THE PROCESS

We will meet with you and thoroughly investigate your case.  As we mentioned, we will travel to see you, as we want to meet with you in person and review all documents you may have to support your case.  We will then investigate on our own and prepare a complaint for filing in federal court.  The case will be filed under seal, and served on the U.S. Attorney’s Office along with a Declaration of Evidence that is not filed but also served on the Government.

Once the case is filed, a United States Attorney investigates the lawsuit and underlying allegations of fraud for an initial period of 60 days. If after investigating the claim the U.S. Attorney believes the allegations of fraud are meritorious, the United States Government takes over the case and either enters into a settlement or continues the lawsuit against the wrongdoer. The Relator would then be entitled to a portion of the recovery despite the fact that the government has taken over the case.

The amount that the Relator would be entitled to receive would be approximately 15 percent to 25 percent of the decision. It is estimated that the government intervenes and takes over a case approximately 30 percent of the time.

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FREE NATIONWIDE CASE EVALUATIONS: CALL 1-800-632-1404

Our team of attorneys are now investigating claims and prepared to file Mirena lawsuitsinvolving the intrauterine contraceptive device Mirena®. Manufactured by Bayer Healthcare Pharmaceuticals, Inc., Mirena is an IUD device [intrauterine device] that must be inserted by a trained health care provider and is intended to provide contraceptive protection for up to five years. Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of theMirena device, including perforation of or imbedment in the uterus.

Mirena Injuries

Mirena is alleged to have many side effects. Mirena is an interuterine contraceptive device {IUD}. Our team includes Mirena attorneys that want to provide information to women or their loved ones about making a Mirena claim or to discuss a Mirena lawsuit.

Lawsuits can come in two forms.  First, there are claims that can be made when the device itself causes harm to the patient. These claims can include perforation of the uterus, embedding in the uterilne lining, and adhesion or other damage to the body.  Some of our clients have endured unnecessary surgeries, including removal of the device after it became embedded in the peritoneal cavity / abdominal cavity.  An unnecessary surgery could also include a hysterectomy, whether before the patient has decided to have children or afterwards.

There is unfortunately anothere category of claims that can be made surrounding Mirena, and this includes claims of medical malpractice against a physician.  Mirena in our opinion should be implanted either when the patient is postpartum or on their menstral cycle to ensure the patient is not pregnant.  In the event the patient is not in one of these two periods, we believe the standard of care requires a physician to perform a pregnancy test and WAIT for the pregnancy test results before implanting the device.

We are saddened to recieve calls from women across the country after learning they were implanted with a Mirena either (1) without a pregnancy test or (2) without the physician waiting for the pregnancy test results.  The end result, as feared, was the these women were pregnant, and the implantation of the Mirena device resulted in the death of the unborn child.

If you fit any of these descriptions above, we urge you to contact our team of Mirena lawyers at 1-800-632-1404 to discuss, or please fill out a form to the right or below. We stand ready to discuss how we can try and help you.

Side Effects Discussed in More Detail

Some women who have had Mirena implanted experienced serious and even debilitating or life-threatening side-effects. The device may migrate from its original position after being inserted, perforating the uterus or embedding itself in the uterus. In both instances, a doctor must locate and surgically remove the device. Mirena may also migrate outside the uterine cavity and cause adhesions or scarring that can lead to infertility. Depending on the damage caused, affected women may require a complete hysterectomy, and more serious complications could result in death.

Serious side effects that have been linked to Mirena include:

• - Abscesses
• - Embedment in the uterus
• - Erosion of adjacent areas such as the vagina
• - Infertility
• - Inflammation of the membrane that lines the abdominal cavity and internal organs (Peritonitis)
• - Intestinal perforations or obstruction
• - Pelvic Inflammatory Disease
• - Perforation of the uterus

If you experienced adverse Mirena side effects, required surgery or have a loved one who suffered death following the implantation of Mirena, you may have a potentialMirena lawsuit.

No Recovery, No Fee

We take Mirena litigation cases on a contingency basis. That means that there is no cost to you unless we and our co-counsel are able to recover a settlement or judgment on your behalf. So, unless your case is resolved by trial, arbitration, settlement, or other resolution, you do not have to pay any attorney fees to us, or pay any costs. Litigation costs include filing fees, court reporter fees for deposition, copying costs, experts, and travel. Litigation costs are paid by our firm so you don’t have to have cash to pursue justice against medical device corporations.

About us

Our team of attorneys have been retained by clients across the country as to allegedly defective and improperly designed Mirena devices.  In fact, our team of attorneys has represented patients around the globe for the allegedly defective Advanced Bionics HiRes90k cochlear implant device and other medical devices including the DePuy hip implant and the transvaginal mesh and transvaginal sling devices.

As a Mirena attorney, we will investigate your claim and with our co-counsel we stand ready to push your case ahead.

FOR A FREE CASE EVALUATION:

CALL TOLL FREE: (800) 632-1404

EMAIL: clicking here.

FILL OUT THIS FORM FOR FREE HELP:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

• Comments

FOR A FREE CASE EVALUATION, CALL 1-800-632-1404

If you took Actos® (pioglitazone) for a year or longer and have been diagnosed with bladder cancer, call the Actos bladder cancer lawyers with our firm at 1-800-632-1404. Our firm is currently reviewing cases involving persons who took Actos® for control of blood sugar. This includes but is not limited to persons residing in Tennessee, Arkansas, Mississippi or anywhere in the United States.

BLADDER CANCER AND YOU.

Actos® is a pioglitazone drug used to tr eat type 2 diabetes. Pioglitazone is an insulin sensitizer that works by making the tissues more sensitive to the effects of insulin. Bladder Cancer is a potential side effect of Actos®.

One of the more serious side effects of consuming Actos for the treatment of diabetes is baldder cancer. Bladder cancer brings with it a plethora of problems. Regardless of the specific type of the disease, cancer tends to cause certain common symptoms in patients.

Diarrhea

Diarrhea is a disturbing symptom that can cause considerable discomfort and eventually lead to dehydration. As diarrhea typically results from intestinal “bugs,” either bacterial or viral, most patients are instructed to take antidiarrheal medication and increase fluid intake. Any cancer patient who experiences this symptom for more than a day or two, however, should be weighed, because rapid weight loss often signifies dehydration, a condition that may require the administration of intravenous fluids in a hospital.

Patients receiving antibiotics can also develop diarrhea. This type of diarrhea is caused by intestinal bacteria (Clostridium difficile) that proliferate as the balance of benign bacteria is disrupted by the antibiotic. C. difficile diarrhea is treated with antidiarrheal medication, yogurt, and the antibiotic vancomycin.

Diarrhea can also be induced by chemotherapy drugs, especially methotrexate, 5-FU, leucovorin, and adriamycin. Usually developing 10 days after the drugs are initiated, such diarrhea is frequently accompanied by mouth sores.

Depression, Loss of Appetite, and Weight Loss

More than 50% of cancer patients experience depression at some point in the course of illness. Such manifestations as crying, loss of appetite, and social withdrawal are often associated with depression, but an underappreciated symptom of depression is the inability to sleep. Many cancer patients are quite reluctant to admit to depression, believing as they do that the condition is a sign of personal weakness. They must often be helped to understand that depression is an entirely normal and appropriate reaction to a life threatening diagnosis. Two related symptoms that the cancer patient and family find disturbing are reduced appetite and weight loss. It is often assumed, especially in the case of weight loss, that growth of the cancer is the cause. Weight loss among cancer patients is extremely common, however, and the reasons for it are varied. One highly treatable cause that must be considered is depression, particularly when x rays and laboratory tests indicate a good response to treatment. Drugs, too, can contribute to loss of appetite, principally chemotherapy drugs. Narcotic pain medications can also induce nausea and resultant weight loss, thus necessitating a change in drug.

