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Earlier Pradaxa Settlements Do Not Stop Filing Of New Pradaxa Lawsuits

As can be seen from the following set of drug safety alerts, Pradaxa has caused significant concern among doctors and patients since soon after it first became available for use in the US.

In early December 2011 the FDA announced it would evaluate reports of bleeding in patients taking Pradaxa that have been submitted to the agency’s Adverse Events Reporting System (AERS) database to determine whether serious side effects are occurring at a higher rate than should be expected.

From the ISMP QuarterWatch 2011 Quarter 1 edition, which was published January 12, 2012, we get this summary of those adverse event reports to the FDA as regards the “substantial bleeding risks” associated with Pradaxa. In particular, gastrointestinal hemorrhages and hemorrhagic strokes were identified as some of these serious side effects in those elderly patients using Pradaxa.

The next Pradaxa safety “update” came from the ISMP QuarterWatch 2011 Quarter 2 edition, which was released April 5, 2012:

[Pradaxa], a new anticoagulant intended to reduce the risk of stroke, was a suspect drug in 856 reported cases, more than any other regularly monitored drug, but showed a decrease from 931 reports in the previous quarter. The new quarterly total included 117 reported patient deaths. With 511 reported cases of hemorrhage, and a median patient age of 80 years, these new bleeding reports reinforce our concern that vulnerable older patients may be receiving an overdose of this one-size-fits-all drug.

Due to these serious side effects, beginning in 2012 a growing number of personal injury and wrongful death Pradaxa lawsuits were filed against Boehringer Ingelheim Pharmaceuticals, Inc.

In August 2012 this federal court Pradaxa MDL, or case consolidation, was created: IN RE: PRADAXA (DABIGATRAN ETEXILATE) PRODUCTS LIABILITY LITIGATION, MDL No. 2385.

In May 2014, following several years of legal proceedings in the Pradaxa MDL, the defendant Boehringer Ingelheim agreed to settle most if not all of the approximately 4,000 filed Pradaxa lawsuits. This so-called “global-settlement” deal was reached just as the first federal court Pradaxa cases were set to go to trial in September 2014.

In May 2015 U.S. District Judge Herndon issued an Order which disbanded and ended the federal court Pradaxa MDL litigation he had presided over since August 2012. His reason for doing so: There were no active federal court Pradaxa lawsuits pending other than those which were part of the 2014 global settlement by Boehringer.

But at about the same time as Judge Herndon’s Order, there began to be a number of new Pradaxa lawsuits being filed in various state courts around the country. And this was the start of what has been referred to as a “round two” or the “second wave” of Pradaxa drug injury litigation.

The only difference, essentially, is that this round two or second wave of Pradaxa litigation is being pursued at the state court level.

The bottom line is this: If you experienced serious side effects from the use of Pradaxa, or a person died due to an adverse reaction while taking Pradaxa, you may still have a claim for legal compensation.

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Eliquis MDL For Federal Lawsuits; In California, JCCP Petition Pending

In the federal court system, there are now more than 50 Eliquis lawsuits filed, and more of these drug injury and death cases are expected. Given this situation, in early February 2017 the United States Judicial Panel on Multidistrict Litigation (JPML) established this consolidation of all federal court Eliquis cases, IN RE: ELIQUIS (APIXABAN) PRODUCTS LIABILITY LITIGATION — MDL No. 2754.

From the February 7, 2017 JPML Order establishing this Eliquis federal court MDL we get this information about the litigation:

[W]e find that these actions involve common questions of fact, and that centralization will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. 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….

We conclude that the Southern District of New York is an appropriate transferee district for this litigation. Common defendants BMS and Pfizer both have their corporate headquarters within the district, and therefore relevant documents and witnesses are likely to be located there. Sixteen actions on the motion and three potential tag-along actions are pending there.

In addition to the federal court Eliquis cases, there are a significant number of Eliquis lawsuits filed in the California state court system. As a result, a petition to coordinate those California Eliquis cases was submitted to the Chair of the Judicial Council seeking to establish a consolidation, there, which would be similar to the federal court Eliquis MDL.

