Texas First Degree Felony Crimes and Consequences

By Independent Staff Writer

What is a First Degree Felony in Texas?

Criminal offenses in Texas are charged under the categories of misdemeanors and felonies.  Felonies are the most serious criminal offenses and carry the most severe penalties.  A felony is generally considered any criminal offense more serious than a misdemeanor, and that is punishable by imprisonment of more than one year.  A felony crime is classified as a State Jail Felony, Third-Degree Felony, Second-Degree Felony, First-Degree Felony, or a Capital Felony, the most serious being a Capital Felony that can bring a penalty of life imprisonment or death.

First Degree Felonies are among the most serious crimes in Texas, second only to capital felonies.  Examples of crimes that are considered First Degree Felonies include but are not limited to the following:

Penalties for Assault and Battery in Texas

By Independent Staff Writer

Assault charges in Texas can result from a simple threat or argument, a fistfight, or a violent attack with a weapon.  Assault charges range from misdemeanors to felony charges depending on the circumstances, and are taken especially seriously if injury occurs or if a weapon was used.  The penalties range from fines to prison terms depending on the severity of the assault and the circumstances of each case. Being faced with assault charges of any kind can have drastic negative consequences both personally and professionally.

Texas law defines assault as intentionally, knowingly, or recklessly:

• Causing bodily injury to another person, including the person’s spouse;
• Threatening someone with imminent bodily injury, including the person’s spouse; or
• Causing physical contact with another when the person knows or should reasonably believe that the other will regard the contact as offensive or provocative.

Classes of Misdemeanor Offenses in Texas

By Independent Staff Writer

Criminal offenses in Texas are divided into two main categories, felonies and misdemeanors.  Misdemeanors are considered lesser crimes than felonies and are divided into three classes based on the degree of seriousness of the offense and the severity of the punishments.  It is important to take misdemeanor charges seriously, because having a misdemeanor conviction on your record can impact your life in many negative ways.  You may have difficult time getting the job you want, being admitted to an institution of higher education, or even obtaining an occupational license.

Texas Driver’s License Fines and Suspensions

By Independent Staff Writer

A. The Texas Driver Responsibility Program and Points on Your License

Texas uses the Texas Driver Responsibility Program (DRP) adopted by the state legislature (TRC §708; Article 10, House Bill 3588, 78^th Legislative Session) to track individuals’ traffic violations, assign points to their records, and assess fines to drivers who receive or exceed a certain number of license points.  Not surprisingly, the point system has been an efficient revenue generator for the state.

Defining Felony Crimes in Texas

By Independent Staff Writer

Texas Felony Criminal Offenses

Criminal offenses in Texas are charged under the categories of misdemeanors and felonies.  Felonies are the most serious criminal offenses and carry the most severe penalties.  A felony is generally considered any criminal offense more serious than a misdemeanor and is classified as a State Jail Felony, Third-Degree Felony, Second-Degree Felony, First-Degree Felony, or a Capital Felony, the most serious being a Capital Felony that can bring a penalty of life imprisonment or death. Criminal felony charges of any kind are a very serious matter.  The penalties for conviction are severe and can have profoundly negative and damaging consequences to one’s personal and professional life for many years.  You may face difficulty in finding employment and may face financial problems.

How Strong is Your Pradaxa Case?

By Independent Staff Writer

If your doctor has prescribed the relatively new drug, Pradaxa, as an alternative to Warfarin, you may have been alarmed to hear of the potential issues with Pradaxa. Pradaxa was approved by the FDA in late 2010 after the manufacturer, Boehringer Ingelheim, presented the drug as a much better alternative to Warfarin, which had been used exclusively since the 1950’s as a treatment for the prevention of systemic embolisms and strokes. Pradaxa is used to treat patients with atrial fibrillation and works primarily by thinning the blood of the patient. While Pradaxa did appear to work slightly better than Warfarin, it has been shown to have serious side effects, some of them fatal.

How Does Pradaxa Work?

The primary issue with Pradaxa lies in how it works in the body. While both Pradaxa and Warfarin are used to prevent strokes in patients with atrial fibrillation, Warfarin works through the inhibition of Vitamin K in the body. Vitamin K is a clotting agent, and should Warfarin cause excessive bleeding in a patient, doses of Vitamin K can be administered to slow the bleeding. Pradaxa works by inhibiting an enzyme in the blood known as a thrombin. Thrombins are also responsible for controlling blood clotting, however at this time there is no known reversal agent to Pradaxa and should it cause excessive bleeding physicians have no way of slowing or stopping the bleeding. In the case of excessive bleeding among Pradaxa users they have no choice but to wait 12 to 24 hours until the drug has cleared their system, allowing the blood to clot as it should.
Unfortunately, some patients have bled so excessively they don’t have that amount of time. This has led to the death of several Pradaxa users, particularly those who are over the age of 75 or those with impaired renal function. The Pradaxa drug is also unique in how it gets into the patient’s system. The active ingredient in Pradaxa is actually contained in the outer shell of the drug while the encapsulated portion contains a core of tartaric acid. Scientists believe that this particular type of delivery system allows the drug to be mroe rapidly absorbed by increasing the acidity in the digestive tract. It is theorized that this delivery system can be responsible for major GI bleeds, and those who have experienced minor gastrointestinal symptoms may go on to have a excessive internal bleeding as a fairly minor ulceration turns into a serious or fatal hemorrhage.

