Jury Finds for Plaintiff In Xarelto Trial- Awards $27.8 Million

A Philadelphia jury last week found in favor Lynn Hartman against the manufacturers of the anticoagulant Xarelto. The jury came back from a little over a day of deliberations with an award of $27.8 million. The main defendants in the case were Johnson & Johnson and Bayer AG. The award included roughly $26 million in punitive damages. Hartman suffered serious gastrointestinal bleeding while on the medication. She was an Indiana resident who began taking the drug in 2013.

As part of her claims, Hartman argued that the defendants should have included additional warnings over excessive bleeding risks and that the warnings were inadequate.  The three-week trial centered around arguments that the drug's warning label originally excluded information that the rate of bleeds observed in a clinical trial was significantly higher among patients in the United States than patients elsewhere in the world. Her attorneys proffered evidence that the rate among participants in the United States was 8.1 percent annually versus 3.6 percent annually among participants globally. The information was later added to the drug's labeling in September 2015 as part of the FDA’s efforts to standardize labeling for all of the so-called novel oral anticoagulant medications that have been approved in recent years.

The plaintiff’s case was bolstered by testimony from former Food & Drug Administration chief David Kessler, who told jurors that he believed the Xarelto warning label had lacked key information about the severity of the potential bleeding risk associated with the drug.

Her case is one of about 1,500 pending as part of a consolidated mass tort program in Philadelphia County. The Bayer and Janssen defendants had won defense verdicts in three previous Xarelto injury cases tried out of a multidistrict litigation program in Louisiana federal court earlier this year. Those cases focused on arguments that drugmakers should have encouraged doctors to conduct laboratory testing on their patients to more precisely determine their risk of bleeding from Xarelto. The defense won those cases largely on the learned intermediary doctrine, under which drugmakers must provide all necessary warnings to prescribing physicians in order to properly weigh the risks and benefits of a medication.

The defendants in the Philadelphia trial have vowed to appeal and have already presented the learned-intermediary arguments to the trial court as part of a motion for a directed verdict in the case.

A second case in the consolidated actions is scheduled to go to trial in Philadelphia in January.

Pittman, Dutton & Hellums, P.C., is currently investigating Xarelto cases. If you or a loved one were prescribed Xarelto and suffered an irreversible internal bleeding that lead to hospitalization and/or death, contact Booth Samuels at toll free 1-866-515-8880 or by email at booths@pittmanudutton.com.

Pennsylvania Jury Deliberating in Xarelto Trial

The fourth Xarelto-related product liability case to go to trial went to the jury on Friday as attorneys accused Johnson and Johnson and Bayer of deliberately understating the risks of serious internal bleeding associated with the blockbuster drug. This case was tried in Pennsylvania state court, and not through the Federal MDL out of New Orleans.

The case is one of more than 1,500 Xarelto-related cases pending as part of a mass tort program in the Philadelphia County Court of Common Pleas. The prior three trials in the MDL resulted in verdicts for the Defendants.

The case centered on arguments that the drugmakers failed to include information in Xarelto’s warning label indicating that the rate of bleeding events observed in a clinical trial was significantly higher among patients in the United States than patients elsewhere in the world. According to evidence in the case, the rate among participants in the United States was 8.1 percent annually versus 3.6 percent annually among participants globally. The label was ultimately updated in September 2015 to include such information.

Pittman, Dutton & Hellums, P.C., is currently investigating Xarelto cases. If you or a loved one were prescribed Xarelto and suffered an irreversible internal bleeding that lead to hospitalization and/or death, contact Booth Samuels at toll free 1-866-515-8880 or by email at booths@pittmanudutton.com.

First Xarelto Trial in Consolidated Pennsylvania State Court Starts Today

The first state court trial in a lawsuit alleging Xarelto causes internal bleeding kicked off today in Philadelphia, following three federal cases in which Xarelto makers Janssen Pharmaceuticals Inc and Bayer Pharma AG prevailed. The three previous trials were out of the federally consolidated MDL in New Orleans, although one trial took place in Mississippi.

There are approximately 1,400 Xarelto cases pending in the Philadelphia Court of Common Pleas. There are close to 18,000 cases pending in the MDL. A lot of pretrial motions in October dealt with the exclusions of both sides’ experts, and a question of whether punitive damages would be allowed to be sent to the jury. Hopefully the plaintiff prevails in this case, although there are several other cases set in Pennsylvania.

