Witness: Xarelto is “The Worst” of All Anticoagulents

Frank W. Smart, MD
Frank W. Smart, MD, testified that Xarelto should have an FDA Black Box Warning — the strongest warning.

In damning testimony against drugmakers Janssen Pharmaceuticals and Bayer, an expert cardiologist testified at the second Xarelto bellwether trial that of all the anticoagulants, Xarelto is “the worst.”

“So Xarelto, of all the new oral anticoagulants, is the worst. And that’s well established in the medical literature and even by the FDA. The FDA said that Xarelto was equal to Coumadin. The other drugs which would be apixaban or Eliquis, dabigatran or Pradaxa and edoxaban or Savaysa are in one shape or form superior either in anticoagulation effect or in bleeding or in both,” testified Frank W. Smart, MD, a board-certified doctor in cardiology at LSU School of Medicine.

The case is  In Re: Xarelto (Rivaroxaban) Products Liability LitigationJoseph Orr v. Janssen Research, Case No. 2:15-CV-3708, before US District Judge Eldon Fallon in the Eastern District of Louisiana. Plaintiff attorney Anthony Birchfield, Jr. of Beasley Allen Crow Methvin Portis & Miles in Montgomery, AL, led the direct examination.

Dr. Smart’s  opinion was based on his own research plus internal company e-mails from drug manufacturers Janssen Pharmaceuticals and Bayer, and transcripts of FDA reviewers’ opinions FDA where the Xarelto was discussed.

Stops precribing Xarelto

Xarelto is a NOAC or new oral anticoagulant. Instead of blocking clotting factor Vitamin K, Xarelto is an inhibitor of Factor Xa, and it too stops the prothrombin-to-thrombin conversion and thins a person’s blood.

“I read an article that was in one of the Canadian journals that was very impressive to me, and I started transitioning people off of Xarelto at that time and have completely abandoned the use of it,” he testified. “It was a twice-a-day drug crammed into a once-a-day prescription, and I thought that that was a poor idea. I still think it’s a poor idea.”

“A practicing cardiologist sees people six, seven days a week “and they don’t have time. They don’t physically have time to chase down information like this.”

“Coumadin has a black box warning that says: Bleeding is an issue. You really need to focus on this. Be careful. Monitor it, and then things like that. Xarelto, I believe, should have a black box warning as well because all the literature and the FDA said that there’s no difference,” he testified.

An FDA Black Box Warning is the strongest warning that the US Food and Drug Administration (FDA) puts on a drug. For example, addictive opioids have black box warnings.

After reading FDA transcripts, Smart said, “The conclusion seemed to be that if the FDA had had their druthers, the company would have tested a twice-a-day dose, but they went on to say that they didn’t have the capacity to force the company into doing that, and the only thing that they could do was to consider the information that had been presented to them at the once-a-day dose.

Xarelto worst drug in its class

The ROCKET-AF trial of Xarelto on 7,000 patients with atrial fibrillation (Afib) found that “Xarelto was the worst in the class of these drugs. It was never shown to be superior to warfarin for either stroke or bleeding. But Eliquis, or apixaban, was shown to be superior for both,” Smart testified.

Q. (by attorney Anthony Birchfield) So when we look at these drugs, if we look at Eliquis.  Eliquis in the clinical trial, is it shown to be superior in both safety and efficacy?

A. (by Dr. Smart) Yes, sir. To warfarin.

Q. So Eliquis is superior to them both. And then, when we look at Pradaxa compared to warfarin, was Pradaxa — was it superior to either — in either safety or efficacy?

A. Yes, sir. It was superior in safety.

Q. What about efficacy?

A. Equal.

Q. And then, when we look at Xarelto was Xarelto superior in safety?

A. No, sir.

Q. Was it superior in efficacy?

A. No, sir.

“I think, again, playing Monday morning quarterback, I think had Eliquis been released at the time, there was no way that Xarelto would have been approved,” by the FDA, Smart testified.

“It’s worst in class among the NOACs. That’s pretty accepted. I mean, it’s a four-horse race, and they are the fourth horse. This adds concern that the approval was maybe less grounded in great science.”

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Xarelto Lawsuits Near 19,000 as Second Bellwether Trial Starts Next Week

Johnson & Johnson and Bayer AG have been named defendants in at least 18,900 Xarelto lawsuits, most of which are pending in multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana, according to a May 3 filing with the U.S. Securities and Exchange Commission.

