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Xarelto Manufacturers May Have Concealed Data


Katie Thomas, a writer for the New York Times, recently published an article which reported that drug manufacturing giants Janssen Pharmaceuticals (a division of Johnson & Johnson) and Bayer, Inc, may have withheld important data from a peer reviewer at the New England Journal of Medicine, regarding the drug Xarelto.  

The information withheld could have informed the peer reviewer, whose job it is to examine the design of a study and the resultant data to make sure that the conclusion was fair and accurate, of how blood readings could have differed depending on the device used.

Xarelto has been in the news quite a bit recently, due to the more than 5,000 lawsuits filed against the drug’s manufacturers. In each case, plaintiffs have alleged that the drug caused serious injury or death in a patient that it was prescribed to. With this new information, plaintiffs are wondering if a complete review of all the data could have saved them from the pain and suffering they have experienced.

Why Did Doctors And Patients Get So Excited About Xarelto?

After Xarelto received its U.S. Food and Drug Administration approval in 2011, the drug was heavily advertised as superior to other blood thinners due to the “Xarelto Difference”. What was this difference? That Xarelto is a “one size fits all” type of drug – one dosage for all patients, regardless of age, gender, weight, activity level, and dietary intake.

Before Xarelto, patients on older blood thinners had to frequently return to their doctor for bloodwork to determine if the dosage they were on was correct. A change in lifestyle could easily require a change in dosage. Some patients even had to check in as often as once a week, which could be very inconvenient.

Considering the fact that Xarelto made patients lives easier and checkups less frequent, it is hardly surprising that the drug quickly became the number one prescribed blood thinner, given to millions of patients. Unfortunately, as many have discovered, the drug also comes with some dangerous side effects.

The Side Effects

The most dangerous aspect of the drug is that researchers have yet to find an antidote. This means, that if someone on Xarelto is seriously injured and begins to bleed heavily, or if they have internal bleeding, doctors can’t reverse the effects of the drug and the body won’t do its job of increasing the clotting properties in the blood.

If the blood won’t clot, there is a real danger of the patient dying due to blood loss. When someone has taken an older blood thinner, like Warfarin, doctors can administer Vitamin K to encourage blood clotting and reverse the effects of the drug. With Xarelto, blood transfusions are typically the only possible course of treatment. Often, this isn’t enough.

Plaintiffs also allege that the drug has caused numerous other side effects, such as:

Pulmonary Embolism

When a pulmonary embolism occurs, a blood clot blocks the flow of blood to a portion of or the entire lung. The clot often forms somewhere else, such as the leg, and then travels through the bloodstream to the lungs. Symptoms include chest pain, shortness of breath, coughing which may produce blood, fever, lightheadedness, and a rapid heartbeat.

GI Bleeds

Gastrointestinal bleeds (GI bleeds) can occur anywhere in the digestive tract, including the rectum, colon, large and small intestine, the stomach, and esophagus. GI bleeds are usually diagnosed after a patient presents with bloody vomit or stool and abdominal pain.

Spinal Bleeding

If someone undergoes a medical procedure involving the spine, or suffers from a physical trauma, pooling of the blood around the spine and spinal cord may occur. If the blood is allowed to continue pooling, it can result in paralysis, brain damage, seizures, and death.

Stroke

When a blood clot cuts off the supply of blood and oxygen to the brain, this is called a stroke. Brain cells may die, resulting in paralysis, numbness, memory loss, difficulty speaking, impaired eyesight, and a lack of coordination.

The FDA Warnings

Although many believe that the FDA should have recalled Xarelto completely, the administration has yet to do so. Instead, they have published several warnings:

  1. The first black box warning was issued in August of 2013. It informed the medical community and the public that anyone who discontinues the drug too quickly is at increased risk for forming blood clots, deep vein thrombosis (DVT), and spinal hematomas.
  2. In January of 2014, the FDA released a warning regarding the fact that Xarelto has no known antidote and that patients with excessive bleeding should be treated with blood transfusions.
  3. A second black box warning was issued in March of 2014, which states that anyone undergoing a spinal procedure should wait, if possible, until the drug has been completely metabolized out of their body due to the risk of spinal bleeding.
  4. An Adverse Reaction report was published which indicated that use of Xarelto could result in thrombocytopenia.

The FDA has also concluded that Xarelto should not be prescribed to patients who are already taking:

  • Itraconazole
  • Indinavir
  • Phenytoin
  • St. Johns Wort
  • Carbamazepine
  • Iopinavir
  • Ritonavir
  • Conivaptan
  • Rifampin

Unfortunately, for many, these warnings came too late.

FDA Investigation Into Xarelto’s Approval

It has been announced that the FDA is looking into whether or not the blood-testing device that was used during the clinical trials of Xarelto could have given false results. According to plaintiffs involved in the lawsuits filed against Xarelto’s manufacturers, internal documents from the companies have shown that doctors made complaints about the devices during the study. Not long after the clinical trial was completed, the device used was recalled.

The Ongoing Litigation

More than 5,000 lawsuits have been filed against Johnson & Johnson and Bayer, Inc, each one alleging that Xarelto side effects either caused serious injury in a patient or their death. Nearly 500 of the lawsuits are wrongful death claims, filed by the loved ones of those who died.

So many lawsuits have been filed with similar allegations that the Judicial Panel on Multidistrict Litigation approved the consolidation of these claims into MDL 2592.

MDLs were created by Congress in 1968, in order to help the legal system coordinate complex cases where litigation against the same defendant, with similar allegations, was filed in multiple districts. The purpose of the consolidation is to save all parties involved time and money. It also saves judicial time and resources as well, because all of the cases are assigned to one federal judge, in one court.

The cases filed under MDL 2592 have been moved to the  Eastern District of Louisiana under the honorable Judge Eldon Fallon.

In addition to the MDL, a mass tort group was formed by the Court of Common Pleas in Philadelphia, Pennsylvania.

The number of lawsuits filed has continued to grow steadily and thousands more are expected to be filed, as those whose lives have been impacted by the drug decide to seek compensation for their losses.

What Are Plaintiffs Seeking Compensation For?

In the personal injury complaints filed, plaintiffs are seeking damages that will provide them with compensation for the money they have spent on medical expenses, any earnings that they have lost because they needed to take time off of work in order to receive medical treatment, and their pain and suffering.

If a wrongful death complaint is being pursued, the loved ones of the deceased may seek compensation for:

  • medical expenses
  • loss of the deceased’s earnings
  • loss of other benefits, like insurance policies or pensions
  • the value of the services the deceased provided their loved ones
  • lost inheritance for children
  • loss of companionship
  • funeral and burial expenses

If, at the end of the trials, the court sides with the plaintiffs, the amount awarded in damages to each plaintiff may vary depending on the facts of their individual case.

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