Pittman, Dutton & Hellums, P.C., is currently investigating Xarelto cases. If you or a loved one were prescribed Xarelto and suffered an irreversible internal bleeding that lead to hospitalization and/or death, contact Booth Samuels at toll free 1-866-515-8880 or by email at booths@pittmanudutton.com

Defense Verdict in 3rd Xarelto Bellwether Trial

This month, a jury in the third bellwether trial over the blood thinner Xarelto has sided with defendants Janssen Pharmaceuticals Inc. and Bayer. The jury deliberated for approximately three hours. Unlike the first two bellwether trials that took place in New Orleans, this one took place in Jackson, Mississippi. 

More than 18,000 cases have been filed in the MDL in New Orleans. Many more have been filed throughout the country in other state-consolidated actions. All lawsuits allege that Xarelto, an anticoagulant used to treat blood clots, caused plaintiffs to suffer from uncontrollable bleeding resulting in injury or death.

Pittman, Dutton & Hellums, P.C., is currently investigating Xarelto cases. If you or a loved one were prescribed Xarelto and suffered an irreversible internal bleeding that lead to hospitalization and/or death, contact Booth Samuels at toll free 1-866-515-8880 or by email at booths@pittmanudutton.com

Second Xarelto Bellwether Trial Ends With Defense Verdict

The second bellwether trial in the Xarelto MDL ended with a defense verdict. The jury received the case this last Monday, and deliberated for a few hours before reaching their verdict. The plaintiff in the case suffered a stroke and alleged it was caused by Xarelto. Most of the 18,000 cases filed in the MDL allege bleeding events that led to hospitalization. It is unclear if the Plaintiff will appeal. This is the second trial in a row the plaintiffs have lost.

The plaintiff in the first bellwether trial, who also received a defense verdict from the jury, is asking for a new trial. That plaintiff alleged a gastrointestinal bleed for which he required hospitalization and blood transfusions. Although he is appealing on several grounds, one of his main contentions is that he was prevented from presenting the jury with evidence that a blood clotting test called Neoplastin PT should have been provided to patients in order to monitor any adverse reactions from Xarelto.

Plaintiffs' Experts Can Testify at Xarelto Trial

With the first Xarelto bellwhether trial starting this week, several Daubert motion rulings by presiding Judge Fallon will surely have an impact on the outcome. Judge Fallon admitted four of the Plaintiff’s key expert witnesses in two of the upcoming bellwether trials.

Defendants Janssen and Bayer unsuccessfully tried to block the admission of key expert witnesses. The expert witnesses admitted to testify are Dr. Suzanne Parisian, an expert in the field of FDA regulation; Dr. Laura Plunkett, who will testify about drug pharmacology, general causation, regulatory matters and the adequacy of labels for both prescription and non-prescription drugs; Dr. David Kessler, who will be offering testimony in regards to the conduct of pharmaceutical companies; and Dr. Nathaniel Winstead, who will be called to support the Plaintiff’s position on the probable cause of the Plaintiff’s gastrointestinal bleed.

The Court also allowed the Plaintiffs’ expert witnesses to express opinions regarding the bleeding risk of Xarelto and how it would be reduced if a doctor monitored their patients. “Because of Xarelto’s short half-life and the variability in patients, some patients will retain more Xarelto in their system and will be subject to a greater bleeding risk,” Judge Fallon said.

Judge Fallon also excluded defense expert Dr. James A. Reiffel, who was going to offer the preposterous testimony that patients might have abruptly stopped taking Xarelto due to attorney-led advertising.

The Plaintiffs did not win every Daubert battle, however. Ruling for the pharmaceutical giants, the Judge said that their experts could testify about what might have happened to the Plaintiffs if they had taken a different anticoagulant. The court also will allow several other defense experts to testify, but did limit the extent of their opinions.

First Xarelto Trial To Begin April 24th

The first bellwether trial in the Xarelto MDL is about to begin and the Plaintiffs have won several import legal motions which will help bolster their claims. Judge Fallon, the Louisiana federal judge overseeing the litigation, denied partial summary judgments from the Defendants on some claims against Bayer AG and Janssen Pharmaceuticals Inc., saying they cannot necessarily blame or use FDA red tape for their lack of label updates or for any noncompliance with Louisiana law. The motions dealt with federal preemption of several of Plaintiffs’ claims.

The first MDL trial is set to begin April 24^th, which is one of four set to occur in the coming months. There are more than 16,000 cases pending in the Xarelto MDL, with other cases consolidated in Pennsylvania.