Xarelto litigations have also been established in state courts in Pennsylvania, Delaware, California and Missouri, while class action lawsuits have been filed in Canada.

Xarelto Litigation

Xarelto is an oral anticoagulant jointly marketed by Bayer and Johnson & Johnson. The blood thinner was approved by the FDA in 2011, and is currently indicated for the prevention of strokes in atrial fibrillation patients; the treatment of deep vein thrombosis and pulmonary embolism; and the prevention of deep vein thrombosis in patients undergoing hip or knee implant surgery.

See No Cause for Panic in Defense Verdict in the First Xarelto Bellwether Trial

Xarelto plaintiffs allege that Bayer and Johnson & Johnson failed to provide adequate warnings about bleeding that may occur with its use, and wrongly promoted the blood thinner as a superior alternative to warfarin, says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective medical devices and drugs.

Among other things, plaintiffs note that bleeding associated with warfarin can be reversed via the administration of vitamin K. However, there is no approved antidote to stop Xarelto bleeding events.

The multidistrict litigation underway in the Eastern District of Louisiana houses at least 16,670 Xarelto lawsuits. The second bellwether trial beings on May 30 in New Orleans. Verdicts in these trials may provide insight into how juries could rule in similar Xarelto claims. Johnson & Johnson and Bayer prevailed in the first Xarelto trial, which concluded earlier this month. (In Re: Xarelto Products Liability Litigation, No. 2592).

Xarelto patients who allegedly experienced bleeding-related complications may be entitled to compensation for their medical bills, lost wages, pain and suffering, and more.

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Eliquis State-Law Claims Preempted, MDL Case Dismissed

eliquis-internal-bleeding-lawsuitA federal judge in New York dismissed one of 49 cases brought against Bristol-Myers Squibb Company and Pfizer Inc. over their Eliquis anticoagulant, ruling that the plaintiff’s state-law claims were preempted by federal law.

Granting a motion to dismiss, Judge Denise Cote threw out Utts et al v. Bristol-Myers Squibb Company et al, case number 1:16-cv-05668, in the U.S. District Court for the Southern District of New York, In Re: Eliquis (Apixaban) Products Liability Litigation, MDL No. 2754.

The court said that all the plaintiff’s claims — for failure to warn, design defect claims, warranty violations, fraud, and consumer protection claims — were preempted, adding that the Eliquis label is adequate as a matter of law.

Not ‘newly acquired information’

Showing off her homework in an 85-page opinion, Judge Cote also rejected all nine scientific articles or documents cited by the plaintiffs to create a plausible claim that the Eliquis labeling fails to adequately warn of the risk of excessive bleeding. “The information contained in this literature does not constitute ‘newly acquired information’ under the FDA’s regulation,” the opinion says. “Accordingly, the plaintiffs’ claims are preempted because federal law would not have permitted the defendants to make any change to the Eliquis label.”

“The risk of excessive bleeding from this blood thinner and the lack of an antidote were clearly disclosed to the Food & Drug Administration (“FDA”) when it approved the drug, and are prominently disclosed to medical practitioners and patients on the FDA-approved labeling for the drug,” the judge says.

Charlie Utts of California was diagnosed with atrial fibrillation and prescribed Eliquis by his doctor. After taking Eliquis, he suffered severe gastrointestinal bleeding and was hospitalized in July 2014 for about three weeks to undergo blood transfusions and several rounds of dialysis. He and his wife filed suit in 2016.

Eliquis — the brand name of the prescription medicine apixaban — is a blood-thinning medication used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis belongs to a class of drugs known as novel oral anticoagulants (“NOACs”). It does not have a known antidote or reversal agent. Unlike anticoagulant medications such as warfarin, NOACs, including Eliquis, do not require periodic blood testing or impose dietary restrictions on users.

Eliquis was approved by the FDA in 2012. The judge said the Eliquis label warns about the risk of serious bleeding five times, and warns that there is no specific antidote two times.

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Judge in Xarelto Litigation Addresses Deficiencies in Plaintiff Fact Sheet Compliance

xarelto bleedingFor the fifth time since the federal Xarelto products liability MDL No. 2592 was created, US District Judge Eldon E. Fallon issued a pretrial order addressing the plaintiff’s fact sheets (PFS), which are used instead of interrogatories, because of alleged deficiencies by claimants in completing them properly.

