The Pradaxa litigation has begun and the discovery phase is well under way. After hundreds of Pradaxa patients have died and thousands have suffered injury, over 150 initial cases against Pradaxa's manufacturer. These cases have been consolidated into one multidistrict litigation case, which aims to expedite relief for patients who have suffered injury because of the drug. In comparison to class action lawsuits, the injured parties in this case are allowed to file across the country in federal court to join the litigation.
What are the Pradaxa lawsuits about?
At the heart of the matter in the Pradaxa lawsuits is an assertion by injured patients that the manufacturer may have released a potentially fatal drug onto the market without a means for patients to reverse serious health outcomes. To date, part of the issues discussed in the case is how Pradaxa compares to similar drugs in its class. While this is a great starting point to understand how it differs significantly, the issue that many patients want to focus on is whether or not the company knew its drug could cause deaths when they released it onto the market.
If the plaintiffs can prove that the manufacturer released the drug irresponsibly, they will have a landmark case. As the FDA's number one source for drug fatalities in 2011, these cases could have a huge price tag for manufacturers. Since there is no reversal agent to prevent potentially fatal bleeding events, consumers may have a point. What sort of safety or control options did the manufacturers prepare in case patients experienced severe side effects? What did they think would be the result if there were side effects?
Seek help for Pradaxa injuries
If the judge determines manufacturers released the drug irresponsibly, there could literally be thousands of cases against Pradaxa's manufacturer. Many injured patients are in need of relief to pay mounting medical bills and treat serious injuries. The relief such a case may provide would go a long way to providing for these medical costs. If you or a loved one has been injured taking Pradaxa, you should consult a skilled product liability attorney today to determine whether you may be entitled to compensation for your injuries.
Showing posts with label Pradaxa lawsuit. Show all posts
Showing posts with label Pradaxa lawsuit. Show all posts
Is the FDA Endorsing Risky Blood Thinner Medications?
This past week, the United States Food and Drug
Administration (FDA) concluded a year long study into Pradaxa (dabigatran
etexilate) and determined it was no more dangerous than its competitor,
Warfarin. In a letter to the public, the FDA recognized a number of popular
blood thinners as having beneficial effects to help patients ward off strokes.
This included Warfarin, Pradaxa, and Xarelto.
None of these drugs are perfect, and no medication can
realistically claim to be, but the amount of reported deaths and severebleeding events reported by Pradaxa users is a cause for serious concern. With
similar characteristics and similar trial results, Xarelto has become a concern
for some industry watch dogs.
What is Xarelto
Xarelto (Rivaroxaban) is a blood thinner medication
prescribed to patients with atrial fibrillation, the most common form of
cardiac arrhythmia. This condition affects an estimated 3 million Americans and
15% of elderly Americans over the age of 80. In these patients, there is significant
increased risk for developing a blood clot in the heart due to blood pooling in
a storage chamber of the heart, which can travel to the brain, causing a
stroke.
Xarelto acts by inhibiting the Factor Xa protein. The Factor Xa protein is generated by both
the extrinsic and intrinsic coagulation pathways and it activates prothrombin
to thrombin, which activates the final components of the coagulation pathway to
form clots. Factor Xa inhibitors are generally used as prophylaxis in patients
having hip and knee replacement surgery, where blood clots can form and lead to
deep vein thrombosis and pulmonary embolism.
Traditionally, blood thinners worked by inhibiting vitamin K
production in the blood to prevent blood clots.
Xarelto works differently by inhibiting the Xa protein in the blood and
therefore does not have a reversal agent like its competitors (i.e. Warfarin) which
inhibit vitamin K production in the blood.
What Were the Observed
Complications that Caused Researchers Concern
In the drug trials, researchers named a number of severe
complications which could be caused by Xarelto.
Similar to Pradaxa’s observed side effects and complications, Xarelto is
equally concerning considering its lack of a reversal agent. In the first quarter alone, Xarelto had 356
reported adverse health complications.
