Invokana

Invokana Amputation Risks

INVOKANA® is a pharmaceutical for diabetics that blocks sugar from being absorbed into the bloodstream, and it is associated with devastating side effects. More than 1,000 lawsuits have been filed against drug makers Janssen Pharmaceuticals and Johnson & Johnson, which Janssen is a division of. INVOKANA® is a class of type 2 diabetes drug known as an SGLT2 inhibitor. The severe side effects it is associated with include an increased risk of lower-limb amputation, ketoacidosis, kidney injury, and Fournier’s gangrene, a destructive genital disease. Plaintiffs who have filed lawsuits claim that Janssen and Johnson & Johnson failed to provide adequate warning to patients about the severe side effects and potential hazards of taking INVOKANA®.

Proceedings were begun by Janssen in October 2018 for the establishment of a settlement fund for a majority of the 1,100 lawsuits that had been filed against the company.

Why Lawsuits are Being Filed Against INVOKANA®

The safety of taking canagliflozin, the active ingredient in INVOKANA®, has been called into question, as many taking the SGLT2 inhibitor have suffered increasing illnesses and some have died from related complications. The U.S. Food and Drug Administration (FDA) approved INVOKANA® in March 2013 amidst praise that it was a new class of SGLT2 inhibitors that would significantly help individuals with type 2 diabetes.

Thousands who have made legal claims reference the results of studies which were cited by the FDA, those being CANVAS and CANVAS-R studies. Based on the results, the drug makers failed to adequately warn consumers about known risks of taking INVOKANA®. Rather than warn diabetes patients, the medication was promoted for off-label purposes, such as reducing blood pressure, treating weight loss, and improving cardiovascular (CV) function.

Claimants say that they were denied the opportunity to make an informed decision about whether to take canagliflozin, since the proper warnings were not provided.

Severe Side Effects of taking INVOKANA®

INVOKANA® Causes Lower-Limb Amputations

Severe foot problems are symptoms of diabetes, a condition that causes poor circulation, peripheral arterial disease, and nerve damage. Partial or complete amputation of the feet is associated with diabetes. The FDA conducted a study which found that, over the course of one year, leg and foot amputations were required twice as often among people who took INVOKANA®, compared to diabetics who took a placebo, which is an inactive treatment. The most common of the amputations associated with taking INVOKANA® were the toe and middle of the foot. Sometimes, however, the amputations involved the leg, below the knee. Some patients had more than one amputation and some involved both limbs.

The FDA also found that the most common precipitating medical events leading to amputations were gangrene, lower limb infections, ischemia, and diabetic foot ulcers. Those who were most at risk for amputation were those with a baseline history of neuropathy, peripheral vascular disease, and a prior amputation.

An initial safety alert was released by the FDA in May 2016 in which the public was informed that taking INVOKANA® or Invokamet can increase the risk of needing a foot or leg amputation. Invokamet is a prescription medication that combines INVOKANA® and metformin in one pill. Metformin is in a different class of drugs used to treat diabetes and prediabetes.

Specific information about the two-fold increased risk of lower limb amputations being associated with taking INVOKANA®, as compared with diabetes patients who did not take the medication, was not required by the FDA as a black box warning to be added to the INVOKANA® label until 2017.  

The alleged failure of Janssen to inform patients of the increased risk of amputation is the subject of many lawsuits against the company. The complainants seek compensation for pain and suffering caused by amputations, treatment costs, and other applicable expenses.

INVOKANA®, an SGLT2 Inhibitor, Causes Fournier’s Gangrene

Diabetics have an increased risk for developing a rare condition called Fournier’s gangrene, which is a life-threatening bacterial infection. The risk is increased when taking SGLT2 inhibitors. For males and females, the infection occurs in and around the genitals and can cause severe damage and death. The bacterial infection develops underneath the skin surrounding nerves, blood vessels, muscles, and fat of the perineum, which is the area between the anus and the genitals. The way the bacteria enters the body is typically through a break or cut in the skin. The condition spreads quickly and destroys the affected tissue.

In the five years ending May 2018, the FDA identified a dozen cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor. There may have been more instances of diabetics suffering from the condition because the 12 cases were reports found in medical literature and submitted to the FDA. Among the 12 were five women and seven men. Within a few months of the patients taking an SGLT2 inhibitor, Fournier’s gangrene developed. In most instances, the patients stopped taking the medication. All of the 12 were hospitalized, some required surgery, and some required surgeries that were disfiguring. Some of the patients had multiple disfiguring surgeries. Among some of those, complications occurred, and one of the patients died.

By comparison, a previous 30-year review of antidiabetic drug classes identified only six cases of Fournier’s gangrene, all of which were in males.

