Category: <span>News</span>

An Ohio woman recently filed a new Xarelto lawsuits against Janssen Pharmaceuticals (a division of Johnson & Johnson) and Bayer AG. The plaintiff claims that the new anticoagulant drug caused her a dangerous uncontrollable gastrointestinal bleeding event that threatened her life. The woman allegedly took rivaroxaban for less than one year, and that the bleeding that forced her to call emergency services was sudden and very severe. The plaintiff indicated that she received the medication as a prescription for her atrial fibrillation (Afib), a condition characterized by an abnormal heart rhythm. Her condition is, in fact, associated with an increased risk of stroke and blood clots. The new blood thinner is frequently prescribed to Afib patients to reduce this risk and prevent the formation of lethal blood clots. Due to the absence of a proper Xarelto antidote, however, the gastrointestinal bleeding she suffered may have threatened the woman’s life even more than the risk of a stroke would.

Since it was approved in 2011 by the U.S. Food and Drug Administration (FDA), Xarelto rapidly gained a huge popularity among patients and physicians due to its convenient dosage. Its one-size-fits-all dosing only required one pill per day and no dietary restrictions, regardless of the patient’s age, sex or weight. Despite this apparent convenience, however, its side effects quickly started to raise several concerns among patients and doctors as well. Although the dreaded Bayer’s anticoagulant drug received the infamous “black box” warning from the FDA, many patients who took this medication still suffered from serious injuries and some of them even died. A large percentage of the federal cases has been recollected in a huge Multidistrict Litigation number 2592 in the Eastern District of Louisiana. The number of people who are asking the court for compensation, in fact, recently rose to over 3,000 litigations, with at least 1,000 new cases filed in just a couple of months.

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Women implanted with the contraceptive device Essure are filing lawsuits after they suffered from severe adverse reaction such as excruciating back and joint pain, unusual bleeding, device breakage and organ perforation.

If you or a loved one suffered from any serious side effect after being implanted with this permanent birth control method, you may qualify for a large cash settlement. Contact us right now: our Essure lawyers will provide you with free legal assistance.

What is Essure and how it works?

Originally conceived by Conceptus Inc., a subsidiary of Bayer AG, this device is as an alternative permanent birth control method for women that did not want to undergo surgical laparoscopic tubal ligation. The US Food and Drugs Administration (FDA) granted Essure approval on November 4, 2002. Since then, hundreds of attorneys have filed lawsuits against Essure. The company should be held responsible for all the suffering and adverse reactions woman faced at the hands of Bayer. Among the lawyers representing the injured, the famous consumer advocate Erin Brockovich petitioned the FDA to order a recall of Essure because of its purported lack of safety and advised many women to file lawsuits .The primary benefit associated with Essure was to provide permanent birth control (female sterilization) without the need for invasive surgery or general anesthesia, thus avoiding all the risks related to these procedures. It does not require a surgical incision to be implanted. Essure is inserted through the vagina into the fallopian tubes and consists of two metal flexible coils. Scar tissue slowly forms around the two coils over a period of three months, blocking the tubes and preventing spermatic cells from reaching the eggs. Contraception of this kind is permanent and eliminates the need to use other forms of birth control, as well as avoiding any effect on the menstrual cycle (1). However hundreds of women using this device experienced severe side effects and complications over time, including extreme pelvic and back pain or cramps that prevented them from performing daily activities, constant fatigue, heavy bleeding, headaches and weight gain. Other serious or even life-threatening complications and personal injuries included device migration and breakage that could lead to organ perforation, depression and suicidal thoughts, allergic reactions to nickel and the necessity for reoperation .

The best way to get the compensation you deserve is to file a lawsuit against Essure

In the last few years, many victims emerged, claiming that this medical device caused them several serious injuries and health problems. Many women allegedly accuse Bayer of negligence in warning them about the potential long-term hazards since the company never mentioned there was a risk of organ perforation and extreme pelvic pain and often felt discriminated even by the FDA, who ignored their complaints.

Bayer, however, is actually shielded from all litigations filed against them as their medical product was approved via the FDA’s premarket approval process. However, some plaintiff’s attorneys sought to remove that protection, asking the U.S. District Court, Eastern District of Pennsylvania to invalidate the rules that ensured Essure’s approval. On March 2016, the court ruled that two among five of these cases can continue as they have been deemed reasonable (12). Filing a claim against Bayer is not just a way to receive compensation for all the pain and damages you had to endure during these years. It is also very important to prevent other women from suffering the same fate and to make a statement against a pharmaceutical company that keeps selling its product regardless of the thousands of complaints filed by all those victims.

