human_trafficking

Human Trafficking

A person becomes a victim of human trafficking in the form of sexual exploitation or slave labor every 30 seconds across the globe, including in the United States. Each year, 5 million new victims of human trafficking are forced into becoming commercial sex slaves. Of those 5 million, at least half and up to 60% or more are children. Human trafficking is estimated to be a $150 billion business for traffickers. Whereas selling drugs or guns involves one-time transactions, victims of human trafficking are “reusable.” Karla Jacinto of Mexico City, Mexico, for example, has shared her story of being raped up to 30 times a day, seven days a week, between age 12 and 16—up to 43,200 times. Putting a stop to this growing crisis begins with raising public awareness because the facts indicate that anyone could become a victim at any time.

Human Trafficking Defined

Sex trafficking, as defined in federal law 22 USC § 7102, is: The recruitment, patronizing, harboring, provision, soliciting, or harboring of an individual for the purposes of a commercial sex act, in which said act is induced by coercion, fraud, or force, or in which the individual induced to perform a commercial sex act is younger than 18 years old.

Labor trafficking, as defined in the same law, is: The provision, transportation, obtaining, harboring, or recruitment of an individual for services or labor through the use of fraud, force, or coercion for the purposes of subjection to involuntary debt bondage, slavery, peonage, or servitude.

Reasons to Raise Awareness About Human Trafficking

Human trafficking is a serious public threat. Although every January is Human Trafficking Awareness Month, there is a desperate need for greater public awareness, to achieve the following and more:

  • To help people avoid becoming victims.
  • To shine the light on areas of society in which human trafficking is prevalent.
  • To learn specific strategies used by traffickers to lure children and other vulnerable individuals into sex trafficking or slave labor traps.
  • To recognize signs that an individual is a victim of sex trafficking or slave labor.

Some victims are used for both commercial sex and slave labor, which federal law defines as one of the more severe forms of trafficking in persons.

Some Facts About Human Trafficking

There are many misconceptions about this modern crisis. The following are some important facts about human trafficking:

  • More than 7,500 human trafficking tips were reported in 2016, and 2,075 of these tips, at least, involved U.S. citizens or lawful permanent residents.
  • Sex trafficking occurs in many legal business environments, including escort services, strip clubs, and pornography operations. The setting is irrelevant because any person induced to perform commercial sex or slave labor is a victim of human trafficking.
  • Human smuggling is different from human trafficking. Human smuggling violates immigration laws, and those being illegally brought into a country are consensual participants. If a person who is smuggled in is forced or coerced into slave labor or commercial sex, he or she is a human trafficking victim.
  • Many sex trafficking victims do not realize that they are victims of exploitation or manipulation. Abused and vulnerable youth are the most frequent targets of sex traffickers.

Victims often fear authorities, fear retaliation by traffickers, or blame themselves. In the case of foreign nationals in the U.S., the victims often don’t know their rights.

How Do Traffickers Exercise Control Over Victims?

In a world so connected through the Internet and social media, how is it that so many people are being victimized by human traffickers?

The victims are placed in seemingly impossible situations, and they do not have access to cell phones or other electronics. The traffickers strip their victims of their identity. Identification documents such as passports, drivers’ licenses, birth certificates, and social security cards are taken from them. The victims may live in a crowded space with many others, or they may live with their employer. They are often forced to recite rehearsed or scripted answers to questions others may ask, or they are prevented from speaking with other people at all. Traffickers also use violence, deception, debt bondage, and threats on victims, to coerce them into engaging in slave labor or commercial sex against their will.

Where Do Acts of Commercial Sex Trafficking Occur?

Truck stop and hotel and motel chains are used for incidents of sexual exploitation at an alarming rate. Commercially-operated truck stops have extremely organized sex trafficking rings, and the fact that such locations are often isolated from public view and a law enforcement presence is much of the reason. The traffickers get away with moving freely with no detection or interference. Many truck stop facilities cater to their customers, becoming channels of various types of sexual exploitation, including sex with minors.

Hotels and motels often operate in a similar way, promoting and profiting from human trafficking. According to the National Human Trafficking Hotline, most calls reporting suspicion of sex trafficking involve hotels.