Any patient with diabetes, whether taking an SGLT2 inhibitor like INVOKANA® or not, should immediately seek medical treatment if experiencing any of the following symptoms in the area of the genitals, particularly when combined with a fever above 100.4◦ F or generally feeling unwell:

  • Redness
  • Tenderness
  • Swelling of the perineum (area between the genitals and rectum)

INVOKANA® can Trigger Diabetic Ketoacidosis

Diabetic ketoacidosis is a potentially deadly condition and another serious medical risk associated with taking INVOKANA®. When ketone levels in the body rise too high, diabetic ketoacidosis occurs. Ketones are produced when glucose can’t be used by the body’s cells as a source of energy, and the body begins to break down fat. Acid levels in the blood also rise too high. When these conditions are present, it doesn’t take long for life-threatening diabetic ketoacidosis to occur.

The following are symptoms of diabetic ketoacidosis:

  • Increased need to urinate
  • A feeling of burning when urinating
  • Intense thirst
  • Fatigue
  • Nausea
  • Abdominal pain
  • Shortness of breath
  • Fruit-smelling breath odor

Advanced symptoms of diabetic ketoacidosis include:

  • Vomiting
  • Difficulty breathing
  • Confusion
  • Fainting or dizziness
  • Unconsciousness

In May 2015, the FDA issued a warning about the risk of developing ketoacidosis when taking SGLT2 inhibitors. In a review of the FDA Adverse Event Reporting System (FAERS) database during a five-year period ending May 2015 involving patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors, the FDA identified 73 cases of ketoacidosis. There may have been additional cases that were not reported to the FDA. Among the 73 patients, all of them required emergency department treatment or hospitalization. Treatment of ketoacidosis was delayed in some of the cases because the blood glucose levels were below expectations for a patient suffering from diabetic ketoacidosis.

The FDA issues another warning on December 4, 2015, saying, among other things, that ketoacidosis is a serious condition and patients taking an SGLT2 inhibitor should immediately stop taking the medication and seek medical attention, if suffering from symptoms of ketoacidosis.

Taking INVOKANA® can Lead to Kidney Failure

In an FDA Safety Announcement dated June 14, 2016, an existing warning about the risk of acute kidney injury (renal failure) when taking certain type 2 diabetes medications, including INVOKANA®, was strengthened. Warnings on drug labels were revised to include information about the risk and recommendations for minimizing the danger. Acute kidney injury is a serious condition in which dangerous levels of wastes build up in the body because the kidneys suddenly stop working.

The FDA advised patients to immediately seek medical treatment if they experience signs and symptoms associated with acute kidney injury, such as the following:

  • Decreased urine
  • Swelling of feet or legs

From March 2013, the time canagliflozin was approved, through October 2015, reports were submitted to the FDA regarding 101 confirmable cases of kidney failure. Some of the patients required hospitalization and dialysis. About half of the patients said renal failure occurred within 1 month of taking canagliflozin (INVOKANA®) or dapagliflozin. Most said they improved after they stopped taking the medication. Some of the patients were younger than 65 years of age. Some had low blood pressure, were dehydrated, or were taking other medications that have an effect on the kidneys. Patients who already have a kidney disease were warned by the FDA in a 2016 report that they have an increased risk of death when taking INVOKANA®.

Taking INVOKANA® can Lead to Acute Pancreatitis

Acute pancreatitis is a serious and sometimes fatal inflammation of the pancreas, and the condition has been identified as one of the potential side effects of taking INVOKANA®. Gallstones or alcoholism have typically been the causes of acute pancreatitis. Two studies conducted in 2016 found that patients had developed acute pancreatitis after taking INVOKANA® for a short period of time. In one case, the patient had only taken the diabetes medication for four days.

Statistics show pancreatitis is fatal for 1 in 10 patients who develop the condition.

INVOKANA® is Linked to Heart Disease

It was suggested in early studies that one of the side effects experienced by taking INVOKANA® is heart disease. Among the 15-members on the FDA approval panel, 8 of them expressed concern over clinical data linking the medication to an increased risk of having a heart attack.

Federal and State Invokana Lawsuits

The majority of federal lawsuits against INVOKANA® have been placed in the U.S. Court for the District of New Jersey for multidistrict litigation (MDL) under MDL 2750. 

Depending on factors such as a state’s laws, plaintiffs sometimes have a better chance at receiving compensation in an INVOKANA® lawsuit from state courts. Pennsylvania is the state with the most INVOKANA® lawsuits. The statutes of limitations are important considerations, in state court litigation. Individuals must file lawsuits within a state’s deadlines or risk losing the legal right to seek compensation.

INVOKANA® Verdicts and Settlements

There are currently no known verdicts on lawsuits filed in connection with INVOKANA®. Details of the October 2018 settlement fund for lawsuits filed against Janssen Pharmaceuticals are confidential, and full details were still in negotiation as of November 2018.

