All prescription drugs that desire to be marketed in the U.S. must gain the approval of the Food and Drug Administration (FDA). Through the Center for Drug Evaluation and Research (CDER), which assures that safe and effective drugs are available to the American people, a prescription drug must pass a series of trials. Please understand that the FDA does not develop, manufacture or test drugs. Drug manufacturers submit full reports of a drug’s studies to the CDER so that the Center can evaluate its data. The studies answer the question, “Does this drug work for the proposed use?” By analyzing the data, CDER reviewers assess the benefit-to-risk relationship and determine if the drug will be approved. Once the drug has been placed on the market, the FDA continues to monitor it through post-marketing reports sent in by the manufacturer and through the MedWatch program – an FDA program that allows consumers and health care professionals to report serious side effects, quality control issues, and medical errors associated with drugs and products regulated by the FDA.

Sometimes, an unanticipated side effect manifests itself once the drug has been made available to the U.S. market. If the side effect is serious enough, the FDA may issue a warning to the public and request that changes be made to the drug’s label. If the side effect is extremely serious and the FDA decides that the risks of the drug outweigh its benefits, then the FDA may recall the drug.

Speak to a Lawyer

Each year, thousands of people die from or are seriously injured by prescription drugs, over-the-counter drugs and medical devices they believe to be safe. If you or a loved one have taken a defective drug, experienced problems with a defective medical device or used a defective product, then contact our law firm immediately. Consult an attorney privately to learn your legal rights. All information is held in the strictest of confidence.

Contact a Drug Lawsuit Lawyer & Attorney

For a free and confidential consultation, fill out our online case evaluation form or call us toll free at: 1-800-883-9858.

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Lawsuits have recently been filed against the pharmaceutical giant, Johnson & Johnson, for manufacturing a prescription drug named Risperidone.  The shelf name of this drug is Risperdal.  In 1993, the Food and Drug Administration (FDA) approved this drug as a treatment for autism, schizophrenia and mania.  Risperdal was designed to alter certain hormones and substances in the brain, and is classified as an antipsychotic drug. Although users were experiencing an improvement of their mental condition, there was an associated increase in the risk of development Gynecomastia in boys and young men. The young men have experienced the highest risk, due to the continuing development and growing of their bodies.

Some of the victims have experienced and suffered from enlarged breasts to double mastectomies. The side effects in men and the increased risk of Gynecomastia are terrifying. The side effects not only include the growth of female-like breasts, but also emotional trauma, work depression, and anxiety.  The implications of the social side effects are heavy in men with careers due to the emotional baggage that Gynecomastia can bring into your life. Also, there is no guarantee that a procedure such as a mastectomy will remove the emotional scars cased by the embarrassment and pain while engaging in every day life with a condition as such.

The victims of Risperdal have suffered from the effects far beyond what any man should ever have to endure. Johnson & Johnson has paid billions in fines over Risperdal lawsuits, and are continuing to feel the heat from the FDA, attorneys, and victims of this potent drug that was carelessly manufactured. Several Risperdal Gynecomastia, enlargement of male breast, actions have been reported and filed against Johnson & Johnson and their subsidiary, Janssen.

Mental health physicians strongly encourage these young boys and men to take action before significant mental and emotional pain take over their life. The shame and humiliation can be healed and recovered and we want to help you.  If you or a loved one has been diagnosed with Gynecomastia and has experienced side effects as such listed, you may have a claim against one of the leading pharmaceutical companies in the nation. Call The Willis Law Firm at 1-800-883-9858 for your free case evaluation or fill out the Online Form to the Right ->

Talcum powder used by hundreds of thousands of women may be responsible for causing an increased risk of Ovarian Cancer. Recently, a talcum powder ovarian cancer lawsuit was filed as a class action against Johnson & Johnson (J&J) in California federal court. This lawsuit claims that J & J’s baby powder / talcum powder products can significantly increase the risk of ovarian cancer when used by women for personal hygiene.

Talcum Powder – Cancer Risk

According to cancer studies, women who used baby /talcum powder in their genital areas were at a 33% increased risk of developing ovarian cancer when compared to women who did not use the products on their genitals. The only warnings on many of the baby powder and talc powder is to keep the powder away from the eyes, avoid inhaling it, and to use it only externally.

