Tag Archives: Failure

Medtronic Infuse Bone Graft Failure Allegation Lawsuits Update: Resource4thePeople Reports New Analysis Findings Raise Issues about Side Effects

Posted on by

San Diego, CA (PRWEB) July 05, 2013

http://www.resource4thepeople.com/defectivemedicaldevices/medtronic.html

&#13

Resource4thePeople, in its latest update to customers impacted by operations involving healthcare devices, these days announced that the findings of a two-year study by Yale University researchers have raised issues about the marketing and advertising and security of Medtronic Infuse bone grafts similar to those integrated in allegations now being reviewed.

&#13

The Yale University study, which was published* June 18, 2013 in the Annals of Internal Medicine, was undertaken as an independent study following the health-related devices were the topic of a Class 1 Recall by the Meals and Drug Administration** and a highly vital report*** from a U.S. Senate committee that raised concerns about conflicts of interest simply because of payments the organization produced to health-related researchers and physicians.

&#13

Studies funded by Medtronic underplayed the advantages of the Infuse bone grafts and failed to report numerous critical side effects, according to both Yale researchers and Senate investigators. The Yale researchers reported such severe side effects as excessive bone development, male sterility, inflammations and paralysis, according to the report.

&#13

The findings of this study are constant with some of the allegations that we have been getting in rising numbers considering that the release of the Senates report, said Resource4thePeople.

&#13

We anticipate that the news of the Yale researchers findings will generate even a lot more inquiries from customers about the legal possibilities they might have to seek compensation and consequently, we will continue to provide totally free legal consultations and overview these claims.

&#13

The Yale researchers had been crucial of prior Medtronic-funded study research which provided endorsements of the safety and effectiveness of the Infuse bone grafts. The Yale researchers help those research had been biased, as did Senate investigators in their report.

&#13

The Yale researchers summarized their findings in comparing the Medtronic Infuse bone graft (rhBMP-2) to conventional therapy by saying:

&#13

In conclusion, we discovered substantial proof of reporting bias and no proof that rhBMP-2 is a lot more effective than ICBG in spinal fusion, with some evidence of an association with crucial harms. Far more study is needed to offer a lot more trustworthy estimates of danger for cancer and other adverse events and to determine patient populations in which use of rhBMP-two could be beneficial, such as circumstances where use of bone graft alone is related with a high danger for pseudarthrosis. On the basis of the currently offered evidence, it is difficult to recognize clear indications for rhBMP-two in spinal fusion.

&#13

Resource4thePeople stated it will also continue to offer normal updates supplying buyers who might have been impacted by remedy with Medtronic Infuse bone grafts with data about research and legal developments involving the devices.

&#13

This will continue to be an region of prime concentrate for us as we provide buyers legal options involving allegations that the Medtronic Infuse Bone Grafts might have caused critical, life-threatening health issues, mentioned Resource4thePeople.

&#13

Amongst the allegations we are investigating are claims from buyers alleging that the Medtronic Infuse Bone Grafts had been utilised improperly in medical operations and caused serious side effects to sufferers.

&#13

Resource4thePeople also mentioned that its national network of attorneys will continue to review claims from customers who are alleging they could have suffered extreme back and leg discomfort, infections, bone deterioration, sterility and cancer, amongst other troubles.

&#13

In the FDAs Feb. 16, 2011 Class 1 Recall** of Medtronic Infuse Bone Graft pumps and refill kits, the FDA warned that the merchandise “may outcome in patient harm, serious injury, and/or death due to drug overdose or underdose.

&#13

Class I recalls are the most severe variety of recall and involve situations in which there is a reasonable probability that use of these merchandise will lead to significant adverse overall health consequences or death.

&#13

Resource4thePeoples legal group is also investigating claims similar to those contained in a federal lawsuit**** filed in March in the Southern District of Ohio against Medtronic Inc. and an Ohio surgeon who, according to complaint, was a paid Medtronic consultant in addition to his professional duties.

&#13

The lawsuit includes allegations that 88 sufferers are claiming that underwent spine surgeries involving bone protein that they did not consent to and have suffered detrimental side effects for which they are searching for compensation.

&#13

The lawsuit claims that “medically unnecessary, experimental spine surgeries” had been performed “using falsely and improperly marketed Medtronic healthcare devices and drugs,” according to allegations contained in the court file.

&#13

Resource4thePeople also stated that the allegations filed in the lawsuit raise far more inquiries about the relationships between physicians and Medtronic over costs paid to the medical doctors that have come beneath criticism from the U.S. Senate Finance Committee investigators.

&#13

The revelations integrated in the Oct. 25, 2012 report by the Senate Finance Committee involving payments to doctors and the downplaying of dangerous side effects from this healthcare device have raised significant questions amongst patients who underwent these surgeries and have contacted us,” mentioned Resource4thePeople.

&#13

Resource4thePeople said that over the final few months such inquiries have enhanced as a outcome of news media reports about the findings of the committees investigation into Medtronics spending of millions of dollars to physicians and researchers in return for studies favorable to the Infuse device.