The Polaris Project, an organization on the frontlines of combatting human trafficking, said that an estimated 1,867 victims and survivors that were trafficked through the hotel and motel industry were identified between 2007 and 2015. Among those individuals, 92% had been victims of sex trafficking, 5% were used as slave labor, and 2% were used for both commercial sex and forced labor. Luxury hotels and low-end motels alike have been found to continually ignore evidence of human trafficking, and most have so far refused to implement anti-trafficking policies.

Human Trafficking and the Internet

The Internet has contributed significantly to the growth of human trafficking. Various social media websites are believed to be used for 86% of the child trafficking that occurs in the world. These websites have included Craigslist and Facebook.

Backpage.com is a now-closed website that was believed to have been involved in more than 73% of all reports of child trafficking in recent years. Billions of dollars were spent in advertising on the site, and words used as signals that minors were being trafficked were allegedly stripped from advertisements, so that the website wouldn’t lose out on the income from advertising. Allegedly, Backpage.com sanitized and censored words signaling that an ad involved a minor. Among those words were: “teen,” “innocent,” “Amber alert,” “daddy’s little girl,” and “young.” Once the changes had been made, the true intent of marketing children was hidden on advertisements appearing to involve legalized prostitution.

Protection Through Cyber Laws Erased

Loopholes in cyber laws allowed websites to escape liability for involvement in sex trafficking until April 2018, with the passage of the Fight Online Sex Trafficking Act (FOSTA). Previously, Section 230 of the Communications Decency Act of 1996 contained the loophole. Now its wording allows for prosecution and civil liability of websites proven to knowingly support, facilitate, or assist in sex trafficking.

Victims’ Stories

Many stories of human trafficking victims are being told, and many choose to remain anonymous. Two victims referred to as Jane Doe 1 and Jane Doe 3 said traffickers shuttled them from trucks stops to hotels in the Houston area for nearly two years.

Jane Doe 3 says her ordeal began in her senior year of high school when a boy in class she was attracted to invited her to a party. She went, and he talked her into trying methamphetamine, making her a vulnerable target.

Jane Doe 1 said she thought hotels were supposed to be safe places for families. But she would be in a room next door to families, where she would be raped by anywhere from 10 to 20 men per night. She says that her trafficker got her started at a truck stop. He dressed her in revealing clothing and instructed her to knock on the truck doors and ask if they needed anything, which was a code to indicate she had been sent there for sex by a trafficker.

Both of the girls were shocked to find that they were overlooked, as though invisible. They felt it was obvious that they were being trafficked and yet they passed right by the valet, the concierge desk, and hotel maids in the hallways. It made them feel that no one cared about their situation.

Jane Doe 1 said that people would talk to her and see that she was a teenager and yet stand by and watch men going in and out of her room. She said the hotels are failing to take appropriate actions that could help people who were being victimized.

In Texas, where these stories unfolded, the law says that companies, their shareholders, and their executives can all be held civilly liable if they knowingly or intentionally profit from human trafficking.

In the past 10 years, Polaris Project has recorded more than 3,300 human trafficking cases in hotels, though they say that number is not an accurate representation of the full extent of the crisis.

How to Identify a Victim of Human Trafficking

Various organizations and businesses provide tips for recognizing a possible victim of human trafficking. They also suggest some questions that can be asked of the victim and actions you can take to alert authorities.

The following can be red flags or signs that a person is a victim of human trafficking:

  • Appears to be in a relationship with a person who is dominating over them.
  • Is never alone or someone always answers questions or translates on their behalf.
  • Tearfulness.
  • Appearing depressed, which may be manifested by looking fatigued, restless, sad, or hopeless.
  • Has no documents for identification.
  • Has unexplained cuts, bruises, or other signs of physical abuse.
  • Unable to provide an address on where they live.
  • Inconsistent details when relaying their story.
  • Under age 18 and providing commercial sex acts or any age unwillingly performing commercial sex acts.
  • Expresses fear of law enforcement or receiving help from any outside entity.
  • No control of their own finances.
  • Unable to schedule appointments or leave their residence or job.

Questions to ask a possible victim of human trafficking, if able to get him or her alone:

  • Are you being threatened?
  • How did you get those bruises? Is someone hurting you?
  • Are you free to leave your house or job whenever you want?
  • Are you paid for your job, and is it fair?
  • How many hours per week do you work?
  • Do you owe a debt to someone?
  • Do you live near or with your employer? Are there locks on windows or doors from the outside, where you live?

