Tag Archives: Allegations

Fresenius NaturaLyte, GranuFlo Dialysis Heart Attack Lawsuit Allegations Update: FDA Cites Dialysis Center over Deficiencies as Much more Situations Filed

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San Diego, CA (PRWEB) June 27, 2013

http://www.resource4thepeople.com/defectivemedicaldevices/Dialysis-Lawsuit.html

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Resource4thePeople reports nowadays on its most current update to shoppers who are following the litigation involving allegations that Fresenius NaturaLyte and GranuFlo kidney dialysis products brought on life-threatening troubles for individuals.

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The most current news is that as a federal judge moves forward on consolidated federal lawsuits* involving these allegations a search of U.S. Food and Drug Administration records shows that Fresenius was cited** by federal regulators more than deficiencies uncovered at 1 of the companys facilities.

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In a warning letter dated March 13, 2013, FDA officials informed Fresenius Health-related Care officials that dialyzers manufactured at the companys Ogden, Utah plant are not in conformity with existing federal good manufacturing requirements.

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The FDAs warning letter additional calls into query the good quality of goods that Fresenius is producing for kidney individuals and comes at a time when the federal court method has consolidated situations from across the nation containing allegations that GranuFlo and NaturaLyte allegedly have life-threatening side effects, stated Resource4thePeople.

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We will continue to supply updates for shoppers who may possibly have been impacted by these dialysis goods and will report on the progress of the federal consolidated litigation. We also will continue to offer buyers free consultations about legal rights to which they may be entitled to seek compensation.

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At least 161 federal NaturaLyte and GranuFlo lawsuits alleging severe heart difficulties and deaths from the use of these merchandise have been consolidated ahead of U.S. District Court Judge Douglas P. Woodlock, according to the court docket.*

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The court filings also summarize the particular allegations involved that plaintiffs who used NaturaLyte and GranuFlo claim they must be compensated for:

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These actions share factual troubles arising from allegations that Plaintiffs suffered injury or death brought on by the use of GranuFlo and/or NaturaLyte products in the course of hemodialysis, which allegedly might cause metabolic alkalosis in sufferers resulting in low blood stress, hypokalemia, hypoxemia, hypercapnia, cardiac arrhythmia, or cardiopulmonary arrest.

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All the actions involve factual concerns relating to whether or not GranuFlo and NaturaLyte were defectively developed or manufactured, no matter whether Fresenius, the manufacturer of these dialysate goods, knew or ought to have known of the alleged propensity of these merchandise to result in injury and whether or not it supplied adequate directions and warnings with these goods.

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Resource4thePeople, in response to inquiries from consumers, is informing them that even although this multidistrict litigation has been produced new inquiries will nevertheless be accepted and further circumstances will continue to be filed.

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Amongst numerous new situations that have been not too long ago filed are those by:&#13

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New Bard IVC Filter Failure Lawsuit Allegations Update: Resource4thePeople Adds More Personnel to Handle Consultations with Customers

Posted on by

San Diego, CA (PRWEB) July 01, 2013

http://www.resource4thepeople.com/defectivemedicaldevices/bard-ivc.html

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Resource4thePeople announced these days that it has expanded its legal resources delivering customers with totally free consultations about the possibility of searching for compensation over alleged side effects from Bard IVC filters.

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It has turn out to be required to add personnel in order to adequately address the needs of customers who are inquiring about their legal rights in connection with allegations that Bard IVC filters failed, mentioned Resource4thePeople.

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We are committed to supplying seasoned, aggressive legal representation for buyers who meet the legal standards involved in filing claims or lawsuits more than these allegations. Any shoppers who have questions about their eligibility in such instances ought to get in touch with us immediately to preserve all of their legal options.

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Resource4thePeople said the improved volume of inquiries can be partially attributed to a lately developed info bank on the organizations net website.

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This details is delivering updated details about litigation involving claims that patients who have had Bard IVC Filters implanted in their bodies have suffered alleged severe side effects.

