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Granuflo Lawsuit

Granuflo Lawsuit

Granuflo Lawsuit

10/01/2012 – The Granuflo Lawsuit has officially begun. What may have been the first Granuflo Lawsuit to have been filed was served on the Frienus USA INC, naming the manufacturer of Granuflo and several of its subsidiary companies as defendants in a Granuflo Lawsuit in which a the family of an Alabama man brought suit as a result of the death of their family member.

Granuflo Lawsuit Lawyer

Anyone who has been injured by Granuflo and contact (800) 611-7080 to arrange a free consultation with an attorney accepting clients for the Granflo Lawsuit. You may also arrange a free legal consultation by using the contact form on this page.

Granuflo Lawsuit

The Alabama Granuflo Lawsuit essentially alleges that the death of the plaintiffs family member was a direct result of the the administration of Granuflo. Granuflo is an Acid Concentrate used as an additive in dialysis treatments for patients who have severe kidney problems or total kidney failure.

The Granuflo Lawsuit further alleges that the makers of Granuflo knew as early as November of 2011 that there was a significant increased risk of heart attacks which could lead to death associated with the use of Granuflo. It does not appear however that Fresenius shared this information with the United States Food and Drug administration or patients being administered Granuflo at the time they discovered the problem.

Cases in which significant relevant information can be proven to have been withheld by the manufacturer of a pharmaceutical product can often create a more dire situation for the drug manufacturer  than would existed had they revealed the information to the public as soon as they became aware that their product might have side effects which were previously unknown.

Granuflo Heart Attacks

A person undergoing hemodialysis already has a significant medical condition which can compromise their overall health and make it more difficult for them to withstand or recover from other medical problems they may experience.  Although we are unaware of any studies that have been conducted that focused on the death rate among dialysis patient’s verses otherwise healthy individuals it is logical to assume that anyone with significantly compromised health may be more likely to die as a result of a heart attack than someone who was otherwise healthy.

Granuflo FDA

At some point after the United States Food and Drug Administration became aware of the link between Granuflo and heart attacks. A Grauflo FDA recall was issued in March of 2012. Of course this Granuflo FDA action will have occured too late for those who were administered Granuflo and suffered a heart attack.  The bulk of the Granuflo Lawsuit plaintiffs will be those who suffered a granuflo heart attack prior to the FDA recall.

FDA Recall

The Granuflo Recall by the FDA was a Class 1 Recall. A class one recall is one of the most significant recalls that the FDA issues. In March of 2012 the FDA cautioned clinicians to be aware of the concentration of acetate of sodium diacetate contained in Granuflo..The caution included warnings that these substances increase the risk of law blood pressure, hypoexemia, hyercapnia and cardiac arythmia. The FDA caution when on to warn that these risks can lead to cardiopulmonary arrest. Cardio Pulmonary arrest is more commonly called “heart attack”.  Visit this link for more information on the Granuflo Lawsuit FDA Recall.

Pradaxa Lawsuit Moves Forward

Pradaxa Lawsuit Moves Forward

Pradaxa Lawsuit Moves Forward

09/27/2012 – Pradaxa Lawsuit Moves Forward: The Pradaxa Lawsuit multidistrict ligation certified by the the United States Judicial Panel on Multidistrict litigation earlier this year will continue to move forward despite defendants motions to stop the Pradaxa Lawsuit through various motions.

The number of Pradaxa Deaths that have been reported to the FDA and that the maker of Pradaxa has admitted to being aware of continues to increase. Many Pradaxa Internal Bleeding events, the more serious of the bleeding events linked to Pradaxa are more than likely responsible for the number of Pradaxa Deaths that have occurred to date.

Given that the number of Pradaxa Deaths currently being reported are largely based on reports filed via the FDA Adverse Event reporting system, it is possible that the death toll linked to Pradaxa could be much higher than anyone is currently aware of. The general public is largely unaware of the existence of the FDA Adverse Event reporting system therefore, adverse events of any kind relating to any drug or medical device are most likely significantly under reported.