Evidence shows that Johnson & Johnson knew as early as the early 1980’s. Sixteen years later, the American Cancer Society warned that a new study showed that women who used the powder more frequently and over longer periods of time were at greater risk of ovarian cancer from talc-based baby and body powders.

Talc Powder Ovarian Cancer Lawyer

If you or a loved one used talcum powder, baby or body powders that contained talc and were diagnosed with ovarian cancer, then you may have a right to file a personal injury lawsuit for the injuries and losses that you have suffered.  You may be legally entitled to financial compensation.

Talc Lawsuit Evaluation – Call Nationwide 1-800-883-9858

Talc Powder and Ovarian Cancer Linked

Evidence confirms that since the early 1970s, baby powder manufacturers have been aware, yet unresponsive, to the risks associated with the use of talcum powder and ovarian cancer.  Meanwhile, one of the largest cosmetics corporations in the nation has intentionally partnered with talc mining companies to obtain the intensely dangerous mineral used in these products advertised to be clinically proven as safe, gentle and mild.  Leading the baby powder industry, Johnson & Johnson (J&J) has additionally marketed the use of baby powder to result in smooth and fresh skin, however, numerous cancer prevention associations insist that this marketing has proven Johnson & Johnson irresponsible in marketing such a product in false light.  Despite multiple petitions to the Food and Drug Administration (FDA), the hazardous mineral talc has yet to receive any regulation of its use in the United States.  Subsequently, justice must be obtained for the women who have suffered and died as a result of the use of baby powder, initiated through talcum powder cancer lawsuits.

Science Behind Talc Powder and Cancer Risks to Women

Though one the most natural-occurring substances, talc powder has been linked to ovarian cancer in women. Talc, the main ingredient in baby powder, is an extremely delicate mineral composed of magnesium, silicon and oxygen.  The mineral is mined and used in many industries, including papermaking, paint, electric cable, and cosmetics.  Talc in its powder form is used as a rash preventative, absorbing excess moisture and reducing friction between the skins.  The mineral, while few redeeming qualities do exist, has a comparable chemical composition with asbestos, another substance known to cause life-threatening cancers.  As women use baby powder, the direct application of the talc to the genital area results in the mineral traveling up the vagina and into the ovaries, where the cancer is developed and proliferated.  The cancer cells continue to grow in an uncontrolled manner, invading the tissue and eventually spreading throughout the body. The growth of ovarian cancer cells can be deadly and the use of baby powder can increase your risk of ovarian cancer.

Experts and research shows that approximately one in five American women applies talcum powder to her genital area on a daily bases.  Cancer cell development from talc powder is a product of the talc particles creating an inflammatory response in the ovaries. Medical experts have long known that inflammation in the ovaries causes proliferation of cells, further resulting in the malignant transformation of ovarian cancer cells. The build-up of the talc particles in the ovaries combined with the said inflammation leaves a woman three times as likely to develop ovarian cancer than those who refrain from use. Talc particles can settle into the body tissue for many years, leaving the female users in grave risk of cancer.

Talc Powder Cancer Lawsuit

If you or a loved one has used a talc-based baby powder and was diagnosed with ovarian cancer, our law firm is waiting to diligently work on your behalf to get you the compensation you deserve.  You can rest assured that we will provide the highest quality of legal representation to eliminate your worry and burden during this troubling time, and further guarantee that we will charge you no fee unless we win compensation on your behalf.
Call us TODAY to answer your questions and determine the legal actions available to you through a Talc Powder Cancer Lawsuit. Call our law firm today at 1-800-883-9858

FDA Warns of Benicar Diarrhea Side Effects

Benicar is a drug used to monitor and reduce hypertension, or high blood pressure (HBP).  Common side effects of Benicar that are listed on the label include: back pain, headaches, dizziness and bronchitis, flu-like symptoms and hematuria.  All drugs approved by the Food and Drug Administration (FDA) are required to have a companion warning labels with a list of potential and familiar, yet more infrequent, side effects. Nonetheless, some drugs fail to list all side effects until someone is effected by the drug in a negative capacity, causing severe medical attention.

