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Boehringer Ingelheim Pharmaceuticals Archives - Carey Danis & Lowe

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.

Pradaxa’s Manufacturer Presents New Data about Anticoagulant Drug

By | Pharmaceutical litigation, Pradaxa, Uncategorized

Pradaxa's Manufacturer Presents New Data about Anticoagulant DrugOn December 8, 2012, Boehringer Ingelheim Pharmaceuticals, Inc. delivered a presentation at the 54th Annual Meeting of the American Society of Hematology in Atlanta, Georgia. Boehringer Ingelheim presented new findings pertaining to Pradaxa bleeding risks.

Pradaxa is an anticoagulant medicine prescribed to patients suffering from non-valvular atrial fibrillation. According to researchers involved in Boehringer Ingelheim’s RE-LY trial, observations were made demonstrating that in serious bleeding episodes, patients taking Pradaxa fared better than those patients taking warfarin.

Data from these sub-analyses indicate that patients prescribed with Pradaxa, at least in Boehringer Ingelheim’s studies, exhibit a need for approximately one day less of hospitalization in the intensive care unit (ICU) following a serious bleeding event when compared to those patients prescribed with warfarin. Though, it still remains, and Boehringer Ingelheim recognizes this fact, that to date Pradaxa still does not have a reversal agent to stop excessive bleeding like warfarin does in Vitamin K.

However, in these sub-analyses, the data shows that there is no difference between patients taking Pradaxa and those taking warfarin as regards total length of hospitalization. Though patients using Pradaxa may not need to remain in the ICU longer, these individuals involved in the sub-analyses remained hospitalized for as long as patients using warfarin.

In conducting this study and providing a detailed analysis of the released data, Boehringer Ingelheim has publicly recognized the problems linked to the use of Pradaxa, specifically the serious risk of severe bleeding in patients. Their optimistic comparisons of Pradaxa over warfarin do not make their anticoagulant medicine any less harmful or lethal simply because it represents newer technology when placed alongside warfarin, a drug developed and released onto the market in the 1950s.

Attorneys at Carey Danis & Lowe recognize the risks associated with the use of Pradaxa, and unlike Boehringer Ingelheim, seek to help people who have been injured by Pradaxa use.

For a free legal consultation about your Pradaxa case and more information about filing a Pradaxa lawsuit, contact an experienced pharmaceutical product liability lawyer at Carey Danis & Lowe today by calling 800.721.2519.

Boehringer Ingelheim Pharmaceuticals, Inc. Under Fire for Manufacture and Distribution of Pradaxa

By | Pharmaceutical litigation, Pradaxa, Uncategorized

Pradaxa

The blood thinner medication known as Pradaxa is currently under scrutiny, as the drug has been known to cause severe bleeding, sometimes resulting in death. Pradaxa is a drug manufactured by Boehringer Ingelheim Pharmaceuticals, Inc., a pharmaceutical company headquartered in Germany.

Originally, Pradaxa was developed in an effort to find a better and safer alternative to the generic blood thinner drug first introduced in the 1950s known as warfarin. The blood thinning drug warfarin, since its introduction, has developed a reputation for being unsafe in the treatment of atrial fibrillation.

Patients are prescribed a blood thinning medication, such as warfarin or Pradaxa, the latter drug having been approved for distribution and patient use in October 2010 by the U.S. Food and Drug Administration (FDA), in order to treat a heart condition known as atrial fibrillation.

Patients with this heart condition demonstrate an irregular heart beat, inhibiting the flow of blood, and essentially causing blood to accumulate in one of the heart’s chambers. The accumulation of blood in a chamber can lead to the formation of blood clots, which can migrate towards the brain, resulting in a stroke.

Pradaxa is a drug that works to thin the blood in order to prevent blood clots, and ultimately, to prevent a stroke in the patient suffering from atrial fibrillation.

Unfortunately, Pradaxa does not work as intended. It has been known to cause excessive bleeding, causing death in quite a large number of cases, especially in patients with severe kidney dysfunction and overall poor kidney health. Some important data points have been released by the nonprofit medical organization known as the Institute for Safe Medication Practices.

In their research on the drug Pradaxa, the Institute for Safe Medication Practices noted that in 2011, 542 patients died from taking Pradaxa compared to 72 patients dying from warfarin use.

As a result of the high number of deaths resulting from Pradaxa use, the pharmaceutical company Boehringer Ingelheim is currently facing over two dozen U.S. Federal lawsuits citing Pradaxa’s excessive bleeding risk and negligence to warn atrial fibrillation patients and doctors about the risks involved in taking the drug.

If you have experienced a severe injustice and undue amount of suffering through the use of Pradaxa yourself or have a loved one who has suffered or died as a result of using Pradaxa, expert Pharmaceutical litigation attorneys at Carey Danis & Lowe can provide you first-rate legal counsel to get you the justice and compensation you deserve.

Pharmaceutical company negligence is not acceptable, and attorneys at Carey Danis & Lowe are incredibly skilled in representing clients in cases filed against some of the largest pharmaceutical corporations in the world.