07/30/2012 Pradaxa Lawsuit: The Pradaxa Lawsuit is an individual action taken against the manufacturer of this drug for the effects it caused. Typically, Pradaxa Lawsuit claims involve severe bleeding or a bleed resulting in a death. An attorney involved in the Pradaxa Lawsuit can be reached for you by calling Best Legal Source at (800) 611-7080. A free consultation may give you the answers you need to determine whether a Pradaxa Lawsuit will be an advantageous decision for you.
The Benefit of Working with Best Legal Source Toward Your Pradaxa Lawsuit
When looking for a Pradaxa Lawsuit attorney, it is often beneficial to have a trusted resource working on your side. While many attorneys may take Pradaxa Lawsuit cases, not all attorneys are qualified and experienced in litigation against a large drug company like Boehringer Ingelheim. Best Legal Source will screen the available attorneys working on the Pradaxa Lawsuit and find the best option for you personally. Not all attorneys take cases on a contingency fee basis. Best Legal Source will find you legal representation that will take your case at no upfront cost. The Pradaxa Lawsuit attorney will then be paid through a portion of the earnings from a successful Pradaxa Lawsuit. This means you will not owe any legal fees if the case is not won in your favor. If you have any questions or concerns about the process of a Pradaxa Lawsuit, do not hesitate to contact Best Legal Source. A representative will explain your options and assist you in navigating the complex legal system. Please call today to begin investigating your potential Pradaxa Lawsuit claim.
Pradaxa Lawsuit vs. Pradaxa Class Action Lawsuit vs. Pradaxa Lawsuit MDL
There are many different ways to pursue a Pradaxa Lawsuit, and this can often make the process seem more complicated than it is. Currently, there is a motion to consolidate the existing Pradaxa Lawsuit claims into Multi District Litigation (MDL). An MDL would be similar to a Pradaxa Class Action Lawsuit and is often described as one, although the two are separate actions. Often, for the sake of reader comprehension, we refer to the potential MDL as a Pradaxa Class Action Lawsuit. The action against Pradaxa will probably be classified as an MDL, but we use the term Pradaxa Class Action Lawsuit because it is a more recognized term. The difference between the two is that Multi District Litigation allows each Pradaxa Lawsuit claim to remain separate while a Pradaxa Class Action Lawsuit joins the claims into one lawsuit.
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Sample Pradaxa Lawsuit Follows
We have included actual court filings from a Pradaxa Lawsuit in this post to help victims of Pradaxa bleeding events understand the Pradaxa Lawsuit process. The Pradaxa Lawsuit filing below is an actual example from a recent case filed in the District Court of Ohio. We have added headers, notes, comments and other content to the Pradaxa Lawsuit case below. These sections were not added by a lawyer. Please do not take any content on this website as legal advice or legal opinion. Legal advice regarding your potential Pradaxa Lawsuit should only be taken from a Pradaxa Lawyer with extensive experience in Pradaxa Lawsuit cases.
Pradaxa Lawsuit Excerpt: William Bullock
2012 WL 2936525 (N.D.Ohio) (Trial Pleading)
United States District Court, N.D. Ohio.
WILLIAM J. BULLOCK, Plaintiff,
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., Boehringer Ingelheim Pharma Gmbh & Co. KG, Boehringer Ingelheim International Gmbh, Bidachem S.P.A. Defendants.
STATEMENT OF FACTS
Defendants, directly or through their agents, apparent agents, servants or employees designed, manufactured, marketed, advertised, distributed, promoted, labeled, tested and sold PradaxaTM as a blood-thinning medicine primarily used to reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. PradaxaTM was launched by Defendants in North America in 2010.
PradaxaTM was approved by the Food and Drug Administration (“FDA”) in October of 2010 for prevention of stroke in patients with non-valvular atrial fibrillation. PradaxaTM is the first new treatment alternative to warfarin (Coumadin) in nearly 60 years.
According to the Defendants’ marketing and informational materials, referenced in the paragraphs below, and widely disseminated to the consuming public, atrial fibrillation (“AF”) is the most common sustained heart rhythm condition in the world, with one in four adults over the age of 40 developing the condition in their lifetime.1
Defendants claim their medication, PradaxaTM, is the answer to the worldwide problem of strokes and blood clots in those with AF. They claim, “Many AF-related strokes can be prevented with appropriate medicinal therapy. For this, substances are used which act on the blood clotting system and shall prevent blood clots from forming.”5
Omissions Throughout the Pradaxa Lawsuit Segment
Due to the length and technical nature of the Pradaxa Lawsuit, we have omitted portions of the material for your benefit. The sections of Pradaxa Lawsuit trial document here should be helpful and relevant to your Pradaxa Lawsuit research.