A more serious potential side effect has come to light associated with the drug Benicar. Individuals nationwide are experiencing severe diarrhea, hindering their ability to participate in their daily activities. Amongst the condition patients have experienced nausea, vomiting, and considerable weight loss. In 2013, the FDA required Benicar to enlist new warnings, however, some users of the medication are experiencing a so-called lasting effect of the drug. Individuals who have stopped the medication are still under the wraths of the drug, experience excessive diarrhea and sickness.

The implications of lasting diarrhea and stomach issues extend further than just uncomfortability.  Chronic diarrhea can leave individuals feeling:

  • Dehydrated – loss of the body’s ability to keep and maintain electrolytes
  • Malnourished – inability to consume and ingest nutritional foods and receive the benefits
  • Weak immune system – damage to the bodies vital need to protect and maintain cells, blood, and muscles

Talk to a Benicar Lawyer Today

Amongst all these listed side effects is the potential for Benicar to take the life of a user.  If you or a loved one has been affected by the hypertension, or blood pressure medication, Benicar, call The Willis Law Firm to discuss your legal options. An attorney is waiting to talk to you and give you your FREE consultation. Call toll-free TODAY 1-800-883-9858 or fill out the ONLINE FORM to the Right ->

 

Common Product Found in Baby Powder Connected to Cancer

For over four decades, the healthcare industry including, but not limited to, medical professionals, medical science researchers, and organizations directed towards cancer awareness have been conscious of a potential link between the use of talcum powder and ovarian cancer in women. Unfortunately, only a mediocre effort has been put forth from the healthcare industry in petitioning the Food and Drug Administration (FDA) to investigate and potentially recall thousands upon thousands of bottles of baby powder containing talcum powder.  The leading manufacturer of baby powder has also been aware of the life-threatening risks linked to the product; however, no action has been administrated for a recall, and the manufacturers further continue to market their product as safe, gentle and mild.

Studies and Talcum Powder Awareness

A casual link between ovarian cancer and talcum powder usage has been amongst topics of cancer awareness organizations since the 1970’s.  Talcum powder is used in many cosmetics, predominantly in baby powders as a rash preventative and moisture absorbent.  A study administered by the American Association for Cancer Research (insert hyperlink:http://cancerpreventionresearch.aacrjournals.org/content/6/8/811 ) suggests a high probability of an aggressive connection between ovarian cancer and the use of talcum powder. The numbers within these studies speak volume, particularly those relating a 30% higher risk of cancer with those females who applied talcum powder to the genital area over a period of time.

Jury Found Johnson & Johnson Failed to Warn of Talcum Powder Link to Cancer

A leading manufacturer has failed to warn consumers of a link between cancer and talcum powder.  The powder has an extremely comparable chemical composition with asbestos, another substance known to cause life-threating cancers.  Less than one year ago, Johnson & Johnson (J&J) was found negligent by a jury verdict due to inadequate warning of this known link to cancer and their baby powder product line.   J&J was aware of the impending issues with females applying the powder to their genitals, yet did not allege to any warning whatsoever.  J&J and Talc Powder

Ovarian Cancer Lawyer

Our firm is duly working to gather more information on the safety of talcum powder and the makers of baby powder containing this mineral.  If you or someone you know has been affected with ovarian cancer and has prior use of talcum powder in the vaginal area, please call us TODAY to answer your questions and determine the legal actions available to you through a lawsuit.  Call our firm today at 1-800-883-9858.

