Category

Pradaxa

Pradaxa Lawsuits a Distraction, Says Manufacturer

By | Pharmaceutical litigation, Pradaxa, Uncategorized

pradaxa_lawsuit_pradaxa_internal_bleeding_settlements_mdl_litigation_riskThe German pharmaceutical company responsible for the anticoagulant drug, Pradaxa, offered a $650 million settlement package to wrap up thousands of Pradaxa lawsuits in the U.S. In the statement announcing the proposed settlement, the company, Boehringer Ingelheim, did not accept blame for Pradaxa injuries, the most prevalent among them being excessive bleeding events.

In deflecting responsibility, Boehringer Ingelheim also called the Pradaxa lawsuits a distraction.

Furthermore, the head of the company’s legal department expressed disfavor for trials decided by jury. According to the company’s statement, if all of the Pradaxa lawsuits in the U.S. were to go to trial, they would be decided by juries who most likely would have little to no experience with pharmaceutical and scientific matters, thus, creating a situation where Boehringer Ingelheim would be unable to determine a general verdict.

It appears then that the German pharmaceutical company’s decision to settle was based purely on distraction and uncertainty, rather than accepting responsibility for the serious injuries some patients have sustained while using Pradaxa.

Carey Danis & Lowe Is Here to Help You

As a national law firm practicing defective drug litigation, Carey Danis & Lowe is dedicated to providing legal assistance to individuals and families who have been affected by faulty pharmaceutical products, such as Pradaxa. If you or someone you love has been injured by Pradaxa, we encourage you to contact one of our experienced defective drug lawyers to begin exploring legal options. We believe that when pharmaceutical companies release a potentially dangerous product onto the market, they must take responsibility for the harm inflicted by such a product.

Carey Danis & Lowe offers free initial case evaluations. Discuss your case with one of our lawyers today, and find out if you are eligible for compensation.

Share your Pradaxa story with Carey Danis & Lowe. Contact us by phone at 800.721.2519.

Pradaxa MDL News: Manufacturer Fined for Neglectful Document Handling

By | Pharmaceutical litigation, Pradaxa, Uncategorized

pradaxa_lawsuitIn a federal Illinois court, Boehringer Ingelheim has been fined $1 million for neglecting to retain documents pertinent to a multidistrict litigation (MDL). It is unclear if the German pharmaceutical company can be accused of destroying or withholding the Pradaxa documents.

The fine was brought down upon Boehringer Ingelheim in the U.S. District Court for the Southern District of Illinois in the Pradaxa MDL.

U.S. District Judge David Herndon, who handed the manufacturer of Pradaxa the fine, called Boehringer Ingelheim’s practices regarding document retention outrageously neglectful.

According to Bloomberg, there are approximately over 1,700 Pradaxa bleeding lawsuits pending in the federal Illinois court. Plaintiffs have filed Pradaxa lawsuits alleging incidences of excessive loss of blood. When these excessive bleeding episodes become uncontrollable, they may become fatal, resulting in what is called a bleed-out death.

A blood-thinning agent, Pradaxa is a drug used to prevent incidences of blood clots and stroke in patients with atrial fibrillation.

The Pradaxa MDL is In re: Pradaxa Products Liability Litigation MDL no. 2385, and is being heard in East St. Louis, Illinois.

In addition to the Pradaxa MDL in Illinois, individuals who believe that they have been injured by the use of Pradaxa have filed lawsuits targeted at Boehringer Ingelheim from coast to coast, in Delaware, Connecticut, and California. There are also Pradaxa bleeding lawsuits pending in state courts in Illinois.

National Law Firm Representing Pradaxa Victims

As a national law firm headquartered in St. Louis that provides legal counsel to victims of defective drugs, Carey Danis & Lowe Pradaxa attorneys are currently investigating Pradaxa cases. If you believe that your injuries are the result of Pradaxa use, explore your legal options with one of our Pradaxa attorneys at Carey Danis & Lowe today.

We also have a team of highly experienced nurses and medical experts who are available to listen closely to your concerns about Pradaxa as it concerns patient health and safety.

Share your Pradaxa story with Carey Danis & Lowe today. Call 800.721.2519, or submit a confidential personal injury claim form.

Pradaxa Lawsuit Update: Plaintiffs File Two Motions Proclaiming Defendant Inaction

By | Pharmaceutical litigation, Pradaxa, Uncategorized

pradaxa4The latest development in the Pradaxa multidistrict litigation (MDL) in the U.S. District Court for the Southern District of Illinois involves a recently filed court document from mid-September. Both parties convened on September 18, 2013 to discuss issues that have arisen during the discovery process.