We stand ready to discuss Actos and bladder cancer with you.

MORE ABOUT ACTOS

Actos is a drug used to treat Type 2 diabetes. While the drug is effective, it does have certain side effects, which can include the following:

Pharyngitis

One of the common side effects of Actos is Pharyngitis. Pharyngitis is the inflammation of the pharynx. It is experienced as a sore throat. Pharyngitis can appear suddenly (acute) or it can persist over several months or even years (chronic).

The pharynx provides a vital link between the nose, mouth and the voice box. In doing so it plays a major role in the essential tasks of breathing, eating and speaking. The pharynx is deep lined with muscles and is shaped very roughly like an inverted cone. It extends for about 5 inches behind the arch at the back of the mouth to where it joins the gullet.

Myalgias

Another common side effect of Actos is myalgisa. Myalgisa refers to aching in the muscles. It is common in the upper or lower back and neck areas. It is usually present on both the left and right sides and present as a dull throbbing discomfort.

Sinusitis

Yet another commons side effect of Actos is sinusitis. Sinusitis is inflammation of the mucosal lining of the paranasal sinuses, which leads to stasis, obstruction, and subsequent infection. The sinuses are air-filled bony cavities that produce and drain up to 2 pints of mucus every day. Self-cleaning occurs by movement of the mucus, propelled by cilia, through the ostia, which are located behind the turbinates. Acute sinusitis is a bacterial infection of one or more paranasal sinuses, which occurs when the normal drainage is impaired because of blockage of one or more ostia.

Hypoglycemia 

Some patients who were prescribed Actos for treatment of type 2 diabetes have reported hypoglycemia. Hypoglycemia is the condition in which the level of glucose falls below normal levels affecting the individual’s ability to process information, including interruption in short-term memory, decrements in motor control (weakness), and other autonomic and adrenergic symptoms (e.g., trembling, difficulty concentrating, tiredness, headache, sweating, dry mouth, and hunger).

Serious Complications

Besides the general side effects, Acots can also cause serious medical problems such as bladder cancer and congestive heart failure.

BACKGROUND

Since 1999, Actos® has been prescribed as part of an overall treatment regimen for controlling blood sugar in diabetic patients. In recent years it has also been prescribed as a diabetes preventative in those who show the early signs of the disease. In September 2010, the U.S. Food and Drug Administration (FDA) began a safety review of Actos® when new data was discovered that suggested a link to increased risk of bladder cancer.

The risk of bladder cancer is MUCH HIGHER for those that take the drug at higher cumulative doses and for longer periods of time. This increased risk is also greater in men than in women. The FDA has issued a warning of the elevated risk to patients who have been taking Actos®, but added that patients should not stop taking Actos® unless instructed to do so by their physicians. The active ingredient in Actos® is also contained in other drugs, namely Actoplus Met®, Actoplus Met XR®, and Duetact®.

Although Actos® continues to remain on the shelves of drug stores in the United States, the drug is under a long-term observational study by the FDA. France suspended the drug and Germany recommended not to start new patients on the drug due to mounting concerns for their citizens.

RISK OF BLADDER CANCER

In June of this year the U.S. Food & Drug Administration (FDA) issued a warning about the popular diabetes drug Actos(pioglitazone). The FDA had found that the use of pioglitazone for more than a year may be linked to an increased risk of bladder cancer.

SYMPTOMS OF BLADDER CANCER

Common symptoms of Actos®-related bladder cancer may include:

• ■Blood in urine, sometimes creating a change in urine color
• ■Frequent urination
• ■Painful urination
• ■Urinary tract infection

If you or a loved one developed bladder cancer during or after taking Actos®, Actoplus Met®, Actoplus Met XR®, or Duetact®, call us now at 1-800-632-1404 or SUBMIT A SHORT CASE FORM HERE for a free, no obligation, evaluation of your case.

HERE TO HELP.

If you are interested in claims for Actos, an Actos lawsuit, information on an Actos class action, or want to speak with anActos attorney, please call us today at 1-800-632-1404.

Members of our firm are attorneys currently representing clients who have taken several prescription drugs and claim injuries associated with those drugs, including Topamax®, Wellbutrin®, Fosamax®, and Actos®. Members of the firm also represent clients across the globe pertaining to medical device failures, including the Advanced Bionics HiRes90k® cochlear implant , the TVM / TVT transvaginal mesh – sling and the DePuy hip implant. For a free case evaluation, please contact:

CALL US TOLL FREE: (800) 632-1404

EMAIL: click here

FILL OUT THIS FORM:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

• Comments

FOR A FREE CASE EVALUATION, CALL 1-800-632-1404

If you took Actos® (pioglitazone) for a year or longer and have been diagnosed with bladder cancer, call the Actos bladder cancer lawyers with our firm at 1-800-632-1404. Our firm is currently reviewing cases involving persons who took Actos® for control of blood sugar. This includes but is not limited to persons residing in Tennessee, Arkansas, Mississippi or anywhere in the United States.

BLADDER CANCER AND YOU.

Actos® is a pioglitazone drug used to tr eat type 2 diabetes. Pioglitazone is an insulin sensitizer that works by making the tissues more sensitive to the effects of insulin. Bladder Cancer is a potential side effect of Actos®.

The presence of cancer in human tissues signals a breakdown of normal function. Cancer brings unwelcome changes to the human body that is perfect, marvelously beautiful, and complex beyond measure.

Emotions

From the moment of diagnosis, the experience of bladder cancer evokes many emotions: anger, anxiety, depression, sadness, and despair to name a few. We are primarily concerned about how the diagnosis affects our lives today-how we manage to fit this new responsibility into a schedule already packed to maximum capacity. We are concerned about how we can maintain the equilibrium we have worked so hard to achieve, knowing that the diagnosis we have been given will create major disruptions in our lives. We also worry about recurrence, death, surgery, and other treatments, and how treatments will affect our self-esteem and self-image. We are disquieted by the possibility of disfigurement. We are apprehensive about maintaining our relationships with our partners and significant others; about being able to care for our children, parents, and others who depend upon us; and about the impact of bladder cancer on our careers. Emotional responses include anger, anxiety, crying, despair, joy, love, rage, rationalization, sadness and a sense of loss. All of our emotions, from anger and fear to joy and love, seem to be intensified.

Testing Times

Perhaps the most devastating event in having bladder cancer is hearing the diagnosis for the first time. But there are other points during the course of bladder cancer that are also very difficult — waiting for the results from biopsies and other tests. Finding out about node involvement is a milestone because it tends to be an indicator of prognosis and helps determine the course of adjuvant therapy is one of the most trying times during the course of the diagnosis.

Unexpected Challenges

When a person is diagnosed with bladder cancer, he or she is faced with a new and unexpected challenge: how to find time to gather information, to choose a course of action, to undergo treatment, and, at the same time, to care for themselves. In addition to other physical and emotional ramifications, having bladder cancer is extremely time-consuming.

We stand ready to discuss Actos and bladder cancer with you.

