Xarelto | Blood Thinner Lawsuits

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Xarelto

Xarelto is the number-one-selling blood thinner in its class. Introduced to the market in 2011, Xarelto’s U.S. sales soared to $2.2 billion in 2016. Xarelto is a new kind of blood thinner known as a Novel Oral Anticoagulant. It doesn’t have the same blood monitoring or diet restrictions as traditional blood thinners, such as warfarin, but the drug has been linked to increased risks of dangerous bleeding, including internal bleeding that cannot be stopped. There is no approved antidote to stop a Xarelto bleed and this has helped lead to tens of thousands of lawsuits being filed against the makers of the drug.

Xarelto Lawsuits

Were you injured after taking the blood-thinning drug Xarelto? If you or a loved one took Xarelto and developed uncontrollable bleeding, you may be entitled to financial compensation. There may be significant payouts or cash settlements to those affected by the drug.

Tens of thousands of people who were harmed as a result of taking Xarelto are now filing lawsuits against the blood thinner’s manufacturers, Johnson & Johnson, its subsidiary Janssen Pharmaceuticals, and Bayer.

Xarelto lawsuits accuse the manufacturers of designing a defective product and failing to warn about its risks. People who filed Xarelto claims say they suffered dangerous, uncontrollable bleeding after taking the drug. There are hundreds of lawsuits being filed on behalf of loved ones who died after taking the drug, as well.

Xarelto Multidistrict Litigation (MDL) & Mass Torts

In December 2014, the Judicial Panel on Multidistrict Litigation consolidated less than two dozen Xarelto lawsuits into a multidistrict litigation (MDL) in the Eastern District of Louisiana.

As of March 15, 2017, there were more than 15,600 Xarelto lawsuits pending in the MDL.

In addition to the Xarelto MDL, there are thousands more Xarelto lawsuits pending in state courts nationwide. Some of these cases have been consolidated into mass tort programs, including one in Philadelphia’s Court of Common Pleas. There were roughly 1,300 cases in the Philadelphia mass tort as of March 2017.

Mass torts and MDLs are established when a number of plaintiffs allege similar claims against a corporation. Plaintiffs in Xarelto lawsuits all claim to have suffered bleeding complications after taking the blood thinner and are suing Johnson & Johnson, Janssen Pharmaceuticals and Bayer as a result.

Consolidating similar cases means attorneys and lawyers can pool their resources during the discovery process and save the court system time and money. It can also help encourage settlement negotiations.

MDLs and mass torts are different from class action lawsuits in that cases are filed individually, not by one plaintiff on behalf of many. Jury awards are also handed down individually should the cases head to trial, and settlements are doled out based on individual injuries, not divided equally among the plaintiffs.

Xarelto Lawsuits & Injuries

Thousands of Xarelto lawsuits have been filed in state and federal courts throughout the country. As of Jan. 1, 2017, there were about 16,900 Xarelto lawsuits pending nationwide and that number is expected to continue rising.

The first lawsuits to head to trial in the Xarelto MDL are called bellwether trials and are scheduled to begin in April 2017. Plaintiffs in these first lawsuits allege suffering the following injuries associated with Xarelto:

  • Gastrointestinal (GI) bleeding
  • Brain bleeding
  • Rectal bleeding
  • Xarelto Lawsuit Updates

Xarelto Lawsuit Updates

December 2014 — The Judicial Panel on Multidistrict Litigation consolidated less than two dozen Xarelto lawsuits in the Eastern District of Louisiana before U.S. District Judge Eldon E. Fallon.

January 2015 — The Xarelto mass tort program is established in the Philadelphia Court of Common Plea’s Complex Litigation Center before Judge Arnold New.

August 2016 — Judge Fallon issued a Case Management Order establishing the schedules for the first four bellwether trials in the Xarelto MDL. The first trial was scheduled to begin in February 2017 in St. Louis, with the second, third and fourth trials following in the proceeding months.

October 2016 — Judge Fallon delayed the MDL bellwether trials by one month after the NBA All-Star Games were moved from North Carolina to St. Louis. The games were relocated after the state of North Carolina passed its controversial “bathroom bill.”