Compensations Available in INVOKANA® Lawsuits

INVOKANA® lawsuits are drug-related product liability cases. Legal compensation a person may be entitled to depends on the individual’s unique experience. Judges and juries consider things such as:

  • How long did the individual suffer from side effects of taking the medication?
  • What are the total costs to the patient and his or her family for treatment of side effects?
  • As a result of taking the drug, has the individual suffered any type of disability, whether temporary or permanent?

Some of the damages sought in INVOKANA® cases include:

  • Medical Costs
  • Loss of Income
  • Loss of Companionship
  • Pain and Suffering
  • Funeral Expenses

Contact the Johnston Law Group

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The Johnston Law Group offers experienced nationwide representation and specializes in representing people who have been seriously harmed by the actions of others, including injuries caused by dangerous drugs and medical devices.

Attorneys with the Johnston Law Group have been involved in some of the nation’s most high-profile personal injury cases. If you or a loved one have been harmed by taking INVOKANA®, contact us at the Johnston Law Group. Call toll-free today at (844) 464-0062.

Resources:

https://www.fda.gov/Drugs/DrugSafety/ucm557507.htm

https://www.healio.com/endocrinology/diabetes/news/online/%7B2bc50980-9d8e-4787-962a-3a9fff676e21%7D/fda-approves-cv-events-indication-for-invokana

https://www.fda.gov/Drugs/DrugSafety/ucm617360.htm

https://www.fda.gov/Drugs/DrugSafety/ucm475463.htm

https://www.fda.gov/Drugs/DrugSafety/ucm505860.htm

https://drugsafetynews.com/2016/12/13/invokana-sglt2-inhibitors-linked-acute-pancreatitis/

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.

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    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.

    sex_trafficking_victim_outreach_card_1
    sex_trafficking_victim_outreach_card_2
    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.

    help-me-human-trafficking-1

    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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      Source

      https://www.commerce.senate.gov/public/index.cfm/2018/1/two-senate-commerce-bills-to-combat-human-trafficking-signed-into-law

      https://polarisproject.org/current-federal-laws

      https://humantraffickinghotline.org/what-human-trafficking/federal-law

      https://www.britannica.com/topic/Communications-Decency-Act

      https://www.nytimes.com/2018/10/19/world/europe/grooming-gang-sexual-abuse-uk.html?rref=collection%2Ftimestopic%2FHuman%20Trafficking

      https://www.nytimes.com/aponline/2018/10/11/us/politics/ap-us-trump-human-trafficking.html?rref=collection%2Ftimestopic%2FHuman%20Trafficking

      https://www.nytimes.com/2018/08/21/us/sex-minors-arrest-dominican-republic.html?rref=collection%2Ftimestopic%2FHuman%20Trafficking

      https://www.nytimes.com/2018/07/24/nyregion/nxivm-arrest-seagram-heiress.html?rref=collection%2Ftimestopic%2FHuman%20Trafficking

      https://www.apnews.com/6b899ca752154db18e1f74acc792b614

      https://www.reuters.com/article/us-sex-trafficking-facebook-lawsuit/woman-sues-facebook-claims-site-enabled-sex-trafficking-idUSKCN1MD080

      https://www.nbcwashington.com/news/local/Lawsuits-Accuse-Hotels-Truck-Stops-of-Turning-Blind-Eye-to-Sex-Trafficking-481290921.html

      https://www.cnn.com/2018/05/07/us/taekwondo-lopez-brothers-lawsuit/index.html

      https://www.cnn.com/2015/11/10/americas/freedom-project-mexico-trafficking-survivor/index.html

      https://polarisproject.org/human-trafficking/recognize-signshttp://www.usccb.org/about/anti-trafficking-program/identifying-trafficking-victims.cfm

      pradaxa-packaging

      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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      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-device

        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
        hernia_mesh_surgery

        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

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

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          xarelto

          Xarelto® Bleeding Complications

          Between federal and state courts, more than 20,000 Xarelto® lawsuits have been filed since the blockbuster drug was approved by the U.S. Food and Drug Administration (FDA) in 2011. Xarelto® is the nation’s most-prescribed blood thinner in its class. Drugmakers Johnson & Johnson and Bayer are the companies being sued on claims that knowledge about risks of significant bleeding were consciously concealed for the purpose of boosting sales. The more than 13 million prescriptions of Xarelto® filled since the drug’s release have generated billions of dollars for Johnson & Johnson and Bayer. Though the FDA has said that Xarelto® is associated with as many as 400 deaths, the government agency has not recalled the anticoagulant.

