Approved by the U.S. Food & Drug Administration (FDA) in 2011, the drug known as Xarelto is used to reduce the risk of strokes, pulmonary embolism (PE), blood clots, and deep vein thrombosis (DVT) because it acts as a blood thinner. Johnson & Johnson, the drug’s manufacturer, has promoted Xarelto as superior to older blood thinners when, in fact, it may be more dangerous. This is because – unlike other blood thinners on the market – Xarelto can cause bleeding that cannot be stopped even by a physician.
Potentially Serious Adverse Side Effects
Blood thinners, commonly referred to as anti-coagulants, carry an inherent risk of causing internal bleeding – known as hemorrhaging. Xarelto is no exception. But Xarelto is unique when compared to older anticoagulants because (1) it does not have an antidote to stop internal bleeding once it begins and (2) the drug does not require regular blood monitoring tests, which may help prevent uncontrolled hemorrhaging.
Patients who have used Xarelto have alleged the following side effects while taking the drug as directed by a physician:
- Epidural hematoma
- Retinal hemorrhages
- Intracranial hemorrhages
- Adrenal bleeding
- Cerebrovascular accident (stroke)
- Excessive blood loss
- Wound infections and complications
No Recall by FDA
Unfortunately, Xarelto has yet to be recalled by the FDA. As a result, physicians are still prescribing the drug to patients even though the drug could potentially cause serious harm.
When the drug was undergoing FDA approval in 2011, some primary government scientists assigned to study Xarelto’s safety and effectiveness were unsure about approving the experimental drug. The concerned stemmed from a lack of care in clinical trial design. Specifically, FDA scientists argued patients could be placed at a higher risk of harm from stroke and/or bleeding when treated with Xarelto when compared to an alternate anticoagulant, Warfarin (also known as Coumadin or Jantoven). In one clinical trial of Xarelto, subjects taking the drug experienced 22 strokes 30 days after the study while those treated with Warfarin only suffered six. U.S. patients who were prescribed Xarelto may have received the following dosages of the drug: 10, mg, 15 mg, or 20 mg.
Lawsuits filed against the manufacturers of Xarelto – including Johnson & Johnson (J&J) and Bayer, who jointly developed the drug – allege the companies were negligent in several ways regarding the anticoagulant. Both companies are facing more than 18,000 U.S. patent lawsuits blaming Xarelto for internal bleeding. The drug has also been linked to at least 370 fatalities, according to FDA reports. Xarelto is Bayer’s top selling product – it generated $3.24 billion in sales in 2016 and $2.5 billion the year prior according to the Chicago Tribune. As for J&J, Xarelto is the company’s third-largest selling product bringing in $2.29 billion in revenues in 2016.
Officials for Bayer contend despite complaints from some patients regarding the side effects, the bleeding risks are clearly and fully outlined on the drug’s warning label and are well-known by prescribing physicians. Xarelto was initially approved by the FDA to prevent blood clots in users that were undergoing knee and hip surgeries. Since that date, the drug’s use has been extended to patients who are at a high risk of stroke or suffer from irregular heartbeats.
Both J&J and Bayer are accused of falsely marketing the anticoagulant as more effective at preventing strokes than its competitor manufactured by Bristol-Myers Squibb Co. Coumadin, which has been thinning patients’ blood since the 1960s. Part of the issue is that Xarelto was marketed as both more effective and easier to use because it did not need frequent tests to monitor blood-plasma levels like Coumadin does. Accusations also focus on the lack of antidote for the drug, which puts some users at high risk for bleeding out (hemorrhaging) if they suffer an injury. Coumadin’s blood thinning effects, on the other hand, can be restricted.
Xarelto personal injury and/or wrongful death lawsuits filed in federal courts across the country have been consolidated before U.S. District Judge Eldon Fallon in New Orleans. Other Xarelto-related lawsuits are pending trials in state courts in Delaware and Pennsylvania.
Pharmaceutical Products Liability
Dangerous and defective products injure thousands of innocent victims in the United States every year. These products include all types of consumer goods, including pharmaceutical drugs. Products liability laws are based on the idea that companies have a general duty to protect consumers from potential dangers. Courts across the nation have held manufacturers generally have more knowledge and insight than the average consumer about their products and, as a result, the manufacturer bears the burden of assuming responsibility for injuries or damages that these products cause.
Products liability laws differ from personal injury law. Depending on the type of defect found, several different parties may be held liable for injuries caused. There are three types of defects that may give rise to a products liability lawsuit:
- Design defects – where the problem is present from the beginning, before the product is even manufactured. In other words, something in the design of the product is inherently unsafe;
- Manufacturing defects – these defects occur in the course of the product’s making or assembly. The actual design of the product is not unsafe but, rather, something happened during its manufacture that strayed from the design’s intent; and
- Marketing defects – these are flaws in the manner in which the product is marketed to the public, such as inadequate safety warnings, improper labeling, or insufficient instructions.
Pharmaceutical products liability cases can be complex, both medically and legally speaking. This is because establishing legal fault may require the assistance of testimony from expert witnesses. Moreover, there are several legal theories under which a plaintiff may bring a claim such as negligence or strict liability. Likewise, a defendant – or multiple defendants – may put forth several defenses to try to beat the claim. Every state has its own laws and specific statutes – including timelines – that will directly affect a product liability action.
Xarelto Pharmaceutical Attorneys
If you or someone you care about has been injured – or sadly, died – due to adverse side effects from taking Xarelto prescribed by a physician, it is important that you consult an experienced attorney. The skilled lawyers at the Roger Ghai Law Offices have years of experience recovering compensation on behalf of clients who have been injured by a defective product. Click here today to schedule your free, initial, case evaluation with one of our experienced attorneys.