October 2016 — Judge New opted to use a bellwether method to decide which cases in the Philadelphia mass tort program should be tried first. This is unlike other mass tort programs, which use a first-in first-out system. The first bellwether trial was scheduled to begin in September 2017.

January 2016 — Judge New revised the bellwether trial schedule for the Philadelphia mass tort. The first bellwether trial was revised to begin in November 2017.

February 2016 — At the insistence of both plaintiffs and defendants, the MDL bellwether trials were pushed back again by one month. The first bellwether trial was rescheduled for April 2017, with the following 3 bellwethers slated for trial in May, June and July.

What is Xarelto?

Xarelto is a blood-thinning medication, also called an anticoagulant, used to prevent blood clots in certain patients. Xarelto belongs to a new class of blood thinners called Novel Oral Anticoagulants (NOACs). It is the number one prescribed blood thinner in its class and brought in more than $2.2 billion dollars in sales for Johnson & Johnson and its subsidiary Janssen Pharmaceuticals in 2016. The drug was developed by healthcare giant Bayer and is marketed in the United States by J&J and Janssen.

Xarelto was approved in July 2011 by the U.S. Food and Drug Administration to prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery. DVT is a blood clot that forms in one of the body’s deep veins, typically ill the leg. If the blood clot breaks away and travels to the lungs it is considered a PE.

Xarelto’s use was later expanded to reduce the risk of stroke or systemic blood clots in patients with the heart condition atrial fibrillation. Atrial fibrillation is an irregular or rapid heartbeat that can cause poor circulation in people with the condition.

Like all blood thinners, Xarelto increases a patient’s risk of uncontrollable bleeding, but unlike some other anticoagulants on the market today, there is no approved antidote to stop a Xarelto bleed. This puts patients at serious risk for additional complications or even death.

Xarelto Side Effects

The most common side effect associated with Xarelto is uncontrollable bleeding. Xarelto works to prevent blood clots by blocking a key enzyme needed in the clotting process. This means even beneficial clots, such as those that stop cuts from bleeding, are prevented from forming. This could potentially turn a simple nose bleed into a serious situation. Elderly patients are at the greatest risk for uncontrollable bleeding when taking Xarelto.

Other possible side effects associated with Xarelto include:

  • Upper abdominal pain
  • Feelings of discomfort in upper abdomen (dyspepsia)
  • Toothache
  • Fatigue
  • Sinusitis
  • Urinary tract infection
  • Back pain
  • Osteoarthritis
  • Throat pain
  • Low white blood cell count
  • Blood platelet deficiency
  • Gastrointestinal bleeding
  • Jaundice
  • Liver disorder
  • Hypersensitivity and allergic reactions
  • Brain bleeds
  • Skin disorders and rashes (Stevens-Johnson Syndrome)

Serious Bleeding Complications

Xarelto can cause serious bleeding that sometimes leads to death. Patients taking Xarelto should call their doctor right away if they experience any of the following signs and symptoms of bleeding included on the Xarelto label:

  • unexpected bleeding or bleeding that lasts a long time
    • nose bleeds that occur often
    • unusual bleeding from gums
    • heavier than normal menstrual bleeding
  • severe or uncontrollable bleeding
  • red, pink or brown urine
  • bright red or black stools that look like tar
  • cough up blood or blood clots
  • vomit blood or vomit that looks like coffee grounds
  • headaches, feeling dizzy or weak
  • pain, swelling or new drainage at wound sites

Studies Link Xarelto to Increased Risks of Complications

Numerous studies have been published since Xarelto hit the market in 2011 showing the risks associated with the drug. These studies show Xarelto is associated with increased risks of major bleeding compared to other blood thinners and increased risks of heart attack.

BMJ Study, 2012

A study published in June 2012 — less than one year after Xarelto’s approval in the U.S. — conducted a review of published clinical trials to determine the health outcomes of patients taking NOACs to prevent blood clots after total hip or knee replacement.

More than 38,000 patients from 16 trials were included in the study, which found that NOACs like Xarelto were “generally associated with a higher bleeding tendency.”