The court met to review two motions filed by the plaintiffs, a Motion to Compel and a Motion for sanctions. A Motion to Compel is a request that the court compel action in the other party involved in the lawsuit. A Motion for Sanctions points to the other party’s inability to act in accordance with court orders.

As to the plaintiffs’ Motion for Sanctions, the court ultimately concluded during the meeting that the defendant is not acting in accordance with the court’s orders.

As an advocate of those who claim to have been injured by Pradaxa, Carey Danis & Lowe class action attorneys consider the inability to fulfill the court’s orders as having a significant slowing effect on the multidistrict litigation process. This is most unfortunate, as MDLs are designed to efficiently handle thousands of similar cases.

Carey Danis & Lowe Pradaxa attorneys hope that the defendants in the Pradaxa MDL will quickly organize to better comply with orders.

Our Pradaxa attorneys are currently accepting Pradaxa cases, and are offering free legal evaluations of these cases. The Carey Danis & Lowe team is here to support you and your loved one with expert legal advice.

Also, contact Carey Danis & Lowe’s on-staff medical experts for information about health issues related to the use of Pradaxa. Plaintiffs have filed Pradaxa lawsuits after experiencing serious bleeding events that in some cases have been fatal.

Share your Pradaxa story with Carey Danis & Lowe by calling 800.721.2519, or by submitting a confidential personal injury claim form.

Pradaxa Lawsuit News: Judge Rules to Continue Pradaxa Litigation to Further Examine Effectiveness of Pradaxa Warnings

By | Pharmaceutical litigation, Pradaxa, Uncategorized

pradaxa4A plaintiff in a Pradaxa bleeding risk lawsuit was recently granted approval to move forward with his suit. In the Pradaxa lawsuit, the plaintiff claims that the pharmaceutical company behind Pradaxa, Boehringer Ingelheim, did not sufficiently warn users about Pradaxa bleeding risks. Furthermore, the plaintiff in this case, which is being heard in the U.S. District Court for the Southern District of Illinois, filed his lawsuit alleging that Boehringer Ingelheim created a defective drug.

U.S. District Judge Joseph R. Herndon made the decision against dismissing the plaintiff’s case. Terminating litigation was being considered due to the existence of warnings on the Pradaxa label. However, Judge Herndon determined that, though these warnings exist, an evaluation of them is necessary to decide if they provide sufficient information to Pradaxa users and health care providers.

The plaintiff’s Pradaxa lawsuit is one of thousands that have been consolidated into the Pradaxa multidistrict litigation (MDL). There are currently 1,326 Pradaxa lawsuits in the Pradaxa MDL in Illinois. When Carey Danis & Lowe reported on the Pradaxa MDL in February 2013, there were only 250 cases in the litigation, and now with well over 1,000, this is a sign that there are many individuals who may have been injured by this anticoagulant drug.

The Pradaxa MDL is In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation MDL 2385.

There have been numerous reports since Pradaxa hit the market of individuals experiencing serious bleeding episodes, which in some cases have resulted in fatalities. Unlike the generic anticoagulant warfarin that has been on the market since the 1950s, Pradaxa does not have a reversal agent that could slow or stop the excessive bleeding and potentially save a life.

Carey Danis & Lowe Pradaxa lawyers are pleased that Judge Herndon ruled in favor of allowing the plaintiff’s case to be heard. As a Pradaxa law firm that represents individuals who claim to have been injured by Pradaxa use, Carey Danis & Lowe considers it of utmost importance that individuals who claim to have been injured by a product have the opportunity to voice their grievances before a judge.

Carey Danis & Lowe is currently offering free legal evaluations of Pradaxa cases and assistance with filing Pradaxa lawsuits. Contact Carey Danis & Lowe by phone at 800.721.2519 or submit a personal injury claim form.

Carey Danis & Lowe Pradaxa Lawyers Currently Following Pradaxa MDL 2385

By | Pharmaceutical litigation, Pradaxa, Uncategorized

pradaxa_lawsuit_press_release_mdlCarey Danis & Lowe Pradaxa lawyers are currently following the Pradaxa multi-district litigation (MDL) in Illinois. The Pradaxa MDL is In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation MDL no. 2385. The Pradaxa MDL is being heard in the U.S. District Court for the Southern District of Illinois, and is presided over by Chief Judge David R. Herndon.