Take the following actions, if you suspect a person is a victim of human trafficking:

  • Ask the individual if you can help them to go immediately to a safe place.
  • If time is needed, create an action plan to provide them a safe place, for when they are ready.
  • Call the human trafficking hotline at 1-888-3737-888 or have the victim call the number. The hotline has language capabilities.

Sex Trafficking Cases in the News

According to a CNN story published May 8, 2018, the U.S. Olympic Committee (USOC) and taekwondo stars have been accused of sex trafficking. Four women who trained with a team of two brothers, including one Olympic gold medalist, have accused the U.S. Olympic Committee of ignoring reports of sexual abuse. They have accused the brothers involved with assault, rape, and other types of misconduct. USOC and USA Taekwondo are both accused of knowingly participating in sex trafficking and with allowing young women to be sexually abused by the brothers, who were involved with taekwondo.

In October 2, 2018, news from Reuters, Facebook has been sued by a woman who claims the social media website enabled sex trafficking. At the age of 15, she claims to have been raped, beaten, and sex trafficked by a pimp who had invited her to be a friend on Facebook. The woman alleges that executives of the social network were aware that their platform was being used to lure minors into the sex trade.

Legal Recourse for Human Trafficking Victims

Attorneys at The Johnston Law Group are involved with efforts to represent victims of human trafficking in civil lawsuits against employers that participate in sex trafficking and forced labor. The Trafficking Victims Protection Reauthorization Act of 2003 (TVPRA) is federal legislation allowing for this type of legal recourse. If you or a loved one has been a victim of human trafficking, contact the professionals at the Johnston Law Group by calling 844-464-0062 today.

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stephaniemchugh-writer

Stephanie McHugh​

Stephanie McHugh is a professional writer who specializes in legal articles, technical blogs, and website copy. She is a former Official Court Reporter for a District Court in Houston, Harris County, Texas; newspaper columnist; and teacher. Stephanie is a professional writer with extensive experience reporting on health-related topics for publication. She developed an interest in health-related litigation as a court reporter while taking depositions for a class action lawsuit. Through her writing, she has been glad to help raise awareness about public health threats, to benefit victims.

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If you are in immediate danger, contact 911.

For assistance, call the National Human Trafficking Hotline at 1-888-373-7888. You can reach the Hotline 24 hours a day, 7 days a week in more than 200 languages. All calls are confidential and answered live by highly trained Anti-Trafficking Hotline Advocates.




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    Pradaxa Bleeding Complications

    Pradaxa® is a blood thinner associated with uncontrollable bleeding, death, and thousands of lawsuits. The manufacturer of the drug is Boehringer Ingelheim Pharmaceuticals. The Federal Drug Administration (FDA) initially approved Pradaxa® (dabigatran) in 2010. There were 540 deaths attributed to the anticoagulant in 2011. In addition, thousands of other patients suffered from serious side effects that same year. By 2014, 4,000 lawsuits against Boehringer Ingelheim were settled when the drug manufacturer paid out $650 million. Thousands more lawsuits against the drug maker are pending.

    Red flags

    It wasn’t long after Pradaxa® was released that trauma surgeons and emergency room physicians began reporting that patients taking Pradaxa® were suffering from life-threatening bleeding, and reversing the effects of the drugs was difficult. In the year following release of Pradaxa, 2011, the drug was cited on more reports of death or injury than any other drug being monitored that year by the Institute for Safe Medication Practices, according to a New York Times report.

    Claims Made in Pradaxa® Lawsuits

    Lawsuits against Pradaxa® are being filed because of uncontrollable bleeding and death as well as serious side effects. Pradaxa® increases the risk of brain bleeding, gastrointestinal bleeding, and heart attack, which can all cause death. The following are more of the common side effects of taking Pradaxa®:

    • Pink or brown urine
    • Bloody stools or black, tar-like stools
    • Stomach pain
    • Headache
    • Heartburn
    • Upset stomach and nausea
    • Vomiting or coughing up blood or a substance resembling coffee grounds
    • Difficulty swallowing or breathing
    • Excessive bleeding from a cut
    • Chest tightness or pain
    • Feeling faint, dizzy, or weak
    • Swelling or joint pain
    • Heavy menstrual bleeding
    • Frequent nosebleeds
    • Unusual bleeding or bruising

    In addition, some patients have experienced allergic reactions to taking Pradaxa®. The following are signs of an allergic reaction, and patients who experience any of the symptoms should contact their doctor:

    • Feeling faint or dizzy
    • Swelling of your tongue or face
    • Difficulty breathing
    • Rashes, itching, and hives
    • Chest tightness or pain

    Bleeding and Pradaxa®

    It’s not always apparent when a person is experiencing internal bleeding. If you are taking Pradaxa®, it is important to be aware of signs that internal bleeding may be taking place. Severe symptoms of internal bleeding include vomiting or coughing up blood or a substance similar to blood, black or bloody stools, bleeding that takes longer than usual to stop, and bruising.

