PRADAXA BLOOD THINNER TARGET OF MASS CLAIMS LEGAL CASES

The story originally appeared in THE TENESSEAN and provided a local story based upon a number of residents seeking redress for injuries.

As noted below and elsewhere on PRADAXACASES.com there is significantly more to the story than most casual observers learn. The short history of the novel anti-coagulant has raised International concerns over uncontrollable bleeding events resulting in deaths, disability or extended hospital admissions. Aggressive marketing of the alternative blood thinner and care free comparisons to WARFARIN and COUMADIN may have secured a significant marketshare, in less than 2 years, for the pills. However, some patients and families have sought out legal help to answer questions over injuries and deaths.

ISMP CONFIRMS 542 DEATHS LINKED TO PRADAXA WITH MORE ADVERSE EVENTS REPORTED IN 2011.

As illustrated in posts below, as well as the graphic above, lawyers and families are not the only  people to question the safety of the pills. The ISMP has analyzed FDA’s data and raised serious questions about dosing and the potential for overdosing of patients. Watchdog groups, victims, survivors and their families may not have headed off PRADAXA becoming a Blockbuster, but they are at the forefront of obtaining answers and safeguarding others.

FREE CASE EVALUATIONS ARE AVAILABLE FROM THS SPONSOR OF THIS SITE THROUGH USE OF THE CONTACT FORM BELOW.
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PRADAXA SALES CLIFF - LAWSUIT UPDATE JULY 2012.

Legal cases against BOEHRINGER INGELHEIM, the manufacturer of PRADAXA (DABIGATRAN ETEXILATE) have begun to gain momentum in the United States. As a result, a petition to organize the litigation in a Multi-District Litigation (MDL) in the Federal court system was filed. Naturally, this lead to interested parties presenting arguments, before the Judicial Panel on Multi-District Litigation (JPML), requesting particular venues. Regardless of where the JPML directs the formation of an MDL, it is clear that PRADAXA BLEEDS and related cases will become the subject of litigation nationwide.

Following the publicization of international concerns in November 2011, as well as repeated reports from the ISMP (highlighted below), it is possible that sales of the anti-coagulant may be slowing as word spreads to providers, prescribers and patients of the dangers associated with the use of the novel anti-coagulant.

PRADAXA SALES CLIFF - LAWSUIT UPDATE JULY 2012.

The graphic above, from DRUGS.com, appears to show a drop off in “units”. Whether this downward trend will continue through 2012 remains to be seen. If it is related to growing suspicions and concerns over the future of PRADAXA (DABIGATRAN ETEXILATE) is unclear. Based upon IMSP’s past evaluation of FDA data tying the anti-coagulant to adverse events this trend is not surprising.

FREE PRADAXA CASE EVALUATIONS  ARE AVAILABLE THROUGH THE USE OF THE CONTACT FORM BELOW FROM THE SPONSOR OF THIS SITE.
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IS PRADAXA "PROGRESS" AS ADVERTISED OR NOT?

REUTERS REPORTS ON PRADAXA DEATHS, BLEEDING & LAWSUITS CAUSING CONCERN TO PHYSICIAN PRESCRIBERS.

In a June 14, 2012, REUTERS, entitled: ”TOP HEART DOCTORS FRET OVER NEW BLOOD THINNERS“, Randsell Pierson reports on the serious concerns and trepidation being raised by medical providers and prescribers over “new” blood thinners. PRADAXA (DABIGATRAN) was the first “new generation” blood thinner marketed as a lifestyle change for users because it required little monitoring or dietary changes. However, it has proven to have life altering consequences when the effects of the blood thinner combine with a trauma, or underlying disease, which complicates the outcome drastically and can lead to death. A competitive, and potentially dangerous, problem surrounding PRADAXA (DABIGATRAN) and other new blood thinners is illustrated by the aggressive marketing competing pharmaceutical companies have created to promote their new branded products. Citing the ISMP (Institute for Safe Medication Practices) data discussed in our post below, REUTERS examines, in part, the origin of the problem and again highlights the fact that PRADAXA (DABIGATRAN) has no antidote or quick reversal agent.

While the article quotes physicians, the physicians do not address the fact that ISMP’s data has confirmed 542 deaths and PRADAXA (DABIGATRAN) tops the list of drugs linked to adverse event reports as discussed below. All drugs come with risks. However, you cannot agree to accept the risks, or consequences, if the manufacturer is not providing the warning or information to prescribers so they can in turn pass it on to patients. This is a subtle point to some, but it is at the heart of PRADAXA CASES and ongoing lawsuits. Dr. Richard Besdine, Director of the Center for Gerontology at Brown University, is quoted as stating “[i]f there’s an adverse event lurking in the closet for a new drug, it’s most likely to come out in patients that are old and frail and taking multiple medications. They’re the canary in the coal mine“. Would you want to volunteer to become the canary in the coal mine or advance warning of the potential consequences?