          On December 5, 2017, a jury in a state court ordered the two mega-pharmaceuticals to pay plaintiff Lynn Hartman nearly $28 million due to complications such as internal bleeding that she experienced as a result of using Xarelto®. A doctor had prescribed Xarelto® for Hartman in treatment of atrial fibrillation and other health problems. The compensation the jury awarded to Hartman included $1.8 million in compensatory damages and $26 million in punitive damages.

          Prior to the Hartman case, there were three bellwether trials in federal courts in which the defense in the Xarelto® lawsuits won. A bellwether trial involves a small consolidation of lawsuits taken from a larger group of cases to be tried first. Such trials often set precedent and help others anticipate how future trials may turn out. They can also help plaintiffs determine the types of legal arguments juries may be inclined to respond to.

          What is Xarelto®?

          Xarelto®, which is Rivaroxaban in the generic form, is an anticoagulant or blood thinner. An essential component of healing is coagulation, which is thickening or clotting of the blood. Coagulation prevents dangerously excessive blood loss when there is a cut or internal bleeding. Blood clots can also create significant risk, however, potentially causing catastrophic health problems. Blood thinners like Xarelto® are prescribed to help prevent these types of dangerous conditions.  Doctors prescribe Xarelto® for the following reasons and more:

          • To reduce the risk of blood clots and stroke in individuals with atrial fibrillation that was not caused by a heart valve problem.
          • To treat deep vein thrombosis (DVT), which occurs when a blood clot forms in one or more of the body’s deep veins. DVT most commonly develops in the legs.
          • To treat a pulmonary embolism (PE), which occurs when a blood clot gets caught in an artery that travels from the heart to the lungs. Pulmonary embolisms usually travel to a deep vein in the leg.
          • To reduce the reoccurrence of blood clots in patients who are experiencing a prolonged risk of developing DVT or PE, after blood clot treatments have continued for at least 6 months.
          • To reduce the risk of forming a blood clot in the lungs and legs, among people who have just had hip replacement or knee surgery.

          Xarelto® Timeline of Events

          The many thousands of Xarelto® lawsuits have come as a result of a range of problems with the blood thinner, and signs that the drug can be dangerous emerged quickly. After the 2011 release of Xarelto®, the following is a basic timeline of events related to reported dangers, reported income for Johnson & Johnson and Bayer, and more:

          • In 2012 alone, among the “serious adverse events” patients experienced after taking the prescription Xarelto®, 2,081 were reported to and filed with the FDA.
          • By 2013, the FDA added a black box warning on packaging for Xarelto®, related to spinal hematomas. The FDA, in other words, acknowledged the risk of the drug causing significant spinal cord compressions, potentially resulting in permanent and irreversible neurologic damage.
          • In January 2014, per the FDA, warnings had to be included on the insert of Xarelto® and Rivaroxaban packaging indicating that there is no antidote for Xarelto® bleeding.
          • In May 2014, there were settlements of 4,000 lawsuits amounting to $650 million total in cases related to the use of Pradaxa®, a blood thinner similar to Xarelto®.
          • By December 2014, there were more than 15,000 Xarelto® lawsuits with pending actions filed in multidistrict litigation (MDL). Judge Eldon Fallon in Eastern Louisiana established MDL.
          • In 2014 alone, Xarelto® generated $3.7 billion for Johnson & Johnson.
          • In 2016, Xarelto® generated $2.2 billion for Johnson & Johnson.
          • Three federal bellwether Xarelto® lawsuits resulted in defense verdicts in May, June, and August 2017. In December 2017, a jury awarded plaintiff Lynn Hartman $27.8 million.
          • In January 2018, a state court judge in Pennsylvania overturned the $27.8 million verdict.
          • In February 2018, the plaintiff filed an appeal of the reversal, hoping to obtain fair compensation for injuries suffered as a result of taking Xarelto®.

          In May 2018, the FDA gave initial approval for the only antidote for uncontrolled bleeding caused by Xarelto. The antidote is called AndrexXa®, and it is expected to be available on the market by early 2019.

          xarelto-timeline

          Health Complications Caused by taking Xarelto®

          People who have taken Xarelto® have experienced a wide range of complications, including death. More than 20,000 Xarelto® lawsuits claim that it is a dangerous drug. The complications and serious side effects patients have experienced from taking Xarelto® include cerebral hemorrhaging, stroke, epidural hemorrhaging, abnormal liver failure, gastrointestinal bleeding, rectal bleeding, stroke, painful urination, spinal hemorrhaging, and abdominal bleeding. Post-surgical complications associated with Xarelto® include infection, hematoma, and rupture. To correct wound complications related to the drug, revision surgery is sometimes necessary.

          The common side effects of taking Xarelto® include low blood pressure, nausea and vomiting, muscle pain, edema or swelling, and nose bleed. Other side effects that have regularly been reported after taking the drug include a racing heartbeat, irregular heartbeat, dizziness, fainting, headaches, and pain or weakness in the extremities.