FDA Study, 2016

A study conducted by the U.S. Food and Drug Administration showed Xarelto users were at an increased risk of internal bleeding compared to those taking Pradaxa. The study, published in JAMA Internal Medicine in October 2016, also found that Xarelto users over the age of 75 who had an increased risk of stroke were at a significantly increased risk of dying compared to users of Pradaxa.

The study looked at more than 118,000 patients over the age of 65 who had atrial fibrillation. The study was conducted by researchers from the FDA, the Centers for Medicare & Medicaid Services and Stanford University.

Researchers found that Xarelto was associated with a 65% increased risk for intracranial bleeding, bleeding that occurs inside the skull, and a 48% increased risk for major bleeding occurring outside the skull compared with Pradaxa. The study also found that Xarelto put patients at a 40% increased risk for gastrointestinal bleeding.

Mayo Clinic Study, 2016

A study by the Mayo Clinic showed the risk for gastrointestinal bleeding was higher in atrial fibrillation patients taking Xarelto compared to two other popular NOACs: Pradaxa and Eloquis.

The study was published in the journal Gastroenterology late December 2016 and used data from privately held insurance patients and Medicare patients.

The study looked at data from tens of thousands of patients and found that Xarelto users were at a 20% increased risk for GI bleeding compared to Pradaxa users. The study found that Eloquis had the most favorable GI bleed profile, while Xarelto had the worse. The risk for GI bleeding was also greatest in users over the age of 75.

American Hearth Association Study, 2017

An American Heart Association study, published online in the the journal Stroke in February 2017, compared Xarelto with Pradaxa and warfarin for stroke prevention in patients with atrial fibrillation.

Researchers conducted a review of 17 studies and found the risk for stroke or blood clots in the arteries was similar between Xarelto and Pradaxa, but reduced when compared to warfarin. However, researchers also found that the risk for major bleeding was significantly higher in patients taking Xarelto compared to Pradaxa. The risk for all-cause mortality and gastrointestinal bleeding was also higher in Xarelto patients versus Pradaxa patients.

The risk for stroke or blood clots in patients taking Xarelto was comparable to users of warfarin, the study found, but there was an increased risk for GI bleeding for Xarelto users.

Dutch Study, 2017

A Dutch study published in the British Journal of Clinical Pharmacology in March 2017 looked at the risk of heart attack in patients with atrial fibrillation using the different anticoagulants available today.

Researchers conducted a search of the database Clinical Practice Research Datalink and found more than 30,000 patients with atrial fibrillation who recently started treatment with an NOAC, a vitamin K antagonist (such as warfarin), or low-dose aspirin.

The study found that the risk of heart attack doubled in patients taking either Xarelto or Pradaxa, another popular NOAC, compared to vitamin K antagonists or aspirin.

Japanese Study, 2017

A Japanese study published in the journal Digestive Endoscopy in March 2017 looked at the effect of NOACs on the risk of delayed bleeding following gastric endoscopic treatment.

The study included 97 patients at one medical center who were on an anticoagulant and were receiving treatment for gastric cancer. About 2 dozen of those patients were on an NOAC, 11 of which were using Xarelto.

Researchers found that the delayed bleeding rate was significantly higher in patients on Xarelto compared to Pradaxa. According to the study, Xarelto users had a 45% increased risk of delayed bleeding compared to those taking Pradaxa. The risk of delayed bleeding also increased as the dose of the anticoagulants increased.

Black Box Warning & Other FDA Warnings

Since its introduction to the market in 2011, Xarelto has been slapped with 2 black box warnings — the FDA’s strongest warnings — and numerous safety updates.

May 2016

Use of Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), two popular types of antidepressants, were added to the list of drugs that could potentially interact with Xarelto on the drug’s label.

Information on the use of Xarelto in patients with kidney impairment was also updated. The updated information highlights that patients with kidney impairments should be checked by a doctor periodically to make sure their kidneys are functioning properly.

December 2014

Xarelto’s label was updated to include a deficiency in blood platelets (a condition known as thrombocytopenia) as a possible adverse reaction.

