Update: Federal Court Revises Xarelto Product Liability Cases for Trial

XARELTOIn an update of Case Management Order No. 2a, the court in Xarelto MDL 2592 Federal Litigation updated when four bellwether cases will be tried.

  • March 13, 2017:  (E.D. La., atrial fibrillation + gastrointestinal bleed) Joseph J. Boudreaux, Jr., Case No. 2:14-cv-02720.
  • April 24, 2017:  (E.D. La., atrial fibrillation + brain bleed) Joseph Orr, Jr., Case No. 2:15-cv-03708
  • May 30, 2017:  (Mississippi, deep vein thrombosis/pulmonary embolism + gastrointestinal bleed) Dora Mingo, Case No. 2:15-cv-03469.
  • To be set:  (Texas, atrial fibrillation + gastrointestinal bleed) Henry James, Individually and as Executor of the Estate of William Henry, Case No. 2:15-cv-00224.
There are 10,769 cases filed in the MDL. Judge Eldon Fallon postponed the initial bellwether trials on Sept. 21 because of the NBA All-Star game and related logistical issues this will create.

Hemorrhagic or ischemic strokes

US District Judge Eldon E. Fallon ruled in two separate orders on Aug. 11 and 15. Only claims involving hemorrhagic  strokes (caused by internal bleeding, not a blood clot) can be brought in the federal MDL.

“The ischemic stroke claims [stroke caused by blood clot] cannot be brought in the federal MDL because the argument was not made there,” said Mass Tort Expert John Ray. As a result, thousands of ischemic stroke cases have been filed in the Philadelphia Court Of Common Pleas before Judge Arnold L. New.

Xarelto (Rivaroxaban) is a blood-thinning drug manufactured by Bayer Healthcare AG and Janssen Pharmaceuticals, a division of the Johnson and Johnson Corporation. The drug has been the focus of 2,800 lawsuits filed in MDL 2592, alleging that consumers who took the drug face a risk of spontaneous and uncontrollable bleeding. Xarelto has been associated with gastrointestinal bleeding, blood clots, brain hemorrhages and strokes. Plaintiffs also charge that the manufacturers of Xarelto failed to warn public and medical professionals about the very serious risks.


Ray said he foresees the cases settling, but the defendants’ decision will not be based on legal arguments. Instead, he said the main factor will be “how to do it without harming their market share and having doctors continue to write prescriptions for Xarelto.” As the cases mount up, the manufacturers have increased their TV advertising. See Bayer & Janssen Use Celebrities to Promote Xarelto Despite Ongoing Litigation

The defendants include:

  1. Janssen Research & Development LLC
  2. Janssen Pharmaceuticals, Inc.
  3. Janssen Ortho LLC
  4. Johnson & Johnson
  5. Bayer Healthcare Pharmaceuticals. Inc.
  6. Bayer Pharma AG.
  7. Bayer Corporation.
  8. Bayer Healthcare LLC.
  9. Bayer Healthcare AG.
  10. Bayer AG.

“The defendants are not playing to win,” he said, “but stockholders will only tolerate the litigation going on for so long,” he said. “The legal case is secondary to them. The defendants are concerned with their stockholders and how the litigation is affecting their stock price. The people involved who are making decisions lose their jobs when the companies have to pay out $3-4 billion in a settlement and the stock price takes a hit,” Ray said.

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Considerations for Plaintiff Attorneys when Starting a Successful Mass Tort Practice

John Ray
John Ray

Mass Tort Litigation has emerged as the only effective check on pharmaceutical and medical device companies that make dangerous products injuring thousands of Americans. Mass tort attorneys have filed 140,000 lawsuits in 250 federal multidistrict litigation dockets as of September 2016.

Many attorneys are expanding their personal injury practices to include mass torts because the US Judicial Panel on Multidistrict Litigation has organized the litigation so effectively against the multi-billion-dollar drug and medical device industry.

“The FDA is not a check or a balance on the pharmaceutical industry,” said Mass Tort Nexus Consultant John Ray, recently teaching a four-day course about mass torts in Fort Lauderdale, FL. “Plaintiff attorneys are the only check on the pharmaceutical industry.”