Essure Dangerous Side Effects

Essure is a contraceptive implant that represented a technology marvel when it first came on the market more than 10 years ago. This device allowed women who looked for a permanent method of birth control to undergo a sterilization procedure that did not require invasive surgical incisions. Implantation could be easily done in a day-hospital setting in just a couple of minutes. However, after more than 5,000 women filed their complaint reports claiming that the device caused them all kind of injuries and serious adverse reactions, the general opinion on this devices’s safety is a little more than just controversial. The number of complaints was so high that recently the FDA was forced to issue an investigation panel to determine if this medical device should be recalled in the near future.

  • Headaches
  • Abdominal Cramps
  • Device Breakage and Migration
  • Organ Perforation
  • Back, Neck and Legs Pain
  • Heavier menstrual bleeding
  • Unusual Bleedings and Discharges
  • Chronic Fatigue
  • Weight Gain and Bloating
  • Device Allergies and Anaphylaxis
  • Sexual Dysfunction
  • Depression and Suicidal Thoughts
  • Nausea and Vomiting
  • Mood Swings

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Xarelto is the commercial brand owned and registered by Bayer to market the drug Rivaroxaban (BAY 59-7939). It is a Novel Oral Anticoagulant (NOAC) marketed in the United States Xarelto by Janssen Pharmaceuticals, and was the first orally active direct Factor Xa inhibitor available. Since the first launch in 2008, it has been approved by many international regulatory authorities such as the US Food and Drugs Administration (FDA) as a blood thinner. It is used for several indications, including the prophylaxis and treatment of deep venous thrombosis (DVT) in patients undergoing hip or knee replacement surgery, the reduction of risk of stroke in patients with non-valvular atrial fibrillation, and the treatment of pulmonary embolism (PE) [1]. Atrial fibrillation is one of the most frequent abnormal heart rhythm conditions (irregular heartbeat) and is caused by a disruption in the heart’s electrical system. Typical symptoms include fatigue, palpitations, and shortness of breath.

Xarelto Mechanism of Action

Rivaroxaban inhibits Factor Xa interrupting both the intrinsic and extrinsic pathways of the blood coagulation cascade. Because of its peculiar and unique mechanism of action, there’s still no known antidote, making it very risky for patients in the eventuality of an uncontrollable bleeding accident. Many Xarelto lawsuits were filed in the past to account for several patient‘s internal bleeding cases that eventually caused their deaths. Both Bayer and Janssen Pharmaceuticals were accused of concealing important safety information, of insufficiently warning patients about the drug’s potential risks, and of not testing the drug enough before releasing it on the market.

Is Xarelto a dangerous medication?

Because of the potential risk of internal bleeding and the lack of an approved antidote to correct them, mistakes with the administration of this drug may cause devastating and sometimes fatal effects on patients. For this reason, the Institute for Safe Medication Practices (ISMP) included Xarelto among its list of high-alert medications as a drug with a “heightened risk of causing significant patient harm” [3]. To further underline its dangerousness, the FDA labeled this medication with several warnings about some of the most severe warnings and contraindications, such as gastrointestinal and intracranial bleeding. Also, Xarelto’s label warns about the risk of spontaneous spinal epidural hematoma: a condition which may lead to permanent paralysis in patients receiving anesthesia or undergoing spinal puncture [4].
The risk of severe and uncontrolled internal bleeding has always been one of the major issues with all blood thinners. The incidence of major bleeding incidents observed in patients receiving rivaroxaban was just slightly higher than in those taking Coumadin (Warfarin) (4.3% for Xarelto vs. 3.1% for Warfarin) [5]. However, the effects of Warfarin can be still reversed with the quick administration of vitamin K or other substances [6]. So, while the adverse effects are still dangerous and can be deadly [7], at least there’s still a treatment option available for doctors to save patient’s life. An option which is absent with Xarelto and other NOACs. Also, it should be noted that patients under therapy with Warfarin require to monitor their dietary regime carefully, as well as to avoid any dangerous drug interactions. Thanks to the need of performing frequent blood testing to evaluate the medication’s effectiveness and safety, doctors overseeing such patients may adjust Warfarin’s dosage appropriately [8]. However, as no such monitoring is required with Xarelto, a greater risk for unexpected bleedings effects may endanger a patient’s life, no matter how convenient the “once daily” dosage looks.

Clinical Research and Studies

During the so-called ROCKET AF double-blind trial that involved 14,264 patients with atrial fibrillation, Xarelto was never deemed to be superior to Warfarin. The results observed just defined it as “non-inferior” or just as effective for preventing stroke or systemic embolism as its counterpart [5]. One of the FDA reviewers who examined the data from the trial also pointed out that Warfarin was administered in a sub-optimal way, and the commission recommended that an additional study on rivaroxaban was required to assess its potential stroke and bleeding risks adequately [9].