Ethicon Mesh Recall

In June of 2012, the Ethicon, Inc. division of Johnson & Johnson notified the US Food and Drug Administration that it would no longer be offering some of its Gynecare Women’s Health Mesh products. Although this Ethicon mesh recall was voluntary and not mandated by the FDA, Johnson & Johnson will also case to commercialize these products. They will also be notifying physicians and patients in order to allow them the opportunity to select other treatment options. The four products impacted by this mesh recall decision by Ethicon are the following:

  • Ethicon Gynecare Prolift Pelvic Floor Repair System
  • Ethicon Gynecare TVT Secur System
  • Gynecare Prosima Pelvic Floor Repair System
  • Gynecare Prolift+M Pelvic Floor Repair System

Ethicon Mesh FDA Warning

These decisions by Ethicon to recall the advertisements and offering of these mesh products comes following several warnings from the FDA regarding the increased risk of complications associated with the transvaginal use of surgical mesh. As early as 2008, the FDA warned about vaginal mesh following a large number of adverse event reports in the time period between 2008-2007. However, from2008-2010, there were an even larger number of incidents reported. When the US Food and Drug Administration compiled literature regarding Ethicon and other brands of mesh using data from 1996-2011, they were able to conclude that complications from vaginal mesh are NOT RARE and mesh products were deemed an area of ongoing concern.

Ethicon Mesh Recall Lawsuits

The victims of Ethicon Mesh injuries often choose to pursue litigation against the manufacturer of their particular device. At present there is both state and federal level litigation pending against Johnson & Johnson’s Ethicon, Inc. Additionally, mesh recall lawsuits are pending against several other manufacturers as well, including C. R. Bard, Boston Scientific, and American Medical Systems. Many of these mesh lawsuits were filed after the FDA declared that transvaginal mesh did not appear to provide any benefits for patients that would justify the increase in risk and complications.

File an Ethicon Mesh Recall Lawsuit: Attorney Consultation

Have you experienced mesh erosion or other serious injury following treatment with an Ethicon mesh implant? If so, contact the Willis Law Firm today for a free and confidential recall lawsuit consultation. We know that these are potentially embarrassing women’s health issues, so we have female consultants available for your comfort. Currently, we are assessing Ethicon lawsuit claims in all fifty states, and all mesh clients are represented on a fee contingent basis. If we don’t recover for you, you don’t have to pay any legal or attorney’s fees.

Paxil and Pregnancy

Back in 2006, the Food and Drug Administration (FDA) announced that research evaluations of the prescription antidepressant Paxil discovered that taking Paxil during pregnancy, specifically during the first three months of pregnancy, may significantly raise the risk of having an infant with birth defects. The most common Paxil birth defects found were congenital (present at birth) heart defects.

Paxil is a popular antidepressant medication and is part of a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). SSRI antidepressants work by altering certain chemical levels in the brain used to communicate called neurotransmitters. A lot of scientific experts believe that depression is a result of an imbalance in the numbers of different neurotransmitters in the brain. Other antidepressants in the SSRI class include Zoloft, Prozac, Celexa, and Effexor. Paxil has been approved by the Food and Drug Administration (FDA) to treat depression and certain other psychiatric disorders.

Two studies examined by the Food and Drug Administration (FDA) determined that women who took Paxil during the first trimester of pregnancy were approximately twice as likely to have an infant suffering from a heart defect compared to women who took other antidepressants during pregnancy. The majority of the Paxil heart defects found in the research study were atrial and ventricular septal defects which are holes in the chamber walls in the heart.

Atrial and ventricular septal defects may vary greatly in severity. In some cases they can be fairly minor, and some are more serious which may require operation or even a heart transplant early in life. Among the general population of pregnancies, these types of heart defects occur in about 1 of every 100 births, but in Paxil pregnancies they occur about twice as frequently.

The FDA report has resulted in the manufacturer of Paxil, Glaxo Smith Kline, changing the warning label on their prescription packaging. Where previously it was a pregnancy category C drug, it is now a pregnancy category D drug. This is a significant change because it now recognizes that studies among pregnant women have demonstrated that Paxil causes a risk to unborn children. The FDA is urging medical professionals not to prescribe Paxil to pregnant women or women who are considering becoming pregnant.

Paxil and Pregnancy Lawsuit: Speak to an Attorney

Many new parents ask themselves what was the cause of my child’s birth defects? Did it happen during pregnancy? The antidepressant Paxil may be linked to causing the development of birth defects of unborn babies, infants, and children when their mothers took them while pregnant.