According to Carey Danis & Lowe Pradaxa lawyers, the Pradaxa MDL 2385 continues to move forward with pre-trial proceedings. As documented in minutes from the latest Pradaxa MDL status conference, the plaintiffs’ counsel is currently working on deposition scheduling. Also, the defendants’ counsel supplied an updated on discovery production.

The next Pradaxa MDL status conference is scheduled for May 14, 2013.

At the time of writing, the Pradaxa MDL 2385 comprised 486 cases. Pradaxa lawyers at Carey Danis & Lowe are interested to see if this case number will be affected by the recent news of Pradaxa attaining blockbuster status in the pharmaceutical world.

Reuters recently reported that Pradaxa sales brought in $1.43 billion in 2012. Though sales of the anticoagulant drug appear to be steady, the number of Pradaxa lawsuits being filed against Boehringer Ingelheim citing serious bleeding injuries and even death continue to increase as well.

Carey Danis & Lowe Pradaxa lawyers encourage individuals who have been injured by Pradaxa to contact our law firm today for a free legal evaluation about Pradaxa cases.

Our Pradaxa lawyers can also assist with filing Pradaxa lawsuits. Contact Carey Danis & Lowe today by calling 800.721.2519 or by submitting a legal claim form.

FDA Approves New Anticoagulation Reversal Agent and Boehringer Ingelheim Updates Pradaxa Label

By | Pharmaceutical litigation, Pradaxa, Uncategorized

Pradaxa Bleeding Risk Pharmaceutical LitigationThe U.S. Food and Drug Administration (FDA) recently approved a reversal agent to be used in patients experiencing serious and uncontrollable bleeding. The anticoagulation reversal agent is called Kcentra, a product developed and manufactured by CSL Behring.

The new treatment counteracts the effects of vitamin K antagonist (VKA) anticoagulation, which could be triggered by the use of an anticoagulant medicine such as Pradaxa or warfarin. The advantage of Kcentra is healthcare providers do not have to thaw the reversal agent, as they commonly do with plasma treatments, nor do they have to match blood type. Removing these two steps from the treatment process leaves more time to quickly treat a major bleeding event.

However, the new reversal agent does come with problematic side effects, including a risk of blood clots and stroke. In the Kcentra news release, the FDA states that in clinical trials and post marketing observations, reports have been submitted about blood clots, stroke, and fatalities in patients who were treated with Kcentra.

It was not made clear in the news release if Kcentra is appropriate in treating patients who use Pradaxa.

As the FDA announced its approval of Kcentra, Boehringer Ingelheim, the German pharmaceutical company behind the anticoagulant medicine Pradaxa, released a statement on April 30 announcing changes to the Pradaxa label.

The update includes a new boxed warning about the heightened stroke risk if Pradaxa use is suddenly stopped. Furthermore, the Pradaxa label will include post marketing observations about the risk of thrombocytopenia, a complication wherein a patient has an unusually low blood platelet count.

The Boehringer Ingelheim release also discusses the addition to the Pradaxa label of RE-LY clinical trial information.

Carey Danis & Lowe Pradaxa lawyers are hopeful that the anticoagulation reversal agent will be able to save the lives of individuals suffering from major bleeding events caused by anticoagulation medications like Pradaxa and warfarin.

Our law firm recognizes the serious health risk posed by Pradaxa, and is encouraging individuals who have been seriously injured through Pradaxa use to contact Carey Danis & Lowe today. Our Pradaxa lawyers are offering free legal evaluations of Pradaxa cases, and can assist in filing Pradaxa lawsuits.

Contact a Carey Danis & Lowe Pradaxa lawyer today by calling 800.721.2519 or by submitting a legal claim form.

Pradaxa Timeline: Carey Danis & Lowe Pradaxa Lawyers Chronicle Pradaxa Bleeding Risk

By | Pharmaceutical litigation, Pradaxa, Uncategorized

August 15, 2009 – Boehringer Ingelheim researchers submitted Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial data to The New England Journal of Medicine

October 19, 2010 – Pradaxa approved by FDA to prevent stroke in patients with atrial fibrillation.

December 2011 – FDA announced an investigation into a significant number of reports linking episodes of serious, uncontrollable bleeding with Pradaxa use.

November 2012 – FDA released another opinion on the safety of Pradaxa following an FDA evaluation of Pradaxa bleeding events recorded via the FDA’s Sentinel Initiative Mini-Sentinel pilot program. Though the FDA did not find the Pradaxa bleeding risk to be significantly higher than the warfarin bleeding risk, the regulatory body stated that it is continuing its efforts into investigating Pradaxa’s health risks.