The sprawling nationwide litigation has produced 14,935 lawsuits since the federal MDL was created in 2014 in New Orleans. Even more cases have been filed in state courts in Philadelphia and Los Angeles.

Non-compliant responses

In response to complaints by the defendants — Janssen Research, Johnson & Johnson and Bayer Healthcare — the judge set out a protocol in pretrial order No. 31 to deal with the late filing of PFSs, non-compliant responses and incomplete responses:

  • Where the PFS has not been filed on time, the defendants will send a letter to the plaintiff’s counsel requesting it be served within 20 days.
  • Where the PFS is timely but deficient because it doesn’t comply with the judge’s PFS orders, the defendant will send a letter to plaintiff’s counsel requesting the deficiencies be cured within 20 days.
  • By the first business day of the month, the companies will send the Plaintiff’s Liaison Counsel a list of cases with untimely responses, or a failure to provide medical records proving the use of Xarelto or other deficiencies.
  • After that, the Plaintiff’s Liaison Counsel has 30 days to provide comments or objections.
  • Five days after the comments are received, the defendants must file motions requesting orders to show cause why the cases should not be dismissed.

In January, California Superior Court Judge Kenneth R. Freeman in Los Angeles appointed the plaintiffs’ liaison counsel in the state’s Judicial Council Coordinated Proceedings (JCCP) for all Xarelto cases in the state courts. There are 31 cases pending involving 52 plaintiffs. A status conference was held on Dec. 12, when the parties agreed to submit plaintiff and defendant fact sheets.

In parallel litigation, some 1,100 claims have been filed in the Philadelphia Court of Common Pleas Xarelto Consolidated Litigation to date before Judge Arnold New. For more, read Two Reasons That More Attorneys File Xarelto Claims in Philadelphia Court. The first trial is scheduled for September 2017.

Did Xarelto kill Arnold Palmer?

Remember Arnold Palmer? He advertised blood-thinner Xarelto, which he took daily, in TV commercials until his death September 25, 2016 from gastrointestinal bleeding. Plaintiffs in thousands of lawsuits charge that the makers of the drug failed to warn and actually concealed that Xarelto causes uncontrollable internal bleeding. Meanwhile the defendants continue to promote the blockbuster drug aggressively as the cases mount in two courts. No settlement expected until the litigation affects stock price.

Xarelto is Rivaroxaban, approved by the FDA on July 1, 2011 to reduce stroke and blood clots — deep vein thrombosis (DVT) and pulmonary embolism (PE) — in patients with atrial fibrillation, a heart disorder. It has been prescribed to more than 4 million US patients, generating sales of $2 billion by fiscal year 2013.

The drug has no antidote to stop internal bleeding. The current label reads: Risk of bleeding: XARELTO can cause serious and fatal bleeding. For 2012 a  total of 2,081 “Serious Adverse Event” reports filed with the FDA it its first full year on the market, and 151 were deaths.

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JPMDL Consolidates Eliquis Product Liability Litigation into New MDL in NY

eliquis-5mg-60slblThe Judicial Panel on Multidistrict Litigation created new MDL No. 2754 to hear product liability litigation against Bristol-Myers Squibb Company, Pfizer Inc. and McKesson Corporation charging that blood-thinner Eliquis (apixaban) causes severe and fatal bleeding.

There is a total of 53 actions pending in 17 districts raising substantially the same factual and legal issues concerning plaintiffs’ alleged injuries arising from Eliquis and over a dozen involved plaintiffs’ firms. Moreover, the parties unanimously agree that there is a strong likelihood of additional federal actions and also report a significant number of state court actions.

US District Judge Denise L. Cote in Southern District of New York will supervise the cases. The defendants requested the MDL, and the plaintiffs argued unsuccessfully to continue informal coordination.

“We find that, on this record, informal coordination is not an efficient alternative to centralization,” the JDMDL said. “In addition to the unsuccessful efforts to coordinate discovery informally, it is clear that the number of involved counsel, the large number of actions and districts, and the complexity of the factual issues pose significant obstacles to informal coordination.”

Insufficient testing

All the actions share common factual questions arising out of allegations that plaintiffs suffered severe bleeding and related injuries as a result of taking Eliquis (apixaban), that defendants did not conduct sufficient testing of the drug, and that defendants’ warnings and instructions as to the alleged risks, including the unavailability of a reversal agent to counteract bleeding, were inadequate. Issues concerning the design, testing, manufacture, regulatory approval, labeling, and marketing of Eliquis thus are common to all actions.