Pradaxa Lawsuit AF Description
Historically, conditions such as AF have been treated with the prescription drug warfarin, which is a form of rat poison. Warfarin blocks the formation of the tiny fibrin threads that help hold together the platelets that collect in a person’s blood to form a blood clot. Like all blood thinners, warfarin can cause bleeds. Warfarin has two other noteworthy limitations: (1) it requires blood tests every 1 to 4 weeks to establish the optimal level of anticoagulation, and (2) it interacts (negatively) with scores of other drugs, including drugs frequently used in heart patients. In spite of these apparent limitations; however, warfarin also has an important benefit; if an overdose or unexpected bleed occurs, an antidote (e.g., vitamin K) is readily available and highly effective.
PradaxaTM is administered as an oral anticoagulant and is from the class of the direct thrombin inhibitors (“DTI”).
According to the Defendants’ website, PradaxaTM is “at the forefront of a new generation of oral blood thinning treatments, which prevent blood clots from forming in the body that can lead to devastating strokes in patients with atrial fibrillation. Potent antithrombotic effects are achieved with DTIs by specifically blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for thrombus formation.”
Arrival of Pradaxa in Pradaxa Lawsuit Document
When Pradaxa was released, it was viewed optimistically as the only alternative to Warfarin. The Pradaxa Lawsuit makes note of the arrival of Pradaxa to the marketplace and the rapid acceptance by consumers. This point is worth noting in the Pradaxa Lawsuit because it illustrates the prevalence of Pradaxa among users. Those affected by Pradaxa Lawsuit side effects is a greater number due to the events leading to the release of Pradaxa.
Pradaxa Lawsuit: Testing and Marketing
According to Defendants testing and marketing materials, which extol the supposed benefits and virtues of PradaxaTM, PradaxaTM had fewer drug interactions than warfarin, and the frequent laboratory tests needed to manage warfarin blood levels were not recommended for patients taking PradaxaTM. Moreover, unlike warfarin, which is adjusted for individual patient blood levels on an ongoing basis, PradaxaTM was approved in an allegedly easy “one size fits all” dose of 150 mg twice a day. This “one size fits all” characteristic of the drug, while simple for physicians to follow, means that a lower (or personalized) dose is unavailable and patients ingesting PradaxaTM are not routinely monitored to see if they are getting too much of the drug’s active ingredient, as are patients on other blood thinning medications like warfarin.
In essence, the Defendants have created a new drug, PradaxaTM, that is no better than warfarin from a safety perspective, and at best, perhaps slightly easier to use and administer. The idea of this apparently easier-to-use anticoagulant evidently appealed to physicians, who were subject to extreme marketing and promotion by the Defendants, but it ignores patient safety.
On February 14, 2011, the American College of Cardiology Foundation and American Heart Association added PradaxaTM to their guidelines for management of non-valvular atrial fibrillation with a “Class I” recommendation. The endorsement, along with heavy marketing from the Defendants, caused sales of Pradaxa to skyrocket. By the end of the first quarter of 2011, IMS Health’s National Prescription Audit data showed 272,119 dispensed outpatient prescriptions. But, as prescriptions mounted, reports of serious adverse drug events also surged.9
As a result of the defective nature of PradaxaTM, persons who were prescribed and ingested PradaxaTM for even a brief period of time, including Plaintiff herein, were at increased risk for developing life-threatening bleeds. Due to the flawed formulation of PradaxaTM (and unlike any of the traditional blood thinners on the market, PradaxaTM has a questionable “one size fits all” dose), its levels in the blood are difficult or impossible to assess and bleeds cannot be stopped since there is no known reversal antidote for this dangerous drug.
Side Effects in Pradaxa Lawsuit
The Pradaxa Lawsuit is pursued because users have experienced side effects that can be extremely severe. Specifically, Pradaxa Lawsuit cases are pursued for those who had life-threatening bleeds as it mentions above in the Pradaxa Lawsuit excerpt. If you have experienced a serious bleeding event while taking Pradaxa, you may qualify for a Pradaxa Lawsuit claim.