Do I Have a Pradaxa Case?

If you have had adverse responses to the drug Pradaxa, your personal injury attorney will want to know whether those responses occurred prior to January, 2012, or after that date. This date is important because the FDA mandated changes in the warning labels of Pradaxa in January after receiving numerous adverse reports of serious side effects related to Pradaxa. It is believed that over 260 deaths have been directly tied to Pradaxa through uncontrollable bleeding incidents. Those who had an adverse response to Pradaxa prior to January of 2012 likely have a bit stronger case than those who had a negative incident after the FDA issued their warning. Those Pradaxa users who ended up with an extended hospital stay or died as a result of taking the drug whether through a gastrointestinal bleed, a hemorrhagic stroke or a trauma-induced atypical bleeding event, will likely hold a strong legal position against Boehringer Ingelheim.

Elderly patients with reduced renal functions are more likely to have experienced a serious side effect from Pradaxa since it builds up more quickly in the body. Any significant bleeding event can be responsible for a lack of blood flow to organs in the body which results in organ damage. While some organ damage can be reversible, others may not be. Pradaxa users have also experienced strokes and heart attacks as a result of taking the drug. Whatever damage you suffered as a result of taking Pradaxa, you have likely racked up significant medical expenses, lost time from work and suffered a substantial level of emotional distress, and may have a cause of action against the manufacturer of Pradaxa.
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DISCLAIMER: All cases are based on individual circumstances and the facts pertaining to each case, and the outcome for any particular case depends on a variety of factors. None of the information provided on this website should suggest or guarantee a particular result for any given case. None of the information provided on this website should be construed in any way as legal advice. Further, none of the information provided on this website should suggest or imply the formation of an attorney-client relationship in any capacity whatsoever.

Pradaxa (Dabigatran) and the FDA Safety Review

By Independent Staff Writer

Although only on the market for a relatively short period of time, Pradaxa, the blood-thinning drug manufactured by Boehringer Ingelheim—has already suffered under the weight of threatened recalls, lawsuits and warnings by the FDA. Pradaxa is the first FDA-approved drug of its type since the drug Warfarin was approved in 1954. Both Warfarin and Pradaxa are commonly prescribed as blood thinners to reduce the risk of stroke in patients with heart rhythm irregularities.

Warfarin was used almost exclusively until November of 2005 when Boehringer Ingelheim sponsored a clinical trial to determine the long-term safety and effectiveness of their “new kid on the block,” Pradaxa. The Pradaxa blood-thinning drug trial concluded in March of 2009 to rave reviews. More than 18,000 patients were enrolled in the trial across 44 countries. Boehringer announced that Pradaxa was able to significantly reduce the risk of stroke when compared to the older established drug, Warfarin, and that it had similar or even reduced risks of causing major bleeding in the body—depending on the dosage.

Pradaxa Receives FDA Approval
Pradaxa FDA approval came in October of 2010. The FDA approved Pradaxa as the first anti-coagulant drug approved for the prevention of stroke since the approval of Warfarin. The end of 2010 saw Boehringer Ingelhem Pharmaceuticals aggressively marketing Pradaxa across the United States, touting it as a much more effective alternative to Warfarin. Then, merely three months later, the pharmaceutical company saw the first of what was to be a series of blips on the radar of their new drug which was already adding millions of dollars to their coffers. This first snag was a minor one—the FDA issued a fairly benign alert, stating that Pradaxa must be kept in its original packaging in order to avoid the potential of moisture to cause the drug to break down and lose potency.

Boehringer Reports Increase in Sales
Still riding high in August of 2011, Boehringer reported its business had seen a sixty percent increase in net sales since the launch of Pradaxa in Canada, the United States and Japan. In fact, in less than twelve months on the market, over a million prescriptions for Pradaxa were dispensed to Americans, with nearly 400,000 patients receiving a Pradaxa prescription. Apparently Boehringer should have waited for the announcement of success. Three months later, in November of 2011, Boehringer Ingelheim reported that Pradaxa had been linked to 260 deaths worldwide, then the FDA issued a safety review of Pradaxa in December of 2011. At the end of 2011 the FDA reported they were evaluating reports of serious or even fatal uncontrolled internal bleeding incidents among Pradaxa blood-thinning drug patients.