    Clinical Trials

    The first Pradaxa® clinical trials ran in 2009, and they were called RE-COVER I and Randomized Evaluation of Long-term Anticoagulant Therapy (RE-LY. Boehringer Ingelheim sponsored RE-LY. In the trials, the safety of Pradaxa® was compared to warfarin in the treatment of patients treated for pulmonary embolism (PE) and deep vein thrombosis (DVT). For decades, warfarin had been the traditionally used coagulant for preventing blood clots. In addition, the trials sought to determine whether Pradaxa® was more effective than warfarin at reducing the risk of stroke among patients with atrial fibrillation not caused by a heart valve problem.

    The trials reportedly showed that Pradaxa® prevents blood clots leading to stroke as effectively as warfarin. In addition, Pradaxa® was easier to use and potentially caused fewer side effects. Warfarin requires frequent blood tests and is affected by food, and Boehringer Ingelheim has claimed that neither of those issues apply with Pradaxa®.

    Clinical trials matching Pradaxa® head-to-head with warfarin became the catalyst for FDA approval, but studies done since that time have shown conflicting results. At the University of Pittsburgh, for example, 9,400 men and women with atrial fibrillation covered by Medicare were surveyed. The results of that study showed that 6% of those taking warfarin suffered a major bleed, compared to 9% of those who took Pradaxa®.

    RE-SPECT ESUS is a current and ongoing clinical trial seeking to determine whether Pradaxa® can prevent a second episode of embolic stroke. The participants recruited have experienced a recent episode of embolic stroke of unknown source (ESUS). August 14, 2018, was the scheduled completion date. Results have not yet been released.

    FDA Warnings

    Pradaxa® has not been recalled by the government, in spite of the dangerous side effects and many deaths associated with the drug. However, the FDA has issued a black box warning regarding dangers associated with stopping the use of Pradaxa®. Patients who quit taking the drug can have an elevated risk of stroke and of experiencing a blood clotting complication. The FDA urges patients who wish to discontinue the use of Pradaxa® to only do so under the care and supervision of a doctor.

    Patients sometimes need to stop taking Pradaxa® prior to a dental or medical procedure or surgery. Patients should speak to the physician who prescribed the blood thinner to them and find out when Pradaxa® should no longer be taken, leading up to the procedure. In addition, a doctor should give instructions on when to resume taking Pradaxa® again.

    In addition, in patients who have an epidural or spinal tap, Pradaxa® can cause a dangerous blood clot in the spinal cord, which can lead to paralysis.

    Pradaxa

    Spinal Blood Clots and Pradaxa®

    Patients have a heightened risk of developing a spinal blood clot after receiving a spinal tap or epidural if:

    • An epidural catheter is placed in your spine for the purpose of administering certain medications
    • You have a history of spinal surgeries and other spinal issues
    • You have a history of difficult or repeated spinal punctures
    • You are currently taking blood thinning medicines or other non-steroidal, anti-inflammatory drugs (NSAIDs).

    You should be closely monitored by your doctor for signs of a spinal blood clot if you are taking Pradaxa® and receive a spinal puncture or spinal anesthetic. Immediately contact your doctor if you experience any of the following symptoms:

    • Numbness and tingling
    • Incontinence
    • Back pain
    • Muscle weakness, particularly in your feet and legs

    Heart Attacks and Pradaxa®

    Events such as heart attacks, acute kidney failure, stroke, and liver failure have been reported by patients using Pradaxa®, in addition to the most frequent adverse event, gastrointestinal bleeding. In two separate studies comparing Pradaxa® users with other patients using such blood thinning agents as warfarin, both published reports showed concurrently that there is an increased risk of heart attacks among patients taking Pradaxa®.