MORE ABOUT ACTOS

Actos is a drug used to treat Type 2 diabetes. While the drug is effective, it does have certain side effects, which can include the following:

Pharyngitis

One of the common side effects of Actos is Pharyngitis. Pharyngitis is the inflammation of the pharynx. It is experienced as a sore throat. Pharyngitis can appear suddenly (acute) or it can persist over several months or even years (chronic).

The pharynx provides a vital link between the nose, mouth and the voice box. In doing so it plays a major role in the essential tasks of breathing, eating and speaking. The pharynx is deep lined with muscles and is shaped very roughly like an inverted cone. It extends for about 5 inches behind the arch at the back of the mouth to where it joins the gullet.

Myalgias

Another common side effect of Actos is myalgisa. Myalgisa refers to aching in the muscles. It is common in the upper or lower back and neck areas. It is usually present on both the left and right sides and present as a dull throbbing discomfort.

Sinusitis

Yet another commons side effect of Actos is sinusitis. Sinusitis is inflammation of the mucosal lining of the paranasal sinuses, which leads to stasis, obstruction, and subsequent infection. The sinuses are air-filled bony cavities that produce and drain up to 2 pints of mucus every day. Self-cleaning occurs by movement of the mucus, propelled by cilia, through the ostia, which are located behind the turbinates. Acute sinusitis is a bacterial infection of one or more paranasal sinuses, which occurs when the normal drainage is impaired because of blockage of one or more ostia.

Hypoglycemia 

Some patients who were prescribed Actos for treatment of type 2 diabetes have reported hypoglycemia. Hypoglycemia is the condition in which the level of glucose falls below normal levels affecting the individual’s ability to process information, including interruption in short-term memory, decrements in motor control (weakness), and other autonomic and adrenergic symptoms (e.g., trembling, difficulty concentrating, tiredness, headache, sweating, dry mouth, and hunger).

Serious Complications

Besides the general side effects, Acots can also cause serious medical problems such as bladder cancer and congestive heart failure.

BACKGROUND

Since 1999, Actos® has been prescribed as part of an overall treatment regimen for controlling blood sugar in diabetic patients. In recent years it has also been prescribed as a diabetes preventative in those who show the early signs of the disease. In September 2010, the U.S. Food and Drug Administration (FDA) began a safety review of Actos® when new data was discovered that suggested a link to increased risk of bladder cancer.

The risk of bladder cancer is MUCH HIGHER for those that take the drug at higher cumulative doses and for longer periods of time. This increased risk is also greater in men than in women. The FDA has issued a warning of the elevated risk to patients who have been taking Actos®, but added that patients should not stop taking Actos® unless instructed to do so by their physicians. The active ingredient in Actos® is also contained in other drugs, namely Actoplus Met®, Actoplus Met XR®, and Duetact®.

Although Actos® continues to remain on the shelves of drug stores in the United States, the drug is under a long-term observational study by the FDA. France suspended the drug and Germany recommended not to start new patients on the drug due to mounting concerns for their citizens.

RISK OF BLADDER CANCER

In June of this year the U.S. Food & Drug Administration (FDA) issued a warning about the popular diabetes drug Actos(pioglitazone). The FDA had found that the use of pioglitazone for more than a year may be linked to an increased risk of bladder cancer.

SYMPTOMS OF BLADDER CANCER

Common symptoms of Actos®-related bladder cancer may include:

• ■Blood in urine, sometimes creating a change in urine color
• ■Frequent urination
• ■Painful urination
• ■Urinary tract infection

If you or a loved one developed bladder cancer during or after taking Actos®, Actoplus Met®, Actoplus Met XR®, or Duetact®, call us now at 1-800-632-1404 or SUBMIT A SHORT CASE FORM HERE for a free, no obligation, evaluation of your case.

HERE TO HELP.

If you are interested in claims for Actos, an Actos lawsuit, information on an Actos class action, or want to speak with anActos attorney, please call us today at 1-800-632-1404.

Members of our firm are attorneys currently representing clients who have taken several prescription drugs and claim injuries associated with those drugs, including Topamax®, Wellbutrin®, Fosamax®, and Actos®. Members of the firm also represent clients across the globe pertaining to medical device failures, including the Advanced Bionics HiRes90k® cochlear implant , the TVM / TVT transvaginal mesh – sling and the DePuy hip implant. For a free case evaluation, please contact:

CALL US TOLL FREE: (800) 632-1404

EMAIL: click here

FILL OUT THIS FORM:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

• Comments

FOR A FREE CASE EVALUATION, CALL 1-800-632-1404

If you took Actos® (pioglitazone) for a year or longer and have been diagnosed with bladder cancer, call the Actos bladder cancer lawyers with our firm at 1-800-632-1404. Our firm is currently reviewing cases involving persons who took Actos® for control of blood sugar. This includes but is not limited to persons residing in Tennessee, Arkansas, Mississippi or anywhere in the United States.

BLADDER CANCER AND YOU.

Actos® is a pioglitazone drug used to tr eat type 2 diabetes. Pioglitazone is an insulin sensitizer that works by making the tissues more sensitive to the effects of insulin. Bladder Cancer is a potential side effect of Actos®.

A diagnosis of bladder cancer means:

• significant disruption in work and personal schedules
• quickly learning new jargon and new environments
• developing new schedules for work and home
• learning to cope with stress precipitated by the potential loss of life versus normal stress from work and family

Disruptions to Schedules

Bladder cancer can be a major disruption in your schedules — and possibly a threat to your career. The prospect of adding another “responsibility” to your daily activities is a disturbing thought-and more than just a nuisance.

Side Effects of Chemotherapy

Chemotherapy is one of the most common methods for treatment of cancer. It requires more juggling of work schedules and even changes in responsibilities. Chemotherapy causes more debilitating side effects than does radiation, so incorporating the treatments into your work routine requires planning. Side effects include fatigue, nausea and some mental fuzziness. In addition to nausea, chemotherapy may temporarily cause changes in skin color, hair loss and significant weight gain or loss.

Physical Appearance

No one wants to appear sick or vulnerable to colleagues, clients, students, and customers. However treatment for bladder cancer can affect a person’s appearance. Physical appearance is an important part of professional image or work persona. Cancer treatment often results in visible changes to one’s appearance, which included a sallow look to our skin, loss of hair, and weight gain or loss. It is sometimes difficult to continue working during treatment — to continue functioning in a business or professional environment — because talent and success is attributed greatly to appearance or persona. A “bad hair day” or clothes that are too tight or too baggy can be depressing to the healthiest of us. Add to that extreme fatigue and the feeling of being “on display” because of the disease, and the result is something less than an emotional high.

Reactions

In addition to coping with changes in physical appearance, a cancer patient has to deal with the reactions of clients, customers, and coworkers as a result of their knowing that the person is undergoing therapy for bladder cancer.

We stand ready to discuss Actos and bladder cancer with you.

MORE ABOUT ACTOS

Actos is a drug used to treat Type 2 diabetes. While the drug is effective, it does have certain side effects, which can include the following:

Pharyngitis

One of the common side effects of Actos is Pharyngitis. Pharyngitis is the inflammation of the pharynx. It is experienced as a sore throat. Pharyngitis can appear suddenly (acute) or it can persist over several months or even years (chronic).

The pharynx provides a vital link between the nose, mouth and the voice box. In doing so it plays a major role in the essential tasks of breathing, eating and speaking. The pharynx is deep lined with muscles and is shaped very roughly like an inverted cone. It extends for about 5 inches behind the arch at the back of the mouth to where it joins the gullet.