In recent years mass tort lawyers have recovered $10 billion in settlements for injured Americans: $4.8 billion for Vioxx, $1.8 billion for Yaz, $1.3 billion for the Stryker hip and $2.5 billion for the DePuy hip.

“The drug companies bake these cases into their business model,” Ray said. “Defendants call it a win when they don’t put a warning on their labels, don’t get sued and don’t have to pay a judgment at all. This means they got away with it. That happens a lot.”

When a federal MDL is created, the supervising judge will approve a standard short-form or long-form complaint, plus a plaintiffs’ fact sheet which replaces interrogatories. The consolidation of cases means that a mass tort lawyer can file a notice of appearance and file cases regardless of the jurisdiction of the plaintiff, defendant company or the location of the plaintiff’s attorney.

Criteria for a viable case

Cases that are attracting many mass tort attorneys now involve Xarelto, IVC filters and Pradaxa. Among the many factors determining the viability of a mass tort are:

  • Preemption. Congress has expressly preempted certain claims. Further, courts have ruled that generic manufacturers cannot be sued.
  • Statute of limitations: State laws govern when the statute of limitations starts to run, but in most federal litigation, the date that the FDA issues a “black box warning” for a drug marks the date when the time limit begins to run.
  • Legal viability. In many cases, research will show a connection between a drug and injuries among patients, but specific causation must be proved in a trial. Experts must be found who will survive a Daubert motion to disqualify.
  • Financial viability of the defendant. While Johnson & Johnson had $46.8 billion in annual income in 2015, some small makers of IVC filters went out of business before they could sell one.
  • Average case value. The average Pradaxa case settled for $160,000 in 2014, with some settlements valued up to $500,000, according to a grid created by US District Judge David R. Herndon.
  • Plaintiff numerosity. Cases in the Syngenta Corn Market Crash Litigation involve every corn producer in America, and IVC Filters have been implanted in millions of patients over the last 40 years.
  • Cost per client acquired. Costs can add up with Facebook advertising, website marketing, and lead generation companies. For example, The Sentinal Group will advertise for clients for a fee of $100,000 to obtain 250 calls for Xarelto plaintiffs, with 1 out of 5 calls leading to a signed client.
  • Case duration. Mass torts are litigation for the long haul, with the average case lasting 5 years and 4 months before settlement, according to Ray, with 7 years being a good benchmark for the duration of a case.
  • Case value. An example of a good outcome is with Pradaxa. The average settlement is $162,000. Calculating 40% in gross contingent fees would equal $64,800. Another 7% is deducted ($4,536) for the common benefit to pay the steering committee. Of the remaining fee of $60,204, a 40% referral fee of $24,015 is deducted for the co-counsel that handled the litigation. This leaves a net fee of $36,189 for the attorney who originated the case.
  • Financial resources. Costs to fund a case can be in the tens of thousands of dollars, with costs reaching hundreds of thousands for members of the plaintiffs steering committee.
  • Personnel resources. A law firm will have to train a small army of intake specialists to answer incoming calls when advertising is running. Additional personnel will be needed to obtain and review medical records.

Perfect timing

There are three phases of mass tort litigation, and perfect timing will be needed to enter a particular case.

Emerging Phase Cases. In this early phase, the cost to acquire a client is the least expensive, but there many issues of case viability. For example, the courts are still considering motions to consolidate cases involving Abilify and Roundup. With Abilify the FDA has issued a safety warning but not a black box warning. With Roundup the EPA has not classified the herbicide as a carcinogen, but foreign governments have.

Litigation Phase Cases. It is considered an ideal time to enter into a mass tort when the JPML has created a multi-litigation docket (MDL). Some 250 MDLs include mature litigation involving Benicar, Lipitor, Viagra, Xarelto and Zofran, and many legal issues have been settled. The supervising judge will schedule bellwether or test cases for trial.

Settlement Phase Cases. This is the very safest time to enter litigation because all an attorney must do is find qualified plaintiffs. Example cases involve transvaginal mesh, Levaquin and Pradaxa. However at this late phase the cost to acquire a client is at its highest.