In California, if that petition to coordinate the Eliquis lawsuits — which was submitted to the Chair of the Judicial Council (the Chief Justice) and then assigned to a motion judge for determination — is granted, its result would be called the California Eliquis JCCP (Judicial Council Coordination Proceedings).

It is currently expected that the determination about the creation of this California Eliquis JCCP will be made in the next couple of months.

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Defendants BMS And Pfizer Ask For Eliquis Federal Court Consolidation

On October 13, 2016 attorneys for Bristol-Myers Squibb Company and Pfizer Inc. filed with the United States Judicial Panel on Multidistrict Litigation (JPML) this court document, “BRISTOL-MYERS SQUIBB COMPANY AND PFIZER INC.’S MOTION FOR TRANSFER OF RELATED ELIQUIS (APIXABAN) PRODUCTS LIABILITY ACTIONS FOR COORDINATED PRETRIAL PROCEEDINGS PURSUANT TO 28 U.S.C. § 1407, which will refer to as “Defendants’ MDL Motion” hereafter.

As for why these two drug companies think that Eliquis lawsuits filed in the federal court system should be consolidated as a Multidistrict Litigation (MDL) case, we get this statement from the aforementioned Defendants’ MDL Motion:

While the claims vary slightly among the various complaints, the crux of the Related Actions is that each Plaintiff experienced bleeding while taking Eliquis, and that Defendants should be held liable for Plaintiffs’ injuries under a variety of theories, including that: (1) Defendants failed to warn adequately about the risk of bleeding; and (2) Defendants should not have sold Eliquis without precautions for blood monitoring or an additional drug to reverse its anticoagulant effect. Thus, Plaintiffs’ claims are based on a common set of core facts.

In a separate court document, “BRISTOL-MYERS SQUIBB COMPANY AND PFIZER INC.’S MEMORANDUM OF LAW IN SUPPORT OF THEIR MOTION FOR TRANSFER OF RELATED ELIQUIS (APIXABAN) PRODUCTS LIABILITY ACTIONS FOR COORDINATED PRETRIAL PROCEEDINGS PURSUANT TO 28 U.S.C. § 1407”, the two drug companies suggest to the JPML that this possible Eliquis MDL be assigned to U.S. District Judge Lewis A. Kaplan of the Southern District of New York.

It is currently anticipated that the Defendants’ MDL Motion will be considered by the JPML at the upcoming hearing session scheduled for January 26, 2017, in Miami, Florida.

Be assured we will be watching for the JPML’s determinations about the requested creation and suggested assignment of this federal court Eliquis MDL case.

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Is Eliquis A Safe Alternative To Warfarin For Patients On Dialysis?

In this article published online by Pharmacy Times in August 2016, “Is Apixaban Safe and Effective for Patients on Hemodialysis?”, Brandon Dyson, PharmD, BCPS, who is a clinical pharmacist at an academic medical center, puts some scrutiny on Eliquis, an increasingly popular blood-thinner drug:

[Eliquis (apixaban)] is the only [novel oral anticoagulants (NOAC)] approved for use with creatinine clearance <15 mL/min. In fact, according to its package insert, there isn’t even a dose adjustment….

[T]he clinical trials for [Eliquis (apixaban)] didn’t include hemodialysis (HD) patients, but they’re able to recommend [Eliquis (apixaban)] use in HD patients with no dose adjustment. How?

You must dig deep to find the answer. The [Eliquis] package insert mentions a single-dose pharmacokinetic study in HD patients. If you dig a little further, you’ll eventually find it, and you’ll find out it only involved 8 patients….

What happens if you give multiple doses? [Eliquis (apixaban)] dosing is 5 mg BID in most patients. Does it accumulate in HD? We don’t know; it hasn’t been studied.

All we currently have is data from a single-dose trial in 8 patients. And that’s the point I’m trying to make. [Eliquis (apixaban)] may very well be safe and effective in HD, but we don’t actually know. It might be safe, but not effective, or it might be effective, but not safe. It also may be neither.

As for his mention of that eight (8) patient study, he referenced this medical journal article, “Pharmacokinetics, pharmacodynamics, and safety of apixaban in subjects with end-stage renal disease on hemodialysis.”, published in the May 2016 print edition of The Journal of Clinical Pharmacology.

Of course, this clinical pharmacist’s concern about — or skepticism of, perhaps — Eliquis use in the setting of hemodialysis piqued our interest.