Eliquis is an oral anti-coagulant first put on the market in Europe in 2012 and then approved by the FDA in 2014 for use in the United States. The clinical trials are alleged to have documented adverse effects including severe internal bleeding and other severe adverse symptoms including at least one death caused by Eliquis, which went unreported. Bristol-Myers and Pfizer chose to place Eliquis on the market while failing to disclose this critical information as required.

Currently the claims in the MDL include wrongful death as well as ongoing severe medical injuries. Eliquis is another in the line of recent blood thinner products including Pradaxa and Xarelto that have been the subject of Multi-District Litigations, including drug maker Boehringer Ingelheim’s $650 million settlement in 2014 to settle the Pradaxa MDL.  The recent Eliquis lawsuits center on patients who have died from internal bleeding or suffered other critical life-altering injuries, including Deborah Herschell who’s husband died after using Eliquis in June 2015 and Oliver Becker who suffered from atrial fibrillation (AFib) and also died after being prescribed Eliquis.

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Court Appoints Plaintiffs’ Counsel in California Xarelto JCCP Cases

Derek H. Potts, founder and national partner of Potts Law Firm
Derek H. Potts, founder and national partner of Potts Law Firm

California Superior Court Judge Kenneth R. Freeman in Los Angeles appointed the plaintiffs’ liaison counsel in the state’s Judicial Council Coordinated Proceedings (JCCP) for all Xarelto cases in the state courts.

Derek H. Potts, founder and national managing partner of Potts Law Firm in Houston, was appointed Liaison Counsel. In this role, he serves as the representative of all plaintiff parties and will actively assist the Court and Co-Lead Plaintiffs’ Counsel. Co-Counsel include Mark Milstein with Milstein Adelman Jackson Fairchild & Wade in Los Angeles and Ruth Rizkalla with Kirtland & Packard in El Segundo, CA.

In the California JCCP, there are 31 cases pending involving 52 plaintiffs. A status conference was held on Dec. 12, when the parties agreed to submit plaintiff and defendant fact sheets. A motion is pending to quash service of summons based on lack of personal jurisdiction over nonresident defendants. The parties await the outcome of a US Supreme Court Case on California State Jurisdiction Over Plavix Litigation, where the California Supreme Court ruled that its state courts can take “specific jurisdiction” over mass tort claims by out-of-state plaintiffs against Bristol-Myers Squibb arising from the company’s national marketing and sales campaigns.

Nationwide litigation

Separately, 14,465 cases have been filed in federal court in Xarelto (Rivaroxaban) Products Liability Litigation in MDL 2592 supervised by U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana. For more information see Update: Federal Court Revises Xarelto Product Liability Cases for Trial. The first bellwether trial is scheduled for this March.

In parallel litigation, some 1,100 claims have been filed in the Philadelphia Court of Common Pleas Xarelto Consolidated Litigation to date before Judge Arnold New. For more, read Two Reasons That More Attorneys File Xarelto Claims in Philadelphia Court. The first trial is scheduled for September 2017.

Potts has extensive experience representing plaintiffs in multi-district litigation and in pharmaceutical and medical device cases. He has been appointed by multiple courts to upper-level plaintiffs’ leadership positions in complex litigation and multi-district litigation. Potts has extensive experience representing plaintiffs in multi-district litigation and in pharmaceutical and medical device cases.

“We understand the important nature of the pharmaceutical litigation given the health issues at hand,” said Potts. “We’re glad to be of service to our clients in helping them resolve their cases as quickly as possible.”

Potts was instrumental in establishing the Consolidated Transvaginal Mesh Multi District Litigation in the U.S. District Court for the Southern District of West Virginia. He was appointed by two federal judges overseeing the mesh litigation to coordinate the consolidations on behalf of 100,000 women making claims against the manufacturers of the mesh products. He has successfully resolved tens of thousands of transvaginal mesh claims for his clients.

Xarelto (rivaroxaban) is an oral anticoagulant (blood thinner) used to prevent blood clot formation in people with atrial fibrillation (irregular heartbeat) or those at risk for developing deep vein thrombosis and pulmonary embolism especially after hip or knee replacement surgery. Xarelto inhibits clot formation by blocking a specific clotting protein which is naturally found in the blood.