          Warning Label & Other Updates

          Although many thousands of problems have been reported in association with taking Xarelto®, it has not been recalled by the FDA. Individuals who have suffered serious health issues from taking the blood thinner and who are involved in Xarelto® lawsuits claim that Johnson & Johnson and Bayer have held back important information from the public. Since the drug’s release, there have been various warnings added to the packaging, alerting people of the most prominent risks of taking Xarelto®.

          First Black Box Warning

          A black-box warning added in August 2013 stated that there was a higher risk for deep vein thrombosis, blood clots, and epidural/spinal hematoma among patients who prematurely discontinued use of the blood thinner.

          Warning: No Antidote

          In January 2014, the FDA issued a warning or precaution that they were aware of a bleeding risk associated with taking Xarelto® or Rivaroxaban. Included in the warning was a recommendation that a patient receive blood replacement or transfusions if blood loss was experienced while taking the anticoagulant.

          In addition, the warning discussed the lack of an antidote or reversal agent for Xarelto®. When a patient is taking most other types of blood thinners, doctors can counteract the anticoagulant properties in an emergency by administering protamine sulfate or vitamin K. Xarelto®, however, blocks Thrombin and, as a result, neither of the two antidotes work. This was explained on the page listing Xarelto® Side Effects. Also, the anticoagulant should not be used by anyone with prosthetic heart valves.

          Epidural or Spinal Puncture Treatment Directive

          In March 2014, patients taking Xarelto® received a directive in the second black box warning for the drug. The warning was specifically for patients undergoing a spinal puncture or epidural treatment. They were instructed to wait until Xarelto® has been flushed form their system before undergoing either of these procedures, due to a concern regarding spinal bleeds.

          Thrombocytopenia and Hepatitis Warnings

          An Adverse Reaction report on Xarelto® was issued by the FDA in December 2014. The warning was that the blood thinner could cause thrombocytopenia. Thrombocytopenia is a condition in which the body suffers from low blood platelet counts. Because blood platelets are crucial in the formation of blood clots, thrombocytopenia can cause internal bleeding.

          On the same report, the FDA changed “cytolytic hepatitis” to “hepatitis” in the descriptions of adverse reactions and included hepatocellular injury, which is major injury to the liver.    

          Dangerous Drug Interactions

          The latest FDA warning added to Xarelto® packaging is in regard to dangerous drug interactions with the blood thinning medication. Among the drugs that should not be taken with Xarelto® are SSRI and SNRI antidepressants. The complete list of drugs that the warning said not to take with Xarelto® follows:

          • Carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol-XR, and Teril)
          • Conivaptan (Vaprisol)
          • Indinavir (Crixivan)
          • lopinavir (Kaletra)
          • Itraconazole (Onmel and Sporanox)
          • Phenytoin (Dilantin)
          • Rifampin (Rifadin, Rifamate, Rifater, and Rimactane)
          • Ritonavir (Norvir)
          • John’s wort (Hypericum Perforatum)

          The FDA also added a warning that Xarelto® has not been tested in patients who have a prosthetic heart valve and such patients should not take the blood thinner.

          Faulty Clinical Trial

          Before drugs are approved by the FDA for general use, they must be clinically tested as a way of proving effectiveness and safety. There were some questions related to a clinical trial for Xarelto® because of the use of a device called the Alere INRatio, which was recalled in July 2016. The name of the clinical trial is ROCKET-AF, and it reportedly provided the primary information supporting the FDA’s approval of Xarelto® in 2011.

          The recalled device was used for testing of blood clotting during clinical trials. Problems with the device used to establish approval of Xarelto® dated back to 2002. Before the 2016 recall of the Alere INRatio, studies concluded that the device had a propensity to provide false results favorable Xarelto®. The data collected from the faulty device showed that Xarelto® was likely the safer blood thinner for patients with atrial fibrillation, as compared with warfarin. More specifically, the ROCKET-AF study showed that the effects on bleeding, including bleeding in the head, and strokes were minimal among patients taking Xarelto®. That conclusion is in question.

          Alternate Studies Not Favorable to Xarelto®

          Over-the-counter aspirin has been compared to Xarelto® in various studies, and a common conclusion is that aspirin is as effective as Xarelto® in reducing the risk of systemic embolism and stroke. It has been acknowledged by Bayer as well as Johnson & Johnson’s Janssen Research and Development that Xarelto® failed a trial comparing the drug to aspirin in patients with recent embolic stroke of undetermined source or ESUS. In the study involving 7,214 patients from 31 countries, Xarelto® did not have greater efficacy than aspirin in reducing the risk of stroke and systemic embolism.

          The most dangerous side effect of Xarelto® is the risk of unstoppable bleeding, which can be fatal. Since aspirin appears to be as effective, there seems to be no reason to take on the risks associated with Xarelto®.