Side Effects of Warfarin vs. Pradaxa
Although Warfarin is well-known by health care professionals to sometimes cause excessive bleeding there is a major—and significant—difference between the drugs. In an emergency which involves excess bleeding there are currently no medications known which can reverse the effects of Pradaxa, while in an emergency involving Warfarin, the effects can be reversed by giving the patient Vitamin K. The downside of Warfarin is that it requires several days to take effect and the patient taking Warfarin must undergo frequent testing to arrive at the proper dosage. Warfarin has also been known to react poorly with specific foods or other medications. While Pradaxa has none of these issues, Pradaxa patients are considered to have a 33% higher risk of a heart attack or other heart disease symptoms than the patient using Warfarin. Most alarming, however, is the potential with Pradaxa for excessive bleeding which cannot be stopped, possibly leading to death.

What is the FDA Doing About Pradaxa?
The FDA is currently conducting studies to determine whether the reports of excessive bleeding among patients who are taking Pradaxa is more common than previously expected. The FDA continues to assert that Pradaxa provides important health benefits when used as directed. These studies become more complicated since a wide variety of factors can influence whether or not adverse side effects are reported. After the FDA announced their intent to study the side effects of Pradaxa prior to making a recall determination, findings from a new study were published in a well-known medical journal which suggested there could be an increased risk of heart disease in patients taking Pradaxa as compared to Warfarin.

To date, the FDA has received over 900 reports of serious negative side effects involving Pradaxa as well as reports of 500 hospitalizations and the permanent disability of twenty-five people as a direct result of Pradaxa use. The Journal of the American College of Cardiology released a study showing Pradaxa users had a 16% increased risk of severe bleeding while Warfarin users had only a 6% increased risk.

No Recall, Lawsuits Filed
Although the FDA has not yet issued a recall, they do strongly advise any person taking Pradaxa who has experienced any negative side effects to see their physician immediately. Side effects can include bruising more easily than normal, dizziness or feelings of lethargy, a serious or prolonged headache, vomiting or coughing up blood, unusual or prolonged nosebleeds or bleeding from the gums, urine which is pink or brown-tinged or a weakness or swelling in the extremities. Just this month, the first three Pradaxa lawsuits have been filed, one of which claims the death of a Tennessee woman who suffered a gastrointestinal bleed while taking Pradaxa.

What You Should Do if You Take Pradaxa
Those patients who have put their belief and trust into a drug which has FDA approval and is physician-prescribed can end up feeling confused and overwhelmed when that same drug turns out to be unsafe and is found to cause serious, life-threatening side effects. Many people have suffered serious health issues as a result of taking Pradaxa—if you or a loved one has also suffered such issues you must take steps now to protect your rights and your future. Drug companies must be held accountable for allowing dangerous drugs to flood the market.
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DISCLAIMER: All cases are based on individual circumstances and the facts pertaining to each case, and the outcome for any particular case depends on a variety of factors. None of the information provided on this website should suggest or guarantee a particular result for any given case. None of the information provided on this website should be construed in any way as legal advice. Further, none of the information provided on this website should suggest or imply the formation of an attorney-client relationship in any capacity whatsoever.

Pradaxa (Dabigatran) Lawsuits

By Independent Staff Writer

March of 2012 saw the first lawsuits filed against Boehringer Ingelheim, the manufacturer of Pradaxa. This drug was the first of its type to be marketed in over half a century, and Boehringer had high hopes that Pradaxa would knock its only competitor, Warfarin, out of the running in short order. Pradaxa works differently from Warfarin; while both drugs are used to prevent stroke in patients with atrial fibrillation, Warfarin works by inhibiting the production of Vitamin K, a clotting agent in the body. Should there be excessive bleeding in a patient who has taken Warfarin, doses of Vitamin K can be administered to slow the bleeding. Pradaxa, on the other hand, works by inhibiting thrombin, an enzyme in the blood which also controls blood clotting. At this time there is no known antidote to Pradaxa in the event it leads to excessive or uncontrollable bleeding.

What is Atrial Fibrillation?

Atrial fibrillation affects more than two million Americans and is characterized by rapid, uncoordinated contractions in the upper chambers of the heart. Patients with atrial fibrillation are at a much higher risk of developing blood clots, and since the 1950’s doctors have been using Warfarin—which is also known as Coumadin—to help lessen the likelihood of stroke. The FDA approved Pradaxa for use in patients with atrial fibrillation in October of 2010, yet less than a year later reports were coming in regarding serious side effects and even death among Pradaxa users. In December of 2011, in the face of hundreds of adverse reports, the FDA issued a safety warning to patients and physicians, stating they would taking a hard look at the prior Pradaxa studies.