December 2012 – Food and Drug Administration (FDA) supplied a safety update on Pradaxa regarding to patients with mechanical heart valves. The FDA recommended that Pradaxa not be prescribed to patients with mechanical prosthetic heart valves due to the high occurrence of blood clots, heart attack, or stroke.

Following Pradaxa’s FDA approval, there have been ever increasing adverse event reports submitted to the FDA citing severe bleeding risks and death all linked to Pradaxa. If you or someone you love has been injured by Pradaxa, contact a Carey Danis & Lowe Pradaxa lawyer.

Our Pradaxa lawyers are providing free legal consultations of Pradaxa cases, and can provide assistance in filing a Pradaxa lawsuit. Contact a Pradaxa lawyer today by calling 800.721.2519 or by submitting a legal claim form.

New Pradaxa Analysis Underscores Pradaxa Deaths and Urgency of Further Pradaxa Safety Investigations

By | Pharmaceutical litigation, Pradaxa, Uncategorized

New Pradaxa Analysis Underscores Pradaxa Deaths and Urgency of Further Pradaxa Safety InvestigationsIn January, the Institute for Safe Medication Practices (ISMP) released a report with their safety analysis of three anticoagulant medications, including Pradaxa, warfarin, and Xarelto. The ISMP found that approximately 1,734 adverse event reports were submitted to the U.S. Food and Drug Administration (FDA) in quarter 2 of 2012 for the anticoagulant drugs warfarin, Pradaxa, and Xarelto.

Of those adverse event reports, around 233 detail patient deaths linked to use of these three anticoagulant medications.

These  numbers led the ISMP to conclude that anticoagulant medications in general pose a significant risk to patients. In fact, they found that when patients experienced a bleeding event while using Pradaxa, the likelihood of fatal Pradaxa bleeding was five times higher than that for patients using warfarin.

When combing the reports submitted over four quarters through June 30, 2012, it becomes evident that there is a serious link between the use of Pradaxa and health complications. In four quarters, 3,813 adverse event reports were submitted to the FDA for Pradaxa alone. Of those, about 654 involved patient death linked to Pradaxa use.

Though the ISMP’s analysis shows a markedly increased risk of health complications or death when using Pradaxa, upon submitting their report to Pradaxa’s manufacturer, Boehringer Ingelheim, the German pharmaceutical company asserted that one of their recent Pradaxa comparison studies demonstrated more positive results.

Boehringer Ingelheim’s unpublished study shows that patients using Pradaxa fared better compared to patients using warfarin following a bleeding event.

Despite these findings, there still exists a significant association between Pradaxa and serious bleeding events as well as death.

The ISMP conducted its analysis of adverse event reports submitted to the FDA to better understand the safety risks posed by drugs like Pradaxa and other anticoagulant medications. Their conclusion is that the numbers illustrate a grim reality, one in which Pradaxa use poses a serious threat to a patient’s health and life. In concluding its findings, the ISMP states that reasons for the serious health risks associated with Pradaxa use could be explained by the fact that Pradaxa has no reversal agent.

Such an explanation for high rates of fatality linked to Pradaxa does seem logical, since an antidote to halt excessive bleeding was never developed for Pradaxa.

Though the ISMP’s findings do not mirror those concluded in Boehringer Ingelheim’s study, it is still important to take note of the ever increasing reports submitted to the FDA alleging Pradaxa injury. Pradaxa lawyers at Carey Danis & Lowe agree that the high number of Pradaxa injury reports are a sign that further examination into the safety of this anticoagulant is absolutely necessary for public health reasons.

If you or someone you loved has been injured by Pradaxa use, contact an experienced Pradaxa lawyer at Carey Danis & Lowe. Our lawyers will provide you with a free legal evaluation about your case, and assist with filing a Pradaxa lawsuit.

Contact a Pradaxa lawyer at Carey Danis & Lowe by calling 800.721.2519 or by submitting a legal claim form.

Carey Danis & Lowe Examines FDA Pradaxa Safety Review

By | Pharmaceutical litigation, Pradaxa, Uncategorized

Carey Danis & Lowe Examines FDA Pradaxa Safety ReviewThe U.S. Food and Drug Administration (FDA) recently published a report about the safety of Pradaxa in The New England Journal of Medicine. The article’s intention was to more thoroughly examine the health risks associated with Pradaxa use, especially in light of the increasing reports linking Pradaxa to excessive bleeding and death.