Although the maker of Pradaxa did give warnings regarding the risk associated with Pradaxa Bleeding, Pradaxa Lawsuit Lawyer firms contend that the warnings were not adequate. The fact that Pradaxa Failed to Warn the public that the reversal agent that is effective with similar drugs to Pradaxa does not work for Pradaxa users, is the basis of the “failure to warn” allegations being made by Pradaxa Lawyers.

Vitamin K is effective in helping to stop bleeds in users of drugs in the same class as Pradaxa, such as Warfain. Other drugs in the same class as Pradaxa have been on the market for decades and it has long been known that Vitamin K was helpful in stopping bleeding events in users of these drugs. At this point in time we do not know if the maker of Pradaxa even tested the effectiveness of Vitamin K in stopping Pradaxa Bleeding however, given that the antidote has been well known to help stop bleeds for other drugs, it is reasonable to expect that the makers of Pradaxa did or should have included tests of this reversal agent in their clinical trials.

If you were injured by Pradaxa, please contact us toll free at (800) 611-7080 to arrange a free consultation with a Pradaxa Lawsuit Lawyer.

Nuvaring Lawsuit Plaintiffs May Be More Numerous Than Estimated

Nuvaring Lawsuit Plaintiffs May Be More Numerous Than Estimated

Nuvaring Lawsuit Plaintiffs May Be More Numerous Than Estimated

09/25/2012—Plaintiffs Deborah Payne and Eric Nelson filed a Nuvaring Lawsuit, by and through their Nuvaring Lawyer, in the United States District Court of New Jersey recently.  Plaintiff Deborah Payne utilized Nuvaring from approximately 2004 to October 23, 2010.  On or about October 23, 2010, she suffered a bilateral pulmonary embolism.  Her husband, Plaintiff Eric Nelson has been added to this Nuvaring Lawsuit because he alleges that he has lost the consortium of his wife, who will require continuing medical care as a result of her injuries.

Plaintiffs allege that Defendants marketed, promoted and advertised the ring product to physicians and to the public as equally or more safe than oral contraceptive pills even though Defendants knew that it was less safe. Plaintiffs further allege that Defendants marketed, promoted and advertised the ring product as presenting less of a risk of thrombotic side effects than other means of contraception because of its relatively low amount of estrogen in an attempt to disguise the fact that it had a high level of a dangerous third-generation progestin, capable of causing thrombotic side effects. Plaintiff also states that Defendants failed to warn prescribing physicians and the public that the ring product was associated with more thrombotic events than the pill.

Plaintiff goes on to state that Defendants failed to provide proper and full information as to safety to the Food and Drug Administration, which regulated the sale of the ring, and thereby avoided having appropriate warnings and cautions added to its labeling and advertising.  Plaintiff asserts that Defendants obtained permission to market the ring product by presenting safety data derived from studies on the pill and failed to do proper clinical investigation with actual users of the ring product.  Plaintiff alleges that in actuality, the ring product released a continuous stream of hormones (progestin and estrogen) into the body of the user at a higher level than in its promotional literature explained.

Plaintiff Deborah Payne alleges that Nuvaring is a defective product and that due to Defendants’ failure to warn consumers and medical providers of the risks associated with use of Nuvaring Defendants caused the injuries that Deborah Payne suffered.  Had Ms. Payne known about the risks of using Nuvaring she would not have used the product and would not have been injured.

At this time we do not know if the Plaintiffs case will be added to the Nuvaring Multidistrict litigation or as it is more commonly called, the Nuvaring Class Action Lawsuit. Contact us for more information or to arrange a free legal consultation.

Yaz Lawsuit New Plaintiffs Continue to File Suits

Yaz Lawsuit New Plaintiffs Continue to File

Yaz Lawsuit New Plaintiffs Continue to File

09/25/2012—Recently a Yaz Lawsuit was filed in the Southern District of Illinois by Plaintiff Alexis Carrier, by a Yaz Lawyer representing the plaintiff. The plaintiff has brought this Yaz Lawsuit in the ongoing Yaz Multi District Litigation because of a deep vein thrombosis injury that she suffered in or about October 11, 2011.  She alleges that her injuries were caused by the Defendants in this Yaz Lawsuit, and that her injuries were severe and permanent.