Pradaxa Timeline

Pradaxa was approved in October, 2010, and aggressively marketed as an alternative to Warfarin, yet between the drug’s approval and December of 2010, over 300 adverse event reports were filed with the FDA. Many of these adverse event reports involved serious bleeding, particularly in older patients. This first FDA review also revealed that Pradaxa was being prescribed for off-label use as a general blood thinner. This off-label use was at least in part attributed to Boehringer’s aggressive marketing techniques and failure to provide accurate prescription and warning information. In August of 2011 Japanese officials demanded that Boehringer notify physicians in their country about the potential for excessive or fatal bleeding in patients taking Pradaxa as well as the fact that there is no antidote to reverse bleeding. In November, 2011 Boehringer announced that at least 260 cases of fatal bleeding have been linked to Pradaxa and the next month the FDA announced it would be evaluating the drug further.

Pradaxa Lawsuits
February of 2012 saw a review of Pradaxa published in the Journal of American College Cardiology regarding patients who had experienced adverse bleeding while taking the drug. Hematologists in Australia and New Zealand noted a total of 78 severe bleeds in Pradaxa users in a relatively short amount of time. Then in March the Journal of Neurosurgery published an article detailing an 83-year old Pradaxa user who fell and bumped his head. Although the man appeared to have only a small hemorrhage in the brain, within six hours of the brain scan he fell into a coma and died. The doctors were unable to slow the bleeding and save the man’s life because there is no antidote to Pradaxa.

The first three landmark federal court Pradaxa lawsuits were filed this last week of March in Louisiana, Kentucky and Tennessee. It is likely that Pradaxa lawsuits will focus on Boehringer’s failure to sufficiently warn Pradaxa users about the potential for excessive bleeding or to provide instructions on what to do in the case of an uncontrollable bleed. A Tennessee woman is bringing one of the first three lawsuits on behalf of her elderly mother who suffered an uncontrollable gastrointestinal bleed following the use of Pradaxa. According to court records, after taking Pradaxa for only two months the woman was hospitalized for a gastrointestinal bleed which eventually caused her death.

Possibility of a Class Action Suit

Drug manufacturers are under strict legal obligation to warn consumers of any potential risks their product could present, and when they fail to issue these warnings they may be held accountable. As of this time there is not yet a Pradaxa class action lawsuit, and all complaints are being pursued as individual claims. As more cases come forward it is possible there may be a consolidation or centralization in one court for pretrial proceedings. Although similar to a class action suit each lawsuit remains an individual claim and will be weighed on its own merits.

No Recall–Yet

While the FDA did require a label change for Pradaxa in January of 2012 which added minimal information regarding the potential of the drug to cause excessive bleeding and the current lack of an antidote to this bleeding no black box warning or FDA recall is yet on the horizon. If you or a loved one has taken Pradaxa and suffered grave injury or death, you may have a product liability case against the manufacturer of Pradaxa.

Getting the Help You Need

Because the statute of limitations in product liability cases is relatively short—2 to 6 years depending on the state you reside in—there is a very limited window of time in which you are allowed to file a suit and obtain compensation for your injuries. Pradaxa victims may be entitled to monetary damages for medical expenses, lost wages and certain other damages the court may decide upon.
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DISCLAIMER: All cases are based on individual circumstances and the facts pertaining to each case, and the outcome for any particular case depends on a variety of factors. None of the information provided on this website should suggest or guarantee a particular result for any given case. None of the information provided on this website should be construed in any way as legal advice. Further, none of the information provided on this website should suggest or imply the formation of an attorney-client relationship in any capacity whatsoever.

The Dangers of Pradaxa (Dabigatran): Part 1 of 3: Side Effects and Complications

By Independent Staff Writer

The newest drug approved for use in the treatment of heart valve problems or atrial fibrillation among patients with an increased risk of stroke is the drug Pradaxa, manufactured by Boehringer Ingelheim. The drug Boehringer is seeking to replace with its newest arrival is Warfarin—a blood-thinning drug which has been used since the early 1950’s. Boehringer claims that Pradaxa is over 30% better in decreasing the risk of a serious stroke than Warfarin. The FDA initially agreed with Boehringer, granting FDA approval of Pradaxa in October of 2010.

What is Atrial Fibrillation and How Does Pradaxa Help?

Atrial fibrillation affects over two million Americans and involves excessively rapid, uncoordinated contractions of the upper two chambers of the heart. Those with atrial fibrillation are at a much higher risk of developing blood clots which in turn can lead to a disabling stroke should the clot travel to the brain. Pradaxa works by inhibiting thrombin, an enzyme in the blood which controls blood clotting.

Excessive Bleeding as a Pradaxa Side Effect?

In the initial trials, Pradaxa users suffered fewer strokes than patients taking Warfarin. Pradaxa also appeared to have other benefits over Warfarin in that Warfarin users must undergo blood test monitoring and must be more cautious in what foods and other medications they take while on Warfarin. Unfortunately, one of the primary issues with either drug involves Warfarin or Pradaxa internal bleeding. When the patient taking Warfarin experiences excessive bleeding, doctors can reverse the effects of the bleeding through injections of Vitamin K, however no such antidote exists to reverse the effects of Pradaxa when excessive bleeding occurs.

