Articles Posted in Xarelto

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Xarelto Trial Verdict
Today, a jury in Philadelphia awarded approximately 28 million dollars to a woman who suffered serious gastrointestional bleeding after taking the blood-thinning drug Xarelto. It was a huge win for the plaintiff, Lynn Hartman. Ms. Hartman took Xarelto for over a year to treat atrial fibrillation. She suffered internal bleeding and was eventually hospitalized. She needed four blood transfusions. According to court documents, the internal bleeding eventually stopped, and Ms. Hartman was taken off the medication. After she stopped taking Xarelto and switched to another blood-thinner, she had no further internal bleeding.

Ms. Hartman sued Bayer Healthcare Pharmaceuticals, Janssen Pharmceuticals, and parent company Johnson & Johnson. Her primary claim was that the defendants failed to provide adequate warning of the bleeding risks associated with taking Xarelto.

One important witness for the plaintiff at trial was David Kessler, the former Commissioner of the Food and Drug Administration. Kessler testified that he believed the warning label on Xarelto was inadequate and lacked important information regarding the specific risks of internal bleeding.

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Sadly, I’ve written about allegations of witness-tampering before. It is an awful and unethical thing, and it undermines the ability of a litigant to get a fair trial. Beyond that, it calls into question the legitimacy of our entire legal system.

Testifying under oath in Xarelto trialWitness-tampering is an attempt by one side in a trial to influence or change the testimony of an opponent’s witness. Most of us have seen dramatizations of witness-tampering in movies and on television. Maybe the most famous cinematic depiction of witness-tampering was in Godfather, Part II, when Frank Pentangeli changed his sworn testimony in a Senate Hearing investigating Godfather Michael Corleone’s corruption and murder. Prior to Pentangeli’s testimony, Corleone flies in Pentangeli’s beloved brother from Sicily, an unmistakable message to Pentangeli that Corleone can reach anyone in Pentangeli’s family, and that no one is safe. Once the hearing begins, Frank Pentangeli changes his testimony, and he testifies that he knows nothing about the mafia or Michael Corleone, and that he gave a prior sworn statement under extreme pressure from investigators. It is a dramatic moment in the film, and the witness-tampering allows Michael Corleone to avoid findings of corruption and murder and a likely criminal conviction. You can check out that famous “witness-tampering” scene here.

In the world of product liability cases, allegations of witness-tampering are much less dramatic, but witness-tampering any case can have devastating effects. If a key witness changes his or her testimony, the case can be lost for the litigant who relied on the original evidence.

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Xarelto case underway in PhiladelphiaThe first Xarelto trial is underway in the Philadelphia Court of Common Pleas. The cases in Philadelphia state court are separate from the federal court Xarelto multidistrict litigation situated in Louisiana. I have written about Xarelto often on this website, and you can read more about the medication and the lawsuits that followed here. The cases in the Court of Common Pleas are very similar to the MDL cases, and most of the cases involved allegations of uncontrollable internal bleeding. The Philadelphia state court mass tort program has been taking Xarelto cases since 2014, and currently there are more than 1,500 cases filed there. More cases are being filed each week, in Pennsylvania and in the Louisiana MDL.

The first of these “Philadelphia cases” went to trial this week. For the plaintiffs in both state and federal court, a win would be most welcome, as plaintiffs in the first three MDL bellwether cases lost.

First Philadelphia Xarelto Trial Begins

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Medical device and prescription drug jury verdicts come rapid fire, with a few cases being tried at any given moment across the country. Below is a recap on three recent jury verdicts involving Ethicon pelvic mesh, the blood-thinning drug Xarelto, and the testosterone drug Androgel.

Pelvic Mesh (September 7, 2017)

Pelvic Mesh
Last week a Philadelphia jury awarded a seriously injured woman $57.1 million in damages caused by defective Ethicon TVT pelvic mesh. This was the largest verdict for a pelvic mesh lawsuit against Ethicon, Inc. and Johnson & Johnson (the parent company of Ethicon). The award included $7.1 million in compensatory damages, which encompasses pain and suffering damages, as well as a huge $50 million award for punitive damages.

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Third Xarelto Bellwether Trial
Last Friday in the third Xarelto bellwether trial, a jury in Jackson, Mississippi reached a verdict in favor of defendants. The defendants have now won three straight Xarelto bellwether cases. Plainly, the defense has had a good year. But remember, the MDL judge and the executive committees selected 40 cases for discovery and consideration as bellwethers, not three. As I tell my daughter when she comes home after the third day of school and announces she doesn’t like her teacher: “It’s too soon to have an opinion. Give it more time.”

Let’s take a look:

Third Xarelto Bellwether Trial  

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On June 12, 2017, a jury in New Orleans reached a verdict in favor of defendants in the second Xarelto bellwether trial. This verdict follows a defense verdict in the first bellwether trial. Let’s take a closer look.

