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Boehringer Ingelheim Archives - Carey Danis & Lowe

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 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.

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.

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.

Carey Danis & Lowe Issues an Update on the Pradaxa Multi-District Litigation No. 2385

By | Pharmaceutical litigation, Pradaxa, Uncategorized

Published December 27, 2012 by PR Web

St. Louis, MO (PRWEB) December 27, 2012

Carey Danis & Lowe Issues an Update on the Pradaxa Multi-District Litigation No. 2385Pradaxa lawsuits have been consolidated into a Multi-District Litigation being heard in the U.S. District Court, Southern District of Illinois. The Pradaxa MDL has been named Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation. The last Pradaxa MDL meeting occurred on Thursday, December 13, 2012, where Plaintiffs’ representatives as well as the Defendants’ legal counsel convened for a Status Conference.

The MDL No. 2385 is presided over by Chief Judge David R. Herndon in East St. Louis, Illinois. The MDL is currently in the pre-trial discovery phase.

As outlined in the court’s minutes, both sides have been working to approve the First and Second Sets of Discovery gathered by the Plaintiffs legal representatives. Though the two side came to a written agreement on the Second Set of Discovery, in regards to the First, the Plaintiffs’ legal representatives have been working “to resolve pending disputes.”

According to the Pradaxa MDL 2835 Status Conference minutes from December 13, the Plaintiffs’ First Set of Discovery has resulted in a number of unsettled disagreements between the Plaintiffs Lead Counsel and Boehringer Ingelheim Pharmaceuticals, Inc. As court documents detail, Boehringer Ingelheim has objections with regard to the Plaintiffs Lead Counsel’s First Set of Discovery.

As a result of the yet unresolved issues with the First Set of Discovery, Boehringer Ingelheim is filing a protective order, and plans to do so by December 21, 2012. In response to the protective order and in an effort to acquire vital evidence and documents, the Plaintiffs Lead Counsel plans to file a responsive pleading early next year.

Currently, over 170 plaintiffs have a case that has been consolidated into MDL No. 2385. These plaintiffs claim that the ingestion of Pradaxa led to serious Pradaxa-related injuries including excessive bleeding, uncontrollable bleeding, and fatal bleed-outs. Furthermore, these Pradaxa lawsuits claim that Boehringer Ingelheim neglected to warn healthcare providers and patients about the risks of using Pradaxa.

In addition, plaintiffs accuse Boehringer Ingelheim of further negligence in light of Pradaxa’s release onto the market without the simultaneous release of a reversal agent which is vital in treating excessive bleeding. Unlike warfarin which is counteracted by Vitamin K in excessive bleeding episodes, Pradaxa has no known panacea or reversal agent to control excessive bleeding.

Attorneys at Carey Danis & Lowe are currently seeking claims from individuals who have experienced a Pradaxa injury, including those listed above, such as excessive and uncontrollable bleeding events. For more information about filing a Pradaxa lawsuit, contact a defective drug lawyer at Carey Danis & Lowe at 800-721-2519.

Pradaxa Lawsuit News: Pradaxa MDL Convened in District Court in Illinois for Status Conference on January 14, 2013

By | Pharmaceutical litigation, Pradaxa, Uncategorized

Pradaxa Lawsuit News: Pradaxa MDL Convened in District Court in Illinois for Status Conference on January 14, 2013Court convened in the Pradaxa Multi-District Litigation (MDL) known as In Re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation) MDL No. 2385 for a Status Conference on January 14, 2013. The Pradaxa MDL is being heard in the U.S. District Court for the Southern District of Illinois in East St. Louis, and is being presided over by Chief Judge David R. Herndon.

An attorney on the Plaintiffs’ Co-Lead Counsel, Roger C. Denton, delivered an update on the development of a Privilege Log, a document listing items to be withheld during legal proceedings. Both parties have come to an agreement on what items to list on the Privilege Log as well as when Boehringer Ingelheim is scheduled to begin delivering items for the Privilege Log to the plaintiffs’ counsel.