Myalgias

Another common side effect of Actos is myalgisa. Myalgisa refers to aching in the muscles. It is common in the upper or lower back and neck areas. It is usually present on both the left and right sides and present as a dull throbbing discomfort.

Sinusitis

Yet another commons side effect of Actos is sinusitis. Sinusitis is inflammation of the mucosal lining of the paranasal sinuses, which leads to stasis, obstruction, and subsequent infection. The sinuses are air-filled bony cavities that produce and drain up to 2 pints of mucus every day. Self-cleaning occurs by movement of the mucus, propelled by cilia, through the ostia, which are located behind the turbinates. Acute sinusitis is a bacterial infection of one or more paranasal sinuses, which occurs when the normal drainage is impaired because of blockage of one or more ostia.

Hypoglycemia 

Some patients who were prescribed Actos for treatment of type 2 diabetes have reported hypoglycemia. Hypoglycemia is the condition in which the level of glucose falls below normal levels affecting the individual’s ability to process information, including interruption in short-term memory, decrements in motor control (weakness), and other autonomic and adrenergic symptoms (e.g., trembling, difficulty concentrating, tiredness, headache, sweating, dry mouth, and hunger).

Serious Complications

Besides the general side effects, Acots can also cause serious medical problems such as bladder cancer and congestive heart failure.

BACKGROUND

Since 1999, Actos® has been prescribed as part of an overall treatment regimen for controlling blood sugar in diabetic patients. In recent years it has also been prescribed as a diabetes preventative in those who show the early signs of the disease. In September 2010, the U.S. Food and Drug Administration (FDA) began a safety review of Actos® when new data was discovered that suggested a link to increased risk of bladder cancer.

The risk of bladder cancer is MUCH HIGHER for those that take the drug at higher cumulative doses and for longer periods of time. This increased risk is also greater in men than in women. The FDA has issued a warning of the elevated risk to patients who have been taking Actos®, but added that patients should not stop taking Actos® unless instructed to do so by their physicians. The active ingredient in Actos® is also contained in other drugs, namely Actoplus Met®, Actoplus Met XR®, and Duetact®.

Although Actos® continues to remain on the shelves of drug stores in the United States, the drug is under a long-term observational study by the FDA. France suspended the drug and Germany recommended not to start new patients on the drug due to mounting concerns for their citizens.

RISK OF BLADDER CANCER

In June of this year the U.S. Food & Drug Administration (FDA) issued a warning about the popular diabetes drug Actos(pioglitazone). The FDA had found that the use of pioglitazone for more than a year may be linked to an increased risk of bladder cancer.

SYMPTOMS OF BLADDER CANCER

Common symptoms of Actos®-related bladder cancer may include:

• ■Blood in urine, sometimes creating a change in urine color
• ■Frequent urination
• ■Painful urination
• ■Urinary tract infection

If you or a loved one developed bladder cancer during or after taking Actos®, Actoplus Met®, Actoplus Met XR®, or Duetact®, call us now at 1-800-632-1404 or SUBMIT A SHORT CASE FORM HERE for a free, no obligation, evaluation of your case.

HERE TO HELP.

If you are interested in claims for Actos, an Actos lawsuit, information on an Actos class action, or want to speak with anActos attorney, please call us today at 1-800-632-1404.

Members of our firm are attorneys currently representing clients who have taken several prescription drugs and claim injuries associated with those drugs, including Topamax®, Wellbutrin®, Fosamax®, and Actos®. Members of the firm also represent clients across the globe pertaining to medical device failures, including the Advanced Bionics HiRes90k® cochlear implant , the TVM / TVT transvaginal mesh – sling and the DePuy hip implant. For a free case evaluation, please contact:

CALL US TOLL FREE: (800) 632-1404

EMAIL: click here

FILL OUT THIS FORM:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

• Comments

FOR A FREE CASE EVALUATION, CALL 1-800-632-1404

If you took Actos® (pioglitazone) for a year or longer and have been diagnosed with bladder cancer, call the Actos bladder cancer lawyers with our firm at 1-800-632-1404. Our firm is currently reviewing cases involving persons who took Actos® for control of blood sugar. This includes but is not limited to persons residing in Tennessee.

BLADDER CANCER

Actos® is a pioglitazone drug used to treat type 2 diabetes. Pioglitazone is an insulin sensitizer that works by making the tissues more sensitive to the effects of insulin. Bladder Cancer is a potential side effect of Actos®.

Losing Control

For as long as we can remember, we have taken charge of our lives. We set goals and don’t give up until they are reached. We have worked hard to establish ourselves personally and professionally and have learned our lessons on the way up. We plan, organize, prioritize, set goals, and draw up schedules rather than risk leaving events to outside influences. We are accustomed to structuring our own lives and making our own decisions, and to being rewarded with success. We accept more responsibilities and duties than do our peers. We have earned a reputation for being dependable and “exceptionally competent.” Others rely on us. Control is a fundamental part of our natures. To us, control means discipline, freedom, self-determination, independence, self-reliance, and choice. It is a key element of our outlook on life and an essential underpinning of our success.

Implications

The diagnosis of bladder cancer is an overwhelming blow for the majority of the victims. Compounding this is the necessity of making treatment decisions. Treatment is complex with a variety of options and outcomes. The feeling of being in control deserts a person in an instant if he or she is diagnosed with bladder cancer. No one is prepared for it and the reactions range from confusion and despair to panic. A person diagnosed with bladder cancer is generally concerned about the long-term effects that being a cancer survivor will have on his or he professional lives. Implications include insurance, health, disability, life, ability to change jobs, earning ability and long term career goals.

Expenses

Not only does having bladder cancer disrupt your earnings, but the diagnostic and treatment phases are also very expensive. Even with insurance coverage, deductibles and noncovered expenses must be paid out-of-pocket. Experimental treatments may pose an even greater financial risk. There are also unexpected costs indirectly caused by having cancer, for example, the need to hire an assistant or take on a partner or costs associated with travel and housing when seeking care out of state.

We stand ready to discuss Actos and bladder cancer with you.

MORE ABOUT ACTOS

Actos is a drug used to treat Type 2 diabetes. While the drug is effective, it does have certain side effects, which can include the following:

Pharyngitis

One of the common side effects of Actos is Pharyngitis. Pharyngitis is the inflammation of the pharynx. It is experienced as a sore throat. Pharyngitis can appear suddenly (acute) or it can persist over several months or even years (chronic).

The pharynx provides a vital link between the nose, mouth and the voice box. In doing so it plays a major role in the essential tasks of breathing, eating and speaking. The pharynx is deep lined with muscles and is shaped very roughly like an inverted cone. It extends for about 5 inches behind the arch at the back of the mouth to where it joins the gullet.

Myalgias

Another common side effect of Actos is myalgisa. Myalgisa refers to aching in the muscles. It is common in the upper or lower back and neck areas. It is usually present on both the left and right sides and present as a dull throbbing discomfort.

Sinusitis

Yet another commons side effect of Actos is sinusitis. Sinusitis is inflammation of the mucosal lining of the paranasal sinuses, which leads to stasis, obstruction, and subsequent infection. The sinuses are air-filled bony cavities that produce and drain up to 2 pints of mucus every day. Self-cleaning occurs by movement of the mucus, propelled by cilia, through the ostia, which are located behind the turbinates. Acute sinusitis is a bacterial infection of one or more paranasal sinuses, which occurs when the normal drainage is impaired because of blockage of one or more ostia.