“Whatever you do, maintain your single-event plaintiff’s practice,” Ray advised. “You will have to keep paying the costs of a mass tort case until it settles, and you will need a huge cash supply or credit line.”

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Did Xarelto, the Drug Arnold Palmer Promoted, Lead to His Death?

One of the final images of beloved golfer Arnold Palmer is the 87-year old in a TV commercial wearing a pink sweater and saying, “Treatment with Xarelto was the right move for us.” Many people are wondering if that is true in the wake of his death on September 25, 2016, which was preceded in August 2016 by surgery for colon bleeding, according to Golf Digest.

Xarelto is the target of 10,769 federal and state lawsuits that charge, among other things, that the blood-thinning drug causes death from gastrointestinal and other internal bleeding. Palmer was hospitalized on Sept. 22 in preparation for heart surgery on Sept. 26 at Pittsburgh Medical Center. However, his conditioned steadily weakened and he died “due to complications from heart disease.”

Despite ongoing federal and state litigation, defendants Bayer HealthCare AG and Janssen Pharmaceuticals have broadcast a TV commercial for more than a year, where Palmer and other celebrities tout the dangerous drug.

Just 25 months ago Palmer underwent surgery to have a pacemaker implanted, according to Golf Digest. That procedure marked the first of a series of health issues including high blood pressure, for which he took pills daily. Palmer said in a 2015 interview that he was taking “a blood thinner,” which he attributed to a bout with deep vein thrombosis (blood clots). Deep vein thrombosis is linked with coronary heart disease. Had he been taking Coumadin he would not have needed surgery to stop the colon bleeding.

Defendants in the federal MDL, before US District Judge Eldon E. Fallon, In RE: Xarelto (Rivaroxaban) Products Liability Litigation, include Bayer Healthcare, the designer and manufacturer of Xarelto. Janssen Pharmaceuticals (a Division of Johnson & Johnson) currently sells Xarelto in the United States pursuant to a licensing agreement with Bayer. Plaintiffs involved in the MDL have suffered various harmful side effects, including:

  • Gastrointestinal Bleeding,
  • Intracranial Hemorrhage,
  • Hemorrhagic and Other Severe Internal Bleeding,
  • Stroke,
  • Death (due to one of the aforementioned injuries).

A complete set of federal MDL forms can be found online on the Mass Tort Nexus app.

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Judge Orders Bayer to Turn over Personnel Records to Xarelto Plaintiffs

xarelto internal-bleedingThe judge overseeing federal Xarelto product liability litigation ordered defendant Bayer to turn over the personnel records of two doctors on its payroll who can testify about plaintiff claims that the blood-thinner drug was rushed to the market.

The plaintiffs also seek the records because they may contain evidence of aggressive compensation schemes or rush-to-the-market liability, which is vital to their case-in-chief.

US District Judge Eldon E. Fallon ordered the company to turn over redacted copies the personnel files of Dr. Dagmar Kubitza, Head of Clinical Pharmacodynamics, and Frank Misselwitz, Corporate Vice President, both working in Germany. Excluded from the records are performance reviews, evaluations for promotion and self-assessments.

The court weighed five factors listed the Third Restatement, as referenced in Seoul Semiconductor Co. v. Nichia Corp., 590 F. Supp. 2d 832, 835 (E.D. Tex. 2008).

Evasiveness by Bayer

“The Court is concerned by the evasiveness exhibited by Bayer in certain depositions and is troubled by the possibility of further evasive responses by deponents,” Judge Fallon wrote. “As this is a nationwide MDL, the rights of thousands of American citizens hinge on the timely production of materials that fall within the scope of the Federal Rules of Civil Procedure.”

Thousands of case filings are increasing court dockets in the Xarelto mass tort litigation in federal court and also the Philadelphia Court Of Common Pleas. Only claims involving hemorrhagic strokes (caused by internal bleeding, not a blood clot) can be brought in the federal MDL. As a result, thousands of ischemic stroke cases have been filed in the Philadelphia before Judge Arnold L. New.