Blood platelet deficiencies can cause bleeding into the tissues, bruising or slow blood clotting after injuries.

March 2014 — Black Box Warning

A black box warning was added to the Xarelto label to indicate that the optimal timing between the administration of Xarelto and spinal or epidural anesthesia is not known. There is an increased risk of bleeding in patients receiving spinal or epidural anesthesia. Doctors were advised to monitor for signs and symptoms of bleeding if spinal or epidural anesthesia was administered.

January 2014

The Xarelto label is updated to indicate that no antidote to reverse a Xarelto bleeding episode is available. Physicians were advised to promptly evaluate any signs or symptoms of blood loss and consider the need for a blood transfusion.

August 2013 — Black Box Warning

A black box warning was added to the Xarelto label to indicate that stopping the use of the drug too soon could increase a person’s risk for blood clots and other health problems. Other anticoagulants should be considered before stopping Xarelto.

The Xarelto label was also updated to include information about the use of Xarelto in patients with prosthetic heart valves. The label recommended against using Xarelto in these patients because no studies are available to show the drug was safe in this population.

Controversy around the Xarelto Clinical Trials

The FDA’s approval of Xarelto hinged largely on the results of a clinical trial that compared the effectiveness of Xarelto with the traditional blood thinner warfarin. The ROCKET AF trial, as it was called, was published in the New England Journal of Medicine just months ahead of Xarelto’s approval. It found Xarelto was as effective as warfarin in preventing dangerous blood clots, but not superior.

Several years after ROCKET AF was published, it became known that one of the medical devices used during the trial to measure the amount of warfarin giving to patients in the warfarin group was faulty. The device, called the INRatio Monitor System, was pulled from the market in July 2016 and questions arose about the validity of ROCKET AF’s results.

If patients in the warfarin group were potentially given the wrong dose of warfarin, could this skew the data in Xarelto’s favor?

The FDA began to investigate the study at the same time the British Medical Journal began an investigation of its own.

In a September 2016 press release, the prestigious medical journal accused one of the makers of Xarelto, Janssen Pharmaceuticals, of withholding critical trial data from the FDA. The BMJ investigation reportedly revealed that Janssen executives knew early on about the concerns surrounding the INRatio device, and even created a safety team to address those concerns, but failed to disclose any of that information to any regulatory agency.

Despite the controversies, the FDA concluded its investigation into the ROCKET AF trial and said the faulty blood monitoring device did not substantially affect the trial’s results. The FDA’s analysis was published in October 2016 and concluded no changes to its recommendations about Xarelto were needed.

It should be noted that Dr. Robert Califf, who held the top leadership in the FDA when this investigation occurred, was also one of the researchers in the ROCKET AF study.

No Reversal Agent

Since it hit the market in 2011, there has never been an approved antidote to stop a Xarelto bleed when one occurs. All anticoagulants increase a person’s risk for uncontrollable bleeding, including traditional blood thinners like warfarin. But unlike Xarelto and some other oral anticoagulants, there is an antidote to stop a warfarin bleed.

Xarelto is the number-one-selling drug in its class, yet its competitor Pradaxa has an approved antidote to stop a Pradaxa bleed.

An antidote is under development by San Francisco-based Portola Pharmaceuticals but the FDA put the brakes on the antidote’s approval in August 2016, saying it needed more data before it could make the decision to approve the drug.

Xarelto vs. Warfarin and Other Blood Thinners

There are many different types of anticoagulants on the market today. Many of these drugs are novel oral anticoagulants like Xarelto, while others have been used in medical care for decades.

Warfarin

Warfarin was one of the first anticoagulation medications approved by the FDA and has been the standard of care for decades. Warfarin was marketed under the brand name Coumadin and belongs to the class of drugs called vitamin K antagonists. Patients who use warfarin must undergo routine blood monitoring to ensure correct dosages and must also watch their diet, as foods high in vitamin K can interact with the medication.

Warfarin’s restrictions are one of the main reasons why patients might be attracted to new-generation anticoagulants like Xarelto. Xarelto does not require routine blood monitoring or diet restrictions.