The study that won Pradaxa FDA approval in October 2010, the Randomized Evaluation of Long-Term Anticoagulation Therapy, or RE-LY, trial compared Pradaxa to warfarin. The RE-LY trial results concluded there to be no difference in bleeding risk between Pradaxa and warfarin.

Despite these results from the RE-LY trial, the FDA began to receive a significant amount of adverse event reports associated with Pradaxa shortly following its approval. The ever-increasing number of adverse event reports soon raised red flags about the safety of using Pradaxa, according to a Forbes report.

In light of these adverse event reports, the FDA sought to re-examine the injury risk of using Pradaxa. After conducting its own analysis using the Mini-Sentinel database, with similar results to the RE-LY trial, the FDA chalked up the high number of Pradaxa linked injuries to the drug’s new status. They point to frequent media coverage as a driving factor behind Pradaxa users submitting reports to the FDA.

In concluding their article, the FDA advised that despite the fact that Pradaxa does not have a reversal agent, like warfarin does in vitamin K, there still remain benefits in using Pradaxa.

Carey Danis & Lowe still considers Pradaxa to be a drug that poses serious injury due to the lack of a reversal agent. Furthermore, Pradaxa was originally intended to replace warfarin, and appears to be no better than it in light of a nonexistent panacea for excessive bleeding.

Carey Danis & Lowe is closely examining the association between media coverage, Pradaxa adverse event reports, and the FDA’s stance on Pradaxa safety.  If you or someone you love has been injured by Pradaxa, contact a Pradaxa lawyer at Carey Danis & Lowe for a free legal evaluation and to file a Pradaxa lawsuit.

Contact Carey Danis & Lowe by phone at 800.721.2519 or by submitting a legal claim form.

Pradaxa MDL News: Court Convened for Status Conference in Early February

By | Pharmaceutical litigation, Pradaxa, Uncategorized

pradaxa4The Pradaxa multi-district litigation (MDL) met in early February for a status conference to discuss recent progress made in the discovery and deposition processes. According to Seth A. Katz, one of the lawyers representing the plaintiffs in the Pradaxa MDL, Boehringer Ingelheim Pharmaceuticals Inc. has not been meeting production deadlines.

According to the Pradaxa MDL status conference minutes, the plaintiffs asked for certain documents to be produced by Boehringer Ingelheim, the pharmaceutical company that develops and manufactures Pradaxa, an anticoagulant medicine prescribed to patients with non-valvular atrial fibrillation.

These document requests were made in late December and in mid-January. As of yet, these documents have been provided to neither the plaintiffs nor their legal counsel. Since then, the plaintiffs have voiced concern about whether Boehringer Ingelheim will transmit these custodial files to the plaintiffs for review.

The discovery phase in the Pradaxa MDL is important for the plaintiffs and their legal counsel in that it allows them to review the documents provided by Boehringer Ingelheim, and in doing so, build a case around the evidence presented in these internal documents.

To date, approximately 258 cases have been consolidated into the Pradaxa MDL. These consolidated cases are being heard in the U.S. District Court for the Southern District of Illinois. The Pradaxa MDL is known as in Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation MDL no. 2385. Chief Judge David R. Herndon is presiding over court proceedings.

The court minutes state that the next status conference in the Pradaxa MDL has been scheduled for March 14.

Pradaxa has gained a reputation for causing serious bleeding events that can be fatal. Patients with atrial fibrillation have used Pradaxa to prevent stroke and blood clots. However, Pradaxa has not worked as designed, and has led to a severe bleeding events and numerous deaths.

Boehringer Ingelheim’s anticoagulant medicine was intended to replace warfarin, a drug introduced in the 1950s. Pradaxa has proved to be an insufficient replacement, if it can even be considered a replacement.

An enormous complication with the use of Pradaxa is that it does not have a reversal agent, meaning a medicine that can be ingested to reverse the blood thinning properties present in Pradaxa. Unlike warfarin, Boehringer Ingelheim released Pradaxa onto the market without a panacea for serious bleeding events. The reversal agent for warfarin is Vitamin K.

The defective drug and Pradaxa lawyers at Carey Danis & Lowe continue to follow the Pradaxa MDL in East St. Louis for any updates that may benefit our Pradaxa clients. Carey Danis & Lowe is accepting Pradaxa claims, and offering free legal consultations about Pradaxa cases.

If you or someone you love has been injured by Pradaxa, you and your loved one may be eligible to receive compensation. To file a Pradaxa lawsuit, contact a Pradaxa lawyer at Carey Danis & Lowe today by calling 800.721.2519 or submit a legal claim form.