

 

If you or a loved one has experienced <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawyer/" target="_self">Nuvaring side effects</a></strong> including DVT, <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-side-effects/" target="_self">pulmonary embolism</a></strong> or <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuva-ring-stroke-lawyer/" target="_self">stroke</a></strong> please call or e-mail us to find out your legal options. We offer a free no-obligation consultation from a Nuvaring attorney who can give you the latest updates on Nuvaring lawsuits and claims filing deadlines.

We are currently representing women affected by Nuvaring problems nationwide.]]></content:encoded>
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		<title>Nuvaring Lawsuit &#124; Nuva Ring Lawyer</title>
		<link>http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawsuit-nuva-ring-lawyer/</link>
		<comments>http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawsuit-nuva-ring-lawyer/#comments</comments>
		<pubDate>Fri, 02 Jan 2009 18:45:27 +0000</pubDate>
		<dc:creator>Steve Fields</dc:creator>
				<category><![CDATA[Nuvaring Litigation]]></category>

		<guid isPermaLink="false">http://www.nuvaringsideeffects.com/?p=449</guid>
		<description><![CDATA[We represent all Nuvaring lawsuit clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Nuva ring lawyer will contact you to answer [...]]]></description>
			<content:encoded><![CDATA[We represent all <strong><a href="http://www.birthcontrolringlawsuitcenter.com/" target="_self">Nuvaring lawsuit</a></strong> clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at <strong>1-888-343-5375</strong> or fill out our short online contact form and a Nuva ring lawyer will contact you to answer any of your questions.

Click here for the .pdf of the original document: <strong><a href="http://www.birthcontrolringlawsuitcenter.com/wp-content/uploads/2008/12/doc-7-order-upon-transfer-filed-082708.pdf" target="_blank"><span style="color: #0000ff;">Transfer Order</span></a></strong>.

If you do not have Adobe Acrobat Reader you can get a free copy <strong><a href="http://get.adobe.com/reader/" target="_blank"><span style="color: #0000ff;">here</span></a></strong>.

 
<p style="text-align: center;"><span style="color: #ff0000;">Case 4:08-md-01964-RWS Document 7 Filed 08/27/2008 Page 1 of 2</span></p>

<p style="text-align: center;">UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
EASTERN DIVISION

IN RE NUVARING PRODUCTS   )                                   4:08MD1964 RWS
LIABILITY LITIGATION                   )
                                                           )                                   ALL CASES
<p style="text-align: center;"><strong><span style="text-decoration: underline;">ORDER UPON TRANSFER</span></strong></p>

1.
This order shall govern the practice and procedure in those actions transferred to this Court by the Judicial Panel on Multidistrict Litigation pursuant to their order of August 22, 2008, as well as all related actions originally filed in this Court or transferred or removed to this Court. These actions are listed in Schedule A attached hereto. This order shall also govern the practice and procedure in any tag-along actions transferred to this Court by the Judicial Panel on Multidistrict Litigation and to any related actions subsequently filed in this Court or otherwise transferred or removed to this Court.

2.
The actions described in paragraph 1 of this order are coordinated for pretrial purposes.

3.
This case will use the Court&#8217;s Electronic Case Filing (&#8221;ECF&#8221;) system. All counsel shall register forthwith as an ECF User in this Court and be issued an ECF User ID and password. Forms and instructions can be found on the Court&#8217;s Web site at www.moed.uscourts.gov. All pleadings and papers shall be filed electronically using the Court&#8217;s ECF system.

4.
The Clerk of Court shall issue a new case number to each case transferred to the this Court by order of the MDL Panel. All documents shall be filed only in the main case number 4:08MD1964 RWS. Nothing shall be filed in any of the individual case files. All papers filed in these actions shall bear the case identification &#8220;4:08MD1964 RWS,&#8221; and when such papers relate to all these actions, the MDL case number shall be followed by the notation &#8220;ALL CASES.&#8221;

If such papers do not relate to all of these actions, the individual case number assigned by the Clerk of this Court to the action to which the paper relates shall also be listed below the MDL case number.

5.
Any paper which is to be filed in any of these actions shall be filed only in this MDL case and not with the transferor district court.

6.
Counsel who appeared in the transferor district court prior to the transfer need not enter a separate appearance before this Court. Moreover, attorneys admitted to practice and in
Case 4:08-md-01964-RWS Document 7 Filed 08/27/2008 Page 2 of 2
good standing in any United States District Court are admitted pro hac vice in this litigation, and
the requirements of Eastern District of Missouri Local Rule 12.01 are waived. Association of local counsel is not required.
7.
Prior to the initial case conference service of all papers shall be made on each of the attorneys on the Panel Attorney Service List attached hereto as Schedule B. Any attorney who wishes to have his or her name added to or deleted from such Panel Attorney Service List may do so upon request to the Clerk of this Court, with notice to all other persons on such service list. Service shall be deemed sufficient if made upon all attorneys on the Panel Attorney Service List.