FREE CASE EVALUATIONS are available for patients that have suffered serious injuries, or bleeding events from the use of PRADAXA (DABIGATRAN) through use of the contact form below.
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ISMP CONFIRMS 542 DEATHS LINKED TO PRADAXA WITH MORE ADVERSE EVENTS REPORTED IN 2011.

PRADAXA (DABIGATRAN ETEXILATE) remains under close watch by prescribers that know, or have seen, “safety signals” and red-flags associated with use of the drug.  A recently released report from the Institute for Safe Medication Practices (ISMP): QuarterWatch, Monitoring FDA MedWatch Reports, Anticoagulants the Leading Reported Drug Risk in 2011, May 31, 2012, evaluates new data from 2011 for the 3rd and 4th Quarters. The reports opens by noting that “the most frequently identified suspect drugs in direct reports to the FDA were the anticoagulants dabigatran (PRADAXA) and warfarin (COUMADIN)”. Ironically, PRADAXA has been marketed as a novel replacement for COUMADIN which has been in use for over 1/2 a century. Whether the results should simply raise more red flags or be interpreted as alarming is subject to interpretation. Regardless, here is the sum of ISMP’s findings and numbers. Please note that, these are “reported” and there is no way to account for yet to be reported, or never reported events:

• 817 where PRADAXA (DABIGATRAN) was the leading suspect in a direct report to the FDA in 2011.
• 3,781 domestic, serious adverse events overall in 2011 including both manufacturer and direct reports.
• 542 patient deaths.
• 2,367 reports of hemorrhage – outpacing all other regularly monitored drugs.
• 291 acute renal failure.
• 644 strokes.
• 15 cases where it was suspect in liver failure.

Comparisons to WARFARIN (COUMADIN) are inevitable as it has been the generic anti-coagulant of choice since 1954 and remains a mainstay in therapy. It accounted for 1,106 cases overall in 2011 and 72 deaths according to ISMP.

You have to openly wonder whether or not “PRADAXA is PROGRESS” as claimed in the aggressive direct to consumer marketing campaigns that bombarded the airwaves and remain available on line.

IS PRADAXA "PROGRESS" AS ADVERTISED OR NOT?

The numbers, whether underreported or not, speak for themselves. Sadly, they arguably reflect avoidable events, including deaths, with real people that experienced an injury and related issues. Unless, or until, victims come forward how many have really suffered an injury or event will not be known. Recent lawsuits and related litigation against the manufacturer may assist in helping related issues gain widespread recognition and the public health threat presented by this new anticoagulant.

We are actively investigating, and representing, survivors of deceased family members that used PRADAXA (DABIGATRAN) since October 2010. We are also evaluating and investigating cases involving serious personal injuries, or injuries resulting in disabilities from use of PRADAXA (DABIGATRAN). A FREE CASE EVALUATION is available through use of the contact form below.

IS PRADAXA "PROGRESS" AS ADVERTISED OR NOT?

ISMP’s data revealed that DABIGATRAN was the suspect in 856 reported cases of adverse events in FDA’s MedWatch Adverse Event Reports (AERS). ISMP and FDA recently announced their joint partnership in preventing medication errors and information sharing lending even more support to ISMP’s ability to identify problems and red flags. ISMP analyzed data for the 2nd Quarter of 2011, which includes a snapshot of information following the October 2010 approval and introduction of PRADAXA in the United States. ISMP’s analysis included a “new quarterly total” of 117 reported patient deaths. This is a noteworthy statistic because reports are voluntary and some patient deaths may not have been associated with PRADAXA at the time as widespread reports of international deaths and case reports did not emerge until November 2011 and March 2012 respectively. PRADAXA CASES identified by ISMP include 511 reported cases of hemorrhage, thus reinforcing their concerns that older patients may be overdosing on the new anti-coagulant.

ISMP PRADAXA UPDATE - APRIL 2012.

Again, adverse events may be underreported because there is an expectation that bleeding, or hemorrhage, is associated with anti-coagulant treatments. This may lead to underreporting. This theme will be explored through the initiation of PRADAXA CASES in civil court lawsuits involving fatalities, disabling and serious injuries. ISMP’s data identifies PRADAXA as being associated with more adverse events than any other monitored drug. Can the manufacturer, BOEHRINGER INGELHEIM, claim this does not raise a litany of red flags ? In December 2012, FDA articulated calls for post-marketing surveillance of the new anti-coagulant. This was followed by January 2012 label changes discussed here. Sadly, the eager acceptance and use of PRADAXA between October 2010 and January 2012 may have exposed a patient population to higher risks and adverse events that were arguably avoidable.