The Yaz Lawsuit that was recently filed was filed within the current Multi-District Litigation Action pending within the Southern District of Illinois.  This Multi-District Litigation action includes claims for injuries against the manufacturers of Yaz, Yasmin and Ocella.  The Plaintiff was able to file her Yaz Lawusit within this Multi District Litigation Action because she took Yasmin and Ocella between May 2006 and October 2011 and her injuries are allegedly correlated to her use of these drugs.  This multi-district litigation action differs from a Yaz Class Action Lawsuit.  In the Yaz MDL or Multi-district Litgation each separate Yaz lawsuit filed across the country will be consolidated into this one court and addressed by this one appointed judge.

Plaintiff alleges that Defendants owed a duty to exercise reasonable care in the design, manufacture, testing, marketing, distributing, sale, and/or post-sale surveillance of Yasmin and Ocella. Plaintiff further alleges that Defendants failed to exercise ordinary care in the design, formulation, manufacture, testing, quality assurance, quality control, distribution, marketing, sale, and/or post-sale surveillance of Defendants’ Yasmin and Ocella in that Defendants knew or should have known that Defendants’ Yasmin and Ocella could cause such significant bodily harm and death and were not safe for administration to consumers.  Plaintiff states that despite the fact that Defendants knew or should have known that Defendants’ Yasmin and Ocella posed a serious risk of bodily harm to consumers, Defendants continued to manufacture and market Defendants’ Yasmin and Ocella for administration to patients. Both the Yaz and Yasmin Lawsuit are combined in the Illinois MDL

Plaintiff states that Defendants did not adequately warn consumers of the risks associated with use of Yasmin and Ocella.  She asserts that had she or her medical care providers known of the high level of risk associated with use of Yasmin and Ocella she never would have been injured because she would not have taken these drugs in the first place.

For more information on the Yaz and Yasmin Lawsuits or to arrange a free legal consultation please contact us toll free at 800-611-7080 or via our contact form on this page.

Yaz Lawsuit New Case Filed

Yaz Lawsuit New Case Filed

Yaz Lawsuit New Case Filed

09/20/12 — Plaintiff Suzannah Marek has recently filed a Yaz Lawsuit against multiple Defendants for damages associated with her ingestion of the pharmaceutical drug Yasmin (ethinyl estradiol and drospirenone), which is an oral contraceptive designed, manufactured, supplied, marketed, and distributed by the named Defendants in her Complaint. Specifically, Plaintiff alleges that as a direct result of her use of Yasmin, Plaintiff Suzannah Marek was diagnosed with a pulmonary embolism on March 5, 2003. We have not been informed at this time whether or not this case will be added to the Yaz Multi District Litigation, which is often referred to as the Yaz Class Action Lawsuit.

The Yasmin Lawsuit as well as the Yaz Lawsuit are both based on nearly idenfical causes of action. Yasmin and Yaz contain the same estrogen component, ethinyl estradiol, which has been used in the lower dose birth control pills for decades.  However, its other component, drospirenone, is a new type of progestin and is considered a “fourth generation” progestin. Plaintiff alleges that no other birth control pills contain drospirenone, except for a recently approved generic version of Yasmin marketed under the trade name Ocella and the generic version of Yaz that is marketed under the trade name Gianvi (which The Associated Press and Reuters reported was approved by the FDA in June 2010).    Plaintiff further alleges that Drospirenone is new and there are not decades of data available to support its safe use. Studies that were done prior to FDA approval, however, indicate that drospirenone has certain effects that are different from traditional second generation progestins, and is potentially more dangerous.