Gastrointestinal Dangers of Pradaxa

As with any prescription drug, side effects are possible and even likely. Pradaxa users may have an uncomfortable feeling in their stomach known as dyspepsia, pain in the stomach, excessive heartburn or nausea or bloating in the stomach. It has been suggested that Pradaxa may cause gastrointestinal effects due to the fact that, unlike most drugs, the active ingredient of Pradaxa is actually on the outside of the capsule, forming a shell around a Tartaric Acid Core. This core, once released, creates an acidic environment in the intestinal tract which allows quick absorption of the Pradaxa active ingredients.

More Serious Pradaxa Complications

More serious Pradaxa complications can include uncontrolled bleeding, potentially leading to death. If you are taking Pradaxa and experience any bruising that is unusual or unexpected, notice a pink or brown tinge to your urine, have unexpected swelling or pain in your joints, have a serious headache which lasts a long time, dizziness or weakness or red or black stools you must see your physician immediately as this can indicate internal bleeding. If you have any unusual bleeding in the gums, recurring nosebleeds, or a heavier than normal period you should also seek advice from your doctor. Those patients who are over the age of 75 or have kidney problems or a stomach ulcer should use caution when taking Pradaxa, as these issues make the likelihood of Pradaxa side effects and risks much more likely. Those whose kidney function is less than optimal could experience a greater incidence of Pradaxa side effects since the kidneys are responsible for flushing out excess Pradaxa from the body.

Fatal Effects of Pradaxa

Intra-articular bleeding, pericardial bleeding, subdural bleeds, intracranial hemorrhage and hemorrhagic stroke are all potential fatal effects of taking Pradaxa. The Pradaxa works as a blood clot inhibitor to prevent clots from forming in a different manner than Warfarin or Coumadin. Warfarin is a Vitamin K adversary which prevents the formation of blood clots by intervening in the body’s Vitamin K production. Pradaxa, on the other hand works by inhibiting thrombins which are naturally occurring proteins in the body which encourage clot formation. With no known antidote to the effects of Pradaxa, bleed-outs can happen so swiftly that death occurs before measures can be taken to prevent it. There also currently exists no known method for measuring the anticoagulant effect of Pradaxa, while Warfarin anticoagulant effects can be tested in those taking the older drug.

Negative Reports of Serious Effects of Pradaxa

Agencies outside the United States have taken a harder stance against Pradaxa; in Europe patients whose physicians recommend Pradaxa are advised to first have their kidneys checked since an elderly patient with less-than-optimal kidney function has a much higher risk of suffering from internal bleeding. Europe has reported 21 cases of bleeding deaths related to Pradaxa while Japan has reported 14 cases. Japanese regulators have insisted that the manufacturer of Pradaxa issue strong warnings to physicians regarding the potential for deadly bleeding, especially in older patients.

FDA Stance

A letter which was published in a medical journal, Therapeutics Initiative, stated Boehringer was aware of significant flaws in their initial Pradaxa drug trial but overlooked certain issues in order to gain FDA approval. Despite over 260 deaths worldwide which have been definitively linked to Pradaxa use, the American FDA continues to take a more cautious approach. Although the FDA issued a safety review in December of 2011and is reviewing all reports of serious bleeding in patients using Pradaxa, they continue to state that patients using Pradaxa should continue for now and that Pradaxa offers “an important health benefit when used as directed.”

Lawsuits against Pradaxa Manufacturers

Three lawsuits have been filed against the manufacturers of Pradaxa this month, and it is believed that many more are to come. Many believe that Boehringer should have placed a warning on their “wonder drug,” making physicians and patients aware that there currently exists no quick way to manage a bleed in the body caused by Pradaxa. It is likely that Boehringer will be held responsible for failing to adequately warn those taking Pradaxa of the myriad of potential risks, some of them fatal.

Anyone taking Pradaxa, particularly those who are over the age of 75 or who have a history of kidney problems should be aware of the risks when taking this drug. As more time passes more and more reports are coming in of Pradaxa users who have suffered gastrointestinal bleeding, cerebral bleeds or vascular and cardiovascular health issues. If you have suffered a health issue after using Pradaxa, speak with your physician to determine if Pradaxa was responsible.
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DISCLAIMER: All cases are based on individual circumstances and the facts pertaining to each case, and the outcome for any particular case depends on a variety of factors. None of the information provided on this website should suggest or guarantee a particular result for any given case. None of the information provided on this website should be construed in any way as legal advice. Further, none of the information provided on this website should suggest or imply the formation of an attorney-client relationship in any capacity whatsoever.