The Second Xarelto Bellwether Trial  

Neoplastin PT Blood Test for Xarelto PatientsTo recap briefly, Xarelto (rivaroxaban) was first approved by the FDA for sale in 2011. As an anticoagulant, it was supposed to prevent pulmonary embolism (PE), deep vein thrombosis (DVT), strokes, and other serious conditions. And it was easier to take than warfarin. In studies, however, Xarelto caused a higher rate of complications from internal bleeding; but unlike other anticoagulant drugs, there is no “antidote” for stopping internal bleeding in patients. People bleed and often can’t stop bleeding.

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Jury Verdict in First Xarelto Bellwether Trial

More than 18,000 lawsuits have been filed against the drug manufacturers of Xarelto over internal bleeding injuries. Two weeks ago the first bellwether case in the Xarelto multidistrict litigation was tried to a jury in Louisiana. On May 3, 2017, that jury rendered a verdict in favor of Bayer Healthcare Pharmaceuticals, Janssen Pharmaceuticals, and parent company Johnson & Johnson. After a seven day trial, the jury found in favor of defendants on one narrow issue: that the plaintiff did not prove his claim that the drug makers failed to give adequate instructions to the physician on the safe use of Xarelto; specifically, the plaintiff argued that drug makers failed to give instructions to doctors about the need to perform a blood-clotting test on Xarelto patients before prescribing the drug.

Although a setback for the plaintiffs, this narrow decision makes me confident there is “plenty of game left” in the overall Xarelto litigation. I do not believe the Boudreaux case adequately represents so many of the remaining claims against Bayer, Janssen, and J&J.

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Internal Bleeding on XareltoNext week the first bellwether trial begins in the Xarelto multidistrict litigation. Bellwether trials are important events in the life-cycle of MDLs. Both sides select several representative cases and submit those cases to the MDL judge, who then makes the final selection for a list of bellwether cases to try. From there, these cases are tried one after another. Along the way, the plaintiffs and defendants get a real sense of what juries think of the common issues raised in the MDL. This can lead to global settlements and ultimately to the resolution of hundreds or thousands of cases.

So as I said, the first Xarelto bellwether trial starts on Monday (April 24, 2017), unless the parties settle the case between now and then, which sometimes happens. If not, in a few weeks we will all get to see what the first jury thinks of the first Xarelto case.

I have written about Xarelto several times on this site, but to recap briefly, Xarelto (rivoroxaban) was supposed to be a game-changer as a blood thinning drug medication when it was first approved for sale in 2011. Blood thinning medications are important drugs to treat certain conditions in patients, as they can prevent pulmonary embolism, deep vein thrombosis, and even strokes. These serious conditions often arise after surgery, when blood clots are more likely to occur. Xarelto was later approved to treat people with atrial fibrillation (irregular heartbeat).

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Prescription MedicationsI have to say, there are times I just don’t want to hear any more alarming news. But recently I stumbled upon a disturbing database of payments made by drug and medical device manufacturers to physicians. It can be horrifying to imagine that your doctor or surgeon is getting huge amounts of money from drug companies or device makers, for any reason.  Now imagine that the payments were hundreds of thousands of dollars, or millions. It just doesn’t pass the smell test. Think about it: if a surgeon gets $250,000.00 per year from a medical device manufacturer, do you think the surgeon is likely going to “choose” to implant devices made by the fee-paying medical device manufacturer?

ProPublica is the nonprofit organization who maintains the database. Recently nonprofit organization updated its database of doctors across the country who were paid by medical device manufacturers or drug makers in 2015. ProPublica also compiled statistics on the amount of money drug companies spent promoting certain prescription medications and medical devices. The numbers are staggering. Let’s take a look at a few of the prescription medications on ProPublica’s list that I’ve written about on this site:

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A new study published in December 2016 has shed more light on the potential dangers of taking direct oral anticoagulant (DOAC) drugs, and in particular, the drug Xarelto (rivaroxaban).

First a Little Background on Xarelto

New Xarelto StudyXarelto was first approved by the FDA for sale in July 2011. It was supposed to represent a major advancement in blood thinning (anticoagulant) medication. Xarelto was developed to prevent serious conditions that sometimes arise after surgeries (such as artificial hip and knee surgeries). As an anticoagulant, it was intended to prevent pulmonary embolism (PE) and deep vein thrombosis (DVT) and strokes. Xarelto was also intended to help those patients with atrial fibrillation, a group of people more vulnerable to PE, DVT, and stroke after surgery. Eventually, the FDA expanded approval of Xarelto to treat all patients with PE, DVT and atrial fibrillation.

In studies, however, Xarelto appeared to cause a higher rate of internal bleeding. And while other anticoagulant drugs may also cause internal bleeding, it appears there is no available “antidote” for stopping internal bleeding in patients taking Xarelto. With warfarin, vitamin K has been shown to stop bleeding. But there is no vitamin K “parallel” for people taking Xarelto. For Xarelto, it can take 24 hours for a dose to get out of the body. That means that if internal bleeding starts, the patient may simply have it wait it out and hope it stops on its own.

Now a new study indicates that Xarelto causes more internal bleeding than other leading anticoagulant drugs.

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