          In comparative studies of patients who had undergone hip or knee replacement surgery, some were given Xarelto® to reduce the risk of pulmonary embolism and deep vein thrombosis. Others received aspirin and compression socks. Patients in the latter group had fewer complications with their wounds than those who were treated with Xarelto®. The studies also showed that post-surgical complications included infection, rupture, hematoma, and the necessity for revision surgery, among those who used Xarelto®.

          It has also been discovered through studies that when patients undergoing an epidural anesthetic or spinal tap take Xarelto®, they are at risk of developing a blood clot in the brain or around the spinal cord, leading to a variety of injuries, including stroke and paralysis.

          Has Xarelto® Affected You or a Family Member?

          If you or a member of your family have experienced issues such as excessive bleeding as a result of taking Xarelto®, contact The Johnston Law Group. Our mission is to hold drug companies accountable for consciously endangering patients by inadequately warning them of known potential health threats.

          At The Johnston Law Group, we understand the financial challenges and heartbreak families face as a result of catastrophic prescription drug injury. Contact us today for a free consultation and for filing of a Xarelto® lawsuit.

          Resources:
          https://www.waterskraus.com/xarelto-vs-aspirinthe-outcome-may-shock/

          https://www.bloomberg.com/news/articles/2018-08-26/bayer-j-j-s-blood-thinning-drug-xarelto-fails-mariner-trial

          https://www.forbes.com/sites/legalnewsline/2018/06/12/unbeaten-at-trial-bayer-and-janssen-say-cycle-of-xarelto-lawsuits-needs-to-be-stopped/#2f6e10c6629f

          https://www.reuters.com/article/us-bayer-xarelto/bayer-jjs-bid-to-further-widen-use-of-xarelto-hits-snag-idUSKCN1LC0QS

          https://www.xarelto-us.com/about-xarelto/xarelto-vs-warfarin

          https://www.xareltohcp.com/frequently-asked-questions

          https://www.phrma.org/

          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.

          xarelto

          Get a Free Xarelto® Case Review

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

            IVC-Filter

            IVC Filter Failures

            Thousands of IVC filter lawsuits have been filed against the manufacturers of a medical device designed to protect the lungs from blood clots. Severe IVC filter complications were reported to the United States Food and Drug Administration (FDA) beginning in 2005. Since that time, thousands of patients have reported severe problems resulting from being implanted with IVC filters. Approval by the FDA is still in effect and many of the devices are still being widely used, though at least 39 deaths are known to be associated with IVC filter implants, as of May 2018.

            Patients report such problems as IVC filter fractures, migration of the device to other parts of the body, embolization, movement of the entire device or fragments of it into the lungs and heart, or perforation. IVC filter complications patients have experienced include organ damage, chronic pain, stroke, pulmonary embolism, severe internal bleeding, and death.

            Plaintiffs claim through IVC filter lawyers, among other things, that the manufacturers of IVC filters were aware of the defectiveness of their products and failed to inform doctors and patients about the seriousness of the risks. Manufacturers of the device include: C.R. Bard, Cook Medical, Cordis (OptEase and TrapEase), and Boston Scientific (Greenfield). The majority of IVC filter lawsuits are pending against C.R. Bard and Cook Medical.

            IVC Filter Settlements with C.R. Bard

            IVC Filter Settlements with C.R. Bard

            In 2011, the first IVC filter lawsuit was filed by Plaintiff Lisa Davis in Pennsylvania against C.R. Bard. Davis had a G2 series IVC filter implanted in 2006. She began to experience ongoing heart issues after the medical device fractured and migrated to her heart in 2008. In 2013, the judge in the Eastern District of Michigan Southern Division U.S. District Court case was notified that a settlement was reached between C.R. Bard and Davis, in an undisclosed amount.

            In 2013, Kelly Vlasvich and her husband filed a lawsuit against C.R. Bard with the Northern District of Illinois U.S. District Court. A G2 filter that had been implanted fractured in 2011, which reportedly damaged Vlasvich’s lungs and heart. The case was closed in 2015 after the parties jointly filed a stipulation of dismissal.

            In 2015, Plaintiff Kevin Philips brought a case against C.R. Bard before the U.S. District Court for the District of Nevada. The Recovery IVC filter perforated Philips’ heart. In just 10 days after the filing, C.R. Bard settled the case with Philips.

            IVC Filter Class Action Lawsuits against C.R. Bard

            Among the class-action IVC filter lawsuits are three pending against C.R. Bard. The class action suits are in California, Florida, and Pennsylvania. Plaintiffs claim that the company was negligent, concealing data about defects in their IVC filter devices from doctors and patients. The lawsuits argue that even in cases in which G2, G2 Express, and Recovery filters did not migrate or fracture, patients are entitled to medical monitoring.