Xarelto was developed by Bayer and Johnson & Johnson’s New Jersey-based unit, Janssen Pharmaceuticals. The potential risk of patients taking Xarelto is severe, and uncontrolled bleeding which can lead to organ damage and even death. Due to the lack of a reversal agent, patients are at further risk of prolonged bleeding without an available remedy.

According to one California case, Rudy Benavides v. Janssen, Johnson & Johnson, Bayer Healthcare, et. al., Case No BC 614547, California Superior Court, Los Angeles, Xarelto was approved by the FDA on July 11, 2011. It was marketed as “the first and only once a day prescription blood thinner,” and as a “one size fits all drug.”

The defendants’ boxed warning did not address the increased risk for serious and fatal bleeding, according to the complaint. The Institute for Safe Medication Practices reported on October 3, 2012, that the most-reported adverse event for Xarelto was “serious blood clot related injury — the very event that rivaroxaban is intended to prevent.”

 

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7 Xarelto Cases Chosen for Trial in Louisiana Federal Court

XARELTOIn Case Management Order No. 5 on August 1, US District Court Judge Eldon E. Fallon ordered four categories of Xarelto cases for trial, and set deposition deadlines in the Eastern District of Louisiana.

The cases are in 4 categories in In Re: Xarelto (Rivaroxaban) products liability litigation consolidated in MDL No. 2592 in New Orleans, which includes a total of 400 cases. Another 739 cases have been consolidated in separate litigation in a Xarelto MDL in the Philadelphia Court of Common Pleas.

The federal cases in Louisiana are in 4 categories:

  1. One case in Category 2a from CMO 4 (“Plaintiff took Xarelto® in order to reduce the risk of stroke and systemic embolism due to nonvalvular atrial fibrillation and alleges a gastrointestinal bleed or death due to a gastrointestinal bleed and was between the ages of 50 and 90 at the date of the alleged event.”).
  2. Four cases in Category 2e from CMO 4 (“Plaintiff took Xarelto® in order to reduce the risk of stroke and systemic embolism due to nonvalvular atrial fibrillation and alleges a Brain bleed/hemorrhagic stroke or death due to a brain bleed/hemorrhagic stroke and was between the ages of 50 and 90 at the date of the alleged event.”).
  3. One case in Category 2b from CMO 4 (“Plaintiff took Xarelto® to treat deep vein thrombosis (DVT), to treat pulmonary embolism (PE) and/or to reduce the risk of recurrence of DVT or PE and alleges a gastrointestinal bleed or death due to a gastrointestinal bleed and was between the ages of 40 and 80 at the date of the alleged event.”).
  4. One case in Category 2a from CMO 4 where venue is proper in a federal district in the State of Texas (“Plaintiff took Xarelto® in order to reduce the risk of stroke and systemic embolism due to nonvalvular atrial fibrillation and alleges a gastrointestinal bleed or death due to a gastrointestinal bleed and was between the ages of 50 and 90 at the date of the alleged event.”).

Arguments held on August 4

Judge Fallon is presiding over 6,400 Xarelto lawsuits filed in federal court. In each category, the plaintiffs’ steering committee (PSC) and defendants exchanged via email a list of any cases that either side should be removed from the pool. On August 4, 2016, the Court heard arguments as to whether any cases in each category should be removed from the pool.

Xarelto is prescribed for atrial fibrillation (AFIB), deep vein thrombosis (DVT) and pulmonary embolism (PE). However, it causes brain/cerebral hemorrhage, death, gastrointestinal bleeding, heart attack, kidney bleeding, nosebleeds, rectal bleeding, respiratory failure, hemorrhagic and ischemic strokes, vaginal or uterine bleeding, and other internal bleeding.

The Defendants Include Janssen Research & Development F/K/A Johnson and Johnson Pharmaceutical Research and Development LLC, Janssen Ortho LLC, Janssen Pharmaceuticals, Inc. F/K/A Janssen Pharmaceutica Inc. F/K/A Ortho-Mcneil-Janssen Pharmaceuticals, Inc., Johnson & Johnson Company Bayer Healthcare Pharmaceuticals, Inc., Bayer Pharma Ag, Bayer Corporation, Bayer Healthcare LLC, Bayer Healthcare Ag, and Bayer Ag.

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