Defendants in the MDL include Bayer Healthcare, the designer and manufacturer of Xarelto. Janssen Pharmaceuticals (a Division of Johnson & Johnson) currently sells Xarelto in the United States pursuant to a licensing agreement with Bayer. Plaintiffs involved in the MDL have suffered various harmful side effects, including:

  • Gastrointestinal Bleeding,
  • Intracranial Hemorrhage,
  • Hemorrhagic and Other Severe Internal Bleeding,
  • Stroke, &
  • Death (due to one of the aforementioned injuries).

A complete set of federal MDL forms can be online on the Mass Tort Nexus app.



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Slides & Recording for Webinar: Mass Torts Update for Plaintiff Attorneys

5 Mass Torts for Plaintiff Attorneys Today

Broadcast August 31, 2016

Visit http://goo.gl/rOG9qt to see the slides and recording of this program.

John Ray
John Ray

What you will discover

For lawyers starting a Mass Torts practice, picking the right cases and having an effective law firm marketing campaign are essential. Our presenter John Ray will update plaintiff attorneys about 5 key Mass Torts:

  • New Pradaxa docket in Connecticut
  • IVC Filter
  • Xarelto
  • Fluoroquinolone antibiotics
  • Emerging: Roundup litigation

A Mass Tort is ordinarily a product liability case where hundreds of plaintiffs file suit against a pharmaceutical company. These cases are typically collected into one of 300 federal multi-district litigation dockets (MDLs).

Mass Torts is a multi-billion dollar immature market, with economies of scale and only a single barrier to entry. You have already overcome the barrier if you are admitted to practice law.

About our presenter

John Ray has been a leading consultant to the Mass Tort attorneys for more than a decade. His unique skill sets make him well suited to both teaching and consulting in the Mass Tort arena.

He graduated Magna Cum Laude from Brenau University in Atlanta and started a pharmaceutical and medical device company right out of school, selling it in an eight-figure deal when he was 35.
John’s tenure in the pharmaceutical and medical device field allowed him to gain an in-depth understanding of FDA regulatory matters, as well as, a thorough understanding of the science and epidemiology related to gaining FDA approval to market pharmaceuticals and medical devices. John’s inside knowledge of how “Big Pharma” operates gives him a unique perspective and skill sets that are very useful to Mass Tort plaintiff firms.

When John brought his “insider knowledge” and business acumen to the Plaintiff Mass Tort space, one of the first things he recognized was a lack of common terminology and well-defined metrics. John realized that firms were expressing the same concepts, but were not using the same terminology. As a result, John set out to define common terms and create methods for formulating important metrics for use by Mass Tort firms when evaluating litigations. The terminology and metrics John Ray developed are now commonly used by major Mass Tort Law firms.

John is highly sought after and writes sought-after white papers about both current and emerging torts. The accuracy of his analysis of emerging and ongoing litigations is unmatched.

The fact that John not an attorney has proven to be an asset. John thinks like a business person, employing creative problem solving and possesses an extensive set of business skills and industry-specific knowledge. He assists Mass Tort firms in making sound business decisions before and during any litigation they are involved in or are considering becoming involved in.

John is an expert at evaluating cases and looks at each tort as an individual “investment,” which can be quantified resulting in risk mitigation for you and your firm.

Contrary to popular belief, adding Mass Torts to your practice is not gambling, nor is there a secret society of Mass Tort attorneys. The only information you lack to be successful in the practice of Mass Torts is a business plan. As John says, this type of law is 80% business and 20% law. If you understand the business principles of Mass Tort law, you will be successful.

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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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New Study to Investigate Long-Term Xarelto and Pradaxa Use

xarelto bleedingA patient-centered research institute is conducting two studies that will compare the effectiveness of Pradaxa, Xarelto and other oral blood thinners to determine what the long-term effects are.