Hypoglycemia 

Some patients who were prescribed Actos for treatment of type 2 diabetes have reported hypoglycemia. Hypoglycemia is the condition in which the level of glucose falls below normal levels affecting the individual’s ability to process information, including interruption in short-term memory, decrements in motor control (weakness), and other autonomic and adrenergic symptoms (e.g., trembling, difficulty concentrating, tiredness, headache, sweating, dry mouth, and hunger).

Serious Complications

Besides the general side effects, Acots can also cause serious medical problems such as bladder cancer and congestive heart failure.

BACKGROUND

Since 1999, Actos® has been prescribed as part of an overall treatment regimen for controlling blood sugar in diabetic patients. In recent years it has also been prescribed as a diabetes preventative in those who show the early signs of the disease. In September 2010, the U.S. Food and Drug Administration (FDA) began a safety review of Actos® when new data was discovered that suggested a link to increased risk of bladder cancer.

The risk of bladder cancer is MUCH HIGHER for those that take the drug at higher cumulative doses and for longer periods of time. This increased risk is also greater in men than in women. The FDA has issued a warning of the elevated risk to patients who have been taking Actos®, but added that patients should not stop taking Actos® unless instructed to do so by their physicians. The active ingredient in Actos® is also contained in other drugs, namely Actoplus Met®, Actoplus Met XR®, and Duetact®.

Although Actos® continues to remain on the shelves of drug stores in the United States, the drug is under a long-term observational study by the FDA. France suspended the drug and Germany recommended not to start new patients on the drug due to mounting concerns for their citizens.

RISK OF BLADDER CANCER

In June of this year the U.S. Food & Drug Administration (FDA) issued a warning about the popular diabetes drug Actos(pioglitazone). The FDA had found that the use of pioglitazone for more than a year may be linked to an increased risk of bladder cancer.

SYMPTOMS OF BLADDER CANCER

Common symptoms of Actos®-related bladder cancer may include:

• ■Blood in urine, sometimes creating a change in urine color
• ■Frequent urination
• ■Painful urination
• ■Urinary tract infection

If you or a loved one developed bladder cancer during or after taking Actos®, Actoplus Met®, Actoplus Met XR®, or Duetact®, call us now at 1-800-632-1404 or SUBMIT A SHORT CASE FORM HERE for a free, no obligation, evaluation of your case.

HERE TO HELP.

If you are interested in claims for Actos, an Actos lawsuit, information on an Actos class action, or want to speak with anActos attorney, please call us today at 1-800-632-1404.

Members of our firm are attorneys currently representing clients who have taken several prescription drugs and claim injuries associated with those drugs, including Topamax®, Wellbutrin®, Fosamax®, and Actos®. Members of the firm also represent clients across the globe pertaining to medical device failures, including the Advanced Bionics HiRes90k® cochlear implant , the TVM / TVT transvaginal mesh – sling and the DePuy hip implant. For a free case evaluation, please contact:

CALL US TOLL FREE: (800) 632-1404

EMAIL: click here

FILL OUT THIS FORM:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

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TO DISCUSS YOUR NEEDS, PLEASE CALL 901-527-2125

Our team of attorneys are prepared to represent clients involved in Tennessee probate litigation, including Tennessee will and trust contests, disputes over guardianships, administration of trusts, and inheritance, matters involving significant emotional and financial issues. We are also willing to serve as local counsel for individuals requiring representation in a Tennessee probate court. For more information, or to speak with a member of the firm, please contact our office at (901) 527-2125, (800) 632-1404 or fill out the form to the right. 

CASE LAW COVERS THE BLACK LETTER LAW

The Tennessee Court of Appeals recently issued an opinion in In re: The Estate of Bessie Louise Thornton.  In it, there was a thorough recitation of black letter law on Tennessee probate litigation issues. Relevant portions of the opinion include the following:

At the time a will is executed, the mind of the testatrix must be sufficiently sound to enable her to know and understand the force and consequence of the act of making the will. In re Estate of Elam, 738 S.W.2d 169 (Tenn. 1987); Am. Trust & Banking Co. v. Williams, 225 S.W.2d 79, 83 (Tenn. Ct. App. 1948). 1The mental condition of the testator at the time of executing the will is the only point of inquiry; but evidence of mental condition before and after making the will, if not too remote in point of time, may be received as bearing upon that issue. In re Estate of Elam, 738 S.W.2d 169, 171-72 (Tenn. 1987). Evidence
of the testator’s physical condition before and after the date of the will is also admissible; however, apart from its effect upon the mind, the physical condition of the testator has no bearing on the issue. Id. at 172 (citing Taliaferro v. Green, 622 S.W.2d 829, 834 (Tenn. Ct. App. 1981)). Although evidence regarding factors such as physical weakness or disease, old age, blunt perception or failing mind and memory is admissible on the issue of testamentary capacity, it is not conclusive and the testator is not thereby rendered incompetent if her mind is sufficiently sound to enable her to know and understand what she is doing. Id. The opinions of lay witnesses are admissible on soundness of mind if they are based on details of conversations,
appearances, conduct or other particular facts from which the state of mind may be judged. Id. (citing Am. Trust & Banking Co. v. Williams, 225 S.W.2d 79, 84 (Tenn. Ct. App. 1948)).

A person executing a will must know and understand: (1) the nature and the effect of her act; (2) the property she possesses; and (3) the manner in which her property will be distributed under the will. Childress v. Currie, 74 S.W.3d 324, 328 (Tenn. 2002); In re Estate of Elam, 738 S.W.2d at 171-72; In re Estate of Price, 273 S.W.3d 113 (Tenn. Ct. App. 2008). However, executing a will requires less mental capacity than engaging in business transactions. Owen v. Summers, 97 S.W.3d 114, 125 (Tenn. Ct. App. 2001); Green v. Higdon, 870 S.W.2d 513, 522 (Tenn. Ct. App. 1993).

Once the proponent of the will establishes its due execution, the contestant has the burden to prove by a preponderance of the evidence that the testatrix lacked testamentary capacity, or that her will was the result of undue influence exerted upon her by another. In re Estate of Elam, 738 SW.2d at 171 (citing In re Estate of Rhodes, 436 S.W.2d 429, 435-36 (Tenn. 1968)). As a general rule, it is presumed that undue influence does not enter into the making of a will and the burden of proving undue influence falls upon the person contesting
the will. Kelley v. Johns, 96 S.W.3d 189, 196 (Tenn. Ct. App. 2002); In re Estate of Maddox, 60 S.W.3d 84, 89 (Tenn. Ct. App. 2001).

Undue influence “upon a testator consists in substituting the will of the person
exercising it for that of the testator.” Jack W. Robinson, Sr., & Jeff Mobley, Pritchard on the Law of Wills and the Administration of Estates § 124, at 203 (5 ed. th 1994). Thus, the dispositive issue on a question of undue influence is whether “the will is the will of the testator or that of another.” Id. § 130, at 210. “[I]t is not influence that vitiates a will, but undue influence . . . .” Union Planters Nat’l Bank v. Inman, 588 S.W.2d 757, 761 (Tenn. Ct. App. 1979)(emphasis added). The issue of undue influence should “be decided by the
application of sound principles and good sense to the facts of each case.” Childress, 74 S.W.3d at 329 (citing Matlock v. Simpson, 902 S.W.2d 384, 388 (quoting Halle v. Summerfield, 287 S.W.2d 57, 61 (Tenn. 1956))).
While undue influence can be proved either by direct or circumstantial evidence, see In re Depriest’s Estate, 733 S.W.2d 74, 78 (Tenn. Ct. App. 1986), direct evidence is rarely available. Hager v. Hager, 66 S.W.2d 250, 260 (1933). Thus, in most cases, those attacking a conveyance on the grounds of undue influence must prove the existence of suspicious circumstances warranting the conclusion that the person allegedly influenced did not act freely and independently. Fell v. Rambo, 36 S.W.3d 837, 847 (Tenn. Ct. App. 2000).