    If you are taking Pradaxa® and experience any of the following severe symptoms of heart disease, immediately seek medical help:

    • Shortness of breath
    • Chest pain
    • Loss of consciousness and dizziness

    Antidote and Reversal Agent for Pradaxa®

    Pradaxa® was sold by Boehringer Ingelheim without a bleeding remedy for five years. During that five-year period, reports of adverse events among patients who took Pradaxa® quickly outpaced those who were treated with warfarin. Thousands of the patients taking Pradaxa® suffered uncontrollable bleeding, and sometimes it was fatal.

    Accelerated approval of an antidote to uncontrollable bleeding suffered by Pradaxa® patients was approved by the FDA in October 2015. Praxbind (idarucizumab) can reverse the blood-thinning effects of Pradaxa® in patients experiencing uncontrollable bleeding. It is currently the only antidote for Pradaxa® that has been approved by the FDA.

    Many healthcare providers are concerned about the safety of Praxbind, since it received accelerated FDA approval. Many medical professionals carefully advise patients to consider both benefits and drawbacks associated with taking Pradaxa® and other blood thinners that are relatively new.

    Manufacturing, Design, and Marketing Defects

    From the time of its release, Boehringer Ingelheim promoted Pradaxa® as a better option than the longer-used warfarin, with the following claims:

    • There are fewer interactions with other medications and with foods; and
    • Determining the correct dosage of Pradaxa® doesn’t require weeks of calibration, unlike warfarin.

    These claims have seemingly been disproven, however. The following is a timeline of label updates and Pradaxa® warnings, providing a glimpse into proven results among patients taking the blood thinner:

    2010: The drug label for Pradaxa® was updated after additional bleeding events in the RE-LY trial data were discovered.

    2011: Reports of serious bleeding events resulted in a post-market review of the drug by the FDA. The organization sought to determine whether there were more than the expected number of incidents of serious bleeding.

    2013: A black box warning was added by Boehringer Ingelheim regarding risks of discontinuing the use of Pradaxa® prematurely, and it states that some patients experience an increased risk of spinal hematomas.

    2014: A safety communication was issued by the FDA, stating that Pradaxa® causes a greater risk of gastrointestinal bleeding than warfarin. In addition, the safety communication says Pradaxa® has a lower risk for ischemic stroke, death, and intracranial hemorrhage and a similar risk for myocardial infarction.

    Many individuals involved in lawsuits against the drug maker argue that the higher risk of gastrointestinal bleeding is something they should have been aware of, and Boehringer Ingelheim should have appropriately warned doctors and consumers. Plaintiffs also claim that there was a violation in regulatory requirements because in the manufacture and marketing of Pradaxa®, there was not a proper warning regarding the serious, sometimes life-threatening, risks of taking the anticoagulant. By producing and promoting such a dangerous drug, plaintiffs also argue that Boehringer Ingelheim is guilty of a breach of warranty and of negligence.

    Pradaxa® Bellwether Trials

    Mary Boone was prescribed Pradaxa® by her doctor, to reduce her risk of a stroke from atrial fibrillation. Boone died on March 24, 2014, due to an uncontrollable gastrointestinal bleed. Her estate filed the first Pradaxa® case that went to a jury trial. According to court documents, Boehringer Ingelheim argued that the warnings for Pradaxa® were adequate, and the drug maker maintained that the deceased’s physician understood the risks involved in prescribing the drug. Members of the jury sided with the drug company in a verdict handed down on March 23, 2018.

    A lawsuit filed by Mary Lou Gallam became the second Pradaxa® bellwether trial. According to court records, in 2011, Gallam was prescribed Pradaxa®; and she subsequently experienced a “major bleeding event” in April 2014. Gallam’s case was also a jury trial, and jurors found in favor of the drug company in a verdict given on May 7, 2018.

    Have you Suffered Dangerous Effects of Pradaxa®?

    You may be eligible to file a Pradaxa lawsuit if you took the blood-thinner and suffered dangerous effects, such as severe bleeding. In addition, if you are a family member of someone who died following complications associated with the drug, such as brain bleed or gastrointestinal bleeding, it is possible that you could recover lost income and expenses by filing a lawsuit.

    Types of Pradaxa® Lawsuits

    A short time after the release of the blood thinner in 2010, it was evident that patients were experiencing a higher than usual number of adverse events, such as dangerous gastrointestinal bleeding. Early on, Pradaxa® lawsuits were filed in various states and in different federal district courts. When a Pradaxa® lawyer has examined a case and determined that a viable claim exists, one of the following two basic types of Pradaxa lawsuits is filed:

    • Personal Injury Lawsuits involve claims made by patients who took the anticoagulant and suffered severe bleeding.
    • Wrongful Death Lawsuits are claims filed by family members who died as a result of bleeding complications associated with taking Pradaxa®.