Xarelto was shown to be as effective as warfarin in the ROCKET AF clinical trial, which compared the effectiveness of the two drugs. The trial did not show that Xarelto was superior to warfarin and patients are at an increased risk for GI bleeds when taking Xarelto compared to warfarin. Though patients taking Xarelto have a decreased risk of stroke compared to those taking wafarin, unlike Xarelto, there is an antidote to stop a warfarin bleed when it occurs.

Pradaxa

Pradaxa is an NOAC like Xarelto and was the first drug in its class approved by the FDA. It is manufactured by German pharmaceutical giant Boehringer Ingelheim and gained FDA approval in 2010.

Pradaxa works differently in the body than Xarelto and is considered a direct thrombin inhibitor, whereas Xarelto is a Factor Xa inhibitor. Until recently, there were no studies available that compared the safety and effectiveness of Xarelto with Pradaxa. Studies published in 2016 and 2017 show that while both seem to be equally effective in preventing blood clots, Xarelto may put patients at an increased risk of certain bleeding events compared to Pradaxa. The two drugs were also found to double a person’s risk of heart attack in a recent Dutch study.

There is an approved antidote to counteract a Pradaxa bleed, unlike Xarelto. The FDA approved Praxbind in 2015, making it the only NOAC with an approved antidote at the time.

Eliquis

Eliquis is an NOAC and Factor Xa inhibitor similar to Xarelto. It was approved by the FDA in late 2012 and is manufactured by Bristol-Myers Squibb. Few studies have been conducted to compare Eliquis with Xarelto, but those that have found Eliquis to have a more favorable safety profile than Xarelto when it comes to the risk of bleeding, including a 2016 study by the Mayo Clinic.

Though Eliquis may be associated with a lower bleeding risk than Xarelto, there is no approved antidote to stop an Eliquis bleed either.

Potential Drug Interactions

Xarelto can interact with many different drugs commonly prescribed to or taken by patients in the U.S., increasing a person’s risk for adverse side effects.

Drugs that have the potential to interact with Xarelto include:

  • Other anticoagulants, like warfarin
  • Aspirin and other NSAIDs, such as Ibuprofen, Advil, Motrin, Aleve and Celebrex
  • Some antibiotic, antiviral and anti-fungal medications (ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, rifampicin)
  • The anticonvulsant medication phenytoin

Xarelto and Alcohol

There is no warning about drinking alcohol while taking Xarelto on the drug’s label, however, alcohol has the potential to interact with the anticoagulant and increase a person’s risk for side effects.

Both Xarelto and alcohol have blood thinning properties, this means when taken together, a person could be at even greater risk for dangerous bleeding.

Xarelto and alcohol are both processed by the liver, as well. If the liver is busy breaking down a recent cocktail, an excess amount of Xarelto could build up in the blood as a result.

Who should not take Xarelto?

Xarelto is not right for everyone and some people may be at greater risk for certain side effects.

You should not take Xarelto if you are:

  • pregnant, unless the benefits outweigh risks
  • have impaired kidney function
  • are allergic to Xarelto
  • have a prosthetic heart valve

Xarelto Dosing — Which dosage is the right dosage?

Xarelto is prescribed in one of three doses: 10 mg, 15 mg or 20 mg. The amount of Xarelto prescribed will depend on the condition the drug is used to treat.

To Reduce the Risk of Stroke in Atrial Fibrillation

The recommended doses for patients with atrial fibrillation taking Xarelto to reduce their risk of stroke is 15 mg or 20 mg once a day with the evening meal.

To Treat Deep Vein Thrombosis and Pulmonary Embolism

The recommended dose for patients taking Xarelto to treat DVT or PE is 15 mg twice a day with food for the first 21 days. After 21 days, it is recommended patients switch to 20 mg once a day with food for the remainder of their treatment.

To Reduce the Risk of Recurring DVT and PE

For patients taking Xarelto to reduce their risk of developing deep vein thrombosis or pulmonary embolism again, the recommended dose is 20 mg once a day with food.