Among these reported adverse health complications were the following:
·
Fatal bleeding event
·
Brain hemorrhage
·
Liver abnormalities
·
Kidney abnormalities
·
Collection of clotted blood in the organs or
tissue
·
Jaundice/ yellowing of skin due to liver
problems
·
Spinal epidural hematoma
·
Bleeding in the abdomen
·
Hemorrhage within the skull
·
Blockage of normal bile flow
·
Stevens- Johnson Syndrome (a skin disorder due
to allergic reaction or infection which can be characterized by herpes, skin
lesions, sores, vision problems)
·
Life threatening allergic reaction
·
Severely decreased blood platelets
·
Deficiency of Granulocytes (white blood cells)
If You Have Been
Injured By Your Blood Thinner Medication
Unfortunately, because Xarelto and Pradaxa both lack
reversal agents, these severe complications could turn deadly with little to no
recourse for doctors treating these patients.
In comparison, Warfarin’s side effects can be treated with a vitamin K
shot to clot the blood. Patients and
their families who have suffered Xarelto blood thinner injuries are encouraged
to seek a talented product liability attorney to determine their eligibility
for compensation.
FDA's Pradaxa Study May Be Flawed & Misleading
Year Long FDA Pradaxa Study May Be Deeply Flawed
Over 500 people have died from the popular blood thinner drug, Pradaxa. As reported deaths rose, the U.S. Food and Drug Administration (FDA) began a year long investigation into the drug and its effects upon the human body. As a result, the FDA released its conclusions last week, stating Pradaxa was no more dangerous than other blood thinner medications like Warfarin. But new evidence suggests that this study may have reached premature conclusions and may have been deeply flawed.
In September, the Journal for the American Medical Association (AMA) declared the release of Pradaxa may have been too premature. Studying the initial trials, the AMA expressed concern for the many internal bleeding events that went overlooked when this drug was approved by the FDA. Similarly, USA Today reported in August that the FDA had received 3,781 complaints of adverse health effects and over 542 deaths attributed to Pradaxa. For the FDA to ignore these complaints and classify the drug as no more dangerous than its competition seems suspicious to some health experts.
Were the FDA's Conclusions Merely Guesses?
Critics state the FDA has failed to take the incidents of internal bleeds into account and the fact that Pradaxa has no reversal agent, unlike other blood thinner medications. Doctors have been quick to point out that the FDA's methodology appears to be flawed. The FDA has been using unadjusted incident rate ratios to determine Pradaxa's safety, which leading medical authorities have found severely lacking.
This alleged flawed methodology is important because in some instances, it compares drug outcome pairings where there is no causal relationship. Medical researchers state that this amounts to little more than a guess or a shot in the dark. Researchers further point out that the comparisons seem to be skewed towards drug outcome pairs with known causual relationships such as Warfarin. In a very real sense, it seems Warfarin's reputation is skewing the results unfairly.
If You Have Been Injured By Pradaxa
Despite this FDA study, the Institute for Safe Medical Practices reports Pradaxa is among the drugs responsible for a 37% increase in prescription drug complaints. Because of the high number of Pradaxa injury complaints, the litigation against Pradaxa drug maker Boehringer Ingelheim is expected to be complex and lengthy. Federal Judge Herndon in the Southern District of Illinois has issued an order on July 24, 2012 authorizing patients injured by Pradaxa to proceed with multi-district litigation in case number MDL No. 2385, IN RE: Pradaxa Product Liability Litigation.
If you have been injured by Pradaxa, please call an experienced product liability attorney. Your blood thinner injury could be severe enough to affect your entire life and your quality of life. In order to protect your rights and gain the compensation you need, you should speak with a skilled product liability attorney today.
Over 500 people have died from the popular blood thinner drug, Pradaxa. As reported deaths rose, the U.S. Food and Drug Administration (FDA) began a year long investigation into the drug and its effects upon the human body. As a result, the FDA released its conclusions last week, stating Pradaxa was no more dangerous than other blood thinner medications like Warfarin. But new evidence suggests that this study may have reached premature conclusions and may have been deeply flawed.
In September, the Journal for the American Medical Association (AMA) declared the release of Pradaxa may have been too premature. Studying the initial trials, the AMA expressed concern for the many internal bleeding events that went overlooked when this drug was approved by the FDA. Similarly, USA Today reported in August that the FDA had received 3,781 complaints of adverse health effects and over 542 deaths attributed to Pradaxa. For the FDA to ignore these complaints and classify the drug as no more dangerous than its competition seems suspicious to some health experts.
Were the FDA's Conclusions Merely Guesses?
Critics state the FDA has failed to take the incidents of internal bleeds into account and the fact that Pradaxa has no reversal agent, unlike other blood thinner medications. Doctors have been quick to point out that the FDA's methodology appears to be flawed. The FDA has been using unadjusted incident rate ratios to determine Pradaxa's safety, which leading medical authorities have found severely lacking.