The Dangers of Pradaxa (Dabigatran) Part 2 of 3:

By Independent Staff Writer

Some experts feel that the German pharmaceutical company, Boehringer Ingelheim, rushed their new wonder drug, Pradaxa to the market perhaps a bit too quickly in an attempt to beat the competitors to the mark. Pradaxa subsequently became the first drug to rival Warfarin in over half a century. Boehringer announced that Pradaxa was as much as 35% more efficient in decreasing the risk of serious stroke than Warfarin, and in less than a year there were over a million prescriptions issued for the drug to over 400,000 patients hoping to avoid the negative aspects of Warfarin.

How is Pradaxa Used?

Pradaxa is primarily used for patients suffering from atrial fibrillation and to reduce the risks of stroke. Pradaxa also appeared to offer additional advantages over Warfarin in that there was no need for regular blood level monitoring as well as the fact that Pradaxa users didn’t have to be as concerned with mixing Pradaxa with certain foods and other medications as those taking Warfarin. While Vitamin K antagonists, such as Warfarin, are the mainstay of long-term anti-clotting therapy, there certainly exists a need for newer and safer anticoagulants. Pradaxa and other similar drugs currently undergoing trials use thrombin inhibitors as their primary ingredient; unfortunately the side effects of Dabigatran can be serious or even fatal.
Rushing the Drug to Market

In order to get its drug to market, Boehringer conducted a study of 18,000 patients, however rather than an independent study, this one was paid for by Boehringer, and the doctors who subsequently published glowing reports of the drug in medical journals disclosed at the end of those articles that they received a consulting fee, lecture fee or grant support from Boehringer Ingelheim. Later, doctors began seeing ill effects in Pradaxa users and pointed out that unlike Warfarin no reversal agent existed for the drug. In other words, any patient suffering a catastrophic bleeding event while taking Warfarin would stand a chance of living since Warfarin has an effective antidote. Pradaxa, unfortunately, does not. At this point in time over 260 deaths have been reported in those taking Pradaxa, particularly in older patients or those with a prior history of kidney disease.

Pradaxa and Cardiovascular Risks

While the fact that Pradaxa can cause excessive internal bleeding appears to be the primary risk when taking the drug, there are other potential health risks as well. Recent studies suggest an increased risk of heart attack in patients taking Pradaxa, and one online medical resource, WebMD, reports that when compared to Warfarin Pradaxa posed a 33% increase in the risk of serious heart attack. Even if you believe Boehringer’s statement that there is only a very small increase in the risk of heart attack for those taking Pradaxa, patients who have a history of or prior risk of heart attack may want to reconsider taking the drug.

Another meta-analysis of Pradaxa showed it to be associated with greater odds of myocardial infarction and acute coronary syndrome than control treatments. In fact, in controlled trials, acute coronary syndrome or myocardial infarction occurred at a significantly higher rate in those taking Pradaxa. Although Pradaxa appears to reduce the risk of stroke, for those with any indication or history of cardiovascular incidents, Pradaxa may not be the best choice.

Pradaxa’s Connection to Cerebral Hemorrhage

Bleeding in the brain is also known as a cerebral hemorrhage and is a type of stroke which occurs when a brain artery bursts, leaking blood into the surrounding brain tissues. When this blood comes into contact with brain tissue, it causes those tissues to become irritated and swell up. The blood also disturbs brain cells, in many cases leading to irreparable brain damage. Once the blood pools it can form a hematoma which in turn causes pressure inside the skull. One of the primary causes of a brain hemorrhage is head trauma from a fall. Since falls are common among the elderly, and because nearly half of all people hit their head when they fall, cerebral hemorrhages become more likely.

When an elderly person is taking Pradaxa and hits their head in a fall, the bleeding may become excessive, leading to death. In fact a Journal of Neurosurgery report detailed the death of an 83-year-old Pradaxa patient who suffered a relatively minor fall and later died of a cerebral hemorrhage. When the man arrived at the hospital he was awake and alert, and a CT scan indicated only a small area of bleeding on the brain. The man was given IV fluids and a protein which encourages blood clotting, however the doctors were unaware the man was taking Pradaxa and the protein would be completely useless. Blood soon filled the entire left side of the elderly patient’s brain, causing him to become comatose and die.

How Pradaxa Works

Because the drug Dabigatran is more consistently absorbed in an acidic environment, Boehringer took the unusual stance of applying the Dabigatran coating to the outside of a tartaric acid core to form the tiny pellets which are then placed in a capsule. This ensures that the absorption of theDdabigatran is not dependent on the gastrointestinal acidity of the individual patient rather the tartaric acid core creates its own acidic environment. In theory, this decreases the variable of the individual patient’s gastrointestinal pH environment. Unfortunately the acidic core of the Pradaxa capsule can cause gastrointestinal disturbances among Pradaxa users. Many users experience bloating or an uncomfortable, overly full feeling in their stomach while taking Pradaxa while others suffer heartburn, nausea and diarrhea.