The only thing we were able to readily find on-point was this item, “Apixaban in Hemodialysis”, on the ClinicalTrials.gov website, which provided us some rather limited information:

  • This study has been completed.
  • Sponsor: Jewish General Hospital
  • First received: January 12, 2016
  • Last updated: August 29, 2016
  • No Study Results Posted on ClinicalTrials.gov for this Study

So, it seems, there is not much publicly available data about the safety of using Eliquis in the setting of hemodialysis. Yet, such use was apparently approved by the FDA.

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September 2016 Savaysa Label Change Points Out There Is Still No Antidote

Savaysa (edoxaban) is a factor Xa inhibitor which was approved by the FDA in 2015. Savaysa has the following so-called “indications” or approved uses:

  1. To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; and,
  2. For the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5–10 days of initial therapy with parenteral anticoagulant.

In relevant part, from a September 15, 2016 FDA letter to Daiichi-Sankyo, Inc.:

Prior Approval supplemental new drug application provides for changes to SAVAYSA prescribing information based on results of the Phase 1 trial DU176b-A-U158 that evaluated the effects of Prothrombin Complex Concentrate (PCCs) on reversing the pharmacologic activity of edoxaban tosylate. Sections 5.3 ‘Risk of Bleeding’ and 12.2 ‘Pharmacodynamics’ have been updated to include this information.

For some related news as regards the FDA and Savaysa, see this article, “Xarelto / Savaysa / Eliquis: Antidote Drug AndexXa Is Rejected By FDA In August 2016“, over at our Drug Injury Watch blog.

We will continue to monitor the safety profile of Savaysa as well as Eliquis and Xarelto, especially as regards the current lack of any FDA-approved antidote which would act as a reversal agent for serious bleeding events such as intracranial hemorrhages or hemorrhagic strokes and gastrointestinal (GI) bleeds.

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Eliquis Lawsuits Being Filed Across The Country In Increasing Numbers

It is important to know that as of September 2016 Eliquis does not currently have an FDA-approved antidote, or reversal agent, for a patient experiencing a trauma-induced bleeding event or needing emergency surgery. Eliquis (apixaban) was approved by the FDA in December 2012.

These serious medical conditions have been associated with the use of Eliquis:

• Serious Bleeding Events
• Irreversible Fatal Bleeding Events
• Trauma-induced Atypical Bleeding Incidents
• Gastrointestinal (GI) Bleeds
• Rectal Bleeding
• Hemorrhages
• Brain Hemorrhage
• Intracranial Hemorrhage
• Hemorrhagic Stroke
• Cardiac Bleeds

In recent months we have seen Eliquis lawsuits filed in various states across the country, from New York to Hawaii, from California to Kentucky, from Illinois to Louisiana, as well as in Pennsylvania and elsewhere. We estimate that less than 50 Eliquis lawsuits have been filed to date. This relatively low number of filed Eliquis cases, however, is expected to increase significantly in the months to come.

Our law firm is handling Eliquis cases which involve people who had excessive bleeding, bled to death, or experienced other serious side effects of Eliquis.

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Antidote Drug For Xarelto / Savaysa / Eliquis Is Denied FDA Approval

The following Factor Xa inhibitors, which serve as blood-thinner drugs, are being used by an increasing number of patients for stroke prevention and for treatment of deep vein thrombosis and pulmonary embolism:

  1. Eliquis (apixaban) from Pfizer/Bristol-Myers Squibb;
  2. Xarelto (rivaroxaban) from Bayer/Johnson & Johnson; and,
  3. Savaysa (edoxaban) from Daiichi Sankyo.

In mid-August 2016 the US FDA rejected Portola Pharmaceutical’s application to market AndexXa (andexanet alfa) as an antidote to these three direct Factor Xa inhibitors.

The reason this FDA rejection of the AndexXa application is remarkable: There is no reversal agent for Factor Xa inhibitors approved in the United States.

For some reporting on the unexpected FDA denial of this AndexXa new drug application (NDA), we turn to this August 18, 2016 article, “FDA rejects reversal agent for anticoagulation drugs”, from Healio CardiologyToday:

Portola Pharmaceuticals announced it received a complete response letter from the FDA that its reversal agent for Factor Xa inhibitor anticoagulants will not be approved at this time.