To Prevent DVT after Hip Surgery

The recommended dose for patients taking Xarelto following hip replacement surgery is 10 mg once a day for 35 days.

To Prevent DVT after Knee Surgery

The recommended dose is 10 mg a day for 12 days for patients taking Xarelto to prevent DVT following knee replacement surgery.

Xarelto — Is it Worth the Cost?

Xarelto earned $2.2 billion is sales for its U.S. manufacturer, Johnson & Johnson. The drug is not only the number-one-prescribed in its class, it’s also incredibly expensive compared to traditional blood thinners that have been used for decades.

There is no generic equivalent to Xarelto on the market. The drug was approved in 2011 and it could be many years before a generic is available.

Xarelto can cost about $400 for a 30-day supply compared to warfarin, which costs less than $20 for a 30-day supply. That’s about $4,800 a year for Xarelto compared to $240 for warfarin.

Not only is Xarelto far more expensive than traditional blood thinners, it can also increase a person’s risk for dangerous bleeding episodes compared to those same blood thinners.

Sources

Johnson & Johnson 2016 Annual Report. Retrieved from

https://jnj.brightspotcdn.com/88/3f/b666368546bcab9fd520594a6016/2017-0310-ar-bookmarked.pdf

Judicial Panel on Multidistrict Litigation, Pending MDLs by District. (March 15, 2017). Retrieved from

http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-March-15-2017.pdf

Philadelphia Court of Common Pleas, Xarelto Case List. Accessed March 27, 2017. Retrieved from http://www.courts.phila.gov/apps/clc/caselist.asp?search=Xarelto

Xarelto Label. (2015). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022406s019s020lbl.pdf

BMJ, “Dabigatran, rivaroxaban, or apixaban versus enoxaparin for thromboprophylaxis after total hip or knee replacement: systematic review, meta-analysis, and indirect treatment comparisons.” Gómez-Outes, Antonio et al. (June 14, 2012). Retrieved from

http://www.bmj.com/content/344/bmj.e3675

British Journal of Clinical Pharmacology, “Risk of myocardial infarction in patients with atrial fibrillation using vitamin K antagonists, aspirin or direct acting oral anticoagulants.” Stolk LM et al. (March 22, 2017). Retrieved from

http://onlinelibrary.wiley.com/doi/10.1111/bcp.13264/abstract

Digestive Endoscopy, “Effect of direct oral anticoagulants on the risk of delayed bleeding after gastric endoscopic submucosal dissection.” Yoshi T et al. (March 10, 2017). Retrieved from http://onlinelibrary.wiley.com/doi/10.1111/den.12859/abstract

Stroke, “Rivaroxaban Versus Dabigatran or Warfarin in Real-World Studies of Stroke Prevention in Atrial Fibrillation: Systematic Review and Meta-Analysis.” Bai Y, et al. (Feb. 17, 2017). Retrieved from http://stroke.ahajournals.org/content/48/4/970.long

Gastroenterology, “Gastrointestinal Safety of Direct Oral Anticoagulants: A Large Population-Based Study.” Abraham, Neena S. et al. (Dec. 31, 2016). Retrieved from

http://www.gastrojournal.org/article/S0016-5085(16)35532-9/fulltext

JAMA Internal Medicine, “Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation.” Graham, David J. et al. (November 2106). Retrieved from http://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2560376

New York Times, “F.D.A. Asks if Faulty Blood Monitor Tainted Xarelto Approval.” Katie Thomas. (Feb. 26, 2016). Retrieved from

https://www.nytimes.com/2016/02/23/business/fda-asks-if-faulty-blood-monitor-tainted-xarelto-approval.html?_r=0.

FDA. “FDA analyses conclude that Xarelto clinical trial results were not affected by faulty monitoring device.” (Oct. 11, 2016). Retrieved from

https://www.fda.gov/Drugs/DrugSafety/ucm524678.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

BMJ. Press Release, “Drug company withheld information about faulty device in

key trial of best selling anti-clotting drug.” (Sept. 29, 2016). Retrieved from

http://www.bmj.com/company/wp-content/uploads/2016/09/rivarox-investigation.pdf

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