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A lot of customers in search of details about these allegations have been unaware of the Food and Drug Administrations overall health advisory to physicians and consumers about issues raised by the agency in connection with the use of Inferior Vena Cava (IVC) filters, mentioned Resource4thePeople.

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That is 1 of the factors we posted the FDAs Aug. 9, 2010 wellness advisory* in the information bank and it has generated a substantial enhance in the quantity of inquiries our employees has been getting.

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Resource4thePeople said that in addition to adding extra personnel to manage consumer inquiries, the Bard IVC filters litigation page will continue to be updated with news as this litigation proceeds.

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The web site also contains info about totally free consultations from our national network of attorneys that are getting supplied to shoppers who want to know just what legal rights for which they could be eligible.

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The side effects getting investigated by Resource4thePeople attorneys are these outlined in the overall health warning by the FDA, like lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.

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Right here is portion of the FDA warning:

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Because 2005, the FDA has received 921 device adverse occasion reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device elements), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in individuals. These kinds of events could be related to a retrievable filter remaining in the body for lengthy periods of time, beyond the time when the danger of pulmonary embolism (PE) has subsided.

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The FDA is concerned that these retrievable IVC filters, intended for brief-term placement, are not often removed when a individuals risk for PE subsides. Recognized extended term risks related with IVC filters contain but are not restricted to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.

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FDA reviewed the literature and is conducting quantitative choice evaluation modeling to evaluate the adjust in the danger/advantage profile after retrievable IVC filter implantation more than time. A lot more details about FDAs choice evaluation model such as threat/benefit implantation timeframe recommendations will be made offered in an update to this communication as nicely as in a future publication in a peer-reviewed medical journal.

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The most current lawsuit update from Resource4thePeople involves the filing of a Bard IVC Filter lawsuit by a New York woman who is claiming in her lawsuit that the device was defectively created, broke and brought on her to endure considerable internal injuries.**

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The lady, in her lawsuit, stated the filter was implanted to avoid blood clots but the device broke apart with particles migrating by means of her body and damaging her internal organs.

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“These allegations mirror the complaints that our national team of lawyers has been receiving inquiries about and we will continue to investigate these claims on behalf of the customers that are contacting us,” mentioned Resource4thePeople.

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Resource4thePeople also notes that a respected health-related group has responded*** to concerns about the safety of IVC filters.

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A professional peer group health-related assessment is getting launched by The Society of Interventional Radiology and Society for Vascular Surgery, which announced Feb. 13, 2013 that it will type a task force to measure the well being danger of IVC filters to individuals.

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IVC filters are medical devices created to avert blood clots in sufferers at threat for a pulmonary embolism in circumstances in which an anticoagulant is contraindicated or proven ineffective.

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The FDA’s overall health warning issued to health care specialists and customers reports that critical well being problems can occur on these spider-like devices when the legs that extend from it to block clots break off.

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What can then occur, according to the FDA is that these broken components from the filter may possibly travel to other components of the body and cause severe problems such as decrease limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.

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Resource4thePeople also notes that one more recent lawsuit*** filed by a patient who had a Bard IVC filters implant alleges the devices are prone to fracture and lead to tears in body organs, such as the heart.&#13

The lawsuit also alleges that C.R. Bard is liable simply because firm officials have been conscious of IVC filters troubles but failed to adequately warn individuals and wellness care specialists. The lawsuit claims that an estimated 100,000 of the devices have been implanted in individuals in the United States.

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Sources:&#13

*http://www.fda.gov/Security/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm221707.htm&#13

**Case # 2:13-cv-2281, U.S. District Court, Eastern District of New York&#13

**http://www.sirweb.org/news/newsPDF/Release_PRESERVE_Final_.pdf&#13

****First Judicial District of Pennsylvania, In the Court of Common Pleas, Philadelphia County Case ID120800814

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United Law Group Senior Managing Lawyer Refutes Allegations of Misconduct in Jacobs Case

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Irvine, CA (Vocus) February 24, 2010

United Law Group’s senior managing attorney Robert Buscho right now released a statement and documentation that counters the allegations produced about the firm. The documents contain the request for information submitted to United Law Group by means of the internet on January 18, 2009, a recording of the message left by a United Law Group representative following up on his request, a recording of the get in touch with exactly where Jacobs retained the firm and was advised that the firm would not inform him to cease producing his month-to-month mortgage payments, and a copy of the trial modification agreement dated March 2, 2009 in which the bank offered to lessen his payments by $ 664 by cutting his rate from 8.2% to five.75% and minimizing his principal by more than $ 50,000.

