Jury Selection Starts Today for Second Xarelto Bellwether Trial

By Joseph VanZandt.

The second bellwether trial involving bleeding risks with the blood thinner Xarelto is slated to begin today. The trial is part of the multidistrict litigation (MDL) pending in the United States District Court for the Eastern District for Louisiana before Judge Eldon Fallon.

The Jere Beasley Report explains that Xarelto is an anticoagulant (blood thinner) initially approved in 2011 to reduce the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) following knee and hip replacement surgery. It was later approved to reduce the risk of stroke in patients with non-valvular atrial fibrillation (A-fib) and for treatment of DVT and PE. Xarelto carries a significant risk of severe, uncontrolled internal bleeding and has been linked to bleeding-related deaths.

The second trial involves Joseph Orr, Jr., a Louisiana resident, who filed suit on behalf of his deceased wife, Sharyn Orr. Mrs. Orr suffered a fatal brain bleed while taking Xarelto. She was 67 years old at the time of her death and had been taking the drug to treat A-fib for just over a year when she suddenly become severely ill.

Mrs. Orr was transported to the hospital where a CT scan of her head revealed she was suffering from an extensive, acute hemorrhage in her brain and a hemorrhagic stroke. Although she needed a surgery, she was not stable enough until the next day when Xarelto had the chance to clear her system. Unfortunately, the procedure came too late and Mrs. Orr’s neurologic condition continued to worsen until May 4, 2015, when she passed away.

More than 16,000 Xarelto lawsuits have been filed in the federal multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana.

German drug manufacturer Bayer AG and Johnson & Johnson’s Janssen Pharmaceuticals developed and marketed Xarelto as a blood thinner that does not require coagulation monitoring, the Plaintiffs assert. They argue that the Defendants failed to develop a monitoring test specific to Xarelto and failed to instruct doctors on how to use currently available tests to measure Xarelto’s anticoagulant effect on patients’ blood. Such monitoring would allow doctors to assess whether patients benefited from the use or were at risk of severe internal bleeding.


By Joseph VanZandt, a Medical Devices and Drugs attorney with Beasley, Allen, Crow, Methvin, Portis & Miles, P.C. in Montgomery, AL.


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3,700 IVC Filter Lawsuits Filed Against Bard and Cook Medical

Bard G2 Express IVC Filter
Bard G2 Express IVC Filter

Cook Medical, Inc. and C.R. Bard, Inc. continue to face mounting lawsuits over their retrievable IVC filters, with 3,769 cases filed against the companies in two federal MDLs.

Cook Medical is a defendant in at least 1,918 product liability claims involving its Gunther Tulip and Celect IVC filter blood clot filters. IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation is pending before US District Chief Judge Richard L. Young in MDL 2570 in the Southern District of Indiana.

In March 2017, Judge Young ordered both sides to appear at three hearings with a proposed settlement framework.

Bard’s IVC filters, including its Recovery, G2, Meridian, and Denali product lines, are the target of 1,851 injury claims. IN RE: Bard IVC Filters Products Liability Litigation is pending before US District Judge David G. Campbell in MDL 2641 in the District of Arizona.

On March 21, 2017, Judge Campbell appointed the Plaintiffs’ Co-Lead/Liaison Counsel and State/Federal Liaison Counsel:

  • Ramon R. Lopez, Lopez McHugh, LLP, Newport Beach, CA.
  • Mark S. O’Connor, Gallagher & Kennedy, PA, Phoenix, AZ.

Failure to Warn

IVC filters are implanted into the inferior vena cava – the body’s largest blood vessel – to intercept blood clots before they can travel to the heart and lungs. The devices are indicated for patients at risk for pulmonary embolism, and who are unable to use standard blood-thinning medications. The filters involved in the C.R. Bard and Cook Medical litigations are retrievable, and are intended to be removed once a patient is no longer at risk for pulmonary embolism.

Plaintiffs pursuing IVC filter lawsuits against C.R. Bard and Cook Medical claim that the companies failed to provide doctors with adequate warnings and instructions for removal. They also claim that the devices are defectively designed, and accuse the two companies of concealing the risks associated with their blood clot filters.

The FDA has issued two safety alerts about using retrievable IVC filters.

  • The first was released in August 2010, after the devices were linked to hundreds of adverse events, including reports of filters fracturing and migrating to other areas of the body. In other cases, pieces of the filters perforated organs and blood vessels.
  • The FDA issued a second alert in May 2014 to remind doctors of the importance of IVC filter retrieval. A year earlier, a paper published in JAMA Internal Medicine found only 8.5% of retrievable IVC filters were successfully removed.

“In conclusion, our research suggests that the frequent use of IVC filters for VTE treatment and prophylaxis, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in suboptimal outcomes, such as mechanical filter failure and high rates of VTE,” the authors of the report concluded. “More comprehensive longitudinal data would likely identify additional complications.”

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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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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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Judge Sets 6 Bellwether Trials in Testosterone Mass Torts Litigation

testosterone2US District Judge Matthew F. Kennelly has set June 5, 2017, for the start of first of six AbbVie bellwether trials in MDL 2545, in the Testosterone Replacement Therapy Products Liability Litigation in the Northern District of Illinois.

Discovery deadlines start in September for more than 5,500 cases currently pending. All the actions involve plaintiffs (or their survivors) who used one or more testosterone replacement therapies and contend that their (or their decedent’s) use of the drugs caused their injuries, which include:

  • heart attack
  • stroke
  • deep vein thrombosis
  • pulmonary embolism

On January 31, 2014, the U.S. Food and Drug Administration announced that it was “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” Plaintiffs filed the actions in the wake of this announcement.

In March 2015, the FDA issued a safety communication, cautioning men against taking testosterone products for low testosterone levels associated with aging. The agency also required companies manufacturing these drugs to change their labels to clarify the appropriate usages for their products. Manufacturers were also required to add warnings about the risks of heart attack and stroke associated with taking these drugs.

All testosterone replacement therapy actions share factual questions about general causation and the background science regarding the role of testosterone in the aging body, as well as involve common regulatory issues in light of the FDA’s announcement and subsequent actions, if any.

The hormone has been used off-label to treat a range of symptoms such as loss of energy, decreased muscle mass and reduced libido.

The defendants include:

  • AbbVie Inc. and Abbott Laboratories Inc. (collectively Abbot)
  • Eli Lilly and Co. and Lilly USA LLC
  • Endo Pharmaceuticals
  • Actavis, Inc.
  • Auxilium Pharmaceuticals, Inc.
  • Pfizer, Inc.
  • Pharmacia

All of these cases involve Androgel, a testosterone drug manufactured by AbbVie.

The first case, which is slated to begin July 2017, was filed by Jeffrey Konrad. Konrad claims he suffered a myocardial infarction after taking Androgel. The order of the remaining cases will be determined at a later date. Once these trials are completed, Judge Kennelly is expected to select a second group of bellwether trials that will include Axiron, Testim, Androderm and other testosterone products.

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