Latest Xarelto Trial News: In December 2017, Bayer and Johnson & Johnson were ordered by a jury to pay $28 million in a Pennsylvania court because the companies failed to warn patients about the potential risks of internal bleeding.
Xarelto Lawsuit Update
Xarelto lawsuits have been in the news recently as people have filed claims against the companies that make and market the drug. As juries continue to consider the problems caused by the blood thinner and issue verdicts, even more people affected negatively by the prescription medication are likely to come forward.
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Why Are People Filing Xarelto Lawsuits?
When Xarelto was first introduced, it was considered a groundbreaking new drug on the market. Unlike other anticoagulants, such as the long-used warfarin, Xarelto was praised by researchers for its effectiveness with only a single pill taken once daily. The FDA approved Xarelto for the prevention of blood clots (including traveling clots), reducing the risk of stroke, and preventing deep vein thrombosis.
With approvals for several conditions, Xarelto was prescribed widely to millions of people each year. But with no antidote and severe side effects that were unclear when first approved, patients and their loved ones have seen the dangerous, needless risks of taking Xarelto. Thousands are now taking legal action against the drug companies who produce and market Xarelto.
Serious Xarelto Side Effects
One of the most prominent claims against Xarelto focuses on the dangerous side effects of the drug and the inability to reverse those effects when problems arise.
While Xarelto was praised for its ability to act quickly against blood clots, the lack of an antidote has put patients in serious danger. Patients who take the prescription can experience life-threatening bleeding from even small injuries that normally would clot quickly. Some patients also suffered from severe internal hemorrhaging or brain bleeding. Xarelto does not require blood monitoring when used, which could have helped prevent some of these side effects, or at least detect them early.
Anticoagulants in general can cause many serious side effects. According to the FDA’s adverse drug event data, nearly 22,000 severe injuries, including over 3,000 deaths, resulted from anticoagulants in 2016. In the same year, the CDC released a report stating that blood thinners accounted for more emergency department visits than any other class of therapeutic drug—including opioids and antibiotics.
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Failure to Inform and Misleading Information
Related to the severe side effects, many Xarelto claims also point to the drug companies’ failure to inform patients of these risks and include sufficient warnings on the blood thinner’s label. Many patients were completely unaware that Xarelto didn’t have an antidote available, unlike warfarin which can be reversed by taking vitamin K.
Though Xarelto was approved in 2011, an important clinical trial dubbed ROCKET AF that included over 14,000 patients was later found to have been tainted by the use of a faulty blood-testing device called INRatio. The clinical trial’s results were called into question when J&J revealed the device was recalled in 2014 because it understated the risk of bleeding. The revelation caused regulators to wonder if patients in the trial received incorrect warfarin dosages and thus harsher side effects, ultimately making Xarelto appear safer and more effective.
Since then, the FDA has also called for five updates to Xarelto’s warning label from 2013 to 2016, stating that consumers were not sufficiently warned of all the potential side effects.
- August 2013: Black-box warning added on the increased risk of spinal bleeds
- January 2014: Warnings about the lack of an antidote and that the drug should not to be used by patients with prosthetic heart valves
- March 2014: Additional information added for healthcare professionals on limiting spinal bleeds
- December 2014: Addition of new adverse reactions, thrombocytopenia and hepatitis
- May 2016: Warning of an increased bleeding risk with SSRI and SNRI antidepressants
Holding Drug Companies Liable for Xarelto Injury
Despite the severe risks to patients and the misleading information presented, pharmaceutical companies have seen great financial benefits from Xarelto. The drug quickly became an important aspect of the drug companies’ revenue year after year, accounting for over $2 billion in sales in 2016. By September 2017, reports showed Xarelto earned its manufacturer $1.8 billion in the nine months, despite so many health risks and more emerging lawsuits.
While the two drug companies saw high profits, many patients faced high medical bills as a result of taking the drug. Treatment costs, including hospitalizations and follow-up visits, for a bleeding injury can quickly accumulate and may not be fully covered by insurance. Many patients also lost income while recovering, making it even more difficult to keep up with medical bills.
In addition to being compensated for these bills, as well as funeral expenses for some families, Xarelto lawsuits help hold the drug companies accountable for withholding important medical information and causing needless pain and suffering to so many.
How Do I Qualify for a Xarelto Lawsuit?
Thousands have already pursued legal action against Janssen Pharmaceuticals, a division of J&J, and Bayer because of the harmful risks of Xarelto, and many more may still be eligible to file a lawsuit.
- Patients who took Xarelto as prescribed and suffered a bleeding event, stroke or another severe injury are eligible to file a personal injury claim against Xarelto.
- In cases where the patient has passed away as a result of these injuries, surviving family members may be eligible to file a wrongful death claim.
Types of Xarelto Lawsuits: Multidistrict Litigation and Mass Tort Claims
Over 18,500 Xarelto lawsuits are being handled in a special federal court process known as multidistrict litigation (MDL). An MDL allows complex cases from across the country with the same or very similar complaints to be handled by a single district court. MDLs have an established process for how claims are filed, followed by review by justices familiar with the complexities of these cases.
In December 2014, the Judicial Panel on Multidistrict Litigation established MDL No. 2592 in the Eastern District of Louisiana to handle claims against Xarelto. The court initially ordered transfer of 21 cases from 8 states into the MDL, and since then the number of lawsuits has grown exponentially.