            More than 100 plaintiffs seeking more than $5 million in compensation were involved in a class-action IVC filter lawsuit in Florida that was transferred to the Southern District of Florida U.S. District Court in 2012. In 2015, all federal cases against C.R. Bard were ordered by the U.S. Judicial Panel on Multidistrict Litigation (MDL) to be centralized under MDL-2641 in the Southern District of Arizona.

            A total of 3,834 class-action IVC filter lawsuits were pending against C.R. Bard as of May 2018.

            MDL & Bellwether Trials against C.R. Bard

            A bellwether trial sets precedent and serves as a reference point for a wider range of claims. After an MDL has been established, the judge and attorneys collaborate to choose bellwether cases. There is not a specified number of bellwether cases required, according to legal guidelines. The goal is to select a sampling of lawsuits that are representative of the whole. MDLs are non-binding, which means that they are not in any way restrictive of the proceedings in all other related cases.

            The first bellwether trial for C.R. Bard was held in Phoenix, Arizona, beginning on March 30, 2018. Sherr-Una Booker was the plaintiff. A Bard G2 IVC filter had been implanted in 2007, and Booker suffered health complications after migration of the device and fracturing off of the device, which resulted in perforation of her inferior vena cava. To correct the damage, Booker underwent heart surgery. The federal jury in the case awarded a verdict of $3.6 million to the plaintiff. A total of $1.6 million in compensatory damages and $2 million in punitive damages was awarded to Booker.

            In the second IVC filter lawsuit against C.R. Bard, the jury sided with the defendant on June 1, 2018. The plaintiff was Doris Jones of Georgia, who had a Bard Eclipse IVC filter implanted in 2010. The IVC filter fractured, and a piece blocked a major artery. Most of the fractured filter was removed, but doctors say that plaintiff is still at fatal risk because part of the device blocking the pulmonary artery could not be removed. The jury in the case ruled that Bard had provided doctors with adequate warnings regarding risks and potential complications.

            IVC Filter Lawsuits against Cook Medical

            As of May 2018, a total of 4,189 IVC filter lawsuits were filed against Cook Medical. A federal panel centralized the Cook Medical MDL in the southern district of Indiana. The first two IVC filter lawsuits against Cook were decided in favor of the defendant. In the first, Cook won in a complete jury verdict. In the second, the company won in a complete summary judgment verdict.

            A Verdict of $1.2 Million Against Cook

            The third verdict in an IVC filter lawsuit filed against Cook was announced on May 29, 2018. Plaintiff Jeff Pavlock, a firefighter, was awarded $1.2 million in a jury trial in Houston, Texas. The plaintiff’s claim was that he suffered organ and blood vessel perforations from IVC filter complications after a Cook Celect IVC filter was implanted in 2015 to prevent life-threatening pulmonary embolisms. The device was temporary. Once determined that the danger of a blood clot had passed, Pavlock’s doctors were planning to remove the medical device. Seven weeks after implanting the IVC filter, doctors found that they were unable to retrieve it because the medical device had migrated and become embedded in a blood vessel. A second surgery was done to remove the Cook Celect IVC filter, but it was also unsuccessful. Doctors say Pavlock requires lifetime health monitoring, as a result of the IVC filter complication. Cook announced that it is appealing the jury’s decision to award Pavlock $1.2 million.

            What is an IVC Filter?

            A small spider-like medical device, an Inferior Vena Cava or IVC filter is designed for patients at risk of developing a life-threatening blood clot in the lung, known as a pulmonary embolism, or deep vein thrombosis (DVT). The device has been used when taking blood thinners is not a viable option for a patient.

            IVC Filter Complications

            IVC filters have been in use since 1979, when they were initially approved by the FDA. Originally, IVC filters were made with either stainless steel or titanium. Temporary IVC filters made with less expensive materials were later manufactured, as well. The FDA has issued various warnings through the years regarding the vena cava devices. For instance, from 2005 to 2010, adverse events reports released by the FDA included 202 incidents of filter fractures. Of the 202 events, 146 of them involved fractured pieces of vena cava medical devices migrating toward the heart.

            FDA Recall of the Greenfield IVC Filter

            Boston Scientific Corp. is the manufacturer of the Greenfield IVC Filter. Defects in the IVC filter have resulted in a growing number of federal lawsuits, but there is currently no multidistrict litigation docket (MDL) for the litigation. In one wrongful death lawsuit filed by the family of Cinthia K. Ratliff, the woman’s family alleged that she died in 2013 from severe injuries caused by the Greenfield IVC Filter. An autopsy confirmed their claim that her cause of death was inferior vena cava perforation caused by the IVC filter, resulting in retroperitoneal hemorrhage. A settlement agreement was reached in that case in 2017, and the case was dismissed.