If you or a loved one experience any type of unexpected or unexplained bruising, swelling or pain in the joints, discolored urine (pink or brown), bleeding from the gums or red or black stools, this is definitely cause for alarm and requires a visit to your physician. If you feel you have been harmed from taking Pradaxa, it is important to seek medical help from a qualified physician.
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DISCLAIMER: All cases are based on individual circumstances and the facts pertaining to each case, and the outcome for any particular case depends on a variety of factors. None of the information provided on this website should suggest or guarantee a particular result for any given case. None of the information provided on this website should be construed in any way as legal advice. Further, none of the information provided on this website should suggest or imply the formation of an attorney-client relationship in any capacity whatsoever.

The Dangers of Pradaxa (Dabigatran) Part 3 of 3: Serious Vascular Risks

By Independent Staff Writer

Pradaxa, the drug which less than a couple of years ago seemed like a dream come true for the hundreds of thousands of patients who were taking Warfarin or Coumadin has had its initial glow tarnished by the ever-increasing number of reports of serious side effects from use of the drug. Although Warfarin has been used as a stroke inhibitor and for those suffering from atrial fibrillation since the 1950’s, it comes with certain restrictions and its own set of side effects. Those who are on a Warfarin regimen must have regular blood tests taken, and must also be very careful of foods and other prescription drugs they mix with Warfarin.
However, there is a significant difference in the way Warfarin and Pradaxa work in the body, most notably the fact that in the event Warfarin causes excessive bleeding, the effects can be reversed by administering a dose of Vitamin K. When Pradaxa causes excessive bleeding there is no known antidote, leaving the patient vulnerable to literally bleeding to death. Pradaxa is a direct thrombin inhibitor which, in the initial 18,000 person trial, showed great promise in reducing strokes and helping those patients with atrial fibrillation lead a healthier life. The manufacturer of the drug, Boehringer Ingelheim, has been accused of rushing through the initial trial in order to get their drug on the market before other potential rivals, ignoring some potential risks in the process.

How Does Pradaxa Work?

The simplest explanation as to how Pradaxa works is that it thins the blood in those with atrial fibrillation, lowering their chances of having a life-threatening stroke. When a person’s heart beats irregularly, the blood is not pumped through the body as effectively as it should be which in turn causes blood to pool in the upper chambers of the heart. This pooling of blood then causes clots to form in the heart which can break away and travel to the brain, blocking an artery and causing a stroke.

Pradaxa’s active ingredient works by attaching itself to thrombin which are the blood’s central clotting agencies, reducing the ability of the thrombin to cause a clot and forestalling a possible stroke. Pradaxa was considered a good alternative to those patients with atrial fibrillation who were already on Warfarin yet were having trouble managing the necessary monitoring regimen, or patients who were on no regimen at all but were considered at risk for stroke. Pradaxa was not recommended for those with mechanical heart valves, those with severe valvular disease those on long-term treatment for deep vein thrombosis or patients with renal impairment. Patients who indicated chronic use of NSAIDS or those who were pregnant were also warned not to take Pradaxa, however patients were warned against discontinuing Pradaxa due to the elevated risk of stroke.

Perhaps even more alarming is the fact that one missed does of Warfarin does not significantly affect the efficacy of the drug. One missed dose of Pradaxa, however, significantly decreases the anticoagulant effect, putting the patient at serious risk of stroke, pulmonary embolism and the formation of thrombus. For every person who regularly takes prescription drugs—and who has accidentally missed a dose for a variety of reasons—this fact is a bit frightening particularly remembering the often-prescribed twice-daily dosing regimen.

Serious Vascular Risks Associated With Pradaxa

Less than a year after Pradaxa received FDA approval, reports of adverse effects of the drug started coming in. Of the 260 reported deaths related to Pradaxa, most occurred in older patients and came about through excessive internal bleeding which doctors were unable to reverse or control. Vascular disorders include internal bleeding, pericardial bleeding, intra-articular bleeding, subdural bleeding and in some cases, death. Intracranial bleeding from Pradaxa has also been noted in some patients, especially following a fall resulting in a bump on the head.

Over a period of two months, a group of New Zealand hematologists noted a “cluster” of bleeding episodes—78 to be exact—among patients taking Pradaxa. Over a dozen of these episodes were considered major and severe, while one person died from excessive bleeding. It was noted that a large portion of the bleeding incidents involved patients over the age of 75, or those with impaired renal functions. The New Zealand hematologists also stated that prescriber error accounted for about 25% of the bleeding complications citing a lack of physician awareness of the potentially serious side effects associated with Pradaxa use.