&#13

The Medtronic Infuse bone graft was approved by the Food and Drug Administration as a sanctioned medical device made to stimulate spinal bone development in individuals suffering from reduce spine degenerative diseases.

&#13

Sources:&#13

*http://annals.org/post.aspx?articleid=1696646&#13

**http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm243634.htm&#13

***http://www.finance.senate.gov/newsroom/chairman/release/?id=b1d112cb-230f-4c2e-ae55-13550074fe86&#13

****Case # 1:13cv0202 U.S. District Court, Southern District of Ohio

&#13
&#13
&#13
&#13
&#13

Much more Administrator Press Releases

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

&#13

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.

&#13

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.

&#13

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.

&#13

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

&#13

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.

&#13

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.

&#13

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.

&#13

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.

&#13

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.

&#13

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.

&#13

Right here is portion of the FDA warning:

&#13

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.

&#13

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.

&#13

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.

&#13

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.**

&#13

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.

&#13

“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.

&#13

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

&#13

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.

&#13

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.

&#13

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.

&#13

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.

&#13

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.

&#13

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

&#13
&#13
&#13
&#13
&#13

Bank of America Below Scrutiny For Failure to Modify Mortgages

Posted on by


Roseville, California (PRWEB) September 08, 2011

The most common story I hear at UFAN from possible consumers is that theyve tried diligently for a loan modification, usually for a years time or much more. They are necessary to send in the same paperwork numerous times. Despite the fact that they contact and confirm that the paperwork was received, a couple of weeks (and sometimes months) later, a bank representative calls back and says it never came. Trying to function with bank loss mitigation is maddening. There is no truer instance, in my opinion, of how a single hand doesnt know what the other is doing.

&#13

A current LA Instances report information how Bank of America and other key banks have been censured by the Obama administration for failing to comply with procedures under the Property Cost-effective Modification Program (HAMP).

&#13

An inquiry, performed by the Treasury Division, identified that the 3 banks needed substantial improvement in properly evaluating borrowers’ incomes a key component of figuring out eligibility for HAMP. Below HAMP, a bank receives monetary incentives from the Federal government in exchange for modification of borrowers mortgages. Bank of America, JPMorgan Chase and Wells Fargo have received millions from the system. According to the above referenced report, funds will no longer be distributed to these banks until the necessary improvements have been implemented in their modification programs.

&#13

The report further states that Bank of America, the nations biggest mortgage servicer, was singled out in the investigation as getting the worst offender. The administration concluded that Bank of America needs to make substantial improvement in identifying and contacting borrowers for the plan, clearly demonstrating how the bank reaches its loan-modification choices and making sure the bank was getting the correct incentive payments by means of the system. These findings coincide with allegations of Bank of Americas other current mortgage related abuses reported in the media.

&#13

UFAN lately filed a multi-party suit against Bank of America in California Superior Court (case number 34-2011-0019314), alleging, among other issues, that the bank engaged in misconduct in its mortgage modification procedures. Court documents allege that the lead Plaintiff in the case was told to stop generating mortgage payments in order to be considered for a loan modification. She did so, according to the filing, but kept cash on hand required to bring the mortgage existing if negotiations proved fruitless. The complaint details how regardless of informing the bank of her willingness to spend, and promises by the bank that it would postpone foreclosure, the bank foreclosed and sold her residence, thereby denying her the proper to remedy the deficiency.

&#13

The Washington Post reported in 2008 on a settlement, spearheaded by then California Lawyer Common Jerry Brown, in between Bank of America and 12 State Attorneys Common Bank whereby the bank promised that it would modify mortgages of its distressed borrowers that had been placed in negative loans. But, Bank of America is now below investigation, as reported by media sources, by all 50 state attorneys basic for allegations of reneging on these past promises, as nicely a host of other deficiencies in its mortgage practices.

&#13

Even though HAMP was designed to market modification of 3-four million mortgages, as of Might 2011, only 731,451 borrowers had received permanent loan modifications via the program, the Huffington Post reports.

&#13

Complementary consultations offered.

&#13

By: Kristin Crone, Esq., UFAN Legal Group, Computer dba United Foreclosure Lawyer Network (UFAN)

&#13

ABOUT THE UNITED FORECLOSURE Lawyer NETWORK

&#13

United Foreclosure Attorney Network (UFAN) is a Roseville, California-based law firm delivering mortgage related legal solutions. The devoted attorneys and staff at UFAN operate tirelessly to seek and fight for the rights of American property owners. For much more information call toll totally free 1-866-400-4242.

&#13

This release could constitute attorney advertisement. The data in this release and on the United Foreclosure Lawyer Network (TheUFAN.com) site is for basic details purposes only. Absolutely nothing in this release or on the United Foreclosure Attorney Network (TheUFAN.com) site should be taken as legal advice. Prior successes are no guarantee of future performance. Litigation is inherently uncertain and results in litigation are never ever assured.

&#13

###

&#13
&#13
&#13
&#13
&#13

Connected Loan Modification Services Press Releases