Xarelto (rivaroxaban) is an oral blood thinner medication used to reduce the risk of blood clots and strokes in patients with atrial fibrillation and to treat blood clots in the leg and lungs. However, unlike other blood thinners like Coumadin, Xarelto does not have reversal agents to counteract its anticoagulation effects, according to the FDA.

Plaintiffs who have filed suit have alleged the following injuries:

            Intracranial hemorrhages

            Abdominal hemorrhages

            Retinal hemorrhages

            Epidural hematoma

            Adrenal bleeding

            Excessive blood loss

            GI bleeds

            Death

Pittman, Dutton & Hellums, P.C., is currently investigating and filing Xarelto cases. If you or a loved one were prescribed Xarelto and suffered an irreversible internal bleeding that lead to hospitalization and/or death, contact Booth Samuels at toll free 1-866-515-8880 or by email at booths@pittmanudutton.com.

WARNING- FAKE XARELTO SETTLEMENT PHISHING SCAM

It has been brought to our attention that individuals are attempting to perpetrate a scam by contacting Xarelto claimants directly and claiming to offer settlements on behalf of Johnson & Johnson.  We understand this scam involves individuals who do not work for or have a relationship with Johnson & Johnson.

No settlement discussions have commenced at this point and there is no settlement to report.  Please refrain from providing personal information to individuals that call or contact you about a Xarelto settlement. 

It is our understanding that the scam artists have requested names, social security numbers and bank routing numbers.  In the event you are contacted, gather all possible information so that we can notify the Court and any other proper authorities of the same.  The Plaintiffs' Executive Committee has notified Defendants' Counsel of this matter and the MDL Court.  

Xarelto Cases Consolidated

The Judicial Panel on Multi-District Litigation has consolidated nearly two dozen Xarelto cases. An MDL is now set up in the United States District Court for the Eastern District of Louisiana with Judge Fallon presiding. Judge Eldon Fallon is very familiar with the MDL process as he is the presiding Judge over the Chinese Drywall MDL and presided over the Vioxx MDL.

Lawyers for the Plaintiffs argued that any consolidation should occur in either St. Louis under Judge Freda Wolfson, who is presiding over the Pradaxa MDL, or sent to New Jersey. The Defendants, Johnson & Johnson subsidiary Jannsen Pharmaceuticals and Bayer, argued against consolidation.

Xarelto (rivaroxaban) is an oral blood thinner medication used to reduce the risk of blood clots and strokes in patients with atrial fibrillation and to treat blood clots in the leg and lungs. However, unlike other blood thinners like Coumadin, Xarelto does not have reversal agents to counteract its anticoagulation effects, according to the FDA.

Pittman, Dutton & Hellums, P.C., is currently investigating Xarelto cases. If you or a loved one were prescribed Xarelto and suffered an irreversible internal bleeding that lead to hospitalization and/or death, contact Booth Samuels at toll free 1-866-515-8880 or by email at booths@pittmanudutton.com.

JPML To Hear Xarelto Arguments Today

The Judicial Panel on Multidistrict Litigation (“JPML”), sitting in Charleston, South Carolina, will hear arguments today for and against the consolidation of Xarelto lawsuits. Lawyers for those injured by Xarelto are arguing for a Xarelto MDL, while Bayer and Johnson & Johnson, the manufacturers of Xarelto, are fighting consolidation.

Patients who took Xarelto, a blood-thinning drug, accuse the drugmakers of downplaying the medicine’s bleeding risks and asked that the cases be sent to U.S District Judge David Herndon in East St. Louis, Illinois. Judge Herndon is the same judge who is presiding over the Pradaxa MDL, which settled earlier this year. That settlement is estimated to reach $650 million.

Bayer’s lawyers are arguing that should an MDL be formed over their objections, that the cases  be consolidated in New Jersey under U.S. District Judge Freda Wolfson. Judge Wolfson is located in Trenton and is already presiding over two Xarelto case. Another argument for consolidation in New Jersey is that it is located near corporate headquarters.  

In court filings, it is claimed that 65 deaths have been linked to bleeding caused by the drug, which has no antidote. So far, there are 21 cases filed in 10 federal courts.

As I have posted many times on this blog, MDL’s are a great mechanism for consolidating cases and can save time and money on pretrial discovery, depositions and dispositive motions.