The suspicious circumstances most often relied upon to establish undue influence are: (1) the existence of a confidential relationship between the grantor and the beneficiary at the time of the conveyance (The existence of a confidential relationship is one of the “suspicious circumstances” most frequently relied upon to show undue influence. Fell, 36 S.W.3d at 847-48; Kelly, 558 S.W.2d at 848); (2) the grantor’s physical or mental deterioration; and (3) the beneficiary’s active involvement in procuring the conveyance. In re Estate of Elam, 738 S.W.2d at 173; Kelly v. Allen, 558 S.W.2d 845, 848 (Tenn. 1977); Mitchell, 779 S.W.2d at 388; Taliaferro, 622 S.W.2d at 835-36. Other suspicious circumstances giving rise to undue influence include: (1) secrecy concerning the will’s or conveyance’s existence; (2) the grantor’s advanced age; (3) the lack of independent advice in preparing the conveyance; (4) the grantor’s illiteracy or blindness; (5) the unjust or unnatural nature of the conveyance; (6) the grantor being in an emotionally distraught state; (7) discrepancies between the conveyance and the testator’s expressed intentions; and (8) fraud or duress directed toward the grantor. Halle, 287 S.W.2d at 61-62; Mitchell, 779 S.W.2d at 671.

In Tennessee, where there is a “confidential relationship, followed by a transaction wherein the dominant party receives a benefit from the other party, a presumption of undue influence arises, that may be rebutted only by clear and convincing evidence of the fairness of the transaction by clear and convincing evidence.” Matlock, 902 S.W.3 2d at 386; see also Mitchell, 779 S.W.2d at 389 (finding that a confidential relationship exists combined with
the beneficiary’s involvement in the procurement of the will or conveyance gives rise to a presumption of fraud or undue influence).

[Once a jury makes a finding that a confidential relationship exists between a person and the decedent, the burden shifts to the defendant] to prove, by clear and convincing evidence, that the contested will was not the product of undue influence but, instead, was the product of the free exercise of independent
judgment by the decedent. See In re Estate of Elam, 738 S.W.2d at 171. One means of showing a transaction’s fairness is for the dominant party to establish, by clear and convincing evidence, that the weaker party received independent advice before consummating the transaction that benefitted the dominant party. See Hogan v. Cooper, 619 S.W.2d 516, 519 (Tenn. 1981); see also Richmond v. Christian, 555 S.W.2d 105, 107-08 (Tenn. 1977) (proof that the donor received independent advice respecting the consequences and advisability of the gift).

Thus, the burden of proving that a confidential relationship exists rests upon the party claiming the existence of such a relationship. Childress, 74 S.W.3d at 328 (citing Brown v. Weik, 725 S.W.2d 938, 945 (Tenn. Ct. App. 1983)). [The contestant, bears the initial burden of proof].

In general, a confidential relationship is any relationship which gives a person dominion and control over another. Kelly, 558 S.W.2d at 848. It is not merely a relationship of mutual trust and confidence, rather a confidential relationship is one where confidence is placed by one in the other and the recipient of that
confidence is the dominant personality, with ability, because of that  confidence, to exercise dominion and control over the weaker or dominated party. Childress, 74 S.W.3d at 328.

PLEASE CONTACT US:

If you or a family member has a Tennessee probate litigation matter or potential dispute, please contact us for a free assessment and initial case evaluation session:

TELEPHONE: 901-527-2125

TOLL FREE: 800-632-1404

EMAIL: Click Here

WEBSITE: VISIT OUR PROBATE LITIGATION PAGE

FILL OUT THIS FORM:

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FOR A FREE CASE EVALUATION, CALL 1-800-632-1404

If you took Actos® (pioglitazone) for a year or longer and have been diagnosed with bladder cancer, call the Actos bladder cancer lawyers with our firm at 1-800-632-1404. Our firm is currently reviewing cases involving persons who took Actos® for control of blood sugar. This includes but is not limited to persons residing in Mississippi.

CONSOLIDATION OF CASES

Actos® is a pioglitazone drug used to treat type 2 diabetes. Pioglitazone is an insulin sensitizer that works by making the tissues more sensitive to the effects of insulin. Bladder Cancer is a potential side effect of Actos®.

The Judicial Panel on Multi-District Litigation has recently consolidated all federal Actos cases before the Honorable Judge Rebecca Doherty. More than 100 federal lawsuits where plaintiffs allege developing bladder cancer as a result of taking Actos will be transferred to the Western District of Louisiana.

“Consolidating Actos cases will help those who have been harmed by this popular diabetes drug,” said attorney Tim Edwards of Tennessee whose firm is accepting case evaluations from all persons who ingested Actos and have been diagnosed with bladder cancer. 

As more people learn about the increased risk of bladder cancer associated with Actos, Edwards expects additional lawsuits to be filed. Actos and other forms of drugs containing pioglitazone are used to improve control of blood sugar in adults with type 2 diabetes mellitus. Between Jan. 2012 and Oct. 2010, about 2.3 million patients filled a prescription for a pioglitazone-containing drug. Edwards finds it unfortunate that so many may be diagnosed with bladder cancer.

Patients who take Actos for over a year have a 40 percent increased risk of bladder cancer compared to patients who never took the drug, according to an FDA interim review of an ongoing study. The 5-year study includes data on over 193,000 diabetic patients who were treated with pioglitazone for an average of two years.

As a result, the FDA ordered the drug’s manufacturer, Takeda Pharmaceuticals North America, Inc., to update Actos symptoms on the drug’s label earlier this fall.

We stand ready to discuss Actos and bladder cancer with you.

MORE ABOUT ACTOS

Actos is a drug used to treat Type 2 diabetes. While the drug is effective, it does have certain side effects, which can include the following:

Pharyngitis

One of the common side effects of Actos is Pharyngitis. Pharyngitis is the inflammation of the pharynx. It is experienced as a sore throat. Pharyngitis can appear suddenly (acute) or it can persist over several months or even years (chronic).

The pharynx provides a vital link between the nose, mouth and the voice box. In doing so it plays a major role in the essential tasks of breathing, eating and speaking. The pharynx is deep lined with muscles and is shaped very roughly like an inverted cone. It extends for about 5 inches behind the arch at the back of the mouth to where it joins the gullet.

Myalgias

Another common side effect of Actos is myalgisa. Myalgisa refers to aching in the muscles. It is common in the upper or lower back and neck areas. It is usually present on both the left and right sides and present as a dull throbbing discomfort.

Sinusitis

Yet another commons side effect of Actos is sinusitis. Sinusitis is inflammation of the mucosal lining of the paranasal sinuses, which leads to stasis, obstruction, and subsequent infection. The sinuses are air-filled bony cavities that produce and drain up to 2 pints of mucus every day. Self-cleaning occurs by movement of the mucus, propelled by cilia, through the ostia, which are located behind the turbinates. Acute sinusitis is a bacterial infection of one or more paranasal sinuses, which occurs when the normal drainage is impaired because of blockage of one or more ostia.