The agent, andexanet alfa (AndexXa), was developed for reversal of uncontrolled bleeding in patients treated with direct Factor Xa inhibitors such as apixaban (Eliquis, Bristol Myers-Squibb/Pfizer), edoxaban (Savaysa, Daiichi Sankyo) and rivaroxaban (Xarelto, Janssen Pharmaceuticals) and indirect Factor Xa inhibitors such as enoxaparin, according to a press release issued by the company. Factor Xa inhibitors are often used for stroke prevention in patients with nonvalvular atrial fibrillation and for treatment of deep vein thrombosis and pulmonary embolism.

There is no reversal agent for Factor Xa inhibitors approved in the United States; the FDA in 2013 designated andexanet alfa as a breakthrough therapy and in 2015 designated it as an orphan drug, both enabling expedited review….

“Because AndexXa addresses an urgent unmet medical need, we and the FDA are committed to resolving the outstanding questions to determine the appropriate next steps,” Bill Lis, CEO of Portola, said in the release. “We plan to meet with the FDA as soon as possible.”

At the present time it is unknown when Portola will be in a position to resubmit its AndexXa application to the FDA, much less when the FDA will make its next determination about AndexXa being approved, or not.

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Possible Blood Level Testing For Eliquis / Xarelto / Pradaxa / Savaysa

As background, Xarelto (rivaroxaban) belongs to a class of medicines known as the direct oral anticoagulants (DOAC), which also includes Pradaxa (dabigatran), Eliquis (apixaban), and Savaysa (edoxaban). These still relatively new blood thinners have gained popularity in place of warfarin for the prevention of ischemic stroke in non-valvular atrial fibrillation because, as currently approved by the FDA, routine blood monitoring is not required.

According to this BMJ medical journal article, “Rivaroxaban: can we trust the evidence?”, published on February 3, 2016, a faulty medical device used in the clinical trial leading to the FDA’s approval of Xarelto (rivaroxaban) has called those results into question.

But in this letter to the New England Journal of Medicine (NEJM), “Point-of-Care Warfarin Monitoring in the ROCKET AF Trial”, also published on February 3, 2016, the medical researchers who conducted that Xarelto clinical trial conclude that the use of this device “did not have any significant clinical effect on the primary efficacy and safety outcomes in the trial.”

However, going back to the BMJ article, we get this counterpoint:

In a letter submitted to the NEJM (as yet unpublished) and shown to The BMJ, former FDA cardiovascular and renal drug reviewer, Thomas Marcinicak, says: “The care for the warfarin control arm patients [in ROCKET-AF] appears to have been compromised.”

The medical device at issue, which was later recalled by the FDA, allegedly is prone to giving falsely low INR readings. In the context of this Xarelto clinical trial, such readings would have prompted higher doses of warfarin being given to participants — resulting in higher bleeding risks for those given that warfarin — making Xarelto seem comparatively safer.

Perhaps the most interesting part of the February 2016 BMJ article, “Rivaroxaban: can we trust the evidence?”, is a possible unexpected result flowing from this current Xarelto controversy:

At the end of 2015, both the EMA and the FDA held meetings to discuss the need to measure blood levels of direct oral anticoagulants and adjust the dose accordingly to maximise benefit and minimise harm—despite all the manufacturers claiming that this is not necessary. The meetings were held after The BMJ revealed that Boerhinger Ingelheim, manufacturers of dabigatran, withheld analyses from the regulators that showed how many major bleeds could be prevented by monitoring anticoagulant activity and adjusting the dose.

A presentation to EMA last year by Robert Temple, deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research, suggests that the FDA believes there is a scientific argument for measuring the blood levels of these drugs and adjusting the dose.

However, the latest on this front is found in the February 16, 2016 Reuters news report, “Xarelto trial results reaffirmed despite faulty device”:

Europe’s drug regulator said on Friday the defective blood clotting test device used in a key trial for the approval of Bayer’s top-selling anti-clotting drug Xarelto did not distort the study’s main findings.

“Xarelto can continue to be used as before, in line with the current prescribing information,” the European Medicines Agency (EMA) said on its website.