Clinically relevant and major bleeding event rates during anticoagulant therapy increase significantly up to double if the patients take most common over-the-counter painkillers such as non-steroidal anti-inflammatory drugs (NSAIDs) and Aspirin [10]. Also, sudden discontinuation of treatment with all blood thinners can be fatal because it is associated with an increased risk of blood clots in the brain. Even when Xarelto treatment endangers a patient’s life due to the risk of a fatal bleeding, however, stopping it then increases the risk of brain clots whose consequences include body paralysis and even death [11]. On the other hand, there’s an increasing amount of clinical evidence that points out that this medication can also be linked to an increased risk for blood clot-related injuries such as pulmonary edema or venous thromboembolism, instead of preventing them. During the first quarter of 2012, the ISMP found that out of 356 cases of patients reporting serious, disabling, or fatal injuries in which Rivaroxaban was deemed the principal responsible, 158 of these side effects (44%) were thromboembolic events mostly occurring in younger patients. These constituted the predominant serious adverse event type reported [12].

Xarelto and Pradaxa

In the past FDA, already reported how bleeding events constitute the most serious, highest-risk adverse effect in prescription drug therapy. For this reason, treatment with blood thinners is usually accompanied by risks so substantial, they’re considered even more dangerous than cancer chemotherapy treatment with antiblastic drugs such as carboplatin [13]. Pradaxa (Dabigatran), for example, accounted for 3,781 adverse events in 2011, including 542 patient deaths, surpassing all other regularly monitored drugs in reports of hemorrhage (2,367 cases), acute renal failure (291), and stroke (644) [14].

Similarly to Xarelto side effects, Pradaxa’s ones also represent a serious threat to a patient’s life. Pradaxa is a blood thinner with no known antidote, so there’s no way to reverse its potentially fatal effects, nor to mitigate them by reducing its dosage [15]. Pradaxa’s manufacturer Boehringer Ingelheim faced thousands of lawsuits filed by many patients, who accounted them responsible for the many deaths and severe accidents caused by this medication. Eventually, the pharmaceutical company opted to pay up to $650 million to settle the overwhelming amount of cases. Bayer instead keeps claiming yet today that Xarelto is safe [16]. However, a more recent study pointed out that NOACs were also associated with a significantly higher risk of gastrointestinal bleeding when compared to Warfarin. The study results showed a 50% increase in the risk of gastrointestinal bleeding with Dabigatran, and a more than two-fold higher danger of bleeding accidents with Rivaroxaban compared with Warfarin [17].

More to read: Essure Implant Warning and Lawsuits


Zofran Lawsuit Information

Women are filing lawsuits against Zofran (ondansetron) after they gave birth to a child affected by malformations. This antiemetic drug was only approved by the FDA to prevent nausea and vomiting caused by cancer chemotherapy and surgical interventions. However, GlaxoSmithKline widely marketed it for a whole decade as an off-label treatment for morning sickness in pregnant women.

Zofran during pregnancy exposes your babies to its dangerous effects, causing severe fetal malformations. If your baby was born with a birth defect you might be eligible for a large cash settlement by filing a lawsuit. Call right now at 1-800-430-1673 or click here to speak to one of the best Zofran lawyers that will help evaluate your legal options for free.

The use of this drug as an off-label medication during pregnancy has been determined to be illegal and unreasonably dangerous. Zofran can cause birth defects as well as several other dangerous side effects such as Serotonin Syndrome and Arrhythmias (Abnormal Heart Rhythm) in specific circumstances.

Why should you file a Zofran lawsuit against GlaxoSmithKline?

In the last few years, many victims emerged, Court documents presented during the 2012 lawsuit trial against GSK allegedly showed that the pharmaceutical company knew about the dangers of its use in pregnant women as early as 1992. This drug can cross the human placenta and reach the fetus in toxic levels, causing malformations and birth defects. However, Glaxo ignored these risks and the lack of a proper FDA approval and kept marketing their medication to pregnant women claiming it was safe. All other forms of this medication, including generic Ondansetron as well as the oral dissolving tablets Zuplenz, never received approval for safe use during pregnancy. GlaxoSmithKline made millions out of this drug and even paid kickbacks to convince doctors and other health care providers that prescribing their branded version as an off-label treatment for morning sickness was a good idea. At least 1 million women each year keep taking this drug still today, despite the risks for their fetus and their own health.


  • Glaxo released an unsafe drug to the public, even though is their precise responsibility to determine a medication’s safety as well as its effectiveness.
  • The company never warned the public about the dangers of using this drug in pregnant women.
  • GSK advertised Zofran as a safe drug during pregnancy, concealing the clinical studies that proved the contrary and making deliberately false claims.
  • The pharmaceutical company misrepresented many animal studies they possessed whose results showed that their drug may cause birth defects.
  • The Big Pharma marketed this medication as an off-label treatment for morning sickness without FDA’s approval.
  • Glaxo was negligent in properly evaluating data on this medication’s safety for use in pregnant women.

More to read: Ohio plaintiff claims Xarelto caused uncontrolled gastrointestinal bleeding