            The basket-like Greenfield IVC Filter has six struts, each of which has a curved hook. Boston Scientific designed the medical device to catch blood clots. In May 2007, the Greenfield IVC Filter was recalled by the FDA following reports of a defect in which the bond between the carrier capsule and the filter’s outer sheath would detach, causing a risk of pulmonary and cardiac embolization.

            FDA Recall of the Cordis OptEase IVC Filter

            Under the controversial FDA 510(k) fast track approval process, companies manufacturing IVC filters have been allowed to engage in only minimal testing before placing the devices on the nationwide market for use in patients. Among the devices released through the fast track approval process were those manufactured by Cordis. In 2001, the FDA approved the Cordis TrapEase, which is a permanent IVC filter. In 2003, the Cordis OptEase, a retrievable vena cava filter, was released for use in patients.

            Research studies were done which began to question the safety of IVC filters in general. The studies suggested that the medical devices are not only unreliable and create serious risks, but their effectiveness was called into question, in many cases. The Cordis filters, in particular, were found in studies to have a high failure rate, creating risks associated with filter fractures.

            Half of all TrapEase IVC Filters implanted in patients became fractured after 50 months, on average, according to a 2012 study published in the prestigious JAMA Internal Medicine journal. After four years or more, the filters were fractured 64% of the time. Researchers concluded that there was an extremely high risk of strut fractures in the TrapEase IVC filter.

            In 2013, Cordis informed medical professionals throughout the U.S. and Canada that there was a risk of serious injury or death in implanting the OptEase IVC filter because labeling problems could result in the filters being implanted backwards. The Cordis letter was classified by the FDA as a Class I medical device recall. This is the most serious FDA recall classification, indicating that the defects create the risk of serious adverse events, including possible death.

            Have You Experienced IVC Filter Complications?

            Do you suspect that you or a loved one who has had an IVC filter implantation is experiencing problems of some kind because of the medical device? The types of symptoms individuals experience as a result of IVC filter complications include:

            • Nausea
            • Confusion
            • Neck pain
            • Chest pain
            • Fever
            • Inflammation
            • Hypotension
            • Painful swelling in the legs
            • Lower back pain
            • Heart rhythm anomalies
            • Shortness of breath
            • Lightheadedness
            • Internal bleeding or hemorrhaging
            • Stroke
            • Pulmonary embolism
            • Loss of consciousness
            • Death

            When to File a Claim in an IVC Filter Lawsuit

            If you or a loved one has experienced IVC filter complications, it is important that you speak with an experienced IVC filter lawyer as soon as possible. States each have their own statute of limitations for filing these kinds of claims. You may be entitled to seek compensation from the manufacturer and its subsidiaries for a wrongful death or the following past and future damages:

            • Medical costs associated with the defective filter
            • Lost wages
            • Loss of capacity to earn money
            • Loss of enjoyment of life
            • Pain and suffering

            You could be eligible to seek punitive damages, as well, if it is proven that the IVC manufacturer knowingly sold a defective filter. The types of lawsuits pending in state and federal courts against IVC manufacturers and their subsidiaries include claims of:

            • Failure of the manufacturer of the IVC filter to provide adequate warnings regarding the potential dangers and side effects associated with implantation of the device;
            • Defective designs of the vena cava IVC filter;
            • Defective techniques in the manufacture of vena cava filters;
            • Breach of implied warranty on the IVC filter; and
            • Negligence on the part of the marketing company and/or manufacturer.

            Each case involving complications is unique, and various factors determine the potential value of an IVC filter lawsuit. For example, what is the severity and overall magnitude of injuries suffered? How much time do doctors think it will take for the patient to heal from injuries suffered? Have the IVC filter complications resulted in a long-term or permanent disability?

            RESOURCES USED:

            https://www.massdevice.com/cook-medical-loses-houston-based-ivc-suit-plans-to-appeal/

            https://www.masstortnexus.com/mass-torts-news/tag/boston-scientific-ivc-filter-litigation/

            https://www.prnewswire.com/news-releases/ivc-filter-lawsuit-news-cr-bard-ordered-to-pay-36-million-at-conclusion-of-first-federal-bellwether-trial-bernstein-liebhard-llp-reports-300622672.html

            https://www.healio.com/cardiac-vascular-intervention/venous/news/online/%7Bece04a1d-00a9-428f-ae28-2f0e7a29f4a8%7D/ivc-filter-increases-30-day-mortality-in-vte-with-contraindication-to-anticoagulation

            https://injury.findlaw.com/product-liability/ivc-blood-clot-filter-problems-and-faqs.html

            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.

            ivc-filter

            Get a Free IVC Filter Case Review

            If you or a loved one experienced a complication after getting an IVC filter, you may be eligible for money to pay for health care costs.