U.S. regulators originally approved Xarelto in 2011 to prevent blood clots in patients undergoing knee and hip surgeries. The drug’s use has been extended to patients with irregular heartbeats and potentially deadly leg and lung blood clots. It is similar to Coumadin, or warfarin, used to thin stroke victims’ blood for nearly 50 years.  Xarelto was marketed as more effective at preventing strokes than Coumadin and easier to use since Xarelto patients did not need frequent tests to monitor their blood-plasma levels.

In court filings, Xarelto patients argue the companies did not properly test the blood thinner before putting it on the market, hid the fact the medicine had no antidote, and overstated the drug’s effectiveness.

The case is Xarelto Products Liability Litigation, MDL No. 2592, U.S. Judicial Panel on Multidistrict Litigation. A decision by the JPML will be issued in the coming weeks.

Pittman, Dutton & Hellums, P.C., is currently investigating Xarelto cases. If you or a loved one were prescribed Xarelto and suffered an irreversible internal bleeding that lead to hospitalization and/or death, contact Booth Samuels at toll free 1-866-515-8880 or by email at booths@pittmanudutton.com.

J&J Recall 13,500 Bottles of Xarelto

Johnson & Johnson's Janssen unit is recalling approximately 13,500 bottles of its top-selling anticoagulant Xarelto because of microbial contamination discovered in a sample.

According to a recall notice in an FDA Enforcement Report, the drug manufacturer said that it confirmed that a sales sample of the drug was contaminated after a customer complaint, and so initiated a nationwide, voluntary recall. The company reported that the product came from a plant in Puerto Rico. The plant was among four on the island that J&J slated two years ago for $225 million in upgrades.

To view the notice, click on the link below:

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0006-2015&w=10152014&lang=eng

Xarelto came to market in the U.S. three years ago behind Boehringer Ingelheim's Pradaxa, but which has since eclipsed it in sales. Like Pradaxa, Xarelto has come under scrutiny based on accusations that the drug causes bleed outs and deaths. Lawsuits have been filed against the manufacturer across the country, and a motion has been filed to consolidate cases into an MDL.

Pittman, Dutton & Hellums, P.C., is currently investigating Xarelto cases. If you or a loved one were prescribed Xarelto and suffered an irreversible internal bleeding that lead to hospitalization and/or death, contact Booth Samuels at toll free 1-866-515-8880 or by email at booths@pittmanudutton.com.

Is Xarelto the Next Pradaxa?

Plaintiffs in six lawsuits alleging injuries caused by the prescription blood-thinner Xarelto have filed a motion seeking their cases consolidated into an MDL. The motion was filed October 9th with the Judicial Panel on Multidistrict Litigation and requests that all pending and future cases be sent to a judge in the U.S. District Court for the Southern District of Illinois.

Xarelto (rivaroxaban) is a blood-thinning drug (anticoagulant) that is used to treat blood clots, deep vein thrombosis, and pulmonary embolisms. It has been sold by Bayer HealthCare and Janssen Pharmaceuticals since 2011.

Xarelto is the second FDA-approved drug in a new generation of anticoagulants that are marketed as alternatives to warfarin. Warfarin has been a mainstay of anticoagulation therapy since the 1950s, but it is a problematic drug that requires frequent dosage adjustments and weekly monitoring. Pradaxa is the other drug and was approved in 2010, a year ahead of Xarelto.

Xarelto appears to be extremely similar to Pradaxa.  Both Pradaxa and Xarelto are prescribed in a “one-size-fits-all” pill taken once or twice a day. They both also require less monitoring than warfarin and do not require as harsh dietary restrictions.

The problem is that Xarelto, and Pradaxa, has no effective reversal agent or antidote. Excessive bleeding attributed to Warfarin can be reversed with a dose of Vitamin K.

Some studies have also linked Xarelto to a higher risk of bleeding for acutely ill patients. According to lawsuit allegations filed against Bayer, the company did not warn the public and want the drug removed from the market.

Boehringer Ingelheim, the manufacturer of Pradaxa, agreed in May 2014 to pay $650 million to settle approximately 4,000 lawsuits over claims the drug caused serious bleeding episodes.

Pittman, Dutton & Hellums, P.C., is currently investigating Xarelto cases. If you or a loved one were prescribed Xarelto and suffered an irreversible internal bleeding that  lead to hospitalization and/or death, contact Booth Samuels at toll free 1-866-515-8880 or by email at booths@pittmanudutton.com.