Hypoglycemia 

Some patients who were prescribed Actos for treatment of type 2 diabetes have reported hypoglycemia. Hypoglycemia is the condition in which the level of glucose falls below normal levels affecting the individual’s ability to process information, including interruption in short-term memory, decrements in motor control (weakness), and other autonomic and adrenergic symptoms (e.g., trembling, difficulty concentrating, tiredness, headache, sweating, dry mouth, and hunger).

Serious Complications

Besides the general side effects, Acots can also cause serious medical problems such as bladder cancer and congestive heart failure.

BACKGROUND

Since 1999, Actos® has been prescribed as part of an overall treatment regimen for controlling blood sugar in diabetic patients. In recent years it has also been prescribed as a diabetes preventative in those who show the early signs of the disease. In September 2010, the U.S. Food and Drug Administration (FDA) began a safety review of Actos® when new data was discovered that suggested a link to increased risk of bladder cancer.

The risk of bladder cancer is MUCH HIGHER for those that take the drug at higher cumulative doses and for longer periods of time. This increased risk is also greater in men than in women. The FDA has issued a warning of the elevated risk to patients who have been taking Actos®, but added that patients should not stop taking Actos® unless instructed to do so by their physicians. The active ingredient in Actos® is also contained in other drugs, namely Actoplus Met®, Actoplus Met XR®, and Duetact®.

Although Actos® continues to remain on the shelves of drug stores in the United States, the drug is under a long-term observational study by the FDA. France suspended the drug and Germany recommended not to start new patients on the drug due to mounting concerns for their citizens.

RISK OF BLADDER CANCER

In June of this year the U.S. Food & Drug Administration (FDA) issued a warning about the popular diabetes drug Actos(pioglitazone). The FDA had found that the use of pioglitazone for more than a year may be linked to an increased risk of bladder cancer.

SYMPTOMS OF BLADDER CANCER

Common symptoms of Actos®-related bladder cancer may include:

• ■Blood in urine, sometimes creating a change in urine color
• ■Frequent urination
• ■Painful urination
• ■Urinary tract infection

If you or a loved one developed bladder cancer during or after taking Actos®, Actoplus Met®, Actoplus Met XR®, or Duetact®, call us now at 1-800-632-1404 or SUBMIT A SHORT CASE FORM HERE for a free, no obligation, evaluation of your case.

HERE TO HELP.

If you are interested in claims for Actos, an Actos lawsuit, information on an Actos class action, or want to speak with anActos attorney, please call us today at 1-800-632-1404.

Members of our firm are attorneys currently representing clients who have taken several prescription drugs and claim injuries associated with those drugs, including Topamax®, Wellbutrin®, Fosamax®, and Actos®. Members of the firm also represent clients across the globe pertaining to medical device failures, including the Advanced Bionics HiRes90k® cochlear implant , the TVM / TVT transvaginal mesh – sling and the DePuy hip implant. For a free case evaluation, please contact:

CALL US TOLL FREE: (800) 632-1404

EMAIL: click here

FILL OUT THIS FORM:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

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THE PROCESS

We will meet with you and thoroughly investigate your case.  As we mentioned, we will travel to see you, as we want to meet with you in person and review all documents you may have to support your case.  We will then investigate on our own and prepare a complaint for filing in federal court.  The case will be filed under seal, and served on the U.S. Attorney’s Office along with a Declaration of Evidence that is not filed but also served on the Government.

Once the case is filed, a United States Attorney investigates the lawsuit and underlying allegations of fraud for an initial period of 60 days. If after investigating the claim the U.S. Attorney believes the allegations of fraud are meritorious, the United States Government takes over the case and either enters into a settlement or continues the lawsuit against the wrongdoer. The Relator would then be entitled to a portion of the recovery despite the fact that the government has taken over the case.

The amount that the Relator would be entitled to receive would be approximately 15 percent to 25 percent of the decision. It is estimated that the government intervenes and takes over a case approximately 30 percent of the time.

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FREE CASE EVALUATION: 1-800-632-1404

Tens of thousands of women receive a transvaginal mesh (TVM) device each and every year from numerous suppliers: American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson.  Thousands of women have been injured through no fault of their own, including vaginal erosion, pain, urinary problems, bleeding, infection and more. Our attorneys are representing women in all fifty states and Canada who have been injured.  For a free case evaluation, call 1-800-632-1404.

We are honored to have two women on staff ready and willing to discuss the facts of your case with you as often as needed.

House of Representatives Looking for Hearings and Issue Letter

Bloomberg News reports that

House Democrats called for congressional hearings on transvaginal meshes of the kind made by Johnson & Johnson, saying the devices are hazardous to patients. U.S. Representative Henry Waxman, a California Democrat, and three colleagues urged Republicans who control the House Energy and Commerce Committee to hold the hearing and demand documents from manufacturers. The inquiry is critical as Congress considers an overhaul of Food and Drug Administration rules for medical devices, the Democratic lawmakers said today in a statement. The FDA ordered New Brunswick, New Jersey-based J&J and 32 fellow manufacturers to conduct safety studies of the vaginal implants earlier this month, citing reports of internal injuries.

The Democratic Committee Leaders issued a letter stating:

We are writing to renew our October 12, 2011, request for hearings to examine medical devices that have developed serious defects after being implanted in patients and to propose the Committee seek documents related to the “Lap-Band” weight loss device and urogynecologic surgical mesh.  The Committee has failed to schedule the hearing we requested in our October 12 letter, and we remain concerned that the Committee’s previous hearings on medical devices have presented a skewed and inaccurate picture of the importance of appropriate medical device regulation.  We hope you will reconsider your approach so that the Committee can have a fuller understanding of these critical issues as we prepare to reauthorize the Medical Device User Fees Act.

The “Lap-Band” Gastric Band

            The “Lap-Band” is a type of gastric band device that is surgically implanted and wrapped around the upper portion of a patient’s stomach to reduce the size of the stomach.  When the device is effective, patients feel full more quickly and thus are more likely to eat less and lose weight.  FDA approved the “Lap-Band” device for obese patients, but has indicated that the device can pose serious risks including erosion of the band through the stomach wall, stretching the esophagus, stretching the stomach pouch, stomach pain, gastroesophageal reflux disease, difficulty swallowing, nausea, and vomiting.[1]  In addition, the FDA has said the device is not a “quick fix” for patients struggling with obesity but instead requires “major, long-term changes” to eating habits.[2]

A study published this week in the Archives of Surgery raised questions about the effectiveness of gastric banding, finding that after six years, nearly 50% of patients had either not lost weight or had needed the device to be removed and that over 40% of patients experienced long-term complications.[3]  The study echoed research published in the journal’s March 2011 edition, which found that 40% of patients who received “Lap-Band” surgery had serious complications and concluded that the surgery had “relatively poor long-term outcomes.”[4]  Similarly, a study in the Journal of the American Medical Associationreported that 48% of test group members experienced “adverse events” as a result of the procedure and that nearly 30% required “revisional procedures” to enlarge the stomach above the band.[5]  A study in the Journal of Obesity found high complication and reoperation rates for gastric banding, with 30% requiring an additional operation and 12% requiring the removal of the device altogether.[6]

Even in the face of these serious medical complications, Allergan, the manufacturer of the Lap-Band, is seeking to expand the use of the device in children and young adults.  Allergan is currently seeking FDA approval to market the device to children as young as 14, despite concerns among some physicians that the procedure is too drastic or “extreme” for a young person’s developing body.[7]  The New York Times recently reported that the lure of a seemingly “easy way out” of losing weight may push young people to undergo “Lap-Band” surgery without adequately considering the risks and the dramatic lifestyle changes that are necessary.[8]

The adverse public health consequences associated with use of this device are exacerbated by aggressive marketing and by the lack of a national registry of implanted medical devices, like those that exist in Europe, which would enable public health authorities to obtain more accurate data on the rates of adverse events and device failures.

