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Articles Posted in Xarelto

According to a recently-released report by the news organization ProPublica, manufacturers of the anticoagulant (blood thinner) Xarelto made more physician payments than any other drug company in 2015. Physician payments were made for promotional speaking, travel, gifts, and meals. But not for research. Past studies have shown that when physicians receive payments from a drug manufacturer, they tend to prescribe more of that manufacturer’s drugs than those who do not. Considering the high risk of serious, potentially life-threatening side effects linked to Xarelto, this is certainly cause for concern.

Each year, ProPublica gathers information about payments made by pharmaceutical companies to physicians for promos, travel, royalties, etc. Across the board, pharmaceutical and medical device companies made approximately $2 billion in physician payments in 2014 and 2015, with Xarelto payments taking the cake in 2015. ProPublica’s study is not the only one to find that these payments result in higher prescriptions of related drugs. Researchers at Harvard Medical School had similar findings in 2016. In a study of medical industry payments to physicians in Massachusetts, they found that for every $1,000 a physician received, his or her rate of prescribing the associated drug increased by 0.1 percent. If you have been injured by a dangerous or defective pharmaceutical, contact a Boston drug injury lawyer today.

Xarelto Linked to Excessive Bleeding

There are currently more than 11,000 Xarelto lawsuits pending in the U.S. It goes without saying that plaintiffs in these cases will likely use the findings from the ProPublica report to support their claims that Xarelto’s manufacturers, Johnson and Johnson and AG Bayer, failed to warn physicians and patients about the risks associated with the drug. Marketed as a low-maintenance alternative to warfarin, Xarelto quickly rose in popularity. Due to high demand, Xarelto’s manufacturers may have rushed the product to market without adequate safety testing. Although all anticoagulants come with an increased risk of excessive bleeding (hemorrhaging), warfarin has an antidote to that bleeding, known as a reversal agent. To date, Xarelto has no such reversal agent. Excessive bleeding has resulted in thousands of injuries and some deaths. If you have been harmed by a defective prescription drug, contact a MA drug injury lawyer today.

Symptoms of Internal Bleeding

If you are currently undergoing Xarelto treatment, talk to your doctor about the risks of excessive bleeding. As internal bleeding may not be immediately apparent, it is important to look for possible signs. If the bleeding is rapid and severe, blood may collect under the skin, forming a bulge or discolored spot. Severe bleeding may result in shock or loss of consciousness. If you develop any of the symptoms below, seek immediate medical attention:

  • Uncontrollable bleeding
  • Dark urine
  • Dark stool
  • Unexplained bruises
  • Blood clots
  • Cough that produces blood
  • Blood in vomit
  • Unexplained pain
  • Joint pain
  • Headaches
  • Dizziness
  • Weakness
  • Fatigue

Lawsuits allege that Xarelto manufacturers failed to warn physicians about the risk of uncontrollable bleeding, that the drug was defectively designed, and that warning labels were not updated in a timely manner. Johnson & Johnson and Bayer AG are also under fire for not recalling Xarelto when the risks became apparent. Continue reading

Since being approved in October of 2010, the prescription blood thinning drug, Pradaxa, has established itself as an upgrade to warfarin because it performed the same functions while also preventing strokes. Other competitors to warfarin, such as Xarelto, have also come onto the market.  While these drugs netted gigantic profits for their manufacturers and were used by millions of patients, it has been revealed over time that these drugs can pose a serious, and deadly, risk to certain types of people. In May of 2014 alone, Boehringer Ingelheim, the German manufacturer of Pradaxa, settled more than 4,000 lawsuits for a combined amount of $650 million.

Just two years after its introduction, Pradaxa was blamed for over 500 deaths stemming from uncontrollable bleeding and internal hemorrhaging. The aforementioned settlement came under the condition that Boehringer Ingelheim would have to admit to no fault regarding the deaths, stating that the benefits of the drug far outweighed the negative side effects.  While the benefits of the drug are certainly evident, should thousands of lawsuits and hundreds of deaths prompt, at the very least, more research, development, and awareness campaigns to ensure that the wrong people don’t take the drug and wind up in dire straits? Pradaxa costs about $3,000 a year and made $209 million in sales just in the first quarter of 2012, so it is not an issue of not having enough money.