The defendants argued against the formation of an MDL, claiming each lawsuit was rather different and didn’t have similar enough complaints. The judicial panel, however, ultimately denied their claims and moved ahead with the order. Despite the drug companies’ argument, the panel found several common complaints across these cases that made them suitable for the MDL process.
- The inadequacy of labels on Xarelto packaging about the potential for severe bleeding (as well as other harmful effects);
- The lack of clarity around the absence of an antidote for the drug;
- The omission of results from some clinical trials on the warning label;
- The need for monitoring while taking the blood thinner; and
- The lack of information given to healthcare professionals on safely prescribing Xarelto
Another 1,500 plus Xarelto lawsuits have been filed under a mass tort program in the Philadelphia Complex Litigation Center (CLC). Mass torts are cases that involve multiple plaintiffs filing against the same corporation, in this case Johnson & Johnson and Bayer. This second group of consolidated claims was also established in December 2014 and will be overseen by Judge Arnold New. The first bellwether trial in this state court was held in November 2017.
Do I Need a Xarelto Lawyer?
If you or a loved one have experienced any serious complications from taking this drug, it’s important to be aware of your legal rights and seek the help of an experienced Xarelto lawyer. Pharmaceutical companies like Johnson & Johnson generate huge profits every year, which lets them hire experienced attorneys to fight these claims. Having a legal team on your side who understands the complexities of Xarelto litigation gives you the best chance at receiving compensation.
Also, it’s important to contact an attorney soon after complications arise. Each state has its own statute of limitations and other deadlines that can affect your ability to receive compensation if you wait too long to file a claim.
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Xarelto Lawsuits in 2017
Considering the thousands of cases against Xarelto waiting to be tried, several bellwether trials are being tried first to test arguments and set precedents for the wider set of claims. These trials can highlight the primary arguments, motions and other issues that are expected to arise in other cases moving forward.
While bellwether trials might take a little longer to complete, they can help all the trial participants – including plaintiffs, defendants, lawyers, and judges – smooth out the procedures for later lawsuits, ultimately making the entire process more efficient. It can also help each side determine whether it makes sense to settle rather than bring the lawsuit to trial at all.
Three bellwether trials were set for the Xarelto MDL in 2017 by Judge Eldon E. Fallon. Philadephia’s CLC also scheduled bellwether trials to be held by Judge Arnold New, the first of which occurred in November 2017.
Philadelphia Court Awards $28 Million Verdict
Lynn Hartman and her husband sued Bayer and Johnson & Johnson in 2015 after she faced severe gastrointestinal bleeding from taking Xarelto. She began taking the blood thinner in 2013 to help treat atrial fibrillation. After about a year on the medication, she suffered these bleeding complications and was hospitalized. Fortunately, she recovered from her injuries once taken off of Xarelto.
In a first victory for the claimant, the jury awarded the Hartmans a $27.8 million verdict, with $26 million in punitive damages and $1.8 million in compensatory damages. However, the verdict will continue to be held up as the companies promised to appeal the decision as they stand behind the safety and effectiveness of Xarelto.
Federal Bellwether Trials in Favor of Drug Companies
Judge Eldon E. Fallon scheduled three bellwether trials for 2017. Juries ruled in favor of the defendants – Johnson & Johnson and Bayer – for all three of these trials.
The first trial began on April 24, 2017 on a lawsuit brought forward by Joseph Boudreaux. Boudreaux took Xarelto as prescribed by his cardiologist, which resulted in a week long stay in the hospital. His lawsuit relied on witness testimony that the drug companies failed to disclose the fact that a certain blood test could help predict who might experience adverse reactions to rivaroxaban. Ultimately, the jury sided with the drug companies, determining that they had provided enough information to doctors to make appropriate determinations about Xarelto’s risks when prescribing the medication.
The second bellwether trial for Xarelto was a wrongful death claim brought by Joseph Orr. His wife, Sharon, died of a stroke in May 2015 after being prescribed the blood thinner. Similarly to Boudreaux’s lawsuit, Orr’s attorney argued that doctors were not properly made aware about a simple blood test that could have shown Sharon would have a negative reaction to the medicine. After a few hours of deliberation, the jury sided once again with the drug companies.
In August 2017, the drug companies saw another victory in the third bellwether trial brought by Dora Mingo. In her claim, Mingo stated she suffered severe GI bleeding after taking Xarelto for one month in 2015 to prevent blood clotting following an operation. Within only four hours of deliberation, the jury decided in favor of the defendants.
Similar Blood Thinner Lawsuits
Xarelto isn’t the first anticoagulant to face legal troubles after consumers faced complications. Thousands of people have also filed Pradaxa lawsuits, claiming the blood thinner to be unreasonably dangerous.
When comparing Pradaxa vs Xarelto, it is important to note that dabigatran was on the market without an approved antidote for five years. Despite the potential side effects of taking Pradaxa, manufacturer Boehringer Ingelheim continued to market the drug as safe and effective. As more Pradaxa lawsuits were filed, Boehringer Ingelheim decided to settle in May 2014 for $650 million.
So far, Johnson & Johnson and Bayer have been outspoken about how they stand by their product, claiming the blood thinner is safe and effective. The companies have stated they will not settle with the thousands of plaintiffs who have filed lawsuits, and they will appeal any verdicts not in their favor.