    Should I Get a Pradaxa® Attorney?

    There are many complexities involved with lawsuits related to product liability. A notable complication is that drug makers make billions of dollars annually on their products, and they willingly spend millions of dollars in lawsuits, to maintain the status quo and protect their continued profits. For these reasons, it is very important to work with an experienced Pradaxa® lawyer.

    stephaniemchugh-writer

    Stephanie McHugh

    Stephanie McHugh is a professional writer who specializes in legal articles, technical blogs, and website copy. She is a former Official Court Reporter for a District Court in Houston, Harris County, Texas; newspaper columnist; and teacher. Stephanie is a professional writer with extensive experience reporting on health-related topics for publication. She developed an interest in health-related litigation as a court reporter while taking depositions for a class action lawsuit. Through her writing, she has been glad to help raise awareness about public health threats, to benefit victims.​

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    Case Review

    If you are one of the thousands of people who have experienced uncontrollable bleeding after taking Pradaxa®, you may be eligible to receive compensation for your injuries.

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      Hernia Mesh Complications

      Hernia

      HERNIA MESH LAWSUIT

      Contact The Johnston Law Group for a free consultation about potential representation for a hernia mesh lawsuit.

      Thousands of hernia mesh lawsuits have been filed against various manufacturers. Each year in the U.S., hernia mesh devices are implanted in more than 100,000 ventral hernia surgeries. The U.S. Food and Drug Administration (FDA) has made only a few recalls of the device, although there has been a large volume of complaints and hernia mesh lawsuits from patients who have experienced complications. The amount that a plaintiff may be awarded in a hernia mesh lawsuit differs based on a variety of factors. Among the lawsuits is one in which plaintiff Christopher Thorpe claimed that the implanted Kugel Mesh hernia patch broke inside of him, causing him to suffer a sepsis infection and severe internal injuries. Thorpe was awarded $1.5 million. Many hernia mesh lawsuits are being settled and many others are still being accepted for litigation.

      A Pending Ethicon Trial

      Among the numerous hernia mesh lawsuits is one filed by Matthew Huff, a patient who had hernia mesh implant surgery in 2013. He alleges that he has had multiple complications caused by the device. His claims include that, following the surgery, he went to the hospital with complaints of fever, nausea, severe pain, and chills. Doctors discovered the development of an infection around the Physiomesh hernia mesh device, which was manufactured by Ethicon.

      The infection Huff suffered from resulted in the development of a fistula and several abscesses, which required additional surgery.

      The original trial date was July 31, 2017, but it was reset. A 2018 trial date was postponed, with both the complainant and the defendant both asking for additional time, due to complexities of the case.

      What is a Hernia Mesh Implant Device?

      Hernia mesh or surgical mesh is a medical device that provides support to damaged or weakened tissue. The two types of materials used to construct most hernia mesh devices are synthetic materials and animal tissue.

      Synthetic materials used for surgical mesh can be either non-knitted or knitted sheet forms. The materials can also be non-absorbable, absorbable, or a combination of the two.

      Skin, intestine, and other types of animal tissue are used to make animal-derived absorbable mesh. The animal tissue is usually from a cow or pig and is processed and disinfected prior to use as a surgical implant device.

      Non-absorbable mesh is considered a permanent implant because it indefinitely remains in the body. Absorbable mesh is not intended to provide long-term reinforcement. Over time, the mesh degrades and loses strength. It is intended that new tissue growth will provide strength to the repair site, as the absorbable mesh degrades.

      What is a Hernia Mesh Implant Device?

