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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