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Warren Jacobs reached out to United Law Group and requested a call from the firm by means of an on the internet form that he submitted requesting extra information about a forensic loan audit on January 18, 2009, stated Buscho. He was not contacted by a so-named robo-dialer.

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ULG staff documented speaking to Mr. Jacobs eight occasions in between February 1 and March 9, 2009. File notes also indicate correspondence with the lender throughout that time. On March 2, 2009, a mere six weeks right after becoming retained by Mr. Jacobs, ULGs efforts on his behalf resulted in a loan modification provide that lowered his interest price from 8.2% to five.75%, slashed his monthly principal and interest payment from $ 1,511.22 to $ 847.82 and reduce the quantity owed on the note from $ 207,855.35 to $ 156,250.00 a principal reduction of over $ 50,000.

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ULG employees communicated with Mr. Jacobs about the modification on March 9, 2009 and told him to begin producing payments on the new system. He chose not to take the provide and asked if the firm could do greater. He then lost his job a month later and informed the firm that he wanted to delay issues simply because he lost his job.

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United Law Group personnel either spoke to or left messages for Mr. Jacobs numerous occasions between April and May 2009 to talk about his economic predicament and the danger of foreclosure. He failed to return calls to the firm.

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“While Mr. Jacob’s plight may possibly sound like that of many American’s, the reality is that he was not making proper use of a technique that was developed to aid ‘honest’ property owners,” said Buscho.

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The article contends that Jacobs hired an additional lawyer to file bankruptcy on his behalf in June 2009 soon after United Law Group failed to take certain actions to delay foreclosure.

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“United Law Group did not supply to file bankruptcy on Mr. Jacobs’ behalf due to the fact he previously filed a Petition beneath Chapter 7 on April 15, 2003. With no complaint objecting to the discharge getting been timely filed, he received a discharge from the U. S. Bankruptcy, Northern District of Texas, on July 31, 2003,” said Buscho. “In the article, writer Paul Elias states that Mr. Jacobs claims to have filed one more bankruptcy petition in June of 2009. If this was completed, it would be an illegal filing as Mr. Jacobs is not entitled to far more than a single discharge below Chapter 7 inside seven years. He would therefore be an ineligible debtor below Bankruptcy Code

New Zithromax Arrhythmia and Sudden Death Instances Allegations Update: Consumer Data Center Created

Posted on by

San Diego, CA (PRWEB) June 17, 2013

http://www.resource4thepeople.com/defectivedrugs/Zithromax-lawsuits.html

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Resource4thePeople announced right now that it has designed an info center to inform consumers about the newest data involving legal rights more than allegations that the use of the well-known antibiotics Zithromax and Zmax SR (azithromycin) can cause potentially fatal irregular heart rhythms.

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Integrated on the site are hyperlinks to cost-free consultations for shoppers looking for to decide what legal rights they may possibly have to compensation in such situations.

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The website also will contain information from the May, 17, 2012 warning* by the U.S. Food and Drug Administration alerting individuals and physicians of life-threatening side effects from the drugs that might lead to irregular heart rhythms.

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These are serious wellness issues that the FDA has addressed and we will continue to provide valuable information of interest to consumers who may possibly be amongst the millions who have been or are considering getting treated with these antibiotics, said Resource4thePeople.

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The postings on this web site also will include detailed details about who the FDA considers most at danger of suffering these dangerous side effects.

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Right here is the hyperlink to the site:

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http://www.resource4thepeople.com/defectivedrugs/Zithromax-lawsuits.html

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We encourage any person who has been treated with Zithromax or ZmaxSR and suffered an arrhythmia to speak to our nationwide network of attorneys for a complimentary consultation about their allegations, mentioned Resource4thePeople.