      According to a report in The Wall Street Journal, as many as 30% of all patients who undergo hernia mesh surgery end up experiencing chronic pain. Discomfort is the most common side effect of a defective hernia mesh device. Additional common issues follow:

      • Mesh tearing or erosion
      • Organic puncture or perforation
      • Infection
      • A physical or allergic reaction
      • Chronic pain
      • Intestinal fistulae, which is an abnormal opening in the digestive tract that causes gastric fluids to seep through the stomach or intestinal lining
      • Adhesions of the mesh material to the bowel
      • Lack of ingrowth of mesh
      • Abscesses, which are painful collections of pus, usually caused by a bacterial infection
      • Peritonitis or inflammation of the inner walls of the abdomen
      • Hernia recurrence

      Much more serious medical problems can occur. The following are among the most dangerous complications associated with hernia mesh surgery, though they are somewhat rare:

      • Nerve damage
      • Neurological changes
      • Permanent or long-term liver or kidney problems
      • Autoimmune disorders
      • Sepsis, a potentially life-threatening condition in which a bacterial infection reaches the blood

      FDA Information about Surgery Complications in Hernia Repair

      According to the FDA, complications have been reported in connection with hernia mesh repair surgery. After conducting an analysis of adverse event reports on the medical device as well as scientific, peer-reviewed literature, the following are among the most common complications caused by surgical repair of hernias, with or without hernia mesh, says the FDA:

      • Pain
      • Infection
      • Hernia recurrence
      • Obstruction or blockage of the small or large intestine
      • Adhesion in which scar-like tissue causes tissues to stick together
      • Abnormal connection between intestines, vessels, or organs
      • Perforation, which is a hole in neighboring organs or tissues
      • Fluid build-up at the surgical site

      Additional adverse events unique to surgeries with hernia mesh include mesh shrinkage or contraction and mesh migration.

      The FDA recently reported that many complications with hernia repair that are reported are associated with products that have been recalled and are no longer on the market. An FDA analysis concluded that the main cause of obstruction complications and bowel perforation has been recalled mesh products.

      Types of Hernias Mesh Implants are Used For

      A hernia occurs when weakness in the stomach wall allows either tissue or part of the intestine to break through the weak area. Either stitching used to enclose the tissue or bowel or surgical mesh can be used to cover the hole and strengthen the area of weakness. Hernia mesh can be used for the following types of hernias:

      • Inguinal hernia, located in the groin area
      • Hiatal hernia, an abdominal hernia in the upper part of the stomach
      • Abdominal hernia, located along the abdomen walls
      • Incisional hernia, at the site of a previous surgery or injury
      • Femoral hernia, which is more common among women, being located at the upper thigh around the outer groin or labia
      • Umbilical hernia, which is usually near the naval or belly button and is therefore easy to see
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      Hernia Mesh Recalls, Injunctions, & Warnings

      C.R. Bard/Davol was the first manufacturer with a recalled hernia mesh, and it was issued by the FDA in 2005. An extension to the recall was issued in the following year and also in 2007. Since that time, there have been other recalls, injunctions and warnings related to hernia mesh devices produced by various manufacturers.

      Warnings

      Several public warnings by the FDA about hernia mesh devices were issued in 2014. Companies whose products were the subject of the recalls include the following:

      • Warnings about Bard products specified that there is a possible danger of breaking ring, which can result in various complications, including bowel perforation.
      • The public was warned that Ethicon hernia mesh products have the possible danger of losing the coating of laminate.
      • A warning about Atrium hernia mesh products involved improper packaging.

      C-Qur Mesh Recall

      The C-Qur Mesh device, which is manufactured by Atrium Medical Corporation, was recalled by the FDA in 2013. The safety of the product was not the issue, however. Instead, the recall was in regard to a packaging defect in which the device would get stuck to the inside lining, rendering it unusable. The FDA also received at least 35 complaints regarding human hair found in the C-Qur Mesh device.

      But that was not to be the last of recalls from Atrium Medical Corporation. In 2015, following a multi-year investigation, a permanent injunction was issued by the FDA against Atrium. The investigation revealed that the manufacturer did not address multiple safety violations. As of 2017, Atrium Medical Corporation became one of several manufacturers facing defective hernia mesh class action lawsuits.

      Physiomesh Recall

      The Ethicon Physiomesh™ Composite Mesh was approved by the FDA on a fast-track 510(k) application, meaning that it was available to the public on the market with no additional safety studies because it was “similar” to other hernia mesh devices on the market.

      It was voluntarily recalled by Johnson & Johnson in 2016. Two studies of the mesh were conducted and monitored, tracking the progress of patients with the mesh implants. Both studies revealed that patients using the product had a higher incidence of new surgery or hernia recurrence as compared with patients using other products.

      Versatex Monofilament Mesh

      After the manufacturer noticed that hernia recurrence was reported by a high number of patients, the FDA issued a recall notification for Versatex Monofilament Mesh in 2018.