Plaintiff asserts that one possible mechanism of action is that drospirenone interacts differently with ethinyl estradiol in comparison to other progestins, such that it does not sufficiently counterbalance the clotting effects of estrogen as do other progestins (particularly the second generation progestins).  Plaintiff states that another possible mechanism of action is that drospirenone causes an increase in potassium levels in the blood, which can lead to a condition known as hyperkalemia if the potassium levels become too high.  Hyperkalemia can cause rhythm disturbances, such as extrasystolies, pauses, or bradycardia. If left untreated.  If hyperkalemia disrupts the normal heart rhythms, the flow of blood through the heart can be slowed to the point that it permits blood clots to form. Blood clots in the heart can then lead to heart attacks, or the clots can break off and travel to the lungs where they can cause pulmonary embolism, or can travel to the brain causing stroke.

For more information on the Yaz Lawsuit or the Yasmin Lawsuit or to arrange a free legal consultation with a Yaz Lawyer about your potential Yaz Lawsuit , contact the toll free Yaz Lawsuit Hotline at (800)611-7080.

Pradaxa Lawsuit News From Illinois

Pradaxa Lawsuit News from Illinois

Pradaxa Lawsuit News from Illinois

08/31/2012 Pradaxa Lawsuit News From Illinois. Contact 800-611-7080 for information on Pradaxa Lawsuits.  A new Pradaxa Lawsuit was filed by an Illinois resident adding to the growing number of Pradaxa Lawsuit cases currently being pursued against the manufacturer of the drug.

Among the claims made in the Illinois Pradaxa Lawsuit were the following:

The Pradaxa Lawsuit alleged that the Pradaxa  had not been fully or adequately tested

The Illinois Pradaxa Lawsuit Further Alleged that Pradaxa® does not have any known reversal agents (whereas similar drugs such as Warfarin do and thus the claims made by the manufacturer of Pradaxa that is was superior to alternative treatments were false and misleading.

Further alleged in the Pradaxa Lawsuit was the allegation that Pradaxa® bleeds can not be stopped or controlled by any effective medical processes or medical intervention.

One of the most central claims to the Pradaxa Lawsuit was the claim that the maker of Pradaxa failed to warn that it is difficult or impossible to assess the degree and/ or extent of anticoagulation in patients taking Pradaxa.

The allegation that Pradaxa was not as safe as blood thinners such as warfarin is most relevant to the fact that the manufacturer of Pradaxa Made and to the best of our knowledge is still making claims that Pradaxa is superior to other drugs such as Warfarin. Marketing claims made by drug manufacturers are held to a high standard for accuracy due to the fact that the public as well as prescribers make decisions as to what pharmaceuticals they do and do not take and prescribe based partially and sometimes completely on the marketing representations made by the manufacturer of the medication.

Making false or misleading representations regarding efficacy or other factors related to a drug like Pradaxa can lead to action by the United States Food and Drug Administration as well as lead to claims in lawsuits in the event that the drug has serious negative side effects that lead to injuries of those who take the drug.

The new Pradaxa Lawsuit filed in Illinois is highly unlikely to be the last. It would appear that we are just now seeing the tip of the iceberg of how many people were injured or died as a result of taking Pradaxa.

Pradaxa Lawsuit Motion to Dismiss Denied by Court

Pradaxa Lawsuit Motion News

Pradaxa Lawsuit Motion News

08/30/2011 – Pradaxa Lawsuit Defense Motion to Dismiss Denied: Contact 800-611-7080 for Pradaxa Lawsuit information. The maker of Pradaxa and the defendant in the ongoing Pradaxa Lawsuit, Boehringer Ingelheim Pharmaceuticals Inc, attempted to put an early end to the case by filing a motion to dismiss on one of the Pradaxa Lawsuit cases that is already underway. If the court had ruled in favor of the defendants motion to dismiss, it would have been a victory for the defense that would have most likely led to similar motions to dismiss in other Pradaxa Lawsuit cases. The court however did not rule in Favor of the defense but instead denied the motion and allowed the Pradaxa Lawsuit case to proceed.

Given that a Pradaxa Multidistrict Litigation, often referred to as the Pradaxa Class Action Lawsuit, although the legal processes are different, is moving forward and more information on the Pradaxa Lawsuit Multi District Litigation should be available soon. We will report updated information on all issues related to the Pradaxa Lawsuit as they become known.