The Patient-Centered Outcomes Research Institute (PCORI) announced the $6.5 million studies to scrutinize anticoagulants including:

  • Warfarin
  • Dabigatran (Pradaxa, made by Boehringer Ingelheim)
  • Rivaroxaban (Xarelto, made by Janssen)
  • Apixaban (Eliquis, made by Bristol-Myers Squibb)
  • Edoxaban (Savaysa, made by Daiichi Sankyo)

The drugs are used to to treat clots and are often used for longer than the standard 3-month treatment period to prevent formation of additional clots, but the comparative safety and effectiveness of extended use is unclear, according PCORI.

Federal Xarelto Litigation is consolidated before US District Judge Eldon Fallon in MDL 2592 and the state litigation is consolidated in the Philadelphia Court of Common Pleas before Judge Arnold New. In the state MDL  Judge New has elected to allow “Efficacy Claims” to be filed in that MDL in addition to claims related to uncontrolled bleeding. Judge Fallon has yet to follow suit and may not.

Uncertainty about medications

Venous thromboembolism (VTE) causes more than half 500,000 hospitalizations and more than 100,000 deaths each year in the United States. VTE is typically treated with at least three months of an anticoagulant, or “blood-thinning,” medication. Afterward, patients are often given the option to extend anticoagulant treatment for a longer period to prevent VTE recurrence. Remaining on anticoagulants, however, can lead to serious bleeding complications and can be expensive and inconvenient for patients.

At present, there is much uncertainty about which medication is the best choice for extended VTE treatment, according to PCORI. Choosing the best anticoagulant strategy is particularly difficult when treating people of older age, people who have kidney disease, or people who have high bleeding risk, due to the scant evidence available on the relative benefits and harms in these populations.

The long-term goal of the project is to compare the benefits and harms of different anticoagulant options for the extended treatment of VTE, information that will be critical in helping clinicians and patients personalize their treatment decisions. The study focuses on people who have completed at least three months of anticoagulant treatment for VTE and compares the outcomes of 1) people who stay on anticoagulants with those who stop anticoagulants, and 2) those who are treated with extended warfarin compared with NOAC treatment. PCORI will also examine whether the benefits and harms of treatment differ by age, kidney function, or bleeding risk.

The study will be based in Kaiser Permanente Northern California and Kaiser Permanente Southern California, two large, integrated healthcare delivery systems that provide comprehensive medical care for more than 7.7 million patients in California. PCORI will identify in these health systems all adults treated for VTE from years 2010 to 2015 and collect information from electronic health records on their health history, anticoagulant treatment choices, and clinical outcomes. Next, PCORI will survey patients with VTE treated in more recent years (2014–2016) and measure their self-reported health, well-being, and satisfaction with treatment.

The main outcome of the study is the net benefit of one treatment strategy compared with another, measured in terms of the number of VTE events prevented and the number of bleeding complications induced. Because the study is an observational study of actual clinical care, PCORI will then apply advanced statistical techniques to maximize the validity of the results.

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PA Court Now Allows Ischemic Stroke Claims in Xarelto Litigation

Ischemic strokeIn an important new ruling, Judge Arnold L. New in the Philadelphia Court of Common Pleas amended the master and short form complaint to allow for Ischemic Stroke Claims to be made in that court.

The court covered several topics when it issued Case Management Order #10 on June 6:

Ischemic Stroke Cases Instituted By The Filing Of Long Form Complaints

  • All Plaintiffs who have previously filed Xarelto cases alleging ischemic stroke using a long form complaint shall file a Second Amended Long Form Complaint in the form within 20 days of this Order.

Expert John Ray, a leading consultant to the Mass Tort industry, explained the significance, saying, “these ischemic stroke cases are related to Xarelto being marketed as a one-time per day drug. All that the drug manufacturers did was double the dose and say you only need to take it once per day. They did this for a marketing advantage.

“The problem is that the patient is over-anticoagulated the first half of the day and under-anticoagulated the remaining time before next dose. This leaves the patient unprotected from what Xarelto is suppose to protect them from for the last half of the dose day and more likely to bleed in the first half of the day.”