      Signs of Hernia Mesh Rejection

      If you have had a hernia mesh implant, it is important to speak to your doctor without delay if you experience any of the following conditions because they are signs of hernia mesh rejection:

      • A rash or redness around the surgery area
      • Severe abdominal pain
      • Nausea
      • Unexplained cramps
      • A fever

      Surgical mesh is intended to reduce, not eliminate, the possibility of recurrence. Your hernia could return after surgical hernia mesh has been implanted. The chances of recurrence are further increased, if you have a defective hernia mesh device.

      A bacterial infection is one of the most common causes of hernia mesh rejection. The first 30 days after your surgery is when you are at greatest risk for a bacterial infection, according to medical experts at John Hopkins Medicine.

      You may have an autoimmune response to hernia mesh, in which your immune system attacks the medical device as though it were an infection. This causes swelling and inflammation. More surgery may be needed as a result of an autoimmune response.

      The Value of Hernia Mesh Cases

      In a product liability litigation like hernia mesh lawsuits, there are various types of damages available, including the following:

      • Compensatory damages are awarded to repay the physically injured for the cost of medical bills, pay lost from taking too much sick time, and future loss of pay, due to a reduced capacity to work. The scope of compensatory damages can also include emotional distress for anxiety-related symptoms.
      • Pain and suffering refer to physical pain the complainant experiences as a result of the injury. Types of physical pain include discomfort, pain, aches, scarring, and limitations when performing normal activities.
      • Loss of consortium is when a spouse has been deprived of comfort, affection, and love in a family relationship as a result of the spouse’s injury.
      • Punitive damages are awarded to a complaint for the purpose of punishing the defendant, if it has been determined that the defendant behaved in a wanton or reckless way that, therefore, intentionally caused harm.

      When evaluating a case for consideration of a hernia mesh lawsuit, the following elements are considered:

      • Which company manufactured the hernia mesh device can potentially improve the chances of success in a product liability lawsuit. For example, was the device voluntarily pulled from the market or recalled by the FDA? Are there important studies with adverse conclusions showing that the specific type or model of hernia meshed you used is associated with serious complications?
      • How serious are the injuries suffered? Among the essential factors involved in assessing the value of a hernia mesh claim is the nature and severity of the plaintiff’s injuries. For example, if a plaintiff has endured prolonged hospital stays, has endured multiple surgeries, and has sustained permanent damage, financial awards for the plaintiff are most likely higher.
      • How costly are the medical bills? The total amount paid for doctor visits, hospitalizations, medications, diagnostic testing, assistive medical devices, and surgeries comes into play, when evaluating a hernia mesh lawsuit.
      • How high is the cost of lost and future wages? The total in lost income factors into the jury award or settlement of a product liability case. For example, how long has the plaintiff been unable to work? Can the plaintiff return to previous employment or has permanent disability prevented it? Plaintiffs are entitled to financial recover for past, present, and future loss of wages.
      • To what extent does the injury negatively impact daily life and the ability to work? Compensation awards are higher, for example, if hernia mesh complications have resulted in lifelong digestive problems or chronic infections.

      Product Liability

      Product liability holds a manufacturer or seller responsible for placing a defective product on the market for consumer use. By law, products must meet the ordinary expectations of consumers. If a product is known to have an unforeseen danger or defect, it does not meet reasonable expectations and does not belong on the market.

      Statute of Limitations

      Product liability lawsuits, such as hernia mesh lawsuits, come under a “discoverability rule.” This means that once you learn that your symptoms stemmed from hernia mesh problems, you have a limited amount of time in which to file a hernia mesh product liability claim. The specific laws are determined by the state you live in. We recommend that you contact a product liability attorney as soon as possible, to ensure that you don’t make your claim too late.

      Source

      Written by:

      stephaniemchugh-writer

      Stephanie McHugh

      Stephanie McHugh is a professional writer who specializes in legal articles, technical blogs, and website copy. She is a former Official Court Reporter for a District Court in Houston, Harris County, Texas; newspaper columnist; and teacher. Stephanie is a professional writer with extensive experience reporting on health-related topics for publication. She developed an interest in health-related litigation as a court reporter while taking depositions for a class action lawsuit. Through her writing, she has been glad to help raise awareness about public health threats, to benefit victims.

      Hernia

      HERNIA MESH LAWSUIT

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