Given that the manufacturer of Pradaxa already admits to being aware of a large number of bleeding events that led to the death of Pradaxa users this did not stop the manufacturer from trying to deal a serious blow to the efforts of those attempting to be compensated for injuries caused by Pradaxa.

One issue many attorneys knowledgeable about the facts of the Pradaxa Lawsuit case point out is the fact that the manufacturer marketed Pradaxa as being superior to other drugs used to treat similar disorders when in fact Pradaxa had inherent characteristics that made claiming any superiority over similar products potentially misleading. One aspect of Pradaxa that many attorneys feel made the claims of superiority potentially misleading has to do with the fact that Warfarin, the primary drug Pradaxa competes against has an antidote to stop the bleeding if an uncontrolled bleeding event occurs. We have been informed that this same antidote does not work to stop bleeding events caused by Pradaxa . Given that this information is correct and can be proven in court it may be difficult for the maker of Pradaxa to justify its marketing claims that Pradaxa is superior to Warfarin. To the best of our knowledge these marketing claims are still being made by Pradaxa in what appears to be an advertising blitz that seemed to have coincided with the initial publicity regarding the dangers related to Pradaxa.

If you or a loved one has been injured by Pradaxa, please contact (800) 611-7080 to arrange a free legal consultation with a Pradaxa Lawyer.

Yaz Lawsuit MultiDistrict Litigation News

Yaz Lawsuit MultiDistrict Litigation News

Yaz Lawsuit MultiDistrict Litigation News

08/29/2012  Yaz Lawsuit News: For uptodate information contact 800-611-7080. As of the latest report from the United States Judicial Panel on Multidistrict Litigation, the current number of remaining active lawsuits in the Yaz Lawsuit and Yasmin Lawsuit Multidistrict litigation stands at 8,825 cases down from a historical high of 9,645. This refers to the Multi District Litigation being heard in the Court of Chief Judge David Herndon.  The number of cases included in the MDL do not necessarily represent the total number of outstanding Yaz Lawsuit and Yasmin Lawsuit cases as all plaintiffs do not necessarily chose to add their case to the Multidistrict litigation and new Yaz Lawsuits and Yasmin Lawsuit continue to be filed.

The terms Yaz Multidistrict Litigation and Yasmin Multidistriction  are not commonly known to the public. The terms Yaz Class Action Lawsuit and Yasmin Class Action Lawsuit are more commonly used by the public although a class action lawsuit and a Multidistrict litigation are not technically the same type of legal proceedings. Both class action lawsuits as well as multi district litigations both generally stem from Mass Torts.

A mass tort is simply a legally actionable wrong done to a large (mass) number of people by a single or small group of defendants. One of the primary differences in a class action lawsuit and a multidistrict litigation is the fact that the plaintiffs in a class action must all have nearly identical damages and the case is heard as a single lawsuit. In a multidistrict litigation, cases are consolidated into a single court before a single judge as with a class action lawsuit however, the individual lawsuits in a multidistrict claim remain separate and unique claims. The forming of a Multidistrict Litigation is more common in a pharmaceutical lawsuit as the damages suffered by the plaintiffs from a defective drug can vary widely and thus the group cannot and should not be treated as a class.

If you or a loved one has suffered a blood clot related injury after taking Yaz or Yasmin please contact the toll free Yaz/Yasmin Lawsuit hotline set up by Best Legal Source to arrange a free consultation with an attorney filing Yaz Lawsuit cases and Yasmin Lawsuit cases. The toll free hotline can be reached 24 hours per day at 1-800-611-7080

Alex Begum on Increase in Auto Accidents

Alex Begum on Increase in Auto Accidents

 

Alex Begum on Increase in Auto Accidents

Alex Begum on Increase in Auto Accidents

08/28/2012 – Alex Begum Speaks out on the increase in the rate of auto accidents, there has been a rapid increase in the number of road accidents.