This alleged flawed methodology is important because in some instances, it compares drug outcome pairings where there is no causal relationship. Medical researchers state that this amounts to little more than a guess or a shot in the dark. Researchers further point out that the comparisons seem to be skewed towards drug outcome pairs with known causual relationships such as Warfarin. In a very real sense, it seems Warfarin's reputation is skewing the results unfairly.
If You Have Been Injured By Pradaxa
Despite this FDA study, the Institute for Safe Medical Practices reports Pradaxa is among the drugs responsible for a 37% increase in prescription drug complaints. Because of the high number of Pradaxa injury complaints, the litigation against Pradaxa drug maker Boehringer Ingelheim is expected to be complex and lengthy. Federal Judge Herndon in the Southern District of Illinois has issued an order on July 24, 2012 authorizing patients injured by Pradaxa to proceed with multi-district litigation in case number MDL No. 2385, IN RE: Pradaxa Product Liability Litigation.
If you have been injured by Pradaxa, please call an experienced product liability attorney. Your blood thinner injury could be severe enough to affect your entire life and your quality of life. In order to protect your rights and gain the compensation you need, you should speak with a skilled product liability attorney today.
Do I Have a Pradaxa Case
To patients suffering with atrial fibrillation, blood thinner medication can be life saving. By stopping potentially fatal blood clots from forming, patients are able to avoid strokes and heart attacks. However, the latest blood thinner medication to come under scrutiny has been Pradaxa.
Sold as a new and improved version of Warfarin, Pradaxa was supposed to thin the blood and require less doctor oversight. Instead of blocking Vitamin K production like Warfarin and similar drugs, Pradaxa worked by inhibiting thrombin, the clotting agent in the blood. Unfortunately, because of this significant difference, if patients experienced fatal bleeds, they could not clot the blood with a shot of Vitamin K. In fact, Pradaxa had no reversal or clotting agent to offer patients.
If You Have Been Injured By Pradaxa
Pradaxa patients could face serious and lasting injuries as a result of taking their medication as prescribed. This could include:
How Strong Is Your Pradaxa Case
If you've suffered adverse reactions to Pradaxa, your product liability attorney will want to know whether these began before or after January, 2012, when the FDA mandated changed warning labels. Incidents occuring prior to January 2012 are likely to lead to a stronger case than those experienced after the FDA mandated changed labels.
Patients who suffered the following will have stronger cases:
· gastrointestinal bleeds
· a hemorrhagic stroke
· trauma-induced atypical bleeding event
· death
It is important that you seek medical help for any Pradaxa injuries first. And when you're well, seek the skilled advice of a product liability attorney.
Sold as a new and improved version of Warfarin, Pradaxa was supposed to thin the blood and require less doctor oversight. Instead of blocking Vitamin K production like Warfarin and similar drugs, Pradaxa worked by inhibiting thrombin, the clotting agent in the blood. Unfortunately, because of this significant difference, if patients experienced fatal bleeds, they could not clot the blood with a shot of Vitamin K. In fact, Pradaxa had no reversal or clotting agent to offer patients.
If You Have Been Injured By Pradaxa
Pradaxa patients could face serious and lasting injuries as a result of taking their medication as prescribed. This could include:
·
Potentially fatal bleed outs
·
Increased risk of heart attacks
·
Increased bleeding in the kidneys
·
Bleeding in the brain
·
Purple spots under the skin, abnormal bleeding
from the gums, mouth, vagina, and rectum
·
Blood in your urine or stools
·
Coughing up blood or vomit
·
Intestinal bleeding, ulcers
·
Death
How Strong Is Your Pradaxa Case
If you've suffered adverse reactions to Pradaxa, your product liability attorney will want to know whether these began before or after January, 2012, when the FDA mandated changed warning labels. Incidents occuring prior to January 2012 are likely to lead to a stronger case than those experienced after the FDA mandated changed labels.
Patients who suffered the following will have stronger cases:
· gastrointestinal bleeds
· a hemorrhagic stroke
· trauma-induced atypical bleeding event
· death
It is important that you seek medical help for any Pradaxa injuries first. And when you're well, seek the skilled advice of a product liability attorney.
Subscribe to:
Posts (Atom)