What is Pradaxa?

Xarelto, a blood-thinning medication, was deemed in 2011 to be a safe alternative to traditionally-used warfarin medication in preventing blood clots, which can lead to life-threatening strokes and other ailments. Despite the drug being tested and approved as safe, thousands of cases have emerged over the years that suggest the drug is anything but safe in all applications.  The appeal for a warfarin replacement drug is obvious. Warfarin requires those who take it to adhere to a special diet and mandates keen attention by the patient and doctors to ensure that it is having the intended effect. Xarelto was marketed as a more simplified version of warfarin, achieving the same results but without the drastic change in lifestyle.

 

Xarelto is intended to thin the blood to prevent a blood clot condition known as deep vein thrombosis, which can occur in many places throughout the body but can also lead to developing blood clots in the lungs (known as a pulmonary embolism, a potentially fatal condition.) The most common applications of Xarelto are in people who have just underwent surgery, or people with atrial fibrillation, a heart condition which increases the risk for strokes.   Xarelto has worked successfully for many patients, but conversely, thousands of patients taking Xarelto have experienced excessive bleeding and even blood clots as a result. There is no easy cure for somebody who has a negative reaction to Xarelto and, as a result, there have been thousands of lawsuits filed as a result of the pain, suffering and medical expenses incurred by those taking Xarelto and their families.

Xarelto is a multi-billion dollar cash cow both for its manufacturer, Bayer, and for its pharmaceutical marketing company, Janssen Pharmaceuticals (a subsidiary of Johnson and Johnson). Despite the legal trouble and real cases of patients having life-altering consequences from taking the drug, the FDA recently reiterated that the drug is safe to be taken by patients with heart complications.

Do not take Xarelto if…

  • You have an artificial heart valve
  • You have an established history of uncontrollable bleeding
  • You have underwent spinal surgery or had a spinal tap
  • You are on a regular regiment of nonsteroidal anti-inflammatory drugs (NSAIs) such as Motrin, Advil, Aleve, etc.
  • You experience stomach or intestinal bleeding
  • If you are already on a regiment of aspirin, warfarin, Plavix, or certain antidepressants

The only way to know for sure if you are going to be okay taking Xarelto is to have an in-depth and detailed discussion with a doctor. The problem with Xarelto is not that it is inherently unsafe, but rather it is that there are a multitude of side effects and other conditions that can cause patients to have a life-threatening reaction. Continue reading

Xarelto is a popular anticoagulant (blood thinner) used by thousands of patients at risk of blood clots, atrial fibrillation, and stroke. Marketed as a lower-maintenance alternative to predecessor Coumadin, the relatively new drug grew quickly in popularity. Although Xarelto doesn’t require the regular patient monitoring required by Coumadin, it does have at least one significant drawback – there is no antidote to hemorrhaging or excessive bleeding caused by Xarelto. To be fair, this is much more than a drawback; patients have died.

More than 7,000 lawsuits directed at Xarelto manufacturer, Janssen Pharmaceuticals, have been reported as of this date. Many of these lawsuits claim harm due to uncontrolled bleeding following Xarelto use and failure to warn patients of life-threatening side effects. All anticoagulants have a risk of excessive bleeding. But there’s one major difference. Excessive bleeding linked to Coumadin can be stopped. If a patient begins to hemorrhage after being treated with Coumadin, the bleeding can be halted with relative ease by administering an antidote. Basically, the patient is injected with a combination of vitamin K and fresh blood plasma to reverse excessive bleeding. No such antidote exists for Xarelto.

The first Xarelto-related lawsuit was a wrongful death suit filed against Janssen Pharmaceuticals in 2014. Since then, thousands more have joined, resulting in the formation of a Xarelto multidistrict litigation (MDL). Massachusetts Xarelto patients who have experienced uncontrolled bleeding after using the drug should contact a MA drug injury lawyer today.