Pradaxa Lawsuit Bleed Statistics
In November 2011, Defendants confirmed at least 260 fatal bleeding events were reported in patients taking PradaxaTM worldwide between March 2008 and October 2011. The actual number of PradaxaTM related deaths remains unknown at this time. Moreover, The Institute for Safe Medication Practices, reported that:
In the first quarter of 2011 [PradaxaTM] produced two different kinds of signals of major drug risk: a large volume of total serious reports, and large numbers of reports for a specific adverse event, hemorrhage. Overall [the study] identified 932 serious adverse drug events of all types in which [PradaxaTM] was the primary suspect drug, including 120 patient deaths, 25 cases of permanent disability, and 543 cases requiring hospitalization. For the quarter, this was a higher total than for any drug [The Institute for Safe Medication Practices] monitor[s] with one exception. In the Standardized MedDRA Query (“SMQ”) for Hemorrhage, [PradaxaTM] accounted for 505 cases, more than any other drug. (Warfarin ranked second with 176 cases.) The 932 overall [PradaxaTM] cases in the first quarter [of 2011] included 293 cases that were also classified in the narrower gastrointestinal hemorrhage SMQ, more than any other regularly monitored drug. An additional 120 cases contained event terms in the Hemorrhagic stroke SMQ. The strokes are of particular concern because if treatment intended to prevent ischemic strokes then causes hemorrhagic strokes the risk/benefit balance is called into fundamental question. In 65 hemorrhage cases overall, the patients died.
In other words, the deadly consequences of PradaxaTM use did not go unnoticed.
On December 7, 2011, the FDA initiated an investigation into serious bleeding events associated with PradaxaTM stating that the “FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa [RE-LY trial].”
Finally, in January of 2012, after thousands of PradaxaTM users had been killed or injured as a result of their ingestion of PradaxaTM, the Defendants belatedly initiated an extremely modest, and wholly inadequate, label change.
Pradaxa Lawsuit Forms as a Result of Inadequate Warning
From the above paragraphs in the Pradaxa Lawsuit, it becomes clear that the adverse events created by Pradaxa may have been avoided with better warnings. It is a common complaint of Pradaxa Lawsuit documents that the maker did not adequately warn consumers. If a risk exists for a product, the public should have knowledge of the risk. It is necessary to avoid complaints and legal action such as the Pradaxa Lawsuit. The maker of drug products has the responsibility to demonstrate diligence—otherwise a Pradaxa Lawsuit may occur.
Continued Pradaxa Lawsuit Document
The current warning is simply inadequate. The Defendants have failed and continue to fail in their duties to warn and protect the consuming public, including the Plaintiff herein.
Even if the warnings were sufficient, which Plaintiff strongly denies, PradaxaTM still lacks any benefit sufficient to tolerate the extreme risk posed by the ingestion of this drug. PradaxaTM is quite simply dangerous and defective as formulated. The Defendants should withdraw PradaxaTM from the market.
Indeed, a FDA analysis showed that with PradaxaTM treatment, life-threatening bleeds (a drug adverse effect) occurred at a higher rate than the strokes or systemic embolisms PradaxaTM is intended to prevent (1.5% per year versus 1.1% a year), suggesting that PradaxaTM creates an extreme risk for patients and provides no benefit whatsoever.11 PradaxaTM, under the guise of providing a safe defense against strokes and/or embolisms in AF patients, subjects unsuspecting patients to new dangers of death and injury.
Defendants willfully, wantonly and with malice withheld the knowledge of increased risk of irreversible bleeds in users of PradaxaTM to prevent any chances of their product’s registrations being delayed or rejected by FDA.
Harm to the Pradaxa Lawsuit Plaintiff
Below in the Pradaxa Lawsuit excerpt, you will find information related to the injuries of the Pradaxa Lawsuit plaintiff. These injuries including excessive bleeds have been found through several studies to be associated with Pradaxa. A Pradaxa Lawsuit is pursued for Mr. Bullock for the injuries he sustained and the resulting medical care he needed.
Pradaxa Lawsuit Plaintiff Bullock Details
As a result of Defendants’ actions, Plaintiff William J. Bullock and Plaintiffs physicians were unaware, and could not have reasonably known or have learned through reasonable diligence, that Plaintiff would be exposed to the risks identified in this Complaint. The increased risks and subsequent medical damages associated with Plaintiff’s Pradaxa TM use were the direct and proximate result of Defendants’ conduct.
On or around February 28, 2011, William J. Bullock was first prescribed and began taking PradaxaTM upon direction of Plaintiff’s physician for long-term maintenance and treatment related to Plaintiff’s atrial fibrillation and blood clot condition. Subsequently, as a direct result of Plaintiff’s ingestion of PradaxaTM, Plaintiff William J. Bullock suffered cerebral bleeding on March 2012. Plaintiff required surgery before his cerebral bleeding was corrected.
As a direct result of being prescribed PradaxaTM for this period of time, Plaintiff has suffered significant injuries, such as those described above.
End of Pradaxa Lawsuit
Response to Pradaxa Lawsuit Sample
The above excerpt from a Pradaxa Lawsuit was given to assist your understanding of trial court documents before you enter into a potential Pradaxa Lawsuit. Best Legal Source was not involved in the Pradaxa Lawsuit above.
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