The tragic results of aggressive marketing by several Lap-Band surgical centers are particularly evident in recent events in Southern California.  In December 2011, FDA issued warning letters to a marketing firm called 1-800-GET-THIN, LLC, and eight surgical centers in California that aggressively market the Lap-Band without adequately informing consumers of the risks associated with the device. [9]  According to a series of reports in the Los Angeles Times, the use of lap-bands by these surgical centers appears to have been associated with significant harm to the health of a number of Southern California patients, including the deaths of five patients since 2009.[10]

Despite these serious risks, 1-800-GET-THIN and the related surgical centers have marketed the device with ubiquitous roadside billboards, advertising inserts, and radio and television ads that “display the smiling faces of thin people and catchy phrases about the benefits” of the surgery.[11]  The ads include phrases such as “DIETS FAIL!  The Lap-Band Works!” and “Let Your New Life Begin.”[12]

The advertisements either do not mention the risk information, qualifying age and weight requirements for the procedure, and the need for meaningful life style change or they present limited information in lettering the FDA called “so small as to render the information illegible.”[13]  One FDA official said he was “astonished” by the number of billboards advertising the procedure and noted that the ads target “a very vulnerable patient population.”[14]

Although Allergan has criticized the advertising campaign and issued voluntary advertising guidelines for the “Lap-Band” in February 2011, these voluntary guidelines have not been effective.  It is unclear what, if any, direct action Allergan took to prevent 1-800-GET-THIN or the related surgical centers from advertising the “Lap-Band” in a false and misleading way.[15]

Urogynecologic Surgical Mesh

            Urogynecologic surgical mesh implants are permanently implanted in the vaginal wall of patients suffering from conditions such as pelvic organ prolapse and urinary incontinence in order to repair weakened or damaged tissue.[16]  These mesh devices were permitted on the market under the 510(k) clearance process, meaning that the devices had to demonstrate that they were “substantially equivalent” to one or more devices already on the market.  Although clinical data can be required under this clearance process, many submissions are cleared without such data.  FDA did not require original clinical studies before clearing urogynecologic surgical mesh through the 510(k) process.[17]

Beginning in October 2008, FDA began to respond to rising reports of complications associated with the surgical mesh by issuing a Public Health Notification calling the transvaginal placement of the mesh “an area of continuing concern.”[18]  In the three years before the notification, over 1,000 adverse events related to the mesh had been reported to FDA.[19]   Over the next three years, the number of reported complications rose to more than 2,800, driving FDA to issue an update on the “serious complications” associated with the device in July 2011.[20]

In 2010 alone, nearly 300,000 synthetic vaginal meshes were implanted in American women.[21]  The most common complication associated with the device is erosion through the vagina, which can be potentially debilitating for some women and require multiple surgeries to correct. [22]  Even with multiple surgeries, some women are never able to recover from the damage.[23]

After years of reports of serious complications associated with use of the device and amid a rising chorus of academic and clinical concern, FDA just last week announced that it was considering reclassifying vaginally implanted surgical mesh as a high risk Class III medical device. [24] The agency ordered 33 manufacturers of the device to conduct postmarket safety studies of the device.[25]

It is unclear when the manufacturers of this device became aware of the serious health risks associated with the device.  It is also unclear if the manufacturers and the FDA have taken appropriate steps to protect patients.

Conclusion

            We believe the Committee should hold hearings to examine whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices like the Lap-Band and intravaginal mesh.  We also believe we should hold hearings on the brain stents and metal-on-metal hip implants mentioned in our October 12 letter.

We further ask that the Committee seek documents relevant to both the Lap-Band and intravaginal mesh devices.  In the case of the Lap-Band, we urge you to request documents from Allergan, 1-800-GET-THIN, LLC, and the eight surgical centers named in the FDA’s warning letters to learn the degree to which these entities cooperated in the marketing of the Lap-Band, what steps were taken to minimize the risks the aggressive marketing campaign posed to patients and children in particular, and to obtain additional information regarding their knowledge of and response to device failures and adverse events.  In the case of the intravaginal mesh, we ask that the Committee seek documents from the manufacturers of surgical mesh to ascertain when they first learned of the safety issues associated with certain uses of the device and what, if any, actions they took to limit risks for patients.

As the Committee approaches reauthorization of the Medical Device User Fee Act, we need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks.  It is also vital that we understand whether device manufacturers and the FDA are taking appropriate steps to keep hazardous devices from the market and to protect patients from marketed devices that are later discovered to be dangerous.

The Committee’s reauthorization of the Medical Device User Fee Act is an important opportunity to improve the efficiency of the FDA’s review process while at the same time strengthening assurances of safety and efficacy.  Obtaining information about devices like the Lap-Band and intravaginal mesh will be critical to informing members of the Committee on an issue that has thus far been absent from the Committee’s record.

Our team of attorneys is reviewing case evaluations for women across the country who have received TVM and TVT products from manufactures such as C.R. Bard, Avaulta, Boston Scientific, and Johnson & Johnson’s Ethicon.

If you need help from a transvaginal mesh device injury, call us today for help.

The Problem

In 2008, the FDA first released concerns about the safety of transvaginal placement of mesh. From 2008 to 2010, the FDA received three to five times as many adverse reports associated with mesh used for pelvic organ prolapse repair than what agency received from 2005 to 2007 (nearly 1,000 reports of adverse events were received from 2005-2007).

Many of these patients complain because of erosion or contraction of the mesh material (which has been described as being of a similar material as Rubbermaid storage containers).  The erosion leads to bleeding, severe pelvic pain, painful (or impossible) sexual performance and a recurrence of urinary problems.

In July 2011, the Food and Drug Administration (FDA) issued an update related to what it called ‘serious complications’ related to the use of vaginal mesh for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).  It is now known that complications linked to transvaginal placement of surgical mesh in SUI and POP patients are not rare and can require multiple surgeries to correct problems related to the use of surgical mesh. In fact, the FDA now says that additional surgeries may actually not be able to repair damage caused by implantation of the mesh.

In other words, the side effects of the mesh placement may be permanent.  These complications from transvaginal placement of surgical mesh include:

• -Erosion of the implanted mesh
• -Infection and/or bleeding
• -Pain, including pain during sexual intercourse
• -Problems with organs near the implantation site

Helping You

You may have experienced mesh erosion, bleeding, urinary infections, vaginal scarring, pain during sexual intercourse, failure to conduct sexual intercourse and more. A physician may have tried to remove the mesh and been unable to do so. You may be in excruciating pain, and need help. We are offering free case evaluations to the general public across the United States and Canada. Manufacturers we consider include American Medical Systems, Bard, Boston Scientific, Ethicon,Gynecare, and Johnson & Johnson.

If you received a transvaginal mesh / sling and have been injured, you may be entitled to monetary compensation. Problems include pain, inability to have intercourse,bleeding, mesh growth into the body, mesh erosion, and more. Problems could be irreversible. Please fill out the form to the right or call us so that we can provide you with forms to evaluate your potential case immediately.

We are accepting case evaluations nationwide and in Canada, as well.  Please do not hesitate or delay in contacating TVM / TVT Sling and transvaginal mesh attorneys :

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

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