The defendants in the state litigation include:

  1. Janssen Research & Development LLC
    2. Janssen Pharmaceuticals. Inc.
    3. Janssen Ortho LLC
    4. Johnson & Johnson.
    5. Bayer Healthcare Pharmaceuticals. Inc.
    6. Bayer Pharma AG.
    7. Bayer Corporation.
    8. Bayer Healthcare LLC.
    9. Bayer Healthcare AG.
    10. Bayer AG.

Second Amended Master Long Form Complaint

  • The Court Directs that Plaintiffs’ Second Amended Master Long-Form Complaint and Jury Demand to this Order shall be filed on the Master Docket.
  • The Second Amended Master Long-Form Complaint and Jury Demand will substitute for and supersede all Complaints filed in individual Xarelto cases pending in the Philadelphia County Court of Common Pleas.
  • Defendants (other than those relieved from any answer obligation under CMO-3
    shall have 60 days from the entry of this Order to answer or plead to the Second Amended Master Long-Form Complaint.

Short-Form Complaint–Previously Filed Cases

  • All Short Form Complaints previously filed on or before the date that the Clerk files the Second Amended Master Long-Form Complaint and Jury Demand pursuant to this Order are hereby deemed to incorporate the Second Amended Master Long-Form Complaint and Jury Demand without the need of any plaintiff to take any action to amend their Short Form Complaints that already been filed in this case.

Short-Form Complaint–Newly Filed Cases

  • All Xarelto cases filed after the date of this Order shall be instituted by the filing of a Writ of Summons or a Second Amended Short Form Complaint. If suit is instituted by a Writ of Summons, the Writ of Summons must denote the case to be part of this Mass Tort Program and any named Defendant may file a Rule to File a Complaint, which shall apply to the benefit of all named Defendants.

“This is very important news,” Ray said. “The Ischemic Stroke claims, often referred to as ‘efficacy’ claims, cannot be brought in the Federal multidistrict litigation docket (MDL) because the argument was not made there. Only hemorrhagic  strokes can be brought in the federal MDL.”

US District Judge Eldon E. Fallon is overseeing Xarelto Products Liability Litigation MDL 2592 , based in New Orleans, LA. Click to find out more about Xarelto MDL 2592 Important Developments.



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Alere Recalls Inaccurate INRatio Blood Monitor for Patients Taking Pradaxa or Xarelto

Alere INRatio2 PT/INR Monitor System
Alere INRatio2 PT/INR Monitor System

Diagnostics company Alere Inc. announced  a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR blood Monitoring Systems.

Patients taking blood thinners like Coumadin, Jantoven, Warfilone (warfarin), Pradaxa (dabigatran), Xarelto (rivaoxaban), or Lovenox (enoxaparin), can to monitor their blood levels at home instead of at a lab, by using the Alere INRatio, INRatio2 PT/INR Monitor System, or INRatio Test Strips (collectively the Alere INRatio Monitoring System) to monitor their international normalized ratio (INR) while undergoing anticoagulation therapy.

For more, read our story Xarelto MDL 2592 Important Developments.

The monitor is supposed to perform a simple blood test, letting a patient and doctor doctor know if the medication is working properly or if a dose adjustment is needed.

Over the course of the past two years, Alere invested in the research and development of software enhancements to address the potential, in certain cases, of the system to deliver a result that differs from that of another measurement method.

FDA: Not effective

The FDA notified the company that it believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio device from the market.

Alere seeks an orderly transition for patients requiring anti-coagulation monitoring and will provide a timeline to discontinue the product line. Alere will provide further information on patient transition to patients and healthcare providers. The FDA suggest that patients speak with their healthcare providers prior to making any changes to their current PT/INR monitoring practices.

In other news, Alere Inc. was hit with a securities fraud lawsuit on April 22, accusing it of artificially inflating its share prices ahead of the Feb. 1 announcement of its proposed $5.8 billion acquisition by Abbott Laboratories Inc.

The shareholder lawsuit, filed in federal court in Boston, accused Alere of misleading investors by stating that its financial reporting followed generally accepted accounting principles. The plaintiffs, a group of individual investors, cited a federal probe into the company’s accounting for overseas sales in arguing that Alere had not adhered to those principles.

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