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As we await further findings about these drugs our legal group will continue to aggressively monitor these developments and they will be posted on the new details center.

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Resource4thePeople also notes that there could be legal time limits involved in the filing of a Zithromax lawsuit over allegations of serious side effects so buyers are urged to seek a consultation as quickly as attainable.

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Antibiotics are among the most prescribed drugs and azithromycin is most typically selected by physicians to treat a selection of bacterial infections. The medications are most often employed for bronchitis, pneumonia, chest infections, urinary tract and other frequent infections.

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Resource4thePeople also notes that Canadian authorities have joined the FDA in issuing warnings about issues that the use of these antibiotics may possibly trigger abnormal modifications in the electrical activity of the heart.

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The Canadian Broadcasting Firm reported** on May 17, 2013 that Wellness Canada has issued a warning that a “modest absolute improve in the threat of cardiovascular deaths was observed in patients taking azithromycin as compared to those who took no antibiotics and those who took amoxicillin in a current study.”

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The current health warning issued in Canada that follows issues issued by the FDA about Zithromax and the allegations of severe side effects has improved the number of inquiries we are getting about legal rights, stated Resource4thePeople.

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The improve in customer inquiries stems from issues about side effects from the antibiotics 1st issued in the FDA warning and a report published the same day in a respected healthcare journal*** about regardless of whether sufferers who use the medications are at higher threat of suffering cardiac troubles.

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We have now added additional sources to investigate claims of alleged well being troubles caused by the use of the antibiotics sold as Zithromax, the Z-Pak and azithromycin, said Resource4thePeople.

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FDA officials mentioned that they have been created aware of the study*** published in the New England Journal of Medicine in which health-related researchers found a greater percentage of cardiovascular deaths amongst patients treated with azithromycin (Zithromax) than with other antibiotics or no drugs.

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The FDA announced that it is reviewing the findings of this study and said it will inform health care pros and buyers about the outcomes of this assessment following its completion.

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The FDA also passed on this details about the evaluation and updated warnings on the medicines labels about wellness risks:

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Azithromycin belongs to a class of antibacterial drugs named macrolides, which have been related with cardiovascular effects specifically, prolongation of the QT interval. In 2011, FDA reviewed macrolide drug labeling information connected to QT interval prolongation and TdP.

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The WARNINGS AND PRECAUTIONS section of the Zmax drug label (azithromycin extended release for oral suspension) was revised in March 2012 to contain new information relating to risk for QT interval prolongation, which appears to be low.

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The drug labels for clarithromycin and erythromycin also include data about QT interval prolongation in the WARNINGS section. FDA is in the method of updating danger information in the drug labels for further macrolide antibacterial drugs.

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The FDA also suggested that patients who are taking azithromycin must not quit taking their medicine with no speaking to their wellness care professional and that physicians ought to be conscious of the possible for QT interval prolongation and heart arrhythmias when prescribing or administering macrolides.

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In its Security Data Report the FDA also encouraged individuals and overall health care specialists to report adverse events or side effects brought on by the use of these drugs to the agency, said Resource4thePeople.

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Although the FDA is fulfilling its role of monitoring the security of drugs such as Zithromax we are responding to reports from individuals who are in search of data about what their legal rights may be and we are committed to delivering that info on a case-by-case basis.

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The New England Journal of Medicine study incorporated investigation compiled from information accumulated from about 350,000 patients who have been treated with azithromycin more than a 15-year period and concluded that these sufferers have been a single and a half times much more likely to suffer cardiovascular sudden death than sufferers treated with other antibiotics.

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1 of the variables that made Zithromax so well-known was the truth that it could be taken as a 5-day treatment although most other antibiotics are prescribed to be taken more than a ten-day treatment strategy.

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SOURCES: &#13

*http://www.fda.gov/Drugs/DrugSafety/ucm304372.htm&#13

**http://www.cbc.ca/news/well being/story/2013/05/16/azithromycin-heart.html&#13

*** http://www.nejm.org/doi/complete/ten.1056/NEJMoa1003833

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