Our law firm is handling individual birth defect lawsuits against drug and pharmaceutical companies and currently accepting new Paxil cases across the nation. If your child was born with a birth injury that you believe may have been caused by taking an antidepressant like Paxil during pregnancy, then you should contact our law firm as soon as possible for a free confidential review of your potential birth defect lawsuit case. All cases are handled on a Contingency Fee Basis (no attorney’s fees or expenses charged unless we recover for you).

Contact a Drug Lawsuit Lawyer & Attorney

For a free and confidential consultation, fill out our online case evaluation form or call us toll free at: 1-800-883-9858.

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A woman in Pennsylvania recently filed a lawsuit against Boston Scientific Corporation alleging that one of their products, the Advantage Fit System, caused her serious physical complications. The woman was treated with the transvaginal mesh product in 2009 to help with her issue of stress urinary incontinence, an involuntary urine leakage problem that affects many women. According to her mesh lawsuit claim, the woman began to experience pain, bleeding, and extreme discomfort during intercourse shortly following her initial Advantage Fit SUI treatment. These complications related to transvaginal mesh have been described as “not rare,” by the US Food and Drug Administration in various safety communications and warnings. The Pennsylvania Boston Scientific Advantage Fit Lawsuit plaintiff underwent a transvaginal mesh revision surgery in 2010, but continued to experience mesh complications including: stomach pain, bleeding, and infections. As a result of these continuing discomforts as well as the medical expenses required for treatment, a mesh erosion lawsuit claim was filed.

Boston Scientific Advantage Fit FDA Warning

In October of 2008, the United States Food and Drug Administration alerted the public to the complications connected to transvaginal mesh surgery for pelvic organ prolapse and stress urinary incontinence. In the three years prior to the FDA mesh warning, over one thousand adverse event reports were filed in relation to surgical mesh. Between 2008-2010, this number grew closer to 3000. When another FDA transvaginal mesh warning was made in 2010, vaginal mesh complications and mesh erosion were named as “an area of continuing serious concern.” The FDA is still collecting data and reviewing studies regarding Boston Scientific Advantage Fit as well as all other transvaginal mesh sling devices.

Boston Scientific Advantage Fit Complications

  • Mesh erosion (when the mesh protrudes through vaginal walls)
  • Vaginal Pain
  • Mesh contraction (when the mesh shrinks)
  • Organ perforation (can occur during surgery)
  • Pain during intercourse
  • Reoccurrence of SUI and/or POP
  • Vaginal Scarring
  • Emotional problems

File a Boston Scientific Advantage Fit Lawsuit: Consult with an Attorney

Treatment with Boston Scientific Advantage Fit and other transvaginal mesh slings presents additional risks that are not present in other non-mesh forms of treatment for SUI and POP. If you have suffered injuries resulting from surgical mesh, you may have a potential lawsuit claim. Call the Willis Law Firm in order to have your case evaluated free of charge or obligation by a female member of our talented legal team. At present, we are accepting vaginal mesh clients nationwide.

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For a free and confidential consultation, fill out our online case evaluation form or call us toll free at: 1-800-883-9858.

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Recent studies as well as FDA adverse event reports have linked transvaginal mesh surgery for stress urinary incontinence and pelvic organ prolapse to high risks of complications, like mesh erosion. Medical device manufacturer Boston Scientific is one of four major companies that develops and distributes this problematic type of transvaginal mesh. One such model is called the Solyx SIS System, which is a sling made of Advantage Mesh and is used to treat stress urinary incontinence. Unfortunately, the Solyx System as well as all other transvaginal mesh product can result in serious complications that can require hospitalization and revision surgeries. In many patients, even a second surgery cannot fully fix the problem of mesh erosion, and the quality of life for the victim is permanently diminished.