Xarelto Patients Twice as Likely to Suffer from Stomach Bleeding

In response, Portola Pharmaceuticals has manufactured a possible antidote called AndexXa. However, the FDA has requested more information before it will allow AndexXa to be released to the public. It may be wise of the FDA to prevent AndexXa’s release until they are sure it is safe, but physicians and patients hope a safe option hits the shelves soon. Too many patients have been seriously injured, or have died, as a result of Xarelto use. In fact, studies show that patients taking Xarelto have double the risk of developing stomach bleeding as patients taking a different medication.

Potentially Life-Threatening Risks Linked Associated with Xarelto

Xarelto isn’t the only drug of its type linked to these serious health complications. Pradaxa and Eliquis, two newer drugs belonging to the same category, also have no antidote. Risks associated with Xarelto, Pradaxa and Eliquis include: Continue reading

As with any anticoagulants (blood thinners) on the market today, Xarelto increases the risk of hemorrhaging, also known as excessive bleeding. However, patients on Xarelto have more than double the risk of stomach bleeding than those on another type of blood thinner. Furthermore, there is currently no antidote to reverse excessive bleeding in Xarelto patients. In response to the growing number of lawsuits against Xarelto manufacturer Janssen Pharmaceuticals, some of the thousands of lawsuits have been consolidated into multidistrict litigation (MDL). Contact a Boston Drug Injury Lawyer Today.

A popular blood thinner, particularly among adults undergoing knee and hip replacement surgeries, Xarelto can treat everything from risk of blood clots and hypertension to irregular heart rhythm and other heart conditions. Touted as a low-maintenance alternative to Coumadin, Xarelto is now at the core of thousands of lawsuits alleging serious harm or death. The husband of a patient who died after receiving a blood transfusion to treat Xarelto-related bleeding sued Janssen claiming the company failed to warn physicians and patients about the risks.

Drug companies have a duty to test pharmaceuticals and obtain FDA approval before marketing those drugs to the public. Once that approval is in place, drug companies are required to warn physicians and patients of any known risks or side effects. Failure to properly design or test a drug, or failure to warn the public about associated risks and side effects can result in serious problems for the drug manufacturer.

More than 6,000 Lawsuits Filed Against Xarelto Manufacturer

According to the report released by the United States Judicial Panel on Multidistrict Litigation, a total of 6,457 lawsuits are currently pending against Janssen Pharmaceuticals. Of those cases, 40 have been consolidated into one case in Louisiana federal court. These cases, scheduled to begin in early 2017, will be tried as bellwether cases, setting the tone for upcoming Xarelto lawsuits.

Common Side Effects Associated with Xarelto

Side effects can range from mild to severe. If you develop any of these symptoms or side effects while taking Xarelto, it’s in your best interest to contact your healthcare provider as soon as possible.

  • Bleeding gums
  • Bloody stool
  • Bowel problems
  • Bladder problems
  • Back pain
  • “Pins and needles” or tingling feelings
  • Excessive itching

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We are fortunate to live in a time when medical technology and pharmaceuticals can save us from injuries and illnesses that would have killed us a half century ago. Medical conditions such as heart disease and diabetes were death sentences in the not-so-distant past. Today, with prescription drugs, and certain diet and lifestyle changes, patients with these conditions can live long, healthy lives. Unfortunately, prescription drugs can also be harmful, even fatal.

Most medications have side effects, and some of these side effects can be especially dangerous. When pharmaceutical companies fail to warn about side effects, or neglect to perform proper testing on drugs before marketing them for certain uses, it can result in injury and death. Contact a Boston Drug Injury Lawyer Today.

Top 5 Dangerous Drugs

Most prescription drugs can be dangerous if used incorrectly. However, some drugs are associated with a significantly higher risk of injury and death. Below are the top 5 drugs currently involved in litigation for their link to deadly side effects.