8.
Prior to the initial conference, counsel for the plaintiffs and counsel for defendants shall, to the extent they have not already done so, confer and seek consensus on the selection of a candidate for the position of liaison counsel for each group who will serve as the primary contact person for the Court regarding administrative matters.

Liaison counsel shall be required to maintain complete files with copies of all documents served upon them, and shall make such files available to other parties upon request. Liaison counsel are also authorized to receive orders and notices from the MDL Panel pursuant to Rule 8(e) of the Panel&#8217;s Rules of Procedure on behalf of all parties, and shall be responsible for the preparation and transmittal of copies of such orders and notices to all parties.

9.
Hearings shall not be held on any motions filed except by order of Court upon such notice as the Court may direct.

10.
In accordance with Eastern District of Missouri Local Rule 4.04, attorneys shall only communicate with the Court in writing by motion or memorandum.

11.
Any orders including protective orders previously entered by this Court or any transferor district court shall remain in full force and effect unless modified by this Court upon application.

12.
The Court will be guided by the Manual for Complex Litigation, Fourth, approved by the Judicial Conference of the United States, and counsel are directed to familiarize themselves with that publication.
13. All other matters will be discussed at the initial pretrial conference. An order setting
Dated this 27th day of August, 2008.

-2­
Case 4:08-md-01964-RWS Document 7-2 Filed 08/27/2008 Page 1 of 1
IN RE: NUVARING PRODUCTS LIABILITY LITIGATION MDL No.1964
SCHEDULE A
Northern District of Georgia
Carmita T. Purdiman v. Organon Pharmaceuticals USA, Inc., et al., C.A. No. 2:08-6
Eastern District of Missouri
Sarah M. Jenn v. Organon International, Inc., et al., C.A. No. 4:07-1282
Janice Mitchell-McGuire v. Organon USA, Inc., et al., C.A. No. 4:07-1524
Robin L. Smith v. Organon International, Inc., et al., C.A. No. 4:08-292

District of New Jersey
Brianne Irons, et al. v. Organon USA, Inc., et al., C.A. No. 2:07-2802 Kathi Pieramico v. Organon USA, Inc., et al., C.A. No. 2:07-2803 Stephanie Ferrell Merello v. Organon USA, Inc., et al., C.A. No. 2:07-2874 Kristin Smith, et al. v. Organon USA, Inc., et al., C.A. No. 2:07-2876 Rebecca Winder, et al. v. Organon USA, Inc., et al., C.A. No. 2:07-2877 Laurie Scata, et al. v. Organon USA, Inc., et al., C.A. No. 2:07-2965 Krysti Michelle Zulpo v. Orgaonon USA, Inc., et al., C.A. No. 2:08-1037
Case 4:08-md-01964-RWS SCHEDULE B
Document 7-3 Filed 08/27/2008 Page 1 of 1 Page 1t
Docket: 1964 &#8211; IN RE: NuvaRing Products Liability Litigation Status: Transferred on 08/22/2008 Transferee District: Judge: Sippel, Rodney W.MOE Printed on 08/22/2008
ATTORNEY &#8211; FIRM REPRESENTED PARTY(S)

Akzo Nobel, NV, Velperweg 76 6800 SB Arnhem The Netherlands
Rheingold, Paul D. RHEINGOLD VALET RHEINGOLD SHKOLNIK &amp; MCCARTNEY 113 East 37th Street New York, NY 10016-3042
Weiss, Tracy G. REED SMITH LLP 2500 One Liberty Place 1650 Market Street Philadelphia, PA 19103
=&gt;
Akzo Nobel, NV
=&gt;Phone: (212) 689-1880 Fax: (212) 689-8156 Email: prheingold@rheingoldlaw.com Irons, Brianne*; Jenn, Sarah M.*; Merello, Stephanie Ferrell*; Mitchell-McGuire, Janice*; Moses, Zane*; Pieramico, Kathi*; Purdiman, Carmita T.*; Scata, Joseph*; Scata, Laurie*; Smith, Jarrad*; Smith, Kristin*; Smith, Robin L.*; Winder, Rebecca*; Winder, Todd*; Zulpo, Krysti Michelle*
=&gt;Phone: (215) 851-8100 Fax: (215) 851-1420 Email: tweiss@reedsmith.com
Organon International, Inc.*; Organon Pharmaceuticals USA, Inc.*; Organon USA, Inc.*
Note: Please refer to the report title page for complete report scope and key.

 

 If you or a loved one has experienced <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawyer/" target="_self">Nuvaring blood clot</a></strong> side effects including DVT, pulmonary embolism or stroke please call or e-mail us to find out your legal options. We offer a free no-obligation consultation from a Nuvaring attorney who can give you the latest updates on a <strong><a href="http://www.birthcontrolringlawsuitcenter.com/nuvaring-lawyer/" target="_self">Nuva ring lawsuit</a></strong> and claims filing deadlines.

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