Boehringer Ingelheim’s lawyers supplied an update on defense witness depositions, which have been scheduled for March. According to the Pradaxa MDL Status Conference minutes, both parties are working on scheduling these depositions, but have come across obstacles in determining deposition locations.

To date, there are 183 cases that have been consolidated into the Pradaxa MDL in East St. Louis, Illinois.

Pradaxa is an anticoagulant drug prescribed to patients with non-valvular atrial fibrillation. As an anticoagulant medication, Pradaxa was developed by Boehringer Ingelheim Pharmaceuticals, Inc. with the expectation that the drug would be a superior alternative to warfarin, an anticoagulant drug introduced in the 1950s.

Upon authorizing approval of the drug Pradaxa in October 2010, the U.S. Food and Drug Administration (FDA) began receiving adverse event reports, and more specifically, patient reports detailing episodes of severe and uncontrollable bleeding linked to the use of Pradaxa. As a result of these serious bleeding risk reports, the FDA continues to research the health risks of ingesting Pradaxa in the prevention of strokes and blood clots in patients with atrial fibrillation.

Lawyers at Carey Danis & Lowe are currently accepting Pradaxa claims, and are working on evaluating each Pradaxa lawsuit for inclusion in the MDL in East St. Louis, Illinois. If you or someone you love has suffered a severe bleeding event while taking Pradaxa, you and your loved one may be eligible to receive recompense for such undue suffering.

To submit a Pradaxa claim and for a free legal consultation regarding your Pradaxa case, contact an experienced trial lawyer at Carey Danis & Lowe by calling 800.721.2519.

FDA Releases New Pradaxa Warning about Pradaxa Stroke, Heart Attack, and Blood Clots

By | Pharmaceutical litigation, Pradaxa, Uncategorized

FDA Releases New Pradaxa Warning about Pradaxa Stroke, Heart Attack, and Blood ClotsOn December 19, the U.S. Food and Drug Administration (FDA) released a safety announcement regarding the anticoagulant medicine known as Pradaxa. Pradaxa, known generically as dabigatran etexilate mesylate, is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc., a German pharmaceutical company.

The intention behind the FDA Pradaxa safety announcement is to inform health care providers and the public about the new risks associated with Pradaxa ingestion. In the release, the FDA warns that Pradaxa “should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves.”

The FDA’s recent safety announcement (comes) as data is being released from a European Pradaxa clinical trial, known as the RE-ALIGN trial. Researchers in the RE-ALIGN trial discovered that when patients using Pradaxa, versus those using warfarin, experienced an increased risk for stroke, heart attack, and blood clot development if these patients had mechanical heart valves.

Individuals with mechanical heart valves prescribed with warfarin did not experience such a significantly increased risk for the development of stroke, heart attack, or blood clot formation. Researchers in this European Pradaxa study also observed that patients experienced significantly more bleeding following valve surgery if using Pradaxa versus those using warfarin.

These findings from the European Pradaxa clinical trial clearly demonstrate the increased risk of serious bleeding and bleeding deaths, along with many other serious problems, associated with the use of Pradaxa.

As a result of these findings, the FDA made an urgent mandate that Boehringer Ingelheim update the medicine’s label to include a warning about the risks of using Pradaxa with a mechanical heart valve.

The FDA has already released a safety warning about Pradaxa in the past, with that FDA Pradaxa warning containing information about the high Pradaxa bleeding risk.

Pradaxa is prescribed to treat individuals suffering from non-valvular atrial fibrillation. Though intended to be a less burdensome miracle drug and a replacement for the antiquated warfarin, the reality of Pradaxa use has been fraught with serious bleeding risks and death.

If you or a loved one has suffered from serious bleeding episodes as a result of Pradaxa use, you and your loved one may be entitled to receive compensation for your emotional, physical, and financial losses. Attorneys at Carey Danis & Lowe understand the importance of consumer protection, and work hard with our clients to uphold justice and consumer rights.

Contact an experienced pharmaceutical product liability attorney today at Carey Danis & Lowe for more information about your Pradaxa case and filing a Pradaxa lawsuit.