  1. Invokamet: Designed to treat patients with type 2 diabetes, Invokamet is linked to multiple serious side effects. The drug is successful at managing insulin levels in patients by regulating the levels of glucose released by the liver. However, Invokament use can also cause urinary tract infections, nausea and vomiting, as well as an increased risk of bone fractures.
  1. Onglyza: Also prescribed for patients with type 2 diabetes, Onglyza is linked to even more serious side effects than Invokamet. In fact, the FDA has recently released a warning that medicines like Onglyza “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.”
  1. Risperdal: In patients with bi-polar disorder, schizophrenia, and autism, Risperdal may reduce aggressive behaviors. Unfortunately, it is also linked to gynecomastia, a condition that results in breast enlargement in male patients. Lawsuits allege that Risperdal manufacturer, Johnson & Johnson, failed to warn patients and physicians about the risk of gynecomastia. Furthermore, the drug wasn’t even approved for use in adolescents, the group most affected by side effects. As a result, Johnson & Johnson recently paid $70M in penalties, fines, and victim compensation.
  1. Xarelto: Anticoagulants (blood thinners) have been used for decades to prevent blood clots and strokes in at-risk patients. For a long time, Coumadin was the main option for treatment. Although successful, Coumadin requires constant monitoring, a major inconvenience for patients. Recently, however, a new category of anticoagulants entered the market. Xarelto is included in this new category. This lower-maintenance alternative requires little to no monitoring but, unfortunately, is linked to life-threatening medical conditions. Although hemorrhaging is a risk with all anticoagulants, Coumadin has a reversal agent that stops excessive bleeding in its tracks. Unfortunately, the same is not true for Xarelto and similar drugs.
  1. Zofran: Designed to treat nausea in chemotherapy patients, Zofran’s manufacturer began marketing Zofran to pregnant women as a treatment for morning sickness. Unfortunately, the drug had never been tested on pregnant humans, and its use is now linked to severe birth defects.

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Xarelto, a blood thinner linked to irreversible hemorrhaging and other serious medical problems, is now under investigation for problems that may have occurred during the FDA’s initial testing of the drug. The FDA is investigating whether a device used during clinical tests may have negatively affected test results by understating the bleeding risk of patients. Contact a Boston Defective Medical Equipment Lawyer Today.

Xarelto quickly grew in popularity following its approval by the FDA in 2011. The anticoagulant, which is billed as a low-maintenance alternative to warfarin, is prescribed to patients at risk of blood clots and stroke. Up until recently, warfarin was the only option for patients suffering from these types of conditions. Warfarin requires frequent blood monitoring, an inconvenience that Xarelto patients don’t have to endure. Both warfarin and Xarelto have a risk of excessive bleeding, but there’s one major difference between the two. Warfarin-related bleeding problems have an antidote; a dose of fresh blood plasma and vitamin K, administered by a physician. Unfortunately, no antidote exists for patients who experience hemorrhaging while undergoing Xarelto treatment. This oversight has resulted in thousands of injuries and deaths.

Was there Evidence that the Device was Malfunctioning During Clinical Trials?

Until recently, the FDA’s spotlight was on the drug itself. However, new evidence indicates that a malfunctioning device during clinical trials may be to blame for the injuries and deaths. According to a recent article in the New York Times, the FDA has recently begun asking Xarelto’s manufacturer, Johnson & Johnson (Janssen), “…detailed questions about whether there was evidence that the device was malfunctioning while the trial was underway, according to a legal brief filed in federal court on Monday by lawyers for patients and their families who say they were injured by the drug. The lawyers also cited internal company documents that they said showed doctors were complaining to the trial leadership during the course of the study.”

The article also reported that, “Regulators are looking at whether the malfunctioning device might have led doctors to give patients the wrong dose of warfarin, which could have led to additional bleeding episodes and given an unfair advantage to Xarelto.” It was indicated that Johnson & Johnson (Janssen) and Bayer reportedly, “…notified regulators that the device that was used in the trial had been recalled in 2014 because it was understating patients’ risk of bleeding.” Continue reading

Up until recently, people at risk of stroke and blood clotting only had one highly-effective treatment option, warfarin. This decades-old anticoagulant (blood thinner), also known by its brand name Coumadin, has been used by millions of patients since it was introduced to the market in 1954. Although effective, warfarin is relatively high-maintenance, requiring that patients undergo routine monitoring and testing. In 2012, a new group of oral anticoagulants entered the market. Known as thrombin inhibitors, drugs including Xarelto and Pradaxa are marketed as a lower-maintenance, more convenient alternative to warfarin. The drugs’ manufacturers claim that monitoring and testing are not necessary while taking thrombin inhibitors. Unfortunately, this convenience has come with a price. Contact a Boston Drug Injury Lawyer Today.