Less Serious Risks of Pradaxa

Even in those who don’t suffer serious bleeding events, they may have diarrheas as a side effect of Pradaxa or nausea and heartburn as a side effect of Pradaxa. Many users will have stomach pain or a very uncomfortable feeling in their stomach commonly known as dyspepsia. The stomach may be bloated, and the user may simply feel a general discomfort in the stomach. Because the active ingredient of Pradaxa is actually located on the outside of the capsule, formed around a shell of Tartaric Acid, the likelihood of gastrointestinal issues is fairly high. Since the active ingredient of Pradaxa needs an acidic environment to work, the manufacturers simply added their own source of acid to the drug which allows much quicker absorption of Pradaxa’s active ingredients.

Pradaxa Lawsuits

The first Pradaxa lawsuit was filed just this month against the manufacturer of Pradaxa, Boehringer Ingelheim, by Bertha Bivens who claims her mother died following a gastrointestinal bleed caused by Pradaxa only three months after beginning a Pradaxa regimen. As of November, 2011, over 260 deaths were attributed to Pradaxa, and all of these centered around unexpected and extreme bleeding. Soon after this first lawsuit was filed, five more quickly followed with many more expected.

If you have experienced the less serious gastrointestinal side effects of Pradaxa, you still should discuss the issue with your doctor. If you have experienced any unusual or prolonged bruising, bleeding gums, notice a pink or brown color to your urine, have experienced unexpected swelling or pain in your joints, have suffered a severe headache lasting much longer than normal, have had dizziness, weakness, red or black stools, recurring nosebleeds or heavier than normal periods, see your doctor immediately as these side effects could indicate internal bleeding.
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DePuy Litigation: Statute of Limitations Depuy Lawsuits

By Independent Staff Writer

In August of 2010 DePuy Orthopedics, Inc. recalled two of its most popular hip replacement systems—the ASR XL Acetabular and the ASR Hip Resurfacing System. The recall came on the heels of a study which indicated the five-year failure rate of these products was as high as one in every eight patients. Severe pain and metal toxicity in the blood have required many of those who received a DePuy hip replacement to have revision surgery to replace the defective implant. Although the DePuy Pinnacle system has not yet been recalled it utilizes the same metal-on-metal design as the ASR, and many of those who received the Pinnacle implant have experienced the same symptoms including loosening of the hip implant, unsafe chromium and cobalt levels in the blood and extreme pain.

What is a Statute of Limitations?
All lawsuits filed in the United States have an expiration period known as the Statute of Limitations. After this time period has passed an injured party is prohibited from filing a recovery case. These statutes are meant to guard companies from being exposed to lawsuits for long periods of time as well as to ensure the suits are filed while evidence is preserved and memories are clear. Depending on the state you reside in the statute of limitations for product liability can range from two to six years.

DePuy’s “Offer”
Following DePuy’s recall of their hip implants the company stated that patients who met specific criteria might be able to have some of their medical costs covered. Before any type of reimbursement is issued, however, DePuy will review patient’s medical records to determine whether the patient is eligible for reimbursement. The problem with this is that DePuy states the patient’s medical records must confirm a revision surgery is definitively related to the ASR recall rather than another cause such as a “traumatic fall.” In other words, the company is likely to attempt to blame the failure of the hip implant on a pre-existing condition, an underlying disease, physician error or misuse, therefore providing DePuy with sensitive medical records could well mean you would receive no money at all for the defective product implanted in your body.

Overview of the Statute of Limitations for Recalled DePuy Implants
If you received a DePuy hip implant and have suffered medical issues as a result, you must be aware of how the legal statute of limitations may affect your right to pursue legal action for the harm done to you. It is urged that potential claimants exercise a measure of urgency in obtaining legal representation for a potential recovery suit. The DePuy hip implant recall occurred in August of 2010, and it is estimated it affected more than 90,000 devices worldwide. In most states—including Texas—personal injury and product liability statute of limitations are only two years, therefore those who reside in a state where a two-year product liability statute exists may only have until August of 2012 to file a DePuy hip implant suit. In order to ensure you preserve your rights, it is a good idea for any hip implant recipient who has experienced painful side effects to seek prompt legal action in the event revision surgery becomes necessary.

Has the Statute of Limitations Been Extended for DePuy Lawsuits?
The date the injury occurred often governs when the statutes begin, which could be construed, in the case of the DePuy hip implant, to mean the exact time the DePuy implant was received. This would mean victims had a narrow window of time to seek recovery against the company and could be stuck DePuy’s vague compensation offer. The potentially advantageous news for victims of the defective hip implant is that the damage caused by hip implant could be considered a continuing tort for the amount of time the implant remains in the body of the recipient. The theory is that the defective device is continuously harming the person it was implanted into. If this theory is deemed applicable in this particular case, then the statute of limitations would begin from the date of hip revision surgery. Any person who has had a hip revision surgery and was implanted with a DePuy device should not leave the statute of limitations to chance, rather should seek the immediate advice of a qualified personal injury attorney in your area.