Alexander Begum of  Begum Law Firm recently spoke out on the increase in the number of auto accidents in Texas and the United States in general. He attributes the increase in auto accidents largely to the obvious factor that more and more drivers are present on U.S. Roads each year as the population of the country continues to expand.

Although numerous new driving related laws are passed at the state, federal and county level each year, these new laws do not seem to be sufficient to stem the tide of the increased number of accidents occurring on our roads each year. These accidents often leave drivers and passengers with severe and are also causing a rise in the cost of auto insurance. This rise in the cost of auto insurance could lead to more and more drivers operating vehicles illegally without insurance in place. The Texas Legal Group, where Alex Begum is a partner, often faces situations where clients are injured however, the driver at fault has no insurance nor any way to compensate the injured parties for the medical bills, pain and suffering and other expenses related to an auto accident.

Better driver education of young drivers is one thing that Alex Begum suggests might help to stem the tide of increased auto accidents we are seeing nationwide. Alex Begum notes in his comments that this simple partial solution might not be easy to implement. Alex Begum notes that it goes without saying that increased driver education for young drivers would come at a cost and the funding for this increased education would likely fall on the shoulders of the tax payers.

Alexander Begum is a partner in The Texas Legal Group and practices personal injury law in Texas. In the course of his practice Alex Begum sees victims of auto accidents, many of which he believes could be avoided if young drivers were better educated before being given drivers license. The driving habits that young drivers start out with are likely to be the habits that they maintain throughout their lifetime. Alex also notes that the driving habits of parents can have a major influence on the driving habits their children will develop. As children grow up riding with their parents, they are exposed to their parents driving habits. If parents driving habits are unsafe then in all likelihood this will influence the driving habits of their children once their children reach the age where they become drivers themselves.

FDA GranuFlo Recall

FDA GranFlo Recall

FDA GranFlo Recall

08/27/2012 – GranuFlo Recall:   A U.S. Food and Drug Administration (FDA) Safety Communication was issued May 25, 2012 to all healthcare professionals using dialysis equipment and prescribing dialysate concentrates, such as the concentrate called GranuFlo.  The purpose of this communication was to remind physicians, dialysis nurses and technicians about  acetate, acetic acid, or citrate levels in dialysate concentrates and the effect they can have when administering  a patient’s dialysate prescription.  On March 29, 2012, a Class I GranuFlo Recall was initiated because this product may cause serious adverse health consequences.

The manufacturer of GranuFlo, Fresenius Medical Care North America, treats about one-third of all Americans receiving dialysis.  It also supplies dialysis products and machines to many clinics in addition to their own.  GranuFlo Recall attorneys are reviewing the following FDA’s reason for the GranuFlo Recall.  Incorrect prescription of this product has the potential for high serum bicarbonate levels in patients undergoing hemodialysis.  This could lead to metabolic alkalosis, a risk associated with low blood pressure, hypoxemia, hypercapnia, hypokalemia and cardiac arrhythmia.  If these issues are not treated promptly and appropriately, cardiopulmonary arrest, or even death, could result.

On November 4, 2011, an internal memo from Fresenius Medical Care was sent out to their Medical Directors and Attending Physicians regarding data suggesting GranuFlo could be associated with elevated bicarbonate levels along with an increased risk of cardiopulmonary arrest and sudden cardiac death.  At the time of this internal memo, these results were only sent to company-owned dialysis treatment centers, not other clinics that operate independently.   In March 2012, Fresenius then communicated the warnings to dialysis clinics not owned or operated by the company.  Because of the information listed above, along with the GranuFlo Recall, dialysis centers are now checking bicarbonate levels and adjusting doses if found necessary.

Recalls, such as the GranuFlo Recall, are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative or by FDA request.  The FDA’s definition of a Class I recall is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death”.   If you have been injured or suffered through the death of a loved one due to the use of Granuflo during your dialysis treatment, let Best Legal Source put you in touch with an experienced GranuFlo Lawsuit attorney today, by calling our helpline at (800) 611-7080 or completing the free evaluation form on this page.