Patients taking Xarelto are at an increased risk of dangerous hemorrhaging. 

Warfarin has similar risks, but with one major difference – an antidote. If a patient on warfarin develops uncontrollable bleeding, the physician can administer a dose of vitamin K and fresh blood plasma to halt the bleeding. No such antidote exists for Xarelto. Therefore, uncontrollable bleeding in a Xarelto patient can lead to serious health complications, and even death.

Xarelto Lawsuits Consolidated into Multi-District Litigation in Louisiana

Due to the high volume of lawsuits against Xarelto manufacturer, Bayer, Xarelto cases have been consolidated into a multi-district litigation (MDL) lawsuit in the Eastern District of Louisiana. Many of the claimants allege that after using Xarelto they developed uncontrollable bleeding, resulting in emergency health situations and, in some cases, death. Now that the lawsuits have been consolidated into an MDL, a settlement negotiation process will begin. As the bellwether trial, the outcome of this MDL is likely to set the tone for future Xarelto litigation. In addition to the failure of Bayer to adequately warn physicians and consumers about the risks associated with its drug, the FDA claims that the manufacturer also made misleading claims about the associated risks. Last May, the manufacturer of Pradaxa, a similar thrombin inhibitor, agreed to settle about 4,000 lawsuits for a total of $650 million. This is good news for claimants in Xarelto lawsuits.

Common Xarelto Side Effects That May Indicate More Serious Complications

If you develop any of the following side effects or symptoms, contact your health care provider immediately:

  • Blood in urine or stool
  • Coughing or vomiting up blood
  • ‘Pins and needles’ feeling anywhere on the body
  • Bleeding gums
  • Severe back pain
  • Trouble swallowing
  • Difficulty breathing
  • Dizziness or faintness
  • Severe headache
  • Chronic nosebleeds
  • Numbness
  • Weakness in legs

Continue reading

In the wake of almost countless lawsuits against prescription drug manufacturers, physician groups are advocating a ban on direct-to-consumer advertising. This aggressive form of mass marketing encourages patients to request certain prescription drugs, medical devices, and treatments that they may not otherwise seek out. The American Medical Association (AMA) is concerned that this results in unnecessary prescribing and increases potential risks to patients. Earlier this week, the AMA voted to end aggressive marketing campaigns that do not serve to educate physicians or patients, but rather to encourage patients to ask their doctors about specific medications or products. Contact a Boston Drug Injury Lawyer Today.

In addition to protecting the health and safety of patients, banning direct-to-consumer advertising would likely also result in a significant decline in health care costs. In a press release following the vote, AMA Board Chair-elect, Dr. Patrice A. Harris, said, “Today’s vote in support of an advertising ban reflects concerns among physicians about the negative impact of commercially-driven promotion, and the role that marketing costs play in fueling escalating drug prices.Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.” Approximately $4.5 billion is spent annually on direct-to-consumer advertising, according to the AMA. This is a 30% increase from the previous two years. Interestingly, only the United States and New Zealand allow these types of ads.

Drug Prices Have Spiked 4.7% in the Last Year

The AMA would like to see the creation of a physician task force and an accompanying advocacy campaign that encourages drug pricing transparency. In addition, they wish to see more drug options and an increase in competition among pharmaceutical companies. This year alone, drug prices have escalated by 4.7%. This increase negatively impacts the ability of patients to afford effective drugs, medical products, and treatments. Direct-to-consumer marketing also results in the widespread use of drugs that are sometimes not as effective as another option, and may be altogether unsafe. In fact, a 2014 BBC report revealed that most major pharmaceutical companies spend significantly more on marketing than they do on research. Continue reading

Xarelto, otherwise known as rivaroxaban, is a prescribed blood thinner manufactured by Bayer and marketed by Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson. Xarelto was approved by the Food and Drug Administration (FDA) in 2011 for treatment of deep vein thrombosis as well as pulmonary embolism. There is a mounting sum of evidence that claims, however, that Xarelto was not generally approved as a blood thinner. The approval for Xarelto was revised in 2012 to cover patients with reoccurring blood clots—but the decision came against the approval of the FDA’s own panel.

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