When the quest for market domination and billions of dollars in profits collides with consumer safety in the pharmaceutical world, The Sanders Firm knows that the consumer is likely to be the loser. Such is the case with Xarelto, one of the new oral anticoagulants that have had extraordinary sales success but have spelled tragedy and hardship for thousands as a result of deadly internal bleeding side effects.
If you have used Xarelto and experienced internal bleeding or serious health issues and you wish to file a Xarelto lawsuit, the veteran product liability lawyers at The Sanders Firm will help you get the justice and compensation that you deserve.
The Sanders Firm has earned its nationwide reputation in personal injury litigation by taking on companies like Bayer and Johnson & Johnson that choose to put profits first and consumer safety second.
Xarelto safety concerns
The two anticoagulants feverishly vying for the top of the $10 billion blood thinner market are Xarelto (rivaroxaban), co-developed by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals, and Pradaxa (dabigatran etexilate) developed by Boehringer Ingelheim. Both promised to be hassle-free once a day pill to be used for the prevention of clots that could cause strokes caused by atrial fibrillation. They would both replace what was considered the cumbersome and inconvenient regular monitoring and dosage adjustment required by the long-time market leader Coumadin (warfarin).
Pradaxa, which received FDA approval in 2010, was an immediate market success garnering 28% market share. Xarelto, approved in 2011, was also a resounding market success picking up $1.3 billion in U.S sales in 2013. It has also been approved for bedridden patients recovering from artificial hip implant or knee replacement surgeries.
Deadly internal bleeding side effects have no antidote
Unlike warfarin, neither Xarelto nor Pradaxa have an antidote or reversal agent which can control an internal bleed once it has started, particularly dangerous in the case of brain bleeds or gastrointestinal bleeding where most deadly incidents have occurred. In the case of Pradaxa, there have been 18,000 serious adverse reactions including over 600 deaths and almost 2,400 hemorrhages.
As for Xarelto, in a Phase III study to examine the drug’s safety, 73% of 16,000 participants experienced side effects such as anemia or bleeding. In a clinical trial involving 14,000 patients, the rate of clinically excessive bleeding was very high—15 percent—making Xarelto the riskiest outpatient drug treatment on the market.
Ironically, the highest numbers of reported injuries were pulmonary embolisms, which Xarelto was designed to prevent. The FDA has also released a warning that patients who suddenly stop taking Xarelto may be at risk for developing blood clots. And finally, the FDA still hasn’t mandated a Xarelto black box warning for consumers and physicians that uncontrolled internal bleeding can occur with Xarelto use.
When is injury and death rate acceptable?
German media reports reported that in the first eight months of 2013, Bayer confirmed 968 Xarelto serious adverse effects including 72 deaths up from 750 reports of adverse reactions and 58 deaths in 2012.Bayer contends that, based on the number of prescriptions written, this is an acceptable casualty count.
We, the product liability attorneys at The Sanders firm, do not accept the notion of “acceptable collateral damage” in the name of progress. When a race to company profit comes at the expense of the consumer, we provide unwavering legal support for our clients who endure emotional, medical, and economic hardships because they were led to believe that a product was safe for them to use.
Drug companies must warn of potential dangers
Failure of a drug manufacturer like Bayer to warn the public if its product is potentially hazardous or unsafe may constitute a serious breach for which the company must be held accountable.
If you have used Xarelto and experienced internal bleeding side effects or other injury, speak to a Xarelto attorney at The Sanders Firm. We will help you pursue legal action against Bayer for not providing the proper warning regarding the dangers of using Xarelto. If your loved one was the victim of a wrongful death by using Xarelto, you may be entitled to receive compensation for the lost wages of the deceased, both past and future, and lost companionship.
Xarelto litigation consolidated under MDL 2592
The first Xarelto lawsuit brought against Bayer and Jannsen sought compensation for “fraud, wrongful death, negligence, failure to warn, product liability, unreasonable marketing of a dangerous drug, and breach of warranty.” Over the past two years, more than 2,800 complaints have been filed alleging life-threatening and sometimes fatal Xarelto bleeding injuries. To more efficiently handle the growing litigation, federal Xarelto cases were consolidated as part of multidistrict litigation, currently presiding in the Eastern District of Louisiana. Judge Eldon Fallon is overseeing pretrial processes, and a recent case management orders indicate that bellwether trials will take place in the first quarter of 2017.
As the first Xarelto trial dates approach, Bayer may decide to negotiate settlements rather than litigate each case separately.
The amount of time to file a dangerous drug lawsuit varies from one state to the next. If you fail to file your claim before the statute of limitations expires in your state, your case will be thrown out. It’s important to consult Sanders Firm attorneys immediately so they may determine if you have a viable claim for damages.
Can I file a Xarelto lawsuit?
Product liability claims generally consist of four basic elements:
- you must prove that you have been injured
- you must prove that the product was somehow defective or lacked proper warnings or instructions
- you must prove that the defect or lack of warning was the specific cause of your injuries
- you must prove that you used the product in the manner in which it was intended.
Damages fall into two basic categories: compensatory and punitive. Compensatory damages are intended to restore you to the condition you were in before the injury occurred. These include “economic” losses such as medical expenses or lost wages or profits. They also include certain “non-economic” losses, such as pain and suffering.
Punitive damages apply when a judge or jury decides to punish a defendant for its conduct and deter others from engaging in similar conduct.
Free consult with product liability attorneys
To learn more about your rights and legal options, we invite you to call The Sanders Firm today. Our attorneys have five decades of experience in litigating product liability lawsuits in both state and federal court and have recovered dozens of substantial settlements and verdicts from dangerous drug claims.
Our phone lines are open 24/7, so call our offices at 1-800-FAIR-PLAY (1-800-324-7752) for a free consultation and evaluation of your case.
- FDA, Violation letters to Pharmaceutical Companies,http://www.fda.gov/downloads/Drugs/GuidanceCompliance
- FDA.gov, Xarelto tablets, Safety information,http://www.fda.gov/safety/medwatch/safetyinformation/ucm367392.htm