Other Boston Scientific Transvaginal Mesh Products

The Solyx SIS System is not the only mesh device that has been developed and created by the Boston Scientific Corporation. Currently, Boston Scientific has all of the following mesh products available for the treatment of either pelvic organ prolapse, stress urinary incontinence and/or vaginal wall prolapse:

  • Advantage Fit System
  • Advantage Transvaginal Mid-Urethral Sling System
  • Lynx Suprapubic Mid-Urethral Sling System
  • Obtryx Transobturator Mid-Urethral Sling System
  • Pinnacle Pelvic Floor Repair Kit
  • Pinnacle Posterior Pelvic Floor Repair Kit
  • Prefyx PPS System
  • Solyx SIS System
  • Uphold Vaginal Support System

Boston Scientific Solyx FDA Warning

In January of 2012, the United States Food and Drug Administration is considering that transvaginal surgical mesh be reclassified from Class II to Class III when used in treatment for stress urinary incontinence and pelvic organ prolapse. This decision was based on information collected from adverse event reports of vaginal mesh complications, medical literature published on the subject, as well as the September 2011 meeting of the Obstetrics-Gynecology Devices Panel. Furthermore, the FDA has mandated postmarket studies the manufacturers of transvaginal mesh used in both SUI and POP treatment. As soon as further information is discovered regarding Boston Scientific Solyx and other devices, the FDA will make it available to the public.

File a Boston Scientific Transvaginal Mesh Lawsuit: Speak to an Attorney

Many women who suffer from mesh erosion and other bladder sling complications find themselves bombarded with medical expenses as the result of their injuries. If you have been hurt as the result of treatment with the Solyx SIS System or other type of transvaginal mesh, call the Willis Law Firm today. We may be able to help you secure financial damages in relation to your situation; currently we are looking at mesh cases nationwide. Call us today.

Contact a Drug Lawsuit Lawyer & Attorney

For a free and confidential consultation, fill out our online case evaluation form or call us toll free at: 1-800-883-9858.

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Recently the US Food and Drug Administration has issued several safety communications regarding high risks of serious complications associated with transvaginal mesh, like Ethicon’s Gynecare Prolift System. Many lawsuits have been filed against Ethicon, a division of Johnson & Johnson, by patients who have suffered from painful and even life-threatening adverse effects. Transvaginal mesh bladder slings are used in the treatment of pelvic organ prolapse as well as stress urinary incontinence. However, the FDA has stated that although they pose extra risks to patients, they do not necessarily work better than other non-mesh treatment options.

What is the Ethicon Gynecare Prolift System?

The Gynecare Prolift Pelvic Floor Repair system is a vaginal mesh bladder sling device produced and marketed by Johnson & Johnson’s Ethicon division for the treatment of pelvic organ prolapse. Pelvic organ prolapse (POP) is a condition that takes place when various tissues that hold the organs in the pelvic region become stretched out or weakened. POP can affect the uterus, rectum, bowels, bladder, and vaginal apex. The Gynecare Prolift mesh is transvaginal, meaning that it is inserted through the vagina, and helps to restore support to organs that have prolapsed. Unfortunately, using transvaginal mesh, like the Gynecare Prolift System, can result in harmful complications including: infection, urinary problems, mesh erosion, and others.

Ethicon Gynecare Prolift System Complications

The side effects and complications that can result from transvaginal mesh treatment can seriously affect a patient’s quality of life. The most commonly reported complication with Gynecare Prolift and other similar devices is called mesh exposure, and occurs when the mesh erodes through the vaginal wall. When this erosion takes place, the result is very painful, especially during sexual intercourse. Treatment for these Gynecare Prolift complications often requires a revision surgery in order to remove the mesh, as well as IV treatment and possibly even blood transfusions. Sometimes, even a second surgery cannot fully remove the mesh.

File a Ethicon Gynecare Prolift Lawsuit: Speak to an Attorney

Have you experienced transvaginal mesh erosion or other complications following treatment with the Gynecare Prolift System or similar device? If so, you may be legally entitled to significant financial damages. Call the Willis Law Firm today and we will provide you with a free and confidential Gynecare Prolift Lawsuit Evaluation. Our firm is currently reviewing vaginal mesh cases nationwide, and we have a team of female consultants ready to discuss these sensitive women’s health issues with you in confidence. Call us today, and get the help you need.

Contact a Drug Lawsuit Lawyer & Attorney

For a free and confidential consultation, fill out our online case evaluation form or call us toll free at: 1-800-883-9858.

Contact an Attorney

Legal help: Contact an Attorney