While the EMA has now made its determination, we wait to see what this current Xarelto fiasco leads to in terms of possible action by the FDA and other drug regulators.

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Eliquis, Savaysa, And Xarelto Worry Doctors Because No Antidote, Still

A few recent articles address the fact there is no way to quickly restore normal clotting for patients in need of emergency surgery or to stop a major bleeding episode while on Eliquis, Savaysa, and Xarelto.

What makes these articles interesting is that they are from the perspective of medical doctors who might prescribe Eliquis, Savaysa, and Xarelto as well as emergency room doctors who may have to treat patients on these newer anticoagulant medicines.

From the this December 23, 2015 Reuters news report, “New blood thinner ‘antidote’ to help doctors move past warfarin”, we get some insight about this current “no antidote” situation:

“It may be uncommon, but they’re memorable when they happen,” Dr. Charles Pollack, an emergency physician at Thomas Jefferson University Hospital in Philadelphia, said of major bleeding events.

“We didn’t have a specific reversal strategy for these drugs, and I think that left people feeling a bit insecure,” added Pollack, who has done clinical work on a recently approved antidote to Boehringer Ingelheim’s rival blood clot preventer Pradaxa….

“I have many physicians, particularly surgeons, who hate these drugs. They’re frightened of them because they’ve had to deal with the consequences of somebody coming in with trauma,” while using the new blood thinners.

And as regards how that need for an antidote for Eliquis, Savaysa, and Xarelto has come to be realized by doctors, from this Original Article piece, “Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity”, published in the December 17, 2015 edition of The New England Journal of Medicine:

Anticoagulation-related major bleeding is associated with an increased risk of death and thrombotic events, independent of the class of anticoagulant used. Patients who receive factor Xa inhibitors may also be at increased risk for bleeding if emergency surgery is required. With the increasing use of factor Xa inhibitors, the number of patients who require reversal of the anticoagulant effects is anticipated to rise. Therefore, a specific antidote that can rapidly reverse the anticoagulant effects of factor Xa inhibitors in patients who are bleeding or who require emergency surgery is needed. [footnotes omitted]

We are currently investigating potential drug injury lawsuits involving Eliquis, Savaysa, and Xarelto for patients who had uncontrollable bleeding, some of whom died, unfortunately.

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Eliquis Might Be Safer Than Xarelto, But Neither Has Approved Antidote

In a November 9, 2015 news report, “Antithrombotics Have Varied Risk of Causing Major Bleeds”, there is a summary of one presentation the American Heart Association 2015 Scientific Sessions:

Clot-busting drugs work, but they sometimes cause dangerous major bleeding. Reporting at the American Heart Association 2015 Scientific Sessions in Orlando, FL, a team of drug company researchers offered results of a retrospective cohort study showing that apixaban (Eliquis/Bristol-Myers-Squibb/Pfizer) had a lower risk of bleeding….

Compared to warfarin patients, those on [Eliquis (apixaban)] had about half the risk (HR=0.53) of a major bleed. The research is presented in [“Abstract 18465: Real World Comparison of Major Bleeding Risk Among Non-valvular Atrial Fibrillation Patients Newly Initiated on Warfarin versus Apixaban 5mg BID, Dabigatran 150 mg BID, or Rivaroxaban 20 mg QD.”]

It seems from the summary report of this presentation that the pharmaceutical companies responsible for Eliquis were seeking to distinguish their blood thinner medicine from Pradaxa, Xarelto, and Savaysa. All of these medicines are in the non-vitamin K antagonist oral anticoagulants (NOACs) class of drugs.

But when it comes to there being a specific reversal agent to stop an acute bleed once it start, Eliquis, Xarelto, and Savaysa share the dubious distinction of not currently having one that is FDA-approved for use. For more about this unfortunate and unsafe situation, see this recent article, “Still No Approved Reversal Agents Or Antidotes For Eliquis, Savaysa, And Xarelto To Stop Acute Bleeding”, which has this sub-headline: None Available To Help Patients Who Undergo Emergency Surgery Or When There Is Life-Threatening Uncontrolled Bleeding.

Only Pradaxa has a so-called antidote at the present time. In more detail, On October 16, 2015 the FDA granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.

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