CASE EVALUATIONS are available here through the sponsor of this site.

La experiencia clinica en pacientes de edad avanzada (mas de 75 anos de edad) y PRADAXA (DABIGATRAN ETEXILATO) es limitada. Tratamiento con PRADAXA en pacientes con insuficiencia renal grave esta contraindicado. PRADAXA puede producir episodios de sangrado mayor or grave. Es posible que pueden producir discapacidad, ser potentcialmente mortales o incluso producir la muerte.

In January 2012, new warnings or revised warnings were approved for use in the U.S. in conjunction with prescriptions of PRADAXA (DABIGATRAN EXTILATE). These new and revised warnings only add to questions about why the warnings were not stronger at the time the product was approved and what was known by the manufacturer, BOEHRINGER INGELHEIM, in conjunction with modifications and use in patients with compromised kidney functioning. We will elaborate and discuss the “new” warnings in a separate post on this site.

FREE CASE EVALUATIONS are available from the sponsor of this site.

PRADAXA: Dosing in USA is 75 mg or 150 mg only as of April 2012.

FDA MedWatch Analysis of PRADAXA CASES by QuarterWatch.

QuarterWatch, Monitoring FDA MedWatch Reports, is published by the Institute for Safe Medication Practices. QuarterWatch is a trademarked and independent publication that monitors all domestic, serious adverse drug events reported to the U.S. Food & Drug Administration (“FDA”). An Executive Summary, dated January 12, 2012, examined available data from the FDA, Adverse Reporting System, (AERS), and related MedWatch reports for signals and findings regarding PRADAXA (DABIGATRAN EXTILATE). QuarterWatch noted 500 reports of fatal, disabling or other severe hemorrhages or PRADAXA CASES. QuarterWatch defines the term “signal” as evidence of sufficient weight to justify an alert to the public and scientific community, warranting further investigation. It also reported the manufacturer was continuing to work with the FDA to provider “better guidance to physicians about treating the oldest patients”. Their analysis suggested that elderly patients were at risk for severe bleeds resulting in harm not benefit to this undefined population. The authors of QuarterWatch suggested that review of PRADAXA (DABIGATRAN EXTILATE) and adverse effects on high risk patients need to be a national priority.

Notably, QuarterWatch also questioned a potential relationship between PRADAXA CASES, dosing and the age of patients. Another trend suggests that while prescriptions surged so did reports of serious adverse drug events. As a result, in the 1st Quarter of 2011, QuarterWatch, summarized findings as revealing data that justified their concerns.

The sponsor of this site, Gabriel F. Zambrano, P.A., is investigating PRADAXA CASES that include deaths, permanent disability, hospitalization, gastrointestinal hemorrhaging, hemorrhagic stroke and heart attacks. FREE CASE EVALUATIONS are available through use of the contact form below.

PRADAXA CASES & BLEEDING SYMPTOMS/SIDE EFFECTS.

PRADAXA® CASES OF DEATH REPORTED AS 260 IN NOVEMBER 2011.

PRADAXA LINKED TO 260 DEATHS WORLDWIDE AS OF NOVEMBER 2011
PRADAXA cases involving deaths were reported in November of 2011 as totaling 260 “reported” PRADAXA CASES.  As a result, PRADAXA LAWSUIT investigations have been initiated.  It is anticipated that PRADAXA LAWSUITS will be filed throughout 2012 as a result of PRADAXA CASES where patients have bled irreversibly and uncontrollably leading to their deaths.

REUTERS reported on the potential “safety signal” and rise in PRADAXA CASES in a story published on November 12, 2011, entitled “BOEHRINGER SAYS ABOUT 260 DEATHS RELATED TO PRADAXA“. The REUTERS report notes that this was allegedly “still below the rate that emerged in the clinical trials that led to the drug’s approval”. However, REUTERS also reported that the company had previously “said that 50 reported deaths were a reasonable order of magnitude”. Whether there are in fact more PRADAXA CASES involving deaths or disability is open to question given that as of November 2011 it appeared the company had grossly underestimated the global number of potential deaths.

PRADAXA CASES are being investigated by the sponsor of this site, Gabriel F. Zambrano, P.A..  FREE CASE EVALUATIONS of potential PRADAXA CASES are available upon request through the use of the form below.

Pradaxa® CASES LAWSUITS BLEEDS BLEEDING